Operation Manual

OPERATION MANUAL SMART SERVO-VENTILATOR Equipment code: 201050037 HM Registration No.: 10229820088 Manual Code: 204010210_003 Date: (JUNE/2006)

Manual code: 204010210_003

This Operation Manual has the information that is necessary for the proper usage of the SMART servo-ventilator. Manufacturer: K. Takaoka Indstria e Comrcio LTDA Av. Bosque da Sade, 519 So Paulo SP ZIP: 04142-091 Telephone: (55 11) 5586 1000 Fax: (55 11) 5589 7313 Website: www.takaoka.com.br E- mail: kt@takaoka.com.br CGC: 61.489.381/0001-09 I.E.: 103.735.350.115 Suggestions, doubts or complaints: Call Center: (55 11) 5586 1010 Product Registration at the Health Ministry: Technical Name: Pressure and Volume Ventilator Trade Name: SMART servo-ventilator Registration Number at the Health Ministry: 10229820088 Product Classification: NBR IEC-60601-1/97 (1994) & Erratum No. 1 (1997) & Amendment No. 1 (1997) (Electromedical equipment Part 1: General Safety Prescriptions) NBR IEC 60601-2-12/2004 (particular prescriptions for pulmonary ventilation equipment safety in medical use. Equipment Class - Energized Internally). NBR IEC 60601-1-2/1997 (Electromedical Equipment Part 1: General prescriptions for safety Electromagnetic compatibility - Prescriptions and assays); Equipment Class 1 Energized Internally Type B IPX1 Continuous Operation Technician in Charge : Eng. Mauricio Chiaroni CREA: Registration number 5061714921 - 2. Collateral Norm:

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Manual code: 204010210_003

Product Installation Form EQUIPMENT: ______________________________ Code: ________ _____ Serial Number: ___________
DESCRIPTION 1 2 3 4 5 6 7 8 9 10 ACCESSORIES CODE SERIAL NUMBER

INVOICE:

Original K. Takaoka

] YES ____________________ Invoice Number*

] NO ___________________ Representation Name

INSTITUTION: Corporate Name: ____________________________________Tax Payers ID*:________________________ Address: ________________________________________________________________________________ City: __________________________________________State:_________ ZIP: _______________________ Person in charge of the information*:______________________________Position: _____________________ Sector: ________________________Tel*.: __________________ E-mail: ____________________________ (*) Mandatory Fields YOUR OPINION:
1. Was the product delivered punctually, within the period that was agreed on? 2. Did products and accessories match the order? 3. Was the package damaged in any way? 4. Was there any difficulty in installing the equipment? 5. Is (are) the device(s) and accessories working properly? 6. Were there any accessory, tube, and cable connection problems? 7. Were the data, values, product description, amount, and payment conditions on the invoice correct? 8. Mention any possible inconveniences: Yes Yes Yes Yes Yes Yes Yes No No No No No No No

Installation by: _________________________ Date ____/ ____ /_____ Sig.: _____________________ (Technician Name) Representation: ________________________ Data ____/ ____ /_____ Sig.: _____________________ Send this form to Fax (55 11) 5589 8072, or via registered mail to K. Takaoka. ATTENTION: THE WARRANTEE WILL GO INTO EFFECT AS OF THE CONFIRMATION OF THE INFORMATION CONTAINED IN THIS TERM. THIS TERM MUST BE SENT IN NO MORE THAN 30 DAYS, AS SET FORTH IN THE OPERATION MANUAL. If you have any doubts, or for more information, contact: SAC (55 11) 5586 1010

Manual code: 204010210_003

Manual code: 204010210_003

TABLE OF CONTENTS
DEFINITIONS ......................................................................................................................................................................................9 THE COMPANY .................................................................................................................................................................................10 1 2 3 3.1 4 4.1 5 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 6.4 6.5 6.6 INTRODUCTION .....................................................................................................................................................................12 WARNINGS.............................................................................................................................................................................13 GENERAL DESCRI PTION......................................................................................................................................................17 V ENTILATION MONITOR .........................................................................................................................................................19 TECHNICAL SPECIFICATIONS .............................................................................................................................................20 V ENTILATION MONITOR SPECIFICATIONS...............................................................................................................................22 OPERATING PRINCIPLE.......................................................................................................................................................24 FLOW SERVO - VALVES ..........................................................................................................................................................24 ELECTRONIC BLENDER .........................................................................................................................................................25 ELECTROMAGNETIC VALVE....................................................................................................................................................25 FLOW AND VOLUME MEASU REMENT.......................................................................................................................................25 OXYGEN MEASUREMENT......................................................................................................................................................26 V ENTILATION MONITOR PARAMETERS...................................................................................................................................26 CONTROLS AND COMPONENTS.........................................................................................................................................27 LIST OF COMPONENTS..........................................................................................................................................................27 FRONT VIEW ........................................................................................................................................................................28 FRONT CONNECTION PANEL .................................................................................................................................................33 BACK V IEW ..........................................................................................................................................................................34 LEFT- SIDE VIEW ...................................................................................................................................................................36 ELECTRONIC HEATED HUMIDIFIER (OPTIONAL ).......................................................................................................................37 6.6.1 Safety measures for Heated Humidifier 6060 use...................................................................................................37 6.7 EXPIRATORY V ALVE .............................................................................................................................................................38 6.8 DRAINS................................................................................................................................................................................39 6.9 NEBULIZER ( OPTIONAL).........................................................................................................................................................39 6.10 TGI................................................................................................................................................................................40 6.11 BATTERY ........................................................................................................................................................................41 6.12 MOBILE BASE .................................................................................................................................................................42 7 ASSEMBLING AND PREPARING THE VENTILATOR..........................................................................................................43 7.1 V ENTILATOR MOUNTING............................................................................................................................................................43 7.2 SUPPLY ....................................................................................................................................................................................43 7.3 RESPIRATORY CIRCUIT.........................................................................................................................................................44 7.4 FLOW SENSOR.....................................................................................................................................................................46 7.5 O2 SENSOR ..........................................................................................................................................................................47 7.5.1 Calibrating the O 2 sensor before use.......................................................................................................................48 7.5.2 After calibrating the O 2 sensor.................................................................................................................................48 8 8.1 8.2 CONTROL AND MONITORI NG DISPLAY..............................................................................................................................50 START- UP SCREENS.............................................................................................................................................................50 MAIN SCREEN ......................................................................................................................................................................52 8.2.1 Ventilation Parameters ............................................................................................................................................53 6.2.2 Message Line ..........................................................................................................................................................54 8.2.3 Alphanumeric Window.............................................................................................................................................56 8.2.4 Monitor Graphical Window.......................................................................................................................................57 8.3 CONFIGURATION SCREEN .....................................................................................................................................................60 8.3.1 Parameter set-up.....................................................................................................................................................61 8.3.2 Monitoring................................................................................................................................................................62 8.3.3 Alarm Set-up............................................................................................................................................................63 8.4 SETUP PROCEDURE .............................................................................................................................................................63 8.5 A LARM SYSTEM ...................................................................................................................................................................64 9 9.1 9.2 OPERATION ...........................................................................................................................................................................68 INITIAL TESTS AND PROCEDURES...........................................................................................................................................68 SPONTANEOUS AND MANDATORY CYCLES.............................................................................................................................69 9.2.1 Mandatory cycles.....................................................................................................................................................69 9.2.2 Spontaneous cycles ................................................................................................................................................69 9.3 SELECTING V ENTILATION MODES..........................................................................................................................................70 10 VENTILATION MODES ...........................................................................................................................................................71 10.1 VCV V OLUME CONTROLLED V ENTILATION .....................................................................................................................71 10.2 PCV - PRESSURE-CONTROLLED V ENTILATION .................................................................................................................72 10.2.1 PLV - pressure-limited ventilation............................................................................................................................73 10.3 PCV/AV - PRESSURE CONTROL V ENTILATION /A SSURED V OLUME ..................................................................................74 Manual code: 204010210_003

10.4 10.5 10.6 10.7 10.8 11 12 13 14

SIMV/V - SYNCHRONIZED INTERMITTENT MANDATORY V ENTILATION WITH V OLUME CONTROL............................................75 SIMV/P - SYNCHRONIZED INTERMITTENT MANDATORY V ENTILATION WITH PRESSURE CONTROL......................................76 BIPV - SPONTANEOUS VENTILATION WITH TWO PRESSURE LEVELS.................................................................................77 CPAP - CONTINUOUS POSITIVE AIRWAY PRESSURE V ENTILATION ....................................................................................78 PSV - PRESSURE SUPPORT V ENTILATION ........................................................................................................................78

SPECIAL FEATURES.............................................................................................................................................................80 CLEANING AND STERILIZATION .........................................................................................................................................82 MAINTENANCE......................................................................................................................................................................87 MEASUREMENT METHODS ..................................................................................................................................................89 14.1 14.2 14.3 14.4 14.5 14.6 14.7 14.8 V OLUME.........................................................................................................................................................................89 RATE .............................................................................................................................................................................89 I:E RATIO .......................................................................................................................................................................89 INSPIRATORY AND EXPIRATORY TIMES.............................................................................................................................90 MAXIMUM, A VERAGE, PLATEAU , AND PEEP P RESSURE...................................................................................................90 RESISTANCE...................................................................................................................................................................90 COMPLACENCIES............................................................................................................................................................91 INSPIRATORY WORK.......................................................................................................................................................91

15 16 17

SYMBOLS...............................................................................................................................................................................92 EMERGENCY ACTIONS ........................................................................................................................................................97 TERMS OF WARRANTY........................................................................................................................................................98

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DEFINITIONS

Warning
Warns the user about the possibility of injury, death or other serious adverse reactions associated with equipment misuse.

Attention
Warns the user about possible problems with the equipment associated with its misuse, such as equipment malfunction or failure, damage to the equipment or damage to third-party property.

Note:
Emphasizes important information

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THE COMPANY

K. TAKAOKA is a company that for more than 48 years has dedicated its efforts to the hospital equipment industry, always in close cooperation with physicians. Operating mainly in the Anesthesia, Intensive Medicine, Monitoring, and Oxygen Therapy areas, K. TAKAOKA is proud of its leading position in the market and has a wide range of products. With one of its priorities being ongoing investments in the research and development of new ideas and solutions, K. TAKAOKA has distinguished itself through the constant introduction of technological advancements and industrial innovations in its product line, which puts it on par with its main national and international competitors. Using sophisticated equipment, K. TAKAOKA designs and manufactures most of the components for its devices, and this explains the strict quality control they are submitted to. The company is also concerned with supplying all customers with top-quality assistance by means of its Sales and Technical Assistance departments. With representatives throughout Brazil and a firm foothold in the international market, K. TAKAOKA has deserved its customers trust over the years, in its high-quality standards and the great efficiency of its products and services. Vision: Being a global company. Mission: Being the national leader in manufacturing anesthesia, pulmonary ventilator, vital sign monitors, and oxygen therapy devices, contributing to the preservation of life, offering high technology and better service to our clients. Quality Policy: Continually improve our PRODUCTS, SERVICES and PROCESSES, involve our EMPLOYEES and VENDORS, and obtain our CLIENT and SHAREHOLDER satisfaction.

K. TAKAOKA IND. E COM. LTDA. Av. Bosque da Sade, 519 So Paulo SP CEP: 04142-091 Telephone: (55 0xx11) 5586-1000 Fax: (55 0xx11) 5589-7313 E- mail: kt@takaoka.com.br Website: http://www.takaoka.com.br

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Figure 1: SMART servo-ventilator

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INTRODUCTION

The SMART micro-processed servo-ventilator performs mechanical ventilation aimed at providing temporary, complete, or partial gas to the patient, maintaining the appropriate gas exchanges in adult/pediatric/neonate patient respiratory failure. It has an integrated ventilation monitor. The unique modes and features allow Interactive Respiratory Therapy that is appropriate for the needs of neonatal, pediatric or adult patient needs. SMART is one of the K. Takaoka Servo-ventilator family members that brings together high performance ventilation, a daring design and a complete ventilation monitoring. It has a servo valve system that ensures more flow and allows immediate responses in spontaneous ventilation cycles. It has an intelligent flow measurement system that exempts constant care with cleaning and moisture, in addition to digital control with DSP (Digital Signal Processing) technology, which allows more fidelity for the parameters that are set.

It is an intelligent option for those in search of versatility, feature variety, and low cost, without, however, any loss in technology and performance. The device has 8 ventilation modes: VCV/ASSISTED, ASSISTED PCV/PLV (neonatal), PCV/AV, SIMV/V, SIMV/P, BIPV , CPAP, and PSV. It has an apnea-protection system in the modes that demand inspiratory efforts to begin the cycles, with a backup controlled mode. Cycles may be triggered by pressure or flow. In the BIPV mode, by properly setting Inspiratory Time and Frequency (inverse ratio), one can obtain the APRV mode characteristics. The SMART ventilator has inbuilt monitoring with numerical values for Rate, Inspiratory Time, Expiratory Time, I/E Ratio, Inspiratory Flow, Maximum Inspiratory and Plateau Pressure, Expiration Volume, Dynamic and Static Compliance, Airway Resistance, Tobin Index, P0,1 (Airway Occlusion Pressure), PEEP, and Intrinsic PEEP (Auto PEEP), FiO2. It also has VxP and FxV loop and Pxt, Vxt and Fxt curve display.

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WARNINGS

The Servo-ventilator SMART is a medical device designed to combine the most advanced technology with extreme ease of use. Only professionals who are qualified and trained in its use should operate it. Carefully review the warnings and recommendations provided below. The SMART servo -ventilator is a life-support device, as such, it must only be serviced by authorized K. Takaoka technicians.

Biocompatibility

v According to the ISO 10993-1, the equipment is classified as a device that has no direct and/or indirect contact with the
patients body; therefore it is not included in this norms scope (Clause 4.2.1).

Ventilation

v Once you switch the Ventilator on, enter the patient's ideal weight so the equipment can pre-calculate the appropriate
ventilation parameters.

v For patients 6 kg (newborn and/or premature), the ventilator only has the pressure mode available. v When ventilation is restricted by the inspiratory limit-pressure control in the VCV, SIMV/V, MMV or PSV/AV modes, the value
for the actual volume supplied to the patient must not exceed the value adjusted in the tidal volume control. The message LIMITED PRESSURE indicates this condition in the display.

v After you start ventilation, check that the ventilation parameters as indicated by the monitoring display are properly set. v Make sure all ventilator menu alarm limits have been set properly. v The respiratory pressure is measured within the ventilator; however, the required corrections will be made to represent the
patients maximum pressure.

v To ensure all condensed water within the breathing circuit flows back to the drains and does not reach the patient, the tube
support must be placed near the Y -shaped connector and in a position below the level of the patient's mouth (Support 5.7).

v To prevent accidental gas disconnection or leakage in the breathing circuit, make sure all connections have been tightly secured.
Tightly close the 6060 Heated Humidifier caps threaded lid.

v Check the endotracheal tube connection tightness frequently. v Do not use anti-static or electrically-conductive hoses or tubes. v When the ventilator is in use, an alternative means of ventilation must be available. v If the pneumatic and electric supplies fail, the ventilator will allow spontaneous ventilation at a resistance of 0.45 cmH O/lpm,
2

0.25 cmH2O/lpm, and 0.50 cmH2O/lpm in the 60-, 30-, and 5-lpm flows, respectively.

Assembly

v Closely follow the mounting instructions provided in the explanatory pamphlet provided with the equipment and also guide
yourself using Chapter 8 Ventilator Mounting and Preparation.

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Flow Sensor

v Attach the proper type of flow sensor requested by ventilator during its startup. This will be the most suitable type for the
selected weight of the patient (adult or pediatric).

v Check the correct flow sensor assembly position in the respiratory system. v Only use the flow sensor K. TAKAOKA supplies for the SMART Servo-ventilator. v The SMART servo-ventilator is equipped with a rinse flow system in the flow sensor tubes aiming at avoiding liquid and
secretion accumulation in the sensor tubes.

v During ventilator use, check the flow sensors cleanliness as often as the physician in charge stipulates based on the patients state. v When changing any parameter or mode, check flow sensor and line cleanliness.
Power Supply and Internal Battery

v Only attach the power cord to an outlet that is properly grounded and approved for hospital use. The female tap should be
a 3-pin Nema 5-15P type outlet (item 7.2).

v Keep the internal battery charged at all times so the ventilator keeps working even when the power mains fails. To do this, the
ventilator must be connected to the power mains , even when it is switched off.

v Recharge the battery after using the ventilator with no power supply so it is ready for the next use. v Fully recharge the battery when the ventilator is left unused and disconnected from the power mains for more than
20 (twenty) days.

v The heated humidifier is not supplied by the ventilators internal battery or by the 12-VDC inlet. v If the ventilators internal battery is powering it and the low battery alarm goes off, the ventilator must be connected to the
mains immediately.

v If the battery LED is on, urgent action is required to reestablish the ventilator's inlet voltage. This condition indicates an
imminent risk of total failure in the ventilator.

v The auxiliary outlet is only used to connect the heated humidifier. v Connecting another device to the backup network outlet when the safety ground conductor is damaged may increase the
leakage current through the patient to amounts that exceed the limits allowed.

v The ventilator should be operated using the internal power supply when there is any doubt as to the reliability of the safety
ground conductor installation.

v The detachable power cable should be attached with a strap to prevent accidental disconnection.

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Miscellaneous

v The Ventilator must undergo an annual inspection by an authorized K. TAKAOKA technician to be re-calibrated. Not complying
with this recommendation implies in the loss of guarantee and exempts K. TAKAOKA from the legal responsibilities resulting from technical failures the equipment may present.

v Do not use the ventilator if the automatic test indicates any irregularity (item 6.1). Solve the detected problem. v Make sure the ventilator is set-up properly and that the alarms have been adjusted correctly before using the device. v While the ventilator is on STAND BY (and the flow sensor is connected between the Y connector and the patient), the patient will
continue being monitored and all alarms will be silent, except for the out-of-operation alarm that indicates the STAND BY condition.

v When filling the Nebulizer's container, do not exceed the reservoir's maximum medication capacity. v Do not press any key using surgical instruments or tools. Only use your fingertips to press the keys. Hard or sharp objects may
damage them.

v The SMART Servo-ventilator is not approved for use with flammable anesthetic agents. v Set up an appropriate cleaning and sterilization routine for the ventilators components (Chapter 11). v Continuously watch if the inhalation pressure gauge indicates the proper values. v Keep the patient under constant observation. Frequently watch the patient's pulmonary expansion and free exhalation. v The parts that are used are defibrillation-proof, except for the temperature sensor cable, which must be removed from the
working area (as it might cause burns to the patient) when the defibrillator is used near the ventilator.

v All parts used in the Ventilator are made of inert, non-toxic material that does not cause irritation or allergic reaction in the patient. v All device parts that had contact with any fluids originating from patients (e.g.: breathing circuit, flow sensor, expiratory valve
diaphragm, etc.) may be potentially contaminated after use. Known as semi-critical, they must undergo a high-level disinfection or sterilization before being discarded (at the end of their service lives) or otherwise be discarded as potentially infected hospital waste.

v Read this Operation Manual very carefully in order to use the equipment properly and to take full advantage of all of its features. v Read the Operation Manual for the Heated Humidifier 6060. v Any repair that may be required for the ventilator should only be performed by K. TAKAOKAS specialized and authorized technicians. v The operation of this equipment is not affected by the nearby use of other equipment such as high-frequency surgical
equipment (diathermy), defibrillators or short-wave therapy equipment. Electromagnetic compatibility assays have been performed by an accredited laboratory.

v This

equipment does not emit electromagnetic waves that may interfere with the operation of nearby equipment.

Electromagnetic compatibility assays have been performed by an accredited laboratory.

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v In this manual and on the ventilator, the pressure unit is shown in water centimeters (cmH O) and not in Pascal (Pa),
2

its corresponding unit in the International System (IS). 1 Pa equals 0.0102 cmH2O.

v In

this manual and on the ventilator, respiratory flow is shown in breaths per minute (bpm) and not in Hertz (Hz),

its corresponding unit in the International System (IS). 1 Hz equals 60 bpm.

v In this manual and on the ventilator, the volume unit is shown in milliliters (ml) or liters (l) ,and not in cubic meters (m ),
3

its corresponding unit in the International System (IS). 1 m equals 1 ml or 0,001 l.

-6

v When the equipment and its accessories are delivered, check their integrity. If there is any apparent damage to the equipment
or its accessories, immediately contact a K. TAKAOKA authorized representative since there are different warranty periods for different components, see Chapter 16.

v This product was manufactured according to Good Manufacturing Procedures (GMP), with silicone rubber that complies with
the required for correlates / contact with food goods. During usage, the customer must take the necessary hygiene or sterilization cares, in addition to tests to ensure the product is appropriate and safe for the intended application since the users product usage approaches and c onditions are not within our control.

v The ventilator cannot be covered or used in places that block air circulation in order to keep it from overheating. v The ventilators stability is limited. It must not be transported or used on surfaces with inclinations equal or superior to 5 , as
o

this may cause the device to topple over.

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GENERAL DESCRIPTION

The SMART Servo-ventilator is an electronic respirator designed for intensive therapy respiratory failure applications in the ICU. Due to its several ventilation modes, this equipment may be applied to a broad range of medical procedures. The ventilator can be applied to all kinds of patients, from premature to adults. The Table below shows the ventilation modes available in the SMART Servo-ventilator. The m odes requiring the patient's inspiratory effort to trigger respiration rely on a safety system against apnea with automatic switch to another backup mode. This feature provides increased safety for the patient. Adjusted mode 1. VCV PCV PLV PCV/AV SIMV/V SIMV/P BIPV CPAP

Description

Apnea Ventilation (Backup)

Volume-Controlled Ventilation Pressure-Controlled Ventilation Pressure-limited Ventilation Pressure Control Ventilation /Assured Volume Synchronized Intermittent Mandatory Ventilation with Volume Control Synchronized Intermittent Mandatory Ventilation with Pressure Control Spontaneous Ventilation with Two Pressure Levels Continuous Positive Airway Pressure Ventilation

Not Applicable

2. 3. 4. 5. 6. 7.

Not Applicable Not Applicable IMV (non-synchronized) IMV (non-synchronized) Not Applicable Unavailable PSV may be used if necessary PCV (adult, pediatric) PLV (neonatal)

8.

PSV

Pressure Support Ventilation

Servo-ventilator SMART has a single display where actual adjustments are made to the ventilation parameters, to the patients breathing mechanic curves and also to the data to monitor ventilation parameters. The display is in liquid crystal and it has high-contrasting lighting for perfect viewing.

Notes:
The SMART Servo-ventilator can only be used with its Ventilation Monitor functions. The Mechanical Ventilation functions must be deactivated by means of the STANDBY control. In this condition, all alarms will be muted, except for the inoperative alarm that indicates a STANDBY state. The operator may change the ventilation parameters, however.

A few other SMART Servo-ventilator features are described below.

v Direct digital controls for the main ventilation parameters, including tidal volume, breathing rate, inspiratory time, inspiratory
pause, pressures, maximum inspiratory flow, etc. There are quick-access keys to adjust ventilation parameters.

v Only active controls are shown in each ventilation mode, following the sequence they should be adjusted in. This feature
provides increased ease and safety when adjusting the Ventilator.

v Changing to any other mode implies the adjustment of each of the active parameters in this mode before it is put into operation. v Digital oxygen concentration control in the air/O
2

mixture supplied to the patient.

v The pressure control is measured directly in cmH 0 to make it easier to set the ventilator.
2

v Electronic endotracheal pressure gauge with graphical view by means of a linear bar display (bar graph). The pressure gauge
shows the last inhalations maximum pressure value during the expiratory phase, allowing better viewing for this parameter. Manual code: 204010210_003 17

v Complete system of audio-visual alarms for ventilation parameters with adjustable limits set by the operator. These alarms can
indicate a number of irregularities during ventilation, which significantly increases therapy safety.

v Audiovisual alarms to detect possible failures of the ventilator's supply systems including oxygen, compressed air, and low
internal battery systems.

v Safety system against apnea in modes requiring the patients inspiratory effort to begin cycles. This system performs the
automatic switch to a different backup mode.

v Barotrauma safety system using an over-pressure valve. v Flow or pressure-assisted cycle triggering. The flow -trigger feature also enables neonatal patients to trigger ventilator cycles. v STANDBY condition activated manually at any time to prevent audible alarms during patient preparation or any other special
event. Except for the inoperative alarm that indicates the STANDBY condition.

v Automatic mode selection for the patient - adult, infant, or neonate - according to his/her weight as entered by the operator
when the Ventilator is switched on (item 6.1).

v Pre-adjustment of the ventilation parameters for WEIGHT, as informed when the ventilator is switched on. v Nebulizer for medication - nebulizer flow is automatically compensated when setting the tidal volume. The Nebulizer is an
optional accessory.

v TGI (Tracheal Gas Insufflation) function available for adult patients in controlled ventilations. v Special inspiratory pause functions for 5 seconds, 100%-oxygen supply for 90 seconds, auto-PEEP measurement and
programmed sigh.

v Electronic manual cycle button. v Main electronic on/off switch. v Electronically controlled expiratory valve eas ily disassembled for internal cleaning and inspection of its diaphragm. v Highly
accurate system to control the inspiratory flow and the air/oxygen mixture by means of two servo-valves controlled electronically.

v Built-in pressure control valves for oxygen and compressed air. v Safety valves to prevent asphyxia and high pressure. v Heated humidifier with electronic temperature control and digital thermometer (optional). v Articulated support arm for corrugated tubes which can be set up on either side of the ventilator, depending on which
side the patient is.

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v Rechargeable
the ventilator.

internal battery for power failure or transportation situations, when the battery will automatically supply

v Electric supply with 100-240 VAC network (automatic commutation) to operate the ventilator and recharge the internal battery.
A 12 VDC inlet enables the ventilator to be supplied by an external battery.

v Internal battery or electric distribution network supply visual indicators. v Ergonomic panel with membrane keyboard and advanced design. v Silent operation. v Front grip allowing for the proper positioning of the SMART Servo-ventilator. v Mobile base with hooks for extensions, transportation handle, and mobile trolley with brakes. v Upper shelf to support electronic monitors.
3.1 Ventilation Monitor
The Ventilation Monitor built into the SMART Servo-ventilator has multiple functions for monitoring the mechanical ventilation. A graphic monitoring display shows numerical values in real time for all measured parameters as well as several options for endotracheal pressure, tidal volume, flow, etc. for a more detailed ventilation analysis. The knowledge of the parameters displayed by the monitor allows for a more comprehensive monitoring of the patient's ventilation. A few other important Ventilation Monitor features are described below.

v Audiovisual alarms for measured parameters with minimum and maximum limits adjustable by the operator. v Flow, volume and inspiratory pressure measurement by means of the flow sensor placed in the respiratory system. The flow
sensor is highly accurate and has a low response time.

v FiO2 Measurement. v Tobin Index and P0.1 measurement. v Inspired/expired tidal volume and volume-per-minute measurement. v Real-time graphs with automatic scale adjustment and image freezing control. v 2-minute alarm silencing key (except for the inoperative alarm activated by the STANDBY key).

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TECHNICAL SPECIFICATIONS

Classification
NBR IEC-60601-1/97 (1994) & Errata No. 1 (1997) & Amendment No. 1 (1997) (Electromedical device Part 1: General Safety Prescriptions) NBR IEC 60601-2-12/2004 (particular prescriptions for pulmonary ventilation equipment safety in medical use. Equipment Class Energized Internally). NBR IEC 60601-1-2/1997 (Electromedical Equipment Part 1: General prescriptions for safety - 2. Collateral Norm: Electromagnetic compatibility - Prescriptions and assays); Equipment Class 1 Energized Internally Type B IPX1 Continuous Operation

Ventilation Modes
1 2. 3. 4. 5. 6. 7. 8. VCV ................................................................................................................................................Volume-Controlled Ventilation PCV ..............................................................................................................................................Pressure-Controlled Ventilation PCV/AV .................................................................................................................Pressure Control Ventilation/Assured Volume SIMV/V.................................................................................synchronized intermittent mandatory ventilation with volume control SIMV/P ...............................................................................pressure-controlled mandatory intermittent-synchronized ventilation BIPV ...................................................................................................................spontaneous ventilation with two pressure levels CPAP............................................................................................................ventilation with continuous positive airway pressure PSV .................................................................................................................................................... pressure support ventilation

2.1 PLV ........................................................................................................................................................pressure-limited ventilation

Ventilation Parameters
Parameter Rate (rpm) Inspiratory time(s) Range 1 to 150 0.10 to 0.70 0.70 to 1.00 1.00 to 5.50 Oxygen concentration (%) Maximum limited pressure (cmH2O) Maximum work pressure (cmH2O) PEEP/CPAP (cm H 2O) Support pressure (cmH2O) Inspiratory pause(s): Tidal volume in adults (ml) Tidal volume for children (ml) Flow (l/min) Sensitivity per Flow (l/min) Sensitivity per Pressure (cm H2O) Sigh (cycles) Patient Weight (kg) 21 to 100 0 to 100 0 to 100 0 to 50 0 to 80 0.1 to 5.5 200 to 1000 1000 to 2000 20 to 300 4 to 120 OFF, 1 to 20 OFF, -1 to -20 OFF, 5 to 100 0.3 to 5.0 5.0 to 20.0 20.0 to 200.0 Volume/weight ratio (ml/kg) Inspiratory time in BIPV (s) 5 to 12 0.01 to 0.70 0.70 to 1.00 1.00 to 9.90 Base flow (l/min) Audible alarm silencer (s) OFF, 4 to 40 120 Resolution 1 0.01 0.05 0.10 1 1 1 1 1 0.1 10 50 10 1 1 1 1 0.1 0.5 1.0 1 0.01 0.05 0.10 1 fixed

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Inspiratory pressure gauge electronic bar graph (cm H2O)

-10 to 100

2.5

Note
Sub-atmospheric pressure is not available in the expiratory phase.

Nebulizer
Capacity for medication....................................................................................................................................................................7 ml Nebulizer flow........................................................................................5 to 10 l/min synchronized with the beginning of the inhalation

TGI
Insufflation flow ....................................................................................5 to 10 l/min synchronized with the beginning of the exhalation

Special Features

v Backup modes in cases of apnea; v Complete alarm system; v Types of curve: squared, decelerated, accelerated and sinusoid; v Differential pressure flow sensor; v Electronic inspiratory pressure manometer with bar graph, on a scale of -10 to 100, 2.5 cmH O resolution and exactness
2

of (2 cmH2O + 4% of the measurement);

v Automatic compensation for breathing circuit compliance; v Electronic on/off switch; v Electronic & synchronized manual inhalation v Pressure regulating valves; v Anti-asphyxia safety valve with resistance between 0.3 and 0.5 (cm H O/lpm); v Electronic overpressure valve fixated at the set limit pressure; v Flow sensor tube rinse flow between 2 and 10 (ml/min).
2

Gas Supply
Gases.........................................................................................................................................................oxygen and compressed air Supply pressure................................................................................................................................... 45 to 150 psi (280 to 1035 kPa) Pressure regulated by the equipment..........................................................................................................................35 PSI (241 kPa) Supply flow........................................................................................................................................................................50 to 70 l/min Threaded connections.................................................................................................................... according to norm NBR12188/2003 Extension/Hose..........................................................................................................................................according to norm ISO 5359

Notes:
The SMART Servo-ventilator is equipped with internal pressure regulation valves, which may be connected directly to the hospital gas network outlet installed as per the norm in effect, ISO 7396. Therefore, it is not recommended to use an external adjustment valve. The gas inlet connections have unidirectional internal valves that ensure reverse gas flow limitation.

Warning
Using a high pressure inlet on the patient may be hazardous for him/her.

Others
Conical connections...................................................................................................................................according to norm ISO 5356 Corrugated tubes........................................................................................................................................according to norm ISO 5367

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Electrical Features
Supply ............................................................................ 100 to 220 VAC with automatic switching, 50/60 Hz, power mains according to the NBR-13534/95 regulation, or 12-VDC 2.2 Ah external battery (ventilator only it does not power the Humidifier) Network connector........................................... Three-pin Nema 5-15P type electrical , where the round central pin is the ground pin. Power mains inlet fuses ...................................................................................................20 - 1,0 A / 250 VAC mm, made out of glass Humidifier inlet fuse..........................................................................................................20 - 2.0 A / 250 VAC mm, made out of glass Internal power source fuse...............................................................................................20 - 3.0 A / 250 VAC mm, made out of glass Power consumed by the Ventilator.............................................................................................................................30 VA (maximum) Power consumed by the Humidifier............................................................................................................................90 VA (maximum) Internal battery...................................................................sealed lead/acid, 12 VDC, 2,2 Ah, and maximum required current of 0.6A. Internal battery autonomy...................................................approximately 120 minutes for an average ventilation condition in VCV, tidal volume=500 ml and respiratory rate = 12 rpm Full battery recharge time................................................................................ approximately 10 hours with the ventilator switched off. Graphic display .............................................................................................high-contrast liquid crystal with a cold cathode light bulb.

Notes:
The internal rechargeable batteries may only be replaced by the authorized K. TAKAOKA Technical Assistance. The internal battery may be tested, turning the ventilator on while disconnected from the power mains and checking the charge indication on the display (Figure 8.21). The hospital's electrical system should be properly grounded and in accordance with the ABNT NBR 13534 norm Electric installations in health assistance establishments - Safety requisites. Failure to comply with this recommendation can result in injury to the patient, operator or damage to the device, in addition to voiding the ventilator warranty.

Dimensions and Weight

Ventilator only With mobile base and accessories Height........................................385 mm............................................................1360 mm Width.........................................372 mm..............................................................390 mm Depth.........................................250 mm..............................................................430 mm Weight..........................................12 kgf................................................................ 29 kgf

Packaging
Individual packaging developed to support transportation and storage at a temperature ranging from -10C to +70C, at atmospheric pressure from 500 to 1060 hPa and at relative humidity from 10% to 100% (non-condensed).

Environmental Use Conditions

Temperature of 10oC to +70oC, atmospheric pressure of 500 to 1060 hPa, and a relative humidity of 10% to 100% (non-condensed).

4.1

Ventilation Monitor Specifications

Parameters measured in ATPD (ambiance temperature and pressure dry)

Parameter Average exhaled tidal volume (ml) Minute volume (I) Respiratory rate (rpm) Maximum inspiratory pressure (cmH2O) Range 100 to 2600 0.1 to 50 1 to 200 -30 to 120 Resolution 5 0.01 1 1 Accuracy (15% or 20 ml) (15% or 0.5 l/min) (1 s -1 or 10%) (2 cm H2O + 4% of the average) (2 cm H2O + 4% of the average) (2 cm H2O + 4% of the average) (2 cm H2O + 4% of the average) 22

Plateau inspiratory pressure (cmH2O)

-30 to 120

End-expiratory pressure (PEEP) (cm H2O)

-30 to 120

Average inspiratory pressure (cmH2O)

-30 to 120

Manual code: 204010210_003

Static pulmonary complacency (Cstat) (ml/cm H2O) Dynamic pulmonary complacency (Cdyn) (ml/cm H2O) Airway resistance (Raw) (cm H2O/l/min) Inspiratory time(s) I:E Ratio FIO2 (%) Intrinsic end-expiratory pressure (ipeep) (cm H2O)

1.00 to 100.00 1.00 to 100.00 1.0 to 100.0 0.01 to 20 6:1 to 1:10 14 to 100 -30 to 120

0.01 0.01 0.1 0.01 0.1 1 1

10% 10% 10% 0.2 s 30% 5% (2 cm H2O + 4% of the average) (2 cm H2O + 4% of the average) 5%

Occlusion pressure (P0.1) (cmH2O) Tobin Index (iT)

-30 to 120 0 to 500

1 1

Notes:
The SMART servo-ventilator only monitors tidal volumes exhaled above 100 ml due to the sensitivity of the flow sensor that is used. The FiO2 monitor complies with norm ISO 7767.

Graph Options
Graph Unit Flow x time ................................................................................................................................................................................l/min x s Pressure x Time ....................................................................................................................................................................cmH2O x s Volume x time ...............................................................................................................................................................................ml x s Flow x Volume......................................................................................................................................................................... l/min x ml Volume x Pressure...............................................................................................................................................................ml x cmH2O

Alarm Setting
Parameter Apnea Time Alarm (s): Audio volume alarm Cell calibration with 21% O2 Cell calibration w ith 100% O2 Low Pressure Alarm (cmH2O) High Pressure Alarm (cmH2O) Low PEEP Alarm (cmH2O) High PEEP Alarm (cmH2O) High Minute Volume Alarm (l) Low Minute Volume Alarm (l) Low Rate Alarm (rpm) High Rate Alarm (rpm) Low FiO2 Alarm (%) High FiO2 Alarm (%) Na does not apply Range OFF, 4 to 60 2 to 10 OFF (do not calibrate) ON (calibrate) OFF (do not calibrate) ON (calibrate) OFF, 1 to 125 OFF, 1 to 125 OFF, 1 to 60 OFF, 1 to 60 OFF, 0.1 to 30.0 OFF, 0.1 to 30.0 OFF, 1 to 180 OFF, 1 to 180 OFF, 15 to 100 OFF, 15 to 100 Resolution 1 1 Na Na 1 1 1 1 0,1 0,1 1 1 1 1

Note:
The SMART servo-ventilator alarm system has the characteristics specified in ISO 9703-1, ISO 9703-2, and ISO 9703-3.

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OPERATING PRINCIPLE

Oxygen (O2) and compressed air flow into the SMART Ventilator down their respective threaded connections. Pressure is reduced by means of a set of regulating valves. Then each gas flows to its corresponding flow control servo-valve, which is controlled electronically in order to supply the exact amount of gas at each instant. The oxygen and compressed air flows are then mixed and supplied to the breathing circuit during the inspiratory phase. During the expiratory phase the amount of flow that is supplied will depend on the ventilation mode selected and the parameters adjusted in the equipment. Inspiratory pressure is controlled by means of an electromagnetic valve operating in the respiratory circuit, which is run by an electronic microprocessed system.

Re-supply

Figure 5.1: Ventilator operating principle

5.1

Flow Servo-valves

The flow servo-valve converts the current signal to flow when pressurized gas is present in the inlet. In Figure 5.2, one can see that by maintaining the current in the valve at zero, the outlet flow is also zero, since its regular position is NORMALLY CLOSED (NC). The valve is kept closed by a calibrated s pring, which exerts sufficient pressure for the needle to keep the gas supply closed. When a current flows over the needle, it compresses the spring, which allows the gas to move from the inlet to the outlet. This flow servo-valve is also called the Proportional Valve since the gas flow is directly proportional to the current applied.

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I=0
5.2
flow desired.

I>0

Figure 5.2: Flow servo-valves (I = tidal)

Electronic Blender

Gas mixture is controlled electronically by means of two servo-valves to which currents are applied in direct proportion to the total

ITotal Flow = I O2 + IAir

5.3 Electromagnetic valve

Figure 5.3 shows a cross-section of the electromagnetic valve construction, the operating principles which are very simple and safe. The diaphragm controls the flow passage and isolates the inner part of the valve to prevent contamination. A pin that moves along with the mobile coil that moves inside a magnet performs diaphragm control. The diaphragm closing force is dependent on the electric current applied to the coil and it is electronically controlled by means of a feedback system.

Figure 5.3: Electromagnetic valve.

5.4

Flow and volume measurement

The SMART Servo-ventilator has two flow sensors to measure the flow and volume of gases. One is internal and the other is external, being attached to the respiratory system. An adapter with two conical connections composes each differential pressure flow sensor. There is a resistance to flow passage in it (Figure 5.4). Two lateral tubes lead the inlet and outlet pressure signals from the flow sensor to a differential pressure transducer located inside the ventilator cabinet. The value of the inhaled or exhaled flow is measured at each instant in terms of the pressure difference through the sensor. The flow sensor also detects the Ventilators cycling instants. Knowing the amount of flow at each instant allows the tidal volumes being inhaled and exhaled to be calculated by flow data integration over the time. This data integration is performed by a microprocessor.

Figure 5.4: Flow sensor. (?P = pressure variation)

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5.5

Oxygen Measurement

The Oxygen Analyzer that is built into the SMART Servo-ventilator (Figure 5.5) measures the percentage of Oxygen in the gas mixture that is in contact with the sensor. The O2 sensor incorporates a galvanic cell with an electrode system that, via electrochemical reactions, supplies a voltage signal to the SMART Servo-ventilator electronic circuit that is proportional to the Oxygen concentration in the mixture. The microprocessor analyzes this signal, and it is then converted into a digital value indicating the Oxygen volume percentage.

1 O2 Sensor 2 Cable 3 Connector

Figure 5.5: Oxygen Analyzer.

5.6

Ventilation Monitor Parameters

The definitions for some parameters measured by the Ventilation Monitor are shown below. The formulae are in Chapter 14: Airway resistance (Johnson Method) : Pressure at the end of the inhalation - PEEP/ maximum exhaled flow Static pulmonary compliance: Inhaled tidal volume / (plateau pressure - PEEP) Dynamic pulmonary compliance: Inhaled tidal volume / (peak pressure - PEEP) Inspiratory work: Pressure integral during inhalation, in volume P0.1 (airway occlusion pressure): Inhalation pressure after 100 milliseconds of the occlusion Tobin index: Spontaneous breaths/minute/liters

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CONTROLS AND COMPONENTS

6.1 List of Components

The following components are provided with the SMART Servoventilator, and are to be used solely with it: Code 202010588 202011542 203100149 202011182 202012068 202010614 201050003 202010612 202011152 202012085 203060031 204010210 Item Complete silicone adult breathing circuit 1800-mm flow sensor tube Adult flow sensor O2 Extension Air Extension Compressed air filter Heated Humidifier Articulated arm Expiratory valve diaphragm FiO2 Kit Luer lock lid Operation manual Quantity 01 01 01 01 01 01 01 01 01 01 01 01

Code: 202010588

Code: 202011542

Code: 203100149

Code: 202011182

Code: 202012068

Code: 202010614

Code: 201050003

Code: 202010612

Code: 202011152

Code: 202012085

Code: 203060031

Code: 204010210

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Optional items (exclusive use):

202010621 202011153 202011033 202010632 202011938 203100150 Nebulizer for medication Expiratory Valve Block Complete silicone respiratory circuit - pediatric Complete silicone respiratory circuit - neonatal O2 filter Pediatric flow sensor 01 01 01 01 01

Code: 202010621

Code: 202011153

Code: 202011033

Code: 202010632

Code: 202011938

Code: 2031000150

Notes:
When you receive the material, if one of the components above is missing or damaged, contact the K. TAKAOKA authorized representative immediately, as there are different warranty periods for the various components. See Chapter 16. To purchase optional or replacement parts, contact the authorized K. TAKAOKA distributor.

K. TAKAOKA has a full range of equipment and optional accessories for Intensive Care. Contact your authorized K. TAKAOKA representative for further information.

6.2

Front View

The items below refer to the front view of the SMART Servo-ventilator (Figures 6.1 and 6.2). 1 Endotracheal Pressure Gauge

Bar graph-type linear manometer indicating endotracheal pressure variations through a horizontal bar ranging from -10 to 100 cmH2O. The pressure gauge continues showing the maximum pressure value of the last inhalation during the expiratory phase allowing this parameter to be better seen. Over and beyond this graphical display, the inspiratory pressure is also indicated digital and graphically in the alphanumerical and graphical windows, respectively, of the ventilator display. 2 Alarm Muting Indicator

If a stop alarm condition is activated by the RESET (3) key, this indicator is continuously lit. 3 Alarm Muting Ke y

By pressing this key when any alarm is triggered, the alarm system will be muted for 2 minutes. The visual RESET indicator (2) will remain on continuously as long as there is a temporary alarm muting condition. Except for the inoperative alarm activated by the STANDBY key. 4 Manual Inhalation Button

This button triggers a new inspiratory phase when quickly pressed. Furthermore, the button is used to activate a few of the SMART Servo-ventilators special functions, as described in Chapter 10. 5 Distribution Network Supply Indicator - Network (green)

As long as the ventilator's power supply is performed through a 100-240 VAC distribution network, this light will remain on. If the mains fail, this light will be turned off.

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Dead Internal Battery Indicator - BATTERY ( red)

Visual indicator for the dead internal battery alarm. When this alarm is activated, the ventilators operation will soon be shut off.

Attention
The Ventilator should be connected to the power mains urgently when the LOW BATTERY alarm goes off.

Ventilator Control and Monitoring Panel

Display and controls to adjust and monitor the ventilation parameters.

Figure 6.1.

Front view SMART Servo-ventilator

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Figure 6.2.

Front view Ventilator Control and Monitoring Panel.

Control and Monitoring Display

Liquid crystal display that centralizes the following functions: Ventilation parameter control, alarm message and graph display, in addition to the display of other information regarding ventilator operation conditions. This displays resources are detailed in Chapter 6 "Control Display." 9 Oxygen Concentration Key

Key to adjust the oxygen concentration of the gases supplied to the patient. When pressed, this key highlights the oxygen concentration value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. Setting is done on a scale ranging from 21 to 100% O2. 10 Inspiratory Pause Key

Key to adjust the inspiratory pause time to provide an inspiratory plateau in the ventilation modes with volume controlled. When pressed, this key highlights the inspiratory time value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is directly performed in seconds.

Note:
The I/E ratio value will be affected by any adjustment made in the inspiratory pause control. After starting ventilation, check if the I/E ratio value, as shown in the alphanumerical screen, is appropriate.

11

Pressure-Assisted Sensitivity Key

Key to set the necessary negative pressure (trigger ) level so the patient can trigger a ventilator cycle. This control is available in all ventilation modes. When pressed, this key highlights the sensitivity value in the display so this numerical value can be set by means of the increase (13) and decrease (19) keys. The adjustment is made directly in cmH2O (negative pressure).

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Notes:
The value adjusted by this control refers to the level of negative pressure below the PEEP value. In a few modes, this control can be deactivated by adjusting it to "- - - -". The triggering of cycles by the patient can be done either by measuring the pressure drop (pressure trigger) or by measuring the inhaled flow (flow trigger) depending on the pressure and flow sensitivities adj usted. Flow sensitivity is adjusted in the menu screen of the control display (item 6.3.1). The condition that will prevail is the first to happen, either pressure trigger or flow trigger. In order to facilitate the correct sensitivity adjustment, an assisted or spontaneous trigger message briefly appears in the control display each time the patient succeeds in triggering a ventilator cycle.

12

Pressure Support Ventilation Key

Key to set the pressure support ventilation used in several ventilation modes. When pressed, this key highlights the pressure support ventilation value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is made directly in cmH2O. 13 Control Display Increase Key

Key that increases the ventilation parameter value (item 6.2.1) highlighted on the display. On the ventilator's setup screen (item 6.3), this key increases the parameter value highlighted in the display. To change the value slowly, press this key intermittently. To change the value quickly, keep this key pressed. 14 1) 2) 3) Control Display Confirmation Key - ENTER After mode selection, using the MODE key (15). After the value adjustment of each ventilation parameter, using the increase (13) and decrease (19) keys. In the set-up screen, keep pressing ENTER successively so the items are highlighted, allowing their individual adjustment.

Key used to confirm the adjustments performed by the operator in ventilator controls. This key should be pressed in the following cases:

If any parameter is not confirmed by the ENTER key within 30 seconds after being changed, it will be reset. 15 Mode Key - MODE

This key selects the ventilation mode from among the following options when weight is 6 kg: VCV, PCV, PCV/AV , SIMV/V, SIMV/P, BIPV, CPAP, and PSV; and for weights 6 kg: PLV, SIMV/P, BIPV, CPAP, and PSV. Press this key repeatedly until the desired mode is highlighted in the control display and then press the ENTER key (14) to confirm the selection. 16 Key to Change the Control Display Screen - MENU

This key puts the ventilators display (8) in the configuration mode. The detailed procedure for performing these adjustments can be found in items 6.3, 6.4, and 6.5. The display returns to the main screen by pressing the MENU key (16). 17 Graph Change Key - GRAPH

Key that changes the graph shown on the graphics screen. The available graph options are described in the item 6.2.4 of this manual. 18 Standby Key - STAND BY

When this key is pressed for 2 seconds, the ventilator enters the STANDBY mode and a message will appear on the display. The ventilator will remain inactive ; however, it will be possible to set the ventilation parameters. To cancel this condition, the operator must press STANDBY again. The STAND BY mode may be used during patient preparation or other special events, when you want to perform the monitoring but do not want the alarms activated.

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Notes:
Patient monitoring will keep operating as long as the ventilator is in the STANDBY mode. However, all alarms will be muted. By activating the STANDBY mode, the SMART Servo-ventilator can only be used with its Ventilation Monitor functions.

19

Control Display Decrement Key

Key that reduces the ventilation parameter value (item 6.2.1) highlighted on the display. On the ventilator's setup screen (item 6.3), this key reduces the parameter value highlighted in the display. To change the value slowly, press this key intermittently. To change the value quickly, keep this key pressed. 20 PEEP/CPAP Key

Key to set the PEEP/CPAP value. When pressed, this key highlights the PEEP/CPAP value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is made directly in cmH2O. In the CPAP mode, this control regulates the continuous positive airway pressure (CPAP). In other modes, this control regulates the positive end-expiratory pressure (PEEP) value. 21 Limit Inspiratory Pressure Key

Key to set the maximum inspiratory pressure limit. When pressed, this key highlights the value for the maximum inspiratory pressure limit in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is made directly in cmH2O.

Note:

In the PCV/PLV, level 2 BIPV and SIMV/P modes, this control regulates the inspiratory pressure value. In the VCV, SIMV/V, and PSV/AV modes, this control acts as a safety limit against barotrauma caused by excessive pressure.

22

Maximum Inspiratory Flow Key

Key to set the maximum flow value during the inspiratory phase. When pressed, this key highlights the Maximum Inspiratory Flow value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is performed directly in liters per minute.

Notes:
In the VCV and SIMV/V modes, the Maximum Inspiratory Flow and the Tidal Volume will determine the inspiratory time. After starting the ventilation, check whether the resulting value for the inspiratory time indicated by the ventilator's display is appropriate. In the controlled modes, the Maximum Inspiratory Flow key is not active, and the maximum inspiratory flow supplied by the equipment during inspiration is FREE, according to the need to keep the pressure set in the ventilator control panel, except for modes available for neonatal patients (weight = 6 kg), where the operator may adjust the flow.

23

Inspiratory Time Key

Key to set the inspiratory time. When pressed, this key highlights the inspiratory time value in the display so that this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is directly performed in seconds.

Notes:
The inspiratory time key is not enabled in the VCV and SIMV/V modes when the inspiratory time results from adjusting other ventilator controls. The I/E ratio value will be affected by any adjustment made in the inspiratory time control. After starting the ventilation, check if the I/E ratio value the ventilator's display indicates is appropriate.

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24

Breathing Rate Key

Key to set the breathing rate. When pressed, this key highlights the rate value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is made directly in breaths per minute.

Notes:
In the VCV and SIMV/V modes, the breathing rate will determine the I/E ratio. After starting ventilation, check whether the I/E ratio indicated by the ventilator's display is adequate. In a few modes, the patient will normally determine the rate, and the adjustment of this control will merely set a backup respiratory rate value.

25

Volume Key

In the VCV, PCV/AV , and SIMV/V modes, this key regulates the desired tidal volume. When pressed, this key highlights the tidal volume value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is directly performed in millimeters.

Attention
When ventilation is being limited by the inspiratory limit pressure (21), the control di splay (8) will show the LIMITED PRESSURE message (in the VCV, SIMV/V, and PSV/AV modes), and the value for the actual tidal volume supplied to the patient will be smaller than the one indicated by this tidal volume control .

6.3

Front Connection Panel

The items below refer to the SMART Servo-ventilator front connection panel (Figure 6.3). 1 Connector for Flow Sensor Tube (Blue)

Inlet for the blue flow sensor tube. The other end of the tube must be attached to the flow sensor nozzle, next to the side of the sensor that has the largest diameter (female). Only use the sensor supplied by TAKAOKA. 2 Connector for Flow Sensor Tube (Transparent)

Inlet for the transparent flow sensor tube. The other end of the tube must be attached to the flow sensor nozzle on the side of the sensor that has the smallest diameter (male). Only use the sensor supplied by TAKAOKA.

Attention
The two tubes must be assembled in the correct position according to the color codes located at the ventilator's connectors. The tubes have different colors for quick identification. See item 7.4 for more information.

Expiratory Valve Block

This block contains the expiratory valve and two conical connectors for the corrugated tubes of the breathing circuit. The expiratory valve controls the inspiratory and expiratory phases. This set can be disassembled for cleaning and sterilization of its diaphragm and must be correctly assembled in accordance with the instructions in item 5.7. 4 Connector for the Nebulizer Tube or the TGI Catheter

Inlet for the medication Nebulizer tube, which is an optional SMART Servo-ventilator accessory. The other end of this tube must be connected to the lower part of the Nebulizer container. Inlet for the TGI catheter. The required catheter for the procedure is not supplied with the equipment.

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2
Figure 6.3.

3
Front connection panel SMART Servo-ventilator.

6.4

Back View

The items listed below refer to the back view of the SMART Servo-ventilator (Figure 6.4).

Attention
Controls (8), (10), (12) and (14) should only be adjusted by technicians who have been trained and authorized by K. TAKAOKA.

Humidifier Outlet Fuses

Compartment with a fuse to protect the electrical parts of the Humidifier 6060. 2 Serial Outlet (Optional)

Serial outlet for ventilator synchronization in the ILV function through the appropriate cable (this item is optional).

Note:
Parts for signal outlet or for signal inlet are only used to connect the device according to Norm NBR IEC 60601-1. The serial cable is not provided with the SMART servo-ventilator, and is an optional accessory. For information on the hardware and software requirements, contact an authorized K. TAKAOKA distributor.

12 VDC Power Tap

Electric socket to supply electricity to the SMART Servo-ventilator by means of an external 12-VDC battery. This is useful for transportation or as an spare source of energy. The Heated Humidifier will not work with this type of power supply. 5 Electric Tap for the Heated Humidifier

Electrical outlet socket for power supply to Heated Humidifier 6060, with voltage and rate equal to the 100 to 240-VAC mains inlet cable. (The Heated Humidifier has an automatic voltage converter). This source only supplies power. See the technical specifications for more information. 6 Inlet Connection - Oxygen

Threaded connection for the oxygen extension tube supplied with the ventilator to attach it to the oxygen gas supply. The oxygen supplys pressure and flow must comply with the technical specification. 7 Pressure Regulating Valve - Oxygen

This valve reduces the oxygen pressure that supplies the ventilator to 45 PSI (310 kPa). 8 Socket for Pressure Calibrator - Oxygen

Tap for the pressure calibrator gauge to measure the pressure value as controlled by the valve (9). It is designed to facilitate the maintenance performed by an authorized K. TAKAOKA technician .

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Pressure Regulating Valve - Oxygen

This valve reduces the oxygen pressure that supplies the ventilator to 35 PSI (241 kPa). 10 Socket for Pressure Calibrator - Oxygen

Tap for the pressure calibrator gauge to measure the pressure value as controlled by the valve (11). It is designed to facilitate the maintenance performed by an authorized K. TAKAOKA technician . 11 Pressure Regulating Valve - Compressed Air

Valve that reduces the oxygen pressure feeding the ventilator to 45 PSI (310 kPa). 12 Pressure Calibrator Socket - Compressed Air

Tap for the pressure calibrator gauge to measure the pressure value as controlled by the valve (13). It is designed to facilitate the maintenance performed by an authorized K. TAKAOKA technician . 13 Pressure Regulating Valve - Compressed Air

Valve that reduces the oxygen pressure feeding the ventilator to 35 PSI (241 kPa). 14 Pressure Calibrator Socket - Compressed Air

Tap for the pressure calibrator gauge to measure the pressure value as controlled by the valve (15). It is designed to facilitate the maintenance performed by an authorized K. TAKAOKA technician . 15 Inlet Connection - Compressed Air

Threaded connection for the compressed air filter supplied with the ventilator. The filter inlet must be attached to this gas power supply by means of the compressed air extension supplied with the equipment. The compressed air supplys pressure and f low must comply with the technical specification. 16 On/Off main switch

Electro-pneumatic key which, when on the OFF position, cuts the gas flow and automatically turns the SMART Servo-ventilator and Heated Humidifiers electric circuits off. When switched to ON, the ventilator and the Heated Humidifier are switched on. 17 Power Cable Inlet - 100-240 VAC

Inlet to attach the Ventilator to a 100 to 240VAC power supply by means of a removable power cable provided with the ventilator. This cable has a 3-pin connector to be coupled to a properly grounded distribution network.

Notes:
The ventilator can be supplied with voltage between 100 and 240VAC as it has automatic voltage conversion. Follow the power supply recommendations described in item 7.2.

18

Ventilator inlet fuse

Compartment with a fuse to protect the ventilators electrical parts. 19 Identification Tag

Tag showing the ventilators model and serial number for identification purposes.

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Figure 6.4.

Back view SMART Servo-ventilator

6.5

Left-side View

The items listed below refer to the SMART Servo-ventilators left side view (Figure 6.5). 1 Audible Device

Outlet for the alarm system's audible signal. 2 Contrast Button for the Control Display

Button to set the ventilators display contrast. This button should be adjusted until you achieve the best screen view. 3 FiO2 Connector

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Figure 6.5.

Left-side view - SMART Servo-ventilator.

6.6 Note:

Electronic Heated Humidifier (optional)

Read the 6060 Heated Humidifier Instruction Manual carefully.

The 6060 Heated Humidifier (Figure 6.6) was designed specifically for use with respiratory circuits. It has an electronic temperature control, a digital thermometer, pilot and electric resistance operation lights, on/off switch, and a transparent chamber with capacity for 400 ml of sterile water. The gas temperature is measured near the patient's mouth by means of an electronic thermometer. The SMART Servo-ventilators on/off switch also switches the Heated Humidifiers power supply on and off. The Heated Humidifier warms and saturates the inspiratory flow that passes through its chamber with water steam. The gases then flow through a path between the chamber outlet and the patient by means of two corrugated tubes supplied with drains. Water condensation commonly forms in the corrugated tube leading to the patient due to the cooling of the gases between the humidifier outlet and the Y-shaped connector. The amount of condensed water in the circuit will increase as the humidifier heating adjustment increases.

6.6.1
1.

Safety measures for Heated Humidifier 6060 use

It is necessary to prevent the water condensed in the circuit from reaching the patient, as it would therefore reach the

patient's lungs. To ensure that all the water condensed in the circuit flows towards the drains, the corrugated tubes should slope up to the patient or be horizontal (Figure 6.7). 2. If the water condensation in the circuit exceeds the allowed limits, decrease the humidifier's heating setting.

The Heated Humidifiers chamber can be easily disassembled for disinfecting since the cap is merely screwed onto the container. When assembling the chamber again, make sure the rubber mounting on the cap is correctly positioned and in perfect condition so no gas leaks during ventilation. Close the cap, fastening it tightly.

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1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Chamber Outlet Connection (Patient) Humidifier Chamber Lid (autoclavable) Humidifier Chamber (autoclavable) Chamber Mounting Clamps Chamber Mounting Button Temperature display Heating Control Pilot Light (Heater On) Heating Light (Power On) Re-supply inlet

Figure 6.6.

Heated Humidifier 6060.

Right

Exp.

Wrong

Insp. Patient Water to patient

Water draining

Heated humidifier

Figure 6.7.

Corrugated tube positioning.

6.7

Expiratory Valve

The expiratory valve is an electro-magnetic valve that sets the SMART Servo-ventilator inspiratory and expiratory phases. During the expiratory phase, the valve is opened to allow the release of exhaled gases. The expiratory valve block is attached to the ventilators front connection panel (item 5.3). This allows the breathing circuit's tubes to be directed to either side of the ventilator depending on which side the patient is. Figure 6.8 shows the cross-section assembly of the components from the expiratory valve block. This block has two conical connections in its body for the corrugated tubes of the breathing circuit. The expiratory valve should be periodically disassembled to disinfect its components and inspect or replace its diaphragm . After each assembly of the exhalation valve, when its diaphragm is correctly placed, switch the ventilator on and perform a testing procedure to check its perfect operation.

Attention
Periodically check the cleanliness and the condition of the expiratory valve diaphragm. In case there is any fissure or other abnormality in this component, replace it with a new one. Periodically check state of the sealing ring (O-ring). The block must be tightly fastened to the ventilators front connection panel so there is no gas leakage.

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DIAPHRAGM O-RING BLOCK

PIN

P ATIENT

NUT HUMIDIFIER

Figure 6.8.

Assembling of the expiratory valve.

6.8

Drains

The SMART Servo-ventilators respiratory circuit has 2 (two) drains to collect the water that accumulates in the corrugated tubes. One drain is for the inspiratory branch and the other for the expiratory branch. Using drains is very important to avoid the problems caused by water accumulation in the breathing circuit. Emptying To empty the drain, simply remove the threaded container and pour the accumulated water. Screw the container back onto the drain afterwards. This operation does not interfere with patient ventilation since the drain closes automatically when the container is removed. Disinfection or Sterilization The drain is easily disassembled for disinfection or sterilization by unscrewing the container and removing the piston mechanism (Figure 6.9).

BODY

PL UNGER

CUP

Figure 6.9.

Breathing circuit drain.

6.9

Nebulizer (optional)

The Nebulizer is an optional accessory of the SMART Servo-ventilator to administer medication to the patient by means of a gas flow that enters the breathing circuit during the inspiratory phase. The Nebulizer's reservoir has a 7-ml medication capacity. The configuration screen of the ventilators control display allows the operator to turn the nebulizer function on or off (item 6.3).

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Another option is to assemble it between the flow sensor and the mask or endotracheal tube (6.10). The nebulizer supply tube should be connected to the respective NEBULIZER connection nozzle located on the front connection panel of the ventilator (item 5.3).

Notes:
The Nebulizer is for use with adult, infant and neonatal patients, although only in some modes. The nebulizer flow is automatically adjusted when the tidal volume is defined. When filling the Nebulizer's container, do not exceed the reservoir's maximum medication capacity. The FiO2 may be influenced while the nebulizer is used. When filling the Nebulizer's container, do not exceed the reservoir's maximum medication capacity.

Attention
Humidifier filters and/or heaters should not be placed after the nebulizer when this resource is in use. These filters may cause a considerable increase in respiratory resistance. Never leave the supply tube connected to the front panel when the nebulizer resource is not being used, even if the reservoir is empty.

Figure 6.10.

Nebulizer assembled between the flow sensor and the patient.

6.10

TGI

TGI (tracheal gas insufflation) is a resource available in the SMART Servo-ventilator to raise the release of CO2 aided by the anatomic dead space cleaning. The TGI runs by means of a flow of fresh gas that is injected in synchronization with the end of the exhalation into the trachea (though a special catheter placed inside the endotracheal tube). This flow is intended to push the anatomical dead space volume out, which is rich in CO2, ensuring that at each inspiratory cycle, the volume supplied to the patient is only formed by fresh gases containing no CO2. The ventilators control display set-up screen allows the operator to turn the TGI function on or off (item 6.3). The TGI catheter must be coupled to the NEBULIZER's nozzle located on the ventilator's front connection panel (item 5.3).

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Notes:
The TGI is intended to be used only in adult patients (weighting 26 kg or more). The TGI feature is available only in controlled modes (VVC, PVC, and PCV/AV). The TGI flow is automatically compensated for during tidal volume determination; thus, the exhaled volume will be slightly bigger than the inhaled volume. The FiO2 may be influenced while the TGI is used. When an auto-peep occurs, the fact that there is now flow equal to zero, indicating the end of the exhalation, will imply in the TGI not being activated.

6.11

Battery

The SMART Servo-ventilator has an internal battery that allows it to keep working even when there is a mains power failure. The SMART Servo-ventilators internal battery can be recharged and is sealed. It need not be removed even when the equipment is not used for extended periods of time.

Autonomy
The ventilators internal battery lifecycle, when fully charged, will depend on the mode that is used and on ventilation parameter adjustments. Example: When fully charged the battery can keep the ventilator working for about 120 minutes under average ventilation conditions.

Charge
When the ventilator is not being supplied by the power mains, the NO POWER MAINS alarm will go off and the battery charge will be shown where the patients weight appears. This allows the battery charge to be followed up on during use. The battery charge may be: Full charge (100%) Partial charge (60% of the total charge):

Final charge (30% of the total charge):

No charge (10% of the total charge):

(will activate the alarm: LOW BATTERY)

Recharging
Fully recharging the battery takes about 10 (ten) hours when the Ventilator is switched off and connected to the power mains. For a longer battery life always keep it fully charged when possible. Constantly discharging the battery will decrease its life span. When there is a failure of the electric mains that supplies the ventilator, it will automatically switch to its internal battery power supply. When the ventilator is being powered by the internal battery, the NO POWER MAINS audiovisual alarm will appear on the display, the (green) power mains LED will go off, showing the ventilator is being powered by the internal battery. When the battery LED (red) turns on, this means its charge has been depleted and the audiovisual alarm for this condition will be LOW BATTERY.

Attention
Keep the internal battery charged at all times. To accomplish this, the ventilator can be kept connected to the mains even when its on/off key is on the OFF position. Recharge the battery after using the ventilator while unconnected from the electric mains. Fully recharge the battery when the ventilator is left unused and disconnected from the power mains for more than 20 (twenty) days. The Heated Humidifier will not work until the ventilator is supplied by its internal battery.

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6.12

Mobile Base

The SMART Servo-ventilators mobile base (Figure 6.11) has four mobile trolleys, with brakes on the front ones to ensure excellent mobility, hooks to support extension tubes, and a handle to help when moving the base. The ventilator is assembled to the top of the mobile base by a set of four screws. The Heated Humidifier is fixed to the front part of the mobile base by means of coupling pins.

1
CICLO

4 3 5 6 7 6

2 3 6

1 Monitor shelf 2 SMART ventilator 3 Ventilator connection panel 4 Handle to position the Ventilator 5 Knob for locomotion 6 Extension support 7 Heated Humidifier fixture 8 Wheel with break

Figure 6.11.

Mobile base.

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ASSEMBLING AND PREPARING THE VENTILATOR

7.1 Ventilator Mounting
1. 2. 3. 4. 5. Mount the column on the ventilator base. Mount the ventilator to the column that has already been mounted on the base. Mount the shelf on the ventilator. Mount the articulated arm on the ventilator. Mount the Heated Humidifier on the ventilator column.

7.2 Supply
1. 2. Initially, make sure the main on/off key located at the rear panel of the SMART Servo-ventilator is on off. Attach the O2 and compressed air inlet connections located at the rear panel of the SMART Servo-ventilator to the

corresponding gas supply sources. Use the extensions provided with the ventilator. Never use the pipeline pressure control valve (on the wall).

Attention
The oxygen and compressed air supply pressures must be in a range between 40 and 150 psi (280 and 1035 kPa). Connect the air filter provided with the equipment between the ventilator's compressed air connection and its respective extension. The compressed air from the supply must be free of humidity, oil, and impurities.

3.

Supply the SMART Servo-ventilator with a distribution network of 100 to 240 VAC by means of the power cable provided

with the equipment or with a 12 VDC 2.2 Ah source (internal battery). 4. Assemble the 6060 Heated Humidifier on the column and supply it with the electric outlet plug located on SMART

Servo-ventilators rear panel. The heated humidifier will only operate if the ventilator is supplied by a distribution network from 240 to 240 VAC (range, resolution, precision). 5. The ventilator has an internal rechargeable battery that allows the equipment to be used temporarily without being connected

to the power mains. In the event of a power failure, the ventilator will shift automatically to its internal battery supply and Ventilation will not be interrupted. The electric supply indicator (5) will blink while the ventilator is being supplied by its internal battery.

Note:
Commuting between the external source (power mains) and the internal one (battery) does not interfere in the ventilators operation.

RECOMMENDATIONS ON POWER SUPPLY (*):

v Only connect the power cord to an outlet that is properly grounded and approved for hospital use and to a power source that
complies with the ABNT NBR 13534 norm - Electric installations in health assistance establishments - Safety requisites. The female three-pin plug must be of the Nema 5-15P type where the round central pin is the ground, as indicated in Figure 7.1.

v Keep the internal battery charged at all times so the ventilator keeps working even when the power mains fails. To do this,
the ventilator must be connected to the power mains , even when it is switched off.

v Recharge the battery after using the ventilator with no electric network supply so it is ready for the next use. v Fully recharge the battery when the ventilator is left unused and disconnected from the power mains for more than 20 (twenty) days. v The Heated Humidifier is not supplied by the ventilators internal battery or by the 12-VDC inlet.

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v If the ventilators internal battery is powering it and the low battery alarm goes off, the ventilator must be connected to the
mains immediately.

v If the equipment is connected to the auxiliary power supply when the ground conductor is faulty, there may be an increase in
the leakage current flowing through the patient that exceeds the amount permitted.

v When installing the ventilator fix the electrical power cable 42902003 with the bracket 203060266 by means of screw
314020013 to the rear panel. (*) Failure to comply with this electrical recommendation can result in injury to the patient, operator or equipment, and it will void the ventilators warranty.

Figure 7.1.

Three-pin Nema 5-15P type electrical plug.

7.3

Respiratory Circuit

The SMART Servo-ventilator is provided with three types of breathing circuits: adult, pediatric, and neonatal. The neonatal circuit has tubes with a reduced diameter, which, therefore, reduce its tolerance for use with the low flow of neonatal and premature patients. The SMART Servo-ventilators breathing circuit is comprised of a set of corrugated tubes, two drains, a Y-shaped connector and a flow sensor with tubes. The drains built into the inspiratory and expiratory branches avoid the accumulation of water in the circuit. 1. 2. 3. Check that the drain containers are empty. Otherwise, empty them (item 5.8). Make sure the expiratory valve block is correctly and tightly coupled to the ventilator's front connection panel (item 5.7). Check that all the breathing circuit components have undergone the correct disinfecting procedures. This includes the

corrugated tubes, connectors, drains, humidifier chamber, etc. 4. 5. For proper 6060 Heated Humidifier assembly and use, read its instruction manual. Place the articulated arm on one of the respective lateral ventilator supports so the corrugated tubes can be fitted properly

(Figure 5.4). The articulated arm can be assembled on either side of the ventilator, according to the side the patient is on. 6. Assemble the SMART Servo-ventilator respiratory circuit according to the diagrams in Figures 7.2, 7.3 and 7.4.

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P ATIENT

VENTILATOR

TEMPERAT U R E SENSOR

WATER COLLECTOR RESPIR ATORY CIRCUIT

HUMIDIFIER

ADUL T
Adult breathing circuit.

Figure 7.2.

P ATIENT

VENTILATOR

WATER COLLECTOR

TEMPER ATURE SENSOR

RESPIR A TOR Y CIRCUIT

HUMIDIFIER
Figure 7.3. Pediatric breathing circuit.

PEDIATRIC

PATIENT

VENTILATOR

WATER COLLECTOR

TEMPERATURE SENSOR

RESPIR ATORY CIRCUIT

NEONAT E

HUMIDIFIER

Figure 7.4.

Neonatal breathing circuit.

7. (item 5.3).

If desired, properly assemble the medication Nebulizer, which is an optional accessory that may be used (item 5.9). The

nebulizer supply tube must be connected to the respective connection nozzle located at the front connection panel of the ventilator

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8.

If the TGI feature (item 5.10) is used, its catheter must be coupled to the nebulizer nozzle located on the ventilator's front

connection panel (item 5.3). 9. 10. Check that the electronic temperature sensor is correctly and firmly connected to the Y-shaped connector of the breathing circuit. The drain containers can be easily emptied without discontinuing ventilation as there is an automatic closing mechanism

in the drain for use when the container is removed. Empty the drains before they are full of water (item 5.8).

Attention
To prevent accidental disconnection or gas leakage in the breathing circuit, make sure all connections are tightly secured. Tightly close the 6060 Heated Humidifier caps threaded lid. To ensure that all water that condenses in the respiratory circuit flows back to the drains and does not reach the patient, the tube support should be placed near the Y-shaped connector and in a position below the level of the patient's mouth (Figure 5.7). Do not use anti -static or electrically-conductive hoses or tubes.

7.4

Flow Sensor

The SMART Servo-ventilator measures the flow, volume and pressure by means of a differential pressure flow sensor. Assemble the flow sensor according to the following procedure. 1. Connect the type of flow sensor requested by the control screen (8) during ventilator start-up. This will be the most

suitable type for the weight of the patient as informed by the operator. The two flow sensor options available are adult and pediatric.

Note:
The pediatric flow sensor is suitable both for neonates and children.

2.

Attach the appropriate flow sensor between the Y -shaped connector of the respiratory circuit and the mask or

endotracheal tube (Figure 7.5). Check correct mounting position.

1. 2. 3. 4. 5. 6. 7.

Headed Humidifier Sensor Connector to anesthetic gas monitor (optional) Flow sensor Flow sensor tube next to the patient (blue) Flow sensor tube next to the Y connector (transparent) Y connector Corrugated tube

Figure 7.5. 3.

Flow sensor assembly.

Connect the two flow sensor tubes to their respective connectors located on the ventilators front connection panel,

checking that the positions are correct (Figure 7.6).

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Blue tube

Transparent tube

Figure 7.6.

Flow sensor tube connection to the ventilator.

Attention
Check the flow sensor and tube color codes to ensure correct positioning. The 15-mm female connection (larger) relates to the patient's side and the 15-mm male connection (smaller) relates to the respiratory system side of the ventilation equipment. The two tubes have different colors for quick identification. When using the ventilator, frequently check flow sensor cleanliness.

7.5

O2 Sensor

The SMART Servo-ventilator measures the FiO2 through an Oxygen Analyzer using an O2 sensor. Follow the procedure bellow to perform this assembly: a) Remove the sensor from its package.

Notes:
When the O 2 Sensor is not being used, it must be stored in a sealed, air-tight package in order to keep it from coming into contact with room air. Such contact causes a reduction in its useful life. Temperatures above 25oC also reduce the sensors useful life.

b) c)

The package must be kept for sensor storage at a later time. Interconnect the O 2 sensor cable connector (Figure 7.7) to its respective housing located on the right side of the SMART Servo-ventilator. Then, connect the O2 sensor (properly cleaned or sterilized) to the other tip of this cable.

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Figure 7.7.

Oxygen Analyzer. 1 O2 Sensor 2 Cable 3 Connector

7.5.1

Calibrating the O2 sensor before use

The O2 sensor must be calibrated at 21% O2 (room air); when it is in use for extended periods of time (2160 hours) also calibrate at 100% O2.

Attention
Calibration request at 21% or 100% O2 implies in an automatic change in the ventilators oxygen concentration, and the return to the desired/set concentration also occurs automatically at the end of the calibration.

a) b) c) d) e)

Press MENU (27), where the first value is highlighted. Press the front panel ENTER key (30) successively until the Cell O2 Cal 21% or 100% is highlighted on the display. Change the status from OFF (do not calibrate) to ON (calibrate). Calibrate the oxygen cell at one concentration at a time. After the calibration, CALIBRATION OK will appear on the lower right portion of the display. When calibration is not achieved, CALIBRATION FAILURE will appear on the lower right portion of the display.

Attention
When calibration is not achieved, check: Oxygen sensor conditions. The cells last about 8640 hours after taken out of their package; Cable conditions; Proper cable connection to the oxygen sensor and ventilator panel.

7.5.2
a)

After calibrating the O 2 sensor

Put the O2 sensor in contact (on the horizontal position) with the gas mixture that must be monitored. The T connector is used for this. It is coupled between the expiratory valve and the corrugated tube on the inspiratory branch (Figure 7.8).

b) c)

Check whether the sensor connection was perfectly sealed, so no gases leak. The ventilator monitoring display will then show the FiO2 concentration in the gas mix.

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Attention
If there is any doubt regarding correct O 2 sensor calibration during use, repeat the calibration procedure.

Expiratory Valve Block

O2 sensor cable

T connector

O2 sensor

Inspiratory branch

Figure 7.8. Correct position of the O2 sensor in the respiratory circuit.

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8
Note:

CONTROL AND MONITORING DISPLAY

The numbers in brackets refer to the numbering in the front view of the SMART Servo-ventilator (Figures 6.1 and 6.2).

The control and monitoring display is located on the SMART Servo -ventilators front panel (8), and may have the following screen options: 1. 2. 3. Start-up screens Main screen Configuration screen

Cycling through screens is performed by pressing the front panels MENU key (16). Returning to the main set-up screen is achieved by pressing the MENU key (16) again.

Attention
When switching the device on, if there is a lack of one of the gases, the equipment will inform the missing gas and continue initializing the system. The device will maintain an audiovisual alarm for 90 seconds informing the missing gas; the alarm will be visual only thereafter. In the lack of O2, the FiO 2 value that will be shown will be 21%, while in the lack of compressed air, its value will be 100%. In the absence of both gases, the following self-test will not be carried out and the message will read self-test FAILURE. In this case, the device will remain inoperable.

8.1

Start-up Screens

As soon as the ventilator is switched on, the control display shows a system start-up screen, indicating the ventilators software release. This information is used for equipment maintenance. This screen prompts the operator to enter the patient's weight in kilograms as well the volume/weight ratio for the tidal volume (from 5 to 12 ml/kg) so the ventilator can pre-calculate the appropriate ventilation parameters (Figure 8.1). The result of the patient's weight times the volume/weight ratio is then shown, representing the pre-calculated tidal volume. Carry out the following procedure to adjust or confirm those parameters: Example: Suppose the operator enters a weight of 50 kg and 10 ml/kg as the volume/weight ratio. The pre-calculated tidal volume will be 500 ml. 1. 2. Use the increase (13) and decrease (19) keys on the control panel to set the value shown in the display. Press the ENTER (14) key to confirm and input the value.

According to patient weight and to flow sensor position (coupled to the Y connector or to the expiratory valve), the ventilator will automatically perform the following functions: (A) It will select the patient's type and mode:

- Weight > 25 kg -- enters the ADULT mode, requesting the adult sensor and the VCV mode. - Weight > 10 kg and = 25 kg -- enters PEDIATRIC mode, requesting the pediatric sensor and the VCV mode. - Weight > 6 kg and = 10 kg -- enters PEDIATRIC mode, requesting the infant sensor and the PCV mode. - Weight = 6 kg -- enters NEONATAL mode, requiring the infant sensor and the PLV mode. In neonatal mode the available modes are: PLV, SIMV/P, BIPV, CPAP, and PSV.

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3
Figure 8.1. Tidal volume calculation screens.

B) The ventilator will then perform a self-test procedure and request the most adequate flow sensor be coupled according the adult or child patients weight (Figure 8.2). Couple the sensor according to the instructions in item 8.4. After the device passes the self -test, it will go to the main screen and start ventilation and monitoring.

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Any system failures detected during the self-test procedure will be indicated by means of alarm messages and an audible alarm. The auto-test procedure takes approximately 30 seconds to be concluded.

Attention
Do not use the SMART Servo-ventilator if the self-test detects any abnormality. Solve the problem before using the equipment.

Figure 8.2. (C)

Screen to release the equipment for use.

It will perform an automatic start-up adjustment for the ventilation parameters.

Attention
The operator must not necessarily consider the automatic ventilation parameter start-up adjustment as a final and ideal adjustment for the patient. Before starting ventilation, be sure to perform an optimal adjustment for each parameter.

8.2

Main Screen

This is the screen that is normally displayed during ventilation, as illustrated in Figure 8.3. The most important functions of the main screen are described below and consist in the adjustment of ventilation parameters, mode indication, operating messages and alarm messages. The main screen is divided into four parts, as explained below (Figure 8.4).

Figure 8.3: Main Screen

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- Ventilation Parameters - Graphic Screen

- Message Line - Alphanumerical Screen

Figure 8.4: Main Screen Division

8.2.1

Ventilation Parameters

The ventilation parameters, as adjusted by the operator, are shown continually in the upper and lower rows of the control display. Next to the display values (below or above) there are identifications of the respective parameters as well as of the quick-access keys for their adjustment (Figure 8.5). Regarding the assisted sensitivity adjustment, there are visual indications showing that pressure sensitivity ( P) and/or flow sensitivity (F) was enabled by the operator. The letter P and/or F appear to the right of the flow sensitivity value, next to the key (11). Flow sensibility may only be adjusted in the set-up screen. Parameter O2 Concentration Inspiratory pause Assisted Sensitivity Support Pressure Mode Tidal Volume Rate Inspiratory Time Inspiratory Flow Limit Pressure PEEP CPAP Unit % seconds cmH2O cmH2O VCV, PCV/PLV, PCV/AV , SIMV/V, SIMV/P, BIPV ,CPAP, PSV. ml breath /min seconds l/min cmH2O cmH2O

Note:
For more information on these ventilation parameters see the description of the respecti ve quick-access adjustment keys in item 5.2 Front View. Chapter 4 Technical Specifications provides the variation ranges for adjusting ventilation parameters.

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Figure 8.5: Ventilation Parameters

6.2.2

Message Line

The message line starts with ADU>, INF> or NEO>. This line shows all alarm messages, operational messages, inspiratory time, inspiratory pause time, expiration time, and I:E ratio (Figure 8.7).

Operating messages
For each mode, the display can show additional messages related to the ventilators operating conditions. These operating messages are described below:

v Ti =

Tp =

Te =

I:E =

Message indicating the inspiratory time (iT), inspiratory pause time (Pt), expiratory time (Et), and I:E ratio during ventilation. To show this message, press any one of the quick access keys on the ventilator control panel and then press ENTER (14).

v LIMITED PRESSURE
Message indicating that, in VCV and SIMV/V modes, ventilation is limited by controlling the inspiratory limit pressure.

Attention
As the LIMITED PRESSURE message is shown in the display, the actual volume supplied to the patient will be smaller than the volume adjusted in the tidal volume control (25).

v ASSISTED -> FLOW TRIGGER

ASSISTED -> PRESSURE TRIGGER ASSISTED -> MANUAL TRIGGER This message appears on the screen briefly each time the patient triggers a ventilator cycle. It also indicates if the trigger was caused by FLOW, PRESSURE or by pressing the MANUAL CYCLE key. This message allows the patients ability to trigger ventilators cycles to be followed-up on visually. Thus, flow and pressure sensitivity controls (11) can be more easily adjusted.

v SPONTANEOUS -> FLOW TRIGGER

SPONTANEOUS -> PRESSURE TRIGGER This message appears briefly on the screen each time the patient initiates a spontaneous respiratory cycle using support pressure. It also indicates whether the sensitivity was by FLOW or PRESSURE.

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v SPONTANEOUS
This message appears briefly on the display each time the patient starts a spontaneous breathing cycle. It also indicates if the trigger was caused by PRESSURE or FLOW.

v WINDOW
This message appears when the ventilator is waiting for the patients inspiratory effort to trigger a new breathing.

v
This message indicates that the 100% O2 for 90 seconds special function is in progress. See Chapter 11 for more information on this special SMART ventilator function.

v AUTO PEEP =
This message indicates the AUTO-PEEP value, as measured by the SMART Servo-ventilator. See Chapter 11 for more information on this special SMART Servo-ventilator function.

v MANUAL EXPIRATORY PAUSE

This message indicates that the ventilator is in the expiratory pause mode for 5 seconds following the expiratory time, to allow the AUTO-PEEP to be measured. See Chapter 11 for more information on this special SMART Servo-ventilator function.

v MANUAL INSPIRATORY PAUSE

This message indicates that the 5-second inspiratory pause special function is in progress. See Chapter 11 for more information on this special SMART Servo-ventilator function.

v CONTROLLED PVC
This message indicates that the ventilator has switched automatically to the backup mode because the patient has stopped breathing spontaneously or is not managing to trigger the v entilator.

v STANDBY
This message indicates that the ventilator is in the standby mode, which is activated by the STANDBY key (18).

v SIGH
This message indicates that the ventilator is in the programmed sigh feature. The alarm messages shown in this line are dealt with later on in this manual, in item 8.5.

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Figure 8.6: Message Line

8.2.3

Alphanumeric Window

The alphanumerical display window on the monitoring display has a vertical row that appears in the right corner of the display. It shows the numerical values of the monitored parameters in real time. Figure 8.7 shows the contents of the alphanumerical display window where the following measured parameters can be read: Parameter Expired Tidal Volume Weight Breathing Rate Maximum Pressure Plateau Pressure FiO2 Unit ml kg rpm cmH2O cmH2O O2%

There is a dynamic drawing of the lung in the alphanumerical window display indicating the inspiratory and expiratory phases. The Setup Screen, item 8.3, shows more monitored parameters.

Figure 8.7: Alphanumeric Window In neonate patients, or, weight = 6 Kg, the alphanumerical window content is changed (Figure 8.8).

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Parameters Expired Tidal Volume Weight Breathing Rate Maximum Pressure Average Pressure FiO2

Units ml kg rpm cmH2O cmH2O O2%

Figure 8.8: Alphanumerical Window - Neonate

8.2.4

Monitor Graphical Window

The monitoring display graphical window is constituted by the displays left central part, showing several curves available in the ventilation mechanics and parameter monitoring in real time. Figure 8.9 shows the contents of the graphical display window, where the following graphics can be observed:

Graphics: Pressure x Time Flow x time Volume x time Volume x Pressure Flow x Volume

Units cmH2O x s l/min x s ml x s ml x cmH2O l/min x ml

Parameters Peep, iT (Tobin Index) and P0.1 (Airway occlusion pressure). iPeep (Intrinsic Peep) in exhalation. -

Cycling through screens is performed, in the sequence described above, by pressing the GRAPH key (17). Only the P x t graph will be shown for neonate patients, i.e., weight = 6 Kg.

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Figure 8.9: Graphics Window. This window can show other graph options, as in the following figures.

Figure 8.10.

1st graph shown: Pressure x Time.

Figure 8.11.

2nd graph shown: Flow x Time

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Figure 8.12.

3rd graph shown: Volume x Time

Figure 8.13.

4th graph shown: Volume x Pressure.

Figure 8.14.

5th graph shown: Flow x Volume.

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Offset verification
The monitoring display allows the offset to be checked as follows: a) b) c) Make sure the monitoring display shows the flow x time curve. After exhalation, check if the graph points match the zero line (horizontal axis) and that the value is equal to In the event of a deviation upward or down ward that prevents the ventilator from adjusting itself automatically in

zero on the upper left corner. approximately 10 cycles, switch the ventilator off and then on again.

Re-set

Attention
During the first 10 minutes after turning the ventilator on, check the proper offset carefully. The offset must be adjusted to zero to ensure correct volume measurement.

8.3

Configuration Screen

The display set-up screen shows a menu to adjust a few of the ventilators operational conditions and alarms and it shows a few of the parameters that are monitored while the set-up is carried out (Figure 8.15), divided into:

v Parameter set-up v Monitor v Alarm set-up

To adjust this set-up screens items, follow the procedure described in item 8.4.

Figure 8.15: Adult setup screen

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8.3.1

Parameter set-up

In the part that involves FUNCTION/ADJUSTMENTS, the first screen column (FUNCTION) shows the item to be adjusted and the second column (ADJUSTMENTS) shows the adjustment options. The following items should be adjusted:

v FLOW TYPE
Selects the type of flow curve during inspiration for mandatory cycles in the VCV and SIMV/V modes. Four options are available: Squared curve (SQUAR) .....................................................the flow is kept under a constant value during inhalation. Accelerated curve (UP) ........................................................the inspiratory flow starts at a low value and increases linearly up to a maximum value during inhalation. Decelerated curve (DOWN) ..................................................the inspiratory flow starts at a maximum value and decreases linearly to a lower value during inhalation. Sinusoid curve (SINU)............................................................the inspiratory flow increases and decreases according to a sinusoid curve.

v BASE FLOW / EXPIRATORY

Sets the flow value that goes through the breathing circuit during the expiratory phase. This flow can be mainly used as a "washing flow" to eliminate CO2 from the breathing circuit during expiration.

Note:
During exhalation, the flow can never be above the value set in the maximum inspiratory flow control (22). The base flow adjustment range varies from 4 to 40l/min.

v TRIGGER FLOW (flow sensitivity)

Sets the flow value the patient must trigger (flow assisted sensitivity) to allow this patient to trigger a ventilator cycle. This control is available in all ventilation modes. Adjustment range = 1 to 30 l/min and turned off in the OFF position (default = OFF).

Note:
Patient cycle triggers can be made by measuring pressure falls and inhaled flows (flow trigger), according to operator-set flow and pressure sensitivities. The condition that occurs first will prevail, either pressure trigger or flow trigger, as indicated in the display.

v NEBUL/TGI
The options for these parameters are: OFF turns the nebulizer and the TGI function off. NEB activates the nebulizer and the flow will be supplied automatically during the inspiratory phases (approximately 7l/min). TGI activates the TGI and the TGI flow will be supplied automatically during the end-expiratory phase (approximately 7 l/min).

v SIGH
The sigh can be programmed to happen at each 5 to 100 cycles or even to not take place (OFF). When the sigh feature is programmed, the ventilator will supply 150% of the tidal volume set at each number of programmed cycles. See Chapter 11 for further information on the special SMART Servo-ventilator functions.

v APNEA
Sets the delay time for apnea alarm triggering. If the patient does not breathe for a period of time above this value, the apnea alarm will sound and the ventilator will switch to backup mode. The APNEA message will start flashing in the message line (8). Default adjustment: 12 seconds.

v AUDIO VOLUME
Sets the volume for the monitors audio signals within a range from 2 to 10. Default adjustment (4).

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8.3.2

Monitoring

The third column (MONITOR) shows a few of the parameters that are monitored while the set-up is performed (Figure 8.16): iVOL..........................Tidal volume inhaled in milliliters. eVOL.........................Tidal volume exhaled in milliliters. FLW ..........................Proximal flow measured near the patients mouth. It is a momentary value measured in liters per minute.
iFLW..........................Internal flow supplied by the ventilator to the breathing circuit. It is a instant value measured in liters per minute.

PAW..........................Airway pressure. It is an instantaneous value, measured in cmH2O. Pmed.........................Average airway pressure. It is an instantaneous value, measured in cmH2O. Cstat/Cdyn Static complacency (Csta), when it has a set inspiratory pause and dynamic complacency (Cdyn) when it doesnt. Measured cycle to cycle in ml/cmH2O. This is not available for neonates (Figure 8.17). Raw ...........................Airway resistance Measured cycle to cycle in cmH2O/ml/min. This is not available for neonates (Figure 8.17). Vmin..........................Volume in liters.

Figure 8.16. Screen setup with SIGH: OFF highlighted.

Figure 8.17: Setup screen for neonate patients (weight = 6 kg) with CAL.O2 21%:OFF highlighted.

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8.3.3

Alarm Set-up

The SMART Servo-ventilator's monitoring display has an audiovisual alarm system for the ventilation parameters, ensuring increased safety during ventilation. This screen allows the adjustment of lower (LOW) and upper (HIGH) limits from the maximum inspiratory pressure, breathing rate, PEEP, volume per minute, and FiO2 alarms. The following items should be adjusted: PRESSURE Sets the limits for high and low maximum inspiratory pressure alarms. PEEP Sets the limits for high and low PEEP (end-expiratory pressure) alarms. VOLUME PER MINUTE Sets the limits for high and low volume per minute alarms. RATE Sets the limits for high and low breathing rate alarms. FiO2 Sets the limits for high and low FiO2 alarms.

Notes:
When the ventilator is switched off, the alarm adjustments are not stored in the memory. When the ventilator is switched on again, the values must be readjusted. The adjustment intervals for each of the parameters above are described in Chapter 4 - "Technical Specifications".

8.4

Setup Procedure

Follow the procedure below to make the desired adjustments to the control display setup screen (item 8.3): 1. 2. 3. 4. 5. Press the MENU key (16) for the setup screen to appear in the display (8). The first value will then be highlighted (Figure 8.18). Press the front panel ENTER key (14) repeatedly until the value to be adjusted is highlighted on the screen. Use the increase (13) and decrease (19) keys on the control panel to adjust each value individually. If the MENU key (16) is not activated, the main screen will be displayed again in 20 seconds . However, the previous values will remain. Pressing the MENU key (16) again returns the operator to the main screen.

Figure 8.18 Screen setup with SIGH: OFF highlighted.

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8.5

Alarm System

The SMART Servo-ventilator has a complete audiovisual alarm system that provides a high level of safety during ventilation. If an alarm condition occurs, the ventilator will show Audible Signs and written messages on the screen to assist the operator in the immediate identification of the factor that caused the alarm. The intensity and intermittency of the alarm condition are directly related to the occurrences level of priority, as specified below.

1. Alarm Priority Levels

The high-priority and active alarms will interrupt the ventilation cycle for safety reasons. Alarm triggering will obey the following priority order: 1. 2. INOPERATIVE STANDBY

High-priority alarms: 3. 4. 5. 6. 7. 8. 9. Low O2 Pressure Low Air Pressure Obstruction (Active) Disconnection Apnea See the line and sensor High Pressure (Active)

10. Low minute volume Medium-priority alarms: 11. Low battery 12. High FiO2 13. Low FiO2 14. Low pressure 15. High minute volume 16. High PEEP 17. Low PEEP 18. High rate 19. Low rate 20. I:E >4:1 21. Power Mains (no audio) 22. PEEP Alert = Limit-pressure (no audio) 23. Inverted I:E Ratio Alert (no audio)*

2. Alarm Priority Level Sound Differentiation

The alarms will have differentiated audible signals and intermittency according to the generating occurrences priority level, always in decreasing order of importance. INOPERANT 1 STANDBY High priority Medium priority
2

Audible, ongoing, independent Intermittent Sound Intermittent Sound Audible, Intermittent 1 signal every 10 s 5 signals every 10 s 3 signals every 25 s

1 2

The inoperative alarm does not show a message on the screen. Inverted Relation and PEEP=Limit Pressure and NO POWER MAINS alarms do not have audible signals. 64

Manual code: 204010210_003

3. Alarm Priority Level Visual Differentiation

The high-priority alarms will present an outline in the alarm text (Figure 8.19) for ready differentiation of the distance of these alarms relative to the medium-priority alarms, the outline of which WILL NOT exist (Figure 8.21). When a high-priority alarm is activated and when the condition that generates this alarm no longer exists, the previous alarm condition will display continuously on the display (Figure 8.21) until the new condition occurs, i.e., the ENTER key is pressed.

Figure 8.19 High-priority alarm: LOW MINUTE VOLUME with outline.

Figure 8.20 High-priority alarm: LOW MINUTE VOLUME without outline indicating the last alarm condition. When more than one alarm-generating condition occurs simultaneously, all will be shown sequentially in the ventilator's display. However, if the medium- and high-priority alarms occur simultaneously, only the high-priority one will be shown and audible. The alarms connected to the SMART Servo-ventilator are:

v VERIF. NETWORK-O2 - FIO2 = 21%

This indicates that there is low pressure in the oxygen system supplying the ventilator. In this condition, the ventilator will only work with compressed air, with the O2 concentration at 21% being shown on the ventilators control panel. When the O2 network is reestablished, the O2 concentration on the control panel must be set to the desired value.

v VERIF. NETWORK-AR - FIO2 = 100%

This indicates that there is low pressure in the compressed air system supplying the ventilator. In this condition, the ventilator will only work with O2, with the O2 concentration at 100% being shown on the ventilators control panel. When the compressed air network is reestablished, the O2 concentration on the control panel must be set to the desired value. When setting the Compressed Air (optional) up, this alarm will also indicate a low pressure condition in its reservoir.

v DISCONNECTION
This indicates that something has been disconnected in the breathing circuit or in the flow sensor tubes.

v APNEA
This indicates that the patient has stopped breathing spontaneously. Immediate action by the operator is required. Depending on the selected mode, the ventilator will switch to the backup mode automatically.

v HIGH PRESSURE
1. This indicates that the actual inspiratory pressure has exceeded the value adjusted in the inspiratory limit pressure control by 5 cmH2O due to some abnormal operating condition. This is an active alarm that will interrupt inhalation automatically to avoid excess pressure. 2. Indicates that the inspiratory pressure exceeded the upper limit value adjusted for the ventilation monitors alarm.

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v LOW PRESSURE
This indicates that the inspiratory pressure is not reaching the lower limit set in the ventilation monitors alarm menu.

v INVERTED RATIO (visual alarm)

This indicates that an inverted ratio condition has occurred in the ventilation and that the inspiratory time is greater than the expiratory time. This alarm is visual only as the operator may want such condition to occur. In volume-controlled modes, the ventilator has a safety system that will block an adjustment that results in an I:E ratio above 4:1.

v I:E >4:1
This indicates an inverted ratio condition in the ventilation greater than 4:1. The inspiratory time is greater or equal to 4 times the expiratory time.

v PEEP=LIMIT PRESSURE (visual alarm)

This indicates a setting condition in which the limit pressure is equal to the PEEP. This alarm is visual only as the operator may want such condition to occur.

v HIGH PEEP
This indicates that the end-expiratory pressure exceeded the upper limit set in the alarm menu of the ventilation monitor.

v LOW PEEP
This indicates that the end-expiratory pressure didnt reach the lower limit set in the alarm menu of the ventilation monitor.

v HIGH VOLUME PER MINUTE

This indicates that the measured volume per minute exceeded the upper limit set in the alarm menu of the ventilation monitor.

v LOW VOLUME PER MINUTE

This indicates that the measured volume per minute didnt reach the lower limit set in the ventilation monitors alarm menu.

v HIGH RATE
This indicates that the measured respiratory rate exceeded the upper limit set in the alarm menu of the ventilation monitor.

v LOW RATE
This indicates that the measured respiratory rate didnt reach the lower limit set in the alarm menu of the ventilation monitor.

v HIGH FiO v LOW FiO

This indicates that the measured FiO2 exceeded the upper limit set in the alarm menu of the ventilation monitor.

This indicates that the measured FiO2 didnt reach the lower limit set in the alarm menu of the ventilation monitor.

v NO POWER MAINS (visual alarm)

This indicates that the internal battery is supplying the ventilator and no energy is coming from the distribution network. It is necessary, therefore, to connect the ventilator to an alternative external power supply before the battery charge runs out (approximately 120 minutes when the battery is fully charged). This alarm is visual only.

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When the NO POWER MAINS alarm is active (Figure 8.21), the place where the patients weight is shown will display the battery charge:

Full charge (100%) Partial charge (60% of the total charge): Final charge (30% of the total charge):

No charge (10% of the total charge): This will allow a battery charge follow -up during use.

(will activate the alarm: LOW BATTERY)

Figure 8.21 High-priority alarm: NO POWER MAINS is the BATTERYs partial charge indication (arrow).

v LOW BATTERY
This indicates that the internal battery charge has been depleted and needs urgent recharging. The word BATTERY (4) represents this alarms the visual indication.

Attention
The ventilator must be connected immediately to the mains when this message appears so the internal battery can be recharged.

v EXPIRATORY OBSTRUCTION
This indicates there was a expiratory valve obstruction. It may have been caused by a bend or an obstruction (secretions) in the expiratory branch or by problems in the expiratory valve diaphragm (assembly, integrity and cleanliness). The detection takes place when, at the end of the exhalation, the pressure that is measured is above or equal to the limit or work pressure that was set, in this case an over-pressure valve is activated allowing exhalation. The maximum time for this alarm to be detected is a respiratory cycle (60 / respiratory rate).

v CHECK SENSOR
This indicates that one of the flow sensors tubes (blue or transparent) is disconnected or obstructed.

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OPERATION

Attention
When using the ventilator, frequently check flow sensor cleanliness. The operator must not consider the automatic adjustment of ventilation parameters, when the ventilator is switched on, as the final and ideal adjustment for the patient. Before starting ventilation, be sure to perform an optimal adjustment for each parameter. For newborn and premature patients, preferentially perform pressure-controlled ventilation.

9.1

Initial tests and procedures

Arrange for a balloon with complacency and resistance values as per IEC60601-2-2-12:2004 Table 101. These testes must be made with this balloon. Connect the ventilator to the gas source and to the power network. Turn the ventilator on and set 50 kg and 10 ml/kg. Disconnect the inlet cable from the distribution network. Observe the lighted network LED, the audiovisual alarm on the display ( NO POWER MAINS) and the appearance of the battery symbol with its respective charge. Re-connect the electricity. Disconnect the main O2 supply and verify the audiovisual alarms (CHECK O2 MAINS SUPPLY). REDE-O2 - FIO2 = 21%). Reconnect O2 supply mains. Disconnect the main O2 supply and verify the audiovisual alarms ( CHECK O2 MAINS SUPPLY). REDE-AR - FIO2 = 100%). Reconnect O2 supply mains. Disconnect the PATIENT trachea connection in the expiratory valve and verify the audible and visual alarms ( DISCONNECTION). Obstruct this trachea in a sterile manner and observe the audible and visual alarm (EXP VALVE OBSTRUCTION) and system depressurization after the limit pressure is reached. Reconnect the trachea. Disconnect one of the flow sensor tubes and note the audiovisual alarm (CHECK SENSOR). Reconnect the flow sensor tube. Se the PEEP value equal to the limit pressure and observe the visual alarm (PEEP = LIMIT PRESSURE). Return the PEEP value to the one that was suggested initially. Set the flow value to the half of the suggested value and observe the visual alarm (INVERTED RATIO). Set the flow value to the half of the previous value and observe the visual alarm (I:E > 4:1 ). Return the flow value to the one that was suggested initially. In the alarm menu, set the LOW PEEP value above the one reached during the inhalation (use the Pxt graph as a reference) and observe the audiovisual alarm (LOW PRESSURE). Return the LOW PRESSURE value to the one that was suggested initially.

In the alarm menu, set the HIGH PRESSURE value above the one reached during the inhalation (use the Pxt graph as a reference) and observe the audiovisual alarm (HIGH PRESSURE). Return the HIGH PRESSURE value to the one that was suggested initially.

In the alarm menu, set the LOW PEEP value above the one reached during the exhalation (use the Pxt graph as a reference) and observe the audiovisual alarm (LOW PEEP ). Return the LOW PEEP value to the one that was suggested initially.

In the alarm menu, set the HIGH PRESSURE value above the one reached during the exhalation (use the Pxt graph as a reference) and observe the audiovisual alarm (HIGH PEEP ). Return the HIGH PEEP value to the one that was suggested initially.

In the alarm menu, set the LOW RATE value above the one that was reached and observe the audiovisual alarm ( LOW RATE). Return the LOW RATE value to the one that was suggested initially.

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In the alarm menu, set the HIGH RATE value above the one that was reached and observe the audiovisual alarm ( HIGH RATE ). Return the HIGH RATE value to the one that was suggested initially. In the alarm menu, se the LOW MIN. VOL. value above that which was reached during the cycles (use the Vmin value in the menu as reference) and observe the audiovisual alarm (LOW MINUTE VOLUME). Return the LOW MIN VOL. value to the one that was suggested initially.

In the alarm menu, se the HIGH MIN. VOL. value above that which was reached during the cycles (use the Vmin value in the menu as reference) and observe the audiovisual alarm (HIGH MINUTE VOLUME). Return the HIGH MIN VOL. value to the one that was suggested initially.

In the alarm menu, calibrate the O2 sensor according to item 7.5.1, assembling it on the circuit as per item 7.5.2. In the alarm menu, set the HIGH FiO2 value below that which is monitored by the sensor (use the main screens HIGH FiO2 value as reference) and observe the audiovisual alarm (HIGH FIO2). Return the HIGH FiO2 value to the one that was suggested initially.

In the alarm menu, set the LOW FiO2 value below that which is monitored by the sensor (use the main screens FiO2 value as ref erence) and observe the audiovisual alarm (LOW FIO2). Return the LOW FiO2 value to the one that was suggested initially.

Change the mode to CPAP, confirming all parameters Stimulate the balloon, and observe whether at the end of the stimulation and as the apnea time goes by the APNEA audiovisual alarm is triggered.

Attention
Do not use the SMART Servo-ventilator if the automatic start-up tests detect any abnormality. Solve the problem before using the equipment.

9.2

Spontaneous and Mandatory Cycles

When using the SMART Servo-ventilator, the respiratory cycles can be classified as mandatory or spontaneous. Combinations of the two make up the several ventilation modes available.

9.2.1

Mandatory cycles

For the mandatory cycles, the operator adjusts the ventilation parameters that will define the inspiratory and expiratory times, the tidal volume, and other variables. The patient, therefore, has no control over what happens during inhalation. There are two types of trigger to begin each inhalation: a) b) Triggered by the Ventilator - the ventilator determines the beginning of each cycle and therefore the respiratory rate, in Triggered by the Patient - the patient determines the beginning of each cycle, and therefore the respiratory rate, by means

accordance with the controls as adjusted by the operator. These cycles are found in the controlled ventilation mode. of inspiratory effort. The level of effort required to trigger the ventilator is determined by the pressure or flow sensitivity controls.

9.2.2

Spontaneous cycles

For spontaneous cycles, the patient plays an active role in what happens during inhalation. There are two types of inhalation available for spontaneous cycles: a) b) Pressure support - during inhalation, pressure is kept at the constant level as adjusted by the operator by means of the Purely spontaneous - the ventilator does not cycle the air and the patient breathes spontaneously as a result of the

pressure support ventilation (12). At each moment, the ventilator supplies the required flow to meet the patients needs. positive pressure maintained in the respiratory circuit by the ventilator. This pressure can be kept at a constant level (CPAP) or can range between two different levels (BIPV ).

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Sensitivity adjustment
The level of effort required for the patient to trigger the ventilator can be determined either by measuring the pressure fall (pressure trigger) or by measuring inspiratory flow (flow trigger) in accordance with the adjusted sensitivities. The condition that will prevail is the first to happen, either pressure trigger or flow trigger. The pressure sensitivity is set by the key (11).

v The flow sensitivity is set in the control display set-up screen. v In order to facilitate the correct sensitivity setting, an assisted or spontaneous trigger message briefly appears in the control
display each time the patient succeeds in triggering a ventilator cycle.

9.3

Selecting Ventilation Modes

To select the ventilation mode, press the MODE key (15) located on the front SMART Servo-ventilator panel. This key allows the selection of the desired mode, by means of the procedure described below, among the following options: VCV, PCV/PLV (neonatal), PCV/AV , SIMV/V, SIMV/P, BIPV , CPAP, and PSV. 1. 2. 3. 4. 5. Press the MODE key (15). Press the MODE key (15) successively until the desired mode appears in the control display (8). Press the ENTER key (14) to confirm the selection made in the previous step. The control display will then enter the ventilation parameters adjustment mode. After adjusting each parameter using the increase (13) and decrease (19) keys, press the ENTER (14). The next

parameter will automatically be placed in adjustment mode until the last parameter is shown.

Active controls
For each ventilation mode selected in the SMART Servo-ventilator, the control display will only show values for the active parameters in the selected mode. The inactive parameter spaces will be filled in with . This feature means that setting the ventilator is an extremely easy, quick and safe procedure.

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10

VENTILATION MODES

The following Table shows the ventilation modes available with the SMART Servo-ventilator. The modes requiring the patient's inspiratory effort to trigger respiration rely on a safety system against apnea with automatic switch to another backup mode. This feature provides increased safety for the patient. Apnea Ventilation (Backup) Not Applicable

Patient Adult, pediatric

Adjusted mode

Description

1.

VCV PCV PLV PCV/AV

Volume-Controlled Ventilation

2.

PCV adult, pediatric PLV - neonatal Adult, pediatric

Pressure-Controlled Ventilation

Not Applicable

3.

Pressure Control Ventilation/Assured Volume Synchronized Intermittent Mandatory Ventilation with Volume Control Synchronized Intermittent Mandatory Ventilation with Pressure Control Spontaneous Ventilation with Two Pressure Levels Continuous Positive Airway Pressure Ventilation Pressure Support Ventilation

Not Applicable

4.

Adult, pediatric

SIMV/V

IMV (non-synchronized)

5.

Adult, pediatric, neonatal

SIMV/P

IMV (non-synchronized)

6.

Adult, pediatric, neonatal

BIPV

Not Applicable Does not have if necessary, use PSV PCV (adult, pediatric) PLV (neonatal)

7.

Adult, pediatric, neonatal

CPAP

8.

Adult, pediatric, neonatal

PSV

Notes:

In the NEONATAL mode (patient weight = 6 kg), the available modes are: PLV, SIMV/P, BIPV, CPAP, and PSV. The change to backup ventilation will occur after the patient stops breathing for a time which is above the time set on the apnea control screen. The apnea alarm will sound at the same time. Mechanical ventilation will start after the last ventilation parameter is set and confirmed on the control panel.

10.1

VCV Volume Controlled Ventilation

In the volume-controlled ventilation (VCV) mode, the ventilator tries to supply the patient with a preset value of tidal volume. There may be two different types of cycles to begin inhaling. Controlled cycles - the patient will be passive and the device totally controls ventilation. The operator adjusts all cycles and the desired value for the tidal volume, performing volume-limited ventilation. The control of inspiratory pressure limit functions as a safety precaution against barotrauma. Assisted cycles - the beginning of each cycle and the respiratory rate is determined by the patient's inspiratory effort, which triggers respiration. If the patient goes into a state of apnea or cannot trigger the equipment because the sensitivity adjustment is very heavy, the ventilator will start supplying mandatory cycles with the rate value regulated in the corresponding control (24). If the patient reacts, then ventilation will automatically return to the assisted cycles. The following ventilation parameters should be adjusted in VCV (in the sequence of the ventilators adjustment mode):

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Attention
After ventilation starts, check that the values resulting from the inspiratory time and the I/E ratio, as indicated by the displays Message Line, as well other ventilation parameters, are appropriate. If necessary, reset ventilator controls. If ventilation is limited by the inspiratory limit pressure control, the actual volume supplied to the patient will be below the value the ventilator's tidal volume control sets and this condition will be indicated in the control display with the LIMITED PRESSURE message line.

P (cmH2
O)

INS. T.

EXP. T.

PEE P 0

TRIGGER PRESS.

F (l/mi
n)

FLO W

0
FLO TRIGGE W R PAUSE T.

Figure 10.1.

VCV Mode: curve examples: Pressure x Time and Flow x Time.

Figure 10.1 shows pressure and flow curves as a function of time, to help in the understanding of the VCV mode. The beginning of each breath can be commanded by the ventilator or by the patient. In the latter case, the trigger can be performed by pressure or flow. During inhalation, the flow takes-on a wave shape set by the operator and the pressure increases until the adjusted tidal volume is supplied (or until the limit pressure is reached). An inspiratory pause can be used.

10.2

PCV - Pressure-Controlled Ventilation

This mode is a variation of the VCV ventilation. The basic differences between them are in the way they control cycles and the inspiratory pressure. For PCV, the operator determines the inspiratory pressure and not the tidal volume. The ventilator will supply the amount of gas required by the patient to keep inspiratory pressure at a constant level according to the value set on the inspiratory limit pressure control (21). This mode is indicated, for example, in cases where there is a major leak in the endotracheal tube and in patients with different resistance/compliance between parts of the lungs. This mode can function, basically, in two different ways so far as the start of inhalation is concerned: 1) Under regular PCV conditions, the start of each cycle and the respiratory rate are determined by the patient's inspiratory

effort resulting in an assisted ventilation. 2) If the patient goes into a state of apnea or cannot trigger the equipment because the sensitivity adjustment is very

heavy, the ventilator will start supplying mandatory cycles with the value in the rate control (24). If the patient reacts, than ventilation will return automatically to the normal trigger condition by the patient. The following ventilation parameters should be set in PCV (in the sequence of the ventilators setting mode):

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Attention
After ventilation starts, check if the ventilation parameters, as indicated by the display (8), are set properly. If necessary, reset ventilator controls.

LIMIT PRESS. PEE P 0

INS. T.

1/ RATE

5 cmH 2O

TRIGGER PRESS.

F (l/mi
FLO W
n)

0
FLO TRIGGE W R

Figure 10.2.

PCV Mode: curve examples: Pressure x Time and Flow x Time.

Figure 10.2 shows pressure and flow curves as a function of time to help in the understanding of the PCV mode. The beginning of each breath can be commanded by the ventilator or by the patient. In the latter case, the trigger can be performed by pressure or flow. At the beginning of inhalation, the flow reaches its maximum value and afterwards it decreases until the end of the inspiratory time. The pressure is kept constant during inhalation. If for any reason the actual inspiratory pressure exceeds the adjusted inspiratory limit pressure by more than 5 cmH2O, the high-pressure alarm will sound and inhalation will be interrupted automatically.

10.2.1

PLV - pressure-limited ventilation

This type of ventilation is used solely for neonatal patients. During controlled ventilation, the mandatory cycles to begin inhaling may be of two different types: a. b. Controlled cycles: The patient will be passive and the device controls ventilation totally. Assisted cycles: The beginning of each cycle and the respiratory rate are determined by the patient's inspiratory effort, which triggers breathing. If the patient goes into a state of apnea or cannot trigger the equipment because the sensitivity setting is too heavy, the Ventilator will start supplying controlled cycles with the rate value set in the corresponding control. If the patient reacts, then ventilation will automatically return to the assisted cycles. Controlled ventilation may aim both at the volume and at the pressure and the ventilator cycles per time with continual flow.

Note:
1 If you want to allow the patient to trigger the cycles, adjust the breathing rate control to a value smaller than the patient's spontaneous rate. 2 The patient can trigger the cycles by pressure or flow, depending on the assisted cycle sensitivity setting. If the operator deactivates sensitivity, all cycles must be controlled.

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P( cmH2O )
Max. P .

INS .T .

E XP .T .

PEEP

F( l/min )
F LOW

Figure 10.2.1: PLV Mode: curve examples: pressure x time and flow x time. Ventilation graphs in PLV pressure-limited mode Figure 10.2.1 shows pressure and flow curves as a function of time to help in the understanding of the PLV pressure-limited mode. Pressure increases during inhaling until the set inspiratory pressure limit is reached; the flow reaches its maximum value at the beginning of inhaling, decreasing until the end of inhaling time (decreasing flow). As such, it reaches a plateau at the beginning of exhaling. If for any reason the actual inspiratory pressure surpasses the adjusted inspiratory limit pressure by more than 5 cmH2O, the high-pressure alarm will sound and inhalation will be automatically interrupted.

Attention
In limited maximum pressure ventilation, the actual volume supplied to the patient will be less than that set with the ventilators flow and inspiration time controls.

10.3

PCV/AV - Pressure Control Ventilation /Assured Volume

This mode is a variation of the PCV mode. The basic difference between these modes is in the way they control inspiratory pressure. In PCV/AV, the operator sets the value for the tidal volume to be supplied to the patient and the ventilator ensures it by automatically increasing or reducing the inspiratory pressure. The following ventilation parameters should be set to PCV/AV (in the sequence they are placed by the ventilator in the adjustment mode):

Attention
After ventilation starts, check if the ventilation parameters, as indicated by the display (8), are set properly. If necessary, reset Ventilator controls.

Figure 10.3.

PCV/AV Mode: curve examples: Pressure x Time and Flow x Time.

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Figure 10.3 shows pressure and flow curves as a function of time to help one understand the PCV/AV mode. The beginning of each breath can be commanded by the ventilator or by the patient. In the latter case, the trigger can be performed by pressure or flow. At the beginning of inhalation, the flow reaches its maximum value and afterwards it decreases until the end of the inspiratory time. The pressure is kept constant during each inhalation and the inspiratory pressure level can be changed automatically by the ventilator among the consecutive cycles to allow the adjusted tidal volume to be supplied.

Startup Sequence - PCV/AV

Cycles 1,2 and 3 Cycle 4 Cycle > 5

PEEP + 5 cmH2O to measure the dynamic compliance. 60% of the pressure required to ensure the desired volume. Pressure level control to ensure the desired volume.

Note:
The automatic pressure control goes to the set limit-pressure.

If the limit pressure is reached but the volume does not go to the value that is set, the LIMITED PRESSURE message will appear, meaning that the supplied volume is below the intended volume. If there is any change in the Limit Pressure or Tidal Volume values, the sequence described above will be reset.

10.4

SIMV/V - Synchronized Intermittent Mandatory Ventilation with Volume Control

For the SIMV/V ventilation, the patient breathes spontaneously between the ventilator's mandatory cycles. The mandatory cycles are volume-controlled as in the VCV mode. The beginning of each cycle and the respiratory rate are determined by the patient's inspiratory effort, which triggers breathing. If the patient goes into a state of apnea or cannot trigger the equipment because the sensitivity setting is too "heavy", then the ventilator will automatically switch to the IMV mode (non-synchronized) - thus ensuring backup ventilation at the rate set in the display. If the patient reacts, then ventilation will automatically return to SIMV. Both mandatory and spontaneous cycles can be triggered by the patient and are adjusted in the following way: Spontaneous cycles - The pressure-supported feature can be used, provided the pressure-supported control (12) is adjusted to a value above the PEEP (20). The pressure support ventilation control (12) can be adjusted to the OFF position to deactivate this feature. Mandatory cycles - The SIMV rate determines the interval that allows each mandatory cycle trigger. The SIMV rate is normally adjusted to a low value, allowing the patient to develop several spontaneous cycles between two sequential mandatory cycles. The operator will set the tidal volume for the mandatory cycles, and the inspiratory limit pressure will work as a safety procedure against barotrauma. The following ventilation parameters should be adjusted in SIMV/V (in the sequence they are entered in the ventilators adjustment mode):

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Attention
After ventilation starts, check if the ventilation parameters, as indicated by the display (8), are set properly. If necessary, reset Ventilator controls. If ventilation is limited by the inspiratory limit pressure control, the actual volume supplied to the patient will be below the value the ventilator's tidal volume control sets and this condition will be indicated in the control display with the LIMITED PRESSURE message line.

Figure 10.4.

SIMV/V Mode: curve examples: pressure x time and flow x time.

Figure 10.4 shows pressure and flow curves as a function of the time to help in the understanding of the SIMV/V mode. The mandatory cycles (1) operate in a similar way as the VCV mode. The spontaneous cycles can have their Pressure Support Ventilation feature deactivated (2) or activated (3). The start of each breath can be controlled by the ventilator or by the patient. In the latter case, the patient can only trigger the cycle during the "synchronized window" time. An inspiratory pause can be introduced during mandatory cycles (4).

10.5

SIMV/P - Synchronized Intermittent Mandatory Ventilation with Pressure control

In SIMV/P ventilation, the patient breathes spontaneously between the ventilator's mandatory cycles. The mandatory cycles are pressured-controlled in a similar way as in the PCV mode. The beginning of each cycle and the respiratory rate are determined by the patient's inspiratory effort, which triggers breathing. If the patient goes into a state of apnea or cannot trigger the equipment because the sensitivity setting is too "heavy", then the ventilator will automatically switch to the IMV mode (non-synchronized) - thus ensuring backup ventilation at the rate set in the display. If the patient reacts, then ventilation will automatically return to SIMV. Both mandatory and spontaneous cycles can be triggered by the patient and are adjusted in the following way: Spontaneous cycles - The pressure-supported feature can be used, provided the pressure-supported control (12) is adjusted to a value above the PEEP (20). The pressure support ventilation control (12) can be adjusted to the OFF position to deactivate this feature. Mandatory cycles - The SIMV rate determines the interval that allows each mandatory cycle trigger. The SIMV rate is normally adjusted to a low value, allowing the patient to develop several spontaneous cycles between two sequential mandatory cycles. The operator will adjust the inspiratory pressure for the mandatory cycles. The following ventilation parameters should be adjusted in SIMV/P (in the sequence of the ventilators adjustment mode):

Attention
After ventilation starts, check if the ventilation parameters, as indicated by the display (8), are set properly. If necessary, reset Ventilator controls.

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Figure 10.5.

SIMV/P Mode: curve examples: pressure x time and flow x time.

Figure 10.5 shows pressure and flow curves as a function of time, to help in the understanding of the SIMV/P mode. The mandatory cycles (1) function in a similar way to the PCV mode. The spontaneous cycles can have their Pressure Support Ventilation feature deactivated (2) or activated (3). The start of each breath can be controlled by the ventilator or by the patient. In the latter case, the patient can only trigger the cycle during the "synchronized window" time.

10.6

BIPV - Spontaneous Ventilation with Two Pressure Levels

This is a ventilation support mode that maintains constant positive pressure (inspiratory limit pressure) during a part of the cycle. Relief is provided, therefore, when this pressure drops to a lower level (CPAP). This pressure difference is responsible for introducing a determined tidal volume into the patient and increasing the exchange of gases. It is a constant flow ventilation mode that allows the patient to breathe spontaneously during both intervals of the ventilation cycle. The following ventilation parameters should be set in BIPV (in the ventilators adjustment mode sequence):

Attention
After ventilation starts, check if the ventilation parameters, as indicated by the display (8), are set properly. If necessary, reset Ventilator controls.

Figure 10.6.

BIPV Mode: example of a pressure x time curve.

Figure 10.6 shows pressure and flow curves as a function of time to help in the understanding of the BIPV mode. Spontaneous ventilation uses two separate pressure levels. During the T1 period, the patient breathes at the adjusted limit pressure and during the period T2 at the CPAP pressure. The Pressure Support Ventilation feature can be activated or deactivated.

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10.7

CPAP - Continuous Positive Airway Pressure Ventilation

In the CPAP mode, the patient breathes spontaneously at the constant positive pressure kept by the ventilator in the breathing circuit. This mode is similar to the BIPV one, except for having only one pressure level. The following ventilation parameters should be set in CPAP (in the ventilators adjustment mode sequence):

Attention
After ventilation starts, check if the ventilation parameters, as indicated by the display (8), are set properly. If necessary, reset Ventilator controls. If there is an apnea alarm, re-establish the patient's ventilation immediately.

Figure 10.7.

CPAP Mode: curve examples: pressure x time and flow x time.

Figure 10.7 shows pressure and flow curves as a function of time to help in the understanding of the CPAP mode. Spontaneous ventilation is performed over a pressure level regulated by the CPAP control. The Pressure Support Ventilation feature can be activated (1) or deactivated (2).

Attention
In CPAP, set the PPEP alarm to detect a possible disconnection.

10.8

PSV - Pressure Support Ventilation

For the PSV mode, the patient inhales and starts a cycle. Pressure is kept at a constant level during inhalation (pressure support) by means of an automatic system which controls the flow supplied at each moment according to the patient's needs and the value adjusted in the support pressure ventilation control (12). The following ventilation parameters should be set in PSV (in the ventilators adjustment mode sequence):

Note:
The Inspiratory Limit Pressure, Inspiratory Time, and Respiratory Rate parameters should be set to control the backup ventilation (PCV/PLV (neonate)).

Attention
After ventilation starts, check if the ventilation parameters, as indicated by the display (8), are set properly. If necessary, reset Ventilator controls.

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Figure 10.8.

PSV Mode: curve examples: pressure x time and flow x time.

Figure 10.8 shows pressure and flow curves as a function of time to help in the understanding of the PSV mode. The Pressure Support Ventilation feature keeps pressure at a constant level during inhalation. If the patient stops breathing for a period of time above the apnea time, the ventilator will automatically start the PCV / PLV (neonate) cycles (3).

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11

SPECIAL FEATURES

The SMART Servo-ventilator has some special functions, which are useful in certain clinical situations. These functions are described below.

Inspiratory Pause
This feature forces a 5-second inspiratory pause. It can be used, for example, to determine the Plateau and/or leakage pressure. To impose an inspiratory pressure, perform the following procedure during an inspiratory phase: 1. 2. While holding the inspiratory pause key (10) during inspiration, press the manual inspiration button (4). The ventilator will provide an inspiratory pause for 5 seconds and will show the MANUAL INSPIRATORY PAUSE

indication in the control display message line (8).

100% Oxygen
This feature forces a 100% oxygen concentration for 90 seconds. To activate this function, do the following: 1. 2. While holding the O2 concentration key (9), press the manual inhalation button (4). The ventilator will supply 100% O2 for 90 seconds and will show the letter F near the O2 concentration in the control

display (8). It will also show the O2 indication in the operating message line in the control display (8), as well as a graphical display showing this procedures development. 3. When the 90-second period expires, the concentration will automatically revert to the previous value.

AUTO-PEEP Measurement
This feature performs an AUTO-PEEP measurement. This function can be used, for example, to check that the patient has enough time to exhale. To measure the AUTO-PEEP, do the following during an expiration phase : 1. 2. 3. While holding the PEEP key (20) during an expiration, press the manual inspiration button (4). The ventilator will perform an expiratory pause to measure the AUTO- PEEP and the MANUAL EXPIRATORY PAUSE When the expiratory pause expires, the AUTO-PEEP value will appear for a few seconds in the control displays

message will appear in the display. message line (8).

Note:
The AUTO-PEEP value displayed corresponds to the measured value added to the PEEP adjusted in the ventilator. Example: If the PEEP is set to 5 cmH2O and the measured AUTO-PEEP is 10 cmH2O, the total end-expiratory pressure is 10 cmH2O.

Sigh
Automatically supplies a tidal volume that is 50% greater than the tidal volume adjusted every N cycles. This feature is activated or deactivated by means of the setup screen in the control display.

Tobin Index Measurement

Performs the Tobin Index measurement, which is the ratio of the spontaneous ventilation rate (breaths/min) and the tidal volume in liters. This index has proven to be a good forecast of successful weaning in many patients requiring mechanical ventilation. The Tobin Index (iT) of f/Vt with <105 breaths/min/l can be an accurate and early forecast for the weaning results. For this measurement, the patient must be in the CPAP mode, without pressure support (totally spontaneous), without PEEP and with a base flow equal to zero. This parameter is calculated automatically by the equipment and appears in the monitoring display on the f x t curve.

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P0. 1 Measurement Airway Occlusion Pressure

This performs the P0 measurement. 1, which is the inspiratory pressure measured in 100 milliseconds after the airway occlusion. P0. 1 is independent from efforts and is closely related to the central respiratory impulse. Patients that depend on the ventilator present a P0. 1 of > 6cmH2O tend to be difficult to remove from the device. If a PEEP value is being used, it will be the baseline for the P0. measurement. 1. For this measurement, the patient must be in the SIMV/P mode. This device calculates this parameter automatically and it is shown in the P x t curve monitoring.

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12

CLEANING AND STERILIZATION

Switch the SMART Servo-ventilator off before cleaning it. Do not immerse the ventilator into any kind of liquid.

Attention

This cleaning, disinfection, and sterilization procedure for the parts that come into contact with the patient must be carried out before the first use and for subsequent uses. 1. To clean external ventilator, parts use a clean, soft cloth, dampened in water and soap (detergent). Be careful to avoid the

accumulation of any cleaning product residue in the equipment connections. After cleaning, rinse and dry with a clean, soft, dry cloth. 2. To clean the ventilator's displays use a soft, clean, and lint-free cloth. Do not use paper towels or rough cloths to avoid

scratching the screen surface. 3. 4. Do not use abrasive or corrosive agents when cleaning. If no bacteria filter was used, the breathing circuit components should be disassembled for disinfection or sterilization after

being used with each patient, including: corrugated tubes (plastic or silicone), heated humidifier chamber (item 6.7), drains (item 6.9), drains (item 6.9), nebulizer (item 6.10), expiratory valve (item 6.8), expiratory valve diaphragm, flow sensor (item 6.x), flow sensor tubes and connectors. Use glutaraldehyde, hydrogen peroxide or ethylene oxide. The plastic corrugated tubes, the nebulizer, the connectors and the flow sensors white cover can be submitted to thermo-disinfection, however only in a sensitive cycle (chemical thermo-disinfection), i.e., they support low temperatures, of no more than 60oC. The others may be sterilized in autoclave up to a maximum temperature of 136 oC. If the respiratory circuit components are used with a bacterial filter, establish a daily routine (once a day) to disinfect or sterilize them. The ICU Servo-ventilator circuits must be reprocessed after each patient, whether bacterial filters are used or not. 5. The silicone parts (tubes and tracheas) have characteristics that are intrinsic to silicone, including non-deformation

(at up to 150oC) and an undetermined useful life at room temperature, maintaining silicone properties. It is suggested its storage conditions be in a clean and organized place, free of perforating materials or contaminants, preferably according to the good manufacturing practice (GMP) cleanliness and organization instructions, protected from direct sunlight and avoiding temperatures above 40oC or locations next to equipment that heats (such as incubators or sterilizers).

Note
After starting using the device, it is suggested the tracheas/tubes have a life cycle of no more than 50 sterilizations in a steam sterilization process (autoclave) in 30-minute cycles at 1 bar/15 PSI and 121oC/250oF.

Attention
Perform a visual and functional inspection of the components after the cleaning/sterilization procedure to detect signs of wear and tear in them. Dried-out tubes and/or tubes with cracks and irregular fittings are a sign of the need to replace these components. Special attention must be given to the flow sensors cleanliness, as liquid or non-liquid substance accumulation may interfere with the values the ventilation monitor measures and shows. Therefore, the physician must establish a cleaning frequency according to the patients state, or no less than every 2 hours. It is convenient to have one or more flow sensors and flow sensor tubes during the procedures for quick replacement. When using ethylene oxide, follow the instructions provided by the sterilizing equipment manufacturer to determine the correct temperatures and indicated aeration times.

6.

Cleaning the expiratory valve diaphragm is essential for the correct operation of the Ventilator and should be performed

after the ventilator is used for a patient.

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RECOMMENDATIONS TO PROCESS TAKAOKA MECHANICAL VENTILATION AND ANESTHESIA EQUIPMENT COMPONENTS

The hospital accessories used in gas anesthesia and mechanical ventilation are classified as semi -critical , due to the potential risk they pose for transmitting infection. Semi-critical articles are all those that come into contact with mucous membranes and/or skin wounds, in other words, they generally do not penetrate sterile body cavities, and thus are capable of preventing invasion of the sub-epithelial tissue, which require a high-level of disinfection or sterilization to ensure quality in multiple-use situations. Choosing the processing method - disinfection or sterilization - depends on the nature of the materials. CHART 1 presents the recommended methods to process K. TAKAOKA anesthesia and mechanical ventilation equipment components, considering their composition and technical specifications. The recommended methods are: cleaning, chemical and thermal disinfection and gas, chemical or plasma sterilization. The processing should be performed according to the step sequence shown in the following FLOWCHART. CONCEPTS OF: CLEANING - A process that removes soil and organic matter from any surface or object. Cleaning is done by mechanical friction, immersion, cleaning machines and ultra-sound machines. It is the most important step in decontamination; all items must be washed before passing through any disinfection or sterilization process. No object should be sterilized if there is any organic matter (oil, fat, blood...) on it. Cleaning should always be done with soap and water. When the immersion method is used, preferentially use an enzyme detergent. Enzyme detergents have specific action on organic matter: they degrade and dissolve it in a matter of minutes. The objects should remain immersed for 5 minutes. DISINFECTION A thermal or chemical process that eliminates all microorganisms, except for those with spores. Disinfection is classified in three categories: high-, medium-, and low -level. HIGH LEVEL DISINFECTION - A process that eliminates all microorganisms except a large number of spores (bacteria, almost all fungi spores, TB bacilli, viruses) after an exposure time of 10 to 30 minutes. Ex.: Glutaraldehyde immersion. INTERMEDIATE LEVEL DISINFECTION - A process that inactivates vegetative bacteria, fungi, and almost all viruses, except spores. Ex.: Mechanical friction with 70% Alcohol. LOW LEVEL DISINFECTION - A process that inactivates most bacteria, some fungi, some viruses, however does not affect more resistant bacteria like TB bacilli or spores. Used only for surfaces. Ex.: Water and detergent cleaning. THERMAL DISINFECTION A thermal process, which uses thermal disinfectant liquids against all vegetative forms, destroying some of the spores when used at a temperature of between 60 and 90O C. This process is done in a thermal-disinfection unit, the machine that works with two types of cycles for sensitive and resistant materials, using the appropriate detergent, one for sensitive materials and one for resistant materials. STERILIZATION A process that completely eliminates or destroys all microorganisms (spores, bacteria, fungi and protozoa) and is performed by physical (steam) or chemical processes (liquid-glutaraldehyde, gaseous -ethylene oxide gas and plasma-hydrogen peroxide). The spore is the most difficult microorganism to inactivate. Ex.: Autoclave, Hydrogen Peroxide, ethylene oxide, Glutaraldehyde (exposure of the material for 10 hours).

Note:
Hydrogen peroxide (oxygenated water) is a sterilization process that takes place at a maximum temperature of 45C. Materials that cannot be autoclaved can be sterilized with peroxide, except for those materials derived from cellulose.

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FLOWCHART
Anesthesia and Mechanical Ventilation Equipment component processing sequential step flowchart
WITH ORGANIC MATTER OR SOIL

CONSIDER ALL CONTAMINATED

CLEA N

MOIST CLOTH

DETERGENT SOLUTION

RINSE

DRY

ACCORDING TO ARTICLE DESTINATION

IF STERILIZATION

IF PROCESSING CONCLUDED

IF DISINFECTION

PHYSICAL MEDIUM (STEAM)

CHEMICAL MEDIUM

STORE

LIQUID CHEMICAL MEDIUM (70% ALCOHOL)

LIQUID PHYSICAL MEDIUM (THERMAL DISINFECTION)

LIQUID CHEMICAL MEDIUM (GLUTARALDEHYDE)

CONDITION

LIQUID (GLUTARALDEHYDE)

GASEOUS (ETHYLENE OXIDE)

PLASMA (HYDROGEN PEROXIDE)

MECHANICAL FRICTION

SUBMERGE FOR THE APPROPRIATE TIME AT THE APPROPRIATE TEMPERATURE

SUBMERGE THE ARTICLE

STERILIZE

TOTALLY SUBMERGE

CONDITION

CONDITION

CONDITION

DRY ASEPTICALLY

FILL TUBING

STORE

FILL PIPING

STERILIZE

STERILIZE

STORE

CONDITION

RINSE WITH STERILIZED H20

RINSE WITH STERILIZED H2O

STORE

STORE

STORE

DRY ASEPTICALLY

DRY ASEPTICALLY

CONDITION

CONDITION IN A STERILIZED VIAL

STORE

STORE

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CHART
Methods recommended to process K. TAKAOKA Anesthesia and Mechanical Ventilation equipment components.

Component

Cleaning

Disinfection

Sterilization

Sphygmomanometer bracket

Detergent Solution

NOT RECOMMENDED Glutaraldehyde

NOT RECOMMENDED Ethylene Oxide Glutaraldehyde or Hydrogen Peroxide NOT RECOMMENDED

Anti-pollution bag

Detergent Solution

Thermal disinfection sensitive 70% Alcohol Synthetic phenol Synthetic phenol

Rotameter block

Damp cloth

Sphygmomanometer cable

Detergent Solution

NOT RECOMMENDED

EKG Cable / Oximeter

Detergent Solution

Synthetic phenol Glutaraldehyde

NOT RECOMMENDED

Humidifier Chamber

Detergent Solution

Thermal disinfection resistant Glutaraldehyde

Steam

Ethylene Oxide Glutaraldehyde or Hydrogen Peroxide Ethylene Oxide Glutaraldehyde or Hydrogen Peroxide NOT RECOMMENDED Ethylene Oxide or Glutaraldehyde Ethylene Oxide or Glutaraldehyde Steam Hydrogen Peroxide

Bell

Detergent Solution

Thermal disinfection sensitive Glutaraldehyde

Canister

Detergent Solution

Thermal disinfection sensitive

Oximeter Galvanic Cell Bell Rod Set

Detergent Solution Detergent Solution

NOT RECOMMENDED Glutaraldehyde 70% Alcohol Glutaraldehyde 70% Alcohol Glutaraldehyde Thermal disinfection resistant

Air Vent Elbow

Detergent Solution

Drains

Detergent Solution

Flow meter

Damp cloth

70% Alcohol Synthetic phenol Glutaraldehyde Thermal disinfection resistant Glutaraldehyde

NOT RECOMMENDED

Diaphragms

Detergent Solution

Steam or Glutaraldehyde Hydrogen Peroxide Ethylene Oxide Glutaraldehyde or Hydrogen Peroxide Steam or Glutaraldehyde

Y-Shaped Connector (nozzle)

Detergent Solution

Thermal disinfection sensitive Glutaraldehyde 70% Alcohol

Aspirating Flask

Detergent Solution

Manual code: 204010210_003

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Component

Cleaning

Disinfection Glutaraldehyde

Sterilization Ethylene Oxide Glutaraldehyde or Hydrogen Peroxide Ethylene Oxide or Glutaraldehyde NOT RECOMMENDED

T-Shaped Capnograph Connector

Detergent Solution

Thermal disinfection sensitive

Mask Monitor Module

Detergent Solution Damp cloth

Glutaraldehyde 70% Alcohol Synthetic phenol 70% Alcohol Synthetic phenol 70% Alcohol Synthetic phenol 70% Alcohol

Ventilator Module

70% Alcohol

NOT RECOMMENDED

Cabinet (external parts)

70% Alcohol

NOT RECOMMENDED Ethylene Oxide

Mask Strap

Detergent Solution

Glutaraldehyde

Glutaraldehyde or Hydrogen Peroxide

Glutaraldehyde Flow Sensor Detergent Solution Thermal disinfection resistant Auxiliary Thermometer Detergent Solution Synthetic phenol 70% Alcohol 70% Alcohol Ethylene Oxide Hydrogen peroxide Ethylene Oxide Hydrogen peroxide Ethylene Oxide Hydrogen peroxide Ethylene Oxide Hydrogen peroxide Ethylene Oxide or Glutaraldehyde Ethylene Oxide or Glutaraldehyde NOT RECOMMENDED Ethylene Oxide Glutaraldehyde or Hydrogen Peroxide NOT RECOMMENDED Steam

Injected Liquid Thermometer

Detergent Solution

Esophageal Temperature Sensor

Detergent Solution

Glutaraldehyde

Side Stream (capnograph) Canister Support

Detergent Solution Detergent Solution

Glutaraldehyde Glutaraldehyde 70% Alcohol Glutaraldehyde

Corrugated Tubes **

Detergent Solution

Thermal disinfection sensitive Glutaraldehyde 70% Alcohol Glutaraldehyde

Vacuum meter

Detergent Solution

Inhalation and Exhalation Valves

Detergent Solution

Thermal disinfection sensitive Synthetic phenol 70% Alcohol Synthetic phenol 70% Alcohol

Calibrated Vaporizer

Damp cloth

Multi-agent Vaporizer

Damp cloth

NOT RECOMMENDED

Note:
* The Galvanic Cell for FiO 2 measurement should be cleaned with a cloth dampened in soap and water, it should not be immersed in solution. ** Silicone treated corrugated tubes may be autoclaved and submitted to thermal resistant disinfection.

Manual code: 204010210_003

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13
1.

MAINTENANCE
At least once a month, check that the tubes, sensors, cables, and other Ventilator components are not damaged, worn out

or cracked. If there is any damage, provide for component replacement. Do not use damaged components . 2. The exhalation valve diaphragm must be carefully inspected at least once a month or after each disassembly to ensure

its integrity. 3. The exhalation valve diaphragm should be replaced at least once every 6 (six) months and whenever necessary.

Note:
The exhalation valve block must be tightly fastened to the Ventilators front connection panel so there is no gas leakage. Periodically check state of the sealing ring (O-ring).

4. 5.

The flow sensor tubes should be replaced at least once every 2 (two) months and whenever necessary. Periodically check the perfect conservation of the rubber mounting of the Heated Humidifier's cap so the chamber is

tightly sealed when closed. If necessary, replace it with a new gasket. 6. Check the condition and periodically replace the breathing circuit's corrugated tubes, as these are components subject to

normal wear and tear. 7. . 8. . . 9. . 10. If the maximum inhalation pressure does not reach the expected value, check, initially: that there is no leakage in the breathing circuit; that there is no leakage in the humidifier cap; that all connections are firmly tightened; that the pressure control is not adjusted too low; that the tidal volume control is not adjusted too low; that O2 and compressed air supply pressures are not too low; that the exhalation valve set is correctly assembled with a clean and well-preserved diaphragm. that the inspiratory flow pressure control is not adjusted too low. If the tidal volume does not reach the expected value, check, initially: that there is no leakage in the breathing circuit; that there is no leakage in the humidifier cap; that all connections are firmly tightened; that the pressure control is not adjusted too low; that O2 and compressed air supply pressures are not too low; that the exhalation valve set is correctly assembled with a clean and well-preserved diaphragm. that the inspiratory flow pressure control is not adjusted too low. if the flow tube position at the end of the F x t graph exhalation is not at zero, in this case, adjust it according to item 6.2. If you are unable to supply the SMART Servo-ventilator with the mains, initially check: if there is electric energy at the 100 to 240 VAC outlet; That the ventilator fuse has not blown whether the O2 and compressed air system pressures are not too low; The compressed air filter should be opened and cleaned two or three times a year, depending on the amount of use that

the ventilator has and on the purity of the compressed air. The condensed material from the filter drains automatically. 11. 12. Only use sensors, cables, and tubes K. TAKAOKA specifies for the SMART Servo-ventilator. Do not use the SMART Servo-ventilator if the automatic test indicates any irregularity (item 6.1). Solve the problem by

calling an authorized K. TAKAOKA representative. 13. The ventilator must undergo an annual revision by an authorized K. TAKAOKA technician to be re-calibrated.

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Rechargeable internal battery:

Whenever possible, keep the internal battery fully charged to obtain a longer service life from it. Constant battery The internal battery is sealed and does not require maintenance. In the event the battery presents any operating problem, If it is not possible to charge the battery normally through the electric mains, check whether there is power in the network tap.

discharges decrement the service life. call the authorized K. TAKAOKA Technical Assistance.

Attention
Only use genuine K. TAKAOKA replacement parts. Using parts that are not genuine may place the patients safety at risk. Do not perform any internal service on the SMART Servo-ventilator and do not open its case. To perform any internal maintenance on the ventilator or to make a periodic revision, call TAKAOKA'S authorized Technical Assistance.

Fuse replacement instructions

Insert a screwdriver in the fuse-holder slot; Spin counterclockwise as far as it will go (do not force) to unlock the fuse holder; Pull the fuse-holder out; Replace the fuse as per its technical specification; Push the fuse-holder; Spin clockwis e as far as it will go (do not force) to unlock the fuse holder; Reconnect the ventilators cord to the outlet.

Note
If agreed, additional documentation will be provided for preventive/corrective maintenance.

Manual code: 204010210_003

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14

MEASUREMENT METHODS

Attention
All calculations are based on flow and proximal pressure measurements. The times are taken from the flow curves, the volumes are taken from the flow integral, the pressure is taken from the pressure curve and the work and resistance compliance are taken from the flow and pressure set.

14.1

Volume
ti

Volumeinsp = Flowexp dt
0 te

In which ti is the inspiratory time

Volumeexp = Flowexp dt
0

In which te is the expiratory time

Volumeinsp_average =

Volume [n]
n=1 insp

Volumeminute = Volumeexp Frequencyaverage

14.2 Rate

Frequency average =

Frequency [n]
n=1

The rate is taken form the elapsed time between two inspiratory cycles.

14.3

I:E Ratio

I : E =1

ti te

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14.4

Inspiratory and Expiratory Times

Timeins_average =

Time [n]
n=1 ins

Timeexp_averag e =
14.5

Time [n]
n=1 exp

Maximum, Average, Plateau, and PEEP Pressure

Pressuremax ? During the inspiratory cycle, the greater value for the pressure read is searched. Pressureplateau ? During the inspiratory cycle and after the greater pressure value is taken, a pressure stabilization is searched for at a value below the MaxP which is longer than 100 milliseconds. The PEEP is measured during the expiratory cycle, searching for a point where the flow is less than 3 Lpm and the temporal stabilization is greater than 200 milliseconds.

Pressure average =

Pressure[n]
n =1

Measured at the beginning of the inspiratory cycle (n=1) up to the beginning of the next inspiratory cycle (N).

14.6

Resistance

The Johnson method is applied, where

Resistance =

Pressureend _ of _ inspiration Flowexpiration_maximum

Manual code: 204010210_003

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14.7

Complacencies

Complacencystatic =

Volumeexp Pressureplateau PEEP

Volumeexp Pressuremax imum PEEP

Complacencydynamic =

Note:
The alphanumeric display window shows the static compliance value. However, according to the previously described method to measure the plateau pressure, this compliance can be equal to the maximum pressure and in such case the value displayed will be the dynamic compliance value.

Static Compliance

Dynamic Compliance

14.8
vf

Inspiratory Work

Workinsp = Pressure_ dV
vi

where vi is the initial volume and vf the final one.

Attention
Excessive noise in the flow measurement line can affect volume and time calculations. The ventilator compensates automatically for thermal deviations that result in 5 lpm, above this value switch the ventilator off and back on.

Manual code: 204010210_003

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15

SYMBOLS

Manual code: 204010210_003

92

Manual code: 204010210_003

93

Manual code: 204010210_003

94

Manual code: 204010210_003

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Manual code: 204010210_003

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16

EMERGENCY ACTIONS

In the event of an adverse event, K. Takaoka suggests the following procedure:

v Contact the manufacturer (Technical Assistance) about the devices condition, and dont perform any test or investigation in the
absence of an authorized K. Takaoka technician.

v Register the manufacturer, model, and serial number of all devices involved in the adverse event. Record this information in
the patients records and/or in an uncommon event form. If the device is discardable or has discardable accessories, also record the classification number and all of the discardable accessory numbers. It is important to keep the device and any accessory that was involved in the adverse event.

v Do not clean or submit the device to a chemical or physical process or fix it. These actions may affect its performance and safe use. v Record the names of all health professionals who were present during the incident. v Identify the device, indicating it was involved in an adverse event, record the event date, and the name of the person who tagged
the device. Indicate on the tag that the device must not be used, cleaned, fixed or destroyed without the approval of an authority, such as a risk manager. If the adverse event involves more than one device, all devices involved must be tagged and stored.

v Preserve the packages of all discardable accessories involved in the event and store them with the device. The discardable
accessory packages typically include not only the devices catalogued number, but the lot number. Furthermore, a few specifications included on the package may be useful for the expert investigation.

v Before unplugging the device or removing its batteries, make sure its memory will not be lost. Many devices have computerized
memories that may be lost if the batteries are removed or if the device is unplugged. Experts may use this memory to determine specifically when the conditions of the related device occurred. To determine which devices have computerized memories and how they must be controlled after an event, read the instruction manual or contact your clinical engineer.

v Put the device and its accessories in a safe place to prevent subsequent damage. This will keep the device from being put
back into service; protected rooms and devices may have to be used regardless of a previous incident.

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17

TERMS OF WARRANTY

K TAKAOKA IND. E COM. LTDA. guarantees the equipment it produces against manufacturing defects for a period of one year from the date of acquisition by the first owner. The following is list showing the technical assistance companies authorized by K TAKAOKA IND. E COM. LTDA., both in Brazil and abroad, which, besides the manufacturer, have exclusive maintenance rights. Modification, violation, adjustment or maintenance by third parties is not permitted. The equipment manufactured or overhauled by K TAKAOKA IND. E COM. LTDA. has a breakable warranty seal. If this seal is broken, the warranty will become automatically void. The improper use of the equipment and/or the non-compliance with the instructions contained in this manual, the use of a voltage different from that specified and of parts and/or accessories which have not been approved by K TAKAOKA IND. E COM. LTDA. will void the warranty. Damage caused by accidents or Acts of God are not covered by the warranty; the same applies to batteries, fuses, filters, etc. Following are items provided with the equipment, as well as some optional accessories and their respective periods of warranty against "manufacturing defects". Code 202011410 202010588 202011542 203100149 202011182 202012068 202010614 202011639 202011152 202011154 429020003 204010210 202012085 201050003 202010621 202011153 202011033 202010632 202011938 203030769 202012015 202012016 202011287 203100150 Item Mobile base Complete silicone adult breathing circuit 1800-mm flow sensor tube Adult flow sensor O2 Extension Air Extension Compressed air filter Articulated arm Expiratory valve diaphragm Basic ventilator unit Removable power cord Operation manual FiO2 Kit 6060 Heated Humidifier Medication nebulizer (optional) Expiratory Valve Block Complete silicone respiratory circuit - pediatric (optional) Complete silicone respiratory circuit - neonatal (optional) O2 filter (optional) 90o Y connector - (optional) Neonate Y connector (optional) Straight Y connector (optional) Fastening kit (optional) Pediatric flow sensor (optional) Guarantee 1 year 3 months 3 months 3 months 1 year 1 year 6 months 1 year 3 months 1 year 3 months None 6 months 1 year 6 months 6 months 3 months 3 months 6 months 3 months 3 months 3 months None 3 months

The SMART Servo-ventilator useful life is estimated to average 5 years. This may vary according to use and to adequate preventive maintenance.

Person Technically in Charge: Mauricio Chiaroni CREA No. 5061714921

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K. TAKAOKA DISTRIBUTORS IN BRAZIL

ALAGOAS CASA DO MDICO R. Roberto Simonsen, 412 Cep: 57052 -675 Tel/Fax: (82) 338-8777 Cel: (82) 9381-2526 E-mail: compras_cmedico@hotmail.com MACEI / AL - Rogrio AMAP / PAR MEDICINAL Com. e Repres. Ltda Av. Cipriano Santos, 580 Cep: 66070-000 Tel/Fax: (91) 266 -0203 Cel: (91) 9981-8137 E-mail: medcinal@amazon.com.br BELM / PA - Arlindo AMAZONAS / RONDNIA DANI Com. Repres. Prest. Servios Ltda R. 10 de Julho, 489A Cep: 69010 -060 Telephone: (92) 622 -2700 / 622-2701 Fax: (92) 233 -3093 Cel: (92) 9146-0305 (Nelson) / (92) 9146 -0304 (Andr) E-mail: dani.compras@horizon.com .br MANAUS / AM - Nelson BAHIA ODONTOBIOMED Comercial Ltda Av. Anita Garibalde, 1815 Ed. CME Lj. 11 Bl. A Ondina Cep: 40170 -130 Telephone: (71) 245 -6547 Fax: (71) 237 -0384 / 235 -9390 Cel: (71) 8814-1920 / 9143-6547 / 9983-5683 E-mail: odontobiomed@uol.com.br SALVADOR / BA - Keller CEAR HOSP TRADE do Brasil Rua Dom Lino, 672 A Parquelndia Cep: 60450-280 Telephone: (85) 281 -7400 / Fax: 223-5262 E-Mail: comercial@hosptrade.com.br FORTALEZA / CE Paulo Marcelo Gomes DISTRITO FEDERAL CTI Com. Repres. Assist. Tcnica Ltda SHN, Qd. 02 Bl. E Ed. Kubitscheck Plaza Sl. 69 Sobreloja 79 Cep: 70710 -908 Tel/Fax: (61) 327 -6166 / 327 -5483 / 329-3583 Cel: (61) 9981-0040 (Marco) / (61) 9983 -2830 (Gilvan) E-mail: cti.com@uol.com.br BRASLIA / DF - Marco e Gilvan ESPRITO SANTO MEDSHOP Comrcio Produtos Mdicos Ltda R. Leoni Souza Guedes, 12 - Ilha Monte Belo Cep: 29040-550 Telephone: (27) 3222 -2666 Fax: (27) 3222-3413 Cel: (27) 9982-2666 (Paulo) / (27) 9989 -6372 (Rinaldo) E-mail: medshop@veloxmail.com.br VITRIA / ES - Paulo Bastos / Rinaldo / Alex GOIS MS Equipamentos Hospitalares Ltda Av. Areio, 595 Setor Pedro Ludovico Cep: 74820 -370 Tel/Fax: (62) 281 -1177 Cel: (62) 9972-2187 E-mail: mseh@terra.com.br GOINIA / GO - Divino MARANHO HOSPFARMA Repres. Com. de Mat. Hospitalar Ltda Av. dos Holandeses QD 37 Lote II - Calhau Cep: 65071-380 Tel/Fax: (98) 227 -5345 / 5392 E-mail: medsurgery@elo.com.br SO LUIS / MA Alex Lima MATO GROSSO MEDLAB Com. Equip. Mdico-Hospitalares Av. So Sebastio, 1603 Cep: 78020 -510 Tel/Fax: (65) 624 -3824 Cel: (65) 9982-6263 (Anselmo) / (65) 9981 -7407 (Holanda) E-mail: medlabmt@terra.com.br CUIAB / MT - Anselmo / Holanda MATO GROSSO DO SUL CENTRO AMRICA Mat. Mdicos e Hospitalares Ltda R. Rui Barbosa, 3845 Cep: 79002 -363 Tel/Fax: (67) 324 -1212 / 324 -9413 / 324-5003 Cel: (67) 9983-1982 E-mail: camerica@brturbo.com CAMPO GRANDE / MS Mauro Boer / Moacir MINAS GERAIS ARS Eletromedicina Ltda (Juiz de Fora ) R. Monsenhor Gustavo Freire, 114 Cep: 36016-470 Tel/Fax: (32) 3216-6617 Cel: (32) 9987-4062 (Gilson) E-mail: arsvend@uai.com.br JUIZ DE FORA / MG Gilson BELMED Eletromedicina Ltda (BH e Grande BH) R. Alvares Maciel, 337 Cep: 30150 -250 Telephone: (31) 3241 -1913 / Fax: (31) 3241 -2723 Cel: 31 9974 8373 (Carlos) / (31) 9981 -1913 (Delio) E-mail: belmed@belmed.com.br BELO HORIZONTE / MG - Carlos / Dlio / Adriana ANESTEMINAS Ltda (Norte e Sul) Av: Cel Alfredo Custdio de Paula, 193 Cep: 37550-000 Telephone: (35) 3422 -8532 / Fax: (35) 3425 -6309 Cel: (35) 9191-9000 (Luiz Carlos) (11) 9939-3683 (Carlos) E-mail: anesteminas@anesteminas.com.br POUSO ALEGRE / MG - Luiz Carlos CIRRGICA VILA Ltda (Tringulo Mineiro) R. Pde. Euclides, 671 Campos Elseos Cep: 14080 -200 Tel/Fax: (16) 636 -5412 Cel: (16) 9791-3984 E-mail: avila@convex.com.br RIBEIRO PRETO / SP - Joo Carlos PARABA / PERNAMBUCO / RIO GRANDE DO NORTE ANESTENORTE Com. Repres. Ltda R. Costa Gomes, 163 Madalena Cep: 50710 -510 Telephone: (81) 3228 -1722 Fax: (81) 3228-4261 Cel: (81) 9111-0764 (Hlio) / (81) 9172-1200 (Gilberto) E-mail: anestenorte@uol.com.br RECIFE / PE - Hlio Lucena / Gilberto PARAN MEDITCNICA Repres. Equip. Hosp. Ltda R. Chile, 1107 Rebouas Cep: 80220-180 Telephone: (41) 332 -6364 Fax: (41) 332 -8766 Cel: (41) 9972-3881 (Lcio) / (41) 9975-1336 (Lori) E-mail: meditecnica@terra.com.br CURITIBA / PR - Lcio / Lori PIAU REMAC Odontomdica Hospitalar Ltda R. Barroso, 1.009 Centro Cep: 64000-130 Telephone: (86) 221 -3011 Fax: (86) 221 -2280 Cel: (86) 9981-1108 (Srgio) / (86) 9432-4406 (Ana) E-mail: remacvendas.takaoka@veloxmail.com.br TERESINA / PI Srgio/Ana Valeska RIO DE JANEIRO RIO TAK Com. e Repres. Mat. Cirrg. Ltda R. Sacadura Cabral, 81 Grupo 701 Cep: 20081 -260 Telephone: (21) 2263 -9602 Fax: (21) 2253-3458 Cel: (21) 7837-8864 (Roberto) / (21) 9985-0787 (Marcos) E-mail: riotak@terra.com.br RIO DE JANEIRO / RJ Roberto / Marcos / Felipe PB HOSPITALAR R. Dr. Borman, 23 Grupo 801 Niteri Cep: 24020 -320 Tel/Fax: (21) 2719-6611 / 2620-4377 / 2719-6611 Cel: (21) 9995-1727 (Wagner) / (21) 9197 -6141 (Padilha) E-mail: pbhospitalar@urbi.com.br RIO DE JANEIRO / RJ Wagner RIO GRANDE DO SUL HOSPITRADE Ltda R. So Manoel, 1994 Santana Cep: 90620-110 Tel/Fax: (51) 3217-6771 / 3223-1436 / 3223-0460 Cel: (51) 9956-0510 (Carlos) / (51) 9961-4506 (Artur) E-mail: htrade@hospitrade.com.br PORTO ALEGRE / RS Carlos / Artur SANTA CATARINA HOSPITLIA Cirrgica Catarinense Ltda R. Prof. Custdio de Campos, 281 Cep: 88090 -720 Telephone: (48) 241 -1100 / 241-5567 / Fax: (48) 241 -5585 Cel: (48) 9982-1608 (Elson) / ( 48) 9981-2602 (Carlos) E-mail:hospitalia.cirurgica@terra.com.br FLORIANPOLIS / SC - Elson / Carlos SERGIPE ODONTOMEDICAL Comrcio Ltda R. Acre, 1.442 Amrica Cep: 49080 -010 Telephone: (79) 241 -3131 / Fax: (79) 241 -4400 Cel: (71) 8814-1920 E-mail: odontomedical@infonet.com.br ARACAJU / SE - Keller SO PAULO Capital MEDESOL Prod. Md. Hosp. Ltda R. Guaraciama, 42 Jd da Sade Cep: 04153 -070 Telephone: (11) 5058 -9334 / Fax: (11) 5058 -9698 Cel: (11) 9988-1904 (Edison Luiz) / 9995 -7828 (Wilson) E-mail: medesol@superig.com.br SEGURAMED Com. De Mat. Equip. Hosp. Av. Gov. Ademar Pereira de Barros, 120/126 Cep: 03454-070 Telephone: (11) 6721 -4414 / Fax: (11) 6721 -0159 Cel: (11) 9996-2439 (Hamilton) / (11) 9191-1177 (Rodrigo) E-mail: seguramed@seguramed.com.br Guarulhos / Jundia / Itatiba / Bragana e regio BIOCOM Ltda R. das Orqudeas, 321 Mirandpolis Cep: 04050 -000 Tel/Fax: (11) 5585-1913 Cel: (11) 9976-3916 (Fbio Souza) / (11) 9913 -9227 (Ktia) E-mail: diretoria@biocomtec.com.br Itapecerica da Serra / Taboo W/ MD Wassimon Fonseca de Brito R. Augusto Hog, 129 Guarulhos Cep: 07172 -200 Tel/Fax: (11) 6432-4352 Cel: (11) 9993-9847 (Wassimon) / (11) 9515 -3004 (Edson) E-mail: wmed.kt@terra.com.br Piracicaba / Botucatu e regio SPEED MED Paulo Sussumu Av. Moaci, 534 Apto 54A - Moema Cep: 04083 -001 Tel/Fax: (11) 5042-1105 Cel: (11) 9939-0074 E-mail: speedmed@uol.com.br ABCD / Baixada Santista / Litoral SP / Vale do Ribeira WORK AND LIFE Comercial Ltda R. das Roseiras, 53 Vl. Bela Cep: 03144 -090 Tel/Fax: (11) 6345-9595 Cel: (11) 8139-4600 (Nilmar) / (11) 8139-4500 (Alexian) E-mail: work@workandlife.com.br SO PAULO / SP Alexian / Nilmar Campinas e regio LAC Com. Manut. Equip. Md. Hosp. Ltda R. Henrique Nazar Martins, 59 Cep: 13085-005 Tel/Fax: (19) 3289-4449 / Cel: (19) 9791 -3808 E-mail: vendas@lacmedic.com.br CAMPINAS / SP Helio Nei Regio Alta Paulista So Jos do Rio Preto e regio ULYMED Com. e Representaes R. dos Bombeiros, 227 Boa Vista Cep: 15025-420 Tel/Fax: (17) 234 -3825 Cel: (17) 9772-6272 E-mail: ulymed@terra.com.br SO JOS DO RIO PRETO / SP Ulysses / Bete Regio Nordeste CIRRGICA VILA Ltda Tel/Fax: (16) 636 -5412 Cel: (16) 9791-3984 E-mail: avila@convex.com.br RIBEIRO PRETO / SP - Joo Carlos CIRRGICA NEVES Ltda. R. Presidente Vargas, 169 Cep: 17501-550 Tel/Fax: (14) 3413-2483 Cel: (14) 9601-2990 E-mail: cir.neves@terra.com.br MARLIA / SP Odair Vale do Paraba ANESTEMINAS Ltda Telephone: (35) 3423 -3348 / Fax: (35) 3425 -6309 / Cel: (35) 9191-9000 (Luiz Carlos) / (11) 9939-3683 (Carlos) / (35) 9191 -0011 (Hugo) E-mail: anesteminas@anesteminas.com.br

Sales and Showroom: R. Bertioga, 385 Cep: 04141-100 So Paulo SP Customer Service: (11) 5586-1100 Telephone: (11) 5586 -1000 / Fax: (11) 5589 -8072 E-mail: ktvendas@takaoka.com.br Home page: www. takaoka.com.br

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TAKAOKA INTERNATIONAL DEALERS

SOUTH AMERICA BRASMED S/A Anesthesia Line Talcahuano, 958 L. 416 CF 1013 Tel: (54114) 814-3677 Fax: (54114) 814-3813 E-mail: info@brasmed.com.ar BUENOS AIRES ARGENTINA - Sra. Ana Magalhes ING. CARUSO SRL ICU Line Burela, 1957 (1431) Tel: (54114) 522-1317 Fax:(54114) 523 -4919 E-mail: ing.caruso@ciudad.com.ar BUENOS AIRES ARGENTINA - Ing. Miguel Caruso IMPORTADORA FERNANDO Calle Tucabaca, Esq. Burapucu Casilla 5 Tel: (5913) 354-2525 Fax: (5913) 354-2526 E-mail: imp-fernando@cotas.com.bo SANTA CRUZ BOLVIA - Sr. Erwin Hurtado MEDI MARK MERCADOTECNICA MEDICA Av. Argentina, 2001 casi esquina Villalobo Tel / Fax: (5912) 224-6493 E-mail: medi_mark@yahoo.com LA PAZ BOLIVIA - Sr. Leopoldo Antezana INGEMEDICA S.A ICU Line Manuel Galecio, 231 entre Ximena y Boyac Tel: (5934) 230-3173 / 230-3185 Fax: (5934) 230-1428 E-mail: ingemedica@gye.satnet.net GUAYAQUIL ECUADOR - Sr. Ernesto Rovayo COMERCIALIZADORA DE PRODUCTOS FCV Calle, 155 A NR. 23-58 Floridablanca Tel: (577) 639-6767 Ext. 810 Fax: (577) 639 -2595 E-mail: comercial@fcv.org SANTANDER COLOMBIA - Ing. Giovanni Gutierrez BIOXEL S/A Araucana, 1277 CP. 11400 Tel: (5982) 606-0172 Fax: (5982) 600-5435 E-mail: marielk@bioxel.com Dra. Mariel Kuehr / Carlos Bonilla MONTEVIDEO URUGUAY AREAMEDICA EL BOSQUE, C.A. Av. El Carmen, Quinta Torre Lavega, Local n1, Urbanizacin el Bosque, Municipio Chacao Tel: (58212) 731-3913 Fax: (58212) 731-3928 E-mail: carlosgaravito@cantv.net Sr. Carlos Garavito / Abel Maestre CARACAS VENEZUELA A.JAIME ROJAS S/A JR. Garcia Y Garcia, 870 Barranco Tel: (511) 477-8410 Fax: (511) 477-1316 E-mail: import@ajaimerojas.com LIMA PERU - Sr. Juan Santa Cruz CARIBBEAN & CENTRAL AMERICA 2N S.A DE CV Primeira Calle Ponient, 2904 3. Planta Local 3 Cond. Monte Maria Tel: (503) 260-5288 Fax: (503) 208-1895 E-mail: nuila02@yahoo.com SAN SALVADOR EL SALVADOR - Sr. Rene Nuila EUROTADE IBERICA Aerocaribean, km 1 1/2 Tel: (537) 540-000 E-mail: eurotade@enet.cu LA HABANA CUBA - Sr. Igncio Quintero IMPORTADORA JAEGER S/A 12 Calle 8-53 Zona 01 Tel: (502) 232-2285 Fax: (502) 251-4137 E-mail: jaeger@intelnet.net.gt GUATEMALA CA GUATEMALA - Mr. Alexander Huschke MEDI EQUIPOS S.A C./ Wenceslao Alvarez # 260 Zona Universitria (UASD) Tel: (809) 688-5520 Fax: (809) 221-0124 E-mail: medequip@tricom.net SANTO DOMINGO REPBLICA DOMINICANA CORPORACION MEDICA INTERNATIONAL Baja California, 167-102 CP 06760 Col Romasur Tel: (5255) 5264-7006 Fax: (5255) 5264-7593 E-mail: leguisi@yahoo.com.mx MEXICO CITY MEXICO - Sr. Leonardo Guinea TECNOLOGIA HOSPITALARIA RYM Avenida 12, Calle 28 Plz Aventura Tel: (506) 223-7446 Fax: (506) 255-3165 E-mail: thrymsa@racsa.co.cr SAN JOSE COSTA RICA - Sr. Roberto Molina ULTRAMED Avenida Ricardo Arango Y Calle 53 Ed. Fursys Tel: (507) 263-7087 Fax: (507) 269-3561 E-mail: allan@ultramedcorp.com PANAMA CITY PANAMA - Sr. Allan Figueroa SNCHEZ & COLLADO CIA LTDA Ferretera Sinsa, 75 Vs. Altamira Deste, 448 Tel: (505) 278-0999 Fax: (505) 278-4928 E-mail: sacol@ibw.com.ni MANAGUA - NICARAGUA - Sr. Abelardo Snchez DIST. EQUIPOS MEDICOS Col. Ruben Dario, 2117 Tel: (504) 232-3544 Fax: (504) 232-2503 E-mail: demlf@multivisionhn.net TEGUCICALPA HONDURAS - Sra. Yma de Sabillon ASIA / FRICA BEYOND ENGINEERING Nr. 30, Jalan Maju 4 Taman Pelangi Tel/Fax: (607) 331-4262 E-mail: bydeng@tm.net.my JOHOR BAHRUI MALAYSIA - Mr. A. Dass HI-MED EGYPT 41 El- Montaza St. Tel: (202) 240-2591 Fax: (202) 635-2977 E-mail: hanyhimed@hotmail.com CAIRO EGYPT - Dr. Hany K. El-Shafei GR MEDI CORP 5, Kaveri Street CP 600073 Tel: (9144) 2227-5297 Fax: (9144) 2227-1206 E-mail: grmedi@satyam.net.in GOMATHI NAGAR CHENNAI - Mr. Krishna Kumar PROGRESSIVE MEDICAL CORP. 29 F/Antel Global Corporate Center n 3 Dona Julia Vargas Avenue Tel: (632) 687-7788 Fax: (632) 687-2190 E-mail: hclim@pmcgroupl.com PASIG CITY PHILIPPINES - Mr. Homer C. Lim PT BERSAUDARA JL Penjernihan Raya, 38 Tel: (6221) 5701-1467 Fax: (6221) 5701-1468 E-mail: sholahudin@bersaudara.com JAKARTA INDONESIA - Mr. Sholahudin Husni SIGMA STAR MED LTDA 1089/1091 Onnuch Road, Suanluang Tel: (662) 742-1015 Fax: (662) 311-3550 E-mail: starmed@ksc.th.com BANGKOK THAILAND - Mrs. Kunvadee Egnukal ETHOS TRADE CONCERN EPC 7181 POBOX 8975 Tel: (977 -1) 477205 Fax: (977 -1) 473874 E-mail: ethos@wlink.com.np KATHMANDU NEPAL - Mr. Rajesh Man Shrestha BIOLOGIC MEDICAL SYSTEMS Poonawala Terrace, Plo # JM711/5 Offive n6, Mezzanine Floor New M. A. Jinnah Road Karachi 74800, Pakistan Tel: (9221) 492-4029 Fax: (9221) 412-7459 E-mail: lighting@cubexs.net.pk PAKISTAN Mr. Shahid Suri MIDDLE EAST NOMAS TRADING EST P.O.BOX 105823 Riyadh 11 656 Tel: (9661) 472-5862 Fax: (9661) 472-5867 E-mail: nomas@nomas-nte.com SAUDI ARABIA - Mr. Jamil H.Al Shahed ABAJI CO. Eskandaroon Street POBOX 11096 Tel: (963 -21) 228-3216 Fax: (963-21) 224-0042 E-mail: jamilia@net.sy ALEPPO SYRIA - Mr. Jamal Abaji EUROPE LA BOUVET Av. Bruselas, 38 Tel: (341) 726-4229 Fax: (341) 356-6101 E-mail: grupacer@teleline.es MADRID ESPAA - Mr. Jorge Perez UAB REMEDA 29, Siltnamiu Tel: (3702) 36 2028 Fax: (3702) 36 2130 E-mail: remeda@takas.it Mr. Romaldas Bogusis / Mr. R. Jonelis VILNIUS 2043 LITHUANIA PROMEI LTDA. Rua do Fetal, lote 5 Fornos Tel: (3512) 3943-1198 Fax: (3512) 3943-1700 E-mail: rcruz@promei.pt COIMBRA PORTUGAL - Sr. Ramos da Cruz B&MC CARDIO-VOLGA 36, Sverdlov, Volzhsky Tel: (7-8443) 31 2221 Fax: (7-8443) 31 2523 E-mail: irina@bimcvol.vlz.ru VOLGOGRAD RUSSIA - Mrs. Irina Khorochoun

FOR MORE INFORMATION: R. Bertioga, 385 Cep: 04141-100 So Paulo SP Brazil Tel: (5511) 5586-1089 Fax: (5511) 5586-1052 E-mail: comex@takaoka.com.br www.takaoka.com.br

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TECHNICAL ASSISTANCE K. TAKAOKA

K. TAKAOKA Indstria e Comrcio Ltda. informs that only its Technical Service Centers are authorized to service the equipment it supplies.

Service rendered by third parties pose serious risks once the origin of the parts employed is unknown and workmanship does not meet the stringent standards set by K. TAKAOKA

We are not in a position to ensure the correct operation of the equipment we manufacture if it has been repaired by non-authorized third parties.

Any requests regarding Technical Assistance Service and preventive maintenance, by contract or else, shall be addressed directly to K. TAKAOKA or to one of its exclusive and duly authorized representatives.

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AUTHORIZED K. TAKAOKA TECHNICAL ASSISTANCE

ALAGOAS CASA DO MDICO R. Roberto Simonsen, 412 Cep: 57052 -675 Tel/Fax: (82) 338-8777 Cel: (82) 9381-2526 E-mail: compras_cmedico@hotmail.com MACEI / AL - Rog rio

MINAS GERAIS ARS Eletromedicina Ltda (Juiz de Fora) R. Monsenhor Gustavo Freire, 114 Cep: 36016-470 Tel/Fax: (32) 3216-6617 Cel: (32) 9987-4062 (Gilson) E-mail: arsvend@uai.com.br JUIZ DE FORA / MG Gilson

SANTA CATARINA HOSPITLIA Cirrgica Catarinense Ltda R. Prof. Custdio de Campos, 281 Cep: 88090 -720 Telephone: (48) 241 -1100 / 241 -5567 / Fax: (48) 241-5585 Cel: (48) 9982 -1608 (Elson) / (48) 9981-2602 (Carlos) E-mail: hospitalia.cirurgica@terra.com.br FLORIANPOLIS / SC - Elson / Carlos SERGIPE ODONTOMEDICAL Comrcio Ltda R. Acre, 1.442 Amrica Cep: 49080 -010 Telephone: (79) 241 -3131 / Fax: (79) 241-4400 Cel: (71) 8814 -1920 E-mail: odontomedical@infonet.com.br ARACAJU / SE - Keller SO PAULO Campinas e regio LAC Com. Manut. Equip. Md. Hosp. Ltda R. Henrique Nazar Martins, 59 Cep: 13085-005 Tel/Fax: (19) 3289-4449 / Cel: (19) 9791 -3808 E-mail: vendas@lacmedic.com.br CAMPINAS / SP Helio Nei Regio Alta Paulista So Jos do Rio Preto e regio CLINITCNICA Equipamentos Mdicos Ltda R. Major Joo Batista Frana,2108 Cep:15025 -610 Tel/Fax: (17) 212-2566 / 212 -2995 E-mail: clinitecnica@goldnet.com.br SO JOS DO RIO PRETO / SP Vlter Regio Nordeste CIRRGICA VILA Ltda Tel/Fax: (16) 636-5412 Cel: (16) 9791-3984 E-mail: avila@convex.com.br RIBEIRO PRETO / SP - Joo Carlos CIRRGICA NEVES Ltda. R. Presidente Vargas, 169 Cep: 17501-550 Tel/Fax: (14) 423-2483 Cel: ( 14) 9601-2990 E-mail: cir.neves@terra.com.br MARLIA / SP Odair Vale do Paraba ANESTEMINAS Ltda Telephone: (35) 3423-3348 / Fax: (35) 3425 -6309 / Cel: (35) 9191 -9000 (Luiz Carlos) / (11) 9939-3683 (Carlos) / (35) 9191 -0011 (Hugo) E-mail: anesteminas@anesteminas.com.br

AMAZONAS / RONDNIA DANI Com. Repres. Prest. Servios Ltda R. 10 de Julho, 489A Cep: 69010 -060 Telephone: (92) 622 -2700 / 622 -2701 Fax: (92) 233-3093 Cel: (92) 9146 -0305 (Nelson) / (92) 9146 -0304 (Andr) E-mail: dani.compras@horizon.com.br MANAUS / AM - Nelson

BELMED Eletromedicina Ltda (BH e Grande BH) R. Alvares Maciel, 337 Cep: 30150 -250 Telephone: (31) 3241-1913 / Fax: (31) 3241 -2723 Cel: 31 9974 8373 (Carlos) / (31) 9981 -1913 (Delio) E-mail: belmed@belmed.com.br BELO HORIZONTE / MG - Carlos / Dlio / Adriana

BAHIA ODONTOBIOMED Comercial Ltda Av. Anita Garibalde, 1815 Ed. CME Lj. 11 Bl. A Ondina Cep: 40170 -130 Telephone: (71) 245-6547 Fax: (71) 237-0384 / 235-9390 Cel: (71) 8814 -1920 / 9143 -6547 / 9983 -5683 E-mail: odontobiomed@uol.com.br SALVADOR / BA - Keller

ANESTEMINAS Ltda (Norte e Sul) Av: Cel Alfredo Custdio de Paula, 193 Cep: 37550-000 Telephone: (35) 3422-8532 / Fax: (35) 3425 -6309 Cel: (35) 9191 -9000 (Luiz Carlos) (11) 9939-3683 (Carlos) E-mail: anesteminas@anesteminas.com.br POUSO ALEGRE / MG - Luiz Carlos

CEAR HOSP TRADE do Brasil Rua Dom Lino, 672 A Parquelndia Cep: 60450-280 Tel/Fax: (85) 281-7400 E-Mail: comercial@hosptrade.com.br FORTALEZA / CE Paulo Marcelo Gomes

CIRRGICA VILA Ltda (Tringulo Mineiro) R. Pde. Euclides, 671 Campos Elseos Cep: 14080 -200 Tel/Fax: (16) 636-5412 Cel: (16) 9791-3984 E-mail: avila@convex.com.br RIBEIRO PRETO / SP - Joo Carlos

DISTRITO FEDERAL CTI Com. Repres. Assist. Tcnica Ltda SHN, Qd. 02 Bl. E Ed. Kubitscheck Plaza Sl. 69 Sobreloja 79 Cep: 70702-904 Tel/Fax: (61) 327-6166 / 327 -5483 / 329 -3583 Cel: (61) 9981 -0040 (Marco) / (61) 9983-2830 (Gilvan) E-mail: cti.com@uol.com.br BRASLIA / DF - Marco e Gilvan

PAR MEDICINAL Com. e Repres. Ltda Av. Cipriano Santos, 580 Cep: 66070-000 Tel/Fax: (91) 266-0203 Cel: (91) 9981-8137 E-mail: medcinal@amazon.com.br BELM / PA - Arlindo

ESPRITO SANTO EMILTEC Assist. Tec. Equip. Mdicos Ltda R. Leoni Souza Guedes, 12 Cep: 29040-550 Tel/Fax: (27) 3222-2666 / (27) 3222-0131 Cel: (27) 9981 -2267 VITRIA / ES Svio

PARABA / PERNANBUCO / RIO GRANDE DO NORTE ANESTENORTE Com. Repres. Ltda R. Costa Gomes, 163 Madalena Cep: 50710 -510 Telephone: (81) 3228-1722 Fax: (81) 3228 -4261 Cel: (81) 9111 -0764 (Hlio) / (81) 9172-1200 (Gilberto) E-mail: anestenorte@uol.com.br RECIFE / PE - Hlio Lucena / Gilberto

GOIS MS Equipamentos Hospitalares Ltda Av. Areio, 595 Setor Pedro Ludovico Cep: 74820 -370 Tel/Fax: (62) 281 -1177 Cel: (62) 9972 -2187 E-mail: mseh@terra.com.br GOINIA / GO - Divino

PARAN MEDITCNICA Repres. Equip. Hosp. Ltda R. Chile, 1107 Rebouas Cep: 80220-180 Telephone: (41) 332 -6364 Fax: (41) 332-8766 Cel: (41) 9972 -3881 (Lcio) / (41) 9975-1336 (Lori) E-mail: meditecnica@terra.com.br CURITIBA / PR - Lcio / Lori PIAU REMAC Odontomdica Hospitalar Ltda R. Barroso, 1.009 Centro Cep: 64000-130 Telephone: (86) 221 -3011 Fax : (86) 221 -2280 Cel: (86) 9981 -1108 (Srgio) / (86) 9432 -4406 (Ana) E-mail: remacvendas.takaoka@veloxmail.com.br TERESINA / PI Srgio/Ana Valeska RIO DE JANEIRO RIO TAK Com. e Repres. Mat. Cirrg. Ltda R. Sacadura Cabral, 81 Grupo 701 Cep: 20081 -260 Telephone: (21) 2263-9602 Fax: (21) 2253 -3458 Cel: (21) 7837 -8864 (Roberto) / (21) 9985-0787 (Marcos) E-mail: riotak@terra.com.br RIO DE JANEIRO / RJ Roberto / Marcos / Felipe

LOCATIONS THE MAIN OFFICE SERVES (11) 5586-1001 ABCD Itapecerica da Serra Baixada Santista and SP Coast Itatiba Botucatu & region Jundia Bragana & region Piracicaba Capital & So Paulo Metro Region Sorocaba Guarulhos Taboo

MARANHO QUARK Eletrnica de Preciso e Comrcio Ltda Rua N, Qd 13 n04 Planalto Anil III Cep: 65053 -212 Tel/Fax: (98) 238-7034 Cel: (98) 9973-0858 E-mail: quark.ma@elo.com.br SO LUIS / MA Roberto Sasso

MATO GROSSO MEDLAB Com. Equip. Mdico-Hospitalares Av. So Sebastio, 1603 Cep: 78020 -510 Tel/Fax: (65) 624-3824 Cel: (65) 9982 -6263 (Anselmo) / (65) 9981 -7407 (Holanda) E-mail: medlabmt@terra.com.br CUIAB / MT - Anselmo / Holanda

Customer Service: (11) 5586-1100 Sales and Showroom: R. Bertioga, 385 Cep: 04141 -100 So Paulo SP Telephone: (11) 558610 00 / Fax: (11) 5589 8072 E-mail: ktvendas@takaoka.com.br Home page: www. takaoka.com.br

Last Update 06.18.04

MATO GROSSO DO SUL CENTRO AMRICA Mat. Mdicos e Hospitalares Ltda R. Rui Barbosa, 3845 Cep: 79002 -363 Tel/Fax: (67) 324-1212 / 324 -9413 / 324 -5003 Cel: (67) 9983 -1982 E-mail: camerica@brturbo.com CAMPO GRANDE / MS Mauro Boer / Moacir

RIO GRANDE DO SUL HOSPITRADE Ltda R. So Manoel, 1994 Santana Cep: 90620-110 Tel/Fax: (51) 3217-6771 / 3223-1436 / 3223 -0460 Cel: (51) 9956 -0510 (Carlos) / (51) 9961 -4506 (Artur) E-mail: htrade@hospitrade.com.br PORTO ALEGRE / RS Carlos / Artur

Cdigo do manual: 204010210_003

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Information for Technical Assistance

This card must be filled -out and returned together with the device. Name:

Hospital:

Address:

Phone:

District:

ZIP: -

City:

State

Descrio do defeito:

Information for Technical Assistance

This card must be filled -out and returned together with the device. Name:

Hospital:

Address:

Phone:

District:

ZIP: -

City:

State

Descrio do defeito:

Cdigo do manual: 204010210_003

103