Está en la página 1de 48

Manual

Operation

OPERATION MANUAL
1415 MULTIAGENT VAPORIZER

Equipment code: 201030023


Manual Code: 204010170_004
Date: (AGO/2008)

Código do manual: 204010170_004 1


His Operation Manual has the information that is necessary for the proper usage of Multiagent Vaporizer 1415.

Manufacturer:
K. Takaoka Indústria e Comércio LTDA
Rua General Izidoro Dias Lopes, 121/141
Bairro Vila Paulicéia - São Bernardo do Campo / SP
ZIP: 09687-100
Telephone: (55 11) 4176-3500
Fax: (55 11) 4176-3570
Website: www.takaoka.com.br
E-mail: kt@takaoka.com.br

CGC: 61.489.381/0001-09
I.E.: 635.547.970.118
Suggestions, doubts or complaints:
Call Center: (55 11) 4176 3636

Product Registration at the Health Ministry:


Technical Name: Vaporizer
Trade Name: Multiagent Vaporizer 1415
Registration Number at the Health Ministry: 10229820077

Product Classification:
• IEC-60601-1:1988+amendment 1994– (Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance)
• IEC 60601-2-13/2003- (Medical electrical equipment - Part 2-13: Particular requirements for the safety and
essential performance of anaesthetic systems)
• Equipment Class 1 – Energized Internally
• Type B – IPX1 – Continuos Operation

Technician in Charge:
Eng. Mauricio Chiarioni
CREA: Registration number 5061714921

Código do manual: 204010170_004 2


Product Installation Form

EQUIPMENT: ___________________________ Code: ____________ Serial Number: _________

DESCRIPTION CODE SERIAL NUMBER


1
2
ACCESSORIES

3
4
5
6
7
8
9
10

INVOICE: Original K. Takaoka [ ] YES _______________ [ ] NO ______________________


Invoice Number* Representation Name
INSTITUTION:

Corporate Name: ____________________________________Tax Payer’s ID*:_______________________

Address: _______________________________________________________________________________

City: __________________________________________State:_____________ ZIP: __________________

Person in charge of the information*:______________________________Position: ____________________

Sector: ______________________ Phone*: ___________________ E-mail: _________________________


(*) Mandatory Fields
YOUR OPINION:

1. Was the product delivered punctually, within the period that was agreed on? Yes No
2. Did products and accessories match the order? Yes No
3. Was the package damaged in any way? Yes No
4. Was there any difficulty in installing the equipment? Yes No
5. Is (are) the device(s) and accessories working properly? Yes No
6. Were there any accessory, tube, and cable connection problems? Yes No
7. Were the data, values, product description, amount, and payment conditions on the Yes No
invoice correct?
8. Mention any possible inconveniences:

Installation by: ________________________ Date ____/ ____ /_____ Sig.: __________________


(Technician Name)
Representation: _______________________ Data ____/ ____ /_____ Sig.: _________________

Send this form to Fax (11) 4176-3570, 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) 4176 3636

Código do manual: 204010170_004 3


TABLE OF CONTENTS

1 WARNINGS ............................................................................................................................................................................8
2 QUICK INSTALLATION GUIDE............................................................................................................................................10
3 GENERAL DESCRIPTION....................................................................................................................................................12
4 TECHNICAL SPECIFICATION..............................................................................................................................................13
5 OPERATING PRINCIPLE .....................................................................................................................................................15
6 CONTROLS AND COMPONENTS........................................................................................................................................17
6.1 LIST OF COMPONENTS...................................................................................................................................................17
6.2 FRONT VIEW .................................................................................................................................................................17
6.3 REAR VIEW ..................................................................................................................................................................19
6.4 MINI-PINOMATIC BUBBLING CHAMBER ............................................................................................................................19
7 DISPLAY...............................................................................................................................................................................22
7.1 SCREENS .....................................................................................................................................................................22
7.2 MESSAGES ...................................................................................................................................................................24
8 ASSEMBLING AND PREPARING THE VAPORIZER...........................................................................................................25
8.1 ASSEMBLING THE ANESTHESIA MACHINE ........................................................................................................................25
8.2 CONNECTIONS ..............................................................................................................................................................27
8.3 POWER SUPPLY............................................................................................................................................................27
8.4 MOUNTING THE MINI-PINOMATIC BUBBLING CHAMBER .................................................................................................29
9 OPERATION .........................................................................................................................................................................30
9.1 INITIAL PROCEDURES ....................................................................................................................................................30
9.2 FILLING THE CHAMBER ..................................................................................................................................................30
9.3 VAPORIZATION INSTRUCTIONS .......................................................................................................................................31
9.4 CHAMBER DRANING ......................................................................................................................................................31
10 CLEANING AND STERILIZATION........................................................................................................................................33
11 MAINTENANCE ....................................................................................................................................................................33
12 SYMBOLS.............................................................................................................................................................................38
13 EMERGENCY ACTIONS.......................................................................................................................................................43
14 WARRANTY .........................................................................................................................................................................44

Código do manual: 204010170_004 4


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

Código do manual: 204010170_004 5


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.


Rua General Izidoro Dias Lopes.121/141
Bairro Vila Paulicéia – São Bernardo do Campo / SP
ZIP: 09687-100
Telephone: (55 11) 4176 3500
Fax: (55 11) 4176 3570
E-mail: kt@takaoka.com.br
Website: http://www.takaoka.com.br

Código do manual: 204010170_004 6


Figure 1. Vaporizer 1415

Código do manual: 204010170_004 7


1 WARNINGS

Using the Equipment

 Always verify the desired bubbling flow in order for the anesthetic agent concentration in the circuit to be the desired one for the
inhaling anesthesia.

 Always verify what type of anesthetic agent is being used by pressing the AGENT key.

 If there is any doubt regarding the type of anesthetic agent present in the bubbling chamber, replace it.

 When replacing the anesthetic agent, make sure you reposition the anesthetic agent indicator pin to the correct position. Pin
positioning reading ensures the correct calculation of the bubbling flow table.

 Never exceed maximum chamber capacity, i.e. 100 ml.

 The chamber’s filling funnel must be tightly closed during anesthesia so there is no gas leakage.

 Vaporizer 1415 has two scales for bubbling flows, one for low and another one for high flows. Do not add the readings.

 During a lack of power emergency, Vaporizer 1415 can continue being used without its electronic functions. However, special care
should be taken to prevent high anesthetic concentrations.

 Maintain the bubbling chamber empty and dry every time the vaporizer is not being used in order for the equipment to be better
conserved.

 The Vaporizer 1415 should be kept in the upright position while it is filled with anesthetic agent.

 This operation manual should be read very carefully in order for one to use the equipment correctly and gain maximum benefit from
all its features.

 Also, read the Operation Manuals for the other anesthetic machine parts and accessories.

 The operator must supervise the anesthesia device continually while administering gas to the patient.

Fire and Associated Risks

 Do not use the equipment in the presence of flammable agents. Additionally, do not apply oil or grease on the equipment to avoid the
risk of combustion.

 To reduce the risk of fire, only use tubes and circuits designed for oxygen-enriched environments. Do not use electrically conductive
or anti-static tubes.

 In case of fire, take care of the patient's needs immediately, turn Vaporizer 1415 off, and disconnect it from the power and gas
sources.

Service and Tests

 Do not perform any internal servicing of any part of the apparatus. For regular equipment servicing or to troubleshoot any abnormality
in its operation, call K. TAKAOKA’S Authorized Technical Assistance.

 To reduce the risk of electric shocks, do not remove the cap or any part of the equipment for internal access.

 To reduce the risk of electric shock, disconnect the equipment’s power source before any maintenance service is performed.

 Do not perform any maintenance procedure except for those specified in the device’s service manual.

 Only use parts and pieces supplied by K. TAKAOKA Ind. & Com. Ltda.

 Any attempt to change the hardware or firmware without K. TAKAOKA’S formal approval in writing will automatically void all
equipment guarantees.

 Vaporizer 1415 should be calibrated and serviced annually by an authorized K. TAKAOKA technician.

Código do manual: 204010170_004 8


 To ensure the equipment operates safely, always run the tests and procedures prescribed in item 9.1 before using the vaporizer in
the patient’s breathing circuit. If the equipment fails any of the tests, remove it from clinical use immediately. Do not use the
equipment until the necessary repairs have been carried out.

 The K. TAKAOKA product technical features are subject to changes without prior notice due to their constant technological
development.

Electromagnetic Susceptibility

 The equipment may suffer interference from certain transmission machines (for example: cell phones, walkie-talkies, wireless
phones, pagers, high-frequency surgical equipment (diathermy), defibrillators, short-wave therapy devices), which could interrupt the
equipment’s normal operation. Do not use these transmission devices near vaporizer 1415. Do not use Vaporizer 1415 in an
environment where there is magnetic resonance imaging equipment.

Power Source

 Only connect the 12-VDC cable provided with the equipment between the Pinomatic Support’s 12-VDC “input” and the Rotameter
Block’s 12-VDC “output.”

Miscellaneous

 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.

 Establish an appropriate cleaning and sterilization routine for the vaporizer components.

Disposal ("waste")

 All parts and components that have contact with fluids originating from patients (for example: respiratory circuit), are potentially
contaminated. These are named semi-critical components and they must undergo a high-level disinfections or sterilization process
before being discarded (at the end of their service lives), or be discarded as potentially infected hospital waste.

 Discard all parts removed from the equipment in accordance with your organization’s part and component disposal protocol. Follow
local government environmental protection recommendations, particularly for electronic waste or parts.

"FIRMWARE" Release

 Vaporizer 1415’ control program has a release number that allows one to identify its level of review and it is presented when the
equipment is started up (switched on).

Biocompatibility

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

Código do manual: 204010170_004 9


2 QUICK INSTALLATION GUIDE

For quick, safe, and proper installation, follow the procedure described below (for a more detailed installation, check item 8 in this manual):

Item Procedure Figure

Check package integrity. If there is any damage, contact your None


01
representative.

Open the package and check its contents. If there is any None
02
discrepancy, contact your representative.

Remove the equipment and its accessories; check the integrity of all
None
03 components. If there is any apparent damage in the equipment or in
any of its accessories, contact your representative.

Use the 12-VDC cable connected to the rotameter block output to


04
supply the pinomatic support.

Install Vaporizer 1415 on the pinomatic support. Check whether


05
the vaporizer is firmly installed on
the support.

Open the bubbling chamber removing the funnel’s screw-on lid


and fill the bubbling chamber with the desired anesthetic agent.
06
The level must always be between 10 and 100 ml during the
anesthesia procedure.

Firmly close the funnel with its lid on.


07

Set-up the chamber placing the agent’s indicator pin to its correct
08
position.

Código do manual: 204010170_004 10


Install the bubbling chamber on the Mini-Pinomatic support (right-
09 side of the vaporizer). Check whether the installation is firm in
order for there to be
no leakage.

10 Switch the ventilator on. During start up, the display shows the
firmware release that is installed.

The display will show a bubbling flow concentration


11 correspondence table, which must be used to adjust the desired
anesthetic agent concentration.

Using the “DISPLAY” key, one can browse through other


12
correspondence tables.

Using the “AGENT” key, one may check the anesthetic agent
13 being used.

Continue reading this manual to achieve full understanding of the


14 None
Vaporizer’s operation.

Código do manual: 204010170_004 11


3 GENERAL DESCRIPTION

Vaporizer 1415 was designed to integrate the K. TAKAOKA line of Anesthesia Devices. It is a rotameter-controlled universal vaporizer
designed to use the HALOTHANE, ENFLURANE, ISOFLURANE or SEVOFLURANE agents. Vaporizer 1415 is microprocessed and has
important features that render it an easy-to-use, versatile device.

TOTAL GAS FLOW is a mixture of oxygen, nitrous oxide or compressed air, regulated at the anesthesia device’s rotameter block. This
flow enters in the Multiagent Vaporizer, where it is divided in to two parts:

1- BUBBLING FLOW – small parcel of the total flow that is controlled by the flow control button on Vaporizer 1415 and is measured by
the respective rotameter. The flow crosses the bubbling chamber, becoming saturated with anesthetic agent steam.

2- DILUENT FLOW – another part of the total flow that goes directly to Vaporizer 1415’s output and then mixes with the bubbling flow
that is saturated with anesthetic.

The continual flow of fresh gases that leaves Vaporizer 1415 is, therefore, constituted by the total gas flow with a certain concentration of
the volatile anesthetic agent steam.

Main Features

 High luminosity liquid crystal display to view the concentration versus bubbling flow/anesthetic agent flow ratio table set-up in the
chamber (indicated by the pin).

 The required bubbling flow calculation function dispenses the use of the calculation rule to determine the desired concentration,
making it even easier to use the vaporizer.

 The Dilumatic® safety system blocks vaporization and the supply of anesthetic agents unless the total flow is open at the rotameter.

 The exclusive Pinomatic® system, that allows for easy interchange between Multiagent Vaporizers and K. TAKAOKA Calibrated
Vaporizers, through a quick connection system.

 Two rotameters for the bubbling flow with differentiated scales for low (5 to 350 ml) and high (400 to 2200 ml) flows; This
characteristic makes Vaporizer 1415 adequate for any anesthetic agent, allowing the operator to view the bubbling inside it.

 Amber glass bubbling chamber to protect the anesthetic agent from degradation due to sun light; however, allowing the operator to
view the bubbling inside it. Capacity for 100 ml of anesthetic agent.

 Automatic recognition of the anesthetic agent indicator pin’s position on the chamber.

 Bubbling flow control button protected against accidental activation with a 360o protection rim.

 Internal sensors for automatic total flow measurement.

 Internal one-way valves that ensure constant concentrations even when using controlled ventilation, avoiding an increase in
concentration due to the “pumping” effect.

 Housed in a steel plate case coated with highly resistant electrostatic powder painting. This box performs as an extra heat exchange
surface, increasing the anesthetic’s thermal stability.

 During a lack of power emergency, Vaporizer 1415 can continue being used without its electronic functions.

 12-VDC power supply. The 12-VDC cable comes with the equipment for connection.

Código do manual: 204010170_004 12


4 TECHNICAL SPECIFICATION

Classification

• IEC-60601-1:1988+amendment 1994– (Medical electrical equipment - Part 1: General requirements for


basic safety and essential performance)
• IEC 60601-2-13/2003- (Medical electrical equipment - Part 2-13: Particular requirements for the safety and
essential performance of anaesthetic systems)
• Equipment Class 1 – Energized Internally
• Type B – IPX1 – Continuos Operation

Anesthetic Agents

• HALOTHANE
• ENFLURANE
• ISOFLURANE
• SEVOFLURANE

The anesthetic agent must be indicated in the Mini-Pinomatic bubbling chamber through the indicator pin. The pin’s position is read
electronically to determine the proper CONCENTRATION x BUBBLING FLOW table calculation.

MINI-PINOMATIC Bubbling Chamber

Anesthetic agent tank .........................................................................................................................100 ml


Scale....................................................................................................................................................100 ml
Minimum grading..................................................................................................................................2.5 ml
Precision...............................................................................................................................................1.0 ml
Minimum work level...............................................................................................................................10 ml
Maximum work level............................................................................................................................100 ml

Bubbling Rotameter

Low flow rotameter...............................................................................................scale from 5 to 350 ml/min


High flow rotameter...............................................................................................scale from 0.4 to 2.2 l/min
Calibrated for 760 mmHg and 20oC (not compensating the pressure).
Reading is taken in the center of the sphere.

Safety Device

Dilumatic® protection system against the absence of total flow.


Flow control with a 360o protection rim against accidental activation.

Graphic Display

Type of display .....................................liquid crystal with back lighting.


Two 24-character 5 x 7-point lines.

Bubbling Flow Calculation

The table shows the concentration versus necessary bubbling flow.

Concentration ............................... ...................................................................... …….... 0.5% to 9.0%, resolution of 0.5%.


Bubbling flow … ................................................................ ...........….................5 to 100 ml/min, resolution of 5 ml/min.
... 100 ml/min to 1.0 l/min, resolution of 50 ml/min.
1.0 l/min to 2.0 l/min, resolution of 0.1 l/min.

Total Flow Reading

Total flow ........................................................0.5 to 15 l/min, resolution of 0.1 l/min. Precision of 0.2 l/min.

Código do manual: 204010170_004 13


Serial Outlet for Microcomputers

Type.......................................................................................................................................RS 232C serial port, 9 pins, male, isolated


Data transmission rate ........................................................................................ ................................................19.200 bps
Data format ......................................................................................................... .........................................................1N81

Electrical Features

Supply...................................................................................................................................................12Vdc
Vaporizer power consumption… ........................................................................................ 6 VA (maximum)

Notes:
The hospital's power system should be properly grounded and in accordance with the ABNT NBR 13534 regulation - “Instalações elétricas
em estabelecimentos assistenciais de saúde - Requisitos de segurança”. Failure to comply with this recommendation can result in injury to
the patient or operator or equipment damage, and it voids the Vaporizer's warranty.

Dimensions and Weight

Vaporizer
Height 320 mm
Width 226 mm
Depth 190 mm
Weight 6.7 Kgf

Código do manual: 204010170_004 14


5 OPERATING PRINCIPLE

Figure 5.1 allows a simplified view of the flows that circle internally in Vaporizer 1415.

The TOTAL FLOW that comes from the Rotameter enters Vaporizer 1415 and reaches the flow divider, where it is divided into two parts:

1- BUBBLING FLOW – small parcel of the total flow that is regulated by the flow control button on Vaporizer 1415, and is measured
by the respective vaporizer rotameter. The flow crosses the bubbling chamber, becoming saturated with anesthetic agent steam.

2- DILUENT FLOW – one part of the total flow that goes straight to the Vaporizer 1415’s outlet without coming into direct contact with
the anesthetic.

TOTAL FLOW = BUBBLING FLOW + DILUENT FLOW

The bubbling and diluent flows mix immediately before the vaporizer’s output. The continuous flow of fresh gases that leaves Vaporizer
1415 is, therefore, constituted by the total gas flow with a certain concentration of anesthetic agent steam.

The anesthetic agent vaporizing process takes place through a high number of small bubbles going through the bubbling chamber,
resulting in a large area of contact between the gas and the liquid anesthetic agent.

The Dilumatic® safety system blocks the anesthetic agent’s supply without there being an oxygen flow (or total flow) open in the
ROTAMETER, since bubbling flow is a derivation of the total flow.

The Mini-Pinomatic bubbling chamber has another internal chamber, also made out of glass, where vaporizing occurs from a bubbling
gasket located at its base. This internal chamber avoids excessive bubbling in Vaporizer 1415, and it keeps the liquid level stable in order
to make it easier to read its volume.

There are also one-way valves that avoid the “pumping effect” under controlled ventilation, also avoiding anesthetic reflux to the rotameter.

The total flow that enters Vaporizer 1415 is measured by an internal sensor. This flow sensor is constituted by a pneumatic component
that has resistance to the flow, associated to a differential pressure transducer. The differential pressure transducer supplies an indication
to the microprocessor on pressure falls through the pneumatic component, and this value is related to the existing flow.

Then, the microprocessor, through firmware elaborated especially for Vaporizer 1415, calculates the CONCENTRATION versus
BUBBLING FLOW correlation table by reading the TOTAL FLOW parameters, the anesthetic agent in use and by considering a barometric
pressure of 700 mmHg (altitude of the city of São Paulo)

Código do manual: 204010170_004 15


TF DF
TF VF

BF VF

BF

TF = Total Flow
BF = Bubbling Flow
DF = Dilute Flow
VF = Vapor Flow

Figure 5.1 – Vaporizer 1415 Operation Principle

Código do manual: 204010170_004 16


6 CONTROLS AND COMPONENTS

6.1 List of Components


The components listed below are supplied with Vaporizer 1415:

Item Code Description


1 204010170 Operation Manual
2 202010813 Mini-Pinomatic torn off Bubbling Chamber

Notes:
When you receive the device, if any of the components above is missing or damaged, contact the K. TAKAOKA’S authorized
representative immediately, as there are different warranty periods for the various components. See Chapter 14.
To purchase optional or replacement parts, contact the authorized K. TAKAOKA distributor.

6.2 Front View


The items below refer to Ventilator 1415’s front view (Figure 6-1).

1- “AGENT” Key

When depressed, this key shows the anesthetic agent indicated by the Mini-Pinomatic bubbling chamber indicator pin.

Warning
The electronic recognition system reads the agent indicator pin position and DOES NOT IDENTIFY THE ANESTHETIC
AGENT.

2- Liquid Crystal Display “ Manual”


This display shows the data calculated in form of a CONCENTRATION x BUBBLING FLOW table according to the following identified
parameters:

 Position of the anesthetic agent indicator pin;


 Total flow originating from the rotameter.
3- High Flow Rotameter
Rotameter that measures the bubbling flow as adjusted by the control (6). This rotameter should be used to read flows between 0.4 and
2.2 l/min. Reading is taken in the middle of the sphere.

4- Low Flow Rotameter


Rotameter that measures the bubbling flow as adjusted by the control (6). This rotameter should be used to read flows between 5 and 350
ml/min. Reading is taken in the middle of the sphere.

Warning
Do not add the readings from both rotameters (3) and (4), since both indicate the same flow. Use the rotameter suited for
the flow range that is being measured – low or high.

5- Bubbling Chamber Support for the MINI-PINOMATIC® System


Bubbling Chamber support with a flow input orifice and a flow output orifice, to be coupled to the bubbling chamber’s upper base, by this
constituting Vaporizer 1415’s MINI-PINOMATIC® quick coupling system.

6- Mini-Pinomatic Bubbling Chamber


The bubbling chamber has a quick coupling system to allow for anesthetic agent exchanges during the patient’s anesthesia procedure (for
example: induction with SEVOFLURANE and maintenance with ISOFLURANE). See more details in item 6.4.

7- Bubbling Flux Control


Button that controls bubbling flow in Vaporizer 1415, which corresponds to the parcel of the total flow that crosses the Mini-Pinomatic
bubbling chamber (5). The value of this flow will be read in the respective flowmeters (3) and (4). It opens counterclockwise.

Código do manual: 204010170_004 17


Warning
The bubbling flow determines the actual concentration Vaporizer 1415 provides directly. Therefore, it is important that
the flow this button adjusts – read at rotameter (3) and (4) – equals the bubbling flow required for the desired
concentration, as shown by the liquid crystal display (2).

8- On/Off Key
Key that turns Vaporizer 1415’s electric part on or off.

Attention
This key only influences the vaporizer’s electronic functions (liquid crystal display and control electronics). The anesthetic
gas supply system functions independently of the electronic part, and in an emergency it can work even without electronic
supply.

9- “DISPLAY” Key

When this key is depressed, it presents the next concentration versus bubbling flow sequence.
The process is cyclical. After the last screen, the cycle goes back to showing the 0.5% to 3% table.

Figure 6-1: Front View of Vaporizer 1415

Código do manual: 204010170_004 18


6.3 Rear View
The following items refer to Vaporizer 1415’s rear view (Figure 6-2).

1- Quick Coupling for the PINOMATIC® System


System with a flow input orifice, a flow output orifice, a guiding pin, two electrical contacts and a grounding contact to be coupled to
the anesthesia device’s PINOMATIC® quick coupling system.

2- RS-232-C Connector
Serial communication connector between the Vaporizer and the PC, used to update the equipment control and diagnosis program
dynamically. The serial cable and the PC are not supplied with the Vaporizer. They are optional accessories. The serial cable’s
specifications are detailed in Chapter 4.

3- Identification Tag
Tag showing Vaporizer 1415’s model and serial number for identification purposes.

Figure 6-2: Rear View of Vaporizer 1415

6.4 Mini-Pinomatic Bubbling Chamber


The following items refer to the Vaporizer 1415’s Mini-Pinomatic Bubbling Chamber (Figure 6-3).

1- Bubbling Chamber
The bubbling chamber has a quick coupling system to allow for anesthetic agent exchanges during the patient’s anesthesia procedure (for
example: induction with SEVOFLURANE and maintenance with ISOFLURANE).

Transparent amber glass chamber used to receive the liquid anesthetic agent and where vaporizing occurs. It has volume grading (in ml),
for the liquid level in it to be read.

Código do manual: 204010170_004 19


Attention
The agent level inside the chamber must be between 10 and 100 ml during the anesthesia procedure.

2- Quick Coupling for the Mini-Pinomatic® System


System with a flow input orifice and a flow output orifice to be coupled to Vaporizer 1415’s lateral support.

3- Anesthetic Agent Indicator Pin


A special pin recognized electronically by Vaporizer 1415, which, according to the position of the insertion in the upper part of the
Mini-Pinomatic bubbling chamber indicates which anesthetic agent is in it.

Warning
The electronic recognition system reads the agent indicator pin position and DOES NOT IDENTIFY THE ANESTHETIC
AGENT PRESENT IN THE BUBBLING CHAMBER.
THE PIN IS SPECIAL. If it is lost, request replacement from your TAKAOKA authorized representative immediately.
Firmly screw-on the agent indicator pin (clockwise).

4- Anesthetic agent identification tag


This is a tag that allows one to insert and screw-on the anesthetic agent indicator pin correctly. The tag follows anesthetic agent color
identification.

HALOTHANE

ISOFLURANE
SEVOFLURANE
ENFLURANE
5- Funnel Lid
Screw-on lid to close the bubbling chamber. The lid is placed onto its position by turning it clockwise.

Warning
The lid must be firmly closed during the anesthesia procedure to prevent any gas leakage. Make sure the funnel’s
plastic washer seal is in good condition to prevent gas leakage (Figure 9-1).

6- Bubbling Chamber Filling Funnel


Funnel used to drain and fill the bubbling chamber with anesthetic agents.

7- Product Identification Tag


Tag showing bubbling chamber model information.

Código do manual: 204010170_004 20


4

5
3
6

Figure 6-3: Mini-Pinomatic Bubbling Chamber

Código do manual: 204010170_004 21


7 DISPLAY

Vaporizer 1415’s front panel has a display that shows important alphanumeric information to regulate Vaporizer 1415 and for better
anesthesia control. The microprocessor performs the required bubbling flow calculation, dispensing the use of a calculation rule to
determine the desired concentration.

The most important information the computerized display shows is the anesthetic agent concentration versus flow bubbling relation
table. These required bubbling flow values appear below the concentration values shown on the display.

The microprocessor calculates the display information theoretically, based on values measured by internal sensors and on data supplied
by the operator, according to the following table:

Parameter used for the calculations Value measured by the internal sensor Value adopted by the operator
Desired concentration X
Type of agent X
Total Flow X

7.1 Screens

7.1.1 Start-up

As soon as Vaporizer 1415 is turned on, its computerized display shows a system start-up screen (Figure 7-1). This screen has
information on the anesthetic agent being used and on the software release number. The latter is important for maintenance purposes.
After a short period of time, the display will progress automatically to the first concentration versus bubbling flow table screen.

Figure 7-1: Start-up Screen

7.1.2 Concentration x bubbling flow relation tables

This is the most important information displayed, and these are the required bubbling flows shown under the values of the different
concentrations. These values guide the operator on the bubbling flow that must be opened manually on Vaporizer 1415 for the respective
concentrations to be reached. The bubbling flow is expressed in ml/minute.

Vaporizer 1415 allows anesthetic agent concentrations ranging from 0.5 to 9.0% to be adjusted in the mixture. These concentrations are
divided into three screens:

− 0.5 to 3.0% (Figure 7-2)


− 3.5 to 6.0% (Figure 7-3)
− 6.5 to 9.0 % (Figure 7-4)

To go through the three possible screens, press the DISPLAY key repeatedly. The process is cyclical. After the last screen, the cycle goes
back to showing the 0.5% to 3.0% table.

Código do manual: 204010170_004 22


Figure 7-2: First Screen: CONCENTRATION from 0.5% to 3.0%

Figure 7-3: Second Screen: CONCENTRATION from 3.5% to 6.0%

Figure 7-4: Third Screen CONCENTRATION of 6.5 to 9.0%

7.1.3 Agent

Another important piece of information the display shows is the type of anesthetic agent that is in the bubbling chamber (Figure 7-5). The
system recognizes this automatically according to the ANESTHETIC AGENT INDICATOR PIN position. To access the type of anesthetic
agent, press the AGENT key.

Figure 7-5: ANESTHETIC AGENT presentation screen

Código do manual: 204010170_004 23


7.2 Messages
The display may show two messages:

7.2.1 NO DILUENT FLOW

This means there is no TOTAL FLOW regulated by the Rotameter; therefore, the Dilumatic safety system will stop the vaporization. This
message will be shown at the bubbling flow site (Figure 7-6).

Figure 7-6: NO DILUENT FLOW message

7.2.2 VAPORIZER WITHOUT CHAMBER!!!

This means that the Mini-Pinomatic Bubbling Chamber or ANESTHETIC AGENT INDICATOR PIN are not positioned precisely on their
respective housing areas, therefore, the microprocessed internal safety system will block vaporization. This message will be shown on the
central portion of the display (Figure 7-7).

Figure 7-7: Message: VAPORIZER WITHOUT CHAMBER!!!

Código do manual: 204010170_004 24


8 ASSEMBLING AND PREPARING THE VAPORIZER

When you receive Vaporizer 1415, follow steps 1 to 3 in item 2, “Quick Installation Guide” carefully.

More information will be provided on mounting and preparing Vaporizer 1415 on the Anesthesia Device Cabinet using the PINOMATIC®
support below.

8.1 Assembling the Anesthesia Machine


The exclusive PINOMATIC® system allows easy interchanges between the Multiagent Vaporizers and the different K. TAKAOKA
Calibrated Vaporizers through its quick coupling connection (Figure 8-1). The PINOMATIC® Support components are listed below for a
better understanding of their operation.

Figure 8-1: PINOMATIC® Support

1 Guide Pin Orifice


Orifice for Vaporizer 1415’s connection block guide pin.

2 Power Contacts
Two power contact points with Vaporizer 1415’s connection block. The electrical current passes from the Pinomatic® Support to the
Vaporizer through these contacts.

3 Vaporizer Inlet Connection


Connection nozzle for total flow entry in Vaporizer 1415. This nozzle has a floating system and sealing rings for perfect coupling.

Attention
Make sure all Pinomatic® support connection nozzles are clean and its rubber disks are in perfect condition.

4 Vaporizer Outlet Connection


Connection nozzle for total flow output in Vaporizer 1415. This nozzle has a floating system and sealing rings for perfect coupling.

5 Fuse
Fuse to protect Rotameter 1415’s electrical part. The fuse compartment cover is threaded and can be easily opened for
replacement purposes.

6 12-Volt Source Input


12-VDC inlet to supply Vaporizer 1415’s electronic components. This inlet must be connected to the Rotameter Block 12-VDC outlet
through the appropriate cable that is provided with the equipment.

Código do manual: 204010170_004 25


7 Ground Contact
A ground contact with Vaporizer 1415’s connection block. This contact grounds Vaporizer 1415.
Mounting the PINOMATIC® Support on the anesthesia device’s rule must be done as follows:

1. Attach the PINOMATIC support to the anesthesia machine’s ruler, as described in Figure 8-2. Use a ½-inch Phillips or ring
screwdriver (approximately 13 mm) to fasten the four screws.

2.

Attaching
Ruler

PINOMATIC
Support

Screw
Housing

Figure 8-2: PINOMATIC support fixture

3. Couple the desired vaporizer on the Anesthesia Device’s PINOMATIC® support simply by gently placing it on its position, lowering it
from top to bottom (Figure 8-3). If no vaporizer is coupled, connect the rigid joining tube (that comes with Vaporizer 1415),
interconnecting the Support’s two upper nozzles (Figure 8-4).

PINOMATIC ® quick
connection system
Vaporizer
1415

PINOMATIC®
Support

Attaching
Ruler

Figure 8-3: Mounting Vaporizer 1415 on the PINOMATIC® support

Código do manual: 204010170_004 26


Figure 8-4: Rigid tube

8.2 Connections
Mounting the PINOMATIC® Support connections on the Anesthesia Device’s Cabinet must be done as follows:

1- Firmly interconnect the Rotameter’s output to the PINOMATIC® support’s lower INPUT connection (Figure 8-5), making sure to
avoid possible gas leakage or flow obstruction.
2- Firmly interconnect the PINOMATIC® support’s OUTPUT to the respective input connection on the Anesthesia Device base or on
the Rotameter, depending on the equipment model (Figure 8-5), making sure to avoid possible gas leakage or flow obstructions.

Gases that Gases entering


leave PINOMATIC
Vaporizer 1415 Support

Figure 8-5: PINOMATIC support connections

Warning
The two lower PINOMATIC support connections must be interconnected to the Rotameter or to the Anesthesia Device
by means of two distinct tubes (a braided and a transparent one) preventing accidental inversions. These tubes are
supplied with the equipment.

8.3 Power Supply


1- Initially, check if the on/off key (7) located on Vaporizer 1415’s side panel is on the OFF position.

2- Connect an end of the 12-VDC cable (Figure 8-6) to the Rotameter Block 12-VDC output.

Figure 8-6: 12-VDC Cable.

3- Connect the other end of the 12-VDC cable to the 12-VDC input (Figure 8-7) on the right side of the PINOMATIC® Support.

Código do manual: 204010170_004 27


PINOMATIC
Support 12-VCD input
connection

Figure 8-7: PINOMATIC® Support 12-VCD input connection.

Código do manual: 204010170_004 28


Warning
Failure to comply with these electrical recommendations may result in injury to the patient, operator or equipment and
will void Rotameter 1415’s warranty.

8.4 Mounting the MINI-PINOMATIC Bubbling Chamber


1- Mount the bubbling chamber on Vaporizer 1415’s MINI-PINOMATIC® support simply by gently placing it on its position from top to
bottom (Figure 8-8).

Figure 8-8: Mounting Vaporizer 1415’s Bubbling Chamber.

Código do manual: 204010170_004 29


9 OPERATION

Before using the device, follow the procedure below to make sure Vaporizer 1415 is operating properly.

Attention
Before starting any procedure, make sure that the control button for the bubbling flow is fully closed (button fully
turned counter-clockwise).

Notes:
The figures between parentheses refer to Vaporizer 1415’s front view (fv) and to the bubbling chamber’s (bc) numbering.

9.1 Initial Procedures


1- Check that the total gas flow of the anesthesia device’s Rotameter is initially closed.
2- Make sure the PINOMATIC® support and its interconnections and tubes are properly and firmly attached. Always be alert to the
possibility of gas leakage or flow obstruction.
3- Feed Multiagent Vaporizer 1415 with the correct electric current, as provided for in the instructions.
4- Turn Vaporizer 1415’s electric components on using the on/off key (7-fv), and check if the computerized display turns on (2-fv).
5- Check whether the bubbling chamber (5-fv) is totally dry or, if the chamber already has an anesthetic agent in it, check what type
of agent it is and if it does not show signs of aging.

Warning
If you are in doubt about the type of anesthetic agent that is in the bubbling chamber, empty (discard the agent), dry,
and fill the chamber with the proper agent.

6- Fill the bubbling chamber (5-fv) according to instructions in item 9.2.


7- Identify the anesthetic agent present in the bubbling chamber correctly (5-fv) through the anesthetic agent identification pin (3-bc)
on the upper part of the chamber.
8- Check whether the anesthetic agent level in the bubbling chamber (5-fv) is appropriate for the foreseen anesthesia time (the level
must always be between 10 and 100 ml).
9- Check whether the funnel lid is tightly screwed on the bubbling chamber (5-bc).
10 - Check whether the Mini-Pinomatic chamber (5-fv) mounting is correct and firm on its respective support (9-fv) on the right side of
Vaporizer 1415 Plus.

9.2 Filling the Chamber


For initial bubbling chamber filling or refilling with the liquid anesthetic agent, follow this procedure:

1- Close the bubbling flow control (6-fv).


2- Remove the Mini-Pinomatic bubbling chamber (5-fv) from its support (9-fv) on the right side of Vaporizer 1415.
3- Remove the funnel threaded cover (5-bc).
4- Fill the bubbling chamber (5-fv) or complete its level with the proper anesthesia agent. The level must be between 10 and 100 ml.
5- Check whether the plastic sealing washer located on the lid of the funnel (5-bc) is in perfect condition (Figure 9-1) to avoid gas
leakage during the anesthesia procedure.
6- Firmly close the funnel with its lid (5-bc).
7- Check whether the Mini-Pinomatic chamber (5-fv) mounting is correct and firm on its respective support (9-fv) on the right side of
Vaporizer 1415.

Código do manual: 204010170_004 30


Warning
Make sure that the bubbling chamber is filled with the correct agent. Identify the Mini-Pinomatic chamber’s content
through the indicator pin located on its upper part.
The funnel lid must be tightly closed so there is no gas leakage.
Never exceed the maximum chamber capacity, i.e., 100 ml.

Filling
Funnel

Figure 9-1: Location of the filling funnel lid-sealing washer.

9.3 Vaporization Instructions


After completing the initial procedures and when both patient and equipment are ready to start the anesthesia procedure, follow the steps
described below:

1- Turn Vaporizer 1415 on using its ON/OFF key (7-fv), located on the right side of the vaporizer.
2- Depress the “AGENT” key (1-fv) and make sure the agent that is shown is the same as the one selected in the Mini-Pinomatic
bubbling chamber through its indicator pin.
3- Through the “DISPLAY” key (8-fv), select the desired CONCENTRATION versus BUBBLING FLOW table.

Warning
When there is a divergence between the indicator pin and the agent shown on the display, don’t use the
CONCENTRATION versus BUBBLING FLOW table as the values that are shown will not match the agent in the bubbling
chamber.

4- In the anesthesia device’s Rotameter, regulate the total gas flow to be used.
5- Set the bubbling flow button (6-fv) according to the desired concentration.

Warning
Changes made to the total fresh gas flow or to the anesthetic agent’s temperature inside the bubbling chamber will cause
changes to the concentration value that is being supplied. In this case, conveniently readjust the bubbling flow according to
the value shown in the CONCENTRATION versus BUBBLING FLOW table.

6- The anesthetic agent level in the bubbling chamber (5-fv) can be filled during anesthesia, according to the CHAMBER FILLING
procedure described above.
7- To stop the vaporization, completely close the bubbling flow control (6-fv).
8- Completely drain and dry the bubbling chamber (5-fv) for better Mini-Pinomatic chamber conservation (Item 9.4).

9.4 Chamber Draning


To drain the anesthetic liquid in the bubbling chamber totally or partially, follow the procedure below:

Attention
To collect the anesthetic agent, only use a flask destined specifically for the agent that is being discarded. The flask
must also be marked with the name of this agent.

1- Close the bubbling flow control button (6-fv).


2- Remove the Mini-Pinomatic bubbling chamber (5-fv) from its support (9-fv) on the right side of the Vaporizer.
3- Remove the funnel lid (5-fv).

Código do manual: 204010170_004 31


4- Slowly pour the chamber’s content into the flask of origin.
5- Maintaining its lid off (5-fv), couple the bubbling chamber (5-fv) to the support (9-fv).
6- Keeping the bubbling flux control button (6-fv) open, allow it to drain for a few minutes at a high total flow rate through Vaporizer
1415, so it will dry completely. Use a flow value between 5 and 10 l/min open in the Anesthesia Device Rotameter Block.
7- Once the drying procedure has been concluded, close the total gas flow and the bubbling flow control button (6-fv).
8- Firmly place the funnel with its lid on it (5-fv).
9- Mount the Mini-Pinomatic bubbling chamber (5-fv) on its respective support (9-fv) on the right side of Vaporizer 1415.

Código do manual: 204010170_004 32


10 CLEANING AND STERILIZATION

Switch Ventilator 1415 off before cleaning it. Do not immerse the Vaporizer in any kind of liquid.

1. To clean the external parts of Ventilator 1415, use a clean, soft cloth (or sponge) moistened with isopropyl alcohol, soap and water,
or a suitable germicidal solution. Be careful to avoid the accumulation of any cleaning product residue in the equipment connections.
After the cleaning, rinse (not required for alcohol) and dry it with a clean, dry and soft cloth.

2. To clean the Vaporizer’s screen, use a soft and clean, lint-free clothe. Do not use paper towels or rough cloths to avoid scratching the
screen surface.

3. The Vaporizer’s bubbling chamber must be kept totally empty and dry while the Anesthesia Device is not being used to keep the
bubbling gasket orifices from getting clogged (item 9.4).

Do not use abrasive or corrosive agents when cleaning.

RECOMMENDATIONS FOR PROCESSING K. 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 are capable of
preventing invasion of the sub-epithelial tissue and which require high-level disinfection or sterilization to ensure quality in multiple-use
situations.

Choosing the processing method - disinfection or sterilization - depends on the nature of the materials. The TABLE shows the methods
recommended to process K. TAKAOKA anesthesia and mechanical ventilation equipment components, considering their composition and
technical specifications. The recommended methods are: cleaning, chemical disinfection, and gas or chemical sterilization. The processing
should be performed according to the step sequence shown in the following FLOWCHART.

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. There are three
disinfection 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 the majority of 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 plant forms, destroys 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); it is
performed by physical processes (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:

Código do manual: 204010170_004 33


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

FLOWCHART
Flowchart of the sequential steps for processing of the
Anesthesia and Mechanical Ventilation Equipment components

WITH PRESENCE OF ORGANIC MATTER OR SOIL

CONSIDER ALL CONTAMINATED

CLEAN

DAMP CLOTH DETERGENT SOLUTION

RINSE

DRY

ACCORDING TO ARTICLE DESTINATION

IF IF PROCESSING IF
STERILIZATION CONCLUDED DISINFECTION

PHYSICAL MEDIUM CHEMICAL STORE LIQUID CHEMICAL MEDIUM LIQUID PHYSICAL MEDIUM LIQUID CHEMICAL MEDIUM
(STEAM) MEDIUM 70% ALCOHOL THERMO DISINFECTION GLUTARALDEHYDE

PACK LÍQUID GASEOUS PLASMA MECHANICAL IMMERSE FOR THE TIME AND AT IMMERSE THE ARTICLE
(GLUTARALDEHYDE) (ETHYLENE OXIDE) (HYDROGEN PEROXIDE) FRICTION THE TEMPERATURE REQUIRED

STERILIZE IMMERSER PACK PACK PACK DRY IN AN FILLIN


FULLY ASEPTIC WAY TABULATIONS

STORE FILLIN STERILIZE STERILIZE STORE PACK RINSE WITH


TABULATION STERILIZED H2O

RINSE WITH STORE STORE STORE DRY IN AN


STERILIZED H2O ASEPTIC WAY

DRY IN AN PACK
ASEPTIC WAY

PACK IN STORE
STERILIZED FLASK

STORE

Código do manual: 204010170_004 34


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

Component Cleaning Disinfection Sterilization

Sphygmomanometer bracket Detergent Solution NOT RECOMMENDED NOT RECOMMENDED

Glutaraldehyde Ethylene Oxide


Anti-pollution bag Detergent Solution Thermal disinfection Glutaraldehyde or
Sensitive Hydrogen Peroxide
70% Alcohol
Rotameter block Damp cloth NOT RECOMMENDED
Synthetic phenol

Sphygmomanometer cable Detergent Solution Synthetic phenol NOT RECOMMENDED

EKG Cable / Oximeter Detergent Solution Synthetic phenol NOT RECOMMENDED

Glutaraldehyde
Humidifier Chamber Detergent Solution Thermal disinfection Steam
resistant
Glutaraldehyde Ethylene Oxide
Bell Detergent Solution Thermal disinfection Glutaraldehyde or
Sensitive Hydrogen Peroxide
Glutaraldehyde Ethylene Oxide
Canister Detergent Solution Thermal disinfection Glutaraldehyde or
Sensitive Hydrogen Peroxide

Oximeter Galvanic Cell Detergent Solution NOT RECOMMENDED NOT RECOMMENDED

Glutaraldehyde Ethylene Oxide or


Bell Rod Set Detergent Solution
70% Alcohol Glutaraldehyde

Glutaraldehyde Ethylene Oxide or


Air Vent Elbow Detergent Solution
70% Alcohol Glutaraldehyde
Glutaraldehyde
Steam
Drains Detergent Solution Thermal disinfection
Hydrogen Peroxide
resistant
70% Alcohol
Flow meter Damp cloth NOT RECOMMENDED
Synthetic phenol
Glutaraldehyde
Steam or Glutaraldehyde
Diaphragms Detergent Solution Thermal disinfection
Hydrogen Peroxide
resistant
Glutaraldehyde Ethylene Oxide
Y-Shaped Connector (nozzle) Detergent Solution Thermal disinfection Glutaraldehyde or
sensitive Hydrogen Peroxide
Glutaraldehyde Ethylene Oxide
T-Shaped Capnograph Connector Detergent Solution Thermal disinfection Glutaraldehyde or
sensitive Hydrogen Peroxide
Ethylene Oxide or
Glutaraldehyde
Mask Detergent Solution Glutaraldehyde
70% Alcohol

Synthetic phenol
Monitor Module Damp cloth NOT RECOMMENDED
70% Alcohol

Glutaraldehyde
Aspirating Flask Detergent Solution Steam or Glutaraldehyde
70% Alcohol

Synthetic phenol
Ventilator Module 70% Alcohol NOT RECOMMENDED
70% Alcohol

Synthetic phenol
Cabinet (external parts) 70% Alcohol NOT RECOMMENDED
70% Alcohol
Ethylene Oxide
Mask Strap Detergent Solution Glutaraldehyde Glutaraldehyde or
Hydrogen Peroxide

Código do manual: 204010170_004 35


Component Cleaning Disinfection Sterilization

Glutaraldehyde
Flow Sensor Detergent Solution Thermal disinfection Steam
resistant
Synthetic phenol Ethylene Oxide
Auxiliary Thermometer Detergent Solution
70% Alcohol Hydrogen peroxide

Ethylene Oxide
Injected Liquid Thermometer Detergent Solution 70% Alcohol
Hydrogen peroxide

Ethylene Oxide
Esophageal Temperature Sensor Detergent Solution Glutaraldehyde
Hydrogen peroxide

Ethylene Oxide
Side Stream (capnograph) Detergent Solution Glutaraldehyde
Hydrogen peroxide

Glutaraldehyde Ethylene Oxide or


Canister Support Detergent Solution
70% Alcohol Glutaraldehyde
Glutaraldehyde
Ethylene Oxide or
Corrugated Tubes ** Detergent Solution Thermal disinfection
Glutaraldehyde
sensitive
Glutaraldehyde
Vacuum meter Detergent Solution NOT RECOMMENDED
70% Alcohol
Glutaraldehyde Ethylene Oxide
Inhalation and Exhalation Valves Detergent Solution Thermal disinfection Glutaraldehyde or
sensitive Hydrogen Peroxide
Synthetic phenol
Calibrated Vaporizer Damp cloth NOT RECOMMENDED
70% Alcohol

Synthetic phenol
Multi-agent Vaporizer Damp cloth NOT RECOMMENDED
70% Alcohol

Código do manual: 204010170_004 36


11 MAINTENANCE

Correct preventive Vaporizer 1415 maintenance will guarantee it can be used accurately and safely for an extended period of time.

1- Carry out a periodical visual inspection of Vaporizer 1415. Should there be any apparent damage, do not use the device.

2- At least once a month inspect the condition of the plastic washer placed in Vaporizer 1415’s bubbling chamber funnel lid. If this
washer is damaged, take steps to have it replaced to prevent gas leakages during anesthesia.

3- If it is not possible to switch Vaporizer 1415’s electric components on normally, initially check:
 If there is power in the electric output that feeds the Rotameter Block;
 12-VDC cable integrity;

4- Periodically, check if the flowmeter spheres are moving freely along the entire length of their respective conical tubes and if they fall
to zero when the flow control is closed. If this does not happen, call K. TAKAOKA’S authorized Technical Assistance.

Attention
Only use genuine K. TAKAOKA replacement parts. Using parts that are not genuine may place the patient’s safety at
risk.
Do not perform any internal maintenance on the Vaporizer and do not open its case. For periodic service or to perform
any maintenance on the Vaporizer, call K. TAKAOKA’S authorized Technical Assistance.

Código do manual: 204010170_004 37


12 SYMBOLS

Código do manual: 204010170_004 38


Código do manual: 204010170_004 39
Código do manual: 204010170_004 40
Código do manual: 204010170_004 41
Código do manual: 204010170_004 42
13 EMERGENCY ACTIONS

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

 Contact the manufacturer (Technical Assistance sector Manager) about the device’s condition, and don’t perform any test or
investigation in the absence of an authorized K. TAKAOKA technician.

 Register the manufacturer, model, and serial number of all devices involved in the adverse event. Record this information in the
patient’s 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.

 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.

 Record the names of all health professionals who were present during the incident.

 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.

 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 device’s catalogued number, but also the lot number. Furthermore, a few
specifications included on the package may be useful for the expert investigation.

 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.

 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.

Código do manual: 204010170_004 43


14 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. Other items provided with the equipment are listed below.

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 ITEM PERIOD OF WARRANTY


201030023 Vaporizer 1415 1 year
204010170 Operation Manual No guarantee
202010813 Separate Mini-Pinomatic Bubbling Chamber (optional) 1 year

Multiagent Vaporizer 1415’s useful life is estimated to average 5 years. This may vary according to use and to adequate preventive
maintenance.

Person Technically in Charge: Mauricio Chiarioni


CREA: Registration number 5061714921

Código do manual: 204010170_004 44


K. TAKAOKA DISTRIBUTORS IN BRAZIL

Código do manual: 204010170_004 45


TECHNICAL ASSISTANCE
K. TAKAOKA

K. TAKAOKA Indústria e Comércio 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.

Código do manual: 204010170_004 46


AUTHORIZED K. TAKAOKA TECHNICAL ASSISTANCE

Código do manual: 204010170_004 47


Information for Technical Assistance
This card must be filled-out and returned together with the device.

Name:

Hospital:

Address:

Phone: District:

ZIP: City: State


-

Defect description:

Rua General Izidoro Dias Lopes, 121/141– CEP 09687-100


– São Bernardo do Campo- SP
Tel.: (5511) 4176-3500 – Fax.: (5511) 4176-3570

Information for Technical Assistance


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

Name:

Hospital:

Address:

Phone: District:

ZIP: City: State


-

Defect description:

Rua General Izidoro Dias Lopes, 121/141– CEP 09687-100 –


São Bernardo do Campo - SP
Tel.: (5511) 4176-3500 – Fax.: (5511) 4176-3570

Intereses relacionados