Manual Operation

OPERATION MANUAL 1415 MULTIAGENT VAPORIZER Equipment code: 201030023 Manual Code: 204010170_004 Date: (AGO/2008)

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His Operation Manual has the information that is necessary for the proper usage of Multiagent Vaporizer 1415.
Manufacturer:
K. Takaoka Indstria e Comrcio LTDA Rua General Izidoro Dias Lopes, 121/141 Bairro Vila Paulicia - So Bernardo do Campo / SP ZIP: 09687-100 Telephone: (55 11) 4176-3500 Fax: (55 11) 4176-3570 Website: www.takaoka.com.br E-mail: [email protected] 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

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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 INSTITUTION:

] YES _______________ [ Invoice Number*

] NO ______________________ Representation Name

Corporate Name: ____________________________________Tax Payers 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? 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 (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

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

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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. Rua General Izidoro Dias Lopes.121/141 Bairro Vila Paulicia So Bernardo do Campo / SP ZIP: 09687-100 Telephone: (55 11) 4176 3500 Fax: (55 11) 4176 3570 E-mail: [email protected] Website: http://www.takaoka.com.br

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Figure 1. Vaporizer 1415

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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 chambers 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. TAKAOKAS 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 equipments power source before any maintenance service is performed. Do not perform any maintenance procedure except for those specified in the devices service manual. Only use parts and pieces supplied by K. TAKAOKA Ind. & Com. Ltda. Any attempt to change the hardware or firmware without K. TAKAOKAS formal approval in writing will automatically void all equipment guarantees. Vaporizer 1415 should be calibrated and serviced annually by an authorized K. TAKAOKA technician.

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To ensure the equipment operates safely, always run the tests and procedures prescribed in item 9.1 before using the vaporizer in the patients 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 equipments 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 Supports 12-VDC input and the Rotameter Blocks 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 organizations 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 patients body; therefore it is not included in this norms scope (Clause 4.2.1).

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

01

02

Open the package and check its contents. If there is any discrepancy, contact your representative.

None

03

Remove the equipment and its accessories; check the integrity of all components. If there is any apparent damage in the equipment or in any of its accessories, contact your representative.

None

04

Use the 12-VDC cable connected to the rotameter block output to supply the pinomatic support.

05

Install Vaporizer 1415 on the pinomatic support. Check whether the vaporizer is firmly installed on the support.

06

Open the bubbling chamber removing the funnels screw-on lid and fill the bubbling chamber with the desired anesthetic agent. The level must always be between 10 and 100 ml during the anesthesia procedure.

Firmly close the funnel with its lid on. 07

08

Set-up the chamber placing the agents indicator pin to its correct position.

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09

Install the bubbling chamber on the Mini-Pinomatic support (rightside 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.

11

The display will show a bubbling flow concentration correspondence table, which must be used to adjust the desired anesthetic agent concentration.

12

Using the DISPLAY key, one can browse through other correspondence tables.

13

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

14

Continue reading this manual to achieve full understanding of the Vaporizers operation.

None

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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 devices rotameter block. This flow enters in the Multiagent Vaporizer, where it is divided in to two parts: 1BUBBLING 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. 2DILUENT FLOW another part of the total flow that goes directly to Vaporizer 1415s 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 pins 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 anesthetics 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.

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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 pins 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.

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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 - Instalaes eltricas em estabelecimentos assistenciais de sade - Requisitos de segurana. 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 Width Depth Weight 320 mm 226 mm 190 mm 6.7 Kgf

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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: 1BUBBLING 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. 2DILUENT FLOW one part of the total flow that goes straight to the Vaporizer 1415s outlet without coming into direct contact with the anesthetic. TOTAL FLOW = BUBBLING FLOW + DILUENT FLOW The bubbling and diluent flows mix immediately before the vaporizers 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 agents 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 So Paulo)

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TF

DF TF BF BF VF VF

TF = Total Flow BF = Bubbling Flow DF = Dilute Flow VF = Vapor Flow Figure 5.1 Vaporizer 1415 Operation Principle

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CONTROLS AND COMPONENTS

6.1 List of Components

The components listed below are supplied with Vaporizer 1415: Item 1 2 Code 204010170 202010813 Operation Manual Mini-Pinomatic torn off Bubbling Chamber Description

Notes:
When you receive the device, if any of the components above is missing or damaged, contact the K. TAKAOKAS 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 1415s front view (Figure 6-1). 1AGENT 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. 3High 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. 4Low 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 chambers upper base, by this constituting Vaporizer 1415s MINI-PINOMATIC quick coupling system. 6Mini-Pinomatic Bubbling Chamber

The bubbling chamber has a quick coupling system to allow for anesthetic agent exchanges during the patients anesthesia procedure (for example: induction with SEVOFLURANE and maintenance with ISOFLURANE). See more details in item 6.4. 7Bubbling 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.

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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 1415s electric part on or off.

Attention
This key only influences the vaporizers 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

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6.3

Rear View

The following items refer to Vaporizer 1415s rear view (Figure 6-2). 1Quick 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 devices PINOMATIC quick coupling system. 2RS-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 cables specifications are detailed in Chapter 4. 3Identification Tag Tag showing Vaporizer 1415s 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 1415s Mini-Pinomatic Bubbling Chamber (Figure 6-3). 1Bubbling Chamber

The bubbling chamber has a quick coupling system to allow for anesthetic agent exchanges during the patients 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.

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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 1415s lateral support. 3Anesthetic 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 5Funnel 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 funnels 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. 7Product Identification Tag

Tag showing bubbling chamber model information.

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4 5 3 6 7 2

Figure 6-3: Mini-Pinomatic Bubbling Chamber

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DISPLAY

Vaporizer 1415s 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 Desired concentration Type of agent Total Flow X Value measured by the internal sensor Value adopted by the operator X 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.

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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

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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!!!

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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 1415s connection block guide pin. 2 Power Contacts

Two power contact points with Vaporizer 1415s 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.

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

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Ground Contact

A ground contact with Vaporizer 1415s connection block. This contact grounds Vaporizer 1415. Mounting the PINOMATIC Support on the anesthesia devices rule must be done as follows: 1. Attach the PINOMATIC support to the anesthesia machines ruler, as described in Figure 8-2. Use a -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 Devices 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 Supports 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

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Figure 8-4: Rigid tube

8.2

Connections

Mounting the PINOMATIC Support connections on the Anesthesia Devices Cabinet must be done as follows: 1Firmly interconnect the Rotameters output to the PINOMATIC supports lower INPUT connection (Figure 8-5), making sure to avoid possible gas leakage or flow obstruction. 2Firmly interconnect the PINOMATIC supports 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 leave Vaporizer 1415

Gases entering PINOMATIC 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
12-

Power Supply

Initially, check if the on/off key (7) located on Vaporizer 1415s side panel is on the OFF position. Connect an end of the 12-VDC cable (Figure 8-6) to the Rotameter Block 12-VDC output.

Figure 8-6: 12-VDC Cable. 3Connect the other end of the 12-VDC cable to the 12-VDC input (Figure 8-7) on the right side of the PINOMATIC Support. 27

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PINOMATIC Support 12-VCD input connection

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

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

8.4
1-

Mounting the MINI-PINOMATIC Bubbling Chamber

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

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

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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 1415s front view (fv) and to the bubbling chambers (bc) numbering.

9.1
12-

Initial Procedures

Check that the total gas flow of the anesthesia devices Rotameter is initially closed. 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.

345-

Feed Multiagent Vaporizer 1415 with the correct electric current, as provided for in the instructions. Turn Vaporizer 1415s electric components on using the on/off key (7-fv), and check if the computerized display turns on (2-fv). 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.

67-

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

910 -

Check whether the funnel lid is tightly screwed on the bubbling chamber (5-bc). 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: 12345Close the bubbling flow control (6-fv). Remove the Mini-Pinomatic bubbling chamber (5-fv) from its support (9-fv) on the right side of Vaporizer 1415. Remove the funnel threaded cover (5-bc). Fill the bubbling chamber (5-fv) or complete its level with the proper anesthesia agent. The level must be between 10 and 100 ml. 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. 67Firmly close the funnel with its lid (5-bc). 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.

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Warning
Make sure that the bubbling chamber is filled with the correct agent. Identify the Mini-Pinomatic chambers 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
described below: 12-

Vaporization Instructions

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

Turn Vaporizer 1415 on using its ON/OFF key (7-fv), located on the right side of the vaporizer. 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, dont use the CONCENTRATION versus BUBBLING FLOW table as the values that are shown will not match the agent in the bubbling chamber.

45-

In the anesthesia devices Rotameter, regulate the total gas flow to be used. 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 agents 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.

78-

To stop the vaporization, completely close the bubbling flow control (6-fv). 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.

123-

Close the bubbling flow control button (6-fv). Remove the Mini-Pinomatic bubbling chamber (5-fv) from its support (9-fv) on the right side of the Vaporizer. Remove the funnel lid (5-fv).

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456-

Slowly pour the chambers content into the flask of origin. Maintaining its lid off (5-fv), couple the bubbling chamber (5-fv) to the support (9-fv). 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.

789-

Once the drying procedure has been concluded, close the total gas flow and the bubbling flow control button (6-fv). Firmly place the funnel with its lid on it (5-fv). Mount the Mini-Pinomatic bubbling chamber (5-fv) on its respective support (9-fv) on the right side of Vaporizer 1415.

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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 Vaporizers 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 Vaporizers 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:

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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.

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 STERILIZATION

IF PROCESSING CONCLUDED

IF DISINFECTION

PHYSICAL MEDIUM (STEAM)

CHEMICAL MEDIUM

STORE

LIQUID CHEMICAL MEDIUM 70% ALCOHOL

LIQUID PHYSICAL MEDIUM THERMO DISINFECTION

LIQUID CHEMICAL MEDIUM GLUTARALDEHYDE

PACK

LQUID (GLUTARALDEHYDE)

GASEOUS (ETHYLENE OXIDE)

PLASMA (HYDROGEN PEROXIDE)

MECHANICAL FRICTION

IMMERSE FOR THE TIME AND AT THE TEMPERATURE REQUIRED

IMMERSE THE ARTICLE

STERILIZE

IMMERSER FULLY

PACK

PACK

PACK

DRY IN AN ASEPTIC WAY

FILLIN TABULATIONS

STORE

FILLIN TABULATION

STERILIZE

STERILIZE

STORE

PACK

RINSE WITH STERILIZED H2O

RINSE WITH STERILIZED H2O

STORE

STORE

STORE

DRY IN AN ASEPTIC WAY

DRY IN AN ASEPTIC WAY

PACK

PACK IN STERILIZED FLASK

STORE

STORE

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

Component

Cleaning

Disinfection

Sterilization

Sphygmomanometer bracket

Detergent Solution

NOT RECOMMENDED Glutaraldehyde Thermal disinfection Sensitive 70% Alcohol Synthetic phenol Synthetic phenol

NOT RECOMMENDED Ethylene Oxide Glutaraldehyde or Hydrogen Peroxide NOT RECOMMENDED

Anti-pollution bag

Detergent Solution

Rotameter block

Damp cloth

Sphygmomanometer cable

Detergent Solution

NOT RECOMMENDED

EKG Cable / Oximeter

Detergent Solution

Synthetic phenol Glutaraldehyde Thermal disinfection resistant Glutaraldehyde Thermal disinfection Sensitive Glutaraldehyde Thermal disinfection Sensitive NOT RECOMMENDED Glutaraldehyde 70% Alcohol Glutaraldehyde 70% Alcohol Glutaraldehyde Thermal disinfection resistant 70% Alcohol Synthetic phenol Glutaraldehyde Thermal disinfection resistant Glutaraldehyde Thermal disinfection sensitive Glutaraldehyde Thermal disinfection sensitive Glutaraldehyde 70% Alcohol Synthetic phenol 70% Alcohol Glutaraldehyde 70% Alcohol Synthetic phenol 70% Alcohol Synthetic phenol 70% Alcohol Glutaraldehyde

NOT RECOMMENDED

Humidifier Chamber

Detergent Solution

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

Bell

Detergent Solution

Canister

Detergent Solution

Oximeter Galvanic Cell

Detergent Solution

Bell Rod Set

Detergent Solution

Air Vent Elbow

Detergent Solution

Drains

Detergent Solution

Flow meter

Damp cloth

Diaphragms

Detergent Solution

Y-Shaped Connector (nozzle)

Detergent Solution

T-Shaped Capnograph Connector

Detergent Solution

Mask

Detergent Solution

Monitor Module

Damp cloth

NOT RECOMMENDED

Aspirating Flask

Detergent Solution

Steam or Glutaraldehyde

Ventilator Module

70% Alcohol

NOT RECOMMENDED

Cabinet (external parts)

70% Alcohol

NOT RECOMMENDED Ethylene Oxide Glutaraldehyde or Hydrogen Peroxide

Mask Strap

Detergent Solution

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Component

Cleaning

Disinfection Glutaraldehyde Thermal disinfection resistant Synthetic phenol 70% Alcohol 70% Alcohol

Sterilization

Flow Sensor

Detergent Solution

Steam 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

Auxiliary Thermometer

Detergent Solution

Injected Liquid Thermometer

Detergent Solution

Esophageal Temperature Sensor

Detergent Solution

Glutaraldehyde

Side Stream (capnograph)

Detergent Solution

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

Canister Support

Detergent Solution

Corrugated Tubes **

Detergent Solution

Vacuum meter

Detergent Solution

Inhalation and Exhalation Valves

Detergent Solution

Calibrated Vaporizer

Damp cloth

Multi-agent Vaporizer

Damp cloth

NOT RECOMMENDED

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11

MAINTENANCE

Correct preventive Vaporizer 1415 maintenance will guarantee it can be used accurately and safely for an extended period of time. 12Carry out a periodical visual inspection of Vaporizer 1415. Should there be any apparent damage, do not use the device. At least once a month inspect the condition of the plastic washer placed in Vaporizer 1415s bubbling chamber funnel lid. If this washer is damaged, take steps to have it replaced to prevent gas leakages during anesthesia. 3If it is not possible to switch Vaporizer 1415s electric components on normally, initially check: If there is power in the electric output that feeds the Rotameter Block; 12-VDC cable integrity; 4Periodically, 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. TAKAOKAS authorized 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 maintenance on the Vaporizer and do not open its case. For periodic service or to perform any maintenance on the Vaporizer, call K. TAKAOKAS authorized Technical Assistance.

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12

SYMBOLS

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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 devices condition, and dont 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 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. 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 devices 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.

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

Multiagent Vaporizer 1415s 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

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K. TAKAOKA DISTRIBUTORS IN BRAZIL

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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

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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

Defect description:

Rua General Izidoro Dias Lopes, 121/141 CEP 09687-100 So 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 So Bernardo do Campo - SP Tel.: (5511) 4176-3500 Fax.: (5511) 4176-3570