Operation Manual

OPERATION MANUAL SIVA - Ventilator/Anesthesia Interface System

Equipment code: 201060013 (1 canister) Equipment code: 201060014 (2 canisters) Manual Code: 204010289_004 Date: (August/2010)

This Operation Manual has the information that is necessary for the proper use of the Ventilator/Anesthesia Interface System, model 3339 (1 canister) and model 3340 (2 canisters).

Manufacturer:
K. TAKAOKA IND. E COM. LTDA. Rua General Izidoro Dias Lopes, 121/141 Bairro Vila Paulicia - So Bernardo do Campo / SP CEP 09687-100 - Brasil Tel.: (11) 2948-5923 Fax.: (0xx11) 2948-5914 Web site: www.ktk.ind.br e-mail: kt@ktk.ind.br CGC: 61.489.381/0001-09 I.E.: 103.735.350.115 Sugestes, dvidas ou reclamaes: Call Center: (11) 2948-5923

Product Registration at the Health Ministry:

Technical Name: Ventilator/Anesthesia Interface System Trade Name: SIVA 3339 (1 canister) Trade Name: SIVA 3340 (2 canister)

Product Classification:
NBR 13750/1996 (Respiratory systems - Systems with absorbers - performance and safety requirements) Type B IPX1 Continuous Operation

Technician in Charge:

Eng. Alexandre Rodrigues da Silva CREA Registro N 0682082567

Product Installation Form EQUIPMENT: ___________________________ Code: ____________ Serial Number: _________
DESCRIPTION 1 2 3 4 5 6 7 8 9 10 ACCESSORIES CODE SERIAL NUMBER

INVOICE:

Original K.TAKAOKA

] YES ________________ [ Invoice Number*

] NO ______________________ Representation Name

INSTITUTION: Corporate Name: ____________________________________Tax Payers ID*:________________________ Address: _______________________________________________________________________________ City: __________________________________________State:_________ ZIP: __________________ Person in charge of the information*:______________________________Position: _____________________ Sector: ________________________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: ________________________ Date ____/ ____ /_____ Sig.: _________________ Send this form to Fax (55 11) 2948-5914, 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) 2948-5923

TABLE OF CONTENTS
DEFINITIONS..........................................................................................................................................5 THE COMPANY ......................................................................................................................................6 1 2 3 4 5 INTRODUCTION .............................................................................................................................9 WARNINGS ..................................................................................................................................10 GENERAL DESCRIPTION............................................................................................................12 TECHNICAL SPECIFICATIONS ...................................................................................................13 OPERATING PRINCIPLE .............................................................................................................14 5.1 5.2 5.3 6 BELLOWS MODULE ...................................................................................................................14 CONTROLLED VENTILATION .......................................................................................................15 MANUAL VENTILATION ..............................................................................................................15

CONTROLS AND COMPONENTS................................................................................................16 6.1 LIST OF COMPONENTS .............................................................................................................16 6.2 FRONT VIEW ...........................................................................................................................18 6.3 LEFT VIEW ..............................................................................................................................20 6.4 INHALATION AND EXHALATION VALVES .......................................................................................23 6.5 APL (AIRWAY PRESSURE LIMIT) VALVE .....................................................................................24 6.6 BAG/VENTILATOR KEY ........................................................................................................25 6.7 SODA LIME .............................................................................................................................25 6.8 CANISTER ...............................................................................................................................26 6.9 DRAIN ...........................................................................................................................................27

ASSEMBLY AND PREPARATION................................................................................................28 7.1 ASSEMBLING THE SIVA ..........................................................................................................28 7.2 OTHER COMPONENTS .....................................................................................................................28 7.3 RESPIRATORY CIRCUIT ...................................................................................................................31 7.3.1 Unidirectional Valve 300 ...............................................................................................31 7.3.2 Open System O2 / N2O / Air / Halogenated .................................................................33 7.3.3 Semi-closed System .....................................................................................................34 7.4 FLOW SENSOR ........................................................................................................................36

8 9 10 11 12 13 14

SIVA CHECKING PROCEDURE...................................................................................................38 CHECK LIST.................................................................................................................................40 CLEANING AND STERILIZATION............................................................................................41 MAINTENANCE........................................................................................................................46 SYMBOLS ................................................................................................................................47 ACTIONS TO BE PERFORMED IN AN EMERGENCY .............................................................52 TERMS OF WARRANTY ..........................................................................................................53

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

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) 2948-5923 Fax: (55 11) 2948-5914 E-mail: kt@takaoka.com.br Website: http://www.takaoka.com.br

Figure 1: SIVA 3339

Figure 2: SIVA 3340

INTRODUCTION

The purpose of this manual is to instruct the user about how to use the SIVA soda lime filter. The person technically in charge at the hospital and the users of the anesthesia device the SIVA filter is part of must read this manual in full, or at least the Important Warnings, Technical Specifications, Controls and Components, Assembly and Preparation, SIVA Verification, Cleaning, and Sterilization Procedures. This manual must be kept in a place of easy access for any queries that may be necessary. The SIVA is a soda lime filter that is part of K.TAKAOKAs mid-size and large anesthesia devices. It is a patented soda lime filtering system which operates as a interface with the ventilator and has as a unique characteristic the use of gases in the anesthesia circuit, as part of the ventilators ventilation gases without, however, being diluted by them. The XS FREE escape valve is a patented valve that is part of the SIVA and allows excess gases to leak only when the bellows reaches the upper bell parts, allowing the physician to set the smallest escape of excess FGF as possible, keeping gas consumption as low as possible and, thus, allowing for product savings.

WARNINGS
Always go through the check list before using the SIVA (Chapter 9). Do not use the device if it is not in perfect working order. Always make sure that the diaphragm reaches the upper part of the bell at the end of the exhalation, thereby indicating that the total adjusted flow in the Rotameter is appropriate. It is recommended that an oxygen analyzer always be used together with the Anesthetic Machine, as well as other optional monitors. If the Y-shaped connector has a socket for a gas monitor, this socket must always be tightly closed either by the monitor tube itself or by the appropriate plug provided with this Y-shaped connector. Since this is an ascending passive bellows, it is necessary to continually observe the bellows course within the bell. If the bellows takes-on a lower position (compromising the patients ventilation) the user must provide for the necessary correction, checking the system and supplying additional gases. If an aspiration capnograph is being used, keep in mind that this equipment removes (varying according to the equipment) from the circuit a certain volume to make the CO2 reading and does not return it to the system. When the low flow technique is used, the volume the capnograph removes may cause the need for FGF adjustments (fresh gas flow). It is recommended that you install the sample return system on the breathing circuit exhalation branch. During anesthesia, make frequent checks to ensure firm connection of the endotracheal tube and other SIVA connections to avoid accidental disconnection. Before closing the canister, check that it is correctly assembled, that the rubber seal is free of all traces of soda lime and that the canister is not overfilled, so that there will be no gas leakage. For increased protection against contamination, two bacteria filters (optional) can be used between the inhalation/exhalation valves and the corrugated tubes leading to the patient. Set up an appropriate cleaning and sterilization routine for the SIVA components. All parts used in SIVA are made out of inert, non-toxic material that does not cause irritation or allergic reactions in the patient. Do not use the Anesthesia Device in the presence of flammable agents. Additionally, do not apply oil or grease on the equipment to avoid the risk of combustion. Keep the patient under constant observation. Observe the patient's pulmonary expansion and free exhalation. This Operation Manual should be read very carefully so the equipment is used properly and maximum benefit is achieved from all of its features. Also read the Operation Manuals for the other Anesthesia Machine parts and accessories. K.TAKAOKA has a full range of accessories that can be purchased individually to assemble different types of respiratory anesthesia systems. A few flow units are in ml, as this is the unit that is most commonly used in the medical area; 1000 ml equals 1 l. Some pressure units indicated in millibars (mbar) and hectopascals (hPa) are used by some institutions instead of cmH2O. Since 1 mbar is equal to 1 hPa, which in turn is equal to 1.016 cmH2O, these units can be freely interchanged.

10

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

Disposal ("waste")
All parts and components that have contact with fluids originating from patients (for example: respiratory circuit), are potentially contaminated. These are semi-critical components that must undergo high-level disinfection 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 recommendations regarding environmental protection, particularly for electronic waste or parts.

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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GENERAL DESCRIPTION

The SIVA was designed exclusively to form the respiratory system for K.TAKAOKA Anesthesia Devices, performing a coupling function between the ventilator and the anesthesia circuit and also allowing for the use of systems of circular valve type using carbon dioxide absorption, in which this type of respiratory system permits the reuse of gases exhaled by the patient. The SIVA has the following main characteristics: A passive bellows allowing the physician to have direct view of the tidal volume by means of the diaphragm excursion (provided that the fresh gas flow is not too high). Greater safety during low flow (base flow), since at any sign of the absence of FGF due to consumption or because of system leakage, the condition is quickly identified by viewing the diaphragm. This diaphragm also functions as an FGF reservoir. Total fidelity of the adjusted Tidal Volume in the Ventilator, since there is no Fresh Gas Flow interference. Better circuit saturation due to the absence of stagnation areas and the reduced response time. Few cycles are needed for the variations desired by the anesthetist to be attained. Better usage of the FGF, since SIVA only eliminates excesses, thereby resulting in anesthesia gas savings. The design of the device allows excess fresh gas to be eliminated only when the diaphragm reaches the top of the bell, by means of the patented XS FREE valve. Coaxial filter that allows for better soda lime usage, with 80% more durability. The device is extremely simple to handle, using a single connection for gas input and output. Transparent 800-g canister that allows the soda lime inside to be seen. Easy and fast soda lime replacement due to the canisters closing system using a quick tightening mechanism with an easy-to-activate lever. The canister and bellows are universal and can be used for all patients, from neonatal to adult. Inspiratory and expiratory valves are easily disassembled for cleaning and sterilization with transparent caps that clearly display their operation. Pressure control valve (APL) with gradation incorporated to the SIVA casing. This valve can be used in the controlled or spontaneous mode. Manometer for pressure reading in the manual ventilation. APL valve with a totally closed setting position, preventing gas escape. Inlet for constant fresh gas flow built into the SIVA cabinet. Drain with a removable lid to collect the water accumulated in the canister. Heating and moisturizing of the gases administered to the patient. Less atmospheric pollution with anesthetics. Mechanical bag/ventilator key. Ergonomic support for the bag. Totally dismountable breathing circuits. Articulated support arm for corrugated tubes.

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TECHNICAL SPECIFICATIONS

SIVA is an interface ascending passive bellows system between the ventilator and the anesthesia circuit that allows for all ventilation resources found in Intensive Therapy ventilators to be used. A coaxial soda lime CO2 absorbing filter comes with the device, which makes it much easier to substitute the canister for simultaneous gas input and output, thus making better use of the soda lime due to more uniform consumption. The respiratory circuit can be disassembled and sterilized. The coaxial canister and the bellows are universal. They can be used for neonatal to adult patients. The SIVA also has a ventilator bag key and a pressure limit valve (APL) for manual ventilation. APL Valve adjustment.............................................................................................................0 to 50 cmH2O Tidal Volume .....................................................................................................................................1600 ml Soda lime capacity in the canister................................................800 g (Filter 3339) or 1600 g (Filter 3340) Balloon-type reservoir................................3 liters Conical connections. 22 mm and 15 mm, according to the ABNT Manometer........................................................................................................................ 10 to 90 cmH2O

Dimensions:
Filter (1 canister) 3339 : Height x Width x Depth ..........................................................652 x 200 x 318 mm Filter (2 canisters) 3340: Height x Width x Depth 743 x 198 x 318 mm

Weight:
Filter (1 canister) 3339.......................................................................................................................11.5 kgf Filter (2 canisters) 3340.....................................................................................................................12.0 kgf

The SIVA complies with the requirements in the following ABNT: Norm NBR 13750/1996: Respiratory Systems Systems with absorber Performance and safety requirements.

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OPERATING PRINCIPLE

Figure 5.1 illustrates the function of each SIVA component and the gas flows that circulate in this equipment. The canister contains soda lime, which is a granulated consumable material. Soda lime reacts chemically with the carbon dioxide (CO2) the patient exhales. This allows the exhaled gas to be recycled with no CO2 being re-inhaled. The inhalation and exhalation valves are one-way valves that set a single direction for the evacuation of gases from inside SIVA. The inhalation and exhalation branches are two corrugated tubes coupled to the inhalation and exhalation valves that supply and remove gases to/from the patient. The connecting nozzle built into the SIVA cabinet allows a constant inflow of fresh gas. The APL valve ensures the removal of excess gas from the system during spontaneous or manually-controlled ventilation.

EXP

FGF APL

INHALATION

BAG/ VENTILATOR KEY

VENTILATOR TO ANESTHESIA

Figure 5.1: SIVA Operating Principle

Note:
The traced line in the figure shows where the flow sensor must be placed in ventilators that work with this device.

5.1

Bellows module

The bellows module interconnects to the ventilator through a coupling set. This module consists of a box containing various pneumatic components and internal connections, as well as a bell with a bellow coupled to its upper part. A mixture of gases (or O2) supplied by the Ventilator activates the bellows. The bellows is located inside a transparent bell and are used to dose and store the tidal volume that will be sent to the patient. The inner space of the bellows is in contact with the respiratory system, whereas the space between the diaphragm and the bell jar interconnects with the ventilator system. The bellows represents, therefore, an interface between two different gas systems, moving according to the differences between their pressures.

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5.2

Controlled ventilation

At the beginning of an inhalation phase, the diaphragm expands and is filled with the FGF to be supplied to the patient plus the exhaled gases. The ventilator then sends a flow that enters the space between the bellows and the bell, generating an increased pressure that causes the bellows to move down. The gases go to the canister, where the soda lime absorbs the carbon dioxide. The gases then pass through the inhalation valve and, finally, arrive at the patient. The SIVA exhalation valve remains closed. During the exhalation phase, the gases exhaled by the patient initially go through the exhalation valve before they fill the bellows (ascending passive bellows). The gases that were between the diaphragm and the bell are released to the antipollution system by the Ventilators exhalation valve block. The SIVA inhalation valve remains closed.

Note:
The bellows is filled by the FGF plus the volume exhaled by the patient and, when this volume is greater than the volume available in the diaphragm, the XS FREE valve in the upper part of the diaphragm will exhaust the excess gases through the expiratory valve of the Ventilator, thereby eliminating the chance of an unwanted PEEP occurring. In this situation, the bag does not work as a fresh gas reservoir.

5.3

Manual ventilation

When the VENTILATOR/BAG is place on the BAG position, the fresh gases together with the gases the patient exhales are stored in the bellows, which is the bag that performs the Ventilators operation, i.e., in the inhalation phase, the bags volume goes to the canister, where the soda lime absorbs the carbon dioxide. The gases then pass through the inhalation valve and, finally, arrive at the patient. The SIVA exhalation valve remains closed. The maximum inhalation pressure is set by the APL valve, which eliminates excess gases during the inhalation. The pressure value gradation and the manometer allow better manual ventilation control. Note: Check how much the bag fills during the inhalation and exhalation phases. It should be kept around the half-full level. During the exhalation phase, the gases the patient exhales initially go through the exhalation valve and join the fresh gases to fill the bag that is used in the next cycle.

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CONTROLS AND COMPONENTS

6.1 List of Components

The components listed below are supplied with the SIVA 3339 and SIVA 3340: ITEM PRODUCT DESCRIPTION CODE

One exhalation valve

202010754

One inhalation valve

202010922

One 3-liter bag

203061127

Bag rod set

202011944

Canister 800 g

202012014

Bellows 1600 ml

202012049

Bell 1600 ml

202012048

Operation Manual

204010289

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

K TAKAOKA also has a complete range of optional accessories for anesthesia equipment that should be ordered separately as desired. Contact a K.TAKAOKA authorized representative for further information.

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6.2

Front View

The items below refer to the front view of SIVA 3339 and 3340 (Figure 6.1). A - Articulated Arm Support An attachment support for the optional articulated arm that is used as a support for the corrugated tubes of the respiratory circuit. B - Bag Support A ergonomic support made out of steel with anticorrosion painting with a connecting piece at its upper extremity with a 22-mm conical connection (male), to couple to the bag. C - Bag A latex bag with a 22-mm conical connection (female) that is utilized in spontaneous or manually-controlled ventilation.

Note:
The bag must be connected permanently, since the change between the spontaneous/manual and mechanical ventilations is done simply using the BAG/VENT key, without any need for manual connection changes. A corrugated tube (optional accessory) may be used between the bag and the support so that the bag is in a more convenient position during the anesthesia.

D - APL Valve A pressure-limit adjustment valve in spontaneous or manually-controlled ventilation. E - BAG/VENTILATOR Key A key with two positions, for quick change between spontaneous and manual ventilation, controlled without the need for manual connection changes. Item 6.6 provides more details about this key. 1. In the BAG position (Figure 6.4), the SIVA bag will automatically be interconnected to the respiratory system, activating the diaphragm in spontaneous or manually-controlled ventilation. In this case, the APL valve must be adjusted (item 6.6).

Attention
When the BAG/VENTILATOR key is placed in the BAG position, place the Ventilator on STANDBY.

2.

On the VENTILATOR position (Figure 6.4), the Ventilator will automatically be interconnected to the respiratory system, activating the diaphragm in controlled ventilation.

Note:
Both the bag and the coupling set must be constantly interlinked to their respective SIVA connections.

F - Canister The canister for storing soda lime in SIVA. The canister is transparent to allow the color of the soda lime inside it can be clearly seen. The lower canister edge has a silicone protection to prevent gas leakage. The canisters are closed by means of a quick-fastening mechanism (item 6.8). Filter 3339 is equipped with 1 canister, while filter model 3340 has 2 canisters.

Attention
To prevent deficient sealing and gas leakage in the canister, when closing it always check: whether the canister is correctly assembled; whether the silicone protections in the canister and in the SIVA are free of soda lime residues; whether the canister is not overfilled with soda lime. Fill the canisters up to 10 mm of the edge.

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G Manometer Manometer to view the maximum inhalation pressure value used to better control manual ventilation.

A
G

Figure 6.1.1: Front View of the SIVA 3339

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A
G

Figure 6.1.2: Front View of the SIVA 3340

6.3

Left View

The items below refer to SIVA 3339 and 3340 left side view (Figure 6.2). A - Connection to the Ventilator Connection for interlinking SIVA with the Ventilator. This interconnection is done through a coupling set that must remain permanently connected, since the change between spontaneous and controlled ventilations is achieved simply through the BAG/VENTILATOR key, with no need to change the connections manually. This connection has differentiated diameters, preventing a mistaken connection of the trachea coming from the ventilator in any other position, such as in the inhalation and exhalation valves, bag, etc.

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B - Connection to the Oxygen Analyzer Sensor 15-mm conical connection (female) to the O2 analyzer sensor that monitors the O2 concentration in the inhaled gases. If an O2 analyzer is not used incorporated to the Ventilator, this connection must be closed with its appropriate lid that comes with the SIVA to prevent gas leakage. C - Fresh Gas Inlet A connection nozzle for continual fresh gas flow input coming from the quick connection clamp of the Anesthesia Device, through a flexible tube with an internal diameter of inch (6,4 mm). D - Exhalation Valve A one-way exhalation valve with a transparent threaded cover allowing its internal operation to be viewed. It has a 22-mm male conical connection for the exhalation branchs corrugated tube. Item 6.5 provides further details of the exhalation valve. E - Bellows Set Bell with bellows to dose and store the tidal volume to be supplied to the patient. The bellows is located in a transparent bell, which is coupled on to the bellows module case. The connections must be tightly fastened. The SIVA bellows is passive, allowing the physician to have direct view of the tidal volume by means of the diaphragm excursion (provided the fresh gas flow is not too high).

Attention
The vertical movement of the diaphragm represents the gas volume sent to the patients respiratory circuit.

F - Inhalation Valve A one-way inhalation valve with a transparent threaded cover that allows its internal operation to be viewed. It has a 22-mm male conical connection for the corrugated tube of the inhalation branch. Item 6.5 provides more details of this valve. G - Cabinet A cabinet containing the SIVA connections and internal valves. The cabinet also contains the openings that are used to attach SIVA to the Anesthesia Equipment Cabinet. H - Canister Closing Lever Anatomical lever for quick canister closing, facilitating soda lime replacement. The closed position corresponds to the lever positioned up, vertically; the open position is down, horizontal. I - Drain Drain with a removable lid to collect the water accumulated in the SIVA . It must normally be kept closed to prevent gas leakage (item 6.10).

Note:
Water formation in the canister is an inevitable consequence of the soda limes chemical reaction with CO2. Therefore, dry the canisters periodically.

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B A
H I

Figure 6.2.1: Left-side View of the SIVA 3339.

22

B A

H I

Figure 6.2.2: Left-side View of the SIVA 3340.

6.4

Inhalation and Exhalation Valves

The SIVA inhalation and exhalation valves are two one-way valves that determine the direction of gas flow evacuation inside the respiratory system. Both valves have a 22-mm male conical connection for the corrugated tubes of the patients inhalation and exhalation branches. They have different colors to prevent mistaken connections, guided as shown on the cabinet. The valve lids are transparent, allowing a clear view of the valves internal cleanliness and of the correct movement of their internal discs during the anesthesia.

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The internal valve discs have small pins that keep the discs from sticking to valve lids when there is excessive moisture, since this would result in the loss of valve effectiveness. The inhalation and exhalation valves can easily be disassembled for cleaning and sterilization, as represented in Figure 6.3. The following procedure must be carried out for proper inhalation and exhalation valve assembly: 1. 2. 3. Make sure the sealing ring (O-ring) is not worn out and that it is positioned correctly on the valve cap. Place the disc inside the valve with its pins facing up. Thread the valve cover on the body and give it a final twist to ensure perfect sealing.

Attention
Always make sure inhalation and exhalation valve components are clean, guaranteeing their perfect working order. Firmly tighten the conical connections between the inhalation and exhalation valves, the corrugated tubes and SIVA.

2
1 Transparent lid

2 Ring (O-ring) 3 - Disc (pins facing up) 4 - Body

Figure 6.3: Inhalation and exhalation valve assembly

6.5

APL (Airway Pressure Limit) Valve

Valve to adjust the pressure limit in the airways, located on the frontal part of the SIVA cabinet. This valve allows excess gases to leave the SIVA according to the pressure the user sets.

Attention
Switch the Ventilator to STANDBY before moving the BAG/VENTILATOR switch to the BAG position.

The exhaust is opened counterclockwise, and to adjust the valve, follow the steps below: In spontaneous ventilation, open the pressure limit adjustment valve totally and leave it on the MINIMUM position; In manual ventilation, adjust the pressure limit adjustment valve opening according to the desired level of respiratory system exhaust, while viewing the maximum pressure value reached via the ventilator display. Check the bag filling level during the inhalation and exhalation phases, to keep it at around half full.

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For obstructive patients that need high-pressure manual ventilation, the valve can be set at the position, indicating obstruction, not allowing flow escape.

Attention
Always make sure the APL valve is not on the maximum occlusion position to prevent high-pressure hazards for the patient. This valve does not need to be adjusted in Ventilator-controlled ventilation, since excess gas exhaust takes place in the Ventilator itself.

6.6

BAG/VENTILATOR Key

The BAG/VENTILATOR key allows for easy and quick alteration between spontaneous or manual ventilation (SIVA) and mechanical ventilation (SIVA with Ventilator), with no need for manual connection changes. 1. In the BAG position (Figure 6.4a), the SIVA bag will automatically be interconnected to the respiratory system, storing the gases that will be sent to the patient in the spontaneous or manually-controlled ventilation. In this case, the APL valve must be adjusted (item 6.5).

Attention
When the BAG/VENTILATOR key is switched to the BAG position, place the Anesthesia Ventilator on STANDBY.

2.

In the VENTILATOR position (Figure 6.4b), the Ventilator will automatically be interconnected to the respiratory system, activating the bellows in controlled ventilation.

Note:
Both the bag and the coupling set must be constantly interlinked to their respective SIVA connections.

a) Position: BAG

b) Position: VENT Figure 6.4: BAG/VENTILATOR Key

6.7

Soda Lime

The SIVA makes it possible for exhaled gas to be recycled without any risk of the patient re-inhaling carbon dioxide. Soda lime is used for this purpose. This is a granular substance placed in the canister to absorb the carbon dioxide from exhaled gases by means of a chemical filtering process. The chemical reaction from the absorption of carbon dioxide by the soda lime results in the formation of water inside the canister, and also heats it up.

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Soda lime is only effective for a limited amount of time. It must then be replaced. Determining when the soda lime must be changed should be done mainly by observing its color and by checking canister cooling. Soda lime in good condition is white; its color changes when it is worn out, indicating the need for replacement. Worn-out soda lime is typically slightly blue or purple.

Attention
Evaluating state of soda lime merely based on its color may be misleading since worn-out soda lime will regain its original color when left unused for some time. Using worn-out soda lime would lead to the patient re-inhaling carbon dioxide and to all related unwelcome physiological consequences.

6.8

Canister

The canister is the receptacle for the SIVA soda lime. The canister is transparent to allow the color of the soda lime inside it can be clearly seen. The canister is sealed by silicone gaskets, one in the canister and another in the SIVA cabinet. The canisters are closed by means of a quick-fastening mechanism, thus streamlining soda lime replacement. This system makes it easy and quick to replace the soda lime. Follow the procedure below to fill the canister with soda lime appropriately and to assemble it correctly to the SIVA: 1. 2. 3. 4. 5. Check if the silicone gaskets are clean and in good conditions and whether the canisters central sieve is not obstructed; Fill the canister with soda lime to a level of approximately 1 (one) centimeter below the top. When filling, slightly tap the canisters' sides so the soda lime can be easily and evenly accommodated inside them. Open the canister by moving the closing lever down, to the horizontal position (Figure 6.5a); Centralize the canister carefully in order for it to fit perfectly on the silicone gasket in the SIVA during closing. Close the canister moving the lever up, to the vertical position (Figure 6.5b).

a) Position: OPEN

b) Position: CLOSED

Figure 6.5: Canister closing lever

Attention
Do not overfill the canister so the soda lime does not prevent it from being closed and in order for there to be no leakage (Figure 6.6). Make sure the seal is free soda lime traces and that it is in perfect condition to ensure good sealing against possible gas leakage.

26

Minimum = 1 cm

Figure 6.6: Maximum Soda Lime Level The SIVA is supplied with a spare canister that allows some lime to be quickly replaced during anesthesia. As the gas flow through the canisters follows a descending movement, the upper part of soda lime in the SIVA will be worn-out before the upper part is. To use soda lime in a more effective manner, keep the spare canister filled with fresh soda lime as soon as the soda lime lower canister requires replacement. Fitting in the

6.9 Drain
The SIVA has a drain located on its lower part so that excess water accumulated in the canisters can be removed. Water formation in the canister is an inevitable consequence of the soda limes chemical reaction with CO2. Figure 6.7 shows a detail of the drain with its lid. To drain accumulated water, remove the drain plug by pulling it and allow the condensed material to flow into a proper container, and then by placing the plug again to avoid gas leakage.

Attention
Drain the canister periodically to avoid water accumulation. The drain must be closed tightly to prevent gas leakage during anesthesia. Avoid direct contact of the discarded water with the skin.

Tampo

Figure 6.7: Drain

27

ASSEMBLY AND PREPARATION

7.1 Assembling the SIVA

Follow the instructions provided below to set the SIVA up on the Anesthesia Machine cabinet. 1. Attach SIVA to the Anesthesia Device simply by gently slotting the pins of the Anesthesia Machine cabinet into the holes in the SIVA cabinet (Figure 7.1). Check the perfect fit.

Fixation Orifices on the SIVA

Fixation pins on the Cabinet

Figure 7.1: Attaching SIVA to the Anesthesia Machine cabinet. 2. Assemble the canister correctly, according to the instructions in item 6.9.

7.2 Other components

123Check that all the respiratory circuit components have undergone proper disinfection procedures. This includes the corrugated tubes, connectors, exhalation valve, flow sensor, etc. Make sure the canisters have been assembled correctly, according to the instructions in item 6.8. Connect the inhalation and exhalation valves to their corresponding positions in the SIVA, thus providing an ascending flow of gases. The cabinet has incisions to guide the user. Make sure the valves have been correctly and firmly coupled. Also check the conservation and positioning of the O-rings and disks. 456Assemble the desired respiratory system (open or semi-closed), according to item 7.3 in this manual. Connect the bag support to the SIVA cabinet. Connect the 3-liter bag to the SIVA bag support. A corrugated tube may be used between the bag and the support so that the bag is in a more convenient position during the anesthesia (optional).

Attention
For more protection against contaminations, bacteria filters (optional) may be used between the flow sensor and the patient. All connections must be firmly tightened to avoid accidental disconnection during anesthesia.

7-

Connect the Ventilator to the SIVA through the coupling set (Figure 7.2). This coupling set is made out of a trachea and a coupling connector and is used both for adult patients and for infant and neonate ones.

28

Figure 7.2: Connecting the SIVA to the Ventilator

29

8-

Interconnect the fresh gas outlet from the Cabinet, which has a quick-latching connection (that allows for easy coupling), to the SIVA (Figure 7.3) through the inch internal diameter flexible tube (6.4 mm).

Quick connection

Flexible tube

SIVA Connection

Figure 7.3: Connecting the Cabinet to SIVA 9If an O2 analyzer is used with the Ventilator, couple its sensor to the respective connection located on the left of the SIVA (Figure 7.4).

30

Figure 7.4: Connecting the O2 Sensor to the SIVA

Note:
If an O2 analyzer is not used incorporated to the Ventilator, this connection must be closed with its appropriate lid that comes with the SIVA to prevent gas leakage.

7.3 Respiratory Circuit

The SIVA was designed aiming at, when associated to the Ventilator, allowing anesthesia to be administered via respiratory systems with a valvular circular absorber (semi-closed) or without it (open), in spontaneous ventilation, controlled or manual. Assembling the open system requires the use of the KT-300 Unidirectional Valve (item 7.3.1). Fresh gas flow referred to here as FGF, meaning the total value for the continuous flow that leaves the common gas outlet of the Anesthetic Machine. Therefore, the FGF is equal to the sum of oxygen and nitrous oxide flows and, or oxygen and compressed air flows, as regulated in the Anesthesia Machines Rotameter Block.

Attention
Using of each accessory or component requires the careful reading of its corresponding Instruction Manual.

7.3.1

Unidirectional Valve 300

Unidirectional Valve 300 is used to assemble the open respiratory system.

Note:
To assemble the open system, use the male-male 22-mm connector (optional) to connect the corrugated tube to the valves exhalation branch.

31

This valve should be disassembled periodically to disinfect its components, inspect or replace its diaphragm. Figure 7.5 shows the assembly scheme of the KT-300 Unidirectional Valve. The inspiratory branch has a 22mm (male) conical connection, the expiratory branch has a 22mm (female) conical connection, and the patient's branch has a 22m (male) and 15mm (female) conical connection - for the endotracheal tube connector or the mask. Valve assembly into the breathing system should be done according to the identifications written in the three branches: inspiration, expiration, and patient.

Attention
Check the cleanness and perfect state of conservation of the KT-300 Unidirectional Valve diaphragm periodically. In case there is any fissure, deformation or any other abnormality in this component, replace it for a new one. For a perfect assembly, first couple the diaphragm set into the cap (properly fixing the pin into the orifice), and then couple the valve's threaded cap.

Figure 7.5: Unidirectional Valve 300

32

7.3.2

Open System O2 / N2O / Air / Halogenated

Figure 7.6 outlines the assembly and operation of a breathing system without CO2 absorption, with a unidirectional valve and mechanical ventilation to supply O2, N2O (or compressed air) and halogenated anesthetic agent to the patient. After items 7.1 and 7.2 have been carried out, follow these steps to elaborate this system: 123Place the SIVA bag/ventilator valve on the VENTILATOR position. Connect a corrugated tube between the inhalation valve (without the disk, but with the lid) and the KT-300 Unidirectional Valve, forming the inhalation branch. Check the proper assembly position, as indicated on the KT-300 Unidirectional Valve itself. Couple the appropriate flow sensor between the KT-300 Unidirectional Valve and the mask or the endotracheal tube. Check that it has been correctly positioned as indicated on the flow sensor itself. Connect the two flow sensor tubes to their respective connectors located on the left side of the Ventilator, checking that the positions are correct. During the exhalation phase, the gases the patient exhales will be released to the environment through unidirectional valve 300, while the bellows goes up filled by the FGF. During the inhalation phase, the bellows goes down, pushing to the patient the gas volume contained in it, through the corrugated tube connected to the inhalation valve and to the KT-300 unidirectional valve. Simultaneously, the FGF that is admitted is eliminated to the environment through the Ventilators valve. In this system, the Tidal Volume supplied to the patient is only set according to the volume displaced by the bellows, as supplied by the Ventilator. Tidal Volume = Volume Displaced by the Bellows

Attention
The FGF value, as regulated in the Rotameter, must be at least the same as the patient's volume per minute (tidal volume x respiratory rate) so that there is no gas shortage in the system. Since this is an ascending passive bellows, it is necessary to continually observe the bellows course within the bell. If the bellows take-on an inferior position (compromising the patients ventilation) the user must provide for the necessary correction, checking the system and supplying additional gases. Do not use the Rotameters direct oxygen valve to fill the bellows. To do so, adjust a high flow in the Rotameter until the bellows touch the top of the bell, and readjust the flow after the situation has been normalized. If an aspiration capnograph is being used, keep in mind that this equipment removes (varying according to the equipment) from the circuit a certain volume to make the CO2 reading and does not return it to the system. When the low flow technique is used, the volume the capnograph removes may cause the need for FGF adjustments. It is recommended that you install the sample return system on the breathing circuit exhalation branch. To exhaust the excess gases to outside of the room, use a corrugated tube connected to the Ventilators valve. Do not interconnect the free end of this tube directly into an aspirator or vacuum system. It is normally recommended that a FGF between 1 l/min and 5 l/min be used. Also prevent excessive flow.

33

Figure 7.6: Open System

7.3.3

Semi-closed System

Figure 7.7 outlines the assembly and operation of a breathing system with circular, valve, and CO2 absorption and with mechanical ventilation. Do the following to assemble this system: 123Place the SIVA bag/ventilator valve on the VENTILATOR position. Connect a corrugated tube between the inhalation valve and the "Y" connector, forming the inhalation branch. Connect a corrugated tube between the inhalation valve and the "Y" connector, forming the inhalation branch.

34

4-

Attach the appropriate flow sensor between the Y-shaped connector of the respiratory circuit and the mask or endotracheal tube. Check that it has been correctly positioned as indicated on the flow sensor itself. Connect the two flow sensor tubes to their respective connectors located on the left side of the Ventilator, checking that the positions are correct.

During the expiratory phase, the bellows moves up and is filled by part of the gases expired by the patient plus the FGF. This mix is admitted to the SIVA through the exhalation valve and the flexible tube, respectively. An excessive amount of gases in the system is unloaded through the X-FREE valve located in the upper portion of the bellows. A possible lack of gases in the system is observed by the bellows course, which during each cycle takes-on smaller positions. During the inhalation phase, the Ventilator pushes the bellows, which sends the gas volume contained in it to the canister to absorb the CO2, the gases flow through the inhalation valve to the patient. In this system, the Tidal Volume supplied to the patient is only set according to the volume displaced by the bellows, as supplied by the Ventilator. Tidal Volume = Volume Displaced by the Bellows

Attention
As this is an ascending passive bellows, it is necessary to observe the bellows excursion constantly in the bell if the bellows takes-on a lower position (compromising the patients ventilation). The user must provide the proper correction by checking the system and providing additional gases. Do not use the Rotameters direct oxygen valve to fill the bellows. To do so, adjust a high flow in the Rotameter until the bellows touch the top of the bell, and readjust the flow after the situation has been normalized. If an aspiration capnograph is being used, keep in mind that this equipment removes (varying according to the equipment) from the circuit a certain volume to make the CO2 reading and does not return it to the system. When the low flow technique is used, the volume the capnograph removes may cause the need for FGF adjustments. It is recommended that you install the sample return system on the breathing circuit exhalation branch. To exhaust the excess gases to outside of the room, use a corrugated tube connected to the Ventilators valve. Do not interconnect the free end of this tube directly into an aspirator or vacuum system. It is normally recommended that a FGF between 1 l/min and 5 l/min be used. Also prevent excessive flow.

35

Figure 7.7: Semi-closed System

7.4

Flow Sensor

The Ventilator measures the flow, volume and pressure by means of a differential pressure flow sensor. Assemble the flow sensor according to the following procedure. 1Connect the type of flow sensor requested by the Ventilator display at the time the Ventilator is being started up. This will be the most suitable type for the weight of the patient as informed by the operator. The two flow sensor options available are adult and pediatric.

36

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

2-

Attach the appropriate flow sensor between the Y-shaped connector of the respiratory circuit and the mask or endotracheal tube (Figure 7.8). Check that it has been correctly positioned as indicated on the flow sensor itself.

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

Trachea Connector for anesthesia gases monitor (optional) Flow sensor Flow sensor tube (next to the patient) Flow sensor tube Y-shaped connector

Figure 7.8: Flow sensor assembly. 3Connect the two flow sensor tubes to their respective connectors located on the left side of the Ventilator, checking that the positions are correct.

Attention
During Ventilator use, check the flow sensor and tube cleanliness frequently, as excess moisture or secretion accumulation in the flow sensor or in the tubes can cause erroneous measurements and compromise the devices operation. Check the flow sensor and tube color codes to ensure correct positioning. The 15-mm female connection (larger) relates to the patient's side and the 15-mm male connection (smaller) relates to the respiratory system side of the ventilation equipment. The two tubes have different colors for quick identification. For more protection against contaminations, bacteria filters (optional) may be used between the flow sensor and the patient. All connections must be firmly tightened to avoid accidental disconnection during anesthesia. The optional gas socket for the Y-shaped connector monitor must be tightly closed either by the monitor tube itself or by the appropriate plug provided with the connector.

37

SIVA CHECKING PROCEDURE

This inspection procedure must be done periodically to check perfect SIVA operation. Read the Anesthesia Devices component, accessory and monitor operation manuals in order to perform a more complete inspection. Instructions for the check list are in Chapter 9.

Attention
Perform this procedure periodically. Do not use the equipment if the inspection routine reveals any irregularity whatsoever. In this case, solve the problem or return the defective product to K.TAKAOKA Technical Assistance.

1234567

Check the SIVA assembly on the Anesthesia Device cabinet. Check whether the condensed water was drained from the canister and if the drain lid is tightly closed. Check if the central canister sieves are obstructed. Check that the quality and condition of the soda lime are adequate. Check the canisters assembly and perfect closing. Check that all tubes and sleeves are correctly and firmly mounted. Check that there is no leakage in the system, as per the following procedure: Assemble the semi-closed circuit as per Figure 7.7.

Connect a 500-mL test bag firmly to the Y part.

Position the Bag/Ventilator valve on the Ventilator position

Set a mechanical ventilation with a 1.0-L tidal volume.

38

*A

During the cycles, if the bellows reaches heights that are increasingly low in subsequent cycles, there is a leak in the circuit.

Adjust the Rotameter flow until the bellows reaches equal heights in subsequent cycles. Under such conditions the value of the flow corresponds to the leakage.

* If leakage is above 150 ml/min ( *A), it is recommended that both the connections and the soda lime reservoir are checked and the test repeated.

If leakage continues, the device can be used by compensating with a larger opening of gases in the Rotameter. However, before the device is used again, it should be sent to the Technical Assistance.

Check the proper functioning of the SIVA APL, according to the following procedure: Obstruct the patients output at the Y intermediary, placing a test bag. Press the Rotameter direct O2 valve until the two bags are partially filled. Rotate the SIVA APL valve clockwise and at each value set on the button, check if there is any gas escaping, checking the values through the manometer.

9-

Check that the inhalation and exhalation valves have been correctly assembled and that they are working correctly according to the following procedure:

Perform the previous procedure and, when pressing the bag, check if the inhalation valve opens and the exhalation one closes. When you release the bag, check if the exhalation valve opens and the inhalation one closes.

39

CHECK LIST

The check list is a simple and quick procedure the operator will perform before each anesthesia to check the perfect SIVA operation.

Attention
Go through the check list before each procedure. Do not use the equipment if the inspection routine reveals any irregularity whatsoever. In this case, solve the problem or return the defective product to K.TAKAOKA Technical Assistance.

1 2 3 4

Make sure the device is connected to the gas network. Make sure the device is connected to the power line. Make sure the Vaporizer Chamber is well fit and totally closed. Check if the Ventilators INS/EXP valve block is assembled properly, if the diaphragm is well positioned and whether it is not deformed or tainted. Also check the connector and the trachea connections.

In the SIVA, make sure the Inhalation and Exhalation valves are well connected and properly placed. Also make sure the valve disks are dry and well positioned.

6 7 8 9

Then, check whether the canister is positioned correctly. Check the soda lime fill and make sure it is new. Make sure the bell is well coupled. Make sure the Fresh Gas Flow (FGF) outlet has been connected to the SIVA. Make sure all of the Respiratory Circuits connections are properly placed and firm. Also make sure the flow sensor is positioned after the Y and that it is in agreement with the type of patient, adult or neonatal/pediatric. The flow sensor lines must also be properly connected to the ventilator, as indicated by the colors registered on the equipment.

40

10

CLEANING AND STERILIZATION

Establish a cleaning and sterilization routine for the SIVA components. The SIVA components must be frequently dismantled for cleaning and sterilization, including: corrugated tubes, inhalation and exhalation valves, canister, rubber parts, etc. The external SIVA parts can be cleaned with a cloth that is just moistened in an appropriate germicidal solution, while always taking care that none of the cleaning product residue collects on the SIVA connectors. After cleaning, dry with a clean, soft and dry cloth. Never use abrasive products to clean the canister to avoid scratching it. Do not use alcohol to clean the plastic parts. Always keep the SIVA cabinet seals clean to avoid leakage. Always keep the canister sieve unblocked. The silicone parts (tubes and tracheas) have characteristics that are intrinsic to silicone, including non-deformation (at up to 150oC) and an undetermined useful life at room temperature, maintaining silicone properties. It is suggested their storage conditions be in a clean and organized place, free of perforating materials or contaminants, preferably according to the good manufacturing practice cleanliness and organization instructions, protected from direct sunlight and avoiding temperatures above 40oC or in locations near equipment that heats (such as incubators or sterilizers). After they start being used, it is suggested the tracheas have a maximum life cycle of up to 50 sterilizations in a vapor-sterilization Autoclave process, in 30-minute cycles at 1.03 bar/15 psi and 121C/250F.

Attention
When using ethylene oxide, follow the instructions provided by the manufacturer of the sterilizing equipment for deciding on the correct temperatures and aeration times indicated.

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. Disinfection is classified in three categories: high-, medium-, and low-level.

41

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 vegetative 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) and is performed by physical (steam) or chemical processes (liquid-glutaraldehyde, gaseous-ethylene oxide gas and plasma-hydrogen peroxide). The spore is the most difficult microorganism to inactivate. Ex.: Autoclave, Hydrogen Peroxide, ethylene oxide, Glutaraldehyde (exposure of the material for 10 hours).

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

42

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

43

TABLE
Methods recommended processing 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

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 NOT RECOMMENDED

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

Bellows

Detergent Solution

Y-Shaped Connector (nozzle)

Detergent Solution

T-Shaped Capnograph Connector

Detergent Solution

Mask

Detergent Solution

Monitor Module

Damp cloth

Aspirating Flask

Detergent Solution

Steam or Glutaraldehyde

Ventilator Module

70% Alcohol

NOT RECOMMENDED

Cabinet (external parts)

70% Alcohol

NOT RECOMMENDED

44

Component

Cleaning

Disinfection

Sterilization Ethylene Oxide Glutaraldehyde or Hydrogen Peroxide 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

Mask Strap

Detergent Solution

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

Flow Sensor

Detergent Solution

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

Note:
* The Galvanic Cell for FiO2 measurement should be cleaned with a cloth dampened in soap and water, it should not be immersed in solution. ** Silicone treated corrugated tubes may be autoclaved and submitted to thermal resistant disinfection.

45

11

MAINTENANCE

Perform a periodic visual inspection on the SIVA. Do not use equipment if it shows any apparent damage. Replace soda lime as necessary (item 6.7). Carry out the check list procedures, as described in Chapter 9, before every Anesthesia. Periodically check that the SIVA tubes and rubber parts, as well as the inhalation and exhalation valve discs, are in perfect condition. Replace them as necessary. Do not use damaged components. Pay special attention to the conservation state of the SIVA cabinet gaskets, so that there is no gas leakage. Do not use damaged gaskets. If the inhalation pressure does not reach the expected levels, first check: That there is no leakage in the respiratory system. That all connections are firmly tightened. That the optional gas monitor socket in the Y-shaped connector is tightly closed. That the canister is not overfilled with soda lime. That the canister is correctly assembled.

Attention
Do not perform any internal servicing of any part of the Anesthesia Apparatus. For regular equipment servicing or to troubleshoot any abnormality in its operation, call K.TAKAOKAS Authorized Technical Assistance.

46

12

SYMBOLS

47

48

49

50

51

13

ACTIONS TO BE PERFORMED IN AN EMERGENCY

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.

52

14

TERMS OF WARRANTY

K TAKAOKA IND. E COM. LTDA. guarantees the equipment it produces against manufacturing defects for a period of one year from the date of acquisition by the first owner. 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 201060013 201060014 202010754 202010922 203061127 202011944 202012014 202012049 202012048 204010288 SIVA 3339 SIVA 3340 Exhalation Valve Inhalation Valve 3-liter bag Bag rod set Canister 800 g Bellows 1600 ml Bell 1600 ml Operation Manual

ITEM

PERIOD OF WARRANTY 1 year 1 year 6 months 6 months 3 months 6 months 6 months 6 months 6 months No guarantee

The SIVA 3339 and 3340 Filter useful life is estimated to average 5 years. This may vary according to use and to adequate preventive maintenance.

Person Technically in Charge: Eng. Alexandre Rodrigues da Silva CREA Registro N 0682082567

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K.TAKAOKA DISTRIBUTORS IN BRAZIL

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TAKAOKA INTERNATIONAL DEALERS

SOUTH AMERICA BRASMED S/A Anesthesia Line Talcahuano, 958 L. 416 CF 1013 Tel: ( 54114) 814 3677 Fax: ( 54114) 814 3813 E-mail: info@brasmed.com.ar BUENO AIRES ARGENTINA Sra. Ana Magalhes ING. CARUSO SRL ICU Line Burela,1957 (1431) Tel: ( 54114) 522 1317 Fax: ( 54114) 523-4919 E-mail: ing.caruso@ciudadd.com.ar BUENO AIRES ARGENTINA Ing. Miguel Caruso IMPORTADORA FERNANDO Calle Tucabana, Esq. Burapucu Casilla 5 Tel: ( 5913) 354 2525 Fax: ( 5913) 354-2526 E-mail: imp_fernando@cotas.com.bo SANTA CRUZ BOLIVIA Sr. Erwin Hurtado MEDI MARK MERCADOTECNICA MEDICA Av. Argentina,2001 casi esquina Villalobo Tel / Fax: ( 5912) 224-6493 E-mail: medi_mark@yahoo.com LA PAZ BOLIVIA Sr. Leopoldo Antezana INGEMEDICA S.A ICU Line Manuel Galecio,231 entre Ximena y Boyac Tel: ( 5934) 230-3173 / 230-3185 Fax: (5934) 230-1428 E-mail: ingemedica@gye.satnet.net GUAYAQUIL ECUADOR Sr. Ernesto Rovayo COMERCIALIZADORA DE PRODUTOS FCV Calle, 155 A NR.23-58 Floridablanca Tel: (577) 639-6767 Ext.810 Fax: ( 577) 639-2595 E-mail:comercial@fcv.org SANTANDER COLOMBIA Ing. Giovanni Gutierrez BIOXEL S/A Araucana, 1277 CP, 11400 Tel: ( 5982) 606-0172 Fax: (5982) 6005435 E-mail: marielk@bioxel.com MONTEVIDEO URUGUAY AREAMEDICA EL BOSQUE, C.A. Av. El Carmen, Quinta Torre Lavega Local n 1, Urbanizacin el Bosque, Municpio Chacao Tel: ( 58212) 731-3913 Fax: ( 58212) 731-3928 E-mail: carlosgaravito@cantv.net CARACAS VENEZUELA Sr. Carlos Garavito / Abel Maestre A.JAIME ROJAS S/A JR. Garcia, 870 Barranco Tel: ( 511) 477 8410 Fax: ( 511) 477-1316 E-mail: import@ajaimerojas.com LIMA PERU Sr. Juan Santa Cruz CARBEAN & CENTRAL AMERICA 2N S.A DE CV Primeira Calle Ponient, 2904 3. Planta Local 3 Cond. Monte Maria Tel: ( 503) 260-5288 Fax: ( 503) 208-1895 E-mail: nuila02@yahoo.com SAN SALVADOR EL SALVADOR Sr. Rene Nuila EUROTADE IBERICA Aerocaribean, Km 1 1/2 Tel: ( 537) 540-000 E-mail: eurotade@enet.cu LA HABANA - CUBA Sr. Igncio Quintero

MEDI EQUIPOS S.A C./ Wencesao Alvarez # 260 Zona Universitria (UASD) Tel: ( 809) 688-5520 Fax: ( 809) 221-0124 E-mail: medequip@tricom.net SANTO DOMINGO REPUBLICA DOMINICANA CORPORACION MEDICA INTERNATIONAL Baja Califrnia,167-102 cp 06760 Col Romasur Tel: ( 5255)5264-7006 Fax: ( 5244) 5264 - 7593 E-mail: leguisi@yahoo.com.mx MEXICO CITY MEXICO Sr. Leonardo Guinea TECNOLOGIA HOSPITALARIA RYM Avenida12, Calle 28 Ptz Aventura Tel: ( 506) 223-7446 Fax: ( 506) 255-3165 E-mail: thrymsa@racsa.co.cr SAN JOSE COSTA RICA Sr. Roberto Molina ULTRAMED Avenida Ricardo Arango Y Calle 53 Ed. Fursys Tel: ( 507) 263-7087 Fax: ( 507) 269-3561 E-mail: allan@ultramedcorp.com PANAMA CITY PANAMA - Sr. Allan Figueroa SANCHEZ & COLLADO CIA LTDA Ferreteria Sinsa, 75 Vs. Altamira Deste, 448 Tel: ( 505) 278-0999 Fax: ( 505) 278-4928 E-mail: sacol@ibw.com.ni MANAGUIA NICARAGUA Sr. Abelardo Snchez DIST. EQUIPOS MEDICOS Col. Ruben Dario, 2117 Tel: ( 504) 232-3544 Fax: ( 504) 232- 2503 E-mail: demif@multivisionhn.net TEGUCICALPA HONDURAS - Sra. Yma de Sabillon ASIA / FRICA BEYOND ENGINEERING Nr. 30, Jalan Maju 4 Taman Pelangi Tel/Fax: (607) 331-4262 E-mail: bydeng@tm.net.my JOHOR BAHRUI MALAYSIA Mr. A. Dass HI-MED EGYPT 41 El Montaza St. Tel: ( 202) 240-2591 Fax: ( 202) 635-2977 E-mail: hanyhimed@hotmail.com CAIRO EGYPT Dr. Hany K. El-Shafei GR MEDI CORP Talcahuano, 958 L. 416 CF 1013 Tel: ( 54114) 814 3677 Fax: ( 54114) 814 3813 E-mail: info@brasmed.com.ar BUENO AIRES ARGENTINA Sra. Ana Magalhes PROGRESSIVE MEDICAL CORP. 29 F/Antel Global Corporate Center n3 Dona Julia Vargas Avenue Tel: ( 632) 687-7788 Fax: ( 632) 687-2190 E-mail: hclim@pmcgroupl.com PASIG CITY PHILIPPINES Mr. Homer C. Lim PT BERSAUDARA JL Penjerniban Raya,38 Tel: ( 6221) 5701-1467 Fax: ( 6221) 57011468 E-mail: sholahudin@bersaudara.com JAKARTA INDONSIA Mr. Sholahudin Husni SIGMA SATR MED LTDA 1089/1091 Onnuch Road, Suanluang Tel: ( 662)7421-015 Fax: ( 662) 311-3550 E-mail: starmed@kxc.th.com BANGKOK THAILAND Mrs. Kunvadee Egnukai

ETHOS TRADE CONCERN EPC 7181 POBOX 8975 Tel: ( 977-1) 477205 Fax: ( 977-1) 473874 E-mail: ethos@wlink.com.np KATHMANDU - NEPAL Mr. Rajesh Man Shrestha BIOLOGIC MEDICAL SYSTEMS Poonawala Terrace, Plo # JM711/5 n6,Offive Mezzanine Floor New M. A. Jinnah Road Karachi 74800,Pakistan Tel: ( 9221) 492-4029 Fax: ( 9221) 412-7459 E-mail: lighting@cubexs.net.pk PAKISTAN Mrr. Shahid Suri MIDDLE EAST NORMAS TRADING EST P.O.BOX 105823 Riyadah 11 656 Tel: ( 9661) 472-5862 Fax: ( 9661) 472-5867 E-mail: normas@normas-nte.com SAUDI ARABIA Mr. Jamil H. Al Shahed ABAJICO Eskandaroon Street POBOX 11096 Tel: ( 963-21) 228-3216 Fax: (963-21) 224-0042 E-mail:jamilia@net.sy BUENO AIRES ARGENTINA Sra. Ana Magalhes EUROPE LA BOUVET Av. Bruselas,38 Tel: (341) 726-4229 Fax: ( 341) 356-6101 E-mail: grupacer@teleline.es MADRID ESPAA - Mr. Jorge Perez UAB REMEDA 29,Siltnamiu Tel: ( 3702) 362028 Fax: ( 3702) 362130 E-mail: remeda@takas.it VILNIUS 2043 LITHUANA Mr. Romaldas Bogusis / Mr. R. Jonelis PROMEI LTDA Rua do Fetal, lote 5 fornas Tel: ( 3512) 3943-1198 Fax: ( 3512) 3943-1700 E-mail: rcruz@promei.pt COIMBRA PORTUGAL Sr. Ramos da Cruz B&MC CARDIO-VOLGA 36, Sverdlov, Volzhsky Tel: (7-8443) 312221 Fax: ( 7-8443) 312523 E-mail: irina@bimcvol.vlz.ru VOLGOGRAD RUSSIA -MrS. Irina Khorochoun

FOR MORE INFORMATION: Rua General Izidoro Dias Lopes, 121/141 Bairro Vila Paulicia So Bernardo do Campo/SP CEP: 09687-100- Brasil Tel: (11) 4176 - 3500 Fax: ( 11) 4176-3570 E-mail:k@takaoka.com.br WEB Site: www.takaoka.com.br

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TECHNICAL ASSISTANCE K.TAKAOKA

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

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

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

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

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AUTHORIZED K.TAKAOKA TECHNICAL ASSISTANCE

57

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) 2948-5923 Fax.: (5511) 2948-5914

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) 2948-5923 Fax.: (5511) 2948-5914

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