CASI & CASII Circle Absorbers 1kg and 2kg User Manual Rev. A Oct 2009

CAS I/CAS II Absorbers User Manual

MODIFICATIONS LABEL ECO

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ECO

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ECO

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ECO

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ECO

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ECO

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ECO

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ECO

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ECO

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PR020214 ECO

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Spacelabs Healthcare Ltd. (Anesthesia and Ventilation Division) Beech House • Chiltern Court • Asheridge Road • Chesham • Buckinghamshire • HP5 2PX • England Tel: +44 (0)1494 784422 Fax: +44 (0)1494 791497 Part Number: 073-0149-00 e-mail (enquiries): [email protected] e-mail (technical): [email protected] www.spacelabshealthcare.com

CAS Absorber User Manual

Rev. A/ October 2009

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Important Information Symbols & Abbreviations APL

Airway Pressure Limiting

Approval under European Mediical Device Directive and the Notified Body Number

CAS

Circle Absorber System

Absorber

C.G.O.

Common Gas Outlet

Absorber Bypass Switch

cmH2O

Gauge Pressure in Centimeters of Water

Bag

CO2

Carbon Dioxide

Ventilator

CPAP

Continuous Positive Airway Pressure

Canister Locked

PEEP

Positive End Expiratory Pressure

Canister Unlocked

lpm

Liters per Minute

Canister Seal Canister

MRI

Magnetic Resonance Imaging

End of Case

Caution - Consult the Instructions

Latex Free Material

Warning - Danger of Personal Injury

Face Up

Useful Information

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CAS Absorber User Manual

Important Information

Important! The user must be familiar with the anesthesia machine, its components and its various functions before using it on a patient. Federal law in the US restricts the sale, distribution or use of this device to, by or on the order of a licensed medical practitioner. Incorrect use of the equipment described herein may result in injury to the patient. Read this manual before operating the machine. You must be familiar with the machine and its functions before using it on a patient. Be sure to pay special attention to warnings, cautions and notes within the manual. A full list of these hazard notices starts on the next page.

Warning Notices Warning notices denote a potential hazard to the health and safety of users and/or patients. These notices clearly state the nature of the respective hazard and the means to avoid it. Warning notices appear in full in the preliminary pages and are repeated at their points of application in the manual. Caution Notices Cautionary notices denote a potential hazard to the physical integrity of equipment/software, but NOT a danger to personnel. These notices clearly state the nature of the hazard and the means by which it can be avoided. Relevant or helpful information

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Important Information

Hazard Notices This section contains important hazard information. You must read this hazard information before using the CAS I or CAS II Absorber with your anesthesia machine. The following icons identify special information. Pay attention to the Warning and Caution notices.

Warnings

ABSORBER ORIENTATION Use the absorber in the upright position only. Use in any other orientation may affect the gas flow or damage the absorber. SODA LIME Soda Lime is caustic. Observe the manufacturer’s instructions for correct handling and storage. When handling, always wear suitable eye, face and hand protection as crushed soda lime can degrade to a fine dust which may be harmful by inhalation. To minimize the levels of soda lime dust, ensure that the soda lime is not crushed and that regular cleaning of the absorbers and breathing circuits is carried out. To prevent injury to the patient, always protect the patient’s face with a face mask. FILLING REUSABLE CANISTERS Fill the reusable canisters only to recommended level. Under filling the canisters can lead to inefficient CO2 absorption. Overfilling can result in poor canister sealing. CAUSTIC CONDENSATE The condensate in the bottom of the canister is caustic. Always wear suitable eye, face and hand protection when handling the outer canister. Drain the outer canister periodically. Rinse accidental splashes immediately with water. ABSORBER SEALS When re-assembling the absorber, verify that all seals are replaced and properly seated, including the upper seal. The upper seal fits above the upper soda lime canister and attaches to the molding within the body of the absorber. Improper placement will cause a leak. 6

CAS Absorber User Manual

Important Information DESICCATED ABSORBENT Desiccated (dehydrated) absorbent material may produce dangerous chemical reactions when exposed to inhalation anesthetics. Take adequate precautions to ensure that the absorbent does not dry out. Reduce the flow level of all gases between cases. Turn off the machine when finished using it for the day. AMSORB DISPOSABLE CANISTERS For Amsorb canisters: The canister seal must be removed PRIOR to use in a BleaseSirius Absorber. ABSORBER MALFUNCTION Patient injury may result if you use a faulty absorber. If the absorber malfunctions or if the absorber does not pass all pre-use tests, do not use the absorber. Patient injury may result. If the absorber is not operating correctly, contact an authorized technical engineer or return the unit to the supplier. SPONTANEOUS BREATHING If the APL valve is not in the OPEN position, it will not operate until the pressure reaches approximately 65 cm H2O. To allow spontaneous breathing, set the APL valve to OPEN. MRI COMPATIBLE MODELS Only MRI CAS I Absorber model 12200905 and MRI CAS II Absorber model 12200907 with their appropriate MRI Manometer and bracket are MRI compatible. One of these models must be used on the BleaseGenius MRI System. The use of any other model CAS I Absorber will adversely affect the picture quality of the MRI system. When fitted to a BleaseGenius MRI System, the system can operate up to the 1000 gauss line with up to 3-Tesla MRI systems. The MRI CAS I and MRI CAS II Absorber models are made entirely of nonferous materials. Only the MRI Manometer can be used on MRI systems. USE OF HAND TOOLS Hand tools are not required to perform routine maintenance of the CAS I/II Absorbers. Never use tools in the active area of an MRI scanner.

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Important Information

Cautions

DISPOSABLE CANISTERS Only the following disposable canisters have been tested and shown to seal correctly and are therefore approved for use with Spacelabs Healthcare Anesthesia equipment. Checking for a correct seal with any manufacturer’s disposable canisters is the responsibility of the user. Please contact Spacelabs Healthcare – for advice, if in any doubt. •

Intersurgical – The Drum

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GE – MediSorb Pre-packed cartridge disposable.

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Allied Healthcare – Carbolime.

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Armstrong Medical-Amsorb (canister seal must be removed)

OCCLUDING BREATHING SYSTEM When occluding the breathing system for test purposes, do not use any object small enough to slip completely into the system. Objects in the breathing system can interrupt or disrupt the delivery of breathing system gases, possibly injuring the patient. Before using the breathing system on a patient, always check the breathing system components for foreign objects. POP-OFF VALVE AND BELLOWS Take care when filling the bellows for pre-use testing, etc, as overfilling with the flush control will cause the bellows to rise rapidly and hit the top of the canister. This causes the valve to open fully, visibly swelling the bellows. This excess pressure will then take a moment to dissipate through the revised exhaust path, causing the valve to remain slightly open, which may result in the bellows dropping slightly giving the impression of a leak. Therefore, it is recommended that, when filling the bellows, use the flush control to bring the bellows up to within 25mm/1inch of the top of the canister, then allow the flowmeter/fresh gas flow to bring the bellows up to its full extent. CLEANING Do not use caustic substances, such as trichlorethylene, for cleaning the absorber, as it may damage the surfaces. 8

CAS Absorber User Manual

Important Information MANOMETER Do not sterilize or autoclave the manometer. Sterilization will damage the manometer. Always remove the manometer before sterilizing the absorber.

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Important Information

Notes

ABSORBER USAGE Read this manual before operating the absorber. CONDENSATE Under some conditions, gas flows will cause condensation on the inside of the outer canister, this is normal and does not interfere with its normal function. CANISTER ASSEMBLY When filling a canister, pour the soda lime carefully and steadily. Gently tap the sides to settle the granules and carry on filling until the canister is almost full. Do not tap the canister violently as this will create dust. PRESSURE MEASURING DEVICE A suitable pressure measuring device is required for this test. APL VALVE TEST These instructions assume that you have performed the absorber leak test immediately prior to this test. EXTERNAL MONITORING It is recommended that some external monitoring of O2 , CO2 and anesthetic agent is used with the absorber. ABSORBER STERILIZATION Other than stated, the components and materials of the absorber are compatible with autoclaving and Ethylene Oxide sterilization processes. AUTOCLAVING Autoclave the canisters and separate plastic parts in an upright position and away from other components. APL ALIGNMENT Ensure that the APL valve remains vertical during re-fitting, by aligning the scallop in the cover edge with the cover stop before engaging the bayonet fitting past two notches. 10

CAS Absorber User Manual

Important Information OXYGEN SENSOR The oxygen sensor measures the concentration of oxygen on the patient circuit. WARRANTY If the equipment is serviced by an unauthorized party during the warranty period, the warranty will be void.

Using This Manual Follow the instructions given in this manual as you learn to use and maintain the CAS I or CAS II Absorber. Be sure to read all sections in this manual. Use this manual as a reference once you are familiar with the CAS I/II Absorber.

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Contents

Table of Contents Hazard Notices... 6 Using This Manual ... 11 1 - Introduction ... 17 Principles of Operation ... 20 Spontaneous Breathing ... 20 CO2 Bypass (not available in US) ... 20 Scavenging ... 20 Absorbent... 20

2 - Installation ... 25 Install the Absorber ... 25 Fill the Soda Lime Canister(s) ... 25 For Disposable Soda Lime Canister(s) ... 27 For Reusable Soda Lime Canister(s)... 28 Connect the Bag Arm Link Pipe ... 29 Attach the Absorber Tubing ... 29 Pre-Use Checks... 30 Absorber Leak Test ... 31 APL Valve Test ... 31 Circle Test – Valves ... 33 Set Up Mechanical Ventilation ... 34 Set Up Spontaneous Breathing ... 35

3 - Maintenance... 39 Replace the Reusable Canister Soda Lime ... 39 Absorbent Capacity of Canister Soda Lime ... 40 When to Replace the Soda Lime ... 40

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CAS Absorber User Manual

Contents Change a Disposable Canister ... 42 Storage of Soda Lime ... 43 Cleaning and Sterilization ... 43 Routine Maintenance Checks ... 46 Replace the Non-return Valve Discs ... 46 Annual Maintenance ... 46

4 - Appendix ... 49 Absorber Parts and Accessories... 49 Manometer... 51 Install the Manometer ... 51 Remove the Manometer ... 51 Oxygen Sensor ... 52 CAS I/II Absorber Technical Specifications ... 53 Performance ... 53

5 - Notices & Important Information ... 57 Product Improvement ... 57 Responsibilities of the User ... 57 Responsibilities of the Manufacturer... 57 Disclaimer ... 58 Technology Disclaimer ... 58 Note to Service Personnel ... 58 Contact Information ... 59 Copyright ... 59 CE Marking ... 59 Trademarks and Acknowledgements ... 60

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List Of Figures

List of Figures Figure 1 - Absorber Components ...18 Figure 2 - Absorber System ...21 Figure 3 - Installing the Absorber...25 Figure 4 - Amsorb Seal. Remove and discard package seal before use. ..27 Figure 5 - Canister Seal-Orientation Icon ...27 Figure 6 - Center Seal Icon ...27 Figure 7: Absorber Upper Seal ...28 Figure 8 - Connect the Bag Arm Link Pipe ...29 Figure 9 - Connect the Absorber Tubing...29 Figure 10: Large Upper Seal ...41 Figure 11 - Canister-Seal Orientation Icon ...41 Figure 12 - Center Seal Icon ...41 Figure 13 - Reinstall the APL Valve Past Two Notches ...45 Figure 14 - Non-MRI Manometer...51

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CAS Absorber User Manual

CAS I and CAS II Absorber

Chapter 1 Introduction

CAS Absorber User Manual

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1 - Introduction

1 - Introduction Please refer to Figure 1 on the next page as you read this section. Two models of the CAS Absorber are available - CAS I and CAS II. The CAS I model houses one soda lime canister, while the CAS II model houses two canisters. All of the plastic moldings are made from fully autoclavable polymers. An Airway Pressure Limiting [APL] valve (A) sets the ventilating pressure during manual operation mode. The APL valve incorporates a 65 cmH2O safety valve. The optional Bypass Valve (B) allows gas flow to completely bypass the absorbent. This valve can be used to allow a build-up of CO2 or enable canister removal/replacement without disconnecting the breathing circuit. The Bag/Vent switch (K) allows the ventilator or bag to be connected to the absorber at the same time. Use the selector knob to choose the desired mode of ventilation.

CAS Absorber User Manual

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1 - Introduction

M N

A

O

L K J

I

B C H G F

E

D

Figure 1 - Absorber Components

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CAS Absorber User Manual

1 - Introduction

Figure 1 Key A

APL Valve

B

Bypass Switch [optional] (not available in USA)

C

Expiratory Non-return Valve

D

Canister

E

Bag Arm Link Pipe (Bag Port)

F

Patient Expiratory Connector (22mm male and 15mm female taper)

G

Oxygen Sensor Port & Oxygen Sensor Port Blanking Plug

H

Patient Inspiratory Connector (22mm male and 15mm female taper)

I

Bag Arm & Port (optional)

J

Inspiratory Non-return Valve

K

Bag/Vent Switch

L

Manometer Gauge

M

Fresh Gas Port

N

APL Exhaust Port

O

Vent Port

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1 - Introduction

Principles of Operation Please refer to Figure 2 on the next page as you read this section. Spontaneous Breathing When used with spontaneously breathing patients, the required gas flow is set and continuously tops off the bag. When the patient breathes in, gas is drawn through the inspiratory non-return valve (B) from the bag via the canisters (F) containing soda lime. Upon exhalation, the gas flows through the expiratory non-return valve (E), some gas is blown through the APL valve (G), which should be set to balance the fresh gas flow, while the bulk is returned to the bag via the bag port (N). CO2 Bypass (not available in US) The CO2 Bypass valve (I) allows gas to be delivered to the patient without passing through the canister(s), so that CO2 levels can be increased or the canister(s) can be replaced while the absorber remains in use. Scavenging The APL valve (G) has a 30 mm taper port for removing exhaust gases. Absorbent Gas flows down the centre through the soda lime canister(s) and then up between the outer and inner canisters. Under some conditions, this gas flow will cause condensation on the inside of the outer canister. This condensation is normal and does not interfere with its normal function. Normally, soda lime contains an indicator that changes color when the soda lime is exhausted. When the color change reaches the top of the lower canister on a CAS II Absorber, you should replace its contents and switch the positions of the two canisters. Also, if the CO2 monitor registers a rise in the inspired CO2 level, you should check the absorbent to determine if it needs to be replaced. For a CAS I Absorber, the contents of the single canister should simply be replaced. Alternatively, you may use disposable canisters.

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CAS Absorber User Manual

1 - Introduction

Figure 2 - Absorber System

Figure 2 Key A

Manometer

H

Oxygen Sensor Port

B

Inspiratory Non-return Valve

I

Absorber CO2 Bypass Valve (not available in USA)

C

Patient Inspiratory Connector

J

APL Exhaust Port

D

Patient Expiratory Connector

K

Fresh Gas Port

E

Expiratory Non-return Valve

L

Bag/Vent Valve

F

Canister(s)

M

Ventilatory Port

G

APL Valve

N

Bag Port

CAS Absorber User Manual

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1 - Introduction

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CAS Absorber User Manual