Aisys Users Reference Manual Part 2 of 2 Sw Rev 4.X

User Responsibility This Product will perform in conformity with the description thereof contained in this User’s Reference manual and accompanying labels and/or inserts, when assembled, operated, maintained, and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should repair or replacement become necessary, Datex-Ohmeda recommends that a telephonic or written request for service advice be made to the nearest Datex-Ohmeda Customer Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Datex-Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be altered without the prior written approval of Datex-Ohmeda. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Datex-Ohmeda.

CAUTION

U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the U.S.A., check local laws for any restriction that may apply. Datex-Ohmeda products have unit serial numbers with coded logic which indicates a product group code, the year of manufacture, and a sequential unit number for identification. The serial number can be in one of two formats. AAA X 11111

AAA XX 111111AA

The X represents an alpha character The XX represents a number indicating indicating the year the product was the year the product was manufactured; manufactured; H = 2004, J = 2005, etc. 04 = 2004, 05 = 2005, etc. I and O are not used.

Aisys, Carestation, Advanced Breathing System, Aladin, Aladin 2, ComWheel, D-fend, Disposable Multi Absorber, Easy-Fil, Reusable Multi Absorber, PSVPro, and SmartVent are registered trademarks of Datex-Ohmeda, Inc. Other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.

Table of Contents 1 Setup and Connections Canister setup... 1-4 When to change the absorbent... 1-5 Removing a canister... 1-6 Removing an EZchange Canister... 1-6 Reusable Multi Absorber canister filling... 1-7 Electrical connections... 1-9 Port... 1-9 Outlets... 1-9 Mains inlet... 1-9 Serial port...1-10 Pneumatic connections...1-11 Pipeline Inlets...1-11 Scavenging...1-11 Sample gas return port...1-12 Pneumatic power outlet...1-12 Suction regulator (optional)...1-13 Auxiliary O2 flowmeter (optional)...1-13 How to install gas cylinders...1-14 High-pressure leak test...1-14 How to attach equipment to the top of the machine...1-15 Installation notes...1-15

2 Cleaning and Sterilization Breathing system autoclavable parts... 2-3 Special requirements... 2-4 How to clean and disinfect the flow sensors... 2-5 CIDEX disinfection... 2-5 Remove the breathing system bag hose... 2-8 Remove the breathing system... 2-8

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Aisys Carestation Disassemble the breathing system... 2-9 Disassemble the bellows assembly...2-15 Assemble the bellows assembly...2-17 Bellows assembly test...2-19 Assemble the breathing system...2-21 Install the breathing system...2-26 Remove the AGSS receiver...2-27 Remove the AGSS receiver filter...2-29 Absorber canister...2-30 Mechanical cleaning in washer or washer-disinfector...2-30 Manual cleaning...2-30 High level disinfection...2-30 Aladin cassette cleaning...2-31 EZchange Canister and condenser...2-31

3 User Maintenance Repair policy... 3-3 Maintenance summary and schedule... 3-3 User maintenance... 3-3 Datex-Ohmeda approved service... 3-4 Circuit O2 cell replacement... 3-5 Flow and pressure calibration... 3-6 Circuit O2 cell calibration... 3-6 21% O2 calibration... 3-6 100% O2 calibration... 3-6 Airway gas calibration... 3-7 Backlight test... 3-7 How to prevent water buildup... 3-7

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4 Parts Breathing circuit module... 4-3 Bellows... 4-4 Absorber canister... 4-5 Exhalation valve assembly... 4-6 AGSS... 4-7 EZchange Canister system... 4-8 Condenser... 4-9 Test tools and system parts...4-10

5 Specifications and Theory of Operation System pneumatic circuits... 5-2 Gas supplies... 5-4 O2 flow... 5-4 Air and N2O... 5-4 Mixed gas... 5-4 EZchange Canister... 5-5 Condenser... 5-5 Pneumatic specifications... 5-5 Gas supplies... 5-5 ACGO port relief... 5-6 Non-circle circuit relief... 5-6 Electrical power... 5-7 Power cord... 5-7 Battery information... 5-7 Electrical block diagram... 5-8 Flow specifications...5-10 Breathing system specifications...5-11 Gas scavenging...5-13 Physical specifications...5-13 Environmental requirements...5-14 Airway module specifications...5-14 Gas specifications...5-14 Typical performance...5-15 Suction regulators (optional)...5-15 Ventilator theory...5-16

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Aisys Carestation O2 monitoring...5-17 Modes...5-17 Ventilation operating specifications...5-25 Pneumatics...5-25 Fresh gas compensation...5-25 Pressure...5-25 Volume...5-26 Oxygen...5-26 Ventilator accuracy data...5-27 Electronically controlled vaporizer and Aladin cassette...5-28 Aladin2 cassettes...5-29 Aladin cassettes...5-30 Electromagnetic compatibility (EMC)...5-31 Guidance and manufacturer's declaration electromagnetic emissions...5-31 Guidance and manufacturer's declaration electromagnetic immunity...5-32 Recommended separation distances...5-34 Electrical safety...5-35 IEC-60601-1 Classification...5-36

6 Super User Mode Install/Service menu... 6-2 Using super user mode... 6-3 Menus... 6-5

Index Warranty

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1 Setup and Connections

In this section

Canister setup... 1-4 Electrical connections... 1-9 Pneumatic connections...1-11 How to install gas cylinders...1-14 How to attach equipment to the top of the machine...1-15 Installation notes...1-15

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WARNING

Residual patient risk can be greatly reduced by proper configuration and use of the following monitoring in conjunction with this equipment and are all strongly recommended by DatexOhmeda: O2, anesthetic agent, CO2, and expired volume. Standards such as EN-740 require the use of these monitors. Always refer to local standards for mandatory monitoring in conjunction with use of this equipment. For reference, a partial listing of major standards covering monitoring is included below: • O2 monitor according to ISO 7767/EN 12598/ANSI ISO 7767 • Agent monitor according to ISO 11196/EN ISO 11196/ANSI 21647 • CO2 monitor according to ISO 9918/EN864/ANSI 21647 • Expired volume monitor according to IEC 60601-2-13/EN 740/ASTM F-1850

w

Always make sure that the pipeline supply hoses and the breathing circuit components are not toxic and will not: • Cause an allergic reaction in the patient. • React with the anesthetic gases or agent to produce dangerous by-products.

w

To prevent incorrect values or equipment malfunction, use only Datex-Ohmeda cables, hoses and tubing.

w

This system operates correctly at the electrical interference levels of IEC 60601-1-2. Higher levels can cause nuisance alarms that may stop mechanical ventilation.

w

To help prevent false alarms from devices with high-intensity electrical fields: • Keep the electrosurgical leads away from the breathing system, the flow sensors and the oxygen cell.

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1 Setup and Connections

• Do not allow the electrosurgical leads to contact any part of the anesthesia system. • Do not use cell phones near the anesthesia system. w

To protect the patient when electrosurgical equipment is used: • Monitor the correct operation of all life support and monitoring equipment. • Keep backup manual ventilation available in case the electrosurgical equipment prevents safe use of the ventilator.

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Do not use antistatic or electrically-conductive breathing tubes or masks. They can cause burns if used near high frequency surgical equipment.

w

Use only reservoir bags that comply with EN1820 on this system.

w

Use only breathing tubes that comply with EN12342 on this system.

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Canister setup

1

6

5 2

4 3

AB.74p042 AB.74p043

7

1. Canister support pin 2. Canister handle 3. Disposable Multi Absorber canister 4. Absorbent 5. Expiratory water reservoir 6. Canister release latch 7. Reusable Multi Absorber canister

Figure 1-1 • Canister

WARNING

Obey applicable safety precautions: • Do not use the absorber with chloroform or trichloroethylene.

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1 Setup and Connections

• The Disposable Multi Absorber is a sealed unit which should not be opened or refilled. • The Disposable Multi Absorber cannot be disinfected and is not autoclavable. Be aware that cross-contamination is possible. • Avoid skin or eye contact with the contents of the absorber. In the event of skin or eye contact, immediately rinse the affected area with water and seek medical assistance. • Do not change the absorber during ventilation unless the EZchange Canister system is installed. • Change absorbent often to prevent the buildup of non-metabolic gases when the system is not in use. • Inspect absorbent color at the end of a case. During non-use, absorbent can go back to the original color. Refer to the absorbent labeling for more information about color changes. • If the absorbent completely dries out, it may give off carbon monoxide (CO) when exposed to anesthetic agents. For safety, replace the absorbent. • Desiccated (dehydrated) absorbent material may produce dangerous chemical reactions when exposed to inhalation anesthetics. Adequate precautions should be taken to ensure that absorbent does not dry out. Turn off all gases when finished using the system. The absorber canister is available in two versions: Disposable Multi Absorber and Reusable Multi Absorber. Both are removed and installed on the breathing system in the same way. Each canister holds 800 grams of loose absorbent. Datex-Ohmeda recommends MedisorbTM absorbent. Both absorber versions should only be used with mixtures of air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.

When to change the absorbent

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A gradual color change of the absorbent in the canister indicates absorption of carbon dioxide. The color change of the absorbent is only a rough indicator. Use carbon dioxide monitoring to determine when to change the canister.

1-5

Aisys Carestation Discard the absorbent when it has changed color. If left standing for several hours, absorbent may regain its original color giving a misleading indication of activity. Read the canister instructions completely before using the product. 1. Hold the canister by the handle and push on the release latch to unlock the canister.

AB.74p058

Removing a canister

2. Remove the canister by tilting it downward and off the two support pins. 1. Hold the canister by the handle and push the canister cradle release latch to unlock the canister cradle.

AB.75p088

Removing an EZchange Canister

AB.75p089

2. Slide the canister up and out of the cradle.

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1 Setup and Connections 1. Turn the canister upside down and, using your thumbs, turn the cover locking ring counterclockwise to unlock it.

AB.4p044

Reusable Multi Absorber canister filling

2. Push up to release the seal.

AB.74p046

3. Lift off the cover to remove it.

4. Remove and properly discard the foam filters, the absorbent, and any water in the reservoir.

Be careful when draining condensate from the absorber. The liquid is caustic and may burn skin.

AB.74p047

WARNING

5. To clean and disinfect the canister, see “Absorber canister” in section 2 “Cleaning and Sterilization.”

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Aisys Carestation 6. Place a new filter in the bottom of the canister, pour absorbent into the canister and place a new filter over the absorbent before closing and locking the cover. Wipe off any absorbent dust.

AB.82p001

7. Align the cover slots with the canister locking tabs and press the cover down into place. Turn the cover locking ring clockwise to lock the cover in place. Ensure cover is properly sealed to prevent leaks and spillage. Alignment of the arrows helps to indicate correct assembly.

WARNING

The filters must be in place to help prevent dust and particles from entering the breathing circuit. 8. When replacing the canister, make sure that it is seated properly on the support pins or in the EZchange canister module before latching it into place.

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Electrical connections The port for the battery backup of the monitor is located above the isolated outlets.

AB.75p087

Port

Labels show outlet voltage ratings and circuit breaker amp ratings. These are isolated outlets. Regularly test the leakage current.

AB.75p.009

Outlets

Arrow shows the mains power inlet and cord.

AB.75p.008

Mains inlet

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Serial port

The system has an RS-232C electrical interface. The RS-232C connector allows serial input/output of commands and data. The 15-pin connector is located on the back of the display unit.

AB.75p090

The 15-pin female D connector - Data Communications Equipment configuration (DCE): • Pin 1 - Monitor On/Standby • Pin 5 - Signal ground • Pin 6 - Receive data • Pin 9 - Monitor On/Standby Return • Pin 13 - Transmit data

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Pneumatic connections CAUTION

Use only medical grade gas supplies. Other types of gas supplies may contain water, oil, or other contaminants which could affect the operation of the pneumatic system. The gas supplies provide gas to these optional devices through internal connections: • venturi suction regulator (optional). • auxiliary O2 flowmeter (optional).

AB.75p.010

Pipeline Inlets

Scavenging

The scavenging assembly is located below the bellows on the breathing system. Adapters may be necessary to interface to the scavenging connector.

AB.91p045

See “Operation and Tutorial” in Part 1 of the User’s Reference manual for more scavenging information.

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Aisys Carestation Connect the Datex-Ohmeda sample gas exhaust tube to the gas return port. Exhaust gas will be directed to the scavenging system.

AB.75p.109

Sample gas return port

AB.75p.007

Pneumatic power outlet

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Suction regulator (optional)

Venturi regulators use the system air or O2 supply. Vacuum regulators must be connected to an external vacuum supply.

4 2

3

5

2 1

AB.75p.007 AB.75p126

1

1. Overflow safety trap 2. External vacuum (non-venturi) connection 3. Splash guard 4. Collection bottle connection 5. Venturi muffler

Auxiliary O2 flowmeter (optional)

1

AB.75o011

2

1. Auxiliary O2 flow control 2. Auxiliary O2 outlet

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How to install gas cylinders CAUTION

Do not leave gas cylinder valves open if the pipeline supply is in use. Cylinder supplies could be depleted, leaving an insufficient reserve supply in case of pipeline failure. 1. Locate the cylinder wrench. 2. Close the cylinder valve on the cylinder to be replaced. 3. Loosen the cylinder connector. 4. Remove the used cylinder and the used gasket. 5. Remove the cap from the cylinder valve on the new cylinder. 6. Point the cylinder outlet away from all items that can be damaged by a release of high-pressure gas. 7. Quickly open and close the cylinder valve. This removes dirt from the cylinder outlet.

WARNING

No gasket or more than one gasket can cause a leak. 8. Install a new gasket. 9. Install a new cylinder. 10. Perform a “High-pressure leak test.”

High-pressure leak test

1. Turn on the system. 2. Disconnect pipeline supplies. 3. Turn off the auxiliary O2 flowmeter and the venturi suction. 4. Open the cylinder. 5. Record the cylinder pressure. 6. Close the cylinder. • If the cylinder pressure decreases more than 690 kPa (100 psi) in one minute there is a significant leak. 7. To repair a leak, install a new cylinder gasket and tighten the adapter. 8. Repeat the leak test. If the leak continues, do not use the system.

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