Aespire 7900 Users Reference Manual Rev ZAA Part 2 Nov 2015

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.

w 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. AAA F 12345

This alpha character indicates the year of product manufacture and when the serial number was assigned; “D” = 2000, “E” = 2001, “F” = 2002, etc. “I” and “O” are not used.

S/5 Aespire, Link-25, Disposable Multi Absorber, Reusable Multi Absorber, SmartVent, Tec 6 Plus, and Tec 7are 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 Symbols used in the manual or on the equipment... v

1 Setup and Connections Canister setup... 1-3 When to change the absorbent... 1-4 Removing a canister... 1-5 Reusable Multi Absorber canister filling... 1-6 Pneumatic and electrical connections... 1-7 How to install gas cylinders (high pressure leak test)... 1-8 Pin indexed cylinder yokes... 1-8 DIN cylinder connections... 1-10 Installation notes... 1-11 How to attach equipment to the top shelf... 1-12

2 Cleaning and Sterilization Breathing system cleanable parts... 2-3 Special requirements... 2-4 How to clean and disinfect the flow sensors... 2-4 CIDEX sterilization... 2-4 Procedure... 2-5 Remove the breathing system bag hose... 2-6 Remove the breathing system... 2-7 Disassemble the breathing system... 2-8 Disassemble the Bellows assembly... 2-12 Assemble the Bellows assembly... 2-14 Bellows assembly tests... 2-15 Assemble the breathing system... 2-18 Install the breathing system... 2-22 Remove the AGSS receiver... 2-23 Remove the AGSS receiver filter... 2-24 Absorber canister... 2-25

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S/5 Aespire Mechanical cleaning in washer or washer-disinfector... 2-26 Manual cleaning... 2-26 High level disinfection... 2-26

3 User Maintenance Repair policy... 3-2 Maintenance summary and schedule... 3-2 User maintenance... 3-2 Datex-Ohmeda approved service... 3-3 Breathing system maintenance... 3-4 O2 sensor replacement... 3-4 O2 sensor calibration... 3-5 21% O2 sensor calibration... 3-5 100% O2 sensor calibration... 3-9 Flow sensor zeroing... 3-11 How to prevent water build-up... 3-12

4 Alarms and Troubleshooting About alarms... 4-2 Alphabetical list... 4-4 Breathing system problems (no alarm)... 4-13 Electrical problems (power failure, etc.)... 4-14 Pneumatic problems... 4-16 Alarm settings range and default values... 4-17

5 Parts Flow sensor module... 5-2 Breathing circuit module... 5-3 Bellows... 5-4 Absorber canister... 5-5 Exhalation valve assembly... 5-6 AGSS... 5-7 Test tools and system parts... 5-8

6 Specifications and Theory of Operation System pneumatic circuits... 6-2 Gas supplies... 6-4 ii

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O2 flow... 6-4 Air and N2O... 6-4 Mixed gas... 6-5 System specifications... 6-5 Pneumatic... 6-5 Flow... 6-5 Electrical power... 6-6 Power cord... 6-7 Battery information... 6-7 Electromagnetic compatibility... 6-8 Guidance and manufacturer's declaration - electromagnetic emissions... 6-9 Recommended separation distances... 6-12 Figure 6-2 legend... 6-14 Physical specifications... 6-15 System... 6-15 Casters... 6-15 Drawers... 6-15 Ventilator display... 6-15 Environmental requirements... 6-15 Temperature... 6-15 Humidity... 6-15 Altitude... 6-15 Breathing system specifications... 6-16 General... 6-16 Gas scavenging... 6-17 Ventilator theory... 6-18 ... 6-18 Modes... 6-19 Minimum monitoring... 6-22 Ventilation operating specifications... 6-23 Ventilator accuracy data... 6-26 Delivery accuracy... 6-26 Monitoring accuracy... 6-26 Suction regulators (optional)... 6-28 Venturi suction regulator... 6-28

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S/5 Aespire Continuous suction regulator... 6-28 Auxiliary O2 flowmeter (optional)... 6-28

Warranty

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Symbols used in the manual or on the equipment w WARNINGS and w CAUTIONS tell you about dangerous conditions that can occur if you do not follow all instructions in this manual. Read and follow all warnings and cautions. WARNINGS tell about a condition that can cause injury to the operator or the patient. CAUTIONS tell about a condition that can cause damage to the equipment. A Note provides additional information to clarify a statement in text. An Important statement is similar to a Note, but provides a comment of greater emphasis. Other symbols replace words on the equipment or in Datex-Ohmeda manuals. No one device or manual uses all of the symbols. These symbols include:

ø On (power)

Í Not autoclavable

O Off (power)

m Type B equipment

o Standby

µ Type BF equipment

q Standby or preparatory state for part of the

H Type CF equipment

equipment

p “ON” only for part of the equipment

w Caution, ISO 7000-0434

œ “OFF” only for part of the equipment

wW Attention, refer to product

† Direct current

N N

instructions, IEC 601-1.

∏ Alternating current

π Dangerous Voltage

x Protective earth ground

≈ Input

y Earth ground

This way is up.

Output

r Frame or chassis ground

REF Stock Number

å Alarm silence button

SN Serial Number

Y Equipotential

R

t Variability

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Bag position/ manual ventilation Read top of float

v

Aespire 7900

T Variability in steps

Vacuum inlet

+ Plus, positive polarity - Minus, negative polarity P Lamp, lighting, illumination

O + O Flush button 2

2

Cylinder

N Movement in one direction

Isolation transformer

ˆ Movement in two directions

Low pressure leak test

z Lock Z Unlock 134°C C Autoclavable

u Open drain (remove liquid)

q

Inspiratory flow

t O sensor connection 2

Volume alarms On/Off touch key

vi

Suction bottle outlet

r Mechanical ventilation U Close drain Q

Expiratory flow

Alarm silence touch key

Menu touch key

Alarm silence touch key (Tec 6)

End case touch key

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Table of Contents

XXXX

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Systems with this mark agree with the European Council Directive (93/42/EEC) for Medical Devices when they are used as specified in their Operation and Maintenance Manuals. The xxxx is the certification number of the Notified Body used by Datex-Ohmeda’s Quality Systems.

European Union Representative

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Aespire 7900

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1 Setup and Connections

In this section

Canister setup... 1-3 Pneumatic and electrical connections... 1-7 How to install gas cylinders (high pressure leak test)... 1-8 Installation notes...1-11 How to attach equipment to the top shelf...1-12

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1-1

Aespire 7900 Important

Datex-Ohmeda strongly recommends that you use O2 monitoring with this equipment. Refer to local standards for mandatory monitoring.

Important

European Standard EN 740 and International Standard IEC 60601-2-13/ISO 8835-1 require exhaled volume monitoring, O2 monitoring (in accordance with EN 12342, or ISO 7767) and CO2 monitoring (in accordance with EN 864 or ISO 9918) be used with this equipment.

Important

European Standard EN 740 and International Standard IEC 60601-2-13/ISO 8835-1 also require anesthetic agent monitoring (in accordance with ISO 11196) be used when anesthetic vaporizers are in use.

wWARNING

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

Desiccated absorbers can be hazardous in the presence of anesthetic agents. Adequate precautions should be taken to ensure that soda lime in absorbers does not become desiccated. Turn off all gases when finished using the system.

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 and the flow and oxygen sensors. • Do not put the electrosurgical leads on any part of the anesthesia system.

w

1-2

To protect the patient when electrosurgical equipment is used:

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1 Setup and Connections

• 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. • Do not use conductive masks or hoses.

Canister setup wWARNING

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Obey applicable safety precautions:

w

Do not use the absorber with chloroform or trichloroethylene.

w

The Disposable Multi Absorber is a sealed unit which should not be opened or refilled.

w

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.

w

Do not change the absorber during ventilation.

w

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.

w

Desiccated (dehydrated) absorbent material may produce dangerous reactions when exposed to inhalation anesthetics.

w

For systems with dual absorbent canisters, the carbon dioxide absorbent material in both canisters shall be changed at least weekly, preferably every Monday morning. For single canister systems the absorbent material shall be changed every day, preferably at the start of the day.

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Aespire 7900

w

Carbon dioxide absorbent material shall be changed whenever users cannot assure the degree of hydration of the absorbent. Such conditions may include finding a machine with fresh gas that has been flowing for an unknown period of time, or using a machine that is used infrequently.

w

All fresh gas flows shall be terminated when the machine is NOT in use. (User manuals describe how to achieve null flows).

w

Users are advised to consider the use of low-flow techniques when the machine is in use and whenever clinically appropriate to maintain hydration of the absorbent material.

w

Always perform a breathing system leak test in the Bag Mode after opening the absorber. 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 g of loose absorbent. Datex-Ohmeda recommends Medisorb absorbent. Both absorber versions should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.

When to change the absorbent

A gradual color change of the soda lime in the canister indicates absorption of carbon dioxide. The color change of the soda lime is only a rough indicator. Use carbon dioxide monitoring to determine when to change the canister. Discard the absorbent when it has changed color. If left standing for several hours, soda lime may regain its original color giving a misleading indication of activity. Read the canister instructions completely before using the product.

1-4

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1 Setup and Connections

Removing a canister

The absorber canister is available in two versions: Reusable Multi Absorber and Disposable Multi Absorber. Both are removed and installed on the breathing system in the same way.

3 2 4

5

1

6 7

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

Figure 1-1 • Canister

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1-5

Aespire 7900 1. Hold the canister by the handle and push on the release latch (1) to unlock the canister. 2. Remove the canister by tilting it downward and off the two support pins. 1

Reusable Multi Absorber canister filling

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

2. Push up with your thumbs to release the seal. 3. Lift off the cover to remove it.

4. Remove and discard the foam filters (1), the absorbent and any water in the reservoir.

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

1-6

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1 Setup and Connections

wWARNING

The filters must be in place to prevent dust and particles from entering the breathing circuit. 6. When dry, place a new filter in the bottom of the canister, pour soda lime into the canister and place a new filter over the soda lime before closing and locking the cover. Wipe off any soda lime dust. 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. 7. When replacing the canister, make sure it is resting on both support pins before latching it into place.

Pneumatic and electrical connections wWARNING

Equipment connected to the electrical outlets can increase the leakage current. Regularly test the leakage current. An optional isolation transformer kit is available to reduce total leakage current.

wCAUTION

Use only medical grade gas supplies. Other types of gas supplies may contain water, oil, or other contaminants.

Mains inlet

Arrow shows the mains power inlet and cord.

Outlets

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Labels show outlet voltage ratings and circuit breaker amp ratings.

1-7

Aespire 7900 The gas supplies also supply these devices through internal connections: • The venturi suction regulator (optional) • The auxiliary O2 flowmeter (optional) • Ventilator drive gas

Pipeline Inlets

Serial port RS-232C signal standards

The ventilator has an RS-232C electrical interface. The RS-232C connector allows serial input/output of commands and data. 15-pin Female D connector - Data Communications Equipment configuration (DCE): • Pin 1 - Monitor On/Stby • Pin 5 - Signal ground • Pin 6 - Receive data • Pin 9 - Monitor On/Stby Rtn • Pin 13 - Transmit data

How to install gas cylinders (high pressure leak test) Pin indexed cylinder yokes

1-8

1. Find the cylinder wrench.

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1 Setup and Connections 2. Close the cylinder valve on the cylinder to be replaced.

3. Fully loosen the tee handle.

4. Open the cylinder yoke.

5. Remove the used cylinder and the used gasket.

6. Remove the cap from the cylinder valve on the new cylinder. 7. Point the cylinder outlet away from all items that can be damaged by a release of high pressure gas. 8. Quickly open and close the cylinder valve. This removes dirt from the cylinder outlet.

wWARNING

No gasket or more than one gasket can cause a leak. 9. Install a new gasket. 10. Align the cylinder post with the index pins. 11. Close the yoke gate and tighten the tee handle. 12. Install a cylinder plug and gasket in all empty cylinder yokes. 13. Do a high pressure leak test: • Disconnect pipeline supplies.

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1-9

Aespire 7900 • • • • • •

Turn off the auxiliary O2 flowmeter and venturi suction. Set the system switch to Standby. Open the cylinder. Record the cylinder pressure. Close the cylinder. If the air or oxygen cylinder pressure decreases more than 5000 kPa (100 psi) in one minute, there is a significant leak. • For N2O cylinders, a pressure decrease of 690 kPa (100 psi) in one minute represents a significant leak. To repair a leak: • Install a new cylinder gasket and tighten the tee handle. • Do this step again. If the leak continues, do not use the system.

wCAUTION

DIN cylinder connections

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. Close the cylinder valve on the cylinder to be replaced.

2. Loosen the adapter and remove the cylinder.

3. Remove the cap from the cylinder valve on the new cylinder. 4. Point the cylinder outlet away from all items that can be damaged by a release of high pressure gas. 5. Quickly open and close the cylinder valve. This removes dirt from the cylinder outlet. 6. Install the cylinder. 7. Do a high pressure leak test: • Disconnect pipeline supplies. • Turn OFF the auxiliary flowmeter and the venturi suction. • Set the system switch to Standby. • Open the cylinder. • Record the cylinder pressure. • Close the cylinder.

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