Aespire 7900 Users Reference Manual Rev ZAB Part 1 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 1 Introduction What is an Aespire 7900?... 1-2 Symbols used in the manual or on the equipment... 1-3

2 System Controls and Menus Anesthesia system controls... 2-2 Breathing system components... 2-5 ACGO... 2-8 Scavenging the ACGO sample flow... 2-9 Scavenging from the external manual breathing circuit... 2-10 Vaporizer controls... 2-10 Ventilator controls... 2-12 Optional Features... 2-12 Control panel... 2-12 How to set controls... 2-14 How to use the menu... 2-15 Menu map... 2-16 More about menu functions... 2-17 How to change menu settings... 2-18 Optional auxiliary O2 flowmeter and suction regulators... 2-19

3 Operation and Tutorial Pre-use check list... 3-3 Turn On the system... 3-4 Set the alarm loudness... 3-5 Show or hide alarm limits and units... 3-7 Turn the volume alarms on or off... 3-8 Set alarm limits... 3-9 Set an audible alarm for circuit leaks... 3-10 Set Cardiac Bypass... 3-11

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i

S/5 Aespire Start mechanical ventilation...3-13 Stop mechanical ventilation...3-14 Alarms...3-15 Alarm Tones...3-15 Alarm Silence...3-15 Alarm Suspend...3-15 Set the ventilation mode...3-16 Set ventilator controls...3-18 Optional features...3-18 Ventilator controls...3-18 Volume Control mode...3-19 Pressure Control mode...3-20 SIMV mode...3-20 PSVPro mode...3-20 Set inspiratory pause (volume modes)...3-22 Set SIMV and PSVPro controls...3-24 Silence alarms...3-26 Reading the pressure waveform (Paw)...3-27 Scales...3-27 Measure circuit compliance...3-30 Show the service settings...3-31 Measure circuit compliance...3-33

4 Preoperative Tests Aespire 7900 Preoperative tests schedules... 4-2 Test Intervals... 4-2 Test devices... 4-3 Inspect the System... 4-4 Power failure alarm test... 4-5 Minimize alarms (optional)... 4-5 Pipeline and cylinder tests... 4-6 Flow control tests... 4-7 Vaporizer installation... 4-9 Vaporizer back pressure test...4-10 Low-pressure leak test...4-11 Negative low-pressure leak test...4-11

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ISO 5358 or BSI standard positive low-pressure leak test...4-13 Alarm tests...4-14 Breathing system tests...4-16 Monitor and ventilator tests...4-18

Index Warranty

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1 Introduction

In this section

What is an Aespire 7900?... 1-2 Symbols used in the manual or on the equipment... 1-3

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1-1

Aespire 7900

What is an Aespire 7900? The Aespire 7900 is a compact, integrated and intuitive anesthesia delivery system. The ventilator portion provides mechanical ventilation for patients during surgery as well as monitoring and displaying various patient parameters. The system uses a microprocessor-controlled ventilator with internal monitors, electronic PEEP, Volume Mode, and other optional features. A serial interface permits communication to cardiovascular and respiratory gas monitoring. Illustrations in this manual may not cover all types of options available. Other equipment may be attached to the system on the top shelf or on the side dovetail rails. Consult with your Datex-Ohmeda representative for details about systems available in your location. The Aespire 7900 is not suitable for use in an MRI environment.

Figure 1-1 • Aespire 7900 example

1-2

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1 Introduction

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

T Variability in steps

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Bag position/ manual ventilation Read top of float

Vacuum inlet

1-3

Aespire 7900

+ 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

XXXX

1-4

Suction bottle outlet

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.

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

European Union Representative

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2 System Controls and Menus

In this section

Anesthesia system controls... 2-2 Breathing system components... 2-5 Vaporizer controls...2-10 Ventilator controls...2-12 Optional auxiliary O2 flowmeter and suction regulators...2-19

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Aespire 7900

Anesthesia system controls wWARNING

Explosion Hazard. Do not use S/5 Aespire systems with flammable anesthetic agents.

wWARNING

Do not use antistatic breathing tubes or masks. They can cause burns if you use them near high frequency surgical equipment.

3

2

4 5

1

6

10

9

7, 8

1. Breathing system 2. Flow controls 3. Ventilator / monitoring display 4. Dovetail rails 5. Vaporizer 6. System switch 7. Pipeline pressure gauge(s) (upper row) 8. Cylinder pressure gauge(s) (lower row) 9. Brake 10. O2 flush button

Figure 2-1 • Aespire (front view)

2-2

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2 System Controls and Menus Figure 2-1 shows these controls on the front of the S/5 Aespire. Item

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Description

2

Flow controls

Turn the control counterclockwise to increase the flow and clockwise to decrease. The system switch must be On for gas to flow.

7

System switch

Set the switch to the on (|) position to permit gas flow and to turn on the system.

9

Brake

Push down to lock. Lift to release.

10

O2 flush button

Push the O2 flush button to supply high flows of O2 to the breathing system.

2-3

Aespire 7900

1 2

7

6 5

4 3

1. Circuit Breaker for Electrical Outlet 2. Electrical Outlet (optional) 3. Equipotential Stud 4. Mains Inlet 5. System Circuit Breaker 6. Cylinder(s) (optional) 7. Pipeline Connection(s)

Figure 2-2 • Aespire rear view

2-4

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2 System Controls and Menus

Breathing system components 19

17

16 15 1

14 13

2

12 11 10 9

18 8

7

6

5

4

3

1. Auxiliary common gas outlet (ACGO) switch 2. ACGO 3. Inspiratory check valve (unidirectional valve) 4. Inspiratory flow sensor / patient connection (circuit connections) 5. Canister (carbon dioxide absorbent) 6. Canister release 7. Expiratory flow sensor / patient connection (circuit connections) 8. Leak test plug 9. Expiratory check valve (unidirectional valve) 10. Breathing system release 11. Manual bag port 12. APL (adjustable pressure-limiting) valve 13. Bag/mechanical ventilation switch 14. Bellows assembly (mechanical ventilation) 15. Pressure gauge (airway) 16. Sample gas return port 17. Serial port 18. Manual Bag (optional; no bag arm) 19. Bag arm (optional)

Figure 2-3 • Breathing system parts

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2-5

Aespire 7900 Figure 2-3 shows these controls on the front of the S/5 Aespire. Item 1

Description Auxiliary Common Gas Outlet switch (ACGO)

Sends fresh gas to the ACGO when the switch is activated. The ACGO may be used to provide fresh gas to an external manual breathing circuit. Mechanical ventilation is not available when the auxiliary outlet is selected and a medium priority alarm will sound and a message “Aux Gas Outlet On” is displayed. Pressure and volume monitoring are not available when the ACGO is selected. Fresh gas oxygen monitoring is available when the ACGO is selected. The ACGO should not be used to drive external ventilators or for jet ventilation. Breathing system selected:

Auxiliary outlet selected:

4&7

2-6

Flow sensor

Flow sensors provide volume measurements for some monitoring functions. All systems have flow sensors in both positions of the flow sensor module.

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2 System Controls and Menus

Item

Description

6

Canister release

Push to remove the canister. This allows the breathing system to vent to the room. Be sure to hold the canister by the handle before releasing the canister. Note: Always do a leak test after operating the canister release.

12

APL valve

Adjusts breathing system pressure limit during manual ventilation. The scale shows approximate pressures. Above 30 cm H2O, you will feel clicks as the knob turns. Turn clockwise to increase. The following example setting is at about 20 cm H2O:

MI

N

30

70

20

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2-7

Aespire 7900

Item 13

Description Bag / Mechanical Ventilation switch

Selects between manual ventilation (bag) or mechanical ventilation (ventilator). Mechanical ventilation Off (gas to bag):

Mechanical ventilation On (gas to bellows):

17

Bag arm (optional)

Squeeze at (1) to raise or lower the arm. The Bag arm rotates at (2).

1

2

ACGO

2-8

When you operate a breathing apparatus with fresh gas from the ACGO: • Mechanical ventilation is not available. • The pressure gauge, Bag/Vent switch, APL valve, and bag arm are not part of the external circuit. • Volume and pressure monitoring are not available. • O2 monitoring of fresh gas is available automatically when the ACGO is selected if the system has the O2 monitoring option.

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2 System Controls and Menus • Fresh gas oxygen concentration is displayed on the ventilation screen. Set alarm limits appropriately. Note that fresh gas oxygen concentration may not reflect FiO2 in rebreathing circuits such as the Mapleson series. Use an external O2 monitor if using a rebreathing circuit on ACGO. • A sample of the fresh gas is diverted to the O2 cell in the breathing system. • The sample flow to the O2 sensor is dependent on the pressure in the external circuit. The sample flow reduces the fresh gas flowrate to the external breathing circuit as shown in the graph. • Do not use an external ventilator on the ACGO. • Do not use the ACGO to drive external ventilators or for jet ventilation. Estimate the mean pressure required for ventilation and determine a mean sample flow rate from the graph:

3

2

L/min 1

10

20

30

40

50

60

70

80

cm H2 0 Figure 2-4 • Back pressure (cm H20) vs. flow to O2 sensor (L/min)

Scavenging the ACGO sample flow

If the external manual breathing circuit is to be used with N 2O or volatile anesthetics, the sample flow should be scavenged. 1. Occlude the patient circuit of the breathing system by using the leak test plug located to the rear of the expiratory port. 2. Check for clinically correct settings. Set the Bag to Vent switch to the ventilator mode. Alternatively set the Bag to Vent switch to the bag mode and set the APL to MIN and attach a bag. 3. The bellows, or bag, will fill slowly with the fresh gas sample flow and then spill to the AGSS.

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2-9

Aespire 7900

Scavenging from the external manual breathing circuit

If the external manual breathing circuit is to be used with N 2O or volatile anesthetics, the exhaust should be scavenged. An auxiliary inlet is available for active AGSS units. It provides a 30 mm male connection into the auxiliary port under the breathing system. • The auxiliary inlet is a convenience inlet to the air brake of active AGSS units. There is a reservoir to capture exhaust flows higher than the extract flow. For all AGSS, a separate exhaust hose is necessary from the external manual circuit to the disposal point.

Vaporizer controls Refer to the description in this section and the vaporizer operation and maintenance manual for more detailed information on the vaporizer. Figure 2-5 shows the vaporizer controls. 1 2 3 4

1. Lock Lever 2. Concentration Control and Release 3. Tec 6 Plus 4. Tec 7

Figure 2-5 • Vaporizer controls

Item 1

2-10

Description Lock lever

Turn the lever fully clockwise to lock the vaporizer in position.

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2 System Controls and Menus

Item 2

Description Concentration Push the release and turn the concentration control control and release to set the agent concentration. The Tec 6 Plus concentration control does not turn as long as the warm-up indicator is on.

Åben

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