Datex-Ohmeda Aespire 7900 Reference Manual

Page 1
Aespire 7900
User’s Reference Manual—Part 2
Setup, Cleaning and Sterilization, Maintenance and Troubleshooting
Page 2
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 7 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.
Page 3
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
2 Cleaning and Sterilization
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
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
1009-0633-000
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
3 User Maintenance
Mechanical cleaning in washer or washer-disinfector . . . . . . . . . . . . 2-26
Manual cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
High level disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
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
O
sensor replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
2
sensor calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
O
2
21% O
100% O
sensor calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
2
sensor calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
2
Flow sensor zeroing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
4 Alarms and Troubleshooting
5 Parts
How to prevent water build-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
About alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Alphabetical list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Breathing system problems (no alarm) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Electrical problems (power failure, etc.) . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
Pneumatic problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18
Alarm settings range and default values . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19
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
6 Specifications and Theory of Operation
ii
Test tools and system parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
System pneumatic circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Gas supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
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O
flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
2
Air and N
O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
2
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
1009-0633-000
Ventilator accuracy data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-26
Delivery accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Monitoring accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-26
Suction regulators (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-28
Venturi suction regulator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
iii
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S/5 Aespire
Continuous suction regulator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Warranty
Auxiliary O
flowmeter (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-28
2
iv
1009-0633-000
Page 7
Symbols used in the manual or on the equipment
w WARNINGS and w
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:
On (power)
øø
øø
Off (power)
O
Standby
o
Standby or preparatory state for part of the
q
equipment
CAUTIONS tell you about dangerous conditions that
Not autoclavable
ÍÍ
ÍÍ
Type B equipment
mm
mm
Type BF equipment
µµ
µµ
Type CF equipment
HH
HH
“ON” only for part of the equipment
p
“OFF” only for part of the equipment
œ
Direct current This way is up.
Alternating current
Protective earth ground
x
Earth ground Output
y
Frame or chassis ground
r
Alarm silence button
å
Equipotential
Y
ww
ww WW
wwwwWW
N
N
ππ
ππ
REF Stock Number
NN
SSSSNN
R
t
Variability
Caution, ISO 7000-0434
Attention, refer to product instructions, IEC 601-1.
Dangerous Voltage
Input
Serial Number
Bag position/ manual ventilation
Read top of float
1009-0633-000
v
Page 8
Aespire 7900
T
++
++
P
N
ˆ
z
Z
Variability in steps Vacuum inlet
Plus, positive polarity Suction bottle outlet
Minus, negative polarity
--
--
Lamp, lighting, illumination Cylinder
Movement in one direction Isolation transformer
Movement in two directions Low pressure leak test
Lock
OO
OO
O
Flush button
2
++
++
22
22
Mechanical ventilation
r
Unlock
Close drain
U
44
1111333344
°CC
u
q
t
CC
Autoclavable
Expiratory flow
Q
Open drain (remove liquid) Alarm silence touch key
Inspiratory flow Menu touch key
O2 sensor connection Alarm silence touch key
(Tec 6)
Volume alarms On/Off touch key End case touch key
vi
1009-0633-000
Page 9
Table of Contents
XXXX
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
1009-0633-000 vii
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Aespire 7900
viii 1009-0633-000
Page 11
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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Aespire 7900
Important Datex-Ohmeda strongly recommends that you use O
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, O with EN 12342, or ISO 7767) and CO 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.
ww
ww
WARNING Always make sure that the pipeline supply hoses and the
monitoring (in accordance with EN 864
2
monitoring with this
2
monitoring (in accordance
2
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
w
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.
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.
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.
1-2
w
To protect the patient when electrosurgical equipment is used:
1009-0633-000
Page 13
Canister setup
ww
ww
• 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.
WARNING Obey applicable safety precautions:
1 Setup and Connections
w
w
w
w
w
w
Do not use the absorber with chloroform or trichloroethylene.
The Disposable Multi Absorber is a sealed unit which should not be opened or refilled.
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.
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.
Desiccated (dehydrated) absorbent material may produce dangerous reactions when exposed to inhalation anesthetics.
1009-0633-000
w
For systems with dual absorbent canisters, the carbon dioxide absorbent material in both canisters shall be changed at least weekly systems the absorbent material shall be changed every day
, preferably every Monday morning. For single canister
,
preferably at the start of the day.
1-3
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Aespire 7900
w
w
w
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.
All fresh gas flows shall be terminated when the machine is NOT in use. (User manuals describe how to achieve null flows).
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.
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.
When to change the
absorbent
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.
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
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
6
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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.
1-6
1
5. To clean and disinfect the canister, see “Absorber canister” in section 2 Cleaning and Sterilization.”
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Page 17
1 Setup and Connections
w WARNING
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
w WARNING
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.
w CAUTION
Mains inlet
Outlets
Use only medical grade gas supplies. Other types of gas supplies may contain water, oil, or other contaminants.
Arrow shows the mains power inlet and cord.
Labels show outlet voltage ratings and circuit breaker amp ratings.
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Aespire 7900
Pipeline Inlets
The gas supplies also supply these devices through internal connections:
The venturi suction regulator (optional)
The auxiliary O
Ventilator drive gas
flowmeter (optional)
2
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
1. Find the cylinder wrench.
1-8
yokes
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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.
w WARNING
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.
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.
1009-0633-000
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.
1-9
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Aespire 7900
Turn off the auxiliary O
flowmeter and venturi suction.
2
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 N
O cylinders, a pressure decrease of 690 kPa (100 psi) in one
2
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 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.
DIN cylinder
1. Close the cylinder valve on the cylinder to be replaced.
connections
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.
1-10
1009-0633-000
Page 21
wWARNING Do not leave gas cylinder valves open if the pipeline supply is in
Installation notes
1 Setup and Connections
If the cylinder pressure decreases more than 5000 kPa (725 psi) for
O
and air in one minute, there is a significant leak.
2
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 adapter.
Do this step again. If the leak continues, do not use the system.
use. Cylinder supplies could be depleted, leaving an insufficient reserve supply in case of pipeline failure.
When the system is installed, the Datex-Ohmeda representative will check the following settings and change them if necessary.
wWARNING These settings can only be changed by qualified personnel.
Language.
Automatic calculation of VE alarm limits during mechanical ventilation.
Altitude.
Ventilator drive gas.
User Select Defaults.
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How to attach equipment to the top shelf
wWARNING The top shelf has a weight limit of 34 kg (75 lb).
Place the equipment between the straps. Fold the straps over each other and fully tighten and fasten them with the hook and loop surfaces.
wWARNING If you do not fully tighten the strap, equipment can fall off the
shelf.
1-12 1009-0633-000
Page 23
2 Cleaning and Sterilization
In this section
Breathing system cleanable parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Special requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
How to clean and disinfect the flow sensors . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
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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w WARNING Obey applicable safety precautions:
• Read the material safety data sheet for each cleaning agent.
• Read the operation and maintenance manual for all sterilization equipment.
• Wear gloves and safety glasses. A damaged O leak and cause burns (contains potassium hydroxide).
• Do not breathe the fumes.
w CAUTION To help prevent damage:
• Refer to the manufacturer’s data if you have questions about a cleaning agent.
• Do not use organic, halogenated, or petroleum based solvents, anesthetic agents, glass cleaners, acetone, or other harsh cleaning agents.
• Do not use abrasive cleaning agents (such as steel wool, silver polish or cleaner).
• Keep all liquids away from electronic parts.
• Do not permit liquid to go into the equipment housings.
sensor can
22
22
2-2
• Do not soak synthetic rubber parts for more than 15 minutes. Swelling or faster aging can occur.
• Only autoclave parts marked 134°C.
• Cleaning solutions must have a pH of 7.0 to 10.5.
1009-0633-000
Page 25
Breathing system cleanable parts
1
2 Cleaning and Sterilization
2
3
8
4
7
5
6
1. Bellows assembly
2. APL Valve Ramp
3. APL Diaphragm
4. Breathing circuit module (O
5. Absorber canister (reusable only)
6. Flow sensor cover
7. Flow Sensor Module (plastic flow sensors not autoclavable)
8. Exhalation Valve assembly
sensor not autoclavable)
2
Figure 2-1 • Autoclavable assemblies
Parts marked 134°C are autoclavable or washable by hand or machine (mild detergent pH <10.5). Rinse and dry completely. All parts except the O
sensor
2
and disposable flow sensors can be washed.
1009-0633-000
If the flow sensors are plastic, refer to the “How to clean and disinfect the flow
sensors” procedure. If metal, they can be autoclaved at 134°C.
2-3
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Aespire 7900
Special requirements
To clean the circuit O sensor in liquid.
To clean/disinfect metal or plastic flow sensors, use the flow sensor cleaning procedures. Do not get the connectors wet.
Disassemble the bellows assembly before you wash it. If not, it will take a very long time to dry. Hang the bellows upside down (extended) to dry. If not, the convolutions can stick together.
Assemble the bellows assembly before you autoclave. Autoclave the bellows assembly upside down.
sensor, wipe it with a damp cloth. Do not put the
2
w WARNING Do not use talc, zinc stearate, calcium carbonate, corn starch or
equivalent materials to prevent tackiness. These materials can go into the patient’s lungs and airways and cause irritation or injury.
w CAUTION
w
w
Do not put the circuit O
Do not autoclave the circuit O
Do not clean the interior surfaces of the flow sensors. Use a damp cloth on external surfaces only.
sensor or flow sensor connector in liquid.
2
sensor or the plastic flow sensors.
2
Inspect all parts for deterioration. Replace them if necessary.
The “Preoperative Tests” section in Part 1 of the User Reference Manual tells you how to test the system for correct operation.
How to clean and disinfect the flow sensors
w CAUTION Do not autoclave plastic flow sensors.
w Do not use high pressure gas or brushes to clean the flow sensors.
w Do not use cleaning solvents that are not approved for use with
polycarbonates (e.g. CIDEX Plus).
CIDEX sterilization
Both Datex-Ohmeda and the manufacturer of CIDEX (Johnson & Johnson) have tested this procedure.
CIDEX must be 14 day mixture, with activator vial (REF reorder #2245).
2-4
1009-0633-000
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2 Cleaning and Sterilization
One liter of this solution cleans four (4) flow sensors.
Procedure
1. Pull the latch to unlock the flow sensor module from the breathing system.
2. Pull the flow sensor module from the breathing system.
3. Remove the flow sensors from the module.
Completely loosen the thumbscrew (1).
Pull off the flow sensor cover (3) from the flow sensor holder (2).
Remove the flow sensor connectors (4) from the flow sensor holder.
Pull the flow sensors (5) from the flow sensor holder.
1
4
2 3
5
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4. Submerge the flow sensor and tubes in activated CIDEX solution. Keep the connector dry.
5. Keep the solution in the tubes for the sterilization period.
6. Submerge the flow sensor and tubes in distilled water. Again, do not get the connector wet.
7. Rinse as indicated in CIDEX instructions.
8. Do steps 6 and 7 again to remove all CIDEX.
9. COMPLETELY dry the flow sensor and the tubes before you use the sensor. Use a dry syringe or connect vacuum or pressure to remove all liquid from the sensor (sensor, tubes, and connector):
w CAUTION Dry for > 1 min with these precautions:
• Maximum flow 10 L/min
• Maximum pressure ±100 cmH
10. Reverse steps 2 and 3 to reassemble the flow sensor module. Be sure to align the flow sensor tubes with the grooves in the flow sensor holder.
11. Before you use the system, complete the “ Preoperative Tests ” in section 4 of the User Reference Manual, Part 1.
Remove the breathing system bag hose
1. Disconnect the bag hose (1) from the bag hose connector (2). Also remove the hose from the clip (3).
2. If bag arm option is present, remove the bag port elbow from the bag arm support. Push down on the release latch and slide the bag port elbow out of the holder.
O
2
1
3
2
2-6
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Page 29
Remove the breathing system
1. Hold the canister (2) 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.
3. Push the release button (3) and gently pull the latch handle (4) to release the breathing system.
2 Cleaning and Sterilization
1
2
3
4
4. Lightly grasp the rear handle (5) to support the breathing system. Slide the breathing system away from the workstation pulling with the latch handle.
5
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Disassemble the breathing system
The breathing system assembly can be disassembled for cleaning, sterilization and part replacement.
1. Remove the breathing system and place on a flat surface.
2. Pull the latch to unlock the flow sensor module from the breathing system.
3. Pull the flow sensor module from the breathing system.
4. Unscrew the sensor counterclockwise and remove it. To remove the sensor cable from the breathing system, press on the connector button (1) while pulling the connector out.
1
2-8
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2 Cleaning and Sterilization
5. Remove the flow sensors from the module:
Completely loosen the thumbscrew (1).
Pull off the cover (2) from the Flow Sensor Holder (3).
Remove the flow sensor connectors (4) from the Flow Sensor Holder.
Pull the flow sensors (5) from the Flow Sensor Holder.
1
2 3
4
5
6. Rotate the breathing circuit module at the point shown by the dotted line.
1009-0633-000
7. After rotating, separate the two sections by pulling them apart.
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Aespire 7900
1
8. On the manifold assembly, remove the check valves circuit lens (1) by squeezing the latches (2) together and pulling up on the lens.
2
9. Press at (2) to unlock the ramp (1). Rotate the ramp and remove the tabs from the slots (3) to remove the ramp.
10. Lift the diaphragm to remove it.
1
2
3
2-10
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2 Cleaning and Sterilization
11. Turn over the bellows base assembly, grasp the bellows boot with three fingers in the openings at the points shown and pull straight away to remove it.
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12. With the breathing system removed, the exhalation valve assembly can be removed for cleaning if desired. Loosen the two thumbscrews indicated and lift the assembly off.
Disassemble the Bellows assembly
The bellows assembly can be disassembled for cleaning, sterilization, and part replacement.
1. Turn the housing counter-clockwise and lift.
2. Remove the bottom edge of the bellows from the rim.
2-12
1009-0633-000
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2 Cleaning and Sterilization
3. Push the latch toward the center and remove the rim.
4. Remove the pressure-relief valve.
w WARNING Do not disassemble the pressure relief valve. This can damage the
seat or diaphragm and cause injury to the patient.
5. Push the latch toward the center and remove the locking tabs.
6. Remove the seal.
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Aespire 7900
Assemble the Bellows assembly
1. Install the seal. Verify the arrow on the seal points up.
2. Push the latch toward the center and attach the locking tabs.
3. Install the pressure-relief valve.
4. Push the latch toward the center and install the rim. Verify you hear a double-click when you install the rim.
2-14
1009-0633-000
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2 Cleaning and Sterilization
5. Attach the bottom edge of the bellows to the rim. Verify only the bottom ring of the bellows is fitted over the rim.
6. Lower the housing and turn it clockwise to lock. Verify you cannot lift off of the housing.
Bellows assembly tests
w WARNING Objects in the breathing system can stop gas flow to the patient.
7. In the above steps, if you see a dust-like powder on the bellows housing or on the bellows, apply a thin layer of KRYTOX lubricant to the ribs of the bellows housing. Make sure the lubricant is applied smoothly and there are no lumps.
8. Perform the Bellows assembly tests before completing the assembly of the breathing system.
This can cause injury or death:
• Do not use a test plug that is small enough to fall into the breathing system.
• Make sure that there are no test plugs or other objects caught in the breathing system.
1009-0633-000
w The bellows assembly test does not replace the preoperative
tests. Always complete the tests in the section Preoperative tests before you use the system with a patient.
2-15
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Aespire 7900
This test makes sure that all components are correctly assembled. It is not an alternative to a complete system checkout.
If the bellows assembly operates correctly, complete the assembly of the breathing system.
If there is a problem, disassemble the bellows assembly. Look for and replace damaged parts.
1. Hold the bellows assembly vertical and close the ports (1 and 2).
2
1
2. Invert the bellows assembly. The bellows must not fall within one minute. If it does:
The ports are not tightly sealed.
The bellows is incorrectly installed.
The seal inside the bellows is not correctly installed (with its groove
pointed up).
Parts are damaged.
1
2
2-16
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2 Cleaning and Sterilization
3. Remove the plugs from the ports. Permit the bellows to fully extend.
4. Close port 3.
3
5. Hold the bellows assembly upright. The bellows must not fall past the guide line within one minute. If it does:
The port is not tightly sealed.
The bellows or the pressure relief valve is not correctly installed.
Parts are damaged.
3
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Aespire 7900
6. If the result for all the bellows assembly tests was “passed,” complete the assembly of the breathing system.
Assemble the breathing system
1. Replace the exhalation valve assembly as shown. Tighten the two thumbscrews.
2. Turn over the bellows base assembly. Replace the boot. Be sure to insert it correctly into the ports as shown by the arrows. Then, press on the center of the boot (arrow) to snap it into place on the bellows base assembly.
2-18
1009-0633-000
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2 Cleaning and Sterilization
3. Replace the diaphragm.
4. Insert the ramp tabs (1) into the slots (2). Rotate the ramp until it locks at (3).
1
2
3
5. On the manifold assembly, press the check valves circuit lens (1) down onto the latches (2) to lock the lens.
1
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2
2-19
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Aespire 7900
6. Insert the breathing circuit module into the bellows assembly aligned as shown.
7. Rotate the breathing circuit module at the point shown by the dotted line to attach it to the bellows assembly.
8. Make sure the o-ring (3) is on the O screwing it in clockwise. Replace the O
sensor. Replace the sensor (1) by
2
sensor cable connector (2).
2
1
2
9. Attach the flow sensors to the module:
Insert the flow sensors (1) into the flow sensor holder. Note the
groove locations.
Attach the flow sensor connectors (2) to the flow sensor holder.
Attach the cover (4) to the flow sensor holder (3).
Tighten the thumbscrew (5) to fasten the cover.
3
2-20
1009-0633-000
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2 Cleaning and Sterilization
2
1
3
4
5
10. Attach the flow sensor module to the breathing system.
11. Push the latch (1) to lock the flow sensor module onto the breathing system.
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1
2-21
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Aespire 7900
12. This is assembled breathing system.
Install the breathing system
1. Locate guide pin openings 1 and 2.
1
2. Align opening 1 onto the guide pin 1, then align opening 2 onto guide pin
2.
12
2
2-22
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2 Cleaning and Sterilization
3. Holding the rear handle (1) and the latch handle (2) as shown, slide the breathing system onto the guide pins.
1
4. Use the grip under the latch handle to push the breathing system in fully until it latches firmly.
5. Install the absorber canister and bag hose.
6. Before you use the system, complete the “Preoperative Tests” in section 4 of the User Reference Manual, Part 1.
2
Remove the AGSS receiver
The AGSS receiver may be removed for cleaning and sterilization.
1. On the back of the system, loosen the two thumbscrews (1) to release the system side panel (2).
2
1
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Aespire 7900
2. Slide the side panel out by removing its tabs from their slots (1).
1
3. Loosen the thumbscrew and remove the reservoir (2). It is not autoclavable.
2
4. Loosen the thumbscrew (1) and lower the receiver to remove it.
1
5. Replace the filter as necessary. (See following steps.)
6. Do these steps in the opposite order to replace the receiver and the side panel.
7. Before you use the system, complete the “Preoperative Tests” in section 4 of the User Reference Manual, Part 1.
Remove the AGSS receiver filter
The AGSS receiver may be autoclaved. To autoclave AGSS receivers which have a filter, the filter must be removed because it is not autoclavable.
2-24 1009-0633-000
Page 47
1. Pull the flexible gasket (1) from the receiver.
1
2. Pull the filter (1) out of its holder (2).
2
1
2 Cleaning and Sterilization
Absorber canister
wCAUTION The filters must be in place to prevent dust and particles from
3. Do these steps in the opposite order to replace the filter and gasket after autoclaving the receiver and gasket. Be sure the gasket is firmly pressed into place at all points.
4. Before you use the system, complete the “Preoperative Tests” in section 4 of the User Reference Manual, Part 1.
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.
Refer to “Removing a canister” in section 1 “Setup and Connections”.
Only the Reusable Multi Absorber canister may be cleaned.
entering the breathing circuit.
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Mechanical cleaning in
washer or washer-
disinfector
Manual cleaning 1. Flush the canister and the lid with fresh running water.
1. Place the canister without filters and the lid in the washer or washer­disinfector and clean them with a decontaminating program.
2. Dry the canister and the lid in a warming closet, maximum 80°C (176°F) or at room temperature.
3. If the washer or washer-disinfector is not used for disinfection of equipment, Datex-Ohmeda recommends that a further high level disinfection is conducted.
4. 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.
5. 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 arrows helps to indicate correct assembly.
2. Clean the canister and lid under total immersion in a sink with water and cleaning agent for at least 3 minutes. The water temperature should be approximately 40°C (104°F).
3. Flush the canister and lid with fresh running water.
4. 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.
5. 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 arrows helps to indicate correct assembly.
6. Datex-Ohmeda recommends that manual cleaning is always followed by a high level disinfection.
High level disinfection 1. Always clean the canister before high level disinfection.
2. The canister can be steam autoclaved. Maximum recommended temperature is 134°C (273°F).
3. 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.
4. 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 arrows helps to indicate correct assembly.
2-26 1009-0633-000
Page 49
3 User Maintenance
w WARNING To help prevent fires:
• Only use lubricants approved for anesthesia or O
equipment,
2
such as Krytox.
• Do not use lubricants that contain oil or grease. They burn or explode in high O
concentrations.
2
• All covers used on the system must be made from antistatic (conductive) materials. Static electricity can cause fires.
w WARNING Obey infection control and safety procedures. Used equipment
may contain blood and body fluids.
w WARNING Movable part and removable components may present a pinch or
a crush hazard. Use care when moving or replacing system parts and components.
In this section
Repair policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Maintenance summary and schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Breathing system maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
1009-0633-000
sensor replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
O
2
sensor calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
O
2
Flow sensor zeroing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
How to prevent water build-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
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Repair policy
Do not use malfunctioning equipment. Make all necessary repairs or have the equipment serviced by an authorized Datex-Ohmeda service representative. After repair, test the equipment to ensure that it is functioning properly, in accordance with the manufacturer’s published specifications.
To ensure full reliability, have all repairs and service done by an authorized Datex-Ohmeda service representative. If this cannot be done, replacement and maintenance of those parts listed in this manual may be undertaken by a competent, trained individual having experience in the repair of devices of this nature.
w CAUTION No repair should ever be attempted by anyone not having
experience in the repair of devices of this nature.
Replace damaged parts with components manufactured or sold by Datex­Ohmeda. Then test the unit to ascertain that it complies with the manufacturer’s published specifications.
Contact your local Datex-Ohmeda Field Service Representative for service assistance. In all cases, other than where Datex-Ohmeda’s warranty is applicable, repairs will be made at Datex-Ohmeda’s current list price for the replacement part(s) plus a reasonable labor charge.
Maintenance summary and schedule
These schedules are the minimum frequency based on typical usage of 2000 hours per year. You should service the equipment more frequently if you use it more than the typical yearly usage.
User maintenance
Minimum Frequency
Daily
Weekly
Maintenance
Clean the external surfaces.
21% O
Flow sensor zeroing.
calibration (circuit O
2
sensor).
2
3-2
Two weeks
Drain the vaporizers and discard the agent. This is not necessary for Tec 6 vaporizers.
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3 User Maintenance
Minimum Frequency
Maintenance
Monthly
During cleaning and setup
Annually
As necessary
100% O
calibration (circuit O
2
sensor).
2
Put Krytox (or a lubricant approved for use with 100% O
) on all tee handle threads.
2
Inspect the parts for damage. Replace or repair as necessary.
Replace the external o-rings on the vaporizer ports.
Install new cylinder gaskets on cylinder yokes.
•Empty the water reservoir and replace the absorbent in the canister.
•Empty the overflow trap on the optional suction regulator.
Replace the circuit O
sensor.
2
(Under typical use the sensor meets specifications for 1 year.)
Replace the disposable flow sensors (plastic). (Under typical use the sensor meets specifications for a miminum of 3 months.)
Replace the autoclavable flow sensors (metal). (Under typical use the sensor meets specifications for a minimum of 1 year.)
Replace the receiver filter (active gas scavenging only).
1009-0633-000
Datex-Ohmeda
approved
service
Minimum Frequency
12 months Have a qualified service person complete the scheduled
Planned Maintenance
service maintenance checks, tests, calibrations and parts replacement as defined in the service manual.
::
NNNNooootttteeee::
This is the minimum level of maintenance recommended by Datex-Ohmeda. Local regulations may contain additional maintenance requirements. Datex-Ohmeda advocates compliance with local regulations which meet or exceed this minimum level of maintenance.
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Breathing system maintenance
When cleaning the breathing system, replace any parts that are visibly cracked, chipped, distorted or worn.
Refer to the appropriate section for reassembly and tests.
O
sensor replacement
2
w WARNING Handle and dispose of sensors according to your biohazard
policies. Do not incinerate.
1. Pull the latch (1) to unlock the flow sensor module from the breathing system.
1
2. Pull the flow sensor module from the breathing system.
3. Remove the O unscrew the sensor counterclockwise. Don’t lose the sensor o-ring.
sensor cable connector (2) from the O
2
sensor (1) and
2
1
2
3-4
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3 User Maintenance
4. Make sure the o-ring (1) is on the sensor. Install the replacement O sensor. Reconnect the O
5. Replace the flow sensor module on the system and press the latch (1) in to secure the module.
sensor cable.
2
1
1
2
O
sensor calibration
2
w WARNING Do not perform calibration while unit is connected to a patient.
21% O
sensor
2
calibration
w The O
sensor must be calibrated at the same environment
2
pressure at which it will be used to monitor oxygen delivery in the patient circuit.
w Operation at pressures other than the pressures present during
calibration may result in readings outside of the stated monitoring accuracy.
This procedure takes three minutes or less.
You must do the 21% O calibration the screen replaces O
calibration before the 100% O
2
data with ---- --
2
--
.
calibration. During O
2
2
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Step 1
Push the Menu key to see the main menu.
Step 2
Turn the knob to select the Calibration screen.
Step 3
Push the knob to show the next screen.
Step 4
Turn and push the knob to select O
Sensor Cal.
2
Step 5
Select 21% then push the knob.
3-6
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Step 6
Complete the steps shown on the screen. To remove the O
from the circuit:
sensor
2
Pull the latch (1) to unlock the flow sensor module from the breathing system.
3 User Maintenance
1
Pull the flow sensor module (2) from the breathing system.
Remove the O
2
sensor (3) and leave it exposed to room air.
2
3
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Step 7
Select Start Cal and push the knob to start calibration.
The screen shows
After a successful calibration, the screen shows “Complete” and a flashing “Reinstall Sensor”.
After installing the sensor, you can continue to 100% calibration (step 11) or exit to the normal screen (step 7).
“ CCCCaaaalllliiiibbbbrrrraaaattttiiiinnnngg
gg
” during
the procedure.
An unsuccessful calibration shows “ FFFFaaaaiiiilllluuuurrrree
ee
”. If the calibration fails:
Do the calibration again.
If it still fails, do a 100% O
sensor calibration (step 11). If 100% O
2
at 21% again.
After repeated failures, replace the O
Step 8
To exit, select “Go to Cal Menu” and push the knob. You can also press the menu key to exit to the normal screen. Select “Go to Main Menu” and push the knob.
Step 9
Select “Exit to Normal Screen” and push the knob.
2
sensor and re-calibrate at 21%.
2
Go to Main Menu
Exit to Normal Screen
sensor calibration passes, calibrate
3-8
Step 10
If you are not doing the 100% calibration which follows, do a breathing circuit leak test before using the system.
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3 User Maintenance
100% O
sensor
2
calibration
w WARNING Do not perform calibration while unit is connected to a patient.
Step 11
Turn then push the knob to select O
Step 12
Select 100% then push the knob.
Sensor Cal.
2
This procedure takes three minutes or less.
You must complete the 21% calibration before you can select the 100% calibration.
Step 13
With the O circuit, fill the circuit with
100% O
sensor in the
2
:
2
Push the flush button.
Then
flow 100% O
5 L/min. (Circuit should be open.)
Step 14
Select Start Cal. Then push the knob to start calibration.
at
2
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The screen shows ‘Calibrating ... ‘, followed by the result: ‘Complete’ or ‘Failure’. If the calibration fails,
do it again or
decrease the airway pressure. Then try again.
After repeated failures replace the O Continue with steps 14 through 16 to exit to a normal screen.
Step 15
To exit, select “Go to Cal Menu” and push the knob. You can also press the menu key to exit to the normal screen
Step 16
Select “Go to Main Menu” and push the knob.
sensor and re-calibrate at 21%.
2
Go to Cal Menu
Go to Main Menu
Step 17
Select “Exit to Normal Screen” and push the knob.
Step 18
Do a breathing circuit leak test before using the system.
Exit to Normal Screen
3-10
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Flow sensor zeroing
wWARNING Do not perform calibration while unit is connected to a patient.
3 User Maintenance
The system automatically corrects for zero offset when you unplug the flow sensor connectors with power on. You must stop mechanical ventilation before you calibrate the flow sensors.
Note: Properly performing the O2 cell zeroing will also zero the flow sensor.
Step 1
Pull the latch (1) to unlock the flow sensor module from the breathing system.
Step 2
Pull the flow sensor module from the breathing system.
Step 3
When zeroing is complete, the screen shows, “No Insp flow sensor” and “No Exp flow sensor.”
1
NNNNoooo IIIInnnnsssspppp FFFFlllloooowwww SSSSeeeennnnssssoooorr NNNNoooo EEEExxxxpppp FFFFlllloooowwww SSSSeeeennnnssssoooorr
rr
rr
Step 4
Install the flow sensor module.
Step 5
Do a breathing circuit leak test before using the system. Refer to “Breathing system tests” in section 4 Preoperative Tests of the User Reference Manual, Part 1.
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How to prevent water build-up
Why is water buildup a
problem?
How much water is
acceptable?
Where does the water
come from?
Solutions: •Empty the water reservoir in the canister when changing the soda lime.
Pooled water in the flow sensor or water in the sensing lines causes false alarms.
Small beads of water or a foggy appearance in the flow sensors is OK.
Water comes from exhaled gas and a chemical reaction between CO2 and the absorbent in the absorber.
At lower fresh gas flows more water builds up because less gas is scavenged and:
More CO
More moist, exhaled gas stays in the absorber.
Ensure that water condensing in the breathing circuit tubes is kept lower than the flow sensors and is not allowed to drain into the flow sensors.
stays in the absorber to react and produce water,
2
•Water condensation in the breathing circuit tubing can be eased using a Heat & Moisture Exchange (HME) filter at the airway connection.
3-12 1009-0633-000
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4 Alarms and Troubleshooting
w CAUTION No repair should ever be attempted by anyone not having
experience in the repair of devices of this nature.
In this section
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
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About alarms
w WARNING If an alarm occurs, safeguard the patient first, before
troubleshooting or repair procedures.
Two areas on the screen show alarms. The area at the top of the display shows most alarms. If there are more than 4 alarms at the same time, the lower priority alarms cycle every two seconds.
During severe malfunctions that prevent mechanical ventilation and/or monitoring, the area under the waveform shows minimum system messages. During normal operation, this area shows instructions (push the knob, etc.).
Alarms
Alarm priority depends on the level of danger to the patient. High priority alarms require immediate attention.
Priority Alarm tone Alarm silence Note
High 10 tones,
10 second pause, repeat
Medium 3 tones,
25 second pause, repeat
Low Single tone Tone does not repeat ---
120 seconds or cannot be silenced
120 seconds ---
Reverse video
AB.90.025
4-2
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4 Alarms and Troubleshooting
Alarm messages have three general causes.
Malfunctions: Some malfunctions cause reduced function (for example, no PEEP). Others prevent mechanical ventilation (Minimum shutdown).
Patient monitoring: These are high and low limit settings that you adjust.
Informational: Control settings or system conditions can change operation. For example, if the audible circuit leak alarm is Off, the screen shows “Circuit Leak Audio Off” as a low priority alarm.
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Alphabetical list
The instructions in this section tell you what you can do:
During a case to protect the patient
After the case to repair a problem
This table does not include operator instructions.
There are two special types of alarms:
Minimum monitoring alarms stop mechanical ventilation.
Minimum shutdown alarms stop mechanical ventilation and monitoring.
Message Priority Cause Action/Concerns Repair
+15V Analog Out-of­Range
-15V Analog Out-of­Range
12 Hour Test Low System in use for more than
A/D Converter Failure
Absorber panel open Medium The top panel is not
Adjust Low Ve Limit Medium The audible circuit leak
Min. shutdown (High)
Min. shutdown (High)
Min. shutdown (High)
Ventilator malfunction. Ventilate manually. Monitoring is
Ventilator malfunction. Ventilate manually. Monitoring is
12 hours without a power-up self test.
Ventilator malfunction. Ventilate manually. Monitoring is
completely closed.
alarm is Off (Alarm menu) but the low VE alarm is not set.
VE alarm is Off in SIMV or PSVPro modes.
Contact a qualified
not reliable.
not reliable.
To do the test, move the system switch from Standby to On.
not reliable.
Push the breathing system into the frame and ensure it latches.
Increase the low VE alarm limit. - - -
service representative.
Contact a qualified service representative.
Not necessary, informational.
Contact a qualified service representative.
- - -
Apnea Alarm Standby
Apnea Alarm Off Low The cardiac bypass option is
4-4
Low Normal condition after End
Case, power-up, or ACGO change from On to Off
selected (alarm limit menu).
Monitoring resumes after first breath (mechanical) or 2 breaths within 30 seconds (non­mechanical).
Apnea alarms are normally turned off when this option is selected.
- - -
- - -
Page 65
4 Alarms and Troubleshooting
Message Priority Cause Action/Concerns Repair
Aux Gas Outlet On Medium
(low after acknowledged)
The outlet selection switch is set to the auxiliary common gas outlet.
Backup Mode Active Low SIMV-PC + PSV mode
entered.
Battery Charger Fail Low The current in the battery
charging circuit is too high.
Battery Charging Low The battery is not fully
charged. If power fails, the total backup time will be less than 30 minutes.
Battery Current High Low Battery current >
6
amps
for
10 seconds.
Battery Failure High Low Battery voltage > 16 V for 10
seconds.
Connect the patient circuit to the auxiliary outlet. For mechanical ventilation or manual ventilation with monitoring, select the breathing system.
Spontaneous breath rate fell below the set breath rate
The system is operational, but may fail later depending on what caused this alarm.
Leave the system plugged in to charge the battery.
The system continues to operate, but may fail.
The system continues to operate, but may fail.
- - -
- - -
Contact a qualified service representative.
- - -
Contact a qualified service representative.
Contact a qualified service representative.
Battery Failure Low Low The battery voltage is too low
(<7 V) to supply the system if power fails.
Cal Flow Sensors Low The last flow sensor
calibration failed.
Calibrate O2 Sensor Low O
%>110% Does the sensor measure 21%
2
Cannot Drive Bellows Low The internal manifold
pressure is higher than Paw + tolerance.
Cardiac Bypass Low The alarm limit settings are
set for a patient on cardiac bypass. Apnea alarms are off.
The battery does not have enough charge to power the equipment if power fails. Leave the system plugged in to
If the battery does not charge in 24 hours, contact a service representative.
charge the battery.
Calibrate the flow sensors. Look for water in the flow sensor
Contact a qualified service representative.
tubes. Dry if necessary.
Calibrate O
O
in room air?
2
Fill the bellows if empty. - - -
Use the alarm limits menu to
- - -
change this setting.
sensor.
2
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Message Priority Cause Action/Concerns Repair
Check Flow Sensors Medium
(low after acknowledged)
Circuit Leak Audio
Low Control setting on the Alarm
Off
Connect O
Sensor Low The O
2
CPU Failure Minimum
shutdown (High)
CPU Internal Error Minimum
shutdown (High)
Display Voltage Out­Of-Range
Minimum shutdown (High)
No flow or negative flow on inspiratory sensor during
Are the flow sensors correctly
installed? inspiration in a circle system or negative flow on expiratory sensor in
Water build-up in the flow sensor
tubes? expiration (for 6 breaths in a row).
Is a flow sensor tube cracked or
broken?
This message tells you that the limit menu.
audio alarm for circuit leaks was
turned off.
sensor is not
2
Connect the sensor. Contact a qualified connected to the cable.
Ventilator malfunction. Ventilate manually. Monitoring is
not reliable.
Ventilator malfunction. Ventilate manually. Monitoring is
not reliable.
Ventilator malfunction. Ventilate manually. Monitoring is
not reliable.
Inspect one way valves (breathing circuit module).
Replace flow sensor module. Check the condition of the flow sensor and its tubing.
- - -
service representative to replace the cable.
Contact a qualified service representative.
Contact a qualified service representative.
Contact a qualified service representative.
Exp Flow Sensor Fail Low The system cannot read the
calibration data stored in the sensor.
Exp Reverse Flow Medium
(low after acknowledged)
Flow Valve (DAC) Failure Flow Valve (current)
Minimum monitoring (Medium)
Flow through the expiratory sensor during inspiration (for 6 breaths in a row).
Ventilator malfunction. Ventilate manually. Monitoring is
Failure
Gas Inlet Valve Failure
Hardware Watchdog Failure
Minimum shutdown (High)
Minimum shutdown (High)
Ventilator malfunction. Ventilate manually. Monitoring is
a
Ventilator malfunction. Ventilate manually. Monitoring is
Operation continues with default
values.
Replace the flow sensor.
Look at the check valves.
Water build-up in the flow sensor
tubes?
Is a flow sensor tube cracked or
broken?
still available.
still available.
not reliable.
- - -
Replace the expiratory check valve.
Check the condition of the flow sensor.
Contact a qualified service representative.
Contact a qualified service representative.
Contact a qualified service representative.
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4 Alarms and Troubleshooting
Message Priority Cause Action/Concerns Repair
High O
2
Medium O
% > alarm high limit
2
setting.
High Paw High Paw is greater than Plimit.
The ventilator cycles to expiration.
High Ve Medium The minute volume is greater
than the set high limit. This alarm is suspended for 9 breaths or one minute after you change the ventilator settings.
High Vte Medium VTE is greater than high
alarm limit. This alarm is suspended for 9 breaths after you change the ventilator settings.
Is the limit set correctly? What is
the O
flow?
2
Did you just push Flush? Does
the sensor see 21% O
in room
2
air?
Are Plimit and other controls set
correctly? Look for blockages.
Check the patient connection.
Check patient for spontaneous
breathing. Adjust control
settings.
Check patient for spontaneous
breathing. Check ventilator and
alarm settings.
Calibrate O Replace O
sensor.
2
sensor.
2
Calibrate the flow sensors. Replace the receiver filter.
- - -
- - -
Insp Flow Sensor Fail Low The system cannot read the
calibration data stored in the sensor.
Inspiration Stopped High Drive gas safety switch
activated (high internal pressure)
Insp Reverse Flow Medium
(low after acknowledged)
Internal Ventilator Clock Too Fast
Internal Ventilator Clock Too Slow
Invalid Circuit
Minimum shutdown (High)
Minimum shutdown (High)
Low Ventilator malfunction. Ventilate manually; monitoring is
Flow through the inspiratory sensor during expiration (for 6 breaths in a row).
Ventilator malfunction. Ventilate manually. Monitoring is
Ventilator malfunction. Ventilate manually. Monitoring is
Module
Operation continues with default
values.
Replace the flow sensor.
Adjust controls. Check systems
for blockages.
Look at the check valves.
Water build-up in the flow sensor
tubes?
Is a flow sensor tube cracked or
broken?
not reliable.
not reliable.
not reliable.
- - -
- - -
Replace the inspiratory check valve.
Check the condition of the flow sensor.
Contact a qualified service representative.
Contact a qualified service representative.
Contact a qualified service representative
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Message Priority Cause Action/Concerns Repair
Limit Task Light Use Low The system is running on
battery power. Turn off the light to save power.
Loss of Backup Audio
Medium (low after
The audio alarm will not sound for a CPU failure.
acknowledged)
Low Battery Voltage Medium Voltage is <11.65V while
using battery power.
Low Drive Gas Pres Medium The ventilator did not detect
a rise in internal pressure when the flow valve opened.
Low O
2
High O
% < alarm low limit setting Is the limit set correctly? Is the
2
Turn off the light to extend
- - -
battery backup.
Monitor system operation. Contact a qualified
service representative.
Manually ventilate the patient to
save power.
Make sure power is connected and circuit breakers are closed. Contact a qualified service representative.
Manually ventilate the patient. Make sure that the
appropriate gas supplies (O
or Air) are
2
connected and pressurized.
O
flow sufficient? Does the
2
sensor see 21% O
in room air?
2
Calibrate O Replace O sensors wear out, the
measured % O
sensor.
2
sensor. As
2
2
decreases.
Low Paw Medium Paw does not rise at least 4
cm from the lowest pressure measured during the last 20 seconds.
Low Ve Medium Exhaled minute volume <low
limit alarm setting. This alarm is suspended for 9 breaths or one minute after you change the ventilator settings.
Low Vte Medium Exhaled tidal volume <low
limit alarm setting. This alarm is suspended for 9 breaths after you change the ventilator settings.
Manifold Pressure Sensor Failure
Minimum monitoring
Ventilator malfunction. Ventilate manually. Contact a qualified
(Medium)
Are circuit connections OK? Look
at the Paw gauge on the
absorber.
Check patient condition. Check
tubing connections.
Check alarm settings.
Check patient condition. Check
tubing connections. Check alarm
settings.
Look for circuit disconnection.
- - -
- - -
service representative.
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4 Alarms and Troubleshooting
Message Priority Cause Action/Concerns Repair
Memory (EEPROM) Fail
The system cannot access some stored values.
Default settings are used.
Ventilation is still possible but
Contact a qualified service representative.
service is necessary.
Memory (flash) Failure
Memory (RAM) Failure
Memory (Redundant Storage) Fail
Minimum shutdown (High)
Minimum shutdown (High)
Minimum monitoring
Ventilator malfunction. Ventilate manually. Monitoring is
not reliable.
Ventilator malfunction. Ventilate manually. Monitoring is
not reliable.
Ventilator malfunction. Ventilate manually. Monitoring is
still available.
Contact a qualified service representative.
Contact a qualified service representative.
Contact a qualified service representative.
(Medium)
Memory (video) Failure
Monitoring Only Medium A severe malfunction
Minimum shutdown (High)
Ventilator malfunction. Ventilate manually. Monitoring is
not reliable.
Ventilate manually. Cycle system prevents mechanical ventilation. Other alarms may also occur.
power (On- Standby-On). If the
alarm clears, restart mechanical
ventilation.
Contact a qualified service representative.
Contact a qualified service representative.
No Circuit Module Low Ventilator malfunction. Ventilate manually. Optical sensors look for
tabs on the back of the module. Is the module assembled? are the sensors dirty?
No CO
Absorption Medium
2
No Exp Flow Sensor
No Insp Flow Sensor
No message, only specific shutdown message
No O
Pressure High
2
The absorber canister is
(low after acknowledged)
open (out of the circuit) but the bypass mechanism prevents a leak (optional feature).
Medium (low after acknowledged)
Electrical signals show the flow sensor is not connected.
High A severe malfunction
prevents mechanical ventilation and monitoring. Other alarms may also occur.
The O
supply has failed. Air flow will continue. Ventilate
2
(cannot be silenced)
User setting. Reinstall the
absorber canister to remove CO
from exhaled gas
Connect the flow sensors. Make
sure the flow sensor module is
on all the way.
Ventilate manually. Use a stand-
alone monitor. Cycle system
power (On- Standby-On). If the
alarm clears, restart mechanical
ventilation.
manually if necessary. Connect a
pipeline supply or install an O
2
cylinder.
- - -
2
- - -
Contact a qualified service representative
- - -
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Message Priority Cause Action/Concerns Repair
O
Flush Failure Low The pressure switch that
2
detects flush flow has seen a very long flush (≥30 seconds).
O
Sensor out of
2
Low Ventilator malfunction. Ventilate manually. Contact a qualified
circuit
This alarm occurs if you hold
down the Flush button for more
than 30 seconds.
If the alarm occurs when flush is not in use, contact a qualified service representative.
service representative.
On Battery - Power OK?
Medium (low after acknowledged)
The mains supply is not connected or has failed and the system is using battery power.
Patient Circuit Leak? Medium Exhaled volume <50% of
inspired volume for at least 30 seconds (mechanical ventilation).
Paw < -10 cmH
O High Subatmospheric pressure
2
(<-10 cmH
O).
2
PEEP Not Achieved Low Pmin does not reach within
±
2 cmH
O of PEEP by the
2
end of mechanical expiration for 6 consecutive breaths.
Positive SIB Vref Out­of- Range
Minimum shutdown (High)
Ventilator malfunction. Ventilate manually. Monitoring is
Ventilate manually to save
power. At full charge, the battery
permits approx. 30 minutes of
mechanical ventilation.
Check breathing circuit and flow
sensor connections.
Check patient condition,
spontaneous activity? Increase
fresh gas flow. Look for high flow
through gas scavenging.
Check tubing connections. Rate
and/or I:E ratio may prevent
ventilator from reaching desired
PEEP level.
not reliable.
Make sure power is connected and circuit breakers are closed.
- - -
Calibrate the flow sensors.
b
With active scavenging, check the negative relief valve on the receiver.
- - -
Contact a qualified service representative.
Pres Mode Not Avail Medium
(Pressure, PSVPro and SIMV modes)
Low (Volume mode)
Pres/Vol Mon
Medium Outlet selection switch is set
Inactive
4-10
Manifold pressure not tracking airway pressure, or manifold pressure ≤ -15 cmH
O.
2
to auxiliary gas outlet.
Pressure control mode and PEEP are not available. Switch to Volume mode or ventilate manually.
Check patient for spontaneous breathing. Check ventilator settings.
Connect the patient circuit to the auxiliary gas outlet or set the switch to the circle breathing system.
Contact a qualified service representative.
- - -
Page 71
4 Alarms and Troubleshooting
Message Priority Cause Action/Concerns Repair
Pressure Limit Switch Failure
Replace O
Sensor Low O
2
Minimum monitoring (Medium)
A pressure safety switch activated at a Paw <90 cmH
O and Pmanifold <80
2
cm H
O.
2
% < 5% Makes sure patient receives O
2
Select Gas Outlet Medium Fresh gas may not flow to the
patient. Auxiliary gas outlet is On, but flow sensors have seen 3 breaths in patient circuit during the last 30 seconds.
Service Calibration Low Internal calibrations are
necessary for maximum accuracy.
Software Error Minimum
Ventilator malfunction. Ventilate manually. Monitoring is
shutdown (High)
Ventilate manually. Monitoring is still available. Extreme control combinations may cause this alarm. Check control settings.
.
2
Does the sensor see 21% O
in
2
room air? Use different monitor.
Select the circle breathing system or connect the patient circuit to the auxiliary outlet.
The system is operational. Operation continues with default values.
not reliable.
Contact a qualified service representative.
Calibrate O Replace O
sensor.
2
sensor.
2
Note: the bag arm will
not ventilate a patient at the auxiliary outlet.
Contact a qualified service representative.
Contact a qualified service representative.
Software Watchdog Failure
Sustained Airway Pressure
Minimum shutdown (High)
Minimum shutdown (High)
Ventilator malfunction. Ventilate manually. Monitoring is
Paw > 100 cmH
O for 10
2
seconds.
Sustained Paw High Paw > sustained pressure
limit for 15 seconds
c
.
System Leak? Medium Delivered volumes do not
match set volumes.
Vaux_ref Out-of­Range
Vext_ref Out-of­Range
Minimum shutdown (High)
Minimum shutdown (High)
Ventilator malfunction. Ventilate manually. Monitoring is
Ventilator malfunction. Ventilate manually. Monitoring is
not reliable.
Check tubing for kinks, blockages, disconnects.
Check tubing for kinks, blockages, disconnects.
Look for leaks in the breathing system. Compare set to delivered volumes.
not reliable.
not reliable.
Contact a qualified service representative.
Calibrate the flow sensors.
Calibrate the flow sensors.
Calibrate the flow sensors. Drain water buildup from the breathing system.
Contact a qualified service representative.
Contact a qualified service representative.
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Message Priority Cause Action/Concerns Repair
Volume Apnea Medium No mechanical breaths or
spontaneous breaths >20 mL in last 30 seconds.
Check patient. Bag as needed. Check for disconnects. If the patient is on a heart lung
- - -
machine, select Cardiac Bypass on the main menu.
Vol Apnea > 2 min High No mechanical breaths or
See above. - - ­spontaneous breaths >20 mL in last 120 seconds.
Vt Not Achieved Low Tidal volume measured by
inspiratory flow sensor < set value 6 breaths in a
Adjust controls to supply
adequate tidal volumes. Check
I:E; Plimit; and volume settings.
Possible leak.
row after the first minute of mechanical ventilation.
Vte > Insp Vt Medium Expired volume > inspired
Check patient condition. - - ­volume for 6 breaths with a circle breathing system.
a. When power is first turned on.
b. Flow sensors are also used to measure pressures.
c. The sustained pressure threshold is calculated from the pressure limit setting. When mechanical ventilation is
on, the sustained limit is calculated as follows: for pressure limits < 30 cmH cmH
O; for Plimit between 30 and 60 cmH
2
pressure limits > 60 cmH
O, the sustained pressure limit is 12 cmH
2
are on, the sustained pressure limit increases by PEEP - 2 cmH
O, the sustained limit is 20% of the pressure limit (Plimit); for
2
O. If both PEEP and mechanical ventilation
2
O (the compensated weight of the bellows).
2
O, the sustained pressure limit is 6
2
When mechanical ventilation is off, the sustained pressure limit is calculated as follows: for pressure limits ≤ 60 cmH
O, the sustained pressure limit is 50% of the pressure limit (Plimit); for pressure limits > 60 cmH
2
sustained pressure limit is 30 cmH
O.
2
O, the
2
4-12
Page 73
Breathing system problems (no alarm)
Symptom Problem Solution(s)
Gas scavenging flow is too low. Suction supply problem. Use a different suction supply.
Filter blockage. Active systems have a flow indicator to show this.
The bellows fills when the Bag/Vent switch is set to Bag or the bag fills when the switch is set to Vent.
The ventilator does not read the position of the Bag/Vent switch. Use manual ventilation, if necessary.
APL valve does not operate correctly. APL valve problem Replace APL Valve seal and
Leak through Bag/Vent switch. Ask a qualified service
Ventilator or absorber malfunction.
4 Alarms and Troubleshooting
Replace the filter. Refer to “Remove the AGSS receiver filter” in section 2, “ Cleaning and
Strerilization” .
representative to repair the system.
Ventilate manually. Ask a qualified service representative to repair the system.
diaphragm - Refer to User Maintenance
1009-0633-000
4-13
Page 74
Aespire 7900
Electrical problems (power failure, etc.)
w WARNING
If a circuit breaker opens frequently, do not use the system. Have a qualified service representative repair the system
Symptom Problem Solution
Mains indicator is not ON. The electrical power cable
is not connected.
The inlet circuit breaker (toggle switch) is open.
The power cable is damaged.
The electrical socket the power cable connects to has no power.
An internal fuse is open. Have a qualified service
One electrical outlet does not have power.
The outlet circuit breaker is open.
Connect the power cable.
Close the circuit breaker (Figure 4-1).
Replace the power cable.
Use a different electrical socket.
representative repair the system.
Close the circuit breaker.
.
A circuit breaker opens frequently.
Tec 6 Plus vaporizer has no power.
The ventilator does not correctly identify the breathing circuit module.
Equipment connected to the outlet(s) (figure 4-1) uses more current than the circuit breaker rating.
The equipment connected to the outlet has a short.
Not plugged into outlet. Connect power cable.
Ventilator malfunction. Ask a qualified service
Use a different power supply for some of the equipment.
Do not use the equipment until it is repaired.
representative to repair the system.
4-14
Page 75
4 Alarms and Troubleshooting
1
4
5
2
1. Inlet Circuit Breaker*
2. Mains Indicator
3. Outlet CIrcuit Breakers*
4. Open (No power)
5. Closed (OK)
3
* Labels show ratings.
Figure 4-1 • Circuit breakers and the mains indicator
1009-0633-000
4-15
Page 76
Aespire 7900
Pneumatic problems
Symptom Problem Solution
High-pressure leak test fails.
Low-pressure leak test fails with a vaporizer on.
Controls are not set correctly. Set the system switch to
Standby and the auxiliary flowmeter to OFF.
Incorrect cylinder connection (cylinder yokes).
Incorrect cylinder connection (DIN connection.)
The vaporizer is not correctly installed. Correctly install the
The vaporizer filler is loose (fill port type vaporizer).
Vaporizer port o-rings (external) are damaged or not installed.
A vaporizer malfunction (the leak stops if you use a different vaporizer in the same position).
A port valve malfunction (the leak continues if you use a different vaporizer in the same manifold position).
Make sure that there is only one cylinder gasket, the gasket is in good condition, and the T- handle is tight.
Make sure the nut is tight.
vaporizer.
Tighten the filler.
Install new o-rings.
Send the vaporizer to a Datex-Ohmeda Service Center for repair.
Have an qualified service person repair the vaporizer manifold.
4-16
Low-pressure leak with a vaporizer OFF.
Anesthesia machine problem. Contact a qualified service
representative.
w CAUTION No repair should ever be attempted by anyone not having
experience in the repair of devices of this nature.
Page 77
Alarm settings range and default values
Setting Range Increment Default
4 Alarms and Troubleshooting
Low O
2
High O
)21-99%, Off 1% Off
2
Low VE Off, 0.1-10 L/min 0.1 L/min 2.0 L
High VE 0.5-30, off L/min 0.5 L/min 10.0 L
Low VTE Off, 5-1500 mL 5 mL if <20 mL,
High VTE 20 - 1600 mL, off 20 mL 1000 mL
Circuit leak Audio on or Audio off n/a Audio on
Cardiac bypass No or In Progress n/a No
18-99% 1% 21%
Off
20 otherwise
1009-0633-000
4-17
Page 78
Aespire 7900
4-18
Page 79
5 Parts
In this section
This section lists user-replaceable parts only. For other components, refer to the Technical Reference manual.
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
1009-0633-000
5-1
Page 80
Aespire 7900
Flow sensor module
1
3
2
AB.82.019
Item Description Stock number
Flow sensor module (does not include flow sensors) 1407-7001-000 1 Flow sensor cover 1407-3000-000 2 Flow sensor cuff 1407-3004-000 3 Flow sensor, disposable (plastic) 1503-3856-000
Flow sensor, autoclavable (metal) 1503-3244-000
5-2
1009-0633-000
Page 81
Breathing circuit module
5 Parts
1
2
3
4
5
AB.82.021
Item Description Stock number
Breathing circuit module (does not include O
cell,
2
140 7-7002-000
O-ring, or cable) 1 Check valves circuit lens 1407-3101-000 2 Check valve assembly 1406-8219-000 3 O-ring for O
4O
cell 6050-0004-110
2
5 Cable, O
Plug (without O
cell 1406-3466-000
2
cell 1009-5570-000
2
sensing) 1407-3111-000
2
O-ring for plug 1407-3112-000
1009-0633-000
5-3
Page 82
Aespire 7900
Bellows
1
2
8
7
Item Description Stock number
1 Bellows housing 1500-3117-000 2 Bellows 1500-3378-000 3 Rim 1500-3351-000 4Pressure relief valve assembly 1500-3377-000 5 Latch, rim 1500-3352-000 6 Manifold, bellows base 1407-3702-000 7 Bellows base with latch 1407-7006-000 8 Seal, base 1500-3359-000 – Diaphragm, APL 1406-3331-000 –Poppet, APL valve 1406-3332-000 – Cage, APL 1406-3333-000
3
4 5
6
AB.82.018
5-4
1009-0633-000
Page 83
Absorber canister
5 Parts
2
3
1
3
4
5
AB.82.017
Item Description Stock number
1 Multi absorber, reusable (includes 40 pack of foam)
140 7-7004-000
(does not include absorbent) 2Cover assembly, CO
3 Foam, CO
canister (pack of 40) 1407-3201-000
2
canister 1009-8240-000
2
4 O-ring 1407-3204-000 5 Canister, CO
Multi absorber, disposable, white to violet,
, with handle 1407-3200-000
2
8003138
(pack of 6) – Multi absorber, disposable, pink to white, (pack of 6) 8003963
1009-0633-000
5-5
Page 84
Aespire 7900
Exhalation valve assembly
AB.82.035
Description Stock number
Exhalation valve assembly 1407-7005-000
5-6
1009-0633-000
Page 85
AGSS
5 Parts
Description Stock number
Common
Cap 3.18 barb silicone 1406-3524-000 Connector, inlet 30 mm male to 19 mm male M1003134 Connector, inlet 30 mm male to 30 mm male M1003947 O-ring for connector, 21.95 ID 1406-3558-000 O-ring for receiver, 22 ID 1407-3104-000 O-ring for thumbscrews, 4.47 ID 1407-3923-000 Reservoir scavenger 1407-3903-000 Seal, down tube scavenger 1407-3904-000 Seal, receiver scavenger 1407-3901-000 Thumbscrew M6 X 28.5 1406-3305-000 Thumbscrew, M6 X 43 1406-3304-000 Valve, unidirectional (complete assembly) 1406-8219-000
Passive AGSS
Adapter, outlet 30 mm female to 19 mm male (pack of 5) 1500-3376-000 Exhaust hose 8004461 Plug assembly 30 mm ISO 1407-3909-000 Screw, shoulder 4 dia X 4 L M3 X 0.5 sst 1407-3915-000
Active AGSS, adjustable flow
Bag with 30 mm male connector 8004460 Plug assembly 30 mm ISO 1407-3909-000
Active AGSS, high flow
Filter, 225 micrometer nylon screen AGSS 1406-3521-000 Seal, filter scavenger 1407-3902-000
Active AGSS, low flow
Filter, 225 micrometer nylon screen AGSS 1406-3521-000 Seal, filter scavenger 1407-3902-000
1009-0633-000
5-7
Page 86
Aespire 7900
Test tools and system parts
Description Stock number
Cylinder gasket (pin indexed cylinders only) 0210-5022-300 Cylinder wrench (DIN 477 and high-pressure hose) 1202-3651-000 Cylinder wrench for pin-indexed cylinder 0219-3415-800 DIN O
Handle for yoke tee 0219-3372-600 Krytox 1001-3854-000 Negative low pressure leak test device 0309-1319-800 Positive low pressure leak test device (BSI) 1001-8975-000 Positive low pressure leak test device (ISO) 1001-8976-000 Positive pressure leak test adapter 1009-3119-000 Ring, sealing gasket (for DIN 477 and O
Ring, sealing gasket (for N
Test lung 0219-7210-300 Test plug 2900-0001-000 Touch-up paint, Neutral Gray N7 (Medium Dark), 18 ml 1006-4198-000 Touch-up paint, Neutral Gray N8 (Medium), 18 ml 1006-4199-000 Touch-up paint, Neutral Gray N9 (Light), 18 ml 1006-4200-000 Vaporizer port o-rings, external (6 pack) 1102-3016-000 Yoke plug 0206-3040-542
plug (cylinder connection) 1202-7146-000
2
high-pressure hose) 1001-3812-000
2
O high-pressure hose) 1202-3641-000
2
5-8
1009-0633-000
Page 87
6 Specifications and
Theory of Operation
In this section
::
NNNNooootttteeee::
All specifications are nominal and subject to change without notice.
System pneumatic circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
System specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Electrical power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Environmental requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15
Breathing system specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16
Ventilator theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-18
Ventilation operating specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-23
Ventilator accuracy data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-26
Suction regulators (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-28
1009-0633-000
Auxiliary O
flowmeter (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-28
2
6-1
Page 88
Aespire 7900
System pneumatic circuits
57
61
60
62
59
63
64
PPPP
69 70 68
DPL
S
67
71
66
28
27
29
42
58
30
43
31
44
45
32
2
47
46
15
34
33
65
48
16
49
35
17
18
50
51
36
38
19
54
52
20
37
25
53
55
P
56
41
39
40 40
26
6-2
P
5
3
4
1
3
P
1414
P
3
676
9
8
3
P
3
P
14
Figure 6-1 • Pneumatic circuit diagram
10
P
3
12
11
3
13
P
1009-0633-000
Page 89
6 Specifications and Theory of Operation
Figure 6-1 legend
1. Auxiliary O
2. O
2
, 0-10 LPM (optional)
2
flush
3. Gauge
4. O
P-Line
2
5. 110 psi relief
6. Venturi
7. Vent drive
8. Air P-line (optional)
9. 110 psi relief
10. Air cylinder (optional)
O pipeline (optional)
11. N
2
12. 110 psi relief
13. N
O cylinder (optional)
2
cylinder (optional)
14. O
2
15. 0 - 120 L/min flow
16. System switch
17. NC
18. NO
19. 30 psi
supply switch
20. O
2
21. -
22. -
23. -
24. -
25. Link 25
26. Flowmeter module (dual tubes optional)
27. Atmosphere
28. Free breathing check valve
29. Vaporizer
30. Mechanical overpressure valve (110
O)
cm H
2
31. Drive gas check valve
32. Inspiratory flow control valve
33. Gas inlet valve
34. 25 psi @15 LPM
35. Vent to ambient
36. Balance regulator
37. Link 25
38. Air (optional)
39. Selectatec manifold
40. Vaporizer
41. 5.5 psi pressure relief valve
42. Popoff valve
43. Exhalation valve (2.0 cm H
44. 10 cm H
O
2
O bias)
2
45. 0-10 LPM drive gas, 0-10 LPM patient and fresh gas, 0-20 LPM total typical flow
46. 200 mL reservoir
47. Negative pressure relief valve
48. Control bleed to ambient approximately 1.0 L/min at 0.29 kPa (3.0 cm H
O) if continuous (rate
2
dependent
49. Absorber
50. 5.4 psi O
flush switch
2
51. NO
52. NC
53. ACGO selector valve
sensor
54. O
2
55. ACGO
56. Airway pressure gauge
57. APL valve 0-70 cm H
O
2
58. Bag
59. Expiratory flow sensor
60. (Optional)
61. To scavenging
62. Gas monitor
63. Patient
64. Inspiratory flow sensor
65. -
66. Manifold pressure transducer
67. Drive pressure limit switch
68. Expiratory flow transducer
69. Inspiratory flow transducer
70. Paw transducer
71. Enhanced sensor interface board
1009-0633-000
6-3
Page 90
Aespire 7900
Gas supplies
Gas goes into the system through a pipeline or cylinder connection. All connections have indexed fittings, filters, and check (one-way) valves. Gauges show the cylinder and pipeline pressures.
A regulator decreases the cylinder pressures to the appropriate system pressure. A pressure relief valve helps protect the system from high pressures.
To help prevent problems with the gas supplies:
Install yoke plugs on all empty cylinder connections.
•When a pipeline supply is connected, keep the cylinder valve closed.
w WARNING 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.
O
flow
2
Pipeline or regulated cylinder pressure supplies O (O
Ventilator).
2
The flush valve supplies high flows of O
to the fresh gas outlet when you push
2
directly to the ventilator
2
the flush button. The flush switch uses pressure changes to monitor the position of the flush valve. A message on the ventilator tells you when Flush is ON.
Air and N
When the system switch is ON, O minimum flow through the O
A secondary regulator supplies a constant O
flows to the rest of the system and there is a
2
flowmeter.
2
pressure to the flow control
2
valve.
An electrical switch monitors the O
supply pressure. If the pressure is too low,
2
an alarm appears on the ventilator.
O
2
A balance regulator controls the flow of N
O to the flow control valve. Oxygen
2
pressure at a control port adjusts the output of the regulator. This stops flow during an O decrease with the O
supply failure and ensures that the hypoxic gas pressures
2
supply pressure. Changes in O
2
pressure do not affect
2
Air.
A chain linkage on the N
O and O
2
flow controls helps keep the O
2
2
concentration higher than approximately 21% at the fresh gas outlet.
Pipeline or regulated cylinder pressure directly supply Air to the ventilator (Air Ventilators). When the system switch is ON, air flows to the rest of the system. Because there is no balance regulator, air flow continues at the set rate during an O
supply failure.
2
6-4
1009-0633-000
Page 91
O
O
O
6 Specifications and Theory of Operation
Mixed gas
System specifications
Pneumatic
Gas supplies
The mixed gas goes from the flowmeter outlet through the vaporizer that is ON, to the fresh gas outlet, and into the breathing system. A pressure relief valve sets the maximum outlet pressure.
PPPPiiiippppeeeelllliiiinnnneeee ggggaaaasssseeeess
CCCCyyyylllliiiinnnnddddeeeerrrr ggggaaaasssseeeess
CCCCyyyylllliiiinnnnddddeeeerrrr ccccoooonnnnnnnneeeeccccttttiiiioooonnnnss
PPPPrrrriiiimmmmaaaarrrryyyy rrrreeeegggguuuullllaaaattttoooorrrr oooouuuuttttppppuuuutttt pppprrrreeeessssssssuuuurrrree
ss
ss
O
, Air, N
2
2
O
, N
O, Air (maximum: 2 cylinders of each gas); 1
2
2
cylinder max. on pendant model; 3rd cylinder is N
O
2
only
ss
Pin indexed (all gases); nut and gland DIN 477 (O Air); large cylinder kit available for O
Pin indexed: The primary regulator is set to pressure
ee
less than 345 kPa (50 psi).
and N
2
, N
O,
2
2
2
DIN-477: The primary regulator is set to pressure less than 414 kPa (60 psi)
PPPPrrrreeeessssssssuuuurrrreeee rrrreeeelllliiiieeeeffff vvvvaaaallllvvvvee
PPPPiiiippppeeeelllliiiinnnneeee ccccoooonnnnnnnneeeeccccttttiiiioooonnnnssss
))
((((ffffiiiilllltttteeeerrrreeeedddd))
ee
Approximately 758 kPa (110 psi)
DISS-Male; DISS-Female; AS 4059 (Australian); S90­116 (French Air Liquide); BSPP 3/8 (Scandinavian) or NIST (ISO 5359). All fittings available for O
ss
Color coded gauges
ee
280-600 kPa (41-87 psi)
ACGO Port relief
PPPPrrrreeeessssssssuuuurrrreeee ddddiiiissssppppllllaaaayyyyss
PPPPiiiippppeeeelllliiiinnnneeee iiiinnnnlllleeeetttt pppprrrreeeessssssssuuuurrrree
Valve limits fresh gas pressure to 35 kPa (5.5 psi) at the flush flow.
w CAUTION All gases supplied to the system must be medical grade.
Flow
Flow rates: Minimum O
Gas
O
2
N
O 0.05 -0.95 L/min
2
Scale (two flow tubes)
0.05 -0.95 L/min 1-15 L/min
1-10 L/min
flow: 25 to 75 mL/min.
2
Note: The link system sets the nominal O
25% of the total O N
O flow.
2
flow
2
and
2
, Air, and N
2
2
1009-0633-000
6-5
Page 92
Aespire 7900
IEC-60601-1 Clasification
Gas
Air 0.05 -0.95 L/min
Accuracy: At 20
Scale (two flow tubes)
1-15 L/min
° C with gas supply pressures at 345 kPa (50 psi) and an
outlet pressure of 101.3 kPa (absolute) (14.7 psi) flowmeter accuracy agrees with VDE 3513 Part 3, Accuracy Class 2.5 or better.
Different breathing circuit pressures, barometric pressures or temperatures change the accuracy. With some conditions, these changes can be larger than the tolerances.
Flush flow: 25-75 L/min.
supply failure alarm and shutoff:
O
2
OO
OO
ssssuuuuppppppppllllyyyy ffffaaaaiiiilllluuuurrrreeee aaaallllaaaarrrrmmmm::
22
22
NN
NN
OOOO sssshhhhuuuuttttooooffffffff::
22
22
::
OO
OO
PPPPrrrreeeessssssssuuuurrrreeee::
22
22
::
193 to 221 kPa (28 to 32 psi)
3.5 kPa (0.5 psi)
::
The S/5 Aespire is classified as follows.
Class I Equipment
Type B Equipment
Ordinary Equipment
Not for use with flammable anesthetics
Continuous operation
Steam autoclavable or disinfectable per recommendations (see section 2 “Cleaning and Sterilization” .
Electrical power
6-6
Supply voltage: 100-120 or 220-240 Vac
± 10% at 50 or 60 Hz.
Inlet Circuit Breakers:
100-120 Vac 220-240 Vac
15A 8A
Outlet Circuit Breakers:
100-120 Vac 220-240 Vac Japan
(3) 2A (1) 3A
(3) 1A (1) 2A
(2) 2A (1) 4A
System leakage current limit - do not exceed:
UL and CSA rated systems (USA and Canada): <300 µamps for the system and all systems connected to electrical outlets.
IEC rated systems (Not USA and Canada): <500 µamps for the system and all systems connected to electrical outlets.
1009-0633-000
Page 93
6 Specifications and Theory of Operation
Note Products connected to the electrical outlets may increase the leakage current
above these limits.
w WARNING The connection of equipment to the auxiliary mains electrical
outlet(s) may increase the patient leakage currents to values exceeding the allowable limits in the event of a defective earth conductor.
Resistance to ground: <0.2 Ω
Power cord
Length: 5 meters
Voltage rating: 90 to 264 Vac
Current capacity: 10 A for 220-240 Vac
15 A for 100-120 Vac
w WARNING Use the battery if the integrity of the protective earth conductor is
Battery information
Type: Three conductor power supply cord (medical grade
where required).
in doubt.
The system is not a portable unit; a sealed lead acid battery supplies battery backup. Batteries are used as backup power in case of a power failure. Thus, the battery is in a float charge state most of the time. Batteries meet the following:
1. Capacity to operate for 90 minutes under typical operating conditions; 30 minutes under extreme conditions.
2. Unit functions to specifications through the transition to battery power.
3. Long float charge life.
4. Battery pack has an auto-resettable thermal fuse.
5. Battery terminals and connecting wires are protected against short circuits.
Only Datex-Ohmeda service representatives are to replace the battery. Contact a Datex-Ohmeda service representative to disconnect the battery if the equipment is not likely to be used for some time. Batteries must be disposed of in accordance with applicable regulatory requirements in effect at the time and place of disposal.
1009-0633-000
6-7
Page 94
Aespire 7900
Electromagnetic compatibility
Changes or modifications to this equipment not expressly approved by Datex­Ohmeda could cause EMC issues with this or other equipment. Contact Datex­Ohmeda for assistance. This device is designed and tested to comply with applicable regulations regarding EMC as follows.
w WARNING Use of portable phones or other radio frequency (RF) emitting
equipment near the system may cause unexpected or adverse operation. Monitor operation when RF emitters are in the vicinity.
• Use of other electrical equipment on or near this system may cause interference. Verify normal operation of equipment in your configuration before use on patients.
The system provides connections for items such as printers, visual displays and hospital information networks. When these items (non-medical equipment) are combined with the S/5 Aespire, these precautions must be followed:
Don’t place items not approved to IEC 60601-1 closer than 1.5 m to the patient.
All items (medical electrical equipment or non-medical electrical equipment) connected to the S/5 Aespire by a signal input/signal output cable must be supplied from an AC power source which uses a separating transformer (in accordance with IEC 60989) or be provided with an additional protective earth conductor.
If a portable multiple socket outlet assembly is used as an AC power source, it must comply with IEC 60601-1-1. The assembly must not be placed on the floor. Using more than one portable multiple socket outlet assembly is not recommended.
Do not connect non-medical electrical equipment directly to the AC outlet at the wall instead of an AC power source which uses a separating transformer. Doing so may increase enclosure leakage current above levels allowed by IEC 60601-1 in normal conditions and under single-fault conditions. This may cause an unsafe electrical shock to the patient or operator.
The S/5 Aespire provides multiple AC outlet sockets for connecting only other medical electrical equipment. Do not connect non-medical electrical equipment to these sockets. Doing so may increase enclosure leakage current above levels allowed by IEC 60601-1 in normal conditions and under single-fault conditions. This may cause an unsafe electrical shock to the patient or operator.
6-8
After connecting anything to these outlets, conduct a complete system leakage current test (according to IEC 60601-1).
1009-0633-000
Page 95
6 Specifications and Theory of Operation
w WARNING An operator of the medical electrical system must not touch non-
medical electrical equipment and the patient simultaneously. This may cause an unsafe electrical shock to the patient.
Guidance and
manufacturer's
The system is suitable for use in the specified electromagnetic environment. The customer and/or the user of the system should assure that it is used in an electromagnetic environment as described below.
declaration -
electromagnetic
emissions
Emissions test Compliance Electromagnetic environment guidance
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Immunity test IEC 60601-1-2 test level Compliance level Electromagnetic environment guidance
Electrostatic discharge (ESD) IEC 61000-4-2
Group 1 The system uses RF energy only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
Class B The system is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power supply
Class A
network that supplies buildings used for domestic purposes.
Complies
± 6 kV contact ± 8 kV air
± 6 kV contact ± 8 kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000­4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
1009-0633-000
± 2 kV for power supply lines ±1 kV for input/output lines
± 1 kV differential mode ±2 kV common mode
< 5 % UT (> 95% dip in U for 0,5 cycle
40 % U
(60% dip in U
T
for 5 cycles 70 % U
(30% dip in U
T
for 25 cycles < 5% U
(> 95 % dip in U
T
for 5 sec
± 2 kV for power supply lines ±1 kV for input/output lines
± 1 kV differential mode ±2 kV common mode
)
< 5 % UT (> 95% dip in
T
U
) for 0,5 cycle
T
)
40 % U
T
)
T
)
T
(60% dip in
T
U
) for 5 cycles
T
70 % U
(30% dip in
T
U
) for 25 cycles
T
< 5 % U U
T
) for 5 sec
T
(> 95% dip in
Mains power quality should be that of a typical commercial and/or hospital environment.
Mains power quality should be that of a typical commercial and/or hospital environment.
Mains power quality should be that of a typical commercial and/or hospital environment. If the user of the system requires continued operation during power mains interruptions, it is recommended that the system be powered from an uninterruptible power supply or a battery.
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Immunity test IEC 60601-1-2 test level Compliance level Electromagnetic environment guidance
Power frequency
3 A/m 3 A/m If display distortion or other abnormalities occur, it (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m
Note: U
is the AC mains voltage before application of the test level.
T
may be necessary to position the S/5 Aespire Anaesthetic System further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low.
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6 Specifications and Theory of Operation
Immunity test
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-6
IEC 60601-1-2 Test Level
3 Vrms 150 kHz to 80 MHz outside ISM bands
10 Vrms 150 kHz to 80 MHz in ISM bands
10 V/m 10 V/m (E1) D=1.2√P 80 mHz to 800 mHz
80 MHz to 2,5 GHz D=3.5√P 800 mHz to 2.5 GHz
Compliance level
3 Vrms (V1) D=3.5√P
10 Vrms (V2) D=12√P
Electromagnetic environment guidance
Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter.
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and D is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
Recommended separation distance
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz are intended to decrease the likelihood that a portable communications device could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re­orienting or relocating the system. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
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Aespire 7900
Recommended
separation distances
Between portable and mobile
RF communications
equipment and the system
Separation distance in meters (m) according to frequency of the transmitter
Rated maximum
output power of
transmitter
W
0,01 0.35 1.2 0.12 0.23
0,1 1.1 3.8 0.38 0.73
1 3.5 12 1.2 2.3
10 11 38 3.8 7.3
150 kHz to
80 MHz
Outside ISM bands
35,
D
--------­V1
The system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum power of the communications equipment.
150 kHz to
80 MHz
In ISM bands
P=
12
D
------­V2
P=
80 MHz to
800 MHz
D
12
------­E1
800 MHz to
2,5 GHz
23
P=
D
------­E1
P=
100 35 120 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance D in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz to 800 MHz the separation distance for the higher frequency range applies.
Note 2: The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
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14
12
6 Specifications and Theory of Operation
10
11
9
4
8
7
6
5
1
2
3
17
15
13
34
36
35
29
28
16
26
27
30
18-21
22
24
31
32
23
Figure 6-2 • Electrical block diagram
25
33
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Aespire 7900
Figure 6-2 legend
Inside Anesthesia System
1.
Power cord
2.
AC inlet with breaker and line filter
3.
Isolation transformer
4.
Inrush board
5.
Fuses
6.
Line filter
7.
Outlet box
8.
Universal power supply
9.
Battery, 12 V
10.
Integrated CPU board
11.
On/Standby switch
12.
O2 supply switch
13.
Task light switch
14.
Task light
15.
RS232 port
16.
Ventilator display module
17.
Display connector board
18.
EL display
19.
Keyboard membrane switch
20.
ComWheel
21.
Ventilator engine board
22.
Gas inlet valve
23.
Flow control valve
24.
Breathing system
25.
Bag/Ventilator switch
26.
ABS on switch
27.
Canister switch (optional)
28.
CO2 bypass switch (optional)
29.
Bulkhead connector
30.
Expiratory flow sensor
31.
Inspiratory flow sensor
32.
O2 sensor
33.
Enhanced sensor interface board
34.
ACGO select
35.
O2 flush switch
36.
6-14 1009-0633-000
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