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
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 currentThis way is up.
†
Alternating current
∏
Protective earth ground
x
Earth groundOutput
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 stepsVacuum inlet
Plus, positive polaritySuction bottle outlet
Minus, negative polarity
--
--
Lamp, lighting, illuminationCylinder
Movement in one directionIsolation transformer
Movement in two directionsLow 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 flowMenu touch key
O2 sensor connectionAlarm silence touch key
(Tec 6)
Volume alarms On/Off touch keyEnd 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.
How to attach equipment to the top shelf . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
1009-0633-000
1-1
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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
Page 14
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
1009-0633-000
Page 15
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
1009-0633-000
1-5
Page 16
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.”
1009-0633-000
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.
1009-0633-000
1-7
Page 18
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
1009-0633-000
Page 19
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
Page 20
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.
wCAUTIONDo 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
wWARNINGDo 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.
wWARNINGThese 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.
1009-0633-000 1-11
Page 22
Aespire 7900
How to attach equipment to the top shelf
wWARNINGThe 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.
wWARNINGIf you do not fully tighten the strap, equipment can fall off the
• 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
Page 26
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
Page 27
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
23
5
1009-0633-000
2-5
Page 28
Aespire 7900
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
1009-0633-000
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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Aespire 7900
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
1009-0633-000
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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
23
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
1009-0633-000
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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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Aespire 7900
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.
1009-0633-000
1
2-21
Page 44
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
1009-0633-000
Page 45
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
1009-0633-0002-23
Page 46
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.
2-241009-0633-000
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
wCAUTIONThe 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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Aespire 7900
Mechanical cleaning in
washer or washer-
disinfector
Manual cleaning1. 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 disinfection1. 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.
2-261009-0633-000
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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.
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 monthsHave 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.
3-3
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Aespire 7900
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
1009-0633-000
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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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Aespire 7900
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
1009-0633-000
Page 55
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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Aespire 7900
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.
1009-0633-000
Page 57
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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Aespire 7900
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
1009-0633-000
Page 59
Flow sensor zeroing
wWARNINGDo 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.”
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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Aespire 7900
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.
3-121009-0633-000
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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.
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.
PriorityAlarm toneAlarm silenceNote
High10 tones,
10 second pause,
repeat
Medium3 tones,
25 second pause,
repeat
LowSingle toneTone does not repeat---
120 seconds or cannot
be silenced
120 seconds---
Reverse video
AB.90.025
4-2
Page 63
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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Aespire 7900
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.
1Multi absorber, reusable (includes 40 pack of foam)
140 7-7004-000
(does not include absorbent)
2Cover assembly, CO
3Foam, CO
canister (pack of 40)1407-3201-000
2
canister1009-8240-000
2
4O-ring1407-3204-000
5Canister, CO
–Multi absorber, disposable, white to violet,
, with handle1407-3200-000
2
8003138
(pack of 6)
–Multi absorber, disposable, pink to white, (pack of 6) 8003963
1009-0633-000
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Aespire 7900
Exhalation valve assembly
AB.82.035
DescriptionStock number
Exhalation valve assembly1407-7005-000
5-6
1009-0633-000
Page 85
AGSS
5 Parts
DescriptionStock number
Common
Cap 3.18 barb silicone1406-3524-000
Connector, inlet 30 mm male to 19 mm maleM1003134
Connector, inlet 30 mm male to 30 mm maleM1003947
O-ring for connector, 21.95 ID1406-3558-000
O-ring for receiver, 22 ID1407-3104-000
O-ring for thumbscrews, 4.47 ID 1407-3923-000
Reservoir scavenger1407-3903-000
Seal, down tube scavenger1407-3904-000
Seal, receiver scavenger1407-3901-000
Thumbscrew M6 X 28.51406-3305-000
Thumbscrew, M6 X 431406-3304-000
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 hose8004461
Plug assembly 30 mm ISO1407-3909-000
Screw, shoulder 4 dia X 4 L M3 X 0.5 sst1407-3915-000
Active AGSS, adjustable flow
Bag with 30 mm male connector8004460
Plug assembly 30 mm ISO1407-3909-000
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 cylinder0219-3415-800
DIN O
Handle for yoke tee0219-3372-600
Krytox1001-3854-000
Negative low pressure leak test device0309-1319-800
Positive low pressure leak test device (BSI)1001-8975-000
Positive low pressure leak test device (ISO)1001-8976-000
Positive pressure leak test adapter1009-3119-000
Ring, sealing gasket (for DIN 477 and O
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
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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
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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.
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
O0.05 -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
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Aespire 7900
IEC-60601-1 Clasification
Gas
Air0.05 -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.
•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 Vac220-240 Vac
15A8A
Outlet Circuit Breakers:
100-120 Vac220-240 VacJapan
(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
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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
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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 ComplianceElectromagnetic 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 testIEC 60601-1-2 test levelCompliance levelElectromagnetic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Group 1The 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 BThe 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.
6-9
Page 96
Aespire 7900
Immunity testIEC 60601-1-2 test levelCompliance levelElectromagnetic environment guidance
Power frequency
3 A/m3 A/mIf 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.
6-10
1009-0633-000
Page 97
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/m10 V/m (E1)D=1.2√P 80 mHz to 800 mHz
80 MHz to 2,5 GHzD=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.
1009-0633-000 6-11
Page 98
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
0,010.351.20.120.23
0,11.13.80.380.73
13.5121.22.3
1011383.87.3
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=
100351201223
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.
6-12 1009-0633-000
Page 99
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
1009-0633-000 6-13
Page 100
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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