Manual de Referencia - Aespire
Manual de Referencia - Aespire
AAAX11111 AAAXX111111AA
The X represents an alpha The XX represents a number
character indicating the year indicating the year the product
the product was manufactured; was manufactured; 04 = 2004,
H = 2004, J = 2005, etc. I and 05 = 2005, etc.
O are not used.
1 Introduction
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ii M1116146
Table of Contents
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Monochrome display . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Color display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Latching alarms with software version 1.X . . . . . . . . . . . 6-2
Latching alarms with software version 2.X . . . . . . . . . . . 6-3
List of alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Ventilate manually alarms . . . . . . . . . . . . . . . . . . . . . . 6-10
Breathing system problems . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Electrical problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Pneumatic problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
7 User Maintenance
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iv M1116146
Table of Contents
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Warranty
vi M1116146
1 Introduction
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What is an Aespire?
The Aespire anesthesia system is a compact, integrated and intuitive
anesthesia delivery system. The 7100 Ventilator provides mechanical
ventilation for patients during surgery as well as monitoring and
displaying various patient parameters.
The 7100 Ventilator uses a microprocessor-controlled ventilator with
internal monitors, electronic PEEP, Volume Mode, and other optional
features. A serial interface permits communication to cardiovascular
and respiratory gas monitoring.
The Aespire anesthesia system is not suitable for use in an MRI
environment.
This system must only be operated by authorized medical personnel
well trained in the use of this product. It must be operated according
to the instructions in this User’s Reference manual.
Note Configurations available for this product depend on local market and
standards requirements. Configurations covered in this manual
include the Aespire and Aespire 100 anesthesia systems. Illustrations
in this manual may not represent all configurations of the product.
This manual does not cover the operation of every accessory. Refer
to the accessory documentation for further information.
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1 Introduction
AB.74.121
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Standby
O2+ O2 flush button
SN Serial number
REF Stock number
1-4 M1116146
1 Introduction
Max Vacuum
Lock Unlock
134°C
Autoclavable Not autoclavable
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Alarm silence touch key (Tec 6) Volume alarms On/Off touch key
Systems with this mark agree with the Authorized representative in the European
European Council Directive (93/42/EEC) for Community
Medical Devices when they are used as
specified in their User’s Reference manuals.
The xxxx is the certification number of the
Notified Body used by GE Healthcare’s
Quality Systems.
This way up
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1 Introduction
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2 System Controls and Menus
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11
1
10
2
3
9
4
5
6
8
AB.74.121
1. Dovetail rails
2. Vaporizer
3. Pipeline pressure gauge(s) (upper row)
4. Cylinder pressure gauge(s) (lower row)
5. System switch
6. Integrated suction (optional)
7. Brake
8. O2 flush button
9. Breathing system
10. Flow controls
11. Ventilator display (color or monochrome)
Figure 2-1 • Front view
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2 System Controls and Menus
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1
2
5
4
AB.74.004
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2 System Controls and Menus
Vaporizer controls Refer to the vaporizer operation and maintenance manual for more
detailed information on the vaporizer.
3 3
4 4
AB.80.009
AA43051
5
1 2
1. Tec 6 Plus
2. Tec 7
3. Lock lever
4. Concentration control and release
5. Indicators (Tec 6 Plus)
6. Alarm silence touch key (Tec 6 Plus)
Figure 2-3 • Vaporizer controls
4 Concentration control Push the release and turn the concentration control to set
and release the agent concentration. The Tec 6 Plus concentration
control does not turn as long as the warm-up indicator is on.
5 Indicators (Tec 6 Plus) All indicators come on briefly at the start. The warm-up
indicator goes off after approximately 10 minutes when the
operational indicator comes on. Other indicators come on to
advise the user of required action.
6 Alarm silence touch key Push to silence alarms. Hold for 4 seconds to sound the
(Tec 6 Plus) speaker and light all indicators (alarm test).
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15
14
13
12 1
2
11 3
10 4
9 5
6
AB.74.005
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2 System Controls and Menus
MI
N
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Optional ABS
components
AB.74.120
AB.82.043
4
3 EZchange Canister release Push to drop the canister to EZchange position. This seals
the breathing circuit, permitting continued ventilation and
rebreathing of exhaled gases. Be sure to hold the canister
by the handle before releasing the canister.
4 Condenser drain button Push to drain water out of the condenser.
2-8 M1116146
2 System Controls and Menus
ACGO
Fresh gas flow is directed through the Auxiliary Common Gas Outlet
(ACGO) on the front of the system when the ACGO switch is in the
ACGO position. Mechanical ventilation is not available when
operating an auxiliary manual breathing circuit with fresh gas from the
ACGO. The Bag/Vent switch, APL valve, and bag arm are not part of
the external circuit. Volume and pressure monitoring are not
available.
O2 monitoring of fresh gas is available automatically when the ACGO
is selected if the system has the O2 cell monitoring option. A sample
of the fresh gas is diverted to the O2 cell in the breathing system. The
sample flow to the O2 cell is dependent on the pressure in the
external circuit. The sample flow reduces the fresh gas flow rate to
the auxiliary breathing circuit equal to the amount delivered to the O2
cell.
Fresh gas oxygen concentration is displayed on the screen. Set the
alarm limits appropriately. Note that fresh gas oxygen concentration
may not reflect FiO2 during spontaneous breathing or in rebreathing
circuits. Use an external O2 monitor if using a rebreathing circuit on
ACGO.
Do not use an external ventilator on the ACGO. Do not use the ACGO
to drive external ventilators or for jet ventilation.
See “Scavenging” in the “Setup and Connections” section for more
information on connections.
Scavenging the A sample of the fresh gas is diverted to the O2 cell in the breathing
ACGO sample flow system. If an auxiliary manual breathing circuit is used with N2O or
volatile anesthetics, this sample flow should be scavenged.
1. Attach a circle breathing circuit to the inspiratory and expiratory
ports. Occlude the circle circuit by connecting the Y-piece to the
plug located to the rear of the expiratory port.
2. Check for clinically correct settings. Set the Bag/Vent switch to
mechanical ventilation mode. (Mechanical ventilation will not start
when ACGO is selected.) Alternatively, set the Bag/Vent switch
to the bag mode, set the APL valve to MIN, and attach a bag.
3. The bellows, or bag, fills slowly with the fresh gas sample flow
and then spills to the AGSS.
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Scavenging from an Scavenge the exhaust if an auxiliary manual breathing circuit is used
auxiliary manual with N2O or volatile anesthetics.
breathing circuit An auxiliary inlet is available for active and passive AGSS units. It
provides a female connection with 30 mm - 30 mm male connector
(or a 30 mm - 19 mm male connector) into the auxiliary port under the
breathing system. Do not use these connectors as an outlet for
exhaust flow.
The auxiliary inlet is a convenience inlet to the air brake of active
AGSS units. There is a reservoir to capture exhaust flows higher than
the extract flow.
A separate exhaust hose is needed from the auxiliary manual
breathing circuit to the disposal point for all AGSS units.
Scavenging a gas Sample gas from a gas monitor can be scavenged using the sample
monitor sample flow gas return port or the AGSS. To scavenge from a gas monitor using
the sample gas return port, connect the tubing from the monitor to the
sample gas return port. To scavenge from a gas monitor using the
AGSS, connect tubing from the monitor to the male luer inlet on the
bottom of the AGSS underneath the breathing system.
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2 System Controls and Menus
Ventilator controls
The ventilator controls include touch keys, menu screens, and a
control knob. The system switch provides power functions to the
ventilator display. The Bag/Vent switch starts and stops mechanical
ventilation.
11
1
10
2
8 7 6 5 4 AB.43.161
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Ventilator screen
6 3
4
5 AB.43.162
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2 System Controls and Menus
Using menus
Push the Menu key to display the Main Menu. Use the ComWheel to
navigate through the menu. The screen returns to the normal view 25
seconds after the last action.
1. Push the Menu key to show the Main Menu.
2. Turn the ComWheel counterclockwise to highlight the next menu
item. Turn the ComWheel clockwise to highlight the previous
menu item.
3. Push the ComWheel to enter the adjustment window or a sub
menu.
4. Turn the ComWheel clockwise or counterclockwise to highlight
the desired selection.
5. Push the ComWheel to confirm the selection.
6. Push the Menu key to exit the menu and return to the normal
monitoring screen.
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3 Operation
Ventilator setup
The system has two modes of mechanical ventilation:
• Volume Control.
• Pressure Control (optional).
Note See the “Specifications and Theory of Operation” section for more
information on ventilation modes.
Using quick keys The five main ventilator settings for each mode can be easily
changed using the ventilator quick keys.
1. Push a ventilator quick key to select the corresponding ventilator
setting.
2. Turn the ComWheel to make a change.
3. Push the ComWheel to activate (confirm) the change.
Setting inspiratory Inspiratory pause is only available in volume control ventilation mode.
pause The inspiratory volume stays in the patient’s lungs for the set pause
time at the end of inspiration. Inspiratory pause can be set to Off or 5
to 60 percent of the inspiratory time in increments of 5.
1. Push the Menu key.
2. Select Setup.
3. Select Inspiratory Pause.
4. Select the setting and push the ComWheel to activate the
change.
5. Select Go to Main Menu to return to the Main Menu, or push the
Menu key to return to the normal monitoring screen.
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Show or hide alarm Simplify the screen by hiding the alarm limits. If the screen is set to
limits hide the alarm limits, the limits automatically show when an alarm
occurs, volume monitoring is off, or the auxiliary common gas outlet is
selected.
1. Push the Menu key.
2. Select Screen and Audio Setup.
3. To hide alarm limits, select Alarm Limits and set to Hide.
4. To show the alarm limits, select Alarm Limits and set to Show.
5. Select Go to Main Menu to return to the Main Menu, or push the
Menu key to return to the normal monitoring screen.
Show or hide units of Simplify the screen by hiding the units of measure.
measure 1. Push the Menu key.
2. Select Screen and Audio Setup.
3. To hide the units of measure, select Units of Measure and set to
Hide.
4. To show the units of measure, select Units of Measure and set
to Show.
5. Select Go to Main Menu to return to the Main Menu, or push the
Menu key to return to the normal monitoring screen.
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3 Operation
Alarm Settings
Setting volume The volume alarms key turns the volume alarms on and off. When the
alarms alarms are off, an X covers the alarm limits. Use this control during
manual ventilation when constant attention is on the patient.
Use the End Case key to minimize alarms between cases. The
alarms will activate when two or more breaths are detected within 30
seconds.
Setting alarm limits If the Alarm Settings menu shows Ve Auto Limits during
mechanical ventilation, the system is set to automatically calculate
VE limits to the ventilator parameter settings.
1. Push the Menu key.
2. Select Alarm Settings.
3. Scroll to the desired alarm.
4. Select the alarm limit and change the value.
5. Select Go to Main Menu to return to the Main Menu, or push the
Menu key to return to the normal monitoring screen.
Setting an audible The patient circuit leak alarm activates during mechanical ventilation
alarm for circuit leaks if less than half of the inspired volume returns though the expiratory
flow sensor. Prevent nuisance alarms from known circuit leaks by
setting the Circuit Leak to Audio Off.
Volume alarms must be on and the low VE limit must be set to a value
other than off.
1. Push the Main menu key.
2. Select Alarm Settings.
3. Select Circuit Leak.
4. Select the desired setting.
• ‘Circuit Leak Audio Off’ shows on the screen when Audio Off
is selected.
5. Select Go to Main Menu to return to the Main Menu, or push the
Menu key to return to the normal monitoring screen.
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Cardiac Bypass Cardiac Bypass suspends alarms for patients on cardiac bypass
when the ventilator is not mechanically ventilating. Mechanical
ventilation must be off. When mechanical ventilation is turned on,
Cardiac Bypass is turned off, the alarms are enabled, and monitoring
is available.
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3 Operation
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1
3
AB.29.104
2
1. Pmean
2. PEEP
3. Pmax
Figure 3-1 • Volume control mode waveform
1
3
2
AB.29.103
1. Pinsp
2. PEEP
3. Pmax
Figure 3-2 • Pressure mode waveform
3-8 M1116146
3 Operation
AB.82.042
To return to absorber mode, reinsert the canister into the holder and
push the canister back up and snap it into absorber position. When
the canister is in the absorber position, the exhaled gas flows through
the absorber, removing CO2.
Note Check the absorber canister to ensure it has side rails. If the canister
does not have side rails, it will not work on the EZchange Canister
holder.
AB.74p.043
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Condenser (optional)
Visually check the condenser reservoir daily. If needed, drain the
reservoir. Place a container under the reservoir. Push the drain
button to empty any water in the condenser reservoir.
AB.75p.080
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3 Operation
Connecting active To use the optional active AGSS on a system that has a flow
AGSS with a flow indicator, connect it as follows.
indicator 1. Connect the proper hose to the AGSS outlet connector on the
bottom of the AGSS underneath the breathing system. Attach the
other end to the hospital disposal system.
2. With the AGSS operating, verify that the flow indicator ball on the
flow indicator rises to the green zone, indicating adequate flow.
Note The ball in the upper red zone indicates excessively high extraction
flow. The ball in the lower red zone indicates extraction flow rate is
too low or a blocked filter.
3. Complete the tests in the “Preoperative Tests” section of this
manual.
Connecting active The active adjustable AGSS option flow rate is limited to 30 l/min with
adjustable AGSS this option.
To use the optional active AGSS installed on the system which uses
the three-liter bag as a visual indicator, connect it as follows.
1. Connect a disposal hose to the DISS connector on the needle
valve on the bottom of the AGSS (underneath). The hose should
be flexible and reinforced to help prevent kinking and crushing.
2. Attach the other end of the hose to the hospital disposal system.
3. Attach the three-liter bag to the 30-mm auxiliary 1 port on the
bottom of the AGSS.
4. Use the needle valve to adjust the flow rate to match the amount
of gas being scavenged. Use the visual indicator bag when
adjusting the flow rate. The bag should remain partially inflated.
AB.75p.110
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4 Preoperative Checkout
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Check that the equipment is not damaged and that components are
correctly attached.
Check that pipeline gas supplies are connected and cylinders are
installed.
Set the appropriate controls and alarm limits for the case.
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4 Preoperative Checkout
Set the appropriate controls and alarm limits for the case.
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5 Preoperative Tests
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5 Preoperative Tests
Pipeline test
1. Disconnect the pipeline supplies and close all cylinder valves.
2. If the pipeline and cylinder pressure gauges are not at zero:
• Connect an O2 supply.
• Set the System switch to On.
• Set the flow controls to mid range.
• Make sure that all of the gauges except for O2 go to zero.
• Disconnect the O2 supply.
• Make sure that the O2 gauge goes to zero. As the pressure
decreases, the alarms for O2 supply failure should occur.
3. Connect the pipeline supplies.
4. Verify the pipeline pressure is between 280 and 600 kPa.
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Cylinder test
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5 Preoperative Tests
Systems without O2
monitoring
WARNING Keep the Link system engaged. Adjust only the test
control for the following steps.
• Test first N2O and then O2.
• If the test control is adjusted too far, set the flow
controls to the previous position and do the step again.
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7. Adjust the flow of all gases through the full range and make sure
that the flow tube floats move smoothly.
8. Disconnect the O2 pipeline supply or close the O2 cylinder valve.
9. Make sure that:
• The low O2 supply alarm occurs.
• The N2O and the O2 flows stop. The O2 flow should stop last.
• The air flow continues.
• The gas supply alarms occur on the ventilator if the ventilator
uses O2 as the drive gas.
10. Turn all the flow controls fully clockwise for minimum flow.
11. Reconnect the O2 pipeline supplies or open the O2 cylinder valve.
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5 Preoperative Tests
WARNING Keep the Link system engaged. Adjust only the test
control for the following steps.
• Test first N2O and then O2.
• The O2 cell must be correctly calibrated.
6. Test the Link system with the flow increasing:
• Turn the N2O and the O2 flow controls fully clockwise for
minimum flow.
• Slowly turn the N2O flow control counterclockwise.
• Make sure that the O2 flow increases. The measured O2
concentration must be greater than or equal to 21% through
the full range.
7. Test the Link system with flow decreasing.
• Set the N2O flow to 9 l/min.
• Set the O2 flow to 3 l/min or higher.
• Slowly turn the O2 flow control clockwise.
• Make sure that the N2O flow decreases. The measured O2
concentration must be greater than or equal to 21% through
the full range.
8. Adjust the flow of all gases through the full range and make sure
that the flow tube floats move smoothly.
9. Disconnect the O2 pipeline supply or close the O2 cylinder valve.
10. Make sure that:
• The low O2 supply alarm occurs.
• The N2O and the O2 flows stop. The O2 flow should stop last.
• The air flow continues.
• The gas supply alarms occur on the ventilator if the ventilator
uses O2 as the drive gas.
11. Turn all the flow controls fully clockwise for minimum flow.
12. Reconnect the O2 pipeline supplies or open the O2 cylinder valve.
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Vaporizer installation
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5 Preoperative Tests
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5 Preoperative Tests
WARNING Agent mixtures from the low-pressure leak test stay in the
system. Clear the system by flowing O2 at 1 l/min for one
minute.
8. Clear the system of agent.
• Set the O2 flow to 1 l/min.
• Flow O2 for one minute.
• Turn the O2 flow control fully clockwise for minimum flow.
Positive low- 1. Connect the test device to the ACGO port with the positive-
pressure leak test pressure leak test adapter. Push the adapter into the ACGO port
throughout the test for a tight seal.
CAUTION If the needle valve is not fully open, this test can damage
the pressure gauge on the test device.
6. Open the O2 flow control and set for a total flow on the test device
of 0.4 l/min.
7. Make sure that the pressure gauge on the test device is at zero,
and make sure that all other flow controls are fully closed.
8. Close the needle valve on the test device until the gauge reads
20 kPa for BSI or 3 kPa for ISO.
9. If the flow through the test device is less than 0.35 l/min ISO or
0.3 l/min BSI, there is a low pressure leak in the system. See
“Pneumatic problems” in the “Alarms and Troubleshooting”
section.
10. Test each vaporizer. Turn on the vaporizer being tested, and set
it to 1%. Perform steps 5 through 9 of this test for each vaporizer.
11. Make sure all vaporizers are turned off.
WARNING Agent mixtures from the low-pressure leak test stay in the
system. Clear the system by flowing O2 at 1 l/min for one
minute.
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Alarm tests
1. Connect a test lung to the patient connection.
2. Set the Bag/Vent switch to Vent.
3. Set the System switch to On.
4. Push the Menu key.
5. Select Ventilation Mode - Volume Control.
6. Set the ventilator parameters:
• VT 400 ml
• Rate 12
• I:E 1:2
• Plimit 40 cmH2O
• PEEP Off
7. Set the O2 flow to the minimum flow.
8. Turn off all other gases.
9. Push the O2 flush button to fill the bellows.
10. Set the Bag/Vent switch to Bag and then to Vent. Make sure that:
• Mechanical ventilation starts.
• A subatmospheric pressure alarm does not occur.
• The ventilator shows the correct data.
• The bellows inflate and deflate during mechanical ventilation.
11. Set the O2 flow control to 5 l/min. Make sure that:
• The end expiratory pressure is approximately 0 cmH2O.
• The ventilator shows the correct data.
• The bellows inflate and deflate during mechanical ventilation.
12. Test the O2 monitor and alarms:
• Remove the O2 cell, and make sure that the cell measures
approximately 21% O2 in room air.
• Set the Low O2 alarm to 50%, and make sure that a Low O2
alarm occurs.
• Set the Low O2 alarm to 21%, and make sure that the Low O2
alarm stops.
• Put the O2 cell back into the circuit.
• Set the High O2 alarm to 50%.
• Push the O2 flush button to fill the breathing system, and
make sure that the High O2 alarm occurs.
• Set the high O2 alarm to 100%, and make sure that the alarm
stops.
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5 Preoperative Tests
• Flow 100% O2 for 2 minutes, and make sure that the O2 cell
measures 100% O2.
• Other alarms may occur.
13. Test the low minute volume alarm:
• Push the menu key.
• Select Alarm Settings.
• Set the alarm limit for low minute volume to 6 l/min.
• Make sure that the low minute volume alarm occurs.
• Set the low minute volume alarm to Off.
14. Test the apnea and low airway pressure alarms:
• Remove the test lung from the patient connection.
• Make sure that the low airway pressure and apnea alarms
occur (other alarms may occur).
15. Test the sustained airway pressure alarm:
• Set the APL valve to 70.
• Set the Bag/Vent switch to Bag.
• Occlude the patient connection and push the O2 flush button.
• Make sure that the sustained airway pressure alarm occurs
after approximately 15 seconds at the sustained pressure
limit.
WARNING Objects in the breathing system can stop gas flow to the
patient, causing injury or death. Use a test plug that is the
appropriate size so that it will not fall into the breathing
system.
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5 Preoperative Tests
WARNING Flush the system with 5 l/min of O2 for at least one minute
to remove any gas mixtures or by-products from the
system.
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6 Alarms and Troubleshooting
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Alarms
When an alarm occurs during a case, an alarm tone sounds and the
alarm message is displayed in the alarm message field. If more
alarms occur than able to show in the available alarm message area,
the alarms cycle every two seconds.
Alarms have three general causes:
• Malfunctions - Result in reduced system function or prevent
mechanical ventilation
• Patient monitoring - Are caused by high and low limit settings that
are adjusted by the user.
• Informational - Are caused by control settings or system
conditions that may change system operation.
Alarm priority is dependent on the level of risk to the patient.
A high-priority alarm tone sounds in two burst of five tones, a pause,
and then repeats. Some high-priority alarms can be silenced for 120
seconds.
Medium-priority alarm tones sound in 3 tones with a 25-second
pause, then repeat. Medium priority alarms can be silenced for 120
seconds.
Informational alarms have a single alarm tone, and the tone does not
repeat.
Silencing an alarm stops the audible tone for 120 seconds. Pushing
the Silence Alarms key when no medium or high-priority alarms
are active suspends audible alarm tones for 90 seconds.
Monochrome display Messages for high-priority alarms show in reverse font. Messages for
medium-priority alarms and informational messages show in normal
video.
Color display Messages for high-priority alarms show in white text on a red
background. Messages for medium priority alarms show in yellow text
on a gray background. Informational messages show in white text on
a gray background.
Latching alarms with Certain alarms cause a flashing box around the alarming parameter
software version 1.X area during the alarm condition.
6-2 M1116146
6 Alarms and Troubleshooting
Latching alarms with Certain alarms cause a flashing box around the alarming parameter
software version 2.X area during the alarm condition.
Some patient parameter alarms latch when the alarm condition is
corrected. When an alarm is latched on a color display, the alarm
messages shows in white text on a black background. The parameter
box stops flashing and the box is removed from the screen.
The alarm remains in this condition until it is acknowledged by
pushing the Silence Alarms key or until the alarm re-occurs. When
the alarm is acknowledged, it is removed from the screen. If an alarm
has latched and the alarm re-occurs before it is acknowledged, the
alarm will revert to an active state.
Latching alarms include: High Paw, Sustained Paw, Paw < -10 cm
H2O, Low O2, No O2 Pressure.
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List of alarms
If corrective action does not resolve the alarm, contact a
manufacturer-trained service representative.
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6 Alarms and Troubleshooting
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6 Alarms and Troubleshooting
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6 Alarms and Troubleshooting
1The sustained pressure threshold is calculated from the pressure limit setting. The sustained limit is calculated as
follows:
Volume mode - PEEP Off For Plimit less than or equal to 30 cmH2O, the sustained pressure limit is 6 cmH2O.
For Plimit between 30 and 60 cmH2O, the sustained pressure limit is 20% of Plimit.
For Plimit greater than or equal to 60 cmH2O, the sustained pressure limit is 12 cmH2O.
Volume mode - PEEP On For Plimit less than or equal to 60 cmH2O, the sustained pressure limit is 50% of Plimit
plus set PEEP.
For Plimit greater than 60 cmH2O, the sustained pressure limit is 30 cmH2O plus set
PEEP.
Pressure mode - PEEP Off For Pinsp less than or equal to 30 cmH2O, the sustained pressure limit is 6 cmH2O.
For Pinsp greater than 30 cmH2O, the sustained pressure limit is 20% of Pinsp.
Pressure mode - PEEP On For Plimit less than or equal to 60 cmH2O, the sustained pressure limit is 50% of Plimit
plus set PEEP.
For Plimit greater than 60 cmH2O, the sustained pressure limit is 30 cmH2O plus set
PEEP.
Mechanical Ventilation Off: For Plimit less than or equal to 60 cmH2O, the sustained pressure limit is 50% of Plimit.
For Plimit greater than 60 cmH2O, the sustained pressure limit is 30 cmH2O.
M1116146 6-9
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6-10 M1116146
6 Alarms and Troubleshooting
M1116146 6-11
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Electrical problems
6-12 M1116146
6 Alarms and Troubleshooting
Pneumatic problems
M1116146 6-13
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6-14 M1116146
7 User Maintenance
M1116146 7-1
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Repair policy
Do not use malfunctioning equipment. Make all necessary repairs or
have the equipment serviced by a manufacturer-trained 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 a
manufacturer-trained 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.
User maintenance
Minimum Frequency Maintenance
Daily Clean the external surfaces.
Perform 21% O2 calibration.
Check the condenser reservoir. Drain if needed.
Weekly Zero the flow sensors.
Two weeks Drain the vaporizers and discard the agent. This is not
necessary for the Tec 6 series vaporizers.
Monthly Perform 100% O2 calibration.
Lubricate all tee handle threads with Krytox or a lubricant
approved for use with 100% O2.
During cleaning and Inspect the parts for damage. Replace or repair as
setup necessary.
Annually Replace the external o-rings on the vaporizer ports.
7-2 M1116146
7 User Maintenance
M1116146 7-3
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O2 cell replacement
AB.74p.052
2. Pull the flow sensor module out of the breathing system.
3. Remove the cable connector from the O2 cell, and unscrew the
cell counterclockwise.
AB.74p.065
4. Make sure that the o-ring is on the cell. Install the replacement O2
cell. Reconnect the O2 cell cable.
AB.74p.083
5. Put the flow sensor module back into the system. Push the latch
closed to secure the flow sensor module.
7-4 M1116146
7 User Maintenance
O2 cell calibration
21% O2 cell Perform 21% O2 calibration before performing the 100% O2 cell
calibration calibration. During the calibration, the O2 data is replaced with “--” on
the screen.
1. Remove the O2 cell from the circuit:
• Pull the latch to unlock the flow sensor module.
• Pull the flow sensor module out of the breathing system.
• Remove the O2 cell by unscrewing the cell counterclockwise.
2. Push the Menu key.
3. Select Calibration.
4. Select O2 Sensor Cal - 21%.
5. Expose the cell to room air.
6. Select Start Cal to start the calibration.
7. ‘Complete’ shows on the screen upon successful calibration.
‘Reinstall Sensor’ flashes on the screen.
• Reinstall the O2 cell.
• Select Go to O2 Cal Menu.
8. If the screen shows ‘Failure,’ repeat the 21% O2 cell calibration.
9. If the calibration fails after another attempt, perform a 100% O2
cell calibration. Then try the 21% O2 cell calibration again.
10. Replace the O2 cell if repeated failures occur.
M1116146 7-5
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7-6 M1116146
7 User Maintenance
M1116146 7-7
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7-8 M1116146
8 Setup and Connections
M1116146 8-1
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w Always make sure that the pipeline supply hoses and the
breathing circuit components are not toxic and will not:
• Cause an allergic reaction in the patient.
• React with the anesthetic gases or agent to produce
dangerous by-products.
8-2 M1116146
8 Setup and Connections
M1116146 8-3
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Canister setup
6
1
AB.74p042
AB.74p043
1. Canister support pin
2. Canister handle
3. Disposable Multi Absorber canister
4. Absorbent
5. Expiratory water reservoir
6. Canister release latch
7. Reusable Multi Absorber canister
Figure 8-1 • Canister
8-4 M1116146
8 Setup and Connections
M1116146 8-5
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When to change the A gradual color change of the absorbent in the canister indicates
absorbent absorption of carbon dioxide. The color change of the absorbent is
only a rough indicator. Use carbon dioxide monitoring to determine
when to change the canister.
Discard the absorbent when it has changed color. If left standing for
several hours, absorbent may regain its original color giving a
misleading indication of activity.
Read the canister instructions completely before using the product.
Removing a canister 1. Hold the canister by the handle and push on the release latch to
unlock the canister.
AB.74p058
2. Remove the canister by tilting it downward and off the two
support pins.
8-6 M1116146
8 Setup and Connections
Removing an 1. Hold the canister by the handle and push the canister cradle
EZchange Canister release latch to unlock the canister cradle.
AB.75p088
2. Slide the canister up and out of the cradle.
AB.75p089
M1116146 8-7
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Reusable Multi 1. Turn the canister upside down and, using your thumbs, turn the
Absorber canister cover locking ring counterclockwise to unlock it.
filling
AB.74p044
2. Push up to release the seal.
3. Lift off the cover to remove it.
AB.74p046
4. Remove and properly discard the foam filters, the absorbent, and
any water in the reservoir.
8-8 M1116146
8 Setup and Connections
AB.82p001
M1116146 8-9
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Electrical connections
Outlets Labels show outlet voltage ratings and circuit breaker amp ratings.
AB.74p049
Mains inlet Arrow shows the mains power inlet and cord.
AB.74p048
8-10 M1116146
8 Setup and Connections
Serial port The system has an RS-232C electrical interface. The RS-232C
connector allows serial input/output of commands and data.
The 15-pin female D connector - Data Communications Equipment
configuration (DCE):
• Pin 1 - Monitor On/Standby
• Pin 5 - Signal ground
• Pin 6 - Receive data
• Pin 9 - Monitor On/Standby Return
• Pin 13 - Transmit data
AB.74p051
M1116146 8-11
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Pneumatic connections
CAUTION Use only medical grade gas supplies. Other types of gas
supplies may contain water, oil, or other contaminants
which could affect the operation of the pneumatic system.
The gas supplies provide gas to these optional devices through
internal connections:
• venturi suction regulator (optional).
• auxiliary O2 flowmeter (optional).
Pipeline Inlets
AB.91p040
8-12 M1116146
8 Setup and Connections
Sample gas return Connect the sample gas exhaust tube from the airway module to the
port gas return port. Exhaust gas will be directed to the scavenging
system.
AB.74p051
Suction regulator Venturi regulators use the system air or O2 supply. Vacuum
(optional) regulators must be connected to an external vacuum supply.
2
1
3
4
5
AB.74p189
AB.74p032
M1116146 8-13
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Auxiliary O2
flowmeter (optional)
AB.91p039
1. Auxiliary O2 outlet
2. Auxiliary O2 flow control
8-14 M1116146
8 Setup and Connections
M1116146 8-15
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WARNING The top of the machine has a weight limit of 34 kg (75 lb).
WARNING Fully tighten the straps. If straps are not fully tightened,
equipment can fall off the top of the machine.
Installation notes
When the system is installed, the manufacturer representative will
check the following items and change them if necessary.
8-16 M1116146
9 Cleaning and Sterilization
M1116146 9-1
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9-2 M1116146
9 Cleaning and Sterilization
2
9
10
4
8
11
AB.82.008
AB.82.045
AB.82.048
6 5
1. Bellows assembly
2. APL valve ramp
3. APL valve diaphragm
4. Breathing circuit module (O2 cell not autoclavable)
5. Absorber canister (reusable only)
6. Flow sensor cover*
7. Flow sensor module (plastic flow sensors not autoclavable)
8. Exhalation valve assembly
9. Condenser module
10. Condenser
11. EZchange Canister module
Figure 9-1 • Autoclavable assemblies
M1116146 9-3
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Special requirements • To clean the circuit O2 cell, wipe it with a damp cloth.
• If the flow sensors are plastic, see the “How to clean and disinfect
the flow sensors” procedure. Do not get the electrical connectors
wet.
• Autoclave metal flow sensors at 134°C.
• Disassemble the bellows assembly before washing. 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.
• Parts marked 134°C are autoclavable or washable by hand or
machine (mild detergent pH 7 - 10.5). Rinse and dry completely.
All parts except the O2 cell and disposable flow sensors can be
washed.
w Do not insert any objects into the flow sensor to clean the
interior surfaces. Damage to the flow sensor can occur.
Use a damp cloth to clean external surfaces if needed.
9-4 M1116146
9 Cleaning and Sterilization
w Only use cleaning solvents that are approved for use with
polycarbonates (for example, do not use CIDEX Plus).
Note Autoclavable metal flow sensors are available and can be sterilized at
134°C.
CIDEX disinfection Both the system manufacturer and the manufacturer of CIDEX
(Johnson & Johnson) have tested this procedure.
• CIDEX must be 14 day mixture, with activator vial.
• One liter of this solution cleans four flow sensors.
1. Pull the latch to unlock the flow sensor module from the breathing
system.
AB.74p052
M1116146 9-5
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1 3 2
AB.74p053
4
5. Keep the flow sensors and tubes in the solution for the required
period.
6. Submerge the flow sensor and tubes in distilled water. Again, do
not get the connector wet.
9-6 M1116146
9 Cleaning and Sterilization
9. COMPLETELY dry the flow sensor and the tubes before using
the sensor. Use a dry syringe or connect vacuum or pressure to
remove all liquid from the sensor (sensor, tubes, and connector).
CAUTION Dry for more than one minute with these precautions:
• Maximum flow 10 l/min.
• Maximum pressure ±100 cmH2O.
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. Complete the tests in the “Preoperative Tests” section.
M1116146 9-7
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AB.74p057
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.
9-8 M1116146
9 Cleaning and Sterilization
3. Push the release button (1) and gently pull the latch handle (2) to
release the breathing system.
AB.74p059
2
4. Grasp the rear handle to support the breathing system. Slide the
breathing system away from the workstation pulling only with the
latch handle.
AB.74p060
M1116146 9-9
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AB.74p063
2. Pull the latch to unlock the flow sensor module from the breathing
system.
AB.74p052
3. Pull the flow sensor module from the breathing system.
AB.74p064
4. Remove the O2 cell cable from the cell. Unscrew the O2 cell
counterclockwise and remove it. Remove the O2 cell cable from
the breathing system by pressing on the connector button while
pulling the connector out.
9-10 M1116146
9 Cleaning and Sterilization
AB.74p065
5. Remove the flow sensors from the module.
• Completely loosen the thumbscrew (1).
• Pull off the flow sensor cover (2) from the flow sensor holder.
• Remove the flow sensor connectors (3) from the flow sensor
holder.
• Pull the flow sensors (4) from the flow sensor holder.
1 3 2
AB.74p053
4
6. Rotate the breathing circuit module counterclockwise at the point
shown by the dotted line.
AB.74p066
M1116146 9-11
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AB.74p067
8. On the breathing circuit module, remove the check valve circuit
lens (1) by squeezing the latches (2) together and pulling up on
the lens. Lift out the check valve assemblies (3).
AB.74p068
2
9-12 M1116146
9 Cleaning and Sterilization
9. Press the latch (1) to unlock the ramp (2). Rotate the ramp and
remove the tabs from the slots (3) to remove the ramp.
AB.74p071
AB.74p070
10. Lift the APL valve diaphragm to remove it.
AB.74p072
M1116146 9-13
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11. Turn over the bellows base assembly, grasp the bellows manifold
with three fingers in the openings at the points shown and pull
straight away to remove it.
AB.74p073
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.
AB.74p075
9-14 M1116146
9 Cleaning and Sterilization
AA.96p051
2. Remove the bottom edge of the bellows from the rim.
AA.96p052
3. Push the latch toward the center and remove the rim.
AA.96p033
M1116146 9-15
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AA.96p034
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.
AA.96p035
9-16 M1116146
9 Cleaning and Sterilization
AA.96p036
2. Push the latch toward the center and attach the locking tabs.
AA.96p035
3. Install the pressure-relief valve.
AA.96p034
4. Push the latch toward the center and install the rim. A double-
click should be heard when the rim is installed.
AA.96p033
M1116146 9-17
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5. Attach the bottom edge of the bellows to the rim. Verify only the
bottom ring of the bellows is fitted over the rim.
AA.96p052
6. Lower the housing and turn it clockwise to lock. Verify the
housing is secure and the guidelines are facing forward.
AA.96p051
7. Perform the “Bellows assembly test” before completing the
assembly of the breathing system.
9-18 M1116146
9 Cleaning and Sterilization
WARNING Objects in the breathing system can stop gas flow to the
patient. 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.
AB.74p077
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.
M1116146 9-19
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3. Remove the plugs from the ports. Permit the bellows to fully
extend.
4. Use the appropriate test plug to seal the port shown.
AB.74p078
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.
6. If all tests pass, complete the assembly of the breathing system.
9-20 M1116146
9 Cleaning and Sterilization
AB.74p075
2. Turn over the bellows base assembly. Replace the manifold. Be
sure to insert it correctly into the ports as shown. Then, press on
the center of the manifold to snap it into place on the bellows
base assembly.
AB.74p073
M1116146 9-21
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AB.74p072
4. Insert the ramp tabs (1) into the slots (2). Rotate the ramp until it
locks at (3).
1
2
3
AB.74p071
AB.74p070
9-22 M1116146
9 Cleaning and Sterilization
AB.74p068
3
AB.74p067
M1116146 9-23
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8. Make sure the o-ring (1) is on the O2 cell. Replace the cell by
screwing it in clockwise. Connect both ends the O2 cell cable (2).
AB.74p083
AB.74p065
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. Make sure that the arrows point up.
• Attach the cover (3) to the flow sensor holder.
• Tighten the thumbscrew (4) to fasten the cover.
4 2 3
AB.74p053
9-24 M1116146
9 Cleaning and Sterilization
AB.74p064
11. Push the latch closed to lock the flow sensor module onto the
breathing system.
AB.74p052
12. This is the assembled breathing system.
AB.74p063
M1116146 9-25
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AB.74p084
2. Align the openings with the guide pins as shown.
AB.74p081
AB.74p084
9-26 M1116146
9 Cleaning and Sterilization
3. Holding the rear handle and the latch handle as shown, slide the
breathing system onto the guide pins.
AB.74p060
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. Complete the tests in the “Preoperative Tests” section.
M1116146 9-27
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2. Slide the side panel out by removing its tabs from their slots.
AB.74p086
3. Loosen the thumbscrew and remove the reservoir.
AB.74p087
9-28 M1116146
9 Cleaning and Sterilization
M1116146 9-29
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Absorber canister
The absorber canister is available in two versions: Disposable Multi
Absorber and Reusable Multi Absorber. Only the Reusable Multi
Absorber canister may be cleaned. See “Removing a canister” in the
“Setup and Connections” section.
Mechanical cleaning 1. Place the reusable canister (without filters) and the lid in the
in washer or washer- washer or washer-disinfector and clean them using the
appropriate procedures.
disinfector
2. If the washer or washer-disinfector is not used for disinfection of
equipment, the manufacturer recommends that a further high
level disinfection is conducted.
3. Ensure the canister is dry before replacing the filters and refilling
with absorbent. See “Removing a canister” in the “Setup and
Connections” section.
High level 1. Always clean the canister before high level disinfection.
disinfection 2. The canister can be steam autoclaved. Maximum recommended
temperature is 134°C (273°F).
3. Ensure the canister is dry before replacing the filters and refilling
with absorbent. See “Removing a canister” in the “Setup and
Connections” section.
9-30 M1116146
9 Cleaning and Sterilization
4
1
AB.75p080
2
M1116146 9-31
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2. Push the release latch and pull down on the unit to remove it from
the breathing system.
AB.75p081
3. For systems with the EZchange Canister only, pull the release
latches out to remove the cap.
AB.75p078
9-32 M1116146
9 Cleaning and Sterilization
AB.75p085
6. When reinstalling the reservoir, ensure the curved end of the
reservoir lines up with the curved end of the seal. Push the
reservoir into the gasket.
AB.75p084
7. Ensure the lip of the gasket fully covers all edges of the reservoir
for a leak-tight fit.
AB.75p083
M1116146 9-33
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9. When inserting the unit back onto the breathing system, set the
unit on the two support pins and push it up until it snaps into
position.
AB.75p082
9-34 M1116146
10 Parts
M1116146 10-1
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AB.82.019
2
10-2 M1116146
10 Parts
AB.82.021
5
M1116146 10-3
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Bellows
3
7
4
5
AB.82.018
10-4 M1116146
10 Parts
Absorber canister
3
1
AB.82.017
Item Description Stock number
1 Multi absorber, reusable (includes 40 pack of foam) 1407-7004-000
(does not include absorbent)
2 Cover assembly, CO2 canister 1009-8240-000
3 Foam, CO2 canister (pack of 40) 1407-3201-000
4 O-ring 1407-3204-000
5 Canister, CO2 with handle 1407-3200-000
- Multi absorber, disposable, white to violet, (pack of 6) 8003138
- Multi absorber, disposable, pink to white (pack of 6) 8003963
M1116146 10-5
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10-6 M1116146
10 Parts
AGSS
M1116146 10-7
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1
3
2 4
AB.82.044
AB.82.057
Item Description Stock number
1 EZchange Canister module, includes valve and cap 1407-7021-000
2 Valve 1407-3126-000
3 Cap 1407-3130-000
4 Condenser 1407-7024-000
- EZchange Canister module with condenser 1407-7027-000
10-8 M1116146
10 Parts
Condenser
AB.82.045
Item Description Stock number
Condenser assembly (includes module and condenser) 1407-7026-000
1 Condenser module 1407-7025-000
2 Condenser 1407-7024-000
M1116146 10-9
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10-10 M1116146
11 Specifications and Theory of
Operation
Note All specifications are nominal and subject to change without notice.
Note All displayed values are shown at ambient temperature and pressure
dry.
M1116146 11-1
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AB.74.123
11-2 M1116146
11 Specifications and Theory of Operation
1. Auxiliary O2, 0-10 l/min (optional) 36. Scavenging pressure relief valve, 1.0 kPa (10
2. O2 flush cmH2O)
3. 241 kPa (35 psi) second O2 regulator 37. 0-10 l/min drive gas, 0-10 l/min patient
4. Gauge and fresh gas, 0-20 l/min total typical flow
5. O2 P-Line 38. 200 mL reservoir
6. O2 cylinder (optional) 39. Control bleed approximately
7. Air P-Line (optional) 1.0 l/min at 0.29 kPa (3.0 cmH2O) if
8. Maximum 3 cylinders continuous (rate dependent)
9. Air cylinder (optional) 40. Pressure switch
10. N2O P-Line (optional, standard U.S. variant) 41. ACGO selector valve
11. 758 kPa (110 psi) relief 42. 22 mm port (ACGO)
12. N2O cylinder (optional) 43. O2 sensor
13. Cylinder supply 44. Inspiratory flow sensor
Pipeline supply 45. Absorber
14. Ventilator drive gas select 46. Drain
15. Venturi 47. Negative pressure relief valve (-14 cmH2O)
16. System switch 48. Optional connection
17. O2 secondary regulator 207 kPa (30 psi) 49. Bag/Vent switch
18. Link 25 50. Bag
19. Flowmeter module (single flow tubes 51. APL valve
optional) 52. Gas monitor
20. 0 - 120 l/min flow 53. Expiratory flow sensor
21. Air (optional) 54. Inspiratory flow transducer
22. Selectatec manifold 55. Expiratory flow transducer
23. 37.9 kPa (5.5 psi) pressure relief valve 56. Ventilator monitoring board
24. Vaporizer 57. Pneumatic engine board
25. N2O slave regulator (optional) 58. Patient
26. Regulator 172 kPa (25 psi) at 15 l/min 59. 30 mm male - to disposal system
27. Inspiratory flow control valve 60. 0.05 kPa (0.5 cmH2O) entrainment
28. PEEP safety valve 61. Passive gas scavenging interface
29. Supply pressure switch 62. Injector based scavenge
30. Proportional PEEP valve 63. Filter
31. Mechanical overpressure valve, 10.8 kPa 64. High or low flow restrictor
(110 cmH2O) 65. Flow indicator
32. Free breathing check valve 66. To disposal system
33. Room Air 67. Active gas scavenging interface
34. Popoff valve (4 cmH2O) 68. EZchange Canister
35. Exhalation valve 0.20 kPa (2.0 cmH2O bias) 69. Condenser
M1116146 11-3
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AB.74.122
11-4 M1116146
11 Specifications and Theory of Operation
1. Auxiliary O2, 0-10 l/min (optional) 36. Scavenging pressure relief valve, 1.0 kPa (10
2. O2 flush cmH2O)
3. 241 kPa (35 psi) second O2 regulator 37. 0-10 l/min drive gas, 0-10 l/min patient
4. Gauge and fresh gas, 0-20 l/min total typical flow
5. O2 P-Line 38. 200 mL reservoir
6. O2 cylinder (optional) 39. Control bleed approximately
7. Air P-Line (optional) 1.0 l/min at 0.29 kPa (3.0 cmH2O) if
8. Maximum 3 cylinders continuous (rate dependent)
9. Air cylinder (optional) 40. Pressure switch
10. N2O P-Line (optional, standard U.S. variant) 41. ACGO selector valve
11. 758 kPa (110 psi) relief 42. 22 mm port (ACGO)
12. N2O cylinder (optional) 43. O2 sensor
13. Cylinder supply 44. Flow port adapter
Pipeline supply 45. Absorber
14. Ventilator drive gas select 46. Drain
15. Venturi 47. Negative pressure relief valve (-14 cmH2O)
16. System switch 48. Optional connection
17. O2 secondary regulator 207 kPa (30 psi) 49. Bag/Vent switch
18. Link 25 50. Bag
19. Flowmeter module (single flow tubes 51. APL valve
optional) 52. Gas monitor
20. 0 - 120 l/min flow 53. Flow port adapter
21. Air (optional) 54. Pneumatic engine board
22. Selectatec manifold 55. Patient
23. 37.9 kPa (5.5 psi) pressure relief valve 56. 30 mm male - to disposal system
24. Vaporizer 57. 0.05 kPa (0.5 cmH2O) entrainment
25. N2O slave regulator (optional) 58. Passive gas scavenging interface
26. Regulator 172 kPa (25 psi) at 15 l/min 59. Injector based scavenge
27. Inspiratory flow control valve 60. Filter
28. PEEP safety valve 61. High or low flow restrictor
29. Supply pressure switch 62. Flow indicator
30. Proportional PEEP valve 63. To disposal system
31. Mechanical overpressure valve, 10.8 kPa 64. Active gas scavenging interface
(110 cmH2O) 65. EZchange Canister
32. Free breathing check valve 66. Condenser
33. Room Air
34. Popoff valve (4 cmH2O)
35. Exhalation valve 0.20 kPa (2.0 cmH2O bias)
M1116146 11-5
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Gas supplies Pressurized gas supplies enter the system through a pipeline or
cylinder connection. All connections have indexed fittings, filters, and
check 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.
• Disconnect the pipeline supplies when the system is not in use.
Air and N2O A balance regulator controls the flow of N2O to the flow control valve.
Oxygen pressure at a control port adjusts the output of the regulator.
This stops flow during an O2 supply failure and ensures that the
hypoxic gas pressures decrease with the O2 supply pressure.
Changes in O2 pressure do not affect Air.
A chain linkage on the N2O and O2 flow controls helps keep the O2
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. A secondary regulator supplies the air flow
control valve. Because there is no balance regulator, air flow
continues at the set rate during an O2 supply failure.
11-6 M1116146
11 Specifications and Theory of Operation
Mixed gas 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.
EZchange Canister When activated, this mode permits continued ventilation and
rebreathing of exhaled gases without any gas passing through the
absorbent.
Condenser The condenser removes water in the system that is produced from
the reaction of CO2 gas with the absorbent during low flow anesthesia
(fresh gas flows less than 1.5 l/min). The condenser is connected
between the outlet of the absorber canister and the inlet of the circuit
module. Moisture in the gas is condensed into water droplets, which
run into the condenser’s reservoir.
Pneumatic specifications
Gas supplies
Pipeline gases O2, Air, N2O
Cylinder gases O2, Air, N2O (maximum: 2 cylinders of each
gas); 3 cylinders total; 1 cylinder maximum on
pendant model
Cylinder connections Pin indexed (all gases); nut and gland DIN-477
(O2, N2O, Air); large cylinder kit available for
O2 and N2O
Primary regulator output Pin indexed: The primary regulator is set to
pressure pressure less than 345 kPa (50 psi).
DIN-477: The primary regulator is set to
pressure less than 414kPa (60 psi).
Pressure-relief valve Approximately 758 (110 psi)
Pipeline connections DISS - Male; DISS-Female; AS 4059
(filtered) (Australian); S90-116 (French Air Liquide);
BSPP 3/8 (Scandinavian) or NIST (ISO 5359).
All fittings available for O2, Air, and N2O.
Pressure displays Color coded gauges
Pipeline inlet pressure 280-600 kPa (41-87 psi)
ACGO Port relief Valve limits fresh gas pressure to 138 kPa (20 psi) at the flush flow.
M1116146 11-7
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AB.43.163
11-8 M1116146
11 Specifications and Theory of Operation
M1116146 11-9
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Electrical power
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
Type Three conductor power supply cord (medical grade where
required).
WARNING Unplug the system power cord to run the system on the
battery power if the integrity of the protective earth
conductor is in doubt.
11-10 M1116146
11 Specifications and Theory of Operation
Battery information The system is not a portable unit; a sealed lead acid battery supplies
backup power in the event of a power failure.
• Capacity to operate for 90 minutes under typical operating
conditions; 30 minutes under extreme conditions.
• The system functions to specifications through the translation to
battery power.
• Long float charge life.
• Battery pack has an auto-resetable thermal fuse.
• Battery terminals and connecting wires are protected against
short circuits.
Only trained service representatives are to replace the battery.
Batteries must be disposed of in accordance with applicable
regulatory requirements in effect at the time and place of disposal.
Contact a trained service representative to disconnect the battery if
the equipment is not likely to be used for an extended time.
Flow specifications
O2 pressure
O2 supply failure alarm 193 to 221 kPa (28 to 32 psi)
N2O shutoff 3.5 kPa (0.5 psi)
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11-12 M1116146
11 Specifications and Theory of Operation
Gas scavenging
All scavenging
Positive pressure relief 10 cmH2O
Passive scavenging
Negative pressure relief 0.3 cmH2O
Outlet connector 30 mm male taper ISO
Active scavenging
Outlet
Disposal system type Flow range Pressure
connector*
Adjustable DISS EVAC Up to 30 l/min not applicable
High flow, low vacuum BS6834 50 to 80 l/min 1.6 kPa
(12 inHg)
Low flow, high vacuum DISS EVAC 36 +/- 4 l/min 305 mmHg
(12 inHg)
minimum vacuum
*Other market-specific connectors may be available.
Particle filter at the outlet has a pore size of 225 microns. All flow data uses a new
filter.
M1116146 11-13
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Physical specifications
All specifications are approximate values and can change without
notice.
Environmental requirements
11-14 M1116146
11 Specifications and Theory of Operation
M1116146 11-15
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Ventilator theory
The ventilator pneumatics are located in the rear of the breathing
system. A precision flow valve controls the amount of flow provided to
the patient, while a second, smaller flow valve is used to control the
exhalation valve sealing pressure.
Breaths are provided to the patient by sealing the exhalation valve
and providing flow to the breathing circuit. During exhalation, the
sealing pressure on the exhalation valve is released and flow
exhausts from the breathing circuit. Electronic control of PEEP is
achieved by maintaining a small amount of sealing pressure on the
exhalation valve.
Volume measurements come from two flow sensors in the flow
sensor module. Two tubes from each sensor connect to a transducer.
The transducer measures the pressure change across each sensor,
which changes with the flow. A third pressure transducer measures
the airway pressure at the outlet of the breathing circuit. Safety
redundant valves are used to limit the airway pressure, based on the
user’s Plimit setting.
With circle circuit modules, volume monitoring uses the rear
(expiratory) flow sensor. The ventilator uses the other flow sensor to
adjust the tidal volumes being delivered into the patient circuit tubing
for changes in fresh gas flow, small leaks and gas compression within
the breathing circuit.
There is no adjustment for compression in the patient circuit. If
necessary, add the compression loss to the tidal volume setting
(Volume Control mode). The average volume changes due to
compression in the breathing circuit is small (0.5 to 1.25 ml/cmH2O).
Note that the 7100 Ventilator provides a small amount of bleed flow
through a pneumatic resistor to control the exhalation valve. At high
airway pressures this can cause a slight hiss during inspiration.
11-16 M1116146
11 Specifications and Theory of Operation
Volume control
1
2
AB.91.038
4
1. Paw
2. Plimit
3. PEEP
4. Time
Figure 11-3 • Volume control diagram
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Pressure mode
1
2
AB.91.039
4
5
1. Paw
2. Plimit
3. Pinsp
4. PEEP
5. Time
Pressure mode generates a pressure plateau linked to the Pinspired
setting. While observing the monitored Pmax failure, the user adjusts
Pinspired until Pmax is reached. The ventilator delivers a constant 30
l/min (inspiration) during this mode. Pinspired, Rate, and I:E settings
are used to create the breathing profile. PEEP is available and is
additive.
Pressure mode settings:
• Pinsp (control pressure)
• Rate
• I:E
• Plimit (pressure limit)
• PEEP
11-18 M1116146
11 Specifications and Theory of Operation
Pneumatics
Gas source Anesthesia system
Gas composition Medical air or O2
Nominal supply pressure 350 kPa (50 psi)
Pressure range at inlet 240 to 700 kPa (35 to 102 psi)
Flow valve range 2 to 70 l/min at 240 kPa (35 psi)
Fresh gas
compensation
Flow compensation range 150 ml/min to 15 l/min
Gas composition O2, N2O, Air, anesthetic agents
Pressure
Patient airway pressure range -20 to +120 cmH2O
Patient airway display range -9 to 99 cmH2O
High pressure alarm set range 12 to 99 cmH2O, 1 cm increment
Sustained pressure alarm range 6 to 30 cmH2O, 1 cm increment
Volume
Tidal volume display range 5 to 9999 ml, 1 ml resolution
Setting range 45 to 1500 ml
Minute volume 0.0 to 99.9 liters
Breath rate 4 to 65 bpm, 1 bpm resolution
Volume sensor type Variable flow orifice
Oxygen
Display range 5 to 110% O2
Display resolution 1% increments
Sensor type: Galvanic fuel cell
Measurement range 0 to 100% O2
Measurement accuracy ± 3% of full scale
Cell response time 35 seconds, 10 to 90%
Response time of cell and adapters is
measured using the test method
described in ISO 7767 (1997)
Low O2 alarm range 18% to 100%
High O2 alarm setting 21% to 100%
Low O2 limit may not be set above
High O2 limit. High O2 limit may not be
set below the Low O2 limit.
Expected cell life Four months of shelf life (23°C room
air) and one year of normal operation.
M1116146 11-19
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Delivery accuracy
Volume control mode Less than 200 ml tidal volume -
accuracy better than ±10% of set VT.
75 to 200 ml tidal volume - accuracy
better than ±20 ml
Less than 75 ml tidal volume -
accuracy better than ±15 ml
VT comp off Accuracy better than ±15% of set VT
Pressure mode Inspiratory pressure - accuracy ±2.0
cmH2O (repeatability only)
PEEP - accuracy ±2.0 cmH2O
(repeatability only)
Monitoring accuracy
Volume control Greater than 200 ml tidal volume -
accuracy better than ±10% of VT
75 to 200 ml tidal volume - accuracy
better than ±20 ml
Less than 75 ml tidal volume -
accuracy better than ±15 ml
Pressure mode Accuracy better than ±2.0 cmH2O or
±5% of reading whichever is greater.
Note: Gas composition errors may be in addition to the above normalized
accuracy. When adding errors, positive errors can have the effect of nulling out
negative errors.
Note: Use of anesthetic agent could affect the errors by approximately -0.95%/%
volume agent.
Oxygen monitor accuracy
When subjected to gas mixtures containing the following concentrations of
gases, the oxygen monitor has been tested to be within ±5% of the actual gas
concentration. Gas mixtures other than the ones listed below may result in an
accuracy of the oxygen monitor outside of the ±5% V/V.
Gas At concentration:
Helium 50%
Carbon dioxide 5%
Nitrous oxide 80%
Halothane 4%
Enflurane 5%
Isoflurane 5%
Sevoflurane 5%
Desflurane 15%
11-20 M1116146
11 Specifications and Theory of Operation
AB.74.027
Figure 11-4 • Gas composition related errors
M1116146 11-21
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Guidance and The system is suitable for use in the specified electromagnetic
manufacturer’s environment. The customer and/or the user of the system should
assure that is used in an electromagnetic environment as described
declaration - below.
electromagnetic
emissions
Emissions test Compliance Electromagnetic environment guidance
RF emissions Group 1 The system uses RF energy only for its internal function. Therefore, its RF emissions are
CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions Class B The system is suitable for use in all establishments, including domestic establishments
CISPR 11 and those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic Class A
emissions
IEC 61000-3-2
Voltage Complies
fluctuations/flicker
emissions
IEC 61000-3-3
11-22 M1116146
11 Specifications and Theory of Operation
Guidance and The system is suitable for use in the specified electromagnetic
manufacturer’s environment. The customer and/or the user of the system should
assure that it is used in an electromagnetic environment as described
declaration - below.
electromagnetic
immunity
Radiated immunity
Electromagnetic
environment guidance
Immunity test IEC 60601-1-2 test Level Compliance level
Recommended separation
distance
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.
Conducted RF 3 Vrms 3 Vrms (V1) D=3.5√P
IEC 61000-4-6 150 kHz to 80 MHz outside
ISM bands
10 Vrms 10 Vrms (V2) D=12√P
150 kHz to 80 MHz in ISM
bands
Radiated RF 10 V/m 10 V/m (E1) D=1.2√P 80 mHz to 800 mHz
IEC 61000-4-6
80 MHz to 2.5 GHz D=3.5√P 800 mHz to 2.5 GHz
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.
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 re-
orienting 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.
M1116146 11-23
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11-24 M1116146
11 Specifications and Theory of Operation
Electrical safety
IEC-60601-1 Classification
This system is classified as follows.
• Class I Equipment.
• Type B Equipment.
• Ordinary Equipment.
• Not for use with flammable anesthetics.
• Continuous operation.
M1116146 11-25
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11-26 M1116146
Index
M1116146 I-1
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I-2 M1116146
Warranty
This Product is sold by the manufacturer under the warranties set
forth in the following paragraphs. Such warranties are extended only
with respect to the purchase of this Product directly from the
manufacturer or the manufacturer’s Authorized Dealers as new
merchandise and are extended to the Buyer thereof, other than for
the purpose of resale.
For a period of twelve (12) months from the date of original delivery to
Buyer or to Buyer’s order, but in no event for a period of more than
two years from the date of original delivery by the manufacturer to a
manufacturer Authorized Dealer, this Product, other than its
expendable parts, is warranted against functional defects in materials
and workmanship and to conform to the description of the Product
contained in this User’s Reference manual and accompanying labels
and/or inserts, provided that the same is properly operated under the
conditions of normal use, that regular periodic maintenance and
service is performed and that replacements and repairs are made in
accordance with the instructions provided. This same warranty is
made for a period of thirty (30) days with respect to expendable parts.
The foregoing warranties shall not apply if the Product has been
repaired other than by the manufacturer or in accordance with written
instructions provided by the manufacturer, or altered by anyone other
than the manufacturer, or if the Product has been subject to abuse,
misuse, negligence, or accident.
The manufacturer’s sole and exclusive obligation and Buyer’s sole
and exclusive remedy under the above warranties is limited to
repairing or replacing, free of charge, at the manufacturer’s option, a
Product, which is telephonically reported to the nearest manufacturer
Customer Service Center and which, if so advised by the
manufacturer, is thereafter returned with a statement of the observed
deficiency, not later than seven (7) days after the expiration date of
the applicable warranty, to the manufacturer Customer Service and
Distribution Center during normal business hours, transportation
charges prepaid, and which, upon the manufacturer’s examination, is
found not to conform with above warranties. The manufacturer shall
not be otherwise liable for any damages including but not limited to
incidental damages, consequential damages, or special damages.
There are no express or implied warranties which extend beyond the
warranties hereinabove set forth. The manufacturer makes no
warranty of merchantability or fitness for a particular purpose with
respect to the product or parts thereof.
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