Avea Service - 3 PDF
Avea Service - 3 PDF
Removal
1. Referring to the instructions in this chapter, remove the following components:
• UIM and the top cover.
• Exhalation filter & watertrap.
2. Remove the third (and last) screw from the exhalation assembly cover of the left hand corner
of the AVEA. Remove the cover.
3. Pull the locking shroud of the connector back and disconnect the sensor from the chassis.
4. Grasp the rubber elbow and slide it towards you and remove.
5. Gently remove the exhalation flow sensor by pulling straight towards you.
6. Push in the locking tab on the exhalation valve body and twist the body counterclockwise to
remove.
7. Remove the silicon diaphragm from the exhalation valve assembly.
8. Disconnect the two wires from the wiring harness.
9. Carefully cut the cable tie retaining the exhalation valve.
10. Remove the (2) KEPS nuts and Phillips screws from the top and bottom of the exhalation
valve assembly and the bracket. (recommend using a 3/8 box or open-end wrench for this
task)
11. Remove the exhalation valve by sliding it out of the brackets and slightly spreading the mount
so as not to damage the wires..
CAUTION
Ensure that you do not damage the small wires when removing the exhalation valve.
Installation
1. Position the exhalation assembly onto the chassis by lining up the screw holes on the front
panel and sliding it into the exhalation valve bracket.
CAUTION
Ensure that you do not damage the small wires when installing the exhalation valve.
2. Install the (2) Phillips screws through the top and bottom of the exhalation valve assembly and
the bracket and secure with (2) KEPS nuts.
3. Connect the cables to the wiring harness.
4. 4. Leaving room for the gas delivery engine, run the wire harness under the tab in the
exhalation valve assembly bracket.
5. Insert the silicon diaphragm into the exhalation valve body by seating it into the lip with the
point out.
6. Install the exhalation valve body; line up the flange on the valve body with the tabs on the
receptacle and twist clockwise until secure.
7. Install the exhalation flow sensor by sliding it into the gasket with the tubing facing up and
ensure the tubing is under the retaining notch.
8. Slide the blue rubber elbow sensor boot in by lining it up with the grooves.
9. Attach the connector to the chassis by pulling back the plastic sleeve and pushing it into place.
10. Push the locking clip back to secure the sensor.
11. Reinstall the exhalation assembly cover using 2 of the 3 screws (side and bottom front).
12. Referring to the instructions in this chapter, re-install the following components:
• UIM and the top cover.
Removal
1. Remove the (4) Phillip #1screws holding the shield.
2. Remove (2) KEP nuts at the base.
3. Disconnect the 3-pin and 2-pin connectors and label.
4. Remove (2) 11/32 KEP nuts on the back of the front panel shielding the flow sensor PCB.
5. Remove (2) Phillips #2 screws from the front panel.
Removal
1. Referring to the instructions in this chapter, remove the following components:
• UIM and the top cover.
2. Remove attachment screws, disconnect and lift off the microswitch.
Installation
1. Reattach using screws provided. Re-connect the wiring.
2. Referring to the instructions in this chapter, install the following components:
• UIM and the top cover.
EMI Shield
Removal
1. Referring to the instructions in this chapter, remove the following components:
• UIM and the top cover.
2. Remove the protective box cover by removing the (1) Phillips screw.
3. Remove the EMI shield protective box by removing the (2) KEPS nuts that secure it.
Installation
1. Replace the EMI shield protective box and secure it with (2) KEPS nuts.
2. Replace the protective box cover and secure with (1) Phillips screw.
3. Referring to the instructions in this chapter, install the following components:
• UIM and the top cover.
Removal
1. Referring to the instructions in this chapter, remove the following components:
• UIM and the top cover.
• Ventilator assembly (from the base).
• Gas delivery engine assembly.
2. Remove the flow sensor cover by removing the (3) SEMS screws.
3. Remove the (2) KEPS nuts, the EMI shield, brass bracket, and ribbon cable.
4. Turn the unit over and support it on 2x4 pieces of wood so as not to put the entire weight of the unit on the 4
standoffs.
5. Remove (7) Phillips screws; (2) from the lower back panel and (5) from the bottom panel.
6. Remove bottom panel
7. Remove (2) screws from the top of the front panel.
8. Loosen (2) KEPS nuts from the bottom that hold the front panel.
9. Pull off the front panel.
10. Loosen (1) KEPS nut from the bottom and (4) screws on the front panel.
11. Remove the blue tubing from the nebulizer to the front panel.
12. Gently pull the blue ribbon cable through the narrow slot at the top center of the front interface panel and the
rest of the wiring through the recessed compartment in the chassis.
Installation
1. Gently feed the blue ribbon cable through the narrow slot at the top center of the front panel and
the wiring through the recessed compartment in the chassis.
2. Attach the blue tubing from the nebulizer to the front panel.
Removal
1. Referring to the instructions in this chapter, remove the following:
• UIM and the top cover.
• Gas delivery engine assembly.
• Fan assembly connections
• Scroll compressor connections.
• Front interface panel connections.
2. Disconnect the wiring to the power supply board and the battery.
3. Remove the spiral wrap to the alarm connector, and feed the wires out of the hole in the chassis
one connector at a time.
4. Remove the (2) Phillips screws and flat washers from the chassis.
5. Remove the Phillips screws on the board bracket and remove the board from the bracket.
Installation
1. Mount the driver transition board into the first half of the bracket; place the board on the three
round threaded studs with the cables spread outward, and secure the (3) Phillips screws.
2. Place the flat side of the other half of the bracket on the two mounting pins and slide it down.
3. Install (1) Phillips screw from the front to the rear of the bracket and leave finger tight.
4. Align the bracket over the two threaded holes in the chassis and install (2) Phillips screws using flat
washers.
5. Align the driver transition board; slide in the gas delivery engine assembly, carefully connect it to
the driver transition board, adjusting the bracket as necessary.
6. Once the alignment is complete, secure the driver transition board and the height adjustment pin
on the bracket, and then remove the gas delivery engine assembly.
7. Feed the top wiring harness through the small hole in the front right of the chassis, one connector
at a time.
8. Install the spiral wrap, leaving the alarm connector hanging off to the side.
9. Make the appropriate connections to the power supply board and to the battery.
10. Referring to the instructions in this chapter, install the following components:
• Front interface panel.
• Scroll compressor.
• Fan assembly.
• Gas delivery engine assembly.
• UIM and the top cover.
Installation
1. Position the speaker onto the two threaded studs and secure with (2) 11/32 KEPS nuts.
2. Connect the wire to the driver transition board.
3. Referring to the instructions in this chapter, install the following components:
• Bottom cover.
• Front panel.
• Ventilator assembly onto the base.
• UIM and the top cover.
Removal
1. Referring to the instructions in this chapter, remove the following components:
• UIM and the top cover.
• Ventilator assembly from base.
• Bottom cover.
2. Cut tie wraps on the nebulizer booster.
3. Remove wire harness.
4. Disconnect the two solenoid connectors to the driver transition board.
5. Disconnect the tubing from the accumulator.
6. 6 Remove the (3) KEPS nuts that secure the nebulizer; (2) on the left side and (1) on the right,
Maneuver the nebulizer out from behind the accumulator.
7. Disconnect blue tube just in front of the solenoid.
Installation
1. Turn the unit over and support it on 2x4 pieces of wood so as not to put the entire weight of the unit
on the 4 standoffs.
2. Position the nebulizer onto the three threaded studs and using ong needle-nosed pliers, secure
with (3) 11/32 KEPS nuts; (2) on the left side and (1) on the right.
3. Connect the tubing from the accumulator to the left side of the nebulizer.
4. Feed the tubing from the gas delivery engine through the U-shaped notch on the left side of the
chassy and connect it to the nebulizer.
5. Connect the two solenoid connectors from the driver transition board.
6. Referring to the instructions in this chapter, install the following components:
• Bottom cover.
• Gas delivery engine assembly.
• UIM and the top cover.
Removal
1. Referring to the instructions in this chapter, remove the following components:
• UIM and the top cover.
• Gas delivery engine assembly.
• Ventilator assembly from base.
• Bottom cover.
• Front panel.
• Speaker.
• Nebulizer.
2. Disconnect the solenoid cable from the driver transition board.
3. Disconnect the tubing from the solenoid drain panel.
4. Remove the (4) 11/32 KEPS nuts; one from each corner.
5. Remove the accumulator, twisting to carefully remove the gas delivery engine supply tubing out of
the slot on the bottom left of the chassis.
Installation
1. Turn the unit over and support it on 2x4 pieces of wood so as not to put the entire weight of the unit
on the 4 standoffs.
2. Rotate the supply tube to the gas delivery engine into the slot on the bottom left of the chassis.
3. Position the accumulator by sliding the two notches over the threaded studs at the bottom and
seating the top onto the two mounting studs.
4. Secure the accumulator with (4) 11/32 KEPS nuts, one on each corner.
5. Connect the tubing to the solenoid drain panel.
6. Connect the solenoid cable to the driver transition board.
7. Referring to the instructions in this chapter, install the following components:
• Speaker.
• Bottom cover.
• Front panel.
• Nebulizer.
• Ventilator assembly onto the base.
• Gas delivery engine assembly.
• UIM and the top cover.
Set up
1 Plug the AVEA into a suitable AC Power source and connect an adult patient circuit and an
adult test lung.
NOTE
Manufacturer recommends the use of a nondisposable adult patient circuit and test lung in testing VIASYS ventilatory
equipment:.
Figure 5.1
4 Press the EST touch screen icon to highlight. (A message will appear instructing you to remove
the patient and block the patient circuit wye.) Remove the test lung and plug the wye connector.
Figure 5.2
5 After confirming that the patient has been disconnected and the circuit wye blocked press the
Continue (Cont) button. (The ventilator will perform the EST and display a countdown clock.)
Figure 5.3
Figure 5.4
After each test is complete the ventilator will display a “Passed” or “Failed” message next to the
corresponding test.
Once the test is complete press the continue button to return to the set up screen.
Note
If you do not connect the ventilator to an oxygen supply, the O2 Sensor Calibration will immediately fail.
CAUTION
Although failure of any of the above tests will not prevent the ventilator from functioning, it should be checked to make
sure it is operating correctly before use on a patient.
Note
To ensure proper calibration of the oxygen sensor, you should always perform an EST prior to conducting Manual Alarms Testing.
WARNING
User Verification Testing should always be done off patient.
CAUTION
Following each alarm verification test, ensure that the alarm limits are reset to the recommended levels shown in this
chapter before proceeding to the next test.
Table 5.1: Test Setup Requirements
Adult Setting Pediatric Setting Neonate Setting
To conduct Manual Alarms Testing on the AVEA ventilator using default settings, complete the following
steps (A table describing the default settings for Adult, Pediatric and Neonatal patient sizes is included in
this manual).
Table 5.2: Ventilation Setup
1. Make the appropriate connections for air and O2 gas supply. Connect the power cord to an
appropriate AC outlet. Attach an appropriate size patient circuit and test lung to the ventilator.
2. Power up the ventilator and select “NEW PATIENT” when the Patient Select Screen appears.
Accept this selection by pressing “PATIENT ACCEPT”. This will enable default settings for the
Manual Alarms Test.
3. Select the appropriate patient size for your test (Adult, Pediatric or Neonate) from the Patient Size
Select Screen. Accept this selection by pressing “SIZE ACCEPT”. Set Humidifier Active off.
4. Make any desired changes or entries to the Ventilation Setup Screen and accept these by pressing
“SETUP ACCEPT”.
5. Press Alarm Limits button on the upper right of the user interface.
6. Verify that no alarms are active and clear the alarm indicator by pressing the alarm reset button on
the upper right of the user interface.
7. Set the % O2 control to 100%. Disconnect the Oxygen sensor from the back panel of the ventilator
and verify that the Low O2 alarm activates. Return the O2 control setting to 21% with the sensor still
disconnected from the rear panel. Remove sensor from back panel. Provide blow-by to the sensor
from an external oxygen flow meter. Verify that the High O2 alarm activates. Return the % O2 to
21%, reconnect the Oxygen sensor to the back panel. Clear all alarm messages by pressing the
alarm reset button.
8. Set PEEP to 0. Set Low PEEP alarm to 0. Disconnect the patient wye from the test lung. Verify
that the Low Ppeak alarm activates, followed by the Circuit Disconnect alarm. This second alarm
should activate after the default setting of 20 seconds for the apnea interval has elapsed.
Reconnect the test lung to the circuit clear the alarm by pressing the reset button.
9. Disconnect the AC power cord from the wall outlet. Verify that the Loss of AC alarm activates.
Reconnect the AC power cord. Clear the alarm by pressing the reset button.
10. Occlude the exhalation exhaust port. Verify that the High Ppeak alarm activates, followed 5
seconds later by the activation of the High Ppeak, Sust. alarm.
11. Set the control setting for rate to 1 bpm. Verify that Apnea Interval alarm activates after the default
setting of 20 seconds. Return the control setting to its default value and clear the alarm by pressing
the reset button.
12. Set the Low PEEP alarm setting to a value above the default control setting for PEEP on your
ventilator. Verify that the Low PEEP alarm activates. Return the alarm setting to its default value
and clear the alarm by pressing the reset button.
13. 13.Set the High Ppeak alarm setting to a value below the measured peak pressure or in neonatal
ventilation, the default control setting for Inspiratory Pressure on your ventilator. Verify that the
High Ppeak alarm activates. Return the alarm setting to its default value and clear the alarm by
pressing the reset button.
14. 14.Set the Low Ve alarm setting to a value above the measured Ve on your ventilator. Verify that
the Low Ve alarm activates. Return the alarm setting to its default value and clear the alarm by
pressing the reset button.
15. 15.Set the High Ve alarm setting to a value below the measured Ve on your ventilator. Verify that
the High Ve alarm activates. Return the alarm setting to its default value and clear the alarm by
pressing the reset button.
16. Set the High Vt alarm setting to a value below the set Vt on your ventilator. Verify that the High Vt
alarm activates. Return the alarm setting to its default value and clear the alarm by pressing the
reset button.
17. Set the Low Vt alarm setting to a value above the set Vt on your ventilator. Verify that the Low Vt
alarm activates. Return the alarm setting to its default value and clear the alarm by pressing the
reset button.
18. 18.Set the High Rate alarm to a value below the default control setting for rate on your ventilator.
Verify that the alarm activates. Return the alarm to its default setting and clear the alarm by
pressing the reset button.
NOTE
Repeat steps 11 through 17 with a pediatric circuit and test lung.
Repeat steps 11 through 17 with an infant circuit and test lung.
CAUTION
Although failure of any of the above tests will not prevent the ventilator from functioning, it should be checked to make
sure it is operating correctly before use on a patient.
19. Screens and Main buttons - Press the Screens button and the Screen Select screen should appear.
Press Monitor, the Monitor screen should display. Press Main and the screen should go back to
Main screen.
Note
All equipment is as stated or equivalent .
Test Procedure
1. Attach the adult patient circuit and test lung to the test ventilator. Connect to a regulated wall air supply
as indicated above.
2. Turn on the ventilator and set parameters shown in the table below.
3. Turn off the wall air supply.
4. Verify that the compressor activates
5. Verify that the “scroll” symbol is displayed in the bottom right corner of the UIM
6. Verify ventilator continues to ventilate and no alarms are activated
7. Allow ventilator to continue to cycle using the compressor for approximately two minutes.
8. Disconnect the expiratory limb of circuit. The Circuit Disconnect and Low Ppeak alarms should activate.
NOTE:
Leave expiratory limb disconnected for remainder of test
Control Setting
Tidal Volume (Vt) 2.0L,
Rate 19 bpm,
Peak Flow 150 L/MIN.
10. Change the scale on Flow waveform graphic display to 300 L/min.
11. Allow ventilator to cycle for approximately two minutes then Press the Alarm Reset membrane button.
12. Verify that no alarms except for Circuit Disconnect and Low Ppeak are active
13. Press the Freeze button.
14. Verify the flow at the end of inspiration is between 67 and 83 L/min.
15. Re-connect wall air supply.
16. Verify compressor shuts off and ventilation continues uninterrupted using the wall air supply.
I here by certify that the product with the above Serial Number has passed all operational specification
and is certified for clinical use (The unit must be signed off before returning to clinical use.)
Signature: _________________________________ Date: _______________
Please complete this check sheet and fax to Regulatory Affairs at (760) 778-7301
Or mail to: Regulatory Affairs Department VIASYS Healthcare Critical care Division 1100 Bird Center Dr.
Palm Springs, Ca. 92262
Figure 5.5
1. Plug unit in, turn power on and adjust settings as follows:
a. Mode: Pediatric, Volume A/C
b. Settings: 40 BPM, Volume 200ml, Peak Flow 30 L/min, PEEP 5cmH2O, Flow Trigger 20
L/min, and FIO2 21%.
c. Advanced Settings: Vsync off, Waveform Square, Bias Flow 3 L/min, and Pressure Trigger
20cmH2O.
2. Verify that the Power Indicator “EXT” is illuminated and the Power Status is on AC (~).
3. Verify battery indicator LED’s function and progressively charge from Red to Yellow to Green.
4. Disconnect AC Power.
5. Verify that unit runs on both internal and external batteries.
6. Verify that the Power status indicator “EXT” is illuminated indicating the ventilator is running on
external battery.
7. Turn unit off.
Note
All gases used for testing the AVEA should be verified clean medical grade gas sources. The ventilator should be operating in Adult
patient mode with all settings at defaults.
1. Apply a regulated 50 PSI medical air source to the AVEA Air Inlet on the
rear panel of the ventilator.
2. Apply regulated 50 PSI medical O2 Source to the O2 Inlet. (Verify the Air
and O2 Inlet monitors read 50 PSI (+/- 3 PSIG). You can check this by
scrolling to the air inlet and O2 inlet monitored parameter displays on the
left of the Main screen
or by pressing the screens button, selecting the
Monitor screen and scrolling to the air inlet and O2 inlet
parameters and Accept.
Figure 5.6
3. Lower the air inlet pressure gage to 18 psi. The compressor should turn on in a unit with compressor.
In a unit with no compressor, the Low Air alarm should activate.
Figure 5.7
5. Lower the O2 inlet pressure gage to 18 psi. The Low O2 alarm should activate.
Note
Make sure the ventilator is set to Adult size and default settings.
1. Allow the ventilator to cycle and using a stopwatch, count the cycles and ensure the breath rate
matches the Rate setting of the AVEA.
2. Verify the following rates( +/- 2)
5 bpm
20 bpm
60 bpm
Note
Make sure the ventilator is set to Adult size and default settings.
Record the readings from the external O2 Analyzer and the AVEA FIO2 (% O2) monitor/setting. Check the
FiO2 (% O2) readings per table below to compare set FIO2 to analyzed FIO2.
Table 5.8: FiO2 Readings
O2% Tidal Volume Breath Rate Peak Flow % Tolerance
21% 0.50L 25 30 L/min +/- 3%
30% 0.10 50 30 L/min +/- 3%
30% 0.50 25 30 L/min +/- 3%
60% 0.10 50 30 L/min +/- 3%
60% 0.50 25 100 L/min +/- 3%
90% 0.10 50 30 L/min +/- 3%
90% 0.50 25 30 L/min +/- 3%
100% 0.50 25 30 L/min +/- 3%
PEEP Verification
1. Connect an Adult test lung and accept the default settings.
2. Change the Rate to 4 bpm. Using the Paw (cmH2O) portion of the wave form screen, freeze and
measure baseline pressures at each of the following PEEP settings: (The tolerance is +/- 3.5 % of
reading or +/- 2 cm.)
6 cm
20 cm
40 cm
From a CD
With the CD inserted in the computer, copy the new software binary files to the computer hard drive as
follows:
1. Double click on “My Computer”.
2. Double click on the CD ROM Drive to open the window & display the files.
3. Right click on each of the files displayed in turn and select Copy, then right click on
the computer desktop and select Paste.
4. The files should appear on the desktop.
5. Remove the CD ROM from the computer drive.
Serial port #1
6. Type AVEA into the Name bar and click OK. The Connectivity window opens.
7. In the Connect Using bar, type Direct to Com1 (or Com2 if that is your computer connection).
The Port Settings window opens
7. Select the file to transfer (63568X.bin) and click Send. The file will begin transferring and should
be monitored on the display. A confirmation will be displayed in the terminal window when the
file has successfully transferred.
Checks
When you turn the Ventilator Back “ON“ the Power On Self Tests (POST) will be performed
automatically as detailed in the Operator’s Manual. When the MAIN screen displays, you will see the
new version (version 1.9) displayed on the bottom of the Touch Screen.
Confirm active waveforms are displayed on the MAIN screen.
Complete the checklist attached to this procedure and return or fax to VIASYS Critical Care Division
Regulatory Affairs Dept as follows:
Note
The User Verification Tests (i.e. The EST and Manual Alarms Checks) detailed in the operator’s manual, should be performed
prior to patient connection.
Installation Verification
Monitor processor __________* verified
Confirmation checks
Ventilator power up and POST
New software version displayed
Active waveforms on MAIN screen
Title: ___________________________________
SEND TO:
Regulatory Affairs Dept.
VIASYS Critical Care Division
1100 Bird Center Drive
Palm Springs, CA 92262
USA
Fax number: 1 760-778-7301
Chapter 7 Calibration
Note
Prior to calibration, warm the unit for 30 minutes.
Transducer Calibration
Current copies of these documents can be obtained from VIASYS Healthcare Technical Support as
shown in Appendix A.
51000-40022 Gas Delivery Engine Schematic
51000-40697 Test Requirements, Gas Delivery Engine
51000-40843 Test Requirements, Pneumatic Module
Equipment Required.
The following list of parts & tools is recommended for calibrating the AVEA.
Calibration setup
The generic setup shown in figure 7.1 is recommended for calibrating the low pressure ports of the
AVEA.
Tee fitting
Appropriate port adapter or fitting
Note
Before using any test equipment [electronic or pneumatic] for calibration procedures, the accuracy of the
instruments must be verified by a testing laboratory. The laboratory master test instruments must be traceable to
the NIST (National Institute of Standards Technology) or equivalent. When variances exist between the indicated
and actual values, the calibration curves [provided for each instrument by the testing laboratory] must be used to
establish the actual correct values. This certification procedure should be performed at least once every six
months. More frequent certification may be required based on usage.