Haemonetics
Haemonetics Cell Saver System
Cell Saver Elite Ver 7.0 Service, Calibration and Inspection Guide SB-OTH-000067(Rev AA)
Service, Calibration and Inspection Guide
49 Pages
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Page 1
SB-OTH-000067 (AA) Cell Saver® Elite® - Version 7 INSPECTION, CALIBRATION AND SERVICE
Purpose With the new version software, 7.0, there were some minor changes in the way one would test and calibrate the Cell Saver® Elite®. Most functions are exactly the same as previous versions with an updated look and feel to the User Interface and screen navigation. Although very intuitive, the purpose of this bulletin is to provide direction on how to service the Cell Saver® Elite® with version 7.0 software loaded. This bulletin is an interim solution until the new manual, SM-CS Elite-02-EN, can be released.
Required equipment
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
#2 Phillips® head screwdriver
#1 Phillips head screwdriver
3/
7/
9/
1/
.9 mm Allen wrench
11/
8 inch adjustable wrench (21 mm minimum)
Fixture, optics TF7911-00
Digital pressure gauge
Digital tachometer and reflective tape
Stop watch (or equivalent)
Valve module, test harness (ETC-6228-00)
Fixture, vacuum calibration tool (TF7090-00)
Fixture, Harmony® flow test (TF7280-00)
Cell Saver® Elite® calibration wedge (TF8218-00)
32 inch hex driver (or equivalent) 64 inch hex driver (or equivalent) 64 inch hex driver (or equivalent) 8 inch hex driver (or equivalent)
11/
32 inch nut driver (or equivalent)
32 inch open-end wrench (or equivalent)
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
Manifold pressure sensor weight (TF8217-00)
100 gram weight
200 gram weight (or empty dry waste bag from disposable set CSE-P-225, CSE-P-125, or CSE-P-70)
Disposable, vacuum line (HAR-A-1000)
SmartSuction® harness fixture (TF8197-00) or A&A line (HAR-A-1003)
Weight, level sensor calibration (offset) 639±5g or empty LN205 reservoir)
Weight, level sensor calibration (full scale) 2639±5g or LN205 reservoir with 2 liter water or empty reservoir with 2 Kg weight)
Water filled tubing, air detector
Clear tubing, line sensor
Disposable Test Harness Fixture (TF8196-00) or CSE-P-225, CSE-P-125, or CSE-P-70 tubing harness Disposable set tubing, functional test, (CSE-P-225, CSE-P-125, or CSE-P70 tubing harness)
Clean dry Latham bowl, 125 or 225 ml
Clean dry 70 ml bowl
Chuck adaptor (107581-00)
Magnet
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Procedure Visual Inspection
Inspect the following items to ensure that they are in good working order. Tighten or replace hardware as necessary. Replace any damaged hardware if it interferes with the operation of the machine.
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
Chassis
IV pole and fittings
Cart
Panel screws
Power cord
Touch screen display cord
Reservoir weigher cord
Touch screen display
Device cover
Line sensor
Air detector
Valve module
Waste bag weigher
Centrifuge drain bag
Pump assembly
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
Initial Operational Integrity
Power on the Cell Saver® Elite® device and ensure it passes the power on selftest before performing the service procedures in this chapter. This will verify the machine was operational as per the diagnostic tests performed during the power on self-test.
Program Revision Level
The program revision level is displayed on the power on self-test screen. Note: The self-test starts before the GUI is up and when the top cover is closed. If the top cover is closed at the time of self-test you may not see the self-test progress
Equipment Integrity Inspection Electrical Connections
1. Inspect the power cord(s). Ensure that the cord is not damaged in any way. Replace as necessary. 2. If the molded plug has been removed, d i s a s s e mb l e t h e power cord plug and inspect the electrical connections at the plug. 3. Tighten the connections. Disinfect them as necessary. 4. Remove the side panels to gain access to the internal components. 5. Inspect for loose or broken electrical connections on all assemblies. Tighten or repair them as required.
Equipment Integrity Inspection Hardware
1.
Inspect for loose or missing mounting hard ware. Pay close attention to the valve door (knob bushing and O-rings) centrifuge knob, latching post and mounting plate. Tighten and repair the hardware as required.
2. Inspect the centrifuge drain tubes for proper placement. Ensure that there is unobstructed passage for fluids from the centrifuge. 3. Inspect the centrifuge mounting to ensure proper fit.
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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COMPONENT TESTING The components in the Cell Saver® Elite® device generate enough heat that some circuits may drift if the cooling system is not intact. It is advisable to keep the side access panels in place during service, only removing for component inspection or replacement, and adjustment of the 24-volt power supply. The cooling system is most efficient when all panels are in place. To allow stabilization of internal temperatures, and to ensure accuracy of measurements, power on the Elite with all panels in place for at least 10 minutes. Warning: Follow proper Electrostatic Discharge (ESD) precautions throughout this procedure.
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
Power on and software version check
1. Plug the unit into the correct, power outlet source. 2. Verify the valve module cover is closed and locked, the centrifuge arm is closed and latched, the platen is closed, and the device cover is closed. 3. Turn on the Elite system using the power switch on the power entry module, located at the back of the unit. 4. While the Powering subsystems and performing self-test message displays (figure 6-1), note the application, GUI, and SmartSuction revisions Note: The self-test starts before the GUI is up and when the top cover is closed. If the top cover is closed at the time of self-test you may not see the self-test progress. An alternative to get this information is under the device
history tab accessed by touching
Figure:6-1 Note: Values pictured are examples only. .
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Accessing System Settings and Service Screens
1. Touch screen
on the top right corner on the scan disposable screen or ready
2. Touch
from the drop down
Figure 6-2
Three levels of access control
3.
Touch
User - Surgeons, Surgery Type and Clock access Administrator – Above + Startup Mode, Sounds, Options, Software Update, Import/Export Settings Haemonetics Service – Access to all
and type password followed by User access is ‘USER’ Administrator access is ‘T3CH’ (confidential) Service access is ‘HA3MO’ (confidential)
Caution: ‘HA3MO’ should only be used by an authorized factory trained individual as some settings can disable the Cell Saver® Elite® requiring service.
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
Figure 6-3
Figure 6-4
4.
Touch
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Figure 6-5 Unlocked Service Screen Note: Each of the various screens can be accessed by selecting the appropriate button.
Note:
Power must be cycled to exit Service Screens
Note: When entering Service Screens during a system alert you are required to acknowledge the alert by minimizing the message using the before you can continue to the password screen. In addition if a system alert is generated while navigating Service Screens you can minimize to regain visual of the screen where you left off.
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
System voltage test
Verify that the voltage across TP1 (+24V) and TP8 (ground) on the application/ control PCB is (24.5±.2). The PCB is located toward on the front, behind the right panel of the device. If the voltage is not within that range, adjust the trim pot on the power supply, located behind the left side panel, above and behind the step of the chassis side rail.
Figure 6-6 Application/Control PCB
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Touchscreen calibration
If the touchscreen requires calibration, perform the following procedure: Note: It is suggested to use a stylus when pressing the targets for improved accuracy
1. 2. 3.
Rapidly and repeatedly press the until the Touch Screen calibration screen appears. Start Calibration by touching the Red Target Touch and hold the center of each target, a total of 4 targets, to successfully calibrate the Touch Screen.
Note: Ignore the message “Touch the screen to verify the cursor moves to your finger” 4. 5.
Software version update
Touch Accept Device restart is required
Use the following procedure to update the device with new software versions. 1. 2.
Contact Haemonetics technical support to verify the latest available revision of the software. Access System Settings and Service Screens using the Admin or Service password
3.
Touch
4. 5. 6.
Firmly install USB Available versions will populate on the display Ensure the new version you want to update to is highlighted
7. 8. 9.
Touch Touch Update Software again to proceed with update Cycle power when prompted
Note: Upgrade process will take approximately 10 mins.
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
Serial Number and Battery replacement Settings
The serial Number and Battery replacement fields are in the Service screens. 1.
Access System Settings and Service Screens
2. 3.
Touch Select the ‘Serial Number’ row so that it is highlighted and then touch
4.
Enter the serial number of the unit located on the rear panel or right side of the chassis, above and between the two PCBs and touch when done
5. Select the Battery Replaced row so that it is highlighted and touch 6. Enter the Date that the User Interface Battery was replaced and touch Note: The UI battery should be replaced every 2 years or when the time and date are no longer able to hold following power cycle
Date and time settings
The date and time are set in the System settings screen. Note: Note: A password will be required if service screen were accessed first
1.
Touch
Note: The Offset is an easy time zone or day light savings adjustment. UTC is typically set at the time of manufacturing. If the time requires adjustment (e.g. to adjust for drift, dead battery, etc.), then the local time can be edited which will reflect UTC once saved
3.
Touch the field you wish to adjust and ensure it’s highlighted (Month, Day, Year, Hour or Minute) Use the white up or down arrow to change the value accordingly
4.
Touch
when complete and the Local time will store in the UTC
5.
Touch
when complete
2.
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
Regionalization settings
If the regionalization needs to be changed, perform the following procedure: 1. Access System Settings and Service Screens.
2. 3. 4.
Touch .to set Language, Disposables Region, date and time formats, Post-Op, pressure units, etc… Touch the field you wish to adjust and ensure it’s highlighted Use the white up or down arrows to change the value
5.
Touching
will reset all values to MFG default
Note: Any value outside MFG default will be indicated with a right for that setting
6.
Touch
on the
when complete
Figure 6-10 Options Menu
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
Reservoir offset test and calibration
The reservoir offset test and calibration is performed within the Calibration screen. 1.
Enter Calibration screen by touching display.
at the top of the
Figure 6-11 Calibration screen Note: Values illustrated are from simulator and not actual calibration values. With no weight or reservoir loaded in the reservoir scale, the Current ADC Counts field should display a value of at least 145 digital counts. 2. Place offset weight equivalent to 639±5 g on the reservoir scale. 3. Allow 5 seconds to pass for the reading to stabilize. The current ADC counts should be between 170 and 260 and within 10% of the stored offset. The stored offset can be calibrated to the current ADC by touching the
to store the value. 4. Remove the weight. Note: An empty, dry reservoir could be used as an alternate reference weight
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
Reservoir range test and calibration
1.
Place full scale weight equivalent to 2639±5 g on the reservoir scale.
2.
Allow 5 seconds for the reading to stabilize.
3.
The current ADC counts should be between 360 and 470 counts, and within 10% of the stored range.
4.
The stored range can be calibrated to the current ADC by touching the
5.
to store the value.
6.
Remove the weight.
7.
Touch
Note: An empty, dry reservoir with 2kg weight, resting on top of the reservoir, could be used as an alternate reference weight.
Waste bag offset test and calibration
Note: Ensure that the unit is secured to the cart to prevent tipping of the machine With no weight or bag on the waste bag scale, the Current ADC Counts field should display a value between 60 and 446 digital counts. 1. Place a 200-gram wei ght or an empty 10L waste bag on the waste bag scale and allow 5 seconds for the reading to stabilize. The current ADC counts should be between 60 and 275 counts, and within 10% of the stored offset. The stored offset can be calibrated to the current ADC by touching the to store the value. 2. Remove the weight.
Waste bag range test and calibration
1. Place a waste bag with 10L of water or a downward force of 10.2kg on the waste bag scale and allow 5 seconds for the reading to stabilize. The current ADC counts should be between 390 and 810, and within 10% of the stored range. The stored range can be calibrated to the current ADC by touching the
to store the value. 2. Remove the weight(s) 3. Touch
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
.
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
Manifold load cell offset test and calibration
If the manifold load cell requires calibration, perform the following procedure: 1. Enter the Calibration screen by touching the display.
at the top of the
2. Remove the waste bag(s) from the shelf under the unit. 3. Unlatch t h e two clamps fro m under t he cart shelf to unsecure the machine. 4. Lift the unit up at the front and place the calibration we d g e (TF8218-00) onto the two retainer post on the top of the cart shelf so that the fixture number is facing forward. 5. Seat the two retainer holes on the bottom of the machine, in the service position (Waste bag tray mount holes), onto the post on top of the calibration wedge. This will tilt the machine back, leveling the deck and the manifold assemblies.
Figure 6-13 Leveling Deck and Manifold Assembly 6.
With no tubing in the pinch valve module, the current ADC counts in the LOAD CELL: Manifold Pressure field should be between 42 and 1470 digital counts (This is Empty Valve (no tubing) value or EV) and touch
.
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com
7.
Open the pinch valve door and place the manifold pressure sensor weight (TF8217-00) - protruding end down - onto the pressure switch located on the left side of the front tubing channel
Note: Ensure the weight is fully seated on the sensor, and not leaning on either side of the manifold prior to executing calibration
Figure 6-14 Pressure Sensor Switch
Figure 6-15 Pressure sensor TF8217-00 placed on pressure switch 8. Allow 5 seconds to pass for the current ADC counts to settle. SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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The current ADC counts should be within 10% of the Stored Offset.
9. Touch the to store the value: Store Offset (SO). This calibrates the stored offset to the Current ADC and also automatically calculates the ΔOV (SO - EV). 10. Verify the ΔOV value is between 1100 and 1700.
Manifold load cell range test and calibration
1. Place a 100 gram weight on top of the TF8217 fixture so that the fixture is level.
Figure 6-16 l e v e l i n g the fixture 2. Allow 5 seconds for the Current ADC Counts to settle. The Current ADC Counts should be within 10% of the Stored Range. The Stored Range can be calibrated to the Current ADC by touching the to store the value (SR). 3. This calibrates the stored range to the Current ADC and also automatically calculates the ΔRV (SR - SO). 4. Verify the ΔRV value is between: 150 to 500. 5. Remove the fixture and 100 gram weight from the pinch valve module and close the valve door 6. Close device cover 7. Lift up on the front of the machine and remove the Calibration W e d g e from the cart shelf 8. Seat the machine back on the cart and latch the machine to the cart 9.
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
Touch
.
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SmartSuction calibration
If the SmartSuction® system requires calibration perform the following procedure within the Calibration screen. Access to Service Screens is required 1. Connect HAR-A-1000 filtered vacuum line to the quick disconnect on the back of the unit and connect the other end to the clear end of the Smart Suction test harness (TF8197-00) or A&A set. 2. Connect t h e blue end of the SmartSuction t e s t harness ( TF8197-00) or A&A set to a Flow Meter. 3. If using an A&A line remove the drip chambers from the smaller line on the A&A set and splice/adapt it to a Vacuum Meter. If using the TF8197-00, connect the pressure meter to the line with the luer lock connector. 4. In the SmartSuction field touch
.
5. Verify that the three Stored Values appear on the display along the Stored Offset line. Values will be updated in <10 seconds. 6. Touch
in the Delta field to turn the pump on.
7. Verify that the value on the Flow Meter is between 20-40 LPM. 8. Touch
in the Delta field and a keypad will appear.
9. Enter the value that is on the Flow meter and touch the when done. The Keypad will disappear and Calibration screen will return.
10. Touch and a value should appear in the SmartSuction field under the Delta column. 11. Touch
in the Delta field to turn the pump off.
12. Remove the Flow meter from the A&A line and Plug/Pinch off the line. 13. Touch ON.
in the Gauge & Watchdog field to turn the pump
14. Allow a few moments for the pump to reach maximum Vacuum level -90 to -115 mmHg (11.9 to 15.3 kPa). Record the value. 15. Touch
in the Gauge & Watchdog field and a key- pad will appear.
16. Enter the value on the vacuum meter and touch the when done. The Keypad will disappear and the Calibration screen will return
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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17. Touch in the Gauge & Watchdog field and the Values should appear in the SmartSuction field under the Gauge and Watch- dog columns. Note: If the vacuum level is < 90mmHg repeat the last six steps.
18. Touch
in the Gauge & Watchdog field to turn the pump off.
19. Touch
Figure 6-17 Example of Diagnostics 1
SmartSuction test
The SmartSuction® test is performed within the Diagnostic1. 1. Connect a HAR-A-1000 filtered vacuum line to the quick disconnect on the back of the unit and connect the other end to the clear end of the Smart Suction Test Harness (TF8197-00) or A&A set. 2. Insert the POOLED end of flow fixture (TF7090-00) into the end of the SmartSuction test harness TF8197-00 and connect the pressure meter to the line with the luer lock connector. If using an A&A line remove the drip chambers from the smaller line on the A&A set and splice/adapt it to a pressure meter
SB-OTH-000067 Rev. AA SBC100416 Copyright © 2016 Haemonetics Corporation
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Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Tel: 781.848.7100 www.haemonetics.com