WI-0015 Test Lung Bias Measurement

Facility*
Bias Calculation Date/Time*
:  
Performed By:*
If you are not at an AutoMedx facility and would like a copy of the test record sent to you, please provide an email address.
Technician training date
MM/DD/YYYY. If known
Is the test lung compliance locked?*
Test Lung: Calibration Last Performed
MM / DD / YYYY. Check with your organization to determine if the test lung is still within the calibration window. Michigan Instruments generally recommends 2 years before a recalibration is due.
Verify Software Revision
Syringe - next Calibration due
If known
If known

This procedure is a component of the SAVe II and SAVe II+ recommended annual preventative maintenance. It has been developed to enable service technicians with the proper equipment and training to verify the SAVe II or SAVe II+ is operating within the lower range of its specified Tidal Volume.

This procedure is required to verify the SAVe II/II+ meets its +/- 10% tidal volume specification due to extremely narrow tolerances when delivering very low tidal volumes. The Michigan Instruments 3600i and SL3 test lungs are accurate to +/- 20mL or 3% when calibrated using standard factory procedures. This measurement error spans the full range of the SAVe II/II+ tolerance at its lowest tidal volume setting which makes it impossible to make a definitive judgement regarding whether or not the SAVe II/II+ is within specification. For example, if PneuView indicates a measurement of 215mL when the device is set to deliver 200mL then the actual value could be anywhere between 195mL and 235mL. Expanded SAVe II acceptance criteria can be used to verify the SAVe II is meeting Essential Performance and Safety requirements if users do not have access to the equipment required by this procedure.

The repeatability of any one lung is considerably better than the overall accuracy limits that have been specified. This permits the special calibration of individual units, and the development of "correction curves" for a particular unit, extending the accuracy of a particular test lung well beyond the standard manufacturing tolerance spread. This special calibration can be accomplished by ordering a special factory calibration from Michigan Instruments or by an individual user by following this procedure. The following additional equipment is required to perform this special calibration.

Special Test Lung Calibration Equipment:

  • Hans Rudolph Calibrated Syringe capable of injecting 200mL
  • Pick-off adapter
  • Reducing adapter
Training Requirements:


The use of this procedure requires that the user have the proper equipment and training. This procedure does not attempt to instruct users in how to setup and operate calibration syringes or the Michigan Instruments test lungs. Users must read the Hans Rudolph calibration syringe instruction for use. This document can be found here:

Hans Rudolph IFU

Users must also refer to the Training and Test Lung (TTL) Operation Manual and PneuView instructions. The latest version of these manuals can be request from Michigan Instruments or accessed here:

Michigan Instruments 3600i Test Lung

PneuView3 Manual

Please contact Automedx by sending an email to service@automedx.biz or calling (972) 586-7500 if you have any questions or would like Automedx to verify the performance of the device.

Special Test Lung Calibration Procedure

This procedure should only be performed by a technician who is able to operate the Test Lung and the Hans Rudolph Calibration Syringe.

Test Rig Settings*
Syringe Injection Volume*

Calibration Procedure - Compliance #1

  1. Set the test lung and PneuView to Rp5 resistance and either .02 or .05cmH2O/L compliance
  2. Remove the port cap (if connected) from the air outlet port of the syringe
  3. Follow Hans Rudolph instructions to set calibrated syringe to deliver an injection volume of 200mL or the volume indicated in the previous field
  4. Connect the "Reducing Adapter" to the inlet port of the test lung airway
  5. Carefully pull the plunger of the syringe out until it hits the volume stop
  6. Connect the "Pick-off Adapter" to the lung port
  7. Slowly connect the syringe to the reducing adapter. Monitor the airway pressure and volume in PneuView to verify that neither exceeds 10 while connecting the syringe
  8. Holding the syringe in 1 hand carefully remove the pick-off adapter with the other hand
  9. Using a slow and steady motion inject the volume of the syringe into the lung over 1 second
  10. With the plunger remaining depressed, remove the syringe from the reducing adapter using a quick motion
  11. Refer to the inspiratory time recorded by PneuView
  12. Record the Tidal Volume (TV) measurement if the inspiratory time is between 0.8 - 1.2 seconds.
  13. If the inspiratory time is greater than 5 seconds then it is likely that the test lung began measuring the tidal volume when the syringe was connected. This can occur if the syringe was attached too quickly or if the pick-off adapter was not connected to the lung when the syringe was attached
  14. Repeat steps 5 - 13 until 3 acceptable breaths have been measured

Note: Each of the measurements should be within +/- 3mL of each other if this procedure is performed correctly.

Test Lung Compliance*
Test Lung Resistance*

Injection Acceptance Criteria

Injection Volume (mL)___ Inspiratory Time (seconds)
200 0.8 - 1.2


Record this value in the special calibration field of the SAVe II/II+ field performance test

Calibration Procedure - Compliance #2

  1. Set the test lung and PneuView to the other compliance
  2. Carefully pull the plunger of the syringe out until it hits the volume stop
  3. Connect the "Pick-off Adapter" to the lung port
  4. Slowly connect the syringe to the reducing adapter. Monitor the airway pressure and volume in PneuView to verify that neither exceeds 10 while connecting the syringe
  5. Holding the syringe in 1 hand carefully remove the pick-off adapter with the other hand
  6. Using a slow and steady motion inject the volume of the syringe into the lung over 1 second
  7. With the plunger remaining depressed, remove the syringe from the reducing adapter using a quick motion
  8. Refer to the inspiratory time recorded by PneuView
  9. Record the Tidal Volume (TV) measurement if the inspiratory time is between 0.8 - 1.2 seconds.
  10. If the inspiratory time is greater than 5 seconds then it is likely that the test lung began measuring the tidal volume when the syringe was connected. This can occur if the syringe was attached too quickly or if the pick-off adapter was not connected to the lung when the syringe was attached
  11. Repeat steps 2 - 10 until 3 acceptable breaths have been measured

Note: Each of the measurements should be within +/- 3mL of each other if this procedure is performed correctly.

Test Lung Compliance*
Test Lung Resistance*

Injection Acceptance Criteria

Injection Volume (mL)___ Inspiratory Time (seconds)
200 0.8 - 1.2


Record this value in the special calibration field of the SAVe II field performance test

REVISION HISTORY

RevisionDateAuthorSummary of Changes
B10/5/2021L. Alex. PrangerUpdated from original procedure and assigned WI-0015.
C12/6/2021L. Alex. PrangerAdjusted for to allow for only testing one compliance IF lung compliance is locked.
D5/13/2022L. Alex. PrangerUpdated to send email copies of the test record.


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