Changes to instructions for use regarding occlusion of the sampling line

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Purpose

This customer service note provides additional instructions and troubleshooting for Capnography Pod, Capnography Module, and Multigas Module to address occlusion of the sampling line.


Note: Capnography Module (91517) and Multigas Module (91518) are at end of support/end of sales.

Background information

Occlusion of the sampling line will cause an occlusion alarm. After 40 seconds of alarm, the unresolved occlusion will result in the product entering a Suspend Processing state. To start monitoring for capnography again, the clinician must go into the capnography settings and resume processing. To start monitoring for multigas again, the clinician must go into the Gas-Main setting and resume sampling.
Considering a hypothetical user error, the user may become confused about the device operating state and not understand that the monitor is in suspend state and expect the monitor and alarms to be active. A respiratory stress or arrest event may occur, and the monitor will not alarm.

Solution

To reduce the risk of the occurrence of this hypothetical user error, the following information provides additional instructions and troubleshooting for Capnography Pod, Capnography Module, and Multigas Module.

For active products Capnography Pod (92516), Capnography Module (92517), and Multigas Module (92518), these changes are available in the latest version of Clinical Parameters Operations Manual (P/N 070-2113-06 Rev. E).

Capnography Pod (92516)
Observe the following warning:

Troubleshooting:

If the message SAMPLE LINE OCCLUDED displays, replace the NomoLine adapter after occlusion is detected.

Capnography Module (92517)
Observe the following warning:

Troubleshooting:

If the message CHECK SENSOR – Sample Line Occluded displays, replace the NomoLineadapter after occlusion is detected.

Multigas Module (92518)
Observe the following warning:

Troubleshooting:

If the message SAMPLING LINE OCCLUDED displays, replace the NomoLine adapter afterocclusion is detected.

If the message SAMPLING SUSPENDED – Patient is not monitored displays, a possiblecause is the occlusion of the sampling line. The solution is to replace the NomoLineadapter after occlusion is detected.

Capnography Module (91517)

Note: Capnography Module (91517) is at end of support/end of sales.

Observe the following warning: 

Troubleshooting:

If the message OCCLUSION OR LEAK -Remove and check sampling line displays, replacethe NomoLine adapter after occlusion is detected.

If the problem CO2 sampling suspended occurs, a possible cause is the occlusion of thesampling line. The solution is to replace the NomoLine adapter after occlusion isdetected.

Multigas Module (91518)

Note: Multigas Module (91518) is at end of support/end of sales.

Observe the following warning: 

Troubleshooting:

If the message OCCLUSION – Check system displays, replace the NomoLine adapter after occlusion is detected.

If the message SAMPLING SUSPENDED – Patient is not monitored displays, a possible cause is the occlusion of the sampling line. The solution is to replace the NomoLine adapter after occlusion is detected.

 


Released 4 April 2024

The source of this article is the following software update bulletin, 077-0645-00 Rev A, released 4 April 2024: https://manuals.spacelabshealthcare.com/wp-content/uploads/2024/04/077-0645-00RevA-ENG-CSN-Capno-Multigas-Samp-line-Occlusion.pdf 

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