IMPORTANT SAFETY INFORMATION
Integra® Camino® ICP Monitor (CAM02)
In mid-April 2015, Integra determined that the speaker in the Camino® ICP Monitor (CAM02) may potentially malfunction and if this occurs, the monitors may stop providing an audible tone at start-up or at alarm points during use. A corrective action to eliminate the problem has been verified and will be implemented in two phases.
This CAM02 unit has received the first phase of the corrective action which is a software upgrade to lower the input signal supplied to the speaker assembly. Lowering this signal helps reduce the likelihood of a speaker problem. A residual effect of this upgrade is a decrease in decibel level of the audible alarms. This decrease has been measured at 5 to13 dB versus the current level. To account for this, a user study was conducted to demonstrate customers are still able to hear the alarms properly.
NOTE: A red sticker on the rear left side of the CAM02 unit, to the left of the “Next Maintenance Due Date” label, indicates that the software upgrade has been completed on this unit.
Per the User Manual, (www.integralife.com/CAM02_Manual) the Camino ICP Monitor assigns each error condition that may activate a physiological or technical alarm type with a range of clinical priorities between medium and low. The chart below provides the decibel levels (dB) stated in the IFU and the difference in dB levels once the software and hardware upgrades have been implemented.
|
IFU |
Software |
Monitor |
|
CAM02 |
Case |
|||
dB Level |
Upgrade |
|||
|
Upgrade |
|||
|
|
|
||
Low - technical (dB) |
69 |
56 |
64 |
|
|
|
|
|
|
Med - technical (dB) |
70 |
65 |
68 |
|
|
|
|
|
|
Med - physiological (dB) |
70 |
61 |
70 |
|
|
|
|
|
Integra will contact you separately to coordinate the second phase of the corrective action which will require the return of your monitors to modify the case in order to increase the volume of the audible tone.
Should you have any questions regarding these instructions, please contact Customer Service at 1-800-654-2873 or your local sales representative. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.
Sincerely,
Integra LifeSciences
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