Integra Camino ICP Monitor User manual

IMPORTANT SAFETY INFORMATION

Monitor

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.

CAM02

Low - technical (dB)

Med - technical (dB)

Med - physiological (dB)

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

IFU

dB Level

69 56 64

70 65 68
70 61 70

Software

Upgrade

Case

Upgrade