User's Manual

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LBL-0151 | User Supplemental Information, Effective: xxXXX2013
3
Extended-Use PATCH 
continued safety, should the enclosure become penetrated or torn, remove the Patch
immediately and replace it with a new one.
1. 5 – Avoiding Unsafe Use Conditions
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The Proteus Patch is not a diagnostic device. DO NOT attempt to use it to diagnose heart-
related conditions, an incorrect diagnosis may result.
The Proteus Patch has not been tested or approved as safe for operation during air travel.
DO NOT use the Patch during air travel; it may interfere with the aircraft navigational
instruments.
The Proteus Patch has not been tested or approved for use in the presence of strong
magnetic or electric fields. DO NOT wear the Patch during magnetic resonance imaging
(MRI), cautery, and external defibrillation procedures. Damage to the Patch, your skin, or
an unexpected magnetic attraction may result. Please inform your healthcare professional
that the Patch must be removed prior to engaging in one of these procedures.
WARNING: No modification of this equipment is allowed. Modifying the Proteus Patch may
cause a safety hazard for the user.
1. 6 – Information on Electromagnetic and Other Interferences
The Proteus Patch has been evaluated and deemed compliant with the requirements in
EN60601-1-2 Class B for Electromagnetic Compatibility (EMC). Medical Electrical
Equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in this User Manual. Portable and
mobile RF communications equipment can affect Medical Electrical Equipment. The
Proteus Patch should not be used adjacent to or stacked with other electromagnetic
equipment. If adjacent or stacked use with other electromagnetic equipment is necessary,
verify that the Proteus Patch operation is normal in the configuration(s) in which it will be
used.
1. 7 – Information on t he Radio Subsystem
The Proteus Patch incorporates a Bluetooth
Tm
radio subsystem which is compliant with the
Bluetooth standard. The following information is provided to satisfy the requirements of
EN/IEC 60601-1-2:
The Bluetooth radio transmits and receives on 40 frequency bands which are equally
spaced at 2MHz intervals between 2402MHz and 2480MHz.
The effective receive bandwidth is 1.25MHz.