Philips IntelliVue TRx, Instructions For Use Manual

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Draft - 1 Aug 08
Regulatory Information
12-4 Safety Standards & Specifications
System Classification
The TRx4841A and TRx4851A Transceivers are FDA Class II devices. They
have the following characteristics
.
FCC
Compliance
(M4840A/
USA only)
Operation of this equipment requires the prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry Service.
The transceiver and the IntelliVue Telemetry System are subject to radio
frequency interference. In the event of suspected radio frequency interference
with your device, contact your service provider. This device complies with Parts
15 and 95H of the Federal Communications Commission (FCC) Rules.
Operation is subject to the condition that this device does not cause harmful
interference.
Pursuant to Part 15.21 of the FCC Rules, any changes or modifications to this
equipment not expressly approved by Philips Medical Systems may cause
harmful radio frequency interference, and void your authority to operate this
equipment.
Characteristic Definition
Internally Powered
Equipment The TRx4841Aand TRx4851A transceivers are
internally powered devices.
Continuous Operation All equipment is Ordinary Equipment, IPX0, and
provides continuous operation
Type CF
Defibrillation Proof The TRx4841A and TRx4851A transceivers are
Type CF Defibrillation Proof relative to ECG and
SpO
2
patient applied parts.
Water Resistance IPX0, Non-Protected
When placed inside a Philips-specified carrying
pouch with the velcro closures secured, the
combination of the transceiver and pouch will
withstand showering for up to 10 minutes.