R F Technologies PGR2CCZ24 User Manual

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3125 North 126th Street, Brookfield, WI 53005
Phone: [phone] Web: www.rft.com

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Care Manager

In-Service Guide

P/N: 0510-1067-B

Release Date: 02/26/10

Users must read this Guide before using the Product.

Compliance

Federal Communication Commission (FCC) Compliance

FCC ID: KXU-PGR2CCZ24
IC: 2719A-PGR2CCZ24

This device complies with Part 15 of the FCC rules. Operation is subject to the
following to conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operations.

Technologies could void the user’s authority to operate the equipment.

FCC and IC Radiation Exposure Statement for Portable Devices

(For the Care Manager model 9600-0500)
This equipment complies with FCC and IC radiation exposure limits set forth for an

uncontrolled environment. This equipment is in direct contact with the body of the
user under normal operating conditions. This transceiver must not be co-located or
operating in conjunction with any other antenna or transceiver.

Industry Canada Compliance

Changes or modifications not expressly approved by RF Technologies could void the user’s
authority to operate the equipment. The Term “ IC” before the radio certification number only
signifies that Industry Canada technical specifications were met.

Operation is subject to the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received, including
interference that may cause undesired operation of the device.

This device has been designed to operate with the antennas listed below, and having a
maximum gain of 3dBi. Antennas not included in this list or having a gain greater than 3dBi
are strictly prohibited for use with this device. The required antenna impedance is 50 ohms.
Acceptable antennas are PCB antennas in all ca ses of the Router which uses a 2.4 GHz 1/2
wave RP-SMA.

To reduce potential radio interference to other users, the antenna type and its gain should be
so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that
permitted for successful communication.

Changes or modifications not expressly approved by RF

Copyright 2010 by RF Technologies, Inc.

All Rights Reserved. No Part of this work may be reproduced or copied in any form
or by any means without written permission from RF Technologies, Inc.

Important W arnings

It is important for your facility to implement and enforce the following W A RNINGS in order to keep
all equipment functioning properly. Disregarding the information and instructions in this document is
considered abnormal use and may result in injury or system failure.

WARNING

ACCESSORIES (SUPPLIES)—To ensure patient safety and proper operation
of equipment, use only parts and accessories manufactured or recommended
by RF Technologies, Inc. Parts and accessories not manufactured or
recommended by RF Technologies, Inc. may not meet the requirements of the
applicable safety and performance standards.

Failure to use the components and supplies specified by RF Technologies, Inc.
may result in equipment and/or system failure.

WARNING

EXPLOSION HAZARD—This device should not be used in the presence of
flammable gas mixtures. It should also not be used in oxygen enriched atmospheres.

WARNING

HIGH RISK FOR FALL—The CA 520 System may not be suitable for patients who
are at “HIGH RISK FOR FALL.” Other monitoring measures may also be required.
The Motion Alert System should not be a substitute for routine visual monitoring
protocol by caregiving personnel.

WARNING

INSTALLATION AND CONFIGURATION—It is the responsibility of the
facility to follow the installation instructions carefully, as outlined in the Series 6.0
Software Administrator Guide, and to use the components and supplies specified by
RF Technologies, Inc. for all installations.

Failure to use the components and supplies specified by RF Technologies,
Inc. may result in equipment and/or system failure.

WARNING

INSTRUCTIONS FOR SET UP AND USE—It is the responsibility of the facility to
follow the instructions for set up and use carefully, as outlined in this manual, and to
use the components and supplies specified by RF Technologies, Inc. for set up and
use. Do not attempt to use extension cords or other equipment not supplied by RF
Technologies, Inc.

Failure to use the components and supplies specified by RF Technologies, Inc.
may result in equipment and/or system failure.

WARNING

PATIENT GENERATED ALARMS—Do not rely exclusively on patient
generated alarms for patient care and safety. The alarm function of equipment
in the possession of patients must be verified periodically and regular patient
surveillance is recommended.

WARNING

PATIENT MONITORING—The most reliable method of patient monitoring
combines close personal surveillance with correct operation of monitoring
equipment. It is the responsibility of the facility to periodically check on
patients in possession of RF Technologies, Inc.'s equipment (i.e. Pendants,
Pull Cords, Control Units) to mitigate risk of inappropriate use of equipment
or strangulation and stumbling hazards from cables and cords

WARNING

PRODUCT WARRANTIES—Failure to follow the Warnings and Cautions in
this guide voids any and all Product Warranties

WARNING

ST ATIC DISCHARGE—Do not touch the conductor portion of any conductor
or port. Damage tot he device may result.

WARNING

STRANGULATIONS AND TRIPPING HAZARD—Due to the possibility of
strangulation, all cables and cords should be routed away from the patient’s throat.
Cables and cords must be routed in a way to prevent tripping hazards.

WARNING

SYSTEM INSPECTION—It is the responsibility of the facility to establish
and facilitate a regular inspection schedule for your system. RF Technologies,
Inc. recommend quarterly inspections of your system for safety and
performance by a qualified RF Technologies, Inc. representative.

To arrange for a quarterly inspection by RF Technologies, Inc., call our
Technical Support Department at (800)-669-9946 or [phone].

Failure to provide regular inspection of these products may result in equipment
and/or system failure.

WARNING

SYSTEM MAINTENANCE AND TESTING—It is the responsibility of the
facility to establish and facilitate a regular maintenance schedule for your
system, as outlined in the Series 6.0 Software Administrator Guide . This includes
regular inspection, testing, and cleaning. RF Technologies, Inc. recommend
monthly maintenance and testing of your system. It is also recommended that
your facility keep records of maintenance and test completions.

Failure to provide regular maintenance and testing of these pr oducts may result
in equipment and/or system failure.

WARNING

SYSTEM WIRING—All permanent supply connections must be done in
accordance with National Electric Code, NFP A 70.

WARNING

USER TRAINING—Only users who have received adequate training on the use of
the system, as outlined in this manual, should use the system. It is the responsibility of
the facility to ensure all users have been trained.

Failure to adequately train employees may cause system failure due to us er error.
In addition, incorrect use of the equipment may also result in system failure.

WARNING

WORN OR DAMAGED PARTS—If the control unit pads or cables are worn or
damaged, you must have the product serviced. For more information, see the section
entitled “Service and Return.”

WARNING

All RF Technologies transmitters, pendants and banding material
“PRODUCT” have been determined to be MR Unsafe as defined by ASTM F
2503-05. Use of “PRODUCT” in a Magnetic Resonance Imaging system will
cause injury to patients and staff, MR system malfunction or “PRODUCT”
malfunction. Do not bring “PRODUCT” into the MR system area and follow
your facilities policies to classify and label “PRODUCT” as MR Unsafe.

CAUTION

DISPOSAL—At the end of their service life the products described in this
manual, as well as accessories (i.e. lithium batteries, banding material,
disposable pads, etc.), must be disposed of in compliance with all applicable
federal, state and local guidelines regulating the disposal of products
containing potential environmental contaminants. Dispose of the packaging
material by observing the applicable waste control regulations.

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