R F Technologies FMFSZ24 User Manual

CA630 System

In-Service Manual

PN 0510-1116-A

Released 04/15/13

Users must read this Guide before using the Product.

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

Do not immerse in water

Attention: Consult accompanying documents

Type BF Device

Direct Current
RF Symbol

Copyright 2013 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.

Classifications

The following information can be found on the back label of the CA630 control unit.

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

CHANGES OR MODIFICATIONS TO PRODUCT—RF Technologies prohibits
changes or modifications to the product; this may void the user’s authority to oper-

ate the equipment (FCC Code of Federal Regulations Title 47 Part 15.21).

WARNING

HIGH RISK FOR FALL—The CA630 System may not be suitable for patients who are at
“HIGH RISK FOR FALL.” Other monitoring measures may also be required. The Fall

Management 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 current Series 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.

Important Warnings

It is important for your facility to implement and enforce the following WARNINGS 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

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

STATIC DISCHARGE—Do not touch the conductor portion of any conductor or
port. Damage to the 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.
recommends 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 current Series Software Administrator Guide. This includes regular
inspection, testing, and cleaning. RF Technologies, Inc. recommends 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 products may result in
equipment and/or system failure.

WARNING

SYSTEM WIRING—All permanent supply connections must be done in
accordance with National Electric Code, NFPA 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 user 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. alkaline battery, 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.

Compliance

FCC

This device complies with Part 15 of the FCC Rules. 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.

RF Technologies prohibits changes or modifications to the product; this may void the

user’s authority to operate the equipment (FCC Code of Federal Regulations Title 47 Part

15.21).

Industry Canada

This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause
undesired operation of the device.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils
radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1)
l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter
tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en
compromettre le fonctionnement.

Under Industry Canada regulations, this radio transmitter may only operate using an
antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry
Canada. 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 necessary for successful communication.

Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut
fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur) approuvé pour
l'émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage
radioélectrique à l'intention des autres utilisateurs, il faut choisir le type d'antenne et son
gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas
l'intensité nécessaire à l'établissement d'une communication satisfaisante.

FCC and IC Radiation Exposure Statement for Portable Devices

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 transmitter must not be co-located or operating
in conjunction with any other antenna or transmitter.

Product Warranty

RF Technologies, Inc. (herein referred to as “Seller”), warrants to the Buyer that during

the warranty period (defined below) the RF Technologies, Inc. products (herein referred

to as “Product”) will be free from manufacturing defects and will conform to the Seller’s

product specifications. The warranty period is defined as one of the following:

For product installed by Seller other than product identified below, warranty coverage is

provided for a period of twelve (12) months from the date of system “go live.” Warranty
coverage includes parts and labor during Seller’s standard business hours.

 Fall Management pads are warranted for the period of days as indicated on the pad

label, or for a period not to exceed twelve (12) months from the date of shipment from
Seller.

 All Sensatec Fall Management control units are warranted for a period of twenty-four

(24) months from the date of invoice.

Technical phone support for application assistance is available 24/7 during the warranty
period only.

This warranty is a limited warranty and it is the only warranty made by Seller. Buyer’s
sole remedy for any defect shall be repair or replacement, at Seller’s discretion, of any
part, returned to the Seller, shipment prepaid, and which upon examination is found by
Seller to be defective. Alternatively, Seller may, at its sole option, elect to refund the
purchase price paid for the defective product.

The criteria for all testing shall be based on Seller’s product specific test procedures.

Exclusions

Warranty coverage does not include, and Seller disclaims any liability for, any defect or
performance failure or deficiency (including failure to conform to product descriptions or
specifications) which results, in whole or in part, from (1) improper storage, handling,
misuse, maintenance, installation, or modification of the Product by Buyer, its employ­ees, agents, or contractors, (2) absence of any product, component, or accessory recom­mended by Seller, but omitted at Buyer’s direction, including but not limited to transmit­ters and banding materials not tested and approved, (3) any design, specification, or in­struction changed by Buyer, its employees, agents, or contractors, (4) failure to comply
with any applicable instructions or recommendations of Seller, including installation,
maintenance, testing, and training procedures, (5) physical damage occurring to transmit­ters or other components after receipt and acceptance by Buyer, (6) integration or use of
any components, systems, process, software patches, software, or equipment not sold or
provided by Seller, (7) acts of God, acts of civil or military authority, fires, floods,
strikes, or other labor disturbances, war, riot, or other causes beyond the reasonable con­trol of the Seller, (8) damage due to moisture, dust, dirt, and facility renovations, (9) un­regulated and or out of specification electric power, temperature, humidity, or (10) radio
frequency interference in the Product’s operating environment. It is the Buyer’s responsi­bility to make the necessary repairs to the building, power supply, or any sources of radio
frequency interference or noise that prevents the Product from operating properly.

This includes, but is not limited to, doorways, elevator drives, door motors, light ballasts,
door sensors, televisions, and computer monitors. The Buyer is responsible for labor and
expenses for investigation (i.e. noise assessment) that results in the finding of a condition

listed in warranty exclusions, (11) Buyer’s non performance of its responsibilities and

obligations. Non-compliance with remote connectivity requirements outlined in the
Terms and Conditions may result in loss of Buyer’s privileges to Seller’s technical phone
and warranty on-site support.

The preceding paragraphs set forth Buyer’s exclusive remedies and Seller’s sole liability

for claims based on the failure of the products to meet any warranty, whether the claim is
in contract, warranty, tort (including negligence and strict liability), or otherwise, and
however instituted, and upon the expiration of the applicable warranty period of such
liability shall terminate. IN NO EVENT SHALL SELLER BE LIABLE FOR ANY DI­RECT, INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL, OR CONSEQUENTIAL
DAMAGES OF ANY KIND RESULTING FROM THE USE, INABILITY TO USE,

OR FAILURE OF ANY OF SELLER’S PRODUCTS, WHETHER OR NOT SUCH

DAMAGES ARE FORESEEABLE OR IN CONTEMPLATION OF THE PARTIES,
EVEN IF SELLER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAM­AGES.

EXCEPT AS EXPRESSLY SPECIFIED, THE PRODUCTS ARE PROVIDED “AS IS”.
THIS WARRANTY IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCT
AND IS IN LIEU OF ANY OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR OF TECHNOLOGI­CAL VALUE.

Contents

Preface ................................................................................................................... 1

Overview.............................................................................................................................................. 1

Intended Audience ............................................................................................................................. 1

Additional Detailed Documentation ............................................................................................... 2

Contact Information ........................................................................................................................... 2

Chapter 1 .............................................................................................................. 3

System Overview ..................................................................................................... 3

System Overview ............................................................................................................................... 3

Control Unit ......................................................................................................................................... 4

Control Unit Indicators ...........................................................................................................4

Control Unit Buttons ...............................................................................................................5

Control Unit Jacks ...................................................................................................................5

Chapter 2 .............................................................................................................. 7

Set Up .................................................................................................................... 7

Setting Up The System ...................................................................................................................... 7

Fall Alert ...................................................................................................................................7

Nurse Call ................................................................................................................................8

Guidelines for Pressing the Hold Button ..............................................................................8

Chapter 3 ............................................................................................................ 9

Responding to Alarms.......................................................................................... 9

Fall Alert ...................................................................................................................... 9

Nurse Call ................................................................................................................................ 10

Low Battery ................................................................................................................................ 11

Chapter 4 ............................................................................................................ 13

Maintenance .......................................................................................................... 13

Caring For Your System ................................................................................................................. 13

Troubleshooting Your System ....................................................................................................... 13

Testing Your System ....................................................................................................................... 13

Operating and Storage Conditions ................................................................................................. 14

Pads ........................................................................................................................................ 14

Control Unit .......................................................................................................................... 14

Service and Return ........................................................................................................................... 14

Supplies .............................................................................................................................................. 15

CA630 System (0510-1116-A) - In-Service Manual ix