Fukuda Denshi Co HTC702 User Manual

Bidirectional Wireless Communications Module
(TCON)

HTC-702

Instruction Manual
Before using this device, read this “Instruction Manual” thoroughly.
CAUTION
Federal Law restricts this device to sale by or on the order of a physician.
CAUTION:
The company and product names used in this manual are trademarks or registered trademarks.
If this manual has pages missing or out of order, contact Fukuda Denshi for replacement.
Only physician or persons instructed by physicians are allowed to use the equipment.
The information contained in this document is subject to change without notice due to improvement in the equipment.
Copyright © 2010 by Fukuda Denshi Co., Ltd. No part of this document may be copied or transmitted in any form without the prior written permission of Fukuda Denshi Co., Ltd.
Printed in Japan
Thank you for purchasing this product.
Before using this product, please read through this “Instruction Manual” to make sure
the product is used correctly and safely. Even if you are familiar with our devices,
there are certain handling procedures that are unique to this device. Therefore, please
make sure you read this manual thoroughly before use.

Safety Precautions

The safety precautions shown in this manual contain important details on the safe use
of this product, and must be obeyed. Symbols and their meanings are shown below.
Be sure to understand the contents below before reading the rest of the manual.
WARNING
CAUTION
NOTE
Failure to follow this message may result in death or serious injury, or complete failure of the equipment.
Failure to follow this message may cause injury or failure of the equipment.
A note is not related to product safety, but provides information about the correct use and operating procedures to prevent incorrect operation and malfunction of the equipment.
i

Precautions for Safety and Hazard Prevention

This section contains general information on how to handle this device for safety use.
Precautions unique to this device are detailed throughout the manual.
CAUTION
1. Users should have a thorough knowledge of the operation before using this device.
2. Pay attention to the following when installing and storing the device.
Do not install or store in an area where the equipment will be subject to
splashing water.
Do not install or store in an area where the environmental conditions, such
as humidity, ventilation, sunlight, and air containing dust, salinity, or sulfur, will adversely affect the system.
Place the equipment on a stable surface where there is no inclination,
vibration, or shock (including during transportation).
Do not install or store in an area where chemicals are stored or gasses are
evolved.
3. Before operating the device, verify the following items.
This equipment is not designed to prevent explosions etc. due to flammable
anesthetics or oxygen etc. Therefore, do not use this equipment in a flammable atmosphere.
Check that the device is operating normally and safely. Ensure that all cables are firmly and safely connected. Pay special attention when this device is used in conjunction with other
devices, as it may cause erroneous judgment and danger.
4. During operation of the device, verify the following items.
Make sure the time required for diagnosis, observation, and treatment is not
exceeded.
Always observe the device and patient to ensure safe operation of the
equipment.
If any abnormality is found on the device or patient, take appropriate
measures such as ceasing operation of the device in the safest way for the patient.
Do not allow the patient to come into contact with the device or electronic
components.
5. After using the device, verify the following items.
Return all operating switches, knobs etc to the position before using the
equipment, and then switch off the power.
When unplugging the cables, do not apply excessive force by pulling on the
cable. Pull by the connector part of the cable.
Clean the accessories and cables, and keep them together in one place. Keep the unit clean to ensure proper operation of the next use.
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CAUTION
6. If the device is damaged and in need of repair, users should not attempt to service the device themselves. Label the unit “OUT OF ORDER”, and contact Fukuda Denshi representative.
7. Do not disassemble or remodel the device.
8. Maintenance Check
Make sure to periodically check the device and accessories. Before reusing a device that has been left unused for a while, make sure that
the device works normally and safely.
WARNING
This radio frequency device is susceptible to interference from outside sources. Interference may prevent the monitoring of patients connected to this devices. If a problems exists, contact your local service representative.
iii

Precautions for Use of Bidirectional Wireless Communications (TCON)

CAUTION
To operate the device correctly, read the following precautions carefully.
The medical institution (hereinafter referred to as “Institution”) must execute
investigation required to prevent interference including types of radio waves, frequencies, and antenna power if wireless equipment is already installed and being used in the facility.
Even if this device is installed within the range of radio communication, the
communication may not be possible due to noise or multi-path phasing etc. Always consider this thoroughly before use.
Do not install this device in an area where it will be subject to splashing water.
Water entering the equipment may cause the equipment to malfunction or be damaged.
In managing, be sure to follow the precautions below.
The Institution should appoint a person (hereinafter referred to as the “Overall
Manager”) to manage the wireless devices for the whole facility.
When installing TCON, the Overall Manager has to receive an explanation of
the precautions for use of the TCON from the manufacturer or sales representative.
The Overall Manager is responsible for the maintenance and storage of the
equipment.
The Overall Manager should create a management log (hereinafter referred to
as the “log”), which contains a list of the management status of the wireless channels for the whole facility. When assigning or changing wireless channels, register it in the log, and give proper instructions to the TCON user.
The user needs to verify operation of the transmitter/receiver before use. If interference or breakdown occurs in the communication, the TCON user is
required to stop using TCON and to inform the Overall Manager of the problem. The Overall Manager is to deal with the problem properly and/or contacts the nearest Fukuda Denshi representative for service.
CAUTION
Users are advised to periodically contact the FCC or specified frequency coordinator and determine if other or your transmitter frequencies that may cause interference.
iv
CAUTION
Precautions for Use
The Bidirectional Wireless Communications Module (TCON) uses radio waves to transmit data. Therefore, the necessary precautions need to be taken for the characteristics and difficulties of using the device that emits radio waves. The TCON user should fully understand these precautions beforehand, and use the TCON device safely. Furthermore, situations in which interference may occur are outlined below. In such cases, pay special attention to the condition of the patient connecting to the bedside monitor, and eliminate the cause of the interference.
1. The patient’s data may become mixed with a different patient’s data due to
Interference.
When there are multiple TCON communication devices set to the same
channel and group (ID).
2. When symptoms such as being unable to communicate, unstable communication, or poor reception may occur.
When the radio communication is bad because there are metal, concrete, or
other such obstacles between the Bidirectional Wireless Communications Modules (TCON).
When a different wireless device is using the same frequency (or the same
channel).
When there are other TCON devices nearby using different channels or
groups.
When a cell telephone or other wireless device is being used nearby. When citizens broadcast bands such as amateur radio or truck radios are
used in the vicinity of the TCON operating area.
When a computer or word processor, or electrical device that has an internal
computer, is used near the TCON device antenna.
When the TCON device is installed or moved to a location that is outside the
radio communication range.
If a nearby different group is set with a TCON channel frequency that is too
close to the channel frequency set for the current TCON group.
v

FCC Radiation Exposure Statement

WARNING
This transmitter must not be co-located or operated in conjunction with any other
antenna or transmitter.
This equipment complies with FCC radiation exposure limits set forth for an
controlled environment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C to OET65. This equipment has very low levels of RF energy that it deemed to comply without maximum permissive exposure evaluation (MPE). But it is desirable that it should be installed and operated keeping the radiator at least 20cm or more away from person’s body (excluding extremities: hands, wrists, feet and ankles).
Operation of this equipment requires the prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry Service.
vi

Contents

Safety Precautions...................................................................................... i
Precautions for Safety and Hazard Prevention....................................... ii
Precautions for Use of Bidirectional Wireless Communications
(TCON) ....................................................................................................... iv
FCC Radiation Exposure Statement ....................................................... vi
Contents.................................................................................................vii
1. Overview .................................................................................................. 1
2. Names of Parts and Their Functions .......................................................3
HTC-702.............................................................................................. 3
3. Installation to the Patient Monitor............................................................. 5
Example Installation of HTC-702 to Bedside Monitor, DS-7100 .........5
Example Installation of HTC-702 to Central Monitor, DS-7600........... 7
4. System Configuration Example................................................................ 9
5. Cleaning, Disinfection, and Sterilization................................................. 11
Cleaning ............................................................................................ 11
Disinfection and Sterilization ............................................................. 11
6. Maintenance Check ...............................................................................13
Daily Check ....................................................................................... 13
Periodic Inspection............................................................................ 13
Daily Check List .................................................................................... 14
7. Specifications.........................................................................................15
8. Accessories............................................................................................ 17
Optional Accessories.........................................................................18
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