Fukuda Denshi HLX-561 User manual

EXHIBIT D: User Manual
FCC ID DV8HLX561

Telemetry Transmitter Module
HLX-561
Operation Manual
Read this manual prior to use of the HLX-561.
Store this operation manual in an easily accessible place near the
unit for future reference.

CAUTION
Federal law restricts this device to sale by or on the order of a
physician.
NOTE: Only a physician or a person under the guidance of a
physician can use this device.
Copyright © 2001 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

i
Telemetry Precautions
For proper management of the telemetry installation, consult your
Fukuda Denshi representative concerning the following:
•Plan the installation of your telemetry system taking into account
your entire medical facility needs and plant requirements.
•Be sure the antenna system installed meets the facility and plant
requirements.
WARNING
This Radio Frequency device is susceptible to interference
from outside sources. Interference may prevent the
monitoring of patients connected to this device. If problems
exist contact your local service representative.
NOTE :This device operates in the 600MHz UHF band. The exact
frequency of operation depends on designation, and each
individual county's wireless service regulation.
To assure safe and reliable operation, observe the following
precautions:
•Be sure that no other devices are using the frequency assigned to this
transmitter.
•This device is susceptible to interference from electrosurgical knives
and other computerized equipment. If problems occur contact your
local Fukuda Denshi service representative.
•Any obstruction such as reinforced concrete or large metallic surfaces
between the receiver and the transmitter can affect reception. If
problems occur contact your local Fukuda Denshi service
representative.
•When the low battery alarm is present at the central monitor, charge
the battery in the patient monitor.

ii
CAUTION
Users are advised to periodically contact the FCCor specified
frequency coordinator and determine if other or your
transmitter frequencies that may cause interference.
CAUTION
The manufacturers, installers and users of Wireless Medical
Telemetry System equipment are cautioned that the operation
of this equipment could result in harmful interference to other
nearby medical devices.

iii
Thank you for purchasing the HLX-561 telemetry transmission module
from Fukuda Denshi. Before use, read this operation manual
thoroughly for correct handling and operation. If you are familiar with
a similar type of product, it is recommended this operation manual be
read and understood since the HLX-561 has unique operation and
handling methods.
Safety Information and Messages
Be sure to observe the warning and cautionary messages related to
important safety information. These instructions are described under
the following message headings. Understand the meaning of the
different types of messages while reading this operation manual.
WARNING
Erroneous operation by failure to observe
instructions when this message is printed
may result in death or serious injury to the
patient, operator, or create a fire hazard.
CAUTION
Erroneous operation by failure to observe
instructions when this message is printed
may result in injury to the patient or
operator, or may cause damage to the
HLX-561 and/or related instruments.
NOTE A NOTE is not a warning instruction but offers information for correct use of the
HLX-561 to avoid erroneous operation.

iv
Safety Considerations in Using Medical Electrical
Equipment
Contents described here are general safety considerations to be taken
for proper operation of medical electrical equipment and for the safety
of both the patient and operator. Safety considerations specific to the
use of the HLX-561 telemetry transmission module are described on
the next page.
CAUTION
1. Do not use the equipment unless familiar with its operation.
2. Observe the following when installing or storing the
equipment:
•Select a place where the equipment may not be contaminated
with splashing water.
•Consider the atmospheric pressure, temperature and humidity
and provide adequate ventilation. Avoid direct sunlight. The
equipment should not be installed or stored in a location where it
may beadversely affected by air containing dust, saline or sulfur.
•Avoid inclination, vibration and shock, even during transport to
ensure stable operating conditions.
•Do not install or store the equipment where chemicals are stored
or gases are generated.
3. Precautions before Operation
•The equipment is not designed to be explosion-proof. Do not use
the equipment in the presence of flammable gasses or
anesthetics.
•Make sure the equipment is operating safely and normally at all
times.
Ensure that all cords and cables are correctly connected.
•Improper use of multiple instruments simultaneously may result
in erroneous information or lead to a hazardous accident. (Refer
to the Section 9.)

v
CAUTION
4. Precautions during Operation
•Do not to operate the equipment beyond the time period
necessary that is required for diagnosis, monitoring or treatment.
•Observe the equipment and patient constantly for any
abnormality.
•If the equipment or patient indicates any abnormality, stop the
equipment from operating or take proper measures (e.g.
disconnect transducers and electrodes) to ensure patient safety.
•Instruct the patient not to contact the equipment.
5. Cares after Operation
•Disconnect cords and cables by holding the connector plugs. Do
not apply excessive force to cords and cables by pulling to
disconnect.
•Keep the equipment clean in preparation for the next use.
6. If the equipment gets out of order, ensure patient safety by
immediately turning the equipment off and disconnecting
electrodes and or transducers from the patient.
Contact your nearest Fukuda representative and label the
device as "OUT OF ORDER".
7. Do not disassemble or attempt service on the equipment.
Contact your nearest Fukuda Denshi representative for
service.
8. Maintenance and Inspection
•Be sure to perform periodic inspection of the equipment and
accessories.
•Before operating the equipment which has not been used for a
long period of time, make sure that the equipment operates
normally and safely.

vi
CAUTION
9. When using an electrosurgical unit or defibrillator in
conjunction with this equipment, take care of the following.
•The high-frequency energy produced by electrosurgy equipment
may result in burns to the patient or possible damage to the
equipment. Be sure to observe the precautionary instructions
described in the operation manual of the electrosurgical unit.
•Some types of equipment may be damaged by the energy
discharged by a defibrillator. Ensure a thorough understanding
of the precautionary instructions described in the operation
manual of the equipment before using a defibrillator.
•Some types of equipment other than electrosurgical units and
defibrillators may cause accidental hazards to the patient and
operator when operated under adverse conditions. Read the
operationmanual attached to each individual unit and understand
the precautionary instructions prior to use.

Contents
Telemetry Precautions  i
Safety Information and Messages  iii
Safety Considerations in Using
Medical Electrical Equipment  iv
1. General Description 1
2. Controls and Indicators 2
3. Mounting the HLX-561 to the Bedside Monitor
Mounting into the DS-5100  4
Mounting into the DS-5300  7
4. Setting the Receiving Channel of the Monitor 10
5. Cleaning, Sterilization and Disinfection 11
6. Maintenance and Inspection 12
7. Specifications 14
8. Accessories  16