Fukuda Denshi Co HLX801 User Manual
TM XMTR Module HLX-801
Operation Manual
● Before using this device, read this manual thoroughly.
● Store this manual near the deivce where it can be always
referred.
CAUTION
Federal Law restricts this device to sale by or on the order of a physician.
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.
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.
CAUTION:
• This equipment for sale by or on the order of a physician.
• The company and product names used in this manual are trade marks 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 © 2011 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 the HLX-801 telemetry transmission module from Fukuda
Denshi. Before use, read this operation manual thoroughly for correct handling and
operation.
Safety Precautions
The safety precautions shown in this manual contain important details on the safe use
of this product, and must be obeyed. Make sure to follow the precautions indicated
below, as these are important messages related to safety.
Failure to follow this message may cause
DANGER
WARNING
CAUTION
NOTE
Precaution from Fukuda Denshi
Fukuda Denshi is liable for the safety, reliability, and performance of its equipment.
Maintenance, modifications, and repairs are carried out by authorized personnel.
Components are used in accordance with Fukuda Denshi operating instructions.
If the equipment is used incorrectly and become unusable, Fukuda Denshi is not liable
for the malfunction. Use the equipment only for the purpose specified in this manual.
immediate threat of death, serious injury, or
complete failure of the equipment.
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 HLX-801.
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Graphic Symbols
Refer to the following for the meaning of the symbol indicated on the equipment.
Symbols indicated on the main unit of the HLX-801
Symbol Description
Caution; refer to accompanying documents
Indicates the need to refer to related accompanying documents
before operation.
Refer to accompanying documents
Indicates the need to refer to related accompanying documents
before operation.
Year of Manufacture
Indicates the manufactured year.
WEEE (Waste Electrical and Electronics Equipment)
Indicates a separate collection for electrical and electronic
equipment.
ii
Precautions for Safe Operation of Medical Electrical Equipment
Cautions described here are regarding the general instructions for safety use to the
patient and users. For cautions about the HLX-801, refer to the following pages.
CAUTION
1. Do not use the equipment unless you are familiar with its operation.
2. Pay attention to the following when installing or storing the equipment.
y Install or store in a place where the equipment will not be exposed to
splashing water.
y Store in a place where the device will not be adversely affected by
atmospheric pressure, temperature, humidity, ventilation, sunlight, dust or
atmosphere containing salt or sulfur.
y Prevent inclination, vibration, or shock (including during transportation).
y Do not install or store in an area where chemicals are stored or gasses are
evolved.
3. Precautions before Operation
y Check the cable connection and polarity to ensure safe and proper operation of
the equipment.
y Make sure that all cables are correctly and safely connected. Especially,
recheck the attachment and connection condition of electrodes and
transducers.
y Pay special attention when the equipment is used in conjunction with other
equipment because it may cause erroneous judgment and danger.
y Check the remaining battery level.
When replacing the battery, make sure that the battery polarity is correct. Do
not charge the battery.
4. Precautions during Operation
y Make sure the time required for diagnosis, or medical care is not exceeded.
y Do not pick up or swing the equipment pulling the probe or cable. It may
damage the equipment and lead to measurement error.
y Always observe the device and patient to ensure safe operation of the
equipment.
y If any abnormality is found on the equipment or patient, take appropriate
measures such as ceasing operation of the equipment or detaching the sensor
or electrode in the safest way for the patient.
y Prevent patients from touching the equipments or other electric apparatus.
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CAUTION
5. Cares after Operation
y Return all operating switches or knobs to the position before using the
equipment, and then switch off the power.
y When unplugging the cables, do not apply excessive force by pulling on the
cable. Pull from the connector part of the cable.
y Clean the accessories and cables, and keep them together in one place.
y Keep the equipment clean to ensure proper operation for the next use.
y Make sure to remove the batteries if the equipment is not used for a long time.
The leakage from the batteries may damage the equipment, or an explosion
from the batteries may occur.
6. If the equipment gets out of order, immediately turn off the equipment and
ensure patient safety by disconnecting electrodes and cables from the
patient.
Label the equipment "OUT OF ORDER" and contact your nearest
Fukuda Denshi representative.
7. Do not disassemble or remodel the device.
8. Maintenance check
y Make sure to periodically check the equipment and accessories. (Maintenance
contract is recommended.)
y Before reusing the equipment that has been left unused for a while, make sure
that the equipment works normally and safely.
9. When using an electrosurgical unit or defibrillator in conjunction with this
equipment, take care of the following.
y To prevent patient from burn injury, verify proper attachment of patient
ground plate and ECG electrode type when using the electrosurgical knife, and
verify paste volume and output energy when using the defibrillator.
y Devices other than the above may cause accidental hazards to the patient and
operator due to the conditions of the equipment. Read the operation manual
attached to each device and understand the precautionary instructions prior to
use.
Non-Explosion Proof
DANGER
z Never use the equipment in the presence of flammable anesthetics or high
concentration of oxygen. It may cause an explosion or fire.
z Never use the equipment inside a hyperbaric chamber.
It may cause an explosion or fire.
z Never use the equipment where flammable gas or fluid such as anesthetic,
oxygen, and hydrogen are used.
It may cause an explosion or fire.
iv
Precautions about Magnetic Resonance Imaging (MRI)
WARNING
z Do not use this equipment in magnetic resonance imaging (MRI) environments.
This equipment may be pulled towards the MRI device. The local heating by
the induced electromotive force may cause burn injury to the patient or
deteriorate the performance of this equipment. For details, refer to the operation
manual for the MRI testing device.
Precautions about the installation of the equipment
WARNING
z This equipment is a module dedicated to the bedside monitor manufactured by
Fukuda Denshi Co., Ltd. The use of the power separated from the commercial
power guarantees the safety.
z Do not connect this equipment to a device other than the bedside monitor
manufactured by Fukuda Denshi Co., Ltd. The equipment may be damaged or
leakage current increases and the safety of the patient and operator cannot be
guaranteed.
Precautions about Accessories and Optional Accessories
WARNING
Use only the accessories and optional accessories specified by Fukuda Denshi. Or
the equipment can not only deliver maximum performance but also may be
damaged and then the safety may not be guaranteed.
Precautions about Output Signal
WARNING
Do not use the output signal of the monitor that receives radio wave signal from
this equipment as the cardiac synchronization signal for the IABP, MRI,
echocardiograph, or defibrillator. A trigger signal unrelated to the heart rate may
be generated by the operating timing delay caused by the delay of waveform
transmission and the interfusion of spike noise at weak electric field.
v
b
Precautions about Alarm
CAUTION
z The alarm generation may be delayed
monitor depending on the communication specification (wired or wireless)
between the bedside monitor and central monitor. Read the operation manual
thoroughly and set the alarm.
z The Alarm System is different between the bedside monitor and central monitor
depending on the communication specification (wired or wireless). Read the
operation manual thoroughly and set the alarm.
z When a parameter monitored on a bedside monitor is in a connector-off condition,
the numeric data and waveform for the parameter will not be displayed on the
central monitor. In addition, the alarm for the parameter will not generate. Make
sure that the connector is securely connected.
z When the “Alarm Mute” (Hospital Setup) is set ON, all the alarm will not be
generated. Read the operation manual thoroughly and set the alarm.
Precautions about Cleaning and Disinfection
etween the bedside monitor and the central
CAUTION
z Soak a piece of gauze or absorbent cotton in alcohol or a weak acidic or alkaline
or neutral detergent, wring the gauze or cotton, and wipe the equipment using it.
At this time, make sure the chemicals do not enter the connectors or equipment.
Do not use organic solvents, thinner, toluene and benzene to avoid damaging the
resin case.
z If there is a fear of contagion, soak a piece of gauze or absorbent cotton in
antiseptic soap or alcohol, wring the gauze or cotton, and wipe the equipment
using it. At this time, do not immerse the connector parts of the equipment in any
chemical solution. Contact failure may occur.
z Do not sterilize using an autoclave apparatus because it may damage the
equipment.
z When performing simultaneous disinfection inside the ward or room using
chemical sprays, make sure that the chemicals do not enter the equipment or come
into contact with the connectors.
Precautions about Disposing of Equipment, Accessories, or
Components
CAUTION
z When disposing of the equipment, accessories, or components, use an
industrial waste distributor. Do not dispose of as ordinary waste.
z Used disposal items (shall be discarded as medical waste.
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Precautions for Safe Operation of Medical Telemetry
WARNING
z The HLX-801 transmitter must not be co-located or operated in
conjunction with any other antenna or transmitter.
z The HLX-801 complies with FCC radiation exposure limits set forth for a
controlled environment and meets the FCC radio frequency (RF)
Exposure Guidelines in Supplement C to OET65. The HLX-801 has
been confirmed to comply with maximum permissive exposure
evaluation (MPE). But 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).
z Operation of HLX-801 requires the prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry
Service.
z This radio frequency device is susceptible to interference from outside
sources. Interference may prevent the monitoring of patients connected
to this equipment. If a problem exists, contact your local service
representative.
z The HLX-801 transmits vital signs to the receiving monitor using radio
wave signal. Under unstable radio wave signals, the receiving monitor
will not generate any alarms. This situation may miss sudden change in
the patient's condition and may cause a serious accident. Under
unstable radio wave signals, check the patient status consistently under
this situation. To get stable radio wave signals, make sure to have a
proper telemetry installation.
CAUTION
• For installation, make sure the following.
• The medical institution (hereinafter referred to as the “Institution”) must
decide the telemetry installation plan for the medical department in order
to prevent interference and interference between transmitters (telemetry
based on destination country’s radio law). When telemetry has already
been installed and been used, radio format, frequency, and antenna power
are required to be examined to prevent interference.
• When using telemetry, which requires zone location, the Institution is to
set up the zones as an operation unit for each transmitter to prevent
electronic interference between telemetry throughout the Institution.
• When using telemetry, which requires zone location, display and identify
each prepared zone in the equipment.
• When laying receiver antenna for each transmitter, the Institution has to
examine the installation so that electronic interference does not occur.
• Based on the above examination result, the Institution should install each
receiver antenna as required.
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CAUTION
• For management, make sure to follow the precautions below.
• The Institution should appoint a person (hereinafter referred to as the
“Overall Manager”) to manage the wireless channels for the whole
Institution.
y And when using telemetry, which requires zone location, the Institution
should nominate a person (hereinafter referred to as the “Zone Manager”)
to manage the wireless channels in each zone. However, when using such
telemetry in a local Institution, one person can perform both functions.
y The Overall Manager and Zone Manager must be selected from people
who understand the characteristics and functionality of telemetry systems,
and are skilled in operating telemetry.
y When installing telemetry, the Overall Manager and the Zone Manager
have to understand the precautions for use of telemetry in advance.
y The Overall Manager is responsible for maintenance of wireless channel
and storage and maintenance of telemeter in the overall medical facilities
to give proper instructions to the Zone Manager when using telemetry
needing zone alignment, and to the telemetry user when using telemetry
not-needing zone alignment.
y 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 Institution. When changing a wireless
channel, register it in the log and give proper instructions to the Zone
Manager or to the user.
y The Zone Manager assumes responsibility for managing the wireless
channels, storing, and managing telemetry.
y The Zone Manager assigns the transmitter to the user, and provides
enough education for use inside the zone.
y The telemetry user verifies operation of the transmitter/receiver before
use.
• The telemetry user, if using the telemetry in a zone location, follows the
instructions of the Zone Manager for the zone and gives instructions to the
patient if required.
y When interference or breakdown occurs in telemetry communication, the
user is required to inform the Zone Manager and the Overall Manager of
the problems. The Zone Manager and Overall Manager are to deal with the
problem properly and/or contact their nearest Fukuda Denshi
representative for service.
viii
Electromagnetic Compatibility
The performance of this device under electromagnetic environment complies with
IEC60601-1-2 (2007).
Precautions for Safe Operation under Electromagnetic Influence
CAUTION
If any sorts of electromagnetic wave, magnetic field, or static electricity
exist around the equipment, noise interference or malfunction of the
device may occur. If any unintended malfunction or noise occurs in
monitoring, check the magnetic influence and take appropriate
countermeasures
The following are examples of the common cause and
countermeasures.
z Cellular Phone
The radio wave may cause malfunction to the device.
Cellular phones and radio sets should be turned off in the room
(building) where a medical device is located.
z Static Electricity
In a dry environment (room), static electricity is likely to occur. Take the
following countermeasures.
y Both operator and patient should remove any static electricity before
entering the room.
y Humidify the room.
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EMC Guidance
This equipment complies with IEC60601-1-2 (2007). However, if portable transmitter
or wireless LAN equipment is used extremely nearby, the electromagnetic influence
may largely exceed the compliance level and may cause unexpected phenomenon such
as noise interference on the waveform.
Therefore, this equipment should be used in a location specified by each medical
institution.
If any unexpected noise interference on the waveform or failure to the peripheral
device occurs, stop using the equipment and follow the instruction of the technical
engineer.
The following is the information relating to EMC (Electromagnetic Compatibility).
(When using this equipment, verify that it is used within the environment specified
below.)
●Compliance to the Electromagnetic Emissions
The HLX-801 system is intended for use in the electromagnetic environment specified
below.
Emissions Test Compliance
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Group 1
Class A
Electromagnetic Environment -
Guidance
The HLX-801 uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
The HLX-801 is suitable for use in all
establishments other than domestic
buildings.
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