Fukuda Denshi Co HLX801 TM XMTR Module User Manual
Fukuda Denshi Co Ltd TM XMTR Module
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 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 © 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
i
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.
DANGER Failure to follow this message may cause
immediate threat of death, serious injury, or
complete failure of the equipment.
WARNING Failure to follow this message may result in
death or serious injury, or complete failure of
the equipment.
CAUTION Failure to follow this message may cause
injury or failure of the equipment.
NOTE
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.
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.
ii
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.
iii
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.
iv
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.
v
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.
vi
Precautions about Alarm
CAUTION
z The alarm generation may be delayed
b
etween the bedside monitor and the central
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
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.
vii
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.
viii
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.
ix
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.
x
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 Electromagnetic Environment -
Guidance
RF Emissions
CISPR 11 Group 1
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.
RF Emissions
CISPR 11 Class A
The HLX-801 is suitable for use in all
establishments other than domestic
buildings.
xi
●Compliance to the Electromagnetic Immunity (1)
The HLX-801 is intended for use in the electromagnetic environment specified in
below tables. It should be assured that the HLX-801 is used in such an environment.
Immunity Test IEC60601-1-2
Test Level Compliance Level Electromagnetic
Environment -
Guidance
Electrostatic
Discharge
(ESD)
IEC61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC61000-4-4
±2kV
Power supply
lines
±1kV
for input/output
lines
±2kV
Complies
±1kV
for input/output
lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power Frequency
(50/60Hz)
Magnetic Field
IEC61000-4-8
3A/m 3A/m Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Note: UT is the AC mains voltage prior to application of the test level.
xii
●Compliance to the Electromagnetic Immunity (2)
The HLX-801 is intended for use in the electromagnetic environment specified below.
It should be assured that the HLX-801 is used in such an environment.
Immunity Test IEC60601-1-2
Test Level Compliance
Level Electromagnetic Environment
- Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
HLX-801, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended Separation Distance
Conducted RF
IEC61000-4-6
3Vrms
150kHz to 80MHz
3Vrms d = 1.2 P
Radiated RF
IEC61000-4-3
3V/m
80MHz to 2.5GHz
3V/m d = 1.2 P 80MHz∼800MHz
d = 2.3 P 800MHz∼2.5GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya),
should be less than the compliance
level in each frequency rangeb).
Interference may occur in the
vicinity of equipment marked with
the following symbol:
Note 1 : At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
Note 2 : These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
Notea) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast can not be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered.
If the measured field strength in the location in which the HLX-801 is used exceeds the
applicable RF compliance level above, the HLX-801 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the HLX-801.
b) Over the frequency range 150kHz to 80MHz, field strength should be less than 3V/m.
xiii
●Recommended Separation Distances between Portable and
Mobile RF Communications Equipment and the HLX-801
The HLX-801 is intended for use in an environment in which radiated RF disturbances
are controlled. The electromagnetic interference can be prevented by maintaining a
minimum distance between portable and mobile RF communications equipment
(transmitters) and the HLX-801 as recommended below, according to the maximum
output power of the communications equipment.
Separation Distance according to Frequency of Transmitter (m)
R
ated Maximum
Output Power of
Transmitter (W
）
150kHz to 80MHz
d = 1.2 P
80MHz to 800MHz
d = 1.2 P
800MHz to 2.5GHz
d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
Note 1 :At 80MHz and 800MHz, the separation distance for the higher frequency
range applies.
Note 2 :These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
xiv
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xv
Contents
Safety Precautions.................................................................................. i
Precaution from Fukuda Denshi....................................................... i
Graphic Symbols..............................................................................ii
Precautions for Safe Operation of Medical Electrical Equipment....iii
Non-Explosion Proof.......................................................................iv
Precautions about Magnetic Resonance Imaging (MRI)................. v
Precautions about the installation of the equipment........................ v
Precautions about Accessories and Optional Accessories ............. v
Precautions about Output Signal .................................................... v
Precautions about Alarm.................................................................vi
Precautions about Cleaning and Disinfection .................................vi
Precautions for Safe Operation of Medical Telemetry....................vii
Electromagnetic Compatibility..................................................................ix
Precautions for Safe Operation under Electromagnetic Influence...ix
EMC Guidance................................................................................ x
1. General Description........................................................................... 1
2. Name of Parts and Their Functions.................................................. 3
3. Preparation ......................................................................................... 5
■ Installation to the Bedside Monitor............................................. 5
■ Installation to the Patient Monitor DSL-8001 ............................. 6
4. Operation............................................................................................ 7
■ Operation Procedure ................................................................. 7
■ Changing the Transmitter Channel............................................ 7
■ Changing the Group ID.............................................................. 7
5. Troubleshooting................................................................................. 9
6. Cleaning and Disinfection ............................................................... 11
■ Cleaning .................................................................................. 11
■ Disinfection.............................................................................. 11
7. Maintenance Check ......................................................................... 13
■ Daily Check ............................................................................. 13
■ Periodic Check ........................................................................ 13
■ Periodic Replacement ............................................................. 13
8. Accessories / Optional Accessories .............................................. 15
■ Standard Accessories.............................................................. 15
■ Optional Accessories (sold separately) ................................... 16
9. Specification..................................................................................... 17
■ Specification ............................................................................ 17
1
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1
1. General Description
The HLX-801 is a transmitter module to wirelessly transmit vital signal waveforms
and Numeric Data which are monitored on the DS-8000 series bed side monitors. A
telemetry monitoring system is constructed in combination with a central monitor such
as DS-7700 system.
A telemetry channel can be set with an arbitrary channel on the bedside monitor.
Before using the HLX-801, also read the operation manuals of the patient monitor and
central monitor thoroughly.
External appearance
2
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3
2. Name of Parts and Their Functions
Screw Hole
A hole to secure the mounting
bracket with a screw to a bedside
monitor externally
Connecting Plug
A connector to communicate
with the external equipment
Anntena
Used to send and receive
radio waves.
Refer to “Safety
Precautions” in
this manual’s
preface
4
A
ttachment cove
r
To fix the HLX-801 to the
monitor.
A hole to run the HLX antenna
through this cover
5
3. Preparation
■ Installation to the Bedside Monitor
For procedure to install to the bedside monitor, refer to the operation manuals of the
bedside monitor and optional mounting bracket.
WARNING
z The HLX-801 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 the HLX-801 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.
CAUTION
z When installing the HLX-801, verify that the power of the bedside monitor is
OFF before the procedure.
z After installation, make sure it operates normally.
6
■ Installation to the Patient Monitor DSL-8001
c Loosen the screw on the rear of the DSL-8001 and remove the
maintenance cover.
The removed maintenance cover is not used
when the HLX-801 is installed. Make sure to
store the cover because it is needed when the
HLX-801 is removed.
d Connect the connection cable of the DSL-8001 maintenance part
to the HLX-801 connector.
Pay attention to the connector orientation and
connect the connector.
After connection, insert the HLX-801 in the
maintenance part of the DSL-8001. At this
time, insert it paying attention to the
following precautions.
Make sure that the connection cable is not
caught.
Pay attention to the orientation of the HLX-
801. Make sure that the Rating Label is
facing upward.
e Use the attachment cover supplied with the HLX-801 and attach
it, instead of the maintenance cover which was removed in c.
Run the HLX-801 antenna through the cover
and attach it on the rear side of the DSL-8001
using the screw removed in c.
Bend the antenna vertically.
7
4. Operation
■ Operation Procedure
For operation procedure, refer to the operation manual of the bedside monitor to which
the-HLX-801 is connected.
■ Changing the Transmitter Channel
The HLX-801 is a synthesizer type transmitter module which the transmitter channel
can be changed. It can be set up with an arbitrary channel among the channels assigned
by the Telemetry Laws (according to each country). For details on the setting
procedure, see the operation manual of the bedside monitor.
WARNING
z Follow the instruction by the person in charge of the radio telemetry
channel in your facility when the transmitter channel is changed.
Mismanagement may result in a serious accident, such as interference and
mixing up patients.
z Replace promptly the new channel label if the transmitter channel has
been changed.
■ Changing the Group ID
The HLX-801 transmits its group ID to prevent interference with neighboring
hospital's transmitter. The central monitor checks whether the incoming group ID is
the same as the programmed one that the central monitor has and displays the
waveform.
The transmitter group ID can be changed if there is interference with a neighboring
hospital's transmitter. For details on the setting procedure, see the operation manual of
the bedside monitor.
CAUTION
Possible causes of interference other than radio telemetry from neighboring
hospital's transmitter are the proximity of mobile phone, amateur radio
station, radio taxi, and illegal citizens band, which may be a cause of
interference. In such a case, the situation should be carefully observed to find
the cause of interference.
.
8
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9
5. Troubleshooting
If the measurement waveform is not properly displayed on the central monitor, check
the following items.
If the phenomenon cannot be improved, refer to your local Fukuda Denshi service
representative.
Pattern on the central
monitor Cause Solution
The connection is
not properly set.
Check the
connection between
the HLX-801 and
bedside monitor.
The power of the
bedside monitor is
turned OFF.
Check if the power
on the bedside
monitor is turned
ON.
The channel
numbers between
the transmitter
and the receiving
monitor are not
the same.
Make sure that the
channel number of
the bedside monitor
and central monitor
is the same.
Check the antenna of
the HLX-801.
Poor transmission
Check the antenna of
the central monitor.
The radio
waves are not
transmitted.
Transmitter
malfunction
Contact Fukuda
Denshi
representative.
Other wireless
device uses the
same channel
nearby,
(If the transmitter
module is turned
ON, the central
monitor is in the
receiving
condition.
Follow the
instruction by the
person in charge of
radio telemetry
channel in your
facility and set the
HLX-801 with the
correct channel
setting.
Interference
with
radiowave of
other wireless
device
Interference Follow the
instruction by the
person in charge of
radio telemetry
channel in your
facility and set the
HLX-801 with the
correct channel
setting.
10
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11
6. Cleaning and Disinfection
Clean and disinfect the HLX-801 as shown below.
CAUTION
Do not sterilize the HLX-801 in any manners since it is not ready for
sterilization.
■ Cleaning
Soak a piece of gauze or absorbent cotton in alcohol or a neutral detergent, wring the
gauze or cotton, and wipe the HLX-801 using it.
CAUTION
z Clean the equipment frequently so stains can be removed easily.
z To prevent injury, it is recommended to wear gloves when cleaning the
equipment.
z Do not allow liquids or cleaning solution to enter the equipment or
connectors.
z The HLX-801 cannot be sterilized.
z Do not use organic solvents, thinner, toluene and benzene to avoid damaging
the resin case.
z Do not polish the housing with abrasive or chemical cleaner.
z Use only neutral detergent to clean the housing. Do not use chemical cloth,
scrub brush, abrasive, polishing powder, hot water, volatile solvent and
chemicals (cleanser, thinner, toluene, benzine, benzol, and synthetic
detergent for house and furniture), or sharp-edged tools. The surface resin
coating may be damaged, resulting in discoloration, scratches, and other
problems.
■ Disinfection
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 HLX-801 using it.
CAUTION
z Do not immerse the connector parts of the HLX-801 in any chemical solution.
Contact failure may occur.
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.
12
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13
7. Maintenance Check
Periodic check must be performed. When reusing the HLX-801 which was left unused
for a while, always check that the unit operates properly and safely before use.
In this section, the maintenance check items that must be performed for the HLX-801
are explained. To ensure safety, reliability, and high performance, a “Daily Check” and
“Periodic Check” must be performed. Be aware that Fukuda Denshi is not liable for
any accidents arising from the lack of maintenance check.
CAUTION
z Do not open the housing.
z Avoid alcohol or other liquids from getting into the equipment.
■ Daily Check
Perform the daily check according to the “Daily Check List”.
■ Periodic Check
Periodic inspection of medical electronic equipment is mandatory to prevent failures
and accidents and to ensure safety and reliability.
Periodic check may be performed by the medical institution or a third party by
concluding a “Maintenance Contract”.
For more details, contact your local Fukuda Denshi service representative.
■ Periodic Replacement
No periodic replacement parts.
14
Daily Check List
No.
Checked Date Checked by Location
Model: HLX-801 Serial No. Date of Purchase
Item Check Details Criteria Judgement
External
appearance
Visually inspect for damage,
cracks, breaks,and chips of the
exterior, peeling label, and
loose screws.
No remarkable
abnormalities
should be found.
OK/NG
Transmitting
function
Connect to the bedside
monitor, operate under normal
operating conditions, and
check the communication
function and operation on the
central monitor.
The waveform
and numerical
value should
properly be
received.
OK/NG
Telemetry
Channel
Check if the Transmitter
Channel and Group IDs are as
specified by the telemetry
channel administrator.
It should
conform to the
telemetry
channel
checklist.
OK/NG
Zone location
Visually check the color and
location of the zone location
label and make sure that they
are as specified by the
telemetry channel
administrator.
It should
conform to
telemetry the
channel
checklist.
OK/NG
Periodic Check Check the date of the previous
periodic check.
Should be
within 1 year. OK/NG
Comment
15
8. Accessories / Optional Accessories
WARNING
Use only the accessories specified by Fukuda Denshi for the HLX-801.
Otherwise, the HLX-801 cannot deliver its maximum performance and may
be damaged, resulting in a safety hazard.
CAUTION
For quality improvement, specifications are subject to change without prior
notice.
■ Standard Accessories
No. Item Model Type Q’ty Note
c Attachment cover 1
d Operation Manual 1 This manual
c
16
■ Optional Accessories (sold separately)
The following accessories are available as optional for the HLX-801. Purchase them as
required.
In order to satisfy product performance requirements, always use the accessories
specified by Fukuda Denshi. When ordering spare parts, inform Fukuda Denshi of the
Model Type.
Mounting Bracket
Item Model Type Note
HLX-801 mounting
bracket
(For DS-8500)
OAT-8185A
A mounting bracket to fix the HLX-
801 to the DS-8500 and the cable to
connect the HLX-801 to the DS-8500
17
9. Specification
■ Specification
CAUTION
For quality improvement, specifications are subject to change without prior
notice.
Standard Specification
Size: 42(W)×93(D)×16(H) mm
(not including the antenna, protrusion, and option unit)
Weight: Approx. 60g
Communication method
Modulation method: F1D
Frequency: 608MHz to 614MHz
Oscillation method: PLL Synthesizer method by crystal control
Channel spacing: 12.5kHz
Occupied bandwidth: Within 8.5kHz
Frequency deviation: Within ±2.5ppm
Adjacent channel power
ratio:
-40dBc or below
Effective radiated power: Within 1mW ±2dBm
Transmission antenna: 1/4λwhip
Gain 2.14dBi or below
Safety
General
Standard: IEC 60601-1: 1988 +Am1:1991 +Am2:1995
(Medical Electrical Equipment- Part 1: General Requirements for
Safety)
EM Standard: IEC 60601-1-2:2007
(Medical electrical equipment – Part 1: General requirements for
safety – 2. Collateral standard: Electromagnetic compatibility –
Requirements and tests)
18
Operating Environment
Temperature: 10 to 40°C
Humidity: 30 to 85%RH (non-condensing)
Vibration/Shock: Comply with IEC60068-2-64：2008, IEC60068-2-32
Ed.2:1975 Amd.1:1982 Amd.2:1990, IEC60068-2-6：
2007,
IEC60068-2-27：2008
Transport and Storage Environment
Temperature: -10 to 60°C
Humidity: 10 to 95% (non-condensing)
Head office : 39-4, Hongo 3-chome, Bunkyo-ku, Tokyo, Japan
Phone : -81-3-3815-2121
Fax : -81-3-3814-1222
Printed in Japan 4L0108010 201110