Fukuda Denshi Co HLX801G Users manual

This operation manual is for the HLX-801(G) Ver. 01.

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.

• 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.

© 2016 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.

Thank you for purchasing the HLX-801(G) telemetry transmitter 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 immediate

DANGER

WARNING

CAUTION

NOTE

Precaution from Fukuda Denshi

Fukuda Denshi is liable for the safety, reliability, and performance of its equipment
only if;

 Maintenance, modifications, and repairs are carried out by authorized personnel

or organization.

 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.

threat of death or serious injury.

Failure to follow this message may result in death or
serious injury.

Failure to follow this message may cause injury or
failure to 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(G).

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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(G)

Symbol Description

UFollow operating instructions (Information)

Indicates the need to refer to related accompanying documents
before operation.

Year of Manufacture
Indicates the manufactured year.

Serial Number

WEEE (Waste Electrical and Electronics Equipment)

UIndicates a separate collection for electrical and electronic

equipment.

Non-ionizing radiation
Indicates the including RF transmitter.

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Precautions for Safe Operation of Medical Electrical Equipment

Cautions described here are regarding the general instructions for safety use to the
patient and users. Precautions unique to this device are detailed throughout the manual.

CAUTION

1. Users should have a thorough knowledge of the operation before using this
equipment.

2. Pay attention to the following when installing or storing the equipment.

 Do not install or store in an area where the unit will be subject to splashing

water.

 Do not install or store in an area where the environmental conditions, such

as atmospheric pressure, temperature, humidity, ventilation, sunlight, dust,
sodium, sulfur, will adversely affect the equipment.

 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 equipment, verify the following items.

 Check the cable connection and polarity to ensure safe and proper

operation of the equipment.

 Ensure that all cables are firmly and safely connected. Especially, recheck

the attachment and connection condition of electrodes and transducers.

 Pay special attention when the equipment is used in conjunction with other

equipment because it may cause erroneous judgment and danger.

 Check the remaining battery level.

When replacing the battery, make sure that the battery polarity is correct.
Do not charge the battery.

4. During operation of the equipment, verify the following items.

 Do not operate the equipment beyond the time period required for

diagnosis and medical care.

 Do not pick up and/or swing the equipment pulling/grabbing the probe

(sensor) or cable part. It may damage the equipment and lead to
measurement error.

 Always observe the equipment and patient to ensure safe operation of the

equipment.

 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.

 Do not allow the patient to come in contact with the equipment.

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CAUTION

5. After using the device, verify the following items.

 Return all operating switches or knobs 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 from the connector part of the cable.

 Clean the accessories and cables, and keep them together in one place.
 Keep the equipment clean to ensure proper operation for the next use.
 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 is damaged and in need of repair, ensure patient safety by
immediately turning the equipment off and remove the electrodes and/or
probe from the patient. 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 equipment and accessories.

(Maintenance contract is recommended.)

 Before reusing the equipment that has been left unused for a while, make

sure that the equipment works normally and safely.

9. When using electrosurgical knives or defibrillator with this equipment, take
care of the following.

 To prevent patient from burn injury, verify proper attachment of patient

ground plate, ECG electrode type when using the electrosurgical knife,
and verify paste volume, output energy when using the defibrillator.

 Some types of equipment 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

 Never operate the equipment in the presence of flammable anesthetics or

high concentration of oxygen. It may cause an explosion or fire.

 Never operate the equipment inside a hyperbaric chamber.

It may cause an explosion or fire.

 Never operate the equipment where flammable gas or fluid such as

anesthetic, oxygen, and hydrogen are used.
It may cause an explosion or fire.

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Precautions about Magnetic Resonance Imaging (MRI)

WARNING

 Do not use this equipment in magnetic resonance imaging (MRI)

environments.
This equipment may be pulled towards the MRI device. And 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

 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.

 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.
Otherwise, the HLX-801(G) cannot deliver its maximum performance and may
be damaged, resulting in a safety hazard.

Precautions about Output Signal

WARNING

Do not use the output signal of the monitor that receives radio wave signal from
the HLX-801(G) as the trigger signal for IABP, MRI, echocardiographic, or
defibrillator for the following reasons. It may lead to a delay of operating timing
due to the delay time of waveform transmission. A trigger signal unrelated to the
heart rate may be generated due to the interfusion of spike noise at weak
electric field.

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Precautions about Alarm

CAUTION

 The alarm generation may be delayed between 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.

 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.

 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.

Precautions about Cleaning and Disinfection

CAUTION

 Wipe using gauze or absorbent cotton etc. that has been soaked in alcohol, or

a weak acidic, weak alkaline, or neutral detergent and wrung. 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.

 If there is a fear of contagion, wipe using a gauze or absorbent cotton soaked

in antiseptic soap or alcohol and wrung. At this time, do not immerse the
connector parts of the equipment in any chemical solution. Doing so may
cause contact failure.

 Sterilizing in high-temperature by using gas sterilization or autoclave

equipment will damage this product, and should therefore not be used.

 When sterilizing the entire room using a spray solution, pay close attention not

to have liquids get into the equipment or connectors.

Precautions about Disposing of Equipment, Accessories, or
Components

CAUTION

 When disposing of the equipment, accessories, or components, use an

industrial waste distributor. Do not dispose of as ordinary waste.

 Used disposal items shall be discarded as medical waste.

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Precautions for Safe Operation of Medical Telemetry

WARNING

The HLX-801(G) transmitter must not be co-located or operated in

conjunction with any other antenna or transmitter.

This equipment complies with FCC/IC radiation exposure limits set forth for

an uncontrolled environment and meets the FCC radio frequency (RF)
Exposure Guidelines and RSS-102 of the IC radio frequency (RF) Exposure
rules. This equipment should be installed and operated keeping the radiator
at least 20cm or more away from person’s body

Operation of HLX-801(G) requires the prior coordination with a frequency

coordinator designated by the FCC for the Wireless Medical Telemetry
Service.

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.

The HLX-801(G) 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

Regarding introduction, make sure of the following precautions.

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 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.

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.

The telemetry user verifies operation of the transmitter/receiver before use.

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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.

 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.

 Static Electricity

In a dry environment (room), static electricity is likely to occur. Take the
following countermeasures.

 Both operator and patient should remove any static electricity before entering

the room.

 Humidify the room.

viii

EMC Guidance

This equipment complies with IEC 60601-1-2 (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(G) system is intended for use in the electromagnetic environment
specified below.

Emissions Test Compliance

RF Emissions
CISPR 11

RF Emissions
CISPR 11

Harmonic Emissions
IEC 61000-3-2

Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3

Group 1

Class A

NA

NA

Electromagnetic Environment -

The HLX-801(G) 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(G) is suitable for use in
all establishments other than domestic
buildings and those directly connected
to a low-voltage power supply network
which supplies buildings used for
domestic purposes.

Guidance

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