Fukuda LX-8000 Series User manual

*
Before installation/maintenance,
read this service manual thoroughly.
*
After reading this service manual,
store it in a safe place.
ServiceManual
LX-8000 series
ECG & Respiration Transmitter
LX-8100
LX-8100(G)

©2018 Fukuda Denshi Co., Ltd.
No part of this document may be reproduced or transmitted in any form without the prior written
permission of Fukuda Denshi Co., Ltd.
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.
CAUTION
Federal Law restricts this device to sale by or on the order of a physician.
CAUTION
<For USA>
This device bears the CE label in accordance with the provisions of Medical Device Directive
93/42/EEC.
This device bears the CE label in accordance with the provisions of RE Directive 2014/53/EU.
This device bears the CE label in accordance with the provisions of RoHS Directive 2011/65/EU.
We, FUKUDA DENSHI CO., LTD. hereby declare that this transmitter model LX-8100 is in compliance
with the essential requirements and other relevant provisions of RE Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
http://fukuda.com/
<For Europe>
Fukuda Denshi Co., Ltd.
3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan
Fukuda Denshi UK
Unit 7, Genesis Business Park, Albert Drive, Woking, Surrey GU21 5RW, United Kingdom

Revision History
Equipment
LX-8100/LX-8100(G) Service Manual
Edition Revised Items Reason of the Revision Date
1
－
New Edition 2018.01
2 The entire document Added description of LX-8100(G). 2018.08

i
Preface
Before using this product, read the following precautions to make sure the product is
used correctly and safely.
Safety Precautions ........................................................ ii
Graphic Symbols ....................................................... iii
Symbols indicated on the main unit .......................... iii
Symbols indicated on the screen .............................. iv
Precautions for Safe Operation of Medical Electrical
Equipment ................................................................. v
Non-Explosion Proof .................................................. vi
Precautions about Magnetic Resonance Imaging
(MRI) ......................................................................... vi
Electrosurgery Safety ................................................ vi
Defibrillation Safety ................................................... vii
Precautions about the Pacemaker ........................... vii
Precautions about the LX-8100/LX-8100(G) ............ vii
Precautions about Waterproof ................................. viii
Precautions about ECG ........................................... viii
Precautions about Output Signal ............................... i x
Precautions about Accessories and Optional
Accessories ............................................................... ix
Precautions about Battery ......................................... ix
Precautions about Nickel Metal Hydride Battery (for
Europe) ...................................................................... ix
Precautions about Disposing of Equipment,
Accessories, or Components ..................................... ix
Precautions about Disposing of Battery ..................... x
Precautions about Disposing of Nickel Metal Hydride
Battery (for Europe) ................................................... x
Precautions for Use of Medical Telemeter (for Europe)
.................................................................................. x
Precautions for Use of Medical Telemeter (for USA) . xi
Electromagnetic Compatibility (for Europe) ............ xiii
Precautions for Safe Operation under Electromagnetic
Influence .................................................................. xiii
EMC Guidance ........................................................ xiv
●Compliance to the Electromagnetic Emissions ... xiv
●Compliance to the Electromagnetic Immunity ...... xv
Electromagnetic Compatibility (for USA) ................. xvi
Precautions for Safe Operation under Electromagnetic
Influence .................................................................. xvi
EMC Guidance ....................................................... xvii
●Compliance to the Electromagnetic Emissions .. xvii
●Compliance to the Electromagnetic Immunity ... xviii

ii
Safety Precautions
Read the “Safety Precautions” thoroughly before use to ensure correct and safe use of the product. 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 or
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 equipment.

iii
Graphic Symbols
Refer to the following symbols indicated on the LX-8100/LX-8100(G) for their meanings.
Symbols indicated on the main unit
<For Europe>
Symbol Description
Warning (indicated in yellow)
Follow operating instructions (Warning); (indicated in blue)
Indicates that the failure to follow operating instructions could place the patient or
operator at risk.
Type CF Applied Part with Defibrillation-Proof
Indicates that the degree of protection against electric shock is Type CF Applied Part
with defibrillation-proof.
Indicates the power ON/OFF status.
Indicates the point to close the battery compartment lid.
Indicates the battery type and direction.
Name and Address of Manufacturer
Date of Manufacture
Indicates the name and address of manufacturer, and date of manufacture.
WEEE (Waste Electrical and Electronics Equipment)
Indicates a separate collection for electrical and electronic equipment.
Non-ionizing electromagnetic radiation
Indicates the radio transmitting device.

iv
<For USA>
Symbol Description
Warning (indicated in yellow)
Follow operating instructions (Warning); (indicated in blue)
Indicates that the failure to follow operating instructions could place the patient or
operator at risk.
Follow operating instructions (Information);
Indicates the need to refer to the related accompanying documents before operation.
Type CF Applied Part with Defibrillation-Proof
Indicates that the degree of protection against electric s
hock is Type CF Applied Part
with defibrillation-proof.
Indicates the power ON/OFF status.
Indicates the point to close the battery compartment lid.
Indicates the battery type and direction.
Name and Address of Manufacturer
Date of Manufacture
Indicates the name and address of manufacturer, and date of manufacture.
Date of Manufacture
Indicates the date of manufacture.
Non-ionizing electromagnetic radiation
Indicates the radio transmitting device.
Symbols indicated on the screen
<For Europe and USA>
Symbol Description
Synchronized Mark
This mark flashes synchronizing to the heartbeat.
Indicates the remaining battery level.

v
Precautions for Safe Operation of Medical Electrical Equipment
Cautions described here are regarding the general instructions for safety use to the patient and the
users. As for cautions about the LX-8100/LX-8100(G), please refer to the following pages.
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 a place where the equipment will be subjected 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 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 gas may generate.
3. Before operating the equipment, verify the following items.
Check the cable connection and polarity to ensure 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 as it may cause
erroneous diagnosis 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 and/or detaching the probe (sensor) and/or electrode, in the safest way for
the patient.
Do not allow the patient to come in contact with other equipment.
5. After using the equipment, 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 on the cable and pull from its connector.
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 battery if the equipment is not used for a long time. The leakage from the
battery may damage the equipment or an explosion from the battery 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. Users should not attempt
service.
7. Do not disassemble or remodel the equipment.
8. Maintenance
Make sure to periodically check the equipment and accessories.
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 burn injury to the patient, verify proper attachment of the patient ground plate, the ECG
electrode type for the electrosurgical knives, and the quantity of gel, output energy for the defibrillator.
Also, verify that a proper ground is selected.
Some types of equipment other than above may cause accidental hazards to the patient and operator
due to the conditions of the equipment. Read the operation manual attached to each equipment and
understand the precautionary instructions prior to use.

vi
Non-Explosion Proof
DANGER
Never operate the equipment in the presence of flammable anesthetics, 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.
Precautions about Magnetic Resonance Imaging (MRI)
WARNING
Do not operate this equipment in magnetic resonance imaging (MRI) environments.
When conducting MRI test, remove the electrodes and sensors connected to the patient
(test subject).
The local heating caused by the induced electromotive force may cause burn injury to the
patient (subject). For details, refer to the operation manual for the MRI testing device.
Electrosurgery Safety
WARNING
The monitoring system contains protection against interference generated by electrosurgical
instruments. However, depending on the operating conditions, surgery site with respect to the
location of ECG electrodes, ground plate attachment condition, or the type of instrument used, it
may cause burn injury at the electrode site or noise on the ECG. The noise is generated at the tip
of the electrosurgical knife and is difficult to completely eliminate because of the frequency
components of the ECG. To reduce electrosurgical interference, take the following precautions:
Location:
Locate the electrosurgical unit as far as possible from this equipment and the patient cable.
This will help reduce interference on the ECG through the monitor or cables.
Electrode Placement:
The amount of noise interference is considerably different depending on the electrode position
and surgery site. Place the ECG electrodes as far away as possible from the surgery site and
the ground plate. Do not place electrodes in the path between the surgery site and the ground
plate. If the electrodes are placed in this path, the amount of interference will be quite large.
Position (+) and (–) electrodes as close as possible to each other.
Ground Plate:
When using electrosurgical instruments, make sure the contact between the patient and the ground
plate is secure. If the connection is incomplete, the patient may suffer from burn at the electrode site.

vii
Defibrillation Safety
WARNING
Use only the lead cable specified by Fukuda Denshi when defibrillating. If used by
unspecified lead cable, the equipment may be damaged, resulting in a safety hazard.
When using the defibrillator, keep away from the electrodes or medicament applied to the
patient chest. If this is not possible, remove the electrodes or medicament before using it.
If the defibrillator paddles are directly in contact with the electrodes or medicament, an
electrical shock may result from the discharged energy.
When using the defibrillator, do not touch the patient and the metal part of the equipment or
cables. Electric shock may result from the discharged energy.
This equipment will return to standard operating mode within 10 seconds after defibrillating.
The stored data will not be affected.
The measurement accuracy will temporarily decrease during defibirillation, but it will not
compromise the safety of patient and the equipment.
Precautions about the Pacemaker
WARNING
Minute ventilation rate-adaptive implantable pacemakers can occasionally interact with
certain cardiac monitoring and diagnostic equipment, causing the pacemakers to pace at
their maximum programmed rate. The cardiac monitoring and diagnostic equipment may
possibly send wrong information.
If such event occurs, disconnect the cardiac monitoring and diagnostic equipment, or follow
the procedures described in the operation manual of the pacemaker.
Rate meters may continue to count the pacemaker rate during occurrences of cardiac
arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker
patients under close surveillance.
➡Reference
“Minute Ventilation Rate-Adaptive Pacemakers”
FDA alerts health professionals that minute ventilation rate-adaptive implantable pacemakers
can occasionally interact with certain cardiac monitoring and diagnostic equipment, causing
pacemakers to pace at their maximum programmed rate.
[October 14, 1998 –FDA]
Precautions about the LX-8100/LX-8100(G)
WARNING
Do not connect cables not authorized by Fukuda Denshi to any I/O connector. If done so by
mistake, the LX-8100/LX-8100(G) cannot deliver its maximum performance and may be
damaged, resulting in a safety hazard.
Do not use this equipment with multiple patients simultaneously.
This equipment itself has no alarm function. Do not use it if an alarm function is necessary.
The alarm function with the receiving monitor, refer to the operation manual of the receiving
monitor.
CAUTION
Do not pick up and/or swing the LX-8100/LX-8100(G) pulling/grabbing the probe (sensor) or
cord part. The cable could break or get disconnected from the LX-8100/LX-8100(G). And it
may hit people or damage other equipment around.

viii
Precautions about Waterproof
CAUTION
Replace the “Battery Compartment Lid Unit” of the LX-8100/LX-8100(G) regularly to keep
the performance of waterproof. If not regularly replaced, the quality of the unit will
deteriorate and cannot keep the waterproof performance.
The equipment may be damaged from high impact. If the transmitter is dropped or is
subjected to a high impact, make sure that the transmitter is not damaged.
The lid may be damaged from high impact. If the LX-8100/LX-8100(G) is dropped or is
subjected to a high impact, make sure that the lid is not damaged.
Do not use the LX-8100/LX-8100(G) wet. Always wipe the LX-8100/LX-8100(G) with a soft
cloth and dry it thoroughly before use.
Precautions about ECG
CAUTION
When removing electrodes from the patient, remove them carefully and slowly. Do not
apply excessive force to remove them. Otherwise, it may damage the skin.
If any electrodes get detached from the patient after being connected to the lead cable and
the patient monitor, pay attention that the metal part of the electrode does not get in touch
with any metal parts of the bed or any conductive parts. Also, the operator should not touch
any conductive parts with bare hands. Otherwise, it may cause electric shock to the patient
and/or operator due to excessive leakage current.
The indication for continuous use of the electrode is about one day.
Replace the electrode if the skin contact gets loosen due to perspiration, etc.
When an electrode is attached to the same location for a long period, some patients may
develop skin irritation. Check the patient's skin condition periodically and change the
electrode site as required.
For stable ECG monitoring, verify proper electrode placement, lead, and waveform size. If
not properly selected, it may cause erroneous detection.
There are some cases when the pacemaker pulse cannot be detected depending on the
pacemaker type, pulse voltage, pulse width, electrode lead type (unipolar, bipolar), or
electrode placement which causes the pacemaker pulse amplitude to decrease, and
disables the pacemaker pulse detection.
If signals similar to a pacemaker pulse are present, such as electric blanket noise or
excessive AC frequency noise, these may be erroneously detected and displayed as a
pacemaker pulse. In this case, check the condition of the electrodes and ECG lead cable to
resolve the cause or turn off the pacemaker detection setting on the receiving monitor.
If a pacemaker pulse is continuously detected due to AC frequency interference, QRS
detection will be suspended and the heart rate will be reduced.
If an arrhythmia accompanied by an irregular rhythm occurs, there is a possibility of
temporarily displaying an incorrect heart rate. When using this device in conjunction with
an electrocautery scalpel, noise from an electric scalpel may be misrecognized as
heartbeat or arrhythmia.

ix
Precautions about Output Signal
WARNING
Do not use the output signal of the monitor that receives radio wave signal from the
LX-8100/LX-8100(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.
Precautions about Accessories and Optional Accessories
WARNING
Use only the accessories such as disposable electrodes and electrode codes specified by
Fukuda Denshi. Otherwise, this equipment cannot deliver its maximum performance and may
be damaged, resulting in a safety hazard.
CAUTION
Do not reuse disposable products.
Store the disposable products properly as mentioned in their user manuals.
Precautions about Battery
WARNING
Use new "AA" size (“LR6” size) alkaline cell.
Install the battery with the correct polarity.
Do not charge the battery. Any attempt to charge the battery may cause it to leak or break.
Do not short the (+) and (-) terminals. It may result in exothermic heat and fire.
Do not throw the battery into fire. It may explode.
Precautions about Nickel Metal Hydride Battery (for Europe)
WARNING
Use "AA" size (“HR6” size) fully charged nickel metal hydride battery.
Install the battery with the correct polarity.
Read the manual of the battery, charger and accessories prior to use.
Do not short the (+) and (-) terminals. It may result in exothermic heat and fire.
Do not throw the battery into fire. It may explode.
Precautions about Disposing of Equipment, Accessories, or Components
CAUTION
When disposing of equipment, accessories, or components, use an industrial waste
distributor. Do not dispose of as ordinary waste.
Used disposal items (ECG electrodes, etc.) shall be discarded as medical waste.

x
Precautions about Disposing of Battery
CAUTION
Follow the local municipal rule to dispose the used dry cell batteries.
Precautions about Disposing of Nickel Metal Hydride Battery (for Europe)
CAUTION
Recycling is recommended for used nickel metal hydride batteries. For details, refer to the
manual attached to the battery.
Follow the local municipal rule to dispose nickel metal hydride batteries.
Precautions for Use of Medical Telemeter (for Europe)
WARNING
The LX-8100 transmitter must not be co-located or operated in conjunction with any other
antenna or transmitter.
For the receiving monitor of the LX-8100 transmitter, make sure to use the Fukuda Denshi
products with the receiving range of 433 MHz-435 MHz.
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 LX-8100 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 to follow the precautions below.
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.

xi
CAUTION
For management, make sure to follow the precautions below.
The Institution should appoint a person (hereinafter referred to as the “Coordinator”) to manage the
wireless channels for the whole Institution.
The Coordinator must be selected from people who understand the characteristics and functionality
of telemetry systems, and are skilled in operating telemetry.
When installing telemetry, the Coordinator has to understand the precautions for use of telemetry in
advance.
The Coordinator is responsible for maintenance of wireless channels and storage and maintenance
of telemeter in the overall medical facilities to give proper instructions to the telemetry users.
The Coordinator 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 user.
The telemetry user verifies operation of the transmitter/receiver before use.
When interference or breakdown occurs in telemetry communication, the user is required to inform
the Coordinator of the problems.
Precautions for Use of Medical Telemeter (for USA)
WARNING

The LX-8100/LX-8100(G) transmitter must not be co-located or operated in conjunction
with any other antenna or transmitter.
For the receiving monitor of the LX-8100 transmitter, make sure to use the Fukuda Denshi
products with the receiving range of 608 MHz-614 MHz.
For the receiving monitor of the LX-8100(G) transmitter, make sure to use the Fukuda
Denshi products with the receiving range of 1395 MHz-1400 MHz and 1427 MHz-1432
MHz.
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 has very low levels of RF
energy that are deemed to comply without testing of specific absorption rate (SAR).
Operation of LX-8100/LX-8100(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 LX-8100/LX-8100(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
For installation, make sure to follow the precautions below.
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.

xii
CAUTION
For management, make sure to follow the precautions below.
The Institution should appoint a person (hereinafter referred to as the “Coordinator”) to manage the
wireless channels for the whole Institution.
The Coordinator must be selected from people who understand the characteristics and functionality
of telemetry systems, and are skilled in operating telemetry.
When installing telemetry, the Coordinator has to understand the precautions for use of telemetry in
advance.
The Coordinator is responsible for maintenance of wireless channels and storage and maintenance
of telemeter in the overall medical facilities to give proper instructions to the telemetry users.
The Coordinator 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 user.
The telemetry user verifies operation of the transmitter/receiver before use.
When interference or breakdown occurs in telemetry communication, the user is required to inform
the Coordinator of the problems.

xiii
Electromagnetic Compatibility (for Europe)
This equipment complies with EN 60601-1-2 (2015), safety standard regarding the electromagnetic
disturbances of medical electrical equipment. To ensure maximum performance against the
electromagnetic disturbances, make sure to follow the precautions for installation and usage described
in this manual.
●This equipment is intended for use in the medical facility (except inside the shield room of MRI device),
and satisfies the immunity level for professional healthcare facility environment stipulated in
EN 60601-1-2.
●An excessive magnetic disturbance may degrade the HR measurement accuracy (refer to
2. Specification, ECG, HR measurement detection), which is the essential performance of this equipment,
and may cause delay in treatment or inaccurate diagnosis.
●When using this equipment, interference with other medical electrical equipments or non-medical
electrical equipments may oocur. Make sure that no interference is present before usage.
●To ensure basic safety and essential performance related to electromagnetic distrubances during the
expected service life of this equipment, “Daily Check” and “Periodic Check” must be performed.
(refer to 7. Maintenance and Inspection)
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 equipment may occur. If any unintended
malfunction or noise occurs during monitoring, check the magnetic influence and take
appropriate countermeasures.
The followings are examples of the common cause and countermeasures.
●Mobile Phone
The radio wave may cause malfunction to the equipment.
Mobile phones and radio sets should be turned off in the room (building) where 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.
CAUTION
If this equipment is installed close to, or stacked with other equipment, malfunction may
occur. Make sure to verify that the equipments operate properly in a used location.
Use of accessories, probes, or cables other than specified may cause increase in
electromagnetic emission or decrea
se in electromagnetic immunity resulting in malfunction of
the equipment.
The portable RF communications equipment (including antenna cable and peripheral
equipment such as external antenna) with the specified cable should be used in a location at
least 30 cm apart from any part of this equipment. Otherwise, it may result in performance
degradation of this equipment.

xiv
EMC Guidance
This equipment complies with EN 60601-1-2 (2015). 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, etc.
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 technician.
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
This equipment complies with the following emission standard.
Emission test Compliance
RF Emission
EN 55011 Group 1 Class A
CAUTION
The emission performance of this equipment is suitable for use in industrial environment and
hospital environment (EN 55011 Class A). To use in home environment (generally, EN 55011
Class B is required), this equipment may not be properly protected from wireless frequency
communication service. It may be necessary to take measures such as changing the
installation location or equipment orientation.

xv
●Compliance to the Electromagnetic Immunity
The LX-8100 is intended for use in the electromagnetic environment specified below. The customer or
the user of the LX-8100 should assure that it is used in such an environment.
Basic EMC standard or test method Immunity test levels
Electrostatic discharge
IEC 61000-4-2 ±8kV contact
±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM fields
IEC 61000-4-3 10V/m 80MHz to 2.7GHz
1kHz 80%AM
Proximity fields from RF wireless
communications equipment
IEC 61000-4-3
Refer to the following table.
Conducted disturbances induced by RF
fields
IEC 61000-4-6
3V
0.15MHz to 80MHz
1kHz 80%AM
6V
0.15MHz to 80MHz
(in ISM bands between 0.15 MHz and 80MHz)
1kHz 80%AM
Rated power frequency magnetic fields
IEC 61000-4-8 30A/m 50Hz
Immunity test specifications for RF wireless communications equipment.
Test frequency
(MHz) Modulation Maximum power (W) Distance (m) Immunity test level (V/m)
810, 870, 930 PM, 18Hz 2 0.3 28
1720, 1845, 1970 PM, 217Hz 2 0.3 28
2450
PM, 217Hz
2
0.3
28
5240, 5500, 5785 PM, 217Hz 0.2 0.3 9

xvi
Electromagnetic Compatibility (for USA)
This equipment complies with IEC 60601-1-2 (2014), safety standard regarding the electromagnetic
disturbances of medical electrical equipment. To ensure maximum performance against the
electromagnetic disturbances, make sure to follow the precautions for installation and usage described
in this manual.
●This equipment is intended for use in the medical facility (except inside the shield room of MRI device),
and satisfies the immunity level for professional healthcare facility environment stipulated in
IEC 60601-1-2.
●An excessive magnetic disturbance may degrade the HR measurement accuracy (refer to
2. Specification, ECG, HR measurement detection), which is the essential performance of this equipment,
and may cause delay in treatment or inaccurate diagnosis.
●When using this equipment, interference with other medical electrical equipments or non-medical
electrical equipments may oocur. Make sure that no interference is present before usage.
●To ensure basic safety and essential performance related to electromagnetic distrubances during the
expected service life of this equipment, “Daily Check” and “Periodic Check” must be performed.
(refer to 7.Maintenance and Inspection)
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 equipment may occur. If any unintended
malfunction or noise occurs during monitoring, check the magnetic influence and take
appropriate countermeasures.
The followings are examples of the common cause and countermeasures.
●Mobile Phone
The radio wave may cause malfunction to the equipment.
Mobile phones and radio sets should be turned off in the room (building) where 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.
CAUTION
If this equipment is installed close to, or stacked with other equipment, malfunction may
occur. Make sure to verify that the equipments operate properly in a used location.
Use of accessories, probes, or cables other than specified may cause increase in
electromagnetic emission or decrease in electromagnetic immunity resulting in malfunction of
the equipment.
The portable RF communications equipment (including antenna cable and peripheral
equipment such as external antenna) with the specified cable should be used in a location at
least 30 cm apart from any part of this equipment. Otherwise, it may result in performance
degradation of this equipment.