Fukuda Denshi Co LX8100 ECG & Respiration Transmitter User Manual 4L0114970 LX 8100 FA V01

Fukuda Denshi Co Ltd ECG & Respiration Transmitter 4L0114970 LX 8100 FA V01

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LX8100 User Manual HTML Version

05 (Short-Term Confidential) User Manual

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Thank you for purchasing our product.

Before using this product, read this operation manual thoroughly for correct

handing and operation.

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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.

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DANGER Failure to follow this message may cause

immediate threat of death or serious injury, or

complete failure of the equipment.

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WARNING Failure to follow this message may result in death

or serious injury, or complete failure of the

equipment.

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CAUTION Failure to follow this message may cause injury or

failure of the equipment.

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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.

Precaution from Fukuda Denshi

Fukuda Denshi is responsible for the safety, reliability, and performance of its

equipment only if;

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.

Intended Use of this Equipment

This equipment is designed for the following <Intended Use>.

This equipment is intended for measuring parameters of ECG, respiration in surgery

room, ICU, ward, emergency room in the medical facility and transmitting the

measured data by wireless network to the central monitor continuously.

This equipment is intended for monitoring one patient. It is not intended for

monitoring multiple patients.

For specification of this equipment, refer to "Chapter 14 Specification" of this

manual.

This equipment is intended to be used by healthcare professionals. Users should

have a thorough knowledge of the function and operation before using this

equipment. The maintenance of this equipment should be performed by skilled

personnel who received a training of possible hazards and measures to avoid those

hazards. Also, your local regulation must be followed. If this equipment is used for

the purpose other than intended, or if the user does not follow the safety

instructions, the following hazard may result.

ȷHazard to the Life and Health of the Patient or the User

ȷA Problem Related to Medical Practice

ȷDamage to the Equipment

iii

Graphic Symbol

The following symbols are used for this equipment.

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LX-8100 Symbols indicated on the main unit

Symbol Description

Warning (indicated in yellow)

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Follow operating instructions (Warning); (indicated in blue)

Indicates that the failure to follow operating instructions

could place the patient or operator at risk.

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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.

Non-ionizing electromagnetic radiation

Indicates the radio transmitting device.

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LX-8100 Symbols displayed on the display screen

Symbol Description

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Synchronized Mark

This mark flashes synchronizing to the heartbeat.

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Indicates the remaining battery level.

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, 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.

y Do not install or store in a place where the equipment will be subjected to

splashing water.

y 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.

y Place the equipment on a stable surface where there is no inclination,

vibration, or shock (including during transportation).

y 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.

y Check the cable connection and polarity to ensure proper operation of the

equipment.

y Ensure that all cables are firmly 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 as it may cause erroneous diagnosis and danger.

y Check the remaining battery level.

y 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.

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

diagnosis and medical care.

y 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.

y Always observe the equipment 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 and/or detaching the

probe (sensor) and/or electrode, in the safest way for the patient.

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

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CAUTION

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

y Return all operating switches, knobs etc to the position before using the

equipment, and then switch off the power.

y When unplugging the cables, do not apply excessive force on the cable

and pull from its connector.

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 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. Label the unit “OUT OF ORDER” and contact Fukuda Denshi

representative.

7. Do not disassemble or remodel the eqipment.

8. Maintenance

y Make sure to periodically check the equipment and accessories.

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 electrosurgical knives or defibrillator with this equipment,

take care of the following.

y 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.

y 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.

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Non-Explosion Proof

DANGER

z Never operate the equipment in the presence of flammable

anesthetics, high concentration of oxygen. It may cause an explosion or

fire.

z Never operate the equipment inside a hyperbaric chamber. It may

cause an explosion or fire.

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

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

or fire.

vii

Precautions about Magnetic Resonance Imaging (MRI)

WARNING

z Do not operate this equipment in magnetic resonance imaging (MRI)

environments.

z 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.

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viii

Defibrillation Safety

WARNING

z 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.

z 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.

z 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.

Precautions about the Pacemaker

WARNING

z 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.

(For more details, contact FUKUDA DENSHI personnel, your

institution’s professionals, or your pacemaker distributors.)

z 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

WARNING

z Do not connect cables not authorized by Fukuda Denshi to any I/O

connector. If done so by mistake, the LX-8100 cannot deliver its

maximum performance and may be damaged, resulting in a safety

hazard.

z Do not use this equipment with multiple patients simultaneously.

z 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.

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CAUTION

Do not pick up and/or swing the LX-8100 pulling/grabbing the probe

(sensor) or cord part. The cable could break or get disconnected from the

LX-8100. And it may hit people or damage other equipment around.

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Precautions about Waterproof

CAUTION

z Replace the “Battery Compartment Lid” of the LX-8100 regularly to

keep the performance of waterproof. If not regularly replaced, the

quality of the lid will deteriorate and cannot keep the waterproof

performance. For details about the regular replacement, contact your

local Fukuda Denshi service representative.

z The lid may be damaged from high impact. If the LX-8100 is dropped or

is subjected to a high impact, make sure that the lid is not damaged.

z Do not use the LX-8100 wet. Always wipe the LX-8100 with a soft cloth

and dry it thoroughly before use.

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Precautions about ECG

CAUTION

z 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.

z 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.

z The indication for continuous use of the electrode is about one day.

z Replace the electrode if the skin contact gets loosen due to

perspiration, etc.

z 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.

z For stable ECG monitoring, verify proper electrode placement, lead,

and waveform size. If not properly selected, it may cause erroneous

detection.

z 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.

z 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.

z If a pacemaker pulse is continuously detected due to AC frequency

interference, QRS detection will be suspended and the heart rate will

be reduced.

Precautions about Output Signal

WARNING

Do not use the output signal of the monitor that receives radio wave signal

from the LX-8100 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

z Do not reuse disposable products.

z Store the disposable products properly as mentioned in their user

manuals.

Precautions about Battery

WARNING

z Use new "AA" size (“LR6” size) alkaline cell.

z Install the battery with the correct polarity.

z Do not charge the battery. Any attempt to charge the battery may

cause it to leak or break.

z Do not short the (+) and (-) terminals. It may result in exothermic heat

and fire.

z Do not throw the battery into fire. It may explode.

Precautions about Disposing of Equipment, Accessories, or

Components

CAUTION

z When disposing of equipment, accessories, or components, use an

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

z Used disposal items (ECG electrodes, etc.) shall be discarded as

medical waste.

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Precautions about Disposing of Battery

CAUTION

Follow the local municipal rule to dispose the used dry cell batteries.

xii

Precautions for Use of Medical Telemeter

WARNING

z The LX-8100 transmitter must not be co-located or operated in

conjunction with any other antenna or transmitter.

z 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).

z Operation of LX-8100 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 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 of the following.

y 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.

y When laying receiver antenna for each transmitter, the Institution has to

examine the installation so that electronic interference does not occur.

y Based on the above examination result, the Institution should install each

receiver antenna as required.

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xiii

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CAUTION

For management, make sure to follow the precautions below.

y The Institution should appoint a person (hereinafter referred to as the

“Coordinator”) to manage the wireless channels for the whole Institution.

y The Coordinator 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 Coordinator has to understand the

precautions for use of telemetry in advance.

y 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.

y 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,

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

y When interference or breakdown occurs in telemetry communication, the

user is required to inform the Coordinator of the problems. The Coordinator

is to deal with the problem properly and/or contact their nearest Fukuda

Denshi representative for service.

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xiv

Electromagnetic Compatibility

This equipment complies with IEC 60601-1-2 (2014), safety standard

regarding the electromagnetic distrubances of medical electrical equipment. To

ensure maximum performance against the electromagnetic distrubances,

make sure to follow the precautions for installation and usage described in this

manual.

ŪThis 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.

ŪAn excessive magnetic disturbance may degrade the HR measurement

accuracy (refer to 14. Specification, ECG, HR measurement detection),

which is the essential performance of this equipment, and may cause delay

in treatment or inaccurate diagnosis.

ŪWhen 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.

ŪTo 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 12.Maintenance and Inspection)

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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.

ەMobile 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.

ەStatic 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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CAUTION

z 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.

z 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.

z 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.

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xvi

EMC Guidance

This equipment complies with IEC 60601-1-2 (2014). 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.)

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䖃Compliance to the Electromagnetic Emissions

This equipment complies with the following emission standard.



Emission test Compliance

RF Emission

CISPR 11 Group 1 Class A



CAUTION

The emission performance of this equipment is suitable for use in industrial

environment and hospital environment (CISPR 11 Class A). To use in

home environment (generally, CISPR 11 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.

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xvii



䖃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 r8kV contact

r2kV, r4kV, r8kV, r15kV 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

0.15MHz to 80MHz

1kHz80%AM

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)

710, 745, 780 PM, 217Hz 0.2 0.3 9

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



xviii

Contact

If you need more information, please contact the following.

(1) Fukuda Denshi Co., Ltd., Head Office

3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan

Tel: +81-3-5684-1455 Fax: +81-3-3814-1222

E-mail: info@fukuda.co.jp

Home Page: http://www.fukuda.com

(2) Sales Representative

Write the name, address, phone, fax number of your local sales

representative.

(Name of Sales Representative, Address, Phone/Fax)



Contents

Safety Precautions ............................................................................................. i

Precaution from Fukuda Denshi ................................................................ i

Intended Use of this Equipment ............................................................... ii

Graphic Symbol ...................................................................................... iii

Precautions for Safe Operation of Medical Electrical Equipment ............. v

Non-Explosion Proof ............................................................................... vi

Precautions about Magnetic Resonance Imaging (MRI) ........................ vii

Electrosurgery Safety ............................................................................. vii

Defibrillation Safety ............................................................................... viii

Precautions about the Pacemaker ........................................................ viii

Precautions about the LX-8100 ............................................................... ix

Precautions about Waterproof ................................................................ ix

Precautions about ECG ........................................................................... x

Precautions about Output Signal ............................................................. x

Precautions about Accessories and Optional Accessories ..................... xi

Precautions about Battery ....................................................................... xi

Precautions about Disposing of Equipment, Accessories, or Components

........................................................................................................... xi

Precautions about Disposing of Battery .................................................. xi

Precautions for Use of Medical Telemeter ............................................. xii

Electromagnetic Compatibility ................................................................... xiv

Precautions for Safe Operation under Electromagnetic Influence ......... xiv

EMC Guidance ...................................................................................... xvi

Contact ......................................................................................................... xviii

1. General Description ...................................................................................... 1

2. Names of Parts and Their Functions ............................................................. 3

3. Preparation ................................................................................................... 5

(1) Installing the Battery ........................................................................... 5

(2) Operating Power Switch ..................................................................... 9

4. ECG Monitoring .......................................................................................... 11

ŠConnecting the ECG Lead Cable and Electrodes .............................. 11

ŠAttaching the Electrodes .................................................................... 14

ŠConnecting the ECG Lead Cable to the LX-8100 ............................... 15

5. Respiration Monitoring ................................................................................ 17

6. Measurement .............................................................................................. 19

ŠStarting Screen ................................................................................... 19

ŠWaveform Display Screen .................................................................. 19

ŠBattery Level Check ........................................................................... 21

ŠWaveform Display .............................................................................. 22

7. Operation .................................................................................................... 31

ŠChanging Setup .................................................................................. 31

ŠRestarting the display ......................................................................... 37

ŠPressing the EVENT button ................................................................ 37

8. Other Setting Items ..................................................................................... 39

ŠChanging the Time Constant .............................................................. 40

ŠChanging the Detection Sensitivity of the Pacemaker Pulse .............. 40

ŠChanging QRS Detection ................................................................... 41

ŠChanging the Respiration Detection Signal ON/OFF ......................... 42

ŠChanging the display Brightness ........................................................ 42

ŠChanging Display Timeout Duration ................................................... 42

ŠChanging Sound ON/OFF .................................................................. 43

9. Changing the Transmitter Channel and Group ID ....................................... 45

ŠChanging the Transmitter Channel ..................................................... 45

ŠChanging the Group ID ...................................................................... 45

10. Troubleshooting ........................................................................................ 47

ŠList of Displayed messages ................................................................ 47

ŠIn Case of Dropping the LX-8100 into Water ...................................... 51

11. Cleaning and Disinfection ......................................................................... 53

ŠCleaning ............................................................................................. 53

ŠDisinfection ......................................................................................... 53

ŠCleaning the ECG lead cable ............................................................. 54

12. Maintenance and Inspection ..................................................................... 55

ŠRepairing the Equipment .................................................................... 63

ŠReplacing the Battery Compartment Lid Unit ..................................... 63

13 . Standard and Optional Accessories ......................................................... 67

ŠStandard Accessories ........................................................................ 67

ŠOptional Accessories .......................................................................... 68

14. Specification .............................................................................................. 69

ŠSpecification ....................................................................................... 69

ŠDisplays .............................................................................................. 73

ŠDetails of the “Electrode” Message .................................................... 75

ŠList of Setup Items .............................................................................. 76



1. General Description

The LX-8100 is a telemetry transmitter designed to measure the ECG and

respiration waveform with a “AA” size (“LR6” size) alkaline battery.

Information such as ECG measurements, respiration waveform, battery level,

and the conditions of the ECG electrodes are displayed on the front panel.

ECG lead selection is available using the two buttons (ENTER and ť) on the

front panel (In case of using a 3-electrode lead cable or a 5-electrode chest

lead cable).

Before using the LX-8100, read also the operation manual of the patient

monitor at the receiving side thoroughly.

External Appearance



1. General Description



2. Names of Parts and Their Functions



ECG/RESP Input Connector

Connects the ECG lead cable to

measure ECG and respiration

waveform.

Refer to “Safety

Precautions in this

manual’s preface”

EVENT Button

Transmits EVENT Information

Display

Displays measurement

waveform and

transmitter information.

Power Switch

Turns ON/OFF the power

Electrode Position Label

Indicates standard ECG

electrode position.

Channel Number

Indicates transmitter channel

number.

Power Supply LED

Indicates the power supply status

x Light ON: In nomal operation

x Light OFF: Power Off

ENTER Button

For Setup

ۃButton

For Setup

2. Names of Parts and Their Functions



Strap Hole

Attaches the strap.

Battery Lid Lock Button

Unlocks the battery compartment lid.

Refer to “Safety Precautions” in

this manual’s preface.

Battery Compartment Lid Open/Close Lever

To open/close the battery compartment lid,

slide this lever up/down.

3. Preparation

(1) Installing the Battery

The LX-8100 functions with an “AA” size (“LR6” size) alkaline battery. Use the

battery specified by Fukuda Denshi.

Use a newßAA” size (“LR6” size) alkaline battery.

Specified types of batteries

Type Product Manufacturer Operation time

“AA” size (“LR6” size)

alkaline battery MX1500 DURACELL

Approximately

6 days*1

*1: When using a new battery.

(ECG measurement, RESP measurement, Default setting, Operating

environments in 23qC)

*The operation times are estimated for operations with specified types of

batteries by Fukuda Denshi.

WARNING

z Unplug the ECG lead cable when the battery compartment lid is

opened. Otherwise, patient leakage current beyond the allowable value

may occur.

z Use a new ”AA” size (“LR6” size) alkaline battery.

z Do not short out the (+) and (-) terminals. It may result in exothermic

heat and fire, the leakage from the batteries may damage the

equipment, or an explosion from the batteries may occur.

z Install the batteries with the correct polarity.

z Do not charge alkaline batteries. Any attempt to charge the batteries

may cause them to leak or break.

z Do not use disassembled or damaged batteries due to drop or shock.

The leakage from the batteries may damage the equipment, or an

explosion from the batteries may occur.

3. Preparation

WARNING

z Remove the exhausted batteries immediately. The leakage from the

batteries may damage the equipment, or an explosion from the

batteries may occur.

z If the equipment is not in use for a long period of time, remove the

batteries and store the equipment in an appropriate place. If the

batteries are left in the equipment for a long period of time, the leakage

from the batteries may damage the equipment or an explosion from the

batteries may occur.

CAUTION

z Use alkaline battery (AA) specified by Fukuda Denshi.

z Do not replace the batteries with wet hands.

z In case of storing the used or unused batteries, make sure that the

terminals are not touching other batteries or metal parts.

z Use the same type of battery as its setting otherwise the accurate

battery level cannot be displayed.

3. Preparation



Unlock and open the battery compartment lid

by sliding the open/close lever towards

OPEN while pressing the lock button.

Install a new battery according to the polarity

indication inside the battery compartment.

After installing the battery, lock the battery

compartment lid by sliding the open/close

lever towards CLOSE while pressing over

“PUSH” on the lid.

Ĭ ĭ

3. Preparation

Make sure that the battery compartment lid

is locked. (If you can still see red, then it is

not locked properly.)

CAUTION

z Make sure that any foreign particles, such as hairs, are not held on the

battery compartment lid and dust is not adhered to the edge of the lid to

prevent water entering into the battery compartment area.

z Do not keep the compartment lid unlocked as the battery may

unexpectedly get out from the compartment.

3. Preparation

(2) Operating Power Switch



Turning the power switch to “ON”

Press the power switch.

Display screen turns ON and measurement

starts.

Regarding the display screen, refer to page 19.

The display screen automatically turns itself OFF

by following the setting.



After the power is turned ON, make sure to check the remaining battery level

on the display screen.

Refer to the following symbol about the remaining battery level.



Battery SymbolRemaining Battery Level

Full

Getting low but still available



Nearly empty;

Replace the battery

Turning the power switch to “OFF”



Press the power switch for two seconds,

then display screen displays as the left

illustration to confirm. Choose “Yes” and

press the ENTER button.

3. Preparation

4. ECG Monitoring



䕔

Connecting the ECG Lead Cable and Electrodes

The optional ECG lead cables for LX-8100 are as follows.



ECG Lead Cables

Item No. Applicable Lead Remark

CMT-01CTH-0.8DA Limb Lead (1CH) 3-electrode Clip Type

CMT-02CTH-0.8DA Limb Lead (2CH) 4-electrode Clip Type

CMT-03CTH-0.8DA Limb Lead (1CH)

+Chest (1CH) 5-electrode Clip Type

CMT-01HTH-0.8DA Limb Lead (1CH) 3-electrode Hook Type

CMT-02HTH-0.8DA Limb Lead (2CH) 4-electrode Hook Type

CMT-03HTH-0.8DA Limb Lead (1CH)

+Chest (1CH) 5-electrode Hook Type

WARNING

Use only the specified lead cable by Fukuda Denshi. Otherwise, proper

monitoring may not be performed, and also it may fail defibrillation or cause

a malfunction of the equipment when the equipment is used with a

defibrillator.



4. ECG Monitoring

The relations between the attached electrode positions and lead method are

as follows. Attach the electrodes to monitor proper waveform.

For 3-electrode lead cable



Limb leads

Standard Limb leads can be selected from lead I, lead II, or lead III under the

setting of the equipment.

Refer to “7. Operation ŠChanging Setup ŪECG Display Screen (1)

<<Switching Lead>>” .

For 4-electrode lead cable



Limb leads

Two leads such as lead I and II can be measured. Lead III, aVR, aVL, and aVF

can be also displayed from the setting on the receiving monitor. For details,

refer to the operation manual of the receiving monitor

Black

(LA)

Red

(LL)

White

(

)

Green

(

)

White

(RA) Black

(LA)

Red

(LL)

4. ECG Monitoring

For 5-electrode (Chest) lead cable



Limb Lead

+Chest

One limb lead and one chest lead (Brown) measurements are available.

Standard Limb leads can be selected from lead I, lead II, or lead III under the

setting of the equipment.

Refer to “8. Operation ŠChanging Setup ŪECG Display Screen (1)

<<Switching Lead>>” .

The chest lead waveform is measured from the chest lead (Brown) positioned

on the chest.



Brown

(

)

Red

(LL)

Green

(RL)

White

(RA) Black

(LA)

4. ECG Monitoring

䕔

Attaching the Electrodes

CAUTION

z Always use the same type of electrodes. If different types of electrodes

are used at the same time, the difference between the polarization

potential from each electrode may interfere with monitoring.

z Do not reuse the disposable electrodes. It is intended for single patient

use only.



Clean the electrode sites with alcohol wipes

or other skin preparation. If necessary,

shave the electrode sites to remove

excessive hair.



Peel off the disposable electrode

Pay attention not to touch the electrode gel.

ttach the lead cable end to the electrode

(convex part).

Turn right and left to verify that it is securely

attached.

4. ECG Monitoring

䕔

Connecting the ECG Lead Cable to the LX-8100

Insert the ECG lead cable firmly into the ECG/RESP input connector matching

the transmitter’s connector guide and the direction of the notched part on the

connector.



ECG Lead cable

4. ECG Monitoring



CAUTION

z There are some cases when pacemaker pulse cannot be detected

depending on the pacemaker type, pulse voltage, pulse width,

electrode lead type (unipolar, bipolar), electrode placement, or lead

method which causes the pacemaker pulse amplitude to decrease and

disables pacemaker pulse detection.

z 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.

z Time constant of this equipment is shorter than Fukuda Denshi

monitors (direct ECG connection). Therefore, there is a difference in the

ST measurement value between them. Pay attention to the difference

when monitoring a patient from a transmitter or a monitor.

z When an electrode is attached on the same location for a long time,

some patients may develop skin irritation. Check the patient’s skin

condition periodically and change the electrode position as required.

z The indication for continuous use of an electrode is about one day.

z Replace the electrode if the skin contact gets loosen due to perspiring,

etc.

z Make sure to use new disposable electrodes. Otherwise, the waveform

quality may become poor and it may fail to perform correct monitoring

z When “Check Electrode” message is displayed on the screen of the

receiving monitor or the display of this equipment, check the condition

of the electrodes and ECG lead cable to resolve the cause.

z 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.

z It may not perform a correct measurement due to the attached position

of the electrodes. Attach the electrodes on the patient referring to page

12 and 13 and make sure that the correct waveform is measured on the

display.

5. Respiration Monitoring

Follow the preparation of “4. ECG Monitoring” to allow the respiration

monitoring.

This respiration monitoring is performed with impedance method.

The ECG electrodes are also used for detecting the respiration. Each lead

cable specifies the electrodes to detect the respiration. For 3-electrode and 5-

electrode (chest) lead cable, the electrodes to detect the respiration are fixed

as follows. Even if lead method is switched, they are no changes.

Lead Cable Color of Electrode

3-electrode White (RA) and Red (LL)

4-electrode White (RA) and Red (LL)

5-electrode (Chest) White (RA) and Red (LL)



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, please disconnect the cardiac monitoring and

diagnostic equipment, or follow the procedures described in the operation

manual of the pacemaker.

(For more details, contact FUKUDA DENSHI personnel, your institution’s

professionals, or your pacemaker distributors.)

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]



CAUTION

z Even if the electrodes are attached on the proper positions for ECG

monitoring, it may not be always the proper ones for respiration

monitoring as well.

z When a defibrillator is used during respiration monitoring, a large offset

voltage will be placed on the ECG electrodes, which may cause

interruption of monitoring for a few seconds.

5. Respiration Monitoring



6. Measurement

Turn ON the power and the measurement starts.



䕔

Starting Screen

When the power is turned ON, the channel number configured on the LX-8100

is displayed at the top of the display.

Make sure whether the channel number on the

display matches the channel number indicated on

the label of the LX-8100 and the channel number

configured on the receiving monitor.

䕔

Waveform Display Screen

ECG waveform (1CH when using 3-electrode lead cable, 2CH when using

other lead cable), heart rate, pacemaker marker, respirogram, respiration rate,

remaining battery level, and various messages are displayed.



CAUTION

z The LX-8100 does not have a diagnostic function. Check the diagnostic

function on the receiving monitor.

z The LX-8100 does not have an alarm function. Check the alarm

function on the receiving monitor.

z The ECG waveform size and sweep speed settings displayed on the

display of the LX-8100 do not interface with the ones displayed on the

screen of the receiving monitor.

z The heart rate and respiration rate displayed on the display of the LX-

8100 may be different from the ones displayed on the receiving monitor

because the algorithm of the ECG and respiration rate is different.



6. Measurement

䖃Display Switch

The screen can be switched to the other selected screen such as to

ECG/RESP. The screen automatically turns itself OFF by following the setting

if no operation is done. To restart the display, refer to “7. Operation

ŠRestarting the display”.

When the display is active, press the ť button to move onto the next

screen. The screen will be switched in the following order.



Press and hold ENTER for 2 seconds.

Move onto ECG1

Lead/Waveform size setting

display.

Move onto ECG2

Lead/Waveform size setting

display.

Move onto RESP waveform

size setting display.

6. Measurement

䕔

Battery Level Check

Check the battery level on the waveform display screen.

Battery

Symbol Remaining Battery Level

Full

Getting low, but still available

Nearly empty

Replace the battery.

A message that prompts the

battery check appears on the

screen of the receiving

monitor.

6. Measurement

䕔

Waveform Display



䖃ECG Display Screen (1)

ECG1 waveform, heart rate, pacemaker marker, remaining battery level, and

electrode check message are displayed.

The screen automatically turns itself OFF by following the setting if no

operation is done. To restart the display, refer to “7. Operation

ŠRestarting the display”.

When the display is active, press the ť button to move onto the next

waveform display screen.



࠙Descriptions of the Screenࠚ

The descriptions of contents displayed on the display are as follows

Indicates ECG 1.

Indicates the vertical scale of the

displayed ECG waveform.

One scale corresponds to 1mV.

In the left illustration, it can display

ECG waveform between -1mV and

+1mV.

Indicates the horizotal scale of the

displayed ECG waveform.

One scale corresponds to one

second.

Displays the ECG waveform.

6. Measurement

Displays the heart rate.

Ɔ is displayed in synchronization

with the heart rate.

Displays the detection marker when

a pacemaker pulse is detected.

Indicates the measuring lead.

CAUTION

z The ECG waveform size setting displayed on the display does not

interact with the one displayed on the screen of the receiving monitor.

If the ECG waveform size displayed on the screen of the receiving

monitor is changed, follow the instruction in the operation manual of the

receiving monitor.

z When Wide is selected in the QRS Detection and in case it is outside of

the heart rate range (12 bpm to 300 bpm), 0 bpm will be displayed if 11

bpm and below is measured and 300bpm will be displayed if

300 bpm and above is measured.

z When Narrow is selected in the QRS Detection and in case it is outside

of the heart rate range (30 bpm to 300bpm), 0bpm will be displayed if

29 bpm and below is measured and 300 bpm will be displayed if 300

bpm and above is measured.

Indicates the ECG waveform size

displayed on the display.

6. Measurement

Indicates the remaining battery level.

For details of the battery level, refer to

page 21.

Displays the electrode check.

“Electrode?” message appears when

an ECG electrode is detached.

Displays the speaker mark when

Sync. Tone setting is active.

For details, refer to “7. Operation

ŠChanging Setup”.

6. Measurement

䖃ECG Display Screen (2)

ECG2 waveform, heart rate, pacemaker marker, remaining battery level, and

electrode check message are displayed.

NOTE

If a 3-electrode lead cable is used, this screen will not appear.

The screen automatically turns itself OFF by following the setting if no

operation is done. To restart the display, refer to “7. Operation ŠRestarting

the display”.

When the display is active, press the ť button to move onto the next

waveform display screen.



࠙Descriptions of the Screenࠚ

The descriptions of contents displayed on the display are as follows.

Indicates ECG 2.

Indicates the vertical scale of the

displayed ECG waveform.

One scale corresponds to 1mV.

In the left illustration, it can display

ECG waveform between -1mV and +1

mV.

Indicates the horizotal scale of the

displayed ECG waveform.

One scale corresponds to one

second.

Displays the ECG waveform.

6. Measurement



Displays the heart rate.

Ɔ is displayed in synchronization with

the heart rate.



Displays the detection marker when a

pacemaker pulse is detected.



Indicates the measuring lead.



CAUTION

z The ECG waveform size setting displayed on the display does not

interact with the one displayed on the screen of the receiving monitor.

z If the ECG waveform size displayed on the screen of the receiving

monitor is changed, follow the instruction in the operation manual of the

receiving monitor.

z When Wide is selected in the QRS Detection and in case it is outside of

the heart rate range (12 bpm to 300 bpm), 0 bpm will be displayed if 11

bpm and below is measured and 300 bpm will be displayed if

300 bpm and above is measured.

z When Narrow is selected in the QRS Detection and in case it is outside

of the heart rate range (30 bpm to 300 bpm), 0bpm will be displayed if

29 bpm and below is measured and 300 bpm will be displayed if 300

bpm and above is measured.



Indicates the ECG waveform size

displayed on the display.



Indicates the remaining battery level.

For details of the battery level, refer to

page 21.

6. Measurement



Displays the electrode check.

“Electrode?” message appears when

an ECG electrode is detached.



Displays the speaker mark when

Sync. Tone setting is active.

For details, refer to “7. Operation

ŠChanging Setup”.



6. Measurement

䖃Respiration Display Screen

Respiration waveform, respiration rate, remaining battery level, and electrode

check message are displayed.

The screen automatically turns itself OFF by following the setting if no

operation is done. To restart the display, refer to “7. Operation ŠRestarting

the display”.

When the display is active, press the ť button to move onto the next

waveform display screen.

࠙Descriptions of the Screenࠚ

The descriptions of contents displayed on the display are as follows.



Indicates the respiration waveform

display screen.





Indicates the vertical scale of the

displayed respiration waveform.

One scale corresponds to 1ȍ.

In the left illustration, it can display

the change of respiration waveform

between -1ȍ and +1ȍ.



Indicates the horizontal scale of the

displayed respiration waveform.

One scale corresponds to one

second.



Displays the respiration waveform.



6. Measurement



Displays the respiration rate.



CAUTION

z The ECG waveform size setting displayed on the display does not

interact with the one displayed on the screen of the receiving monitor.

z If the ECG waveform size displayed on the screen of the receiving

monitor is changed, follow the instruction in the operation manual of the

receiving monitor.

z In case it is outside of the respiration rate range (4 Bpm to 150 Bpm), 0

Bpm will be displayed if 3 Bpm and below is measured and 150 Bpm

will be displayed if 150 Bpm and above is measured.



Indicates the respiration waveform

size displayed on the display.



Indicates the remaining battery level.

For details of the battery level, refer to

“6. Measurement ŠBattery Level

Check”.



Displays the electrode check

“Electrode?” message appears when

an ECG electrode is detached.

6. Measurement

7. Operation

䕔

Changing Setup

䖃ECG Display Screen (1)

In the ECG display screen (1), the ECG waveform size and lead displayed on

the display of the LX-8100 can be changed and the Synchronized Tone can be

set up.

࠙Setting Methodࠚ

How to enter the setup mode:

Press and hold the ENTER button for 2 seconds in the ECG display screen

(1).

䍾Switching Lead䍿

Lead of ECG 1 can be switched when 3-electrode lead cable or 5-electrode

(Chest) lead cable is used.

Select an appropriate lead by checking the ECG waveform on the display.

The lead indication of ECG 1 is

highlighted.

Pressing the ENTER button

will sequentially change the lead

of ECG 1.

Lead I Æ II Æ III Æ I

䍾Changing ECG1 Waveform Size on display䍿

Press the ť button to highlight

the size indication of ECG 1.

Pressing the ENTER button

will sequentially change the size

of ECG 1.

Size ×1 Æ ×1/2 Æ ×1

When changing the size of the

ECG waveform on the display, the

ECG scale will also change.

In the left illustration, it can

display the ECG waveform

between -2mV and +2mV.

7. Operation

CAUTION

The ECG waveform size setting displayed on the display of the LX-8100

does not interact with the one displayed on the screen of the receiving

monitor. To change the waveform size of the receiving monitor, follow the

instruction in the operation manual of the receiving monitor.

䍾Returning to ECG Display Screen (1)䍿

Press the ť button to highlight

the “Back”.

Press the ENTER button to

return to the ECG display screen

(1).



CAUTION

Do not operate the LX-8100 with the setup screen open because it may

lead to an unintended operation and cause setting changes. Make sure to

press the “Back” to terminate the setup screen. The display will

automatically turn itself OFF by following the setting if the “Back” is not

pressed.

࠙Setting the Synchronized Toneࠚ

Press and hold the ENTER button and ť button for 2 seconds in the ECG

display screen (1).

The speaker symbol can be switched to display ON/OFF.

䍾Generate a Synchronized Tone䍿

When the speaker symbol is displayed, a Synchronized Tone will generate

along with the Synchronized mark. The Synchronized Tone will generate only

in the ECG screen.

Press and hold the ENTER button and

ť button for 2 seconds then the speaker

symbol will be displayed.

Press and hold the ENTER button and

the ť button again for 2 seconds, then the

speaker mark will disappear and the

synchronized tone will stop. The setting

synchronizes the ECG screen (2) so this

setting is also reflected in the ECG screen

(2).

7. Operation

䖃ECG Display Screen (2)

In the ECG display screen (2), the ECG waveform size displayed on the

display of the LX-8100 can be changed and the synchronized tone can be set

up.

࠙Setting Methodࠚ

How to enter the setup mode.

Press and hold the ENTER button for 2 seconds in the ECG display screen

(2).

䍾Changing ECG2 Waveform Size on display䍿

The size indication of ECG 2 is

highlighted.

Pressing the ENTER button

will sequentially change the size

of ECG 2.

Size ×1 Æ ×1/2 Æ ×1

When changing the size of the

ECG waveform on the display,

the ECG scale will also change.

In the left illustration, it can

display ECG waveform between

-2mV and +2mV.



CAUTION

The ECG waveform size setting displayed on the display of the LX-8100

does not interact with the one displayed on the screen of the receiving

monitor. To change the waveform size of the receiving monitor, follow the

instruction in the operation manual of the receiving monitor.



7. Operation

䍾Returning to ECG display screen (2)䍿

Press the ť button to highlight

the “Back”.

Press the ENTER button to

return to the ECG display screen

(2).



CAUTION

Do not operate the LX-8100 with the setup screen open because it may

lead to an unintended operation and cause setting changes. Make sure to

press the “Back” to terminate the setup screen. The display will

automatically turn itself OFF by following the setting if the “Back” is not

pressed.

࠙Setting Methodࠚ

Press and hold ENTER button and ť button for 2 seconds in the ECG

display screen (2).

䍾Generate a Synchronized Tone䍿

When the speaker symbol is displayed, a Synchronized Tone will generate

along with the Synchronized mark. The Synchronized Tone will generate only

in the ECG screen.

Press and hold the ENTER

button and ť button for 2 seconds

then the speaker symbol will be

displayed.

Press and hold the ENTER

button and the ť button again for

2 seconds, then the speaker mark

will disappear and the synchronized

tone will stop. The setting

synchronizes the ECG screen (1) so

this setting is also reflected in the

ECG screen (1).

7. Operation

䖃Respiration Display Screen

In the respiration display screen, the respiration waveform size displayed on

the display of the LX-8100 can be changed.

࠙Setting Methodࠚ

How to enter the setup mode:

Press and hold the ENTER button for 2 seconds in the respiration display

screen.

䍾Changing Respiration Waveform Size on display䍿

The size indication of the

respiration is highlighted.

Pressing the ENTER button

will sequentially change the size

of respiration.

Size ×1 Æ ×1/2 Æ ×1

When changing the size of the

respiration waveform on the

display, the respiration scale will

also change.

In the left illustration, it can

display the respiration waveform

until 4ȍ of change.

CAUTION

The ECG waveform size setting displayed on the display of the LX-8100

does not interact with the one displayed on the screen of the receiving

monitor. To change the waveform size of the receiving monitor, follow the

instruction in the operation manual of the receiving monitor.

7. Operation

䍾Returning to the Respiration Display Screen䍿

Press the ť button to highlight

the “Back”.

Press the “Back” to return to the

Respiration Display Screen.

CAUTION

Do not operate the LX-8100 with the setup screen open because it may

lead to an unintended operation and cause setting changes. Make sure to

press the “Back” to terminate the setup screen. The display will

automatically turn itself OFF by following the setting even though the

“Back” is not pressed.

7. Operation

䕔

Restarting the display

The display automatically turns itself OFF after the preprogrammed duration if

no operation is done.

Press the ENTER button or press and hold the ť button to restart the

display.

The starting screen with the telemetry channel number appears, and then the

waveform display screen appears.

The setting for the timeout duration of the display screen can be changed. For

details, refer to page 50.

CAUTION

z The heart rates and respiration rates are not measured during display

OFF. Therefore, the display screen may not accurately display heart

rates and respiration rates right after restarting.

z If battery level 1 is displayed, the display will not automatically

turn OFF. In such case, replace the battery.

䕔

Pressing the EVENT button

Press and hold the EVENT button for 2 seconds to activate the function

assigned on the receiving monitor. The following message appears on the

display while the “EVENT” is transmitted.

After the transmission is completed, the waveform display screen appears.

“EVENT” operation is available as a remote recording.

For details of the receiving monitor operation and settings related to the

“EVENT” function, refer to the operation manual of the receiving monitor.



7. Operation

8. Other Setting Items

The following settings are available for the LX-8100 depending on the use and

condition of the patient. For details of the settings, contact our service

representative.

Items Selection Default Backup

Time Constant 0.4 sec, 0.1 sec 0.4 sec Ũ

Detection Sensitivity of

Pacemaker Pulse

(Pace Sens.)

Low, Mid, High Mid Ũ

QRS Detection

(QRS Width) Wide, Narrow Wide Ũ

Respiration Detection

Signal (Display) ON, OFF ON Ũ

Display Brightness

(Brightness) 8 levels 5 Ũ

Turn Off Display Time

(Display OFF) 1 min, 3 min, 10 min,

OFF 3 min Ũ

Sound

(Sound) ON, OFF ON Ũ

Transmitter Channel

(CH) One from following

channels.

0801 to 0879

0900 to 0979

1000 to 1079

1100 to 1179

1200 to 1279

1300 to 1379

Ყ Ũ

Group ID One from 00 to 63, 00 Ũ



8. Other Setting Items



䕔

Changing the Time Constant

The default setting of the time constant is “0.4 seconds”.

If a stable monitoring is difficult with excessive change in the baseline due to

excessive body motion of the patient or an interference noise, such as AC

frequency, by changing the time constant to “0.1 second” the monitoring may

become relatively stable.

For details of the setting, contact your local Fukuda Denshi service

representative.

CAUTION

z When changing the time constant to “0.1 seconds”, the lower frequency

characteristic becomes 1.6 Hz ± 25%. This setup does not meet IEC

60601-2-27 standard. It may lead to a change in the ECG waveform

and the ST measurement value may be especially affected. Fukuda

Denshi recommends “0.4 seconds” setting in normal use.

z The display screen in normal use does not indicate the selection of time

constant. Make sure to take measures, such as marking on the

LX-8100, to distinguish whether the selection of time constant has

changed.

䕔

Changing the Detection Sensitivity of the Pacemaker Pulse

The default setting of pacemaker pulse detection sensitivity is “Mid”.

The “Mid” setting can detect and reject the following pacemaker pulse

specified in IEC 60601-2-27 standard.

Detection/Rejection of Pacemaker Pulse:

a) Pacemaker Pulse without Over/Undershoot:

Capable to detect pulses of pulse width 0.1 ms to 2 ms,

amplitude ±2 mV to ±700 mV.

b) Pacemaker Pulse with Over/Undershoot:

Rejection is not possible.

Fukuda Denshi recommends the “Mid” setting in normal use.

There may be some cases when the pacemaker pulse cannot be detected

depending on the pacemaker type, pulse voltage, pulse width, electrode lead

type (unipolar, bipolar). In this case, change the lead or the position of the

electrodes to be able to detect the pacemaker pulse.

Nonetheless, if the detection is still undetectable, change the setting to “High”

in order to increase the detection sensitivity. So that smaller pacemaker pulse

can be detected. However, the “High” setting may lead to erroneous detection

due to interference noise, such as AC frequency.

8. Other Setting Items

41

If erroneous detections occur due to interference noise, such as AC frequency,

turn OFF the setting of the pacemaker pulse detection in the receiving monitor.

If erroneous detections occur due to interference noise, such as AC frequency,

while monitoring a patient with a pacemaker and the setting of the pacemaker

pulse detection cannot be turned OFF, replace the electrodes or change the

lead to remove the interference noise, such as AC frequency.

Nonetheless, if erroneous detections still occur, change the setting to “Low” in

order to decrease the detection sensitivity. It makes the LX-8100 less likely to

be interfered by noise, such as AC frequency.

The “Low” setting decreases the detection sensitivity. Therefore, it cannot

detect the pacemaker pulse specified in IEC 60601-2-27 standard.

For details of the setting, contact your local Fukuda Denshi service

representative.

CAUTION

The display screen in normal use does not indicate the setting status of the

pacemaker pulse detection. Make sure to take measures, such as marking

on the LX-8100, to distinguish whether the setting of the pacemaker pulse

detection has changed.

䕔

Changing QRS Detection

The QRS detection mode of the LX-8100 is initially set as “Wide”. The setting

can be changed to “Narrow” if it cannot detect the heart rates due to narrow

QRS amplitude.

For details of the setting, contact your local Fukuda Denshi service

representative.

CAUTION

z This setting is effective only for the display screen of the LX-8100 and it

is not reflected in the QRS detection setting of the receiving monitor. To

change the QRS detection in the receiving monitor, refer to the

operation manual of the receiving monitor.

z The display screen in normal use does not indicate the setting status of

the QRS detection mode such as ”Wide/Narrow”. Make sure to take

measures, such as marking on the LX-8100, to distinguish whether the

setting of the QRS detection mode has changed.

8. Other Setting Items

䕔

Changing the Respiration Detection Signal ON/OFF

The default setting of the respiration detection signal is “ON”.

The respiration waveform can be detected when the setting of the respiration

detection signal is turned “ON”.

WARNING

If the LX-8100 is used with minute ventilation rate-adaptive implantable

pacemaker, the respiration detection signal may cause the pacemaker to

pace at its maximum programmed rate. If such event occurs, change the

setting to “OFF” to prevent an occurrence of erroneous pacing rate.

For details of the setting, contact your local Fukuda Denshi service

representative.



CAUTION

z The respiration waveform cannot be measured if the setting of the

respiration detection signal is turned “OFF”.

z Make sure to turn OFF the respiration measurement function on the

receiving monitor to prevent an erroneous detection of the respiration

alarm (on the receiving monitor side)

z The display screen in normal use does not indicate the setting status of

the respiration detection signal ON/OFF. Make sure to take measures,

such as marking on the LX-8100, to distinguish whether the setting of

the respiration detection signal ON/OFF has changed.

䕔

Changing the Display Brightness

The display brightness of the LX-8100 can be changed in 8 levels.

For details of the setting, contact your local Fukuda Denshi service

representative.

䕔

Changing the Display Timeout Duration

The time to automatically turn OFF the display while not in operation can be

selected from 1 min, 3 min, 10 min or OFF (The display will not turn off).

The default setting is “3 min”.

For details of the setting, contact your local Fukuda Denshi service

representative.

CAUTION

If battery level 1 is displayed, the display will not automatically turn

OFF. In such case, replace the battery.

8. Other Setting Items

43

䕔

Changing Sound ON/OFF

When the sound setting is “ON”, Alarm will generate in the following situation.

ȷECG Lead Off

The default setting is “ON”.

Alarm will not generate with Display OFF status.

For details of the setting, contact your local Fukuda Denshi service

representative.

8. Other Setting Items

9. Changing the Transmitter Channel and Group ID

䕔

Changing the Transmitter Channel

The LX-8100 is a transmitter of PLL synthesizer type, and its transmitter

channel can be programmed. It can be set up with an arbitrary channel among

the channels assigned by the Telemetry Laws (according to each country).

For details of the setting, contact your local Fukuda Denshi service

representative.



WARNING

z If the transmitter channel is changed, follow the instruction by the

person in charge of the radio telemetry channel in your facility.

Mismanagement may result in a serious accident, such as interference

and mixing up patients.

z Replace promptly with new channel label if the transmitter channel has

been changed.



䕔

Changing the Group ID

The LX-8100 transmits its group ID, which it belongs to, to prevent interference

with neighboring hospital's transmitter.

The receiving monitor checks whether the incoming group ID is the same as

the programmed one that the receiving monitor has. There are 64 group codes

available. The default setting is “00”.

The transmitter group ID can be changed if there is interference with a

neighboring hospital's transmitter.

For details of the setting, contact your local Fukuda Denshi service

representative.

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.



9. Changing the Transmitter Channel and Group ID



10. Troubleshooting

䕔

List of Displayed messages



Transmitter (Main Unit)

Message CauseSolution



Failed to transmit

waveform and

value.

Contact your local Fukuda

Denshi service

representative.



Faulty EEPROM.



Failed to initialize

CPU.



Faulty Speaker.



10. Troubleshootimg



ECG

Message Cause Solution



Electrode is off.Check the electrode

condition.

Character string

displayed, such as LA,

depends on the

detached electrode

position



10. Troubleshootimg

49

䕔Troubleshooting

Make sure of the following. However, if there is no improvement in the

phenomenon, contact your local Fukuda Denshi service representative.

Transmitter (main unit)

Phenomenon Cause Solution

Nothing is displayed

on the display when

the power switch is

turned ON.

No battery or wrong

polarity. Install the battery correctly.

Battery level is

empty. Replace the battery with a

new one.

Restart Battery level is

empty. Replace the battery with a

new one.

Nothing is displayed

on the display even

though LED is on

when the power switch

is turned ON.

Battery level is

empty. Replace the battery with a

new one.

Nothing is displayed

on the receiving

screen.

The channel

number between

the transmitter and

the receiving

monitor do not

match up.

Set the same channel

number for the transmitter

and the receiving monitor.

Transmission problem. Same channel

number is already

used.

Make sure to not duplicate

channel numbers.

Follow the instruction by the

person in charge of radio

telemetry channel in your

facility and use the LX-8100

with the correct channel

setting.

Channel

interference. Follow the instruction by the

person in charge of radio

telemetry channel in your

facility and use the LX-8100

with the correct channel

setting.

Transmitter failure. Contact your local Fukuda

Denshi service

representative.



10. Troubleshootimg



ECG

Phenomenon Cause Solution

“ELECTRODE?”

message is displayed. Lead cable is off. Check the connection

between the lead cable and

the LX-8100.

Check the connection

between the lead cable and

the electrode.

Faulty Lead cable. Replace the ECG cable with

a new one.

Electrode is peeling

off. Replace the electrode with a

new one.

Polarization

potential of the

electrode is too

high.

ECG waveform

contains noise. Electrode gel is dry Replace the electrode with a

new one.

Electrode is peeling

off.

Electric blanket is

used. Cover the electric blanket

with a shield cover.

AC filter setting of

the receiving

monitor is OFF.

Set the AC filter up as ON.

Respiration waveform

cannot be measured. Electrode gel is dry Replace the electrode with a

new one.

Electrode is peeling

off.

The positions of the

electrodes are

improper.

Attach the electrodes where

the respiration waveform can

be measured appropriately.



10. Troubleshootimg

51

䕔

In Case of Dropping the LX-8100 into Water

In case of dropping the LX-8100 into water containing disinfectant, pick up the

LX-8100 quickly from it. Rinse it well with running water, and dry it thoroughly

with a soft cloth

CAUTION

z Do not use a dryer. The LX-8100 shape may change or be broken.

z When the LX-8100 is rinsed with running water, make sure to close

the battery compartment lid.



10. Troubleshootimg



11. Cleaning and Disinfection

The cleaning and disinfection of the LX-8100 and ECG lead cable shall be

performed as follows.

CAUTION

Do not sterilize the LX-8100 and ECG lead cable in any manners, such as

radioactive rays, steam, or ethylene oxide.

䕔

Cleaning

Clean the LX-8100 using a squeezed gauze or an absorbent cotton cloth

dampened with alcohol or a neutral cleanser.

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 any chemical solution to enter the inside of LX-8100 or

connectors

z The LX-8100 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, 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.



䕔

Disinfection

If there is a possibility of being infected, clean the LX-8100 using a squeezed

gauze or an absorbent cotton cloth dampened with alcohol or invert soap.

CAUTION

z Do not immerse the connector parts of the LX-8100 in any chemical

solution to prevent connection failure.

z When disinfecting the entire room using a spray solution, pay close

attention not to have liquids get into the LX-8100 or connectors.

11. Cleaning and Disinfection

䕔

Cleaning the ECG lead cable

After using the cable, clean it with neutral detergent or 70% isopropyl alcohol.

CAUTION

z Do not use thinner, toluene, or other organic solvents to clean the

cables.

z Do not pull the cable and do not hold the connector part when

cleaning.

(It may degrade the cable coating and result in damage. Particularly

organic solvents and antiseptic solution such as cresol soap solution

will degrade the cable coating.)

z After cleaning, dry it completely before usage.

z Do not use high temperature sterilization such as steam or EOG

method.

12. Maintenance and Inspection

This section explains the daily checks and periodic checks of the LX-8100. To

ensure safety, reliability, and high performance, a “Daily Check” and “Periodic

Check” must be performed. We are not liable for any accident arising from lack

of maintenance. A full technical description of the LX-8100 is available from

your local Fukuda Denshi representative.

CAUTION

z Do not open the housing

z Do not allow excessive moisture or cleaning agents into the

connectors or inside the equipment.



Daily Check



Perform daily checks using the “Daily Check List” on the next page.

Periodic Check



Periodic check of medical electronic equipment is mandatory to prevent

failures and accidents, and to ensure safety and reliability.

Periodic maintenance may be performed by the medical institution or by a third

party by concluding a “Maintenance Contract”.

For more details, contact your local Fukuda Denshi service representative.

Perform Periodic check using the “Periodic Check List”.

The periodic check should be performed once a year.

If there is an item with “Fail” judgement, the overall judgement will be “Fail”.

Make sure to take countermeasures for the “Fail” item.

Use the equipment only if the judgements of all the items are “Pass”.

Periodic Replacement Parts

The “Battery Compartment Lid (Waterproof)” is the only periodic replacement

part.

To ensure the reliability of waterproof (IPX8) performance of the LX-8100,

replace it once a year.

Contact your local Fukuda Denshi service representative for replacement. The

reliability of water resistance (IPX8) performance will not be ensured without

yearly replacement.

CAUTION

The periodic replacement parts must be replaced at specified period.



Daily Check List



No.

Inspected Date Inspected by Location

Device Type LX-8100 S/No. Date of Purchase



Items Details Criteria Judgment

Appearance Visually check for any damage,

cracks, chip, peeled label, and

loosen screw on the housing.

No abnormality should be

found. ڧOK/ ڧNG

Battery

Compartment

Visually check for the ring

condition of the battery

compartment lid.

No damage, kink, floating,

and adhesion of dust

should be found.

ڧOK/ ڧNG

Visually check for the contact

springs, inside the LX-8100, to

the battery and the lock lever of

the battery compartment lid.

No deformation, cracks,

and rust should be found.

ڧOK/ ڧNG

Power Supply Turn the power ON/OFF to verify

proper switch operation.

With batteries installed,

the display should turn

ON.

ڧOK/ ڧNG

ECG Connectors Visually check the connectors of

the cable and the LX-8100.

No damage, chip, and

adhesion of dust should

be found.

ڧOK/ ڧNG

ECG Lead cable Visually check each lead for

damages. No crack and damage

should be found.

ڧOK/ ڧNG

Wireless Channel

Verify whether the transmitting

channel and group ID are the

same with the receiving monitor.

Must match the wireless

channel check list.

ڧOK/ ڧNG

Transmission

Function

Turn the power ON and make

sure the information is displayed

on the receiving monitor.

Waveforms and values

should be received

without any problem.

ڧOK/ ڧNG

Display Function Turn the power ON and verify

each display condition. All data should be

properly displayed.

ڧOK/ ڧNG

Periodic Check Check the date of the previous

periodic check. Should be within one

year.

ڧOK/ ڧNG



Comment

12. Maintenance and Inspection

57

Periodic Check



The periodic maintenance check is intended to check the medical equipment

used daily in a medical institution to prevent failures and accidents and to

ensure safety and reliability.

The check procedures are described for daily and periodic checks. Each check

item must be performed according to the described check procedure.

The consignee can select the check items according to the product quality,

frequency of usage, and maintenance check period. However, electrical safety

items must also be performed.

For details of the electrical safety check procedure, refer to IEC 60601-1.

䖃Periodic Check Items

The periodic check items are as follows.

No. Check Item

1 External Appearance

2 Power Supply Switch

3 Display / Operation / Record

4 ECG

5 Respiration

6 Speaker

7 Electrical Safety

No. Check Item Check Procedure Criteria

1. External Appearance, Accessories

01 Appearance Visually check the exterior for

scratches, cracks,

deformation, andrust.

No abnormality should

be found.

02 Cables Visually check all cables for

any damage or being

disconnected.

No damage should be

found.

03 Operation

Manual Check if the operation manual

and other accompanying

documents are stored in the

specified places.

Should be stored in the

specified place.

No Check Item Check Procedure Criteria

2Power Supply Switch

01 Power Supply

Switch Turn ON/OFF the power

switch. Should turn ON/OFF

the power switch

properly.

12. Maintenance and Inspection

No Check Item Check Procedure Criteria

3Display, Operation, Record

01 Labels Visually check the labels,

caution labels, etc. Should be clean, clear

and firmly attached.

02 Operation,

Switches and

keys

Check by operating the

switches and keys. Should operate

properly.

03 Display Check that the characters and

waveforms appear on the

display.

The characters and

waveforms should be

clearly displayed. The

brightness should be

sufficient.

No Check Item Check Procedure Criteria

4ECG

01 Input

Impedance* According to test procedure of

IEC 60601-2-27:2011

201.12.1.101.3

Should be 2.5M or

above.

02 Suppression

Characteristic of

Common-Mode

Signal*

According to test procedure of

IEC 60601-2-27:2011

201.12.1.101.10

Should be 10mmp-p or

below for standard

sensitivity (sensitivity

1).

03 Transient

Characteristic* With comprehensive tester,

apply

standard voltage of 1mV, and

check

the time the amplitude natural

logarithmically drops and

becomes

37% of the waveform of 0.04

sec. after the application of

standard voltage.

Should be 0.4 ± 0.1

seconds.

(When the time

constant is set to

0.4seconds.)

04 Frequency

Characteristic* With comprehensive tester,

apply sinusoidal voltage.

Measure the frequency

characteristic at test voltage of

40Hz.

According to test procedure of

IEC 60601-2-27:2011

201.12.1.101.8

Should be 40Hz (-3dB)

or above.

05 Heart Rhythm

Detection* With comprehensive tester,

input both positive and

negative polarity of 0.3mV and

3mV with sensitivity 1.

According to test procedure of

IEC 60601-2-27:2011

201.12.101.15

The heart beat rhythm

should be detected

with sensitivity 1

according to the peak-

to-peak signal of

0.3mV and 3mV.

12. Maintenance and Inspection

59

06 ECG Sensitivity With comprehensive tester,

apply 1mV voltage and

measure the displayed

amplitude.

According to test procedure of

IEC 60601-2-27:2011

201.12.1.101.1

Wave form size on the

receiving monitor

should be within 0mm

d10% at sensitivity1.

07 Heart Rate

Accuracy* With ECG simulator, test

heartbeat 60,

180 beats/min., and check the

displayed HR value.

According to test procedure of

IEC 60601-2-27:2011

201.12.101.15

For reference

heartbeat signal of 60,

180 beats/min., error

of the displayed HR

value should be within

±3 beats/min.

08 ECG Lead

Switch With ECG simulator, check

that each lead is displayed

properly.

(Check for 3-electrode, and

4-electrode, 5-electrode.)

For each lead cable,

lead should be

correctly switched, and

waveform should be

correctly displayed.

09 Lead-Off

Indication Remove each electrode, and

check that lead-off message is

displayed.

Lead-Off message for

the corresponded lead

should be displayed.

10 ECG Lead Cable

Recognition Switch the ECG lead cable or

switch the setup of lead cable. Should correctly

recognize the

connected lead cable.

* As these functions are dependent on the design or software, these items

are not mandatory for periodic checks. Perform the test as necessary.

12. Maintenance and Inspection

No Check Item Check Procedure Criteria

5Respiration

01 Respiration

Waveform

Sensitivity

With comprehensive tester or

reference respiration signal

generator, input sinusoidal

waveform of 0.5Hz with base

resistance of 1.5kȍ/1ȍ

change.

The amplitude

displayed on the

receiving monitor

screen should be

within 10 mm ± 2 mm.

02 Respiration Rate

Accuracy* Input reference respiration

signal to comprehensive tester

or respiration simulator, and

check the respiration rate

display. Test with the

respiration reference

load signal of 60, 120/min.

Error should be within

±5 Bpm.

03 Frequency

Characteristic* With comprehensive tester or

reference respiration signal

generator, input 0.5Hz and

1.5Hz or 2.5Hz, and measure

the frequency characteristic.

The crest value at

1.5 Hz should be more

than 70% of the crest

value at 0.5 Hz input.

* As these functions are dependent on the design or software, these items

are not mandatory for periodic checks. Perform the test as necessary.

No Check Item Check Procedure Criteria

6Speaker

01 Generation Generate synchronized tone

and check the sound. Generating

synchronized tone.

No Check Item Check Procedure Criteria

7Electrical Safety

01 Contact current

Measure the leakage current

that runs through the ground

from the enclosure of the

device under normal condition

using a leak measurement

safety tester.

According to test procedure of

IEC 60601-1 8.7.4

From the enclosure to

the ground (NC)

ġ0.1mA.

02 Patient leakage

current that runs

through the

ground from the

patient

connecting part

(NC)

Measure the patient leakage

current that runs through the

ground from the patient

connecting part using a leak

measurement safety tester.

According to test procedure of

IEC 60601-1 8.7.4

ƂAC/DCƃ

From the patient

connecting part to the

ground (NC)

ġ0.01mA.

12. Maintenance and Inspection

61

No Check Item Check Procedure Criteria

03 Leakage current

when external

voltage is

applied to the

patient

connection in

the Type F

attaching part

(SFC)

Measure the leakage current

when external voltage is

applied to the patient

connection in the Type F

attaching part using a leak

measurement safety tester.

According to test procedure of

IEC 60601-1 8.7.4

Leakage current when

external voltage is

applied to the patient

connection in the Type

F attaching part. (SFC)

ġ0.05mA.

04 Total patient

leakage current

that runs

through the

ground from the

total patient

connecting part.

(NC)

Measure the total patient

leakage current that runs

through the ground from the

patient.

According to test procedure of

IEC 60601-1 8.7.4

ƂAC/DCƃ

From the patient

connecting part to the

ground (NC)

ġ0.05mA.

05 Leakage current

when external

voltage is

applied to the

patient

connection in

the Type F

attaching part

(SFC)

Measure the leakage current

when external voltage is

applied to the patient

connection in the Type F

attaching part using a leak

measurement safety tester

According to test procedure of

IEC 60601-1 8.7.4

Leakage current when

external voltage is

applied to the patient

connection in the Type

F attaching part. (SFC)

ġ0.01mA.

06 Patient auxiliary

current (NC) Measure the patient auxiliary

current (NC) using a leak

measurement safety tester

According to test procedure of

IEC 60601-1 8.7.4

Patient auxiliary

current (NC)

ġ0.01mA.

No Check Item Check Procedure Criteria

7 Electrical Safety (*)

Perform the following check item as appropriate. Check these items when

you have disassembled the equipment to check/ replace the boards or units.

07 Withstand

Voltage Test

(the enclosure –

isolated

connecting part)

Apply AC1500V for 1 minute

between the enclosure and a

connecting part.

Note: The voltage differs

depending on the internal

protective circuit composition

of the equipment.

According to test procedure of

IEC 60601-1 8.8.3

Should withstand

applied voltage.

12. Maintenance and Inspection

Periodic Check List

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㻼㼑㼞㼟㼛㼚㻌㼕㼚㻌㼏㼔㼍㼞㼓㼑

㻱㻯㻳

㻜㻝

㻾㼑㼜㼘㼍㼏㼑㼙㼑㼚㼠㻌㼜㼍㼞㼠

㻿㼥㼚㼏㼔㼞㼛㼚㼕㼦㼑㼐㻌㼀㼛㼚㼑

㻾㼑㼝㼡㼑㼟㼠㼑㼐㻌㻵㼠㼑㼙

㻯㼔㼑㼏㼗㻌㻵㼠㼑㼙

㻾㻾㻌㻭㼏㼏㼡㼞㼍㼏㼥㻻㼜㼑㼞㼍㼠㼕㼛㼚㻌㻹㼍㼚㼡㼍㼘㼟

㻱㼤㼠㼑㼞㼕㼛㼞

㻯㼍㼎㼑㼘㼟

㻱㼤㼠㼑㼞㼕㼛㼞㻘㻌㻭㼏㼏㼑㼟㼟㼛㼞㼕㼑㼟

㻰㼑㼟㼏㼞㼕㼜㼠㼕㼛㼚

㻯㼔㼑㼏㼗㻌㻵㼠㼑㼙

㻭㼐㼖㼡㼟㼠㼙㼑㼚㼠

㻭㼏㼏㼑㼜㼠㼍㼚㼏㼑㻌㻰㼍㼠㼑

㻯㼔㼑㼏㼗㻌㻵㼠㼑㼙

㻾㼑㼟㼜㼕㼞㼍㼠㼕㼛㼚

㻺㼑㼤㼠㻌㻯㼔㼑㼏㼗㻌㻰㼍㼠㼑

㻼㼑㼞㼕㼛㼐㼕㼏㻌㻯㼔㼑㼏㼗㻌㻯㼛㼚㼠㼞㼍㼏㼠

䕕㼅㼑㼟䚷䚷䕕㻺㼛

㻹㼛㼚㼠㼔㻌㻯㼔㼑㼏㼗

㻰㼑㼘㼕㼢㼑㼞㼥㻌㻰㼍㼠㼑

㻯㼡㼟㼠㼛㼙㼑㼞㻌㻯㼛㼐㼑

㼀㼑㼘㼑㼙㼑㼠㼞㼥㻌㼀㼞㼍㼚㼟㼙㼕㼠㼠㼑㼞㻌㻼㼑㼞㼕㼛㼐㼕㼏㻌㻯㼔㼑㼏㼗㻌㻾㼑㼜㼛㼞㼠

㻸㼛㼏㼍㼠㼕㼛㼚

㻹㼛㼐㼑㼘㻌㻺㼍㼙㼑㻿㼑㼞㼕㼍㼘㻌㻺㼛㻚㻦㻼㼞㼛㼐㼡㼏㼠㻌㻯㼛㼐㼑

㻰㼕㼟㼜㼘㼍㼥㻘㻌㻻㼜㼑㼞㼍㼠㼕㼛㼚㻘㻌㻾㼑㼏㼛㼞㼐

䕕㻴㼛㼘㼕㼐㼍㼥䚷䚷㻌㻌䕕㻺㼕㼓㼔㼠

㻾㼑㼜㼘㼍㼏㼑㼙㼑㼚㼠㻌㼜㼍㼞㼠㼟㻯㼘㼍㼟㼟㼕㼒㼕㼏㼍㼠㼕㼛㼚

䕕㻻㼚㻙㼟㼕㼠㼑䚷䚷㻌㻌䕕㼀㼍㼗㼕㼚㼓㻙㼛㼢㼑㼞

㻯㼔㼑㼏㼗

㻻㼜㼑㼞㼍㼠㼕㼛㼚㻌㻿㼣㼕㼠㼏㼔㻛㻷㼑㼥

㻼㼛㼣㼑㼞㻌㻿㼡㼜㼜㼘㼥㻌㻿㼣㼕㼠㼏㼔

㻺㼛㼠㻌㼏㼛㼢㼑㼞㼑㼐

㻴㼑㼍㼞㼠㻌㻾㼍㼠㼑㻌㻭㼏㼏㼡㼞㼍㼏㼥

㼀㼞㼍㼚㼟㼕㼑㼚㼠㻌㻯㼔㼍㼞㼍㼏㼠㼑㼞㼕㼟㼠㼕㼏

㻱㻯㻳㻌㻸㼑㼍㼐㻌㻿㼣㼕㼠㼏㼔

㻵㼚㼜㼡㼠㻌㻵㼙㼜㼑㼐㼍㼚㼏㼑

㻸㼑㼍㼐㻙㻻㼒㼒㻌㼕㼚㼐㼕㼏㼍㼠㼕㼛㼚

㻜㻝

㻸㼍㼎㼑㼘㼟

㻸㻯㻰

㻼㼛㼣㼑㼞㻌㻿㼡㼜㼜㼘㼥㻌㻿㼣㼕㼠㼏㼔

㻜㻞

㻿㼡㼜㼜㼞㼑㼟㼟㼕㼛㼚

㻯㼔㼍㼞㼍㼏㼠㼑㼞㼕㼟㼠㼕㼏㻌㼛㼒

㻯㼛㼙㼙㼛㼚㻙㻹㼛㼐㼑㻌㻿㼕㼓㼚㼍㼘

㻻㻷㻌㻌㻺㻳

㻱㻯㻳㻌㻿㼑㼚㼟㼕㼠㼕㼢㼕㼠㼥

㻝㻜㻱㻯㻳㻌㻸㼑㼍㼐㻌㻯㼍㼎㼘㼑

㻾㼑㼏㼛㼓㼚㼕㼠㼕㼛㼚㻻㻷㻌㻌㻺㻳

㻲㼞㼑㼝㼡㼑㼚㼏㼥㻌㻯㼔㼍㼞㼍㼏㼠㼑㼞㼕㼟㼠㼕㼏

㻴㼑㼍㼞㼠㻌㻾㼔㼥㼠㼔㼙㻌㻰㼑㼠㼑㼏㼠㼕㼛㼚

㻜㻢㻼㼍㼠㼕㼑㼚㼠㻌㼍㼡㼤㼕㼘㼕㼍㼞㼥㻌㼏㼡㼞㼞㼑㼚㼠

㻺㻯㻌㻔㻌㻌㻌㻌㻌㻌㻕㼙㻭

㻾㼑㼟㼜㼕㼞㼍㼠㼕㼛㼚㻌㼃㼍㼢㼑㼒㼛㼞㼙

㻿㼑㼚㼟㼕㼠㼕㼢㼕㼠㼥㻻㻷㻌㻌㻺㻳㻲㼞㼛㼙㻌㼠㼔㼑㻌㼜㼍㼠㼕㼑㼚㼠㻌㼏㼛㼚㼚㼑㼏㼠㼕㼚㼓

㼜㼍㼞㼠㻌㼠㼛㻌㼠㼔㼑㻌㼓㼞㼛㼡㼚㼐

㻺㻯䠄䚷䚷䚷䚷䠅㼙㻭

㻜㻞

㻼㼍㼠㼕㼑㼚㼠㻌㼘㼑㼍㼗㼍㼓㼑㻌㼏㼡㼞㼞㼑㼚㼠㻌㼠㼔㼍㼠

㼞㼡㼚㼟㻌㼠㼔㼞㼛㼡㼓㼔㻌㼠㼔㼑㻌㼓㼞㼛㼡㼚㼐㻌㼒㼞㼛㼙

㼠㼔㼑㻌㼜㼍㼠㼕㼑㼚㼠㻌㼏㼛㼚㼚㼑㼏㼠㼕㼚㼓㻌㼜㼍㼞㼠

㻺㻯㻌㻔㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻕㼙㻭

㻜㻟

㻻㻷㻌㻌㻺㻳

㻜㻠

㼀㼛㼠㼍㼘㻌㼜㼍㼠㼕㼑㼚㼠㻌㼘㼑㼍㼗㼍㼓㼑㻌㼏㼡㼞㼞㼑㼚㼠

㼠㼔㼍㼠㻌㼞㼡㼚㼟㻌㼠㼔㼞㼛㼡㼓㼔㻌㼠㼔㼑㻌㼓㼞㼛㼡㼚㼐

㼒㼞㼛㼙㻌㼠㼔㼑㻌㼠㼛㼠㼍㼘㻌㼜㼍㼠㼕㼑㼚㼠

㼏㼛㼚㼚㼑㼏㼠㼕㼚㼓㻌㼜㼍㼞㼠㻚

㻺㻯㻌㻔㻌㻌㻌㻌㻌㻌㻌㻌㻕㼙㻭

㻻㻷㻌㻌㻺㻳

㻜㻡

㻸㼑㼍㼗㼍㼓㼑㻌㼏㼡㼞㼞㼑㼚㼠㻌㼣㼔㼑㼚㻌㼑㼤㼠㼑㼞㼚㼍㼘

㼢㼛㼘㼠㼍㼓㼑㻌㼕㼟㻌㼍㼜㼜㼘㼕㼑㼐㻌㼠㼛㻌㼠㼔㼑

㼜㼍㼠㼕㼑㼚㼠㻌㼏㼛㼚㼚㼑㼏㼠㼕㼛㼚㻌㼕㼚㻌㼠㼔㼑㻌㼀㼥㼜㼑

㻲㻌㼍㼠㼠㼍㼏㼔㼕㼚㼓㻌㼜㼍㼞㼠㻚

㻿㻲㻯㻌㻌㻔㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻕㼙㻭

㻻㻷㻌㻌㻺㻳

㻸㼑㼍㼗㼍㼓㼑㻌㼏㼡㼞㼞㼑㼚㼠㻌㼣㼔㼑㼚㻌㼑㼤㼠㼑㼞㼚㼍㼘

㼢㼛㼘㼠㼍㼓㼑㻌㼕㼟㻌㼍㼜㼜㼘㼕㼑㼐㻌㼠㼛㻌㼠㼔㼑

㼜㼍㼠㼕㼑㼚㼠㻌㼏㼛㼚㼚㼑㼏㼠㼕㼛㼚㻌㼕㼚㻌㼠㼔㼑㻌㼀㼥㼜㼑

㻲㻌㼍㼠㼠㼍㼏㼔㼕㼚㼓㻌㼜㼍㼞㼠㻚

㻿㻲㻯㻌㻔㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻕㼙㻭

㻻㻷㻌㻌㻺㻳

㻯㼘㼑㼍㼚㼕㼚㼓

㻾㼑㼜㼍㼕㼞

㻻㻷㻌㻌㻺㻳

12. Maintenance and Inspection

63

䕔

Repairing the Equipment

This equipment is basically repaired at Fukuda Denshi factory.

If detailed information about the repair is needed, contact Fukuda Denshi.

On-site repair is possible for the following parts.

ȷReplacing the battery compartment Lid Unit

CAUTION

Make sure to replace the parts correctly. Otherwise, it may cause damage

and heat generation of the equipment.

䕔

Replacing the Battery Compartment Lid Unit

䖃Life of the Battery Compartment Lid Unit

Life of the waterproof battery compartment lid unit is one year. If this unit is

used for more than a year, the waterproof (IPX8) performance cannot be

guaranteed. Replace the battery compartment lid unit to maintain its

waterproof performance.

CAUTION

z The battery unit must be replaced at specified period.

z Even if the LX-8100 is used less than one (1) year, the unit may be

damaged from high impact. If the LX-8100 is dropped or is subjected to

a high impact, make sure that the unit is not damaged.

Battery Compartment Lid Unit

12. Maintenance and Inspection

䖃Tools

ȷPhillips screwdriver (#0)

䖃Assembly and Disassembly

Follow the procedure below to remove the battery compartment lid unit.

1.㻌Remove the label.

2.㻌Remove the 2 installation screws then remove the battery compartment

lid unit.

Label

Installation screw

12. Maintenance and Inspection

65

Follow the procedure below to attach the battery compartment lid unit.

1.㻌Set the battery compartment lid unit adjusting to the front case.

2.㻌Secure the battery compartment lid unit with new 2 installation screws.

Make sure that the screws are securely tightened.

Installation screw

12. Maintenance and Inspection

3.㻌Make sure that the battery compartment lid unit opens/closes smoothly.

4.㻌Attach the label firmly aligning with the groove of the battery

compartment lid unit.

(1)

(2)

Groove

Label

13 . Standard and Optional Accessories

WARNING

Use only the accessories specified by Fukuda Denshi for the LX-8100.

Otherwise, the LX-8100 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.

䕔

Standard Accessories

No. Item Model Type Q’ty Remarks

1 Neck Strap OAT-03A 1

2 4-electrode ECG lead

cable CMT-02HTH-

0.8DA 1 AHA color code,

Hook Type,

Limb Lead (2CH)

3 Disposable portable

case ABT-810D 1

4 Operation Manual 1



(1) (2)

(3)



(4)



㻌

This

Document

13. Standard and Optional Accessories

䕔

Optional Accessories

The following optional accessories are available for the LX-8100.

Purchase them as required.

䖃LX-8100

Lead cables

Item Model Type Remarks



ECG Clip Type Lead

Cable CMT-01CTH-0.8DA 3-electrode (White, Black,

Red)

ECG Clip Type Lead

Cable CMT-02CTH-0.8DA 4-electrode (White, Black,

Green, Red)

ECG Clip Type Lead

Cable CMT-03CTH-0.8DA 5-electorode (Chest)

(White, Black, Green,

Red, Brown)

ECG Hook Type Lead

Cable CMT-01HTH-0.8DA 3-electrode (White, Black,

Red)

ECG Hook Type Lead

Cable CMT-02HTH-0.8DA 4-electrode (White, Black,

Green, Red)

ECG Hook Type Lead

Cable CMT-03HTH-0.8DA 5-electorode (Chest)

(White, Black, Green,

Red, Brown)

Pochette

Item Model Type Remarks



Disposable Portable

Case ABT-810D 5 pieces /pack

14. Specification



14. Specification

䕔

Specification

CAUTION

For quality improvement, specifications are subject to change without prior

notice.



Standard Specification

Size: 72.0(W) mm x 67.0(H) mm x 23.4(D) mm

(not including the protrusion)

Weight:

pproximately 100 grams (with battery)

Transmitting Waveform: ECG 1CH or 2CH (selectable from the ECG lead

cables), Respiration waveform.

ECG Lead cable Type: 3-electrode, 4-electrode, or 5-electrode (Limb+Chest)

lead cable. Automatically detect the type by inserting

the lead cable.

Transmitting Status

Data: Electrode Off, Low Battery, Event Switch,

Pacemaker

OLED: Built-in

Waterproof: IPX8 (If periodic replacements are performed) / IPX5

IPX5: Protection from water.

IPX8: Protection from submerge

Power Supply: DC: One “AA” size (“LR6” size) alkaline battery.

Continuous Operating

Time: “AA” size (“LR6” size) alkaline battery Approximately

6 days with MX1500 (DURACELL)

Conditions: ECG measurement, RESP

measurement, Set as Initial setting, operating

temperature 23qC

Operation mode: Continuous operation

*Continuous operating time is assumed when using a new ”AA” size

(“LR6”size) Alkaline battery specified by Fukuda Denshi.



14. Specification

ECG

Particular Standard: IEC 60601-2-27:2011

(Medical electrical equipment - Part 2-27:

Particular requirements for the basic safety and

essential performance of electrocardiographic

monitoring equipment)

*Suitable when using DS-8900 System (Central

Monitor) and LW-7080(Central Telemetry

Receiver).

Numbers of Lead

Electrode: 3-electrode, 4-electrode, or 5-electrode

(Limb+Chest) lead cable

Numbers of Input Channel:1CH (3-electrode) or 2CH

ccuracy of Sensitivity: Complies with IEC 60601-2-27:2011 and

201.12.1.101.1

(±20% or 100uV, whichever is greater.)

ECG Input Impedance: Complies with IEC 60601-2-27:2011 and

201.12.1.101.3

(2.5Mȍ and above)

Input dynamic range and

Offset voltage: Complies with IEC 60601-2-27:2011 and

201.12.1.101.2

(Input dynamic range: ±5 mV

Offset voltage: ±300 mV

Change of amplitude caused by offset voltage:

Within ±10%)

Common Mode

Rejection Ratio: Complies with IEC 60601-2-27:2011 and

201.12.1.101.10

(Less than 1mVp-p (RTI))

HR measurment

detection: Complies with IEC 60601-2-27:2011 and

201.12.1.101.15

(HR Measurement Accuracy:

Less than ±10% or ± 5bpm, whichever is greater

HR measurement range and accuracy are as

follows.

HR measurement range: 0, 12 bpm to 300 bpm)

HR Display Range: QRS Detection Wide0, 12 bpm to 300 bpm

(1bpm increment)

QRS Detection Narrow0, 30 bpm to 300 bpm

(1 bpm increment)

Frequency

Characteristic: 0.5 Hz to 40 Hz (within -3dB)

Time Constant: 0.4 sec ± 25%

Switching and available to set 0.1 sec ± 25%

Rejection of Pacemaker

Pulse: a) Pacemaker Pulse without Over/Undershoot

Capable to reject pulses of pulse width 0.1 ms

to 2 ms, amplitude ±2 mV to ±700 mV

b) Pacemaker Pulse with Over/Undershoot

Rejection is not possible.

Protection to Defibrillation: Meets the requirement of IEC 60601-2-27

14. Specification



Lead-off Detection

Current: 100 nA and below

Tall T-wave Rejection

Capability: 1.2 mV T-wave can be removed when tested

according to IEC 60601-2-27

verage of Heart Rate: HR measured from 6 seconds of heartbeat for

setting QRS width: wide, and 4 seconds of

heartbeat for setting QRS width: narrow.

Response time of heart

rate meter to change in

heart rate:

HR change from 80 bpm to 120 bpm:

Range 6 sec. to 8 sec., Average 7 sec.

HR change from 80 bpm to 40 bpm:

Range 6 sec. to 8 sec., Average 7 sec.

Sweep speed 9.0 mm/s



Heart rate

meter accuracy

and response

to irregular

rhythm:

80 bpm Ventricular Bigeminy: 80 bpm

60 bpm Ventricular Bigeminy: 60 bpm

120 bpm Ventricular Bigeminy: 120 bpm

90 bpm Bidirectional Systoles: 90 bpm



14. Specification

Respiration (Impedance Method)

ccuracy of Sensitivity: 10 mm/1ȍ ± 2 mm

(When standard Impedance is 480ȍ.)

Resp. Display Range: 0, 4 Bpm to 150 Bpm

Display Error of

Respiration Rate: ±3 Bpm

Measured Current of

Respiration: Below 100PA (42kHz)

Transmission Method

Modulation Mode: Digital, Frequency shift keying

Frequency: 608 MHz to 614 MHz

Oscillation Method: PLL Synthesizer method by crystal control

Channel Spacing: 12.5 kHz

Occupied Frequency

Bandwidth: Within 8.5 kHz

RF Output Power: 1 mW ± 2 dB

Transmitting Antenna: Dielectric Antenna

Safety

General Standard:

AMI / ANSI ES 60601-1:2005(R)2012 and A1:2012,

C1:2009(r)2012 and A2:2010(r)2012

(Medical electrical equipment - Part 1: General

requirements for basic safety and essential

performance)

EMC Standard:

IEC 60601-1-2: 2014

(Medical electrical equipment – Part 1-2: General

requirements for basic safety and essential

performance – Collateral standard: Electromagnetic

disturbances – Requirements and tests)

The class of protection

against electric shock: Internally Powered Equipment

The type of protection

against electric shock: Type CF Applied Part



Operating Environment

Temperature: 10qC to 40qC

Humidity: 30% RH to 85% RH (non-condensing)

tmospheric Pressure: 70 kPa to 106 kPa



Transport / Storage Environment

Temperature: -10qC to 60qC

Humidity: 10% RH to 95% RH (non-condensing)

tmospheric Pressure: 70 kPa to 106 kPa

14. Specification



䕔

Displays

The following displays are shown on the display of the LX-8100.



Display Description

Starting Screen

Displayed after turning on the power.

Automatically moves onto the channel

display screen.

Channel Display

Screen

Displays the transmitter channel after

turning on the power and also when

refreshing the screen.

Automatically move s onto the waveform

display screen.

Event

Displayed when the EVENT button is

pressed.

Electrode?

Displayed when the ECG electrode is

disconnected or the ECG/RESP

waveform cannot be measured normally.

For details about electrode check

message, refer to “14. Specification

ŠDetails of the “Electrode” Message”.

14. Specification

Display Description

Error Message: If messages are not cleared, contact your local Fukuda

Denshi service representative.

Telemeter Error

Displayed when the transmitter is faulty

EEPROM Error

Displayed when the EEPROM is faulty

CPU Error

Displayed when the CPU is faulty

Speaker Error



Displayed when the speaker is faulty.



14. Specification



䕔

Details of the “Electrode” Message

The following “Electrode?” messages are displayed on the display depending

on the selected lead cable and lead.

Check

Position

3-electrode lead

cable

Lead I display

3-electrode lead

cable

Lead II display

3-electrode lead

cable

Lead III display

Several

Position

Simultaneously



Check

Position

4-electrode lead

cable

5-electrode (Chest)

lead cable

ECG1+

ECG1-

ECG2+

ECG2-

Several

Position

Simultaneously

14. Specification

䕔

List of Setup Items

Followings are the items that can be set up in the LX-8100.

Items Selection Default Backup

ECG Lead I, II, III II Ũ

Display Size of ECG (1) ×1, ×1/2 ×1 Ũ

Display Size of ECG (2) ×1, ×1/2 ×1 Ũ

Display Size of

Respiration Waveform ×1, ×1/2 ×1 Ũ

Synchronized Tone ON, OFF OFF g

Items Selection Default Backup

Time Constant 0.4 sec, 0.1 sec 0.4 sec Ũ

Detection Sensitivity of

Pacemaker Pulse

(Pace Sens.)

Low, Mid, High Mid

QRS Detection

(QRS WidthᲣ Wide, Narrow Wide Ũ

Respiration Detection

Signal (DISPLAY) ON, OFF ON Ũ

Display Brightness

(Brightness) 8 levels 5 Ũ

Turn Off Display Time

(Display OFF) 1 min, 3 min, 10

min, OFF 3 min Ũ

Sound

(Sound) ON, OFF ON Ũ

Transmitter Channel

(CH)

One from the

following

channels.

0801 to 0879

0900 to 0979

1000 to 1079

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Fukuda Denshi Co LX8100 ECG & Respiration Transmitter User Manual 4L0114970 LX 8100 FA V01

Fukuda Denshi Co Ltd ECG & Respiration Transmitter 4L0114970 LX 8100 FA V01

05 (Short-Term Confidential) User Manual

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