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

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Thank you for purchasing our product.
Before using this product, read this operation manual thoroughly for correct
handing and operation.
Safety Precautions
Read the “Safety Precautions” thoroughly before use to ensure correct and
safe use of the product. Make sure to follow the precautions indicated below,
as these are important messages related to safety.
DANGER
Failure to follow this message may cause
immediate threat of death or serious injury, or
complete failure of the equipment.
WARNING
Failure to follow this message may result in death
or serious injury, or complete failure of the
equipment.
CAUTION
Failure to follow this message may cause injury or
failure of the equipment.
NOTE
A note is not related to product safety, but provides
information about the correct use and operating
procedures to prevent incorrect operation and
malfunction of the equipment.
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 .

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
ii
Graphic Symbol
The following symbols are used for this equipment.
LX-8100 Symbols indicated on the main unit
Symbol
Description
Warning (indicated in yellow)
Follow operating instructions (Warning); (indicated in blue)
Indicates that the failure to follow operating instructions
could place the patient or operator at risk.
Type CF Applied Part with Defibrillation-Proof
Indicates that the degree of protection against electric
shock is Type CF Applied Part with defibrillation-proof.
Indicates the power ON/OFF status.
Indicates the point to close the battery compartment lid.
Indicates the battery type and direction
Name and Address of Manufacturer
Date of Manufacture
Indicates the name and address of manufacturer, and
date of manufacture.
Non-ionizing electromagnetic radiation
Indicates the radio transmitting device.
iii

LX-8100 Symbols displayed on the display screen
Symbol
Description
Synchronized Mark
This mark flashes synchronizing to the heartbeat.
Indicates the remaining battery level.
iv
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.
2.
Users should have a thorough knowledge of the operation before
using this equipment.
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.

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.
7.
8.
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.
Do not disassemble or remodel the eqipment.
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.
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.
vi
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.
vii
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]
viii
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.
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.
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.
ix
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.
Precautions about Disposing of Battery
CAUTION
Follow the local municipal rule to dispose the used dry cell batteries.
xi
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.
xii

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,
register it in the log and give proper instructions to the user.
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.
xiii
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)
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.
xiv
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.
xv
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.)
䖃Compliance to the Electromagnetic Emissions
This equipment complies with the following emission standard.
Emission test
RF Emission
CISPR 11
Compliance
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.
xvi

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
Electrostatic discharge
IEC 61000-4-2
Radiated RF EM fields
IEC 61000-4-3
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3
Conducted disturbances
induced by RF fields
IEC 61000-4-6
Rated power frequency
magnetic fields
IEC 61000-4-8
Immunity test levels
r8kV contact
r2kV, r4kV, r8kV, r15kV air
10V/m
80MHz to 2.7GHz
1kHz 80%AM
Refer to the following table.
3V
0.15MHz to 80MHz
1kHz 80%AM
6V
0.15MHz to 80MHz
(in ISM bands between 0.15 MHz and 80MHz)
1kHz 80%AM
30A/m
50Hz
Immunity test specifications for RF wireless communications equipment.
Maximum
Test frequency
Distance Immunity test level
Modulation
power
(MHz)
(m)
(V/m)
(W)
710, 745, 780
PM, 217Hz
0.2
0.3
810, 870, 930
PM, 18Hz
0.3
28
1720, 1845, 1970
PM, 217Hz
0.3
28
2450
PM, 217Hz
0.3
28
5240, 5500, 5785
PM, 217Hz
0.2
0.3
xvii
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)
xviii
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.
EVENT Button
Transmits EVENT Information
Refer to “Safety
Precautions in this
manual’s preface”
Electrode Position Label
Indicates standard ECG
electrode position.
Power Switch
Turns ON/OFF the power
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
Display
Displays measurement
waveform and
transmitter information.
Channel Number
Indicates transmitter channel
number.
2. Names of Parts and Their Functions
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.
Battery Lid Lock Button
Unlocks the battery compartment lid.
Strap Hole
Attaches the strap.
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)
Approximately
MX1500
DURACELL
*1
alkaline battery
6 days
*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
Ĭ
Unlock and open the battery compartment lid
by sliding the open/close lever towards
OPEN while pressing the lock button.
ĭ
Install a new battery according to the polarity
indication inside the battery compartment.
Ĭ
ĭ
After installing the battery, lock the battery
compartment lid by sliding the open/close
lever towards CLOSE while pressing over
“PUSH” on the lid.
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
10
4. ECG Monitoring
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.
CMT-01CTH-0.8DA
CMT-02CTH-0.8DA
CMT-03CTH-0.8DA
CMT-01HTH-0.8DA
CMT-02HTH-0.8DA
CMT-03HTH-0.8DA
Applicable Lead
Limb Lead (1CH)
Limb Lead (2CH)
Limb Lead (1CH)
+Chest (1CH)
Limb Lead (1CH)
Limb Lead (2CH)
Limb Lead (1CH)
+Chest (1CH)
Remark
3-electrode Clip Type
4-electrode Clip Type
5-electrode Clip Type
3-electrode Hook Type
4-electrode Hook Type
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.
11
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
Black
(LA)
White
(RA)
Red
(LL)
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)
<>” .
For 4-electrode lead cable
White
(RA)
Green
(RL)
Black
(LA)
Red
(LL)

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
12
4. ECG Monitoring
For 5-electrode (Chest) lead cable
Black
(LA)
White
(RA)
Brown
(V)
Green
(RL)
Red
(LL)
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)
<>” .
The chest lead waveform is measured from the chest lead (Brown) positioned
on the chest.
13
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.
Attach the lead cable end to the electrode
(convex part).
Turn right and left to verify that it is securely
attached.
14
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
15
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.
16
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 5electrode (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
3-electrode
4-electrode
5-electrode (Chest)
Color of Electrode
White (RA) and Red (LL)
White (RA) and Red (LL)
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.
17
5. Respiration Monitoring
18
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 LX8100 may be different from the ones displayed on the receiving monitor
because the algorithm of the ECG and respiration rate is different.
19
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.
ť
20
Press and hold
ENTER
for 2 seconds.
Move onto ECG1
Lead/Waveform size setting
display.
ť
Press and hold
ENTER
for 2 seconds.
Move onto ECG2
Lead/Waveform size setting
display.
ť
Press and hold ENTER for 2 seconds.
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.
21
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.
22
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.
23
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”.
24
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.
25
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.
26
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”.
27
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.
28
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.
29
6. Measurement
30
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.
31
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).
32
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.
33
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
display screen (2).
button and ť button for 2 seconds in the ECG
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).
34
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.
35
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.
36
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.
37
7. Operation
38
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
Time Constant
Detection Sensitivity of
Pacemaker Pulse
(Pace Sens.)
QRS Detection
(QRS Width)
Respiration Detection
Signal (Display)
Display Brightness
(Brightness)
Turn Off Display Time
(Display OFF)
Sound
(Sound)
Transmitter Channel
(CH)
Selection
0.4 sec, 0.1 sec
Low, Mid, High
Default
0.4 sec
Mid
Backup
Ũ
Ũ
Wide, Narrow
Wide
Ũ
ON, OFF
ON
Ũ
8 levels
Ũ
1 min, 3 min, 10 min,
OFF
ON, OFF
3 min
Ũ
ON
Ũ
One from following
channels.
Ყ
Ũ
00
Ũ
0801 to 0879
0900 to 0979
1000 to 1079
1100 to 1179
1200 to 1279
1300 to 1379
Group ID
One from 00 to 63,
39
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.
40
8. Other Setting Items
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.
41
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.
42
8. Other Setting Items
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.
43
8. Other Setting Items
44
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.
45
9. Changing the Transmitter Channel and Group ID
46
10. Troubleshooting
䕔List of Displayed messages
Transmitter (Main Unit)
Message
Cause
Failed to transmit
waveform and
value.
Solution
Contact your local Fukuda
Denshi service
representative.
Faulty EEPROM.
Failed to initialize
CPU.
Faulty Speaker.
47
10. Troubleshootimg
ECG
Message
Character string
displayed, such as LA,
depends on the
detached electrode
position
48
Cause
Electrode is off.
Solution
Check the electrode
condition.
10. Troubleshootimg
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 Install the battery correctly.
polarity.
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
Battery level is
on the display even
empty.
though LED is on
when the power switch
is turned ON.
Replace the battery with a
new one.
Nothing is displayed
on the receiving
screen.
Set the same channel
number for the transmitter
and the receiving monitor.
The channel
number between
the transmitter and
the receiving
monitor do not
match up.
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.
49
10. Troubleshootimg
ECG
Phenomenon
Cause
“ELECTRODE?”
Lead cable is off.
message is displayed.
Solution
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 Replace the electrode with a
off.
new one.
Polarization
potential of the
electrode is too
high.
ECG waveform
contains noise.
Respiration waveform
cannot be measured.
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.
Electrode gel is dry Replace the electrode with a
new one.
Electrode is peeling
off.
The positions of the Attach the electrodes where
electrodes are
the respiration waveform can
improper.
be measured appropriately.
50
10. Troubleshootimg
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.
51
10. Troubleshootimg
52
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.
53
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.
54
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.
‫ڦ‬Daily Check
Perform daily checks using the “Daily Check List” on the next page.
‫ڦ‬Periodic 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”.
‫ڦ‬Periodic 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.
55

Daily Check List
No.
Inspected Date
Inspected by
Location
Device Type
S/No.
Date of Purchase
LX-8100
Items
Appearance
Battery
Compartment
Details
Visually check for any damage,
cracks, chip, peeled label, and
loosen screw on the housing.
Visually check for the ring
condition of the battery
compartment lid.
Visually check for the contact
springs, inside the LX-8100, to
the battery and the lock lever of
the battery compartment lid.
Power Supply
Turn the power ON/OFF to verify
proper switch operation.
ECG Connectors
Visually check the connectors of
the cable and the LX-8100.
ECG Lead cable
Wireless Channel
Transmission
Function
Display Function
Periodic Check
Comment
56
Visually check each lead for
damages.
Verify whether the transmitting
channel and group ID are the
same with the receiving monitor.
Turn the power ON and make
sure the information is displayed
on the receiving monitor.
Turn the power ON and verify
each display condition.
Check the date of the previous
periodic check.
Criteria
Judgment
No abnormality should be
found.
‫ڧ‬OK/ ‫ڧ‬NG
No damage, kink, floating,
and adhesion of dust
should be found.
‫ڧ‬OK/ ‫ڧ‬NG
‫ڧ‬OK/ ‫ڧ‬NG
No deformation, cracks,
and rust should be found.
With batteries installed,
the display should turn
ON.
No damage, chip, and
adhesion of dust should
be found.
No crack and damage
should be found.
Must match the wireless
channel check list.
Waveforms and values
should be received
without any problem.
All data should be
properly displayed.
Should be within one
year.
‫ڧ‬OK/ ‫ڧ‬NG
‫ڧ‬OK/ ‫ڧ‬NG
‫ڧ‬OK/ ‫ڧ‬NG
‫ڧ‬OK/ ‫ڧ‬NG
‫ڧ‬OK/ ‫ڧ‬NG
‫ڧ‬OK/ ‫ڧ‬NG
‫ڧ‬OK/ ‫ڧ‬NG
12. Maintenance and Inspection
‫ڦ‬Periodic 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
External Appearance
Power Supply Switch
Display / Operation / Record
ECG
Respiration
Speaker
Electrical Safety
No. Check Item
Check Procedure
1. External Appearance, Accessories
01
Appearance
Visually check the exterior for
scratches, cracks,
deformation, and rust.
02
Cables
Visually check all cables for
any damage or being
disconnected.
03
Operation
Manual
Check if the operation manual
and other accompanying
documents are stored in the
specified places.
No Check Item
Check Procedure
2 Power Supply Switch
01
Power Supply
Turn ON/OFF the power
Switch
switch.
Criteria
No abnormality should
be found.
No damage should be
found.
Should be stored in the
specified place.
Criteria
Should turn ON/OFF
the power switch
properly.
57
12. Maintenance and Inspection
No Check Item
Check Procedure
3 Display, Operation, Record
01
Labels
Visually check the labels,
caution labels, etc.
02
Operation,
Check by operating the
Switches and
switches and keys.
keys
03
Display
Check that the characters and
waveforms appear on the
display.
No Check Item
4 ECG
01
Input
Impedance*
02
03
Suppression
Characteristic of
Common-Mode
Signal*
Transient
Characteristic*
04
Frequency
Characteristic*
05
Heart Rhythm
Detection*
58
Check Procedure
According to test procedure of
IEC 60601-2-27:2011
201.12.1.101.3
According to test procedure of
IEC 60601-2-27:2011
201.12.1.101.10
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.
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
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
Criteria
Should be clean, clear
and firmly attached.
Should operate
properly.
The characters and
waveforms should be
clearly displayed. The
brightness should be
sufficient.
Criteria
Should be 2.5M€ or
above.
Should be 10mmp-p or
below for standard
sensitivity (sensitivity
1).
Should be 0.4 ± 0.1
seconds.
(When the time
constant is set to
0.4seconds.)
Should be 40Hz (-3dB)
or above.
The heart beat rhythm
should be detected
with sensitivity 1
according to the peakto-peak signal of
0.3mV and 3mV.
12. Maintenance and Inspection
06
ECG Sensitivity
07
Heart Rate
Accuracy*
08
ECG Lead
Switch
09
10
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
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
With ECG simulator, check
that each lead is displayed
properly.
(Check for 3-electrode, and
4-electrode, 5-electrode.)
Remove each electrode, and
check that lead-off message is
displayed.
Switch the ECG lead cable or
switch the setup of lead cable.
Wave form size on the
receiving monitor
should be within 0mm
d10% at sensitivity1.
For reference
heartbeat signal of 60,
180 beats/min., error
of the displayed HR
value should be within
±3 beats/min.
For each lead cable,
lead should be
correctly switched, and
waveform should be
correctly displayed.
Lead-Off
Lead-Off message for
Indication
the corresponded lead
should be displayed.
ECG Lead Cable
Should correctly
Recognition
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.
59
12. Maintenance and Inspection
No Check Item
5 Respiration
01
Respiration
Waveform
Sensitivity
02
03
No
Check Item
7 Electrical Safety
01
Contact current
60
Criteria
With comprehensive tester or
The amplitude
reference respiration signal
displayed on the
generator, input sinusoidal
receiving monitor
waveform of 0.5Hz with base
screen should be
resistance of 1.5kȍ/1ȍ
within 10 mm ± 2 mm.
change.
Respiration Rate Input reference respiration
Error should be within
Accuracy*
signal to comprehensive tester ±5 Bpm.
or respiration simulator, and
check the respiration rate
display. Test with the
respiration reference
load signal of 60, 120/min.
Frequency
With comprehensive tester or
The crest value at
Characteristic*
reference respiration signal
1.5 Hz should be more
generator, input 0.5Hz and
than 70% of the crest
1.5Hz or 2.5Hz, and measure
value at 0.5 Hz input.
the frequency characteristic.
* 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
6 Speaker
01
Generation
02
Check Procedure
Patient leakage
current that runs
through the
ground from the
patient
connecting part
(NC)
Check Procedure
Generate synchronized tone
and check the sound.
Check Procedure
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
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
Criteria
Generating
synchronized tone.
Criteria
From the enclosure to
the ground (NC)
ġ0.1mA.
ƂAC/DCƃ
From the patient
connecting part to the
ground (NC)
ġ0.01mA.
12. Maintenance and Inspection
No
03
04
05
06
Check Item
Leakage current
when external
voltage is
applied to the
patient
connection in
the Type F
attaching part
(SFC)
Total patient
leakage current
that runs
through the
ground from the
total patient
connecting part.
(NC)
Leakage current
when external
voltage is
applied to the
patient
connection in
the Type F
attaching part
(SFC)
Patient auxiliary
current (NC)
Check Procedure
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
Criteria
Leakage current when
external voltage is
applied to the patient
connection in the Type
F attaching part. (SFC)
ġ0.05mA.
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.
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.
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
Apply AC1500V for 1 minute
Should withstand
Voltage Test
between the enclosure and a
applied voltage.
(the enclosure – connecting part.
isolated
Note: The voltage differs
connecting part) depending on the internal
protective circuit composition
of the equipment.
According to test procedure of
IEC 60601-1 8.8.3
61
12. Maintenance and Inspection
Periodic Check List
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㻞 㻼㼛㼣㼑㼞㻌㻿㼡㼜㼜㼘㼥㻌㻿㼣㼕㼠㼏㼔
㻜㻝 㻼㼛㼣㼑㼞㻌㻿㼡㼜㼜㼘㼥㻌㻿㼣㼕㼠㼏㼔
㻺㼛㻚
㻜㻝
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
㻜㻞 㻾㻾㻌㻭㼏㼏㼡㼞㼍㼏㼥
㻻㻷㻌㻌㻺㻳
㻜㻟 㻲㼞㼑㼝㼡㼑㼚㼏㼥㻌㻯㼔㼍㼞㼍㼏㼠㼑㼞㼕㼟㼠㼕㼏
㻻㻷㻌㻌㻺㻳
㻢 㻿㼜㼑㼍㼗㼑㼞
㻻㻷㻌㻌㻺㻳
㻜㻝 㻿㼥㼚㼏㼔㼞㼛㼚㼕㼦㼑㼐㻌㼀㼛㼚㼑
㻟 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
㻜㻝 㻸㼍㼎㼑㼘㼟
㻻㻷㻌㻌㻺㻳
㻜㻞 㻻㼜㼑㼞㼍㼠㼕㼛㼚㻌㻿㼣㼕㼠㼏㼔㻛㻷㼑㼥
㻻㻷㻌㻌㻺㻳
㻜㻟 㻸㻯㻰
㻻㻷㻌㻌㻺㻳
㻠 㻱㻯㻳
㻜㻝 㻵㼚㼜㼡㼠㻌㻵㼙㼜㼑㼐㼍㼚㼏㼑
㻿㼡㼜㼜㼞㼑㼟㼟㼕㼛㼚
㻜㻞 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
㻜㻟 㼀㼞㼍㼚㼟㼕㼑㼚㼠㻌㻯㼔㼍㼞㼍㼏㼠㼑㼞㼕㼟㼠㼕㼏
㻻㻷㻌㻌㻺㻳
㻜㻠 㻲㼞㼑㼝㼡㼑㼚㼏㼥㻌㻯㼔㼍㼞㼍㼏㼠㼑㼞㼕㼟㼠㼕㼏
㻻㻷㻌㻌㻺㻳
㻜㻡 㻴㼑㼍㼞㼠㻌㻾㼔㼥㼠㼔㼙㻌㻰㼑㼠㼑㼏㼠㼕㼛㼚
㻻㻷㻌㻌㻺㻳
㻜㻢 㻱㻯㻳㻌㻿㼑㼚㼟㼕㼠㼕㼢㼕㼠㼥
㻻㻷㻌㻌㻺㻳
㻜㻣 㻴㼑㼍㼞㼠㻌㻾㼍㼠㼑㻌㻭㼏㼏㼡㼞㼍㼏㼥
㻻㻷㻌㻌㻺㻳
㻜㻤 㻱㻯㻳㻌㻸㼑㼍㼐㻌㻿㼣㼕㼠㼏㼔
㻻㻷㻌㻌㻺㻳
㻜㻥 㻸㼑㼍㼐㻙㻻㼒㼒㻌㼕㼚㼐㼕㼏㼍㼠㼕㼛㼚
㻻㻷㻌㻌㻺㻳
㻱㻯㻳㻌㻸㼑㼍㼐㻌㻯㼍㼎㼘㼑
㻝㻜
㻾㼑㼏㼛㼓㼚㼕㼠㼕㼛㼚
㻻㻷㻌㻌㻺㻳
㻻㻷㻌㻌㻺㻳
㻻㻷㻌㻌㻺㻳
㻻㻷㻌㻌㻺㻳
㻣 㻱㼘㼑㼏㼠㼞㼕㼏㼍㼘㻌㻿㼍㼒㼑㼠㼥
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
㻜㻝 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
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
㻜㻞
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
㻻㻷㻌㻌㻺㻳
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
㻜㻟 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 㻻㻷㻌㻌㻺㻳
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
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
㻜㻠 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
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
㻜㻡 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 㻻㻷㻌㻌㻺㻳
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
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
㻻㻷㻌㻌㻺㻳
㻜㻣 㼃㼕㼠㼔㼟㼠㼍㼚㼐㻌㼂㼛㼘㼠㼍㼓㼑㻌㼀㼑㼟㼠㻌
㻻㻷㻌㻌㻺㻳
㻜㻢
㻰㼑㼟㼏㼞㼕㼜㼠㼕㼛㼚
㼀㼔㼑㻌㼏㼔㼑㼏㼗㻌㼞㼑㼟㼡㼘㼠㻌㼕㼟㻌㼍㼟㻌㼒㼛㼘㼘㼛㼣㼟㻦
䕕㻺㼛㼞㼙㼍㼘㻌㻻㼜㼑㼞㼍㼠㼕㼛㼚䚷䕕㻹㼍㼘㼒㼡㼚㼏㼠㼕㼛㼚㼕㼚㼓㻚䚷䕕㻺㼑㼑㼐㼟㻌㼠㼛㻌㼎㼑㻌㼞㼑㼜㼍㼕㼞㼑㼐㻚
䝺
㻯㼔㼑㼏㼗
䠝
㻭㼐㼖㼡㼟㼠㼙㼑㼚㼠
㽢
㻾㼑㼜㼘㼍㼏㼑㼙㼑㼚㼠㻌㼜㼍㼞㼠
䠟
㻯㼘㼑㼍㼚㼕㼚㼓
䠋
㻺㼛㼠㻌㼏㼛㼢㼑㼞㼑㼐
䠮
㻾㼑㼜㼍㼕㼞
㻯㼛㼙㼜㼍㼚㼥
㻔㻰㼑㼠㼍㼕㼘㼟㻌㼛㼒㻌㼙㼍㼘㼒㼡㼚㼏㼠㼕㼛㼚㻌㼍㼚㼐㻌㼞㼑㼜㼍㼕㼞䛋
㻵㼚㼟㼜㼑㼏㼠㼛㼞
㻼㼑㼞㼟㼛㼚㻌㼕㼚㻌㼏㼔㼍㼞㼓㼑
㻾㼑㼜㼘㼍㼏㼑㼙㼑㼚㼠㻌㼜㼍㼞㼠㼟
62
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
䕕㻴㼛㼘㼕㼐㼍㼥䚷䚷㻌㻌䕕㻺㼕㼓㼔㼠
12. Maintenance and Inspection
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.
Battery Compartment Lid Unit
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.
63
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.
Label
2.㻌 Remove the 2 installation screws then remove the battery compartment
lid unit.
Installation screw
64
12. Maintenance and Inspection
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
65
12. Maintenance and Inspection
3.㻌 Make sure that the battery compartment lid unit opens/closes smoothly.
(1)
(2)
4.㻌 Attach the label firmly aligning with the groove of the battery
compartment lid unit.
Label
Groove
66
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
Neck Strap
OAT-03A
4-electrode ECG lead
cable
CMT-02HTH0.8DA
ABT-810D
Disposable portable
case
Operation Manual
Remarks
AHA color code,
Hook Type,
Limb Lead (2CH)
(1)
(2)
(3)
(4)
㻌 This
Document
67
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
ECG Clip Type Lead
Cable
ECG Clip Type Lead
Cable
ECG Clip Type Lead
Cable
ECG Hook Type Lead
Cable
ECG Hook Type Lead
Cable
ECG Hook Type Lead
Cable
Model Type
CMT-01CTH-0.8DA
CMT-02CTH-0.8DA
CMT-03CTH-0.8DA
CMT-01HTH-0.8DA
CMT-02HTH-0.8DA
CMT-03HTH-0.8DA
Remarks
3-electrode (White, Black,
Red)
4-electrode (White, Black,
Green, Red)
5-electorode (Chest)
(White, Black, Green,
Red, Brown)
3-electrode (White, Black,
Red)
4-electrode (White, Black,
Green, Red)
5-electorode (Chest)
(White, Black, Green,
Red, Brown)
Pochette
Item
Disposable Portable
Case
68
Model Type
ABT-810D
Remarks
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)
Approximately 100 grams (with battery)
Weight:
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
Electrode Off, Low Battery, Event Switch,
Data:
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 “AA” size (“LR6” size) alkaline battery Approximately
Time:
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.
69
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
3-electrode, 4-electrode, or 5-electrode
Electrode:
(Limb+Chest) lead cable
Numbers of Input Channel:1CH (3-electrode) or 2CH
Accuracy 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 Complies with IEC 60601-2-27:2011 and
Offset voltage:
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
Complies with IEC 60601-2-27:2011 and
Rejection Ratio:
201.12.1.101.10
(Less than 1mVp-p (RTI))
HR measurment
Complies with IEC 60601-2-27:2011 and
detection:
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
0.5 Hz to 40 Hz (within -3dB)
Characteristic:
Time Constant:
0.4 sec ± 25%
Switching and available to set 0.1 sec ± 25%
Rejection of Pacemaker a) Pacemaker Pulse without Over/Undershoot
Pulse:
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
70
14. Specification
Lead-off Detection
Current:
Tall T-wave Rejection
Capability:
Average of Heart Rate:
Response time of heart
rate meter to change in
heart rate:
Sweep speed
100 nA and below
1.2 mV T-wave can be removed when tested
according to IEC 60601-2-27
HR measured from 6 seconds of heartbeat for
setting QRS width: wide, and 4 seconds of
heartbeat for setting QRS width: narrow.
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.
9.0 mm/s
Heart rate
80 bpm Ventricular Bigeminy: 80 bpm
meter accuracy
and response
to irregular
60 bpm Ventricular Bigeminy: 60 bpm
rhythm:
120 bpm Ventricular Bigeminy: 120 bpm
90 bpm Bidirectional Systoles: 90 bpm
71
14. Specification
Respiration (Impedance Method)
Accuracy of Sensitivity: 10 mm/1ȍ ± 2 mm
(When standard Impedance is 480ȍ.)
Resp. Display Range:
0, 4 Bpm to 150 Bpm
Display Error of
±3 Bpm
Respiration Rate:
Measured Current of
Below 100PA (42kHz)
Respiration:
Transmission Method
Modulation Mode:
Frequency:
Oscillation Method:
Channel Spacing:
Occupied Frequency
Bandwidth:
RF Output Power:
Transmitting Antenna:
Digital, Frequency shift keying
608 MHz to 614 MHz
PLL Synthesizer method by crystal control
12.5 kHz
Within 8.5 kHz
1 mW ± 2 dB
Dielectric Antenna
Safety
General Standard:
EMC Standard:
The class of protection
against electric shock:
The type of protection
against electric shock:
AAMI / 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)
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)
Internally Powered Equipment
Type CF Applied Part
Operating Environment
Temperature:
Humidity:
Atmospheric Pressure:
10qC to 40qC
30% RH to 85% RH (non-condensing)
70 kPa to 106 kPa
Transport / Storage Environment
Temperature:
Humidity:
Atmospheric Pressure:
72
-10qC to 60qC
10% RH to 95% RH (non-condensing)
70 kPa to 106 kPa
14. Specification
䕔Displays
The following displays are shown on the display of the LX-8100.
Display
Description
Displayed after turning on the power.
Automatically moves onto the channel
display screen.
Starting Screen
Displays the transmitter channel after
turning on the power and also when
refreshing the screen.
Automatically move s onto the waveform
display screen.
Channel Display
Screen
Displayed when the
pressed.
EVENT
button is
Event
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”.
73
14. Specification
Display
Description
Error Message: If messages are not cleared, contact your local Fukuda
Denshi service representative.
Displayed when the transmitter is faulty
Telemeter Error
Displayed when the EEPROM is faulty
EEPROM Error
Displayed when the CPU is faulty
CPU Error
Speaker Error
74
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.
3-electrode lead
3-electrode lead
3-electrode lead
Check
cable
cable
cable
Position
Lead I display
Lead II display
Lead III display
LL
RA
LA
Several
Position
Simultaneously
Check
Position
4-electrode lead
cable
5-electrode (Chest)
lead cable
LL
RA
LA
RL
ECG1+
ECG1ECG2+
ECG2Several
Position
Simultaneously
75
14. Specification
䕔List of Setup Items
Followings are the items that can be set up in the LX-8100.
Items
ECG Lead
Display Size of ECG (1)
Display Size of ECG (2)
Display Size of
Respiration Waveform
Synchronized Tone
Items
Time Constant
Detection Sensitivity of
Pacemaker Pulse
(Pace Sens.)
QRS Detection
(QRS WidthᲣ
Respiration Detection
Signal (DISPLAY)
Display Brightness
(Brightness)
Turn Off Display Time
(Display OFF)
Sound
(Sound)
Transmitter Channel
(CH)
Group ID
76
Selection
I, II, III
×1, ×1/2
×1, ×1/2
Default
II
×1
×1
×1, ×1/2
×1
ON, OFF
OFF
Selection
0.4 sec, 0.1 sec
Low, Mid, High
Default
0.4 sec
Mid
Backup
Ũ
Ũ
Ũ
Ũ
Backup
Ũ
Ũ
Wide, Narrow
Wide
Ũ
ON, OFF
ON
Ũ
8 levels
Ũ
1 min, 3 min, 10
min, OFF
ON, OFF
3 min
Ũ
ON
Ũ
One from the
following
channels.
1100
Ũ
00
Ũ
0801 to 0879
0900 to 0979
1000 to 1079
1100 to 1179
1200 to 1279
1300 to 1379
One from 00 to 63


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