Fukuda Denshi Co LX7120 ECG & Respiration Transmitter User Manual
Fukuda Denshi Co Ltd ECG & Respiration Transmitter
User manual
ECG & Respiration Transmitter
LX-7120
Operation Manual
● Before using this device, read this operation manual thoroughly.
● Keep this manual near the device for future reference.
CAUTION
Federal Law restricts this device to sale by or on the order of a physician.
CAUTION
Users are advised to periodically contact the FCC or specified frequency
coordinator and determine if other or your transmitter frequencies that
may cause interference.
CAUTION
The manufacturers, installers and users of Wireless Medical Telemetry
System equipment are cautioned that the operation of this equipment
could result in harmful interference to other nearby medical devices.
CAUTION:
• This device for sale by or on the order of a physician.
• The company and product names used in this manual are trademarks or
registered trademarks.
• If this manual has pages missing or out of order, contact Fukuda Denshi
for replacement.
• Only physician or persons instructed by physicians are allowed to use the
equipment.
• The information contained in this document is subject to change without
notice due to improvement in the equipment.
Copyright © 2010 by Fukuda Denshi Co., Ltd.
No part of this document may be copied or transmitted in any form without the prior
written permission of Fukuda Denshi Co., Ltd.
Printed in Japan
Thank you for purchasing this product from Fukuda Denshi.
Before use, read this operation manual thoroughly for correct handling
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.
WARNING Failure to follow this message may result in death or
serious injury.
CAUTION Failure to follow this message may cause injury or
failure to 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 liable for the safety, reliability, and performance of its device
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.
i
Equipment Symbols
Refer to the following symbols indicated on the LX-7120 for their meanings.
Symbols indicated on the main unit
Symbol Description
Caution; read the operation manual.
Indicates the need to refer to the operation manual before
operation.
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 battery type and direction.
Symbols indicated on the LCD screen
Symbol Description
Heart Rate Synchronization Mark:
This mark flashes synchronizing with the heartbeat.
Battery Mark:
Indicates the remaining battery level.
ii
Precautions for Safe Operation of Medical Electrical Equipment
Cautions described here are regarding the general instructions for safety use
to the patient and the operator. As for cautions about the LX-7120, please refer
to the following pages.
CAUTION
1. Users should have a thorough knowledge of the operation before
using this equipment.
2. Pay attention to the following when installing or storing the
equipment.
Do not install or store in an area where the equipment will be subject
to splashing water.
Do not install or store in an area where the environmental
conditions, such as atmospheric pressure, temperature, humidity,
ventilation, sunlight, dust, sodium, sulfur, will adversely affect the
system.
Place the equipment on a stable surface where there is no
inclination, vibration, or shock (including during transportation).
Do not install or store in an area where chemicals are stored or
gases are generated.
3. Before operating the equipment, verify the following items.
Check the cable connection and polarity to ensure proper operation
of the equipment.
Ensure that all cables are firmly and safely connected. Especially,
recheck the attachment and connection condition of electrode.
Pay special attention when the equipment is used in conjunction with
other equipment as it may cause erroneous judgment and danger.
Check the remaining battery level.
When replacing the battery, make sure that the battery polarity is
correct. Do not charge the battery.
4. During operation of the equipment, verify the following items.
Do not operate the equipment beyond the time period required for
diagnosis and medical care.
Do not pick up and/or swing the equipment pulling/grabbing the
cable part. It may damage the equipment and lead to measurement
error.
Always observe the equipment and patient to ensure safe operation
of the equipment.
If any abnormality is found on the equipment or patient, take
appropriate measures such as ceasing operation of the equipment
and/or electrode, in the safest way for the patient.
Do not allow the patient to come in contact with other equipments.
iii
CAUTION
5. After using the equipment, verify the following items.
Make sure to turn off the power of the equipment.
When unplugging the cables, do not apply excessive force on the
cable and pull from its connector.
Clean the accessories and cables, and keep them together in one
place.
Keep the equipment clean to ensure proper operation for the next
use.
Make sure to remove the battery if the equipment is not used for a
long time. The leakage from the battery may damage the device or
an explosion from the battery may occur.
6. If the equipment is damaged and in need of repair, ensure patient
safety by immediately turning the equipment off and remove the
electrodes and/or cable from the patient. User should not attempt
service. Label the unit “OUT OF ORDER” and contact Fukuda
Denshi representative.
7. Do not remodel the equipment.
8. Maintenance Check
Make sure to periodically check the equipment, and accessories.
Before reusing the equipment that has been left unused for a while,
make sure that the equipment works normally and safely.
9. When using electrosurgical knives or defibrillator with this
equipment, take care of the following.
To prevent burn injury to the patient, verify proper attachment of
patient ground plate, ECG electrode type for the electrosurgical
knives, and the quantity of gel, output energy for the defibrillator.
Also, verify that a proper ground is selected.
Some types of equipment other than the above may cause
accidental hazards to the patient and operator due to the conditions
of the equipment. Read the operation manual attached to each
device and understand the precautionary instructions prior to use.
Non-Explosion Proof
DANGER
Never operate the equipment in the presence of flammable anesthetics,
high concentration of oxygen. It may cause an explosion or fire.
Never operate the equipment inside a hyperbaric chamber. It may
cause an explosion or fire.
Never operate the equipment where flammable gas or fluid such as
anesthetic, oxygen, and hydrogen are used. It may cause an explosion
or fire.
iv
Precautions about Magnetic Resonance Imaging (MRI)
WARNING
Do not operate this equipment in magnetic resonance imaging (MRI)
environments.
When conducting MRI test, remove the electrodes and sensors
connected to the patient (test subject).
The local heating caused by the induced electromotive force may cause
burn injury to the patient (subject). For details, refer to the operation
manual for the MRI testing device.
Electrosurgery Safety
WARNING
When using electrosurgical instrument, make sure the contact between
the patient and the ground plate is secure. If the connection is
incomplete, the patient may suffer a burn at the electrode site.
When using an electrosurgical instrument, it may misidentify noise from
the electrosurgical instrument as a heartbeat or arrhythmia.
Defibrillation Safety
WARNING
Use only the lead cable specified by Fukuda Denshi when defibrillating.
If used by unspecified lead cable, the device may be damaged, resulting
in a safety hazard.
When using the defibrillator, keep away from the electrodes or
medicament applied to the patient chest. If this is not possible, remove
the electrodes or medicament before using it.
If the defibrillator paddles are directly in contact with the electrodes or
medicament, an electrical shock may result from the discharged energy.
When using the defibrillator, do not touch the patient and the metal part
of the device or cables. Electric shock may result from the discharged
energy.
v
Precautions about the Pacemaker
WARNING
Minute ventilation rate-adaptive implantable pacemakers can
occasionally interact with certain cardiac monitoring and diagnostic
equipment, causing the pacemakers to pace at their maximum
programmed rate. The cardiac monitoring and diagnostic equipment
may possibly send wrong information.
If such event occurs, 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 (Letter: www .fda.gov/cdrh/safety.html) – FDA]
ECG meter may continue to count the pacemaker rate during
occurrences of cardiac arrest or arrhythmias. Do not rely entirely upon
the ECG meter alarms. Keep pacemaker patients under close
surveillance. Check this manual for disclosure of the pacemaker pulse
rejection capability of this instrument.
Precautions about the LX-7120
WARNING
Do not connect cables not authorized by Fukuda Denshi to any I/O
connector. If done so by mistake, the LX-7120 cannot deliver its
maximum performance and may be damaged, resulting in a safety
hazard.
Do not use this device with multiple patients simultaneously.
CAUTION
Do not pick up and/or swing the LX-7120 pulling/grabbing the cord part.
The cable could break or get disconnected from the LX-7120. And it may
hit people or damage other equipment around.
vi
Precautions about Waterproof
CAUTION
Replace the “Battery Compartment Lid” of the LX-7120 regularly to keep
the main unit 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.
The lid may be damaged from high impact. If the LX-7120 is dropped or
is subjected to a high impact, make sure that the lid is not damaged.
Do not use the LX-7120 wet. Always wipe the LX-7120 with a soft cloth
and dry it thoroughly before use.
Precautions about ECG
CAUTION
When removing electrodes from the patient, remove them carefully and
slowly. Do not apply excessive force to remove them. Otherwise, it may
damage the skin.
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), electrode placement, or lead method which
causes the pacemaker pulse amplitude to decrease and disables
pacemaker pulse detection.
If signals similar to a pacemaker pulse are present, such as electric
blanket noise or excessive AC frequency noise, these may be
erroneously detected and displayed as a pacemaker pulse. In this case,
check the condition of the electrodes and ECG lead cable to resolve the
cause or turn off the pacemaker detection setting on the receiving
monitor.
Precautions about Output Signal
WARNING
Do not use the output signal of the monitor that receives radio wave signal
from the LX-7120 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.
vii
Precautions about Accessories and Optional Accessories
WARNING
Use only the accessories, such as ECG Lead cable, specified by Fukuda
Denshi for the LX-7120. Otherwise, the LX-7120 cannot deliver its
maximum performance and may be damaged, resulting in a safety hazard.
CAUTION
Do not reuse disposable products.
Store the disposable products properly as mentioned in their user
manuals.
Precautions about Battery
WARNING
Use new "AA" size (“LR06” size) alkaline cell.
Install the battery with the correct polarity.
Do not charge the battery. Any attempt to charge the battery may cause
it to leak or break.
Do not short the (+) and (-) terminals. It may result in exothermic heat
and fire.
Do not throw the battery into fire. It may explode.
Precautions about Disposing of Equipment, Accessories, or
Components
CAUTION
When disposing of the equipment, accessories, or components, use an
industrial waste distributor. Do not dispose of as ordinary waste.
Used disposal items (ECG electrodes, etc.) shall be discarded as
medical waste.
Precautions about Disposing of Battery
CAUTION
Obey the local municipal rule to dispose the used dry cell battery.
viii
Precautions for Use of Medical Telemeter
WARNING
The LX-7120 transmitter must not be co-located or operated in
conjunction with any other antenna or transmitter.
The LX-7120 complies with FCC radiation exposure limits set forth for a
controlled environment and meets the FCC radio frequency (RF)
Exposure Guidelines in Supplement C to OET65. The LX-7120 has very
low levels of RF energy that are deemed to comply without testing of
specific absorption ratio (SAR).
Operation of LX-7120 requires the prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry
Service.
This radio frequency device is susceptible to interference from outside
sources. Interference may prevent the monitoring of patients connected
to this device. If a problem exists, contact your local service
representative.
The LX-7120 transmits vital signs to the receiving monitor using radio
wave signal. Under unstable radio wave signals, the receiving monitor
will not generate any alarms. This situation may miss sudden change in
the patient's condition and may cause a serious accident. Under
unstable radio wave signals, check the patient status consistently under
this situation. To get stable radio wave signals, make sure to have a
proper telemetry installation.
CAUTION
For installation, make sure the following.
The medical institution (hereinafter referred to as the “Institution”) must
decide the telemetry installation plan for the medical department in order
to prevent interference and interference between transmitters (telemetry
based on destination country’s radio law). When telemetry has already
been installed and been used, radio format, frequency, and antenna power
are required to be examined to prevent interference.
When using telemetry, which requires zone location, the Institution is to
set up the zones as an operation unit for each transmitter to prevent
electronic interference between telemetry throughout the Institution.
When using telemetry, which requires zone location, display and identify
each prepared zone in the equipment.
When laying receiver antenna for each transmitter, the Institution has to
examine the installation so that electronic interference does not occur.
Based on the above examination result, the Institution should install each
receiver antenna as required.
For management, make sure to follow the precautions below.
The Institution should appoint a person (hereinafter referred to as the
“Overall Manager”) to manage the wireless channels for the whole
Institution.
ix
x
And when using telemetry, which requires zone location, the Institution
should nominate a person (hereinafter referred to as the “Zone Manager”)
to manage the wireless channels in each zone. However, when using such
telemetry in a local Institution, one person can perform both functions.
The Overall Manager and Zone Manager must be selected from people
who understand the characteristics and functionality of telemetry systems,
and are skilled in operating telemetry.
When installing telemetry, the Overall Manager and the Zone Manager
have to understand the precautions for use of telemetry in advance.
The Overall Manager is responsible for maintenance of wireless channel
and storage and maintenance of telemeter in the overall medical facilities
to give proper instructions to the Zone Manager when using telemetry
needing zone alignment, and to the telemetry user when using telemetry
not-needing zone alignment.
The Overall Manager should create a management log (hereinafter
referred to as the “log”), which contains a list of the management status of
the wireless channels for the whole Institution. When changing a wireless
channel, register it in the log and give proper instructions to the Zone
Manager or to the user.
The Zone Manager assumes responsibility for managing the wireless
channels, storing, and managing telemetry.
The Zone Manager assigns the transmitter to the user, and provides
enough education for use inside the zone.
The telemetry user verifies operation of the transmitter/receiver before
use.
The telemetry user, if using the telemetry in a zone location, follows the
instructions of the Zone Manager for the zone and gives instructions to the
patient if required.
When interference or breakdown occurs in telemetry communication, the
user is required to inform the Zone Manager and the Overall Manager of
the problems. The Zone Manager and Overall Manager are to deal with
the problem properly and/or contact their nearest Fukuda Denshi
representative for service.
Electromagnetic Compatibility
The performance of this device under electromagnetic environment complies
with IEC 60601-1-2 (2007).
Precautions for Safe Operation under Electromagnetic Influence
CAUTION
If any sorts of electromagnetic wave, magnetic field, or static electricity
exist around the device, noise interference or malfunction of the device
may occur. If any unintended malfunction or noise occurs during
monitoring, check the magnetic influence and take appropriate
countermeasures.
The following are examples of the common cause and countermeasures.
●Cellular Phone
The radio wave may cause malfunction to the device.
Cellular phones and radio sets should be turned off in the room
(building) where medical device is located.
●Static Electricity
In a dry environment (room), static electricity is likely to occur. Take
the following countermeasures.
Both operator and patient should remove any static electricity before
entering the room.
Humidify the room.
xi
xii
EMC Guidance
This equipment complies with IEC 60601-1-2 (2007). However, if portable
transmitter or wireless LAN equipment is used extremely nearby, the
electromagnetic influence may largely exceed the compliance level and may
cause unexpected phenomenon such as noise interference on the waveform,
etc.
Therefore, this equipment should be used in a location specified by each
medical institution. If any unexpected noise interference on the waveform or
failure to the peripheral device occurs, stop using the equipment and follow the
instruction of the technician.
The following is the information relating to EMC (Electromagnetic
Compatibility).
(When using this equipment, verify that it is used within the environment
specified below.)
●Compliance to the Electromagnetic Emissions
The LX-7120 is intended for use in the electromagnetic environment specified
below. The customer or the user of the LX-7120 should assure that it is used in
such an environment.
Emission Test Compliance Electromagnetic Environment –
Guidance
RF Emission
CISPR 11 Group 1
The LX-7120 uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF Emission
CISPR 11 Class A
Harmonic Emission
IEC 61000-3-2 N/A
Voltage Limit /
Flicker Emission
IEC 61000-3-3
N/A
This LX-7120 is suitable for use in all
establishments other than domestic and
those directly connected to the public low-
voltage power supply network that
supplies buildings used for domestic
purposes.
xiii
●Compliance to the Electromagnetic Immunity (1)
The LX-7120 is intended for use in the electromagnetic environment specified
below. The customer or the user of the LX-7120 should assure that it is used in
such an environment.
Immunity Test IEC 60601-1-2
Test Level Compliance
Level
Electromagnetic
Environment
Guidance
Electrostatic
Discharge
(ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material, the
relative humidity
should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV:
Power supply lines
±1kV:
Input/output lines
N/A
Surge
IEC 61000-4-5
±1kV:
differential mode
±2kV:
common mode
N/A
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines.
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5sec.
N/A
Power
Frequency
(50/60Hz)
Magnetic Field
IEC 61000-4-8
3A/m 3A/m
Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Note: UT is the AC mains voltage prior to application of the test level.
●Compliance to the Electromagnetic Immunity (2)
The LX-7120 is intended for use in the electromagnetic environment specified
below. The customer or the user of the LX-7120 should assure that it is used in
such an environment.
Immunity
Test IEC60601-1-2
Test Level Complianc
e Level Electromagnetic Environment
Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
LX-7120, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended Separation Distance
Conducted RF
IEC 61000-4-6
3Vrms
150kHz to 80MHz
3Vrms d = 1.2 P
Radiated RF
IEC 61000-4-3
3V/m
80MHz to 2.5GHz
3V/m d = 1.2 P 80MHz to 800MHz
d = 2.3 P 800MHz to 2.5GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and dis the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey a), should
be less than the compliance level in
each frequency range b).
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Note 1: At 80MHz and 800MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which the LX-7120 is used exceeds the applicable RF compliance
level above, the LX-7120 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the LX-7120.
b) Over the frequency range 150kHz to 80MHz, field strength should be less than
3V/m.
xiv
●Recommended Separation Distances between Portable and
Mobile RF Communications Equipment and the LX-7120
The LX-7120 is intended for use in an environment in which radiated RF
disturbances are controlled. The customer or the user of the LX-7120 can help
prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters)
and the LX-7120 as recommended below, according to the maximum output
power of the communications equipment.
Separation Distance according to Frequency of Transmitter (m)
Rated Maximum
Output Power of
Transmitter
(W)
150kHz to 80MHz
d = 1.2 P
80MHz to 800MHz
d = 1.2 P
800MHz to 2.5GHz
d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1 : At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.
Note 2 : These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
xv
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xvii
CONTENTS
Safety Precautions..................................................................................... i
Precaution from Fukuda Denshi....................................................... i
Equipment Symbols .........................................................................ii
Precautions for Safe Operation of Medical Electrical Equipment ....iii
Non-Explosion Proof .......................................................................iv
Precautions about Magnetic Resonance Imaging (MRI)................. v
Electrosurgery Safety...................................................................... v
Defibrillation Safety ......................................................................... v
Precautions about the Pacemaker ..................................................vi
Precautions about the LX-7120.......................................................vi
Precautions about Waterproof .......................................................vii
Precautions about ECG .................................................................vii
Precautions about Output Signal ...................................................vii
Precautions about Accessories and Optional Accessories ........... viii
Precautions about Battery............................................................. viii
Precautions about Disposing of Equipment, Accessories,
or Components ............................................................................. viii
Precautions about Disposing of Battery ........................................ viii
Precautions for Use of Medical Telemeter ......................................ix
Electromagnetic Compatibility .............................................................xi
Precautions for Safe Operation under Electromagnetic Influence...xi
EMC Guidance...............................................................................xii
1. General Description ............................................................................. 1
2. Names of Parts and Their Functions.................................................... 3
3. Preparation .......................................................................................... 5
1) Installing the Battery ................................................................... 5
2) Operating Power Switch ............................................................. 7
4. ECG Monitoring ................................................................................... 9
■ Connecting the ECG Lead Cable and Electrodes...................... 9
■ Attaching the Electrodes.......................................................... 12
■ Connecting the ECG Lead Cable to the LX-7120 .................... 13
5. Respiration Monitoring ....................................................................... 15
6. Measurement ..................................................................................... 17
■ Starting Screen........................................................................ 17
■ Waveform Display Screen ....................................................... 17
■ Battery Level Check ................................................................ 17
■ Waveform Display ................................................................... 18
7. Operation ........................................................................................... 25
■ Changing Setup....................................................................... 25
■ Restarting the LCD display ...................................................... 29
■ Pressing the EVENT button..................................................... 29
xviii
8. Other Setting Items ............................................................................ 31
■ Changing the Time Constant ................................................... 31
■ Changing the Detection Sensitivity of the Pacemaker Pulse ... 32
■ Changing the Respiration Detection Signal ON/OFF............... 33
■ Changing the LCD Contrast..................................................... 33
9. Changing the Transmitter Channel and Group ID.............................. 35
■ Changing the Transmitter Channel.......................................... 35
■ Changing the Group ID............................................................ 35
10. Troubleshooting ............................................................................... 37
■ List of Displayed messages ..................................................... 37
■ Troubleshooting....................................................................... 38
■ In Case of Dropping the LX-7120 into Water ........................... 40
11. Cleaning and Disinfection ................................................................ 41
■ Cleaning .................................................................................. 41
■ Disinfection .............................................................................. 41
12. Maintenance and Inspection ............................................................ 43
13. Standard and Optional Accessories................................................. 45
■ Standard Accessories.............................................................. 45
■Optional Accessories................................................................. 46
14. Specification..................................................................................... 47
■ Specification ............................................................................ 47
■ Displays................................................................................... 50
■ Details of the “ELECTRODE?” Message................................. 51
■ List of Setup Items................................................................... 52
1
1. General Description
The LX-7120 is a radio telemetry transmitter designed to measure the ECG
and respiration waveform with one (1) “AA” size (“LR06” size) alkaline battery.
Information such as ECG measurements, respiration waveform, battery level,
and the conditions of the ECG electrodes are displayed on the LCD of the front
panel.
ECG lead selection is available using the two buttons (Enter and ▽) on the
front panel. (In case of using a 3-electrode lead cable or a 5-electrode chest
lead cable)
Before using the LX-7120, read also the operation manual of the patient
monitor at the receiving side thoroughly.
External Appearance
1. General Description
2
Blank Page
3
2. Names of Parts and Their Functions
Neck Strap Hole
Battery Lid Lock Lever
Uses to open/lock the
battery compartment lid.
Enter button
Uses for setup.
▽ button
Uses for setup.
A
ttaches the neck strap.
ECG/RESP Input Connector
Connects the ECG lead cable
to measure ECG and
respiration waveform.
Refer to “Safety
Precautions” in this
manual’s preface.
Channel Number Label
Indicates transmitter
channel number.
Power Switch
Turn ON/OFF the power.
LCD
Displays measurement
waveform and transmitter
information.
EVENT Button
A
ctivates the function
assigned on the receiving
monitor.
Electrode Position Label
Indicates standard ECG
electrode position.
Battery Compartment Lid
This is the lid for the battery
compartment.
Make sure to close it when the
transmitter is operated.
2. Names of Parts and Their Functions
4
Blank Page
5
3. Preparation
1) Installing the Battery
The LX-7120 functions with one (1) "AA" size (“LR06” size) alkaline battery.
With new battery, the LX-7120 is capable of approximately 6 days continuous
operation.
WARNING
Unplug the ECG lead cable when the battery compartment lid is
opened. Otherwise, patient leakage current beyond the allowable value
may occur.
Use new "AA" size (“LR06” size) alkaline battery.
Do not short out the (+) and (-) terminals. It may result in exothermic
heat and fire, the leakage from the battery may damage the device, or
an explosion from the battery may occur.
Install the battery with the correct polarity.
Do not use a disassembled or a damaged battery due to drop or shock.
The leakage from the battery may damage the device, or an explosion
from the battery may occur.
Remove the exhausted battery immediately. The leakage from the
battery may damage the device, or an explosion from the battery may
occur.
If the transmitter is not in use for a long period of time, remove the
battery and store the device in an appropriate place. If the battery is left
in the transmitter for a long period of time, the leakage from the battery
may damage the device or an explosion from the battery may occur.
CAUTION
Use only alkaline battery. Other battery will shorten the continuous
operating time.
Once the power switch is on the OFF position, then open the battery
compartment lid.
Do not replace the battery with wet hands.
In case of storing the used or unused battery, make sure that the
terminals are not touching other battery or metal parts.
3. Preparation
6
Lift the lock lever to open the battery
compartment lid as shown in the left picture.
Install new battery according to the polarity
indication inside the battery compartment.
Make sure to first Insert the battery into the
battery compartment from the minus (-)
terminal as shown in the left picture.
Hook the lock lever on the projection from
the body and press it down until it is
horizontal (flat position).
CAUTION
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.
Make sure to only turn ON the LX-7120 after closing the battery
compartment lid.
3. Preparation
7
2) Operating Power Switch
Turning the power switch to “ON”
Rotate the power switch to the left until it clicks.
LCD screen turns ON and measurement starts.
Regarding the LCD screen, refer to page 17 (6. Measurement).
The screen automatically turns itself OFF after a minute.
After the power is turned ON, make sure to check the remaining battery level
on the LCD 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
The battery level estimation is in case of using alkaline battery.
Turning the power switch to “OFF”
Rotate the power switch to the right until it clicks.
3. Preparation
8
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9
4. ECG Monitoring
■ Connecting the ECG Lead Cable and Electrodes
The optional ECG lead cables for LX-7120 are as follows.
ECG Lead Cables
AHA color code:
Item No. Applicable Lead Remark
CMT-01HTH-0.8DA Limb Lead (1CH) 3-electrode Hook Type
(White, Black, Red)
CMT-02HTH-0.8DA Limb Lead (2CH) 4-electrode Hook Type
(White, Black, Red, Green)
CMT-03HTH-0.8DA Limb Lead (1CH)
+Chest (1CH)
5-electrode Hook Type
(White, Black, Red, Green, Brown)
CMT-01FTH-0.8DA Limb Lead (1CH) 3-electrode Clip Type
(White, Black, Red)
CMT-02FTH-0.8DA Limb Lead (2CH) 4-electrode Clip Type
(White, Black, Red, Green)
CMT-03FTH-0.8DA Limb Lead (1CH)
+Chest (1CH)
5-electrode Clip Type
(White, Black, Red, Green, Brown)
WARNING
Use only the specified lead cable from Fukuda Denshi. Otherwise, proper
monitoring may not be performed, and also it may fail defibrillation or cause
a malfunction of the device when the device is used with a defibrillator.
4. ECG Monitoring
10
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
For AHA color code electrode position (No. CMT-01HTH-0.8DA, CMT-01FTH-0.8DA)
Standard Limb leads
Standard Limb leads can be selected from lead I, lead II, or lead III under
the setting of the device.
Refer to “7. Operation ■Changing Setup ●ECG Display Screen (1)
<<Switching Lead>>” in page 25.
Black
(
LA
)
Red
(LL)
White
(
RA
)
For 4-electrode lead cable
For AHA color code electrode position (No. CMT-02HTH-0.8DA, CMT-02FTH-0.8DA)
Standard Limb leads
Two leads measurements, lead I and II are fixed. Lead III, aVR, aVL, and
aVF can be also displayed from the setting on the receiving monitor. For
details, refer to the operation manual of the receiving monitor.
Black
(LA)
White
（RA）
Red
(LL)
Green
(
RL
)
4. ECG Monitoring
11
For 5-electrode (Chest) lead cable
For AHA color code electrode position (No. CMT-03HTH-0.8DA, CMT-03FTH-
0.8DA)
Standard Limb lead
and Chest lead
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 device.
The chest lead waveform is measured from the chest lead (Brown)
positioned on the chest.
Refer to “7. Operation ■Changing Setup ●ECG Display Screen (1)
<<Switching Lead>>” in page 25.
Black
(LA)
White
（RA）
Red
(LL)
Green
Brown
(V)
(
RL
)
4. ECG Monitoring
12
■ Attaching the Electrodes
CAUTION
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.
CAUTION
Do not reuse the disposable electrodes. It is intended for single patent 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.
4. ECG Monitoring
13
■ Connecting the ECG Lead Cable to the LX-7120
Insert the ECG lead cable firmly into the ECG/RESP input connector matching
the transmitter’s connector guide and the direction of the notched part on the
connector.
ECG Lead cable
4. ECG Monitoring
14
CAUTION
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.
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.
Time constant of this device 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.
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.
The indication for continuous use of an electrode is about one day.
Replace the electrode if the skin contact gets loosen due to perspiring,
etc.
Make sure to use new disposable electrodes. Otherwise, the waveform
quality may become poor and it may fail to perform correct monitoring.
When “Check Electrode” message is displayed on the screen of the
receiving monitor or the LCD of this device, check the condition of the
electrodes and ECG lead cable to resolve the cause.
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.
It may not perform a correct measurement due to the attached position
of the electrodes. Attach the electrodes on the patient referring to page
10 and 11 and make sure that the correct waveform is measured on the
LCD.
15
5. Respiration Monitoring
Follow the preparation of “4.ECG Monitoring” to allow the respiration
monitoring.
This respiration monitoring is performed with impedance method.
The ECG electrodes are also used for detecting the respiration. Each lead
cable specifies the electrodes to detect the respiration. For 3-electrode and 5-
electrode (chest) lead cable, the electrodes to detect the respiration are fixed
as follows. Even if lead method is switched, they are no changes.
Lead Cable Color of Electrode
3-electrode White (RA) and Red (LL)
4-electrode White (RA) and Red (LL)
5-electrode (Chest) White (RA) and Red (LL)
WARNING
Minute ventilation rate-adaptive implantable pacemakers can occasionally
interact with certain cardiac monitoring and diagnostic equipment, causing
the pacemakers to pace at their maximum programmed rate. The cardiac
monitoring and diagnostic equipment may possibly send wrong
information.
If such event occurs, please disconnect the cardiac monitoring and
diagnostic equipment, or follow the procedures described in the operation
manual of the pacemaker.
(For more details, contact FUKUDA DENSHI personnel, your institution’s
professionals, or your pacemaker distributors.)
Reference
“Minute Ventilation Rate-Adaptive Pacemakers”
FDA alerts health professionals that minute ventilation rate-adaptive
implantable pacemakers can occasionally interact with certain cardiac
monitoring and diagnostic equipment, causing pacemakers to pace at their
maximum programmed rate.
[October 14, 1998 (Letter: www .fda.gov/cdrh/safety.html) - FDA]
CAUTION
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.
When a defibrillator is used during respiration monitoring, a large offset
voltage will be placed on the ECG electrodes, which may cause
interruption of monitoring for a few seconds.
5. Respiration Monitoring
16
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17
6. Measurement
Turn ON the power and the measurement starts.
■ Starting Screen
When the power is turned ON, the channel number configured on the LX-7120
is displayed at the top of the LCD.
Make sure whether the channel number on the
LCD matches the channel number indicated on
the label of the LX-7120 and the channel number
configured on the receiving monitor.
This screen automatically moves onto the next
waveform display screen.
■ 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
The LX-7120 does not have a diagnostic function. Check the diagnostic
function on the receiving monitor.
The LX-7120 does not have an alarm function. Check the alarm function
on the receiving monitor.
The ECG waveform size and sweep speed settings displayed on the
LCD of the LX-7120 do not interface with the ones displayed on the
screen of the receiving monitor.
The heart rate and respiration rate displayed on the LCD of the LX-7120
may be different from the ones displayed on the receiving monitor.
Because the algorithm of the ECG and respiration rate is different.
■ Battery Level Check
Check the battery level on the waveform display screen.
Battery
Symbol Remaining Battery Level
Full
Getting low but still available
Nearly empty
Replace the battery.
A message that prompts the
battery check appears on the
screen of the receiving
monitor.
6. Measurement
18
■ Waveform Display
●ECG Display Screen (1)
ECG1 waveform, heart rate, pacemaker marker, remaining battery level, and
electrode check message are displayed.
The LCD display will automatically turn itself OFF after 60 seconds if no
operation is done. To restart the LCD display, refer to page 29.
When the LCD display is active, press the ▽ button to move onto the next
waveform display screen.
【Descriptions of the Screen】
The descriptions of contents displayed on the LCD are as follows.
Indicates ECG 1.
Indicates the scale of the displayed
ECG.
One scale corresponds to 1mV.
In the left illustration, it can display
ECG waveform between -1mV and
+1mV.
Displays the ECG waveform.
Displays the heart rate.
♥ is displayed in synchronization with
the heart rate.
6. Measurement
19
Displays the detection marker when
the pacemaker pulse is detected.
Indicates the measuring lead.
Indicates the ECG waveform size
displayed on the LCD.
CAUTION
The ECG waveform size setting displayed on the LCD does not interact
with the one displayed on the screen of the receiving monitor, because
the LX-7120 cannot transmit the setting information of the waveform
size to 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.
In case of the outside of the heart rate range (12 to 300bpm), 0bpm will
be displayed if 11bpm and below is measured and 300bpm will be
displayed If 300bpm and above is measured.
Indicates the remaining battery level.
For details of the battery level, refer to
page 17.
Displays the electrode check
“ELECTRODE?” message appears
when the ECG electrode is detached.
6. Measurement
20
●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 LCD display will automatically turn itself OFF after 60 seconds if no
operation is done. To restart the LCD display, refer to page 29.
When the LCD display is active, press the ▽ button to move onto the next
waveform display screen.
【Descriptions of the Screen】
The descriptions of contents displayed on the LCD are as follows.
Indicates ECG 2.
Indicates the scale of the displayed
ECG.
One scale corresponds to 1mV.
In the left illustration, it can display ECG
waveform between -1mV and +1mV.
Displays the ECG waveform.
Displays the heart rate.
♥ is displayed in synchronization with
the heart rate.
6. Measurement
21
Displays the detection marker when the
pacemaker pulse is detected.
Indicates the measuring lead.
Indicates the ECG waveform size
displayed on the LCD.
CAUTION
The ECG waveform size setting displayed on the LCD of the LX-7120
does not interact with the one displayed on the screen of the receiving
monitor, because the LX-7120 cannot transmit the setting information of
the waveform size to 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.
In case of the outside of the heart rate range (12 to 300bpm), 0bpm will
be displayed if 11bpm and below is measured and 300bpm will be
displayed If 300bpm and above is measured.
Indicates the remaining battery level.
For details of the battery level, refer to
page 17.
Displays the electrode check
“ELECTRODE?” message appears
when the ECG electrode is detached.
6. Measurement
22
●Respiration Display Screen
Respiration waveform, respiration rate, remaining battery level, and electrode
check message are displayed.
The LCD display will automatically turn itself OFF after 60 seconds if no
operation is done. To restart the LCD display, refer to page 29.
When the LCD display is active, press the ▽ button to move onto the next
waveform display screen.
【Descriptions of the Screen】
The descriptions of contents displayed on the LCD are as follows.
Indicates the respiration waveform
display screen.
Indicates the scale of the displayed
respiration waveform.
One scale corresponds to 1Ω.
In the left illustration, it can display
the change of respiration waveform
between -1Ω and +1Ω.
Displays the respiration waveform.
Displays the respiration rate.
Indicates the respiration waveform
size displayed on the LCD.
6. Measurement
23
CAUTION
The respiration waveform size setting displayed on the LCD does not
interact with the one displayed on the screen of the receiving monitor,
because the LX-7120 cannot transmit the setting information of the
waveform size to the receiving monitor. If the respiration waveform size
displayed on the screen of the receiving monitor is changed, follow the
instruction in the operation manual of the receiving monitor.
In case of the outside of the respiration rate range (9 to 150Bpm), 0Bpm
will be displayed if 8Bpm and below is measured and 150Bpm will be
displayed If 150Bpm and above is measured.
Indicates the remaining battery level.
For details of the battery level, refer to
page 17.
Displays the electrode check
“ELECTRODE?” message appears
when the ECG electrode is detached.
6. Measurement
24
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25
7. Operation
■ Changing Setup
●ECG Display Screen (1)
In the ECG display screen (1), the ECG waveform size and lead displayed on
the LCD of the LX-7120 can be changed.
【Setting Method】
How to enter the setup mode:
Press and hold the Enter button for 2 seconds in the ECG display screen (1).
<<Switching Lead>>
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 LCD.
The lead indication of ECG 1 is
highlighted.
Pressing the Enter button will
sequentially change the lead of
ECG 1.
Lead I II III I
<<Changing ECG1 Waveform Size on LCD>>
Press the ▽ button to highlight
the size indication of ECG 1.
Pressing the Enter button will
sequentially change the size of
ECG 1.
Size ×1 ×1/2 ×1
When changing the size of the
ECG waveform on the LCD, the
ECG scale will also change.
In the left illustration, it can
display the ECG waveform
between -2mV and +2mV.
CAUTION
The ECG waveform size setting displayed on the LCD of the LX-7120 does
not interact with the one displayed on the screen of the receiving monitor,
because the LX-7120 cannot transmit the setting information of the
waveform size to 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.
7. Operation
26
<< Returning to ECG Display Screen (1) >>
Press the ▽ button to highlight
the Return button.
Press the Enter button to return to
the ECG display screen (1).
CAUTION
Do not operate the LX-7120 with the setup screen open to prevent the
settings to be changed due to an unintended operation. Make sure to press
the Return button to terminate the setup screen. The LCD display will
automatically turn itself OFF after 60 seconds if the Return button is not
pressed.
7. Operation
27
●ECG Display Screen (2)
In the ECG display screen (2), the ECG waveform size displayed on the LCD
of the LX-7120 can be changed.
【Setting Method】
How to enter the setup mode:
Press and hold the Enter button for 2 seconds in the ECG display screen (2).
<< Changing ECG2 Waveform Size on LCD >>
The size indication of ECG 2 is
highlighted.
Pressing the Enter button will
sequentially change the size of
ECG 2.
Size ×1 ×1/2 ×1
When changing the size of the
ECG waveform on the LCD, 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 LCD of the LX-7120 does
not interact with the one displayed on the screen of the receiving monitor,
because the LX-7120 cannot transmit the setting information of the
waveform size to 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.
<< Returning to ECG display screen (2) >>
Press the ▽ button to highlight
the Return button.
Press the Enter button to return to
the ECG display screen (2).
7. Operation
28
●Respiration Display Screen
In the respiration display screen, the respiration waveform size displayed on
the LCD of the LX-7120 can be changed.
【Setting Method】
How to enter the setup mode:
Press and hold the Enter button for 2 seconds in the respiration display screen.
<< Changing Respiration Waveform Size on LCD>>>
The size indication of the
respiration is highlighted.
Pressing the Enter button will
sequentially change the size of
respiration.
Size ×1 ×1/2 ×1
When changing the size of the
respiration waveform on the LCD,
the respiration scale will also
change.
In the left illustration, it can
display the respiration waveform
until 4Ω of change.
CAUTION
The respiration waveform size setting displayed on the LCD of the LX-7120
does not interact with the one displayed on the screen of the receiving
monitor, because the LX-7120 cannot transmit the setting information of the
waveform size to the receiving monitor. If the respiration waveform size
displayed on the screen of the receiving monitor is changed, follow the
instruction in the operation manual of the receiving monitor.
<< Returning to Respiration Display Screen>>
Press the ▽ button to highlight
the Return button.
Press the Enter button to return to
the respiration display screen.
7. Operation
29
CAUTION
Do not operate the LX-7120 with the setup screen open to prevent the
settings to be changed due to an unintended operation. Make sure to press
the Return button to terminate the setup screen. The LCD display will
automatically turn itself OFF after 60 seconds if the Return button is not
pressed.
■ Restarting the LCD display
The LCD display will automatically turn itself OFF after 60 seconds if no
operation is done.
Press the Enter button or press and hold the ▽ button to restart the LCD
display.
The starting screen with telemetry channel number appears, and then the
waveform display screen appears.
■ 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
LCD while the “EVENT” is transmitted.
After the transmission is completed, the starting screen with the telemetry
channel number appears, and then the waveform display screen appears.
“EVENT” operation is available as a remote recording.
For details of the receiving monitor operation and settings related to the
“EVENT” function, refer to the operation manual of the receiving monitor.
7. Operation
30
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31
8. Other Setting Items
The following settings are available for the LX-7120 depending on the use and
condition of the patient. For details of the settings, contact our service
representative.
Items Selection Default Backup
Time Constant 0.4 sec., 0.1 sec. 0.4 sec. Yes
Detection Sensitivity of
Pacemaker Pulse Low, Mid, High Mid Yes
Respiration Detection
Signal ON, OFF ON Yes
LCD Contrast 8 steps 8 Yes
Transmitter Channel
One from the
following channels.
0801 to 0879
0900 to 0979
1000 to 1079
1100 to 1179
1200 to 1279
1300 to 1379
1100 Yes
Group ID One from 00 to 63 00 Yes
■ 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 change, contact your local Fukuda Denshi service
representative.
CAUTION
When changing the time constant to “0.1 seconds”, the lower frequency
characteristic becomes 1.6Hz ±25%. This setup does not meet IEC
60601-2-27 standard. It may lead to a change in the ECG waveform and
ST measurement value may be especially affected. Fukuda Denshi
recommends “0.4 seconds” setting in normal use.
The LCD screen in normal use does not indicate the selection of time
constant. Make sure to take measures, such as marking on the LX-
7120, to distinguish whether the selection of time constant is changed.
8. Other Setting Items
32
■ 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 ANSI/AAMI EC13 standard.
Detection/ Rejection of Pacemaker Pulse:
a) Pacemaker Pulse without Over/Undershoot:
Capable to reject pulses of pulse width 0.1 to 2ms,
amplitude ±2 to ±700mV
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.
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-7120 less likely to
be interfered by the noise, such as AC frequency.
The “Low” setting decreases the detection sensitivity. Therefore, it cannot
detect the pacemaker pulse specified in ANSI/AAMI EC13 standard.
For details of the setting change, contact your local Fukuda Denshi service
representative.
CAUTION
The LCD 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-7120, to distinguish whether the setting of the pacemaker pulse
detection is changed.
8. Other Setting Items
33
■ 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-7120 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 change, contact your local Fukuda Denshi service
representative.
CAUTION
The respiration waveform cannot be measured if the setting of the
respiration detection signal is turned “OFF”.
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).
The LCD 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-7120, to distinguish whether the setting of the
respiration detection signal ON/OFF is changed.
■ Changing the LCD Contrast
The LCD display contrast of the LX-7120 can be changed in 8 steps.
For details of the setting change, contact your local Fukuda Denshi service
representative.
8. Other Setting Items
34
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35
9. Changing the Transmitter Channel and Group ID
■ Changing the Transmitter Channel
The LX-7120 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 change, contact your local Fukuda Denshi service
representative.
WARNING
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.
Replace promptly the new channel label if the transmitter channel has
been changed.
■ Changing the Group ID
The LX-7120 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 change, 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 cell phone, amateur radio station,
radio taxi, and illegal citizens band, which may be a cause of interference.
In such a case, the situation should be carefully observed to find the cause
of interference.
9. Changing the Transmitter Channel and Group ID
36
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37
10. Troubleshooting
■ List of Displayed messages
Transmitter (main unit)
Message Cause Solution
Failed to transmit
waveform and
value.
Faulty EEPROM.
Failed to initialize
CPU.
Contact your local Fukuda
Denshi service
representative.
ECG
Message Cause Solution
Character string
displayed, such as LA,
depends on the
detached electrode
position.
Electrode is off. Check the electrode
condition.
10. Troubleshooting
38
■ Troubleshooting
Make sure of the followings. However, if there is no improvement in the
phenomenon, contact your local Fukuda Denshi service representative.
Transmitter (main unit)
Phenomenon Cause Solution
No battery or wrong
polarity
Install the battery correctly. Nothing is displayed
on the LCD when the
power switch is turned
ON. Battery level is
empty.
Replace the battery with a
new one.
Nothing is displayed
on the receiving
monitor screen.
The channel
number between
the transmitter and
the receiving
monitor do not
match up.
Set the same channel
number for the transmitter
and the receiving monitor.
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-7120
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-7120
with the correct channel
setting.
Transmission problem.
Transmitter failure Contact your local Fukuda
Denshi service
representative.
10. Troubleshooting
39
ECG
Phenomenon Cause Solution
Check the connection
between the lead cable and
the LX-7120.
Lead cable is off.
Check the connection
between the lead cable and
the electrode.
Faulty Lead cable. Replace the ECG cable with
a new one.
Electrode is peeling
off.
Replace the electrode with a
new one.
“ELECTRODE?”
message is displayed.
Polarization
potential of the
electrode is too
high.
Replace the electrode with a
new one.
Electrode gel is dry.
Electrode is peeling
off.
Replace the electrode with a
new one.
Electric blanket is
used.
Cover the electric blanket
with a shield cover.
ECG waveform
contains noise
AC filter setting of
the receiving
monitor is OFF.
Set the AC filter up as ON.
Electrode gel is dry.
Electrode is peeling
off.
Replace the electrode with a
new one.
Respiration waveform
cannot be measured.
The positions of the
electrodes are
improper.
Attach the electrodes where
the respiration waveform can
be measured appropriately.
10. Troubleshooting
40
■ In Case of Dropping the LX-7120 into Water
In case of dropping the LX-7120 into water containing disinfectant, pick up the
LX-7120 quickly from it. Rinse it well with running water, and dry it thoroughly
with a soft cloth.
CAUTION
Do not use a drier. The LX-7120 shape may change or be broken.
When the LX-7120 is rinsed with running water, make sure to close the
battery compartment lid.
41
11. Cleaning and Disinfection
The Cleaning and disinfection of the LX-7120 and ECG lead cable shall be
performed as follows.
CAUTION
Do not sterilize the LX-7120 and ECG lead cable in any manners, such as
radioactive rays, steam, or ethylene oxide.
■ Cleaning
Clean the LX-7120 using a squeezed gauze or an absorbent cotton cloth
dampened with alcohol or a neutral cleanser.
CAUTION
Clean the equipment frequently so stains can be removed easily.
To prevent injury, it is recommended to wear gloves when cleaning the
equipment.
Do not allow any chemical solution to enter the inside of LX-7120 or
connectors.
The LX-7120 cannot be sterilized.
Do not use organic solvents, thinner, toluene and benzene to avoid
damaging the resin case.
Do not polish the housing with abrasive or chemical cleaner.
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.
■ Disinfection
If there is a possibility of being infected, clean the LX-7120 using a squeezed
gauze or an absorbent cotton cloth dampened with alcohol or invert soap.
CAUTION
Do not immerse the connector parts of the LX-7120 in any chemical
solution to prevent connection failure.
When disinfecting the entire room using a spray solution, pay close
attention not to have liquids get into the LX-7120 or connectors.
11. Cleaning and Disinfection
42
Blank Page
43
12. Maintenance and Inspection
This section explains the daily checks and periodic checks of the LX-7120.
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.
CAUTION
Do not open the housing or attempt service. The service should be done
by Fukuda Denshi or Fukuda Denshi’s representative.
Do not allow excessive moisture or cleaning agents into the connectors
or inside the equipment.
■ Daily Check
Perform daily checks using the “Daily Check List” on the next page.
■ Periodic Check
Periodic check of medical electronic equipment is mandatory to prevent
failures and accidents and to ensure safety and reliability.
Periodic maintenance may be performed by the medical institution or by a third
party by concluding a “Maintenance Contract”.
For more details, contact your local Fukuda Denshi service representative.
■ Periodic Replacement Parts
The “Battery Compartment Lid (Waterproof)” is the only periodic
replacement part.
To ensure the reliability of waterproof (IPX8) performance of the LX-7120,
replace it once a year.
You may be able to keep using the LX-7120 without periodic replacement of
the lid. However, as it gets older, the reliability of water resistance (IPX8)
performance will not be ensured.
When replacing the lid, contact your local Fukuda Denshi service
representative.
CAUTION
The periodic replacement parts must be replaced at specified period.
12. Maintenance and Inspection
44
Daily Check List
No.
Inspected Date Inspected by Location
Device Type LX-7120 S/No. Date of Purchase
Items Details Criteria Judgment
Appearance
Visually check for any damage,
cracks, chip, peeled label, and
loosen screw on the housing.
No abnormality should be
found. □OK/ □NG
Visually check for the ring
condition of the battery
compartment lid.
No damage, kink, floating,
and adhesion of dust
should be found.
□OK/ □NG
Battery
Compartment Visually check for the contact
springs, inside the LX-7120, to
the battery and the lock lever of
the battery compartment lid.
No deformation, cracks,
and rust should be found. □OK/ □NG
Power Supply Turn the power ON/OFF to verify
proper switch operation.
With battery installed, the
LCD should turn ON. □OK/ □NG
ECG Connectors Visually check the connectors of
the cable and the LX-7120.
No damage, chip, and
adhesion of dust should
be found.
□OK/ □NG
ECG Lead cable Visually check each lead for
damages.
No crack and damage
should be found. □OK/ □NG
Wireless Channel
Verify whether the transmitting
channel and group ID are the
same with the receiving monitor.
Must match the wireless
channel check list. □OK/ □NG
Transmission
Function
Turn the power ON and make
sure the information is displayed
on the receiving monitor.
Waveforms and values
should be received
without any problem.
□OK/ □NG
Display Function
Turn the power ON and verify
each display condition, such as
ECG value and waveform.
All data should be
properly displayed. □OK/ □NG
Periodic Check Check the date of the previous
periodic check.
Should be within one
year. □OK/ □NG
Comment
45
13. Standard and Optional Accessories
This section lists the accessories for the LX-7120.
WARNING
Use only the accessories, such as ECG Lead cable, specified by Fukuda
Denshi for the LX-7120. Otherwise, the LX-7120 cannot deliver its
maximum performance and may be damaged, resulting in a safety hazard.
CAUTION
For quality improvement, specifications are subject to change without prior
notice.
■ Standard Accessories
No. Item Model Type Q’ty Note
1 Neck Strap OA-311 1
2 4-electrode ECG
lead cable CMT-02HTH-0.8DA 1
AHA color code,
Hook Type, Limb
Lead (2CH)
3 Operation Manual 1
1.
2.
3.
This manual
13. Standard and Optional Accessories
46
■Optional Accessories
The following accessories are available as optional for the LX-7120. Purchase
them as required.
●ECG, Impedance Respiration Measurement
AHA color code:
Item Model Type
Note
ECG Hook Type Lead Cable CMT-01HTH-0.8DA
3-electrode (White, Black,
Red),
Limb Lead (1CH)
ECG Hook Type Lead Cable CMT-02HTH-0.8DA
4-electrode (White, Black,
Red, Green),
Limb Lead (2CH)
ECG Hook Type Lead Cable CMT-03HTH-0.8DA
5-electrode (White, Black,
Red, Green, Brown),
Limb Lead (1CH)+Chest
(1CH)
ECG Clip Type Lead Cable CMT-01FTH-0.8DA
3-electrode (White, Black,
Red),
Limb Lead (1CH)
ECG Clip Type Lead Cable CMT-02FTH-0.8DA
4-electrode (White, Black,
Red, Green),
Limb Lead (2CH)
ECG Clip Type Lead Cable CMT-03FTH-0.8DA
5-electrode (White, Black,
Red, Green, Brown),
Limb Lead (1CH)+Chest
(1CH)
47
14. Specification
■ Specification
CAUTION
For quality improvement, specifications are subject to change without prior
notice.
Standard Specification
Size: 60.6(W) x 60.0(H) x 20.6(D)mm (not including the
protrusion)
Weight: Approximately 85 grams (with battery)
Transmitting
Waveform:
ECG 1CH or 2CH (selectable from the ECG lead
cable), Respiration waveform
ECG Lead cable Type: 3-electrode, 4-electrode, or 5-electrode (Limb+Chest)
lead cable
Automatically detect the type after inserting the lead
cable
Transmitting Status
Data:
Electrode Off, Low Battery, Event Switch, Pacemaker
Detection, Channel ID, 64group Codes
LCD: Built-in
Waterproof: IPX8
Power Supply: DC: one (1) 1.5 V “AA” size (“LR06” size) alkaline
battery
Continuous Operating
Time:
Approximately 6 days
※Continuous operating time is assumed when using new “AA” size (“LR06”
size) Alkaline battery specified by Fukuda Denshi.
ECG
Numbers of Lead
Electrode:
3-electrode, 4-electrode, or 5-electrode
(Limb+Chest)
Numbers of Input
Channel:
1CH(3-electrode) or 2CH
Accuracy of Sensitivity 10mm /1mV ±1mm
(Display sensitivity on the receiving monitor)
ECG Input Impedance: 5MΩ and above
Maximum Input Voltage: ±5mV and above
Common Mode Rejection
Ratio:
Less than 10mVp-p (95dB and above)
Accuracy of Heart Rate
Measurement:
±10% or ±5bpm, whichever is greater
Display Coverage of
Heart Rate:
0, 12 to 300bpm (1bpm step)
Frequency
Characteristic:
0.5 to 40Hz (within -3dB)
14. Specification
48
Time Constant 0.4 sec ±25%
Switching and available to set 0.1 sec ±25%
Pacemaker Pulse
Detection/ Rejection:
Comply with ANSI/AAMI EC13 Pacemaker pulse
rejection capability
Protection to
Defibrillation:
Meet the requirement of IEC60601-2-27
Respiration (Impedance Method)
Accuracy of Sensitivity: 10mm/1Ω ±2mm
(When standard Impedance is 480Ω.)
Display Coverage of Respiration Rate:0, 9 to 150Bpm
Display Error of Respiration Rate: 3Bpm
Measured Current of Respiration: Below 100μA (at 42kHz)
Transmission Method
Modulation Mode: Digital, Frequency shift keying
Frequency: 608 to 614MHz
Oscillation Method: PLL Synthesizer method by crystal control
Channel Spacing: 12.5kHz
Occupied Frequency
Bandwidth:
8.5kHz
RF output power: 1mW ±2dB
Transmitting Antenna: ECG lead cable
Safety
General Standard: IEC 60601-1:1988 +A1: 1991 +A2: 1995
(Medical electrical equipment – Part 1: General
requirements for safety)
EMC Standard: IEC 60601-1-2: 2007
(Medical electrical equipment – Part 1: General
requirements for safety – 2. Collateral standard:
Electromagnetic compatibility – Requirements and tests)
The class of
protection
against electric
shock
Internally Powered Equipment
The type of
protection
against electric
shock
Type CF Applied part
14. Specification
49
Operating Environment
Temperature: 10 to 40C
Humidity: 30 to 85% RH (No condensation)
Vibration/Shock: Comply with IEC60068-2-64:1987, IEC60068-2-32:1975,
IEC60068-2-6:1995
Transport / Storage Environment
Temperature: -10 to 60C
Humidity: 10 to 95% RH (No condensation)
14. Specification
50
■ Displays
The following displays are shown on the LCD of the LX-7120.
Display Description
Starting Screen
Displays after turning on the power.
Automatically moves onto the channel
display screen.
Channel Display
Screen
Displays the transmitter channel after
turning on the power and also when
refreshing the screen.
Automatically move onto the waveform
display screen.
EVENT
Displays when the EVENT button is
pressed.
Automatically move onto the channel
display screen.
ELECTRODE?
Displays when the ECG electrode is
disconnected or the ECG/respiration
waveform cannot be measured normally.
For details about electrode check
message, refer to page 51.
Display Description
Error Message
Telemeter Error
Displays when the transmitter is faulty
EEPROM Error
Displays when the EERPROM is faulty
CPU Error
Displays when the CPU is faulty
14. Specification
51
■ Details of the “ELECTRODE?” Message
The following “ELECTRODE?” messages are displayed on the LCD depending
on the selected lead cable and lead.
For AHA color code
Check
Position
3-electrode lead
cable
Lead I display
3-electrode lead
cable
Lead II display
3-electrode lead
cable
Lead III display
LL
RA
LA
Several
Position
Simultaneously
Check
Position
4-electrode lead
cable
For 5-electrode
(Chest) lead cable
LL
RA
LA
RL
V
Several
Position
Simultaneously
14. Specification
52
■ List of Setup Items
This section lists the available selection, default setting, and backup status
for each setup item, which is available for the LX-7120.
Items Selection Default Backup
ECG Lead I, II, III II Yes
Display Size of ECG (1) ×1, ×1/2 ×1 Yes
Display Size of ECG (2) ×1, ×1/2 ×1 Yes
Display Size of
Respiration Waveform ×1, ×1/2 ×1 Yes
For details of the following settings, contact our service representative.
Items Selection Default Backup
Time Constant 0.4 sec., 0.1 sec. 0.4 sec. Yes
Detection Sensitivity of
Pacemaker Pulse Low, Mid, High Mid Yes
Respiration Detection
Signal ON, OFF ON Yes
LCD Contrast 8 steps 8 Yes
Transmitter Channel
One from the
following channels.
0801 to 0879
0900 to 0979
1000 to 1079
1100 to 1179
1200 to 1279
1300 to 1379
1100 Yes
Group ID One from 00 to 63 00 Yes
39-4, Hongo 3-chome, Bunkyo-ku, Tokyo, Japan
Phone:+81-3-3815-2121 Fax:+81-3-3814-1222
Printed in Japan 4L0106260 20100805(01)