Fukuda Denshi LX-7230 User manual

ECG, Respiration and SpO2
Transmitter
LX-7230
Operation Manual
LX-7230N LX-7230KM
● 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.
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Equipment Symbols
Refer to the following symbols indicated on the LX-7230 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.
Intermittent SpO2Mode:
Indicates that the SpO2 Intermittent measurement is
activated.
Displayed only on the LX-7230KM.
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Precautions for Safe Operation of Medical Electrical Equipment
Cautions described here are regarding the general instructions for safety use
to the patient and the operator. As for cautions about the LX-7230, 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 and
the probe (sensor).
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
probe (sensor) or cable part. It may damage the equipment and lead
to measurement error.
Always observe the equipment and patient to ensure safe operation
of the equipment.
If any abnormality is found on the equipment or patient, take
appropriate measures such as ceasing operation of the equipment
and/or detaching the probe (sensor) and/or electrode, in the safest
way for the patient.
Do not allow the patient to come in contact with other equipments.
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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 batteries if the equipment is not used for a
long time. The leakage from the batteries may damage the device or
an explosion from the batteries may occur.
6. If the equipment is damaged and in need of repair, ensure patient
safety by immediately turning the equipment off and remove the
electrodes and/or probe from the patient. 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.
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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-7230
WARNING
Do not connect cables not authorized by Fukuda Denshi to any I/O
connector. If done so by mistake, the LX-7230 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-7230 pulling/grabbing the probe
(sensor) or cord part. The cable could break or get disconnected from the
LX-7230. And it may hit people or damage other equipment around.
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Precautions about Waterproof
CAUTION
Replace the “Battery Compartment Lid” of the LX-7230 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-7230 is dropped or
is subjected to a high impact, make sure that the lid is not damaged.
However, the SpO2probes (sensors/relay cables) are not waterproof.
Do not take a bath with them, and ensure to be away from liquid.
Do not use the LX-7230 wet. Always wipe the LX-7230 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.
vii

Precautions about SpO2
WARNING
During SpO2monitoring, always use the probe (sensor)/relay cable
specified by Fukuda Denshi. If any other probe (sensor)/relay cable is
used, a high temperature rise of the probe (sensor) may place the
patient in danger of burns in the worst case.
When the SpO2probe (sensor) is in a connector-off condition, the SpO2
alarm will not be generated on the receiving monitor. Make sure that the
SpO2probe (sensor)/ relay cable is securely connected. If the SpO2
waveform/numeric data is not displayed, check the patient’s condition
and pay attention not to miss the connector-off condition.
When measuring the SpO2of a patient with high fever or peripheral
circulatory insufficiency, check the probe (sensor) attachment
periodically and change the attachment site. The temperature of the
attachment site will rise 2 to 3C due to the sensor heat which may
result in compression necrosis and burn injury.
Even a short duration of attachment may inhibit the blood flow and
generate compression necrosis and burn injury.
When securing the probe (sensor) with tape, do not apply the tape too
tight. At the same time, check the blood flow constantly so that
congestion is not generated at the peripheral. When removing the tape,
remove it slowly with care not to damage the patient’s skin.
CAUTION
For the following case, accurate measurement may not be possible.
Patient with excessive abnormal hemoglobin (COHb, MetHb)
Patient with the pigment injected to the blood
Patient receiving CPR treatment
Placement of SpO2probe (sensor) on limb with a blood-pressure cuff,
arterial catheter, or intravascular line
When measuring at placement position with venous pulse
Patient with body motion
Patient with small pulse
Excessive body motion (patient’s motion)
Excessive light (direct sunlight, fluorescent, light therapy equipment,
surgical light, infrared heat ramp, etc.)
External colorant such as nail polish
Abnormally low or high hemoglobin concentration
Electrosurgery
Influence of electromagnetic waves from other electronics devices
High-intensity radio waves from cell phone
viii