Fukuda Denshi Co LX7230G User Manual

ECG, Respiration and SpO2
Transmitter
LX-7230N
Ver.02
Before using the product, please read this manual thoroughly. Store this manual where it can be always referred to.
Operation Manual
LX-7230N
TYPE:GHz
This operation manual is for the LX-7230 Ver. 02.
CA UT IO N
Federal Law restricts this device to sale by or on the order of a physician.
CA UT IO N
Users are advised to periodically contact the FCC or specified frequency coordinator and determine if other or your transmitter frequencies that may cause interference.
CA UT IO N
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 equipment 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 © 2012 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. Before using this product, 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.
DA NG ER
WARN I N G
CA U T I O N
NO T E
Failure to follow this message may cause immediate threat of death or serious injury.
Failure to follow this message may result in death or serious injury.
Failure to follow this message may cause injury or failure to the equipment.
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 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.
i
Graphic Symbols
Refer to the following symbols indicated on the LX-7230N for their meanings.
Symbols indicated on the main unit
Symbol Description
Caution: Refer To Accompanying Documents Indicates the need to refer to the related accompanying documents before operation.
Type CF Applied Part with Defibrillation-Proof Indicates that the degree of protection against electric shock is Type CF Applied Part with defibrillation-proof.
No Alarm Function Indicates no alarm function.
Battery Type and Direction Indicates the battery type and direction.
Symbols indicated on the LCD screen
Symbol Description
Heart Rate Synchronization Mark This mark flashes synchronizing to 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 users. As for cautions about the LX-7230N, please refer to the following pages.
CA U T I O N
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 evolved.
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.
iii
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 equipment 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 equipment and understand the precautionary instructions prior to use.
Non-Explosion Proof
DA N G E R
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)
WARN I N G
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
WARN I N G
When using electrosurgical instrument, make sure the contact between
the patient and the ground plate is secured. 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
WARN I N G
Use only the lead cable specified by Fukuda Denshi when defibrillating.
If used by unspecified lead cable, the equipment may be damaged, resulting in a safety hazard.
When using the defibrillator, keep away from the electrodes or
medicament applied to the patient chest. If this is not possible, remove the electrodes or medicament before using it. If the defibrillator paddles are directly in contact with the electrodes or medicament, an electrical shock may result from the discharged energy.
When using the defibrillator, do not touch the patient and the metal part
of the equipment or cables. Electric shock may result from the discharged energy.
v
Precautions about the Pacemaker
WARN I N G
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.)
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. [Based on a safety bulletin issued by FDA Center for Devices and Radiological Health on October 14, 1998]
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 equipment.
Precautions about the LX-7230N
WARN I N G
Do not connect cables not authorized by Fukuda Denshi to any I/O
connector. If done so by mistake, the LX-7230N cannot deliver its maximum performance and may be damaged, resulting in a safety
hazard. Do not use this equipment with multiple patients simultaneously. This equipment itself has no alarm function. Do not use it if an alarm
function is necessary. The alarm function with the receiving monitor,
refer to the operation manual of the receiving monitor.
CA U T I O N
Do not pick up and/or swing the LX-7230N pulling/grabbing the probe (sensor) or cord part. The cable could break or get disconnected from the LX-7230N. And it may hit people or damage other equipment around.
vi
Precautions about Waterproof
CA U T I O N
Replace the “Battery Compartment Lid” of the LX-7230N 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. The lid may be damaged from high impact. If the LX-7230N is dropped
or is subjected to a high impact, make sure that the lid is not damaged. However, the SpO2 probes (sensors) are not waterproof. Do not take a
bath with them, and ensure to be away from liquid. Do not use the LX-7230N wet. Always wipe the LX-7230N with a soft
cloth and dry it thoroughly before use.
Precautions about ECG
CA U T I O N
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
WARN I N G
During SpO2 monitoring, always use the probe (sensor) specified by
Fukuda Denshi. If any other probe (sensor) is used, a high temperature
rise of the probe (sensor) may place the patient in danger of burns in
the worst case. When the SpO2 probe (sensor) is in a connector-off condition, the SpO
alarm will not be generated on the receiving monitor. Make sure that the
SpO2 probe (sensor) is securely connected. If the SpO
waveform/numeric data is not displayed, check the patient’s condition
and pay attention not to miss the connector-off condition. When measuring the SpO2 of 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.
CA U T I O N
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 SpO2 probe (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 mobile phones
2
2
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Precautions about Output Signal
WARN I N G
Do not use the output signal of the monitor that receives radio wave signal from the LX-7230N 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
WARN I N G
Use only the accessories, such as ECG Lead cable and SpO2 probe (sensor), specified by Fukuda Denshi for the LX-7230N. Otherwise, the LX­7230N cannot deliver its maximum performance and may be damaged, resulting in a safety hazard.
CA U T I O N
Do not reuse disposable products. Store the disposable products properly as mentioned in their user
manuals.
Precautions about Battery
WARN I N G
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.
ix
Precautions about Disposing of Equipment, Accessories, or Components
CA U T I O N
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
CA U T I O N
Obey the local municipal rule to dispose the used dry cell battery.
Precautions for Use of Medical Telemeter
WAR N I N G
The LX-7230N transmitter must not be co-located or operated in
conjunction with any other antenna or transmitter. The LX-7230N complies with FCC radiation exposure limits set forth for
a controlled environment and meets the FCC radio frequency (RF)
Exposure Guidelines. The LX-7230N has very low levels of RF energy
that are deemed to comply without testing of specific absorption ratio
(SAR). Operation of LX-7230N requires the prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry
Service. This radio frequency device is susceptible to interference from outside
sources. Interference may prevent the monitoring of patients connected
to this equipment. If a problem exists, contact your local service
representative. The LX-7230N 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
x
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. 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.
xi
Electromagnetic Compatibility
The performance of this equipment under electromagnetic environment complies with IEC 60601-1-2 (2007).
Precautions for Safe Operation under Electromagnetic Influence
CA U T I O N
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 following are examples of the common cause and countermeasures.
Mobile Phone
The radio wave may cause malfunction to the equipment. Mobile phones and radio sets should be turned off in the room (building) where medical device is located.
Static Electricity
In a dry environment (room), static electricity is likely to occur. Take the following countermeasures.
Both operator and patient should remove any static electricity before entering the room Humidify the room
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-7230N is intended for use in the electromagnetic environment specified below. The customer or the user of the LX-7230N should assure that it is used in such an environment.
Emission Test Compliance
RF Emission
CISPR 11
RF Emission
CISPR 11
Harmonic Emission
IEC 61000-3-2
Voltage Limit /
Flicker Emission
IEC 61000-3-3
Group 1
Class A
N/A
N/A
Electromagnetic Environment –
The LX-7230N 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.
This LX-7230N is suitable for use in all establishments other than domestic establishments.
Guidance
xiii
Compliance to the Electromagnetic Immunity (1)
magnetic fields should
The LX-7230N is intended for use in the electromagnetic environment specified below. The customer or the user of the LX-7230N should assure that it is used in such an environment.
Immunity Test
Electrostatic Discharge (ESD) IEC 61000-4-2
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines. IEC 61000-4-11
Power Frequency (50/60Hz) Magnetic Field IEC 61000-4-8
Note:
UT is the AC mains voltage prior to application of the test level.
xiv
IEC 60601-1-2
Test Level
±6kV contact ±8kV air
±2kV: Power supply lines ±1kV: Input/output lines ±1kV: differential mode ±2kV: common mode <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.
3A/m 3A/m
Compliance
Level
±6kV contact ±8kV air
N/A
N/A
N/A
Electromagnetic
Environment
Guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Power frequency
be at levels characteristic of a typical location in a typical commercial or hospital environment.
Compliance to the Electromagnetic Immunity (2)
Electromagnetic Environment
a)
The LX-7230N is intended for use in the electromagnetic environment specified below. The customer or the user of the LX-7230N should assure that it is used in such an environment.
Immunity
Test
Portable and mobile RF
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
Where P is the maximum output
Note 1: At 80MHz and 800MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
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-7230N is used exceeds the applicable RF compliance level above, the LX-7230N 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-7230N.
b)
Over the frequency range 150kHz to 80MHz, field strength should be less than
3V/m.
IEC60601-1-2
Test Level
3Vrms 150kHz to 80MHz
3V/m 80MHz to 2.5GHz
affected by absorption and reflection from structures, objects and people.
Compliance
Level
3Vrms
3V/m
Guidance
communications equipment should be used no closer to any part of the LX-7230N, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended Separation Distance
d
= 1.2P
d
= 1.2P 80MHz to 800MHz
d
= 2.3P 800MHz to 2.5GHz
power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range
Interference may occur in the vicinity of equipment marked with the following symbol:
a)
,
b)
.
xv
Recommended Separation Distances between Portable and
Mobile RF Communications Equipment and the LX-7230N
The LX-7230N is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the LX-7230N can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LX-7230N as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum Output Power of
Transmitter
(W)
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
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
Note 2 : These guidelines may not apply in all situations. Electromagnetic propagation
Separation Distance according to Frequency of Transmitter (m)
150kHz to 80MHz
d
1 1.2 1.2 2.3
applies.
is affected by absorption and reflection from structures, objects and people.
= 1.2P
80MHz to 800MHz
d
= 1.2P
800MHz to 2.5GHz
d
= 2.3P
xvi
CONTENTS
Safety Precautions ..................................................................................... i
Precaution from Fukuda Denshi ....................................................... i
Graphic 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-7230N .................................................... vi
Precautions about Waterproof ................................. ...................... vii
Precautions about ECG .................................... ............................. vii
Precautions about SpO2................................................................ viii
Precautions about Output Signal ............................... ..................... ix
Precautions about Accessories and Optional Accessories ............. ix
Precautions about Battery ............................................................... ix
Precautions about Disposing of Equipment, Accessories,
or Components ........................................................................... x
Precautions about Disposing of Battery .......................................... x
Precautions for Use of Medical Telemeter ...................................... x
Electromagnetic Compatibility ............................................................ xii
Precautions for Safe Operation under Electromagnetic Influence .. xii
EMC Guidance .............................................................................. xiii
1. General Description ............................................................................. 1
2. Names of Parts and Their Functions .................................................... 3
3. Preparation .......................................................................................... 5
1) Installing the Batteries ................................................................ 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-7230N ................. 13
5. Respiration Monitoring ....................................................................... 15
6. SpO
Monitoring ................................................................................. 17
2
SpO2 Monitoring ............................................................................ 18
7. Measurement ..................................................................................... 35
Starting Screen ........................................................................ 35
Waveform Display Screen .................................. ..................... 35
Battery Level Check ................................................................ 37
Waveform Display ...................................... ............................. 37
xvii
8. Operation .......................................... ................................................. 47
Changing Setup ....................................................................... 47
Restarting the LCD display ...................................................... 51
Pressing the EVENT button ..................................................... 51
9. Other Setting Items ............................................................................ 53
Changing the Time Constant ............................ ....................... 54
Changing the Detection Sensitivity of the Pacemaker Pulse ... 55
Changing the Respiration Detection Signal ON/OFF ............... 56
Changing the LCD Contrast ..................................................... 56
10. Changing the Transmitter Channel and Group ID ............................ 57
Changing the Transmitter Channel .......................................... 57
Changing the Group ID ............................................................ 57
11. Troubleshooting ........................................ ....................................... 59
List of Displayed messages ..................................................... 59
Troubleshooting ....................................................................... 61
In Case of Dropping the LX-7230N into Water ........................ 63
12. Cleaning and Disinfection ................................................................ 65
Cleaning and Disinfecting the LX-7230N ................................. 65
Cleaning the ECG lead cable .................................................. 66
Cleaning and Disinfecting the SpO2 probe (sensor) ................ 66
13. Maintenance and Inspection ............................................................ 67
14. Standard and Optional Accessories ................................................. 69
Standard Accessories .............................................................. 69
Optional Accessories ............................................................... 70
15. Specification ..................................... ................................................ 73
Specification ............................................................................ 73
Functional Testers and Patient Simulator for SpO2
measurement ........................................................................... 76
Displays ............................................ ....................................... 77
Details of the “ELECTRODE?” Message ................................. 79
List of Setup Items ................................................................... 80
xviii
1. General Description
The LX-7230N is a radio telemetry transmitter designed to measure the ECG, respiration waveform, SpO2 (functional oxygen saturation of arterial hemoglobin), pulse waveform with two “AA” size (“LR06” size) alkaline batteries. Information such as ECG measurements, respiration waveform, SpO2 measurements, pulse waveform, battery level, and the conditions of the ECG electrodes and SpO2 probe (sensor) 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) The LX-7230N can also function as a transmitter to measure only the ECG/Respiration without SpO2 or to measure only the SpO2 without ECG/Respiration.
Before using the LX-7230N, read also the operation manual of the patient monitor at the receiving side thoroughly.
LX-7230N: Built-in Nellcor® SpO2 Module
External Appearance
LX-7230N
1
1. General Description
Blank Page
2
A
2. Names of Parts and Their Functions
Neck Strap Hole
Attaches the neck strap.
ECG/RESP Input Connector
(Type CF Applied Part) Connects the ECG lead cable to measure ECG and respiration waveform.
Refer to Safety Precautions in this manuals preface.
Refer to Safety Precautions in this manuals preface.
Enter button
Uses for setup.
SpO2 Input Connector
Connects the SpO2 probe (sensor).
button
Uses for setup.
Channel Number Label
Indicates transmitter channel number.
LCD
Displays measurement waveform and transmitter information.
Power Switch
Turn ON/OFF the power.
EVENT Button
ctivates the function assigned on the
receiving monitor.
Electrode Position Label
Indicates standard ECG electrode position.
3
2. Names of Parts and Their Functions
transmitter is operated.
Refer to Safety Precautions in this manuals preface.
Battery Lid Lock Lever
Uses to open/lock the battery compartment lid.
Battery Compartment Lid
This is the lid for the battery compartment. Make sure to close it when the
4
3. Preparation
1) Installing the Batteries
The LX-7230N functions with two "AA" size (“LR06” size) alkaline batteries. With new batteries, the LX-7230N is capable of the following operation.
LX-7230N: approximately 2.5 days (However, continuous operating time may be shorter than the above mentioned time depending on the application of the SpO2 probe (sensor).)
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 batteries. 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. Install the batteries with the correct polarity. Do not use a disassembled or a damaged battery due to drop or shock.
The leakage from the batteries may damage the equipment, or an
explosion from the batteries may occur. Do not use different types of batteries at the same time. The leakage
from the batteries may damage the equipment, or an explosion from the
batteries may occur. Remove the exhausted batteries immediately. The leakage from the
batteries may damage the equipment, or an explosion from the batteries
may occur. If the transmitter 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 transmitter for a long period of time, the leakage
from the batteries may damage the equipment or an explosion from the
batteries may occur. Make sure to replace the two batteries simultaneously. If new and used
batteries are mixed, a leakage from the batteries may damage the
equipment or an explosion from the batteries may occur.
Use only alkaline batteries. Other batteries 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 batteries with wet hands. In case of storing the used or unused batteries, make sure that the
terminals are not touching other batteries or metal parts.
WAR N I N G
CA U T I O N
5
3. Preparation
Lift the lock lever to open the battery compartment lid as shown in the left picture.
Install new batteries 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).
CA U T I O N
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-7230N after closing the battery
compartment lid.
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2) Operating Power Switch
Turning the power switch to “ON”
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.
Turning the power switch to “OFF”
Rotate the power switch to the left until it clicks.
LCD screen turns ON and measurement starts. Regarding the LCD screen, refer to page 35 (7. Measurement). The screen automatically turns itself OFF after 180 seconds.
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 batteries.
Rotate the power switch to the right until it clicks.
3. Preparation
7
3. Preparation
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4. ECG Monitoring
When the transmitter is used without the SpO2 probe (sensor), it will measure only ECG and respiration.
CA U T I O N
When using the transmitter with only the ECG lead cable, SpO2 measurements on the receiving monitor shall be turned off to prevent an erroneous alarm.
Connecting the ECG Lead Cable and Electrodes
The optional ECG lead cables for LX-7230N are as follows.
ECG Lead Cables
AHA color code:
Item No. Applicable Lead
CMT-01HTH-0.8DA Limb Lead (1CH)
CMT-02HTH-0.8DA Limb Lead (2CH)
CMT-03HTH-0.8DA
CMT-01FTH-0.8DA Limb Lead (1CH)
CMT-02FTH-0.8DA Limb Lead (2CH)
CMT-03FTH-0.8DA
Limb Lead (1CH) +Chest (1CH)
Limb Lead (1CH) +Chest (1CH)
3-electrode Hook Type (White, Black, Red) 4-electrode Hook Type (White, Black, Red, Green) 5-electrode Hook Type (White, Black, Red, Green, Brown) 3-electrode Clip Type (White, Black, Red) 4-electrode Clip Type (White, Black, Red, Green) 5-electrode Clip Type (White, Black, Red, Green, Brown)
WAR N I N G
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 equipment when the equipment is used with a defibrillator.
Remark
9
4. ECG Monitoring
For 3-
electrode lead cable
For 4-
electrode lead cable
(LA)
(RA)
(RL)
The relations between the attached electrode positions and lead method are as follows. Attach the electrodes to monitor proper waveform.
For AHA color code electrode position (No. CMT-01HTH-0.8DA, CMT-01FTH-0.8DA)
White
Standard Limb leads
Standard Limb leads can be selected from lead I, lead II, or lead III under the setting of the equipment.
Refer to “8. Operation Changing Setup ECG Display Screen (1) <<Switching Lead>>” in page 47.
For AHA color code electrode position (No. CMT-02HTH-0.8DA, CMT-02FTH-0.8DA)
White (RA)
Red (LL)
Black
Black
(LA)
Green
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.
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Red (LL)
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