LX-7120 Operation Manual Ver.01 May 2014

This operation manual is for the LX-7120 Ver. 01.

This device bears the CE label in accordance with the provisions of Medical Device Directive 93/42/EEC. This device bears the CE label in accordance with the provisions of R&TTE Directive 1999/5/EC. This device bears the CE label in accordance with the provisions of RoHS Directive 2011/65/EU. We, FUKUDA DENSHI CO., LTD. hereby declare that this transmitter model LX-7120 is in compliance with the essential requirements and other relevant provisions of R&TTE Directive 1999/5/EC. Fukuda Denshi UK Unit 7, Genesis Business Park, Albert Drive, Woking, Surrey, GU21 5RW, United Kingdom

CAUTION:

• This equipment is 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 © 2014 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.

DANGER

Failure to follow this message may cause immediate threat of death or serious injury.

to follow this message may result in death or W ARNING Failure 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 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.

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Graphic Symbols Refer to the following symbols indicated on the LX-7120 for their meanings. Symbols indicated on the main unit Symbol

Description Warning (indicated in yellow) Follow operating instructions (Warning); (indicated in blue) Indicates that the failure to follow operating instructions could place the patient or operator at risk. General precaution 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.

Year of Manufacture Indicates the manufactured year. WEEE (Waste Electrical and Electronics Equipment) Indicates a separate collection for electrical and electronic equipment.

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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.

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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 users. As for cautions about the LX-7120, please refer to the following pages.

CAUTION 1. 2.

Users should have a thorough knowledge of the operation before using this equipment. Pay attention to the following when installing or storing the equipment. • 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

3.

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. 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

4.

correct. Do not charge the battery. 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 detaching the electrode, in the safest way for the patient. • Do not allow the patient to come in contact with other equipments. iv

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

6.

7. 8.

long time. The leakage from the battery may damage the equipment or an explosion from the battery may occur. 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. Do not remodel the equipment. Maintenance Check • Make sure to periodically check the equipment, and accessories.

• Before reusing the equipment that has been left unused for a while,

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make sure that the equipment works normally and safely. 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. v

Defibrillation Safety

W ARNING  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.

Precautions about Magnetic Resonance Imaging (MRI)

W ARNING  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

W ARNING  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.

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Precautions about the Pacemaker

W ARNING  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-7120

W ARNING  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 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.

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.

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Precautions about Waterproof

CAUTION  Replace the “Battery Compartment Lid” of the LX-7120 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-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.  This equipment will return to standard operating mode within 10 seconds. The stored data will not be affected. The measurement accuracy will temporarily decrease during defibrillation, but it will not compromise the safety of patient and the equipment.

Precautions about Output Signal

W ARNING 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. viii

Precautions about Accessories and Optional Accessories

W ARNING 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

W ARNING  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.

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Precautions for Use of Medical Telemeter

W ARNING  The LX-7120 transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.  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-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.  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. x

CAUTION  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.

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Electromagnetic Compatibility The performance of this equipment under electromagnetic environment complies with EN 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 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

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EMC Guidance This equipment complies with EN 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

RF Emission EN 55011

Group 1

RF Emission EN 55011 Harmonic Emission EN 61000-3-2 Voltage Limit / Flicker Emission EN 61000-3-3

Electromagnetic Environment – Guidance 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.

Class A N/A N/A

This LX-7120 is suitable for use in all establishments other than domestic establishments.

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●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

Electrostatic Discharge (ESD) EN 61000-4-2

Electrical fast transient/burst EN 61000-4-4 Surge EN 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines. EN 61000-4-11

EN 60601-1-2 Test Level

±6kV contact ±8kV air

Compliance Level

±6kV contact ±8kV air

±2kV: Power supply lines N/A ±1kV: Input/output lines ±1kV: differential mode N/A ±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.

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%.

N/A

Power frequency magnetic fields should be at levels characteristic of a 3A/m 3A/m typical location in a typical commercial or hospital environment. Note: UT is the AC mains voltage prior to application of the test level. Power Frequency (50/60Hz) Magnetic Field EN 61000-4-8

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●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

EN 60601-1-2 Compliance Electromagnetic Environment Test Level Level 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 EN 61000-4-6

3Vrms 3Vrms 150kHz to 80MHz

Radiated RF EN 61000-4-3

3V/m 3V/m 80MHz to 2.5GHz

d = 1.2 P 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 d is 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. xv

●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. Rated Maximum Separation Distance according to Frequency of Transmitter (m) Output Power of 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz Transmitter d = 1.2 P d = 1.2 P d = 2.3 P (W) 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.

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CONTENTS Safety Precautions ... i Precaution from Fukuda Denshi... i Graphic Symbols...ii Precautions for Safe Operation of Medical Electrical Equipment ...iv Non-Explosion Proof ... v Defibrillation Safety ...vi Precautions about Magnetic Resonance Imaging (MRI) ...vi Electrosurgery Safety...vi Precautions about the Pacemaker ... vii Precautions about the LX-7120... vii Precautions about Waterproof ... viii Precautions about ECG ... viii Precautions about Output Signal ... viii Precautions about Accessories and Optional Accessories ...ix Precautions about Battery...ix Precautions about Disposing of Equipment, Accessories, or Components ...ix Precautions about Disposing of Battery ...ix 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 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 xvii

■ Pressing the EVENT button ... 29 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 and Disinfecting the LX-7120 ... 41 ■ Cleaning the ECG lead cable ... 42 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

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