Life Scope N OPV-1500 series Service Manual

CONTENTS

Contents GENERAL HANDLING PRECAUTIONS ...i WARRANTY POLICY ... ii EMC RELATED CAUTION ... iii Conventions Used in this Manual and Instrument ... v Warnings, Cautions and Notes ... v Explanations of the Symbols in this Manual and Instrument ... vi On panels ... vi On screen ... vii Others ... vii

Section 1

General...1C.1 Introduction ... 1.1 General Information on Serving ... 1.2 Service Policy, Service Parts and Patient Safety Checks ... 1.4 Service Policy ... 1.4 Service Parts ... 1.4 Patient Safety Checks ... 1.5 Maintenance Equipments and Tools ... 1.5 General Safety Information ... 1.6 General ... 1.6 Installation ... 1.7 Using KC-012P Cart ... 1.8 Using ZB-900PK Transmitter ... 1.8 Using YL-001P Alarm Pole ... 1.8 Battery ... 1.9 ECG Monitoring ... 1.10 Respiration Monitoring ...1.11 SpO2 Monitoring ...1.12 NIBP Monitoring ...1.14 Maintenance ...1.15 Specifications ...1.16 Panel Description ...1.20 Front Panel ...1.20 Power Panel ... 1.20 Socket Panel ...1.21 Right Side Panel ...1.21 Rear Panel ...1.22 Board/Unit Location View ...1.23 Composition ...1.24 Standard Components ...1.24 Options ...1.24 Cable Connections ...1.25

Service Manual OPV-1500K

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CONTENTS

Section 2

Troubleshooting ...2C.1 General ... 2.1 Instrument Problems ... 2.2 Vital Sign Problems ... 2.4 ECG ... 2.4 Respiration ... 2.6 SpO2 ... 2.7 NIBP ... 2.9

Section 3

Diagnostic Check ...3C.1 Introduction ... 3.1 Calling Up the MAINTENANCE MODE Screen ... 3.1 Display Check ... 3.2 Sound Check ... 3.3 Memory Check ... 3.4 Key Check ... 3.5 Optional Transmitter Check ... 3.6 Optional Recorder Check ... 3.7 NIBP Check ... 3.8 Examination ... 3.8 Safety Device Test ... 3.9 Inflation Test ... 3.10 Deflation Test (Quick deflation test) ... 3.11 Step Deflation Test ... 3.12 Air Leak Test ... 3.14 ECG and Impedance Method Respiration Checks ... 3.15 SpO2 Check ... 3.16

Section 4

Board/Unit Description ...4C.1 Block Diagram ... 4.1 Input Board ... 4.2 NIBP Block ... 4.2 SpO2 Block ... 4.2 ECG Block ... 4.2 RESP Block ... 4.2 Control Block ... 4.2 Isolated Power Supply Block ... 4.2 POWER Board ... 4.3 USER IF Board ... 4.3 PRINTER CN Board ... 4.3

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Service Manual OPV-1500K

CONTENTS

CONTROL Board ... 4.3 Power Supply Unit ... 4.3

Section 5

Disassembly and Assembly ...5C.1 Opening the Instrument ... 5.1 Removing the Rear Enclosure ... 5.1 Separating the Front Enclosure and Chassis Block ... 5.1 Removing the LCD Unit ... 5.2 Removing the USER IF Board ... 5.2 Removing the INPUT Board ... 5.3 Removing the NIBP Pump ... 5.4 Removing the POWER Board, CONTROL Board and PRINTER CN Board ... 5.4 Removing the Recorder Unit (Option) ... 5.5 Removing the POWER Board ... 5.5 Removing the CONTROL Board ... 5.5 Removing the PRINTER CN Board ... 5.6 Removing the Power Supply Unit ... 5.6 Replacing the Lithium Battery ... 5.7 Installing the Optional RG-101W Recorder Unit ... 5.8

Section 6

Maintenance ...6C.1 To Be Replaced Periodically ... 6.1 Required Tools ... 6.1 Measuring and Test Equipment ... 6.2 Maintenance Check Items and Schedule ... 6.3 External ... 6.3 Input Conditions ... 6.3 Power ... 6.4 Operations ... 6.4 Display ... 6.4 Sound ... 6.4 ECG ... 6.4 RESP ... 6.5 NIBP ... 6.5 SpO2 ... 6.5 Alarm ... 6.6 Clock ... 6.6 Optional Recorder Built in the Instrument ... 6.6 Optional Transmitter Attached to the Instrument ... 6.6 Safety ... 6.7 Installation Condition ... 6.7

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CONTENTS

Section 7

Replaceable Parts List ...7C.1 Replaceable Parts List ... 7.2

Section 8

Connector Pin Assignment ...8C.1 INPUT Board ... 8.1 CN101 ECG/RESP Socket ... 8.1 CN401 (for quick deflation valve, valve1) ... 8.1 CN402 (for slow deflation valve, valve2) ... 8.1 CN403 (not used) ... 8.1 CN701 SpO2 Socket ... 8.2 CN902 (not used) ... 8.2 CN1001 (for POWER board) ... 8.2 Power Board ... 8.3 CN1 (for power supply unit) ... 8.3 CN2 (for rechargeable battery) ... 8.3 CN3 (for INPUT board)... 8.3 CN4 (for NIBP pump) ... 8.3 CN5 (for CONTROL board) ... 8.4 USER IF Board ... 8.5 CN101 (for CONTROL board) ... 8.5 PRINTER CN Board ... 8.5 CN101 (for CONTROL board) ... 8.5 CN102 (for recorder unit) ... 8.6 CN103 (for recorder unit) ... 8.6 CONTROL Board ... 8.7 CN1 Alarm pole socket ... 8.7 CN2 (for LCD unit) ... 8.7 CN3 (for POWER board) ... 8.8 CN4 (for PRINTER CN board) ... 8.9 CN5 ZB socket ... 8.9 CN6 (for USER IF board) ... 8.10 CN7 (not used) ... 8.10 CN8 (not used) ... 8.10 CN9 (for speaker) ... 8.10

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Service Manual OPV-1500K

GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel. Use only Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input boxes and AC power. Please read these precautions thoroughly before attempting to operate the instrument. 1. To safely and effectively use the instrument, its operation must be fully understood. 2. When installing or storing the instrument, take the following precautions: (1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly ventilated areas, and dust, saline or sulphuric air. (2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport. (3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. (4) The power line source to be applied to the instrument must correspond in frequency and voltage to product specifications, and have sufficient current capacity. (5) Choose a room where a proper grounding facility is available. 3. Before Operation (1) Check that the instrument is in perfect operating order. (2) Check that the instrument is grounded properly. (3) Check that all cords are connected properly. (4) Pay extra attention when the instrument is combined with other instruments to avoid misdiagnosis or other problems. (5) All circuitry used for direct patient connection must be doubly checked. (6) Check that battery level is acceptable and battery condition is good when using battery-operated models. 4. During Operation (1) Both the instrument and the patient must receive continual, careful attention. (2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety. (3) Avoid direct contact between the instrument housing and the patient. 5. To Shutdown After Use (1) Turn power off with all controls returned to their original positions. (2) Remove the cords gently; do not use force to remove them. (3) Clean the instrument together with all accessories for their next use. 6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order. 7. The instrument must not be altered or modified in any way. 8. Maintenance and Inspection: (1) The instrument and parts must undergo regular maintenance inspection at least every 6 months. (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.

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i

(3) Technical information such as parts list, descriptions, calibration instructions or other information is available for qualified user technical personnel upon request from your Nihon Kohden distributor. 9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or location of electrodes and/or transducers to avoid possible burn to the patient. 10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.

WARRANTY POLICY Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from the warranty. NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period, provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals. No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty. Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure. Shipping costs must be pre-paid. This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identification marks have been removed. In the USA and Canada other warranty policies may apply.

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Service Manual OPV-1500K

EMC RELATED CAUTION This equipment and/or system complies with the International Standard IEC60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in the IEC60601-1-2, can cause harmful interference to the equipment and/or system or cause the equipment and/or system to fail to perform its intended function or degrade its intended performance. Therefore, during the operation of the equipment and/or system, if there is any undesired deviation from its intended operational performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the equipment and/or system. The following describes some common interference sources and remedial actions: 1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or cellular phone: Install the equipment and/or system at another location if it is interfered with by an emitter source such as an authorized radio station. Keep the emitter source such as cellular phone away from the equipment and/or system. 2. Radio-frequency interference from other equipment through the AC power supply of the equipment and/ or system: Identify the cause of this interference and if possible remove this interference source. If this is not possible, use a different power supply. 3. Effect of direct or indirect electrostatic discharge: Make sure all users and patients in contact with the equipment and/or system are free from direct or indirect electrostatic energy before using it. 4. Electromagnetic interference with any radio wave receiver such as radio or television: If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or system as far as possible from the radio wave receiver. If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden Corporation subsidiary or distributor for additional suggestions.

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In IEC 60601-1-2 Medical Electronic Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard: Electromagnetic compatibility-Requirements and test. Section 36. 202. 2 Radiated radiofrequency electromagnetic fields, PATIENT COUPLED EQUIPMENT and/or SYSTEMS applicable IMMUNITY test methods are under consideration at SC62A/WG13. The 3 V/m IMMUNITY level may be inappropriate especially when measuring SpO2 because physiological signals can be much smaller than those induced by a 3 V/m electromagnetic field. When measuring SpO2, various interference may produce false waveforms which look like pulse waveforms. SpO2 value and pulse rate may be measured from these false waveforms, causing the alarm to function improperly. When installing the monitor, avoid locations where the monitor may receive strong electromagnetic interference such as radio or TV stations, cellular phone or mobile two-way radios.

WARNING Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic Equipment* The bioelectric impedance measurement sensor of a minute ventilation rate-adaptive implantable pacemaker may be affected by cardiac monitoring and diagnostic equipment which is connected to the same patient. If this occurs, the pacemaker may pace at its maximum rate and give incorrect data to the monitor or diagnostic equipment. If this occurs, disconnect the monitor or diagnostic equipment from the patient or change the setting on the pacemaker by referring to the pacemaker’s manual. For more details, contact your pacemaker distributor or Nihon Kohden distributor.

* Minute ventilation is sensed in rate-adaptive pacemakers by a technology known as bioelectric impedance measurement (BIM). Many medical devices in addition to pacemakers use this technology. When one of these devices is used on a patient with an active, minute ventilation rate-adaptive pacemaker, the pacemaker may erroneously interpret the mixture of BIM signals created in the patient, resulting in an elevated pacing rate. For more information, see the FDA web site. http://www.fda.gov/cdrh/safety.html

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Service Manual OPV-1500K

Conventions Used in this Manual and Instrument Warnings, Cautions and Notes Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.

WARNING A warning alerts the user to possible injury or death associated with the use or misuse of the instrument.

CAUTION A caution alerts the user to possible injury or problems with the instrument associated with its use or misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other property.

NOTE A note provides specific information, in the form of recommendations, prerequirements, alternative methods or supplemental information.

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Explanations of the Symbols in this Manual and Instrument The following symbols found in this manual/instrument bear the respective descriptions as given. On panels Symbol

Description

Symbol

Description

Monitor power on

Home (monitoring screen)

Monitor power off

Setting screen

AC operation (front panel) Alternating current (rear panel)

Record start/stop (for optional recorder unit)

Battery operation

Defibrillation-proof type CF applied part

Battery charging

Defibrillation-proof type BF applied part

Alarm silence

Attention, consult operator’s manual

NIBP

ZB-900PK transmitter socket

NIBP interval

Output terminal

NIBP start

Equipotential terminal

NIBP stop

Year of manufacture

Review

Serial number

The CE mark is a protected conformity mark of the European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC.

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Service Manual OPV-1500K

On screen Symbol

Description

Symbol

Description

Alarm silence with remaining minutes

Body movement (SpO2)

Alarm off

Recording

QRS/pulse sync mark

Recorder door open (when using optional recorder unit)

Respiration sync mark

Out of paper (when using optional recorder unit)

NIBP measurement on neonate

Transmitter connected to the monitor

Others Symbol

Description

Symbol

Description

Recycle (On battery pack)

IPX4

Splash-proof equipment (On transmitter)

Ni-MH

Manufacturer

Authorized representative in the European Community

The CE mark is a protected conformity mark of the European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC.

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Service Manual OPV-1500K

Section 1 General Introduction ... 1.1 General Information on Serving ... 1.2 Service Policy, Service Parts and Patient Safety Checks ... 1.4 Service Policy ... 1.4 Service Parts ... 1.4 Patient Safety Checks ... 1.5 Maintenance Equipments and Tools ... 1.5 General Safety Information ... 1.6 General ... 1.6 Installation ... 1.7 Using KC-012P Cart ... 1.8 Using ZB-900PK Transmitter ... 1.8 Using YL-001P Alarm Pole ... 1.8 Battery ... 1.9 ECG Monitoring ... 1.10 Respiration Monitoring ... 1.11 SpO2 Monitoring ...1.12 NIBP Monitoring ...1.14 Maintenance ...1.15 Specifications ... 1.16 Panel Description ... 1.20 Front Panel ... 1.20 Power Panel ... 1.20 Socket Panel ... 1.21 Right Side Panel ...1.21 Rear Panel ...1.22 Board/Unit Location View ... 1.23 Composition ... 1.24 Standard Components ...1.24 Options ... 1.24 Cable Connections ...1.25

Service Manual OPV-1500K

1C.1

1. GENERAL

Introduction This service manual provides useful information to qualified service personnel to understand, troubleshoot, service, maintain and repair the Life Scope N OPV-1500 Series Hardwire Monitor (referred to as “monitor” in this service manual. All replaceable parts or units of this monitor and its optional units are clearly listed with exploded illustrations to help you locate the parts quickly. The “Maintenance” section in this service manual only describes the maintenance that should be performed by qualified service personnel. The Maintenance section in the operator’s manual describes the maintenance that can be performed by the user. The information in the operator’s manual is primarily for the user. However, it is important for service personnel to thoroughly read the operator’s manual and service manual before starting to troubleshoot, service, maintain or repair this monitor. This is because service personnel needs to understand the operation of the monitor in order to effectively use the information in the service manual.

Service Manual OPV-1500K

1.1

1. GENERAL

General Information on Servicing Note the following information when servicing the monitor.

WARNING To avoid the possibility of injury to yourself or damage to the monitor, do not install or remove any component while the power is on. When disassembling, make sure that the monitor is turned off and the power cord is disconnected from the monitor and AC outlet. There is a high voltage circuit on the inverter for the LCD backlight and power unit.

CAUTIONS Safety • There is the possibility that the outside surface of the monitor, such as the operation keys, could be contaminated by contagious germs so disinfect and clean the monitor before servicing it. When servicing the monitor, wear rubber gloves to protect yourself from infection. • There is the possibility that when the lithium battery, NiMH battery or LCD unit is broken, a solvent could flow out or a toxic substance inside it could come out. If the solvent or toxic substance contacts the eyes or skin, wash immediately and thoroughly with water and see your physician. Never rub your eyes, otherwise you may lose your eyesight.

• To avoid accidental electrostatic discharge which could damage the components of the monitor, use a grounded wrist strap when installing or removing any component of the monitor. • Use a pair of clean cotton gloves when replacing the LCD unit. If it is damaged, your may get injured. Liquid ingress The monitor is not waterproof, so do not install the monitor where water or liquid can get into or fall on the monitor. If liquid accidentally gets into the monitor or the monitor accidentally drops into liquid, disassemble the monitor, clean it with clean water and dry it completely. After reassembling, do the patient safety checks and function/performance checks to verify that there is nothing wrong. If there is something wrong with the monitor, contact your Nihon Kohden representative for repair.

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Service Manual OPV-1500K

1. GENERAL Environmental Safeguards Depending on the local laws in your community, it may be illegal to dispose of the lithium battery in the regular waste collection. Check with your local officials for proper disposal procedures. Disinfection and cleaning To disinfect the outside surface of the monitor, wipe it with a nonabrasive cloth moistened with any of the disinfectants listed below. Do not use any other disinfectants or ultraviolet rays to disinfect the monitor. - Chlorohexidine gluconate solution: 0.5% - Benzethonium chloride solution: 0.2% - Glutaraldehyde solution: 2.0% - Benzalkonium chloride: 0.2% - Hydrochloric alkyl diaminoethylglycine: 0.5% Transport • Use the specified shipment container and packing material to transport the monitor. If necessary, double pack the monitor. Also, put the monitor into the shipment container after packing so that the buffer material does not get inside the monitor. • When transporting a board or unit of the monitor, be sure to put it in a conductive bag. Never use an aluminum bag to transport a board or unit. Also, never use a styrene foam or plastic bag which generates static electricity to wrap the board or unit of the monitor. Handling the monitor • Because the outside surface of the monitor is made of resin, the outside surface of the monitor is easily damaged. So when handling the monitor, remove clutter from around the monitor and be careful to not damage the monitor or get it dirty. • Because most of the boards in the monitor are multilayer boards with surface mount electrical devices (SMD), a special tool is required to remove and solder the electrical devices on it. To avoid damaging other electrical components, do not remove and solder SMD components yourself. Measuring and Test Equipment Maintain the accuracy of the measuring and test equipment by checking and calibrating it according to the check and calibration procedures. Battery Pack • Before disposing of the battery, check with your local solid waste officials for details in your area for recycling options or proper disposal. The battery is recyclable. At the end of its useful life, under various state and local laws, it may be illegal to dispose of this battery into the municipal waste stream.

Service Manual OPV-1500K

1.3

1. GENERAL

Service Policy, Service Parts and Patient Safety Checks Service Policy

Our technical service policy for this monitor is to replace the faulty unit, board or part or damaged mechanical part with a new one. Do not perform electrical device or component level repair of the multilayer board or unit. We do not support component level repair outside the factory for the following reasons: • Most of the boards are multilayer boards with surface mount electrical devices, so the mounting density of the board is too high. • A special tool or high degree of repair skill is required to repair the multilayer boards with surface mount electrical devices.

Only disassemble the monitor or replace a board or unit in an environment where the monitor is protected against static electricity. As background knowledge for repair, pay special attention to the following: • To reduce the repair time, consider the problem before starting repair. • To clarify the source of the troubles, use the information from the diagnostic check function of the monitor and the information described in the troubleshooting section.

Service Parts Refer to “Replaceable Parts List” of this manual for the service parts for technical service that we provide.

NOTE When ordering parts or accessories from your Nihon Kohden representative, please quote the NK code number and part name which is listed in this service manual, and the name or model of the unit in which the required part is located. This will help us to promptly attend to your needs. Always use parts and accessories recommended or supplied by Nihon Kohden Corporation to assure maximum performance from your monitor.

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Service Manual OPV-1500K

1. GENERAL

Patient Safety Checks

Periodic maintenance procedures and diagnostic check procedures are provided in this manual to ensure that the monitor is operating in accordance with its design and production specifications. To verify that the monitor is working in a safe manner with regard to patient safety, patient safety checks should be performed on the monitor before it is first installed, periodically after installation, and after any repair is made on the monitor. For patient safety checks, perform the following checks as described in the IEC60601-1 “Medical electrical equipment - Part 1: General requirements for safety”. • Protective earth resistance check • Earth leakage current check • Enclosure leakage current check • Patient leakage current check • Withstanding voltage check

Maintenance Equipments and Tools

Service Manual OPV-1500K

Test equipment When repairing or calibrating the monitor, the following test equipment is required. • Oscilloscope: 2 channels or more for input signal, 50 mV to 5 V input range, 1/ 10 attenuating probe and 100 MHz or more frequency response characteristic must be provided. • Digital voltmeter: standard type (An oscilloscope can be used instead of the digital voltmeter.)

1.5

1. GENERAL

General Safety Information General WARNING • Never use this monitor in the presence of any flammable anesthetic gas, concentrated oxygen or hyperbaric oxygen. Failure to follow this warning may result in explosion. • Never use the monitor in a high-pressure oxygen medical care tank. Failure to follow this warning may cause explosion or fire. • When using this monitor with an electrosurgery unit, its return plate and the electrodes for monitoring must be firmly attached to the patient. If the return plate is not attached correctly, it may burn the patient’s skin where the electrodes are attached. Refer to the instruction manual for the ESU. • When performing MRI tests, remove the electrodes and transducers connected to the monitor from the patient. The heat generated from the induced electromotive force may burn the patient’s skin. For details, refer to the instruction manual for the MRI. • When performing defibrillation, discharge as far as possible from electrodes and medicine on the chest of the patient. If there is a possibility that the defibrillator paddle could touch electrodes and medicine, remove electrodes and medicine from the patient. If the defibrillator directly contacts these materials, the discharged energy may cause serious electrical burn to the patient. • Before performing defibrillation, check that the cords and cables of the electrodes and transducers attached to the patient are properly connected to the monitor. Touching the metal parts of disconnected cords and cables may cause serious electrical shock or injury by discharged energy. • To avoid the risk of serious electrical burn, shock or other injury during defibrillation, all persons must keep clear of the bed and must not touch the patient or any equipment connected to the patient. • During alarm suspension, all current alarms are temporarily turned off. • When EXIT SLEEP MODE ON ALARM on the SYSTEM SETUP screen is set to NO, the bedside monitor alarm cannot be seen or heard on the bedside monitor during sleep mode. Attach the transmitter (option) to the monitor and monitor the bedside monitor alarm on the central monitor or telemetry system. Otherwise, bedside monitor alarms may be overlooked.

CAUTION • Use only Nihon Kohden specified electrodes, probes and cuffs. Otherwise, the maximum performance from the monitor cannot be guaranteed. • Do not reuse disposable parts. 1.6

Service Manual OPV-1500K