Nihon-Kohden OPV-1500 User manual

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Life Scope N

BEDSIDE MONITOR

OPV-1500K

0614-007018

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 .......................................................................................................................... 1.2

Features ............................................................................................................................... 1.3

Composition ......................................................................................................................... 1.4

Panel Description ................................................................................................................. 1.5

Front Panel ................................................................................................................. 1.5

Power Panel ...............................................................................................................1.5

Socket Panel .............................................................................................................. 1.6

Right Side Panel .........................................................................................................1.6

Rear Panel ................................................................................................................. 1.7

Basic Operating Concepts .................................................................................................... 1.8

Screen Displays .........................................................................................................1.8

Displaying Monitoring Screen and Review Windows .................................................1.10

Displaying Setup Windows ....................................................................................... 1.11

Changing a Setting ................................................................................................... 1.12

General Safety Information ................................................................................................ 1.13

General ..................................................................................................................... 1.13

Installation ............................................................................................................... 1.14

Using KC-012P Cart ................................................................................................. 1.15

Using ZB-900PK Transmitter .................................................................................... 1.15

Using YL-001P Alarm Pole ....................................................................................... 1.15

Battery ..................................................................................................................... 1.16

ECG Monitoring ........................................................................................................1.17

Respiration Monitoring .............................................................................................. 1.18

SpO2 Monitoring ....................................................................................................... 1.19

NIBP Monitoring .......................................................................................................1.21

Maintenance ............................................................................................................ 1.22

Section 2 Preparations ......................................................................... 2C.1

Preparation Flowchart .......................................................................................................... 2.1

Installation Conditions .......................................................................................................... 2.2

Carrying the Monitor ............................................................................................................. 2.3

Preparing the Optional Recorder Unit ................................................................................... 2.4

Operator's Manual OPV-1500K C.1

CONTENTS

Installing the Recorder Unit ........................................................................................2.4

Loading the Recording Paper ......................................................................................2.4

Connecting an External Instrument to the Monitor ................................................................ 2.6

Connecting the Optional ZB-900PK Transmitter ......................................................... 2.7

Connecting the Optional YL-001P Alarm Pole ............................................................ 2.8

Power ................................................................................................................................... 2.9

AC or Battery Power Source Selection .......................................................................2.9

Connecting the Power Cord and Grounding the Monitor ..............................................2.9

Connecting the Power Cord ..............................................................................2.9

Grounding the Monitor .................................................................................... 2.10

Turning the Monitor On .............................................................................................2.10

Check Before Turning On the Monitor ............................................................. 2.10

Turning the Monitor On ................................................................................... 2.11

Check After Turning On the Monitor and During Monitoring ............................ 2.11

Turning the Monitor Off ............................................................................................. 2.12

Check After/Before Turning the Monitor Off .................................................... 2.12

Power and Battery Status Indications ...................................................................... 2.13

Battery Handling and Operation ................................................................................ 2.14

Safety Information.......................................................................................... 2.14

Battery Lifetime.............................................................................................. 2.15

Battery Handling Procedures ......................................................................... 2.15

When Using a Battery for the First Time or After Storage .............................. 2.15

When Not Using the Monitor or Battery ..........................................................2.16

When the LOW BATTERY Message Appears................................................. 2.16

Installing or Replacing the Battery ................................................................. 2.16

Charging the Battery ......................................................................................2.16

Disposal of Battery Pack ................................................................................ 2.17

Changing Date and Time Setting ........................................................................................2.18

Turning the Click Sound for Key Operation On or Off.......................................................... 2.20

Deleting All Stored Data ..................................................................................................... 2.21

Section 3 Changing System Setup Settings ...................................... 3C.1

Displaying the SYSTEM SETUP Screen ............................................................................. 3.2

Changing Settings ......................................................................................................3.3

Closing the SYSTEM SETUP Screen and Displaying the Monitoring Screen ............ 3.3

List and Explanation of the SYSTEM SETUP Settings ........................................................ 3.4

List of All Settings ......................................................................................................3.4

BASIC SETTINGS ..................................................................................................... 3.5

ALARM SETUP ......................................................................................................... 3.6

NIBP SETUP .............................................................................................................3.7

SpO2 SETUP ............................................................................................................. 3.8

ECG/RESP SETUP ................................................................................................... 3.9

Initializing the System ........................................................................................................3.10

Factory Default Settings ..................................................................................................... 3.12

SYSTEM SETUP Screen ......................................................................................... 3.12

ALARM Window ....................................................................................................... 3.12

NIBP Window ........................................................................................................... 3.12

ECG etc Window ...................................................................................................... 3.13

C.2 Operator's Manual OPV-1500K

CONTENTS

REC/SOUND Window ............................................................................................... 3.13

OTHER Window ........................................................................................................ 3.13

Section 4 Alarm Function ..................................................................... 4C.1

Overview of Alarms .............................................................................................................. 4.2

What is an Alarm........................................................................................................ 4.2

Alarm Level ................................................................................................................4.2

Alarm Priority ............................................................................................................. 4.2

Silencing an Alarm ..................................................................................................... 4.3

Automatic Recording ..................................................................................................4.3

Alarm Setting ............................................................................................................. 4.3

Adjusting Alarm Sound Volume .................................................................................. 4.3

Alarm Types ......................................................................................................................... 4.4

Vital Signs Alarms .....................................................................................................4.4

Parameter Alarms ...................................................................................................... 4.4

ECG/Respiration Related Alarms .....................................................................4.4

SpO2 Related Alarms .......................................................................................4.4

NIBP Related Alarms .......................................................................................4.5

Other Alarms .............................................................................................................. 4.5

Messages................................................................................................................... 4.5

ECG Related Messages ................................................................................... 4.5

Respiration Related Messages......................................................................... 4.5

SpO2 Related Messages .................................................................................. 4.6

NIBP Related Messages ..................................................................................4.6

Other Messages .............................................................................................. 4.6

Alarm Indications .................................................................................................................4.7

Overview .................................................................................................................... 4.7

Individual Alarm Indications ....................................................................................... 4.7

Vital Signs Alarms ........................................................................................... 4.7

Parameter Alarms ............................................................................................4.8

Other Alarms.................................................................................................... 4.9

Alarm Control Marks .................................................................................................. 4.9

Alarm Silence Mark .......................................................................................... 4.9

Individual Vital Signs Alarm Setting Indication ................................................. 4.9

Adjusting the Alarm Sound Volume .......................................................................... 4.10

Temporarily Silencing/Suspending Alarms ..........................................................................4.11

Overview .................................................................................................................. 4.11

Silencing an Alarm After Alarm Occurrence ............................................................. 4.11

Silencing an Alarm ......................................................................................... 4.11

Canceling an Alarm Silence ........................................................................... 4.12

Suspending an Alarm Before Alarm Occurrence ...................................................... 4.12

Turning Automatic Alarm Recording On/Off ........................................................................ 4.13

Setting Alarm ..................................................................................................................... 4.15

Overview .................................................................................................................. 4.15

Alarm Limits Ranges ................................................................................................ 4.15

Setting Vital Signs Alarm Limits ...............................................................................4.15

Operator's Manual OPV-1500K C.3

CONTENTS

Section 5 Monitoring Screen and Review Windows ......................... 5C.1

Safety Precautions for Monitoring ........................................................................................ 5.2

Using an Electrosurgery Unit ........................................................................... 5.2

Using a Defibrillator ..........................................................................................5.2

Overview .............................................................................................................................. 5.3

Monitoring Screen ...................................................................................................... 5.3

Review Windows ........................................................................................................ 5.3

Sync Sound ............................................................................................................... 5.3

Adjusting the Sync Sound Volume .............................................................................5.3

Changing Settings and Performing Other Tasks During Monitoring ............................. 5.3

Monitoring Screen ................................................................................................................ 5.4

Changing Displayed Waveforms on the Monitoring Screen .........................................5.5

Using Sleep Mode ................................................................................................................ 5.7

Turning Sleep Mode On ....................................................................................5.7

Turning Sleep Mode Off.................................................................................... 5.8

List Window .......................................................................................................................... 5.9

Overview .................................................................................................................... 5.9

Displaying the List Window ......................................................................................... 5.9

MEMO ........................................................................................................... 5.10

Setting the Data Sampling Interval ........................................................................... 5.10

Recording the List .................................................................................................... 5.11

Recording the Displayed or All List Data ........................................................ 5.11

Auto List Recording ........................................................................................ 5.13

Trendgraph Window ............................................................................................................. 5.14

Overview .................................................................................................................. 5.14

Displaying the Trendgraph Window............................................................................ 5.14

Scrolling the Trendgraph ................................................................................. 5.15

Changing the Trendgraph Time Width ..............................................................5.15

Changing the Trendgraph Scale ...................................................................... 5.16

Recording the Trendgraphs ....................................................................................... 5.16

Section 6 Recording ............................................................................. 6C.1

Overview of Recording ......................................................................................................... 6.1

Recording Modes .......................................................................................................6.1

Manual Recording on the Monitoring Screen ....................................................6.2

Manually Recording on the List and Trendgraph Windows................................. 6.2

Alarm Recording .............................................................................................. 6.2

Recording Mode Annotations .....................................................................................6.3

Recording Sensitivity ................................................................................................. 6.3

Recording Speed ........................................................................................................6.3

Recording Related Messages..................................................................................... 6.3

Recorded Data ...........................................................................................................6.4

Changing the Recording Speed ............................................................................................6.5

Manually Recording Waveforms ...........................................................................................6.6

C.4 Operator's Manual OPV-1500K

CONTENTS

Section 7 ECG Monitoring .................................................................... 7C.1

General ................................................................................................................................. 7.1

Preparing for ECG Monitoring ...............................................................................................7.2

Preparation Flowchart ................................................................................................ 7.2

Electrode Position ...................................................................................................... 7.2

Electrode Position ............................................................................................ 7.2

Lead Connection .............................................................................................. 7.2

Selecting Electrodes and Lead ...................................................................................7.3

Types of Electrodes and Leads ........................................................................ 7.3

Connecting Cables and Attaching Disposable Electrodes .......................................... 7.4

Connecting the Electrode Cable to the Monitor ................................................ 7.4

Attaching Disposable Electrodes to the Patient ...............................................7.5

Monitoring ECG .................................................................................................................... 7.6

ECG Information on the Monitoring Screen ................................................................7.6

Noise Detection and Display ...................................................................................... 7.7

Detached Electrode Detection and Display ................................................................ 7.7

Changing ECG Settings ....................................................................................................... 7.8

Changing the Heart Rate or Pulse Rate Alarm Limits .................................................7.8

Changing the Monitoring Lead .................................................................................... 7.9

Changing the ECG Sensitivity .................................................................................. 7.11

Turning Pacing Spike Detection On/Off .................................................................... 7.12

Changing the Sync Source ....................................................................................... 7.13

Use with an Electrosurgical Unit ......................................................................................... 7.15

Section 8 Respiration Monitoring........................................................ 8C.1

General ................................................................................................................................. 8.1

Preparing for Respiration Monitoring .....................................................................................8.2

Preparation Flowchart ................................................................................................ 8.2

Electrode Position and Waveform Examples ..............................................................8.2

Connecting Cables and Attaching Disposable Electrodes .......................................... 8.4

Monitoring Respiration .......................................................................................................... 8.5

Respiration Information on the Monitoring Screen ...................................................... 8.5

Changing Respiration Settings .............................................................................................8.6

Changing the Respiration Rate Alarm Limits ..............................................................8.6

Changing the Apnea Alarm Limit ................................................................................8.7

Changing the Respiration Sensitivity ..........................................................................8.8

Turning Respiration Monitoring Off.............................................................................. 8.9

Section 9 SpO2 Monitoring ................................................................... 9C.1

General ................................................................................................................................. 9.1

Preparing for SpO2 Monitoring .............................................................................................. 9.2

Preparation Flowchart ................................................................................................ 9.2

Selecting a Probe ....................................................................................................... 9.3

Nihon Kohden Reusable Probes .......................................................................9.3

Nihon Kohden Disposable Probes .................................................................... 9.4

Connecting Cables ..................................................................................................... 9.5

Connecting Cable to the Monitor ...................................................................... 9.5

Operator's Manual OPV-1500K C.5

CONTENTS

Attaching the Probe to the Patient .............................................................................. 9.6

Attaching the TL-201T Finger Probe .................................................................9.7

Attaching the TL-251T/252T/253T Disposable Probes .....................................9.7

Monitoring SpO

SpO2 Information on the Monitoring Screen.............................................................. 9.11

Detection and Display of Measurement Condition .................................................... 9.12

Changing SpO2 Settings ..................................................................................................... 9.13

Changing the SpO2 Alarm Limits .............................................................................. 9.13

Changing the Pulse Waveform Sensitivity ................................................................ 9.14

Changing the Sync Source ....................................................................................... 9.15

Selecting Sync Sound Pitch .................................................................................... 9.16

................................................................................................................. 9.10

SpO2 CHECK PROBE Message (When the Finger Probe is Used) ............... 9.12

SpO2 SEARCHING PULSE Message............................................................ 9.12

M Message ....................................................................................................9.12

Section 10 NIBP Monitoring ................................................................. 10C.1

General ............................................................................................................................... 10.1

Oscillometric Method ..................................................................................... 10.1

Measurement Modes...................................................................................... 10.1

Preparing for NIBP Measurement .......................................................................................10.2

Preparation Flowchart .............................................................................................. 10.2

Selecting the Cuff .................................................................................................... 10.2

Cuff Width and Arm Circumference ................................................................ 10.3

Types of Cuffs.......................................................................................................... 10.4

Reusable Cuffs .............................................................................................. 10.4

Disposable Cuffs ............................................................................................ 10.5

Disinfecting Disposable Cuffs before Use ......................................................10.6

Connecting Cables and Attaching the Cuff to the Patient .........................................10.6

Connecting Air Hose and Cuff to the Monitor ................................................. 10.6

Attaching the Cuff to the Patient ....................................................................10.8

Changing NIBP Settings ................................................................................................... 10.10

Changing the NIBP Alarm Settings ........................................................................ 10.10

Selecting the Measurement Mode .......................................................................... 10.12

Measurement Modes.................................................................................... 10.12

Selecting the Measurement Modes for the Mode Selection ......................... 10.14

Changing the PWTT Settings ................................................................................. 10.15

Setting NIBP Measurement on Vital Sign Alarm Occurrence ................................. 10.16

Measuring and Monitoring NIBP ....................................................................................... 10.18

Recommended Patient State .................................................................................. 10.18

Starting and Stopping NIBP Measurement ............................................................. 10.19

Manual Mode ............................................................................................... 10.19

STAT (Continuous) Mode .............................................................................. 10.19

Auto Mode ................................................................................................... 10.19

NIBP Information on the Monitoring Screen ........................................................... 10.20

When NIBP Data Becomes Dim .................................................................. 10.20

NIBP Pulse Rate Display ............................................................................. 10.21

C.6 Operator's Manual OPV-1500K

CONTENTS

Section 11 Error Messages and Troubleshooting ............................. 11C.1

Monitoring .......................................................................................................................... 11.1

Recording (When Using an Optional Recorder Unit) ........................................................... 11.2

Messages................................................................................................................. 11.2

Problems ..................................................................................................................11.2

ECG Monitoring .................................................................................................................. 11.3

Messages................................................................................................................. 11.3

Problems ..................................................................................................................11.4

Respiration Monitoring ........................................................................................................ 11.5

Messages................................................................................................................. 11.5

Problems ..................................................................................................................11.5

SpO2 Monitoring .................................................................................................................11.6

Messages................................................................................................................. 11.6

Problems ..................................................................................................................11.7

NIBP Monitoring ................................................................................................................. 11.8

Messages................................................................................................................. 11.8

Problems ..................................................................................................................11.9

Section 12 Maintenance ....................................................................... 12C.1

Handling Accessories After Use ......................................................................................... 12.2

Battery Pack ............................................................................................................ 12.2

Battery Lifetime.............................................................................................. 12.2

Replacing Battery Pack .................................................................................. 12.2

Disposal of Battery Pack ................................................................................ 12.2

ECG and Respiration ................................................................................................ 12.2

Electrode Lifetime .......................................................................................... 12.2

Disposing of Electrodes ................................................................................. 12.2

Cleaning and Disinfecting the Electrode Lead and ECG Connection Cord ...... 12.2

SpO2......................................................................................................................... 12.3

Expiration of Probes....................................................................................... 12.3

Disposing of Probes .......................................................................................12.4

Cleaning, Disinfecting and Sterilizing the TL-201T Finger Probe .................... 12.4

Sterilizing the Disposable Probe .................................................................... 12.5

Cleaning and Disinfecting the SpO2 Connection Cord .................................... 12.6

NIBP ........................................................................................................................ 12.6

NIBP Cuff Lifetime .........................................................................................12.6

Cleaning and Disinfecting the YP-950T/951T/952T/953T/954T/955T

Reusable Cuffs .................................................................................... 12.6

Cleaning and Disinfecting the Air Hose and Extension Hose ......................... 12.7

Disinfecting the Disposable Cuffs .................................................................. 12.7

Disposal of Cuffs ........................................................................................... 12.8

Cleaning and Disinfecting the Monitor ................................................................................ 12.9

Cleaning the Display ................................................................................................ 12.9

Monitor Panel ........................................................................................................... 12.9

Cleaning ......................................................................................................... 12.9

Disinfecting ..................................................................................................12.10

Cleaning the Recorder Unit ............................................................................................... 12.11

Cleaning the Thermal Head .......................................................................... 12.11

Operator's Manual OPV-1500K C.7

CONTENTS

Cleaning the Sensors ................................................................................... 12.11

Yearly Inspection .............................................................................................................. 12.12

Clock Accuracy ................................................................................................................ 12.13

Repair Parts Availability Policy ......................................................................................... 12.13

Section 13 Reference ............................................................................ 13C.1

Specifications .................................................................................................................... 13.1

Display ...........................................................................................................13.1

Alarm ............................................................................................................. 13.1

ECG ............................................................................................................... 13.1

Respiration (Transthoracic impedance pneumography)................................... 13.1

SpO2.............................................................................................................. 13.2

Non Invasive Blood pressure, NIBP ............................................................... 13.2

Trendgraph .....................................................................................................13.2

Vital Signs List ............................................................................................... 13.2

Recording (optional, RG-101W) ...................................................................... 13.2

Power Requirement ........................................................................................ 13.2

Environment ................................................................................................... 13.2

Dimensions and Weight (approximate) ........................................................... 13.3

Electromagnetic Compatibility........................................................................ 13.3

Safety Standard ............................................................................................. 13.3

Input/Output Socket Pin Assignment ................................................................................. 13.4

ZB Socket ................................................................................................................ 13.4

General Requirements for Connecting Medical Electrical System ...................................... 13.5

Options and Consumables ................................................................................................. 13.7

Optional Accessory Kit ............................................................................................ 13.7

Options for the Monitor ............................................................................................. 13.7

For ECG and Respiration (Impedance Method) Monitoring .......................................13.8

For SpO2 Monitoring ................................................................................................. 13.8

For NIBP Monitoring ................................................................................................. 13.9

For RG-101W Recorder Unit .....................................................................................13.9

C.8 Operator's 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.

Operator's Manual OPV-1500K 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.

ii Operator's 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.

Operator's Manual OPV-1500K iii

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 radio-

frequency 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

iv Operator's 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.

Operator's Manual OPV-1500K v

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)

Battery operation

Battery charging

Alarm silence

NIBP ZB-900PK transmitter socket

NIBP interval Output terminal

NIBP start Equipotential terminal

NIBP stop Year of manufacture

Record start/stop (for optional recorder unit)

Defibrillation-proof type CF applied part

Defibrillation-proof type BF applied part

Attention, consult operator’s manual

Review Serial number

vi Operator's Manual OPV-1500K

On screen

Symbol Description Symbol Description

Alarm silence with remaining minutes

Alarm off Recording

QRS/pulse sync mark

Respiration sync mark

NIBP measurement on neonate

Others

Symbol Description Symbol Description

Body movement (SpO

Recorder door open (when using optional recorder unit)

Out of paper (when using optional recorder unit)

Transmitter connected to the monitor

Ni-MH

Recycle (On battery pack)

IPX4

Splash-proof equipment (On transmitter)

Operator's Manual OPV-1500K vii

Section 1 General

Introduction ......................................................................................................................... 1.2

Features ..............................................................................................................................1.3

Composition ........................................................................................................................ 1.4

Panel Description ................................................................................................................ 1.5

Front Panel ................................................................................................................ 1.5

Power Panel ..............................................................................................................1.5

Socket Panel ............................................................................................................. 1.6

Right Side Panel ........................................................................................................1.6

Rear Panel ................................................................................................................ 1.7

Basic Operating Concepts ................................................................................................... 1.8

Screen Displays ........................................................................................................1.8

Displaying Monitoring Screen and Review Windows ................................................1.10

Displaying Setup Windows ...................................................................................... 1.11

Changing a Setting ..................................................................................................1.12

General Safety Information ............................................................................................... 1.13

General .................................................................................................................... 1.13

Installation .............................................................................................................. 1.14

Using KC-012P Cart ................................................................................................ 1.15

Using ZB-900PK Transmitter ................................................................................... 1.15

Using YL-001P Alarm Pole ...................................................................................... 1.15

Battery .................................................................................................................... 1.16

ECG Monitoring .......................................................................................................1.17

Respiration Monitoring ............................................................................................. 1.18

SpO2 Monitoring ...................................................................................................... 1.19

NIBP Monitoring ......................................................................................................1.21

Maintenance ........................................................................................................... 1.22

Operator's Manual OPV-1500K 1C.1

1. GENERAL

Section 1 provides a general overview of the equipment and how to operate it. If

you have not used an OPV-1500K bedside monitor before, read this section first.

• Features

• Components in the system

• Panel descriptions

• Screen displays

• Basic operation concepts

• Important safety information

Operator's Manual OPV-1500K 1.1

1. GENERAL

Introduction

The Life Scope N OPV-1500K hardwire bedside monitor can monitor ECG,

impedance method respiration, SpO

lightweight design lets you use this bedside monitor in the general ward,

examination room, dialysis room, treatment room and for patient transport. For

portability, it can operate on battery power as well as AC power.

and NIBP. Its easy operation and compact

NOTE

Use only Nihon Kohden parts and accessories to assure maximum

performance from your instrument.

1.2 Operator’s Manual OPV-1500K

Features

1. GENERAL

• Hardwire system

Monitors ECG, impedance method respiration, SpO

• AC or battery (option) operation

The monitor can operate on AC power or battery for up to 1 hour.

• Color data display

Detailed information is displayed on the wide angle, 5.6 inch color LCD.

Monitoring parameters are automatically identified.

• Easy operation by the hard keys and rotary dial

The monitor can be easily operated using the hard keys and rotary dial on the

panel.

and NIBP.

• Review windows for viewing saved data

Saved data can be displayed on the trendgraph window and list window.

• Thermal array recorder with 60 mm width paper (option)

Waveforms, numeric data, trendgraphs, and vital signs lists can be recorded

manually or automatically on the optional RG-101W recorder unit. Up to two

channels can be recorded.

• Telemetry system (option)

When the optional ZB-900PK transmitter is connected to the bedside monitor,

waveform(s) and parameter data from the bedside monitor can be sent to a

Cardiac Telemetry System or to a Central Monitor via a Multiple Patient

Receiver and recorded. (Available waveforms and parameter data depend on the

receiving monitor.)

Operator's Manual OPV-1500K 1.3

1. GENERAL

Composition

SILENCE

ALARM

INTERVAL

NIBP

START

STOP

MENU/SET

SELECT

Life Scope N Bedside Monitor

OPV-1500K

Options

Accessory Kit, YZ-023H5/YZ-023H6/YZ-023H7/YZ-023H8 (option)

Cart, KC-012P (option)

Recorder Unit, RG-101W (option)

Alarm Pole, YL-001P (option)

Battery Pack, NKB-302 (option)

Transmitter, ZB-900PK (option)

1.4 Operator’s Manual OPV-1500K

Panel Description

Front Panel

1. GENERAL

Alarm indicator

Red or yellow lamp blinks or lights according to the alarm settings.

NIBP lamp

Lights during NIBP measurement.

Screen

Displays monitoring data.

Power panel

Refer to the "Power Panel" section.

Socket panel

Refer to the "Socket Panel" section.

SELECT

SILENCE

ALARM

INTERVAL

NIBP

START

STOP

MENU/SET

SILENCE ALARM key

Silences the alarm sound. When the power key is pressed while this key is pressed, the MAINTENANCE MODE screen is displayed for the SYSTEM SETUP settings and servicing.

NIBP INTERVAL key

Selects NIBP measurement mode. Pressing this key changes the mode.

NIBP START/STOP key

Starts NIBP measurement in selected mode. Pressing this key during measurement stops measurement.

Rotary dial

Selects item on the setup windows. Scrolls data on the review windows.

Center key

Displays the setup windows and registers the setting.

Screen select key

Changes the screen in the following order:

Record key

Press to start or stop recording.

Monitoring screen, list window, trend window, sleep mode screen. Displays monitoring screen when pressed on the setup window.

Power Panel

Power lamp

Lights when the monitor is turned on.

AC power lamp

Lights when the power cord is connected between the AC SOURCE socket and AC outlet.

Battery charging lamp

Indicates the battery status. Lit: Fully charged

Power key

Press and hold for more than one second to turn the monitor on or off.

Battery power lamp

Lights when operating on battery power.

Blinking: Being charged

Operator's Manual OPV-1500K 1.5

1. GENERAL

Socket Panel

Refer to Section 10.

NIBP socket

Connects to the air hose.

Refer to Section 9.

Refer to Sections 7 and 8.

ECG/RESP socket

Connects to the ECG connection cord.

SpO2 socket

Connects to the SpO2 connection cord.

Right Side Panel

RG-101W recorder unit (option)

1.6 Operator’s Manual OPV-1500K

Rear Panel

Alarm pole socket

Connects the YL-001P alarm pole (optional).

Refer to warnings and cautions in Section 2.

ZB socket

Connects the ZB-900PK transmitter (optional).

AUX

100 to 240V

50,60Hz

1. GENERAL

Fuse holder

Battery box

Installs the battery pack (optional).

AC SOURCE power cord socket

Connects the AC power cord.

Equipotential grounding terminal

For an equipotential grounding lead.

Operator's Manual OPV-1500K 1.7

1. GENERAL

Basic Operating Concepts

Screen Displays

Monitoring screen

Following are the screens and windows available on the Life Scope N bedside

monitor. For details about the individual screens and windows, see the appropriate

section.

The shadow of the previous screen may remain for a few minutes after changing

the screen.

One waveform display Two waveform display

Review windows

Trendgraph window for displaying 24 hour trendgraph List window for displaying list of parameter data

1.8 Operator’s Manual OPV-1500K

Sleep mode screen

Sleep mode confirmation screen Sleep mode screen

Setup windows

1. GENERAL

ALARM setting window

ECG etc window for changing parameter

settings other than NIBP

NIBP setting window

REC/SOUND window for setting recording

and sound settings

OTHER window for setting waveform display, list interval, date and time and deleting saved data

Operator's Manual OPV-1500K 1.9

1. GENERAL

SYSTEM SETUP screen

SILENCE

ALARM

For changing system settings.

Displaying the SYSTEM SETUP

screen interrupts monitoring.

Displaying Monitoring Screen and Review Windows

Pressing the HOME/REVIEW key on the front panel changes the screen in the

following order.

Monitoring → list window → trendgraph window → sleep mode confirmation

screen→ monitoring

Pressing the SILENCE

ALARM key on the sleep

mode confirmation screen

enters sleep mode

SILENCE

ALARM

1.10 Operator’s Manual OPV-1500K

1. GENERAL

Displaying Setup Windows

Press the rotary

dial center key on

the monitoring

screen

From the monitoring screen, press the rotary dial center key on the front panel.

The ALARM window is displayed. Turning the rotary dial changes the setup

window in the following order.

ALARM window

Turn the rotary dial to

change the setup window

The red diamond mark in front of the

setting item indicates that this setting

returns to the factory default setting

30 minutes after monitor power off.

NIBP window

Press the rotary dial center

key on the setup window to

enter the window

ECG etc window

REC/SOUND window

CLOSE window for closing the setup windows

Operator's Manual OPV-1500K 1.11

OTHER window

1. GENERAL

Changing a Setting For example, to change the ECG lead:

1. Display the ECG etc window.

a) From the monitoring screen, press the rotary dial center key. The ALARM

window opens.

b) Turn the rotary dial to select “ECG etc” tab.

Tabs

2. Press the rotary dial center key to enter the ECG etc window. The cursor

moves to the “ECG SENS” box.

3. Turn the rotary dial to move the cursor to “ECG LEAD” and press the rotary

dial center key to change the cursor color to blue.

4. Turn the rotary dial to select the lead and press the rotary dial center key to

5. To change other items on the same window, repeat steps 3 and 4.

To change settings on other windows, move the cursor to “RETURN TO TAB”

and press the rotary dial center key. The cursor moves to tab.

To close the setup window, select “CLOSE” on the setup window and press the

rotary dial center key,

or select “CLOSE” on the setup window tab and press the rotary dial center

key,

or press the HOME/REVIEW key on the front panel.

1.12 Operator’s Manual OPV-1500K

General Safety Information

General

••

• 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.

1. GENERAL

WARNING

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.

••

Operator's Manual OPV-1500K 1.13

1. GENERAL

••

• Turn off the power of cell telephones, small wireless devices and

••

other devices which produce strong electromagnetic interference.

Otherwise, the waveforms and measurements are affected by such

interference and the displayed data may be incorrect.

••

• Before monitoring a new patient, first delete all data of the previous

••

patient. Otherwise, the data of the previous patient and new patient

will be mixed together.

••

• Alarm recording is not performed when alarm is suspended or alarm

••

recording is set to off.

••

• When the alarm limit is turned off, there will be no alarm for that

••

parameter limit.

••

• When the “ECG CONNECTOR OFF”, “SpO2 CONNECTOR OFF” or

••

“AIR HOSE OFF” message appears on the screen, check that the

connection cords are connected to the sockets properly. Patient

cannot be monitored and the alarm does not function properly while

this message is displayed.

••

• If fluids are accidentally spilled on the monitor, take the bedside

••

monitor out of service and check for damage.

Installation

WARNING

••

• For patient safety, equipotential grounding of all instruments must

••

be performed. Consult with a qualified biomedical engineer.

••

• Only use the provided power cord. Using other power cords may

••

result in electrical shock or other injury to the patient and operator.

••

• When the provided power cord cannot be used or when equipotential

••

grounding is doubtful (such as in poor grounding facility), operate

the monitor on battery power.

••

• Connect only the specified instrument to the socket marked with

••

by following the specified procedure. Otherwise, electrical leakage

current may harm the patient and operator.

CAUTION

••

• When connecting the monitor to other instruments, the connection

••

must comply with IEC60601-1-1. Refer to “General Requirements for

Connecting Medical Electrical System” in Section 13.

••

• Disconnect the power cord of all instruments from the AC SOURCE

••

socket before connecting the instruments. Otherwise there may be

an electrical shock.

••

• Avoid locations where the monitor and system may be sprinkled with

••

water or chemical solutions. Otherwise the monitor and system may

be damaged.

••

• When not using the KC-012P cart, make sure that the monitor is

••

1.14 Operator’s Manual OPV-1500K

Using KC-012P Cart

1. GENERAL

placed and fastened so that it does not tip over.

••

• Install the monitor and ESU appropriately and perform equipotential

••

grounding. Otherwise, noise from the ESU may interfere with the

ECG and ECG monitoring may not be performed properly.

••

• When the monitor power is turned on, check that one “bong” sounds

••

and the red and orange alarm indicators blink once to show that the

alarm functions properly.

Also read the warning and caution in “Selecting a Suitable Location” in Section 2.

CAUTION

••

• Use only the KC-012P cart for the OPV-1500K bedside monitor. If

••

another cart is used, it may tip over or the monitor may fall off.

••

• When the monitor is mounted on the cart, confirm that the lever on

••

the holder completely springs up. If the monitor is not locked, it may

fall off.

Using ZB-900PK Transmitter

Using YL-001P Alarm Pole

CAUTION

Heart rate may differ between the monitor and the telemetry system or

central monitor due to the difference on the displaying ECG waveform.

CAUTION

••

• Firmly connect the alarm pole connector to the alarm pole socket on

••

the monitor. Otherwise, the lamp may not blink and an alarm may

not be indicated.

••

• Do not carry the monitor by holding the alarm pole. The alarm pole

••

may detach from the monitor and the monitor may fall off.

Operator's Manual OPV-1500K 1.15

1. GENERAL

Battery

WARNING

••

• Keep the battery pack away from fire. Otherwise the battery pack

••

may explode.

••

• Do not heat the battery pack. The battery pack may explode.

••

• Never short-circuit the + and

••

wire or store the battery pack with metals such as necklace or hair

pins. The battery pack may short-circuit, causing the substance

inside the battery to leak or explode.

••

• Never disassemble or modify the battery pack. Never damage or

••

directly solder the sheath tube. The battery pack short-circuits, the

electrolyte comes out and the battery pack explodes.

••

• Do not subject the battery pack to a strong mechanical shock. The

••

battery may leak or explode.

••

• Do not use a battery which is damaged, such as from falling. There

••

is a gas discharge valve inside the battery and if this valve is

damaged, the gas cannot be discharged, causing the battery to

explode.

••

• Only use the battery pack on the specified instrument. If the battery

••

is used on an unspecified instrument, large current may flow,

causing the battery to explode.

••

• If the battery pack is damaged and the substance inside the battery

••

(alkaline liquid) 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.

••

• The battery pack has + and

••

installed with the correct polarity direction. Otherwise, the

substance inside the battery may leak and explode.

••

• Do not connect the battery pack to an AC outlet or lighter socket in a

••

car. The battery may explode.

••

• Do not immerse the battery pack in water or seawater. The battery

••

will rust and may heat up.

••

• Never use a battery pack which is damaged, discolored or has

••

leakage. A damaged battery may explode if used.

••

• Do not leave the battery for more than two years unused. The battery

••

may leak.

−−

− terminals on the battery pack with a

−−

− polarity. Make sure that the battery is

−−

CAUTION

••

• Do not expose the battery pack to direct sunlight or leave in a high

••

temperature place. The lifetime of the battery pack may be shortened

or the substance inside the battery pack may leak.

••

• The battery pack must be replaced by qualified service personnel.

••

• Keep the battery pack away from children.

••

• 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

1.16 Operator’s Manual OPV-1500K

ECG Monitoring

1. GENERAL

battery into the municipal waste stream.

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

WARNING

••

• When using a defibrillator together with the monitor, use Ag/AgCl

••

electrodes. Other types of electrodes, stainless steel in particular,

adversely affect the ECG waveform by slowing the baseline recovery

on the monitor and result in no monitoring immediately following

defibrillation.

••

• False heart rate indicators may occur with certain pacemakers

••

because of electrical overshoots.

••

• Pacemaker patients can only be monitored when the pace program is

••

activated.

••

• Keep pacemaker patients under close observation. The pacemaker

••

rate may be counted during cardiac arrest and certain arrhythmias.

Do not rely only on the monitor.

Operator's Manual OPV-1500K 1.17

1. GENERAL

CAUTION

••

• Use only Nihon Kohden products and specified parts and

••

accessories. When other type of electrodes are used, the “CHECK

ELECTRODE” message may be displayed and monitoring may stop.

••

• Do not reuse disposable electrodes.

••

• When using the electrodes with DIN type lead, use only the Vitrode V

••

or N electrodes. If other electrodes are used, the electrode lead may

not be properly connected and ECG monitoring may be unstable.

••

• If the contact is bad even before the expiration date printed on the

••

package, replace the electrode with a new one.

••

• When the “CHECK ELECTRODE” message is displayed, ECG is not

••

monitored properly. Check the electrode, electrode leads and

connection cord, and if necessary, replace it with a new one.

••

• When using the monitor with an ESU, locate the monitor and ESU

••

following the description in “Use with an Electrosurgical Unit” in

Section 7 and ground the instruments properly. Otherwise noise

from the ESU may interfere with the ECG and the heart rate and

arrhythmia analysis may be incorrect.

••

• Turn the pacing spike detection to On when monitoring a pacemaker

••

patient. Otherwise QRS and pacemaker spike may not be

distinguished and pacemaker failure may not be recognized.

Respiration Monitoring