Nihon Kohden ZM-930PA, ZM-920PA User Manual

TRANSMITTER

ZM-920PA/930PA

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Contents

GENERAL HANDLING PRECAUTIONS ......................................... i

WARRANTY POLICY .................................................................... iii

EMC RELATED CAUTION ............................................................. v

Conventions Used in this Manual and Instrument ....................... vii

Warnings, Cautions and Notes ............................................... vii

Explanations of the Symbols in this Manual and Instrument viii

Introduction ......................................................................................... 1

Panel Description ............................................................................... 3

Top Panel ...................................................................................... 3

Front Panel .................................................................................... 4

ZM-920PA ................................................................................ 4

ZM-930PA ................................................................................ 5

Important Safety Information .............................................................. 6

General ......................................................................................... 6

Battery ........................................................................................... 8

Transmitter Channel Management ............................................... 8

For Patients Using Implantable Pacemaker ................................. 9

Output Signal ................................................................................ 9

ECG Monitoring .......................................................................... 10

SpO

Monitoring .......................................................................... 10

Maintenance ............................................................................... 13

Preparation ....................................................................................... 14

Installing (Replacing) Batteries .................................................. 14

Procedure .............................................................................. 15

WARNING and CAUTION for Battery Handling .......................... 15

Situations Requiring Battery Replacement ................................ 16

Attaching a Strap to the Transmitter ............................................ 16

Turning On/Off the Transmitter .................................................... 17

Check Items Before Turning On the Power ........................... 17

Turning On/Off the Power ...................................................... 17

Operator's Manual ZM-920PA/930PA i

Check Items After Turning On the Power............................... 17

Check Items After the Power Off ............................................ 18

ECG Monitoring ................................................................................ 19

ECG Measurement Procedure ................................................... 20

Selecting Electrode Lead and Disposable Electrode ................ 21

Option .................................................................................... 21

Connecting the Electrode Lead to the Transmitter ..................... 22

Selecting the Electrode Position ................................................. 22

Six Electrodes ....................................................................... 2 3

When Using 4 to 6 DIN Type Leads to Monitor 6 Lead ECG 24

Three Electrodes ................................................................... 25

Connecting the Electrode Lead and Disposable Electrodes ..... 26

Preparing the Patient Skin .................................................... 26

Attaching Electrodes to the Patient ....................................... 26

Detection and Display of Measurement Condition .................... 27

Electrode Detachment .......................................................... 27

Respiration Monitoring ..................................................................... 28

Respiration Measurement Procedure ........................................ 29

Electrode Position for Respiration Monitoring ............................ 29

Electrode Position Examples ................................................ 29

SpO

Monitoring ............................................................................... 31

Measurement Procedure ............................................................ 33

Selecting SpO

Probe ................................................................. 33

Reusable Probes .................................................................. 34

Disposable Probes................................................................ 35

Connecting SpO

Probe to the Transmitter ................................. 38

Attaching the Probe to the Patient .............................................. 39

Starting Measurement ................................................................ 40

Turning SpO

Data and Pulse Level Bar Graph Display On/Off . 41

Detecting and Displaying Measurement Condition ................... 41

External Light Noise Alarm ................................................... 41

Insufficient Light Alarm .......................................................... 42

Probe Malfunction Alarm ....................................................... 42

When Measurement Condition is Unstable .......................... 42

Alarm List .......................................................................................... 43

Troubleshooting................................................................................ 45

ii Operator's Manual ZM-920PA/930PA

Changing the Transmitter Channel .................................................. 47

Lifetime and Disposal ....................................................................... 48

Disposing of Used Batteries ....................................................... 48

Replacement ......................................................................... 48

Disposal ................................................................................ 48

Disposing of Electrodes and SpO

Probes ................................. 4 8

Cleaning, Disinfection and Sterilization ........................................... 49

Transmitter and Electrode Lead ................................................. 49

Cleaning ................................................................................ 49

Disinfection............................................................................ 49

SpO

Probe ................................................................................. 50

Replacing the Battery Case Cover ................................................... 51

Repair Parts Availability Policy ......................................................... 51

Specifications ................................................................................... 52

ECG measurement................................................................ 52

Respiration measurement .................................................... 52

SpO

measurement ............................................................... 5 2

Transmitter ............................................................................. 52

Safety standards ................................................................... 53

Water resistance ................................................................... 54

Power requirements .............................................................. 54

Environment .......................................................................... 54

Dimension and Weight.......................................................... 54

Standard Accessories ...................................................................... 55

Options ............................................................................................. 56

ECG/RESP ............................................................................ 56

SpO

...................................................................................... 57

Operator's Manual ZM-920PA/930PA iii

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 in combination with

other instruments to avoid misdiagnosis or other problems.

Operator's Manual ZM-920PA/930PA i

(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.

(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 representative.

ii Operator's Manual ZM-920PA/930PA

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 prepaid.

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,

Operator's Manual ZM-920PA/930PA iii

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.

CAUTION

United States law restricts this device to sale by or on the order of a physician.

Equipment Authorization Requirement

Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service.

iv Operator's Manual ZM-920PA/930PA

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.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. A humid room can help lessen this problem.

3.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.

Operator's Manual ZM-920PA/930PA v

If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden representative for additional suggestions.

vi Operator's Manual ZM-920PA/930PA

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 the 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 ZM-920PA/930PA vii

Explanations of the Symbols in this Manual and Instrument

The following symbols found in this manual/instrument bear the respective descriptions as given.

Symbol Description Symbol Description

Power On Attention, consult

operator’s manual

Power Off Nurse call

Defibrillation proof type BF applied part

Defibrillation proof type CF applied part

Direct current

Replace battery

Check electrode

viii Operator's Manual ZM-920PA/930PA

Introduction

Model Parameters Functions

ZM-920PA

• ECG

• Impedance respiration

The following information is indicated by LED.

• Check ECG electrodes

• Replace batteries

ZM-930PA

•

ECG

• Impedance respiration

• SpO

The following information is indicated on LCD.

• SpO

value

• Pulse wave amplitude

• Replace batteries

The following information is indicated by LED.

• Check ECG electrodes

The ZM-920PA/930PA transmitter transmits ECG and other data from a patient to a Nihon Kohden monitor for continuous monitoring. Available parameters and functions vary between the models. Read the operator’s manual for the monitor before operation.

The transmitter channel can be changed by the QI-901PK Channel Writer. To change the channel number, refer to the channel writer manual.

The following actions must be taken to properly receive the transmitter signal of the correct patient on the receiving instrument, otherwise, there may be signal loss or signals may mix causing a serious accident, such as monitoring a different patient.

••

• Assign a channel administrator in the hospital and only he or she

••

should manage channel assignments.

••

• The channel administrator must manage the channels in the

••

facility so that there is no signal interference.

••

• When the transmitter channel is changed, the channel

••

administrator must check that the channel on the receiving monitor is also changed and the signal is properly received.

Operator's Manual ZM-920PA/930PA 1

WARNING

••

• The channel administrator must replace the channel number label

••

on the transmitter with the new one after changing the channel.

CAUTION

• Do not use the same channel for different patients. If the same channel is used for two patients, the two patients’ data will be lost due to mutual modulation interference, or another patient’s data may appear on the receiving monitor screen.

• Do not use transmitters of adjacent channels in a hospital. If a transmitter of an adjacent channel is used, radio waves from one transmitter affects the receiver of the adjacent channel’s transmitter and there may be interference.

• Do not use the same transmitter on more than one patient at the same time. Do not connect different sensors on different patients to the same transmitter.

NOTE

• To prevent interference between channels, assign a channel administrator in the hospital and only he or she should manage channel assignment.

• Use Nihon Kohden parts and accessories to assure maximum performance from your instrument.

• For stable signal reception, it is recommended to use a diversity antenna system on the receiving monitor. Otherwise, spike noise from transient fading of electric field strength (for example, people moving) may interfere with the transmitter signal and may be mistaken as an arrhythmia on the receiving monitor.

• For details on the receiving monitor and upgrade information, contact your Nihon Kohden representative.

2 Operator's Manual ZM-920PA/930PA

Panel Description

Top Panel

For attaching a strap

Refer to the warnings below

Refer to the symbol page

ECG/RESP socket

Connects to the electrode lead for measuring ECG and/or respiration by the impedance method.

ZM-930PA only

socket

SpO

Connects to the SpO

Refer to the symbol page

Refer to the warnings below

probe.

WARNING

• Before defibrillation, check that the electrode leads and SpO probe attached to the patient are properly connected to the transmitter. Touching the metal parts of disconnected leads and probes may cause electrical shock or injury by discharged energy.

• When performing defibrillation, discharge as far as possible from electrodes, patches and any gel, cream or medicine on the chest of the patient. If there is a possibility that the defibrillator paddle could touch these materials, remove them from the patient. If the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient.

• Before defibrillation, all persons must keep clear of the bed and must not touch the patient or any equipment connected to the patient. Failure to follow this warning may cause electrical shock or injury.

Operator's Manual ZM-920PA/930PA 3

Front Panel

ZM-920PA

Power switch

Turns transmitter power on or off.

CALL key

When this key is pressed,

Replace batteries LED

Lights when the batteries need replacement.

Check electrodes LED

Lights when the electrode is detached from the patient.

Refer to the warning below.

RALALL

Va Vb

USAch

9002

608.025 MHz

Battery case

Contains two 1.5 V dry cell batteries (AA).

a "peep" sounds at the transmitter, and "CALL" message appears at the monitor. Depending on the settings on the monitor, an ECG waveform is recorded when this key is pressed.

Channel lable

WARNING

Close the battery case cover during operation. If the transmitter is used with the battery case cover open, anyone who touches the opened battery case may receive an electrical shock when defibrillation is performed. Touching the opened battery case may cause electrostatic discharge and intermittently interfere with the waveform or data.

CAUTION

Only use your finger to press the CALL key. Do not press the key with a sharp object, otherwise the key may be damaged.

4 Operator's Manual ZM-920PA/930PA

ZM-930PA

RALALL

Va Vb

USAch

9002

608.025 MHz

Battery replacement mark:

Appears when the batteries are weak. Immediately replace the batteries when this appears.

For the descriptions except for the LCD, refer to the “ZM-920PA” section on the previous page.

LCD

%SpO2:

Displayed when the power is turned on. This indication is not displayed when SpO

display is turned off.

Pulse level bar graph:

Displays pulse level in 7 steps.

SpO2 data:

Displays SpO When SpO When SpO When the detected pulse is too small to measure, “

Operator's Manual ZM-920PA/930PA 5

data.

is 41 to 100%, the value is displayed. (ex. )

is under 40%, “ ” is displayed.

” is displayed.

Important Safety Information

General

WARNING

• Never use the transmitter in the presence of any flammable anesthetic gas or high concentration oxygen atmosphere. Failure to follow this warning may cause explosion or fire.

• Never use the transmitter in a hyperbaric oxygen chamber. Failure to follow this warning may cause explosion or fire.

• Never take this transmitter into an MRI test room.

• When performing MRI test, remove all electrodes from the patient which are connected to this instrument. Failure to follow this warning may cause skin burn on the patient. For details, refer to the MRI manual.

• When the transmitter is used with an electrosurgical unit (ESU), firmly attach the entire area of the ESU return plate. Otherwise, the current from the ESU flows into the electrodes of the transmitter, causing electrical burn where the electrodes are attached. For details, refer to the ESU manual.

6 Operator's Manual ZM-920PA/930PA

• Close the battery case cover during operation. If the transmitter is used with the battery case cover open, anyone who touches the opened battery case may receive an electrical shock when defibrillation is performed. Touching the opened battery case may cause electrostatic discharge and intermittently interfere with the waveform or data.

CAUTION

• Only use Nihon Kohden specified electrodes, electrode leads and SpO

probes. Otherwise, the maximum performance from the

instrument cannot be guaranteed.

• Do not reuse disposable items.

• Do not shake or swing the transmitter while holding the leads or cables connected to the transmitter. The transmitter may come off and injure someone or damage surrounding instruments.

• Attach a strap to the transmitter to prevent the transmitter from falling.

• Turn off the power of mobile phones, small wireless devices and other devices which produce strong electromagnetic interference around a patient (except for devices allowed by the hospital administrator). Radio waves from devices such as mobile phones or small wireless devices may be mistaken as respiration or pulse waves and the displayed data may be incorrect.

Operator's Manual ZM-920PA/930PA 7

Battery

WARNING

• Keep the battery pack away from fire. It may explode.

• Do not damage, disassemble, drop or give impact to the battery. If the battery is damaged and substance inside the battery contacts the skin or clothes, wash immediately and thoroughly with water.

• Never short-circuit the + and – terminals on the battery. It may cause overheating and fire.

• Take care that the patient does not swallow batteries.

CAUTION

• Battery replacement must be performed by the operator. When replacing batteries of the transmitter currently used for a patient, disconnect electrode leads from the transmitter before replacing batteries or do not touch the patient during replacement.

• The battery charger must be used outside the patient environment.

• Refer to the battery and battery charger manuals for details on handling the batteries.

Transmitter Channel Management

WARNING

••

• Assign a channel administrator in the hospital and only he or she

••

should manage channel assignments.

••

• The channel administrator must manage the channels in the

••

facility so that there is no signal interference.

••

• When the transmitter channel is changed, the channel

••

administrator must check that the channel on the receiving monitor is also changed and the signal is properly received.

8 Operator's Manual ZM-920PA/930PA

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