Nihon Kohden ZM-540PA Medical Telemetry Transmitter User Manual OM ZM 540 541PA

Nihon Kohden Corporation Medical Telemetry Transmitter OM ZM 540 541PA

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Transmitter

ZM-540PA/ZM-541PA

0614-902754

The entire contents of this manual are copyrighted by Nihon Kohden. All rights are reserved. No part

of this document may be reproduced, stored, or transmitted in any form or by any means (electronic,

mechanical, photocopied, recorded, or otherwise) without the prior written permission of Nihon

Kohden.

Operator’s Manual ZM-540PA/541PA i

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.

(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

batteryoperated 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.

ii Operator’s Manual ZM-540PA/541PA

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.

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.

Operator’s Manual ZM-540PA/541PA iii

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.

CAUTION

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

iv Operator’s Manual ZM-540PA/541PA

Equipment Authorization Requirement

This device complies with Part 15 of the FCC (Federal Communications Commission) Rules.

Operation is subject to the following two conditions:

(1) this device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause

undesired operation.

This device complies with Part 95 Subpart H of the FCC Rules to be used in wireless medical

telemetry service.

Operation of this equipment requires the prior coordination with a frequency coordinator designated

by FCC for the Wireless Medical Telemetry Service.

CAUTION

To comply with the FCC radio frequency (RF) exposure compliance requirements, no

change to the antenna or the device is permitted. Any change to the antenna or the

device could result in the device, exceeding the RF exposure requirements and void

user’s authority to operate this device.

NOTE

• Use this device only indoors.

• This device has been tested and complies with FCC radiation exposure limits set forth

for an uncontrolled environment. The RF transmission power from the antenna conforms

to the general public FCC RF Exposure Guidelines in Supplement C to OET65 limit of

Speciﬁc Absorption Rate (SAR) 1.6 W/kg. The maximum SAR value measured from this

device was extremely smaller than 1.6 W/kg. This device must not be located together

with or operated in conjunction with any other unspeciﬁed antenna or transmitter.

• The devices require registration and deployment by an authorized frequency coordinator.

The ASHE (American Society for Healthcare Engineering) has been designated by the

FCC to manage the WMTS frequencies. This device has frequency bands which may

not be used in some areas. For details, contact your Nihon Kohden representative. For

details on the guidelines, refer to the ASHE home page.

Operator’s Manual ZM-540PA/541PA v

EMC RELATED CAUTION

This equipment and/or system complies with IEC 60601-2 International Standard for

electromagnetic compatibility for medical electrical equipment and/or system.

However, an electromagnetic environment that exceeds the limits or levels stipulated

in IEC 60601-1-2, 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. Keep the emitter source

such as cellular phone away from the equipment and/or system, or turn off the

cellular phone.

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. A humid room can

help lessen this problem.

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.

5. Interference of lightning:

When lightning occurs near the location where the equipment and/or system is

installed, it may induce an excessive voltage in the equipment and/or system.

In such a case, disconnect the AC power cord from the equipment and/or

system and operate the equipment and/or system by battery power, or use an

uninterruptible power supply.

vi Operator’s Manual ZM-540PA/541PA

6. Use with other equipment:

When the equipment and/or system is adjacent to or stacked with other equipment,

the equipment and/or system may affect the other equipment. Before use, check

that the equipment and/or system operates normally with the other equipment.

7. Use of unspeciﬁed accessory, transducer and/or cable:

When an unspeciﬁed accessory, transducer and/or cable is connected to this

equipment and/or system, it may cause increased electromagnetic emission

or decreased electromagnetic immunity. The speciﬁed conﬁguration of this

equipment and/or system complies with the electromagnetic requirements with the

speciﬁed conﬁguration. Only use this equipment and/or system with the speciﬁed

conﬁguration.

8. Use of unspeciﬁed conﬁguration:

When the equipment and/or system is used with the unspeciﬁed system

conﬁguration different than the conﬁguration of EMC testing, it may cause

increased electromagnetic emission or decreased electromagnetic immunity.

Only use this equipment and/or system with the speciﬁed conﬁguration.

9. Measurement with excessive sensitivity:

The equipment and/or system is designed to measure bioelectrical signals with

a speciﬁed sensitivity. If the equipment and/or system is used with excessive

sensitivity, artifact may appear by electromagnetic interference and this may

cause mis-diagnosis. When unexpected artifact appears, inspect the surrounding

electromagnetic conditions and remove this artifact source.

If the above suggested remedial actions do not solve the problem, consult your Nihon

Kohden representative for additional suggestions.

Operator’s Manual ZM-540PA/541PA vii

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.

viii Operator’s Manual ZM-540PA/541PA

Explanations of the Symbols in this Manual and Instrument

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

On Panel

Symbol Description Symbol Description

Change screen Deﬁbrillation proof type BF

applied part

Attention, consult operator’s

manual

Deﬁbrillation proof type CF

applied part

Moves cursor, scrolls data Serial number

Direction for attaching battery

cover Year of manufacture

Direction for inserting battery RF transmitter

Non-ionizing radiation

Direct current CSA mark

On LCD

Symbol Description Symbol Description

Full battery Battery very weak

Replace battery

Battery 2/3 full Alarm suspended

Low battery

NIBP cannot be measured QRS/pulse sync mark

Operator’s Manual ZM-540PA/541PA 1

Intended Use

General

The ZM-540PA and ZM-541PA transmitter transmits ECG, respiration and pulse waveforms, SpO2

and NIBP data from a patient to a Nihon Kohden monitor for continuous monitoring. The front LCD

displays ECG (or pulse wave), numeric values of monitoring parameters, NIBP measuring mode and

interval, messages and battery condition.* It also displays the compressed waveform and numeric

data of the latest 10 minutes.

* Essential performance of this transmitter.

The difference between the ZM-540PA and ZM-541PA is the transmission frequency range.

ZM-540PA: 608.0250 MHz (channel number 9002) to 613.9750 MHz (channel number 9478)

ZM-541PA: 1395.0250 MHz (channel number E002) to 1399.9750 MHz (channel number E398)

1427.0250 MHz (channel number E502) to 1431.9750 MHz (channel number E898)

The transmitter channel can be changed with a QI-901PK channel writer.

Read the operator’s manual for the receiving monitor together with this manual before use.

WARNING

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.

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 two transmitters with adjacent channels in the same hospital. If

transmitters with adjacent channels are used, their radio waves interfere with each

other.

CAUTION

Be aware that signal loss and artifact may occur because of the multipath

cancellation* when using a transmitter.

* Multipath Cancellation (Standing Wave Interference)

When a radio wave reﬂects off a surface, there may be some points in the room where the

2 Operator’s Manual ZM-540PA/541PA

reﬂected and direct waves are exactly out of phase. At these points in the room, the reﬂected

and direct waves cancel each other out so that the signal strength is 0. This is called “multipath

cancellation” or “standing wave interference”. Locations where signal loss occurs are called “null

spots”. If the transmitter is moving or nearby people or objects are moving, null spots can occur

anytime and anywhere.

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 antennas and antenna construction, contact your Nihon Kohden

representative. You can also refer to the Telemetry System Installation Guide.

• Do not diagnose a patient based on only part of the monitoring data on the transmitter or

only on the data acquired by the transmitter. Overall judgment must be performed by a

physician who understands the features, limitations and characteristics of the transmitter

by reading this operator’s manual thoroughly and by reading the biomedical signals

acquired by other instruments.

Receiving Monitor

Any Nihon Kohden receiving monitor (central monitor with multiple patient receiver) can receive

signals from this transmitter as long as the protocol version and channel setting are the same on the

receiving monitor and transmitter.

NOTE

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

representative.

• The transmitter does not give any patient alarm, only a “no battery” alarm. Patient alarms

must be managed on the receiving monitor.

Operator’s Manual ZM-540PA/541PA 3

Panel Description

Front Panel

Refer to the WARNING

on the next page.

No. Name Description

1 LCD Displays numeric values, ECG or pulse wave, NIBP measuring

mode and interval, messages and battery status. For details, refer to

the “Screen Descriptions” section.

2 Infrared receiver Used for upgrading the transmitter software.

3 Screen key Toggles the screen in the following order.

After power on: Start up → Check electrodes → Numeric and

waveform → Waveform review → Numeric review → Display off

→ Check electrodes …

After auto display off: Numeric and waveform → Waveform

review → Numeric review → Display off → Check electrodes →

Numeric and waveform …

On a SETUP or CHECK screen, this key cancels changing setting

or exits the screen.

4 Operator’s Manual ZM-540PA/541PA

Refer to the WARNING

below.

No. Name Description

4 Function key Depending on the setting on the transmitter, this key suspends

alarms, pauses monitoring on the receiving monitor or transmits

“Patient conﬁrmed” message.

On a SETUP screen, this key registers the selected setting and

moves the cursor to the next setting item.

On a CHECK screen, this key starts or stops maintenance test.

5 NIBP Start/Stop key Starts/stops NIBP measurement in selected mode.

6 NIBP Interval key Selects NIBP measurement mode.

7 Lead/Scroll keys On the numeric and waveform screen, these keys change the ECG

lead.

On the waveform review screen, these keys scroll data.

On a SETUP screen, these keys move the cursor.

8 Battery case Contains three 1.5 V dry cell batteries (AA TYPE).

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.

Operator’s Manual ZM-540PA/541PA 5

Rear Panel

Refer to the symbol

page.

Refer to the WARNING

below.

Lock plate

Fastens the transmitter to an NIBP cuff.

WARNING

This transmitter is not waterproof. If detergent or liquid spills into the transmitter, stop

using it and contact your Nihon Kohden representative. If a wet transmitter is used,

the patient or operator may receive an electrical shock or injury.

6 Operator’s Manual ZM-540PA/541PA

Top Panel

NIBP socket:

Connects the cuff

hose.

Refer to the WARNING on the

next page.

Refer to the symbol page.

Refer to the WARNING on the

next page.

Refer to the symbol

page.

ECG/impedance RESP socket:

Connects the electrode lead for measuring

ECG and/or respiration (impedance).

Bottom Panel

Refer to the WARNING

on the next page.

Refer to the symbol page.

SpO2 socket:

Connects the SpO2

probe.

Channel number label:

Indicates the channel number of the

transmitter. Attach the channel number label

to the panel of the receiving monitor.

Operator’s Manual ZM-540PA/541PA 7

WARNING

Before deﬁbrillation, all persons must

keep clear of the bed and must not

touch the patient or any equipment or

cord connected to the patient. Failure

to follow this warning may cause

electrical shock or injury.

WARNING

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.

WARNING

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.

CAUTION

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.

8 Operator’s Manual ZM-540PA/541PA

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.

WARNING

Never use the transmitter in a

hyperbaric oxygen chamber. Failure to

follow this warning may cause

explosion or ﬁre.

WARNING

Do not take this transmitter into the

MRI test room. This transmitter is not

designed to be used during MRI tests.

WARNING

When performing MRI test, remove all

electrodes, probe and cuff from the

patient which are used with this

transmitter. Failure to follow this

warning may cause skin burn on the

patient. For details, refer to the MRI

manual.

WARNING

Before deﬁbrillation, all persons must

keep clear of the bed and must not

touch the patient or any equipment or

cord connected to the patient. Failure

to follow this warning may cause

electrical shock or injury.

WARNING

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.

Operator’s Manual ZM-540PA/541PA 9

WARNING

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.

WARNING

This transmitter is not waterproof. If

detergent or liquid spills into the

transmitter, stop using it and contact

your Nihon Kohden representative. If a

wet transmitter is used, the patient or

operator may receive an electrical

shock or injury.

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.

WARNING

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.

CAUTION

Only use Nihon Kohden speciﬁed

electrodes, electrode leads, SpO2

probes, and NIBP cuffs. Otherwise,

the maximum performance from the

transmitter cannot be guaranteed.

CAUTION

Do not reuse disposable parts and

accessories.

CAUTION

The measurement values and

displayed waveforms on the

transmitter and receiving monitor may

be different due to timing delay of the

display or difference in detection

settings.

CAUTION

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.

10 Operator’s Manual ZM-540PA/541PA

CAUTION

Be aware that signal loss and artifact

may occur because of the multipath

cancellation* when using a transmitter.

* Multipath Cancellation (Standing Wave

Interference)

When a radio wave reﬂects off a surface,

there may be some points in the room where

the reﬂected and direct waves are exactly

out of phase. At these points in the room, the

reﬂected and direct waves cancel each other

out so that the signal strength is 0. This is

called “multipath cancellation” or “standing

wave interference”. Locations where signal

loss occurs are called “null spots”. If the

transmitter is moving or nearby people or

objects are moving, null spots can occur

anytime and anywhere.

CAUTION

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 pulse waves and the

displayed data may be incorrect.

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 two transmitters with

adjacent channels in the same

hospital. If transmitters with

adjacent channels are used, their

radio waves interfere with each

other.

Output Signal

WARNING

Do not use the output signal from the receiving monitor as the synchronization signal

for other equipment such as IABP, MRI, echocardiography or deﬁbrillator. There may

be time delay between the monitor and the other equipment caused by waveform

transmission delay and spike noise may interfere on the output signal and be

mistaken as a trigger.

Operator’s Manual ZM-540PA/541PA 11

Battery

CAUTION

Battery replacement must be

performed by the operator. When

replacing the batteries of a transmitter

that is currently used for a patient,

disconnect the electrode leads from

the transmitter before replacing

batteries or do not touch the patient

during replacement.

CAUTION

Refer to the battery and battery

charger manuals for details on

handling the batteries.

Transmitter Channel Management

WARNING

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 assignment.

• 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.

• The channel administrator must replace the channel number label on the

transmitter with the new one after changing the channel.

12 Operator’s Manual ZM-540PA/541PA

For Patients Using Implantable Pacemaker

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 transmitter which is connected to the

same patient. If this occurs, the pacemaker may pace at its maximum rate and the

transmitter may give incorrect data to the monitor. If this occurs, disconnect the

electrode leads from the patient or change the setting on the pacemaker by referring

to the pacemaker’s manual. For more details, contact your pacemaker representative

or Nihon Kohden representative.

* 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

ECG Monitoring

CAUTION

Only use Nihon Kohden speciﬁed

electrodes and electrode leads. When

other electrodes or electrode leads

are used, the “CHECK

ELECTRODES” message may appear

and monitoring may stop.

CAUTION

When the “ELECTRODE OFF” or

“CHECK ELECTRODES” message is

displayed on the receiving monitor,

ECG is not monitored properly and

the ECG alarm does not function.

Check the electrode, electrode leads,

and if necessary, replace with new

ones.

Operator’s Manual ZM-540PA/541PA 13

SpO2 Monitoring

WARNING

SpO2 measurement may be incorrect

in the following cases.

• When the patient’s

carboxyhemoglobin or

methemoglobin increases

abnormally.

• When dye is injected in the blood.

• When using an electrosurgical unit.

• During CPR.

• When measuring at a site with

venous pulse.

• When there is body movement.

• When the pulse wave is small

(insufﬁcient peripheral circulation).

WARNING

When not monitoring SpO2,

disconnect the SpO2 cable from the

transmitter. Otherwise, noise from the

probe sensor may interfere and

incorrect data is displayed on the

screen.

WARNING

• When using the TL-201T ﬁnger

probe, do not fasten the probe and

cable to the ﬁnger by wrapping

with tape. This may cause burn,

congestion or pressure necrosis

from poor blood circulation.

• When using probes other than the

TL-201T ﬁnger probe, to avoid poor

circulation, do not wrap the tape too

tight. Check the blood circulation

condition by observing the skin

color and congestion at the skin

peripheral to the probe attachment

site. Even for short-term monitoring,

there may be burn or pressure

necrosis from poor blood circulation,

especially on neonates or low

birth weight infants whose skin is

delicate. Accurate measurement

cannot be performed on a site with

poor peripheral circulation.

WARNING

Check the circulation condition by

observing the skin color at the

measurement site and pulse

waveform. Change the measurement

site every 8 hours for disposable

probes and every 4 hours for reusable

probes (every 8 hours for TL-630T/TL-

631T series probe). The skin

temperature may increase at the

attached site by 2 or 3°C (4 or 5°F)

and cause a burn or pressure

necrosis. When using the probe on the

following patients, take extreme care

and change the measurement site

more frequently according to

symptoms and degree.

• Patient with a fever

• Patient with peripheral circulation

insufﬁciency

• Neonate or low birth weight infant

with delicate skin

14 Operator’s Manual ZM-540PA/541PA

WARNING

When monitoring SpO2 of a patient

who is receiving photodynamic

therapy, the light from the ﬁnger probe

sensor may cause a burn.

Photodynamic therapy uses a

photosensitizing agent that has a side

effect of photosensitivity.

CAUTION

Refer to the probe instruction manual

for details.

CAUTION

The disposable probe is not sterilized.

Use the disposable probe only for a

single patient. Never reuse the

disposable probe for another patient

because it causes cross infection.

CAUTION

NIBP and SpO2 can be measured on

the same limb, but the SpO2

monitoring might not be accurate

during NIBP measurement. Be careful

when reading the SpO2 values.*

* Monitoring SpO2 during NIBP Measurement

When the SpO2 probe is attached to the

same limb as the NIBP cuff, the blood

ﬂow decreases during NIBP measurement

and pulse wave cannot be detected and

SpO2 cannot be monitored properly. When

“INHIBIT SpO2 DURING NIBP” on the

PARAMETER SETUP screen is set to ON

(factory default setting), SpO2 monitoring is

paused during NIBP measurement to avoid

SpO2 alarm occurrence. However, when

monitoring SpO2 on the same limb as the

NIBP, be careful when reading SpO2 values.

CAUTION

While a patient is on medication which

causes vasodilation, the pulse

waveform may change and in rare

cases the SpO2 value might not be

displayed.

CAUTION

Normal external light does not affect

monitoring but strong light such as a

surgical light or sunlight may affect

monitoring. If affected, cover the

measuring site with a blanket.

CAUTION

When a message indicates a faulty

probe, stop monitoring and replace

the probe with a new one.

Operator’s Manual ZM-540PA/541PA 15

CAUTION

Do not use a damaged or

disassembled probe. It causes

incorrect measurement and may

injure the patient.

CAUTION

Do not use a probe which is

deteriorated by aging. Accurate

measurement cannot be performed.

CAUTION

If the attachment site is dirty with

blood or bodily ﬂuids, clean the

attachment site before attaching the

probe. If there is nail polish on the

attachment site, remove the polish.

Otherwise, the amount of transmitted

light decreases, and measured value

may be incorrect or measurement

cannot be performed.

CAUTION

If the skin gets irritated or redness

appears on the skin from the probe,

change the attachment site or stop

using the probe. Take extreme care for

the patients with delicate skin.

CAUTION

Do not pull or bend the probe cable,

and do not put caster feet on the

probe cable. Do not immerse the

disposable probe cable in chemical

solutions or water. Failure to follow

these instructions may cause cable

discontinuity, short circuit, skin burn

on the patient and incorrect

measurement data. Replace any

broken probe with a new one.

CAUTION

When the probe is attached on an

appropriate site with sufﬁcient

circulation and the error message

conﬁrming the probe attachment

repeatedly appears, the probe may be

deteriorated. Replace it with a new

one.

16 Operator’s Manual ZM-540PA/541PA

NIBP Monitoring

WARNING

Be careful when measuring NIBP on a

patient with known bleeding disorders

or coagulation. After NIBP

measurement, there may be dot

hemorrhage, or circulatory disorder by

thrombus where the cuff is attached.

WARNING

NIBP measurement may be incorrect

in the following cases.

• When using an electrosurgical unit

• When there is body movement

• When the pulse wave is small

(insufﬁcient peripheral circulation)

• Too many arrhythmias

• When there is vibration

• When there is a rapid blood

pressure change

• During CPR

WARNING

When performing NIBP

measurements in STAT mode or 5

minute intervals, periodically remove

the cuff from the patient for ventilation.

The skin temperature may increase at

the cuff attachment site by 2 or 3°C (4

or 5°F). When measuring a patient

with a fever or peripheral circulation

insufﬁciency, it may cause a burn.

CAUTION

Do not wrap the cuff on an arm or

thigh which is used for injection. NIBP

measurement on an arm or thigh

which is used for injection may cause

reﬂux of blood and stop injection.

CAUTION

Do not wrap the cuff too tight. It may

cause poor blood circulation and

congestion. If the cuff is wrapped too

loosely, the NIBP value may increase.

CAUTION

Do not attach the cuff to the site

where there is injury or inﬂammation.

If the skin gets irritated or redness

appears on the skin from the cuff,

change the attachment site or stop

using the cuff. Take extreme care on

the patients with delicate skin.

CAUTION

When using an extension hose, check

that the extension hose is not bent or

squeezed. Otherwise, the cuff might

not inﬂate or deﬂate. If the cuff cannot

deﬂate, it may cause congestion on

the patient at the cuff attachment site.

Operator’s Manual ZM-540PA/541PA 17

CAUTION

When performing NIBP measurement

repeatedly, have a rest between

measurements to recover adequate

circulation.

Maintenance

CAUTION

This transmitter is not waterproof. If

detergent or liquid spills into the

transmitter, stop cleaning or

disinfecting it and contact your Nihon

Kohden representative. The

transmitter needs to be checked for

safety and function before use.

CAUTION

Never disassemble or repair the

transmitter. Disassembly and repair

must be performed by qualiﬁed

service personnel.

18 Operator’s Manual ZM-540PA/541PA

Preparation on Transmitter

Batteries

WARNING and CAUTION for Handling Batteries

CAUTION

Refer to the battery and battery

charger manuals for details on

handling the batteries.

CAUTION

When the transmitter is not in use,

remove the batteries. When the

batteries are installed, battery power

is consumed even when

measurement is not performed. When

NiMH batteries are left in the

transmitter when it is not used, the

batteries may overdischarge and leak

liquid which makes the batteries

unusable and damages the

transmitter.

CAUTION

Do not handle the batteries with wet

hands.

NOTE

Remove the batteries from the transmitter before disposing of it.

Battery Lifetime

Use three AA type alkaline dry cell batteries. NiMH batteries can also be used but the lifetime of

alkaline batteries is longer. The lifetime of NiMH batteries is about 1/2 of alkaline batteries (when

fully charged).

With new Nihon Kohden recommended alkaline batteries, the transmitter can continuously measure

ECG, respiration, SpO2 and NIBP for approximately 1 day. The measurement is performed at room

temperature, NIBP is measured in auto mode at 60 minute intervals and SpO2 is measured on an

index ﬁnger of a male patient with weight 60 kg. Operation time depends on the thickness of the

SpO2 probe attachment site.

Recommended batteries

NiMH secondary: SANYO HR-3UF (W)

Battery charger: SANYO NC-M55

Alkaline primary: Nihon Kohden Medipower (equivalent to Panasonic LR6 (G))

Operator’s Manual ZM-540PA/541PA 19

Installing (Replacing) Batteries

CAUTION

Battery replacement must be performed by the operator. When replacing the batteries

of a transmitter that is currently used for a patient, disconnect the electrode leads

from the transmitter before replacing batteries or do not touch the patient during

replacement.

If electrode leads are attached to the patient and the person replacing batteries touches the patient

during battery replacement, excess patient leakage current may ﬂow into the patient.

NOTE

• Replace all batteries at the same time.

• Do not use different types of batteries together.

• Insert the batteries with the correct polarity (+ and –).

• The capacity of rechargeable NiMH batteries is reduced if the batteries are recharged

before they are fully discharged. For details, refer to the battery operator’s manual.

1. Remove the battery case cover.

2. Insert three new or fully charged batteries into

the battery case observing the correct polarity.

20 Operator’s Manual ZM-540PA/541PA

3. Close the cover.

The transmitter is automatically turned on when the

batteries are installed and the cover is closed.

Situations Requiring Battery Replacement

Replace the batteries when any of the following occurs:

• The transmitter displays the “BATTERY WEAK” message or “ ” icon.

• The transmitter generates a constant alarm (continuous “peep” sound).

• The transmitter LCD does not display anything when the power is turned on.

• The receiving monitor displays a battery replacement message.

Battery Level Indication

The following icons on the LCD indicate the battery level. When “PROTOCOL” on the SYSTEM

SETUP screen is set to 57, the battery level indication is transmitted to the receiving monitor.

Indication Battery Level Message on the Receiving Monitor

Fully charged batteries

There is no message on the monitor.

Batteries are 2/3 full.

Batteries are low. NIBP cannot

be measured. Replace batteries.

Batteries are very weak. Message requiring battery replacement is

displayed.

No indication Dead batteries No signal can be transmitted to the monitor.

There is no indication on the monitor.

Turning On the Transmitter

When the batteries are installed correctly, the power is turned on. A one second “peep” sounds and

the startup screen appears, then the check electrodes screen appears. (There is no “peep” sound

when there is no battery power.)

Operator’s Manual ZM-540PA/541PA 21

After checking that the ECG is stable on the check electrodes screen, press the Screen key to display

the numeric and waveform screen.

For details on the screen, refer to the “Screen Descriptions” section.

Check Items Before Use

Before turning on the transmitter power, check the following to conﬁrm that the transmitter can be

used in normal and safe condition.

Appearance

• There are no damaged or dirty parts on the outside of the transmitter (LCD, keys, sockets, battery

case cover, battery case, lock plate, etc.).

• The transmitter is completely dry.

• The electrodes, electrode lead, SpO2 probe and NIBP cuff are not broken.

Batteries

• The battery polarity is correct.

• The battery case spring is ﬁrmly attached and the battery is not loose.

• The battery case cover is ﬁrmly closed.

Channel Setting

• The transmitter channel matches the receiving monitor channel.

• There is no nearby transmitter with the same channel.

22 Operator’s Manual ZM-540PA/541PA

Check Items After Power On

After turning on the power, check the following.

Power On

• The transmitter generates a one second “peep” sound and the startup screen appears.

• The transmitter displays the check electrodes screen.

• The transmitter is not too hot.

• The transmitter does not display the “BATTERY WEAK” message.

• The transmitter does not interfere with the operation of other medical instruments.

Daily Check

• The “signal loss” message is not displayed on the receiving monitor when the transmitter is inside

the receiving range of the monitor.

• The battery replacement message is not displayed on the monitor.

• The keys on the transmitter function properly.

• The LCD brightness is appropriate. To adjust brightness, refer to the “Changing SYSTEM SETUP

Settings” section.

Check Items After Use

To use the transmitter in safe and optimum condition for next time, check the following.

Before Turning Power Off

• Temporarily changed settings are changed back to the previous settings.

• There was no malfunction on the transmitter.

Storage

• ECG electrode leads, SpO2 probe and NIBP cuff are cleaned and disinfected.

• If the transmitter got wet, liquid is wiped off and the transmitter is thoroughly dried.

• There are enough consumables, such as disposable electrodes.

• The transmitter power is turned off by removing batteries from the transmitter.

• Dead batteries are disposed of properly.

Turning Off the Transmitter

To turn off the power, remove batteries. When the power is turned off, the saved waveform and

numeric data are deleted.

Operator’s Manual ZM-540PA/541PA 23

Changing the Transmitter Channel

The channel of the transmitter can be changed with an optional QI-901PK Channel Writer.

WARNING

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 assignment.

• 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.

• The channel administrator must replace the channel number label on the

transmitter with the new one after changing the channel.

NOTE

• The software version of the QI-901PK channel writer must be 02-01 or later to change

the channel on the transmitter.

• The channel writer must be used outside the patient environment.

The channel is displayed in the upper left corner of the screen.

Channel

24 Operator’s Manual ZM-540PA/541PA

Changing Parameter and System Setup Settings

The initial settings on the PARAMETER SETUP and SYSTEM SETUP screens can only be

changed before monitoring. Changing these settings during monitoring interrupts monitoring.

NOTE

Changing Parameter and System Setup settings must be done by qualiﬁed personnel.

Notes on Parameter Settings

When monitoring NIBP and SpO2, the following setting must be set as indicated in the table

to properly transmit the monitoring data to the receiving monitor. Otherwise, SpO2 cannot be

monitored properly during NIBP measurement.

Some receiving monitors require the software to be upgraded. For details, contact your Nihon

Kohden representative.

SpO2 probe attachment site INHIBIT SpO2 DURING NIBP setting

Probe attached to the same limb as the cuff* ON

Probe attached to the limb without cuff OFF

* When the SpO2 probe is attached to the same limb as the NIBP cuff and the cuff is inﬂated,

the SpO2 value becomes unstable and SpO2 or PR alarm may occur.

Operator’s Manual ZM-540PA/541PA 25

Changing PARAMETER SETUP Settings

Parameter Setup Setting List

The factory default settings are underlined.

Setting Item Description Settings

ECG ELECTRODES Select the electrode lead type. IEC, AHA

LEAD TYPE Select the type of ECG leads. AUTO, 6 LEADS

ECG

MEASUREMENT

Turn ECG monitoring on or off. When electrodes are

attached to the patient and ECG leads are connected,

ECG monitoring starts even when this setting is set to

OFF.

If this setting is set to OFF, the same setting on the

receiving monitor must also be set to OFF.

NOTE

When “PROTOCOL” on the transmitter is set to

57 and the receiving monitor is able to receive

protocol 57, ECG measurement on the receiving

monitor is automatically set to OFF when this

setting is set to OFF on the transmitter.

ON, OFF

RESP

MEASUREMENT

Turn respiration monitoring on or off.

When this setting is set to OFF, the same setting on the

receiving monitor is automatically set to OFF.

ON, OFF

SpO2 RESPONSE

Select the SpO2 response mode.

FAST: Select this for special applications that

require a fast response. FAST is suitable

for detecting short apnea.

NORMAL: For normal monitoring.

SLOW: Select this when you need to suppress a

rapid change in SpO2.

FAST, NORMAL,

SLOW

INHIBIT SpO2

DURING NIBP

Turn SpO2 monitoring on or off during NIBP

measurement. ON, OFF

SELECTABLE

INTERVALS (min)

Select the NIBP measurement modes for the mode

selection.

STAT, 5, 10, 15,

30, 60, 120, 240

INITIAL INTERVAL

(min)

Select the initial NIBP measurement mode at power

on.

MANUAL, 5, 10,

15, 30, 60, 120,

240

NIBP MODE AFTER

STAT (min)

Select the NIBP measurement mode after completing

STAT measurement.

MANUAL, 5, 10,

15, 30, 60, 120,

240

START/FINISH

SOUND

Turn ON or OFF the sound for NIBP measurement

start/ﬁnish.

START: ON, OFF

FINISH: ON, OFF

26 Operator’s Manual ZM-540PA/541PA

Setting Item Description Settings

OLD NIBP DATA/

AFTER (min)

Select whether to hide or dim the NIBP data after

measurement and how long to wait after measurement

to dim or hide it.

DATA: HIDE,

DIM

AFTER: 5, 10, 30

INITIAL CUFF

PRESSURE (mmHg) Select the NIBP cuff inﬂation pressure. 120, 150, 180,

210, 240

Displaying the PARAMETER SETUP Screen

1. Turn off the transmitter by removing one

battery.

2. While pressing the Function key, turn on

the transmitter (install the battery). The

MENU screen appears.

3. Press the

▼

key to move the cursor to

“PARAMETER SETUP”.

4. Press the Function key to enter

PARAMETER SETUP. The current

settings are highlighted.

5. Change settings:

• To move the cursor and select the setting

item, press the

▼

key then press

the Function key.

• To select and register the setting, press

the

▼

key then press the Function

key.

• To cancel changing the setting of the

selected item, press the Screen key.

6. When changing settings on the

PARAMETER SETUP screen is complete,

press the Screen key to return to the

MENU screen.

Cursor

MENU screen

Setting item

PARAMETER SETUP screen - page 1

Setting

Cursor

7. Press the

▼

key to move the cursor to “EXIT”.

8. Press the Function key. The numeric and waveform screen appears.

Operator’s Manual ZM-540PA/541PA 27

1. On the PARAMETER SETUP screen,

press the

▼

key to move the cursor to

“ECG ELECTRODES”.

2. Press the Function key. The cursor moves

to the selection item.

3. Press the

▼

key to select “IEC” or “AHA”.

4. Press the Function key to register the

selected setting. The cursor returns to

“ECG ELECTRODES”.

Changing Parameter Setup Settings

ECG ELECTRODES

Select the electrode lead type.

Selected setting

Cursor

LEAD TYPE

Select the type of ECG leads. In normal use, select “AUTO”. When using DIN type lead with 6

electrodes, select “6 LEADS”.

1. On the PARAMETER SETUP screen, press the

▼

key to move the cursor to “LEAD TYPE”.

2. Press the Function key.

3. Press the

▼

key to select “AUTO” or “6 LEADS”.

4. Press the Function key to register the selected setting. The cursor returns to “LEAD TYPE”.

Setting item

Cursor

28 Operator’s Manual ZM-540PA/541PA

ECG MEASUREMENT

Turn ECG monitoring on or off. When electrodes are attached to the patient and ECG leads are

connected, ECG monitoring starts even when this setting is set to OFF.

If this setting is set to OFF, the same setting on the receiving monitor must also be set to OFF.

NOTE

When “PROTOCOL” on the transmitter is set to 57 and the receiving monitor is able to

receive protocol 57, ECG measurement on the receiving monitor is automatically set to

OFF when this setting is set to OFF on the transmitter.

1. On the PARAMETER SETUP screen, press the

▼

key to move the cursor to “ECG

MEASUREMENT”.

2. Press the Function key.

3. Press the

▼

key to select “ON” or “OFF”.

4. Press the Function key to register the selected setting. The cursor returns to “ECG

MEASUREMENT”.

RESP MEASUREMENT

Turn respiration monitoring on or off. When this setting is set to OFF, the same setting on the

receiving monitor is automatically set to OFF.

1. On the PARAMETER SETUP screen, press the

▼

key to move the cursor to “RESP

MEASUREMENT”.

2. Press the Function key.

3. Press the

▼

key to select “ON” or “OFF”.

4. Press the Function key to register the selected setting. The cursor returns to “RESP

MEASUREMENT”.

Operator’s Manual ZM-540PA/541PA 29

SpO2 RESPONSE

Select the SpO2 response mode.

FAST: Select this for special applications that require a fast response. FAST is suitable for

detecting short apnea.

NORMAL: For normal monitoring.

SLOW: Select this when you need to suppress a rapid change in SpO2.

1. On the PARAMETER SETUP screen,

press the

▼

key to move the cursor to

“SpO2 RESPONSE”. “SpO2 RESPONSE”

is on the second page of the PARAMETER

SETUP screen.

2. Press the Function key.

3. Press the

▼

key to select “FAST”,

“NORMAL” or “SLOW”.

4. Press the Function key to register the

selected setting. The cursor returns to

“SpO2 RESPONSE”.

PARAMETER SETUP screen - page 2

INHIBIT SpO2 DURING NIBP

Turn SpO2 monitoring on or off during NIBP measurement.

When the SpO2 probe is attached to the same limb as the NIBP cuff and this setting is set to OFF, the

pulse may become unstable and SpO2 or PR alarm may occur. It is recommended to set this setting

to ON so that SpO2 is not measured during NIBP measurement.

When the SpO2 probe is attached to the other limb from the NIBP cuff, this setting can be set to

OFF.

NOTE

When this “INHIBIT SpO2 DURING NIBP” is set to OFF, refer to the “Monitoring SpO2

during NIBP Measurement” section.

1. On the PARAMETER SETUP screen, press the

▼

key to move the cursor to “INHIBIT

SpO2 DURING NIBP”. “INHIBIT SpO2 DURING NIBP” is on the second page of the

PARAMETER SETUP screen.

2. Press the Function key.

3. Press the

▼

key to select “ON” or “OFF”.

30 Operator’s Manual ZM-540PA/541PA

4. Press the Function key to register the selected setting. The cursor returns to “INHIBIT SpO2

DURING NIBP”.

SELECTABLE INTERVALS (min)

When the NIBP INTERVAL key is pressed, the measurement mode changes according to the modes

selected in this item. MANUAL mode is already selected for the mode selection.

PARAMETER SETUP screen - page 3

1. On the PARAMETER SETUP screen,

press the

▼

key to move the cursor

to “SELECTABLE INTERVALS”.

“SELECTABLE INTERVALS” is on the

third page of the PARAMETER SETUP

screen.

2. Press the Function key.

3. Press the

▼

key to select or unselect the

mode. The selected modes are highlighted.

4. Press the Function key to register the

selected setting. The cursor returns to

“SELECTABLE INTERVALS”.

INITIAL INTERVAL (min)

Select the initial NIBP measurement mode at power on.

1. On the PARAMETER SETUP screen, press the

▼

key to move the cursor to “INITIAL

INTERVAL”. “INITIAL INTERVAL” is on the third page of the PARAMETER SETUP screen.

2. Press the Function key.

3. Press the

▼

key to select the mode. Only the mode or interval selected for “SELECTABLE

INTERVALS” are available.

4. Press the Function key to register the selected setting. The cursor returns to “INITIAL

INTERVAL”.

NIBP MODE AFTER STAT (min)

Select the NIBP measurement mode after completing the STAT measurement.

1. On the PARAMETER SETUP screen, press the

▼

key to move the cursor to “NIBP MODE

AFTER STAT”. “NIBP MODE AFTER STAT” is on the third page of the PARAMETER

SETUP screen.

Operator’s Manual ZM-540PA/541PA 31

2. Press the Function key.

3. Press the

▼

key to select the mode. Only the mode or interval selected for “SELECTABLE

INTERVALS” are available.

4. Press the Function key to register the selected setting. The cursor returns to “NIBP MODE

AFTER STAT”.

START/FINISH SOUND

Turn on or off the sound for NIBP measurement start and ﬁnish.

PARAMETER SETUP screen - page 4

1. On the PARAMETER SETUP screen,

press the

▼

key to move the cursor to

“START/FINISH SOUND”. “START/

FINISH SOUND” is on the fourth page of

the PARAMETER SETUP screen.

2. Press the Function key. The cursor moves

to “START”.

3. Press the

▼

key to turn “ON” or “OFF” the

sound for NIBP measurement start.

4. Press the Function key to register the

setting for “START”. The cursor moves to

“FINISH”.

5. Press the

▼

key to turn “ON” or “OFF” the

sound for NIBP measurement ﬁnish.

6. Press the Function key to register the

selected setting. The cursor returns to

“START/FINISH SOUND”.

OLD NIBP DATA/AFTER (min)

Select whether to dim or hide the NIBP data after measurement and how long to wait after NIBP

measurement to dim or hide it.

1. On the PARAMETER SETUP screen, press the

▼

key to move the cursor to “OLD NIBP

DATA/AFTER”. “OLD NIBP DATA/AFTER” is on the fourth page of the PARAMETER

SETUP screen.

2. Press the Function key. The cursor moves to “DATA”.

32 Operator’s Manual ZM-540PA/541PA

3. Press the

▼

key to select “HIDE” or “DIM” the NIBP data.

4. Press the Function key to register the setting for “DATA”. The cursor moves to “AFTER”.

5. Press the

▼

key to select the interval after NIBP measurement to dim or hide.

6. Press the Function key to register the selected setting. The cursor returns to “OLD NIBP DATA/

AFTER”.

INITIAL CUFF PRESSURE (mmHg)

Select the NIBP cuff inﬂation pressure.

1. On the PARAMETER SETUP screen, press the

▼

key to move the cursor to “INITIAL CUFF

PRESSURE”. “INITIAL CUFF PRESSURE” is on the fourth page of the PARAMETER

SETUP screen.

2. Press the Function key.

3. Press the

▼

key to select the inﬂation pressure.

4. Press the Function key to register the selected setting. The cursor returns to “INITIAL CUFF

PRESSURE”.

Changing SYSTEM SETUP Settings

System Setup Setting List

The factory default settings are underlined.

Setting Item Description Settings

PROTOCOL

Select the transmitting protocol.

57: New protocol. A central monitor with ORG-

9100A/9110A/9700A multiple patient receiver whose

software version 02-01 or later can receive this

protocol.

42: Old protocol. A central monitor with ORG-

9100A/9110A/9700A multiple patient receiver can

receive this protocol.

NOTE

When 57 is set, the receiving monitor must be able

to receive protocol 57. Otherwise, signals from the

transmitter cannot be received.

57, 42

Operator’s Manual ZM-540PA/541PA 33

Setting Item Description Settings

BRIGHTNESS Select the screen brightness. DARK,

BRIGHT

PRESSURE UNIT Select the unit for NIBP. mmHg, kPa

FUNCTION KEY

Select the function of the Function key.

SUSPEND ALARM & PAUSE:

Suspends alarm on the receiving monitor for 2

minutes. Pauses monitoring on the transmitter and

receiving monitor.

SUSPEND ALARM:

Suspends alarm on the receiving monitor for 2

minutes.

CONFIRM:

Displays the “PATIENT CONFIRMED” message

on the transmitter screen and transmits the

message to the receiving monitor.

OFF: No function.

NOTE

“SUSPEND ALARM & PAUSE” and “CONFIRM” can

only be set when PROTOCOL is set to 57.

SUSPEND

ALARM

& PAUSE,

SUSPEND

ALARM,

CONFIRM,

OFF

AUTO RESUME

AFTER PAUSE Select the interval to resume monitoring after PAUSE.

10 s, 30 s, 1

min, 2 min, 3

min, OFF

34 Operator’s Manual ZM-540PA/541PA

1. Turn off the transmitter by removing one

battery.

2. While pressing the Function key, turn on

the transmitter (install the battery). The

MENU screen appears.

3. Press the

▼

key to move the cursor to

“SYSTEM SETUP”.

4. Press the Function key to enter SYSTEM

SETUP. The current settings are

highlighted.

5. Change settings.

• To move the cursor and select the setting

item, press the

▼

key then press

the Function key.

• To select and register the setting, press

the

▼

key then press the Function

key.

• To cancel changing the setting of the

selected item, press the Screen key.

The SYSTEM SETUP screen has two

pages. To display the second page,

press the

▼

key when the cursor is at

“PRESSURE UNIT”.

6. When changing settings on the SYSTEM

SETUP screen is complete, press the

Screen key to return to the MENU screen.

7. Press the

▼

key to move the cursor to

“EXIT”.

8. Press the Function key. The numeric and

waveform screen appears.

Cursor

MENU screen

Setting item

SYSTEM SETUP screen - page 1

Setting

Displaying the SYSTEM SETUP Screen

Operator’s Manual ZM-540PA/541PA 35

Changing System Setup Settings

PROTOCOL

Select the transmitting protocol. For differences between protocols, refer to the table below.

57: New protocol. A central monitor with ORG-9100A/9110A/9700A multiple patient receiver

whose software version 02-01 or later can receive this protocol.

42: Old protocol. A central monitor with ORG-9100A/9110A/9700A multiple patient receiver can

receive this protocol.

NOTE

When 57 is set, the receiving monitor must be able to receive protocol 57. Otherwise,

signals from the transmitter cannot be received.

Differences Between Protocols

Function Protocol 42 Protocol 57

Setting ECG MEASUREMENT to OFF on the

transmitter automatically turns off the ECG

measurement setting on the receiving monitor

No (ECG measurement

must be turned off on

the receiving monitor)

Yes

Pause monitoring on the receiving monitor from

the transmitter No Yes

Transmit “PATIENT CONFIRMED” message No Yes

Display battery level of the transmitter on the

receiving monitor No Yes

Transmit SpO2 messages

Some messages (refer

to the “Indication and

Message List” section)

All messages

Setting

Cursor 1. Press the

▼

key to move the cursor to

“PROTOCOL”.

2. Press the Function key.

3. Press the

▼

key to select “57” or “42”.

36 Operator’s Manual ZM-540PA/541PA

NOTE

FUNCTION KEY (on the second page

of the SYSTEM SETUP screen) can be

set to “SUSPEND ALARM & PAUSE” or

“CONFIRM” only when PROTOCOL is

“57”. If PROTOCOL is changed to “42”,

FUNCTION KEY is automatically changed

to “OFF”.

4. Press the Function key to register the

selected setting. The cursor returns to

“PROTOCOL”.

BRIGHTNESS

Select the screen brightness.

1. Press the

▼

key to move the cursor to “BRIGHTNESS”.

2. Press the Function key.

3. Press the

▼

key to select “DARK” or “BRIGHT”.

4. Press the Function key to register the selected setting. The cursor returns to “BRIGHTNESS”.

PRESSURE UNIT

Select the unit for NIBP.

1. Press the

▼

key to move the cursor to “PRESSURE UNIT”.

2. Press the Function key.

3. Press the

▼

key to select “mmHg” or “kPa”.

4. Press the Function key to register the selected setting. The cursor returns to “PRESSURE

UNIT”.

Operator’s Manual ZM-540PA/541PA 37

FUNCTION KEY

Select the function of the Function key.

SUSPEND ALARM & PAUSE: Suspends alarm on the receiving monitor for 2 minutes. Pauses

monitoring on the transmitter and receiving monitor.

SUSPEND ALARM: Suspends alarm on the receiving monitor for 2 minutes.

CONFIRM: Displays the “PATIENT CONFIRMED” message on the

transmitter screen and transmits the message to the receiving

monitor.

OFF: No function.

NOTE

“SUSPEND ALARM & PAUSE” and “CONFIRM” can only be set when PROTOCOL is set to

57.

SYSTEM SETUP screen - page 2

1. On the SYSTEM SETUP screen, press the

▼

key to move the cursor to “FUNCTION

KEY”. “FUNCTION KEY” is on the

second page of the SYSTEM SETUP

screen.

2. Press the Function key.

3. Press the

▼

key to select the function.

4. Press the Function key to register the

selected setting. The cursor returns

“FUNCTION KEY”.

AUTO RESUME AFTER PAUSE

Select the interval to resume monitoring after PAUSE.

1. Press the

▼

key to move the cursor to “AUTO RESUME AFTER PAUSE”. “AUTO RESUME

AFTER PAUSE” is on the second page of the SYSTEM SETUP screen.

2. Press the Function key.

3. Press the

▼

key to select interval.

4. Press the Function key to register the selected setting. The cursor returns to “AUTO RESUME

AFTER PAUSE”.

38 Operator’s Manual ZM-540PA/541PA

Cursor 1. Turn off the transmitter by removing a

battery.

2. While pressing the Function key, turn on

the transmitter (put back the battery). The

MENU screen appears.

3. Press the

▼

key to move the cursor to

“SYSTEM INITIALIZE”.

4. Press the Function key to enter SYSTEM

INITIALIZE screen.

5. Press the Function key to initialize settings.

The conﬁrmation message appears.

To return to the MENU screen without

initializing, press the Screen key.

6. Press the Function key to initialize settings.

To cancel initializing, press the

▼

key. The

screen returns to the MENU screen.

Initializing Settings

Do the following procedure to initialize all settings, except for channel, to the factory default

settings.

Operator’s Manual ZM-540PA/541PA 39

Attaching Electrodes, SpO2 Probe and NIBP Cuff

to the Patient

The transmitter can be attached to an arm of the patient or placed on the bedside. The required

length of the electrode leads and SpO2 probe cable depends on how the transmitter is to be attached

to the patient.

NOTE

Monitoring SpO2 during NIBP Measurement

When the SpO2 probe is attached to the same limb as the NIBP cuff, the blood ﬂow

decreases during NIBP measurement and pulse wave cannot be detected and SpO2

cannot be monitored properly. When “INHIBIT SpO2 DURING NIBP” on the PARAMETER

SETUP screen is set to ON (factory default setting), SpO2 monitoring is paused during

NIBP measurement to avoid SpO2 alarm occurrence. However, when monitoring SpO2 on

the same limb as NIBP, be careful when reading SpO2 values.

When monitoring SpO2 is important, attach the probe to the limb to which the

NIBP cuff or catheter is not attached.

Attachment Examples

When transmitter is attached on an arm When transmitter is placed on a bedside

NOTE

When placing the transmitter on a bedside,

place it on a stable and ﬂat place. If the

transmitter falls off, it may be damaged.

40 Operator’s Manual ZM-540PA/541PA

Attaching Electrodes

Selecting Electrode Lead

CAUTION

Only use Nihon Kohden speciﬁed electrodes and electrode leads. When other

electrodes or electrode leads are used, the “CHECK ELECTRODES” message may

appear and monitoring may stop.

The following electrode leads can be used on the transmitter (option).

BR-903PA, 3 electrodes, clip type BR-906PA, 6 electrodes, clip type

Connecting the Electrode Lead to the Transmitter

Connect the electrode lead to the ECG/RESP socket on the transmitter.

When transmitter is attached on an arm

CAUTION

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.

CAUTION

Hold the connector of the electrode

lead when connecting/disconnecting

the electrode lead. If you disconnect

the electrode lead by pulling the lead,

it damages the electrode lead.

Operator’s Manual ZM-540PA/541PA 41

Electrode Position

Follow the physician’s instructions for electrode placement when available.

For ECG monitoring, electrodes are attached only on the chest to allow patient movement and

obtain continuous stable ECG. The following leads are examples. When also monitoring respiration,

refer to the “Electrode Position for Respiration Monitoring” section.

NOTE

The optimum electrode positions for ECG measurement are not always optimum for

respiration measurement. Select positions that are suitable for both ECG and respiration

measurement or positions which give priority to either ECG or respiration measurement.

Electrode Positions for ECG Monitoring

Six Electrodes

The 6-electrode method with lead II and lead V5 is effective for monitoring myocardial ischemia.

You can improve monitoring accuracy considerably by adding lead V4 to this combination. Va and

Vb can be at any position of the standard 12 leads V1 to V6, but V4 and V5 are most appropriate for

myocardial ischemic monitoring.

RA/R LA/L

RL/RF LL/F

Va/Ca

Vb/Cb

Electrode Position Symbol Lead Color

AHA IEC AHA IEC

Left infraclavicular fossa LA L Black Yellow

Right infraclavicular fossa RA R White Red

Below lowest rib on the left anterior axillary line LL F Red Green

Right anterior axillary line at the same level as LL/F RL RF Green Black

Fifth intercostal space on the left midclavicular line.

(V4 position of standard 12 leads) Va Ca Brown-blue White-

brown

Left anterior axillary line at the same level as Va.

(V5 position of standard 12 leads) Vb Cb Brown-

orange White-black

42 Operator’s Manual ZM-540PA/541PA

Lead Position

Standard limb leads

Monopolar limb leads

Monopolar chest leads

Lead I Lead II Lead III

aVR lead aVL lead aVF lead

1 to V6 leadsV1 to V6 leads

RA RA RA

LL LL

N (RL)

N (RL) N (RL) N (RL)

N (RL)

Three Electrodes

• Lead MII, which is similar to standard lead II, used when ECG measurement has priority

Electrode Position Symbol Lead Color

AHA IEC AHA IEC

Left infraclavicular

fossa LA L Black Yellow

Right infraclavicular

fossa RA R White Red

Below lowest rib

on the left anterior

axillary line

LL F Red Green

Operator’s Manual ZM-540PA/541PA 43

• Lead MI, which is similar to standard lead I

Change F/LL and L/LA of lead MII.

• Lead MIII, which is similar to standard lead

III

Change R/RA and L/LA of lead MII.

If the electrode positions above are not available due to chest surgery, attach the electrodes to the

root of the limbs or below the clavicles for stable ECG monitoring.

Electrode Positions for Respiration Monitoring

Place the R/RA and F/LL electrodes so that the lungs are between the electrodes.

Position 1

In this position, respiration measurement is available; however, there is a difference in amplitude

between different patients.

R or RA F or LL

Right infraclavicular fossa Fifth intercostal space on the

left midclavicular line, V4

Position 2

In this position, the waveform amplitude is usually large and the ECG lead is similar to Lead MII.

This position can be generally recommended.

R or RA F or LL

Right infraclavicular fossa Fifth intercostal space on the

left midaxillary line, V6

44 Operator’s Manual ZM-540PA/541PA

Position 3

In this position, the respiration waveform is optimum, but the ECG lead is unusual.

R or RA F or LL

Right midaxillary at the

horizontal level of V6

Fifth intercostal space on the

left midaxillary line, V6

Position 4

In this position, the respiration measurement is inﬂuenced by the impedance variation of the

abdomen, so the cardiac pulse wave included in the respiration wave is reduced. Note that the

waveform is inverted in phase compared with the chest movement (the waveform goes down during

inspiration). It is difﬁcult to measure the ECG at the same time.

R or RA F or LL

Lowest rib on the right

anterior axillary line

Lowest rib on the left anterior

axillary line

Attaching Electrodes to the Patient and Connecting the Electrode Leads to

Disposable Electrodes

Prepare the Patient Skin

Shave off excessive body hair.

To reduce skin impedance, clean the electrode site with cream or with a cotton pad moistened with

alcohol. Thoroughly dry the skin with a clean cotton pad.

NOTE

• For a patient with frequent body movement, rub the sites with Skinpure skin preparation

gel. However, do not use Skinpure skin preparation gel on sensitive skin.

• Do not place electrodes on a wound or on an inﬂamed, wrinkled or uneven skin surface.

Attaching Electrodes to the Patient

CAUTION

Do not reuse disposable parts and accessories.

NOTE

• To maintain good contact between the electrode and skin, check that the paste of the

Operator’s Manual ZM-540PA/541PA 45

disposable electrode is not dry.

• When contact between the disposable electrode and skin becomes poor, replace

electrodes with new ones immediately. Otherwise, contact impedance between the skin

and the electrode increases and accurate ECG cannot be obtained.

Refer to the electrode operator’s manual for details.

1. Carefully remove the backing paper from the electrode.

Avoid touching the adhesive surface.

2. Place the electrode on the previously cleaned skin. Pay

attention to the electrode lead color and symbol.

3. Clip the electrode lead to the electrode.

4. Fasten the electrode lead wire with surgical tape with an

extra length of wire between the tape and the electrode.

This lessens the movement of electrode leads by body

movement and helps stable monitoring.

Checking ECG on the Transmitter Screen

After attaching electrodes and connecting ECG leads, check that the electrodes are properly attached

to the patient and the ECG waveform is acquired on the check electrodes screen. For details on the

screen, refer to the “Screen Descriptions” section.

Attaching the SpO2 Probe

Selecting the SpO2 Probe

Select an appropriate probe for the patient.

CAUTION

Only use Nihon Kohden speciﬁed

electrodes, electrode leads, SpO2

probes, and NIBP cuffs. Otherwise,

the maximum performance from the

transmitter cannot be guaranteed.

CAUTION

Do not use a damaged or

disassembled probe. It causes

incorrect measurement and may

injure the patient.

46 Operator’s Manual ZM-540PA/541PA

Reusable Probes

When using a TL-201T ﬁnger probe, choose the appropriate cable length for attachment.

Probe Cable Length Patient Attachment Site

Finger probe TL-201T

0.6 m

Adult or child

20 kg or more

Finger

1.6 m

Multi-site probe TL-220T

Attachment tape

Adult or infant

3 kg or more

Finger or toe

Neonate

3 kg or less

Instep and sole

Finger probe

TL-630T1, TL-630T3,

TL-631T1, TL-631T3

Attachment tape

TL-630T1, TL-

631T1: 0.6 m

TL-630T1/630T3:

Adult or child

50 kg or more

TL-631T1/631T3:

Adult or child

20 kg or more

Finger or toe

TL-630T3, TL-

631T3: 1.6 m

Disposable Probes

CAUTION

The disposable probe is not sterilized. Use the disposable probe only for a single

patient. Never reuse the disposable probe for another patient because it causes cross

infection.

Operator’s Manual ZM-540PA/541PA 47

Probe Patient Attachment Site

TL-251T Adult

30 kg or more

Finger or toe

TL-252T Child

3 to 40 kg

Finger or toe

TL-253T Neonate

3 kg or less

Instep and sole

TL-051S, TL-052S

40 mm

Cable length TL-051S: 0.8 m

TL-052S: 1.6 m

Adult

50 kg or more

Finger

Neonate

3 kg or less

Instep and sole

TL-061S, TL-062S

35 mm

Cable length TL-061S: 0.8 m

TL-062S: 1.6 m

Adult or child

15 to 50 kg

Finger

Infant

3 to 15 kg

Toe

48 Operator’s Manual ZM-540PA/541PA

Probe Patient Attachment Site

TL-271T, TL-271T3

Cable length TL-271T: 0.8 m

TL-271T3: 1.6 m

Adult

30 kg or more

Finger or toe

TL-272T, TL-272T3

Cable length TL-272T: 0.8 m

TL-272T3: 1.6 m

Child

10 to 50 kg

TL-273T, TL-273T3

Cable length TL-273T: 0.8 m

TL-273T3: 1.6 m

Neonate

3 kg or less

Instep and sole

Adult

40 kg or more

Finger or toe

TL-274T, TL-274T3

Cable length TL-274T: 0.8 m

TL-274T3: 1.6 m

Infant

3 to 20 kg

Operator’s Manual ZM-540PA/541PA 49

Connecting the SpO2 Probe to the Transmitter

Connect the probe to the SpO2 socket on the transmitter.

When transmitter is attached on an arm

CAUTION

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.

CAUTION

Do not use a damaged or

disassembled probe. It causes

incorrect measurement and may

injure the patient.

Attaching the Probe to the Patient

Attach the probe to the patient by referring to the probe’s manual. Make sure that the light emitter

and photo detector of the probe face each other at the attachment site.

50 Operator’s Manual ZM-540PA/541PA

WARNING

• When using the TL-201T ﬁnger

probe, do not fasten the probe and

cable to the ﬁnger by wrapping

with tape. This may cause burn,

congestion or pressure necrosis

from poor blood circulation.

• When using probes other than the

TL-201T ﬁnger probe, to avoid poor

circulation, do not wrap the tape too

tight. Check the blood circulation

condition by observing the skin

color and congestion at the skin

peripheral to the probe attachment

site. Even for short-term monitoring,

there may be burn or pressure

necrosis from poor blood circulation,

especially on neonates or low

birth weight infants whose skin is

delicate. Accurate measurement

cannot be performed on a site with

poor peripheral circulation.

WARNING

Check the circulation condition by

observing the skin color at the

measurement site and pulse

waveform. Change the measurement

site every 8 hours for disposable

probes and every 4 hours for reusable

probes (every 8 hours for TL-630T/TL-

631T series probe). The skin

temperature may increase at the

attached site by 2 or 3°C (4 or 5°F)

and cause a burn or pressure

necrosis. When using the probe on the

following patients, take extreme care

and change the measurement site

more frequently according to

symptoms and degree.

• Patient with a fever

• Patient with peripheral circulation

insufﬁciency

• Neonate or low birth weight infant

with delicate skin

WARNING

When monitoring SpO2 of a patient

who is receiving photodynamic

therapy, the light from the ﬁnger probe

sensor may cause a burn.

Photodynamic therapy uses a

photosensitizing agent that has a side

effect of photosensitivity.

Operator’s Manual ZM-540PA/541PA 51

CAUTION

If the attachment site is dirty with

blood or bodily ﬂuids, clean the

attachment site before attaching the

probe. If there is nail polish on the

attachment site, remove the polish.

Otherwise, the amount of transmitted

light decreases, and measured value

may be incorrect or measurement

cannot be performed.

CAUTION

When the probe is attached on an

appropriate site with sufﬁcient

circulation and the error message

conﬁrming the probe attachment

repeatedly appears, the probe may be

deteriorated. Replace it with a new

one.

CAUTION

If the skin gets irritated or redness

appears on the skin from the probe,

change the attachment site or stop

using the probe. Take extreme care for

the patients with delicate skin.

CAUTION

Do not use a probe which is

deteriorated by aging. Accurate

measurement cannot be performed.

CAUTION

Refer to the probe instruction manual

for details.

52 Operator’s Manual ZM-540PA/541PA

Attaching the NIBP Cuff

Selecting the NIBP Cuff

Select the NIBP cuff appropriate for the patient.

NOTE

NIBP cannot be measured on neonates using this transmitter.

Reusable Cuffs

When attaching the transmitter to the patient arm, a special NIBP cuff is required. An optional

YN-990P extension hose (1.5 m) is available to extend the length between the NIBP socket on the

transmitter and NIBP cuff (e.g. when not attaching the transmitter to the patient arm and placing the

transmitter on a bedside).

Reusable Cuff Model Width (cm) Air Hose Length (cm)

For adult Standard YP-503P 13 15

Large YP-504P 15 15

Width

Air hose

When not attaching the transmitter to the patient arm, the following cuffs can be used. To use these

cuffs, an optional YN-990P extension hose (1.5 m) is required.

Reusable Cuff Model Width (cm) Air Hose Length (cm)

For infant YP-960T 5

For child Small YP-961T 7

Standard YP-962T 10

For adult Standard YP-963T 13

Large YP-964T 15

Width

Air hose

Operator’s Manual ZM-540PA/541PA 53

Disposable Cuffs

CAUTION

Disposable cuffs are not sterilized. If necessary, sterilize the cuff using glutaraldehyde

solution.

When not attaching the transmitter to the patient arm, the following disposable cuffs can be used.

To use these cuffs, an optional YN-990P extension hose (1.5 m) is required.

Reusable Cuff Model Width (cm) Air Hose Length (cm)

For infant YP-810P 6 17

For child YP-811P 8 17

For adult

Small YP-812P 10 17

Standard YP-813P 14 20

Medium large YP-814P 15 20

Large YP-815P 17 20

Width

Air hose

Extension Hose

CAUTION

When using an extension hose, check that the extension hose is not bent or

squeezed. Otherwise, the cuff might not inﬂate or deﬂate. If the cuff cannot deﬂate, it

may cause congestion on the patient at the cuff attachment site.

YN-990P extension hose, 150 cm

54 Operator’s Manual ZM-540PA/541PA

Reference for selecting a cuff

The AHA (American Heart Association) recommends that the cuff width be 40% of the

circumference of the upper arm. Refer to the following graph and select the cuff which suits the

patient’s arm.

NOTE

• If a range of arm circumference appropriate for the cuff is prescribed, use a cuff within

that range.

• To obtain accurate measured values, select a wide cuff which can be attached to the

upper arm. Measuring with a very narrow cuff may result in measured values higher than

the actual values.

• The YP-503P NIBP cuff is for standard size adult. Do not use this cuff when it does not ﬁt

the patient.

10 20 30 40 50

10 20 30 40 50 60

Cuff width (cm)

Arm circumference (cm)

Infants YP-960T

Children small YP-961T

Children standard YP-962T

Adults standard YP-503P (cuff for transmitter)

YP-963T

Adults large YP-504P (cuff for transmitter)

YP-964T

Cuff Width and Arm Circumference

Reusable Cuffs

Cuff width (cm)

Arm circumference (cm)

Children standard YP-811P

Adults large YP-815P

Disposable Cuffs

Infants YP-810P

Adults small YP-812P

Adults standard YP-813P

Adults medium large YP-814P

Operator’s Manual ZM-540PA/541PA 55

Connecting the NIBP Cuff to the Transmitter

When Using YP-503P/YP-504P NIBP Cuff

To attach the YP-503P/YP-504P NIBP cuff to the transmitter, the lock plate is required.

YP-503P/YP-504P NIBP cuff

Front cover Air hose

D ring

Belt

Belt for the strap

Lock plate pocket Front cover open

Lock plate

For attaching the NIBP cuff to the transmitter

NOTE

Do not roll up or put weight on the cuff when the lock plate is

attached to it. The lock plate may break if the cuff is rolled up or

weight is put on it when the lock plate attached.

Top tab

Bottom tab

Top tab

Bottom tab

56 Operator’s Manual ZM-540PA/541PA

1. Remove the lock plate from the

transmitter.

2. Insert the lock plate into the lock

plate pocket on the NIBP cuff.

3. Attach the transmitter to the lock

plate by inserting the tabs on the

lock plate into the slots on the

transmitter.

4. Cover the transmitter with the

front cover of the NIBP cuff.

5. Connect the air hose to the NIBP

socket on the transmitter. Turn

the cuff connector joint until it

clicks.

Operator’s Manual ZM-540PA/541PA 57

When Using Disposable Cuffs or YP-960T series Reusable Cuffs

To use these NIBP cuffs, an optional YN-990P extension hose (1.5 m) is required.

NOTE

Connect the joints properly. If there is an air leak, NIBP cannot be measured properly.

1. Connect the NIBP cuff to the extension hose.

2. Connect the other end of the extension hose

to the NIBP socket on the transmitter. Turn

the joint clockwise until it clicks.

To disconnect the cuff from the transmitter,

turn the hose joint counterclockwise.

Attaching the NIBP Cuff to the Patient

WARNING

Be careful when measuring NIBP on a patient with known bleeding disorders or

coagulation. After NIBP measurement, there may be dot hemorrhage, or circulatory

disorder by thrombus where the cuff is attached.

CAUTION

Do not wrap the cuff on an arm or

thigh which is used for injection. NIBP

measurement on an arm or thigh

which is used for injection may cause

reﬂux of blood and stop injection.

CAUTION

Do not attach the cuff to the site

where there is injury or inﬂammation.

If the skin gets irritated or redness

appears on the skin from the cuff,

change the attachment site or stop

using the cuff. Take extreme care on

the patients with delicate skin.

CAUTION

Do not wrap the cuff too tight. It may

cause poor blood circulation and

congestion. If the cuff is wrapped too

loosely, the NIBP value may increase.

CAUTION

Do not reuse disposable parts and

accessories.

58 Operator’s Manual ZM-540PA/541PA

CAUTION

NIBP and SpO2 can be measured on

the same limb, but the SpO2

monitoring might not be accurate

during NIBP measurement. Be careful

when reading the SpO2 values.*

* Monitoring SpO2 during NIBP Measurement

When the SpO2 probe is attached to the

same limb as the NIBP cuff, the blood

ﬂow decreases during NIBP measurement

and pulse wave cannot be detected and

SpO2 cannot be monitored properly. When

“INHIBIT SpO2 DURING NIBP” on the

PARAMETER SETUP screen is set to ON

(factory default setting), SpO2 monitoring is

paused during NIBP measurement to avoid

SpO2 alarm occurrence. However, when

monitoring SpO2 on the same limb as the

NIBP, be careful when reading SpO2 values.

NOTE

• Measuring NIBP at a site other than the upper arm gives different values from those

measured at the upper arm. When making diagnosis based on the NIBP values, measure

NIBP on an upper arm.

• To accurately detect the pulsatile ﬂow of the artery, the cuff should be wrapped around a

bare upper arm.

• Do not use an abnormal cuff. The cuff deteriorates from use and cleaning. Before use,

check the cuff and conﬁrm that there is no ﬂaw, crack or hole in it. Be careful not to

damage the inﬂation bag. If the inﬂation bag has a hole or a ﬂaw, it may burst during use.

Dispose of an abnormal cuff and replace it with a new one.

• Refer to the NIBP cuff manual for details.

Cuff Position

Place the cuffed upper arm (brachium) at the same height

as the patient’s heart. If the cuff is not at the same level as

the heart, the weight of the blood affects the blood pressure

reading. The pressure difference per unit height is 0.7

mmHg/cm. The blood pressure reading decreases when the

arm is higher than the heart and increases when lower.

The best measuring condition is when the patient is lying on

his/her back with arms and legs relaxed. If the cuff position

cannot be on the same level as the heart, the displayed blood

pressure reading must be mathematically adjusted.

When placing the transmitter on

a bed, make sure that the hose is

not bent.

Heart

When placing the transmitter on

a bed, make sure that the hose is

not bent.

Heart

Operator’s Manual ZM-540PA/541PA 59

Attaching the Transmitter on an Arm (Using the YP-503P/504P NIBP Cuff)

1. Attach the NIBP cuff to the transmitter. Refer

to the “Connecting the NIBP Cuff to the

Transmitter” section.

2. Before putting the cuff over the arm, insert the

end of the cuff into the belt and then through the

D ring as shown at left.

3. Put the patient arm through the cuff. Fold back

the cuff at the D ring and fasten it using the

velcro tape.

Make sure that the cuff is not attached on a joint.

NOTE

The cuff must not wrap around the elbow.

Belt

D ring End of cuff

Belt

D ring End of cuff

60 Operator’s Manual ZM-540PA/541PA

Attaching the Strap to the Transmitter

NOTE

• Use the strap to prevent the transmitter from falling.

• Do not attach the clip to hard objects such as thick cloth or zipper. It will break the clip.

Attach a strap provided with the transmitter to the NIBP cuff and patient clothes.

To open the clip, ﬁrmly

pull out the tab in

direction of the arrow. To adjust the strap length,

push down the tab on the

adjuster and slide.

1. Adjust the length of the strap.

2. Clip one end of the strap to the belt for the strap on the NIBP cuff.

3. Clip the other end of the strap to the patient’s clothes as shown left.

Belt for the strap on the NIBP cuff

Operator’s Manual ZM-540PA/541PA 61

Placing the Transmitter on the Bed (Using the Disposable Cuffs or YP-960T series Reusable

Cuffs)

1. Put the cuff on the upper arm so that the ▼ mark

of “ARTERY ▼” aligns with the artery of the

patient.

ARTERY ▼

2. Wrap the cuff so that “INDEX ” comes

within the “ RANGE ”.

If “Index ” is not within the “ RANGE

”, change the cuff size.

RANGERANGE

62 Operator’s Manual ZM-540PA/541PA

Locking the Keys on the Transmitter

To prevent the patient from pressing the keys on the transmitter during monitoring, you can lock the

keys.

Press the

▼

and

▼

keys at the same time and hold for more than 3 seconds. The key lock screen

appears.

When there is no key operation for one minute after locking the keys, the display turns off.

To unlock the keys:

Press the

▼

and

▼

keys at the same time and hold for more than 3 seconds.

Operator’s Manual ZM-540PA/541PA 63

Monitoring

CAUTION

The measurement values and displayed waveforms on the transmitter and receiving

monitor may be different due to timing delay of the display or difference in detection

settings.

Screen Descriptions

When the transmitter is turned on, the startup screen appears, then the check electrodes screen

appears to check the electrode attachment.

The screen changes in the following order each time the Screen key is pressed.

Check electrodes → numeric and waveform → waveform review → numeric review → display off→ numeric and waveform → waveform review → numeric review → display off numeric and waveform → waveform review → numeric review → display off→ waveform review → numeric review → display off waveform review → numeric review → display off→ numeric review → display off numeric review → display off→ display off display off

→ check electrodes . . . check electrodes . . .

Screen key

The screen automatically turns off when there is no key operation for 2 minutes on the check

electrodes screen or 1 minute on other screens.

When the display is off and the Screen key is pressed, the numeric and waveform screen appears.

When the Screen key is pressed within 5 minutes after the display off, the screen before the display

off appears.

64 Operator’s Manual ZM-540PA/541PA

Check Electrodes Screen

You can check whether the electrodes are properly attached to the patient and the ECG waveform is

acquired.

When 6 leads are used, I, II, Va and Vb lead waveforms are displayed.

When 3 leads are used, only II lead waveform is displayed.

Channel number

Battery level

ECG waveform

Filter: off

Sweep speed: 12.5 mm/s

Waveform sensitivity: 0.5 cm/1 mV

Lead

Detached

electrode position

Message

When electrodes are

detached, the “CHECK

ELECTRODES”

message and detached

electrode position appear

on the screen.

NOTE

When ECG measurement is set to OFF on the PARAMETER SETUP screen, the check

electrodes screen does not appear.

Operator’s Manual ZM-540PA/541PA 65

Numeric and Waveform Screen

Numeric values and waveforms of the monitoring parameters are displayed. You can change the

ECG lead with the

▼

and

▼

keys.

Heart rate

QRS sync mark

Pulse bar graph

SpO2

Respiration rate

NIBP values

ECG waveform

Filter: on

Sweep speed: 12.5 mm/s

Waveform sensitivity: auto

Waveform

sensitivity

ECG lead

NIBP measurement

mode

When ECG and respiration measurement is turned off

Pulse rate

Pulse sync mark

Pulse bar graph

SpO2

Pulse wave

sensitivity

Pulse waveform

Sweep speed: 12.5 mm/s

Waveform sensitivity: auto

NIBP values

NIBP measurement

mode

66 Operator’s Manual ZM-540PA/541PA

NOTE

The pulse wave amplitude varies according to the ratio of the pulsation component to the

entire transmitted IR signal. When the pulsation component ratio is 1%, the pulse wave

amplitude is about 5 mm at ×1 sensitivity on the screen.

Waveform Review Screen

ECG full disclosure for up to 10 minutes can be saved and reviewed. When ECG measurement is

turned off and SpO2 is monitored, the pulse waveform is saved.

When ECG lead is changed on the numeric and waveform screen, the ECG full disclosure of the

changed lead is saved.

The saved data is deleted when the transmitter is turned off.

ECG lead

Displayed

page

Compressed ECG waveform

7.5 s x 4 traces per page, total of 20 pages

Older data

Newer data

Time range of the displayed waveform

(time before the waveform review

screen is displayed)

Waveform sensitivity

To scroll the waveform, press the

▼

key. The waveform is scrolled by 30 seconds.

Operator’s Manual ZM-540PA/541PA 67

Numeric Review Screen

Numeric data of heart rate (or pulse rate when ECG is turned off), SpO2 and respiration rate for up

to 10 minutes are saved at 1 minute intervals.

NOTE

NIBP measured values are not saved.

The saved data is deleted when the transmitter is turned off.

Time before the numeric

review screen is displayed

Older data

Newer data

Display Off

The display can be turned off any time. To turn off the display, press the Screen key several times

until the following screen appears then wait 5 seconds.

68 Operator’s Manual ZM-540PA/541PA

Basic Monitoring Operation

Using the Function Key

Function key

One of the following functions can be assigned to the Function key on the SYSTEM SETUP screen.

Refer to the “Changing SYSTEM SETUP Settings” section.

SUSPEND ALARM: Suspends alarms on the receiving monitor before they occur for 2 minutes.

PAUSE: Pauses monitoring on the transmitter and receiving monitor.

CONFIRM: Transmits the signal that the patient is conﬁrmed and displays the “PATIENT

CONFIRMED” message on the transmitter.

NOTE

To use the Function key for PAUSE or CONFIRM, you must set “PROTOCOL” on the

SYSTEM SETUP screen of the transmitter to 57 and the receiving monitor must be able to

receive protocol 57.

Operator’s Manual ZM-540PA/541PA 69

Suspending Alarms on the Receiving Monitor

When the FUNCTION KEY is set to “SUSPEND ALARM” or “SUSPEND ALARM & PAUSE”

on the SYSTEM SETUP screen, alarms can be suspended for 2 minutes on the receiving monitor

before they occur.

To suspend alarms:

1. Press the Function key. The “Suspend alarms” conﬁrmation screen appears.

2. Press the

▼

key to suspend alarms.

To cancel suspending alarms and return to the previous screen, press the Screen key.

When the alarms are suspended, the “ALARMS SUSPENDED” message and alarm suspended icon

with the remaining minutes in alarm suspension appear on the transmitter screen.

Message Icon

To cancel suspending alarms during 2 minute alarm suspension:

1. Press the Function key while the “ALARMS SUSPENDED” message is displayed. The

conﬁrmation screen appears.

70 Operator’s Manual ZM-540PA/541PA

2. Press the

▼

key to cancel alarm suspension.

Press the Screen key to not cancel alarm suspension.

Pause Monitoring

When the FUNCTION KEY is set to “SUSPEND ALARM & PAUSE” on the SYSTEM SETUP

screen, you can pause monitoring on the receiving monitor from the transmitter when the patient

cannot be monitored, such as during X-ray examination.

NOTE

To use the Function key for PAUSE, you must set “PROTOCOL” on the SYSTEM SETUP

screen of the transmitter to 57 and the receiving monitor must be able to receive protocol

57.

To pause monitoring:

1. Press the Function key. The “Suspend alarms” conﬁrmation screen appears.

2. Press the Function key for 3 seconds to display the “Pause monitoring” conﬁrmation screen.

Operator’s Manual ZM-540PA/541PA 71

3. Press the

▼

key to pause monitoring.

To cancel pause monitoring, press the Screen key.

4. Wait about 5 seconds until the “Turn power off” screen appears.

5. Turn off the transmitter.

If the transmitter is not turned off and monitoring continues for the interval set for “AUTO

RESUME AFTER PAUSE” on the SYSTEM SETUP screen, pause monitoring is cancelled and

monitoring continues.

Resume Monitoring after Pause

To resume monitoring after pause, check that the electrodes, electrode leads and probe are attached

to the patient then turn on the transmitter.

72 Operator’s Manual ZM-540PA/541PA

Conﬁrming Patient

When the FUNCTION KEY is set to “CONFIRM” on the SYSTEM SETUP screen, you can

transmit signal to the receiving monitor to indicate that the patient is conﬁrmed by a medical staff by

pressing the Function key.

Message

Turning the Display Off

The display can be turned off any time. To turn off the display, press the Screen key several times

until the following screen appears then wait 5 seconds.

5 second time bar until the display turns off

Turning the Display On after It was Turned Off

Press the Screen key. The numeric and waveform screen appears. If the screen is turned off on the

“Keys locked” screen, the “Keys locked” screen appears.

When the Screen key is pressed within 5 minutes after the display was turned off, the previous

screen appears.

Operator’s Manual ZM-540PA/541PA 73

ECG and Respiration Monitoring

When the electrodes are attached and the ECG leads are connected, the heart rate, ECG waveform,

respiration rate and respiration waveform appear on the receiving monitor. Refer to the operator’s

manual of the receiving monitor for details.

When 6 leads are used on this transmitter, up to 8 lead (I, II, III, aVR, aVL, aVF, Va and Vb) of

ECG waveforms can be displayed on the receiving monitor. The heart rate is also measured.

When 3 leads are used, one channel ECG waveform of lead II can be displayed on the receiving

monitor. Refer to the operator’s manual of the monitor for details.

Heart rate

QRS sync mark Respiration rate

ECG lead

You can change the

ECG lead with the

▼

and

▼

keys.

ECG waveform Filter: on

Sweep speed: 12.5 mm/s

Waveform sensitivity: auto

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 transmitter which is connected to the

same patient. If this occurs, the pacemaker may pace at its maximum rate and the

transmitter may give incorrect data to the monitor. If this occurs, disconnect the

electrode leads from the patient or change the setting on the pacemaker by referring

to the pacemaker’s manual. For more details, contact your pacemaker representative

or Nihon Kohden representative.

* Minute ventilation is sensed in rate-adaptive pacemakers by a technology known as bioelectric

74 Operator’s Manual ZM-540PA/541PA

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 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.

CAUTION

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 pulse waves and the displayed

data may be incorrect.

NOTE

• Noise generated from an electrosurgical unit may interfere on an ECG waveform, but will

not damage it.

• If an electric blanket is used and incorrect heart rate is displayed on the monitor, turn off

the pacing spike detection on the monitor.

• Turn the pacing spike detection to ON on the receiving monitor when monitoring a

pacemaker patient. Pacing pulse is detected by the transmitter and transmitted to the

monitor. If the pacing spike detection is turned OFF, QRS and pacemaker spike might not

be distinguished and pacemaker failure might not be recognized.

• ECG cannot be monitored on a neonate using this transmitter.

Operator’s Manual ZM-540PA/541PA 75

Turning ECG Measurement On/Off

ECG measurement can be turned on or off on the PARAMETER SETUP screen. When electrodes

are attached to the patient and ECG leads are connected, ECG monitoring starts even when ECG is

turned off.

When PROTOCOL on the SYSTEM SETUP screen is set to 57:

ECG measurement on the receiving monitor is automatically set to off.

NOTE

ECG measurement on the transmitter cannot be turned on or off from the receiving

monitor.

When PROTOCOL on the SYSTEM SETUP screen is set to 42:

If ECG measurement is turned off on the transmitter, ECG measurement on the receiving monitor

must also be turned off.

Turning Respiration Measurement On/Off

Respiration measurement can be turned on or off on the PARAMETER SETUP screen. If respiration

measurement is turned off, respiration measurement on the receiving monitor is also turned off.

Electrode Detachment

In the following conditions, the “CHECK ELECTRODES” message is displayed on the transmitter

and receiving monitor.

• Electrode is detached from skin.

• Electrode lead is disconnected from the electrode.

• Polarization voltage between the electrode and skin is excessively high.

In these cases, check the cause and if necessary, replace electrodes with new ones.

CAUTION

When the “ELECTRODE OFF” or “CHECK ELECTRODES” message is displayed on

the receiving monitor, ECG is not monitored properly and the ECG alarm does not

function. Check the electrode, electrode leads, and if necessary, replace with new

ones.

76 Operator’s Manual ZM-540PA/541PA

SpO2 Monitoring

When monitoring starts, SpO2 and pulse waveform are sent to the monitor and SpO2 and pulse level

bar graph are displayed on the transmitter screen. When ECG is not measured, pulse waveform and

pulse rate are also displayed.

Pulse bar graphSpO2

Filter: on

Sweep speed: 12.5 mm/s

Waveform sensitivity: auto

Operator’s Manual ZM-540PA/541PA 77

WARNING

SpO2 measurement may be incorrect

in the following cases.

• When the patient’s

carboxyhemoglobin or

methemoglobin increases

abnormally.

• When dye is injected in the blood.

• When using an electrosurgical unit.

• During CPR.

• When measuring at a site with

venous pulse.

• When there is body movement.

• When the pulse wave is small

(insufﬁcient peripheral circulation).

WARNING

Check the circulation condition by

observing the skin color at the

measurement site and pulse

waveform. Change the measurement

site every 8 hours for disposable

probes and every 4 hours for reusable

probes (every 8 hours for TL-630T/TL-

631T series probe). The skin

temperature may increase at the

attached site by 2 or 3°C (4 or 5°F)

and cause a burn or pressure

necrosis. When using the probe on the

following patients, take extreme care

and change the measurement site

more frequently according to

symptoms and degree.

• Patient with a fever

• Patient with peripheral circulation

insufﬁciency

• Neonate or low birth weight infant

with delicate skin

WARNING

When monitoring SpO2 of a patient

who is receiving photodynamic

therapy, the light from the ﬁnger probe

sensor may cause a burn.

Photodynamic therapy uses a

photosensitizing agent that has a side

effect of photosensitivity.

WARNING

When not monitoring SpO2,

disconnect the SpO2 cable from the

transmitter. Otherwise, noise from the

probe sensor may interfere and

incorrect data is displayed on the

screen.

78 Operator’s Manual ZM-540PA/541PA

CAUTION

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 pulse waves and the

displayed data may be incorrect.

CAUTION

Do not pull or bend the probe cable,

and do not put caster feet on the

probe cable. Do not immerse the

disposable probe cable in chemical

solutions or water. Failure to follow

these instructions may cause cable

discontinuity, short circuit, skin burn

on the patient and incorrect

measurement data. Replace any

broken probe with a new one.

CAUTION

Normal external light does not affect

monitoring but strong light such as a

surgical light or sunlight may affect

monitoring. If affected, cover the

measuring site with a blanket.

CAUTION

When the probe is attached on an

appropriate site with sufﬁcient

circulation and the error message

conﬁrming the probe attachment

repeatedly appears, the probe may be

deteriorated. Replace it with a new

one.

CAUTION

When a message indicates a faulty

probe, stop monitoring and replace

the probe with a new one.

CAUTION

While a patient is on medication which

causes vasodilation, the pulse

waveform may change and in rare

cases the SpO2 value might not be

displayed.

NOTE

In order to maintain sufﬁcient blood circulation, keep the measurement site warm by

covering it with a blanket or something similar. Warming the site is effective, especially for a

patient with a small pulse amplitude.

Operator’s Manual ZM-540PA/541PA 79

Monitoring SpO2 during NIBP Measurement

CAUTION

NIBP and SpO2 can be measured on the same limb, but the SpO2 monitoring might

not be accurate during NIBP measurement. Be careful when reading the SpO2 values.

When the SpO2 probe is attached to the same limb as the NIBP cuff, the blood ﬂow decreases

during NIBP measurement and pulse wave cannot be detected and SpO2 cannot be monitored

properly. When “INHIBIT SpO2 DURING NIBP” on the PARAMETER SETUP screen is set to ON

(factory default setting), SpO2 monitoring is paused during NIBP measurement to avoid SpO2 alarm

occurrence. However, when monitoring SpO2 on the same limb as NIBP, be careful when reading

SpO2 values.

When monitoring SpO2 is important, attach the probe to the limb to which the NIBP cuff or catheter

is not attached.

When SpO2 monitoring is paused during NIBP measurement, the SpO2 value just before the start of

NIBP measurement and an mark are displayed on the transmitter for 30 seconds.

When NIBP measurement is not completed after 30 seconds, “– – –” is displayed for the SpO2 value.

The same data also appears on the monitor screen.

NOTE

• When continuous SpO2 monitoring is necessary, attach the probe to the limb to which the

NIBP cuff is not attached and set “INHIBIT SpO2 DURING NIBP” on the PARAMETER

SETUP screen to OFF.

• When the probe is attached to the same limb as the NIBP cuff, set the sync source to a

parameter other than SpO2 on the receiving monitor.

• When monitoring SpO2 during STAT NIBP measurement, attach the probe to the limb to

which the NIBP cuff is not attached.

80 Operator’s Manual ZM-540PA/541PA

NIBP Monitoring

Selecting the Initial Cuff Inﬂation Pressure

The initial cuff inﬂation pressure can be changed on the PARAMETER SETUP screen. The default

setting is 180 mmHg. To change the setting, refer to the “Changing PARAMETER SETUP Settings”

section.

Selecting the Measurement Mode and Interval

Measurement Modes

There are three measurement modes: manual, auto and STAT. The selected mode or interval is

displayed on the screen.

The measurement mode and interval can be changed by pressing the NIBP Interval key.

When the key is pressed, the NIBP mode setting screen appears. The measurement modes selected

at “SELECTABLE INTERVALS” on the PARAMETER SETUP screen are displayed (key color:

white). Select the measurement mode with the

▼

and

▼

keys or NIBP Interval key and press the

Function key.

Selected mode

(key color: blue)

Modes selected

at “SELECTABLE

INTERVALS” on the

PARAMETERS SETUP

screen

(key color: white)

To select the modes to be displayed on the NIBP mode setting screen, refer to the “Changing

PARAMETER SETUP Settings” section.

Manual Measurement

In Manual mode, a single NIBP measurement is performed when the NIBP Start/Stop key is pressed.

STAT (Continuous) Measurement

In STAT mode, measurement is continuously repeated for 15 minutes after the NIBP Start/Stop key

is pressed.

When the STAT measurement for 15 minutes is completed, the measurement mode automatically

changes to the Manual mode or Auto mode of selected interval depending on the “NIBP MODE

Operator’s Manual ZM-540PA/541PA 81

AFTER STAT” setting on the PARAMETER SETUP screen. The default setting is Manual mode.

Refer to the “Changing Parameter Setup Settings” section.

The STAT measurement completes within 15 minutes. When more than 12 minutes elapse from the

start of measurement, there will be no more measurement performed and the measurement mode

changes to the mode selected for “NIBP MODE AFTER STAT” on the PARAMETER SETUP

screen.

Auto Measurement

In Auto mode, measurement is performed automatically at the preset time intervals.

In Auto mode, a single measurement can be performed by pressing the NIBP Start/Stop key between

auto measurements.

Measuring NIBP

WARNING

Be careful when measuring NIBP on a

patient with known bleeding disorders

or coagulation. After NIBP

measurement, there may be dot

hemorrhage, or circulatory disorder by

thrombus where the cuff is attached.

WARNING

NIBP measurement may be incorrect

in the following cases.

• When using an electrosurgical unit

• When there is body movement

• When the pulse wave is small

(insufﬁcient peripheral circulation)

• Too many arrhythmias

• When there is vibration

• When there is a rapid blood

pressure change

• During CPR

WARNING

When performing NIBP

measurements in STAT mode or 5

minute intervals, periodically remove

the cuff from the patient for ventilation.

The skin temperature may increase at

the cuff attachment site by 2 or 3°C (4

or 5°F). When measuring a patient

with a fever or peripheral circulation

insufﬁciency, it may cause a burn.

CAUTION

When performing NIBP measurement

repeatedly, have a rest between

measurements to recover adequate

circulation.

82 Operator’s Manual ZM-540PA/541PA

NOTE

• When measuring patients who are conscious, help the patient to relax. Measurement

may not be accurate if the patient’s arm is tense or if the patient talks.

• The data for measurement on a leg tends to be higher than measurement on the arm.

When making diagnosis based on the NIBP values, measure NIBP on an upper arm.

• Do not apply pressure to the cuff or air hose. NIBP may not be measured correctly

because of noise or NIBP measurement may stop due to the NIBP safety circuit.

• When the transmitter is attached to the patient arm and the NIBP measurement

is performed when moving, tell the patient to relax and keep quiet. Otherwise,

measurement may be stopped or remeasurement is repeated due to body movement.

• If there is an abnormal noise generated during measurement, stop using the transmitter

and contact your Nihon Kohden representative.

• Do not measure NIBP of a patient on whom an IABP is being used. Measurement may

be incorrect due to the mixing of the patient’s own pulse and IABP pulse.

• NIBP cannot be measured on a neonate using this transmitter.

1. Press the NIBP Interval key to display the NIBP mode setting screen.

NIBP Interval key

2. Select the measurement mode by pressing the NIBP Interval key or

▼

and

▼

keys.

Selected mode

(key color: blue)

3. Press the Function key.

4. Press the NIBP Start/Stop key to perform measurement.

Operator’s Manual ZM-540PA/541PA 83

NIBP Start/Stop key

The cuff is inﬂated and the inﬂation pressure is displayed on the screen.

Inﬂation pressure

In manual mode: Measurement is performed once.

In STAT mode: Measurement is performed repeatedly for 15 minutes.

In auto mode: The ﬁrst measurement is performed when the NIBP Start/Stop key is

pressed. The second measurement is performed when the current time in the

transmitter reaches the selected time interval.

To stop measurement during measurement, press the NIBP Start/Stop key again.

In STAT mode, after completing the STAT measurement, the measurement mode changes to the

mode set for “NIBP MODE AFTER STAT” on the PARAMETER SETUP screen.

In auto mode, to stop measurement in auto mode, change the mode to manual. To cancel one

measurement, press the NIBP Start/Stop key during measurement.

After the measurement is complete, the measured data is displayed on the screen and is transmitted

to the monitor.

84 Operator’s Manual ZM-540PA/541PA

Systolic value Diastolic value

MAP value

NIBP measurement

mode

When ECG and SpO2 are not monitored (ECG measurement is turned off and SpO2 probe is not

connected to the transmitter), the pulse rate at the end of NIBP measurement is displayed.

A buzzer can be set to sound at the start and end of NIBP measurement. Refer to the “Changing

PARAMETER SETUP Settings” section.

Auto Mode Measurement

When auto mode measurement is selected, “STANDBY” message is displayed on the screen until

the NIBP Start key is pressed for the ﬁrst time.

STANDBY message

Operator’s Manual ZM-540PA/541PA 85

A time bar appears to indicate the interval between auto mode measurements.

Time bar indicating

the interval between

measurements

During auto mode measurement, the measurement mode can be changed. During the interval, press

the NIBP Interval key to change the mode. When “MANUAL” is displayed for more than one

second, the measurement in auto mode is stopped.

Data Display After NIBP Measurement

When the time set at “OLD NIBP DATA” on the PARAMETER SETUP screen elapses after the last

measurement, the NIBP data is dimmed or hidden. Whether to dim or hide the old data can also be

selected at “OLD NIBP DATA”. Refer to the “Changing PARAMETER SETUP Settings” section.

Data Display on the Receiving Monitor

When the “BATTERY” message is displayed on the receiving monitor, NIBP might not have

been measured according to the NIBP interval setting. Therefore, the NIBP data displayed on the

receiving monitor might not be updated. In this case, check the measurement time of the NIBP data

displayed on the receiving monitor.

Monitoring SpO2 during NIBP Measurement

When the SpO2 probe is attached to the same limb as the NIBP cuff, the blood ﬂow decreases

during NIBP measurement and pulse wave cannot be detected and SpO2 cannot be monitored

properly. When “INHIBIT SpO2 DURING NIBP” on the PARAMETER SETUP screen is set to

ON (factory default setting), SpO2 monitoring is paused during NIBP measurement to avoid SpO2

alarm occurrence. However, when monitoring SpO2 on the same limb as the NIBP, be careful when

reading SpO2 values.

86 Operator’s Manual ZM-540PA/541PA

Indication and Message List

Indication

Indication Cause Countermeasure

Fully charged batteries

——

Batteries are 2/3 full.

Batteries are low. NIBP cannot be

measured. Replace batteries.

Batteries are very weak.

Alarms on the receiving monitor

were suspended by pressing the

Function key on the transmitter.

Alarms resume when the suspend interval

elapses. To cancel alarm suspension, press

the Function key again.

Messages

When PROTOCOL on the SYSTEM SETUP screen is set to 57, all messages are transmitted.

When PROTOCOL is set to 42, the messages marked with * are not transmitted.

Message Cause Countermeasure

AIR LEAK

The cuff and extension hose are not

properly connected.

Connect them properly.

The cuff hose (or extension hose) is

not properly connected to the NIBP

socket.

The cuff or extension hose is damaged. Replace with a new one.

ALARMS

SUSPENDED

Alarms on the receiving monitor is

suspended by pressing the Function

key on the transmitter.

Alarms resume when the 2 minute

suspend interval elapses. To cancel

alarm suspension, press the Function

key again.

BATTERY

WEAK Dead batteries Replace batteries.

Operator’s Manual ZM-540PA/541PA 87

Message Cause Countermeasure

CANNOT

DETECT

PULSE*

(displayed in blue)

Poor blood circulation for measuring

the SpO2 value.

Check the patient condition, probe

attachment or change the attachment

site.

The probe is attached too tightly and is

obstructing the blood circulation. Reattach the probe.

The probe is not attached to the patient

properly.

Attach the probe to the patient

properly.

“LIGHT INTERFERENCE”,

“CHECK PROBE SITE” or

“DETECTING PULSE” message is

displayed for more than 30 seconds.

Refer to the cause and

countermeasure for each message in

this Messages table and remove the

cause.

CANNOT

DETECT PULSE

(displayed in pink)

The patient’s pulse wave is too small

to measure NIBP. Measure by palpation or auscultation.

The cuff is not wrapped on the patient

properly. Wrap the cuff on the patient properly.

CHECK

ELECTRODES

Electrode lead is disconnected from

the electrode.

Firmly connect the electrode lead to

the electrode.

Electrode lead is disconnected from

the transmitter.

Firmly connect the electrode lead to

the transmitter.

Electrode lead discontinuity. Replace the electrode lead with a

new one.

Electrode is not ﬁrmly attached to the

skin. Replace the electrode with a new

one.

Polarization voltage is abnormally

high.

CHECK PROBE

The probe is not attached to the patient

properly.

Attach the probe to the patient

properly.

The probe is not attached at the

appropriate site.

Attach the probe to an appropriate

site indicated in the probe manual.

The probe is disconnected from the

transmitter.

Connect the probe cable to the

transmitter.

The probe is past its expiration date. Replace the probe with a new one.

CHECK PROBE

SITE*

The probe is not attached at the

appropriate site.

Attach the probe to an appropriate

site indicated in the probe manual.

The probe is deteriorated. Replace the probe with a new one.

The probe is past its expiration date.

CUFF

OCCLUSION Transmitter malfunction.

Immediately remove the cuff from

the patient and contact your Nihon

Kohden representative.

88 Operator’s Manual ZM-540PA/541PA

Message Cause Countermeasure

DETECTING

PULSE

Searching for the correct pulse wave

for SpO2 monitoring. Wait until the pulse wave is detected.

The SpO2 value cannot be obtained

because the waveform is unstable. Attach the probe to the patient

properly.

The probe is not attached to the patient

properly.

HIGH CUFF

PRESS

Enormous pressure was applied by the

pressure of the cuff. Remove the cause.

INFLATION

PRESS LOW Insufﬁcient cuff inﬂation pressure.

Wait for the remeasurement to

be performed with increased cuff

inﬂation pressure.

LIGHT

INTERFERENCE

The SpO2 measurement site is under

ﬂuorescent light, surgical light,

sunlight, or other strong light.

Cover the measurement site with a

blanket or cloth.

Considerable body movement.

When the message is displayed

frequently, check the patient condition

and, if necessary, change the

attachment site.

The probe is not attached to the patient

properly.

SpO2 monitoring is paused for NIBP

measurement. Wait for NIBP measurement to ﬁnish.

MEAS TIME-

OUT

The NIBP measuring time exceeded

the speciﬁed time due to arrhythmia,

body movement, vibration or, cuff or

air hose being squeezed.

Remove the cause if the cause

is body movement, vibration or

squeezing of cuff or hose.

NIBP MODULE

ERROR Module malfunction. Contact your Nihon Kohden

representative.

NO NIBP

CHANGE

BATTERIES

NIBP cannot be measured due to low

battery. Replace batteries with new ones.

PATIENT

CONFIRMED*

Function key is pressed and the

“PATIENT CONFIRMED” signal is

transmitted to the receiving monitor.

(When “PATIENT” is assigned as the

function for the Function key on the

SYSTEM SETUP screen.)

——

PROBE

FAILURE*

The probe is past its expiration date. Replace the probe with a new one.

Probe is damaged or short-circuited.

Operator’s Manual ZM-540PA/541PA 89

Message Cause Countermeasure

REMEASURING

NIBP is being remeasured due to

arrhythmia, body movement, vibration

or, cuff or air hose being squeezed.

If the message still appears after

remeasurement, remove the cause

if the cause is body movement,

vibration or squeezing of cuff or

hose.

SAFETY

CIRCUIT ERROR The NIBP safety circuit error.

Immediately remove the cuff from

the patient and contact your Nihon

Kohden representative.

SAFETY

CIRCUIT

RUNNING

(When this

message is

displayed,

measurement

cannot be

performed for 40

seconds.)

NIBP measurement stopped by the

safety circuit.

Check that the hose is not bent or

squeezed.

Wait 40 seconds, then perform

remeasurement. If the message still

appears, contact your Nihon Kohden

representative.

SpO2 MODULE

ERROR* Transmitter failure. Contact your Nihon Kohden

representative.

SYS OUT OF

RANGE

The maximum blood pressure cannot

be measured even when the cuff

inﬂation pressure exceeded 280 mmHg

when using adult cuff.

Measure by palpation or auscultation.

WEAK PULSE*

(displayed in blue)

Poor peripheral circulation. Check the patient condition and

change the probe attachment site.

The probe is attached too tightly and is

obstructing the blood circulation.

Check the probe attachment

condition and if necessary, reattach

the probe.

WEAK PULSE

(displayed in pink)

The patient’s pulse wave is too small

to measure NIBP.

Measure NIBP by palpation or

auscultation.

The cuff is wrapped too loosely. Wrap the cuff properly.

The cuff size is not appropriate. Use the appropriate cuff.

ZEROING NIBP zero balance is being adjusted. Do not touch the cuff during zeroing.

Wait for the message to disappear.

90 Operator’s Manual ZM-540PA/541PA

Message Display Priority

When more than one message condition occurs on the transmitter, only the message with the highest

priority is displayed.

Priority Message

Highest PATIENT CONFIRMED

SAFETY CIRCUIT RUNNING

CUFF OCCLUSION

PROBE FAILURE

CHECK ELECTRODES

NIBP MODULE ERROR

SYS OUT OF RANGE

HIGH CUFF PRESS

AIR LEAK

MEAS TIME OUT

CANNOT DETECT PULSE (NIBP)

SpO2 MODULE ERROR

CHECK PROBE

CHECK PROBE SITE

CANNOT DETECT PULSE (SpO2)

LIGHT INTERFERENCE

REMEASURING

INFLATION PRESS LOW

WEAK PULSE (NIBP)

ZEROING

NO NIBP CHANGE BATTERIES

DETECTING PULSE

WEAK PULSE (SpO2)

ALARMS SUSPENDED

Lowest BATTERY WEAK

Operator’s Manual ZM-540PA/541PA 91

Troubleshooting

If a problem occurs, use the following to ﬁnd and ﬁx it. If the problem still remains after checking

the following, contact your Nihon Kohden representative.

Transmitter

Problem Cause Countermeasure

Nothing is displayed

on the LCD after

turning the power

on.

Batteries are not installed

correctly. The battery polarity is

wrong.

Install the batteries correctly.

Batteries are completely

discharged.

Replace the batteries with new ones.

LCD is difﬁcult to

see (too dark or too

light).

LCD brightness is not

appropriate.

Change the LCD brightness on the

SYSTEM SETUP screen. Refer to the

“Changing SYSTEM SETUP Settings”

section.

Nothing is displayed

on the receiving

monitor after turning

the transmitter

power on.

The channel of the transmitter

and monitor does not match.

Set the correct channel on the monitor.

The software version of the

multiple patient receiver or

central monitor is old.

Upgrade the multiple patient receiver

or central monitor software to receive

signal from the transmitter. The software

version must be 01-09 or later.

Protocol on the transmitter and

monitor does not match.

Set the same protocol on the transmitter

and monitor.

Protocol on the transmitter is

set to 57 but the monitor cannot

receive protocol 57.

Set the protocol on the transmitter to 42.

Refer to the “System Setup Setting List”

section.

Signal receiving

condition is poor.

Another transmitter with the

same channel is used nearby.

Turn the transmitter power off. If the

monitor still receives a signal, there is a

high probability that another transmitter

of the same channel is used nearby.

Follow the instruction of your

channel administrator and use another

transmitter with a different channel.

Signals of another patient are

mixing.

Follow the instructions of your

channel administrator and use another

transmitter of a different channel.

The transmitter is damaged. Contact your Nihon Kohden

representative.

92 Operator’s Manual ZM-540PA/541PA

ECG/Respiration

Problem Cause Countermeasure

The heart rate is

unstable.

Pacing detection setting on the

monitor is not correct.

Turn off the pacing detection setting on the

monitor. When monitoring a pacemaker

patient, turn on pacing detection.

The “CHECK

ELECTRODES”

message appears

on the receiving

monitor.

Electrode lead is disconnected

from the electrode.

Firmly connect the electrode lead to the

electrode.

Electrode lead discontinuity Replace the electrode lead with a new one.

Electrode is not ﬁrmly attached

to the skin.

Replace the electrode with a new one.

Polarization voltage is

abnormally high.

Use Nihon Kohden speciﬁed electrodes.

ECG baseline is

thick (AC hum)

The gel on the electrode is dried

out.

Replace the electrode with a new one.

The gel on the electrode is

coming off.

An electric blanket is used. Cover the blanket with a shield cover.

The hum ﬁlter is set to OFF on

the monitor

Set the ﬁlter to ON.

The heart rate of a

patient who is using

an electric blanket

is unstable on the

receiving monitor.

Pacing pulse detection is turned

ON on the receiving monitor.

Turn OFF the pacing pulse detection on

the receiving monitor.

No heart rate or

ECG is displayed.

“ECG MEASUREMENT”

on the PARAMETER SETUP

screen is set to OFF.

If ECG monitoring is necessary, set “ECG

MEASUREMENT” to ON.

Respiration

waveform

measurement is

unstable.

The gel on the electrode is dried

out.

Replace the electrode with a new one.

The gel on the electrode is

coming off.

No respiration rate

is displayed.

“RESP MEASUREMENT”

on the PARAMETER SETUP

screen is set to OFF.

If respiration monitoring is necessary, set

“RESP MEASUREMENT” to ON.

Operator’s Manual ZM-540PA/541PA 93

SpO2

Problem Cause Countermeasure

SpO2 data is unstable

and not reliable.

The probe size is not

appropriate for the patient.

Use the appropriate probe for the

patient.

Probe attachment condition

is poor. The probe is partly

detached from the skin.

External light is entering the

probe.

Firmly attach the probe according to

the procedure in the probe operator’s

manual.

Measurement site is dirty.

Patient is wearing nail polish.

Remove dirt and nail polish.

The probe is attached to the

same limb that is used for NIBP

measurement.

Attach the probe to the opposite limb.

Avoid a site where blood circulation

condition changes greatly.

NIBP

Problem Cause Countermeasure

Cuff inﬂation pressure

is less than 10 mmHg.

The cuff hose is not connected

to the NIBP socket properly.

Connect the cuff hose to the socket

properly.

The cuff is not wrapped around

the arm or is wrapped too

loosely.

Wrap the cuff around the upper arm.

The cuff does not

inﬂate when the NIBP

Start/Stop key is

pressed.

The cuff hose is not connected

to the NIBP socket.

Connect the cuff hose to the socket

ﬁrmly.

The cuff hose or extension hose

may be folded or squeezed

when the cuff pressure display

on the screen increases quickly

but the actual cuff does not

inﬂate.

Check the cuff hose and air hose.

Abnormal

measurement results

are displayed.

The cuff size is not correct. Select the cuff which ﬁts the patient’s

limb circumference.

The cuff is not wrapped around

the arm correctly.

Wrap the cuff around the upper arm, not

too tightly or too loosely.

NIBP data is not correct

because of body movement.

Prevent the patient from moving during

measurement.

Vibration on the cuff. Check that nothing is touching the cuff

during measurement.

Change the measuring site.

94 Operator’s Manual ZM-540PA/541PA

Problem Cause Countermeasure

The cuff is suddenly

deﬂated during

inﬂation.

The NIBP Start/Stop key is

pressed during inﬂation. —

Auto mode

measurement does

not start even when

the time interval has

passed.

The NIBP Interval key is

pressed and the measurement

mode is changed.

Check the measurement mode and

interval.

The cuff suddenly

inﬂates.

The measurement mode is set to

auto mode.

Check the time interval. If necessary,

stop measurement.

Cannot connect cuff to

the air hose.

Unspeciﬁed cuff is used. Use a cuff speciﬁed by Nihon Kohden.

Cannot measure NIBP. Vibration on the cuff. Check that nothing is touching the cuff

during measurement.

The cuff hose or extension hose

is bent or squeezed.

Remove the cause.

The cuff has worn out. Use a new cuff.

Blood congestion

occurs.

Measuring over a long period of

time at short intervals.

Increase the measuring interval.

Do not measure NIBP over a long time.

Thrombus occurs. Measuring on a patient with

known bleeding disorders or

coagulation.

Do not perform NIBP measurement on

such a patient.

NIBP data on the

screen is --- or dark.

The time set for “OLD NIBP

DATA” on the PARAMETER

SETUP screen elapsed from the

last measurement.

When NIBP is measured again, the data

is displayed in normal brightness.

Three loud pip sounds

indicating NIBP

measurement cannot

be started.

The cuff is not deﬂated enough

to start another measurement.

Wait 30 seconds and measure again.

Operator’s Manual ZM-540PA/541PA 95

Maintenance

To use the transmitter in safe and optimum condition, perform maintenance check every six months.

The following units are necessary for some checking items.

• AX-400G Vital Sign Simulator

• AX-300T SpO2 Checker

• Electric or mercury manometer

• 700 mL dummy cuff

• Receiving monitor

CAUTION

Never disassemble or repair the transmitter. Disassembly and repair must be

performed by qualiﬁed service personnel.

NOTE

• The measurement accuracy of the above units must be managed to perform accurate

maintenance check.

• For details on the operation of the above units, refer to the manuals provided with these

units.

A maintenance check sheet is provided at the end of this section. Make a copy of this check sheet

before performing maintenance check.

1. External Check

• There is no damage or dirt on the outside of the transmitter.

• The battery case cover is not damaged, the spring is ﬁrmly attached and the battery case cover can

be closed ﬁrmly.

• No keys are damaged.

• NIBP socket is not damaged.

• No electrode leads are damaged.

• There are no blood or chemicals on the transmitter.

2. Transmitter Channel

• The channel number label on the transmitter is not torn or removed.

• The channel of the transmitter matches the label.

The transmitter channel is displayed in the upper left corner of the screen. The channel number

also appears on the startup screen.

96 Operator’s Manual ZM-540PA/541PA

Channel number

Startup screen Numeric and waveform screen

3. Transmitting/Receiving Signal

Use the AX-400G vital sign simulator and receiving monitor.

1. Connect the vital sign simulator to the transmitter.

AX-400G

2. Place the transmitter 2 to 3 m from the receiving monitor.

3. Set the channel on the receiving monitor to the channel of the transmitter.

4. Turn on the transmitter and vital sign simulator.

5. Check that the ECG of the transmitter appears on the receiving monitor.

6. Turn off the transmitter.

7. Check that the ECG disappears from the receiving monitor.

4. Display

Check that there are no dots missing on the screen.

1. Turn off the transmitter.

2. While pressing the Function key, turn on the transmitter. The MENU screen appears.

Operator’s Manual ZM-540PA/541PA 97

3. Press the

▼

key to move the cursor to “MANUAL CHECK” and press the Function key.

Cursor

4. Press the

▼

key to move the cursor to “LCD TEST” and press the Function key.

5. Each time the

▼

key is pressed, the screen changes as below. Check that no dots are missing.

→ → → →

red → green → blue → → . . .

6. Press the Screen key to return to the MANUAL CHECK screen.

7. Press the Screen key again to return to the MENU screen.

98 Operator’s Manual ZM-540PA/541PA

5. Key Operation

1. Turn off the transmitter.

2. While pressing the Function key, turn on the transmitter. The MENU screen appears.

3. Press the

▼

key to move the cursor to “MANUAL CHECK” and press the Function key.

Cursor

4. Press the

▼

key to move the cursor to “KEY CHECK” and press the Function key.

5. Press each key one at a time and check that the pressed key is highlighted on the screen.

Example: when

the Function key is

pressed, the key name

is highlighted

6. After checking, press and hold the Screen key to return to the MANUAL CHECK screen.

Operator’s Manual ZM-540PA/541PA 99

6. ECG Check

1. Connect the vital sign simulator to the transmitter.

AX-400G

2. Place the transmitter 1 m from the receiving monitor.

3. Turn on the transmitter and vital sign simulator.

4. Check that the ECG of the transmitter appears on the receiving monitor.

7. Respiration Check

1. Connect the vital sign simulator to the transmitter.

AX-400G

2. Place the transmitter 1 m from the receiving monitor.

3. Turn on the transmitter and vital sign simulator.

4. Check that the respiration waveform of the transmitter appears on the receiving monitor.

100 Operator’s Manual ZM-540PA/541PA

8. SpO2 Check

1. Connect the SpO2 checker to the transmitter.

AX-300T

2. Place the transmitter 1 m from the receiving monitor.

3. Turn on the transmitter and SpO2 checker.

4. Check that the pulse bar graph appears on the transmitter screen.

5. Check that SpO2 and pulse rate on the transmitter is within the following range.

SpO2 on the SpO2 Checker Range

SpO297% 95 to 99%SpO2 (±2 digit)

80% 78 to 82%SpO2 (±2 digit)

70% 67 to 73%SpO2 (±3 digit)

Pulse rate 60 beats/min 57 to 62 beats/min (±3%/±1 beat/min)

120 beats/min 115 to 124 beats/min (±3%/±1 beat/min)

NOTE

The above range includes the error margin of the SpO2 checker. Therefore, the range is ±1

digit outside the SpO2 measuring accuracy of the transmitter in the “Speciﬁcations” section.

6. Check that the SpO2 and pulse waveform of the transmitter appear on the receiving monitor.

Operator’s Manual ZM-540PA/541PA 101

9. NIBP Check

Check that the transmitter displays the correct cuff pressure and that there is no air leak. The

following procedure uses an electric manometer.

1. Connect the electric manometer and dummy cuff to the transmitter.

NOTE

Air leaks from the rubber ball during inﬂation. Use a clip on the air hose of the rubber ball to

stop air leaking.

Electric manometer Dummy cuff (700 cc)

Clip

Rubber ball

2. Turn on the electric manometer.

3. While pressing the Function key, turn on the transmitter. The MENU screen appears.

4. Press the

▼

key to move the cursor to “MANUAL CHECK” and press the Function key.

Cursor

102 Operator’s Manual ZM-540PA/541PA

5. Press the

▼

key to move the cursor to “NIBP HARDWARE TEST” and press the

Function key.

6. Press the

▼

key to move the cursor to “AIR LEAK TEST” and press the Function key.

7. Press the

▼

key to move the cursor to “AIR LEAK (AUTO)” and press the Function key.

The transmitter inﬂates the cuff up to about 250 mmHg and measures air leakage from 60

seconds to 120 seconds after inﬂation.

Operator’s Manual ZM-540PA/541PA 103

8. Check the following.

• The value for “AIR LEAK (AUTO)” is below 10 mmHg.

• The difference between the pressure value displayed on the manometer and transmitter is

within ±6 mmHg.

10. NIBP Cuff for Attaching Transmitter to Patient Arm

The NIBP cuff is a consumable. Check the following and when necessary, replace it with a new one.

Appearance

• There are no dirty parts.

• There are no broken stitches on the cuff.

• The label on the cuff is readable.

• The velcro tape on the cuff is not removed and there are no broken stitches.

• The lock plate is not damaged and functions properly.

Inﬂation bag

• The inﬂation bag is not torn or damaged.

• There is no water inside the inﬂation bag.

• The connector on the inﬂation bag is not damaged.

104 Operator’s Manual ZM-540PA/541PA

Maintenance Check Sheet

Hospital/Organization:

Service Personnel:

Instrument Name: Transmitter

Instrument Model: ZM-540PA/ZM-541PA

Instrument Serial Number:

Hardware Revision Number:

Software Revision Number:

1. External Check OK No

2. Transmitter Channel OK No

3. Transmitting/Receiving Signal OK No

4. Display OK No

5. Key Operation OK No

6. ECG Check OK No

7. Respiration Check OK No

8. SpO2 Check OK No

9. NIBP Check OK No

10. NIBP Cuff for Attaching Transmitter to Patient Arm OK No

Overall Judgement

□ OK

□ Can be used but needs maintenance

□ Maintenance required. Cannot be used.

Operator’s Manual ZM-540PA/541PA 105

Lifetime and Disposal

CAUTION

Dispose of the transmitter, options and accessories as speciﬁed by Nihon Kohden.

Otherwise, it causes infection or environmental contamination.

Disposing of Used Batteries

Battery Lifetime

Replace the batteries when the battery replacement indication appears on the transmitter. When

using rechargeable batteries, recharge them.

Disposal

NOTE

Remove the batteries before disposing of the transmitter.

Before disposing of the batteries, check with your local solid waste ofﬁcials for details in your area

for proper disposal. It may be illegal to dispose of these batteries in the municipal waste stream.

Disposing of Electrodes, SpO2 Probes and NIBP Cuffs

Refer to the manual for each item.

Disposing of Transmitter

Remove the batteries from the transmitter and dispose of the transmitter following your local laws

for disposal.

106 Operator’s Manual ZM-540PA/541PA

Cleaning, Disinfection and Sterilization

Transmitter and Electrode Leads

CAUTION

This transmitter is not waterproof. If detergent or liquid spills into the transmitter, stop

cleaning or disinfecting it and contact your Nihon Kohden representative. The

transmitter needs to be checked for safety and function before use.

NOTE

The transmitter cannot be sterilized. Sterilizing the transmitter may damage it.

Before cleaning or disinfecting, remove the batteries from the transmitter. Be careful not to let any

liquid get inside the transmitter.

Cleaning

Wipe the transmitter and electrode leads with a soft cloth moistened with disinfecting alcohol or

neutral detergent diluted with water. After cleaning, dry them completely.

Use cotton swab moistened with neutral detergent diluted with water to clean inside the battery

compartment.

Disinfection

CAUTION

Do not immerse the electrode lead connector in liquid.

Wipe the outside surface of the transmitter and electrode lead with a non-abrasive cloth moistened

with any of the disinfectants listed below. For details on the disinfectants, refer to the instruction

provided with the disinfectants. Use the recommended concentration.

Disinfectant Concentration (%)

Glutaraldehyde solution 2.0

Alkyldiaminoethylglycine hydrochloride 0.5

Benzalkonium chloride 0.2

Benzethonium chloride solution 0.2

Chlorhexidine gluconate solution 0.5

Operator’s Manual ZM-540PA/541PA 107

SpO2 Probe

Refer to the probe manual.

YP-503P/YP-504P NIBP Cuffs

NOTE

• Do not autoclave the cuff.

• Use only glutaraldehyde solution.

• Never allow liquid to get inside the inﬂation bag.

• Do not sterilize or disinfect the cuff with ultraviolet light or ozone.

Cleaning

To clean the cuff, remove the lock plate and carefully pull out the inﬂation bag from the cloth cover.

Cloth cover: Wash with neutral detergent and water. Thoroughly dry it. When washing in a washing

machine, put it in a net.

Inﬂation bag:

Wipe with a soft cloth or cotton moistened with isopropyl alcohol. Thoroughly dry it.

Disinfection

To disinfect the cuff, use glutaraldehyde solution. Use the recommended concentration of the

disinfectant. Refer to the disinfectant manual for details. After disinfection, clean the cuff as

described above.

Repair Parts Availability Policy

Nihon Kohden Corporation (NKC) shall stock repair parts (parts necessary to maintain the

performance of the instrument) for a period of 8 years from the date of delivery. In that period NKC

or its authorized agents will repair the instrument. This period may be shorter than 8 years if a board

or part necessary for the faulty section is not available.

108 Operator’s Manual ZM-540PA/541PA

Speciﬁcations

ZM-540PA

Measuring Parameters

Measuring waveforms: ECG, respiration in impedance method, pulse

Measuring numeric data: Heart rate, respiration rate, SpO2, NIBP, pulse rate

Transmitting Data

Waveform data: ECG, respiration, pulse wave

Numeric data: SpO2, NIBP, pulse rate

Status information: Battery replacement, battery level*, alarm suspended,

pause monitoring*, patient conﬁrmed*, ECG lead, pacing

detection, electrode detachment, electrode impedance*,

ECG off*, respiration method (impedance)*, SpO2 status,

NIBP status, channel ID, time constant (3.2 s), type of

transmitter, transmitter code number*, transmitter serial

number*

* The items marked with * are transmitted only when the protocol is “57”.

Display

Display size: 2.2 inch TFT color LCD

Viewing area: 44.16 (H) × 33.12 (V) mm

Resolution: 320 (H) × 240 (V) dots

Displayed Data

Numeric and waveform screen: ECG (one waveform from lead I, II, III, Va or Vb), heart

rate, pulse rate, respiration rate, SpO2, NIBP (systolic,

diastolic, MAP), message, battery level, QRS/pulse sync

mark, pulse bar graph, NIBP measurement mode and status

information, ECG lead

Waveform review screen: ECG or pulse wave of past 10 minutes

Numeric review screen: Heart rate or pulse rate, respiration rate and SpO2 at 1

minute interval for past 10 minutes

Check electrodes screen: ECG for checking electrode attachment

ECG

ECG measurement

Channels: 4

Operator’s Manual ZM-540PA/541PA 109

Input dynamic range: ±10 mV or more

Electrode offset potential tolerance: ±500 mV or more

Input impedance: 5 MΩ or more

Common mode rejection ratio: 95 dB or more

IEC 60601-2-27 50.102.10 complied

Pacing pulse detection: amplitude ±2 to 700 mV, duration 0.1 to 2 ms

IEC 60601-2-27: 2005 complied

Based upon pacemaker pulse rejection capability

Deﬁbrillation-proof: ECG input protected against 400 Ws/DC 5 kV

IEC 60601-2-27 17.101 complied

ECG recovery time after deﬁbrillation: within 10 s

Electrode condition: Displays CHECK ELECTRODES message

Tall T-wave rejection capability: Complies with the heights of T-waves from 0 to 1.6 mV

IEC 60601-2-27: 2005 50.102.17 complied

Pacemaker pulse rejection capability, without overshoot:

Complies with the amplitudes of pacemaker pulses ±2 to

±700 mV and widths 0.1 to 2 ms (As deﬁned by method B

of IEC 60601-2-27: 2005 50.102.13, this corresponds to the

pacemaker pulses amplitudes and widths of ±2.8 mV/2 ms

to amplitudes ±45.6 mV/0.1 ms.)

Pacemaker pulse rejection capability, with overshoot:

Overshoot amplitudes and time constants of ±0.12

mV/100 ms to ±2 mV/4 ms (As deﬁned by method B of

IEC 60601-2-27: 2005 50.102.13, this corresponds to the

pacemaker pulses amplitudes and widths of ±2.8 mV/2 ms

to amplitudes ±45.6 mV/0.1 ms.)

ECG display and heart rate count

Frequency characteristic: ﬁlter on: 1 to 18 Hz, ﬁlter off: 0.05 to 60 Hz

Heart rate detection method: Average

QRS detection: 70 to 120 ms: amplitude ≥ 0.5 mV, rate 30 to 200 beats/min

40 to 120 ms: amplitude ≥ 0.5 mV, rate 30 to 250 beats/min

Heart rate counting range: 0, 15 to 300 beats/min

Heart rate counting accuracy*: ±2 beats/min, (0, 15 to 300 beats/min)

* Essential performance of this transmitter

Respiration Measurement

Measuring method: Impedance method

Measuring lead: Between R and F

Impedance range: 2 kΩ or less

Respiration rate measuring accuracy*: ±2 counts/min (at 0 to 150 counts/min)

Respiration rate counting range: 0 to 150 counts/min

* Essential performance of this transmitter

110 Operator’s Manual ZM-540PA/541PA

SpO2 Measurement (ISO 9919: 2005 complied)

Measuring range: 0 to 100%SpO2

Declared range: 70 to 100%SpO2

Minimum display range: 1%SpO2

Display update cycle: Every 3 seconds

Measuring accuracy (rms)*: Accuracy assurance temperature: 18 to 40ºC

Total accuracy including probe: 80%SpO2 ≤ %SpO2 ≤ 100%SpO2: ±2%SpO2

70%SpO2 ≤ %SpO2 < 80%SpO2: ±3%SpO2

under 70%SpO2: not speciﬁed

Accuracy of the transmitter: 80%SpO2 ≤ %SpO2 ≤ 100%SpO2: ±1%SpO2

50%SpO2 ≤ %SpO2 < 80%SpO2: ±2%SpO2

under 50%SpO2: not speciﬁed

Pulse rate measuring range: 30 to 300 bpm

Pulse rate display range: 30 to 300 bpm

Pulse rate accuracy (rms)*: ±3% ±1 bpm

* Essential performance of this transmitter

NOTE

• The SpO2 measuring accuracy was tested using the TL-201T, TL-260T, TL-271T and

TL-631T SpO2 probes. The testing was performed during induced hypoxia on healthy

volunteers (Ethnicity: 10 Caucasians, 2 Africans, 1 Asian and 3 Indians), (Skin: 8 light,

4 medium, 4 dark), (Age: 21 to 34), (5 women and 11 men) under the condition of no

motion. Arterial blood was sampled and measured by a CO-oximeter. The difference

between SpO2 measured by the SpO2 probe and functional SaO2 measured by a CO-

oximeter was calculated using the root-mean-square (rms) method according to ISO

9919: 2005. This measurement accuracy ﬁgure represents 2/3 of all test measurements.

• A pulse oximeter tester that generates simulated signals can be used to check the

difference from the design speciﬁcation, but it cannot be used as a replacement for

human signals for testings accuracy.

Response time:

Selectable from “Slow”, “Normal” and “Fast”.

The following graphs show the response time example when SpO2 changes 0.6%/s.

Operator’s Manual ZM-540PA/541PA 111

Pulse Rate = 70 bpm

100

0 10 20 30 40 50 60 70 80 90 100 110 120 130 140

Time (seconds)

SpO2 (%)

SpO

Reference SpO

Fast SpO

Normal SpO

Slow

100

0 10 20 30 40 50 60 70 80 90 100 110 120 130 140

SpO

Reference SpO

Fast SpO

Normal

Pulse Rate = 140 bpm

Time (seconds)

SpO

(%)

SpO

Slow

The following graph shows the response time example when pulse rate changes 10 bpm/s.

SpO

= 97

100

110

120

130

140

150

0 102030405060708090100110120

Time (seconds)

PR (bpm)

PR Reference

112 Operator’s Manual ZM-540PA/541PA

Non Invasive Blood Pressure, NIBP (IEC 60601-2-30: 1999 complied)

Measuring method: Oscillometric

Measurement mode: Manual, STAT (≤ 15 min), Periodic

Intended patient type: Adult, child

Measuring range: 0 to 300 mmHg

Pressure display range: 0 to 300 mmHg

Measuring accuracy*: ±3 mmHg (0 mmHg ≤ NIBP ≤ 300 mmHg)

AAMI SP-10: 2002 complied

Cuff inﬂation time: ≤ 20 s (700 cc), 0 to 200 mmHg

≤ 15 s (70 cc), 0 to 200 mmHg

Pressure retention: ≤ 5 mmHg (250 cc at 250 mmHg inﬂation for 10 seconds)

Air leakage: ≤ 3 mmHg/min (700 cc at 300 mmHg inﬂation)

Power discontinuity: Deﬂate immediately after power down

Safety

Maximum pressurization value cuff inﬂation limiter: 300 to 330 mmHg

Cuff inﬂation time limiter: ≤ 180 s

Interval time limiter: ≤ 30 s

* Essential performance of this transmitter

Transmitter

FCC regulation: FCC part 95 Subpart H

Wireless Medical Telemetry Service (WMTS)

Field strength limits: < 200 mV/m (at 3 m)

Undesired emissions: below 960 MHz: < 200 μV/m (at 3 m)

above 960 MHz: < 500 μV/m (at 3 m)

Antenna: Internal

Transmission channel: Indicated on the transmitter

Transmission frequency range: 608.0250 to 613.9750 MHz

Channel spacing: 50 kHz or 37.5 kHz (12.5 kHz when interleaved)

Modulation: FSK (frequency shift keying)

Type of emission: F1D

Occupied bandwidth: < 20 kHz

Effective radiated power: 1.0 mW

Power Requirements

Rated voltage: 3.6 V

Operating voltage: 3.2 to 4.8 V

Battery type: Three AA (R6) type NiMH secondary batteries

Three AA (R6) type alkaline dry cell primary batteries

Battery lifetime (with alkaline batteries, at room temperature):

approximately 1 day

(measuring ECG, respiration, SpO2 of approximately 60 kg

weight adult male patient at the index ﬁnger, NIBP at 60

minute intervals)

Operator’s Manual ZM-540PA/541PA 113

Dimension and Weight

Dimension: 114 W × 125 H × 63 D (mm)

Weight: about 340 g (excluding batteries and other accessories)

about 410 g (including batteries, excluding other

accessories)

Environment

Operating environment

Temperature: 5 to 40°C, 41 to 104°F

Humidity: 30 to 85% (noncondensing)

Atmospheric pressure: 700 to 1060 hPa

Storage and transport environment

Temperature: −20 to +65°C, −4 to +149°F

Humidity: 10 to 95%

Atmospheric pressure: 700 to 1060 hPa

Safety Standards

Safety standard: CAN/CSA-C22.2 No. 601-1 M90

CAN/CSA-C22.2 No. 601-1. 1S1-94

CAN/CSA-C22.2 No. 601-1. 1B-90

CAN/CSA-C22.2 No. 60601-2-49-04

CAN/CSA-C22.2 No. 60601-2-27-06

CAN/CSA-C22.2 No. 60601-2-30-02

IEC 60601-1:1988

IEC 60601-1 Amendment 1: 1991

IEC 60601-1 Amendment 2: 1995

IEC 60601-2-27: 2005

IEC 60601-2-30: 1999

IEC 60601-2-49: 2001

ISO 9919: 2005

Type of protection against electrical shock: INTERNALLY POWERED EQUIPMENT

Degree of protection against electrical shock:

ECG and impedance method respiration: DEFIBRILLATION-PROOF TYPE CF APPLIED

PART

SpO2 and NIBP: DEFIBRILLATION-PROOF TYPE BF APPLIED

PART

Degree of protection against harmful ingress of water: IPX0 (Ordinary equipment)

Degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE

WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE:

Equipment not suitable for use in the presence of

FLAMMABLE ANAESTHETIC MIXTURE WITH

AIR, OR WITH OXYGEN OR NITROUS OXIDE

114 Operator’s Manual ZM-540PA/541PA

Mode of operation: CONTINUOUS OPERATION

Electromagnetic Compatibility

IEC 60601-1-2: 2001

IEC 60601-1-2 Amendment 1: 2004

Electromagnetic Emissions

This Model ZM-540PA is intended for use in the electromagnetic environment speciﬁed below.

The customer or the user of the ZM-540PA should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1 The ZM-540PA uses RF energy only for its internal

function. Therefore, its RF emissions are very

low and are not likely to cause any interference in

nearby electronic equipment.

RF emissions

CISPR 11

Class B The ZM-540PA is suitable for use in all

establishments, including domestic establishments.

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage ﬂuctuations/

ﬂicker emissions

IEC 61000-3-3

Not applicable

Operator’s Manual ZM-540PA/541PA 115

Electromagnetic Immunity

This Model ZM-540PA is intended for use in the electromagnetic environment speciﬁed below.

The customer or the user of the ZM-540PA should assure that it is used in such an environment.

Immunity test IEC 60601 test

level

Compliance

level

Electromagnetic

environment - guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete

or ceramic tile. If ﬂoors are

covered with synthetic material,

the relative humidity should be at

least 30%.

Electrical fast

transient/ burst

IEC 61000-4-4

±2 kV for power

supply lines

±1 kV for input/output

lines

Not applicable

—

Surge

IEC 61000-4-5

±1 kV differential

mode

±2 kV common mode

Not applicable

—

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

<5% UT (>95% dip in

UT) for 0.5 cycle

40% UT (60% dip in

UT) for 5 cycles

70% UT (30% dip in

UT) for 25 cycles

<5% UT (>95% dip in

UT) for 5 s

Not applicable

—

Power frequency

(50/60 Hz)

magnetic ﬁeld

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic ﬁelds

should be at levels characteristic

of a typical location in a

typical commercial or hospital

environment.

NOTE: UT is the AC mains voltage prior to application of the test level

Avoiding Electromagnetic Interference (Impedance Respiration)

Impedance respiration measurement is very sensitive and affected by electromagnetic interference.

Technological limitations do not allow immunity levels higher than 1 V/m for radiated RF

electromagnetic ﬁelds. Electromagnetic ﬁelds with ﬁeld strengths above 1 V/m may cause

measurement error. Do not use electrically radiating equipment near the impedance respiration

measurements.

116 Operator’s Manual ZM-540PA/541PA

Immunity test IEC 60601 test

level

Compliance

level

Electromagnetic environment

- guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3 Vrms

3 V/m 80 MHz to

2.5 GHz

(1 V/m 80 MHz

to 2.5 GHz for

respiration)

Portable and mobile RF communications

equipment should be used no closer to any

part of the ZM-540PA, including cables,

than the recommended separation distance

calculated from the equation applicable to

the frequency of the transmitter.

Recommended separation distance

d = 1.2㺕P

d = 1.2㺕P 80 MHz to 800 MHz

d = 2.3㺕P 800 MHz to 2.5 GHz

(d = 3.5㺕P 80 MHz to 800 MHz for

respiration

d = 7.0㺕P 800 MHz to 2.5 GHz for

respiration)

where P is the maximum output power

rating of the transmitter in watts (W)

according to the transmitter manufacturer

and d is the recommended separation

distance in meters (m).

Field strengths from ﬁxed RF transmitters,

as deter mined by an electromagnetic

site survey*1, should be less than the

compliance level in each frequency

range*2.

Interference may occur in the vicinity of

equipment marked with the following

symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reﬂection from structures, objects and people.

*1 Field strengths from ﬁxed transmitters, such as base stations for radio (cellular/cordless) telephones and

land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted

theoretically with accuracy. To assess the electromagnetic environment due to ﬁxed RF transmitters, an

electromagnetic site survey should be considered. If the measured ﬁeld strength in the location in which

the ZM-540PA is used exceeds the applicable RF compliance level above, the ZM-540PA should be

observed to verify normal operation. If abnormal performance is observed, additional measures may be

necessary, such as re-orienting or relocating the ZM-540PA.

*2 Over the frequency range 150 kHz to 80 MHz, ﬁeld strengths should be less than 1 V/m for respiration

and 3 V/m for all other functions.

Operator’s Manual ZM-540PA/541PA 117

Recommended Separation Distances between Portable and Mobile RF

Communications Equipment

The ZM-540PA is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the ZM-540PA can help prevent

electromagnetic interference by maintaining a minimum distance between portable and mobile RF

communications equipment (transmitters) and the ZM-540PA as recommended below, according to

the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

(W)

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz

d = 1.2㺕P

80 MHz to 800 MHz

d = 1.2㺕P

(For respiration:

d = 3.5㺕P)

800 MHz to 2.5 GHz

d = 2.3㺕P

(For respiration:

d = 7.0㺕P)

0.01 0.12 0.12 (0.35*) 0.23 (0.7*)

0.1 0.38 0.38 (1.1*) 0.73 (2.2*)

1 1.2 1.2 (3.5*) 2.3 (7.0*)

10 3.8 3.8 (11*) 7.3 (22*)

100 12 12 (35*) 23 (70*)

For transmitters rated at a maximum output power not listed above, the recommended separation

distance d in meters (m) can be estimated using the equation applicable to the frequency of the

transmitter, where P is the maximum output power rating of the transmitter in watts (W) according

to the transmitter manufacturer.

(* For respiration)

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reﬂection from structures, objects and people.

Recovery Time after Deﬁbrillation

The transmitter returns to the normal operating mode within 10 seconds after deﬁbrillation. The

stored settings are not affected.

System Composition for EMC Test

The ZM-540PA bedside monitor is tested to comply with IEC 60601-1-2: 2001 with the following

composition.

Units Cable length

ZM-540PA transmitter —

YP-503P NIBP cuff 0.15 m

BR-906P ECG electrode lead 0.8 m

TL-201T ﬁnger probe 1.6 m

118 Operator’s Manual ZM-540PA/541PA

ZM-541PA

Measuring Parameters

Measuring waveforms: ECG, respiration in impedance method, pulse

Measuring numeric data: Heart rate, respiration rate, SpO2, NIBP, pulse rate

Transmitting Data

Waveform data: ECG, respiration, pulse wave

Numeric data: SpO2, NIBP, pulse rate

Status information: Battery replacement, battery level*, alarm suspended,

pause monitoring*, patient conﬁrmed*, ECG lead, pacing

detection, electrode detachment, electrode impedance*,

ECG off*, respiration method (impedance)*, SpO2 status,

NIBP status, channel ID, time constant (3.2 s), type of

transmitter, transmitter code number*, transmitter serial

number*

* The items marked with * are transmitted only when the protocol is “57”.

Display

Display size: 2.2 inch TFT color LCD

Viewing area: 44.16 (H) × 33.12 (V) mm

Resolution: 320 (H) × 240 (V) dots

Displayed Data

Numeric and waveform screen: ECG (one waveform from lead I, II, III, Va or Vb), heart

rate, pulse rate, respiration rate, SpO2, NIBP (systolic,

diastolic, MAP), message, battery level, QRS/pulse sync

mark, pulse bar graph, NIBP measurement mode and status

information, ECG lead

Waveform review screen: ECG or pulse wave of past 10 minutes

Numeric review screen: Heart rate or pulse rate, respiration rate and SpO2 at 1

minute interval for past 10 minutes

CHECK ELECTRODE screen: ECG for checking electrode attachment

ECG

ECG measurement

Channels: 4

Input dynamic range: ±10 mV or more

Electrode offset potential tolerance: ±500 mV or more

Input impedance: 5 MΩ or more

Common mode rejection ratio: 95 dB or more

IEC 60601-2-27 50.102.10 complied

Operator’s Manual ZM-540PA/541PA 119

Pacing pulse detection: amplitude ±2 to 700 mV, duration 0.1 to 2 ms

IEC 60601-2-27: 2005 complied

Based upon pacemaker pulse rejection capability

Deﬁbrillation-proof: ECG input protected against 400 Ws/DC 5 kV

IEC 60601-2-27 17.101 complied

ECG recovery time after deﬁbrillation: within 10 s

Electrode condition: Displays CHECK ELECTRODES message

Tall T-wave rejection capability: Complies with the heights of T-waves from 0 to 1.6 mV

IEC 60601-2-27: 2005 50.102.17 complied

Pacemaker pulse rejection capability, without overshoot:

Complies with the amplitudes of pacemaker pulses ±2 to

±700 mV and widths 0.1 to 2 ms (As deﬁned by method B

of IEC 60601-2-27: 2005 50.102.13, this corresponds to the

pacemaker pulses amplitudes and widths of ±2.8 mV/2 ms

to amplitudes ±45.6 mV/0.1 ms.)

Pacemaker pulse rejection capability, with overshoot:

Overshoot amplitudes and time constants of ±0.12

mV/100 ms to ±2 mV/4 ms (As deﬁned by method B of

IEC 60601-2-27: 2005 50.102.13, this corresponds to the

pacemaker pulses amplitudes and widths of ±2.8 mV/2 ms

to amplitudes ±45.6 mV/0.1 ms.)

ECG display and heart rate count

Frequency characteristic: ﬁlter on: 1 to 18 Hz, ﬁlter off: 0.05 to 60 Hz

Heart rate detection method: Average

QRS detection: 70 to 120 ms: amplitude ≥ 0.5 mV, rate 30 to 200 beats/min

40 to 120 ms: amplitude ≥ 0.5 mV, rate 30 to 250 beats/min

Heart rate counting range: 0, 15 to 300 beats/min

Heart rate counting accuracy*: ±2 beats/min, (0, 15 to 300 beats/min)

* Essential performance of this transmitter

Respiration Measurement

Measuring method: Impedance method

Measuring lead: Between R and F

Impedance range: 2 kΩ or less

Respiration rate measuring accuracy*: ±2 counts/min (at 0 to 150 counts/min)

Respiration rate counting range: 0 to 150 counts/min

* Essential performance of this transmitter

SpO2 Measurement (ISO 9919: 2005 complied)

Measuring range: 0 to 100%SpO2

Declared range: 70 to 100%SpO2

Minimum display range: 1%SpO2

120 Operator’s Manual ZM-540PA/541PA