Nihon Kohden ZM 540PA, ZM 541PA Users manual

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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.

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.

Operator’s Manual ZM-540PA/541PA i

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.

ii Operator’s Manual ZM-540PA/541PA

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.

Operator’s Manual ZM-540PA/541PA iii

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.

iv Operator’s Manual ZM-540PA/541PA

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.

Operator’s Manual ZM-540PA/541PA v

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.

vi Operator’s Manual ZM-540PA/541PA

Conventions Used in this Manual and Instrument

Warnings, Cautions and Notes

Warnings, cautions and notes are used in this manual to alert or signal the reader to speciﬁc information.

WARNING

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

CAUTION

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

NOTE

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

Operator’s Manual ZM-540PA/541PA vii

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

Attention, consult operator’s manual

Deﬁbrillation proof type BF applied part

Deﬁbrillation proof type CF applied part

Moves cursor, scrolls data Serial number

Direction for attaching battery cover

Direction for inserting battery

Year of manufacture

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

viii Operator’s Manual ZM-540PA/541PA

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

Operator’s Manual ZM-540PA/541PA 1

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.

2 Operator’s Manual ZM-540PA/541PA

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.

Operator’s Manual ZM-540PA/541PA 3

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.

4 Operator’s Manual ZM-540PA/541PA

Rear Panel

Lock plate

Fastens the transmitter to an NIBP cuff.

Refer to the symbol page.

Refer to the WARNING below.

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.

Operator’s Manual ZM-540PA/541PA 5

Top Panel

Refer to the WARNING on the next page.

NIBP socket:

Connects the cuff hose.

Refer to the symbol page.

Bottom Panel

Channel number label:

Indicates the channel number of the transmitter. Attach the channel number label to the panel of the receiving monitor.

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).

Refer to the symbol page.

Refer to the WARNING on the next page.

6 Operator’s Manual ZM-540PA/541PA

SpO2 socket:

Connects the SpO2 probe.

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.

Operator’s Manual ZM-540PA/541PA 7

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

Do not take this transmitter into the MRI test room. This transmitter is not designed to be used during MRI tests.

WARNING

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

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

8 Operator’s Manual ZM-540PA/541PA

WARNING

CAUTION

Only use Nihon Kohden speciﬁed electrodes, electrode leads, SpO probes, and NIBP cuffs. Otherwise, the maximum performance from the transmitter cannot be guaranteed.

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.

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 reuse disposable parts and accessories.

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.

Operator’s Manual ZM-540PA/541PA 9

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 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.

10 Operator’s Manual ZM-540PA/541PA

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.

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

CAUTION

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.

Operator’s Manual ZM-540PA/541PA 11

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 rateadaptive 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.

12 Operator’s Manual ZM-540PA/541PA

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.

CAUTION

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 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

When not monitoring SpO2, disconnect the SpO transmitter. Otherwise, noise from the probe sensor may interfere and incorrect data is displayed on the screen.

cable from the

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/TL631T 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

Operator’s Manual ZM-540PA/541PA 13

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

NIBP and SpO2 can be measured on the same limb, but the SpO monitoring might not be accurate during NIBP measurement. Be careful when reading the SpO

* Monitoring SpO2 during NIBP Measurement When the SpO

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 SpO

cannot be monitored properly. When

“INHIBIT SpO

DURING NIBP” on the

PARAMETER SETUP screen is set to ON (factory default setting), SpO paused during NIBP measurement to avoid SpO

alarm occurrence. However, when

monitoring SpO

on the same limb as the

NIBP, be careful when reading SpO

values.*

monitoring is

values.

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

While a patient is on medication which causes vasodilation, the pulse waveform may change and in rare cases the SpO

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.

14 Operator’s Manual ZM-540PA/541PA

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

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

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

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.

Operator’s Manual ZM-540PA/541PA 15

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

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.

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

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.

16 Operator’s Manual ZM-540PA/541PA

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.

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.

Operator’s Manual ZM-540PA/541PA 17

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

Do not handle the batteries with wet hands.

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

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, SpO temperature, NIBP is measured in auto mode at 60 minute intervals and SpO index ﬁnger of a male patient with weight 60 kg. Operation time depends on the thickness of the SpO

probe attachment site.

and NIBP for approximately 1 day. The measurement is performed at room

is measured on an

Recommended batteries

NiMH secondary: SANYO HR-3UF (W) Battery charger: SANYO NC-M55 Alkaline primary: Nihon Kohden Medipower (equivalent to Panasonic LR6 (G))

18 Operator’s Manual ZM-540PA/541PA

Installing (Replacing) Batteries

CAUTION

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.

Operator’s Manual ZM-540PA/541PA 19

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 “

• 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

” icon.

No indication

Batteries are 2/3 full.

Batteries are low. NIBP cannot be measured. Replace batteries.

Batteries are very weak.

Dead batteries

There is no message on the monitor.

Message requiring battery replacement is displayed.

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.)

20 Operator’s Manual ZM-540PA/541PA

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