Nihon Kohden ZM-930PA WMTS TRANSMITTER User Manual Cover2 ZM920PA 930PA OM A pmd

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TRANSMITTER
ZM-920PA/930PA
If you have any comments or suggestions on
this manual, please contact us at:
www.nihonkohden.com
0614-007205A
Contents
GENERAL HANDLING PRECAUTIONS ......................................... i
WARRANTY POLICY .................................................................... iii
EMC RELATED CAUTION ............................................................. v
Conventions Used in this Manual and Instrument ....................... vii
Warnings, Cautions and Notes ............................................... vii
Explanations of the Symbols in this Manual and Instrument viii
Introduction ......................................................................................... 1
Panel Description ............................................................................... 3
Top Panel ...................................................................................... 3
Front Panel .................................................................................... 4
ZM-920PA ................................................................................ 4
ZM-930PA ................................................................................ 5
Important Safety Information .............................................................. 6
General ......................................................................................... 6
Battery ........................................................................................... 8
Transmitter Channel Management ............................................... 8
For Patients Using Implantable Pacemaker ................................. 9
Output Signal ................................................................................ 9
ECG Monitoring .......................................................................... 10
SpO2 Monitoring .......................................................................... 10
Maintenance ............................................................................... 13
Preparation ....................................................................................... 14
Installing (Replacing) Batteries .................................................. 14
Procedure .............................................................................. 15
WARNING and CAUTION for Battery Handling .......................... 15
Situations Requiring Battery Replacement ................................ 16
Attaching a Strap to the Transmitter ............................................ 16
Turning On/Off the Transmitter .................................................... 17
Check Items Before Turning On the Power ........................... 17
Turning On/Off the Power ...................................................... 17
Operator's Manual ZM-920PA/930PA
Check Items After Turning On the Power ............................... 17
Check Items After the Power Off ............................................ 18
ECG Monitoring ................................................................................ 19
ECG Measurement Procedure ................................................... 20
Selecting Electrode Lead and Disposable Electrode ................ 21
Option .................................................................................... 21
Connecting the Electrode Lead to the Transmitter ..................... 22
Selecting the Electrode Position ................................................. 22
Six Electrodes ....................................................................... 23
When Using 4 to 6 DIN Type Leads to Monitor 6 Lead ECG 24
Three Electrodes ................................................................... 25
Connecting the Electrode Lead and Disposable Electrodes ..... 26
Preparing the Patient Skin .................................................... 26
Attaching Electrodes to the Patient ....................................... 26
Detection and Display of Measurement Condition .................... 27
Electrode Detachment .......................................................... 27
Respiration Monitoring ..................................................................... 28
Respiration Measurement Procedure ........................................ 29
Electrode Position for Respiration Monitoring ............................ 29
Electrode Position Examples ................................................ 29
SpO2 Monitoring ............................................................................... 31
Measurement Procedure ............................................................ 33
Selecting SpO2 Probe ................................................................. 33
Reusable Probes .................................................................. 34
Disposable Probes ................................................................ 35
Connecting SpO2 Probe to the Transmitter ................................. 38
Attaching the Probe to the Patient .............................................. 39
Starting Measurement ................................................................ 40
Turning SpO2 Data and Pulse Level Bar Graph Display On/Off . 41
Detecting and Displaying Measurement Condition ................... 41
External Light Noise Alarm ................................................... 41
Insufficient Light Alarm .......................................................... 42
Probe Malfunction Alarm ....................................................... 42
When Measurement Condition is Unstable .......................... 42
Alarm List .......................................................................................... 43
Troubleshooting ................................................................................ 45
ii
Operator's Manual ZM-920PA/930PA
Changing the Transmitter Channel .................................................. 47
Lifetime and Disposal ....................................................................... 48
Disposing of Used Batteries ....................................................... 48
Replacement ......................................................................... 48
Disposal ................................................................................ 48
Disposing of Electrodes and SpO2 Probes ................................. 48
Cleaning, Disinfection and Sterilization ........................................... 49
Transmitter and Electrode Lead ................................................. 49
Cleaning ................................................................................ 49
Disinfection ............................................................................ 49
SpO2 Probe ................................................................................. 50
Replacing the Battery Case Cover ................................................... 51
Repair Parts Availability Policy ......................................................... 51
Specifications ................................................................................... 52
ECG measurement ................................................................ 52
Respiration measurement .................................................... 52
SpO2 measurement ............................................................... 52
Transmitter ............................................................................. 52
Safety standards ................................................................... 53
Water resistance ................................................................... 54
Power requirements .............................................................. 54
Environment .......................................................................... 54
Dimension and Weight .......................................................... 54
Standard Accessories ...................................................................... 55
Options ............................................................................................. 56
ECG/RESP ............................................................................ 56
SpO2 ...................................................................................... 57
Operator's Manual ZM-920PA/930PA
iii
GENERAL HANDLING PRECAUTIONS
This device is intended for use only by qualified medical personnel.
Use only Nihon Kohden approved products with this device. Use of
non-approved products or in a non-approved manner may affect the
performance specifications of the device. This includes, but is not
limited to, batteries, recording paper, pens, extension cables,
electrode leads, input boxes and AC power.
Please read these precautions thoroughly before attempting to operate
the instrument.
1.
To safely and effectively use the instrument, its operation must be
fully understood.
2.
When installing or storing the instrument, take the following
precautions:
(1) Avoid moisture or contact with water, extreme atmospheric
pressure, excessive humidity and temperatures, poorly ventilated
areas, and dust, saline or sulphuric air.
(2) Place the instrument on an even, level floor. Avoid vibration and
mechanical shock, even during transport.
(3) Avoid placing in an area where chemicals are stored or where there
is danger of gas leakage.
(4) The power line source to be applied to the instrument must
correspond in frequency and voltage to product specifications, and
have sufficient current capacity.
(5) Choose a room where a proper grounding facility is available.
3.
Before Operation
(1) Check that the instrument is in perfect operating order.
(2) Check that the instrument is grounded properly.
(3) Check that all cords are connected properly.
(4) Pay extra attention when the instrument is in combination with
other instruments to avoid misdiagnosis or other problems.
Operator's Manual ZM-920PA/930PA
(5) All circuitry used for direct patient connection must be doubly
checked.
(6) Check that battery level is acceptable and battery condition is good
when using battery-operated models.
4.
During Operation
(1) Both the instrument and the patient must receive continual, careful
attention.
(2) Turn power off or remove electrodes and/or transducers when
necessary to assure the patient’s safety.
(3) Avoid direct contact between the instrument housing and the
patient.
5.
To Shutdown After Use
(1) Turn power off with all controls returned to their original positions.
(2) Remove the cords gently; do not use force to remove them.
(3) Clean the instrument together with all accessories for their next
use.
6.
The instrument must receive expert, professional attention for
maintenance and repairs. When the instrument is not functioning
properly, it should be clearly marked to avoid operation while it is
out of order.
7.
The instrument must not be altered or modified in any way.
8.
Maintenance and Inspection:
(1) The instrument and parts must undergo regular maintenance
inspection at least every 6 months.
(2) If stored for extended periods without being used, make sure prior
to operation that the instrument is in perfect operating condition.
(3) Technical information such as parts list, descriptions, calibration
instructions or other information is available for qualified user
technical personnel upon request from your Nihon Kohden
representative.
ii
Operator's Manual ZM-920PA/930PA
9.
When the instrument is used with an electrosurgical instrument,
pay careful attention to the application and/or location of electrodes
and/or transducers to avoid possible burn to the patient.
10. When the instrument is used with a defibrillator, make sure that the
instrument is protected against defibrillator discharge. If not,
remove patient cables and/or transducers from the instrument to
avoid possible damage.
WARRANTY POLICY
Nihon Kohden Corporation (NKC) shall warrant its products against all
defects in materials and workmanship for one year from the date of delivery.
However, consumable materials such as recording paper, ink, stylus and
battery are excluded from the warranty.
NKC or its authorized agents will repair or replace any products which
prove to be defective during the warranty period, provided these products
are used as prescribed by the operating instructions given in the operator’s
and service manuals.
No other party is authorized to make any warranty or assume liability for
NKC’s products. NKC will not recognize any other warranty, either implied
or in writing. In addition, service, technical modification or any other
product change performed by someone other than NKC or its authorized
agents without prior consent of NKC may be cause for voiding this
warranty.
Defective products or parts must be returned to NKC or its authorized
agents, along with an explanation of the failure. Shipping costs must be prepaid.
This warranty does not apply to products that have been modified,
disassembled, reinstalled or repaired without Nihon Kohden approval or
which have been subjected to neglect or accident, damage due to accident,
Operator's Manual ZM-920PA/930PA
iii
fire, lightning, vandalism, water or other casualty, improper installation or
application, or on which the original identification marks have been removed.
In the USA and Canada other warranty policies may apply.
CAUTION
United States law restricts this device to sale by or on the order
of a physician.
Equipment Authorization Requirement
Operation of this equipment requires the prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry
Service.
iv
Operator's Manual ZM-920PA/930PA
EMC RELATED CAUTION
This equipment and/or system complies with the International
Standard IEC60601-1-2 for electromagnetic compatibility for
medical electrical equipment and/or system. However, an
electromagnetic environment that exceeds the limits or levels
stipulated in the IEC60601-1-2, can cause harmful interference to
the equipment and/or system or cause the equipment and/or
system to fail to perform its intended function or degrade its
intended performance. Therefore, during the operation of the
equipment and/or system, if there is any undesired deviation
from its intended operational performance, you must avoid,
identify and resolve the adverse electromagnetic effect before
continuing to use the equipment and/or system.
The following describes some common interference sources and
remedial actions:
1. Strong electromagnetic interference from a nearby emitter
source such as an authorized radio station or cellular phone:
Install the equipment and/or system at another location if it is
interfered with by an emitter source such as an authorized
radio station. Keep the emitter source such as cellular phone
away from the equipment and/or system.
2.Effect of direct or indirect electrostatic discharge:
Make sure all users and patients in contact with the equipment
and/or system are free from direct or indirect electrostatic
energy before using it. A humid room can help lessen this
problem.
3.Electromagnetic interference with any radio wave receiver
such as radio or television:
If the equipment and/or system interferes with any radio wave
receiver, locate the equipment and/or system as far as
possible from the radio wave receiver.
Operator's Manual ZM-920PA/930PA
If the above suggested remedial actions do not solve the
problem, consult your Nihon Kohden representative for additional
suggestions.
vi
Operator's Manual ZM-920PA/930PA
Conventions Used in this Manual and Instrument
Warnings, Cautions and Notes
Warnings, cautions and notes are used in this manual to alert or signal the
reader to specific information.
WARNING
A warning alerts the user to the possible injury or death
associated with the use or misuse of the instrument.
CAUTION
A caution alerts the user to possible injury or problems with the
instrument associated with its use or misuse such as instrument
malfunction, instrument failure, damage to the instrument, or
damage to other property.
NOTE
A note provides specific information, in the form of
recommendations, prerequirements, alternative methods or
supplemental information.
Operator's Manual ZM-920PA/930PA
vii
Explanations of the Symbols in this Manual and Instrument
The following symbols found in this manual/instrument bear the respective
descriptions as given.
Symbol
Description
Power On
Symbol
Description
Attention, consult
operator’s manual
Power Off
Nurse call
Defibrillation proof
type BF applied part
Replace battery
Defibrillation proof
type CF applied part
Check electrode
Direct current
viii
Operator's Manual ZM-920PA/930PA
Introduction
The ZM-920PA/930PA transmitter transmits ECG and other data from a patient to
a Nihon Kohden monitor for continuous monitoring. Available parameters and
functions vary between the models. Read the operator’s manual for the monitor
before operation.
Model
Parameters
ZM-920PA
• ECG
• Impedance respiration
ZM-930PA
• ECG
• Impedance respiration
• SpO2
Functions
The following information is
indicated by LED.
• Check ECG electrodes
• Replace batteries
The following information is
indicated on LCD.
• SpO2 value
• Pulse wave amplitude
• Replace batteries
The following information is
indicated by LED.
• Check ECG electrodes
The transmitter channel can be changed by the QI-901PK Channel Writer. To
change the channel number, refer to the channel writer manual.
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 assignments.
• The channel administrator must manage the channels in the
facility so that there is no signal interference.
• When the transmitter channel is changed, the channel
administrator must check that the channel on the receiving
monitor is also changed and the signal is properly received.
Operator's Manual ZM-920PA/930PA
• The channel administrator must replace the channel number label
on the transmitter with the new one after changing the channel.
CAUTION
• Do not use the same channel for different patients. If the same
channel is used for two patients, the two patients’ data will be lost
due to mutual modulation interference, or another patient’s data
may appear on the receiving monitor screen.
• Do not use transmitters of adjacent channels in a hospital. If a
transmitter of an adjacent channel is used, radio waves from one
transmitter affects the receiver of the adjacent channel’s
transmitter and there may be interference.
• Do not use the same transmitter on more than one patient at the
same time. Do not connect different sensors on different patients
to the same transmitter.
NOTE
• To prevent interference between channels, assign a channel
administrator in the hospital and only he or she should manage
channel assignment.
• Use Nihon Kohden parts and accessories to assure maximum
performance from your instrument.
• For stable signal reception, it is recommended to use a diversity
antenna system on the receiving monitor. Otherwise, spike noise
from transient fading of electric field strength (for example, people
moving) may interfere with the transmitter signal and may be
mistaken as an arrhythmia on the receiving monitor.
• For details on the receiving monitor and upgrade information,
contact your Nihon Kohden representative.
Operator's Manual ZM-920PA/930PA
Panel Description
Top Panel
For attaching a strap
ZM-930PA only
SpO2 socket
Connects to the SpO2 probe.
Refer to the warnings below
Refer to the symbol page
Refer to the symbol page
Refer to the warnings below
ECG/RESP socket
Connects to the electrode lead for measuring ECG
and/or respiration by the impedance method.
WARNING
• Before defibrillation, check that the electrode leads and SpO2
probe attached to the patient are properly connected to the
transmitter. Touching the metal parts of disconnected leads and
probes may cause electrical shock or injury by discharged energy.
• When performing defibrillation, discharge as far as possible from
electrodes, patches and any gel, cream or medicine on the chest
of the patient. If there is a possibility that the defibrillator paddle
could touch these materials, remove them from the patient. If the
defibrillator paddle directly contacts these materials, the
discharged energy may cause skin burn to the patient.
• Before defibrillation, all persons must keep clear of the bed and
must not touch the patient or any equipment connected to the
patient. Failure to follow this warning may cause electrical shock
or injury.
Operator's Manual ZM-920PA/930PA
Front Panel
ZM-920PA
Power switch
Turns transmitter power on or off.
Replace batteries LED
Lights when the batteries
need replacement.
RA LA LL Va Vb
Check electrodes LED
Lights when the electrode is
detached from the patient.
USAch
9002
608.025 MHz
CALL key
When this key is pressed,
a "peep" sounds at the
transmitter, and "CALL"
message appears at the
monitor. Depending on the
settings on the monitor, an
ECG waveform is recorded
when this key is pressed.
Channel lable
Refer to the warning below. Battery case
Contains two 1.5 V dry cell batteries (AA).
WARNING
Close the battery case cover during operation. If the transmitter is
used with the battery case cover open, anyone who touches the
opened battery case may receive an electrical shock when
defibrillation is performed. Touching the opened battery case may
cause electrostatic discharge and intermittently interfere with the
waveform or data.
CAUTION
Only use your finger to press the CALL key. Do not press the key
with a sharp object, otherwise the key may be damaged.
Operator's Manual ZM-920PA/930PA
ZM-930PA
For the descriptions except for the LCD,
refer to the “ZM-920PA” section on the
previous page.
RA LA LL Va Vb
USAch
9002
608.025 MHz
LCD
Battery replacement mark:
Appears when the batteries
are weak. Immediately
replace the batteries when this
appears.
%SpO2:
Displayed when the power is turned
on. This indication is not displayed
when SpO2 display is turned off.
Pulse level bar graph:
Displays pulse level in 7
steps.
SpO2 data:
Displays SpO2 data.
When SpO2 is 41 to 100%, the value is displayed. (ex. )
When SpO2 is under 40%, “ ” is displayed.
When the detected pulse is too small to measure, “
” is displayed.
Operator's Manual ZM-920PA/930PA
Important Safety Information
General
WARNING
• Never use the transmitter in the presence of any flammable
anesthetic gas or high concentration oxygen atmosphere. Failure
to follow this warning may cause explosion or fire.
• Never use the transmitter in a hyperbaric oxygen chamber.
Failure to follow this warning may cause explosion or fire.
• Never take this transmitter into an MRI test room.
• When performing MRI test, remove all electrodes from the patient
which are connected to this instrument. Failure to follow this
warning may cause skin burn on the patient. For details, refer to
the MRI manual.
• Before defibrillation, check that the electrode leads and SpO2
probe attached to the patient are properly connected to the
transmitter. Touching the metal parts of disconnected leads and
probes may cause electrical shock or injury by discharged energy.
• When performing defibrillation, discharge as far as possible from
electrodes, patches and any gel, cream or medicine on the chest
of the patient. If there is a possibility that the defibrillator paddle
could touch these materials, remove them from the patient. If the
defibrillator paddle directly contacts these materials, the
discharged energy may cause skin burn to the patient.
• Before defibrillation, all persons must keep clear of the bed and
must not touch the patient or any equipment connected to the
patient. Failure to follow this warning may cause electrical shock
or injury.
• 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.
Operator's Manual ZM-920PA/930PA
• Close the battery case cover during operation. If the transmitter is
used with the battery case cover open, anyone who touches the
opened battery case may receive an electrical shock when
defibrillation is performed. Touching the opened battery case may
cause electrostatic discharge and intermittently interfere with the
waveform or data.
CAUTION
• Only use Nihon Kohden specified electrodes, electrode leads and
SpO2 probes. Otherwise, the maximum performance from the
instrument cannot be guaranteed.
• Do not reuse disposable items.
• Do not shake or swing the transmitter while holding the leads or
cables connected to the transmitter. The transmitter may come off
and injure someone or damage surrounding instruments.
• Attach a strap to the transmitter to prevent the transmitter from
falling.
• Turn off the power of mobile phones, small wireless devices and
other devices which produce strong electromagnetic interference
around a patient (except for devices allowed by the hospital
administrator). Radio waves from devices such as mobile phones
or small wireless devices may be mistaken as respiration or pulse
waves and the displayed data may be incorrect.
• Do not use the same channel for different patients. If the same
channel is used for two patients, the two patients’ data will be lost
due to mutual modulation interference, or another patient’s data
may appear on the receiving monitor screen.
• Do not use transmitters of adjacent channels in a hospital. If a
transmitter of an adjacent channel is used, radio waves from one
transmitter affects the receiver of the adjacent channel’s
transmitter and there may be interference.
Operator's Manual ZM-920PA/930PA
Battery
WARNING
• Keep the battery pack away from fire. It may explode.
• Do not damage, disassemble, drop or give impact to the battery. If
the battery is damaged and substance inside the battery contacts
the skin or clothes, wash immediately and thoroughly with water.
• Never short-circuit the + and – terminals on the battery. It may
cause overheating and fire.
• Take care that the patient does not swallow batteries.
CAUTION
• Battery replacement must be performed by the operator. When
replacing batteries of the transmitter currently used for a patient,
disconnect electrode leads from the transmitter before replacing
batteries or do not touch the patient during replacement.
• The battery charger must be used outside the patient environment.
• Refer to the battery and battery charger manuals for details on
handling the batteries.
Transmitter Channel Management
WARNING
The following actions must be taken to properly receive the
transmitter signal of the correct patient on the receiving instrument,
otherwise, there may be signal loss or signals may mix causing a
serious accident, such as monitoring a different patient.
• Assign a channel administrator in the hospital and only he or she
should manage channel assignments.
• The channel administrator must manage the channels in the
facility so that there is no signal interference.
• When the transmitter channel is changed, the channel
administrator must check that the channel on the receiving
monitor is also changed and the signal is properly received.
Operator's Manual ZM-920PA/930PA
• The channel administrator must replace the channel number label
on the transmitter with the new one after changing the channel.
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 the 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 distributor or Nihon
Kohden representative.
Output Signal
CAUTION
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-920PA/930PA
ECG Monitoring
CAUTION
• Only use Nihon Kohden specified electrodes and electrode leads.
When other type of electrodes or electrode leads are used, the
“CHECK ELECTRODE” message may be displayed and monitoring
may stop.
• When the “ELECTRODE OFF” or “CHECK ELECTRODE” message
is displayed on the receiving monitor, ECG is not monitored
properly and the ECG alarm does not function. Check the
electrode and electrode leads, and if necessary, replace with new
ones.
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).
• Check the circulation condition by observing the skin color of the
measuring site and pulse waveform. Change the measuring site
every 8 hours for disposable probes and every 4 hours for
reusable probes. 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.
• A patient with a fever
10
Operator's Manual ZM-920PA/930PA
• A patient with peripheral circulation insufficiency
• Neonate or low birth weight infant with delicate skin
• 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.
• 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 shortterm 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.
CAUTION
• NIBP and SpO2 can be measured on the same limb, but the SpO2
monitoring may not be accurate during NIBP measurement. Be
careful when reading the SpO2 values.
• While a patient is on medication which causes vasodilation, the
pulse waveform may change and in rare cases the SpO2 value
may not be displayed.
• 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.
• 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.
• 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-920PA/930PA
11
• Do not use a probe that is deteriorated by aging. Accurate
measurement cannot be performed.
• Do not use damaged or disassembled probe. It causes incorrect
measurement and may injure the patient.
• 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.
• Do not pull or bend the probe cable, and do not put caster feet on
the probe cable. Do not immerse the 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.
• 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.
• When a message indicates a faulty SpO2 probe, stop monitoring
and replace the probe with a new one.
• When removing a probe that is taped to the skin, do not pull the
probe cable because this can damage the cable.
• Neonatal skin is delicate. Remove the probe and tape carefully
and slowly.
• Do not immerse the disposable probe in detergents or water. If the
probe adhesive surface gets wet, adhesiveness becomes weak
and the probe cannot be attached to the skin.
• Before using the TL-260T multi-site Y probe, be sure to attach the
probe to the sponge attachment tape S or L. Do not use the probe
without the sponge attachment tape attached. Using the probe
without the sponge attachment tape causes incorrect
measurement and may injure the skin at the attachment site.
• When fixing the TL-260T multi-site Y probe with the sponge
attachment tape, confirm that the adhesive part of the tape is not
on the skin. The adhesive may cause oversensitive symptoms on
the skin such as redness or itch. If the adhesive touches the skin,
remove it carefully and slowly because neonatal skin is very
delicate.
12
Operator's Manual ZM-920PA/930PA
• Do not use a dirty sponge attachment tape. The measurement
value may be incorrect.
• When removing the probe from the attachment tape, do not pull the
sensor cable because this can damage the cable.
• Use the sponge attachment tape S and L only with the specified
products.
• Refer to the probe instruction manual for details.
• When any of the following occurs, the probe may be broken.
Replace it with a new one and check the probe.
• The transmitter generates “pip” sound every 0.25 seconds.
• SpO2 data is 85% and blinking.
Maintenance
WARNING
If detergents or dirty liquid spills into the transmitter, clean it and dry
it completely before use. If the wet transmitter is used, the patient or
anyone in contact with the transmitter may receive an electric
shock.
CAUTION
Never disassemble or repair the transmitter. When there is any
problem with the transmitter after maintenance and inspection,
contact your Nihon Kohden representative.
Operator's Manual ZM-920PA/930PA
13
Preparation
Installing (Replacing) Batteries
Use two AA(R6) type alkaline dry cell batteries, manganese dry cell batteries,
NiCd rechargeable batteries or NiMH batteries.
With new alkaline batteries, the transmitter can continuously measure ECG,
respiration and SpO2 for approximately 3 days or ECG and respiration for
approximately 4 days. Operation time depends on the thickness of SpO2 probe
attachment site.
NOTE
The capacity of manganese, NiCd and NiMH batteries is less than
that of alkaline batteries, therefore the lifetime of the battery is
shorter.
Type
Manganese
NiCd
NiMH
Lifetime
About 1/2 of alkaline batteries
About 1/3 of alkaline batteries (when fully charged)
About 1/2 of alkaline batteries (when fully charged)
CAUTION
Battery replacement must be performed by the operator. When
replacing batteries of the transmitter currently used for a patient,
disconnect electrode leads from the transmitter before replacing
batteries, or do not touch the patient during replacement.
If electrode leads are attached to the patient and the person replacing the batteries
touches the patient, the patient leakage current over the amount allowed may
occur.
CAUTION
• Replace both batteries at the same time.
• Do not use different types of batteries together.
14
Operator's Manual ZM-920PA/930PA
NOTE
+ and −
Insert the batteries with the correct polarity (+
−).
Procedure
1. Open the battery case cover.
2. Insert two dry cell batteries (LR6)
into the battery case observing the
correct polarity.
3. Close the cover and press it gently
until it clicks.
WARNING and CAUTION for Battery Handling
WARNING
• Keep the battery pack away from fire. It may explode.
• Do not damage, disassemble, drop or give impact to the battery. If
the battery is damaged and substance inside the battery contacts
the skin or clothes, wash immediately and thoroughly with water.
• Never short-circuit the + and – terminals on the battery. It may
cause overheating and fire.
• Take care that the patient does not swallow batteries.
CAUTION
When the transmitter is not in use, remove batteries or turn the
power OFF. With the power ON, battery power is consumed even if
measurement is not performed. The batteries may become
unusable from overdischarge, and leakage from the battery may
damage the transmitter.
Operator's Manual ZM-920PA/930PA
15
NOTE
• When using rechargeable NiCd batteries or NiMH batteries,
shallow charging/discharging shortens battery capacity. For
details, refer to the battery operator’s manual.
• Remove the batteries from the transmitter before disposing of the
transmitter.
Situations Requiring Battery Replacement
Replace the batteries when any of the following occurs.
• The “ ” LED lights (ZM-920PA) or the “ ” mark is displayed on the LCD
(ZM-930PA) on the transmitter.
• The transmitter generates a constant alarm (continuous “peep” sound).
• The monitor displays the battery replacement message on the screen.
• When the power of the LCD transmitter is turned on, no message or icon is
displayed. (Only the ZM-930PA).
Attaching a Strap to the Transmitter
To open the clip, firmly pull out
the tab in direction of the arrow.
NOTE
• Attach a strap to the transmitter to prevent the transmitter from
falling.
• Do not attach the clip to hard objects such as thick cloths or
zippers, or the clip may break.
Attach a strap to the transmitter and fasten the clip to the patients’ clothes or bed
sheets.
If the transmitter falls off, the battery cover may be opened. If the patient touches
the terminals of the batteries, patient leakage current over the allowable amount
can occur.
16
Operator's Manual ZM-920PA/930PA
Turning On/Off the Transmitter
Check Items Before Turning On the Power
To use the instrument in a safe and optimum condition, before turning on the
transmitter power switch, check the following.
Appearance
• There is no damage or dirt on the outside of the transmitter. (Power switch,
LED, LCD, CALL key, junction, battery case cover, battery case, etc.)
• The transmitter is completely dry.
• The electrode lead is not broken.
• There is no damage or dirt on the SpO2 probe or on the disposable electrodes.
Battery
• The battery polarity is correct.
• The battery case spring is firmly fixed and the battery is not loose.
• The battery case cover is firmly closed.
Channel Setting
• The transmitter channel corresponds to those of the receiving monitor.
• The same channel is not being used on a different transmitter in the
surrounding area.
Turning On/Off the Power
ON
To turn on the power, turn the power switch to the right. After
a “peep” sound for about one second, the power is turned on.
(There is no “peep” sound when the “ ” LED light or the
“ ” are blinking on the LCD).
OFF
To turn off the power, turn the power switch to the left.
Check Items After Turning On the Power
After turning on the power, check the following items.
Power On
• The power switch is not damaged.
• The transmitter generates a “peep” sound for about one second.
Operator's Manual ZM-920PA/930PA
17
•
•
•
•
•
All LEDs light and values are displayed on the LCD for about one second.
The transmitter does not generate a continuous “pip” sound.
The transmitter does not liberate excessive heat.
The “ ” LED does not light or the “ ” mark is not displayed on the LCD.
The transmitter does not interfere with the operation of medical instruments
used near it.
Basic Operation
• The “signal loss” message is not displayed on the monitor when the transmitter
is inside the receiving range of the monitor.
• A “peep” sounds at the transmitter and “CALL” message appears at the
receiving monitor when the CALL key is pressed and the transmitter is inside
the receiving range of the monitor.
• The battery replacement message is not displayed on the monitor.
Check Items After the Power Off
• ECG electrode leads and SpO2 probe are cleaned and disinfected.
• When the transmitter gets wet, liquid is wiped off and the transmitter is
thoroughly dried.
• There are enough consumables, such as disposable electrodes.
• The power is turned off.
• The batteries are removed from the transmitter when it will not be used for a
long time.
• Dead batteries are disposed of properly.
18
Operator's Manual ZM-920PA/930PA
ECG Monitoring
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.
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
the 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 distributor 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
Operator's Manual ZM-920PA/930PA
19
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
NOTE
• This transmitter is not protected against noise generated from an
electrosurgery unit.
• If an electric blanket is used and incorrect heart rate is displayed
on the monitor, turn off the pacing pulse detection on the monitor.
ECG Measurement Procedure
1.
Select the type of electrode lead and disposable electrode according to the
purpose.
2.
Connect the electrode lead to the ECG/RESP socket.
3.
Connect disposable electrodes to the electrode lead and attach electrodes to
the patient.
After steps 1 to 3 are finished, ECG monitoring automatically starts.
20
Operator's Manual ZM-920PA/930PA
Selecting Electrode Lead and Disposable Electrode
CAUTION
Only Use Nihon Kohden specified electrodes and electrode leads.
When other type of electrodes or electrode leads are used, the
CHECK ELECTRODE message may be displayed and monitoring
may stop.
Option
Electrode lead
BR-916PA
BR-906PA
6 electrodes, snap type
BR-913PA
6 electrodes, clip type
BR-903PA
3 electrodes, snap type
3 electrodes, clip type
Operator's Manual ZM-920PA/930PA
21
Connecting the Electrode Lead to the Transmitter
Connect the electrode lead to the ECG/RESP socket on the transmitter.
CAUTION
• Do not shake or swing the transmitter holding the leads or cables
connected to the transmitter. The transmitter may come off and
injure someone or damage surrounding instruments.
• 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.
Selecting the 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. 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 of a patient
are not always optimum for respiration measurement of the patient.
Select positions suitable for both ECG and respiration
measurements, or positions which have priority for one
measurement.
22
Operator's Manual ZM-920PA/930PA
Six Electrodes
Electrode Position
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.
LA
RA
Va
N (RL)
Symbol
Vb
LL
Lead Color (Clip Color)
Electrode Position
RA
White (White)
Right infraclavicular fossa
LA
Black (Black)
Left infraclavicular fossa
LL
Red (Red)
N (RL)
Green (Green)
Va
Brown (Brown) (BR-906PA)
Brown-blue (BR-916PA)
Vb
Brown (Brown) (BR-906PA)
Brown-orange (BR-916PA)
Operator's Manual ZM-920PA/930PA
Lowest rib on the left anterior
axillary line
Right anterior axillary line at the
same level as LL
Fifth intercostal space on the left
midclavicular line. (V4 position of
standard 12 leads)
Left anterior axillary line at the
same level as Va. (V5 position of
standard 12 leads)
23
Lead Position
Standard limb leads
Lead I
RA
Lead II
LA
Lead III
RA
LL
N (RL)
Monopolar limb leads
aVR lead
N (RL)
aVL lead
aVF lead
RA
LA
RA
LA
N (RL)
LA
LL
LL
LL
N (RL)
LA
LL
LL
N (RL)
RA
RA
LA
N (RL)
Monopolar chest leads
V1 to V6 leads
to
RA
LA
LL
N (RL)
When Using 4 to 6 DIN Type Leads to Monitor 6 Lead ECG
When the BR-906PA/916PA electrode
ON
leads are not used, the transmitter is fixed
to 3 lead ECG monitoring. To monitor 6
lead ECG using 4 to 6 DIN type leads, the
transmitter must be fixed to 6 lead
monitoring. To fix transmitter to the 6 lead
ECG monitoring, turn off the transmitter
CALL key
power, press and hold the CALL key and
turn on the transmitter power.
9002
RA LA LL Va Vb
USAch
608.025 MHz
When the transmitter power is turned off
and on again, the monitoring mode returns
to the original mode.
24
Operator's Manual ZM-920PA/930PA
Three Electrodes
By using the optional BR-913PA/903PA electrode lead, 3 lead ECG monitoring is
available.
Electrode Position
• Lead MII, which is similar to standard lead II, used when ECG measurement
has priority
Electrode Position
Symbol Lead Color
Left infraclavicular fossa
LA (N)
Black
Right infraclavicular fossa
White
RA (−)
Below lowest rib on the
LL (+)
Red
left anterior axillary line
• Lead MI, which is similar to standard
lead I
Change LL and LA of the lead MII.
• Lead MIII, which is similar to
standard lead III
Change RA and LA of the lead MII.
If the electrode position shown above is not available due to chest surgery, attach
the electrodes to the root of the limbs or below the clavicles for stable ECG
monitoring.
Operator's Manual ZM-920PA/930PA
25
Connecting the Electrode Lead and Disposable
Electrodes
Preparing 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 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 for 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 items.
NOTE
• To maintain good contact between the electrode and skin, check
that the paste of the 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 the correct ECG cannot be obtained.
Refer to the electrode operator’s manual for details.
1.
26
Connect the electrode lead to the electrode.
Operator's Manual ZM-920PA/930PA
2.
Carefully remove the backing paper from
the electrode. Avoid touching the adhesive
surface.
3.
Place the electrode on the previously
cleaned skin. Pay attention to the electrode
lead color and symbol.
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.
Detection and Display of Measurement Condition
Electrode Detachment
The “
” LED lights on the transmitter or the “CHECK ELECTRODE” message
is displayed on the screen of the monitor in the following cases.
• 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 ELECTRODE” message is
displayed on the receiving monitor, ECG is not monitored properly
and the ECG alarm dose not function. Check the electrode and
electrode leads, and if necessary, replace with new ones.
Operator's Manual ZM-920PA/930PA
27
Respiration Monitoring
Respiration is monitored by measuring changes in impedance between the RA and
LL ECG electrodes. This transmitter sends the changes in impedance to the
monitor as a respiration waveform. The monitor displays the respiration
waveform and calculates respiration rate. Refer to the operator’s manual of the
monitor for details.
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
the 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 distributor 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
28
Operator's Manual ZM-920PA/930PA
Respiration Measurement Procedure
1.
Select the electrode lead and disposable electrodes.
2.
Connect the electrode lead to the ECG/RESP socket.
3.
Connect disposable electrodes to the electrode lead and attach electrodes to
the patient.
After steps 1 to 3 are finished, respiration monitoring automatically starts.
Electrode Position for Respiration Monitoring
Place the RA and LL electrodes so that the lungs are between the electrodes.
NOTE
The optimum electrode positions for ECG measurement of a patient
are not always optimum for respiration measurement of the patient.
Select positions suitable for both ECG and respiration
measurements, or positions which have priority for one
measurement.
Electrode Position Examples
NOTE
The following examples are when monitoring with 3 electrodes. ECG
cannot be monitored correctly when electrodes are attached as the
following examples when monitoring with 6 electrodes.
Position 1
In this position, respiration measurement is available; however, there is a
difference in amplitude between different patients.
RA
LL
Right infraclavicular
fossa
Fifth intercostal space on the
left midclavicular line, V4
Operator's Manual ZM-920PA/930PA
29
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.
RA
LL
Right infraclavicular
fossa
Fifth intercostal space on
the left midaxillary line, V6
Position 3
In this position, the respiration waveform is optimum, but the ECG lead is
unusual.
RA
LL
Right midaxillary at the
horizontal level of V4
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.
RA
LL
Lowest rib on the right
anterior axillary line
30
Lowest rib on the left
anterior axillary line
Operator's Manual ZM-920PA/930PA
SpO2 Monitoring
The SpO2 monitoring is only available on the ZM-930PA transmitter.
This transmitter sends SpO2 and pulse waveform to the monitor and displays
SpO2 data and pulse level bar graph on the LCD.
Refer to the operator’s manual of the monitor for details.
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).
• Check the circulation condition by observing the skin color of the
measuring site and pulse waveform. Change the measuring site
every 8 hours for disposable probes and every 4 hours for
reusable probes. 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.
• A patient with a fever
• A patient with peripheral circulation insufficiency
• Neonate or low birth weight infant with delicate skin
• 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.
Operator's Manual ZM-920PA/930PA
31
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 respiration or pulse
waves and the displayed data may be incorrect.
• 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.
• Do not pull or bend the probe cable, and do not put caster feet on
the probe cable. Do not immerse the 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.
• 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.
• While a patient is on medication which causes vasodilation, the
pulse waveform may change and in rare cases the SpO2 value
may not be displayed.
NOTE
When monitoring SpO2, monitor ECG at the same time. The ECG
electrode lead works as an antenna for transmitting data from the
transmitter to the receiving monitor. If ECG is not measured, the
telemetry signal may not be received.
32
Operator's Manual ZM-920PA/930PA
Measurement Procedure
1.
Select the SpO2 probe.
2.
Connect the SpO2 probe to the SpO2 socket.
3.
Attach the SpO2 probe to the patient.
After steps 1 to 3 are finished, SpO2 monitoring automatically starts.
Selecting SpO2 Probe
Select an appropriate probe for the patient.
CAUTION
• Only use Nihon Kohden specified electrodes, electrode lead, SpO2
probe. Otherwise, the maximum performance from the instrument
cannot be guaranteed.
• Do not use damaged or disassembled probe. It causes incorrect
measurement and may injure tha patient.
Operator's Manual ZM-920PA/930PA
33
Reusable Probes
Model
Finger Probe TL-201T
Subject (Weight)
Attachment Site
Adults, children
Finger
(Weight more than
20 kg)
Multi-site probe TL-220T
Adult or Infant
Finger or toe
3 kg or more
Attachment tape
Neonate
Instep and sole
3 kg or less
34
Operator's Manual ZM-920PA/930PA
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.
Model
TL-251T
Subject (Weight)
Attachment Site
Adults
Finger or toe
(Weight more than
30 kg)
TL-252T
Children
Finger or toe
(Weight from 3 to
40 kg)
TL-253T
Neonates
Instep and sole
(Weight less than 3
kg)
TL-260T
Adults, children
Finger or toe
(Weight more than
3 kg)
Neonates
Instep and sole
(Weight less than 3
kg)
Operator's Manual ZM-920PA/930PA
35
Model
TL-051S/052S
Subject (Weight)
Attachment Site
Adults
Finger
(Weight more than
50 kg)
Neonates
Cable length TL-051S: 80 cm
TL-052S: 160 cm
TL-061S/062S
Instep and sole
(Weight less than 3
kg)
Adults, children
Finger
(Weight from 15 to
50 kg)
Children, infants
Cable length TL-061S: 80 cm
TL-062S: 160 cm
36
Toe
(Weight from 3 to
15 kg)
Operator's Manual ZM-920PA/930PA
Model
TL-271T/271T3
Cable length TL-271T: 0.8 m
TL-271T3: 1.6 m
TL-272T/272T3
Cable length TL-272T: 0.8 m
TL-272T3: 1.6 m
TL-273T/273T3
Subject (Weight)
Adult
30 kg or more
Child
10 to 50 kg
Neonate
3 kg or less
Attachment Site
Finger or toe
Instep
Adult
40 kg or more
Cable length TL-273T: 0.8 m
TL-273T3: 1.6 m
TL-274T/274T3
Infant
3 to 20 kg
Finger or toe
Cable length TL-274T: 0.8 m
TL-274T3: 1.6 m
Operator's Manual ZM-920PA/930PA
37
Connecting SpO2 Probe to the Transmitter
Connect the probe to the SpO2 socket on the transmitter.
CAUTION
• Do not shake or swing the
transmitter while holding the cables
connected to the transmitter. The
transmitter may come off and injure
someone or damage surrounding
instruments.
• Hold the connector when
connecting/disconnecting the
probe. If you disconnect the SpO2
probe pulling the cable, it damages
the cable.
Attaching the Probe to the Patient
For details, refer to the operator’s manual of each probe.
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 shortterm 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.
38
Operator's Manual ZM-920PA/930PA
• Check the circulation condition by observing the skin color of the
measuring site and pulse waveform. Change the measuring site
every 8 hours for disposable probes and every 4 hours for
reusable probes. 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.
• A patient with a fever
• A patient with peripheral circulation insufficiency
• Neonate or low birth weight infant with delicate skin
CAUTION
• NIBP and SpO2 can be measured on the same limb, but the SpO2
monitoring may not be accurate during NIBP measurement. Be
careful when reading the SpO2 values.
• 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.
• 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.
• 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.
• Do not use a probe that is deteriorated by aging. Accurate
measurement cannot be performed.
• Neonatal skin is delicate. Remove the probe and tape carefully
and slowly.
• When removing a probe that is taped to the skin, do not pull the
probe cable because this can damage the cable.
• When removing the probe from the attachment tape, do not pull the
Operator's Manual ZM-920PA/930PA
39
sensor cable because this can damage the cable.
• Do not immerse the disposable probe in detergents or water. If the
probe adhesive surface gets wet, adhesiveness becomes weak
and the probe cannot be attached to the skin.
• Before using the TL-260T multi-site Y probe, be sure to attach the
probe to the sponge attachment tape S or L. Do not use the probe
without the sponge attachment tape attached. Using the probe
without the sponge attachment tape causes incorrect
measurement and may injure the skin at the attachment site.
• When fixing the TL-260T multi-site Y probe with the sponge
attachment tape, confirm that the adhesive part of the tape is not
on the skin. The adhesive may cause oversensitive symptoms on
the skin such as redness or itch. If the adhesive touches the skin,
remove it carefully and slowly because neonatal skin is very
delicate.
• Do not use a dirty sponge attachment tape. The measurement
value may be incorrect.
• Use the sponge attachment tape S and L only with the specified
products.
• Refer to the probe instruction manual for details.
Starting Measurement
When monitoring starts, SpO2 and pulse waveform are sent to the monitors and
SpO2 data and pulse level bar graph are displayed on the transmitter LCD.
You can turn off the display of SpO2 data and pulse level bar graph on the LCD.
Refer to the “Turning SpO2 Data and Pulse Level Bar Graph Display On/Off”
section.
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.
40
Operator's Manual ZM-920PA/930PA
Turning SpO2 Data and Pulse Level Bar Graph
Display On/Off
You can turn off the display of SpO2 data and pulse level bar graph on the LCD.
SpO2 display off
Press the CALL key for more than 3
seconds within 10 seconds after turning
transmitter power on (after a “peep” sound).
CALL
key
RA LA LL Va Vb
“%SpO2” is not displayed. When SpO2
monitoring starts, SpO2 data and pulse level
bar graph are not displayed on the LCD.
USAch
9002
608.025 MHz
To turn SpO2 display on, turn the transmitter
power off and turn the power on again.
Detecting and Displaying Measurement Condition
External Light Noise Alarm
CAUTION
When measuring under strong light (surgical light, bilirubin light,
sunlight, etc.), cover the probe with a blanket or cloth. Otherwise,
noise may interfere.
Strong external light (surgical light or inverter type fluorescent lamp, etc.), may
affect SpO2 monitoring. When external light is too strong to correctly measure
SpO2, the transmitter generates an alarm tone (“pip” sound every 0.5 seconds).
Cover the probe attachment site with blanket or cloth.
Operator's Manual ZM-920PA/930PA
41
Insufficient Light Alarm
When sufficient light cannot be obtained from the photo emitter of the probe, the
transmitter generates the following sound and indication.
(4)
(1) “peep” sound (every 1 second)
(2)
(2) pulse level bar graph is maximum
(all bars are lit.)
(3) SpO2 data is displayed as “
”
(4) %SpO2 is blinking.
(3)
In this case, change the attachment site to the appropriate site. Refer to the
operator’s manual of the SpO2 probe.
Probe Malfunction Alarm
CAUTION
When any of the following occurs, the probe may be broken.
Replace it with a new one and check the probe.
• The transmitter generates “pip” sound every 0.25 seconds.
• SpO2 data is 85% and blinking.
When Measurement Condition is Unstable
SpO2 data blinks every 1 second when SpO2 signal stability decreases and the
transmitter cannot detect correct pulse waveform because of patient body
movement, poor attachment condition or poor circulation condition at the probe
attachment site.
CAUTION
SpO2 data blinking every second indicates an unstable pulse
waveform and displayed SpO2 value may be inaccurate. The
displayed data may not reflect sudden SpO2 changes.
42
Operator's Manual ZM-920PA/930PA
Alarm List
(5) %SpO2 indication
(1)
Displayed as LED on ZM-920PA
(4) pulse level bar graph
(2)
Sound
Single
“peep” sound
for 4 s
---
(1)
Continuous
“peep” sound
All lights are
off
---
Intermittent
“pip” sound
every 0.5 s
Display
---
(2)
RA LA LL Va Vb
(3) SpO2 data
Cause
Countermeasure
The CALL key is pressed. The sound lasts
while the key is pressed.
The battery voltage
decreases and battery
charge is almost zero.
Battery is completely
discharged.
Electrode lead is
disconnected from the
electrode.
Electrode lead is
disconnected from the
transmitter.
Electrode lead
discontinuity
---
Electrode is not
firmly attached to the
skin.
Polarization voltage
is abnormally high.
SpO2 measurement
site is under
fluorescent light,
surgical light,
sunlight, etc.
Operator's Manual ZM-920PA/930PA
Replace the
batteries with new
ones.
Replace the
batteries with new
ones. To stop the
sound, turn off the
power.
Firmly connect the
electrode lead to
the electrode.
Firmly connect the
electrode lead to
the transmitter.
Replace the
electrode lead with
a new one.
Replace the
electrode with a
new one.
Cover the
measurement site
with a blanket or
cloth.
43
Sound
Intermittent
“peep” sound
every 1 s
Display
(3)
(4) all lit
(5) blinking
Cause
Cannot receive
sufficient light from
the probe photo
emitter.
Intermittent
“pip” sound
every 0.25 s
---
(3) 85%,
blinking
Broken probe
(3) blinking
Patient body
movement
Probe is not attached
securely.
44
Countermeasure
Attach probe to a
site with 6 to 14
mm thickness
where sufficient
light can be
received.
Replace the probe
with a new one.
Remove the cause
by checking the
patient condition
and changing the
attachment site.
Securely attach the
probe.
Operator's Manual ZM-920PA/930PA
Troubleshooting
If the problem still remains after checking the following, contact your Nihon
Kohden distributor.
Problem
The power cannot be
turned on.
Nothing is displayed
on the LCD after
turning the power on.
(ZM-930PA only)
Nothing is displayed
on the monitor after
turning the
transmitter power on.
Signal receiving
condition is poor.
Cause
Batteries are not
installed correctly.
The battery
polarity is wrong.
Batteries are
completely
discharged.
SpO2 display is
turned off.
The channel of the
transmitter and
monitor does not
match.
Electrode lead is
not connected to
the transmitter.
Another
transmitter of the
same channel is
used near by.
Signals are
mixing.
The transmitter is
damaged.
Operator's Manual ZM-920PA/930PA
Countermeasure
Install the batteries correctly.
Replace the batteries with new
ones.
Turn off the power, and turn on
the power again.
Set the correct channel on the
monitor.
Connect the electrode lead to the
transmitter. ECG electrode lead
works as an antenna for
transmitting data to the receiving
monitor. If ECG is not measured,
the signal may not be received.
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 of a different
channel.
Follow the instruction of your
channel administrator and use
another transmitter of a different
channel.
Contact your Nihon Kohden
distributor.
45
Problem
3 electrode leads
are properly
attached to the
patient but
LEDs light.
Heart rate of the
patient who is
using an electric
blanket cannot be
monitored on the
receiving monitor.
ECG baseline is
thick.
(Hum is
overlapping)
Respiration
waveform
measurement is
unstable.
SpO2 data is
unstable and not
reliable.
Cause
The transmitter is fixed to
6 lead monitoring.
Countermeasure
Turn off and on the
transmitter power.
Pacing pulse detection is
set to ON on the monitor.
Turn off the pacing pulse
detection.
The gel on the electrode is
dried out.
The gel on the electrode is
coming off.
Electric blanket is used.
Replace the electrode with
a new one.
Hum filter is set to OFF on
the monitor
The gel on the electrode is
dried out.
The gel on the electrode is
coming off.
The probe size is not
appropriate for the patient.
Probe is attached to the
same limb that is used for
NIBP measurement.
Probe attachment
condition is poor. Probe is
about to detach from the
skin. External light gets in.
Measurement site is dirty.
Patient is wearing nail
polish.
46
Cover the blanket with a
shield cover.
Set the filter to ON.
Replace the electrode with
a new one.
Use the appropriate probe
for the patient.
Attach the probe to the
opposite limb. Avoid a site
where blood circulation
condition changes greatly.
Firmly attach the probe
according to the procedure
in the probe operator’s
manual.
Remove dirt and nail
polish.
Operator's Manual ZM-920PA/930PA
Changing the Transmitter Channel
The transmitter channel can be changed by the QI-901PK Channel Writer. To
change the channel number, refer to the channel writer manual.
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 assignments.
• The channel administrator must manage the channels in the
facility so that there is no signal interference.
• When the transmitter channel is changed, the channel
administrator must check that the channel on the receiving
monitor is also changed and the signal is properly received.
• The channel administrator must replace the channel number label
on the transmitter with the new one after changing the channel.
Operator's Manual ZM-920PA/930PA
47
Lifetime and Disposal
Disposing of Used Batteries
Replacement
When the “ ” LED is lit or the “ ” is displayed on the LCD during operation,
the batteries are running out.
Replace the batteries with new ones. When using rechargeable batteries, recharge
them.
Disposal
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 and SpO2 Probes
Refer to the manual of each item.
48
Operator's Manual ZM-920PA/930PA
Cleaning, Disinfection and Sterilization
Transmitter and Electrode Lead
WARNING
If detergents or dirty liquid spills into the transmitter, clean it and dry
it completely before use. If the wet transmitter is used, the patient or
anyone in contact with the transmitter may receive an electric
shock.
CAUTION
• Before cleaning or disinfecting the transmitter, remove the
batteries from the transmitter.
• The transmitter cannot be sterilized.
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.
Disinfection
CAUTION
• Do not immerse the electrode lead connector in liquid.
• Do not disinfect with hypochlorous acid.
• Use the recommended concentration.
Wipe the outside surface of the transmitter and electrode lead with a non-abrasive
cloth moistened with any of the disinfectants listed on the next page. Use the
recommended concentration.
Operator's Manual ZM-920PA/930PA
49
Disinfectant
Glutaraldehyde solution
Alkyldiaminoethylglycine hydrochloride
Benzalkonium chloride
Benzethonium chloride solution
Chlorohexidine gluconate solution
Concentration (%)
2.0
0.5
0.2
0.2
0.5
SpO2 Probe
Refer to the probe manual.
50
Operator's Manual ZM-920PA/930PA
Replacing the Battery Case Cover
When the battery case cover is damaged, replace it with a new one.
Battery case cover, code no. 6113-046365C.
Other than the battery case cover, there are no serviceable parts for the transmitter.
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 6 years after NKC
announces discontinuation of the instrument. In that period, NKC or its
distributors will repair the instrument. This period may be shorter than 6 years if
the necessary board or part is not available. For discontinuation announcements,
contact your Nihon Kohden distributor or representative.
Operator's Manual ZM-920PA/930PA
51
Specifications
ECG measurement
Channels:
Input range:
DC offset:
Input impedance:
Pacing pulse detection:
Respiration measurement
Measuring method:
Impedance range:
SpO2 measurement
Measuring range:
Measuring accuracy
When the measuring accuracy of the
SpO2 probe is not considered:
±5 mV or more
±500 mV or more
5 MΩ or more (5 Hz)
ANSI/AAMI EC13
Based upon Pacemaker pulse rejection
Capability
Impedance method
0 to 2 kΩ
0 to 100%, in 1% steps
±1 digit (80% ≤ SpO2 ≤ 100%)
±2 digit (50% ≤ SpO2 ≤ 80%)
Less than 50% is not specified.
When the measuring accuracy of the
SpO2 probe is considered:
±2 digit (80% ≤ SpO2 ≤ 100%)
±3 digit (70% ≤ SpO2 ≤ 80%)
Less than 70% is not specified.
Transmitter
FCC regulation:
Field strength limits:
Undesired emission:
52
FCC part 95 Subpart-H
Wireless Medical Telemetry Service
(WMTS)
<200 mV/m (at 3 m)
below 960 MHz: 200 μV/m (at 3 m)
above 960 MHz: 500 μV/m (at 3 m)
Operator's Manual ZM-920PA/930PA
Antenna:
Transmission channel:
Transmission frequency range:
Channel spacing:
Modulation scheme:
Occupied bandwidth:
Effective radiated power:
Safety standards
Safety standard:
According to the type of protection
against electrical shock:
ECG electrode lead
indicated on the transmitter
608.0250 to 613.9750 MHz
50 kHz or 37.5 kHz (12.5 kHz when
interleaved)
FSK (Frequency Shift Keying)
<20 kHz
1.0 mW (conducted)
CSA C22.2 No. 601-1 M90: 1994
IEC 60601-1: 1988
IEC 60601-1 Amendment 1: 1991
IEC 60601-1 Amendment 2: 1995
IEC 60601-1-2: 1993
IEC 60601-2-27: 1994
INTERNALLY POWERED
EQUIPMENT
According to the degree of protection
against electrical shock:
ECG/impedance method respiration: DEFIBRILLATION-PROOF
TYPE CF APPLIED PART
SpO2:
DEFIBRILLATION-PROOF
TYPE BF APPLIED PART
According to the degree of protection
against harmful ingress of water:
IPX0 (Ordinary equipment)
According to the 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
According to the mode of operation: CONTINUOUS OPERATION
Operator's Manual ZM-920PA/930PA
53
Water resistance
Water does not get inside the transmitter except for the battery case when
immersed in water up to 30 cm deep for 3 minutes.
Power requirements
Battery type:
Battery lifetime:
ZM-930PA:
ZM-920PA:
two AA type alkaline dry cell batteries,
manganese dry cell batteries, NiCd
rechargeable batteries, NiMH batteries
approximately 3 days
(with alkaline batteries, measuring ECG,
respiration and SpO2 of approximately 60
kg weight adult male patient at the pointing
finger)
approximately 4 days
(with alkaline batteries, measuring ECG
and respiration only)
approximately 4 days
Environment
Operating environment
Operating temperature:
Operating humidity:
Operating atmospheric pressure:
Operating voltage:
5 to 40°C, 41 to 104°F
30 to 85% (non-condensing)
70 to 106 kPa
1.6 to 3.2 V
Storage environment
Storage temperature:
Storage humidity:
Storage atmospheric pressure:
Dimension and Weight
Dimension:
Weight (without batteries):
54
−20 to 65°C, −4 to 149°F
15 to 95% (non-condensing)
70 to 106 kPa
78 W × 122 H × 26 D (mm)
ZM-930PA: about 180 g
ZM-920PA: about 165 g
Operator's Manual ZM-920PA/930PA
Standard Accessories
Name
Strap
Operator's Manual ZM-920PA/930PA
Q’ty
Supply code
Y233
55
Options
CAUTION
Use only Nihon Kohden electrodes, electrode leads and SpO2
probes to assure maximum performance from your instrument.
ECG/RESP
56
Name
Application
Electrode
lead
3 electrodes, clip type,
lead length 80 cm
3 electrodes, snap type,
lead length 80 cm
6 electrodes, clip type,
lead length 80 cm
6 electrodes, snap type,
lead length 80 cm
Model
Q’ty
Supply
code
BR-903PA
K911A
BR-913PA
K910B
BR-906PA
K912A
BR-916PA
K915A
Operator's Manual ZM-920PA/930PA
SpO2
Name
Finger probe (reusable)
Multi-site probe
(reusable)
SpO2 probe (for adult,
disposable)
SpO2 probe (for child,
disposable)
SpO2 probe (for neonate,
disposable)
Multi-site Y probe
(for low birth weight
infant/child/ neonate,
disposable)
SpO2 probe (for adult,
disposable)
SpO2 probe (for child,
disposable)
SpO2 probe (for
neonate/adult, disposable)
SpO2 probe (for
child/infant, disposable)
SpO2 probe (for
adult/neonate, disposable)
SpO2 probe (for
child/infant, disposable)
COTTONY tape
Foam tape for
TL-051S/052S/
061S/062S
Attachment tape for
TL-220T/
251T/252T/253T
Attachment tape S for
TL-260T
Attachment tape L for
TL-260T
Cable
length
Model/
Code No.
0.6 m
1.6 m
TL-201T
Q’ty
Supply
Code
No.
P225H
P225F
TL-220T
P225G
TL-251T
P201A
TL-252T
P201B
1.6 m
TL-253T
0.8 m
1.6 m
0.8 m
1.6 m
0.8 m
1.6 m
0.8 m
1.6 m
0.8 m
1.6 m
0.8 m
1.6 m
Operator's Manual ZM-920PA/930PA
P201C
TL-260T
P205A
TL-271T
TL-271T3
TL-272T
TL-272T3
TL-273T
TL-273T3
TL-274T
TL-274T3
TL-051S
TL-052S
TL-061S
TL-062S
340703
P203A
P203E
P203B
P203F
P203C
P203G
P203D
P203H
P228A
P228B
P229A
P229B
P259
24
20
4 × 25
packages
P260
3 × 30
packages
P263
P260A
24
P260B
57

---

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