Monica Healthcare AN24 User manual

Monica
AN24™
Reference
Operator
Manual
100-TF-006 Revision F
00843
©Copyright Monica Healthcare
Ltd 2007-
2009. All rights are
reserved worldwide.
Reproduction in whole or part is
strictly prohibited without prior
consent of the copyright holder.
US law restricts this device to
sale by, or on the order of, a
physician.

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Declaration
The information and descriptions contained in this manual are the property of Monica
Healthcare Ltd and may not be copied, reproduced, disseminated, or distributed without
express written permission from Monica Healthcare Ltd.
Information in this manual is believed to be accurate and reliable. However, Monica
Healthcare Ltd assumes no responsibility for its use, or any infringements of patents or
other rights of third parties that may result from its use. No license is granted by implication
or otherwise under any patent or patent rights of Monica Healthcare.
This Operator’s Manual is intended for trained medical personnel (including obstetricians,
midwives, nurses, and physicians) who are familiar with obstetric procedures. Keep this
operator’s manual with the unit for use by the operator.
Conventions Used in This Operator Manual
Warning: A warning alerts you to a potential serious outcome, adverse event, or safety hazard.
Failure to observe a warning may result in death or serious injury to the user or
patient.
Caution: A caution alerts you to situations where special care is necessary for the safe and
effective use of the product. Failure to observe a caution may result in minor or
moderate personal injury or damage to the product or other property, and possibly in
a remote risk of more serious injury.
On your monitor, this sign indicates that there is detailed information in this book,
which you must read before proceeding with your task.
Monica™and AN24™ are registered trademarks of Monica Healthcare Ltd.
Other brand names and product names are trademarks or registered
trademarks of their respective holders.
™ Trademark of Monica Healthcare Ltd
Numbers in brackets ( ) refer to the key number in Figure 1 or the index of Table 1

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Contents
Section 1 - Unpacking the AN24™.........................................................................................................5
Section 2 - Product Description.............................................................................................................7
2.1 General description.................................................................................................................................................................................7
2.2 Patient attachment..................................................................................................................................................................................7
2.3 Data processing......................................................................................................................................................................................7
2.4 Data viewing and storage........................................................................................................................................................................7
2.5 Heart rate calculation..............................................................................................................................................................................7
2.6 Heart rate data accuracy.........................................................................................................................................................................8
2.7 Uterine Activity from EHG .......................................................................................................................................................................8
Section 3 - Installation............................................................................................................................9
3.1 Battery Charging.....................................................................................................................................................................................9
3.2 Software Install .......................................................................................................................................................................................9
3.3 Instructions .............................................................................................................................................................................................9
Section 4 - Operating the AN24™........................................................................................................10
4.1 Set-up procedure ..................................................................................................................................................................................10
4.2 During monitoring..................................................................................................................................................................................13
4.3 Turn off .................................................................................................................................................................................................13
4.4 Connecting to a computer.....................................................................................................................................................................14
4.5 Wireless configuration...........................................................................................................................................................................15
4.6 USB upload...........................................................................................................................................................................................15
Section 5 - Safety and Standards.........................................................................................................16
5.1 General.................................................................................................................................................................................................16
5.2 Symbols................................................................................................................................................................................................16
5.3 Intended use.........................................................................................................................................................................................17
5.4 Standards .............................................................................................................................................................................................18
5.5 Interpreting Results...............................................................................................................................................................................18
5.6 Safety ...................................................................................................................................................................................................18
5.7 CE.........................................................................................................................................................................................................21
Section 6 - Cleaning and Maintenance................................................................................................21
6.1 AN24™™ Device..................................................................................................................................................................................21
6.2 Batteries................................................................................................................................................................................................22
6.3 Firmware version...................................................................................................................................................................................22
6.4 Calibration.............................................................................................................................................................................................22
6.5 Servicing...............................................................................................................................................................................................22
Section 7 - Monica Accessories...........................................................................................................23

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Section 8 - Monica VR Software...........................................................................................................24
8.1 Overview...............................................................................................................................................................................................24
8.2 System Requirements...........................................................................................................................................................................24
8.3 Software Installation..............................................................................................................................................................................25
Section 9 - Specifications.....................................................................................................................26
9.1 Measured..............................................................................................................................................................................................26
9.2 Calculated.............................................................................................................................................................................................26
9.3 Storage.................................................................................................................................................................................................26
9.4 Interfaces..............................................................................................................................................................................................26
9.5 Data Format..........................................................................................................................................................................................26
9.6 Battery..................................................................................................................................................................................................26
9.7 Battery Charger.....................................................................................................................................................................................26
9.8 Dimensions...........................................................................................................................................................................................26
9.9 Weight ..................................................................................................................................................................................................26
9.10 Operating Temperature.........................................................................................................................................................................26
9.11 Storage Temperature............................................................................................................................................................................26
9.12 Approval................................................................................................................................................................................................26
Section 10 - Troubleshooting...............................................................................................................27
10.1 Signal Quality (Green LED flickers).......................................................................................................................................................27
10.2 Signal Quality (Green) LED constantly on.............................................................................................................................................29
10.3 Battery Status (Yellow) LED flashing when unit is not being charged ....................................................................................................29
10.4 Memory Status (Orange) LED flashing..................................................................................................................................................29
10.5 AN24™ will not turn on..........................................................................................................................................................................29
10.6 AN24™ will not turn off..........................................................................................................................................................................29
10.7 AN24™ will not recharge.......................................................................................................................................................................29
10.8 AN24™ will not connect via USB...........................................................................................................................................................30
10.9 AN24™ will not connect via USB and will not recharge.........................................................................................................................30
10.10 AN24™ will not connect via Bluetooth® ................................................................................................................................................30
Section 11 - Returns Procedure...........................................................................................................31
11.1 Maintenance .........................................................................................................................................................................................31
11.2 Returns.................................................................................................................................................................................................31
Appendix A - CE Approvals..................................................................................................................32
Appendix B – Electrode Placement .....................................................................................................34
I. Patient Posture .....................................................................................................................................................................................34
II. Electrode Location ................................................................................................................................................................................34
IV. Lead connection....................................................................................................................................................................................39
V. Protective cover and neck strap ............................................................................................................................................................39
VI. Lead security.........................................................................................................................................................................................39
VII. Electrostatic Discharge (ESD) precautions............................................................................................................................................39

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Section 1 - Unpacking the AN24™
Table 1 - The Monica AN24™ case should contain the following items
Description
10 Monica AN24™ recorder/monitor [Item1, Figure 1]
11 Electrode lead connector [Item 2, Figure 1]
12 AN24™™ neck strap
13 Battery Charger and lead
14 AN24™™ monitor connector/computer USB cable
15 Monica installation CD (Monica VR installation program, AN24™
Reference & Concise
Operator Manuals, Monica VR Operator Manual)
16 10 Electrodes
17 Roll of abrasive skin tape
18 AN24™ protective cover
19 Bluetooth
®
USB dongle
20 Quick Start Guide
Please confirm that you can identify all the items in the case.

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3. On/Off
4. Memory status LED
5. Signal quality LED
6. Battery status LED
8. Event button
7. Connector locks & release buttons
2. Electrode leads connector
1. AN24 body
9. Neck Strap
connection
Figure 1 Monica AN24™ Controls and Indicators

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Section 2 - Product Description
2.1 General description
The Monica AN24™ is a wearable, battery-powered device for antenatal surveillance of
fetal and maternal well-being. The AN24™ is designed to passively monitor Fetal Heart
Rate (FHR), Maternal Heart Rate (MHR), and Uterine Activity (UA) from the Electro
Hysterogram (EHG) during pregnancy1and can be used at any time from 20 weeks
gestation to the end of first stage labour. Excessive vernix formation in the 26-34 week
gestation period may result in a significant reduction in FHR detection in some patients.
The AN24™ is currently suitable for singleton pregnancies only2
2.2 Patient attachment
. The AN24™ is suitable for
extended monitoring sessions of up to 16 hours.
The Monica AN24™ is attached via a detachable lead assembly that in turn attaches to 5
disposable ECG electrodes placed on the abdomen of a pregnant woman to generate 3
signal channels. The AN24™ then records the electrical signals present at these
electrodes (the Electrocardiogram or ECG) that contains information relating to the
maternal heart, fetal heart and other sources of electrical energy inside the body.
2.3 Data processing
The acquired signals are then converted by the AN24™ into a digital format and processed
in real-time to extract clinically relevant information, such as the Fetal Heart Rate (FHR),
Maternal Heart Rate (MHR) and Uterine Activity from the Electro Hysterogram (EHG).
2.4 Data viewing and storage
The processed data can either be stored by the AN24™ and downloaded to a computer at
the end of the monitoring session, or wirelessly transmitted in real-time for viewing on a
computer. The computer (installed with Monica VR software) enables the data to be
viewed, stored, and printed.
2.5 Heart rate calculation
The time between the R-wave of consecutive fetal QRS complexes in the ECG signal is
used to calculate the FHR. This is called the fetal RR interval. Similarly, the time between
the R-wave of consecutive maternal QRS complexes in the ECG signal is used to calculate
the MHR. This is called the maternal RR interval. See Figure 2.
1Other Fetal/Maternal parameters will be available at a later date.
2Multiple pregnancy monitoring will be available at a later date.

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The FHR and MHR are also ‘2-second averaged’. The 2-second averaged heart rates are
calculated by firstly dividing the ECG into 2-second epochs. Each 2-second epoch is then
checked for a minimum of two consecutive fetal ECG complexes and two consecutive
maternal ECG complexes. If present, these complexes enable a heart rate to be calculated
for that epoch. When more than two consecutive ECG complexes are available in a single
epoch, the heart rates are averaged.
2.6 Heart rate data accuracy
The FHR and MHR data is only
2.7 Uterine Activity from EHG
made available for viewing when the AN24™ is confident
that this data is accurate. Confidence is based upon the general noise in the recorded data
and characteristic shape of the ECG complex. In the event that the AN24™ is not confident
of the accuracy of either the FHR or MHR, they will not be made available; the AN24™ will
not ‘fill in’ any data. This method of providing a 2-second average is very different to the
complex autocorrelation and rule-based methods used to calculate the FHR on Doppler
based recorders.
The Uterine Activity is extracted from the slow-wave of the EHG, i.e. its envelope. The
envelope is obtained by low-pass filtering the rectified fast-wave of the EHG. The UA is
updated every 2 seconds as a number between 0 and 255, representing an EHG envelope
from 0 to 500 microvolts.
Maternal RR interval
Fetal RR
interval
Figure 2 Calculation of FHR & MHR from ECG

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Section 3 - Installation
3.1 Battery Charging
The Monica AN24™ (Figure 1) is dispatched with a non-removable rechargeable battery
which, for shipping, is not fully charged.
The battery must be fully charged prior to use as described below.
Please refer to Figure 1
A. Connect the lead on the supplied battery charger into the socket inside the top of the
AN24™ body (1). Plug the battery charger into a mains outlet and switch on the
mains outlet. The amber battery status LED (6) will flash until the device is charged,
when it will be constantly lit. This should take no more than 2½ hrs.
B. When the electrode leads connector (2) is connected to the Monica AN24™
Recorder (1) disconnect the lead connector (2) from the AN24™ body (1) by
pressing the two buttons (7) on either side of the recorder, and gently pulling apart
the AN24™ body (1) from the lead connector (2).
3.2 Software Install
The Monica VR viewing and reporting software must be installed on a suitable PC or
notebook by following this process:
A. If your PC or notebook is part of a network, please make sure you have
administrative rights and/or contact your network administrator.
B. Insert the Monica Installation CD into your CD drive.
C. The Monica VR Set-up program should launch automatically, displaying the welcome
dialog box. If it does not launch automatically, use Windows explorer to manually
select the CD drive, and open ‘MonicaVR_setup.exe’
Follow the on-screen instructions. If further details are required, please contact your
Distributor or refer to the AN24™ Reference VR Operator Manual.
3.3 Instructions
Please fully read these instructions before using the AN24™.

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Section 4 - Operating the AN24™
4.1 Set-up procedure
4.1.1 Select mode.
The Monica AN24™ can be operated in two modes, namely:
Mode 1 - Retrospective mode
The Monica AN24™ records fetal heart rate (FHR), maternal heart rate (MHR) and Uterine
Activity (UA) for retrospective upload and viewing on a computer running the Monica VR
software or on the VR Monitor.
Mode 2 - Real time mode
The Monica AN24™ transfers FHR, MHR and UA using Bluetooth® wireless transmission
in ‘real-time’ to the VR Monitor or to a Bluetooth® enabled computer running the Monica VR
software for real-time viewing of the data.
The default mode when the Monica AN24™ is turned on for the first time is Mode 1
(Retrospective mode). Connection to a PC is required to set the time for the first recording.
The AN24™ already running in Mode 1 can be set up to run in Mode 2 by making a
wireless Bluetooth® connection using the Monica VR software (see 4.5 Wireless
configuration).
Alternatively, a Real-Time recording can be configured before starting a recording by
connecting it to a PC running the Monica VR program (see 4.4 Connecting to a computer
and 4.5 Wireless Configuration).
4.1.2 Electrode attachment
Prior to applying the electrodes, the skin must be prepared correctly using abrasive skin
tape (17) as described in Appendix B.
Additionally, the electrodes (16) must be positioned correctly on the prospective mother’s
abdomen.
For skin preparation and electrode positions please refer to Appendix B –

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4.1.3 Lead connection
Attach the electrode leads connector (2) to the electrodes (16) following the colour code
guide in Appendix B. Ensure that the electrode leads connector (2) is securely attached to
the AN24™ (1), by pushing the two sections firmly together such that the two buttons (7)
are engaged.
4.1.4 Turn on
Turn on the AN24™ on by pressing the on/off button (3). All three LEDs (4, 5
and 6) will flash 3 times to indicate that the AN24™ has been turned on.
4.1.5 Memory status self-check
If the Orange memory status LED (4) begins to flash when the AN24™ has been
turned on, this indicates there is data from a previous patient stored in the
memory of the AN24™.
The stored data can be a) downloaded using Monica VR via USB or b) deleted
remotely via Bluetooth® connection to the Monica VR software.
a) To download the data via USB, turn off the recorder (see ‘Turn Off’ section below), and
connect the AN24™ to the computer running VR with the USB cable provided (please refer
to the Monica VR Reference Manual for detailed instructions). Once the data has been
downloaded, the recorder can be used for a new recording.
b) To delete the data via Bluetooth®, use Monica VR to connect to the recorder. The VR
software will automatically recognise that there is data stored on the AN24™ and offer to
delete the data or allow the user to disconnect it from VR to download as per a) above
(please refer to the Monica VR reference Manual for detailed instructions). Once the data is
deleted the recorder can be used for Real Time mode recording.
4.1.6 Battery status self-check
If the Yellow battery status LED (6) begins to flash when the AN24™ has been
turned on, this means that the battery charge is too low for recording to begin.
The LED will flash 10 times and then the AN24™ will be automatically turned off.
See ‘Recharging the batteries later in this section.
N.B. If there is data on the recorder, the Memory Status led will flash alongside
the battery status LED.

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4.1.7 Electrode attachment self-check
After turn on, the AN24™ will check the electrodes are attached correctly. The
green signal quality LED (5) will go into one of three states:
•GREEN LED FLICKERS
The green LED flickers rapidly when the electrodes are not correctly attached. To
solve this problem please refer to Section 10 - Troubleshooting. The AN24™ will
continue this self-check until the problem has been resolved and recording will
not begin until it has.
•GREEN LED ON
The green LED is constantly on to indicate that all electrodes are correctly attached to the
skin. Once the AN24™ is satisfied that the electrodes are correctly attached the recording
will begin. The AN24™ will then look for the maternal ECG.
•GREEN LED SLOWLY FLASHES
The green LED will flash (once every 2 seconds) when the AN24™ is satisfied that the
electrodes are correctly attached and that the maternal ECG has been located (note –
maternal ECG location may take up to 30 seconds once the correct electrode attachment
has been confirmed). If the LED remains constantly on, please refer to Section 10 -
Troubleshooting. If the problem persists please contact your distributor.
4.1.8 Secure the AN24™
If the patient wishes to carry the AN24™ it can either be held in their clothing (e.g. a pocket)
or carried around the neck using the supplied neck strap (12). If the patient wishes to use
the neck strap, attach it to the AN24™ main body (1) using the neck strap connection (9)
and hang the neck strap around the patient’s neck. Adjust the length of the neck strap so
that the lowest part of the AN24™ is above the sternum and not touching the electrodes.
4.1.9 Secure Cables
If the ECG cable(s) are loose or hanging, secure them with hypoallergenic tape (not
supplied) to the patient’s abdomen to prevent the cables from pulling on or detaching from
the ECG electrodes.

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4.2 During monitoring
Self checks during a recording
During recording the AN24™ will regularly perform self-checks. The AN24™ can
only be in one of the following four states:
MONITORING OK – GREEN LED FLASHES
The green signal quality LED (5) will continue to flash once every 2 seconds to
indicate that the electrodes remain attached correctly and that the maternal heart
beat has been located.
MATERNAL SIGNAL LOST – GREEN LED ON
The green signal quality LED (13) will remain constantly illuminated to indicate that the
electrodes remain attached correctly but that the maternal heart beat cannot be located.
This is not a cause for alarm and may be temporary and due to interference from other
sources, for example the noise generated by maternal muscle/movement. Section 10 -
Troubleshooting
ELECTRODE DETACHED – GREEN LED FLICKERS
The green signal quality LED (5) will flicker rapidly to indicate that one of the electrodes has
become detached. The recording will not be stopped at this point, if suitably trained staff
are available the electrodes should be re attached to resolve the problem, see Section 10 -
Troubleshooting.
BATTERY LOW – YELLOW LED FLASHES
If the Yellow battery status LED (6) begins to flash, this indicates that the battery
is running low. A short while after this occurs; the AN24™ will automatically turn
off. If the device is in Mode 1 (recording mode) the recorded data will be
retained until it is uploaded, see Mode 1 - USB upload later in this section.
4.3 Turn off
When the recording session is completed, turn the AN24™ off by pressing the
on/off button (3) followed by the event button (8) followed by the event button (8)
again.
This sequence of button presses must be completed within 4 seconds to turn the
device off. When the AN24™ is switched off all three LED’s (4, 5 and 6) will
flash three times.

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Data Upload - If the AN24™ was used in Mode 1 (recording mode), the recorded data must
be uploaded to a computer running the Monica VR software, see ‘USB Upload’ later in this
section.
Clean the AN24™ - Clean the AN24™ (1) and electrode lead connector (2) as described in
Section 6 - Cleaning and Maintenance
Battery Charging - recharge the AN24™ (1) as described in 3.1 Battery Charging.
4.4 Connecting to a computer
Monica devices are an integral part of a personal computer based diagnostic system. The
user must adhere to warnings in order to ensure safe and reliable performance of the
system.
•The personal computer (non-medical electrical equipment) must be situated outside
the patient environment (patient environment according to IEC 60601-1-1: radius
1.5m around the patient).
•The personal computer used should be approved to the appropriate safety standard
for non-medical electrical equipment (IEC 60950, or its national variants).
•If there is a requirement for the personal computer to be situated within the patient
environment it is the responsibility of the user to ensure the system provides a level
of safety that ensures compliance with IEC 60601-1.
•The Monica VR Monitor (PT-100-040) fully complies with the above and is
recommended when using the Monica AN24™™ to monitor in real-time within the
patient environment (as defined by IEC 60601-1-1).
When connecting to a computer in either mode it is firstly necessary to ensure that the
Monica VR software is successfully installed onto a suitable computer, see Section 8 -
Monica VR Software to connect the Monica AN24™ to this computer:
A. Disconnect ECG leads - Disconnect the electrode lead connector (2) from the
AN24™ (1) as described in 3.1 Battery Charging.
B. Launch software – Start the Monica VR software application on your computer.
C. Connect USB lead - Connect the AN24™-to-USB lead (14) into the socket inside the
top of the AN24™ (1). Plug the USB end of the lead into a free USB port on the
computer. The Monica AN24™ device will be automatically recognised by the
computer and will provide status information.
From this point the Monica VR software will know if there is data stored on the device ready
for upload (Mode 1 operation), or, no data stored on the device (Mode 2 operation).
Whatever the status the program will guide you through the correct process to upload the
stored data or configure the AN24™ for wireless operation, see below.

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4.5 Wireless configuration
If there is no data available for upload, the Monica VR program will provide the option to
set-up a wireless real-time monitoring session and will ask you to identify the patient, by
providing the patient’s name and hospital number. Monica VR will then take you through
the set-up process. Alternatively an ad hoc connection can be made using the Monica VR
software. Detailed information on these procedures is available in the Monica VR
Reference Manual.
4.6 USB upload
If data is available for upload, the Monica VR program will give you the option to either
delete the data, or upload it to the computer. If you chose to upload the data you will be
asked to first identify the data, by entering the patient’s name and hospital number. Monica
VR will then take you through the set-up process. Detailed information on this procedure is
available in the Monica VR Reference Manual.

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Section 5 - Safety and Standards
5.1 General
This section describes safety precautions that may appear within the manual and those that
appear as symbols labels on the AN24™ itself. Furthermore, this section describes a group
of precautions that are applicable, in general, when using the AN24™.
The Monica AN24™ is intended for trained medical personnel (including midwives, nurses,
and physicians) who are familiar with obstetric procedures. Keep this operator’s manual
with the unit for use by the operator.
5.2 Symbols
Attention - Refer to manual
Class II Medical Device
Type BF
Batch number
Manufacture date
Bluetooth® approved device
ESD - Static sensitive device
CE approved
WEEE logo
LOT

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5.3 Intended use
The Monica AN24™™ is a monitoring device for non-invasively measuring the
•Fetal Heart Rate (FHR)
•Maternal Heart Rate (MHR)
•Uterine Activity (UA)
•Maternal Movement (MMov)
The Monica VR software, which accompanies the AN24™, enables the measured
parameters to be reviewed graphically using a PC or notebook computer, supports the user
in recognising a non-reassuring trace using a FHR analysis decision support algorithm
based on a method published by G A Dawes and C Redman and to generate hard copy
traces and reports in a ‘standard’ user defined format. This data is intended to aid in
assessment of the wellbeing of the fetus and mother from 20 weeks gestation to the end of
first stage labour in singleton pregnancies.
Application of the device must be by trained personnel, but monitoring sessions can be
carried out in hospitals, clinics, doctors’ offices and in the patient’s home.
Clinical indications for use of monitoring in high risk singleton pregnancies include:
•Ante partum haemorrhage
•Obese mothers
•Reduced Fetal Movements
•Pre-eclampsia
•Hypertension
•Poor Obstetric History
•Abnormal umbilical artery Doppler
velocimetry
•Preterm Labour
•Post fetal surgery
•Known fetal abnormality which
requires monitoring
•Suspected or confirmed
intrauterine growth restriction
•Induction of labour
•Maternal Diabetes
•Home monitoring
•Early labour
This list is not exhaustive.

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5.4 Standards
The Monica AN24™ complies with the following safety standards
Standard Description
IEC EN 60601-1: 1990
UL60601-1:2003
CSA C22.2 No 60601.1
Medical Electrical Equipment
Part 1: General requirements for safety
EN 60601-1-2: 2002
IEC 60601-1-2: 2001
Medical Electrical Equipment
Part 1-2: General requirements for safety – Collateral Standard:
Electromagnetic Compatibility – requirements and tests
EN 60601-2-47: 2001
IEC 60601-2-47: 2001
Medical Electrical Equipment
Part 2-47: Particular requirements for the safety, including essential
performance, of ambulatory electrocardiographic systems
IEC EN 60601-1-4: 1996 Medical electrical equipment
Collateral standard: Programmable Electrical Medical Systems
EN 980: 1996 Graphical symbols for use in the labelling of medical devices
EN 1041: 1998 Information supplied by the manufacturer with medical devices
5.5 Interpreting Results
Monica Healthcare recommend that a repeat test is undertaken, using either the AN24™ or
an alternative device to confirm the results from the initial test. The repeat test should be
carried out in the case of either normal or abnormal results generated by the AN24™.
5.6 Safety
WARNING: The Monica AN24™ is splash proof but is not designed for submersion in
water. Patients must be warned not to immerse the AN24™ or any of its
accessories in water, or to take a shower or bath whilst being monitored.
WARNING: The Monica AN24™ is not explosion-proof and must not be used in the
presence of flammable anaesthetics.
WARNING: SHOCK HAZARD — Do not attempt to connect the battery charger with wet
hands. Make certain that your hands are clean and dry before touching a
power lead or plug.
WARNING: Use only the electrode lead cables supplied with the device. Use of any other
cables may result in out-of-specification performance and possible safety
hazards.
WARNING: Unplug the AN24™ from the AC power source (battery charger and detach all
accessories before cleaning. Do not immerse the unit in water or allow liquids
to enter the case.

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WARNING: Examine the AN24™ and any accessories periodically to ensure that the
leads, connectors and the device itself do not have visible evidence of
damage that may affect patient safety or monitoring performance. The
recommended inspection interval is once per week or less. Do not use the
device if there is any visible sign of damage.
WARNING: Only the Battery Charger and mains plug supplied with the Monica AN24™, or
its equivalent, is approved for use with the AN24™.
WARNING: Do not attempt to service the Monica AN24™. Only Monica approved and
qualified service personnel should attempt any necessary internal servicing.
WARNING: The Monica AN24™ is not specified or intended for operation in conjunction
with any other type of monitoring equipment except the specific devices that
have been identified for use in this Operator’s Manual.
WARNING: Since the Monica AN24™ detects the electrical signals generated from the
fetal heart, if other equipment which introduces electrical energy in to the
mother is used (e.g. TENS machine, diathermy, impedance meter), then the
AN24™ will not be able to detect the fetal heart rate.
WARNING: Do not operate the Monica AN24™ if it fails to pass the power on self-test
procedure, see Section 4.
WARNING: Any unexpected data generated by the Monica AN24™ must result in further
examination of the mother and fetus in a hospital environment. The data
generated by the AN24™ must be backed up by alternative monitoring
technologies.
WARNING: For Electromagnetic Compatibility (EMC). Use of accessories, electrodes and
leads other than those specified in this manual may result in increased EMC
emissions and/or decreased immunity of the Monica AN24™ to other
electrical equipment.
WARNING: For Electromagnetic Compatibility (EMC). The Monica AN24™ has been
tested for to IEC EN 60601-1-2 for EMC. However, the Monica AN24™ picks
up very small electrophysiological signals and so occasionally if other
electrical equipment is in the immediate vicinity of monitoring the AN24™ may
produce spurious results. The operator should ensure that any such
interfering electrical equipment is not in close proximity to the AN24™ during
monitoring.
WARNING: The lithium polymer battery pack used within this device has the potential for
fire or burning. Do not disassemble, crush, heat or burn.

20
WARNING: The lithium polymer battery pack cannot be replaced by the user.
Replacement may only be made with the battery pack specified by Monica
Healthcare, and replacement can only be carried out by Monica Healthcare.
Fire or burning may occur if the customer uses a battery pack other than
specified by Monica Healthcare.
CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or
flammable materials, and extremes of temperature and humidity. The AN24™
and all lead connectors should be kept clean and free of electrode gel and
other substances.
CAUTION: Do not operate the unit if it is damp or wet because of condensation or spills.
Avoid using the equipment immediately after moving it from a cold
environment to a warm, humid location.
CAUTION: Never use sharp or pointed objects to operate the two front-panel membrane
switches.
CAUTION: General-purpose personal computers and modems are not designed to meet
the electrical safety requirements of medical devices.
CAUTION: Do not autoclave the AN24™ or any accessories. Follow cleaning and
disinfection instructions in Section 6 - Cleaning and Maintenance
CAUTION: Do not immerse AN24™, connector or leads in liquid. When using solutions,
use sterile/clean wipes to avoid pouring fluids directly on to the AN24™ and
connector. Follow cleaning and disinfection instructions in Section 6 -
Cleaning and Maintenance
CAUTION: The water temperature must not exceed 40°C (104°F). Do not use chlorine
bleach.
CAUTION: Take extra care when cleaning the membrane switches and LED surfaces,
which are sensitive to rough handling.
CAUTION: Do not autoclave. Do not gas sterilize.
CAUTION: Only the Battery Charger supplied with the device is approved for use in
recharging the internal batteries.
CAUTION: The Monica AN24™ is not specified or intended for operation during the use
of defibrillators or during defibrillator discharge.
CAUTION: The Monica AN24™ is not specified or intended for operation in the presence
of electrosurgical equipment.
CAUTION: There are minimum signal amplitudes under which the Monica AN24™ will
not be able to measure physiological signals.