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.

2
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

3
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

4
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

5
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.

6
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

7
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.

8
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

9
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™.

10
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 –