Analytica PeriCoach User manual

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Instructions for Use

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PeriCoach® is a registered trademark of Analytica Limited
© Analytica Limited 2014. Reproduction, adaptation, or translation of this
manual is prohibited without prior written permission of Analytica Limited,
except as allowed under copyright laws.
The contents of this guide are subject to change without notice.
The Bluetooth® word mark and logo are registered trademarks owned by
Bluetooth SIG Limited.

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1 Table of Contents
1 Table of Contents................................................................. 3
2 Before you begin.............................................................. 5
Items in the PeriCoach kit.........................................................................5
Other items you will need ........................................................................6
Other items you might want to consider.................................................6
Minimum Smartphone requirements...................................................... 7
Intended Purpose - Australia & EU..........................................................8
Application of the PeriCoach system.......................................................8
Safety precautions ....................................................................................9
Other precautions.................................................................................... 11
Conventions used in this manual ...........................................................12
3 Introduction .....................................................................14
Indicator Lights.........................................................................................16
Brief overview of treatment .....................................................................16
4 Setting up PeriCoach ......................................................19
Installing the PeriCoach App...................................................................19
Pairing the App and the probe...............................................................19
Registering your PeriCoach....................................................................22
5 Doing your exercises ..................................................... 24
How to exercise ......................................................................................24
Before you begin.....................................................................................24
Exercise programs..................................................................................26
Exercise settings......................................................................................30
Establishing a starting point...................................................................33
Exercising.................................................................................................44
Your exercise history...............................................................................58
6 Maintenance and troubleshooting ............................... 60
Maintaining power .................................................................................60

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Troubleshooting ......................................................................................64
Cleaning the probe.................................................................................65
Getting help.............................................................................................66
7 Legal notices .................................................................. 68
Electromagnetic compatibility (EMC) .....................................................68
Disposing of the PeriCoach kit...............................................................68
European Authorised Representative....................................................69
Other Information ...................................................................................69
8 Technical Specifications................................................. 70
Equipment type .......................................................................................70
Expected Service Life...............................................................................70
Battery......................................................................................................70
Charging Case ........................................................................................70
Environmental limits................................................................................70
Meaning of other symbols used ...............................................71
Physical attributes...................................................................................72
Cable .......................................................................................................72
Smartphone Requirements ....................................................................72
Manufacturer Details..............................................................................73
9 Warranty Information .................................................... 74
1. Your Consumer Rights ........................................................................74
2. Claiming under our PeriCoach Warranty..........................................74
3. Exclusions and Limitations in the PeriCoach Warranty....................75
10 Index............................................................................... 76

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2 Before you begin
It is essential for your own safety - and for those who could come
into contact with the PeriCoach system - that you read this
instruction manually carefully before using the system. In
particular, make sure you read and understand the safety and other
precautions set out in the following two sections.
If you have any questions or doubts about the PeriCoach system that are not
answered in this instruction manual, consult your doctor before using the
system.
 PLEASE CHARGE YOUR PERICOACH PROBE BEFORE FIRST USE.
Charging instructions are provided on page 63.
 SAVE THIS DOCUMENT on the smartphone, that you will use with
PeriCoach, so that you can refer to it when required.
Items in the PeriCoach kit
The PeriCoach kit comprises a case, probe and a USB cable.
Figure 1: PeriCoach kit contents

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Table 1: Contents on delivery
Item Purpose
PeriCoach probe To indicate the force applied by each
contraction of the pelvic floor muscle.
PeriCoach case To securely store and charge the probe.
Type-A USB-to-mini-
Type-A USB cable
To recharge the battery inside the probe.
If an item is missing, contact Customer Service:
 Within Australia: 1800 016 794, within New Zealand 08 0045 0926
 Within UK: [email protected]
See “Environmental limits” on page 70 for advice on the optimum conditions
for storing and using the PeriCoach kit.
Other items you will need
In addition to the PeriCoach kit, you will need a Smartphone running the
Android or iOS operating system. The PeriCoach App is installed on the
Smartphone system and enables you to choose an exercise program, and
then to display and record pelvic muscle contractions during an exercise
session.
Other items you might want to consider
A power adapter
Purpose : although you can charge the PeriCoach probe by connecting it to a
PC (see “Maintaining power” on page 60), you might find it more convenient
to charge it from regular mains power. For this you will need a power
adapter with a USB socket. (This is not provided in the PeriCoach kit.)

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A computer with a spare USB port
Purpose : provides an additional way of charging the PeriCoach probe (see
“Maintaining power” on page 60). You might also find it easier to view your
exercise history on a larger screen than that offered by a Smartphone. (Your
exercise details are automatically updated to a secure website that can be
accessed by any web browser.)
Minimum Smartphone requirements
Wireless communication between devices
The PeriCoach probe and the Smartphone that records your exercises
communicate using Bluetooth wireless communication. Your Smartphone
must offer Bluetooth as a communication option.
On some phones, tapping Settings on the home screen displays a list of
features, one of which will be wireless and network options. Bluetooth
should be listed as an option as shown in Figure 2.
Figure 2: Android Settings menu showing Bluetooth

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Consult the instruction manual that accompanied the phone if you are
unsure how to find this information.
Operating systems
The PeriCoach system currently works only with Smartphones running the
Android operating system (version 2.3 and later) or iOS operating system
(version 7.0 and later). Your phone should be able to tell you what version of
the operating system it is running. It is also able to be used with Android
tablets or iPads with the previously mentioned operating systems.
Consult the instruction manual that accompanied the phone or tablet if you
are unsure how to find this information.
Some compatible phones
If your Smartphone was purchased after 2010, it should be compatible with
the PeriCoach system.
The phone must be Bluetooth communication capable and run version 2.3 of
the Android operating system (or later) or for iPhone, 4S or later.
Intended Purpose - Australia & EU
The device may be used to assist in the correction of urinary incontinence
and pelvic organ prolapse by means of exercise. It may also be used by a
health care practitioner to assist in the diagnosis and monitoring of urinary
incontinence. The device consists of a rigid probe for temporary intravaginal
use which offers resistance to a patient's voluntary pelvic floor muscle
contractions and can provide an indication of the strength of these muscles.
Application of the PeriCoach system
The intended user is an adult female. If the user is impaired, then a capable
carer may be required to support in the PeriCoach's use.
The body of the probe is meant to be inserted into the user’s vagina. The
PeriCoach system is for one user only and is not to be shared.
Typically the PeriCoach should be used at least 5 days per week, with a

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period of rest in between sessions. Environments for use include: the home,
indoor (e.g. office), and in some transit situations (e.g. private cabin or toilet
in a plane or train).
Safety precautions
 Do not use the PeriCoach system if you are or experiencing
abnormal vaginal discharge (bleeding or otherwise) as
doing so may affect an underlying condition.
 Do not use the system if you are experiencing back pain
severe enough for you to need pain-killers as doing so may
affect an underlying condition.
 Do not use the system if you have recently undergone
surgery, as doing so may affect an underlying condition.
 Do not use the system if symptoms of bladder infection are
present, as doing so may affect an underlying condition.
 Do not use the system if symptoms of a vaginal infection
are present, as doing so may affect an underlying condition.
 Do not use the system if you have a history of urinary
retention or symptoms thereof, as doing so may affect an
underlying condition.
 Do not use the system if you have an anatomical vaginal
morphology and / or structure that does not permit proper
insertion of the probe.
Consult with your doctor if needed for all of the above seven precautions.
 Do not use the system if the covering of the probe appears
to be cracked, torn or damaged in any way, as use of the
probe in this condition may increase likelihood of infection.
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• Inspect the probe before every use. If damaged
then do not use it.
 Do not share the probe with others. There is risk of
infection, even if you wash the probe between exercises.
• Sharing the probe may also corrupt your data and
void any medical reimbursement arrangements
you have with healthcare providers.
 Keep the system out of reach of young infants and children.
The probe is a choking hazard and the USB cable could
cause strangulation.
 Keep the probe away from cats, dogs and other pets. If you
suspect any animal contamination or damage to the probe,
stop using the system, as this may increase the likelihood of
infection.
 Do not disassemble any parts of the PeriCoach system nor
use the system if it has been reassembled by any person
other than a technician authorised by the manufacturer.
 Do not use the PeriCoach probe for more than 30 minutes if
the ambient temperature is greater than 38°C. If the
PeriCoach probe becomes too hot for comfort at any time,
cease using the probe until it is at a comfortable
temperature.
 On rare occasions the probe may cause skin irritation. If that
occurs, cease using the probe and seek advice from your
doctor.
-
It is recommended to use a small amount of water-based
lubricant with the probe, such as KY Jelly.
 No modifications to any item in the PeriCoach system should
be made. Unauthorised modifications will render your
warranty null and void. They might also lead to injury to
yourself or damage to the equipment.

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Other precautions
 Do not store or use this device in excessively hot or cold
environments or environments of extreme humidity (see
“Environmental limits” on page 70). Take special care not to
leave the system in a car during summer, as extreme
temperatures may damage the internal circuitry of the
probe.
 Avoid dust by storing the device in its case between uses.
 Do not immerse any part of the system other than the probe
in water. Only the probe is waterproof. The charging case
and USB cable are not waterproof.
 Do not expose the PeriCoach probe to direct sunlight for
lengthy periods.
 Do not drop the probe, subject it to strong forces or to
continual vibration. Doing so may damage its outer covering
or its internal circuitry.
 To minimise the risk of infection, wash your hands
thoroughly— preferably with anti-bacterial soap—before
touching the probe.
 Do not freeze or microwave the probe, nor place it in an
oven in order to bring it to a comfortable temperature. If the
temperature of the probe is not comfortable, run the body of
the probe under cold or warm water until the temperature is
acceptable.
 Use only the charging case provided when recharging the
probe’s battery.
 Before transporting the probe, place it in the PeriCoach
charging case. This will minimise the risk of damage to its
outer covering or its internal circuitry.
 There may be circumstances that cause interference
between Bluetooth technology (the technology used to

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generate communication between the PeriCoach probe and
your Smartphone) and Wi-Fi technology (another
communication feature offered by many Smartphones). If
this occurs, it may be beneficial to temporarily turn off the
Wi-Fi feature on your Smartphone while using PeriCoach.
 Do not incinerate the PeriCoach probe or discard it as
general waste. The lithium battery inside it is a potential
environmental and fire hazard. Consult your local council for
advice on how best to dispose of such equipment.
Conventions used in this manual
Text
The names for screens, fields, buttons and menus that you see on your
Smartphone or on your computer are set in bold text. Thus:
“… tapping Settings displays a list of features …”
means tap on the button labelled Settings.
Where a series of consecutive actions is required, each action is separated
by the > character. Thus:
“… tapping Settings > About phone displays a list …”
means first tap on the button labelled Settings and then on button labelled
About phone.
Symbols
This symbol is used to indicate that the accompanying instructions
are especially important and should be read carefully to ensure
that you fully understand them. Failure to do so might result in
injury or damage to equipment.
This symbol is used to indicate that the user should exercise general
caution. Consult the instructions for use if unsure of any instruction or
the meaning of any symbol or indicator.
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This symbol is used to indicate a mandatory prohibition – you must
not do this.
Other symbols marked on the underside of the PeriCoach case and on other
labelling are explained in Chapter 8, “Technical Specifications” starting on
page 70.
Audience for this manual
In this manual, the audience is addressed in the second person (“you”).
However, there will be circumstances where more than one person is
involved in the set-up, operation and maintenance of the PeriCoach system.
This may be the case where the primary user of the system has an
impairment that requires them to rely on others if they are to take full
advantage of it (For example, the primary user may have an auditory, visual
or cognitive impairment.) In these cases, the instructions are to be interpreted
as being directed at whoever has assumed responsibility for doing a
particular action. For example, a health professional might take responsibility
for installing the PeriCoach app on the primary user’s Smartphone, in which
case Chapter 3 is primarily directed at them.
Likewise, the carer of the primary user might take responsibility for keeping
the battery charged and the probe clean, in which case Chapter 6 is
primarily directed at them.
Where more than one person is responsible for a PeriCoach exercise
regime, it would be prudent if each person familiarised themselves
with the contents of this manual before the regime begins.
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3 Introduction
Urinary incontinence and prolapse are commonly caused by the weakening
of the pelvic floor muscles. This often occurs during childbirth, but it can also
be a symptom of menopause, ageing, persistent constipation, being
overweight, and other causes. Health practitioners will often recommend
exercises designed to help strengthen the pelvic floor muscles. As these
muscles strengthen over the course of the exercise regime, incontinence
often disappears.
PeriCoach® is a unique device that can help visualise and indicate the
strength improvement of the pelvic floor muscles. It has a number of key
features, including the probe that is shaped in such a way that once inserted
into the vagina, it can show two modes of contraction:
 The sensor on top of the probe indicates the force applied to
the urethral wall, thus capturing the contraction strength
contributed by the puborectalis muscle.
 The two side sensors indicate the force contributed by the
bilateral contraction of the pubococcygeus muscle.
Figure 3: The PeriCoach probe showing the location of the three sensors

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Combining these separate areas of movement enables a more thorough
understanding of the overall strength of the pelvic floor muscles. This may in
turn, lead to better diagnosis of incontinence problems. Further, the
indication of muscle action —being immediately available to you via a
Smartphone—will help you maintain consistency during your exercise
regime and help you know when to move to more advanced exercise
programs.
Many currently available exercise aides measure the change in pressure
inside the vaginal canal upon muscle contraction. This gives no indication of
particular muscle movement. Instead of an improvement in their condition,
some users end up experiencing a deterioration as they pursue seemingly
beneficial contractions that offer no benefit to their particular condition. In
contrast, the PeriCoach indicates the force applied by specific muscles. Key
features of the PeriCoach
 The unique shape is designed to capture the complete
movement of the levator ani (comprising the iliococcygeus,
puborectalis and pubococcygeus muscles). These muscles
are partly responsible for urinary incontinence.
 The top sensor determines the involvement of the
puborectalis muscle.
 The two side sensors determine the involvement of the
pubococcygeus muscle during a contraction.
 The muscle-specific information provided may also help in
treating overactive pelvic floor muscles.
 You get a visual representation of the force of a contraction,
and an audio prompt to begin and end each contraction.
 Unique movement detection within the probe assists in
correctly performing exercises through the use of icons
shown after each repetition indicating “good”, “bad” or
“unknown” technique.
 A history of each exercise is kept and can assist clinicians in
assessing an exercise regime and in diagnosing problems
needing to be remedied.

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 The associated *NEW* PeriTrack feature contains a Bladder
Diary and Surveys that can consistently monitor fluids, pads,
leaks and visits to toilet for valuable insight into your bladder
control progress over time, as well as recording objective
Quality of Life measures for you to use as a comparison tool
over the course of your program.
 The probe is covered in a silicone material that has been
tested for biocompatibility. This material has been selected
such that it should not irritate or damage the vaginal or
nearby tissues. Moreover, the device has a high ingress
protection rating (IP27). This means that internal bodily fluids
will not penetrate the material and damage the inside of the
probe, and the inside of the probe is protected from
penetration by fingers and objects of diameter 12.5mm
(0.49”) or greater.
Indicator Lights
The probe uses different coloured lights to indicate the probe status
 Green = power on
 Blue (continuous) = Bluetooth connected
 Purple = charging indicator – battery is currently being
recharged
The location of the indicator LED lights is shown in Figure 5 on page 20.
Brief overview of treatment
It is recommended to make your first Bladder Diary entry prior to starting
your exercise program so you can track your progress from the beginning.
Follow the prompts once app is installed and make regular entries for more
accurate results.

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The Surveys section also serves to monitor improvements in your quality of
life over time. These should be filled out at the start of your program, and
you will then be prompted every four weeks to fill out the questionnaires.
Figure 4: The Bladder Diary and Surveys feature to track bladder control
progress.
Once you have set up your PeriCoach (see How to Exercise on page 24), you
can begin your pelvic floor exercises. You will need to have the phone on
which you installed the PeriCoach app handy. At the start of your exercise
regime, you insert the probe and record your current maximum contraction
force. This becomes the baseline level for assessing the progress of your
subsequent exercise regime, and also customises the sensor settings for
your abilities.
With your current maximum force recorded, you can begin the first exercise
of the regime. You start by selecting an appropriate exercise program and

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level on your phone. During the exercise, you can see a graph on your
phone of the strength of your contractions relative to your baseline level.
If sound and vibration are enabled on your phone, you will hear a beep and
phone vibrates to let you know when to contract your muscles, and then
again when to relax. This contraction–relaxation cycle continues until the
exercise session ends.
At the end of a session, PeriCoach provides a summary of your improvement
since your last session. You can also view the details of each contraction (as
a percentage of your baseline level) and review the graph of your contraction
activity. The details of the session are automatically uploaded to the
PeriCoach online database (http://my.pericoach.com) where the complete
history of your exercise regime is securely stored.
NOTE
Before using the device, it is recommended that you consult with a health
practitioner to learn how to correctly perform pelvic floor exercises. If you are
not using the correct technique, it may affect your results and prevent
improvement.

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4 Setting up PeriCoach
The PeriCoach probe is powered by a rechargeable battery. As the battery
may have lost some power since the probe left the factory, it is
recommended that you recharge it before using the probe for the first time.
Charging instructions are provided on page 63.
Once the battery is fully charged, you can set up the PeriCoach system in
readiness for your exercise regime. The set-up process involves three steps:
1. Install the PeriCoach app on your Smartphone.
2. Pair the App and the PeriCoach probe so that they can share
information.
3. Register the App online using your username and password.
You only need to do these tasks once.
Installing the PeriCoach App
1. Navigate to your Google Play store or App Store on your phone.
2. In the “Search” bar type in “PeriCoach”.
3. Select the PeriCoach app and follow prompts to download and install.
4. When the app is installed:
 tap Open to start using PeriCoach straight away or
 tap Done to return to the home screen.
Pairing the App and the probe
The PeriCoach system works by the probe passing information from the
probe to your Smartphone using a communication system called Bluetooth.
For this communication to work, you need to set your smartphone to allow

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information to be shared between it and the PeriCoach probe. This is called
‘pairing’ the devices.
Bluetooth communication has a limited range. For best performance, place
the Smartphone you are using within two metres of the PeriCoach probe.
Turn on Bluetooth on your phone.
On some phones, tapping Settings displays the Wireless and network list
as shown in Figure 2. If Bluetooth is off, tap Off to turn it on. Consult the
instruction manual that accompanied your phone if you are unsure about
this.
Turn on the probe by removing it from the charging case. A green LED
should come on in the base of the probe as shown in Figure 5. If the green
light does not come on, give the sensor a quick shake with you hand. The
light should come on. The probe is now powered on and in Bluetooth
discoverable mode.
Figure 5: Location of LED lights.
Open the PeriCoach app and select Connect to Device. In the available list,
one of the items should have a name similar to “PeriCoach-
12345678901234” as shown in Figure 6. Tap on the name to initiate pairing
and connection. Select Pair when prompted.