OML OML Remote User manual

…a confident choice
USER INSTRUCTION MANUAL
OML Remote
Read the instructions and precautions before using
this device.
Keep these instructions for future reference.
Model: OML Remote V1.0
Software: V1.0

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Contents
Introduction
Kit Content 4
Intended Purpose 5
Intended User 5
Introduction 5
Intended Environment 6
Important Information
Warnings 7-8
Precautions 9-11
Adverse Reactions, Residual Risk, Safe Disposal 12
Symbols Denitions 13-15
Denitions and Descriptions 16-17
Warranty 17
Operating Guide
Key Features 18-21
Turning On & O󰀨 22
Battery Level 23
Unlocking and Locking 24
Options Menu 25-26
Joining an ODFS®Pace XL 27
Replacing or Rejoining a Stimulator 28
Removing a Stimulator 29
Wireless Footswitches (OML LINQTM) 30-31
Stimulator Battery, Changing Channel 32
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Contents
Adjusting Intensity 33
Testing Stimulation 34
Active Mode 35
Pause Mode 36
Stimulation Mode Selection 37
Charging the OML Remote 38
Wireless Charging the OML Remote 39
Attaching a Lanyard 40
Screen Symbols, Software Version 41
Caring for your OML Remote
Maintenance, Servicing and Calibration 42
Cleaning and Care Guidance 43
Troubleshooting
Troubleshooting 44
Technical Information
Technical Specication 50-53
Wireless Information 54-55
Electromagnetic Compliance 56-59
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Kit Content
The OML Remote kit contains the following items:
1x OML Remote
Part number: 01-001-0022
1x OML Remote mains charger (power supply unit)
Part number: 05-001-0011
1x Instruction manual - English
Part number: 11-003-0086
1x Warranty card
Part number: 11-003-0067
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Introduction
Intended Purpose
The OML Remote is a hand-held wireless remote control for
compatible OML Stimulators, such as the ODFS®Pace XL. It is
intended to be used to remotely pause and activate stimulation,
trigger a test stimulation burst, adjust pulse width (intensity of
stimulation) and switch between stimulation modes (e.g. Exercise
and Walking modes).
Intended User
The OML Remote is intended to be used by Functional Electrical
Stimulation (FES) users of compatible Odstock Medical Limited
(OML) stimulators, such as the ODFS®Pace XL.
Introduction
The OML Remote can be used to control a maximum of 2
stimulators. It is powered using an internal rechargeable battery
and can be carried using a lanyard (not supplied). The product
is also capable of wireless charging which eliminates the need to
plug in a charger by placing it on an appropriate charging mat (not
supplied). The OML Remote does not need to be present in the
system in order for the ODFS®Pace XL to be used. The ODFS®
Pace XL can still be operated directly.
This User Manual explains the key features of the OML Remote,
describes how it is paired with the ODFS®Pace XL and how it
can be used to control it. This manual should be kept for future
reference.C
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Introduction
Intended Environment
The OML Remote is intended to be used in the home, public and
clinical environment. It is expected that users would store the OML
Remote in their pocket, on a lanyard or in a handbag when out
and about.
Following charging of the battery, the OML Remote may be warm
and may need to be left to cool prior to use. (See page 9)
When the OML Remote is stored in a hot or cold environment
it may be necessary to wait until the OML Remote has reached
operating temperature before use.
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Important Information (Warnings)
The user must familiarise themselves with these
warnings and precautions prior to using the device.
Strangulation
There is a risk of strangulation with the charger leads and lanyard.
Do not place charging leads around the neck. Keep out of reach
of children. If using a lanyard, it is advised to use a lanyard with a
saftey break release clip.
Children
The OML Remote is not a toy! Keep out of reach of children.
Batteries
All battery technologies carry a very small risk of re or explosion
if used incorrectly. Do not expose the OML Remote to re. Do
not charge, operate or store the device outside the specied
temperature ranges (see page 51). Do not expose the product to
temperatures above 60 °C (140 °F).
Wireless Communications
The OML Remote relies on radio-frequency (RF) communication
to control the stimulator(s). This may be subject to interference
from electromagnetic elds or other wireless communication
equipment which may cause it to stop communicating correctly.
Move away from or turn o󰀨 sources of interference.
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Important Information (Warnings)
Air Travel/Wireless Restricted Areas
The OML Remote could cause radio-frequency (RF) interference
to other critical equipment. Do not use the OML Remote in areas
where radio frequency devices are prohibited (e.g. on aircraft).
Flammable Cleaning Products
Do not use ammable cleaning products to clean the device.
Flammability
Do not use the device near ammable fuels, fumes or chemicals.
Allergies
The OML Remote is covered with a rubber e󰀨ect coating which
may cause skin irritation or allergic reaction. If a reaction appears
discontinue use and inform the manufacturer.
Oxygen Rich Environments
Do not use the OML Remote within an oxygen rich environment
such as a hyperbaric oxygen chamber or in close proximity to an
oxygen mask.
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Important Information (Precautions)
Charging
Only use wired chargers and power supplies recommended or
supplied by Odstock Medical Limited.
Only use Qi compliant wireless chargers with a single coil or
those recommended by Odstock Medical Limited. Use of a non-
Qi compliant wireless charger poses a risk of burns or battery
explosion.
Whilst the OML Remote is being charged (wired or wirelessly) it
may get hot along with the power supply or wireless charging mat,
which may in extreme circumstances cause skin burns. When
charged in a warm environment above 36 °C the surface of the
OML Remote and wireless charging mat may exceed 41 °C Do not
handle the device until it has cooled.
Charge the OML Remote if the battery warning is displayed.
The OML Remote cannot be operated (to control a connected
stimulator) whilst it is being charged.
Do not cover the OML Remote when charging, ensuring air is free
to ow round the device.
Damage
If the device has been impacted or has signs of damage, return to
the manufacturer for assessment prior to use of the device.
Degradation
Do not use the OML Remote or accessories if the devices are
damaged or degraded in any way.
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Important Information (Precautions)
Machinery Operation and Driving
The OML Remote should not be used when driving, operating
machinery, or during any activity when use of the device could
distract or put the user or others at risk of injury.
Water Ingress
Do not get the OML Remote wet. Do not use (operate or charge) if
the OML Remote is wet. Water ingress may stop the OML Remote
from working. If submerged, turn o󰀨 the device, dry out thoroughly
and return to the manufacturer for assessment prior to re-use.
Equipment Modication
Do not tamper with or modify the equipment. Risk of electrocution
from the charger and damage to the OML Remote. Doing so will
invalidate the warranty.
Storage Temperature
Do not store the device or accessories (e.g. charger) outside of
the temperature limits as detailed in the specication on pages
50-53. If the OML Remote or accessories have been stored at
the minimum or maximum storage temperatures, allow at least 10
minutes in ambient temperature before use to reach operational
temperature.
UseImPORTANT INFORMATION (PRECAUTINS)
Only use the OML Remote with other Odstock Medical Limited
products. The OML Remote can only be joined to other compatible
wireless Odstock Medical Limited stimulators.
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Important Information (Precautions)
Do not connect non-Odstock Medical Limited products to the OML
Remote either through a wired or wireless connection. No device
should be connected to the charging socket other than those
accessories provided or supplied by Odstock Medical Limited.
Environment
Do not leave the OML Remote or accessories in direct sunlight for
an extended period.
Electromagnetic Compliance
Use of accessories, transducers and cables other than those
specied or provided by Odstock Medical Limited could
result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.
Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation.
If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the OML Remote
including the stimulators joined to it and their accessories.
Otherwise, degradation of the performance of this equipment
could result.
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Important Information (Precautions)
Adverse Reactions
The user should report any undesirable outcomes, malfunctioning
of the device, mistakes in using the device, or injury from the use
of this device to their clinician.
The clinician is responsible for reporting all adverse events to
Odstock Medical Limited, or their local representative.
Residual Risk
The internal battery may explode if impacted, crushed, incorrectly
charged or immersed in water.
Do not touch the terminals of the charging socket.
The ODFS®Pace XL may not immediately unpause or pause
upon pressing the pause button on the OML Remote. Wait for
conrmation from the ODFS®Pace XL or OML Remote prior to
walking.
Safe Disposal of Equipment
Care should be taken to dispose of device parts and accessories in
the correct manner. In order to protect the environment, the product
and its accessories should not be disposed of in household waste.
Please dispose of as per local regulations. Alternatively, equipment
can be returned to Odstock Medical Limited for disposal.
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Symbol Denitions
Caution (used throughout the instruction manual to identify
caution items).
Read the instructions before use.
Consult the instructions for use.
Do not charge if the OML Remote is wet, the charger is
wet, or your hands are wet.
Warning, surfaces may be hot!
This product should not be disposed of with other
household waste. Your OML Remote and accessories can
be returned to Odstock Medical Limited for appropriate
disposal.
Date of manufacture.
The CE mark indicates that the OML Remote complies
with the European Union Medical Device Regulations.
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Symbol Denitions
Protected against the ingress of solid foreign objects of
diameter 12.5 mm or greater. Vertically falling water drops
have no harmful e󰀨ects.
Direct Current (DC)
Not to be used by persons under the age of 3 years.
The OML Remote contains a radio transmitting device.
Do not get any part of the system wet.
Expiry date (Year, Month, Day) of product (may relate to
specic components).
Do not use the OML Remote or accessories if the
packaging is substantially damaged. Proceed with caution
and check components for damage prior to use.
Do not store outside of the specied temperature limits.
If accompanied by <mo; for storage less than 1 month. If
>mo; for storage greater than 1 month.
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Symbol Denitions
Do not store outside the specied relative humidity limits.
Do not store outside the specied atmospheric pressure
limits.
Batch number.
Unique serial number of the OML Remote.
Odstock Medical Limited device reference number.
European authorised representative.
Manufactured by Odstock Medical Limited: Odstock
Medical Limited, National Clinical FES Centre, Salisbury
District Hospital, Salisbury, Wiltshire, UK, SP2 8BJ
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Denitions and Descriptions
Lock/Unlock
The buttons of the OML Remote will be locked (disabled) after
15 seconds of no use, to prevent accidental activation. Press the
‘standby’ button to unlock the buttons. If already unlocked press
the ‘standby’ button if you want to lock the buttons before 15
seconds has elapsed.
Stimulation Intensity
This is a stimulation parameter that a󰀨ects the strength of the
stimulation delivered. It is given in percentage of strength from
0% to 100%.
Pause Mode
In this mode, the ODFS®Pace XL does not deliver stimulation
except when using the test button. This mode should be used
when stimulation is not needed or when resting for example.
Active Mode
In this mode the ODFS®Pace XL delivers stimulation when in
walking or exercise mode.
Test Stimulation
The ODFS®Pace XL can deliver a burst of stimulation when the
test button is pressed. The ODFS®Pace XL must be in pause
mode. This is used to check the stimulation response before using
for walking or exercise.
Number of Stimulators
Up to two ODFS®Pace XLs can be joined and controlled using the
OML Remote.
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Denitions and Descriptions and Warranty
Stimulation Channel
Each pair of electrodes attached to one lead from the stimulator
makes a stimulation channel. The stimulation intensity of each
channel can be adjusted separately.
Joining a Stimulator to the OML Remote
This is the method by which the stimulator and OML Remote
connect wirelessly; allowing the OML Remote to control the
stimulator(s). See page 27.
Wireless Charging
This is a technique used to charge the internal battery of the
OML Remote without connecting it directly to the mains charger.
The transfer of energy is done without wires attached. A wireless
charger is not included. See page 39 (Wireless Charging).
Warranty
The OML Remote is warrantied for a period of one year from
the date of sale or tting. Should any failure of the device occur
during the warranty period, the device should be returned to
Odstock Medical Limited for inspection. Should the failure be due
to manufacturing or material defect the device will be repaired or a
replacement supplied free of charge.
The warranty is valid providing that the failure cannot be attributed
to misuse and the warranty registration card has been completed
and returned to Odstock Medical Limited as soon as possible.
Alternatively, this information can be completed online at:
www.odstockmedical.com
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Key Features
Front View of the OML Remote
Channel
Select
Display
Up
Pause
Standby
Test
Down
Mode
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Key Features
Display
Displays information about the OML Remote and the
stimulator(s) it controls.
Standby Button
Press and hold to power the OML Remote ON and OFF.
Press to lock and unlock the use of the OML Remote.
Pause Button
Press to pause and activate stimulators remotely. If
navigating a menu, press to select menu options.
Channel Select Button
For more than one channel of stimulation, press to
switch channels. Also to display stimulator battery level.
Up Button
Press to increase intensity of stimulation.
Down Button
Press to decrease intensity of stimulation.
Test Button
Press to start and stop test stimulation on the
stimulator(s).
Mode Button
Press to change stimulation mode on the stimulators(s)
e.g. to change between walking and exercise mode.
Press and hold to enter the user menu.
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Charger
Alignment
Guide
Charging
Socket
Lanyard
Attachment
OML Logo
Part Number
Serial Number
Key Features
Rear View of the OML Remote
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