Physiolab S1 User manual

www.physiolab.com
USER MANUAL

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CONTENTS
1.1 Indications for use 5
1.2 Intended users 8
1.3 Contraindications 9
2.1 System overview 11
2.2 Accessories 12
2.3 Device features 13
2.4 Display and controls 14
2.5 Getting started 15
2.6 Filling the device 18
2.7 Connecting a therapy pack 20
2.8 Setting up a treatment 21
2.9 During treatment 23
2.10 End of treatment 24
2.11 After use and storage 25
3.1 Cleaning and disinfecting 27
3.2 Maintenance 30
3.3 Troubleshooting 32
3.4 Warnings and cautions 35
3.5 EMC compliance 38
3.6 Environment, storage and transportation 42
3.7 Technicalspecication 43
3.8 Disposal 44
3.9 Symbols 45
3.10 Manufacturer / contact 46
3.11 Warranty 46

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1.1 INDICATIONS FOR USE
Alwaysfollowtherecommendationsofaqualiedhealthcarepractitioner.
The Physiolab®S1System combines cold and compression therapies.
It is intended to aid soft tissue recovery post-exercise and treat soft tissue
injuries in their early (acute) stage.
Cold and compression can help to reduce pain and swelling.
Theyalsohelptoreduceanexcessiveinammatoryresponsetoaninjury
which helps to limit further damage.
It can be used as part of a holistic sports injury prevention strategy
when used pre and post activity.
The system is designed to be used in hospitals, outpatient clinics,
athletic training settings or home settings.
CAUTION - OPERATION OF THE PHYSIOLAB®S1
SYSTEM BY THE USER RECEIVING THERAPY
As the user receiving therapy, you may operate the S1Control Unit but only
after:
• You have read in their entirety and thoroughly understood all the
instructions for use, contraindications and warnings, and
•Ifthereisanythingthatyoudonotunderstand,pleasecontactaqualied
healthcare professional or your Physiolab®representative. Alternatively you
can refer to the Physiolab®contact information found in section 3.10.
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1.1 INDICATIONS FOR USE
Alwaysfollowtherecommendationsofaqualiedhealthcarepractitioner.
The Physiolab®S1System combines cold and compression therapies.
It is intended to aid soft tissue recovery post-exercise and treat soft tissue
injuries in their early (acute) stage.
Cold and compression can help to reduce pain and swelling.
Theyalsohelptoreduceanexcessiveinammatoryresponsetoaninjury
which helps to limit further damage.
It can be used as part of a holistic sports injury prevention strategy
when used pre and post activity.
The system is designed to be used in hospitals, outpatient clinics,
athletic training settings or home settings.
CAUTION - OPERATION OF THE PHYSIOLAB®S1
SYSTEM BY THE USER RECEIVING THERAPY
As the user receiving therapy, you may operate the S1Control Unit but only
after:
• You have read in their entirety and thoroughly understood all the
instructions for use, contraindications and warnings, and
•Ifthereisanythingthatyoudonotunderstand,pleasecontactaqualied
healthcare professional or your Physiolab®representative. Alternatively you
can refer to the Physiolab®contact information found in section 3.10.

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1.1 INDICATIONS FOR USE1.1 INDICATIONS FOR USE
The Physiolab®S1System is intended for the application of cryotherapy
and intermittent pneumatic compression therapy via a Therapy Pack by
theuserand,whenadvised,byaqualiedhealthcarepractitionerforthe
treatment of soft tissue injury.
It is important to always follow the recommendations of a
healthcare practitioner.
The Physiolab®S1System combines cryotherapy and intermittent
pneumatic compression therapies and is intended for the treatment of
post-surgical and musculoskeletal injuries during both the acute and
sub-acute phases.
Therapy results may vary from person to person and may not be the
sameorhavethesameeect.Pleaseconsultyourhealthcarepractitioner
regarding treatment and individual results.
CRYOTHERAPY:
Cryotherapy is intended for use during the early (internal) bleeding
andinammationstagesofaninjury,wheretheaimistoreducethe
detrimentaleectsofexcessivebleedingandinammation.
INTERMITTENT PNEUMATIC COMPRESSION THERAPY (IPC):
Intermittent pneumatic compression therapy is intended for use during
theinammationandproliferationstagesofaninjury,wheretheaimisto
reduceswelling,inordertopreventthedetrimentaleectsofexcessive
swelling and to improve function in order to increase the rate of healing.
If any problems or unexpected operation errors are detected during the
setup, use or maintenance of the Physiolab®S1System, please contact your
Physiolab®representative. Alternatively, you can refer to the Physiolab®
contact information found in section 3.10.
WARNING – PROLONGED OR EXCESSIVE USE
Improper application or excessive/prolonged use of the
Physiolab®S1System could result in tissue damage such as frostbite.
The repeated application of cryotherapy can result in permanent tissue and/or
nervedamage.Thetreatmentareashouldbegivensucienttimetorecover
between repeat treatments.
Always wait for skin to return to normal temperature; as a minimum
wait 1 hour before administrating another therapy.
Discontinue use immediately if you experience or observe
any of the following:
•Increased pain
•Burning
•Itching
•Increased swelling
•Blisters
•Skin discolouration
• Increased skin redness
•A raised, itchy rash.
It is ESSENTIAL that you read section 3.4, which contains all warnings and
cautions, in detail before using the Physiolab®S1System.

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1.3 CONTRAINDICATIONS1.2 INTENDED USERS
The Physiolab®S1System is intended for use by individuals and
healthcare practitioners.
The user receiving therapy may also become the operator of the S1Control
System but only once they have read in their entirety and thoroughly
understood all of the instructions for use, warnings and cautions.
Ifthereisanythingyoudonotunderstand,pleasecontactaqualied
healthcare practitioner or your Physiolab®representative. Alternatively,
you can refer to the Physiolab®contact information found in section 3.10.
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1.3 CONTRAINDICATIONS1.2 INTENDED USERS
The Physiolab®S1System is intended for use by individuals and
healthcare practitioners.
The user receiving therapy may also become the operator of the S1Control
System but only once they have read in their entirety and thoroughly
understood all of the instructions for use, warnings and cautions.
Ifthereisanythingyoudonotunderstand,pleasecontactaqualied
healthcare practitioner or your Physiolab®representative. Alternatively,
you can refer to the Physiolab®contact information found in section 3.10.
WARNING
The Physiolab®S1system SHOULD NOT be used on individuals who have:
•Diabetes.
•A loss of sensation in the intended therapy area, such as numbness/
paraesthesia caused by nerve damage.
•Aconrmedorsuspectedtissueinfectioninthetreatmentarea.
•Previouslyhadfrostbiteontheaectedlimbortreatmentarea.
•Previously experienced an adverse reaction to cold, such as
development of hives or welts, itchiness and swelling (e.g. cold
induced urticaria or acute paroxysmal cold haemoglobinuria or
cryoglobulinemia).
• A condition which could be exacerbated as a result of cold
(e.g. multiple sclerosis, rheumatoid arthritis, spinal cord injury, clotting
abnormalities, peptic ulcer).
•Experienced slow wound healing in the past.
•Any known circulatory or cardiac conditions (e.g. acute stages of
inammatoryphlebitis,Raynaud’sphenomenon,hypertension,extreme
low blood pressure, arteriosclerosis or other vascular ischemic disease).
•An unstable fracture in the treatment area.
•A tumour in the treatment area.
WARNING
The Physiolab®S1system SHOULD NOT be used on individuals who
have:
•Diabetes.
•A loss of sensation in the intended therapy area, such as
numbness/paraesthesia caused by nerve damage.
•Aconrmedorsuspectedtissueinfectioninthetreatmentarea.
•Previouslyhadfrostbiteontheaectedlimbortreatmentarea.
•Previously experienced an adverse reaction to cold, such as
development of hives or welts, itchiness and swelling (e.g. cold
induced urticaria or acute paroxysmal cold haemoglobinuria or
cryoglobulinemia).
• A condition which could be exacerbated as a result of cold
(e.g. multiple sclerosis, rheumatoid arthritis, spinal cord injury,
clotting abnormalities, peptic ulcer).
•Experienced slow wound healing in the past.
•Any known circulatory or cardiac conditions (e.g. acute stages of
inammatoryphlebitis,Raynaud’sphenomenon,hypertension,
extreme low blood pressure, arteriosclerosis or other vascular
ischemic disease).
•An unstable fracture in the treatment area.
•A tumour in the treatment area.

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Hose
Power Supply
Tank
Physiolab® Therapy Pack
1.3 CONTRAINDICATIONS
WARNING
If you are under 18 you must seek advice from a healthcare practitioner
before using the Physiolab®S1system.
•Deep vein thrombosis (DVT) and/or pulmonary embolus - either current
or in the past – or any recent factors which may increase the risk of DVT
(e.g.youhavebeenbedboundoronalonghaulight).
•A localised skin condition in the intended therapy area
(e.g. dermatitis, vein ligation, gangrene, skin graft).
•Muscle tightness with a reduced ability to stretch, caused by nervous
system damage (e.g. decompensated hypertonia).
•Cognitive impairment / disabilities or communication barriers, whether
temporary due to medication or permanent.
Please note: There may be some instances where your healthcare
practitioner may decide that cold and compression therapy are
appropriate for individuals who have some of the above conditions.
This decision is always a clinical judgment call and must always be
madebyasuitablyqualiedpractitioner.
2.1 SYSTEM OVERVIEW
THE PHYSIOLAB®S1 SYSTEM:

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2.2 ACCESSORIES 2.3 DEVICE FEATURES
A range of Physiolab®Therapy Packs are available for use with the S1
Control System. This includes Therapy Packs for key anatomical locations
andarangeofTherapyPacksofdierentsizesthatcanbeusedonany
limb location. For a full list of the Therapy Packs that are currently available,
please contact your local Physiolab®SalesRepresentative.
Shoulder Pack
Hip Pack
WARNING
Only use Therapy Packs and accessories supplied by Physiolab®Technologies
Ltd.Donotuseothermanufacturer’sTherapyPacksandaccessories.
Ankle Pack
Limb Pack
Tank User Interface Therapy Pack
Connector Port Power Port
Tank Port
(TankRemoved)

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2.4 DISPLAY AND CONTROLS 2.5 GETTING STARTED
1. If assistance is required at any time when setting up, using or maintaining
the Physiolab®S1System, please contact your Physiolab®representative.
2. Before choosing a location to setup the device,
please consider the following:
WARNING
Donotpositionthedevicesothatitisdicultforthepatientand/oruserto:
1) View the display
2) Press the Stop Button
3) Disconnect the Therapy Pack
4) Disconnect the Power Supply from the mains socket.
WARNING
PositionthesystemtominimizetheriskoftrippingovertheS1ControlUnit,
Therapy Pack tubeset or Power Supply and cables.
WARNING
Position the Power Supply out of the way so that liquid will not be dripped on
it or pool nearby during use. Drips and spillages may occur when connecting
anddisconnectingTherapyPacksorbyllingandemptyingtheTank.
WARNING
Liquid may drip from the underside of the device due to condensation.
Ifexcessivewaterisidentiedthenthismaybeduetoaninternalleak.
In this event, remove the device from use and contact your Physiolab®
representative.
Control Dial:
Rotatetochangeoption,
Press to select option
Play/Stop Button:
Press to Play/Stop Treatment
OLED Display
USER INTERFACE
Settings
Adjustment
User
Warning
Action
Required
Error/
Warning
Treatment
Running
Treatment
Complete
Sleep Mode
Cycle Time
Low Ice
Indicator

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2.6 REMOVAL & FILLING OF
THE TANK
2.6 REMOVAL & FILLING OF
THE TANK
2.7 TREATMENT SET-UP
3. Open the case. Make sure the unit is plugged in and switched on at the
wall, with the power jack screwed into the socket in the top right-hand
corner of the unit. The unit will auto power up.
1. Raisethehandleandremovethetankfromtheunit.Ifthetankissti,
pleasepullrmly.
1. Select your chosen therapy pack. Attach your pack to the unit, aligning the
redlinewiththereddot.Pushrmlydownwardsuntilyouhearaclick.
2. Placethetankonaatsurfacewiththelidfacingupwards.Unscrewthelid
andllwithice(approx. 2 kilo bag)tothetopoftherim.Then,llthetankwith
wateruptothelllineindicatedonthesideofthecartridge(approx. 3.2 ltr).
3. Put the lid back onto the tank and screw it closed tightly. Gently lower the
tankbackintotheunitandpushdownfullyuntilitisrmlyinplace.
2. Connect your chosen therapy pack to the hose by aligning the white parts
of each connector.
3. Place the therapy pack around the injured area, leaving any
wound dressings in place.
2.5 GETTING STARTED
*Location of power socket varies depending on your device. It will be in either of the locations shown above.

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The pack can be applied over a thin layer of clothing or onto bare skin as
preferred or advised. Ensure that the tube is not twisted or stretched.
2.8 TREATMENT SET-UP
SELECTING YOUR TREATMENT
2.8 TREATMENT SET-UP
SELECTING YOUR TREATMENT
2.9 TREATMENT SET-UP
DURING YOUR TREATMENT
Press the ( ) start/stop button on the unit to begin the setup of your
treatment.
You are able to select a pre-set protocol dependent on the body part you are
treating. Please view protocols overleaf for more information. Alternatively,
select‘custom’tosetupyourowntreatmentandmanuallyselectyour
temperature, pressure, dwell time and duration. You can also choose to
activatetheauto-repeatsetting.Toviewthedierentoptionsturnthedial
clockwise. To select an option, press down on the dial.
Onceyourchosentreatmenthasbeenselected,presstheashingplay
button to begin your treatment.
At any point during the treatment you can press the Start/Stop button to
stop your treatment.
Duringyourtreatmentyoucanexpecttofeelthepackinatingand
deatingasitappliescompressiontothedesiredarea.Yourskinwill
graduallygetcooleruntilitreachesthetemperatureset,eectively
managing your pain relief. The S1 unit will make a clicking sound during
the treatment - this in indicative of the valves working to deliver your
treatment.
To view the temperature of the water going in/out of the pack and
compression levels during your treatment, click the dial button once the
treatment has started.
Click the dial once more to change temperature and / or compression
levels.
2.7 TREATMENT SET-UP
Thepackwillstarttoinateandtreatmentwillbegin.
WARNING
If during treatment there is any increase in pain, or if you are concerned in
anyway,STOPTHERAPYIMMEDIATELYANDREMOVETHETHERAPYPACK.

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2. To remove the therapy pack from the unit, push the bottom of the logo on
the outside of the connector and pull it upwards.
3. Removethetank,unscrewthelidandemptytheice/watermix.
2.11 AFTER USE AND STORAGE
1. Before storing the device, always check that the Tank is empty.
Pour away any remaining water or ice.
2. WipeoanyexcessuidfromtheinsideoftheTankusingacleandry
disposable cloth.
3. Screw the cap back on and then replace the Tank into the Tank Port.
2.10 AFTER YOUR TREATMENT
1. Once your treatment is complete the screen will display FINISHED. You can
then remove the therapy pack.
WARNING
Reapplyingcryotherapytreatmentsbeforethetissuehasrecoveredcan
result in permanent tissue and/or nerve damage. Do not re-apply therapy
until the skin has returned to normal temperature and always wait a
minimum of 1 hour.

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2.11 AFTER USE AND STORAGE 3.1 CLEANING AND DISINFECTING
4. To power down, twist the collar of the Power Supply plug anti-clockwise
to disengage from the Power Port and disconnect.
5. Close the lid securely using the front clips.
Store the device away in a safe location until its next use.
CLEANING AND DISINFECTING THE PHYSIOLAB®S1CONTROL UNIT
On receipt or after periods of storage, the Physiolab®S1Control Unit must be
cleaned and disinfected before being put into clinical use.
6.
7. See section 3.6 for full storage and transportation guidelines.
8. The Physiolab®S1Control Unit and Therapy Packs must be cleaned and
disinfected before being put back into clinical use. See section 3.1 for
full cleaning and disinfecting instructions.
WARNING
No part of the S1Control Unit or Therapy Pack should be immersed in water
or other liquids during cleaning or disinfection.
WARNING
Before cleaning, disconnect from the mains electrical supply. Do not use the
device during cleaning, servicing and maintenance.
WARNING
Disinfectant products are corrosive in nature; failure to properly wipe
and dry the surfaces could leave a corrosive residue which may cause
latent damage:
• Do not use cleaning or disinfecting solutions which contain Phenol,
Bleach or Chlorine on any part of the S1Control Unit or the Therapy Packs.
• Do not steam clean or jet wash any areas of the S1Control Unit or
Therapy Packs.
CAUTION
Please note - If power is lost or the device is powered down during
treatment, the selected treatment program and any treatment progress
will be lost. The treatment program will need to be set up again each
time the device is powered up.
*Location of power socket varies depending on your device. It will be in either of the locations shown above.

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3.1 CLEANING AND DISINFECTING 3.1 CLEANING AND DISINFECTING
1. The Physiolab®S1 ControlUnitmustbeturnedoanddisconnectedfromthe
mains supply before any cleaning.
2. Clean and disinfect the screen with Alcohol wipes only.
3. RemovetheTank.WipeallsurfacesoftheS1 Control Unit, Tank, Power Supply (and
cables) using a disposable cloth dampened with detergent diluted with water as
perthemanufacturer’sinstructions.Applytheliquidtothedisposableclothand
squeezeoutsurplusliquid.
4. Disinfect all surfaces of the S1 Control Unit, Tank, Power Supply and cables
(disconnected from a mains supply) using a disposable cloth dampened with
disinfectant, which is indicated for use on plastic and metal, and is diluted as per
themanufacturer’sinstructions.Applytheliquidtoadisposableclothandsqueeze
out surplus liquid.
5. Afterthespeciedcontacttimewipedrywithacleananddrydisposablecloth.
Make sure all surfaces are completely dried before reconnecting the Physiolab®S1
Control Unit, power supply and cables to a mains supply. 1. Disconnect the Therapy Pack from the S1 Control Unit.
2. Clean the Therapy Pack using a disposable cloth dampened with detergent,
dilutedwithwaterasperthemanufacturer’sinstructions.Applytheliquidtothe
disposableclothandsqueezeoutsurplusliquid.Donotapplyliquiddirectlytothe
Therapy Pack. It is recommended that the Therapy Pack is cleaned in the following
order: 1) Therapy Pack Connector, 2) Outer surface of Therapy Pack, 3) Inner
surface of Therapy Pack.
3. Disinfect all surfaces of the Therapy Pack using a disposable cloth dampened with
disinfectant which is indicated for use on PU coated Nylon and is diluted as per the
manufacturer’sinstructions.Applytheliquidtoadisposableclothandsqueezeout
surplus liquid. Do not apply liquid directly to the Therapy Pack. It is recommended
that the Therapy Pack is cleaned in the following order: 1) Therapy Pack Connector,
2) Outer surface of Therapy Pack, 3) Inner surface of Therapy Pack.
4. Afterthespeciedcontacttime,wipedrywithacleandrydisposablecloth.
1. The S1 Control Unit Tank must be cleaned twice every month using the supplied
Cleaning Tablets, or an available alternative with the following ingredients:
TROCLOSENESODIUM(CAS:2893-78-9):19.5%W/W.
2. RemovetheTankfromtheS1 Control Unit and follow the steps instructed on the
Cleaning Tablet packaging and place the solution in the Tank.
3. Screw the cap back on and then replace the Tank into the Tank Port, connect a
Therapy Pack to the S1 Control Unit and run a treatment. This will clean the internals
of the S1 Control Unit and the internals of the connected Therapy Pack.
RECOMMENDED CLEANING STEPS FOR OUTSIDE OF UNIT: CLEANING AND DISINFECTING THE PHYSIOLAB®THERAPY PACKS:
RECOMMENDED CLEANING STEPS:
RECOMMENDED CLEANING STEPS FOR S1 CONTROL
UNIT CARTRIDGE AND CONNECTED PACK:
WARNING
•Physiolab®Therapy Packs must be cleaned and disinfected after each use,
particularly when used to treat more than one individual in accordance
with good cross infection prevention practice.
• Physiolab®Therapy Packs should be cleaned and disinfected only using
an appropriate medical device CE marked disinfectant diluted to the
manufacturer’sinstructionsandincludingtheappropriatecontacttime
beforedryingorrinsingo.

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3.2 MAINTENANCE 3.2 MAINTENANCE
Ensure that the Physiolab®S1Control Unit, its parts
(Tank, Power Supply, cables) and the Therapy Packs are in good condition
beforeuseandthatthereisnoleakageofuid.
EXPECTED SERVICE LIFE
The device has an expected service life of 3 years, subject to an annual
Physiolab®approved service.
MAINS ISOLATION
To isolate the equipment from the mains power, disconnect the power supply
from the supply mains.
RECURRENT TESTING
The system should be electrically safety tested on an annual basis in accordance
with EN IEC 62353:2014.
ESSENTIAL PERFORMANCE
In fault state, the device ensures the user remains safe by monitoring for low
output temperatures and high output pressures. In the event that any
potentiallyhazardouseventsaredetected,thedevicewillstopfunctioning
and an error message will be displayed.
WARNING
Beforeeachuse,ensurethedevice’sfunctionsoperatecorrectly.Also
visually inspect the device for any loose or damaged parts.
Ifthedevice’sperformanceormodeofoperationchangesfromthat
speciedorrequired,thedeviceshouldbetakenoutofserviceimmediately.
Requestmaintenancebeforereturningthedevicetoclinicaluse.
WARNING
Before use, check that the Tank is not damaged or leaking. Any part of the
Physiolab®S1System that is damaged or worn should be replaced.
CAUTION
Any servicing or maintenance beyond what is stated in this document
should only be undertaken by Physiolab®or Physiolab®approved
service personnel.
WARNING
Do not use the device during cleaning, servicing and maintenance.

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3.3 TROUBLESHOOTING 3.3 TROUBLESHOOTING
EVENT DESCRIPTION SOLUTION
S1 DOES NOT TURN ON
The S1 is not receiving
power.
Check the power jack is pushed in and
the collar is tightened as described in
section 2.5.
Check the power supply is connected to
the mains and wall socket switched on.
If the S1 is still not operational phone
Physiolab® for technical support.
‘CARTRIDGE REMOVED’
DISPLAYED
Tank is not detected as
being in place.
Ensurethetankislledtothelevel
shown in section 2.6.
Pushthetankdownrmlytoclickitinto
place.
WATER POOLING
UNDERNEATH UNIT Water spillage / leaking.
Please note that condensation can cre-
ate small amounts of water. This can be
expected and is normal.
If there is a large amount of pooling,
check you have tightened the tank lid
fully.
If leak continues contact Physiolab for
technical support.
THERAPY PACK
GETTING COLD Coldwaterisnotowing
through the therapy
packs.
Checkthatthetankhasbeenlledwith
ice and water as described in section 2.6.
Check the hose and pack are connected
rmly.
Check the hose and pipes are not
kinked.
EVENT DESCRIPTION SOLUTION
ERROR 103
DISPLAYED
Safety system stopped
therapy.
Disconnect and reconnect the power
jack to restart the S1 then retry therapy.
If the fault is persistent phone
Physiolab® for technical support
ERROR 106 OR
ERROR 806
DISPLAYED
Pressure measurement
too high.
Check the hose and therapy pack are
connectedrmly.
Check the hose and pipes are not
kinked.
ERROR 110
DISPLAYED
An existing error has
occurred.
Disconnect and reconnect the power
jack and retry applying therapy.
ERROR 200
DISPLAYED
A step has taken too
long and the system has
timed out.
Check therapy pack connectors is fully
clicked together.
Check tank is fully pushed down until it
clicks into place.
ERROR 851
DISPLAYED
No warming detected on
the therapy pack.
Ensure the therapy pack is applied to the
skin without heavy clothing.
ERROR XXX
OTHER NON-LISTED
ERROR NUMBER
DISPLAYED
Contact Physiolab® for technical
support.

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3.3 TROUBLESHOOTING
If any problems or unexpected operation errors are detected during the
setup, use or maintenance of the Physiolab®S1System, please
contact your Physiolab®representative. Alternatively you can refer
to the Physiolab®contact information in section 3.10.
3.4 WARNINGS AND CAUTIONS
A WARNING
isgivenwhenthepersonalsafetyoftheusermaybeaectedandwhen
disregarding this information could result in permanent injury.
WARNING
The repeated application of Cryotherapy can result in permanent tissue
and nerve damage. Skin should always be allowed to return to normal
temperature and, as a minimum, wait 1 hours.
The recovery time will be dependent on a number of factors such as the
type and severity of injury, treatment duration, treatment area, thickness of
adipose tissue and stage of healing. ACPSM guidelines (Bleakley et al, 2010)
advise that this is typically 2 hours.
Your healthcare practitioner will use their clinical judgement when
recommending a treatment protocol.
WARNING
Using the Physiolab®S1System contrary to instructions, or using incorrectly
ttingTherapyPacksmayresultinpermanenttissuedamage.
It is important when using the Physiolab®S1System to regularly view and
monitor the skin in and around the area being treated, particularly the digits
of the extremities, for any increased swelling, burning, or pain.
A CAUTION
is given when special instructions must be followed. Disregarding this
information could result in permanent damage being caused to the
Physiolab®S1System and Therapy Packs.
‘Bleakley,C.M.andDavison,G.,(2010).‘ManagementofacutesofttissueinjuryusingProtectionRestIceCompressionandElevation: 
RecommendationsfromtheAssociationofCharteredPhysiotherapistsinSportsandExerciseMedicine’ACPSM[ExecutiveSummary]. 
Association of Chartered Physiotherapists in Sports and Exercise Medicine.

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3.4 WARNINGS AND CAUTIONS
WARNING
Keepthedeviceandanycablesorhosesoutofthereachofchildrento
prevent the risk of strangulation or misuse.
CAUTION
Do not add water and ice directly to the device during therapy operation.
EnsurethatonlytheTankislledwiththewaterandiceandthenplaced
into the device.
WARNING
Do not use device if the Power Supply or Power Supply cable
appears damaged.
CAUTION
Ensure to wipe up all spillages which occur during use with the unit.
CAUTION
Do not crush Therapy packs during use.
WARNING
DonotllTankwithhotwater.Ifmisusedinthisway,theS1may warm the
Therapy Pack to the temperature of liquid in the Tank.
3.4 WARNINGS AND CAUTIONS
• In the event that any of these symptoms are observed or if there is any
unexpected change to the appearance of the skin (including: non-reactive
hyperaemia, cyanosis, blistering), therapy must be stopped immediately and
a healthcare practitioner must be informed.
• If elevation of the limb is undertaken during therapy, the clinician should look
forsignsofreducedbloodow/perfusioninthefoot/handandtoes/ngers,
and if observed, the treatment should cease immediately.
• Physiolab®Therapy Packs are not sterile and as such should not be brought
into contact with any rash, sore, open wound, infection, or sutures (stitches).
Therapy Packs may be applied over a dressing or clothing upon the
assessment and advice of a healthcare practitioner.
• Physiolab®Therapy Packs are available for a wide range of anatomical
locations but are not intended for all possible orthopaedic uses. The Therapy
Pack should only be used for the anatomical area indicated on the Therapy
Pack and corresponding instructions. It is important for the appropriate
TherapyPacktobeselectedforsuitablettotheindividual’sown
limb and anatomy.
WARNING
Nomodicationofthisequipmentisallowed.
Any servicing or maintenance beyond what is stated in this document
should only be undertaken by Physiolab® or Physiolab® approved
service personnel.
WARNING
EnsuretheTankislledwithwaterandiceonly.

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3.5 EMC COMPLIANCE
Guidance and
manufacturer’s
declaration -
electromagnetic
emissions
IEC 60601 test level Compliance Electromagnetic environment
- guidance
Electrostatic
discharge (ESD) EN
61000-4-2:2009
8kV
contact 15kV air
Class B
Electrical fast
transient/burst
EN61000-4-4:2012
± 2 kV for power
supply lines
Class B Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
EN61000-4-5:2006
± 1.0 kV lines to
lines
± 2.0 kV lines to
earth 20s
Class B Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips
and interrupts
EN61000-4-11:2004
at 240VAC and
100VAC
30%UTfor500ms
@0°0%UTfor20ms
@0°0%UTfor10ms
@ 0°, 45°, 90°, 135°,
180°, 225°, 270°,
315°
0%for5s
Class B
Class B
Class B
Class C
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the Physiolab® S1
System requires continued
operation during power
mains interruptions, it is
recommended that the
Physiolab® S1be powered from
an uninterruptible power
supply or a battery.
Power frequency
Magnetic Field
EN61000-4-8:2010
30 A/m If there is a reduction in delivery
performance it may be
necessary to position the
Physiolab®S1System further
from sources of power
frequencymagneticeldsor
to install magnetic shielding.
The power frequency magnetic
eldshouldbemeasuredinthe
intended installation location to
assurethatitissucientlylow.
NOTE UT is the A.C. mains voltage prior to application of the test level
3.5 EMC COMPLIANCE
Guidance and manufacturer’s
declaration - electromagnetic
emissions
Compliance Electromagnetic environment -
guidance
RFemissionsCISPR11 Group 2 The Physiolab®S1System must emit elec-
tromagnetic energy in order to perform
its intended function. Nearby electronic
equipmentmaybeaected.
RFemissionsCISPR11 Class B The Physiolab®S1System is suitable
for use in all establishments, including
domestic establishments and those
directly connected to the public low
voltage power supply network
that supplies buildings used for
domestic purposes.
Harmonic emissions
EN61000-3-2:2004
N/A Power
<75W
Voltageuctuations/icker
emissions EN61000-3-3:2013
N/A Power
<75W
ETSI EN 302 291-1 V1.1.1 and
ETSI EN 302 291-2 V1.1.1
Complies
The following information is based on the requirements of EN 60601-1-2:2015.
The S1System has been supplied with a mains lead of length 1.8 metres.
Use of accessories or cables other than those supplied with the unit may
result in increased emissions or decreased immunity to EMI.
The S1System should not be used directly adjacent to, or stacked, with other
equipment. If adjacent or stacked use is necessary, the equipment should be
observedtoverifynormaloperationinthecongurationinwhichitwillbeused.
PortableandmobileRFcommunicationsequipmentcanaectmedicalelectrical
equipment. The Physiolab®S1System may be interfered with by other equipment,
includingequipmentthatcomplieswithCISPRemissionrequirements.
All tests have been performed on the Enclosure and / or AC Power Ports as appli-
cable. The Physiolab®S1System has no user accessible DC Power, Signal or Patient
Coupling Ports or outdoor cables.

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3.5 EMC COMPLIANCE
RF TRANSMITTERS WITHIN THE DEVICE
Technology Transmission
frequency(MHz)
EectiveRadiated
Power (pW)
Modulation Scheme
NFC/RFID 13.56 2.7 ASK
RF RECEPTION FREQUENCY BANDS
Technology Receptionfrequency(MHz) Bandwidth(MHz)
NFC/RFID 13.56 0.02
3.5 EMC COMPLIANCE
Guidance and
manufacturer’s
declaration -
electromagnetic
emissions
IEC 60601 test level Compli-
ance
Electromagnetic
environment - guidance
ConductedRF
EN61000-4-6:
2014
3Vrms(1kHz80%)150kHz-
80MHz
6V rms ISM and
amateur radio bands
Class A PortableandmobileRF
communications equipment should
be used no closer to any part of
the Physiolab®S1System including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommendedseparatio
distance
d=0.6√Pforfrequenciesatthe
10V/m test level
d=0.22√Pforfrequenciesatthe
27V/m test level
d=0.67√Pforfrequenciesatthe
27V/m test level
where P is the maximum output
power rating of the transmitter in
watts (W) according to the trans-
mitter manufacturer and d is the
recommended separation distance
in metres (m).
FieldstrengthsfromxedRF
transmitters, as determined by an
electromagnetic site survey, (a)
should be less than the
compliance level in each
frequency range (b)
Interference may occur
in the vicinity of equipment
marked with this symbol
RadiatedRF
EN61000-4-3:
2006
10V/m(1kHz80%)80MHz-2.7GHz
385MHz27V/mPM18Hz
450MHz28V/mFM1kHzsine
710MHz9V/mPM217Hz
745MHz9V/mPM217Hz
780MHz9V/mPM217Hz
810MHz28V/mPM18Hz
870MHz28V/mPM18Hz
930MHz28V/mPM18Hz
1720MHz28V/mPM217Hz
1845MHz28V/mPM217Hz1970
MHz28V/mPM217Hz2450MHz
28V/mPM217Hz5240MHz9
V/mPM217Hz
5500MHz9V/mPM217Hz
5785MHz9V/mPM217Hz
Class A
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaectedbyabsorptionand
reectionfromstructures,objectsandpeople.
(a) Fieldstrengthsfromxedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,ama-
teurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.Toassesstheelectromag-
neticenvironmentduetoxedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.Ifthemeasuredeldstrength
inthelocationinwhichthePhysiolab®S1 SystemisusedexceedstheapplicableRFcompliancelevelabove,thePhysiolab®S1 System
shouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,such
asre-orientingorrelocatingthePhysiolab®S1 System.
(b) Overthefrequencyrange150kHzto80MHz,eldstrengthsshouldbelessthan10V/m.

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3.7 TECHNICAL SPECIFICATION
PART NO / REF:
S1 Control Unit 2101
Power Supply 2001, 2001.1
Tank 2002
MECHANICAL SPECIFICATION:
External Dimensions (mm) 244 (h) x 430 (w) x 341 (d)
Weight (empty) 7.8Kg
Weight (full Tank) 13.4Kg
THERAPY DELIVERY:
Temperature 6°C - 12°C (+/- 1.0°C)
Pressure 25mmHg - 75mmHg (+/- 10mmHg @ 25mmHg)
Pressure Cycle Time 60 sec, 90 sec or 120 sec
Therapy Duration 30 minutes maximum
THERMAL SYSTEM:
Total Volume 4.2 L
Volume of Water 3 L (approx.)
Quantity of Ice 2 kg (approx.)
ELECTRICAL POWER SOURCE:
Power Supply Input - Universal 100 ~ 240Vac,
singlephase,50~60Hz
Output - 12.00V, 7A Max or 12.00V, 5A Max
WARNING
Designed for use with Physiolab®Power Supply 2001 Series.
Do not use with any other Power Supply.
3.6 ENVIRONMENT, STORAGE
AND TRANSPORTATION
ENVIRONMENTAL OPERATING CONDITIONS:
Ambient Temperature 1°C - 40°C
Humidity 15%-90%non-condensing
Altitude Sea level to 3000m
STORAGE AND TRANSPORTATION CONDITIONS BETWEEN USE:
Ambient Temperature 1°C - 70°C
Humidity 10%-90%non-condensing
Atmospheric Pressure 70kPa - 106kPa
IP RATINGS:
S1Control Unit IP23: May be used outdoors in light rain.
Avoid excessive splashing or submersion in water.
Not protected against dust ingress.
Power Supply No IP rating
WARNING
Device is not to be used outside with the Power Supply.
The Physiolab®S1System is intended for use in healthcare environments,
(e.g. hospitals, outpatient clinics), athletic training settings and at home. When used
inhomesettings,avoidplacingorusingthedevicenearreplacesorheaters.
Please ensure the device is not used in areas of high humidity such as a shower room.
The device should not be stored outdoors.
Please note: If stored above 40°C, you may need to allow up to 90 minutes for
the device to cool down to the normal operating temperature before use.
WARNING
Do not use outside listed operating conditions.