Physiolab S1 User manual

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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®S1SYSTEM
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
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 2 hours 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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1.1 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.

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1.2 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 CONTRAINDICATIONS
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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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.

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S1Control Unit
Power Supply
Cartridge
Physiolab®
Therapy Packs
(Supplied
Separately)
2.1 SYSTEM OVERVIEW
THE PHYSIOLAB®S1 SYSTEM:

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2.2 ACCESSORIES
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Tubular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 (Left) Therapy Pack Lower Back Therapy Pack Groin (Right) Therapy Pack
WARNING
Only use Therapy Packs and accessories supplied by Physiolab®Technologies
Ltd.Donotuseothermanufacturer’sTherapyPacksandaccessories.
Ankle Boot Therapy PackM540 (Tubular) Therapy PackS540 (Tubular) Therapy Pack

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2.3 DEVICE FEATURES
Cartridge User Interface
Therapy Pack
Connector Port
Cartridge Port (CartridgeRemoved) Power Port Removable
Fuse

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2.4 DISPLAY AND CONTROLS
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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2.5 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Cartridge.
WARNING
Liquid may drip from the underside of the device due to condensation.
If excessive water pools beneath this may instead be due to unforseen
obstruction. In this event, remove the device from use and contact your
Physiolab®representative.

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2.5 GETTING STARTED
3. Always setup the device in an up-right position on a level surface.
Open the lid fully.
4. Connect the Power Supply to the Power Port on the device by inserting
fully and twisting the collar clockwise to engage. Once engaged, connect
the power supply to the mains outlet socket.
5. Once connected, the device will automatically power on. When using the
deviceforthersttime,theuserwillberequiredtoselecttheoperating
language. To proceed, select Exit on the User Options screen.
< English >
Language

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2.5 GETTING STARTED
6. To reset the operating language at any time: Hold down the Play/Stop
button, disconnect the Power Supply and reconnect the Power Supply.
7. Once the device re-powers on, release the Play/Stop Button. The Language
screen will be displayed again. If the Physiolab®S1User Manual is required
inadierentlanguage,pleasecontactyourPhysiolab®representative.
8. Beforeeachuse,theusermustrstconrmthatyouhavereadthefull
usermanual.PresstheashingPlaybuttontoconrm.
Press Play to conrm.
Please read-conrm you have
read the full user manual
< English >
Language

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2.6 FILLING THE DEVICE
1. Tollthedevice,removetheCartridgefromtheCartridgePort.
2. Unscrew the cap and check to see that the Cartridge is empty.
If the Cartridge contains any water from previous use, pour away.
3. Fill the Cartridge to the top with ice.
100%

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2.6 FILLING THE DEVICE
4. Fill the Cartridge to the top with water (3.2 litres).
5. Screw the cap back on. Carry the Cartridge upright using the handle
this avoids water exiting the air breather hole nearest the lid.
Place the Cartridge into the Cartridge Port.
6. Once replaced, the device will prompt the user to connect the Therapy Pack.
100%
Connect Therapy Pack
Breather
hole

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2.7 CONNECTING A THERAPY
1. ConnecttheTherapyPackConnectortothedevice’sTherapyPack
Connector Port.
2. The Therapy Pack Connector can only be connected in the orientation
shown below (Therapy Pack Tubeset closest to Control Unit lid):
3. Once the Therapy Pack has been connected, the system will automatically
recognise the Pack and the Treatment Program can then be selected.
< Custom >
Treatment Program