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.