Physiolab S1 User manual

PHYSIOLAB.COM
USER MANUAL

2|

|3
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 Removal & lling of the tank 16
2.7 Treatment set-up 17
2.8 Selecting your treatment 18
2.9 During your treatment 19
2.10 After your treatment 20
2.11 After use and storage 21
3.1 Cleaning and disinfecting 23
3.2 Maintenance 26
3.3 Troubleshooting 28
3.4 Warning, cautions and side eects 31
3.5 EMC compliance 34
3.6 Environment, storage and transportation 38
3.7 Technical specication 39
3.8 Disposal 40
3.9 Symbols 41
3.10 Manufacturer / contact 42

4|
|5
4 |
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.

|5
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 at home under the direction of a health care professional.
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.

6|
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 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.

|7
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 and post orthopaedic surgery.
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.

8|
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.
|9
8 |
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.

|9
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.

10 |
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.

|11
Hose
Power Supply
Tank
Physiolab® Therapy Pack
2.1 SYSTEM OVERVIEW
THE PHYSIOLAB®S1 SYSTEM:

12 |
2.2 ACCESSORIES
A range of Physiolab®Therapy Packs are available for use with the S1Control 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

|13
2.3 DEVICE FEATURES
Tank User Interface Therapy Pack
Connector Port Power Port
Tank Port
(Tank Removed)

14 |
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

|15
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.

16 |
2.6 REMOVAL & FILLING OF
THE TANK
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.
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).
2.5 GETTING STARTED
*Location of power socket varies depending on your device. It will be in either of the locations shown above.

|17
2.6 REMOVAL & FILLING OF
THE TANK
2.7 TREATMENT SETUP
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.
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.

18 |
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
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.
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.
The pack will start to inate and treatment will begin.
2.7 TREATMENT SETUP

|19
2.8 TREATMENT SETUP
SELECTING YOUR TREATMENT
2.9 TREATMENT SETUP
DURING 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.
WARNING
During treatment, ensure blood ow is not restricted to the point of
inadequate perfusion; signs would be pins and needles in the extremity of
foot or hand, “dead leg/arm”, pain developing in hand/foot, or signicantly
pale foot/arm in comparison to the other limb.
If uncomfortable at any point during treatment stop and remove the therapy
pack and inspect skin; contact a healthcare professional for advice before
continuing.
If in doubt stop treatment and contact your healthcare professional for
advice.

20 |
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.
2.10 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.