USER MANUAL

www.physiolab.com
 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 specification 43
3.8 Disposal 44
3.9 Symbols 45
3.10 Manufacturer / contact 46
3.11 Warranty 46

2 | | 3
 1.1 INDICATIONS FOR USE
Always follow the recommendations of a qualified healthcare practitioner
1.1 INDICATIONS FOR USE
The Physiolab S System combines cold and compression therapies.
® 1

It is intended
Always to aid soft tissue of
follow the recommendations recovery post-exercise
a qualified and treat soft tissue
healthcare practitioner.
injuries in their early (acute) stage.
The Physiolab® S1 System combines cold and compression therapies.
It isCold and compression
intended can
to aid soft tissue help to
recovery reduce pain
post-exercise and
and swelling.
treat soft tissue
injuries in their early (acute) stage.
They also help to reduce an excessive inflammatory response to an injury
which
Cold helps to limit
and compression further
can help todamage.
reduce pain and swelling.
They also help to reduce an excessive inflammatory response to an injury
It can be used as part of a holistic sports injury prevention strategy
which helps to limit further damage.
when used pre and post activity.
It can be used as part of a holistic sports injury prevention strategy
whenTheused
system is designed
pre and to be used in hospitals, outpatient clinics,
post activity.
athletic training settings or home settings.
The system is designed to be used in hospitals, outpatient clinics,
athletic training settings or home settings.



CAUTION - OPERATION OF THE PHYSIOLAB® S1
CAUTION - OPERATION
SYSTEM OF THE
BY THE USER PHYSIOLAB
RECEIVING S
THERAPY
SYSTEM BY THE USER RECEIVING THERAPY
® 1

As the user receiving therapy, you may operate the S1 Control Unit but only
As the user receiving therapy, you may operate the S1 Control Unit but only
after:
after:
• You have read in their entirety and thoroughly understood all the
• You have read in their entirety and thoroughly understood all the
instructions for use, contraindications and warnings, and
instructions for use, contraindications and warnings, and

• If•there
If there is anything
is anything that
that you doyou do not understand,
not understand, please
please contact contact a qualified
a qualified
healthcare
healthcare professional
professional or youror your Physiolab
Physiolab® ®
representative.
representative. Alternatively
Alternatively you you
can can
referrefer
to thetoPhysiolab
the Physiolab
®
contactcontact information found in section 3.10.
® information found in section 3.10.

4 | | 5
4 |
1.1 INDICATIONS FOR USE 1.1 INDICATIONS FOR USE
The Physiolab® S1 System is intended for the application of cryotherapy
 WARNING – PROLONGED OR EXCESSIVE USE and intermittent pneumatic compression therapy via a Therapy Pack by
the user and, when advised, by a qualified healthcare practitioner for the
Improper application or excessive/prolonged use of the
treatment of soft tissue injury.
Physiolab® S1 System could result in tissue damage such as frostbite.

The repeated application of cryotherapy can result in permanent tissue and/or It is important to always follow the recommendations of a
nerve damage. The treatment area should be given sufficient time to recover healthcare practitioner.
between repeat treatments.
The Physiolab® S1 System combines cryotherapy and intermittent
Always wait for skin to return to normal temperature; as a minimum pneumatic compression therapies and is intended for the treatment of
wait 1 hour before administrating another therapy. post-surgical and musculoskeletal injuries during both the acute and
Discontinue use immediately if you experience or observe sub-acute phases.
any of the following:
Therapy results may vary from person to person and may not be the
• Increased pain same or have the same effect. Please consult your healthcare practitioner
regarding treatment and individual results.
• Burning
CRYOTHERAPY:
• Itching
Cryotherapy is intended for use during the early (internal) bleeding
• Increased swelling
and inflammation stages of an injury, where the aim is to reduce the
• Blisters detrimental effects of excessive bleeding and inflammation.

• Skin discolouration INTERMITTENT PNEUMATIC COMPRESSION THERAPY (IPC):

• Increased skin redness Intermittent pneumatic compression therapy is intended for use during
the inflammation and proliferation stages of an injury, where the aim is to
• A raised, itchy rash. reduce swelling, in order to prevent the detrimental effects of excessive
It is ESSENTIAL that you read section 3.4, which contains all warnings and swelling and to improve function in order to increase the rate of healing.
cautions, in detail before using the Physiolab® S1 System.
If any problems or unexpected operation errors are detected during the
setup, use or maintenance of the Physiolab® S1 System, please contact your
Physiolab® representative. Alternatively, you can refer to the Physiolab®
contact information found in section 3.10.

6 | | 7
1.2 INTENDED USERS 1.3 CONTRAINDICATIONS
1.2 INTENDED USERS 1.3 CONTRAINDICATIONS
The Physiolab® S1 System is intended for use by individuals and  WARNING
The Physiolab
healthcare S System is intended for use by individuals and
® 1
practitioners.
healthcare practitioners. The WARNING S system SHOULD NOT be used on individuals who have:
Physiolab
® 1

The user receiving therapy may also become the operator of the S1 Control
The user • The
Diabetes.
Physiolab® S1 system SHOULD NOT be used on individuals who
System but receiving
only oncetherapy mayread
they have also in
become the operator
their entirety of the S1 Control
and thoroughly
System but only once they have read in their entirety and thoroughly have:
understood all of the instructions for use, warnings and cautions. • A loss of sensation in the intended therapy area, such as numbness/
understood all of the instructions for use, warnings and cautions.
•paraesthesia
Diabetes. caused by nerve damage.
If there is anything you do not understand, please contact a qualified
If there is anything you do not understand, please contact a qualified
healthcare practitioner or your Physiolab®®representative. Alternatively, • •A confirmed
A loss of sensation in thetissue
or suspected intended therapy
infection in area, such as area.
the treatment
healthcare practitioner or your Physiolab representative. Alternatively,
you can refer to the Physiolab® ®contact information found in section 3.10. numbness/paraesthesia caused by nerve damage.
you can refer to the Physiolab contact information found in section 3.10. • Previously had frost bite on the affected limb or treatment area.
• A confirmed or suspected tissue infection in the treatment area.
• Previously experienced an adverse reaction to cold, such as
•development
Previously had frost bite
of hives on the
or welts, affectedand
itchiness limbswelling
or treatment area.
(e.g. cold
•induced urticaria
Previously or acutean
experienced paroxysmal cold haemoglobinuria
adverse reaction to cold, such as or
cryoglobulinemia).
development of hives or welts, itchiness and swelling (e.g. cold
induced urticaria or acute paroxysmal cold haemoglobinuria or
• A condition which could be exacerbated as a result of cold
cryoglobulinemia).
(e.g. multiple sclerosis, rheumatoid arthritis, spinal cord injury, clotting
•abnormalities, peptic
A condition which ulcer).
could be exacerbated as a result of cold
(e.g. multiple sclerosis, rheumatoid arthritis, spinal cord injury,
• Experienced slow wound healing in the past.
clotting abnormalities, peptic ulcer).
• Any known circulatory or cardiac conditions (e.g. acute stages of
• Experienced slow wound healing in the past.
inflammatory phlebitis, Raynaud’s phenomenon, hypertension, extreme
•lowAny known
blood circulatory
pressure, or cardiac conditions
arteriosclerosis or other (e.g. acuteischemic
vascular stages ofdisease).
inflammatory phlebitis, Raynaud’s phenomenon, hypertension,
• Anextreme
unstable fracture
low in the treatment
blood pressure, area. or other vascular
arteriosclerosis
ischemic disease).
• A tumour in the treatment area.
• An unstable fracture in the treatment area.

• A tumour in the treatment area.

8 | | 9
8 | | 9
1.3 CONTRAINDICATIONS 2.1 SYSTEM OVERVIEW
• Deep vein thrombosis (DVT) and/or pulmonary embolus - either current THE PHYSIOLAB® S1 SYSTEM:
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 flight). Tank
Hose
• 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 qualified practitioner.

 WARNING
If you are under 18 you must seek advice from a healthcare practitioner
before using the Physiolab® S1 system.

Power Supply

Physiolab® Therapy Pack

10 | | 11
2.2 ACCESSORIES 2.3 DEVICE FEATURES
Therapy Pack
A range of Physiolab® Therapy Packs are available for use with the S1 Tank User Interface Power Port
Connector Port
Control System. This includes Therapy Packs for key anatomical locations
and a range of Therapy Packs of different 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.

Limb Pack Hip Pack

Shoulder Pack Ankle Pack Tank Port

(Tank Removed)

 WARNING
Only use Therapy Packs and accessories supplied by Physiolab® Technologies
Ltd. Do not use other manufacturer’s Therapy Packs and accessories.

12 | | 13
2.4 DISPLAY AND CONTROLS 2.5 GETTING STARTED
Settings User Action Error/ 1. If assistance is required at any time when setting up, using or maintaining
Adjustment Warning Required Warning the Physiolab® S1 System, 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 difficult 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.
Treatment Treatment Sleep Mode Low Ice
Running Complete Cycle Time Indicator

 WARNING
USER INTERFACE
OLED Display Position the system to minimize the risk of tripping over the S1 Control Unit,
Therapy Pack tubeset or Power Supply and cables.

 WARNING
Liquid may drip from the underside of the device due to condensation.
If excessive water is identified then this may be due to an internal leak.
In this event, remove the device from use and contact your Physiolab®
representative.

 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
Play/Stop Button: Control Dial:
and disconnecting Therapy Packs or by filling and emptying the Tank.
Press to Play/Stop Treatment Rotate to change option,
Press to select option

14 | | 15
2.5 GETTING STARTED 2.6 REMOVAL & FILLING OF
3. Open the case. Make sure the unit is plugged in and switched on at the THE TANK
wall, with the power jack screwed into the socket in the top right-hand
corner of the unit. The unit will auto power up.

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 firmly in place.
*Location of power socket varies depending on your device. It will be in either of the locations shown above.

2.6 REMOVAL & FILLING OF 2.7 TREATMENT SET-UP

THE TANK 1. Select your chosen therapy pack. Attach your pack to the unit, aligning the
red line with the red dot. Push firmly downwards until you hear a click.
1. Raise the handle and remove the tank from the unit. If the tank is stiff,
please pull firmly.

2. Connect your chosen therapy pack to the hose by aligning the white parts
of each connector.
2. Place the tank on a flat surface with the lid facing upwards. Unscrew the lid
and fill with ice (approx. 2 kilo bag) to the top of the rim. Then, fill the tank with
water up to the fill line indicated on the side of the cartridge (approx. 3.2 ltr).

3. Place the therapy pack around the injured area, leaving any
wound dressings in place.

16 | | 17
2.7 TREATMENT SET-UP 2.8 TREATMENT SET-UP
SELECTING YOUR TREATMENT
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. The pack will start to inflate and treatment will begin.

At any point during the treatment you can press the Start/Stop button to
stop your treatment.

2.9 TREATMENT SET-UP

DURING YOUR TREATMENT
During your treatment you can expect to feel the pack inflating and
deflating as it applies compression to the desired area. Your skin will
2.8 TREATMENT SET-UP gradually get cooler until it reaches the temperature set, effectively
managing your pain relief. The S1 unit will make a clicking sound during
SELECTING YOUR TREATMENT
the treatment - this in indicative of the valves working to deliver your
Press the ( ) start/stop button on the unit to begin the setup of your treatment.
treatment.
To view the temperature of the water going in/out of the pack and
You are able to select a pre-set protocol dependent on the body part you are compression levels during your treatment, click the dial button once the
treating. Please view protocols overleaf for more information. Alternatively, treatment has started.
select ‘custom’ to set up your own treatment and manually select your
Click the dial once more to change temperature and / or compression
temperature, pressure, dwell time and duration. You can also choose to
levels.
activate the auto-repeat setting. To view the different options turn the dial
clockwise. To select an option, press down on the dial.
 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.

Once your chosen treatment has been selected, press the flashing play
button to begin your treatment.

18 | | 19
2.10 AFTER YOUR TREATMENT 2.11 AFTER USE AND STORAGE
1. Once your treatment is complete the screen will display FINISHED. You can 1. Before storing the device, always check that the Tank is empty.
then remove the therapy pack. Pour away any remaining water or ice.

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.
2. Wipe off any excess fluid from the inside of the Tank using a clean dry
disposable cloth.

3. Remove the tank, unscrew the lid and empty the ice/water mix.

3. Screw the cap back on and then replace the Tank into the Tank Port.

 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.

20 | | 21
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 CLEANING AND DISINFECTING THE PHYSIOLAB® S1 CONTROL UNIT
to disengage from the Power Port and disconnect.
On receipt or after periods of storage, the Physiolab® S1 Control Unit must be
cleaned and disinfected before being put into clinical use.

 WARNING
Before cleaning, disconnect from the mains electrical supply. Do not use the
device during cleaning, servicing and maintenance.
*Location of power socket varies depending on your device. It will be in either of the locations shown above.

5. Close the lid securely using the front clips.

Store the device away in a safe location until its next use.
 WARNING
No part of the S1 Control Unit or Therapy Pack should be immersed in water
or other liquids during cleaning or disinfection.

 WARNING
Disinfectant products are corrosive in nature; failure to properly wipe
and dry the surfaces could leave a corrosive residue which may cause
6.
latent damage:
 CAUTION
• Do not use cleaning or disinfecting solutions which contain Phenol,
Please note - If power is lost or the device is powered down during
Bleach or Chlorine on any part of the S1 Control Unit or the Therapy Packs.
treatment, the selected treatment program and any treatment progress
will be lost. The treatment program will need to be set up again each • Do not steam clean or jet wash any areas of the S1 Control Unit or
time the device is powered up. Therapy Packs.

7. See section 3.6 for full storage and transportation guidelines.

8. The Physiolab® S1 Control 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.

22 | | 23
3.1 CLEANING AND DISINFECTING 3.1 CLEANING AND DISINFECTING

RECOMMENDED CLEANING STEPS FOR OUTSIDE OF UNIT: CLEANING AND DISINFECTING THE PHYSIOLAB® THERAPY PACKS:

1. The Physiolab® S1 Control Unit must be turned off and disconnected from the
mains supply before any cleaning.
 WARNING
2. Clean and disinfect the screen with Alcohol wipes only. • Physiolab® Therapy Packs must be cleaned and disinfected after each use,
particularly when used to treat more than one individual in accordance
3. Remove the Tank. Wipe all surfaces of the S1 Control Unit, Tank, Power Supply (and
with good cross infection prevention practice.
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 • Physiolab® Therapy Packs should be cleaned and disinfected only using
squeeze out surplus liquid. an appropriate medical device CE marked disinfectant diluted to the
manufacturer’s instructions and including the appropriate contact time
4. Disinfect all surfaces of the S1 Control Unit, Tank, Power Supply and cables before drying or rinsing off.
(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. RECOMMENDED CLEANING STEPS:
5. After the specified contact time wipe dry with a clean and dry disposable cloth.
Make sure all surfaces are completely dried before reconnecting the Physiolab® S1
1. Disconnect the Therapy Pack from the S1 Control Unit.
Control Unit, power supply and cables to a mains supply.
2. Clean the Therapy Pack using a disposable cloth dampened with detergent,
RECOMMENDED CLEANING STEPS FOR S CONTROL 1 diluted with water as per the manufacturer’s instructions. Apply the liquid to the
UNIT CARTRIDGE AND CONNECTED PACK: 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
1. The S1 Control Unit Tank must be cleaned twice every month using the supplied order: 1) Therapy Pack Connector, 2) Outer surface of Therapy Pack, 3) Inner
Cleaning Tablets, or an available alternative with the following ingredients: surface of Therapy Pack.
TROCLOSENE SODIUM (CAS: 2893-78-9): 19.5% W/W.
3. Disinfect all surfaces of the Therapy Pack using a disposable cloth dampened with
2. Remove the Tank from the S1 Control Unit and follow the steps instructed on the disinfectant which is indicated for use on PU coated Nylon and is diluted as per the
Cleaning Tablet packaging and place the solution in the Tank. 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
3. Screw the cap back on and then replace the Tank into the Tank Port, connect a
that the Therapy Pack is cleaned in the following order: 1) Therapy Pack Connector,
Therapy Pack to the S1 Control Unit and run a treatment. This will clean the internals
2) Outer surface of Therapy Pack, 3) Inner surface of Therapy Pack.
of the S1 Control Unit and the internals of the connected Therapy Pack.
4. After the specified contact time, wipe dry with a clean dry disposable cloth.

24 | | 25
3.2 MAINTENANCE 3.2 MAINTENANCE

Ensure that the Physiolab® S1 Control Unit, its parts EXPECTED SERVICE LIFE
(Tank, Power Supply, cables) and the Therapy Packs are in good condition
before use and that there is no leakage of fluid. The device has an expected service life of 3 years, subject to an annual
Physiolab® approved service.

 WARNING MAINS ISOLATION

Before each use, ensure the device’s functions operate correctly. Also To isolate the equipment from the mains power, disconnect the power supply
visually inspect the device for any loose or damaged parts. from the supply mains.

If the device’s performance or mode of operation changes from that

RECURRENT TESTING
specified or required, the device should be taken out of service immediately.

Request maintenance before returning the device to clinical use. The system should be electrically safety tested on an annual basis in accordance
with EN IEC 62353:2014.

ESSENTIAL PERFORMANCE
 WARNING
In fault state, the device ensures the user remains safe by monitoring for low
Before use, check that the Tank is not damaged or leaking. Any part of the output temperatures and high output pressures. In the event that any
Physiolab® S1 System that is damaged or worn should be replaced. potentially hazardous events are detected, the device will stop functioning
and an error message will be displayed.

 WARNING
Do not use the device during cleaning, servicing and maintenance.

 CAUTION
Any servicing or maintenance beyond what is stated in this document
should only be undertaken by Physiolab® or Physiolab® approved
service personnel.

26 | | 27
3.3 TROUBLESHOOTING 3.3 TROUBLESHOOTING

EVENT DESCRIPTION SOLUTION EVENT DESCRIPTION SOLUTION

Check the power jack is pushed in and

Disconnect and reconnect the power
the collar is tightened as described in
jack to restart the S1 then retry therapy.
section 2.5. ERROR 103 Safety system stopped
DISPLAYED therapy.
If the fault is persistent phone
S1 DOES NOT TURN ON The S1 is not receiving Check the power supply is connected to
Physiolab® for technical support
power. the mains and wall socket switched on.

If the S1 is still not operational phone Check the hose and therapy pack are
Physiolab® for technical support. connected firmly.
ERROR 106 OR
Pressure measurement
ERROR 806
DISPLAYED too high. Check the hose and pipes are not
kinked.
Ensure the tank is filled to the level
shown in section 2.6.
‘CARTRIDGE REMOVED’ Tank is not detected as
DISPLAYED being in place. Push the tank down firmly to click it into
place. ERROR 110 An existing error has Disconnect and reconnect the power
DISPLAYED occurred. jack and retry applying therapy.

Please note that condensation can cre-

ate small amounts of water. This can be
Check therapy pack connectors is fully
expected and is normal.
A step has taken too clicked together.
ERROR 200
DISPLAYED
long and the system has
WATER POOLING If there is a large amount of pooling,
Water spillage / leaking. timed out. Check tank is fully pushed down until it
UNDERNEATH UNIT check you have tightened the tank lid
clicks into place.
fully.

If leak continues contact Physiolab for

technical support.
ERROR 851 No warming detected on Ensure the therapy pack is applied to the
DISPLAYED the therapy pack. skin without heavy clothing.
Check that the tank has been filled with
ice and water as described in section 2.6.
THERAPY PACK Cold water is not flowing
GETTING COLD Check the hose and pack are connected
through the therapy ERROR XXX
firmly.
packs. OTHER NON-LISTED Contact Physiolab® for technical
Check the hose and pipes are not ERROR NUMBER support.
DISPLAYED
kinked.

28 | | 29
3.3 TROUBLESHOOTING 3.4 WARNINGS AND CAUTIONS

If any problems or unexpected operation errors are detected during the

setup, use or maintenance of the Physiolab® S1 System, please  A WARNING
contact your Physiolab® representative. Alternatively you can refer is given when the personal safety of the user may be affected and when
to the Physiolab® contact information in section 3.10. disregarding this information could result in permanent injury.

 A CAUTION
is given when special instructions must be followed. Disregarding this
information could result in permanent damage being caused to the
Physiolab® S1 System and Therapy Packs.

 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® S1 System contrary to instructions, or using incorrectly
fitting Therapy Packs may result in permanent tissue damage.
It is important when using the Physiolab® S1 System 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.

‘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.

30 | | 31
3.4 WARNINGS AND CAUTIONS 3.4 WARNINGS AND CAUTIONS

• In the event that any of these symptoms are observed or if there is any  WARNING
unexpected change to the appearance of the skin (including: non-reactive Keep the device and any cables or hoses out of the reach of children to
hyperaemia, cyanosis, blistering), therapy must be stopped immediately and prevent the risk of strangulation or misuse.
a healthcare practitioner must be informed.

• If elevation of the limb is undertaken during therapy, the clinician should look
for signs of reduced blood flow/perfusion in the foot/hand and toes/fingers,
and if observed, the treatment should cease immediately.  CAUTION
Do not add water and ice directly to the device during therapy operation.
• Physiolab® Therapy Packs are not sterile and as such should not be brought
Ensure that only the Tank is filled with the water and ice and then placed
into contact with any rash, sore, open wound, infection, or sutures (stitches).
into the device.
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  WARNING
Pack should only be used for the anatomical area indicated on the Therapy Do not use device if the Power Supply or Power Supply cable
Pack and corresponding instructions. It is important for the appropriate appears damaged.
Therapy Pack to be selected for suitable fit to the individual’s own
limb and anatomy.

 CAUTION
 WARNING Ensure to wipe up all spillages which occur during use with the unit.
No modification of this equipment is allowed.

Any servicing or maintenance beyond what is stated in this document  WARNING

should only be undertaken by Physiolab® or Physiolab® approved
Do not fill Tank with hot water. If misused in this way, the S1 may warm the
service personnel.
Therapy Pack to the temperature of liquid in the Tank.

 WARNING
Ensure the Tank is filled with water and ice only.  CAUTION
Do not crush Therapy packs during use.

32 | | 33
3.5 EMC COMPLIANCE 3.5 EMC COMPLIANCE
The following information is based on the requirements of EN 60601-1-2:2015. Guidance and IEC 60601 test level Compliance Electromagnetic environment
The S1 System has been supplied with a mains lead of length 1.8 metres. manufacturer’s - guidance
Use of accessories or cables other than those supplied with the unit may declaration -
electromagnetic
result in increased emissions or decreased immunity to EMI.
emissions

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

NOTE UT is the A.C. mains voltage prior to application of the test level

34 | | 35
3.5 EMC COMPLIANCE 3.5 EMC COMPLIANCE

Guidance and IEC 60601 test level Compli- Electromagnetic RF TRANSMITTERS WITHIN THE DEVICE
manufacturer’s ance environment - guidance
declaration -
Technology Transmission Effective Radiated Modulation Scheme
electromagnetic
emissions frequency (MHz) Power (pW)

Conducted RF 3V rms (1kHz 80%) 150kHz - Class A Portable and mobile RF

EN61000-4-6: 80MHz communications equipment should NFC / RFID 13.56 2.7 ASK
2014 6V rms ISM and be used no closer to any part of
amateur radio bands the Physiolab® S1 System including
cables, than the recommended
separation distance calculated from RF RECEPTION FREQUENCY BANDS
Radiated RF 10V/m (1kHz 80%) 80MHz -2.7GHz Class A the equation applicable to the
EN61000-4-3: frequency of the transmitter. Technology Reception frequency (MHz) Bandwidth (MHz)
2006 385 MHz 27 V/m PM 18 Hz
450 MHz 28 V/m FM 1 kHz sine
Recommended separatio
710 MHz 9 V/m PM 217 Hz
distance
745 MHz 9 V/m PM 217 Hz NFC / RFID 13.56 0.02
780 MHz 9 V/m PM 217 Hz
d = 0.6√P for frequencies at the
810 MHz 28 V/m PM 18 Hz 10V/m test level
870 MHz 28 V/m PM 18 Hz d = 0.22√P for frequencies at the
930 MHz 28 V/m PM 18 Hz 27V/m test level
1720 MHz 28 V/m PM 217 Hz d = 0.67√P for frequencies at the
1845 MHz 28 V/m PM 217 Hz 1970 27V/m test level
MHz 28 V/m PM 217 Hz 2450 MHz where P is the maximum output
28 V/m PM 217 Hz 5240 MHz 9 power rating of the transmitter in
V/m PM 217 Hz watts (W) according to the trans-
5500 MHz 9 V/m PM 217 Hz mitter manufacturer and d is the
5785 MHz 9 V/m PM 217 Hz recommended separation distance
in metres (m).

Field strengths from fixed 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

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 affected by absorption and
reflection from structures, objects and people.

(a) Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 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, field strengths should be less than 10 V/m.

36 | | 37
3.6 ENVIRONMENT, STORAGE 3.7 TECHNICAL SPECIFICATION
AND TRANSPORTATION
PART NO / REF:
The Physiolab® S1 System is intended for use in healthcare environments,
S1 Control Unit 2101
(e.g. hospitals, outpatient clinics), athletic training settings and at home. When used
in home settings, avoid placing or using the device near fireplaces or heaters. Power Supply 2001, 2001.1

Tank 2002
Please ensure the device is not used in areas of high humidity such as a shower room.

The device should not be stored outdoors. MECHANICAL SPECIFICATION:

External Dimensions (mm) 244 (h) x 430 (w) x 341 (d)

 WARNING Weight (empty) 7.8 Kg

Do not use outside listed operating conditions. Weight (full Tank) 13.4 Kg

THERAPY DELIVERY:
ENVIRONMENTAL OPERATING CONDITIONS:
Temperature 6°C - 12°C (+/- 1.0°C)
Ambient Temperature 1°C - 40°C
Pressure 25mmHg - 75mmHg (+/- 10mmHg @ 25mmHg)
Humidity 15% - 90% non-condensing
Pressure Cycle Time 60 sec, 90 sec or 120 sec
Altitude Sea level to 3000m
Therapy Duration 30 minutes maximum

IP RATINGS:
S1 Control Unit IP23: May be used outdoors in light rain. THERMAL SYSTEM:
Avoid excessive splashing or submersion in water.
Not protected against dust ingress. Total Volume 4.2 L
Power Supply No IP rating Volume of Water 3 L (approx.)

 WARNING Quantity of Ice 2 kg (approx.)

Device is not to be used outside with the Power Supply.

ELECTRICAL POWER SOURCE:

STORAGE AND TRANSPORTATION CONDITIONS BETWEEN USE: Power Supply Input - Universal 100 ~ 240Vac,
single phase, 50 ~ 60 Hz
Ambient Temperature 1°C - 70°C
Output - 12.00V, 7A Max or 12.00V, 5A Max
Humidity 10% - 90% non-condensing
 WARNING
Atmospheric Pressure 70kPa - 106kPa Designed for use with Physiolab® Power Supply 2001 Series.
Do not use with any other Power Supply.
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.

38 | | 39
3.8 DISPOSAL 3.9 SYMBOLS
This symbol on the products and / or accompanying documents means The following symbols apply to the product:
that at the end of life, electrical and electronic products should not be
mixed with general waste.
Warning or Caution, Read the instructions for use
read the instructions for use

Disposing of this product correctly will save valuable resources and prevent any
potential negative effects on human health and the environment which could Manufacturers name and address Mandatory to read
(see section 3.10 for details) instructions for use
otherwise arise from inappropriate waste handling.
The device’s Reference or Model
If you are unsure of your national requirements with respect to disposal please Date of manufacture Number (Type)
contact your local authority, dealer or supplier for further information.
S1 Control Unit has an ingress
The device’s unique Serial Number
The above information is based on the European waste electrical and electronic protection rating of IP23
equipment directive 2012/19/EU.
Electronic Waste Applied Part Type BF or Applied Part
(see section 3.10 for details) Type BF Connection

Therapy Pack Type Example shown is

Compliant to the Medical Device
the Shoulder (Right) Therapy Pack -
Directive 93/42/EEC with 2797 as the
additional therapy packs are available
Notified Body reference number.
2797 for other anatomical locations

Supply Mains Rating -

Period after opening
Class II

Do not use Phenol-based

Supply Frequency
cleaning solutions

Fuse Value Do not expose the device to

temperatures below 1 °C

Packaging - Packaging - Atmospheric

Humidity Limit Pressure Limit

Packaging - Packaging -
Keep Away from Rain Temperature Limit

Therapy Packs - Last Wash Date Packaging - This Way Up

40 | | 41
3.10 MANUFACTURER / CONTACT

Physiolab Technologies Ltd

Unit 2 Centurion Court,
Brick Close,
Kiln Farm,
Milton Keynes,
MK11 3JB,
United Kingdom

Tel: +44 (0)1908 263 331

Email: [email protected]
Website: www.physiolab.com

3.11 WARRANTY
Warranty options are available for the Physiolab® S1 System. For further informa-
tion, please contact your Physiolab® representative.

2797

Conforms to the Medical Device Directive 93/42/EEC and also the RoHS Directive
2011/65/EEC.
© Physiolab® Technologies Ltd. All rights reserved; this document is not to be
reproduced in whole or in part without the permission of the copyright owners.
The Company reserves the right to modify or improve the equipment referred to.

42 | | 43
PHYSIOLAB® S1 - USER MANUAL - DOCUMENT Di1 006 ISSUE 1.0.29