Nice NICE1 User manual

NICE1 Cold + Compression
Therapy System

Thank you for choosing the NICE1
Cold + Compression Therapy
System. The NICE1 uses advanced
technology to greatly improve the
convenience and ecacy of cold +
compression therapy.
This manual has all the information
you need to properly and eectively
operate the NICE1.
Consult a healthcare professional before using NICE1.

QUICK START GUIDE
• Connect the power cord to the
external power supply.
• Plug the circular connector into
the back of the Cooling Unit. You
will hear a click when properly
connected.
• Plug the power cord into the wall
outlet.
Consult a healthcare professional before using NICE1.
It is recommended to read entire user manual before beginning. Refer to the
individual wrap guides for specific information regarding wrap use.
• Connect the hose to the Cooling Unit.
You will hear a click when properly
connected.
• Place the wrap on the appropriate
body part. Secure with hook
and loop.
• Connect the hose to the wrap.
You will hear a click when properly
connected.

Settings for temperature, compression, and duration should be used as directed
by your physician or medical professional.
STEP 1
Turn on the power switch on the back of the
device. The touch screen will illuminate and
display the “Nice” logo. Push “NEXT” . Review
the checklist on the touch screen. Confirm and
press “NEXT”.
STEP 2
Select desired COLD LEVEL and press NEXT.
Cold Settings are as follows:
Level 1 = 58F (14.4C)
Level 2 = 54F (12.4C)
Level 3 = 50F (10C)
Level 4 = 46F (7.7C)
Level 5 = 42F (5.5C)
STEP 3
Select desired COMPRESSION LEVEL and
COMPRESSION TYPE and press NEXT.
STEP 4
Choose a MANUAL time setting of 5 – 40 min-
utes for a single therapy session OR choose a
PRESET PROGRAM for multiple sessions and
press NEXT.
STEP 5
Review and confirm your settings by pressing
START or press BACK to change the settings.
STEP 6
During your therapy session you can change
the cold or compression settings simply by
pressing 1 – 5 or HIGH, MED
or LOW. To Dim, Press Dim switch, to brighten
- touch screen.

Programmable intermittent and
constant compression greatly improves
the eectiveness of cold therapy and
promotes healing.
COMPRESSION
By combining the therapeutic benefits of
cooling and compression in a single easy-
to-use device, recovery times are greatly
improved.
RECOVERY
State-of-the-art technology delivers
therapeutic cooling without ice.
The most convenient way to apply
cold therapy.
COOLING

1. Introduction
2. NICE1 description
3. Indications for use
4. Contraindications, cautions, and warnings
5. Unpacking NICE1
6. Environmental conditions
7. How to set up your NICE1 for therapy
8. Operating instructions
9. Maintenance and cleaning
10. Draining the water from the unit
11. Storage and re-packing the unit
12. Troubleshooting guide
13. Service and customer support
14. Warranty and disclaimer information
15. Electromagnetic compatibility
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TABLE OF CONTENTS

8NICE RECOVERY SYSTEMS
1 INTRODUCTION
NICE1 is designed to provide cold and compression therapy as specified in
this manual. If the system is used in a manner other than as specified, its
operation or the safety protection may be impaired.
Please read the entire manual carefully before operating the NICE1. The
patient is the intended operator. The patient can safely use and maintain
the NICE1 following these instructions.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
2NICE1 DESCRIPTION
NICE1 is a cold and compression therapy device used to aid recovery and
reduce pain associated with soft tissue injuries. The device works by circulating
cooled water and air through a therapy wrap that is placed on the body part.
The cooled water circulates through the therapy wrap and provides cold
therapy; the air inflates the therapy wrap causing it to compress around the
injured body part.
2.1 FEATURES
• Fluid therapy temperature range between 42°F - 58°F (14.4°C - 5.5°C)
• Treatment for edema with alternating compressions of
Low (20 mmHg), Medium (35 mmHg) and High (50 mmHg)
• Programmable therapies
• Lightweight and portable package
• User-friendly interface
• Easy to use and read touch screen display
2.2 GENERAL SPECIFICATIONS
• Weight: 10lbs when full of water
• Hose Length: 6 ft.
• Specified Medical Grade Power Supply (supplied with the system)
• Dimensions: 8.0”W x 7.64”H x 8.0”D
• Operating Fluid: Distilled water, tap water or
glycol/alcohol solution
• Flow Rate: .5 liters per minute
• Water Pressure: <30 PSI
• Water Reservoir Capacity: 300 mL
• Safety: IEC 60601-1:2012 and IEC 60601-1-2:2007
• Air Pump Pressure: 0-50 mm Hg
• Intermittent Compression Setting:
o High: inflate to 50 mmHg for 2 minutes and then deflate
to 5 mmHg for 30 seconds.
o Medium: inflate to 35 mmHg for 2 minutes and then deflate
to 5 mmHg for 30 seconds.
o Low: the NICE1 inflate to 20 mmHg for 2 minutes and then
deflate to 5 mmHg for 30 seconds.
• Cooling Temperature Range:
Level 1 = 58F (14.4C)

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Level 2 = 54F (12.4C)
Level 3 = 50F (10C)
Level 4 = 46F (7.7C)
Level 5 = 42F (5.5C)
• Use Operating Temperature: 60°F - 80°F (15.5°C - 26.7°C)
• Relative Humidity : 10% - 95% non-condensing
• Storage/Transportation Temperature Range: 40°F - 105°F (4°C - 41°C)
• Maximum Sound Pressure Level: 75dBA (with air pump running)
• Maximum Altitude: 4000m (13,123 ft)
• Display accuracy: +/- 2%
2.3 MEDICAL SYSTEM SPECIFICATIONS
• Specified Medical Grade Power Supply. The following
Power Supply is specified for use with the NICE1 unit:
o Class II Power Supply: DC output rated 15Vdc 12A
NOTE: A detachable type power supply cord (rated 125V 10A) is
provided with each power supply, suitable for use in the USA and Canada.
• NICE1 Cooling Unit: Electrical Input Rating of 15Vdc 12A
• Patient Therapy Wrap (patient applied part): Classification
of Patient Applied Part, Type BF
• Insulated Air/Water Hose Assembly for connection between
Control Unit and Patient Therapy Wrap
• Leakage Currents (per IEC 60601-1):
o Touch (Enclosure) Current:
<28uA in Normal Condition
<50uA in Single Fault Condition
o Patient (Applied Part) Leakage Current:
<28uA in Normal Condition
<50uA in Single Fault Condition
2.4 OPTIONS
• Non-Sterile Patient Therapy Wraps (knee wrap, etc.)
• Carrying Case
Caution: Consult accompanying documents Lot or Batch Number
Refer to User Manual and Labels.
Follow instructions for use.
Serial Number
Caution: Federal law restricts this device to sale
by or on the order of a physician.
OFF position for the DC Power Switch
at the rear of the Control Unit
Type BF Patient Applied Part (therapy wrap) ON position for the DC Power Switch
at the rear of the Control Unit
SN
LOT
RxOnly
!

10 NICE RECOVERY SYSTEMS
3INDICATIONS FOR USE
NICE1 combines cold and compression therapies. It is intended to treat
post-surgical and acute injuries to reduce edema, swelling, and pain
where cold and compression are indicated. It is intended to be used by or
on the order of a healthcare professional in hospitals, outpatient clinics,
athletic training settings, or home settings.
4CONTRAINDICATIONS, CAUTIONS, AND WARNINGS
4.2 CONTRAINDICATIONS FOR COLD THERAPY
NICE1 or any cold therapy device should not be used
by patients that:
• have significant vascular impairment in the aected region
(e.g., from prior frostbite, diabetes, arteriosclerosis or ischemia).
• have acute paroxysmal cold hemoglobinuria or cryoglobulinemia.
• have Raynaud’s disease or cold hypersensitivity (cold urticarial).
4.3 PRECAUTIONS
Basic safety precautions should always be followed when using
NICE1 to reduce the risk of fire, electric shock, and personal injury.
Please read the entire User Manual carefully before operating
the unit.
4.4 CAUTION
• Never push objects of any kind into the therapy unit through
the frame.
• Never spill liquid of any kind on the therapy unit.
• Do not overfill the water reservoir.
• If the unit gets wet, unplug the unit from the wall and allow
the unit to dry before use.
• Only use the supplied power supply and power cord.
• Do not operate the unit if it has any noticeable or physical
damage or is leaking fluid.
• Do not operate the unit with a damaged or frayed power cord.
• The therapy unit is not intended to be used in a wet environment
or when relative humidity is greater than 60%.
• Do not spray the unit with any water solvents or cleaners.
• Do not drop the therapy unit or cause impact to the unit.
• Do not pull or otherwise put undue stress on the hoses.
• Do not use near equipment that generates electromagnetic
or other interference, as this may be harmful to the therapy unit.
• Do not smoke while using therapy wraps or use wraps by
an open flame.
• Do not stick a finger or any other foreign objects into
the reservoir.
• Do not stick a finger or any other foreign objects into the fan.
• Do not drink or ingest the coolant or water that has been
circulating in the system.
• Do not service or perform maintenance while the equipment
is in use.

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4.5 WARNINGS
• Use carefully. May cause serious burns.
• Do not use over sensitive skin areas or in the presence
of poor circulation.
• Use of this device may also cause frostbite or tissue damage
if used incorrectly.
• The unattended use of NICE1 by children or incapacitated
persons may be dangerous.
• If unusual swelling, skin discoloration or discomfort occurs,
immediately discontinue use of NICE1 and consult a healthcare
professional.
• Follow the prescribed instructions of your physician for area,
frequency, and duration of treatment.
• Do not apply the therapy wrap so tightly as to restrict blood
or fluid flow.
• Use only NICE1’s approved therapy wraps.
• Therapy wraps are non-sterile and should never be directly
applied to an open wound or breached skin.
• Disposable therapy wraps are designed for single patient use
only and may only be used on the same patient for the length
of the treatment.
• The therapy wrap should be periodically cleaned if it is used
on the same patient for an extended period of time.
• Do not attempt to sterilize this device by any means.
• Dressings used under the therapy wrap should be applied lightly.
Do not use pins to secure the therapy wraps or hoses.
• Do not allow the therapy wrap or hoses to contact sharp objects
that could puncture it.
• All compression therapies must be turned OFF when the unit is
not in use, the wrap is removed from the patient for prolonged
periods, or for repositioning of the wrap.
• Immediately stop compression therapy if you experience any
sense of discomfort, numbness or tingling of the limb.
• Slots and openings in the cabinet are provided for ventilation to
protect the unit from overheating. These openings must not be
blocked or covered at any time except by the supplied air filter.
• No modification of this equipment is allowed.
• Connect only items that have been specified as part of the ME
equipment for NICE1 including the specified external Medical
Grade AC/DC power supply.
• A multiple socket outlet (power strip) or extension cord will not
be used to power the NICE1 unit.
• Do not simultaneously touch parts of other electrical equipment
when using the NICE1 unit.
• Observe all warning and caution labels. Never remove the
caution/warning labels.

12 NICE RECOVERY SYSTEMS
5UNPACKING NICE1
The following instructions apply to all users and settings as described
in section 2 Indications for Use: healthcare professional in hospitals,
outpatient clinics, athletic training settings, or home settings.
When you first unpack the NICE1 carrying case you should have
the following items:
All of these items are needed for safe system operation. If any of these items
are missing, please contact the clinic or hospital that prescribed
the unit, or your Durable Medical Equipment (DME) supplier or provider or Nice
Recovery Systems.
Immediately upon unpacking your NICE1, inspect your unit. If the unit shows
shipping damage, contact your Durable Medical Equipment (DME) provider. Be
sure to retain all packing material and the original box or case.
Along with NICE1 you should have received a disposable therapy wrap(s)
necessary for your prescribed treatment in an individually sealed, unopened bag.
Therapy wraps should never be directly applied to an open wound or
breached skin.
1. NICE1 Cooling Unit
2. Power Supply
3. Power Cord
4. Hose
5. Wrap (optional)

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6ENVIRONMENTAL CONDITIONS
NICE1 is intended for indoor use only. Do not operate NICE1 in or near
a wet environment.
NICE1 is not to be used in a confined space. Adequate airflow is necessary
for the proper functioning of the device. It is recommended that the
device have at least 12 inches of clearance in the front and back for
adequate airflow. Inadequate airflow can result in overheating of internal electri-
cal components and undesirable or excessive noise.
Only use NICE1 in an ambient environment between 60°F - 80°F (15.5°C - 26.7°C)
and a relative humidity below 60%.
Failure to meet these operating environment conditions may result in:
• Condensate buildup inside the unit.
• Overheating or freezing of the unit.
• Internal electronics malfunction.
• A reduction in the heating or cooling capabilities of the unit.
• The inability of the unit to properly regulate and administer
fluid temperature during heat or cold therapies.
• The inability of the unit to properly regulate and administer
pneumatic compression as specified in the indications for use.
Which may void the warranty.
7HOW TO SET UP YOUR NICE1 FOR THERAPY
• Remove the NICE1 Cooling Unit, external power supply, power cord,
and hose from the box or carry case. The wrap is separate and may
not be packaged with the unit. Verify that all of the necessary
equipment is present and not damaged.
• Find a stable location for the Cooling Unit and ensure that nothing is
blocking the airflow in the front and back of the device.
• Open the water reservoir and fill with water.
• Connect the power cord to the external power supply.
• Plug the circular connector into the back of the Cooling Unit.
You will hear a click when properly connected.

14 NICE RECOVERY SYSTEMS
• Plug the power cord into the wall outlet.
• Connect the hose to the Cooling Unit. You will hear
a click when properly connected.
• Place the wrap on the appropriate body part.
Secure with hook and loop.
• Connect the hose to the wrap. You will hear a click
when properly connected.

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8OPERATING INSTRUCTIONS
NOTE: Do not use this device without your physician’s specific
recommendations for the frequency, temperature, and duration
of your treatments.
The patient MUST be familiar with all warnings and cautions listed
in Section 2 before attempting to operate the unit.
NICE1 is capable of performing therapies for the following:
• Cold Therapy
• Cold Therapy + Compression
STEP 1 Turn on the power switch on the back of the device.
The touch screen will illuminate and display the “Nice” logo.
STEP 2 Review the checklist on the touch screen.
Confirm and press “NEXT”.

16 NICE RECOVERY SYSTEMS
STEP 3 Select desired COLD LEVEL and press NEXT.
(level 5 is the coldest setting)
STEP 4 Select desired COMPRESSION LEVEL and
COMPRESSION TYPE and press NEXT.
STEP 5 Choose a MANUAL time setting of 5 – 40 minutes
for a single therapy session OR choose a PRESET
PROGRAM for multiple sessions and press NEXT.

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STEP 6 Review and confirm your settings by pressing
START or press BACK to change the settings.
STEP 7 During your therapy session you can change
the cold or compression settings simply by
pressing 1 – 5 or HIGH, MED or LOW.
STEP 8 When the therapy session is complete is complete
turn the unit OFF. Once the unit is OFF, you may
now remove your therapy wrap.
NOTE: Compression should be turned OFF when the therapy wrap is not on the patient.
Allowing the wrap to inflate while unattended or to inflate all the way can cause damage
to the wrap and will reduce the life of the wrap and may void the warranty.

18 NICE RECOVERY SYSTEMS
9MAINTENANCE AND CLEANING
9.1. COOLING UNIT
• There are no user serviceable internal parts. The system warranty
is voided if the tamper seals are breached or removed.
• Keep water away from vents, power supply, and the power cord
connection of the unit.
• To avoid possible electric shock, do not remove the cover of
the unit.
• Do not immerse the Cooling Unit in water or any liquid.
• If the water becomes discolored or oensive to smell, contact
supplier or Durable Medical Equipment (DME) provider for assistance.
If microbial growth is present, the unit should not be used.
• Wipe the exterior of the unit with a damp cloth to clean.
• Do not use abrasive or solvent-based cleaners on the unit.
9.2. WRAPS
• Clean the therapy wrap if used for longer than 2 weeks or when
noticeably dirty.
• Clean exposed surfaces of the therapy wrap with either a mild
anti-bacterial soap and water solution or an isopropyl alcohol
and water solution (90:10).
• Do not use abrasive or solvent-based cleaners on the wrap.
• Do not use bleach on the wrap.
10 DRAINING FLUID FROM THE COOLING UNIT
Between uses or if the Cooling Unit is going to be stored for a long period
of time, the water reservoir should be drained.
1. Turn the Cooling Unit OFF.
2. Disconnect the therapy wrap from the hose.
3. Connect the Drain Fitting to the end of the hose.
Note: Drain completely before traveling on an airplane or shipping.

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4. Place the tapered end of the drain fitting in bottle or
other receptacle, capable of holding a minimum of 350mL.
5. Turn the Cooling Unit ON.
6. Press the DRAIN COOLANT button.
7. Review the checklist and press NEXT.

20 NICE RECOVERY SYSTEMS
8. Press the DRAIN button to continue with draining
the unit or press CANCEL to go back to the beginning.
9. The Cooling Unit will display confirmation that
the unit has been fully drained.
11 STORAGE AND REPACKING THE UNIT
When therapy is complete and it is time to return or store NICE1.
• Turn the unit OFF and unplug from the electrical source.
• Remove all therapy wraps.
• Disconnect all fittings from the rear and front panel of the unit.
• Follow the “Draining Fluid from the Cooling Unit”
instructions in Section 10.
• Leave reservoir cap o to allow the unit to dry completely.
• Collect the following items together:
o Cooling Unit
o Power Supply
o Power Cord
o Hose
o Wrap
o Padded Carrying Case
o Optional Shipping Box