Nice NICE1 User manual

NICE1 Cold + Compression
Therapy System
3-100176, REV E

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

4
QUICK START GUIDE
Consult a healthcare professional before using NICE1.
• 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.
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)
• 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.
• Connect the hose to the Cooling Unit.
You will hear a click when properly
connected.
STEP 3
Select desired COMPRESSION LEVEL and
COMPRESSION TYPE and press NEXT.
STEP 4
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.
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.
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It is recommended to read entire user manual before beginning. Refer to the
individual wrap guides for specific information regarding wrap use.
Caution: Therapy wraps are
non-sterile and should never
be directly applied to an open
wound or breached skin
Settings for temperature, compression, and duration should be used as directed
by your physician or medical professional.

COOLING
TABLE OF CONTENTS
State-of-the-art technology delivers
therapeutic cooling without ice.
The most convenient way to apply
cold therapy.
COMPRESSION
Programmable intermittent and
constant compression significantly
improves the effectiveness of cold
therapy and promotes healing.
RECOVERY
By combining the therapeutic benefits
of cooling and compression in a single
easy-to-use device, recovery times are
significantly improved.
1. Introduction 8
2. NICE1 description 8
3. Indications for use 10
4. Contraindications, cautions, and warnings 10
5. Unpacking NICE1 12
6. Environmental conditions 13
7. How to set up your NICE1 for therapy 13
8. Operating instructions 15
9. Maintenance and cleaning 18
10. Draining the water from the unit 18
11. Storage and re-packing the unit 20
12. Troubleshooting guide 21
13. Service and customer support 23
14. Serious Injury Reporting 24
15. Warranty and Disclaimer Information 24
16. Electromagnetic compatibility 25

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 for sale by or on the order of a physician.
2 NICE1 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 injured 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. The NICE1 is a non-transit-operable medical device.
2.1 FEATURES
•Fluid therapy temperature range between 42°F - 58°F (14.4°C - 5.5°C)
•Treatment for edema in the upper and lower extremities 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: 10 lbs. when full of water
•
Hose Length: 6 ft.
• Specified Medical Grade Power Supply (supplied with the system)
•Dimensions: 8.6” W x 8.6” H x 9.0” D
•Cooling Temperature Range:
Level 1 = 58F (14.4C) Level 4 = 46F (7.7C)
Level 2 = 54F (12.4C) Level 5 = 42F (5.5C)
Level 3 = 50F (10C)
•User Operating Temperature: +5°C to 40°C
•Relative Humidity: 15% to 90%, non-condensing
•Storage/Transportation Temperature Range: -25°C to +5°C, and +5°C to 35°C at
RH up to 90% non-condensing, and >+35°C to 70°C at water vapor pressure 50hPa
•Atmospheric pressure range: 700 to 1060hPa (13801ft)
•Maximum Sound Pressure Level: 75dBA (with air pump running)
•Maximum Altitude: 4000m (13,123 ft)
•Display accuracy: +/- 2%
• Expected Service Life of the NICE1 Unit: 3 years
• Expected Service Life of the NICE1 accompanying Accessories: 3 years.
• Expected life of Disposable Wraps 1 User, 3 Months
• Expected Service Life of the NICE1 Training Room Wraps: 1-year operational use.
2.3 MEDICAL SYSTEM SPECIFICATIONS
•
Specified Medical Grade Power Supply. The following
Power Supply is specified for use with the NICE1 unit:
oClass 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
2.4 OPTIONS
•Non-Sterile Patient Therapy Wraps (knee wrap, etc.)
•Carrying Case
2.5 SYMBOLS
•Operating Fluid: Distilled water or tap water
•Flow Rate: .5 liters per minute
• Water Pressure: <30 PSI
• Water Reservoir Capacity: 300 mL
•Safety: IEC 60601-1: Ed 3.1 and IEC 60601-1-2 Ed 4.1
•Air Pump Pressure: 0-50 mmHg
•Intermittent Compression Setting:
o
High: inflate to 50 mmHg for 2 minutes and then deflate
to 5 mmHg for 30 seconds.
oMedium: inflate to 35 mmHg for 2 minutes and then deflate
to 5 mmHg for 30 seconds.
oLow: the NICE1 inflate to 20 mmHg for 2 minutes and then
deflate to 5 mmHg for 30 seconds.
Caution:Consult
accompanying documents
Refer to User Manual and
Labels. Follow instructions for
use.
Powered by direct current
Type BF applied parts
Lot or Batch Number
Serial Number
ON position for the DC
Power Switch at the rear of
the Control Unit
Manufacturer
Rx
Only
Caution: Federal law restricts this
device to sale by or on the order of
a physician
OFF position for the DC
Power Switch
Warning: It is Mandatory to fully read
and understand the instructions for use
before using the device. Failure to
follow operating instructions could
result in serious injury.
Medical Device
Recycle: Do not throw unit in trash
-25°C to +5°C, and +5°C to 35°C at RH up to 90%
non- condensing, and >+35°C to 70°C at water vapor
pressure 50hPa
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!
SN
LOT

3 INDICATIONS 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.
4 CONTRAINDICATIONS, CAUTIONS, AND WARNINGS
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.
MEDICAL
CONTRADICTIONS FOR COLD THERAPY
•NICE1 or any cold therapy device should not be used by patients that:
• have significant vascular impairment in the affected 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).
WARNINGS
• Do not use over sensitive skin areas or in the presence of poor circulation.
• Therapy wraps are non-sterile and should never be directly applied to an open wound or
breached skin.
• Dressings used under the therapy wrap should be applied lightly. Do not use pins to secure
the therapy wraps or hoses.
• Do not apply the therapy wrap so tightly as to restrict blood or fluid flow.
• Follow the prescribed instructions of your physician for area, frequency, and duration of
treatment.
• If unusual swelling, skin discoloration or discomfort occurs, immediately discontinue use of
NICE1 and consult a healthcare professional.
• Immediately stop compression therapy if you experience any sense of discomfort, numbness
or tingling of the limb.
POTENTIAL HARM FROM MISUSE
WARNINGS
•Use of this device may also cause frostbite or tissue damage if used incorrectly.
•Use carefully. May cause serious burns.
•The unattended use of NICE1 by children or incapacitated persons may be dangerous.
• Do not drink or ingest the coolant or water that has been circulating in the system.
• Observe all warning and caution labels. Never remove the caution/warning labels.
POWER SUPPLY AND ACCESSORIES
CAUTION
•Only use the supplied power supply and power cord.
•Do not operate the unit with a damaged or frayed power cord.
• A multiple socket outlet (power strip) or extension cord will not be used to power the
NICE1 unit.
WARNINGS
• 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.
•Use only NICE1 approved therapy wraps.
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ENVIRONMENT AND OPERATING CONDITIONS CAUTION
•Do not operate the unit if it has any noticeable or physical damage or is leaking fluid.
•Do not smoke while using therapy wraps or use wraps by an open flame.
• Do not use near equipment that generates electromagnetic or other interference, as this may be
harmful to the therapy unit.
• The therapy unit is not intended to be used in a wet environment.
• The NICE1 has an IPx1 rating and can tolerate light rain during movement or storage. If the
unit gets wet, unplug the unit from the wall and allow the unit to dry before use.
• The NICE1 has an IP2x rating and can tolerate and prevent foreign object intrusion such as a
finger. Do not stick foreign objects into the reservoir, fan protective covers, or power
connectors
•Never push objects of any kind into the therapy unit through the frame.
WARNINGS
• Do not simultaneously touch parts of other electrical equipment when using the NICE1 unit.
• 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.
•Do not allow the therapy wrap or hoses to contact sharp objects that could puncture it.
• Monitor all hose and cord placement when in use to avoid tripping and strangulation hazards for
children and pets. Store hoses and cords when not in use to avoid hazardous situations.
• Keep the system, including hoses and cords, away from children and pets. No parts of the
system are to be used as toys.
• Keep the system away from pest. If your home has problems with insects, please keep the unit
away from problem areas and off the floor.
• 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.
POTENTIAL DAMAGE TO UNIT FROM MISUSE CAUTION
• Do not overfill the water reservoir.
• Never spill liquid of any kind on the therapy unit.
• 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 spray the unit with any water solvents or cleaners.
•Do not service or perform maintenance while the equipment is in use.
WARNINGS
• Do not attempt to sterilize this device by any means.
•No modification of this equipment is allowed.
WRAPS WARNINGS
• The NICE1 contains multiple sensors that monitor device performance and issues error
messages. If the wrap does not become cold, makes unusual noises, or becomes unresponsive,
please turn the device off and contact your NICE representative.
• 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.
DISPOSAL
CAUTION
• The NICE1 and accompanying Power Supply must not be disposed of with your household
waste. To learn where to drop off your electrical and electronic waste, please contact your
local city/municipal waste disposal service office or contact Nice Recovery Systems for
assistance.
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5 UNPACKING 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:
6 ENVIRONMENTAL 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 electrical
components and undesirable or excessive noise.
Although the NICE1 unit can be used between +5°C to 40°C ambient and RH
90% non-condensing, for optimal performance use the system between +15.5°C
to 27.7°C (60°F to 80°F) at 15% to 90% relative humidity.
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.
1. NICE1 Cooling Unit
2. Power Supply
3. Power Cord
4. Hose
5. Drain
6. Wrap (optional)
7 HOW TO SET UP YOUR NICE1 FOR THERAPY
All 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 non-sterile 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.
•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 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. Replace reservoir cap
after filled.
•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.
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•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.
• See wrapspecific instructions for use for additional
information.
8 OPERATING 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 4 before attempting to operate the unit.
NICE1 can perform therapies for the following:
•Cold Therapy
•Cold Therapy + Compression
8.1. TURNING THE UNIT ON FOR THE FIRST TIME
STEP 1 Turn on the power switch on the back of the device.
The touch screen will illuminate and display the “Nice”
STEP 2 Review the checklist on the touch screen.
Confirm and press “NEXT”.
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Caution: Therapy wraps are
non-sterile and should never
be directly applied to an open
wound or breached skin

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 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
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.
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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9 MAINTENANCE AND CLEANING
9.1. COOLING UNIT
•There are no user serviceable internal parts. The system warranty is
voided if the tamper resistant screws 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 offensive 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.
• See wrap specific instructions for use for additional information.
10 DRAINING WATER FROM THE 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.
4. Place the tapered end of the drain fitting in bottle or
another 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.
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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 off to allow the unit to dry completely.
replace cap upon completion.
•Collect the following items together:
oCooling Unit
oPower Supply
oPower Cord
oHose
oWrap
oPadded Carrying Case
oOptional Shipping Box
•Store the above items in the original box or in the
travel case you received.
•Store indoors in an ambient environment of the following ranges:
-25°C to +5°C, and +5°C to 35°C at RH up to 90% non-condensing,
and >+35°C to 70°C at water vapor pressure 50hPa.
Failure to properly store the unit and wraps may result in damage to the unit,
hoses and/or wraps.
12 TROUBLESHOOTING GUIDE
NICE1 has many internal software safeguards to help protect the users and the
unit from unsafe operation. In this section you will find a list of system warnings
and errors that may occur if a potentially unsafe situation arises while using
NICE1. Neither the unit nor the wraps are intended for field repair. Do not
attempt to service the unit in any way. Troubleshooting steps are included.
Errors indicate the system has detected an issue and has stopped to protect
the user. The error state must be corrected before any therapy can be restarted.
An audible notification is also initiated as a beeping noise.
System errors indicate that an error has been detected and all current therapies
are halted to protect the user. System errors typically require service to the
Cooling Unit to correct the problem. If you encounter a system error, notate
code indicated on the display and contact the supplier or Durable Medical
Equipment (DME) provider. If assistance is not available, please contact NICE
Recovery technical assistance.
Below is a list of common user-related warnings and errors that may occur
during therapy operation of the unit.
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22
TYPE OF ERROR AND SCREEN MESSAGE ADDITIONAL SUGGESTED ACTION OF USER
Error 114: Temperature Sensor Error
Restart unit. If error persists contact service
provider.
No additional action needed. If the error persists,
contact service provider.
Error 115: High Air Pressure Error
Disconnect hose from unit and wrap and reapply.
Ensure wrap has a snug fit before session start. If
error persists contact service provider.
Movement of the limb in the wrap should be slow
and persistent if necessary. Fast compression and
release of the of the wrap repeatedly can cause
this error.
Error 201: Low Voltage
Turn off unit and disconnect power. Ensure the
unit is not limited by surge protector or long
extension cord. If error persists contact service
provider.
No additional action needed. If the error persists,
contact service provider.
Error 203-216: System-Off Current Error
Restart unit. If error persists contact service
provider.
Restart unit. If the error persists, unplug the unit
and contact service provider.
Error 212: High Temperature Error
Unit environment is too hot to provide therapy.
Bring to room temp, wait 5 minutes, and restart.
If error persists, unplug and contact service
provider.
Repeat at least twice to allow unit to cool. Ensure
that the front and back of the unit has at least 12
inches of clearance for prop- per air flow. If the
error persists, contact service provider.
Error 217: Cooling Sensor Startup Error
Contact service provider.
No additional action needed. If the error persists,
contact service provider.
Error 218: Low Temperature Error
Unit environment is too cold to provide therapy.
Bring to room temp, wait 5 minutes, and restart.
If error persists contact service provider.
Repeat at least twice to allow unit to cool. If the
error persists, contact service provider.
13 SERVICE AND CUSTOMER SUPPORT
Nice Recovery Systems, LLC is committed to servicing our NICE1
both during and after sale to the customer. If you have any questions
concerning the operation of your Nice Recovery Systems, please
contact us at:
Nice Recovery Systems LLC
2205 Central Ave, Suite A Boulder,
CO 80301
[e-mail]
888.815.9907
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TYPE OF ERROR AND SCREEN MESSAGE ADDITIONAL SUGGESTED ACTION OF USER
Error 101: Low Voltage
Turn off unit and disconnect power. Ensure
the unit is not limited by surge protector or
long extension cord. If error persists contact
service provider.
Re-seat all electrical plugs leading to unit before
restarting it. Ensure firm positive contact. If the
error persists, contact service provider.
Error 103: Air Pump Error
Restart unit. If error persists contact
service provider.
No additional action needed. If the error persists,
contact service provider.
Error 104: Low Air Pressure Error
Disconnect hose from unit and wrap and
reapply. Ensure wrap has a snug fit before
session start. If error persists contact service
provider.
Turn off device. Remove wrap. Disconnect hose from
device and
wrap. Push excess air from the wrap.
Reconnect hose to device
and wrap and make sure you
hear audible click to indicate proper
connection. Reapply
wrap, ensure a snug fit and restart therapy
session. If
the error persists, contact service provider.
Error 105: Low Liquid Flow
Disconnect hose from unit and wrap. Check for
kinks and reapply wrap with a snug fit. Restart
session. If error persists contact service
provider.
Turn off device. Remove wrap. Disconnect hose
from device and wrap. Reconnect hose to device
and wrap and make sure you hear audible click to
indicate proper connection. Reapply wrap and
ensure a snug fit. Check wrap and hose for kinks.
Restart therapy session. If the error persists,
contact service provider.
Error 106: Low Liquid Level
Check water level in tank. Ensure the tank
is halfway full. Do not fill to threads. If error
persists contact service provider.
If the wrap and hose are applied do not fill tank
completely again. This will prevent water in the
wrap from overfilling the tank when the session is
complete. If the error persists, contact service
provider.
Error 107: Water Pump Error
Restart unit. If error persists contact
service provider.
No additional action needed. If the error persists,
contact service provider.
Error 108: Fan Obstruction Error
Check fan for obstructions. Restart unit. If
error persists contact service provider.
Ensure that the front and back of the unit has at
least 12 inches of clearance for proper air flow and
that no small, thin objects that can fit through the
grills are near.
Error 109: Fan Error
Restart unit. If error persists contact
service provider.
No additional action needed. If the error persists,
contact service provider.
Error 111: Cooling System Error
Restart unit. If error persist contact service
provider.
No additional action needed. If the error persists,
contact service provider.
Error 112: High Temperature Error
Unit environment is too hot to provide therapy.
Bring to room temp, wait 5 minutes, and restart.
If error persists contact service provider.
Also ensure that the front and back of the unit has
at least 12 inches of clearance for proper air flow
and that no small, thin objects that can fit through
the grills are near.
Error 113: Low Temperature Error
Unit environment is too cold to provide therapy.
Bring to room temp, wait 5 minutes, and restart.
If error persists contact service provider.
No additional action needed. If the error persists,
contact service provider.

14 SERIOUS INJURY REPORTING
If a serious incident has occurred, please report to Nice Recovery Systems, LLC using
the contact information noted in Technical Support section of this User Manual. If in the
European Union, please also report to your Competent Authority where the serious
incident has occurred.
15 WARRANTY AND DISCLAIMER INFORMATION
Limited Warranty Terms: Nice Recovery Systems LLC (“Nice Recovery”) warrants to the
immediate purchaser from Nice Recovery or an immediate purchaser of an unused unit
from an authorized distributor of Nice Recovery products, that any Nice Recovery
Systems will be free from defects in workmanship and material under normal use for
one year (1) after the date of purchase. Nice Recovery warrants to the immediate
purchaser from Nice Recovery, or an immediate purchaser of an unused wrap from an
authorized distributor of Nice Recovery products, that Nice Recovery single patient use
wraps will be free from defects in workmanship and material under normal use for only
the first use of the wrap.
This Limited Warranty covers only defects in material or workmanship. Therefore, it
does not cover any other claim, service, defect, condition, or damage, including:
installation, set-up, instructions, recommendations on use; accidents, tampering,
improper product selection, misuse, neglect, or abnormal use; use of parts,
accessories or fluids that are incompatible or adversely affect operation, performance,
or durability; unauthorized service, repair or alteration; excessive moisture or
humidity; cleaning or any condition caused by any dirt or foreign substance on or in the
product; or damages resulting from shipping. Installation or use of the product or any
portion thereof in a manner that does not comply with the Operating Instructions voids
the warranty. Any alteration or modification that changes the product’s effectiveness
or intended use voids the warranty.
Nice Recovery will, at its discretion, repair or replace within a reasonable time any
product that is found to have a defect in material or
workmanship under normal use during the applicable warranty period. This is the
immediate purchaser’s sole remedy. Any warranty on a repair or replacement expires
the same time as the warranty expires or would have expired on the original product.
The product must be returned at the immediate purchaser’s expense to an authorized
Nice Recovery Service Center for warranty service.
Because Nice Recovery Systems updates and advances its products and technology,
Nice Recovery Systems reserves the right to modify or improve the design of any
product without assuming any obligation to modify any product previously
manufactured.
16 ELECTROMAGNETIC COMPATIBILITY
NICE RECOVERY SYSTEMS 3-100176, REV E 3-100176, REV E NICERECOVERY.COM
GUIDANCE AND MANUFACTURER’S DECLARATION:
ELECTROMAGNETIC IMMUNITY AND EMISSIONS
The NICE1 is intended for use in the electromagnetic environment specified below. The customer or the user of
the NICE1 should assure that it is used in such an environment.
EMC TEST IEC 60601-1-2 LEVEL TESTED
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT GUIDANCE
RF
CISPR 11:2009+A1:2010
CISPR 11:2009+A1:2010
The NICE1 uses RF
emissions
Class B, Group 1;
Class B, Group 1;
energy only for its internal function.
CISPR 11
IEC 60601-1-
IEC 60601-1-
Therefore, its RF emissions are very
2:Ed.4.1 (4th
2:Ed. 4.1
low and are not likely to cause any
Edition)
b:2014 (4th Edition)
interference in nearby electronic
equipment.
ACPower Line
Conduct- ed
Emissions, 150 kHz –
30 MHz
CISPR 11:2009+A1:2010
Class B, Group 1
CISPR 11:2009+A1:2010
Class B, Group 1
The NICE1 is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public mains that
supplies buildings used for domestic
purposes.
AC Harmonic
current emissions
IEC 61000-3-2:2005
+A1:2008+A2:2009
IEC 61000-3-2:2005
+A1:2008+A2:2009
The NICE1 power supply electrical
harmonics are very low and is suitable
for use in all establishments, including
domestic establishments and those
directly connected to the public mains
that supplies buildings used for domestic
purposes.
Voltage changes,
fluctuations, and
flicker
IEC 61000-3-3:2013 IEC 61000-3-3:2013 Mains power quality can be that of a
typical hospital, commercial, or home
environment.
ElectrostaticDischarge
immunity
IEC 61000-4-2:2008
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
air
IEC 61000-4-2:2008
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15
kV air
While this testing level is high it is not
the maxi- mum observed in some
areas with very low humidity. If used in
a known very dry location the user
should try to discharge/ground
themselves before using the unit.
Radiated RF Immunity IEC 61000-4-3:2006
+A1:2007+A2:2010
10 V/m 80 MHz – 2.7 GHz
80 % AM at 1 kHz
IEC 61000-4-3:2006
+A1:2007+A2:2010
10 V/m 80 MHz – 2.7 GHz
80 % AM at 1 kHz
While tested to a high level, interference
may occur in the vicinity of equipment
marked with the following symbol:
Electrical Fast Transients IEC 61000-4-4:2012 IEC 61000-4-4:2012 Mains power quality can be that of a
/ Bursts
± 2 kV
± 2 kV
typical hospital, commercial, or home
Applied to AC
input no I/O 3 M
100 kHz repetition frequency
100 kHz
repetition
environment.
or longer
frequency
Surge immunity IEC 61000-4-5:2005 IEC 61000-4-5:2005 Mains power quality can be that of a
test Applied to
Line to Line:
Line to Line:
typical hospital, commercial, or home
AC input
± 0,5 kV, ± 1 kV
± 0,5 kV, ± 1 kV
environment.
Line to Gnd:
Line to Gnd:
± 0,5 kV, ± 1 kV, ± 2 kV
± 0,5 kV, ± 1 kV, ± 2 kV
24 25

26
NICE RECOVERY SYSTEMS 3-100176, REV E 3-100176, REV E NICERECOVERY.COM
RECOMMENDED SEPARATION DISTANCES BETWEEN
PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE NICE1
The NICE1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the NICE1 can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the NICE1 as recommended below,
according to the maximum output power of the communications equipment.
RATED MAXIMUM
OUTPUT POWER OF
TRANSMITTER
W
SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER
M
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 GHz
d = 2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
GUIDANCE AND MANUFACTURER’S DECLARATION:
ELECTROMAGNETIC IMMUNITY AND EMISSIONS
The NICE1 is intended for use in the electromagnetic environment specified below. The customer or the user of the
NICE1 should assure that it is used in such an environment.
EMC TEST IEC 60601-1-2 LEVEL TESTED COMPLIANCE LEVEL ELECTROMAGNETIC
ENVIRONMENT GUIDANCE
Immunity to conducted
Disturbances induced by RF
fields
Applied to AC input, No
I/O 3 M or longer
IEC 61000-4-6:2013
3 V - 0,15 MHz –80 MHz
6 V in ISM and amateur radio bands
between
0,15 MHz and 80 MHz
80 % AM at1 kHz modulation
IEC 61000-4-6:2013
3 V - 0,15 MHz –80 MHz
6 V in ISM and amateur radio bands
between
0,15 MHz and 80 MHz
80 % AM at1 kHz modulation
Portable and mobile RF
communications equipment should be
used no closer to any part of the
NICE1, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d = 1.2 √ P
d = 1.2 √P80 MHz to 800 MHz
d = 2.3 √P 800 MHz to
2.5 GHz
where P is the maximum output power
rating of the transmitter in watts
(W) according to the transmitter
manufacturer anddis the recommended
separation distance in meters (m).
Interference may occur in the vicinity
of equipment marked with the following
symbol:
Power FrequencyH-Field
Immunity Applied
around full system
IEC 61000-4-8:2009
30 A/m – 50 or 60 Hz
IEC 61000-4-8:2009
30 A/m – 50 or 60 Hz
NICE1 Does not contain magnetically
sensitive components.
VoltageDips and
Interruptions
IEC 61000-4-11:2004
Voltage Dips:
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % UT; 1 cycle and 70 %
UT; 25/30 cycles Single
phase: at 0° Voltage
Interruptions:
0 % UT; 250/300 cycle h)
IEC 61000-4-11:2004
Voltage Dips:
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0 % UT; 1 cycle
and 70 % UT;25/30
cycles Single
phase: at 0°
Voltage
Interruptions:
0 % UT; 250/300 cycle h)
Mains power quality can be that of a
typical hospital, commercial, or home
environment.
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 strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Model 006 is used exceeds the applicable RF compliance level above, the Model 006 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model
006.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
27

NICERECOVERY.COM
NICE1 IS MANUFACTURED BY:
Nice Recovery Systems LLC
2205 Central Ave, Suite A Boulder, CO 80301
[email protected] 888.815.9907
3-100176, REV E