Introduction; Nice1 Description - Nice NICE1 User Manual

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.
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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
• 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.
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.
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NICE RECOVERY SYSTEMS
2.3
2.4
2.5
3-100176, REV E
• 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.
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
OPTIONS
• Non-Sterile Patient Therapy Wraps (knee wrap, etc.)
• Carrying Case
SYMBOLS
!
Caution: Consult Lot or Batch Number
LOT
accompanying documents
Refer to User Manual and Serial Number
SN
Labels. Follow instructions for
use.
ON position for the DC
Powered by direct current
Power Switch at the rear of
the Control Unit
Type BF applied parts
Manufacturer
Recycle: Do not throw unit in trash
3-100176, REV E
Rx Caution: Federal law restricts this
device to sale by or on the order of
Only
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
-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
NICERECOVERY.COM