Nice NICE1 Manuale utente

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

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)

NICERECOVERY.COM

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

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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