NICE1

Organization name

Nice Recovery Systems LLC

SRN

US-MF-000018331

Manufacturer status

Active

12 warnings recorded — scroll inside the panel to see all entries.

• 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).

  OTHER

• Therapy wraps are non-sterile and should NEVER be directly applied to skin including any open wound or breached skin. Wrap should NEVER be enclosed in a bandage to prevent moisture build up.

  OTHER

• 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.

  OTHER

• Do not sterilise

  Do not attempt to sterilize this device by any means.

• Refer to instruction manual/booklet

  Please read the entire User Manual carefully before operating the unit.

• Warning; Electricity

  Connect only items that have been specified as part of the ME equipment for NICE1. You must only use the specified external Medical Grade AC/DC power supply provided by Nice Recovery.

• For adult use only, the use of NICE1 by children or incapacitated persons may be dangerous.

  OTHER

• Do not drink or ingest the coolant or water that has been circulating in the system.

  OTHER

• 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 therapy if you experience any sense of discomfort, numbness or tingling of the limb.

  OTHER

• • Use of this device may also cause frostbite or tissue damage if used incorrectly. • Use carefully. May cause serious burns.

  OTHER

• 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.

  OTHER

• • No modification of this equipment is allowed.

  OTHER

Primary placement in France; available across 10 countries total.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES
• Z120607PNEUMATIC COMPRESSION EQUIPMENT

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.