WARNING:
DO NOT
use on more than one patient. Single Patient Use pads are designed for use
by a single patient for the length of the individual patient treatment.
DO NOT
apply to open wounds or compromised skin. Single Patient Use Pads can be
applied directly to intact skin or over a thin barrier.
Single Patient Use Pads are NOT sterilized.
DO NOT
place Single Patient Use Pads in
an autoclave or attempt to sterilize.
ALWAYS
follow the protocol provided by the attending physician.
Due to individual differences in sensitivity and susceptibility to cold or heat, the
patient’s skin should be frequently observed. Prolonged exposure to cold or heat has a
potential to cause injury to tissue. Follow the instructions of the attending physician for
length, frequency, and duration of treatment.
Medical supervision is required for patients with decreased skin sensitivity, children,
elderly, or incapacitated patients, as well as those with poor circulation, vein ligation,
recent skin grafts, or extremely low blood pressure.
DO NOT
use
cold therapy on patients with Raynaud’s disease, poor peripheral
circulation, diabetes, or hypersensitivity to cold.
DO NOT
apply Single Patient Use Pads so tightly as to restrict blood or fluid flow.
Dressings used under the pad should be applied lightly.
To avoid adverse effects to the skin, shut off the ThermaZone unit if patient begins to
feel uncomfortable.
Discontinue use if dizziness, severe pain, or severe skin reaction occur.
Disposable pads are designed for post-operative recovery for up to 3 weeks of use.
Single Patient Use Pads should be used only with the ThermaZone unit and in a
medical facility or clinical environment with direct healthcare provider supervision. If a
healthcare practitioner determines it is appropriate for a patient to continue therapy
at home, the healthcare provider must provide patient with adequate and appropriate
instructions for use at home.
DO NOT
use Single Patient Use Pads near an open flame or while smoking.
DO NOT
operate ThermaZone unit in an oxygen-rich environment or where oxygen is
being administered.
DO NOT
operate ThermaZone unit when intended user is connected to life support
equipment, cardiac device, and/or electrophysiology device.
STORAGE AND DISPOSAL
DO NOT
store the unit or the Single Patient Use Pads in a location where the
temperature is below 60˚F (16˚C) or above 85˚F (29.4˚C).
AVOID EXPOSURE
to sunlight and high heat conditions for extended periods. Keep
away from flames.
Dispose of the ThermaZone unit and Single Patient Use Pads in a manner that is
consistent with your federal, state, and local laws and regulations.
Copyright Innovative Medical Equipment, LLC 2013
Item # 103-26 v1 01/2013
