WARNINGS AND
PRECAUTIONS
WARNINGS
Contact ThermoTek™Customer Service at 877-242-3232 for any questions or to
request a replacement. Do not attempt to repair the device. Do not attempt to
open or remove covers.
CLEANING AND DISINFECTING
NOTE: Inspect the device and follow the cleaning and disinfecting procedures prior to
each use.
WARNING: Device must be turned off and disconnected from the wall outlet prior to
and during cleaning or disinfecting.
WARNING: DO NOT IMMERSE DEVICE IN ANY LIQUID FOR ANY REASON. DO NOT
PLACE DEVICE IN AUTOCLAVE.
Clean the outer surface of the pump unit using a soft cloth, moistened with soapy
water or 70% isopropyl alcohol. Air dry only.
Clean the exterior of the cuffs using a soft cloth, moistened with soapy water or 70%
isopropyl alcohol. Air dry.
Unit must be completely dry prior to use. To ensure that, leave the device in the OFF
position and disconnected from the wall outlet for at least 30 minutes (and as long as
necessary for the unit to dry completely) after cleaning or disinfecting.
radiators to accelerate drying.
USING THE AC ADAPTER /
BATTERY CHARGER
IMPORTANT:
Charge both devices before first use.
WARNING:
Use only the charger provided by ThermoTek™. The use of the wrong charger can cause excessive
heat, damage to the circuit and shorten the life of the battery.
WHEN DEVICE IS OFF:
Plug in the power supply adapter to the wall socket using the plug located at
the bottom end of the device. The RED “Charging” LED indicator (located above the Power Button) on the device will
illuminate or flash, depending of the state of the charge. When the battery is charging, the LED indicator will be RED.
Once the battery if fully charged, the LED indicator will be solid BLUE.
WHEN DEVICE IS ON:
The AC adapter can be connected while the device is in use. Whenever the device
is ON and the charger is connected and plugged in to the wall socket, the LED indicator on the device will show BLUE.
ALARMS
E1
-
E1 displayed in the Mode/Counter display can indicate that the Battery charge is LOW or that there is an air LEAK.
Battery Low: Power down device and power back on. If LED is RED, this indicates that the battery power is
low. Plug in to charge unit. If this alarm continues to present after charging, call ThermoTek Customer
Service at 877-242-3232.
Low Pressure or Air Leak: Power down device and power back on. If LED is BLUE, this indicates that there is a leak
or issue attaining pressure. Remove wrap and reapply, being sure that the wrap is secure but not tight around calf
and restart device. If this alarm continues to present after reapplication, call ThermoTek Customer Service at
877-242-3232. DO NOT ATTEMPT TO REPAIR THE DEVICE.
E2
-
E2 displayed in the Mode/Counter display indicates that the Battery charge is CRITICALLY LOW.
Connect to wall power to continue use.
Alarm Reset:
System must be power cycled to reset alarms.
WARNING: This device is not protected against water. Equipment is not
suitable for use in the presence of flammable anesthetic mixture with
air, oxygen, or nitrous oxide. The rechargeable batteries supplied in this
unit are not field replaceable. If you have any issues please contact
877-242-3232.for a replacement unit.
The use of accessories, power supplies and cables other than
those specified, with the exception of components sold by the
manufacturer of the ThermoTek Evolution 2 as replacement parts,
may result in increased emissions or decreased immunity of the
ThermoTek Evolution 2.
Designates Class II medical electrical equipment.
This unit is an electromechanical device that includes printed
circuit boards and rechargeable batteries. Do not discard in landfill.
Consult local county requirements for proper disposal instructions.
This symbol designates the degree of protection against electrical
shock from the wrap as being a type B applied part.
Consult instructions for use.
CAUTION: Federal Law restricts this device to sale by or on the
order of a physician.
Do not remove the pump unit from the cuff. Do not attempt to modify or change
the device. NEVER attempt any service while the device is in use. Do not attempt
to connect the wall supply if any damage is noticed. Avoid subjecting the unit to
physical abuse, such as dropping the pumps. Do not handle the leg cuffs with any
sharp objects. If a bladder is punctured or you notice a leak, do not attempt to
repair the unit or cuffs. Replacement units are available through customer
service. Avoid folding or creasing the bladder during use and transportation of the
unit. Rechargeable Battery is not replaceable; replacement units are available
through customer service. Contact ThermoTek to receive replacements
instructions for any damaged items.
ThermoTek Evolution 2 is a Medical Electrical Device. The following are precautions
specific
to Medical Electronic Devices:
instructions refer to “Cleaning and Disinfecting” section.
air or with oxygen or nitrous oxide.
room temperature.
affectedbyMedical Electrical Devices.
CAUTIONS
This device is to be sold by or on the order of the physician.
Operation of the device can be done by the patient.
The ThermoTek Evolution 2 cuffs are designed for single patient use. The device
must be
ONLY used for its intended use by the patient prescribed. The device
must not be transferred to another patient.
Stop using device if swelling, skin irritation or any other unpleasant or painful
sensation occurs and consult a Physician.
Loosen cuffs immediately if pulsation or throbbing occurs as the cuffs may be
wrapped too tightly.
Patients with diabetes or vascular disease require frequent skin assessment.
Consult a Physician.
Patients who use warming devices in combination with cuffs require frequent
assessment as skin irritation may occur. Consult a Physician.
Patients positioned in the supine lithotomy position (with or without cuffs) for
an extended period of time require special attention to avoid extremity
compartment syndrome. Consult a Physician.
