Foreword
COOLTONE User Manual
10
-C
Precautions
The system is intended for use by a trained physician or by a physician-designated medical
professional.
If the operator observes a potential safety issue or operational abnormality during use, the operator
should stop the treatment immediately and contact Zeltiq Customer Service (see page 5).
The use of other equipment and supplies with the system has not been tested and may cause
unexpected results.
Adverse Events
Common adverse events may include but may not be limited to:
•
Muscular pain
•
Temporary muscle spasm
•
Temporary joint or tendon pain
•
Local erythema or skin redness
Application Information
Before using the CoolTone on a patient, the user should become acquainted with the
operating instructions and individual treatment methods as well as the indications /
contraindications, warnings and application information. Additional sources of
information about types of treatment should be consulted.
Before use, ensure that the device is powered via a properly earthed plug with a
grounded mains outlet. The device must only be operated with the supplied power
cord.
During use, the device is to be located in a position allowing direct access to the
central mains supply so that it can be disconnected for the mains at any time.
The CoolTone is not suitable for use in areas with an oxygen rich, explosive,
flammable or combustive environment.
Inspect the device before use. If there is any damage, it must not be used.
Only accessories provided by the manufacturer must be used.
The maximum treatment time is 30 minutes per treatment cycle. Allow a cool down
period after each treatment.
Maximum surface temperature of the applicator is 43°C. If the maximum temperature
is reached allow the system to cool down. Place the applicators as defined in the
chapter about applicator placement.
During treatment the applicator will warm up, this is normal, If the patient experiences
any discomfort due to excessive heat from the applicator (>43°C) then discontinue
treatment.
