Possible Adverse Effects; Handpiece Cleaning Instruction Prior To Use - InMode System with BodyFX Handpiece Operator's Manual

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 As per the practitioner's discretion, refrain from treating any condition that might make
it unsafe for the patient.

Possible Adverse Effects

Possible side effects include but are not limited by: discomfort or pain, excessive skin
redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister,
burn), change of pigmentation (hyper- and hypo-pigmentation), scarring, vacuum
bruising.
Erythema and edema lasting not longer than 24h is typical skin reaction to the treatment.
The patient must understand the importance of pre-treatment and post-treatment
instructions and that failure to comply with these instructions may increase the probability
of complications.

Handpiece Cleaning Instruction Prior to Use

Warning!
These cleaning instructions are for Clinical Use only.
The following processes are validated for the InMode BodyFX Handpiece when used in
accordance with the instructions provided for cleaning products and/or processes. Any
deviation from said instructions or the cleaning agents listed below may impact the
performance or durability of the product and is prohibited. Review those instructions for
additional warnings and cautions.
We recommend the usage of the following cleaning agent that was tested in our company
for material compatibility as 70% alcohol solution.
Cleaning Procedure:
1. Clean the Handpiece thoroughly with alcohol absorbed pad and repeat as
necessary.
2. Leave it for complete drying.
Pre-Use Check:
Before each use of the Handpiece, the device must pass the following:
1 . Check to ensure proper cleaning and drying of the Handpiece.
2. Inspect all components of the Handpiece for visible damage.
InMode BodyFX Operator Manual
29

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