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InMode VOTIVA - Possible Adverse Effects; Handpiece Cleaning Instruction Prior to Use

InMode VOTIVA
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Votiva Operator Manual DO607094B 32
Possible Adverse Effects
Certain side effects may be experienced during treatment or shortly afterwards which may
or may not be a result of improper use of the system. Although these side effects are rare
and temporary, they should be reported immediately to a physician for proper treatment.
These are the side effects that may appear in the treatment area:
Pain
Excessive redness (erythema)
Damage to natural tissue texture (crust, blister, burn)
Change of pigmentation (hypo- or hyper-pigmentation)
Swelling
Bruising
Vaginal discharge during or after treatment (extreme vaginal atrophy)
Urinary Tract Infection
Minor bleeding
Handpiece Cleaning Instruction Prior to Use
The following processes are validated for the Handpieces 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. Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30
sec 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:
These cleaning instructions are for CLINICAL USE only.

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