LB0261 Rev A 01/2018
© Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc.
Page 14
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DO NOT use the miraDry System to deliver microwave energy to people wearing metallic
jewelry, or clothing containing metallic material (for example, metallic buttons, clips or
thread). Patients with metal implants near their axillae should not be treated unless
specialized medical advice is obtained. Hearing aids should be removed from the body.
Patients with implanted cardiac pacemakers, electrodes, or electronic device implants
should be excluded from treatment with microwaves and from areas where the miraDry
System is operated.
8.3.
CLINICAL WARNINGS AND PRECAUTIONS
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CAUTION:
Federal (USA) law restricts this device to sale by or on the order of a
physician.
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DO NOT use the miraDry System for treating hyperhidrosis related to other body
areas or for generalized hyperhidrosis. The miraDry System is designed to only treat
axillary hyperhidrosis.
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The miraDry System has not been tested on patients with Fitzpatrick skin type VI
(very dark skin).
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The miraDry System has not been tested on women who are pregnant. The
treatment of pregnant women is discouraged.
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Consider not treating patients who are immuno-compromised, have a history of poor
healing, or are taking medications which might interfere with healing post-procedure.
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Patients with very little to no subcutaneous fat in the axilla are at higher risk for
nerve-related injuries, because there is a greater likelihood that one or more
branches of the brachial plexus may be in close proximity to the target area.
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The miraDry System has not been tested on patients who have had surgery in the
axilla. Examples include patients with extensive lymph node dissection, patients with
breast implants with axillary incision, or patients who have had prior surgery for
hyperhidrosis or cyst removal. Such surgery may change the way the System will
interact with the axillary sweat glands and is discouraged.
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Prior to treatment, the operator should evaluate the patient’s axilla to determine
whether it is technically feasible to treat. Examples of difficult-to-treat patients include
overweight patients, patients with extensive skin folds which will make placing a
template difficult, and patients with extensive skin disorders such as eczema or
psoriasis.
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DO NOT operate the miraDry System unless the miraDry
Handpiece is positioned at
the intended target site. See the Instructions for Use for the miraDry Handpiece for
proper positioning of the Handpiece.
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DO NOT treat the same skin site multiple times in a given treatment session.
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ALWAYS use the lowest possible power/energy necessary to achieve the desired
effect.
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DO NOT lift the miraDry Handpiece off the patient’s skin until the treatment cycle is
completed.
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DO NOT continue to use the miraDry System if high temperature or skin contact
errors persist.
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DO NOT administer anesthesia unless skin is disinfected prior to administration.
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ALWAYS follow directions of the anesthesia labeling. Inject the appropriate type and
quantity of anesthesia. Make sure that for each recommended injection site the
appropriate quantity is administered. DO NOT inject anesthesia into the dermis.