LB0261 Rev A 01/2018
© Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc.
Page 13
8.2.
EQUIPMENT USE WARNINGS AND PRECAUTIONS
•
ALWAYS place the miraDry Handpiece (without the bioTip attached) securely in the
holster in the “down” position during the System self-test.
•
DO NOT allow fluid to come in contact with the miraDry Console, cables, connectors
or attachments except when the miraDry Console is being cleaned. DO NOT hang
fluids above the miraDry Console. The miraDry Console may not function correctly if
the electronic circuitry or the connectors/attachments are wet. DO NOT soak the
cables.
•
DO NOT bend cables at acute angles or coil them tightly as the interior components
within the cables might get damaged.
•
DO NOT operate the miraDry System if you are wet or damp. Electrical shock may
occur. Make sure there is no water or skin contact with electrically active
components.
•
DO NOT use the miraDry System if the patient is in contact with pooled fluid.
•
DO NOT insert any foreign bodies inside the miraDry Console.
•
ALWAYS position the miraDry System such that the user has access to the
emergency button and/or power cord in case of emergency.
•
ALWAYS provide as much distance as possible between the miraDry System and other
electronic equipment. The use of any electrosurgical device can cause electromagnetic
interference (EMI) with other electrical medical equipment. Precautions should be taken
to ensure that the well-being of the patient is maintained in the event of such interference.
It may be necessary to take mitigation measures, such as reorienting or relocating the
MD4000-MC Console or shielding the location.
•
DO NOT place fingers in front of the cooling plate of the miraDry Handpiece at any time
during application of microwave energy.
•
DO NOT direct the miraDry Handpiece towards the eyes or testes. During treatment, the
patient’s head should always be turned away from the Handpiece.
•
DO NOT use this device in the presence of flammable anesthetics; other flammable
gases; near flammable fluids such as skin prepping agents and tinctures; flammable
objects; or with oxidizing agents. Observe appropriate fire precautions at all times.
•
DO NOT use this device in oxygen enriched atmospheres, nitrous oxide (N
2
O)
atmospheres, or in the presence of other oxidizing agents. Be sure that all oxygen
connections do not leak.
•
DO NOT obstruct the activation light or speaker on the miraDry Console. The activation
tone and light are important safety features.
•
DO NOT accidentally press the foot switch on the miraDry Console or the handswitch on
the miraDry Handpiece to avoid unintended delivery of microwave energy.
•
Failure of the miraDry System may result in unintended increase in output energy.
•
DO NOT ship the miraDry Console with any deionized water inside. Make sure to
completely empty the deionized water out of the miraDry Console to prevent equipment
damage due to freezing during shipment.
•
DO NOT connect or disconnect the miraDry Handpiece when the miraDry Console is
turned ON. Make sure to turn the miraDry Console OFF prior to connecting or
disconnecting the miraDry Handpiece.
