Miramar Miradry MD4000-MC User manual

LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 1
MD4000-MC
User Manual

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1. CONTACT INFORMATION
Manufactured by:
European Authorized Representative:
Miramar Labs, Inc.
2790 Walsh Avenue
Santa Clara, CA 95051
United States
Telephone:
1-855-miraDry (1-855-647-2379)
1-408-940-8700
Fax:
1-888-498-2878
1-408-940-8796
MedPass International Ltd.
Windsor House
Bretforton
Evesham
Worcestershire WR11 7JJ
United Kingdom
Tel: [phone]
[e-mail]

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TABLE OF CONTENTS
1. CONTACT INFORMATION .................................................................................................... 2
2. EXPLANATION OF SYMBOLS .............................................................................................. 4
3. SYSTEM DESCRIPTION........................................................................................................ 6
3.1. MIRADRY CONSOLE CONNECTIONS AND CONTROL FEATURES........................ 7
4. INDICATIONS FOR USE........................................................................................................ 7
5. CONTRAINDICATIONS.......................................................................................................... 8
6. POTENTIAL RISKS................................................................................................................ 8
7. CLINICAL DATA..................................................................................................................... 9
7.1. RANDOMIZED, BLINDED, MULTICENTER STUDY .................................................... 9
7.2. SINGLE GROUP, COMMERCIAL DEVICE STUDY.................................................... 10
8. WARNINGS AND PRECAUTIONS ...................................................................................... 12
8.1. SET-UP AND ENVIRONMENTAL WARNINGS AND PRECAUTIONS....................... 12
8.2. EQUIPMENT USE WARNINGS AND PRECAUTIONS............................................... 13
8.3. CLINICAL WARNINGS AND PRECAUTIONS ............................................................ 14
8.4. CLEANING WARNINGS AND PRECAUTIONS.......................................................... 15
8.5. MAINTENANCE WARNINGS AND PRECAUTIONS .................................................. 15
9. OPERATING INSTRUCTIONS............................................................................................. 15
9.1. OPERATION – PRE PATIENT SETUP ....................................................................... 15
9.2. OPERATION – GEAR MENU...................................................................................... 18
9.3. OPERATION – PRE-TREATMENT SETUP ................................................................ 20
9.4. OPERATION - TREATMENT....................................................................................... 25
9.5. OPERATION – STOPPING A TREATMENT............................................................... 31
9.6. OPERATION – POST TREATMENT........................................................................... 32
9.7. OPERATION – TOUCH-UP MODE............................................................................. 33
9.8. OPERATION – PROCEDURE TROUBLESHOOTING................................................ 34
9.9. SYSTEM SHUTDOWN PROCEDURE........................................................................ 36
10. TRAINING, CLEANING, AND MAINTENANCE ................................................................... 36
10.1. TRAINING.................................................................................................................... 36
10.2. CLEANING AND DISINFECTING................................................................................ 36
10.3. STORAGE.................................................................................................................... 36
10.4. MAINTENANCE AND SERVICE INFORMATION....................................................... 37
10.5. HOW TO CHANGE THE CONSOLE FUSES............................................................. 37
11. HOW SUPPLIED .................................................................................................................. 37
11.1. DESCRIPTION OF MD4000-MC CONSOLE COMPONENTS.................................... 37
11.2. DESCRIPTION OF MIRADRY SYSTEM COMPONENTS.......................................... 37
12. TROUBLESHOOTING GUIDE ............................................................................................. 38
13. SPECIFICATIONS................................................................................................................ 40

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2. EXPLANATION OF SYMBOLS
Symbols on the Device and Packaging
Conforms to:
IEC 60601-1:2005+A1:2012,
IEC 60601-1-2:2007,
IEC 60601-1-6:2010, IEC 60601-2-
6:2012
Water fill location
Warning: Service By Qualified Personnel
Only Manufacturer
Fuse
Date of manufacture
Type BF (body floating) applied part
Waste electrical and electronic
equipment
Serial number Do not sit on the equipment
ON (AC main power)
Do not stand on the equipment
OFF (AC main power)
Pushing Prohibited
Emergency Stop
Model number
Non-ionizing radiation Footswitch connector
Equipotential ground connection Consult operating instructions
Power Input Frequency
AC Voltage Safe Working Load
Mass
Maximum Ouput Power
Stand-by
Temperature limitation: Ship and
store at a temperature range
between -29˚C to +60˚C
Atmospheric pressure limitation: Ship and
store at an atmospheric pressure range
of 55kPa to 101kPa
Humidity limitation: Ship and
store at a humidity range
between15% to 90% RH

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Icons that appear on the Touchscreen Graphical User Interface (GUI)
Symbol Title of Symbol Symbol Title of Symbol
Display Gear Menu Select the microwave energy output level
Close Gear Menu Adjust display brightness up or down
Purge the vacuum Adjust speaker volume up or down
Remove the bioTip from the
Handpiece
Stop the treatment session
Unlock fixed energy level in first
few rows of template

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3. SYSTEM DESCRIPTION
The miraDry® System from Miramar Labs®, Inc. utilizes miraWave®technology to deliver precise
amounts of shallow, localized microwave energy to soft body tissue in the underarm. The System
is designed to be used in the health-care office setting by health-care professionals, under the
direction of a physician. As the System delivers microwave energy, it protects the tissue surface
with an active contact cooling system.
The miraDry System (see Figure 1) consists of the following components:
•MD4000-MC miraDry Console (Main Body and Touchscreen)
•MD4000-BT miraDry bioTip
•MD4000-HP miraDry Handpiece
Figure 1: Fully-assembled miraDry System.
Handpiece
and cable
bundle
bioTip
MD4000-MC
Console
Main Body
MD4000-MC
Console
Touchscreen

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The miraDry Console contains a power supply, microwave (5.8GHz frequency) module, vacuum
pump, cooling fans, water chiller and pump, and a Touchscreen display that guides you through
System operation.
The miraDry Handpiece contains microwave antennas, vacuum ports, and a surface cooling
plate. The miraDry Handpiece is magnetically attached to the miraDry bioTip. This attachment
enables body tissue to be drawn into the acquisition chamber from the vacuum that is drawn from
the Console.
The miraDry Template System is an accessory that guides you through a patient treatment
session. Refer to the separate Instructions for Use for the miraDry Template System.
3.1. MIRADRY CONSOLE CONNECTIONS AND CONTROL FEATURES
•Handpiece Cable Connector – The cable that connects the Handpiece to the Console.
•AC Power Supply Cord –The cord that connects the Console to an AC power outlet.
•Equipotential Ground Connector – The connector that is used in some countries to
ensure that the Console is at the same ground potential as other nearby electrical
equipment.
•Footswitch Connector – Used to connect the footswitch to the Console. The footswitch
lets you start or stop treatment using your foot.
•Fan Vent Inlets/Outlets – Console vents that let air flow to and from the Console. One
set of Outflow vents let the fans exhaust air from the rear of the Console. A second set of
Intake vents on the bottom of the Console let air flow into the Console. DO NOT block
these vents to ensure proper cooling of the Console.
•AC Main Power Switch – Enables AC power flow to the System.
•Standby Button – Turns the System ON and OFF.
•Emergency Stop Button – Lets you shut down the System immediately in the event of
an emergency. To turn the System back ON, rotate the Emergency Stop Button
clockwise to reset it.
4. INDICATIONS FOR USE
The miraDry System MD4000 is indicated for use in the treatment of primary axillary
hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair
of all colors for Fitzpatrick skin types I – IV.
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs
regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

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5. CONTRAINDICATIONS
The miraDry System is contraindicated in people:
oWith heart pacemakers and other electronic device implants.
oWho need supplemental oxygen.
oWith known resistance to or history of intolerance of local anesthesia including lidocaine
and epinephrine.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a
physician.
6. POTENTIAL RISKS
As with any medical device, there are possible risks associated with the use of the miraDry
System. Patients should be monitored closely for symptoms to allow for early intervention.
The most common side effects observed within or near the treatment area follow below. Most of
these side effects can last from a few days to a few weeks following treatment. Others can last
from one to several months or longer as noted.
•Swelling/tightness in the treated area
•Discomfort, tenderness or pain in the underarm when touched, usually treatable with non-
prescription medications such as ibuprofen
•Redness from the device suction
•Bruising at the numbing injection sites
•Bumps under the treated area (can last for several months)
•Temporary altered sensation or tingling in the treated skin and/or upper arm (can last for
several months)
Other less common side effects include:
•Swelling in the adjacent arm or torso (usually lasting a few days)
•Hyperpigmentation (darkening of skin) in the treatment area
•Soreness in the shoulders or arms due to positioning of the arms during the procedure
•Numbness or tingling in the arm due to the anesthesia (usually lasting less than 24 hours)
•Shaking due to epinephrine in the anesthesia (usually lasting less than 24 hours)
•Tight banding in the underarm (gradually resolves)
There have been rare reports of:
•Altered sweating elsewhere on the body
•Small blisters/ulcerations or rashes in the treatment area
•Temporary altered sensation or tingling in the forearm or fingers (can last for several
months)
•Weakness in the arm or fingers that gradually goes away (but can last for several months)
•Pain in the arm or fingers that gradually goes away (can last for several months)
•Pain in the underarm requiring prescription medications
•Infection/abscess
•Burns

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7. CLINICAL DATA
The ability of the miraDry System to treat axillary hyperhidrosis has been studied in two separate
clinical studies that utilized earlier versions of the miraDry System. A study using the
most current miraDry System has been completed to measure the amount of underarm hair
reduction.
7.1. RANDOMIZED, BLINDED, MULTICENTER STUDY
Device:
The device used in this study was the DTS G2 System, the predecessor of the miraDry System.
Microwave energy settings that were used with the DTS G2 System were equivalent to
Microwave Energy Setting 1 on the miraDry System.
Study Design:
The study involved two patient groups. In the first group, the subjects received the DTS G2
System procedure with microwave energy treatment for axillary hyperhidrosis in both axillae
(the “treatment group”). The second group of subjects had the same procedure but without
microwave energy applied (the “placebo group”). Subjects were randomized to one of the two
groups with twice as many patients being assigned to the treatment group. Subjects were also
“blinded” as to whether they were to receive the microwave energy or placebo treatment. The
majority of subjects (83%) were treated with two treatment sessions, separated by
approximately 14 days. In all these cases the full hair-bearing area of both axillae were treated
in the first session. The second session was used to “touch-up” any remaining areas of active
sweat. Another 9% of subjects only received one treatment session, and the remaining 8% of
subjects had 3 treatment sessions.
All subjects had follow up assessments at 14 days, 30 days, 3 months and 6 months following
their final treatment session. At 6 months, the subjects were unblinded as to their group
assignment. Placebo group subjects exited the study while treatment group subjects remained
in the study and had additional follow-up visits at 9 months and 12 months following their final
treatment session.
Subjects:
One hundred and twenty (120) adult subjects enrolled in the study. Eighty-one (81) subjects
were randomized to the treatment group and thirty-nine (39) subjects were randomized to the
placebo group. The mean age of subjects was 32.8 years and 58% of the subjects were
female. Eighty-four percent (84%) of the subjects were “White”, 6.7% were “African American”,
and the rest were categorized as “Other”. The majority of subjects were of Fitzpatrick skin type
III, but the study also included subjects with skin types I-V. There were no subjects enrolled that
had skin type VI.
Results:
The study primary endpoint compared the Hyperhidrosis Disease Severity Scale (HDSS)
quality of life success rate of the treatment group to the placebo group based on data collected
at the 30-day follow-up visit. Success was defined as moving from a pre-treatment baseline
score of 3 or 4 to a post-treatment score of 1 or 2. Last-observation-carry-forward was used to
impute missing data. Overall, 89% of the treatment group had success versus 54% for the
placebo group (p<0.001).
In addition, the 81 treatment group subjects showed good long-term efficacy with 69.1% of
these subjects having HDSS success at their final study visit.

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No treatment-related serious adverse events occurred. Adverse events related to the procedure
or device were generally mild in nature and all but one (compensatory sweating) resolved over
time. The most common reported adverse events related to the device or procedure were
reports of numbness, tingling or sensitivity in the treatment limb (12%), pain or soreness (10%),
swelling in the treatment limb (9%), and blisters/ulcerations/burns (6%). There have been no
reports of late-onset adverse events associated with the device or procedure.
All subjects experienced some mild treatment effects. The most common were vacuum
acquisition “suction” marks caused by the vacuum acquisition of the skin, soreness in the
shoulder or arm due to arm positioning during the procedure, and discomfort/ tenderness in the
treatment area. These were well-tolerated and generally of short duration.
7.2. SINGLE GROUP, COMMERCIAL DEVICE STUDY
Device:
The device used in this study was the MD3000 version of the miraDry System. This system is
therapeutically equivalent to the MD4000 miraDry System, and the same device parameters
and settings were available.
Study Design:
This study was conducted at two centers, with all subjects receiving treatment in both
underarms. Approximately half of the patients received two treatments, with two to three
months between treatment sessions. 13% of the subjects had only one session; 38% of the
subjects were treated in three sessions, again separated by two to three months. The full
axillae were treated in the first treatment session, with other treatment sessions “touching-up”
any remaining areas of sweat. Microwave Energy Setting 3 was used for the first treatment
session for 74% patients, with increased settings used for subsequent sessions depending on
the subject’s acceptance of side effects. Lower initial energy settings were used for patients
with low axillary fat.
Formal office follow-up visits were conducted at 1 month, 3 months, 6 months and 12 months
post final treatment. Last-observation-carry-forward was used to impute missing data.
Subjects:
Thirty-one adult subjects were enrolled; 26 of those subjects completed the final follow-up visit.
The mean age of the patients was 33 years; 75% of the subjects were female and 87% were
Caucasian. All subjects had HDSS scores of 3 or 4 at baseline.
Results:
As with the prior study, the primary endpoint examined the percentage of subjects that reduced
their HDSS scores to a value of 1 or 2 at the 1 month follow-up visit. This value was 90.3%
(28/31) and the result remained stable and above 90% for all subsequent visits. The average
reduction in sweat as measured by weight was stable at 82%±1% for all follow-up visits. Patient
satisfaction (% of patients that were “very satisfied” or “somewhat satisfied”) was 89% or above
at all follow-up visits.
Most subjects experienced acute mild transient post-treatment effects such as localized edema,
discomfort, bruising and erythema. 61% (19/31) of subjects experienced at least one (1)
treatment-related adverse event (AE); 88% of AE’s were rated as mild (Grade=1) in severity.
The most common AE’s were numbness or tingling in an area of the treatment limb (n=12
subjects, 39%) and short-term (~1 week) edema in the chest or treatment limb (n=8 subjects,
26%). One subject experienced treatment-related neuropathy of the left tricep muscle after the
first treatment session that was resolving at 6 months, after which she was lost to follow-up.

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7.3. SINGLE GROUP, COMMERCIAL DEVICE STUDY
Device: The device used was the MD4000 miraDry System.
Study Design: The primary objective of the study was to quantify hair reduction in the axillae
after treatment(s) with the miraDry System. The study device was used in the same manner as
the commercially available technique cleared by the FDA for the treatment of primary axillary
hyperhidrosis. The study was conducted at three dermatology clinics in the United States. The
study was initiated at the first site in September of 2012. Adult subjects seeking hair reduction
in the axillae that showed at least 16 viable hairs in a 2cm X 2 cm box in the center of each
axilla were considered for enrollment. Subjects were treated with the miraDry System using the
standard miraDry procedure in one or two treatment sessions 3 months apart. Follow-up visits
were conducted 3, 6, 9 and 12 months after treatments were complete.
Subjects: Fifty-six subjects were enrolled in the study. The mean age was 33 years; 80% of the
subjects were female and 88% were Caucasian. The majority of the subjects were of Fitzpatrick
skin type I-IV. 23% (13/56) of the subjects completed only one treatment session; 5 of these 13
subjects declined a second session due to adverse events.
Results: The primary endpoint of this study was to show >30% reduction (baseline to 3 month,
measured by hair counts) in >50% of subjects. There were 42 subjects assessable for this
endpoint. The secondary endpoint was to show >30% reduction (comparing baseline to 12
months photos) to make a claim for permanent axillary hair reduction. Additional analyses
used a blinded comparison of baseline to follow-up full-axilla photos by an independent
reviewer to correctly identify which photo had more hair and score hair reduction at follow-up.
Also, a subject assessment of overall satisfaction, odor rating and sweat ratings was
determined at the follow-up visits. See the table below.
Efficacy measure
Follow-up visit time from the last treatment session
3 months
6 month
9 month
12 month
Hair count:
% of subjects with >30%
reduction [lower 95% CL]
Primary:
88.1% (37/42)
[76.6%]
97.5% (39/40)
[88.7%]
92.1% (35/38)
[80.8%]
Secondary:
95.5% (42/44)
[86.4%]
Hair count:
Average reduction [std]
Light hair subgroup (n)
66% [± 30%]
66% (n=12)
72% [± 29%] 75% [± 28%] 75% [± 27%]
72% (n=13)
Side-by-side axilla review:
% of pairs having at least
26-50% reduction
74% (63/85) 78% (65/83) 78% (66/85) 89% (83/93)
Patient satisfaction with
hair reduction: % of
subjects rating “very
satisfied” or “somewhat
satisfied”
81%
(38/47) 70% (31/44) 68% (30/44) 70% (33/47)
Odor self-assessment,
Mean reduction 10pt scale 2.6 ± 3.0 2.8 ± 2.8 2.5 ± 2.8 2.4 ± 2.7
% of subjects with HDSS
reduction to score of 1 or 2 92%
(23/25) 96% (25/26) 96% (24/25) 89% (25/28)
All subjects experienced at least one (1) treatment-related adverse event (AE), 99% (324/326)
of all AE’s were rated as mild in severity. As in prior studies, many subjects experienced the
expected mild transient post-treatment effects; the most common were localized edema (55%),
tingling or numbness in the treatment area (30%), vacuum acquisition marks (29%), bumps or
lumps under the skin (29%) or discomfort or tenderness in the treatment area (26%). Other
rarer treatment effects affecting more than the treatment area were noted in 18% of subjects
(10/56), 75% of which were rated as mild. These included numbness or tingling in the arms
(n=6 events); more extensive swelling in the adjacent area (e.g. arms) (n=4 events); and
bruising outside the treatment area (n=2 events). One patient experienced unilateral ulnar
neuropathy that was improving but not completely resolved at study exit.

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8. WARNINGS AND PRECAUTIONS
8.1. SET-UP AND ENVIRONMENTAL WARNINGS AND PRECAUTIONS
•DO NOT use the miraDry System until you have thoroughly read the Miramar Labs
MD4000-MC Console User Manual, Handpiece Instructions for Use (IFU), and bioTip
Instructions for Use (IFU). Observe all Warnings and Precautions. Failure to do so may
result in complications.
•DO NOT set up or use the miraDry System unless instructed and trained in the correct
use of the equipment by designated Miramar Labs Representatives. The miraDry System
is to be used by qualified clinical personnel only.
•DO NOT damage the equipment during unpacking, assembly and preparation.
•DO NOT use the miraDry System if the equipment was damaged in transit, or during
unpacking and assembly.
•DO NOT use the miraDry System if the equpment was not unpacked and assembled by
designated Miramar Labs Representatives.
•DO NOT operate the miraDry System outside the environmental operating ranges stated
in this User Manual. These include a temperature range of 15˚C to 26.7°C (60˚F to 80°F),
10%-60% relative humidity (non-condensing) at 26.7°C, 20%-60% relative humidity
(non-condensing) at 15°C, an altitude of 0-2000 meters (0-6562 feet), or a pressure of
760 to 571 mm of Hg (29.9 to 22.5 in of Hg).
•DO NOT use components and parts other than those supplied by Miramar Labs.
•ONLY use miraDry Handpieces with the miraDry Console, and only when they are
properly connected to the Console.
•ALWAYS connect the AC Power Supply Cord to a properly grounded AC power outlet.
DO NOT use extension cords and/or adaptor plugs. Plug equipment into 100-240V AC
50/60 Hz power outlets.
•ALWAYS plug the equipment in properly and verify that fuses are intact. ALWAYS use
the correct replacement fuses.
•ONLY use deionized or distilled water provided by Miramar Labs (or an equivalent) with
the miraDry System. DO NOT over fill.
•DO NOT use the System unless the miraDry Handpiece is properly connected to the
Console.
•DO NOT use the miraDry System until the miraDry bioTip security feature has been
properly “read” by the miraDry Console after the bioTip has been attached to the miraDry
Handpiece.
•DO NOT obstruct the intake vents on the bottom of the miraDry Console, or the exhaust
vents on the rear of the miraDry Console, to ensure proper air flow.
•When moving the system from room to room, always push using the handles on the
holster side. DO NOT push sideways.
•DO NOT use the foot switch in rooms where it is likely to be exposed to liquids.
•NO modification of this equipment is allowed.

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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 (N2O)
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.

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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
•CAUTION:Federal (USA) law restricts this device to sale by or on the order of a
physician.
•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.
•The miraDry System has not been tested on patients with Fitzpatrick skin type VI
(very dark skin).
•The miraDry System has not been tested on women who are pregnant. The
treatment of pregnant women is discouraged.
•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.
•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.
•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.
•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.
•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.
•DO NOT treat the same skin site multiple times in a given treatment session.
•ALWAYS use the lowest possible power/energy necessary to achieve the desired
effect.
•DO NOT lift the miraDry Handpiece off the patient’s skin until the treatment cycle is
completed.
•DO NOT continue to use the miraDry System if high temperature or skin contact
errors persist.
•DO NOT administer anesthesia unless skin is disinfected prior to administration.
•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.

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•ALWAYS wait a minimum of 10 minutes after administering anesthesia to initiate
treatment. NEVER initiate treatment if more than 60 minutes have elapsed since
administering anesthesia.
•DO NOT use the miraDry System unless the axilla size has been measured and
selected appropriately on the Touchscreen GUI (unless you are operating in Touch-
up Mode). The axilla size selection determines the recommendations for anesthesia
administration.
•ALWAYS place ice packs, wrapped in a towel on the patient’s treated skin after the
procedure.
•DO NOT use lubricants other than the recommended lubricants (KY® jelly or KY®
liquid). Use of other substances such as ultrasound gel or IPL laser coupling gel can
reduce the effectiveness of the surface cooling, leading to blisters or burns.
•DO NOT use the miraDry System unless an appropriate amount of skin lubricant is
applied to the axilla treatment area.
•DO NOT use the miraDry System unless the skin surface is wiped clean using
antiseptics before treating.
8.4. CLEANING WARNINGS AND PRECAUTIONS
•ALWAYS turn the miraDry Console OFF and disconnect the AC Power Supply Cord from
the AC power supply before cleaning.
•ALWAYS clean, disinfect, and maintain the electrical units in accordance with the
operating instructions.
•ALWAYS clean and remove any dust, lint or particulate materials from the air intake
screen filter located underneath the miraDry Console. Use a vacuum cleaner and/or
water. Make sure to remove the filter from the miraDry Console before cleaning. This
filter is attached to the bottom of the Console using magnetic attachment and is
easily removed. Thoroughly dry the filter before reattaching it to the Console.
8.5. MAINTENANCE WARNINGS AND PRECAUTIONS
•DO NOT remove the covers of any of the miraDry System components. There are no
user-serviceable parts inside. Opening the cover of any component may result in
electrical shock or thermal burns.
•DO NOT attempt to repair or alter any of the miraDry System components.
9. OPERATING INSTRUCTIONS
When you are ready to unpack and set up the miraDry System, contact a Miramar Labs
Representative for assistance. It is important that a Miramar Labs Representative be
present and set the System up for you. DO NOT attempt to set up the System without the
help of a Miramar Labs Representative.
9.1. OPERATION – PRE PATIENT SETUP
Step 1 Attach the Handpiece to the Console
Attach the miraDry Handpiece to the miraDry Console as shown in Figures 2a, b and c. Use
one hand to stabilize the Handpiece Cable Connector and the other to turn the black Handpiece
Collar. Screw the Handpiece Collar clockwise onto the male connector threads on the Console
until the red ring is fully concealed.

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Figure 2:
a) Screw on Handpiece
b) Red ring still visible
c) Proper attachment (red ring covered)
Step 2 Turn the System ON
Press the green Standby as shown in Figure 3 to turn the System ON.
Figure 3: Console Standby Button
Step 3Navigate the Touchscreen GUI
On-screen graphics will guide you through setup and operation. Simply touch the screen with
your finger to navigate the on-screen Graphical User Interface (GUI) as shown in Figure 4.
Touch the right and left arrow buttons ( and )on GUI screens to proceed from one
screen/instruction to another.
Figure 4: Touchscreen to navigate the Graphical User Interface (GUI)
Step 4Add Deionized or Distilled Water if Prompted
Add deionized or distilled water only when prompted by the Touchscreen GUI as shown in
Figure 5. Only use new deionized or distilled water when filling the reservoir. The W01
prompt to add more water will appear occasionally.

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Figure 5: “Add Water” Popup Prompt
When the W01 add water popup appears, remove the plastic cap at the water fill location by
unscrewing it counter-clockwise. Pour the water over the top of the filter to fill the console, and
the water will flow through the membrane. Fill the water until the water level is all of the way
up the threads above the perforated metal shielded membrane filter (Figure 6), even
though a beep will sound and the “Add Water” popup prompt will close well before the
water reaches this level.
Figure 6: Perforated Metal Shielded Membrane Filter
If the miraDry Handpiece has just been attached for the first time, you will be prompted to add
more water with a W08 popup message. It will take approximately 40 ml of deionized or distilled
water to fill a completely empty Handpiece.
Step 5Place the System for Patient Treatment
Position the System close to the patient and make sure none of the air vents located at the
bottom or rear of the Console are obstructed.
Step 6Position the Handpiece in the Holster to Start the System Self-Test
The System performs a self-test when power is turned ON to ensure that all functions are
working as expected.
Place the Handpiece in the holster and lower it to the “down” position as shown in Figure 7. The
Handpiece must be in the “down” position to complete the self-test.
Perforated Metal Shielded
Membrane Filter

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Figure 7: Handpiece must be in the down position (far right) to start the self-test
9.2. OPERATION – GEAR MENU
At any time during setup or operation touch the Gear Menu Icon ( ) on the Touchscreen
GUI to display the Gear Menu Drop Down and adjust system settings. The Gear Menu Drop
Down will also display the console software release version and identification code (2.2.1 and
4FE40D7C in this example) and the Handpiece software release version and identification code
(1.3.0 and FE93B83C in this example) on the top of the screen. See Figure 8.
Figure 8: Gear Menu Drop Down
To close the Gear Menu Drop Down, touch the X button ( ) at the top right of the Drop
Down.

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System Settings
Icon
Description
Pressing icon will
display pop-up
Instructions
Completing task
Purge
(“unclog”) the
bioTip
Turn the purge on and off by
touching the up arrow button
().
Touch the check
mark button
() when
finished.
Remove
bioTip from
Handpiece
Remove bioTip by pressing
the handswitch.
Unlock fixed
energy level
in first few
rows of
template
Microwave
energy level
Touch the circular button()
below the desired lock
setting. (see below for more
detail)
Touch the circular button( )
below the desired microwave
energy level. (see below for
more detail)
Touch the arrow
button ( ) to
proceed.
Unlock fixed
energy level
in first few
rows of
template
Touch the check mark button
to unlock fixed energy level in
first several rows to allow all
rows to be treated with the
desired energy level
Touch the check
mark button
() to confirm
or touch X button
() to leave
locked.
Touchscreen
display
brightness
Touch the arrow buttons (
or ) to adjust the
brightness up or down.
Touch the check
mark button
() to confirm.
Console
volume
Touch the arrow buttons (
or ) to adjust the volume
up or down.
Touch the check
mark button
() to confirm.
Stop
treatment
session
Remove bioTip by pressing
the handswitch. Dispose of used bioTip.

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Microwave Energy Level Settings
There are five pre-set microwave energy levels. Levels determine how long (in seconds) the
microwave energy is applied to a particular target site. The System default microwave energy
level is Setting 1 (2.40 sec).
Microwave Energy
Level #
Microwave Energy Delivery
Time (sec)
1
2.40
2
2.55
3
2.70
4
2.85
5
3.00
The energy level is fixed to level 1 for the first few rows of each guided treatment template,
regardless of the selected energy level.
Total # of rows for
template
Treat these rows at
energy level 1
11
4
13
4
15
5
17
6
Touching the button under the lock symbol on the microwave energy level screen will leave the
fixed energy level 1 in the first few rows. You may override the fixed energy level for a single
treatment (patient) by touching the button under the unlock symbol on the microwave energy
screen.
Alternatively, select the gear icon at the top left corner of the screen. The dropdown menu will
appear which includes a lock symbol. Touching the lock symbol will display a popup screen. By
touching the check mark on the popup screen you can unlock the fixed energy levels. Touching
the X button () will leave the default fixed energy level 1 in the first few rows.
On the top left corner of the treatment screen, the green energy level icon will be displayed
below the gear icon. The selected energy level will be shown on the left, above the radio button
icon, and the current energy level will be shown to the right ( ).
9.3. OPERATION – PRE-TREATMENT SETUP
You must complete these steps prior to initiating treatment.
Step 1 Attach the Handpiece to the Console
If the miraDry Handpiece has not already been attached, you will be prompted to do so at this
time as shown in Figure 9. Refer to Section 9.1 for attachment instructions. Turn the System
OFF before connecting the Handpiece.
Figure 9: “Attach Handpiece” Screen