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LB0261 Rev A 01/2018

Page 4

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

Содержание Miradry MD4000-MC

Страница 1: ...LB0261 Rev A 01 2018 Miramar Labs Inc 2018 Confidential Information of Miramar Labs Inc Page 1 MD4000 MC User Manual...

Страница 2: ...uropean 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...

Страница 3: ...NS 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 T...

Страница 4: ...nic 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 Footswitc...

Страница 5: ...er 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 s...

Страница 6: ...sed 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 cool...

Страница 7: ...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 t...

Страница 8: ...scription 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...

Страница 9: ...other 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 followi...

Страница 10: ...ssions 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 th...

Страница 11: ...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 ove...

Страница 12: ...umidity 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...

Страница 13: ...tient 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 fin...

Страница 14: ...ranches 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 extensi...

Страница 15: ...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 U...

Страница 16: ...gh 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...

Страница 17: ...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 deioniz...

Страница 18: ...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...

Страница 19: ...e 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 th...

Страница 20: ...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 To...

Страница 21: ...ession Touch the right arrow button as shown in Figure 11 to initiate a treatment session Figure 11 Press arrow button to initiate a treatment session Step 4 Attach a new bioTip to the Handpiece The m...

Страница 22: ...Tip You must replace the bioTip before you can continue bioTip Read Error You must remove rotate and re attach the bioTip before you can continue If this error does not clear after trying this several...

Страница 23: ...d prior to anesthesia administration Note that if you use alcohol for disinfection it may remove the Template ALWAYS wait a minimum of 10 minutes after administering anesthesia to initiate treatment N...

Страница 24: ...ults This may happen when you need a different size Template for each axilla when the axilla require different treatment modes e g Guided Treatment Mode on one axilla and Touch Up Treatment Mode on th...

Страница 25: ...ottom right of the Advanced Template Selection Screen To switch back to the Simple Template Selection Screen Figure 14 touch the template button on the top right Note Selections made on the Advanced T...

Страница 26: ...6 Step 1 Select a Microwave Energy Level Microwave energy from the Console is delivered to target sites on the patient s axilla through the Handpiece bioTip You will need to select the microwave energ...

Страница 27: ...ws the axilla you have selected to be treated first and the selected template size see Figure 18 Figure 18 Pop up screen indicating which side will be treated first and the selected template size If a...

Страница 28: ...appropriate amount of skin lubricant is used Step 3 Position the Handpiece on the Axilla Place the miraDry Handpiece in the appropriate position on the patient s skin For Guided Treatment Mode the To...

Страница 29: ...Console vacuum skin tissue is first drawn into the bioTip acquisition chamber and then placed against the cooling plate While the skin is in the chamber microwave energy is delivered to the target sit...

Страница 30: ...rompt you with the appropriate sequence of treatment target sites DO NOT pull the Handpiece off of the patient s skin until you complete the treatment cycle at a particular target site or the skin wil...

Страница 31: ...nd highlight each placement flag A B or C with the same blue outline found on other buttons Touching a placement flag will switch its status back and forth between Pending black and Completed grey Tou...

Страница 32: ...own in Section 9 2 This will terminate the treatment session and return you to the Welcome Screen Emergency stop To instantly shut off of the system at any time press the red Emergency Stop Button on...

Страница 33: ...own in the example in Figure 29 The screen summarizes the number of completed placements at each microwave energy level and the guided treatment template size for each axilla Figure 29 Treatment Summa...

Страница 34: ...the System performs a self check The test verifies that the patient s skin is in contact with the miraDry Handpiece cooling plate and a good vacuum seal has been achieved If one or both of these condi...

Страница 35: ...h The System will automatically clear this Pop up when the water returns to the proper treatment temperature Figure 32 Water Temperature Wait Pop up If the System was displaying a Treatment Screen whe...

Страница 36: ...tal grade detergent Gently wipe down all cords switches buttons and device housing taking special care not to get liquid into the housing or electrical components Gently dry the entire Console includi...

Страница 37: ...iraDry Console fuses with fuses that have been repaired or with short circuited fuse holders Only use standard time delay fuses that are current rated T8A 250 V Two fuses are located in the power entr...

Страница 38: ...nd re align to achieve suction Skin is too cold already Remove Handpiece Wait 10 seconds and try again Lubricant has dried and made the skin sticky Apply thin layer of lubricant in target area Too muc...

Страница 39: ...and run auto prime If auto prime passes turn off system and reattach Handpiece If auto prime does not pass call Miramar Labs Customer Service W06 followed by Temperature Wait Pop Up Room temperature i...

Страница 40: ...ntal Operating Temperature Humidity Altitude Pressure Ambient Temperature 15 0 C to 26 7 C 60 F to 80 F Relative Humidity Non condensing 10 to 60 at 26 7 C 20 to 60 at 15 0 C Altitude 0 2 000 m or 760...

Страница 41: ...iguration in which it will be used prior to using it in a surgical procedure Consult the tables below for guidance in placing the miraDry System Guidance and Manufacturer s Declaration Electromagnetic...

Страница 42: ...urge IEC61000 4 5 1kV differential mode 2kV common mode 0 5 1kV differential mode 0 5 1 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips...

Страница 43: ...n meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the...

Страница 44: ...d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation d...

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