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PLEASE READ INSTRUCTIONS BEFORE USE.
Caution: R x Only. This medical device is to be operated by a healthcare professional in accordance with the instructions for use.
Generator
3
2
4
5
Applicator
22
23
GENERATOR
1 Generator
2 Power Switch (Back of Generator)
3 Generator Power Cord
4 Peristaltic Pump
5 Tubing Guides
6 Adjustable Hook
7 Indicator Light
8 Treatment Wand Connector
9 Treatment Wand Cradle
10 USB Port/Cover
1
10
9
8
7
6
18
21
19
20
UltraMIST ™ System
TREATMENT WAND
11 Treatment Wand
12 Display Screen
13 Keypad
14 Treatment Wand Cable with Connector
15 Tubing Channel
16 Treatment ON/OFF Button (Trigger)
17 Treatment Wand Tip
ULTRAMIST™ SYSTEM
Treatment Wand
13
12
11
17
16
15
Other Materials Required
• 0.9% Normal Saline 100cc - 1000cc bag
• Germicidal wipes for cleaning/disinfecting
• Absorbent pads
APPLICATOR
18 Applicator
19 Tubing-Cable Clip
20 Tubing Clamp
21 Infusion Tubing
22 Tubing Spike
23 Tubing Spike Protective Cover
INSTRUCTIONS FOR USE
14
1
PL-61044_B
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Summary of Contents for Celleration Ultramist
- Page 1 Generator Treatment Wand Applicator Other Materials Required • 0.9% Normal Saline 100cc - 1000cc bag • Germicidal wipes for cleaning/disinfecting • Absorbent pads UltraMIST ™ System GENERATOR TREATMENT WAND APPLICATOR 1 Generator 11 Treatment Wand 18 Applicator 2 Power Switch (Back of Generator)
- Page 2 CLEANING THE ULTRAMIST SYSTEM Clean the UltraMIST System prior to and after each treatment session with the Power Switch in the “off” position. Prior to treatment, clean the entire system using facility approved Do not sterilize the treatment wand including tip with steam, infection control procedures.
- Page 3 This is a single use treated. Press to continue. product that once removed will need to be replaced with a new applicator. Select Back (Forward) Down Preparing the UltraMIST System continued on next page PL-61044_B...
- Page 4 ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE PREPARING THE ULTRAMIST™ SYSTEM Insert applicator tubing into the treatment wand tubing The display screen will ask for the saline pump to be channel and attach the tubing clip to the treatment wand loaded. Open the saline pump door. cable. Place treatment wand in cradle once completed.
- Page 5 Note: You may pause treatment by depressing and releasing the treatment on/off button. The treatment timer will be paused until restarted. Spray Pattern The UltraMIST System will begin to deliver the ultrasound through a continuous mist. Move the treatment wand vertically across the wound using multiple passes. Follow this by moving the treatment wand horizontally across the wound using multiple passes. The treatment wand should be moved across the wound using slow, even strokes.
- Page 6 ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE TREATING THE PATIENT WITH THE ULTRAMIST™ SYSTEM Once all the wounds are completed, the summary screen will NOTE: To cancel a treatment at any time press the back be displayed. button. The “cancel treatment” screen will appear. Use the up down buttons to select “yes”...
- Page 7 APPLICATOR treatment wand wand For errors not listed or more details, refer to the Troubleshooting section of the Instructions for Use or contact Celleration Customer Service for futher information. INDICATOR LIGHT (located on front of generator) An error has occurred - refer to the Troubleshooting section for more details...
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Page 8: Troubleshooting
FUNCTIONING ALL KEYS ON KEYPAD NOT System software error Shut down system by turning off power and FUNCTIONING then restart. If error continues, call Celleration Customer Service OVERHEAT Treatment wand temperature has The system alarm for overheating indicates exceeded the allowed limit... - Page 9 ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE TROUBLESHOOTING PROBLEM CAUSES SOLUTIONS NO SALINE OR INSUFFICIENT Wound ready screen is not visible on Complete set up process until wound ready SALINE IS COMING OUT OF display screen screen is seen on display APPLICATOR...
- Page 10 Operating Frequency: 40 Khz ± 1 Khz Maximum Unintentional Ultrasound Energy: < 100mW/cm Tip Displacement Range: 65µm ± 10µm TECHNICAL SERVICE For technical questions about the operation of the UltraMIST System contact Celleration Customer Service: PHONE: 1-866-307-MIST (6478) ADDRESS: 6321 Bury Drive, Suite 15, Eden Prairie, MN 55346 WEBSITE: www.Celleration.com...
- Page 11 Allows full set up of treatment parameters Treatment ON/OFF Button Front treatment wand handle Controls ultrasound and saline on and off Note: No parts of the UltraMIST System are serviceable during use or by user. EXPLANATION OF SYMBOLS Consult Instructions Do Not Dispose in...
- Page 12 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTRONIC EMISSIONS The UltraMIST Therapy System is intended for use in the electromagnetic environment specified below. The customer or the user of the UltraMIST Therapy System should assure that it is used in such an environment.
- Page 13 FEDERAL COMMUNICATIONS COMMISSION (FCC) USER INFORMATION The UltraMIST System has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.