Celleration Ultramist Instructions For Use Manual

Caution: R x Only. This medical device is to be operated by a healthcare professional in accordance with the instructions for use.

Applicator

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

UltraMIST ™ System

TREATMENT WAND

11 Treatment Wand

12 Display Screen

14 Treatment Wand Cable with Connector

15 Tubing Channel

16 Treatment ON/OFF Button (Trigger)

17 Treatment Wand Tip

ULTRAMIST™ SYSTEM

Treatment Wand

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

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.