Caution: Federal law restricts this device to sale by or on the order
of a licensed practitioner.
Risk of electric shock - Do not remove cover or loosen cable
connections. Refer servicing to qualified service personnel.
Do not use if treatment wand or cables show evidence of
deterioration or damage. Discard disposable applicator
components appropriately.
Risk of burns - Do not touch the metal tip of the treatment wand
during operation - Never depress treatment on/off button without
applicator in place.
Always have the applicator properly seated and tubing clamp open
when activating the treatment on/off button.
Treatment effectiveness may be diminished if any of the
following occur:
The applicator is not fully engaged, aligned and securely
attached to the treatment wand.
The distance between the leading edge of the applicator and
the wound is greater than 1.5 cm (0.6 inches).
The treatment wand is not held perpendicular to the wound.
WARNINGS
PRECAUTIONS
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
EMAIL:
TECHNICAL SERVICE
ULTRAMIST
™
PRODUCT SPECIFICATIONS
SAFETY REQUIREMENTS
Meets requirements of IEC 60601-1, 3rd Edition
ETL listed as ‘Conforms to UL 60601-1’
Reference file: 3055920
ELECTRONIC COMPATIBILITY
SYSTEM CLASSIFICATION
Meets the requirements of IEC 60601-1-2 and FCC Part 18
Class II equipment
Type BF applied parts
STERILIZATION METHOD
IPX RATING
Gamma Sterilization (applicators only)
Generator: IP21
Treatment Wand: IP22
INPUT
DETACHABLE POWER CORD
CURRENT
FUSE
100-240 VAC; 50-60Hz
125V, 10A UL or equivalent listed for hospital grade. Note: this Class II equipment
does not rely on grounding from power cord as means of insulation.
2.0A
T2AL250V
OPERATING AND STORAGE
CONDITIONS
Operating: Temperature: 15
º
to 25
º C
Atmospheric Pressure: 700 to 1060 mmHg
Applicator/System Transport and Storage: Temperature: -25
º
to 75
º C
Relative Humidity: 30% to 75% (non-condensing)
ACOUSTIC OUTPUT POWER
Operating Frequency: 40 Khz
± 1 Khz
Maximum Unintentional Ultrasound Energy: < 100mW/cm
2
Tip Displacement Range: 65
µm
±
10µm
PL-61044_B
10
ULTRAMIST
™
SYSTEM
INSTRUCTIONS FOR USE