2
Liability Disclaimer
Before administering any treatment to a patient you should become acquainted with the operating
procedures, as well as the indications, contraindications, warnings and precautions. Consult other
resources for additional information regarding the application of therapeutic ultrasound.
Precautionary Instructions
1.
CAUTION:
Read, understand and practice the precautionary and operating instructions. Know the
limitations and hazards associated with using any ultrasound device. Observe the
precautionary and operational decals placed on the unit.
2.
CAUTION:
DO NOT operate the Intelect
®
Legend Ultrasound when connected to any unit other than
Chattanooga Group, Inc. devices. DO NOT operate the unit in an environment of
shortwave diathermy use.
3.
WARNING:
Federal law restricts this device to sale by, or on the order of, a physician or licensed
practitioner. This device should be used only under the continued supervision of a
physician or licensed practitioner.
4.
CAUTION:
The Ultrasound generator should be routinely checked before each use to determine that
all controls function normally; especially that the intensity control does properly adjust
the intensity of the ultrasonic power output in a stable manner. Also, determine that the
treatment time control does actually terminate ultrasonic power output when the timer
reaches zero.
5.
CAUTION:
Use of controls, adjustments or performance of procedures other than those specified
herein may result in hazardous exposure to ultrasonic energy.
6.
CAUTION:
DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the buttons
on the control panel as damage may result.
7.
WARNING:
Explosion hazard if used in the presence of flammable anesthetics.
The warning symbol for this hazard is prominently displayed on the cabinet.
8.
WARNING:
For continued protection against fire hazard, replace fuses only with ones of the same
type and rating.
9.
WARNING:
Make certain that the unit is electrically grounded by connecting only to a grounded
electrical service receptacle conforming to the applicable national and local electrical
codes.
10.
WARNING:
This device should be kept out of the reach of children.
11.
WARNING:
This device should be used only under the continued supervision of a
licensed practioner.
12.
CAUTION:
Meets IEC/EN 60601-1-2 Electromagnetic Compatibility/Interference safety standard.
(Care must be taken when operating this equipment around other equipment. Potential
electromagnetic or other interference could occur to this or to the other equipment. Try
to minimize this interference by not using other equipment in conjunction with it.)
13.
WARNING:
Type B Equipment
14.
CAUTION:
This unit should be operated, transported and stored in temperatures between
15° - 40° C, with relative humidity ranging from 30% - 60%.
15.
ATTENTION:
Consult accompanying documents.
16.
DANGER:
Patients with an implanted neurostimulation device must not be treated with or be in
close proximity to any shortwave diathermy, microwave diathermy, therapeutic
ultrasound diathermy or laser diathermy anywhere on their body. Energy from diathermy
(shortwave, microwave, ultrasound and laser) can be transferred through the implanted
neurostimulation system, can cause tissue damage and can result in severe injury or
death. Injury, damage or death can occur during diathermy therapy even if the implanted
neurostimulation system is turned "off."