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6 OMNISTIM
®
500A USER MANUAL
COPYRIGHT 2001 - 2007, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
CONFIDENTIAL AND PROPRIETARY
Precautions
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Application site and settings should be based on the guidance of the prescribing practitioner.
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All equipment and accessories should be kept out of the reach of children or unqualified persons.
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Do not connect this device to any wall outlet that has not been properly grounded, or to any electrically non-
isolated medical device.
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Use only ACP specified accessories and/or supplies with ACP devices. Do not use any power cords, or power
supplies, other than the ones provided or specified for this device. Use of any other power supply could
seriously damage the device and will void the warranty.
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When cleaning the device, never immerse them or wash them with water. See the Infection Control section in
this manual for cleaning instructions. Devices should not be submerged in water or other liquids.
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Failure to follow the manufacturer’s prescribed maintenance for this device may lead to device failure and
transient or unreliable performance. State and federal survey and JCAHO require all equipment to be
maintained and calibrated according to the manufacturer recommended schedules.
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A potential electric shock hazard exists once the device outer casing has been in part, or fully, removed. Only
qualified service personnel should perform Service and repairs. Warranty will be voided if the outer casing has
been removed or tampered with.
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Do not apply over areas of hemorrhage or active bleeding. Modalities should be applied following cessation of
hemorrhage or active bleeding as they may promote increased circulation and inhibit coagulation.
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Inspect and cleanse the skin prior to application. Following treatment check the skin for evidence of irritation
or burns, and if present, treat as appropriate. If the patient has, or complains of, skin irritation following
treatment, shorten the treatment time on the next treatment session, or use an alternative type of therapy or
electrode placement.
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Gradually increase the output intensity/power to required dose or patient tolerance while monitoring the device
display.
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Caution should be taken with patient exhibiting psychological or physical hypersensitivity to the therapeutic
treatment. Several attempts should be made to place them at ease so that their confidence and cooperation can
be gained during the treatment.
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The treatment area should be checked from time to time, and if there is evidence of, or if the patient complains
of, pain during treatment, adjust the output downward until it is tolerated by the patient. If the patient continues
to complain of pain, discontinue the treatment and shorten the treatment time on the next treatment session, or
use an alternative type of therapy or electrode placement.
•
Do not apply treatment directly over/under hot or cold packs. Caution is recommended when treatment follows
the application of hot or cold therapy, which may alter the patient’s sensation. Application of thermal agents
over areas of impaired circulation should be performed with caution as the circulation may be insufficient to
heat or cool the tissue, altering the patient’s perception of warmth and pain, and burns or tissue necrosis may
result from subsequent treatment.
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Caution is recommended when treatment follows the application of medicated patches, salves, or creams which
may alter the patient’s sensation. If there is a medical necessity to perform such treatments, these patients
should be monitored diligently during application. The presence of electrical stimulation may be altered by the
presence of these materials on the patient’s skin.
•
Caution should be used over areas of body where circulation is impaired, or which lack normal sensation.
Absent or diminished sensation should be avoided or, if unavoidable, treated with caution. Establishment of
acceptable intensity levels for desensitized areas may be related to the intensity levels tolerated on normal skin
in opposite or related body parts.
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Caution should be used in the presence of recent surgical procedures, fractures or healing bone and soft tissue
when muscle contraction may disrupt the healing process.
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Caution should be used for persons with suspected or diagnosed heart problems.