Contraindications; Potential Complications; Precaution - EMS DOLORCLAST RADIAL Instructions For Use Manual

Contraindications

Do not use this device under these conditions:
• Treatment over air-filled tissue (lung, gut),
• Treatment of pre-ruptured tendons,
• Treatment of pregnant women,
• Treatment of patients with blood-clotting disorders
(including local thrombosis),
• Treatment of patients treated with oral anticoag-
ulants,
• Treatment of tissue with local tumors or local
bacterial and/or viral infections,
• Treatment of patients treated with cortisone (within
the 6-week period following the last local cortisone
injection),
• Do not apply pulses to any regions near large
nerves, vessels, the spinal column or head,
• NEVER use this device on the unconscious,
or anyone who cannot give verbal consent or
warnings about pain.
Warnings
Before using this product, please carefully
read, understand, and follow the recommen-
dations in the instruction manual. Failure to
observe the operating instructions may result
in the patient or user suffering serious injury or
the product being damaged. This product may
only be applied for its intended use by qualified
personnel and for the applications described
in this manual. If the product is used in combi-
nation with other instruments, please refer to
their instruction manual.
No modification shall be made on the product.
Unauthorized modification may result in serious
injury to patient or user, and damage of the
product.
This device should not be used over swollen of
inflamed areas or skin eruptions.
Do not use in the presence of unexplained pain.
If a patient reports significant or unexplained
pain, immediately stop the treatment and
consult a physician.
Do not treat wounds, infected areas, skin tumors,
open sores, or scars from recent surgery.
Precautions
ALWAYS move the handpiece over the treatment
zone. This enables visual feedback of potential
side effects such as redness, petechias, or
bruising. Continuous repetitive pulses concen-
trated in one spot may lead to bruising.
Caution should be used over joints or bony
prominences such as vertebrae.
Use of this device may be painful or cause
bruising.
In case of extended use of more than 6 hours, it is
recommended that the user wear ear protection.
Installation of the unit shall always permit the
ventilation to work properly. Never hide the back
of the unit (with a towel, etc.). Distance from a
wall should be at least 10 cm.
The device is disconnected from the supply
network when the connector of power cord is
disconnected from the device. The power cord
connector must be accessible at any time
Treatment locations and explanation of preset
protocol can be found in section 18 appendix.

Potential complications

Potential side effects associated with this treatment
include:
• Petechia,
• Irritation,
• Hematoma,
• Swelling and numbness of the skin over the
treatment area,
• Pain and discomfort during and after treatment
(anesthesia is not necessary),
• Reddening of the skin.
Please make sure that all side effects have
subsided before resuming treatment.
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