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Indications

• For relief of minor muscle aches and pains.

 

Contraindications

• vascular diseases present in or near the treatment area

• local infections in the treatment area

• around malignant or benign tumors

• directly on cartilage surfaces or near the small facet joints of the spinal column

• directly over implanted electronic devices such as pacemakers, analgesic pumps, etc.

• in areas, in which mechanical energy in the form of vibrations may lead to tissue damage such as metal implants after a fracture

 

In General, Advised Against Treatments

• if blood clotting disorders are present or the patient is receiving treatment that results in a change in the blood clotting behavior

• during pregnancy

• on patients with neurological diseases resulting in impairment of the vasomotor function in the treatment area

• over air-filled cavities such as treatment on the thoracic spine, etc.

• on children, particularly around the epiphyseal plates

 

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Care is Required for Patients

• with impaired sensibility

• with severe autonomic disorders

• under the influence of drugs and/or alcohol as circulatory stresses and inadequate treatment responses cannot be excluded.

 

Side Effects

Treatments with Eclipse eVIVE™ may occasionally cause irritation, petechial, bruising, swelling or pain.

 

Warnings

Before using the device on a patient, the user should become acquainted with the operating instructions and individual treatment methods as well as the indications / contraindications, warnings and application information. Additional sources of information about types of therapy should be consulted.

Caution

  • Before use, ensure that the device is powered via a plug with a grounded outlet (electrical installation according to DIN VDE 0100 Part 710). The device must only be operated with the supplied power cord. The power cord must be protected against mechanical stress.
  • Operation of this equipment in the vicinity of strong electromagnetic fields (e.g. tomography, x-ray or diathermy equipment) may interfere with the operation of the device. Please keep a safe distance of several meters.
  • Eclipse eVIVE™ is not suitable for use in areas with an explosive, flammable or combustive environment.
  • When in operation, the device must be positioned in such a way that direct access to the device’s central power supply is possible, so that it can be disconnected from the mains at any time.
  • To avoid the risk of electric shock, the device must be disconnected from the mains supply before performing any maintenance or cleaning activities.
  • Inspect the device prior to use. If damaged, it must not be used.
  • Only accessories provided by Eclipse/Zimmer are to be used.
  • The device may cause malfunctions or may interfere with the operation of equipment in the vicinity by electromagnetic effects. It may be necessary to take appropriate remedial action, such as realignment, re-arrangement of the device or the electromagnetic shielding.
  • The hand piece of the device is not designed for continuous operation. After max. 6,000 shocks, a break of 15 min. must be observed.
  • If Eclipse eVIVE™ is not mounted on the designated system cart, make sure that Eclipse eVIVE™ is placed on a stable surface.
  • To avoid heat accumulation in the hand piece, it is essential to ensure that your hand or any other object does not block the ventilation openings on the top and especially on the bottom of the hand piece.
  • In exceptional cases, the maximum treatment time is limited to 4 minutes followed by a break of at least 15 min. If the treatment time is exceeded, the hand piece may overheat.
  • Users of the Eclipse eVIVE™ radial pulse therapy device must be instructed in the proper use of the system and must possess the appropriate skills.
  • The device is intended to be used exclusively by medical professionals.
  • Any treatment instructions regarding treatment location, duration and intensity require medical knowledge and should be given by authorized physicians. It is imperative that these instructions are followed.
  • The patient must not be left unattended during therapy.
  • Persons undergoing simultaneous treatment involving the reduction and / or alteration of blood clotting or the prolongation of the blood clotting time (e.g. acetylsalicylic acid) should consult their doctor regarding a possible suspension of this therapy, as the use of radial pulse in such patients may cause bleeding and bruising in varying degrees.
  • Radial pulse become significantly scattered in air-filled areas and generate reflections that can have negative effects. Therefore, do not perform treatments directly above the lungs (intercostal space) or the gastrointestinal area.
  • The use in wet areas is not permitted and may in case of non-compliance lead to considerable damage to the device and endanger both the patient and the user.
  • Dispose of the packaging material properly. Make sure that it is not accessible to children.
  • On patients with implants or implanted electronic device do not conduct treatment before the risk has been assessed and found negligible.
  • Patients may not be connected to a high-frequency surgical device at the same time. This can lead to burns.
  • This device should not be used over swollen or inflamed areas or skin eruptions. Do not use in presence of unexplained calf pain. Consult a physician.
  • In worst case condition maximum therapy time is limited to 4 minutes treatment time and a break time of 5 minutes. If you exceed this duty cycle the hand piece can over temperature.
Eclipse Aesthetics

5916 Stone Creek Dr. Suite #120
The Colony, TX 75056
United States

Call or fax us

Toll-free: 1-800-759-6876
Local: 1-972-380-2911
Fax: 1-866-558-0415

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sales@eclipsemed.com

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