Information

MikroFlex hat folgende Prüfzeichen: EMC und CE 0088

 und somit für den Vertrieb in Deutschland und Europa zugelassen

 

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Lieferumfang

zum Lieferumfang gehören:

1 x MikroFlex Gerät

2 x Akkus

1 x Ladegerät mit Netzteil

2 x Anschlußkabel

1 x Verpackungstasche

1 x Bedienungsanleitung

4 Stück Elektroden

 

   Die 7 Mikrostrom Programme von MikroFlex

   Technische Spezifikationen

Vom Gesetzgeber vorgegebene Angaben:

Bitte nicht anwenden wenn Sie einen Herzschrittmacher, einen Defibrillator oder andere implantierte Geräte im Körper tragen.

Bitte nicht anwenden wenn Sie schwanger sind.

Bitte niemals vom Arzt verschriebenen Medikamente oder Anwendungen einstellen.

Vorher mit dem Arzt sprechen.

Standardvorgaben bei Reizstrom Therapiegeräten in der EU in englischer Sprache:

WARNING AND CAUTIONS

 

Contraindications:
1.    Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other implanted electronic devices,         because this may cause electric shock, burns, electrical interference, or death.
2.    Do not use this device on patients whose pain syndromes are undiagnosed.

Warnings:
1.   Do not apply stimulation over the neck or mouth because this could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
2.   Do not apply stimulation across the chest, because IFT currents penetrate deep into the tissue and the introduction of electrical current into the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.
3.   Do not apply stimulation over the pregnant uterus.
4.   Do not apply stimulation, other than microcurrent, over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins).
5.   Do not apply stimulation over, or in proximity to, cancerous lesions.
6.   Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use.
7.   Do not apply stimulation when in the bath or shower.
8.   Do not apply stimulation while driving, operating machinery, or during any activity in which electrical stimulation can put the patient at risk of injury.
9.   Consult with your physician before using this device, because the device may cause lethal rhythm disturbances to the heart in susceptible individuals.
10.  Apply stimulation only to normal, intact, clean, healthy skin.
11.  Using the device directly over metallic implants could cause the currents to focus over a small area, causing tissue burns. If you have metal implants, do not place the pads near, or across the implant, and adjust the intensity with care.

Precautions:
1.    Since the effects of stimulation of the brain are unknown, stimulation should not be applied across the head and electrodes should not be placed on opposite sides of the head, unless you are in Microcurrent mode.
2.    The safety of electrical stimulation during pregnancy has not been established.
3.    Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel).
4.    Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians.
5.    Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians.
6.    Use caution when the patient has a tendency to bleed internally, such as following an injury or fracture.
7.    Use caution following recent surgical procedures when stimulation may disrupt the patient’s healing process.
8.    Use caution if stimulation is applied over areas of skin with less than normal sensitivity.
9.    Keep this device out of the reach of children.

Adverse Reactions:
•     Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin.
•     Patients may experience headache and other painful sensations during or following the application of electrical stimulation near the eyes and to the head and face.
•     Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the device.

General Warnings:
1.   Do not immerse any part of the unit in water
2.   Do not place the unit close to excessive heat.
3.   Do not use any electrodes which are less than 50mm X 50mm.
4.   Use only the specified battery: 1x 3.7volt rechargeable lithium battery. The use of any other battery could damage the unit.
5.   Remove battery if unit is not used for a long period of time.
6.   Do not use the unit while asleep.
7.   Do not put the lead wire on, or wrapped around the neck.
8.   Use this device only with the leads, electrodes and accessories recommended by the manufacturer. Use of other parts materials supplied by the manufacturer can degrade minimum safety and invalidate the warranty.
9.   After inserting plugs into both CH1 and CH2 sockets, please do not remove the plugs when the unit is working. Ensure that the unit is switched OFF before removing the plugs.
10. Keep the unit away from sources of high magnetic fields such as TV’S, microwave ovens and hi-fi speakers, as these may affect the LCD screen.
11. Keep the device away from a fireplace or radiant heater, as the heat may affect the device.
12. Keep the device away from nebulizer or steam kettle, as the moisture may affect the device.
13. Keep the device away from sunlight, as long-term exposure to sunlight may affect the rubber causing it to become less elastic and crack.
14. Keep the device away from lint and dust, as long-term exposure to lint or dust may affect the sockets or cause the battery connector to develop a bad contact.
15. Temperature & Relative Humidity of storage: -20°C–+40°C, 8%--70% R.H.
16. Temperature & Relative Humidity of transportation: -20°C–+40°C, 8%--70% R.H.