Orthofix 1114RC L Скачать руководство пользователя

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Known and Expected Adverse Events

Adverse effects may be experienced when using the RCStim device. These

adverse effects may include increased pain, numbness and tingling, headache,

migraines, and nausea. These effects may or may not be directly related to use

of the RCStim device. Any adverse effects that are related to the RCStim device

should stop when you discontinue use.

Содержание 1114RC L

Страница 1: ...Subject Manual For the Orthofix Rotator Cuff Repair Study Models 1114RC R L...

Страница 2: ...Device Patents No U S 5 743 844 U S 6 132 362 Assembled in the United States of America ASSEMBLED IN USA...

Страница 3: ...sual and Audio Indicators Device Compliance Device Use and Care Care and Cleaning Storage of the Device Traveling with the RCStim Device Disposal Service Contraindications Warnings Precautions Adverse...

Страница 4: ...that your rotator cuff muscles will receive an adequate amount of electromagnetic field generated by the RCStim device The device comes in either a right shoulder or a left shoulder model Your doctor...

Страница 5: ...d Electromagnetic Field PEMF signal as a nonsurgical prescription treatment to increase the chances of a successful rotator cuff repair The device is lightweight and portable including a rechargeable...

Страница 6: ...red through clothing and skin directly to the treatment site Device Life The RCStim device provides 90 minute daily treatments for 6 months Putting the RCStim Device on your Shoulder 1 Fasten one end...

Страница 7: ...LCD will then show the Treatment Screen with the prescribed treatment time remaining and the battery status The flashing colon on the LCD screen and the flashing On Off button indicate that the devic...

Страница 8: ...instructions Treatment Sessions The RCStim device tracks the treatment time this tracking or timing begins when the device is turned on and at least one minute of treatment is complete The LCD shows a...

Страница 9: ...e Control Unit 3 Plug the power supply into any standard AC Wall Outlet Do not plug in the power supply for the RCStim device where it will be difficult to unplug 4 The LED on the power supply will li...

Страница 10: ...g with three fast beeps when recharging is recommended Charging Complete Charging Complete Indicates when the battery is fully charged Battery must be charged to turn on E12345678 E12345678 Battery Em...

Страница 11: ...e Use of the device in any other manner could have harmful effects Inspect the device prior to each use for wear deterioration or damage Do not use or charge the device if it does not appear to be in...

Страница 12: ...a water vapor pressure greater than 50 hPa 700 1060 hPa Traveling with the RCStim Device When traveling by air the RCStim device may be packed in carry on or checked luggage since it only contains a...

Страница 13: ...your pacemaker or defibrillator If you use the RCStim device and it affects your pacemaker or defibrillator it may injure your heart Consult your cardiologist before using the RCStim device Remove th...

Страница 14: ...tim device These adverse effects may include increased pain numbness and tingling headache migraines and nausea These effects may or may not be directly related to use of the RCStim device Any adverse...

Страница 15: ...evice Box Year of Manufacture for Active Device Device and Device Box Manufacturer Instruction Manual Not for General Waste Device and Device Box Keep Dry Device and Device Box FCC Mark Device and Dev...

Страница 16: ...Input 100 240VAC 50 60Hz 200mA 150 350mA Output Voltage 5VDC 1 3A Output Voltage 5VDC 2 4A Compliance Statements This device complies with part 15 of the FCC Rules Operation is subject to the followin...

Страница 17: ...for help Information regarding Electromagnetic Compatibility and Immunity The RCStim device complies with IEC 60601 1 2 for electromagnetic compatibility EMC The RCStim device needs special precaution...

Страница 18: ...arkway Lewisville Texas 75056 Clinical Helpline 866 657 7030 orthofix com P N 20123119 Rev 02 BS 1629 Orthofix Holdings Inc 3 2017 Caution Investigational Device Limited by Federal or United States la...