Rubicson TENS Machine KTR-2610

Overview

The TENS machine features a display showing:

• Current program
• Active function
• Channel 1 intensity
• Adjust program buttons
• Intensity level (CH1)
• Function/time button
• Battery indicator
• Frequency
• Channel 2 intensity
• Timer
• Adjust program buttons
• Intensity level (CH2)
• On/off button
• USB-C port

Specifications

Environment for use

• Temperature: +5 °C to +40 °C
• Humidity: 15-93% RH
• Barometric pressure: 700-1060 hPa

Environment for storage

• Temperature: -25 °C to 55 °C
• Humidity: 15-93% RH
• Barometric pressure: 700-1060 hPa

When the product is stored at around its minimum or maximum storage temperature, it needs to be placed at a normal ambient temperature (about 20 °C) for about 2 hours to restore its function.

Included

TENS/EMS main unit, 4x electrode pads, electrode wire, USB-A to USB-C charging cable (50 cm), manual.

Charging

Connect the included USB-C cable to the USB-C port and a USB power adapter. The battery indicator shows the status of the battery and when it is fully charged.

Use

Connect the electrode wires to the electrode pads and the main unit. Attach the pads to the part of your body you wish to massage. The skin must be dry and clean.

Turn the machine on by pressing the On/off button. The TENS starts the first program automatically. Press the Function/time button to switch between TENS, EMS or Fitness.

TENS (prg. 1–20) is intended for use for general pain relief associated with sore and/or aching muscles.

EMS (prg. 1–20) is intended for relaxation of muscle spasms, increasing local blood circulation and prevention of disuse atrophy.

Fitness (prg. 1-10) is intended as a complement for abdominal toning and strengthening.

Press the Adjust program buttons to change between the programmes. Press the Intensity buttons (CH1, CH2) to adjust the intensity of each pair of electrode pads. Press and hold the Function/time button to activate the timer. Press again to set the timer to 15, 30 or 45 minutes.

Notes

Only attach the electrode pads to dry skin. The electrode pads can be used up to 80 times and can be stored for 24 months.

Maintenance

Always turn the machine off and disconnect the electrode wires before cleaning the main unit or the electrode pads.

Clean the electrode pads after each use by wiping them with a damp and soft cloth or towel. Add a small amount of medicinal alcohol (75% concentration) if the pads are particularly dirty. The main unit can be cleaned with a soft cloth or towel.

Charge the machine if it has not been used for over a month.

If the main unit has been stored at the minimum/maximum storage temperature/humidity, wait 30 minutes before use.

Do not use the machine in temperatures above/below the recommended working environment as it may drastically decrease the performance of the main unit and its battery.

Store the TENS machine in a well-ventilated dry place, away from water, strong electromagnetic radiation, high temperatures, direct and strong sunlight.

Safety information

Attention

• Do not use high-frequency surgical equipment and the TENS machine at the same time. This might cause burns on the part where the electrode pad is pasted to, or cause damage to the machine.
• If the TENS machine is used in the vicinity (1 m) of a short wave or microwave therapy stimulator, the output of the machine might become unstable.
• Do not place the electrode pads close to the chest or thorax. Risk for cardiac fibrillation.
• Do not modify the TENS machine without authorization of the manufacturer.
• The battery should be replaced by professional maintenance staff.
• Do not use the TENS machine and high-frequency surgical ME equipment at the same time. This might cause burns on the part where the electrode pad is pasted to, or cause damage to the machine.
• Do not place the electrode pads across or through the head, directly on the eyes, covering the mouth, on the front of the neck, (especially the carotid sinus), or from electrode pads placed on the chest and the upper back or crossing over the heart.
• Do not inhale or swallow small parts.
• Prevent sharp parts from damaging the product.
• Do not use accessories not specified by the manufacturer.

Contraindications

• Consult a doctor before use if you suffer from very sensitive skin, heart disease, abnormal blood pressure, malignant tumours, cerebrovascular disease, epilepsy, acute disease currently under doctor's treatment, or if you are having your menstrual period or are pregnant.
• People who are not sensitive to or do not feel pain or heat on the skin should not use the TENS machine. It can lead to injuries.
• It is prohibited to use when bathing, sweating and sleeping.
• The patient with cerebral hemorrhage: It should be disabled in unsteady phase; the person who has sequela must be used under supervision of doctors.
• It is contraindicated for use by persons who has purulent inflammation, acute blood poisoning and continuous hyperpyrexia.
• It is contraindicated for use by persons who have acute cardiovascular and cerebrovascular diseases.
• Stop using the machine and consult a doctor if you at any point feel unwell during use.

Precautions

• Do not place the electrodes near the heart, head, eyes, front neck (especially the carotid artery), lower back, oral cavity or pudendum. Do not use if you have a skin disease.
• Do not move the electrode pads during use. Turn off the machine before detaching the pads and moving them to a new spot as it might cause unpleasant stimulation.
• Do not use the machine on children or people with no ability to express their own consciousness.
• Stop using the machine and consult a doctor if you at any point feel unwell during use.
• Unplug the TENS machine from the power supply when you are done using the product.
• Do not use the TENS machine along with other medical electronic stimulators such as a cardiac pacemaker, artificial heart-lung which is used to maintain life, and electrocardiograph. This can lead to danger.
• Do not use the TENS machine in direct sunlight, high heat, inflammable environments, electromagnetic radiation and humidity.
• Do not disassemble, repair or modify the TENS machine, it can cause failure or you can get an electric shock.
• Place the electrode pads where it is easy to move in an emergency.
• Check the equipment before each use to avoid the exposed wires caused by accidental damages or other reasons.
• Dust may affect the performance of the TENS machine, use a dry soft cloth to clean the machine when needed.
• Make sure the electrodes are not loose before use.
• This product contains connecting wires. Please prevent children from misusing them to avoid the risk of strangulation.

Symbols

Graphic symbol	Paraphrase
LOT	Product batch number tag
SN	Product serial number tag
	Manufacturer
	Production date
	Precautions
EC REP	EU representative
	Warning against danger
	Applies part of type BF
	Class II equipment
	Indoor use only
	Prohibition (things that are not allowed to do)
	Constraint (things that must be observed)
	Keep out of the sun
	Keep away from rain

Standards and Declarations

Executive standards

The product conforms to the following standards and laws:

• IEC 60601-1:2005+A1:2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-11: 2015 Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
• IEC 60601-2-10: 2013 Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
• IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests

Appendix EMC declaration

The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the EQUIPMENT should assure that it is used in such an environment.

The Transcutaneous Electrical Nerve Stimulators is suitable for use in a professional health care environment, not including areas where there are sensitive equipment or sources of intense electromagnetic disturbances, such as the RF shielded room of an imaging system magnetic resonance imaging, in operating rooms near active AF surgical equipment, electrophysiology laboratories, armored rooms or areas where short wave therapy equipment is used.

Do not use the system around strong electric filed, electromagnetic filed (e.g. MRI scan room) and mobile wireless communication devices. Using the device in an improper environment may cause malfunction or damage.

The compliance with EMC and EMI regulation cannot be guaranteed by the use of modified cables or those which does not comply with the same standards under what the equipment was validated.

The system must not be used adjacent or supported by other equipment.

The recommendations of this manual must be followed.

Do not use accessories, transducers, internal parts of components and other cables other than those previously specified by the manufacturer. This may result in increased emission or decreased electromagnetic immunity and result in improper operation.

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should by used no closer than 30cm to any part of the ultrasound system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

To maintain basic safety in relation to electromagnetic disturbances during the expected service life, always use the system in the specified electromagnetic environment and follow the maintenance recommendation described in this manual.

Following cable types must be applied to ensure compliance with standard of radiation interference and noise immunity:

Table 1 - Compliance class

Table 2 - Compliance standards

Table 3 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipments

Manufacturer Information

Shenzhen Kentro Medical Electronics Co.,Ltd

2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District, Shenzhen City, Guangdong Province, China

[Tel]: +86(755)33825998, [Fax]: +86(755)33825996

EC REP WellKang Ltd (www.ce-marking.eu)

Enterprise Hub, NW Business Complex, 1 Beraghmore Road, Derry, BT48 8SE, Northern Ireland