Comfytemp K6145 TENS Unit
Brand: Comfytemp
Model: K6145
Foreword and Intended Use
The Comfytemp K6145 is a Transcutaneous Electrical Nerve Stimulator (TENS) unit. TENS is a scientifically proven method for reducing the sensation of pain by stimulating nerves, primarily through high-frequency electrical pulses that trigger the release of endorphins, the body's natural pain relievers.
Getting to Know TENS
This section provides an overview of TENS technology and its application.
Package Included
The package typically includes the TENS device, electrode cables, electrode pads, a user manual, and a charging cable. Specific contents may vary.
Device Description
The Comfytemp K6145 is a handheld electronic device designed for pain management. It features a display screen and several control buttons for operation. The device is rated for specific waterproof and dustproof levels.
Interaction (Button, Display)
The device is operated via buttons and provides feedback through its display screen. Key functions include timing settings and density adjustments.
How to Use
First-time Use: Ensure the electrode pads are properly connected to the device via cables. Attach the electrode pads to the desired treatment areas on the skin. Do not use sharp objects on the electrode pads.
Operation: Short press the power button to turn the device on or off. Use other buttons to select modes and adjust intensity. Ensure electrodes are correctly placed and connected before starting treatment.
Electrode Placement: Diagrams illustrate recommended electrode placement on various body parts, such as the calves, feet, and back. Ensure electrodes are attached to clean, dry skin.
Mode Overviews
The Comfytemp K6145 offers various modes for treatment, including:
- Compose Mode: For specific therapeutic applications.
- Modulation Mode: Adjusts pulse characteristics for varied stimulation.
- Treatment Time: Adjustable duration for sessions.
Charging Instruction
Low Battery: When the battery level is low, indicated on the display, charge the device. Use a certified 5V/1A or 5V/2A adapter. Charging with a 5V/1A adapter typically takes approximately 4 hours for a full charge.
Charging Indicator: The device usually has an indicator light to show charging status.
Cleaning and Storage
Adhesive Electrodes
To ensure the longevity and effectiveness of adhesive electrode pads, store them properly after use. Avoid applying skin care products to the skin before attaching electrodes, as this can reduce adhesion.
Device Care
Clean the device with a soft, dry cloth. Avoid using harsh chemicals or abrasive materials. Store the device in a cool, dry place away from direct sunlight and extreme temperatures.
Problems and Solutions
| Problem | How to Proceed |
|---|---|
| Power button not working | Ensure the device is charged. Try charging with a 5V/1A or 5V/2A adapter. If the issue persists, contact customer support. |
| Weak or no stimulation | Check electrode connections and placement. Ensure electrodes are properly attached to the skin and are not worn out. Replace electrodes if necessary. |
| Device malfunction / unexpected behavior | Restart the device. If the problem continues, contact customer support. |
Warnings
⚠️ General Warnings:
- Do not use the device if it is damaged or malfunctioning.
- Do not use the device while charging.
- Do not immerse the device in water.
- Do not use the device on children without adult supervision.
- Consult a physician before use if you have any medical conditions, especially heart conditions, epilepsy, or are pregnant.
- The effects of TENS on the human body are not fully known.
- Patients with cardiac pacemakers or other implanted electronic devices should not use this device.
- Do not use on the head, neck (especially the carotid artery), or during sleep.
- Avoid using the device if you have phlebitis or varicose veins.
- Do not use the device if the electrodes are damaged or worn out.
- Do not use the device if you have metal allergies.
- Do not use the device over areas with reduced sensation or open wounds.
- Do not use the device if it causes discomfort or skin irritation.
Safety Precautions
⚠️ Precautions:
- This manual is intended to ensure safe and proper use.
- The device should be maintained and operated as described in this manual.
- If you experience any adverse reactions, discontinue use and consult a healthcare professional.
- Do not attempt to repair the device yourself. Unauthorized modifications can be dangerous.
- Keep the device out of reach of children.
- Avoid using the device near strong electromagnetic fields or equipment that generates them.
Precautions
❗ Important Precautions:
- Please do not use in areas with open wounds or skin infections.
- Do not use on the head, neck (especially the carotid artery), or during sleep.
- Avoid using the device if you have heart rhythm abnormalities or heart and lung conditions.
- Do not use the device if you have metal allergies.
- Do not use the device if it causes discomfort or skin irritation.
- Do not use the device over the same area for extended periods without breaks.
- Do not use the device while driving or operating heavy machinery.
Technical Specifications
| Parameter | Specification |
|---|---|
| Power Supply | Internal rechargeable battery (details not specified, likely Li-ion) |
| Charger Input | 5V DC, 1A or 2A |
| Output Channels | 2 Channels |
| Waveform | Asymmetrical biphasic pulse |
| Pulse Width | 120-400 µs (adjustable) |
| Pulse Rate | 2-80 Hz (adjustable) |
| Output Current | Max 136 mA @ 5000 Ω load (per channel) |
| Dimensions | 118mm x 65mm x 20mm |
| Weight | Approx. 110g / 0.24 lb (device only), 340g / 0.75 lb (with packaging) |
| Treatment Time | Adjustable (e.g., 15, 30, 60 minutes) |
Appendix: EMC Declaration
This equipment complies with the basic safety and essential performance requirements of EN 60601-1-2:2015 for electromagnetic compatibility (EMC).
Guidance and Manufacturer's Declaration - Electromagnetic Emissions:
The Comfytemp K6145 is intended for use in the electromagnetic environment specified below. The customer or the user of the Comfytemp K6145 should ensure that it is used in such an environment.
| Emissions Test | Compliance | Electromagnetic Environment Guidance |
|---|---|---|
| RF emissions CISPR 11 | Group 1 | The Comfytemp K6145 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are unlikely to cause any interference in nearby electronic equipment. |
| RF emissions CISPR 11 | Class B | The Comfytemp K6145 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
| Harmonic emissions IEC 61000-3-2 | Class A | |
| Voltage fluctuations/flicker emissions IEC 61000-3-3 | Complies |
Guidance and Manufacturer's Declaration - Electromagnetic Immunity:
| Immunity Test | IEC 60601 Test Level | Compliance | Electromagnetic Environment Guidance |
|---|---|---|---|
| Electrostatic discharge (ESD) IEC 61000-4-2 | ± 6 kV contact ± 8 kV air | ± 6 kV contact ± 8 kV air | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. |
| Electrical fast transient/burst IEC 61000-4-4 | ± 2 kV for power supply lines ± 1 kV for input/output lines | ± 2 kV for power supply lines ± 1 kV for input/output lines | Mains power quality should be that of a typical commercial or hospital environment. |
| Surge IEC 61000-4-5 | ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth | ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth | Mains power quality should be that of a typical commercial or hospital environment. |
| Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 | < 5 % UT (> 10 s) 60 % UT (100 ms) < 5 % UT (> 10 s) | < 5 % UT (> 10 s) 60 % UT (100 ms) < 5 % UT (> 10 s) | Mains power quality should be that of a typical commercial or hospital environment. If the user of the Comfytemp K6145 requires continued operation during power mains interruptions, a UPS or a battery is recommended. |
| Power frequency magnetic field 50/60 Hz | 30 A/m | 30 A/m | Power frequency magnetic fields should be at levels characteristic of a typical location in the commercial or hospital environment. |
Guidance and Manufacturer's Declaration - Electromagnetic Immunity:
| Immunity Test | IEC 60601 Test Level | Compliance | Electromagnetic Environment Guidance |
|---|---|---|---|
| Conducted RF IEC 61000-4-6 | 150 kHz to 80 MHz, 10 Vrms | 10 Vrms | Portable and mobile RF communications equipment should be used no closer to any part of the Comfytemp K6145, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. |
| Radiated RF IEC 61000-4-3 | 80 MHz to 2.5 GHz, 10 V/m | 10 V/m | An electromagnetic environment is assured by the use of portable and mobile RF communications equipment. |
Recommended Separation Distances:
The Comfytemp K6145 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Comfytemp K6145 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Comfytemp K6145 as recommended below, according to the maximum output power of the communications equipment.
| Maximum output power of transmitter | Separation distance at 150 kHz to 80 MHz | Separation distance at 80 MHz to 800 MHz | Separation distance at 800 MHz to 2.5 GHz |
|---|---|---|---|
| d = 1.2√P | d = 1.2√P | d = 2.3√P | |
| 150 kHz to 80 MHz | |||
| 80 MHz to 800 MHz | |||
| 800 MHz to 2.5 GHz |
NOTE 1: At 80 MHz and 230 MHz, the separation distance for the higher frequency applies. NOTE 2: This guideline may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
WARNING: Do not use this equipment adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Comfytemp K6145 should be observed to verify normal operation in the configuration in which it will be used.
WARNING: Do not use near strong electric or magnetic fields, or in MRI scan rooms, as this may cause malfunction.
WARNING: Use only cables and accessories specified by the manufacturer. Using other cables or accessories may increase emissions or decrease immunity.
Warranty
The Comfytemp K6145 comes with a 365-day warranty.
Contact Information
For support or inquiries:
Telephone: +44 87514-671808
Email: help@comfytemp.com
Website: help@comfytemp.com
