LIORQUE Transcutaneous Electrical Nerve Stimulators

Product Introduction

The LIORQUE Transcutaneous Electrical Nerve Stimulators (models: KTR-2612) offer Transcutaneous Electrical Nerve Stimulation (TENS). The device features 15 operation modes: 9 Manual modes and 6 automatic modes. These modes deliver electrical pulses through electrode pads placed on the skin to provide body stimulation.

The electronic stimulatory module includes an ON/OFF key, a display screen, a Mode Selection key, and Intensity Modification keys. The LCD display shows the selected mode, program, output intensity, stimulate frequency, and remaining time. The device comes with electrode pads, electrode wires, and batteries. The electrode wire connects the pads to the main unit. The electrode pads comply with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization) and are interchangeable.

Product Intended Use

This device is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot. This pain relief is achieved by applying current to stimulate nerves, often due to strain from exercise or normal household work activities. The device offers 9 Manual modes and 6 automatic modes.

Contraindication and Adverse Reaction

3.1 Contraindication

• The long-term effects of chronic electrical stimulation on the human body are not fully known.
• Patients with cardiac pacemakers are advised not to use this device.
• Patients with suspected or confirmed epilepsy, heart disease, pregnancy, or menstruating women are prohibited from using this device.
• Treatment should not be applied to areas with hemorrhage after acute trauma or fractures, or during the wound healing stage after surgery.
• Patients with impaired sensitivity to heat or electrical stimulation of the skin should not use this device.
• Individuals with a disturbance of consciousness or disabled children should not use this device.
• Patients with swelling, skin infections, skin diseases, or phlebitis should not use this device.
• Do not use the device on wet skin after showering, while sweating, or when going to sleep.
• Do not operate traffic tools or drive while using the device.
• Individuals with metal allergies are advised not to use this device.

3.2 Adverse Reaction

• Skin irritation and burns may occur beneath the stimulation electrodes.
• Headache and other painful sensations may be experienced during or after electrical stimulation, especially near the eyes, head, and face.

If you experience any adverse reactions, stop using the device and consult your physician.

Primary Structure of Product

The Transcutaneous Electrical Nerve Stimulators consist of a main unit, electrode pads, and electrode wires. The primary structure of the main unit is illustrated below:

Main Unit Components:

• Display Screen (showing electric quality, timer, waveform, mode, channel intensity)
• Buttons: ON/OFF, W/P (Waveform/Mode selection), A (Auto mode), M (Manual mode), +, - (Intensity adjustment for Channel 1 and Channel 2)
• Function module switch/set time

Electrode Pads: Three types are available: EPAD-D01 (70x52mm, 33cm²), EPAD-D02 (50x50mm, 25cm²), and EPAD-D03 (50x50mm, 25cm²). All are made of Hydrogel.

Product Main Features

• Ergonomic, beautiful, compact, and portable design.
• Generates efficient composite energy fields through low-frequency electrical pulses.
• Multi-function and multi-site pain relief.
• Features optional functional modules, adjustable treatment time, and intensity.
• Clear LCD display.

Product Requirements and Major Parametric Description

6.1 Product Power Requirement

• Power source: 3.7V/250mAh lithium battery.
• Device safety class: Class II type BF.

6.2 Product Main Technical Parametric Description

• Impulse frequency: TENS (20-100)Hz.
• Pulse width: TENS: 120μs.
• Impulse waveform: Square wave.
• Individual pulsing electric quantity at maximum output amplitude: >7µC.
• Maximum output energy of individual pulse: ≤300mJ.
• Output end open circuit and short circuit: The device supports influence of output end open and short circuit without performance degradation.
• Output amplitude adjustment: 0-16 levels.
• Therapeutic equipment timer: 15 minutes, 30 minutes, 45 minutes (±10% tolerance).
• Boundary dimensions: Main unit: 122mm x 55mm x 15.7mm.
• Electrode Pads: EPAD-D01 (70x52mm), EPAD-D02 (50x50mm), EPAD-D03 (50x50mm).
• Service life: The shelf life of the device is 2 years. The use life of the small electrode pad is 80 times, with a shelf life of 2 years.

6.3 Product Environmental Requirement

• Normal work environment: Temperature: +5°C to +40°C; Humidity: 15%-93% RH; Atmospheric pressure: 700hPa-1060hPa.
• Storage environment: Temperature: -25°C to +70°C; Humidity: 0-93% RH; Atmospheric pressure: 700hPa-1060hPa.
• Transport environment: Temperature: -25°C to +70°C; Humidity: 0-93% RH; Atmospheric pressure: 700hPa-1060hPa.

Note: Allow at least 30 minutes for the device to return to normal operating temperature from minimum/maximum storage temperature.

Method of Application

7.1 Power Supply Operation

1. Charge the lithium battery using the provided adapter.
2. Connect the components: Attach the main unit and electrode pads using the electrode wires as shown in Fig 1.
3. Turn on/off: Press the "On/Off" key to turn on the main unit. The power light will illuminate, the working routine starts, and the LCD backlight turns on. Press the "On/Off" button again to shut down the device and turn off the screen.

7.2 Functional Operation

1. Attach the electrodes to the stimulation areas. Ensure the skin is clean, especially if perspiring.
2. Press the "On/Off" key to turn on the device. The device defaults to "A" mode.
3. Use the "+" and "-" keys to adjust the intensity for Channel 1 and Channel 2. Each channel has 0-16 levels. "+" increases intensity, "-" decreases intensity.
4. Mode switch: Briefly press the "W/P" key to switch between "W" (Wide) and "P" (Point) waveforms. Press "A" to select automatic modes and "M" to select manual modes.
5. Timing adjustment: Long press the "W/P" key for 3 seconds to set the stimulation time to 15, 30, or 45 minutes.
6. The device offers 6 automatic modes and 9 manual modes.
7. The output waveform is displayed on the LCD.

7.3 The Use of Battery

• The device is powered by a rechargeable lithium battery.
• If the LCD brightness significantly weakens or intensity adjustment is slightly affected when pressing keys, the battery may be low and requires charging.
• If the device is not used for one month or longer, fully charge the battery first.
• Do not use the device in environments exceeding 45°C, as this may affect performance and battery life.
• Dispose of used batteries according to local environmental regulations.

Safety Precautions

Warning signs and legends in this manual are intended to ensure safe and proper product use and to prevent harm to users and others.

Warning Signs and Meanings:

• Danger (Triangle with lightning bolt): Indicates a dangerous situation that could result in serious injury or death if not avoided.
• Warning (Triangle with exclamation mark): Indicates a hazardous situation that could result in serious injury or death if not avoided.
• Caution (Triangle with exclamation mark): Indicates a hazardous situation that could result in minor or moderate injury or property damage if not avoided.

General Precautions:

• Do not use with HF (High Frequency) apparatus to avoid burns or equipment damage.
• Using the device near shortwave or microwave therapeutic apparatus (within 1 meter) may cause instability in the output.
• Applying electrode pads near the thorax may increase the risk of cardiac fibrillation.
• Avoid applying stimulation across or through the head, directly on the eyes, covering the mouth, on the front of the neck (especially the carotid sinus), or from pads placed on the chest and upper back crossing the heart.
• Prevent inhalation or accidental swallowing of small parts.
• Prevent sharp parts from damaging the product.
• Only use accessories specified by the manufacturer.
• Contraindications: Pregnant women, individuals with sensitive skin, heart disease, abnormal blood pressure, malignant tumors, cerebrovascular diseases, acute illnesses, or those undergoing medical treatment should consult a doctor before use.
• Do not use if you have skin perceptual disturbances or are insensitive to heat.
• Do not use while bathing, sweating, or sleeping.
• Patients with cerebral hemorrhage should use under supervision.
• Do not use if you have purulent inflammation, acute blood poisoning, or continuous hyperpyrexia.
• Do not use if you have acute cardiovascular and cerebrovascular diseases.
• Stop use immediately and consult a doctor if you feel unwell or experience skin complaints.

Product Maintenance

1. Before turning on the main unit, check if the battery is charged.
2. If the device operates abnormally, turn it off and then on again. If the issue persists, check if the device is broken.
3. If the device operates normally but there is no output (no sensation), check if the electrode pads are in direct contact with the skin and if there is hair or clothing obstructing contact.
4. When cleaning, turn off the device and disconnect the power. Wipe with a soft cloth or towel with a little water and dry thoroughly.
5. After each use, clean the electrode pads with a soft cloth or towel with a little water and dry. For particularly dirty pads, use a soft cloth with a little medicinal alcohol (75% concentration).
6. Store the device in a dry, ventilated, and well-insulated place.
7. Handle the device with care when moving it to avoid shaking.
8. Check the battery status and output. Address any abnormal conditions promptly.
9. Protect the device casing from abrasion.
10. Do not disassemble the host unit. Non-professionals attempting disassembly risk electric shock or device damage.

Accessories and Parts

• Main Unit: 1 pc
• Electrode Pads: 10 pcs
• Manual: 1 pc
• Charging Cable: 1 pc
• Electrode Wire: 2 pcs

Note: Three types of electrode pads are available for customer selection.

Graphic Symbol Paraphrase

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 specified electromagnetic environment. Users must ensure the equipment is used in such an environment.

The Transcutaneous Electrical Nerve Stimulators are suitable for use in a professional healthcare environment, excluding areas with sensitive equipment or intense electromagnetic disturbances (e.g., MRI rooms, near active AF surgical equipment, electrophysiology labs, armored rooms, or areas with shortwave therapy equipment).

• Do not use the system near strong electric fields, electromagnetic fields (e.g., MRI scan rooms), or mobile wireless communication devices. Use in an improper environment may cause malfunction or damage.
• Compliance with EMC and EMI regulations is not guaranteed if modified cables or non-compliant cables are used.
• The system should not be used adjacent to or supported by other equipment.
• Follow the recommendations in this manual.
• Do not use accessories, transducers, internal parts, or cables other than those specified by the manufacturer, as this may increase emissions or decrease electromagnetic immunity, leading to improper operation.
• Portable RF communication equipment should be used at least 30cm away from any part of the system.
• To maintain basic safety, use the system in the specified electromagnetic environment and follow maintenance recommendations.

EMC Compliance Information: The following tables provide information on the equipment's compliance according to EN 60601-1-2:2015.

Table 1 Compliance class

Table 2- Compliance standards

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

Product Scrap Processing

As a medical device, if the complete machine is aging or unusable, it should be scrapped according to local legislation.

The Paraphrase of Graphic Symbol

Other Symbols Explained

• Danger symbol: Warning against danger.
• EU representative symbol: Indicates the EU representative.
• Warning against danger symbol: Warning against danger.
• Applied part of type BF symbol: Indicates the applied part of type BF.
• Class II equipment symbol: Indicates Class II equipment.
• Indoor use only symbol: This product is only for indoor use.
• Prohibition symbol: Indicates something that is not permitted.
• Enforcement symbol: Indicates something that must be observed.
• Keep out of the sun symbol: Keep out of direct sunlight.
• Keep away from rain symbol: Keep away from rain.
• Disposal symbol: Contact local authorities for proper disposal of potentially biohazardous parts and accessories.
• CE label and noticed body code: CE marking and notified body code (0413).
• IP22 rating: Indicates dustproofing and waterproofing grade. It prevents solid objects greater than 12mm from invading and can withstand dripping invasion at a 15-degree inclination without harmful effects.
• Symbol directing to documentation: This symbol directs the user to refer to documentation for additional information regarding system use or description.

Precautions

• Do not use on parts near the heart, head, eyes, front neck (especially the carotid artery), lower back, oral cavity, or pudendum, or on areas with skin disease.
• If moving the apparatus or changing therapeutic parts during use, shut it down and restart to avoid strong stimulation.
• Not permitted for children or individuals unable to express consciousness.
• If you feel unwell, stop using the product immediately and consult a doctor.
• Pull out the power plugs when done or not in use.
• Do not use in conjunction with other medical electronic devices (e.g., cardiac pacemakers, artificial hearts, ECG machines) as it may lead to danger.
• Do not use in places with direct sunlight, high heat, flammable materials, strong electromagnetic radiation, or humidity.
• Do not disassemble, repair, or modify the apparatus to avoid failure or electric shock.
• Place the apparatus where plugs are easily accessible for emergency disconnection.
• Check the equipment before each use for exposed wires caused by accidental damage or other reasons.
• Dust may affect performance; clean the device with a dry soft cloth as needed.
• Ensure electrode pads are securely attached before each use to avoid adverse effects on performance.

Vorschläge für Therapiepositionen (Therapy Position Suggestions)

The manual includes diagrams illustrating 28 different electrode placement positions for various therapeutic applications.

Content Overview

The manual is divided into sections covering English (EN) and German (DE) content. English content spans pages 01-16, and German content spans pages 17-24.

Contact Information

Web: www.liorque.net

E-mail: support@liorque.net