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Kentro KTR-101 Product Manual

Neck electronic muscle stimulator
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CE Technical file of Neck Electronic Muscle Stimulator
——
Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862
Effective Date: 2023.03.28
Product Manual
Neck Electronic Muscle Stimulator
Model：KTR-101
Document Reference No： KTR-JS-101-11-01-A
Version: A/3
@Thank you for choosing and using this product, and please read this manual completely!
Shenzhen Kentro Medical Electronics Co., Ltd
Date: 2023-03-28 Version: A/2
1

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Summary of Contents for Kentro KTR-101

  • Page 1 Effective Date: 2023.03.28 Product Manual Neck Electronic Muscle Stimulator Model：KTR-101 Document Reference No： KTR-JS-101-11-01-A Version: A/3 @Thank you for choosing and using this product, and please read this manual completely! Shenzhen Kentro Medical Electronics Co., Ltd Date: 2023-03-28 Version: A/2...

  • Page 2: Table Of Contents

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 Contents Product Introduction ..........................3 Product Intended use ..........................3 Indication ..............................3 Contraindication ............................3 Warnings ..............................4 Precautions ..............................

  • Page 3: Product Introduction

    Effective Date: 2023.03.28 1. Product Introduction The design of KTR-101 Neck Electronic Muscle Stimulator is mainly based on the principle of nourishing qi and blood according to traditional Chinese medicine. It helps to promote blood circulation to remove meridian obstruction, dissipate wound, relieve pain and other types of muscle discomfort. It adopts the summarized long-term clinical practice experience as well as combines with modern electronic science and technology, developing a new generation of high-tech products neck prevention.

  • Page 4: Warnings

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 sequela must be used under the supervision of doctors. It is forbidden for those who has purulent inflammation, acute blood poisoning and continuous hyperpyrexia.

  • Page 5: Precautions

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 humid. 17) Do not disassemble, repair and transform the therapeutic apparatus, otherwise cause failure or get an electric shock accident. 18) The therapeutic apparatus should be placed in the position which is easy to move the plugs to use, it is easy to move the plugs in emergency circumstances.

  • Page 6: Adverse

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 7. Adverse Be caution that research and statistics show that the use of stimulator might lead the skin beneath the electrodes to irritation and burn.

  • Page 7: Product Main Features

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 Host 9. Product Main Features  The product is designed on the basis of ergonomics which is in line with the neck curve and of aesthetics and science.

  • Page 8: Product Requirements And Major Parametric Description

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28  There are two automatic combinational massage modes and four manual massage modes to be fit for wider range of people, and it can be selected according to different needs. ...

  • Page 9: Product Environmental Requirement

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 Adjustment of output amplitude: continuous and balanced, the minimum output is not more than 2% of maximum output. Rated load impedance: 500Ω, ±10% franchise. m) The timer of therapeutic equipment: 15 minutes, ±...

  • Page 10: Functional Operation

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 The built-in rechargeable battery can be powered without the external power supply. The installation of battery The remote control uses the CR2032 Button battery, the positive pole upwards when is installed. 11.2 Functional operation 1）User should towel the cervical part and conductive plate with water, then press therapeutic apparatus close to the neck.
  • Page 11 CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 ①automatic mode: vibration + heating, heating + pulse, heating + pulse, heating, vibration, electric pulse auto-cycle running; ②vibration + heating; ③heating + pulse;...

  • Page 12: The Use Of Rechargeable Batteries

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 10）The adjustment of timing item by ―∧‖ and ―∨‖ button. Press the ―＜‖ and ―＞ button to switch the timing, Select the the adjustable range is 5 to 30 minutes, it can increase or decrease 5 minutes each pressing.

  • Page 13: Safety Precautions

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 12. Safety Precautions ■The manual said that the purpose of warning sign and legend is safe and proper using the product by yours, and prevents the harm to you and others.
  • Page 14 CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 fibrillation. 10) Advice that stimulation should not be applied across or through the head, such as directly on the scalp, eyes, covering the mouth, on the front of the neck, (especially the carotid sinus).
  • Page 15 CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 after operation and those at healing stage after the operation should not use. 3) It is contraindicated for those who has a skin perceptual disturbance or cannot feel the heat.

  • Page 16: Product Maintenance

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 1) Safety of stimulators for use during pregnancy has not been established. 2) Caution should be used for patients with suspected or diagnosed heart problems.
  • Page 17 CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 If this apparatus there is no evidence in the charging status, you should check whether there is a power supply, the power plugs are plugged in good, host toggle switch is in the ―charging‖...

  • Page 18: Emc Declaration

    Warning The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the KENTRO Neck Electronic...
  • Page 19 Muscle Stimulator as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Neck Electronic Muscle Stimulator. Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions The MODEL KTR-101 is compliance for each EMISSIONS test specified by the standard, e.g. EMISSIONS class and group. Emissions Compliance...
  • Page 20 Revision: A/2 2862 Effective Date: 2023.03.28 Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity The MODEL KTR-101 is compliance for each IMMUNITY test specified by the standard, e.g. IMMUNITY test level. Immunity test IEC 60601-1-2 Compliance level test level Electrostatic ±...
  • Page 21 CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 IEC 61000-4-8 NOTE a) U is the a.c. mains voltage prior to application of the test level; b) E.g. 25/30 means 25 periods at 50 Hz or 30 periods at 60 Hz. Table 3 –...

  • Page 22: Product Scrapping Disposal

    CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
  • Page 23 CE Technical file of Neck Electronic Muscle Stimulator —— Instructions for Use File No.: KTR-TCF-02-02-01-01 Revision: A/2 2862 Effective Date: 2023.03.28 Applied part of type BF Class II equipment This product only for indoor use It means prohibition (the thing was not permitted to do) It means enforcement (the thing must be observed) Keep out of the sun Keep away from rain...

  • Page 24: Executive Standards

    20. Contact Information Shenzhen Kentro Medical Electronics Co., Ltd. 2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District, Shenzhen City, Guangdong Province, China Attn: Mr.Zhang...

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