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09 / Instructions for Use Medical device · EU MDR

Kinetrace R1 — fitting, operation and care

Patient-facing instructions for a wearable surface electromyography (sEMG) rehabilitation device, for home use without clinical supervision.

DisclaimerKinetrace R1 is a fictional device created for this portfolio. Document numbers, revision history and clinical figures are illustrative. No proprietary or client material is reproduced. The regulatory structure and document conventions are real.
Document
KIN-IFU-0001
Revision
03
Effective
2026-03-02
Reading level
Grade 8 (validated)
Languages
EN · KO · DE · FR
ℹ
About this documentWritten for an adult patient using the device at home without clinical supervision. Structured to EU MDR Annex I Chapter III Section 23 and IEC 82079-1, with safety information ordered by severity.

1. Intended purpose

The Kinetrace R1 is a wearable surface electromyography (sEMG) system intended to measure and record muscle activation in the upper and lower limbs, and to deliver guided rehabilitation exercise programmes prescribed by a healthcare professional.

The device is intended for adults aged 19 years and over who are recovering from musculoskeletal injury or undergoing neuromuscular rehabilitation. It is intended for use in the home environment and in clinical settings.

The device does not diagnose any condition and does not deliver electrical stimulation.

2. Contraindications

Do not use the Kinetrace R1 if any of the following apply:

  • You have an implanted pacemaker, defibrillator or other active implanted device.
  • The skin where the band will sit is broken, inflamed, infected, or has an open wound.
  • You have a known allergy to silicone or to hydrogel electrode adhesive.
  • You are pregnant.

3. Safety information

WarningDo not wear the band while bathing, showering or swimming. Water entering the sensor housing can cause the battery to overheat and burn your skin.
WarningStop using the device and contact your healthcare professional if you feel pain, numbness or tingling during a session. Continuing an exercise through pain can worsen an existing injury.
CautionDo not clean the electrodes with alcohol, solvent or abrasive cloth. These damage the conductive surface and the device will report a poor-contact error.
NoteReadings may be less accurate for the first two minutes of a session while the electrodes reach skin temperature.

4. Symbols used on the device and packaging

CautionISO 15223-1 · 5.4.4
Consult instructions for useISO 15223-1 · 5.4.3
Keep dryISO 15223-1 · 5.3.4
Single patient, multiple useISO 15223-1 · 5.4.9

5. Fitting the band

Fit the band before you open the Kinetrace Connect app. The app cannot start a session until it detects good electrode contact.

  1. Wash the skin where the band will sit with soap and water. Dry it completely. Do not apply lotion, oil or powder.
  2. Hold the band with the sensor housing facing your skin and the charging port pointing towards your hand.
  3. Position the sensor housing over the middle of the muscle, halfway between the joint and the thickest part of the muscle.
  4. Pull the strap until the band stays in place when you move the limb, but you can still slide one finger underneath it.
    CautionDo not tighten the band further to improve the signal. A band tight enough to leave a mark restricts blood flow.
  5. Press and hold the power button for two seconds. The indicator light turns steady green when contact is good.

If the indicator light flashes amber, the electrodes are not making contact. Remove the band, dry the skin again, and repeat from step 2.

6. Cleaning after each session

  1. Remove the band and switch it off.
  2. Wipe the electrodes with a damp, lint-free cloth. Use water only.
  3. Wipe the strap with a cloth dampened with mild soap solution.
  4. Leave the band to air-dry for 30 minutes before charging or storing it.

7. Service life and disposal

The band has a service life of 24 months or 500 sessions, whichever comes first. The app shows the remaining service life in Settings.

Do not put the band in household waste. The band contains a lithium-polymer battery. Return it to your healthcare provider or to a collection point for electrical equipment.

Standards applied

EU MDR 2017/745 Annex I Ch. III §23 IEC 82079-1 ISO 15223-1 IEC 60601-1-11 (home environment) ISO 10993-5/-10

Authoring notes

Every warning states the hazard and its consequence, not just the prohibition — "water can cause the battery to overheat and burn your skin" rather than "keep away from water". Reviewers look for that pairing, and patients act on it. Safety information is ordered warning, caution, note so severity is visible without reading the text, and the step-level caution sits inside step 4 rather than in a block at the top, because that is the moment the error occurs.