Samsung GEMS-H, Instructions For Use Manual

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SAIT‐IFU‐GEMS‐H Rev.1.1 (2019‐11) Page 10 of 79
3.2. Safety
Risk of electrical shock hazard and performance degradation if this equipment is modified!
Unauthorized modification of this equipment can affect the safety and effectiveness of the equipment.
‐ Do not modify this equipment without authorization of the manufacturer.
Risk of serious injury due to misuse!
Use of the device without training can result in serious injury to the patient.
‐ Users must successfully complete a training program provided by Samsung prior to use of the GEMS‐H.
Risk of serious injury due to use of the device in improper environments!
Use of the device in environments not recommended by the manufacturer may result in injury to the patient.
‐ Do not use in improper environments (e.g., on the sand, in stony areas, or any surface that is not
recommended by manufacturer). Refer to section 2.3 Safe environments.
Risk of serious injury to the patient who is distracted or cannot pay attention to tasks!
If the patient is distracted or uses the device without caution, it could result in loss of balance and possible injury.
‐ The GEMS‐H must be used under supervision of a trained physical therapist.
‐ The user should cease using this device with patients who are distracted or cannot pay attention to the
tasks.
Risk of serious injury due to misuse!
Use of the device without fitting and customizing can result in serious injury (e.g., fracture) to the patient.
‐ The GEMS‐H must be fitted to each patient properly by a trained physical therapist.
‐ Software settings must be customized for each patient by a trained physical therapist.