Table of Contents
Advertisement
Chapter 2. Introduction
2.1. Indications for use
The GEMS‐H is a robotic exoskeleton that fits orthotically on the wearer's waist and thigh, outside of clothing. The
device is intended to help assist ambulatory function in rehabilitation institutes under the supervision of a trained
physical therapist for the following population:
Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4 m/s and are able to
walk at least 10 meters with assistance from a maximum of one person.
The trained physical therapist must successfully complete a training program prior to use of the device. The device is
not intended for sports.
2.2. Training
The GEMS‐H should be used only by medical personnel who have received specific training provided by Samsung, Inc.
in the use of this device. Training provided by Samsung is limited to the use of the GEMS‐H and does not replace the
necessary medical training and experience required to perform rehabilitation.
2.3. Safe environments
The GEMS‐H is intended to be used under the supervision of a trained physical therapist in all use environments.
Suitable use environments include:
Hospital's internal facilities (indoor only): a rehabilitation treatment room, hospital hallway, or gait analysis lab
Surface type: smooth, cement, carpet, transitions, thresholds
Stairs of height less than nine (9) inches
Surfaces inclined at 5 degrees or fewer
Treadmills
SAIT‐IFU‐GEMS‐H Rev.1.1 (2019‐11)
Page 6 of 79
Advertisement
Table of Contents
