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Risk of injury to the patient and device damage due to sitting and leaning backward on a surface while wearing
the device!
If the patient wearing the device sits and leans back onto a surface (e.g., chair), it may cause discomfort, skin
pressure, and/or device damage.
‐
Do not lean backward onto a surface while wearing the device and sitting.
Risk of injury to the patient due to skin pressure!
If the patient has something in their pockets or is wearing a belt while wearing the device, this may cause
discomfort and pressure on the patient's body.
‐
Belts should be removed prior to putting on the device.
‐
Pockets should be emptied prior to putting on the device.
Risk of potentially falling due to using discharged battery!
Use of the device with a low battery may result in the device may suddenly turning off during rehabilitation
which stops the assistive force. This may result in the patient having difficulty balancing and potentially falling.
‐
To ensure continuous power during use, always charge the battery at the end of each training session.
‐
When the battery level is below 20 %, charge the battery within 5 minutes.
Risk of electrical shock hazard and performance degradation when the device is dropped!
Should the device be dropped during use, it can affect the safety and effectiveness of the equipment.
‐
Stop using it immediately and report the situation to the manufacturer.
3.3. Safety standards
The GEMS‐H conforms to the following international standards:
•
IEC 60601‐1:2005+A1:2012
•
IEC 60601‐1‐2:2014
•
IEC 60601‐1‐6:2010+A1:2013
•
IEC 62366‐1:2015
•
IEC 62304:2006
•
ISO 15223‐1:2012
•
ISO 14971:2007
•
ISO 13485:2016
SAIT‐IFU‐GEMS‐H Rev.1.1 (2019‐11)
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