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Risk of serious injury to the patient due to loss of control!
Should the therapist lose control of the device, or if a device is used without the supervision of the trained
physical therapists, this may result in the patient having difficulty balancing and potentially falling while using
the device.
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At least one therapist should monitor patients at all times while the devices are turned on and/or while the
patients are walking.
Risk of serious injury to the patient by potentially falling due to a device malfunction!
Should the device malfunction, the 12 Nm torque provided by the device may suddenly stop. This may result in
the patient having difficulty balancing, and potentially falling.
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In order to prevent malfunctions, users should make sure that the device has been maintained according to
specifications and that the software is in working order prior to use.
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Users may conduct rehabilitation with a gait belt or a harness (e.g., body weight support system) and
assistive devices such as cane or a walker as needed.
Risk of serious injury to the patient due to improper fitting or fitting too tightly!
Skin abrasions, including discomfort, skin pressure/friction, bruising, pain, or unusual swelling, may result from
the device being improperly fitted or fitted too tightly.
‐
The device must be fitted over clothing to prevent skin abrasions.
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When putting on the device, the thigh support straps should be fitted with the knees slightly bent to avoid
excessive tightening or pressing.
‐
Users should examine the discomfort and skin pressure of the patient.
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Care should be taken to avoid pinching skin when fitting the device.
Risk of muscle soreness to the patient due to excessive rehabilitation!
Should the patient perform dynamic and complex training at the first time of use, this may result in muscle
soreness after the training session.
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Patients should start with simple activities, then increase the intensity of the training including more
dynamic and complex activities.
‐
Patients should be provided with adequate rest periods and asked about discomfort regularly.
Risk of injury to the patient and device damage due to pressing on the patient's body!
If the patient opens the leg excessively to the side while wearing, it may cause discomfort, skin pressure, and/or
device damage.
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Do not open the leg excessively to the side while wearing.
SAIT‐IFU‐GEMS‐H Rev.1.1 (2019‐11)
Page 11 of 79
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