Gait up GO Instructions For Use Manual page 9

● Operate the Gait Up GO medical device at ambient room conditions in terms of temperature
(0°C - 30°C), humidity (10%-70% - non-condensing) and pressure (600 to 1070 hPa).
● Store Gait Up GO medical device in a safe place out of reach of people not trained for a safe
device use.
● Do not introduce any pointy object in the hole present on the backside of the Physilog6 sensor
device accessory. On the internal face of the hole, a membrane that ensures the IP64
protection index of the sensor device is placed. By damaging it, the protection is no longer
ensured and water ingress can damage the electronics and battery housed in the enclosure of
the Physilog6. Be aware that there is no reset button behind such hole in the device.
● Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
● Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
● Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the [ME
EQUIPMENT or ME SYSTEM], including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
1.1.2. Warnings related to the conditions and awareness of the end-users
● Before using the Gait Up GO medical device, evaluate the conditions of the Participant (see
definition in section 2.1) and the appropriateness of using such a medical device. The
Participants must be conscious, capable to understand and follow the instructions and able to
actively participate in the session (i.e. follow the instructions shown in the screen of the mobile
phone where the Gait Up GO mobile application is installed while performing the different
tests)
● Before using Gait Up GO medical device, instruct the Participants in the safe use of the device.
● Uttermost caution should be exercised when using the device in Participants with the
following risk factors:
○ suspected or diagnosed heart problem like ventricular arrhythmia, heart insufficiency
or hemodynamic instability;
○ Visual/auditive problems
● DO NOT use the Gait Up GO in other parts of the Participant body but in the ones indicated in
the Instructions For Use.
● DO NOT manipulate or remove Gait Up Go accessories from the user body during the session.
Accurate results are only guaranteed if the Physilog6 sensor accessory is firmly attached on the
user shoe or belt and the Instructions for Use are followed during the duration of the
assessment.
● When using the Gait Up GO wearable accessories (Physilog6 sensor device and its clip
accessories) on different Participants, disinfect the applied parts in potential contact with the
skin of the Participant before using it on another Participant, as there is the risk of spreading
infections.
● Keep device away from pets
ENGLISH 9/84