Adverse Reactions - Gait up GO Instructions For Use Manual

time. Do not operate several Gait Up GO medical devices on the same Participant at
the same time.
● Do not combine the equipment of the Gait Up GO with the equipment or the applied
parts of other devices/accessories. Always refer to the manufacturer indications;
● Do not operate the device and contact your Healthacre Professional with the error
message given by the Gait Up GO Mobile Application if the Physilog6 sensor device
accessory fails to perform the firmware update.
● Do not operate Gait Up GO medical device if the Physilog6 sensor device accessory is
not correctly placed on the end-user's body
● Any part of the Gait Up GO must not be maintained or serviced while the device is in
use; do not perform an operating system update of the mobile phone/tablet during or
when you have planned to use the device.
● Liquids and foreign material (e.g. dust) must not be allowed to enter the Physilog6
sensor device accessory. Do not clean the device with excessive liquid. For cleaning
and maintenance instructions, refer to the section 5 of the present document.
● Do not subject the Physilog 6 device accessory, containing batteries, to intentional or
repetitive mechanical shocks;
● Do not leave the Physilog6 device accessory exposed directly to the sun.
● Store all Gait Up GO medical device accessories in the original Gait Up GO casing
provided together with the device.
● Transport the Gait Up GO medical device, including all its accessories, within the
original container case. Mindmaze SA is not liable for transport damage if the Gait Up
GO medical device is not packed in its original container case.
1.3. Contraindications for Gait Up GO medical device
Do not use the Gait Up GO medical device, version 1.0, on Participants:
● in combination with active implantable medical devices and/or electromedical devices
that have direct impact on the health condition of the patient;
●
in combination or in close proximity to any life supporting medical device;
● in direct contact with open wounds, pressure sores, inflammation or skin irritated
area;
●
Electromagnetic Hypersensitivity syndrome: Idiopathic Environmental Intolerance to
Electromagnetic Fields.
● The consequences of the performance of the tests included in the Gait Up GO medical
device by pregnant women is unknown. Therefore, it is not recommended the use of
Gait Up GO medical device on pregnant women.

1.4. Adverse reactions

In the unlikely event that any adverse reactions occur in participants, stop using Gait Up GO
medical device immediately.
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