Gait up GAIT UP GO User manual

ENGLISH
D-2017-LBL-0083-AAA – Sep 2020

INSTRUCTIONS FOR USE
HOME USE
GAIT UP GO
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Legal manufacturer:
Mindmaze SA
Chemin de Roseneck, 5
1006 Lausanne
Switzerland
Contact email: xxxxxxxx
Website: www.mindmaze.ch
Commercialized by:
Gait Up SA
EPFL Innovation Park
Batiment C
CH-1015 Lausanne
Switzerland
General Contact email: [email protected]
Website: https://clinical.gaitup.com/
Support email: [email protected]
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TABLE OF CONTENT
TABLE OF CONTENT 4
TABLE OF FIGURES 5
INDEX OF TABLES 6
1. SAFETY INFORMATION 7
1.1. WARNINGS 7
1.1.1. WARNINGS RELATED TO THE OPERATING
CONDITIONS OF THE DEVICE 7
1.1.2. WARNINGS RELATED TO THE CONDITIONS
AND AWARENESS OF THE END-USERS 8
1.2. CAUTIONS 8
1.3. CONTRAINDICATIONS FOR GAIT UP GO MEDICAL
DEVICE 9
1.4. ADVERSE REACTIONS 9
2. BEFORE USE 11
2.1. DEFINITIONS 11
2.2 INTENDED USE 11
2.3. INDICATIONS FOR USE 12
3. DESCRIPTION 13
3.1. OVERVIEW 13
3.2. DESCRIPTION OF DEVICE COMPONENTS 14
3.3 USER INDICATORS 18
3.3.1 VISUAL USER INDICATORS RELATED TO
BATTERY CHARGING 18
3.3.2 VISUAL AND AUDITORY INDICATORS RELATED
TO THE OPERATION OF THE DEVICE 18
4. USE 20
4.1. OVERVIEW 20
4.2. DISCOVER THE PHYSILOG®6 SENSOR DEVICE 20
4.3 CHARGING OF THE PHYSILOG®6 SENSOR DEVICE21
4.4 CHECKING SYSTEM COMPONENTS AND THEIR
FUNCTIONALITY 21
4.5. OPERATING THE MEDICAL DEVICE 22
4.5.1 OPENING THE MOBILE APPLICATION 22
4.5.2 CONNECTING PHYSILOG6 SENSOR DEVICE
TO THE MOBILE APPLICATION 23
4.5.3 PHYSILOG6 SENSOR DEVICE INFORMATION
SCREEN 24
4.5.4 PERFORMING A TEST 27
5. CLEANING, MAINTENANCE AND STORAGE 35
5.1. CLEANING 35
5.2. MAINTENANCE 35
5.3. STORING AND TRANSPORTING THE DEVICE 36
5.4. ENVIRONMENTAL CONDITIONS FOR OPERATION.
36
6. TROUBLESHOOTING 37
REPORTING AN ADVERSE EVENT 39
7. DISPOSAL 40
8. TECHNICAL SPECIFICATIONS 41
8.1. SPECIFICATIONS 41
8.2. SYMBOLS 43
8.3. EMI EMISSIONS 45
8.4. GUIDANCE AND MANUFACTURER’S DECLARATION -
ELECTROMAGNETIC EMISSIONS 46
8.5. GUIDANCE AND MANUFACTURER’S DECLARATION -
ELECTROMAGNETIC IMMUNITY 46
9. ALPHABETICAL INDEX 50
10. LEGAL MANUFACTURER 51
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TABLE OF FIGURES
Fig. 1 14
Fig. 2a 14
Fig. 2b 14
Fig. 3 15
Fig. 4 17
Fig. 5 20
Fig. 6 23
Fig. 7 23
Fig. 8 24
Fig. 9 25
Fig. 10 25
Fig. 11 26
Fig. 12 27
Fig. 13a 28
Fig. 13b 28
Fig. 14 28
Fig. 15 29
Fig. 16 29
Fig. 17 30
Fig. 18 31
Fig. 19 31
Fig. 20 32
Fig. 21 32
Fig. 22 32
Fig. 23 33
Fig. 24 34
Fig. 25 34
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INDEX OF TABLES
Table 1. Definitions 11
Table 2. Gait Up GO components 13
Table 3. Physilog6 sensor components 16
Table 4. Automatic test end criteria 31
Table 5. Troubleshooting 38
Table 6. Technical specifications 43
Table 7. Symbols 45
Table 8. EMI emissions 45
Table 9. Electromagnetic emissions 46
Table 10. Electromagnetic immunity 48
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1. SAFETY INFORMATION
The safety information is classified as follows:
Warning!
Clinical meaning: Refers to a hazard that, if not avoided, can result in serious
injury or death
General meaning: Advanced notice of something unpleasant or dangerous that
will happen
Caution!
Refers to a potential hazard that, if not avoided, can result in minor personal
injury and/or product/property damage
Read the following safety information before using this medical device.
1.1. Warnings
1.1.1. Warnings related to the operating conditions of the device
●Do not use Gait Up GO medical device in the near proximity of Active Implantable
Medical Devices (AIMD), medical devices that have direct impact on the health
condition of the patient or life supporting medical devices.
●Gait Up GO sensor device accessory, Physilog®6 sensor, should be handled carefully. In
particular, it should not receive intentional shocks, such as fall, crushing, being hit, etc.
●Do not use or charge the Physilog®6 if the sensor, its case or USB cable are damaged.
Contact your medical professional about what further action is needed when any
component is damaged.
●Do not attempt to repair or modify the device or replace any of its components.
Damaged parts must be immediately replaced with original parts. Please contact your
Healthcare Professional, who prescribed you the Gait Up GO medical device,
immediately.
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●Do not use any external power supply (mobile phone charger) other than the one
provided by your Healthcare Professional who prescribed you the medical device.
Always refer to the device manual for proper charging instructions.
●Use of accessories and cables other than those specified or provided by the
manufacturer of this medical device could result in improper operation of the device.
Always refer to the manufacturer indications.
●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).
●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.
1.1.2. Warnings related to the conditions and awareness of the end-users
●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.
●Keep device away from pets
1.2. Cautions
●Operate Gait Up GO medical device only as prescribed by your Healthcare Professional.
Precaution should be exercised when using the device in following conditions:
●Do not use Gait Up GO medical device in case of software malfunctioning, including
mobile phone application, repeated Bluetooth Low Energy (BLE) connection issues,
and repeated reset of the Physilog6 sensor device accessory. In all those cases, contact
your Healthacre Professional who has prescribed you the medical device.
●Gait Up GO medical device uses a single Physilog6 sensor device accessory. A
Participant must not wear more than one Physilog6 accessory on the body at the same
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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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Any serious incident having occurred in relation to Gait Up GO medical device should be
reported to the legal manufacturer (Mindmaze SA) and the competent authority of the
Member State in which the user and/or the Participant is established. Inform your Healthacre
Professional who has prescribed you the medical device if you notice adverse reactions.
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2. BEFORE USE
Please, refer to section 1. Safety Information
2.1. Definitions
Term
Definition
Participant
Term used to describe the end users of the
Gait Up Go medical device, including
patients, healthy individuals and athletes.
User
Term used to describe any actor using the
Gait Up Go medical device, including the
medical professionals, end users and patient
relatives.
BLE
Bluetooth low energy (or Bluetooth smart)
IFU
Instructions for use
eIFU
Electronic version of the Instructions for use
QSG
Quick start guide
eQSG
Electronic version of the Quick start guide
Table 1. Definitions
2.2 Intended use
Gait Up GO is a medical device intended to help therapists, physicians, medical doctors and
rehabilitation specialists to assess the condition of patients suffering from motor disorders.
Furthermore, the device quantifies patients' physical performance which can be used to
understand the impact of treatments and/or rehabilitation therapies on the patients.
Gait Up GO is also used to assess risk of injury for prevention in recreational and professional
athletes of all ages (such as any person performing a sport activity).
Gait Up GO is further used to measure indicators of early-stage signs of diseases affecting
motor function (such as Parkinson Disease).
The device can be used at hospitals, clinics, rehabilitation centers and patient's home.
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2.3. Indications for use
GaitUp GO is a medical device indicated for mobility and physical condition parameter
assessment in:
●child (any gender): 2 - 12 years old
●adolescent (any gender): aged 12 through 21 (up to but not including the 22nd
birthday)
●adult patients (any gender): 22 and older
to help medical professional in getting objective parameters to:
●assess the condition of patients suffering from mobility disorders
●assess the risk of injury in athletes of all age and
●assess indicators of early-stage signs of diseases affecting motor function.
It can be used in hospital, clinics, rehabilitation centers and indoor home environments. The
device is not indicated for uses other than that described in the IFU and labelling. GaitUp GO is
a Px only (under prescription) Medical Device.
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3. DESCRIPTION
3.1. Overview
The Gait Up GO medical device components are delivered in a dedicated shipping box.
Quantity
Component
Article number
1
Instructions for Use Lay
person
GOIFUh
1
Quick start Guide Lay person
GOQSGh
1
Device case
GOC
1
Physilog6 sensor device (*)
P6
1
Belt clip and strap(*)
BCS
1
Shoe clip(*)
SC
1
USB cable(*)
USBCc
1
Gait Up GO mobile
application pre-installed in a
mobile/phone tablet
GO
Table 2. Gait Up GO components. (*) are accessories. The related technical specifications are
provided in section 9 of the present document.
WARNING: Do not use any external power supply (mobile phone charger) other than the one
provided by your Healthcare Professional. Always refer to the device manual for proper
charging instructions.
Note1: Check the shipping box content for any missing component and for any damage that
may have occurred during transportation.
Note 2: It is highly recommended to keep the Gait Up GO medical device components in the
original device case when it is not used, positioned in the corresponding slots as they were
delivered originally.
Gait Up GO medical device can be operated only through a mobile phone (iOS & Android) or a
tablet (iOS & Android) where Gait Up GO app has been installed:
●Gait Up GO Application is freely available for installation on Google Play Store and
Apple App Store
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3.2. Description of device components
Fig 1. Gait Up GO device components
Gait Up Go Mobile Application
Fig 2a. Android application Fig 2b. iOS application
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Gait Up GO Mobile Application is a software used to:
●wirelessly communicate with the Physilog6 sensor accessory via BLE
●provide instructions about the different tests intended for the Participant to perform
●receive, process and analyse the raw data sensed by the Physilog6 sensor device
●generate clinical reports showing the main outcome indicators for the Medical
Professionals to interpret it.
●update the Firmware of the Physilog6 sensor device accessory
The Gait Up GO Mobile application runs on off the shelf Android and iOS mobile phones and
tablets.
The Gait Up GO Mobile application provides guidance to the users on how and where to place
the Physilog6 sensor device on the Participant’s body (see section 4 for further details)
Physilog6 sensor device
Fig 3. Physilog 6 sensor
Physilog 6 sensor device is an accessory of the Gait Up GO medical device intended to
measure human movement parameters.
The Physilog6 sensor device is operated via the Gait Up GO mobile application to perform the
following actions:
●Connect the sensor device to the phone/tablet via BLE
●Send raw data of human movement to the Gait Up GO mobile application
●Disconnect the sensor device from the phone/tablet via BLE
The Physilog6 sensor device has a function called “shake up to wake up”. After 30 seconds of
no activity (i.e. sensor device not moving and not connected to the Mobile Application), the
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Physilog6 goes into stand-by mode. By lightly shaking the device, the BLE turns on and the
sensor device and the mobile application automatically connect over Bluetooth.
The Physilog6 accessory device is composed of:
Component
Function
a) Body of the
device
Encloses all the electronics and the battery. The Physilog6 sensor device
is water and dustproof according to the standard IP64.
b) LED
It emits light indicating the different status of the sensor device;
●Charging
○Blinking white
●Charged
○Shining green
●Errors:
○Blinking red:
■Not enough battery to start a recording
■Cannot start a recording
■Error during a recording
■Hardware part broken
●Recording
○Blinking green
●Warnings:
○Blinking yellow
■Battery starting to be low during recording
c) Button
The button serves to perform a reset of the device in case it is not
responding normally. See section 6. Troubleshooting for more
information.
d) USB-C plug
It allows the users to plug the USB cable included in the device packaging
on the one end to the Physilog6 sensor device and on the other end
either to a computer or to a compatible mobile phone charger (see
specifications on section 9 of the present document) for charging
purposes.
e) Mechanical
connector for
the fixation
clips
Mechanical design feature included in the Physilog6 casing and used to
fit mechanically the fixation clips into the body of the Physilog6 sensor
device. The feature is symmetrically present on both extremities of the
Physilog6 casing.
Table 3. Physilog6 sensor components
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Fixation clips and belt strap
Both the fixation clip for the belt (using the strap) and for the shoe are used to securely
attach the Physilog6 sensor device to the Participant’s body.
Fig 4. Fixation clip accessories
USB cable
USB-A to USB-C cable, included in the Gait Up GO medical device packaging, is used to
charge the battery of the Physilog6 sensor device by connecting it to a computer or to a
mobile phone charger compatible with the specifications set under section 9 of the present
document.
Device case
Primary packaging in which the Gait Up GO medical device components are delivered.
The device components should be kept in this original packaging when not used, positioned
in the correspondent slots as they were delivered originally.
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3.3 User indicators
3.3.1 Visual user indicators related to battery charging
3.3.2 Visual and auditory indicators related to the operation of the device
Physilog6 sensor device visual and auditory indicators
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Gait Up GO mobile application visual indicators
1. Information messages
2. Error messages
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4. USE
Please, refer to section 1. Safety Information.
4.1. Overview
Your doctor/physical therapist has chosen Gait Up GO medical device to assess gait and
functional parameters from your body. It is important however, for you to carefully watch the
Gait Up GO medical device and all its accessories to make sure that the device is working
properly while you are using it alone at home. In this document there is some important
information you should read and understand carefully. If you have any questions, please refer
to the Healthcare Professional who has prescribed you this device.
●The medical professional has programmed the Gait Up GO medical device specifically
for you. Open the mobile application, already pre-installed in the mobile device/tablet
provided by the healthcare professional. Your profile will automatically be shown on
the screen.
●Clip the Physilog6 sensor device in the clip accessories.
●Select one of the tests prescribed by your Healthcare Professional that appear on the
mobile application screen.
●Place the Physilog6 sensor accessory, on your own or with the help of someone, on
your body following the indications provided by the Mobile Application.
●Perform the indicated movements by the screen of the Mobile Application.
●Stop the test
4.2. Discover the Physilog®6 sensor device
Fig 5. Physilog6 sensor device inside its packaging
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