Gait up GAIT UP GO User manual

ENGLISH
D-2017-LBL-0086-AAF – Jan 2021

INSTRUCTIONS FOR USE
GAIT UP GO
ENGLISH
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Legal manufacturer:
Mindmaze SA
Chemin de Roseneck, 5
1006 Lausanne
Switzerland
Contact email: [email protected]
Website: www.mindmaze.ch
Commercialized by:
Gait Up SA
EPFL Innovation Park
Batiment C
CH-1015 Lausanne
Switzerland
FCC ID: 2AYHH-PHY06GAITUP
IC ID: 26802-PHY06GAITUP
General Contact email: [email protected]
Website: https://clinical.gaitup.com/
Support email: [email protected]
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TABLE OF CONTENT
Instructions for Use 2
Gait Up GO 2
TABLE OF CONTENT 4
TABLE OF FIGURES 6
INDEX OF TABLES 7
1. SAFETY INFORMATION 8
1.1. WARNINGS 8
1.1.1. WARNINGS RELATED TO THE OPERATING
CONDITIONS OF THE DEVICE 8
1.1.2. WARNINGS RELATED TO THE CONDITIONS AND
AWARENESS OF THE END-USERS 9
1.2. CAUTIONS 10
1.3. CONTRAINDICATIONS FOR GAIT UP GO MEDICAL
DEVICE 11
1.4. ADVERSE REACTIONS 11
2. BEFORE USE 12
2.1. DEFINITIONS 12
2.2 INTENDED USE 12
2.3. INDICATIONS FOR USE 12
2.4. INTENDED USER POPULATION 13
2.4.1. PATIENT RELATIVE 13
2.4.2. MEDICAL PROFESSIONAL 13
2.5. INTENDED END USER POPULATION 14
2.5.1. PATIENTS SUFFERING FROM MOTOR DISORDERS
14
2.5.2. HEALTHY POPULATION 14
2.6. ESSENTIAL PERFORMANCE 14
3. Description 15
3.1. OVERVIEW 15
3.2. DESCRIPTION OF DEVICE COMPONENTS 16
3.3 USER INDICATORS 20
3.3.1 VISUAL USER INDICATORS RELATED TO BATTERY
CHARGING 20
3.3.2 VISUAL AND AUDITORY INDICATORS RELATED TO
THE OPERATION OF THE DEVICE 20
Physilog6 sensor device visual and
auditory indicators 20
Gait Up GO mobile application visual
indicators 21
4. USE 23
4.1. OVERVIEW 23
4.2. INCLUDED TESTS AND THEIR INDICATIONS 24
4.2.1. FUNCTIONAL TESTS 24
Jump tests 24
5 sit-to-stand tests 24
TUG tests 24
4.2.2. BALANCE TESTS 24
4.2.3. WALK TESTS 24
4.2.4. RUNNING TESTS 25
4.3. INSTALLING AND STARTING THE DEVICE 25
4.3.1. INSTALLATION AND LAUNCHING OF THE GAIT
UP GO MOBILE APPLICATION ON ANDROID DEVICES
25
4.3.2. INSTALLATION AND LAUNCHING OF GAIT UP
GO MOBILE APPLICATION ON IOS DEVICES 25
4.3.3. DISCOVER THE PHYSILOG®6 SENSOR DEVICE
26
Charging of the Physilog®6 sensor
device 26
4.3.4 CHECKING SYSTEM COMPONENTS AND THEIR
FUNCTIONALITY 27
4.4 FIRST USE OF THE DEVICE 28
4.4.1 LOGIN CREATION 28
4.4.2 PAIRING PHYSILOG 6 TO THE GAIT UP GO
MOBILE APPLICATION 28
4.5. NORMAL USE OF THE DEVICE 30
4.5.1. LOGIN 30
4.5.2. FORGOT PASSWORD 30
4.5.3. ADD / SELECT / EDIT / DELETE PARTICIPANT
PROFILES 31
Add new participant 32
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Find a Participant in the list 34
Select a Participant 34
Edit a Participant 35
Delete a Participant 36
4.5.4. GENERAL SETTINGS 37
Credits 38
Physilog 38
Account 40
Info 40
4.5.5. SENSOR INFORMATION AND UPDATE 41
4.5.6. PREPARE AN ASSESSMENT SESSION 42
Assign tests 43
Limited admin mode 43
Assessment session screen 44
Preparing the device for Home use by
the participant 45
4.5.7. OPERATING A TEST 46
Preparing the Participant 46
Check Physilog6 sensor connection
and battery level 46
Select the test 46
Sensor attachment 47
Perform the clinical test 49
End of the test with no direct access
to the results 53
End of the test with Limited admin
mode (direct access to the results) 53
4.5.8 GENERATE, MANAGE AND INTERPRET TEST
REPORTS 54
Generate a report using Limited
admin mode (direct access to the
results) 54
Generate and manage reports inside
the password protected part 55
Delete a report 57
Sharing a report 58
Report interpretation 58
4.5.9. REPORT COMPARISON 60
Comparison report interpretation 61
5. CLEANING, MAINTENANCE AND STORAGE 63
5.1. CLEANING 63
5.2. MAINTENANCE 63
5.3. STORING AND TRANSPORTING THE DEVICE 64
5.4. ENVIRONMENTAL CONDITIONS FOR OPERATION. 64
6. TROUBLESHOOTING 65
WHEN AND HOW TO PERFORM A MANUAL RESET OF THE
PHYSILOG6 SENSOR DEVICE ACCESSORY 66
CUSTOMER SUPPORT 67
REPORTING AN ADVERSE EVENT 67
7. WARRANTY 68
8. DISPOSAL 68
Disposal of Gait Up GO medical device (incl.
all its accessories) 69
9. TECHNICAL SPECIFICATIONS 70
9.1. SPECIFICATIONS 70
9.2. SYMBOLS 72
9.3. EMI EMISSIONS 74
9.4. GUIDANCE AND MANUFACTURER’S DECLARATION -
ELECTROMAGNETIC EMISSIONS 74
9.5. GUIDANCE AND MANUFACTURER’S DECLARATION -
ELECTROMAGNETIC IMMUNITY 75
9.6 Recommended separation distances
between portable and mobile RF
communications equipment bas the Gait Up
GO medical device 78
9.7 FCC - Information to user 79
FCC human exposure limits 80
9.8 Product Compliance - IC statement 80
IC statement - English version 80
IC human exposure limits - English
version 81
Déclaration IC - Version Française 81
IC Exposition humaine - Version française
81
9.9 RF exposure compliance - Europe 82
10. ALPHABETICAL INDEX 83
11. LEGAL MANUFACTURER 84
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TABLE OF FIGURES
Fig. 1 16
Fig. 2a 16
Fig. 2b 16
Fig. 3 17
Fig. 4 19
Fig. 5 26
Fig. 6 28
Fig. 7 28
Fig. 8 29
Fig. 9 29
Fig. 10a 30
Fig. 10b 30
Fig. 11 31
Fig. 12 32
Fig. 13 32
Fig. 14 32
Fig. 15 32
Fig. 16 33
Fig. 17 33
Fig. 18 33
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Fig. 47 43
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Fig. 63 49
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Fig. 83 59
Fig. 84 61
Fig. 85 61
Fig. 86 62
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INDEX OF TABLES
Table 1. Definitions 12
Table 2. Gait Up GO components 15
Table 3. Physilog6 sensor components 18
Table 4. Automatic test end criteria 50
Table 5. List of report components and
their description 60
Table 6. List of comparison report
components and their description 62
Table 7. Troubleshooting 66
Table 8. Technical specifications 72
Table 9. Symbols 74
Table 10. EMI emissions 74
Table 11. Electromagnetic emissions 75
Table 12. Electromagnetic immunity 77
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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
Gait Up 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. For repair,
maintenance and replacements, please refer to Gait Up SA customer support. Damaged parts
must be immediately replaced with original parts by the customer service.
●Do not use any external power supply (mobile phone charger) other than those compatible
with the technical specifications listed in section 9 of the present document. 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.
●Do not operate Gait Up GO medical device in an MRI room
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●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
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1.2. Cautions
●Operate and configure Gait Up GO only if you are a qualified medical professional. You must be
able to correctly place the Physilog6 sensor device, choose the suitable test for the Participant
and interpret the output data offered by the reports generated by Gait Up GO mobile
application. The Participants must use the Gait Up GO medical device only under your medical
supervision and responsibility.
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, the customer support must
be contacted.
●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 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 the customer support 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 OS 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.
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●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.
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.
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2. BEFORE USE
Please, refer to section 1. Safety Information
2.1. Definitions
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.
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)
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
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●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.
2.4. Intended user population
The users of Gait Up GO medical device are patient relatives, medical professionals, patients and
healthy individuals.
2.4.1. Patient relative
The role of the patient relative is to help the patient, while using the device at home, with attaching,
starting, stopping, removing and charging the device if the patient is not able to perform them
her/himself (f.ex. young child).
●Prevalent age: +20 years old.
●Prevalent physical condition: No specific physical conditions are needed.
●Minimum education level: none
●Minimum knowledge required: Understand user manual, be able to use a smartphone
or tablet application
●Minimum experience: be able to place the sensor correctly on the end user's body
according to the graphical illustration contained in the instructions
2.4.2. Medical Professional
Medical professionals set-up the Gait Up GO medical device in a suitable environment, choose the
appropriate tests and program the medical device for a specific Participant following its condition.
Moreover, they are in charge of interpreting the data contained in the reports generated by the
medical device. For those activities, the medical professionals use all the components of the Gait Up
GO medical device.
Only medical professionals (i.e qualified physiotherapists, occupational therapists, etc.) must use Gait
Up GO by fully complying with their respective country’s regulations and accident prevention
measures, and strictly following the instructions for use of the device.
●Minimum education level: nurse, physiotherapist, occupational therapist, ergotherapist,
assistant therapist
●Minimum knowledge required: Understand user manual. Therapist degree: knowledge of
clinical protocols. Be able to use a smartphone or tablet application
●Minimum experience: The medical professional should be able to choose meaningful and safe
protocols for the Participant and be able to place the sensor correctly on the end user's body
according to the graphical illustrations shown in the user interface of the mobile application.
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2.5. Intended End user population
2.5.1. Patients suffering from motor disorders
Patients only use the Gait Up GO medical device under the supervision of a medical professional,
perform the tests and protocols set by the rehabilitation professional and use a device pre-configured
by the medical professional at both, clinical and indoor home environments.
●Prevalent age: 2 -99+
●Prevalent physical condition: suffers from movement disorder or disability
●Minimum education level: none
●Minimum knowledge required: understand instructions
●Minimum experience for proper product usage: no minimum experience required.
2.5.2. Healthy population
Healthy population can use the device in order to assess injury risk for prevention in athletes (f.ex
young football players) or to measure indicators of early-stage signs of diseases affecting motor
function (f.ex. Parkinson Disease). Healthy population only use Gait Up GO medical device under the
supervision of a medical professional and use a pre-configured device by the medical professional and
perform the tests and protocols set by the respective medical professional at both, clinical and indoor
home environments.
●Prevalent age: 2 -99+
●Prevalent physical condition: no specific physical conditions are needed.
●Minimum education level: none
●Minimum knowledge required: understand instructions
●Minimum experience for proper product usage: no minimum experience required
2.6. Essential performance
The Gait Up Go medical device does not have any essential performance according to IEC
60601-1:2005+AMD1:2012 CSV.
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3. DESCRIPTION
3.1. Overview
The Gait Up GO medical device components are delivered in a dedicated shipping box.
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 those compatible
with the technical specifications listed in section 9 of the present document. 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
●The minimum system specifications for a phone or a tablet to be used with Gait Up GO medical
device are provided in section 9 of the present document.
Quantity
Component
Article number
1
Instructions for Use
GOIFU
1
Instructions for Use Lay person
GOIFUh
1
Quick start Guide
GOQSG
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
GO
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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
Gait Up GO Mobile Application is a software used to:
●wirelessly communicate with the Physilog6 sensor accessory via BLE
●set and 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
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●generate clinical reports showing the main outcome indicators for the Medical Professionals to
interpret it.
●manage Participant profiles and access generated reports
●update the Firmware of the Physilog6 sensor device accessory
●provide access to the electronic version of the IFU and the quick start guide
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 such as acceleration, orientation and angular velocity, barometric pressure
and direction, strength and relative change of a magnetic field.
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
●Stream 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 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:
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Table 3. Physilog6 sensor components
Component
Function
a) Body of the
device
It includes a moulded non-flammable ABS casing which embeds the electronics
and the battery of the Physilog6 sensor device. The electronics are composed of
a microcontroller with a wireless communication unit that transmits
bidirectional information between the device and the mobile phone/tablet, the
sensors (IMU, magnetometer and barometer), a power management circuitry, a
flash memory, a LED, a button, a beeper, a RF ISM ceramic antenna and a safety
circuitry. The sensor device is powered by an internal LIB battery (lithium-ion
battery), which is IEC 62133:2012 certified.
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 and end-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.
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Fixation clips and belt strap
Made out of Acrylonitrile Butadiene Styrene (ABS) for medical applications, 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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