Kinesis QTUG User Manual

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User Guide

Health Technologies

QTUG USER GUIDE v1.0

Address: NovaUCD

Belfield Innovation Park

Belfield

Dublin 4, Ireland

Internet address: http://www.kinesis.ie

Email address: info@kinesis.ie

This User Guide introduces you to QTUG (Quantitative Timed Up and Go), and helps you quickly learn how to perform

a mobility assement or a falls risk assessment on a patient. For detailed information about the QTUG application, refer

to the application help-files, which you access through the QTUG Help Menu. The User Guide also contains useful

information about configuring QTUG, transferring data files from the tablet to a PC or microSD card for organizing your

QTUG patient files, and using all of the QTUG features.

Intended Use

QTUG is intended to measure gait and mobility parameters for automated, quantitative gait and mobility assessment

via a Timed Up and Go test, using body-worn inertial sensors.

Indications for Use

QTUG is indicated for use with patients who would benefit from assessment of mobility and falls risk.

Thank you for purchasing QTUG

Please read this user guide throroughly before using QTUG. This guide includes important safety information.

Please keep the user guide for future reference.

Read these safety messages carefully.

This device contains an RF transmitter. It is also an intentional RF receiver and even if other equipment complies with

CISPR emissions requirements, those devices may interfere with the operation of this device.

Radio Information Transmit Characteristics: 2.4GHz Bluetooth radio using GFSK, DQPSK, and 8DPSK modulation and

75kHz bandwidth. Frequency Range in MHz: 2400-2483.5. Output Power in dBm: 5-6.

This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42/EEC

(EN 55011 Class A and EN 60601-1-2).

These limits are designed to provide reasonable protection against harmful interference in a typical medical

installation. The equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in

accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no

guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference

with other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to

correct the interference by one or more of the following measures:

Important Safety Information

WARNING

The use of portable and mobile radio frequency (RF) equipment may have an impact on this and other pieces of medical equipment.

• Reorient or relocate the receiving device.

• Increase the separation between the equipment.

• Connect the equipment into an outlet on a circuit different from that to which the other device(s) is connected.

• Consult the manufacturer for help.

The use of portable and mobile RF equipment may have an impact on this and other pieces of medical equipment.

The use of accessories, cables, or transducers other than those specified in this manual can significantly increase

emissions performance and degrade immunity performance of the product. Also, by using an accessory, transducer,

or cable with the product, other than those specified in this manual, it becomes the responsibility of the third-party

supplier or the user of the product, to determine compliance with the requirements of IEC 60601-1-2 when using this

item.

CAUTION

It is prudent to separate all electrical equipment that is very close in distance to the QTUG system. If it is essential to use the QTUG

system very close to other electrical equipment, it is prudent to determine, by observation, if the performance of either product is

affected by unintended electromagnetic coupling.

WARNING

It is advised not to use equipment other than the following devices listed by manufacturer (Kinesis QTUG sensors with Bluetooth

radio) stacked on or near the product, but if it is required for your location to stack or use equipment that is adjacent to the product, all

must be verified to work and verification shall occur to ensure the product operates properly before conducting any procedures.

WARNING

No modification of this equipment is allowed.

Glossary

Term Definition

Inertial sensor Wireless sensors including tri-axial accelerometer and tri-axial gyroscope daughter board

Timed Up and Go (TUG) test

Standard mobility assessment commonly used to assess mobility and risk of falls.

Longer completion times are thought to indicate higher risk of falling.

Safety instructions in this user guide

Note: contains useful information

Warning/caution: warns of risk of injury, possible material damage, and possible incorrect results

It is recommended to refer to the manual

Contents

1. What’s in the box? 8

2. Getting started with the tablet 9

2.1 Tablet layout 9

2.2 Charging the battery 10

2.3 Turning the tablet on and off 11

2.4 Use of third party applications 11

3. Getting started with the sensor 12

3.1 Sensor layout 12

3.2 Sensor dock layout 13

3.3 Charging the sensor 14

3.4 Turning the sensor on and off 14

3.5 Resetting the sensor 15

4. Set up the QTUG test 16

4.1 QTUG test requirements 16

4.2 Physical set up 17

4.3 Set up QTUG application on the tablet 18

5. Perform the QTUG test 21

6. Interpreting QTUG test results 25

7. Using QTUG test results 26

8. After use 29

9. Troubleshooting 30

10. Parameter definition 31

11. Technical specifications 36

12. Regulatory Information 38

13. Warranty 40

QTUG package includes the following components.

1. What’s in the box?

7” tablet

Power adaptor USB cable

2 wireless

inertial sensors

Sensor dock

Elasticated bandages

Tablet and its accessories Sensor and its accessories Miscellaneous

Measuring tape

Carrying case

Quick Start Guide

Warranty and Safety

Health Technologies

Improving lives through Innovation

QTUG

Quantitative Timed Up and Go

NovaUCD, Belfield Innovation Park, Belfield, Dublin 4, Ireland | www.kinesis.ie, info@kinesis.ie

Health Technologies

QTUG WARRANTY AND SAFETY

Health Technologies

QTUG WARRANTY AND SAFETY

Health Technologies

QTUG QUICK START GUIDE

Health Technologies

QTUG QUICK START GUIDE

1. Chapter

2.1 Tablet layout

2. Getting started with the tablet

HOME button

memory card slot

VOLUME button

POWER button

BACK button

multipurpose jack

MENU button

light sensor

2.2 Charging the battery

When the battery power is low, the tablet emits a warning tone and displays a ‘low battery’ power message.

If the battery is completely discharged, the tablet cannot be turned on immediately when the charger is connected.

Allow a depleted battery to charge for a few minutes before running on the tablet.

Charging with the charger

Connect the large end of the USB cable to the USB power adaptor and then plug the end of the USB cable into the

mulitpurpose jack under the tablet.

Ensure the tablet is charged before performing a QTUG test.

After fully charging, unplug the USB cable from the tablet, and then unplug it from the electric socket.

connect to power adaptor

plug into multipurpose jack

2.3 Turning the tablet on and off

To turn on the tablet, press and hold the POWER button

for a few seconds until you see the Samsung logo. Wait

a moment for the tablet to boot up.

If the tablet’s screen turns off to sleep mode, briefly

press the POWER button or tap once on the screen to

wake it up.

To turn off the tablet, press and hold the POWER

button, and then tap Power off and confirm the shut

down.

2.4 Use of third party applications

The tablet provided should ONLY be used with the

QTUG application. Installing third party applications

on the dedicated tablet may interfere with the correct

operation of the QTUG application.

press and hold

POWER button

The tablet provided is intended to be dedicated for exclusive use with the QTUG application. Installing third party applications onto

the tablet may interfere with the correct operation of QTUG application and interfere with the correct calculation of the results.

Please restrict your use of the tablet to QTUG ONLY.

3.1 Sensor layout

3. Getting started with the sensor

QTUG

BT RADIO ID

Kinesis Health Technologies Ltd.

Model: Shimmer2R w/450mAH Battery

Contains: FCC ID: X2W-SR7-1; T9-RN42

IC: 8838A-SR71; 6514A-RN42

MEDICAL EQUIPMENT INTERMITTENT OPERATION

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND

MECHANICAL HAZARDS ONLY IN ACCORDANCE

WITH UL60601-1, IEC/EC60601, IEC60601-1-2

Made In Ireland 06/14

activity LED

restart pin

charging socket

R indicates the Red sensor attached to the Right leg

L indicates the bLue sensor attached to the Left leg

this side of the sensor facing upwards in orientation

3.2 Sensor dock layout

micro USB power connector

Kinesis Model: QTUG Charger Revision: 1.0.0

Use only supplied power adapter. Approved for use only with Kinesis QTUG system. For indoor use only

RESET button

socket

power LED

charging LED

3.3 Charging the sensor

Place the sensor in the sensor dock, ensuring sensor

socket connected to socket in sensor dock. The power

LED on the sensor dock turns only green when the

sensor is turned on, and when the sensor and the

sensor dock is successfully connected.

The sensor battery is not fully charged while the

charging LED remains orange. If the charging LED turns

off, the sensor battery is fully charged.

The sensor battery should last approximately 5 hours

under normal working conditions.

3.4 Turning the sensor on and off

Turning on and off with the sensor dock

To turn on the sensor, place the sensor in the sensor

dock. If either of the two sensors do not turn on just

reinsert into the dock. The activity LED on the sensor

turns orange. Wait a moment for the sensor to boot up.

When it is ready, the activity LED on the sensor turns

green.

To turn off the sensor, press and hold the RESET

button for a minimum of 7 seconds until the power LED

on the sensor dock turns off.

Charging LED on sensor dock

LED colour Description

Orange Sensor battery is not fully charged.

Off Sensor battery is fully charged.

Power LED on sensor dock

Green

Sensor is successfully connected to the

sensor dock.

Off

Sensor is not turned on and/or is not

connected to the sensor dock.

Activity LED on sensor

LED colour Description

Orange Sensor is turned on and booting up.

Green Sensor is turned on and is ready.

Off Sensor is turned off.

Turning the sensor on and off directly

Use a paper clip or a pen, press the restart pin to turn

on the sensor. The activity LED turns orange. Wait a

moment for the sensor to boot up. When it is ready, the

activity LED turns green.

To turn off the sensor, press and hold the restart pin for

7 seconds until the activity LED turns off.

3.5 Resetting the sensor

Use a paper clip or a pen to reset the sensor. Press

the restart pin once and the activity LED turns orange.

When it is ready, the activity LED turns green.

To reset the sensor with the sensor dock, press the

RESET button once. The activity LED on the sensor

turns orange. When it is ready, the activity LED on the

sensor turns green.

Ensure the sensors are charged before using QTUG.

QTUG

press the restart pin

to turn on or to reset

the sensor

4.1 QTUG test requirements

To perform a QTUG test on a patient, ensure the patient is wearing comfortable walking shoe. You will require the

following to complete a QTUG test:

4. Set up the QTUG test

4m (13’1”) of linear floor space.

One standard chair with seat approx. 46 cm (18”) high and total chair height approx. 65 cm (25.6”) high with arm-rests.

4m / 13’1”

Ensure the chair used for the test is stable (i.e. chair without wheels).

4.2 Physical set up

Position the chair at the start

of the 3m (9’10”) space.

Clearly mark the start and end (turn)

points on the floor placed exactly

3m (9’10”) apart, measured from

patient’s toes when seated.

3m / 9’10”

end (turn) point

start point

Ensure the 3m (9’10”) distance is accurately measured from the chair to the end point.

Incorrectly measured distance may result in incorrectly derived gait and mobility parameters.

4.3 Set up QTUG application on the tablet

Turn on the Red sensor and bLue sensor.

Then turn on the tablet and tap the QTUG

icon to launch the QTUG application.

Tap the HELP button on the action bar to

open a popup window with help information.

Tap the SETTINGS button to change the

patient ID format or measurement units.

SETTINGS button

ABOUT button

HELP button

action bar

Enter DOB, height and weight by tapping the

- and + buttons or the number and entering

manually. Select a gender by tapping the MALE

or FEMALE button. Tap ‘New Test’ to proceed.

Type in a new patient ID to create a new patient

profile and tap the SUBMIT button to proceed to

the patient profile page.

Do not use a patients’ Personally Identifiable

Information (PII) as part of patient ID.

Enter height and weight to nearest cm or ft/inch

and kg or lbs.

If the sensors are not connected yet,

the application will take approx. 5 seconds

to automatically connect to the sensors.

When sensors have connected successfully,

the QTUG test screen will appear.

5. Perform the QTUG test

Ensure the sensors are firmly connected to the patient

to reduce the risk of tripping while walking.

Loosely fitted sensors may result in an invalid test or

adversely affect algorithm operation.

Seat the patient on the chair in

order to explain the test.

Secure the sensors firmly on the shins

(mid-point of the anterior shank) using an

elasticated bandage.

QTUG

Uneven, slippery or otherwise unsuitable underfoot

conditions may affect gait and turning and adversely

affect the mobility assessment.

The sensors must be placed in the correct

orientation with the socket facing down and the

QTUG logo facing out, the Red sensor on the

Right leg and the bLue sensor on the Left leg.

QTUG

user’s point of view

socketsocket

QTUG

When the patient is ready, say ‘Go’ and tap

the START button on the QTUG application.

When START is tapped, the activity LED on the sensor

flashes alternately green-orange in streaming mode.

Failure to use the correct orientation

will result in an incorrect calculation

of mobility parameters and falls risk.

The patient must get up from the chair,

walks 3m (9’10”) to the turning point as

marked on the floor, turn at the turning

point, walk back to the chair and sit down.

3m / 9’10”

The patient has to walk exactly 6m (19’7”). The test is calibrated to give valid results based on accurate measurement of the

3m (19’7”) distance from the chair to the turning point. Incorrectly measured distance may result in incorrectly derived gait

and mobility parameters.

When the patient is reseated, tap the STOP

button to stop recording data. The sensor

data is displayed on the screen.

On the application, tap the ACCEPT button

to confirm that the test is valid (i.e. the patient

performed the test correctly), and to save data.

Tap RETEST if the test is invalid and you wish

to perform test again and discard data, the start

screen is displayed.

An accepted and valid test displays and saves the test results. The definitions

of these results are explained in the table below.

Definition Description

TUG test time Time taken to complete the TUG test.

Falls risk estimate (FRE)

Statistical risk of falls based on a model derived from

community dwelling older adults.

Comparison to ref. data

Comparison of each patients’ mobility (as measured by

QTUG) when compared to average values for the population.

Parameters deemed out of the normal range are shown

here (if no parameters are deemed outside this range, no

parameters are shown here).Al

Detailed results Comprehensive quantitative assessment of mobility.

Inertial sensor data

Graphical representations of left and right shank medio-

lateral angular velocity.

For detailed explanation of the results, read chapter ‘10. Parameter defintion’.

6. Interpreting QTUG test results

Export results from database

The results for all patients can be retrieved as a SQLite database or exported in Excel format. To export results from

database, tap the Export to Excel button in the Settings. The Excel file with the extension *.xls is stored in the ‘My

Files’ / ‘Kinesis’ / ‘Export’ directory.

7. Using QTUG test results

When the results are displayed, options are available to generate a PDF report for an individual test or to export all

patient results from the database.

Generate PDF report

The results for a given test can be exported to a PDF report, which documents the clinical info and QTUG results.

On the results screen, tap the PDF button to generate this report which is stored in the ‘My Files’ / ‘Kinesis’ / ‘Export’

directory of the tablet. In the Export folder, you can find the PDF report with the extension *.pdf.

Backup patients’ data onto a microSD card

To backup the data onto a microSD card, tap the BACKUP button in the Settings. Data can also be retrieved from the

tablet by connecting the tablet to a PC or laptop via the USB cable supplied and browsing to the ‘My Files’ / ‘Kinesis’ /

‘Data’ directory. In the Data folder, you can find the database file with the name qtug.db.

View previous tests

Previous tests from a given patient are listed under the patient profile page for each patient.

Erase patient data from internal storage

Prior to erasing patient data, ensure that data are backed up to a PC or laptop. To erase the data from the internal

storage on the tablet, tap on ‘My Files’ and tick the ‘Kinesis’ folder. On top of the screen, tap on the bin icon and

confirm with ‘Yes’ to delete the ‘Kinesis’ folder. Permanently erased data cannot be recovered.

Erase patient data from microSD card, only if a microSD card is used

To erase the data from the microSD card, tap on ‘My Files’ / ‘extSdCard’ and tick the ‘Kinesis’ folder. On top of the

screen, tap on the bin icon and confirm with ‘Yes’ to delete the ‘Kinesis’ folder.

Sensors

At the end of the assessment, remove the sensors from the elasticated bandages. The sensors can be wiped down

using standard clinical alcohol wipes to reduce risk of infection.

After cleaning, insert the sensors into the sensor dock to be fully charged for the next assessment. Please turn off the

sensors after they are fully charged.

Tabl e t

At the end of the assessment, press the HOME button on the tablet to close the QTUG application. Please turn off the

tablet after use. If the battery power is low, connect the tablet to the USB power adaptor for charging. Before cleaning,

it is essential to remove the connecting USB cable for the tablet from the power inlet socket of the device.

Storage and handling conditions

For safe keeping, place the tablet, sensors and accessories in the designated foam slots in the carry case after use,

cleaning or charging. Store the carry case in a cool, dry location.

8. After use

Ensure no liquids get into the tablet and sensor via the charging socket, otherwise malfunctions may occur. Never immerse the

devices in disinfectant or other liquids; otherwise the tablet and sensor may be damaged, resulting in a hazard to users and patients.

The tablet and sensor must be completely dry before being started up.

9. Troubleshooting

If there are any problems which cannot be rectified immediately, contact Kinesis technical support.

Problem Cause Remedy

The tablet does not turn on The battery is flat Check that tablet is fully charged.

The sensor does not connect The sensor is turned off Check that sensor is switched on.

The sensor does not turn on The battery is flat

Check that sensor is fully charged.

If problem persists, close down the tablet and reboot.

The test keeps failing Sensors are not firmly fastened Ensure sensors are firmly and securely fastened to the patient’s shin.

Sensors are not correctly

positioned

Ensure sensors are oriented correctly with the socket facing down

and the logo facing out, the right sensor on the right leg and the left

sensor on the left leg

10. Parameter definition

Definition of mobility paramters produced by QTUG.

Parameter Description

Falls risk estimate (%) Statistical risk of falling (defined for community dwelling older adults over 60 years of age)

TUG recording time (s) Time to complete TUG test

Temporal gait parameters

Parameter Description

Time taken to stand (s) Time from ‘Go’ to first heel strike or toe-off point

Number of gait cycles Number of gait cycles in total test

Number of steps Number of steps in TUG test

Cadence (steps/min) Average number of steps taken per minute during test

Walk time (s) Time from first to last heel-strike or toe-off point - time patient actually spends in locomotion during TUG test

Average swing time (s)

Average swing time over all gait cycles, averaged across both legs, swing time is defined as the time

between a toe-off point and the heel strike point on the same foot.

Average stance time (s)

Average stance time over all gait cycles, stance time is defined as the time between a heel-strike and toe-

off point on the same foot

Average stride time (s) Time for one stride (time between successive heel-strikes), averaged over all gait cycles

Average step time (s)

Average of times between heel-strike of one foot to heel strike of the opposite foot measured in seconds

(sec)

Average single support (%) Proportion of a gait cycle spent on either foot

Average double suppor t (%) Proportion of a gait cycle spent on both feet

Swing time variability (%) Coefficient of variability in swing time

Stance time variability (%) Coefficient of variability in stance time during TUG test

Stride time variability (%) Coefficient of variability in stride time during TUG test

Step time variability (%) Coefficient of variability in step time during TUG test

Single support variability (%) Coefficient of variability in the proportion of a gait cycle spent on a single foot

Double support variability (%) Coefficient of variability in proportion of a gait cycle spent on both feet

Spatial gait parameters

Parameter Description

Average stride velocity (cm/s) Average walking speed during TUG test

Stride velocity variability (%) Variation in walking speed during TUG test

Average stride length (cm) Average stride length during TUG test

Stride length variability (%) Coefficient of variability in stride length over TUG test

Turn parameters

Parameter Description

Pre-turn time (s) Time from ‘go’ to median gait event of TUG test

Post-turn time (s) Time from median gait event of TUG to end of test

Ratio of pre-turn to post-turn

times

Ratio of Time from ‘go’ to median gait event of TUG to Time from median event of TUG to end of test

Time taken to turn (s) Time taken to turn

Number of strides in turn Number of steps in turn

Turn steps/time ratio Ratio of the number of steps taken to turn to the time taken to turn

Angular velocity parameters

Parameter Description

Forward rotation speed at turn

time (deg/s)

Angular velocity in sagittal plane at median gait event of TUG test

Range of peak forward rotation

speed (deg/s)

Range of angular velocity in the sagittal plane at mid-swing over entire walk

Average peak forward rotation

speed (deg/s)

Average angular velocity in the sagittal plane at mid-swing over entire walk

Minimum side-to-side rotation

speed (deg/s)

Minimum angular velocity in the side-to-side direction during the assessment

Maximum side-to-side rotation

speed (deg/s)

Maximum angular velocity in the side-to-side direction during the assessment

Average side-to-side rotation

speed (deg/s)

Average angular velocity in the side-to-side direction during the assessment

Minimum for ward rotation speed

(deg/s)

Minimum for ward angular velocity in the sagittal plane during the assessment

Maximum forward rotation speed

(deg/s)

Maximum forward angular velocity during the assessment

Average forward rotation speed

(deg/s)

Average forward angular velocity during the assessment

Variation in for ward rotation

speed (%)

Coefficient of variation in forward angular velocity during the assessment

Variation in side-to-side rotation

speed (%)

Coefficient of variation in angular velocity in the side-to-side direction during the assessment

Minimum horizontal rotation

speed (deg/s)

Minimum angular velocity in the transverse plane during the assessment

Maximum horizontal rotation

speed (deg/s)

Maximum angular velocity in the transverse plane during the assessment

Average horizontal rotation

speed (deg/s)

Average angular velocity in the transverse plane during the assessment

Variation in horizontal rotation

speed (%)

Coefficient of variation in angular velocity in the transverse plane during the assessment

Angular velocity x Height parameters

Parameter Description

Minimum for ward rotation speed

x Height (deg.m/s)

Related to average velocity of shank in forward direction

Maximum forward rotation speed

x Height (deg.m/s)

Related to maximum linear velocity of shank in forward direction

Average forward rotation speed x

Height (deg.m/s)

Related to minimum linear velocity of shank in forward direction

Minimum side-to-side rotation

speed x Height (deg.m/s)

Related to minimum linear velocity of shank in side-to-side direction

Maximum side-to-side rotation

speed x Height (deg.m/s)

Related to maximum linear velocity of shank in side-to-side direction

Average side-to-side rotation

speed x Height (deg.m/s)

Related to average linear velocity of shank in side-to-side direction

Minimum horizontal rotation

speed x Height (deg.m/s)

Related to minimum linear velocity of shank in vertical direction

Maximum horizontal rotation

speed x Height (deg.m/s)

Related to maximum linear velocity of shank in vertical direction

Average horizontal rotation

speed x (deg.m/s)

Related to average linear velocity of shank in vertical direction

Specifications

Model Shimmer2R w/450mAH Battery

Power supply Input 100 - 240V AC 50-60Hz

Output 7.5 VDC 15W nominal, 1.7A Max

Current consumption 700mA (7.5V input)

Weight < 700 grams (1.4 pound)

Operating Conditions +5 ˚C – +40 ˚C (20% – 95% Relative Humidity)

Storage/Transport Conditions -20 ˚C – +60 ˚C (20% – 95% Relative Humidity)

Bluetooth Radio Transmit Band 2.4Ghz

Modulation GFSK, DQPSK, and 8DPSK

Frequency Range 2400MHz – 2483.5MHz

Output Power Min: 5 dBm; Typical: 6 dBm; Max: 6 dBm

Bluetooth Radio Receiver Bandwidth 75kHz

Frequency Range 2400MHz – 2483.5MHz

IP Rating None

11. Technical specifications

Sterility The device is not sterile

Re-use The device can be reused

Essential performance The device has no essential performance

Expected service life 3 years, dependent on battery usage

User maintainable parts None

Symbols on QTUG label

This device is authorized under part 18 of the

Declaration of Conformity.

This radio device belongs to Class 2 for which restrictions or bans

apply regarding its placing on the market or putting into service.

This device fulfils the provisions of EC directive

93/42/EEC (EN 55011 Class A and EN 60601-1-2).

This device contains an RF transmitter and an intentional RF

receiver. Interference may occur in the vicinity of equipment.

Correct disposal of this product (Waste Electrical & Electronic Equipment)

This marking shown on the product, accessories or literature indicates that it should not be disposed of,

with other household wastes at the end of its working life. To prevent possible harm to the environment

or human health from uncontrolled waste disposal, please seperate these items other types of waste

and recycle them responsibly to promote the sustainable reuse of material resources.

Users should contact their supplier and check the terms and conditions of the purchase contract. This

product and its electronic accessories should not be mixed with other commercial wastes for disposal.

This product does not contain any hazardous substances.

12. Regulatory Information

Declaration of Conformity

The Kinesis Health Technologies QTUG product meets the relevant medical device regulations in EU and all other geographies in which it is

made available for sale. As the legal manufacturer, Kinesis Health Technologies (and its distributors) shall comply will all applicable laws and

regulations relating to medical devices, specifically the Medical Device Directive 93/42/EEC (‘MDD’) as it pertains to a Class I medical device

(without a measurement function). In the United States, QTUG meets the Quality System Regulations (‘QSR’), specifically the FDA 21 CFR part

820 for a class I medical device (exempt from 501(k) regulation).

Restrictions on Use of QTUG

THE KINESIS QTUG PRODUCT IS NOT INTENDED, DESIGNED OR AUTHORIZED FOR CONTINUOUS COMMUNICATION OF REAL TIME

DATA. THE SOFTWARE IS NOT INTENDED, DESIGNED OR AUTHORIZED FOR PROVIDING TIME-CRITICAL MEDICAL CARE, PROVIDING

MEDICAL OR OTHER EMERGENCY RESPONSE ALERTS OR ANY OTHER ANY APPLICATIONS OUTSIDE THE INTENDED USE SPECIFIED

IN THE USER GUIDE, OR FOR USE IN ANY CIRCUMSTANCE IN WHICH THE FAILURE OF QTUG WOULD PRESENT AN UNREASONABLE

RISK OF ILLNESS OR INJURY TO THE USER.

Medical Device Regulatory Compliance

QTUG is intended to measure gait and mobility parameters for automated, quantitative gait and mobility assessment during the Timed Up and Go

test, using body-worn inertial sensors. QTUG is indicated for use with patients who would benefit from assessment of mobility and falls risk.

In purchasing QTUG, the customer acknowledges and understands that the software is registered as a medical device under the Medical

Device Directive and that Kinesis may not put products ‘on sale’ without first certifying to CE conformance. Similarly, for the US, the customer

acknowledges and understands that the software is registered as a medical device under the Quality System Regulations. For such products,

the purchase and subsequent use or resale by the customer must be with Kinesis express permission and in accordance with relevant medical

device regulations.

Kinesis (or where appropriate, its local distributors) shall act as the complaint handling point of contact for any complaints relating to QTUG.

Complaints shall be defined in accordance with the MDD.

Any complaints should be provided in English and in writing to Kinesis (or where appropriate, its local distributors). Complaints submitted shall be

handled in accordance with complaint handling processes mandated by the MDD.

Representations and Warranties

Kinesis and its Distributors warrant that QTUG, when used in compliance with the documentation complies with the essential requirements of the

MDD. Kinesis will perform its obligations in compliance with all applicable laws and regulations.

By purchasing QTUG, the customer acknowledges that:

• it has been informed by Kinesis and is aware and understands that QTUG, specifically the Software, is a Medical Device within the meaning

of the Section 2(a) of Article 1 of the MDD and further that the customer is responsible for informing its customers that QTUG is a Medical

Device.

• the customer shall not in any way alter, modify, repair, attempt to repair or replace the Hardware or Software or relevant labelling except as

otherwise permitted by Kinesis in writing.

12 Months Warranty

This warranty covers the QTUG sensors, tablet and software and accessories (together referred to as the ‘Product’) supplied by Kinesis Health

technologies. Subject to the warranty conditions below, Kinesis warrants to the original end customer purchasing the Product (‘you’) that,

for a period of 12 months from the original date of the purchase of the Product by you, the Product will be free from defects in materials and

workmanship.

If during the period of the warranty this Product proves defective under normal use and service, you must notify Kinesis or local distributor of

the defect in the Product within 12 months of the date of the purchase of the Product by you and you must return the Product to Kinesis or local

distributor within 30 days of notifying Kinesis or local distributor of that defect. If, having inspected the Product, Kinesis accepts the Product is

defective, Kinesis will (in its sole discretion) either repair or replace the par t causing the defect or replace the Product without charge.

Warranty Conditions

• This warranty does not cover the Product if it has been resold or used for rental purposes.

• This warranty does not cover defects in the Product that are caused by accidental damage, your and/or any third party’s negligence or

unreasonable use, use with products not supplied by Kinesis, use of Product otherwise than in accordance with Kinesis’s QTUG User Guide

or any other instructions provided with the Product, or any other cause unrelated to defects in material and workmanship.

• This warranty does not cover the Product if it has been modified or repaired by any person other than Kinesis.

• Repair or replacement under the terms of this warranty does not give right to extension to or a new starting of the period of warranty.

• This warranty does not cover the following:

» Periodic checks, maintenance, repair and replacement of parts due to normal wear and tear.

» Upgrading of software.

» The product has been used in conjunction with accessories and/or software not approved by Kinesis for use with this Product

» Accidents, Acts of God or any cause beyond the control of Kinesis caused by but not limited to lightning, water, fire, public disturbances

and improper ventilation.

» Un-authorised modifications or repairs to the Product.

13. Warranty

QTUG

Kinesis QTUG User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual