Digitsole Pro Bedienungsanleitung

1 PS_0001_IFU_000 EN rev 09 of 03-2023

User Manual & Technical

documentation

2 PS_0001_IFU_000 EN rev 09 of 03-2023

Precautions to take before use ................................................................................................................. 5

Intended use ............................................................................................................................................. 6

Contraindication ........................................................................................................................................ 6

Adverse effects .......................................................................................................................................... 6

Product description ............................................................................................................................ 7

Kit contents ............................................................................................................................................... 7

Authorized accessories .............................................................................................................................. 8

Recommended Computer/Phone Specifications ...................................................................................... 9

Functioning of the DSPods LEDs ................................................................................................................ 9

Product Installation .......................................................................................................................... 10

Product operation ................................................................................................................................... 10

Account creation ..................................................................................................................................... 11

Two-factor authentication activation ..................................................................................................... 12

Download the mobile application ........................................................................................................... 13

Use of the mobile application .......................................................................................................... 14

Connection to the application ................................................................................................................. 14

DSPods management .............................................................................................................................. 14

Add DSPods ......................................................................................................................................... 14

Update DSPods .................................................................................................................................... 16

Remove DSPods .................................................................................................................................. 16

Check battery levels ............................................................................................................................ 16

Application settings ................................................................................................................................. 17

Units .................................................................................................................................................... 17

Languages ............................................................................................................................................ 17

Patient management ............................................................................................................................... 17

Add a patient ....................................................................................................................................... 17

Delete a patient ................................................................................................................................... 18

Contact a patient ................................................................................................................................. 18

Search a patient .................................................................................................................................. 18

Start and stop data capture .................................................................................................................... 19

View the data .......................................................................................................................................... 21

Using the web interface ................................................................................................................... 22

Login to the interface .............................................................................................................................. 22

Web interface settings ............................................................................................................................ 23

Units .................................................................................................................................................... 23

Languages ............................................................................................................................................ 23

Notifications ........................................................................................................................................ 23

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Workspace ........................................................................................................................................... 24

Features ............................................................................................................................................... 24

Changes to my account ........................................................................................................................... 25

Information management for health practitioners ............................................................................. 25

Patient management ............................................................................................................................... 25

Add a patient ....................................................................................................................................... 25

Edit a patient ....................................................................................................................................... 26

Delete a patient ................................................................................................................................... 27

Search a patient .................................................................................................................................. 27

Patient’s file ......................................................................................................................................... 28

Acquisition management ........................................................................................................................ 29

Rename an analysis ............................................................................................................................. 29

Delete an analysis ................................................................................................................................ 30

View the analysis ..................................................................................................................................... 31

Generate report ...................................................................................................................................... 33

Export report ....................................................................................................................................... 33

Export a Comparative Report .............................................................................................................. 35

Change the information that appears on the report .......................................................................... 37

Print report .......................................................................................................................................... 37

Compare analyses ................................................................................................................................... 38

Add comments ........................................................................................................................................ 39

See the evolution of the parameters ...................................................................................................... 40

Optional feature ............................................................................................................................... 41

Video Module .......................................................................................................................................... 41

Mobile application .............................................................................................................................. 41

Web interface ...................................................................................................................................... 42

PodoSmart migration .............................................................................................................................. 43

You have a Podosmart account but don’t have a Digitsole Pro account ............................................ 43

You have a Digitsole Pro account and can migrate your Podosmart data .......................................... 43

Maintenance .................................................................................................................................... 46

Charging DSPods ..................................................................................................................................... 46

Cleaning instructions for your device ...................................................................................................... 47

Technical Specifications .......................................................................................................................... 47

Battery ..................................................................................................................................................... 47

Charger .................................................................................................................................................... 47

Radio module .......................................................................................................................................... 48

Usage environment ................................................................................................................................. 48

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Product performance .............................................................................................................................. 48

Detailed performance ......................................................................................................................... 49

Gait parameters .............................................................................................................................. 49

Running parameters ........................................................................................................................ 49

Conditions of shipping and storage ......................................................................................................... 50

Symbols definitions ................................................................................................................................. 51

Regulatory conformity ............................................................................................................................ 52

FCC-FCCID: 2AQ4H-DSI ........................................................................................................................ 52

End of product life ................................................................................................................................... 52

Assistance and help .......................................................................................................................... 53

Help - Troubleshooting ............................................................................................................................ 53

Contact .................................................................................................................................................... 53

CE marking .............................................................................................................................................. 53

5 PS_0001_IFU_000 EN rev 09 of 03-2023

Before you begin:

Before using your Device, please read this manual carefully. It contains the information you will

need to use the device safely.

Precautions to take before use

WARNING:

There is a risk of injury or accident to yourself or others, as specified in this

manual.

CAUTION:

This manual indicates that there is a risk of material damage to this or any other

device.

The Digitsole® Pro solution is not intended to be used as a diagnostic tool. Digitsole® Pro can be used to assist a

healthcare practitioner or any user in completing a clinical evaluation using the data offered by the product. The

healthcare practitioner is responsible for making the diagnosis.

Digitsole® Pro is a device that can be used to examine the walking and running gait of patients aged 7 and older who

have a shoe size of ≥ 30 (EU size = 12-12,5 US Kids). The size of the insole should correspond to the patient's foot size.

With Digitsole® Pro and DSPods, and the insoles, it is mandatory that patients wear clean socks.

Analyses should be carried out on patients who are able to:

• Walk and run (depending on the type of analysis the healthcare provider wishes to perform)

• Understand, follow, and apply simple mobility instructions

Additional modules can complement your use of Digitsole Pro:

• A video module allowing you to capture videos during your analyses with the mobile application,

• A migration module allowing you to recover your analyses previously made with PodoSmart,

However, these optional modules are not part of the medical device scope.

WARNING

• Do not open, puncture, or punch the DSPods.

• Do not attempt to repair the DSPods if they are damaged, do not replace any of its components except by an

authorized service agent - Contact the seller

• Do not throw it in a fire.

• Shoes with a metal plate on the lower part should not be worn.

• Avoid bending or twisting your DSPods.

• If the DSPods have deteriorated, do not use them.

• A wound must not come into direct touch with the insole or DSPod.

• Please contact Digitsole support at [email protected]om if the device produces results that differ from your

observations.

• If the device displays conflicting information or text, clear the browser cache and refresh the page with the F5 key.

• Do not use the DSPods near a magnetic resonance device. *

• Only the supplied or authorized accessories should be used to ensure the performance of the device (safety,

electro-magnetic compatibility, etc.).

• This equipment contains non-replaceable batteries. When the battery is at the end of its life, the equipment must

be disposed of properly.

*The product's safety in a magnetic resonance environment has not been investigated. It has not been tested in the

magnetic resonance environment for undesired movement. The product's safety is unclear in the magnetic resonance

environment. A magnetic resonance exam performed on a person who has this medical device may result in damage

or device malfunction.

6 PS_0001_IFU_000 EN rev 09 of 03-2023

RF Warning

The device has been tested to ensure that it meets general RF exposure criteria. The device can be utilized without

restriction under portable exposure conditions. This device conforms with the RF radiation exposure limitations

established by the EC, FCC, and Industry Canada for the general population (uncontrolled exposure). This device must

not be co-located with any other antenna or transmitter, nor may it be used in conjunction with any other antenna or

transmitter.

You can request a paper copy of this notice by emailing us at [email protected]

Intended use

Digitsole Pro® standard version is a solution for healthcare practitioners that displays objective data based on spatio-

temporal and kinematic patient mobility metrics. Mobility reports provide the following information to healthcare

practitioners:

• A set of biomechanical metrics with a visual comparison to literature standards,

• The digital “gaitline” linked to pressure,

• Basic interpretations of mobility parameters,

• The evolution of mobility parameters as a result of various analyses.

A standardized test can be selected by the healthcare practitioner to focus on the biomechanical factors connected to

the patient's mobility.

The healthcare practitioner will use these reports to conduct a more in-depth medical investigation in order to decide

a diagnosis.

Contraindication

There is no specific medical contraindication; nonetheless, testing should only be undertaken on patients who can:

• Walk and run (depending on the type of analysis the healthcare provider wishes to perform)

• Understand, follow, and apply simple mobility instructions.

Adverse effects

To date, no adverse effects have been identified

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Product description

Health practitioners, paramedics, sports coaches, caregivers, and anyone who is qualified to perform quantified mobility

analyses can use the Digitsole Pro® device (gait and run).

Digitsole® Pro can be used as part of a standard mobility analysis protocol (walking or running) at a patient's session

with their health practitioner, whether or not they have reported mobility issues as a result of various reasons.

Digitsole Pro ® can be used in adults and children over the age of 7, with a shoe size of ≥ 30 (EU size = 12-12,5 US Kids),

and in the following situations:

• Mobility assessment

• Follow-up/monitoring on-site or remotely

• Rehabilitation follow-up

Digitsole Pro® insoles and DSPods can be utilized on several patients.

The Digitsole Pro ® device is intended for usage in a medical professional context. However, the system can be utilized

in other settings (hospital, exterior, interior type house or healthcare structure) to monitor and collect daily mobility

data for patients (adults and children aged 7 and over).

The Digitsole Pro ® system can be used to track people's mobility data and provide warnings to patients, family,

caregivers, health practitioners, and paramedical professionals, as well as to export data analyses from a group of

patients in the form of dashboards that show compiled product data. This information can be downloaded and

organized into a dashboard, which can then be shared with health practitioners, paramedics, sports coaches, family

caregivers, or anyone who is qualified to interpret gait or running parameters.

Kit contents

The Digitsole Pro ® kit comes with a case containing the following items:

• 6 insoles with the following sizes:

o (EU size) 36/37, 38/39, 40/41, 42/43, 44/45 and 46/47

o (US Men size) 4.5/5.5, 6-7, 7.5-8.5, 9-10 and 10.5-11.5

o (US Women size) 5.5/6.5, 7-8, 8.5-9.5, 10-11 and 11.5-12.5

• 2 DSPods (1 right, 1 left)

• 1 DSPods charger kit, consisting of a charger plug and a charger dock

• 1 document indicating where the user manual may be found and how DSPods can be inserted into Digitsole

insoles

• 1 document describing how to use the charger kit

• A strap

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Authorized accessories

Extra pair of DSPods

DSPS001-KIT10

Extra Charger

DSPS001-KIT00

- DSPods charger socket

DSPS001-CAB00

- DSPods charger dock

DSPS001-CAB10

Complete Kit of Digitsole Pro Adult Insoles (7 pairs)

DSPS001-KIT20

- Digitsole Pro Adult Insole Size 30-32

(US 12-1,5)

DSPS001-INS30

- Digitsole Pro Adult Insole Size 33-35

(US 2-4)

DSPS001-INS33

- Digitsole Pro 36-37 insole

(US Men 4.5-5.5 – US Women 5.5-6.5)

DSPS001-INS36

- Digitsole Pro 38-39 insole

(US Men 6-7 – US Women 7-8)

DSPS001-INS38

- Digitsole Pro 40-41 insole

(US Men 7.5-8.5 – US Women 8.5-9.5)

DSPS001-INS40

- Digitsole Pro 42-43 insole

(US Men 9-10 – US Women 10-11)

DSPS001-INS42

- Digitsole Pro 44-45 insole

(US Men 10.5-11.5 – US Women 11.5-12.5)

DSPS001-INS44

- Digitsole Pro 46-47 insole

(US Men 12-13 – US Women 13-14)

DSPS001-INS46

- Digitsole Pro 48-49 insoles

(US Men 13.5-14.5)

DSPS001-INS48

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A pair of Digitsole Pro 30-32 insole

(US 12-1,5)

DSPS001-KIT30

A pair of Digitsole Pro 33-35 insole

(US 2-4)

DSPS001-KIT33

A pair of Digitsole Pro 36-37 insole

(US Men 4.5-5.5 – US Women 5.5-6.5)

DSPS001-KIT36

A pair of Digitsole Pro 38-39 insole

(US Men 6-7 – US Women 7-8)

DSPS001-KIT38

A pair of Digitsole Pro 40-41 insole

(US Men 7.5-8.5 – US Women 8.5-9.5)

DSPS001-KIT40

A pair of Digitsole Pro 42-43 insole

(US Men 9-10 – US Women 10-11)

DSPS001-KIT42

A pair of Digitsole Pro 44-45 insole

(US Men 10.5-11.5 – US Women 11.5-12.5)

DSPS001-KIT44

A pair of Digitsole Pro 46-47 insole

(US Men 12-13 – US Women 13-14)

DSPS001-KIT46

A pair of Digitsole Pro 48-49 insoles

(US Men 13.5-14.5)

DSPS001-KIT48

Kit of 6 pairs of Digitsole Pro spares parts

DSPS001-KIT50

- 3 pairs of Digitsole Pro 30-32 insole

(US 12-1,5)

DSPS001-INS30

- 3 pairs of Digitsole Pro 33-35 insole

(US 2-4)

DSPS001-INS33

Digitsole® Pro Kit

DSPS001-KIT60

Recommended Computer/Phone Specifications

The Digitsole Pro interface is compatible with both PCs and tablets.

The interface: MacOS/IOS - Windows - Android.

Web browser: Mozilla Firefox – Google Chrome – Microsoft Edge.

The Digitsole Pro application is compatible with mobile phones.

OS: Android 6.0+/iOS 15.0+.

Functioning of the DSPods LEDs

• LEDs are red: DSPods are charging.

• LEDs are off:

o DSPods are plugged in, which means they are fully charged.

o DSPods are not charged, which means that they are in standby mode. Simply shake them to bring

them out of this mode.

• LEDs are blinking: DSPods are ready for use.

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Product Installation

Product operation

Insert the DSPods into your insoles as follows:

• Identify left and right DSPods

• Identify the left insole and the right insole

• Place the left DSPod in the left insole and the right DSPod in the right insole.

Please keep in mind that the DSPods must be inserted in the correct direction for the data capture to work

(see image below)

The data acquisition can also be done with the use of DSPods positioned on the bottom of the foot if the positioning of

the DSPods avoids any unexpected slippage*.

*The DSPods must be placed in the modules provided. The assembly should be placed on the top of the foot between the middle cuneiform and the proximal half of the

second metatarsal. The labels of the DSPods should face upwards, with the codpieces facing outwards.

PLEASE NOTE:

Before using the DSPods for the first time, it is necessary to recharge them until the LEDs on them turned off.

DSPod right

DSPod left

Left insole

Right insole