PS_001_IFU_000_EN rev01 of 05-2021
Precautions for use .................................................................................................................................... 4 Intended use .............................................................................................................................................. 5 Contraindication......................................................................................................................................... 5 Undesirable effects .......................
Delete an acquisition ............................................................................................................................... 27 Viewing the data ...................................................................................................................................... 29 Generate a report .................................................................................................................................... 30 Exporting a report ...............................
Before you start: Please read this manual carefully before using your device. It contains the information necessary for safe use of the device Precautions for use WARNING: Means in this manual that there is a danger of injury or accident to yourself or others. CAUTION: Means in this manual that there is a possibility of property damage to this or any other appliance. The PodoSmart® solution is not a diagnostic device.
Intended use PodoSmart® standard version is a solution for healthcare professionals to display objective reports based on spatio-temporal and kinematic parameters related to patient mobility. The mobility reports provide the healthcare professional with: A selection of biomechanical parameters with a visual comparison to literature standards, The digital gaitline related to pressure. Basic interpretations related to mobility parameters, The evolution of mobility parameters through different analyses.
Product description The users of the Podosmart® device can be: health professionals, paramedical professions, sports coaches, caregivers, anyone able to perform quantified mobility analysis (walking and running). Podosmart® can be used as part of a standard mobility analysis protocol (walking or running) during an appointment between a patient and their healthcare professional whether or not they have declared mobility problems as a result of various circumstances.
Authorized accessories Kit of one pair of DSPods DSPS001-KIT10 Charger Kit DSPS001-KIT00 - DSPods Charger Socket DSPS001-CAB00 - DSPods Charger Dock DSPS001-CAB10 Podosmart Case DSPS001-PCK00 Podosmart Insole 30-32 DSPS001-INS30 Podosmart Insoles 33-35 DSPS001-INS33 Podosmart Insole 36-37 DSPS001-INS36 Podosmart Insole 38-39 DSPS001-INS38 Podosmart Insole 40-41 DSPS001-INS40 Podosmart Insole 42-43 DSPS001-INS42 Podosmart Insole 44-45 DSPS001-INS44 Podosmart Insole 46-47 DSPS001-INS4
Recommended computer features The PodoSmart interface works on computers and tablets. Interface: MacOS / IOS - Windows - Android. Internet browser: Mozilla Firefox - Google Chrome - Microsoft Edge. The PodoSmart application works on mobile phones. OS: Android 6.0+ / iOS 13.0+.
Installation of the product Installation of the product To insert the DSPods into your insoles: Identify left and right DSPods DSPods left foot DSPods right foot Identify the left and right soles Left insole Right insole Insert the left DSpod into the left shoe and the right DSPod into the right shoe.
Account creation If you have not yet created a PodoSmart® account, please register via the following link: https://podosmart.app/auth/sign-up Enter the email address and password you would like to use for your PodoSmart® account, accept the data processing agreement after reading it. For security reasons, your password must contain at least eight characters, including at least one number, one lower case letter, one upper case letter and one special character.
Then enter your personal information to complete the creation of your account. Enabling two-factor authentication To add your practice, click on the Your Account tab in the top right-hand corner Then click on Enable dual authentication. Scan the QRCode with your dual authentication application (e.g. Google authentificator) and enter the code in the box provided.
Adding a practice To add your practice, click on the Your Account tab at the top right Then click on Add a practice.
Downloading the mobile app The PodoSmart® app is free and compatible with mobile devices that support iOS 13.0 and Android 6.0. To find out which devices are compatible with the apps, please check the firmware version on your phone. To find the app, type PodoSmart® in the search bar: From the App Store® for iOS devices You will need to use Mozilla Firefox, Google Chrome, Safari and the latest version of Microsoft Edge. Please refer to the page https://www.podosmart.
Using the mobile application Connection to the application To access the application, make sure you have created your account on the web interface beforehand, these are the same credentials that will allow you to log into this application. Enter the email address and password of your account to log in. If you forget your password, go to the PodoSmart® interface to generate a new one.
If you already have DSPods, click on View All in the "My DSPods" section, you will be redirected to the list of your DSPods. Click on Add a pair. A new page will open, scan the Data matrix code located on your pair of DSPods to add it to your account. Repeat the process if you have several pairs of DSPods.
Updating DSPods When you add a new pair of DSPods, a version check of your DSPods is performed. If they need to be updated, you will be asked to do so. Removing DSPods From the main screen of the application, click on View All in the "My DSPods" section, you will then be redirected to the list of your DSPods. Click on the bin icon at the top right of the screen, select the pair(s) you wish to delete and then click on Delete Selected Pairs.
Checking battery levels When the DSPods are charging, it is not possible to view the charge level of your DSPods while they are connected and charging. Go to the DSPods page, to see the charge level of your DSPods. The battery levels of the left and right DSPods appear. You can refresh the battery levels by sliding the screen down.
If you already have patients, click on View All in the "My Patients" section You will then be redirected to your patient list. Click on the + icon at the top right of the screen. A form will open, complete the patient form by filling in at least the Information tab, it contains the mandatory information to create a patient. In the Pathology tab, you can add your patient's pathology(s) and in the Contact tab their address, email address and phone number.
Modify a patient From the list of patients, click on the patient you wish to edit, the patient record will open. Click on the menu at the top right of the screen and select Edit. A form opens, fill in the additional information you wish to enter or modify the information already entered. Click on Validate to save your changes. The patient record will then be updated. Delete a patient From the list of patients, click on the patient you wish to delete, the patient record will open.
Starting and stopping an acquisition 1 - Once your patient has been created and your DSPods 2 - Then select the type of analysis you wish added to your account, go to your patient's file. Click on to perform. the New analysis button. 3 -You can then add additional information about your patient via the menu above. In the Pain tab , you can add the location of your patient's pain and its intensity. In the Footwear Type tab , you can add the stiffness and cushioning of your patient's shoes.
Then select the pair of DSPods with which you are going to perform the acquisition, the application will then initiate a connection to the DSPods and you will be redirected to the screen for starting the analysis. CAUTION: If you have more than one pair of DSPods, be sure to select the DSPods that match those in your patient's insoles. Once the DSPods are in the insoles and the insoles are inserted into the patient's shoes, click the Play button to start the acquisition. Your patient can now walk or run.
Using the web interface Connection to the interface To access the interface, make sure you have created your account on the web interface beforehand, these are the same credentials that will allow you to connect to this application. Log in via the following link: https://podosmart.app/auth/sign-in Enter your account email address and password to log in. If you have forgotten your password, click on Forgotten password, enter your email address in the box provided and click on Send code.
You will then be taken to the login page, enter your address and new password to log into PodoSmart®. Edit my account Health professional information management To change your practitioner information, click on the Your Account tab in the top right corner Then click on the Pen icon to change your practitioner information.
Practice management Add a new practice To add a new practice, click on the Your Account tab at the top right Then click on Add a practice to add a new practice. Delete a practice To delete a practice, click on the Your account tab in the top right corner Then click on the Trash icon to delete a practice. Please note: To delete a practice, it is necessary to have several practices.
Then click on the checkbox next to the practice you wish to use to select it. Please note: In order to change the practice, you need to have more than one practice. Patient management Add a patient Click on the Patients tab, then on New Patient A new window opens in which you can fill in your patient's information, address, how you wish to contact him/her, the reason for consultation and any history or pathology. The mandatory fields are marked with *, they are all located in the "Information" section.
Modify a patient To edit a patient record, click on the Patient tab, then click on the desired patient. To modify the personal information of the patient, his address and the means of contact, click on Edit patient. To modify or add known pathology, reason for consultation and history, depending on the data already filled in, you will have the possibility to click on the pen logos to modify this information or on Add to add new information.
Search for a patient On the Home page, in the top right-hand corner, in the search for a patient section, type the name and/or surname of the patient you are looking for and then click on their name to access their patient file. Delete an acquisition Click on the Patients tab and then on the line of the desired patient. You are now on the patient's file. On the right hand side is the section "Analysis". Next to the acquisition you wish to delete, click on ... and choose Delete Analysis.
A window will open to validate your deletion request. If you click on Delete, the acquisition will be permanently deleted.
Viewing the data Click on the Patients tab and then on the line of the desired patient. You are now on the patient's file. On the right hand side is the section "Analyses". Click on the test you want to access. You are then taken to your patient's data analysis.
Generate a report Exporting a report Click on the Patients tab and then on the line of the desired patient. You are now on the patient's file. On the right hand side is the section "Analyses". Click on the test you want to access. Once the analysis is open, click on the ... at the top right and then click on Export PDF. The analysis export page opens.
Modify the health professional information displayed on the report Once your analysis export is complete, you can: Generate a more advanced report by checking the "Advanced" box Select the desired practice if you have more than one registered practice Display or not your email and/or phone number by clicking on the Eye icons. A crossed out eye means that the parameter will not be displayed on the report, an uncrossed out eye means that the parameter will be displayed on the report.
Compare acquisitions Click on the Patients tab and then on the line of the desired patient. You are now on the patient's file. On the right hand side is the "Analyses" section. Click on the test you wish to compare. Once the analysis is open, click on the ... at the top right and then click on Compare. Then select the analysis you wish to compare it with. Adding comments In the analysis results of an activity, at the very bottom of the results, you can leave a comment in the comment box.
To leave a comment in the report, once it has been exported, you can leave a comment in the appropriate sections. The comments entered here will not be kept in the interface. However, you can keep them by printing the report, sending it by email to the patient and saving it as a PDF.
Maintenance Charging the DSPods Remove the DSPods from the soles and place them on either side of the USB plug charger. Once the two boxes are connected to the USB plug, insert them into the USB plug charger receptacle. To power the unit, plug the receptacle into a USB socket on your computer or into a power supply that meets the medical requirements as defined by IEC 60601-1:2005 (1MOOP) or IEC62368 or IEC 60950. Recharge time is approximately 2.5 hours.
Instructions for cleaning the device Caution: Do not use the insole without a clean sock. You can use disposable socks It is recommended that the following operations be carried out regularly and before the first use: Clean with a disinfectant that meets the following characteristics: Bactericide EN1276*, EN13727, EN13697*, EN14561 (including MRSA). Tuberculocid on Mycobacterium Terrae EN14348* and EN14563*. Fungicide EN14562* (on Aspergillus Fugimatus).
Technical data Battery Battery: Li-Ion Polymer Nominal voltage: 3.7V Charging voltage: 4.2V Life cycle ~ 500 cycles Full charge time: 2h30 Active mode: 1.2 mA Total autonomy in standby mode (without use): 1750 h Charger CAUTION The charging equipment must meet the requirements of IEC60601-1 Input: 100-240V - 50/60Hz Output: 5.0V with an output current greater than 30mA Radio module Frequency band: 2402-2480MHz Max power: 0.
Operating environment CAUTION Observe the environmental conditions for safe use of the device Maximum body pressure 50 kg / cm2 (or 500 n / cm2) Maximum sole load 200 kg Atmospheric pressure Between 70-106Kpa Operating relative humidity (humidity level) 10 ~ 95% Recommended operating temperature of use Between 0°C and 40°C (between 32°F and 140°F) EDZ Product performance 40 60 Product lifetime 2 years Warranty period 2 years Storage life 1 year.
o Speed: Average speed of the linear movement of the body in the path of the run o Cadence: Number of steps taken per minute o Asymmetry: Defined as the ratio of the right (resp. left) foot strike time to the sum of the right and left foot strike times.
Symbol IP54 Description Symbol Description On the packaging, this symbol means "Relative humidity limit". IP54 Device protected against strong water jets On the packaging, this symbol means "Atmospheric pressure limit" during transport and storage. On the packaging: this symbol means "Keep dry", as the package must be protected against moisture and water. On the packaging this symbol means "Temperature limit". Refer to the user's manual before use.
The Declaration of Conformity is available on request from contact@digitsole.com FCC ID: 2AQ4H-ZT004 United States: Federal Communications Commission (FCC) Statement. This device complies with FCC Part 15 rules. Operation is subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation.
Support and help Help - Troubleshooting Full information is available at: https://www.podosmart.tech/fr/customer-support Contact Do you have a question or a suggestion? Do not hesitate to contact us! Contact us at: +33 (0)3 83 36 72 72 contact@digitsole.com If you experience an adverse event directly or indirectly related to the use of the device, please contact us at Vigilance@digitsole.
