Impeto Medical SUDOSCAN User Manual
  1. Manuals
  2. Brands
  3. Impeto Medical Manuals
  4. Medical Equipment
  5. SUDOSCAN
  6. User manual

Impeto Medical SUDOSCAN User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

User guide
Version 3
13/01/2017
1

Advertisement

Table of Contents
loading

Related Manuals for Impeto Medical SUDOSCAN

Summary of Contents for Impeto Medical SUDOSCAN

  • Page 1 User guide Version 3 13/01/2017...

  • Page 2: Table Of Contents

    ABLE OF CONTENTS ................... 5 NTRODUCTION ..........................5 ATENT ............................5 ..........................5 RINCIPLE ........................5 NSTALLATION ................6 OWER UP THE SYSTEM ....................7 OME PAGE ..................7 IST OF AVAILABLE FUNCTIONALITIES ......................7 SER NOT LOGGED IN ......................8 OR A LOGGED IN ....................9 OG IN PAGE .........................9 IST OF CONTROLS...
  • Page 3 7.1.1 ...................... 34 THER CONTROLS & ................... 35 ATIENT SETUP START A SCAN ......................37 URING THE SCAN ................39 ATIENT ISTORY PAGE ......................39 IST OF CONTROLS 8.1.1 ...................... 39 THER CONTROLS ) ................40 ELECTION OF PATIENT AND EXAM ................
  • Page 4 18 P ........63 RECAUTION OF USE AND TECHNICAL SPECIFICATIONS ..................... 76 ONTACTS...

  • Page 5: Introduction

    Carefully follow instructions in the corresponding manual to ensure correct installation. Complete installation should take no more than 15-20 minutes. NOTE Impeto Medical is able to provide a printed version of this user guide within 7 business days following the receipt of the request.

  • Page 6: Power Up The System

    2 Power up the system Open the hinged cover located below the screen at the front of the Master Unit. Inside on the right there are 2 USB ports and power button. Press and release the power button to power on. Power button Front...

  • Page 7: Home Page

    3 Home page 3.1 List of available functionalities Please note that a summary of all functions is in the “How to” section on (ref. p61). 3.2 For User not logged in Figure 1 : Home page – no user logged in Click on the Log in button.

  • Page 8: For A Logged In User

    3.3 For a logged in User Figure 2 : Home page –user logged in Click on Log out to log out the current user. Click on Quality Check to launch the system “Quality check” (ref. p13). Click on Shut down to shut down the system. Click on User manual to display the electronic version of the user manual.

  • Page 9: Log In Page

    4 Log in page 4.1 List of controls Home button Help button Figure 3 : Log in page Select the physician in the Physician list. Enter your password in the Password field using the on-screen keyboard. The initial password is provided by your system supervisor. Default password: impeto. Click on Log in button to validate the current password for the selected physician (ref.

  • Page 10: Password Validation

    4.2 Password validation When the password is correct, the following message appears and the application automatically proceeds to the home screen (ref. p8): When the password is not correct, the following message appears and the user has to log in again (ref. p9):...

  • Page 11: Password Modification

    4.3 Password modification Enter your current password in the Current password field. Click Change password to show the new password fields. Fill the two new password fields with the same new password then click on Save password. Figure 4 : Log in page – new password fields displayed When the button Save password is clicked, a check is performed on the different passwords.
  • Page 12 If the new passwords are not identical, the following message appears: If the old password is correct and the new passwords are identical, the following message appears and you are automatically logged in.

  • Page 13: Quality Check Page

    5 Quality check page 5.1 Overview The Quality Check allows the operator to test the internal electronic circuitry of the system. 5.2 List of controls Electrode test buttons Operator name field Home button Help button Figure 5 : Quality Check page – empty Click on the hands (left) and feet (right) Electrode test buttons to check the connectivity with the electrodes.

  • Page 14: During A Quality Check Test

    5.3 During a Quality Check test Figure 6: Quality Check page -During the Quality Check Click on the Cancel test button to stop the Quality Check test. NOTE: It may take up to several minutes for the test to cancel.

  • Page 15: Quality Check Result Interpretation

    5.4 Quality Check result interpretation When the Quality Check is complete and no error occurred, green checkmarks are displayed for every lines as follows: Figure 7: Quality Check page - Complete and valid Quality check If a problem occurs during the Quality Check, some warning icons appear in place of the green checks. In that case, please contact Impeto technical support (ref.
  • Page 16 Problem observed during the test. Figure 8 : Quality Check page -Complete and invalid Quality check Click on the Print button to print or export the Quality Check report. Click on the More details button to display more information regarding to the Quality Check results.

  • Page 17: To Have More Details On The Quality Check Results

    5.5 To have more details on the Quality Check results When an error occurred during the execution of a Quality Check, you can display more information by clicking on the More Details button to know the error source. Figure 9: Quality Check page -More details on the Quality check results Click on the X at the top right corner to close the window.

  • Page 18: Tools & Settings Page(S)

    6 Tools & Settings page(s) 6.1 Standard user – List of controls If you are logged in as Supervisor, please see p20. Physician Hospital data data Help Home button button Figure 10 : Configuration page Enter hospital information in the hospital data fields. Enter the physician information in the physician data field Select the printer from the dropdown list of installed printers (ref.

  • Page 19: Standard Users - Configuration (2) Tab

    6.2 Standard users – Configuration (2) tab Figure 11: Standard users - Additional settings Change your password using the Password management settings. Change your print settings:  Check “Direct print” to display results and automatically print physician and patient reports after a successful scan. (Preferred setting) ...

  • Page 20: Supervisor Users - Additional List Of Controls

    6.3 Supervisor users – Additional list of controls All settings that are available for standard users are also manageable by a supervisor. Change the physician Languages selection Home Help button button Figure 12: Configuration page - Additional controls for supervisor Select the physician you want to modify the settings of.

  • Page 21: Supervisor Users - Configuration (2) Tab

    6.4 Supervisor users – Configuration (2) tab Home Help button button Figure 13 : Supervisor users - Configuration (2) page Select the physician whose settings will be modified. Set the password for the selected physician and click on “Save Password”. Select the time delay before the system locks itself and the physician is logged out the application.

  • Page 22: Other Controls

    Change the report settings for the selected physician:  Activate or deactivate the duplication of comments on both reports.  Activate or deactivate the display of reports for the previous exams (when existing) Select the date format to apply for the selected physician. Default mode is DD/MM/YYYY.

  • Page 23: Supervisor Users - Additional Services

    6.5 Supervisor users – Additional services Exam list Patient list Modify button Home Help button button Figure 14 : Services page - Additional supervisor services Select the physician whose settings will be modified. Click on Import button to import data for the selected physician (ref. p26). Select patients from the list.

  • Page 24: Other Controls

    6.5.1 Other controls Click on Configuration tab to access to the standard user settings (ref. p20). Click on Configuration (2) tab to access to supervisor settings (ref. p21). Click on Interpretation messages to modify messages that appear as interpretation on the Results screen and on the reports.

  • Page 25: Supervisor Users - Interpretation Messages

    6.6 Supervisor users – Interpretation messages When the option to display Interpretation messages is checked (option “Auto conclusion” from supervisor settings ref. p21), a message is displayed on the results screen and within reports regarding to the exam results. Supervisor users can modify the content of these messages for each user. Figure 15: Modify Interpretation messages Select the physician whose settings will be modified.

  • Page 26: Import Data For A Selected Physician

    Click on Import button. A popup window appear to precise the type of data you want to import: You can select several type of data:  Import DB files: these are the raw data on older Impeto Medical systems (2.xx version).  Import Raw files: these are the raw data on Impeto Medical systems since 3.1 version.
  • Page 27 Verify that the USB key is correctly plugged into the system and select if you want to import files or a complete folder: Click OK and select files to import: The files are imported.
  • Page 28 The import is complete. The list of patients is updated with the new data.

  • Page 29: Export Data On Ausb Key For A Selected Physician

    6.8 Export data on a USB key for a selected physician Insert a virus free USB key containing enough free space (100 scans ~ 25MB). Select patient(s), exam(s) (ref. p23) and click on Export button. A popup window appears to precise the type of data you want to export: You can select several type of data: ...
  • Page 30 Click OK and verify that the USB key is correctly plugged into the system: Click OK and the files are exported: The export is complete. NOTE When the export is complete, the data are on the USB key. For the RAW files export, when a file is missing, a file (MissingFiles.txt) is created on the USB key and contains the list of missing files.

  • Page 31: Patient Reconciliation & Patient Demographic Data Modification

    6.9 Patient reconciliation & Patient demographic data modification This feature is also available for standard users when it has been enabled by a supervisor (option “Enable patient modification”, ref. p21). Select one or several patients (ref. p23) and click on the Modify button. When only one patient is selected, a popup window is displayed to modify demographic data of the selected patient (name, first name, date of birth and patient ID):...
  • Page 32 When several patients are selected, a popup window is displayed to gather several patients under one: Select the patients to gather from the list on the left, and the referent patient from the list on the right:...
  • Page 33 Click on Ok to validate, and all the data for the patients to gather will be combined and updated with demographic data from the referent patient. The list of patient is then updated on the Services screen.

  • Page 34: Scan

    7 Scan pages When a patient does not exist already on the system, select New Patient button on the Home screen (ref. p7) and fill in demographic data for the patient. 7.1 List of controls Additional scores to compute Home Help button button...

  • Page 35: Patient Setup & Start A Scan

    7.2 Patient setup & start a scan 1 Set the patient’s demographic information. Enter data by clicking on the corresponding text boxes, which will make the on-screen keyboard appear: Last Name and/or Patient ID (IDENTITY CODE) First name Age or Date of birth (10 to 109 years). This option can be modified by a supervisor (ref.
  • Page 36 3 If all required fields have not been entered and the Scan button is selected, then any missing fields will be highlighted in red. Figure 17: Scan page - Highlighting of empty required fields 4 Click on the Scan button to start the scan (ref. p34). WARNING THE PATIENT MUST NOT TOUCH THE MASTER UNIT.

  • Page 37: During The Scan

    7.3 During the scan 1 The application displays a video and a progress bar during the scan. NOTE A calibration is performed at the beginning of each scan. The patient is requested to remain still during the scan. Figure 18: Acquisition 2 If hand or foot contact on the sensor plates is lost during the calibration, then an error message will appear on the screen.
  • Page 38 3 The scan can be cancelled at any time by selecting the Stop scan button. 4 Scan completion is confirmed by a double-bell sound (unless muted).  Upon successful completion of the scan, the scan number (#) will increase by 1. The result page is displayed once the scan successfully ends (ref.

  • Page 39: Patient History Page

    8 Patient History page To retrieve data for exams and patients, click on the Patient History button from the Home screen (ref. p39). 8.1 List of controls Filter on last name/first name/date of birth/PID Exam list Patient list Modify button Help Home button...

  • Page 40: Selection Of Patient(S) And Exam(S)

    8.2 Selection of patient(s) and exam(s) To select a patient or an exam, select the corresponding checkbox. Use the filter to sort through the patient list by last name, first name, year of birth or patient ID. Select the patients from the patient list.
  • Page 41 Use the date filter to display exams for a period of time The previously selected patients are separated in two categories based on whether or not they have exams corresponding to the date filter (“Filtered patients” or “Selected patients”). Then, the exam list is updated according to the date filter.

  • Page 42: How To Start A New Scan For A Patient

    8.3 How to start a new scan for a patient Select a patient (only one) and click on the New scan button (ref. p34): One patient is selected Figure 20: Start a new scan for an existing patient 8.4 How to display results for a single exam Select a patient and an exam from the exam list and click on the Scan results button (ref.

  • Page 43: How To Display Follow-Up For A Patient

    8.5 How to display follow-up for a patient Select several exams for one patient and click on the Follow-up button: Several exams selected (for one patient) Patient follow-up is displayed when at least 2 exams are selected for the same patient. The device can display up to 15 exams.
  • Page 44 The follow-up screen is displayed. The top graph shows the progression of conductances. It is possible to display the evolution of individual hand and foot (left and right) conductances as well as mean conductances. The bottom graph shows asymmetry (hands and feet) and Body Mass Index (BMI). The user is able to modify which graphs are depicted by selecting the checkboxes on the right.

  • Page 45: How To Export Data

    8.6 How to export data Select patient(s) and exam(s) and click on the Export button: Select an option:...
  • Page 46 The different options are:  Print reports: Select the type(s) of reports to print e.g. physician and/or patient reports. Then, the reports for the selected exams will be printed if a printer was selected from the settings.  Export the reports to a USB key: Export different reports (physician, patient and/or follow-up) for the selected exams to an external USB key.
  • Page 47 The export is complete. NOTE When the export is complete, the data are on the USB key. For the reports export, when a file is missing, a file (MissingFiles.txt) is created on the USB key and contains the list of missing files. IMPORTANT We strongly recommend to back up your data on a regularly basis.

  • Page 48: Result Page

    9 Result page 9.1 List of controls Interpretation message Home Go back Quality of measure button button indication Help button Figure 22: Patient results page Click on the Patient Results tab to view the on-screen results. When available, click on Previous Physician report tab to visualize the last generated report for the selected patient.

  • Page 49: Results

    9.2 Results The SUDOSCAN device immediately populates results after a scan. The measured conductances are displayed on the screen. Test results provide a measure of Galvanic Skin Response for each extremity, and a measure of sudomotor function. Results are expressed as skin conductances measured in micro Siemens (����).
  • Page 50 During the scan, if the patient is either grounded (touched during the scan), or if an internal issue occurs, the following message will appear: After selecting the Re-Scan button, the current scan will be cancelled. The user will return to the scan page to start a new scan.

  • Page 51: Quick Interpretation Of The Results

    9.3 Quick interpretation of the results 9.3.1 Disclaimer Information for user regarding Autonomic Function Testing: Indications for use and utilization guidelines are provided as suggestions only. Physicians should ensure that the billing and coding complies not only with carrier guidelines, but also with applicable laws, rules and regulations. It is incumbent upon the physician to determine the medical necessity and utilization for any test on individual patients.

  • Page 52: Patient With High Sudomotor Dysfunction

    9.3.4 Patient with high sudomotor dysfunction The patient has very low skin conductances on the hands and feet. This suggests advanced sudomotor dysfunction.

  • Page 53: Physician And Patient Report Screens

    10 Physician and Patient Report screens 10.1 Physician report Home Help button button Figure 23 : Physician Report page Click on the Patient Report tab to view the patient version of the report. Click on the Patient Results tab to view the results (ref. p48). Navigate in the report ( buttons) Click on the Print button to physically print the report.

  • Page 54: Patient Report

    10.2 Patient report Home button Help button Figure 24: Patient Report page Click on the Physician Report tab to view the physician version of the report. Click on the Patient Results tab to view the results (ref. p48). Navigate in the report ( buttons) Click on the Print button to physically print the report.

  • Page 55: Add Comments On Physician And/Or Patient Reports

    10.3 Add comments on physician and/or patient reports While the user is visualizing the report, it is possible to add comments and select medication from a list. comments Select medication Figure 25: Add comments on reports Add comments for the selected report (physician or patient). Select medications from the list or add medication using the Other field.

  • Page 56: Cleaning The Sensor Plates

    11 Cleaning the sensor plates IMPORTANT Immediately after each scan, it is important to clean all sensor plates with the manufacturer approved cleaning solution. This will not only disinfect but also neutralize the electrochemical reactions which have taken place on the sensor plates during the scan.

  • Page 57: Replace The Electrodes

    12 Replace the electrodes When the sensor plates have to be replaced, please follow these instructions to unplug the old sensor plates and plug the new ones: Open the back cover by loosening the screws. Unscrew the sensor plates’ cable retention bracket, if installed. Grab the larger part of each plug and gently pull it backwards.

  • Page 58: Printer Drivers Installation

    13 USB printer drivers installation To install USB Printer drivers, you must be logged in as a Supervisor. In Tools & Settings, access the Windows Desktop (ref. p62). Ensure your USB key is free of viruses. IMPORTANT DOUBLE CHECK ON ANOTHER COMPUTER THAT THE USB KEY IS FREE OF ANY VIRUS. Insert a USB key with the appropriate printer drivers.

  • Page 59: Install Software Updates

    14 Install software updates Impeto Medical will occasionally provide software updates to ensure continuous enhancement of SUDOSCAN products. Check with your distributor or contact Impeto Medical to learn how to access updates online. When an update is available, Impeto Medical will provide adequate procedure alog with the software update release.

  • Page 60: Annexes

    16 Annexes 16.1 Import a patient list via a CSV file The template to follow for the CSV file is the following: 16.1.1 Required data Name Firstname DayOfBirth MonthOfBirth YearOfBirth 16.1.2 Optional data Gender...

  • Page 61: How To

    17 How to 17.1 For a standard user Power up the system Shutdown or turn off the system Troubleshoot the system User Log in / Log off Home page Log in page Test the system hardware (via Quality Check): Home page Quality check page Quick start a scan via entering demographical patient data: Home page...

  • Page 62: For A Supervisor User Only

    17.2 For a supervisor user only Access to the desktop: Home page Supervisor users – Additional list of controls Install an USB printer: Home page Supervisor users – Additional list of controls USB printer drivers installation Upgrade the application software Home page Supervisor users –...
  • Page 63 Precautions of use and maintenance Transport If it is necessary to pack, to transport or deliver SUDOSCAN after its use, it is recommended to arrange all its elements in their housing and position of origin.
  • Page 64 The SUDOSCAN device does not comprise any accumulator. Recycling At the end of its lifetime, the SUDOSCAN device must be returned to Impeto Medical’s authorized distributor, which will return it to Impeto Medical, in order to ensure the recycling of certain components.
  • Page 65 All the technical documents (component part lists, descriptions, calibration instructions) are kept by Impeto Medical. The warranty is null and void if the SUDOSCAN device was opened and repaired by any unauthorized person. Warranty will hold only against manufacturing defects and certainly not for any mechanical damage due to mishandlings or misuse.
  • Page 66 Indicates the manufacturer catalogue reference Indicates the manufacturer lot code Indicates the serial number Tells the user the need to consult the instructions for use The product must be disposed in an appropriate structure for recovery and recycling RoHS Restriction of Hazardous Substances directive (Directive 2011/65/UE)
  • Page 67 The following pictograms are affixed on the case: Handle with care Fragile Keep dry Indoor use only Keep upright Recyclable Indicates the temperature limit that the medical device can be safely exposed Indicates the range of moisture that the medical device can be safely exposed...
  • Page 68 USE ONLY THE ORIGINAL SENSOR PLATES PROVIDED BY IMPETO MEDICAL. Impeto Medical cannot guarantee the results of measurements carried out with sensor plates issued from other manufacturers. When it is not in use, the SUDOSCAN device can be stored without disconnecting the sensor plate cables. WARNING THE MAXIMUM WEIGHT ACCEPTED BY THE SENSOR PLATES IS 199KG OR 438LBS.
  • Page 69 Contra-indications WARNING The repeated use of the SUDOSCAN device does not create any side effect. However, it is advised not to proceed with measurements on the following patients: - People with any open or bleeding wounds that would come into contact with the surface of the...
  • Page 70 The SUDOSCAN device is capable of measuring galvanic skin responses and is designed for the medical professional. The SUDOSCAN device is a class IIa medical device (according to the EEC directive 93/42) and a class II medical device (according to FDA 21CFR 882.1540).
  • Page 71 Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions The SUDOSCAN device is intended for use in the electromagnetic environment specified below. The customer or the user of SUDOSCAN should ensure that it is used in such an electromagnetic environment.
  • Page 72 Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity SUDOSCAN is intended for use in the electromagnetic environment specified below. The customer or the user of the SUDOSCAN should ensure that it is used in such an electromagnetic environment. Immunity...
  • Page 73 Table 3 - for ME equipment and ME systems that are not life-supporting Guidance and manufacturer’s declaration – electromagnetic immunity The SUDOSCAN is intended for use in the electromagnetic environment specified below. The customer or the user of the SUDOSCAN should ensure that it is used in such an electromagnetic environment.
  • Page 74 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SUDOSCAN is used exceeds the applicable RF compliance level above, the SUDOSCAN should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SUDOSCAN.
  • Page 75 Recommended separation distances between portable and mobile RF communications equipment and the SUDOSCAN The SUDOSCAN device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SUDOSCAN can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SUDOSCAN as recommended below, according to the maximum output power of the communications equipment.
  • Page 76 Impeto Medical Room 107, Building 81, Stadium Road No.4, Chaoyang District, Beijing, China 100027 Mail: info@impeto-medical.com Impeto Medical, Inc. 8910 University Center Lane, Suite 615 SAN DIEGO, CA 92122 - USA Tel: (858) 450.2800 Fax: (858) 450.2804 http://www.sudoscan.com/ 0120 Cleared in 2016...

Table of Contents