Impeto Medical SudoScan2 User Manual
  1. Manuals
  2. Brands
  3. Impeto Medical Manuals
  4. Medical Equipment
  5. SudoScan2
  6. User manual

Impeto Medical SudoScan2 User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
User guide
Version 3
03/03/2020 rev1
1

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the SudoScan2 and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Impeto Medical SudoScan2

Summary of Contents for Impeto Medical SudoScan2

  • Page 1 User guide Version 3 03/03/2020 rev1...

  • Page 2: Table Of Contents

    ABLE OF CONTENTS ................... 3 NTRODUCTION ..........................3 ATENTS ............................3 ..........................3 RINCIPLE ........................4 NSTALLATION .................... 5 TART A SCAN ..........................5 OG IN ........................5 TART A SCAN 2.2.1 ...................5 TART A SCAN FOR A NEW PATIENT 2.2.2 ........6 TART A SCAN FOR A PATIENT THAT ALREADY EXISTS IN THE SYSTEM .........................6 URING THE SCAN ? .................7...

  • Page 3: Introduction

    1 Introduction The device is powered by the Windows 10 Entreprise LTSB operating system. 1.1 Patents Submission number Country/Region 0601239 200680026807.6 11/922.812 06763845.2 EUROPE, DE, FR, UK 14/613.952 0753461 EP2008/052211 PCT (International) 08717066.8 EUROPE, FR 1258037 1.2 Use The device is a digital chrono-amperometric analyzer used for early identification and follow-up of peripheral autonomic neuropathies.

  • Page 4: Installation

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

  • Page 5: Start A Scan

    2 Start a scan When starting a scan, the first step is to determine if the patient is already in the database of the system, or if it’s his first exam. Note: For any additional help, please press the Help button (bottom right corner).

  • Page 6: Start A Scan For A Patient That Already Exists In The System

    2.2.2 Start a scan for a patient that already exists in the system Once you are connected on the system, click on Patient History on the Home screen. Using filters, select the patient from the patient list. Click on the New Scan button. The patient’s demographic information shall already be set.

  • Page 7: What If The Scan Cannot Be Started

    If the issue persists, please contact Impeto Medical Technical Support (ref. p27). Note: Smart Electrodes: Red LEDS on the docks indicates that the scan cannot be launched. If the issue persists after you followed the procedure above, please contact Impeto Medical Technical Support (ref. p27). 2.5 Results interpretation The device immediately populates results after a scan.

  • Page 8: Quality Of Measure

    Selecting the Re-Scan button will prompt the current scan to be cancelled. The user will be returned to the scan page to start a new scan. If the issue persists, please contact Impeto Medical Technical Support (ref. p27).

  • Page 9: Actions To Perform

    3 Actions to perform 3.1 After each scan: Disinfecting the electrodes (all electrodes) IMMEDIATELY AFTER EACH SCAN, IT IS IMPORTANT TO CLEAN ALL SMART ELECTRODES WITH THE MANUFACTURER APPROVED CLEANING SOLUTION. This will not only disinfect but also neutralize the electrochemical reactions which have taken place on the electrodes during the scan.

  • Page 10: On System Request: Testing The Hardware

    Note: If an error occurs during normal use of the device, perform a Quality Check test. If the test indicates that the device passed and you are still encountering issues, please contact your distributor or Impeto Medical Technical support (ref. p27). It is important that no one stands on the electrodes while performing a Quality Check.

  • Page 11: Replace The Electrodes

    4 Replace the electrodes All options are not available in every region, please check with your distributor to which product is available in your region. 4.1 How to replace Smart Electrodes Please plan in advance when placing your replacement electrodes orders. Upon receiving a new order, a set of electrodes will be shipped to replace existing used electrodes once all scans have been used.
  • Page 12 Then remove the electrode to be replaced by pulling it out gently. Insert the new electrode into the dock by gently sliding it in until the electrode is firmly aligned within the dock base. Tighten the locking screw. Locking screw...
  • Page 13 After the change of electrodes, return to the main program screen and then click the New Patient button. The number remaining of scans will be updated and displayed on the top right header of the screen. IF DOCKS HAVE BEEN DISCONNECTED FROM THE SYSTEM, PLEASE PLUG THEM IN AGAIN AND RESTART THE SYSTEM.

  • Page 14: How To Replace Standard Electrodes

    4.2 How to replace Standard Electrodes When the sensor plates have to be replaced, please follow these instructions to unplug the old sensor plates and plug in the new ones: Unscrew the sensor plates’ cable retention bracket, if installed. Grab the larger part of each plug and gently pull it backwards. When installing a new set of sensor plates, please ensure the plugs are correctly seated in the socket to ensure a proper connection.
  • Page 15 WHEN PLUGGING THE ELECTRODES IN OR OUT OF THE SYSTEM, ENSURE THAT THE PLUGS ARE CORRECTLY INSERTED IN THEIR SOCKET AND REMEMBER TO PULL THEM GENTLY.

  • Page 16: Precautions For Use And Technical Specifications

    5 Precautions for use and technical specifications Principle of the device Low voltage is applied to sensor plates in contact with the hands and feet, areas with the highest sweat gland density. The electric current stimulates the sweat glands which, in response, release chloride ions (Cl-).
  • Page 17 The device does not comprise any accumulator. Recycling At the end of its lifetime, the 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 18 To avoid corrosion and ensure the best conditions of hygiene, the feet and hands sensor plates must be cleaned immediately after each patient with an Impeto Medical approved cleaning solution. ONLY PERSONEL AUTHORIZED BY IMPETO MEDICAL IS ALLOWED TO PERFORM ANY REPAIRS OR MAINTENANCE ON THE DEVICE (MAINTENANCE, CALIBRATION, ETC.).
  • Page 19 Registered Trademark 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 RF Non-ionized radiation RoHS Restriction of Hazardous Substances (Directive 2011/65/UE + 2015/863/UE...
  • Page 20 Fragile Keep dry 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 Indicates the range of atmospheric pressure that the medical device can be safely exposed to Use of the sensor plates Information about the use of the sensor plates are provided as guidance only.
  • Page 21 BEFORE POWERUP CONNECT HAND AND FOOT DOCK CABLE AND MOUNT LOCKING SUPPORT CONNECTORS Impeto Medical cannot guarantee the results of measurements carried out with sensor plates issued from other manufacturers. When it is not in use, the device can be stored without disconnecting the sensor plate cables.
  • Page 22 - Room temperature is between 18 and 35 degrees Celsius (65 and 95 degrees Fahrenheit) - Cardiac holter measurements going on can be altered during the 2 minutes time scan. Contra-indications The repeated use of the 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 sensor plate,...
  • Page 23 Technical specifications • Description The device is capable of measuring galvanic skin responses and is designed for the medical professional. The 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). The device complies with IEC 60601-1 Edition 2 and Edition 3.1 (Medical Electrical Equipment, Part 1: General requirements for safety) and IEC 60601-1-2 Edition 3 and Edition 4 (Electromagnetic compatibility –...
  • Page 24 ® operating normally. Use of accessories and cables other than those specified or provided by IMPETO MEDICAL for SUDOSCAN2 could ® result in increased electromagnetic emissions or decreased electromagnetic immunity of SUDOSCAN2 and result in ®...
  • Page 25 0 % Ut for 1 cycle 0 % Ut for 1 cycle hospital environment. If the user IEC 61000-4-11 Ed 2.0 2004-03 70 % Ut for 25/30 70 % Ut for 25/30 of the SUDOSCAN2 requires ® cycles (50/60 Hz) cycles (50/60 Hz) continued...
  • Page 26 Table 2 Electromagnetic compatibility RADIO tests Standard Transmitter Compliance ETSI EN 302 291-1 V1.1.1 RFID 13,56 MHz Complies ETSI EN 302 291-2 V1.1.1 Transmitter carrier output levels ERC Recommendation 70-03 Transmitter spurious emissions FCC 47 CFR PART 15, SUBPART C, 15.225 RFID 13,56 MHz Complies Conducted emissions and Spurious emissions...

  • Page 27: Contacts

    SudoScan, Inc. 8525 Gibbs Drive, Suite 304 San Diego, CA 92123 - USA Tel: (858) 450-2800 http://www.sudoscan.com/ Email: sales_us@impeto-medical.com Beijing Impeto Medical 北京英佩特医疗器械有限公司 北京市朝阳区工人体育场北路 4 号院 81 号楼 108 室 邮编：100027 电话：+86 10 8527 0285 – 传真：+86 10 8527 0175 网址：http://cn.impeto-medical.com Email: info@impeto-medical.com...

Table of Contents