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ImpediMed SOZO Instructions For Use Manual

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SOZO
Instructions For Use
ImpediMed – Feb 2018
Page 1
LBL-507-en REV C

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Summary of Contents for ImpediMed SOZO

  • Page 1 SOZO Instructions For Use  ImpediMed – Feb 2018 Page 1 LBL-507-en REV C...
  • Page 2 11 rue Emile ZOLA, B.P. 2332, 38033 Grenoble Cedex 2 France 0086 For EU Customers: All products at the end of their life may be returned to ImpediMed for recycling. For patent(s) and/or patent application(s) see: https://www.impedimed.com/patents/  ImpediMed – Feb 2018...

  • Page 3: Table Of Contents

    Step 2: Connecting the Tablet Stand ..................15 Step 3: Connecting Power Supply....................15 SOZOhub installation ....................17 Pairing Tablet and SOZO App to SOZO System ............. 18 Step 1 ............................18 Step 2 ............................18 Step 3 ............................18 Initial setup of SOZO app ......................
  • Page 4 Cole Plots ............................ 32 Viewing Historical Measurements and Patient Trending............. 33 Changing Device Settings ......................36 Selecting SOZO device within the SOZO app ................36 Indications for Use ....................37 SOZOthrive for Lymphoedema ....................38 SOZOthrive Module Results ......................39 SOZOpro for Body Composition Measurements .................

  • Page 5: Minimum Requirements

    SOZO App The supplied tablet is preloaded with ImpediMed’s SOZO app for Android. The tablet and app will need to be paired via bluetooth to the SOZO device at initial setup. The app must also have ® network access over Wi-Fi to the SOZOhub software to function.

  • Page 6: Introduction

    Introduction The SOZO Device SOZO: A bioimpedance spectroscopy device for use on human patients, utilizing ImpediMed’s patented BIS technology in a user-friendly format to allow quick and accurate measurement of fluid levels. This can be used as an “early warning” monitor for determining changes in the fluid status of patients with fluid management problems.

  • Page 7: Components Of The Sozo System

    Components of the SOZO System SOZO by ImpediMed is made up of the following product components and accessories: • SOZOsupport (1) • SOZOtouch (2) • Handplate (3) • SOZOstep (4) • Footplate (5) • Power Adaptor and cord (6) •...

  • Page 8: Safety Instructions

    An action that must be followed. Follow instructions for use. For EU Customers: All products at the end of their life may be returned to ImpediMed for recycling. This device is rated BF as per IEC60601-1. This device meets the standard IEC60601-1-2.

  • Page 9: Intended Use

    The SOZO app is a software application intended to run on the supplied tablet and provides the main user interface for the system. The SOZO device and SOZO app are used in conjunction with SOZOhub, a network- connected database system that securely stores patient data that is primarily accessed by the app.

  • Page 10: Precautions

    Precautions Ensure that you have read and understood this entire instructions for use document before using the SOZO device. No other specific skill or training is required to take readings using the device. Do not allow the SOZO device to come in contact with any liquids.

  • Page 11: Use And Storage Conditions

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should not be used any closer than 30 cm (12 inches) to any part of the SOZO system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 12: Location For Use

    Surface temperature may exceed 47° C (117° F) in normal use. Do not use SOZO device if it is hot to the touch. Disconnect the device by unplugging the power adaptor and call ImpediMed Technical Support.

  • Page 13: Setting Up The Sozo Device And Stand

    7. Connect the SOZOstep (4) to the SOZOconnect cable (7), laced through the SOZOsupport Stand (1). 8. Connect the SOZO power adaptor (6) into the SOZOstep (4) rear plate. 9. Attach the SOZOstep (4) to the footplate (5) by first placing above the screws then pushing forward to lock into place.
  • Page 14  ImpediMed – Feb 2018 Page 14 LBL-507-en REV C...

  • Page 15: Setting Up The Sozo Device Without Stand

    Setting Up the SOZO Device without Stand Step 1: Connecting SOZOtouch and SOZOstep Components required: • SOZOtouch assembly • SOZOstep assembly • SOZOconnect cable Connect SOZOtouch to SOZOstep with the connector cable. (NOTE: the connector cable port is identical on both the hand plate and foot plate.) Place the SOZOtouch assembly on a level surface and at a comfortable height to use while sitting.
  • Page 16 SOZOstep assemblies before connecting the power supply. If the SOZO device must be moved, please ensure the power supply is disconnected from the wall before moving or uninstalling the system. For more information on setting up the SOZO system without the SOZOsupport stand, please visit www.impedimed.com or contact ImpediMed technical support (contact details on page 43 of this guide).

  • Page 17: Sozohub Installation

    SOZOhub installation While setting up the SOZO device, the SOZOhub software will also need to be installed on a network-connected computer. SOZOhub is ImpediMed’s SOZO management system and database software that will support your SOZO use, store patient measurement data, and interface with the SOZO app. Please refer to the SOZOhub instructions for use on installation and set up.

  • Page 18: Pairing Tablet And Sozo App To Sozo System

    The tablet shall come with the ImpediMed SOZO app pre-installed. If the app is not installed, please contact ImpediMed to walk through the download and installation process. With the SOZO app installed, tap on the icon to start it as you would any other app. This will bring you to the login screen: ...
  • Page 19 Note that the SOZOapp version may be at a different level from that presented here. For first-time setup of any SOZO system in the facility, you will need to click on “Set Connection Path” to link the SOZO app to the SOZOhub database on your hospital server.

  • Page 20: Pairing The Sozo App With The Sozo System

    SOZO system. Pairing the SOZO app with the SOZO system During first-time setup, the app will need to be paired with the SOZO system. Once the user account has been created and you have logged in to the dashboard screen, click on ‘Pair Device’:...
  • Page 21 The app and tablet may pair to other devices, but will only control measurements from the device that is identified in the settings tab. Once the SOZO device is shown on the settings tab, you are ready to take measurements. Setup Complete ...

  • Page 22: Preparing The Patient

    *Note: Please also read the Indications For Use section for any indication-specific instructions. Standing vs. Seated positions The SOZO system has been designed to accommodate patients who may not be able to stand. The SOZO system setup provides instructions on how to configure the system for both standing and seated positions.

  • Page 23: Seated Position

    Sit well back in chair with body in balance and shoulders rolled back. • Distribute body weight evenly on both hips. • Bend knees at a right angle, plus or minus 10 degrees.  ImpediMed – Feb 2018 Page 23 LBL-507-en REV C...

  • Page 24: Using The Sozo App

    The following section will describe access and use of the app. Start-up Logging In Tap the SOZO app icon to launch. This will take you to the login screen; use your user name and password, set up through SOZOhub, to access the app. ...
  • Page 25 After logging in, you wil be taken to the Dashboard screen:  ImpediMed – Feb 2018 Page 25 LBL-507-en REV C...

  • Page 26: Creating/Accessing Patient Profiles

    Creating/Accessing Patient Profiles After initial setup, patients will need to be added to the database in order to use the SOZO device. All new patients can be added through the Dashboard screen after login. Note that patients do not have their own login, but profiles are controlled through the clinician’s log in.
  • Page 27 After tapping ‘Create Account’ the app will take you to the patient’s summary screen.  ImpediMed – Feb 2018 Page 27 LBL-507-en REV C...
  • Page 28 An additional segment specific for patients requiring L-Dex assessments is located further down the patient profile: To create additional patients, return to the Patient Dashboard, tap on ‘New Patient’ and repeat the process.  ImpediMed – Feb 2018 Page 28 LBL-507-en REV C...

  • Page 29: Taking Measurements

    Your SOZO device may support multiple measurement types including detection of lymphedema and various body composition outputs. Each of these applications, along with indication-specific information and the reports that SOZO will provide, are discussed in greater detail later in this user guide.

  • Page 30: Weight Entry

    The app will require the patient’s current weight prior to each reading. Enter the patient’s current weight (using their most recent weight measurement if weight was not taken during their visit to your facility) to proceed:  ImpediMed – Feb 2018 Page 30 LBL-507-en REV C...

  • Page 31: Foot Placement

    (completely flat) onto the SOZOtouch with thumbs securely wrapped around the corners of both recesses. Make sure each hand is flat and in full contact with each electrode plate. (*Note: there are two electrode plates for both the left and right hand.)  ImpediMed – Feb 2018 Page 31 LBL-507-en REV C...

  • Page 32: Measurement Time

    Cole Plots The SOZO app will then display Cole Plots after the measurement is taken and allow the user to determine if an adequate reading was taken. The Cole plot, represented on the graph by a solid red semi-circular line, gives a visual representation of the measurement and is used to indicate a valid measurement has been taken.

  • Page 33: Viewing Historical Measurements And Patient Trending

    To access patient records and review their measurements, select the desired patient from the patient list in the Dashboard: From the patient screen, the patient’s history of measurements can be obtained from the ‘Results’ section:  ImpediMed – Feb 2018 Page 33 LBL-507-en REV C...
  • Page 34  ImpediMed – Feb 2018 Page 34 LBL-507-en REV C...
  • Page 35 Note: patient measurement records may also be accessed through SOZOhub if the tablet is unavailable. Other than the SOZO app, no data is stored on your tablet. All clinician and patient data are stored in SOZOhub.

  • Page 36: Changing Device Settings

    Selecting SOZO device within the SOZO app The app will initially be paired to a SOZO device during first setup of the system at your facility. This will not need to be repeated for any new users added through SOZOhub.

  • Page 37: Indications For Use

    Indications for Use The SOZO device is currently configured to provide measurements for three types of measurements as detailed further below: 1) The SOZOthrive measurement aids a clinician in the assessment of lymphoedema in a ® patient by assessing L-Dex scores.

  • Page 38: Sozothrive For Lymphoedema

    If a patient is at risk of bilateral lymphedema in both arms and legs, the SOZO system may not be an appropriate tool. If a patient is at risk of unilateral lymphedema in an arm and a leg, the SOZO app currently does not facilitate measurement of both conditions in the same patient profile.

  • Page 39: Sozothrive Module Results

    Unilateral vs. Bilateral Lymphedema The SOZO system may be used in the clinical assessment of either unilateral or bilateral secondary lymphedema. When results are assessed, a Unilateral Assesssment will display cole plots for measurement quality analysis, present one L-Dex score for consideration, and an overall results tracking chart for the patient.
  • Page 40 Recommended Measurement Frequency ImpediMed recommends the following frequency of measurements for patients at risk of unilateral lymphoedema: Pre-operative baseline Years 1-3: Every 3 months Years 4-5: Every 6 months Year 6+: Annually  ImpediMed – Feb 2018 Page 40 LBL-507-en REV C...

  • Page 41: Sozopro For Body Composition Measurements

    Indications for Use When using the SOZO device’s SOZOpro module for body composition measurements, the following indication for use applies: The SOZO system is a bioimpedance spectroscopy device intended to estimate the following body composition parameters: • Total Body Water (TBW), Extra cellular Fluid (ECF), Intra cellular Fluid (ICF) •...
  • Page 42 Hydration Index (Hy-Dex) Analysis Recommended Measurement Frequency Measurement frequency should be based on clinical evaluation of the patient’s monitoring needs. Daily, weekly or monthly readings may be appropriate using your best clinical judgment.  ImpediMed – Feb 2018 Page 42 LBL-507-en REV C...

  • Page 43: Sozobeat For Fluid Monitoring Measurements

    Instructions for use Ensure you have read and understood the instructions for use in preceding sections regarding setup, installation, patient preparation and use of the SOZO app. All warnings, contraindications and precautions apply. SOZObeat Module Results At the conclusion of a measurement, the app will present a screen containing analysis of the fluid status of the patient.

  • Page 44: Personal Data

    Personal Data Read our privacy policy located at https://www.impedimed.com/privacy-policy/  ImpediMed – Feb 2018 Page 44 LBL-507-en REV C...

  • Page 45: Care And Maintenance

    Care and Maintenance Care of the Product When not in use the SOZO device may remain set up and does not need to be uninstalled. If storage is desired, always keep the SOZO device in its original packaging. The external enclosure of the SOZO device should be cleaned between each use with non- bleach based disinfecting agents such as isopropyl alcohol 70% or Peridox®...

  • Page 46: Technical Support

    Phone: + 61 7 3860 3700 Phone: (877) 247-0111 Option 2 Fax: + 61 7 3260 1225 Fax: (760) 804-9245 SOZO Website: www.hellosozo.com SOZO Help Webpage: https://help.hellosozo.com SOZO Help Email: help@hellosozo.com  ImpediMed – Feb 2018 Page 46 LBL-507-en REV C...

  • Page 47: Troubleshooting

    Troubleshooting Please review the following items. In the event that additional ImpediMed technical support is required, please call them on the numbers listed in the ‘Technical Support’ section, email ImpediMed at help@hellosozo.com, or visit https://hellosozo.com. General Troubleshooting Issue/Error message Potential Cause...
  • Page 48 Contact ImpediMed technical Electrode check failed” any physical damage has occurred support. to hardware electrode check may fail. Error in sending data from SOZO Take another measurement. If error “Measurement get results unknown hardware to tablet. Potential issue persists, contact ImpediMed error”...
  • Page 49 “Status retrieved. Please run a self- Unit has not recently run a self-test Run a self-test per instructions for test and try again.”. use. Clinic IT Admin interfacing with SOZO system Issue/Error message Potential Cause Resolution User already exists. To create a...
  • Page 50 Accessories The following accessories are available from ImpediMed. Please contact ImpediMed or an authorised agent to purchase replacement parts. Description SOZOstand pedestal SOZOconnect connector Cable Power Supply Cable Tablet Tablet sleeves  ImpediMed – Feb 2018 Page 50 LBL-507-en REV C...

  • Page 51: Impedimed Product Warranty

    ImpediMed Product Warranty ImpediMed warrants to the purchaser that in the event of product failure under normal use, due to defects in material or workmanship within the specified period(s) listed below, the device will be repaired, or at ImpediMed’s option, replaced. The device and accessories are to be returned to ImpediMed, accompanied by proof of purchase, your name, your return address and a statement of the defect.

  • Page 52: Regulatory Statement

    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. This device complies with the R&TTE Directive.  ImpediMed – Feb 2018 Page 52 LBL-507-en REV C...

  • Page 53: Product Specifications

    Electromagnetic Meets the requirements of IEC 60601-1-2 and 60601-1-11. Compatibility Minimum service life of Minimum service life and associated warranty of parts and device and accessories accessories is two years.  ImpediMed – Feb 2018 Page 53 LBL-507-en REV C...

  • Page 54: Safety And Electromagnetic Compatibility (Emc) Information

    Compatibility (EMC) Information Guidance and manufacturer’s declaration – electromagnetic emissions The SOZO device is intended for use in the electromagnetic environment specified below. The customer or the user of the SOZO device should assure that it is used in such an environment.
  • Page 55 NOTE Ur is the a.c. mains voltage prior to application of the test level. Guidance and Manufacturer’s Declaration – Immunity The SOZO device is intended for use in the electromagnetic environment specified below. The customer or the user of the SOZO device should assure that it is used in such an environment.
  • Page 56 217 Hz LTE Band 7 5240 Pulse 5100- WLAN 802.11 5500 Modulation 5800 217 Hz 5785 Recommended separation distances between portable and mobile RF communications equipment and the SOZO device  ImpediMed – Feb 2018 Page 56 LBL-507-en REV C...
  • Page 57 The SOZO device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SOZO device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SOZO device as recommended below, according to the maximum output power of the communications equipment.

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