ImpediMed SOZO Manual de usuario

 ImpediMed – Feb 2018 Page 1 LBL-507-en REV C

SOZO

Instructions For Use

 ImpediMed – Feb 2018 Page 2 LBL-507-en REV C

ImpediMed Limited

ABN 65 089 705 144

Unit 1

50 Parker Court

Pinkenba Qld 4008

Australia

Phone: + 61 7 3860 3700

Fax: + 61 7 3260 1225

Email: enquiries@impedimed.com

Website: http://www.impedimed.com/

EC REP

MediMark Europe Sarl

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/

For assistance with product set up

please review the help videos at

https://help.hellosozo.com. For other

assistance, or to report product issues,

please contact ImpediMed by email at

[email protected] or by phone at +

61 7 3860 3700.

 ImpediMed – Feb 2018 Page 3 LBL-507-en REV C

Contents

Minimum Requirements..............................................................................................5

Tablet..............................................................................................................................................5

SOZO App......................................................................................................................................5

Introduction .................................................................................................................6

The SOZO Device..........................................................................................................................6

Bioimpedance Spectroscopy (BIS) ................................................................................................6

Components of the SOZO System.............................................................................7

Safety Instructions......................................................................................................8

Signs and Symbols.........................................................................................................................8

Intended Use..................................................................................................................................9

Contraindications............................................................................................................................9

Warnings ........................................................................................................................................9

Precautions.................................................................................................................................. 10

Use and Storage Conditions ....................................................................................................... 11

Environmental Operating Conditions .......................................................................................... 11

Environmental Transport and Storage Conditions...................................................................... 11

Location for Use .......................................................................................................................... 12

Setting Up the SOZO Device and Stand..................................................................13

Setting Up the SOZO Device without Stand............................................................ 15

Step 1: Connecting SOZOtouch and SOZOstep......................................................................... 15

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............................................................................................................ 18

Pairing the SOZO app with the SOZO system............................................................................ 20

Preparing the patient.................................................................................................22

Standing vs. Seated positions..................................................................................................... 22

 ImpediMed – Feb 2018 Page 4 LBL-507-en REV C

Optimal readings ......................................................................................................................... 22

Standing Position ........................................................................................................................ 22

Seated position............................................................................................................................ 23

Using the SOZO App.................................................................................................24

Overview...................................................................................................................................... 24

Start-up........................................................................................................................................ 24

Logging In.................................................................................................................................... 24

Creating/Accessing Patient Profiles............................................................................................ 26

Taking Measurements................................................................................................................. 29

Weight Entry................................................................................................................................ 30

Foot Placement ........................................................................................................................... 31

Hand Placement.......................................................................................................................... 31

Measurement Time ..................................................................................................................... 32

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......................................................................... 41

SOZOpro Module Results ........................................................................................................... 41

SOZObeat for Fluid Monitoring Measurements .......................................................................... 43

SOZObeat Module Results ......................................................................................................... 43

Personal Data ............................................................................................................44

Care and Maintenance ..............................................................................................45

Care of the Product ..................................................................................................................... 45

Self-Test Function ....................................................................................................................... 45

Repairs ........................................................................................................................................ 45

Technical Support ....................................................................................................................... 46

Troubleshooting........................................................................................................ 47

ImpediMed Product Warranty...................................................................................51

Regulatory Statement ...............................................................................................52

Product Specifications..............................................................................................53

Safety and Electromagnetic Compatibility (EMC) Information.............................. 54

 ImpediMed – Feb 2018 Page 5 LBL-507-en REV C

Minimum Requirements

Tablet

The Samsung Galaxy Tab A (model SM-T580) will be provided to operate the SOZO device.

For more product details, please review www.samsung.com or the tablet’s User Guide.

Note: The Bluetooth®word mark and logos are registered trademarks owned by Bluetooth

SIG, Inc. and any use of such marks by ImpediMed is under license. Other trademarks and

trade names are those of their respective owners.

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.

 ImpediMed – Feb 2018 Page 6 LBL-507-en REV C

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.

Bioimpedance Spectroscopy (BIS)

Bioimpedance spectroscopy (BIS) is the only non-invasive technology available that has the

potential to accurately measure body water volumes. BIS mode measures bioimpedance

parameters over a frequency range of 3 - 1000 kHz with 256 data points. Comparison of the

data collected within that frequency range enables calculation of extracellular, intracellular and

total body water. With additional patient-specific data, further calculations can be made to

determine other body composition results. On-screen graphs also display the measured data in

the form of a Cole plot.

The SOZO device and SOZOthrive module offers rapid, non-invasive, inexpensive comparison

of impedance ratio’s between normal limbs and limbs at risk of lymphoedema. The instruments

also enable long-term patient monitoring and provide reports to support clinical and research

practices.

 ImpediMed – Feb 2018 Page 7 LBL-507-en REV C

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)

•SOZOconnect cable (7)

•Tablet holder (8)

•Tablet including the SOZO app (9)

•Screws and hex key for stand (10)

 ImpediMed – Feb 2018 Page 8 LBL-507-en REV C

Safety Instructions

Signs and Symbols

The warning signs and the symbols below are listed in order to use this product safely and

correctly as well as to prevent risk and injury to you and others.

The meanings of the signs are as follows:

Symbol

Definition

Indicates matters in which bodily harm or material damage

or incorrect measurements may arise as a result of

incorrect handling.

What you should NOT do.

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.

This is a Class 2 medical device.

IP21 Protected from touch by fingers and objects greater than

12 millimeters. Protected from condensation.

 ImpediMed – Feb 2018 Page 9 LBL-507-en REV C

Intended Use

SOZO is a medical device, intended for clinical use by operators who have read this manual.

This device is intended for use, under the direction of the operator, for the noninvasive

monitoring and management of fluid levels in patients. This includes use under direction of a

physician in patients with fluid management problems in a variety of medically accepted clinical

applications.

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.

Contraindications

The SOZO device should not be used by:

•Patients with active implanted medical devices, e.g. cardiac

pacemakers, defibrillators or patients connected to electronic life

support devices.

•Patients undergoing external defibrillation.

Warnings

Pregnant Patients:

•While the use of bioimpedance technology in pregnant patients has

been shown to have had no adverse effects, the SOZO device has yet

to be clinically validated for use with that population group.

 ImpediMed – Feb 2018 Page 10 LBL-507-en REV C

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.

Only use the power adaptor that is supplied with this device. The use of any

other power adaptor may expose the patient to the risk of electrocution.

Do not use or operate the device in the presence of strong electromagnetic

fields. This Medical Device may interfere with other Medical Devices in its

vicinity.

Devices or other sources can potentially cause interference problems:

•Example 1: heat from a radiant heater.

•Example 2: moisture from a nebuliser.

Keep away from small children or animals. Strangulation due to cables may

occur and small parts may be inhaled or swallowed.

Avoid using on subjects with metal allergies. Allergic reactions may be

caused by the stainless steel used in the electrodes of this device.

Avoid using accessories, detachable parts and materials not described in the

instructions for use, interconnecting this device with other equipment not

described in the instructions for use, or modifying this device in any way.

The use of accessories, transducers, and cables other than those specified

may result in increased Emissions or decreased Immunity of the SOZO

device.

Otros manuales para SOZO

Tabla de contenidos

Otros manuales de Equipo médico de ImpediMed

ImpediMed

ImpediMed SOZO Manual de usuario

ImpediMed

ImpediMed SFB7 Manual de usuario

ImpediMed

ImpediMed SOZO Manual de usuario

ImpediMed

ImpediMed SOZO Manual de usuario

ImpediMed

ImpediMed SOZO Manual de usuario

ImpediMed

ImpediMed SFB7 Manual técnico

Manuales populares de Equipo médico de otras marcas

TekTone

TekTone Tek-CARE160 Manual de usuario

NeuroMetrix

NeuroMetrix Quell 2.0 Manual de usuario

AMT

AMT XLR8 Manual de usuario

Medipost-Nutristoma

Medipost-Nutristoma MD300K2 Manual de usuario

EDAN

EDAN SONOTRAX Pro Manual de usuario

Restorative Therapies

Restorative Therapies RT300 Manual de usuario

Gendex

Gendex Expert DC Manual de usuario

Dexcowin

Dexcowin ADX4000W Manual de usuario

Libelium

Libelium MySignals Manual de usuario

Acelity

Acelity V.A.C.ULTA 4 Manual de usuario

Caputron

Caputron ActivaDose II tDCS Manual de usuario

FujiFilm

FujiFilm Sonart Manual del propietario

Plinth 2000

Plinth 2000 93CDT Manual de usuario

GE SENOGRAPHE 800T Manual de usuario

GE Definium 5000 Manual de usuario

Kanmed

Kanmed GE-1380 Manual de usuario

Huntleigh

Huntleigh FD1 Manual de usuario

Stryker

Stryker SPR Plus Manual de usuario