ImpediMed SOZO Manual de usuario

SOZO System

Instructions for Use

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: [email protected]

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

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://www.impedimed.com. For other

assistance, or to report product issues,

please contact ImpediMed by email at

[email protected]m or by phone at +

61 7 3860 3700.

Distributed in the United States by:

ImpediMed Inc.

5900 Pasteur Court, Suite 125

Carlsbad, CA 92008

(877) 247-0111

tsu@impedimed.om

 
 
 
 
©  ImpediMed –April 2019 Page 3 LBL-537-en REV B 
 
 
Table of Contents 
 
0 Minimum Requirements .................................................................................................. 8 
1 Tablet ......................................................................................................................................8 
1.1 Tablet Function ............................................................................................................................................8 
1.2 SOZOapp ......................................................................................................................................................8 
2 User Devices ............................................................................................................................ 8 
3 MySOZO...................................................................................................................................8 
0 Glossary......................................................................................................................... 10 
0 Introduction to the SOZO System................................................................................... 14 
1 Bioimpedance Spectroscopy (BIS) ........................................................................................... 14 
2 SOZO System Overview .......................................................................................................... 15 
3 The SOZO Device.................................................................................................................... 16 
3.1 SOZO Device Hardware Components ........................................................................................................17 
4 Assessment Licences .............................................................................................................. 18 
0 Safety Instructions......................................................................................................... 19 
1 Signs and Symbols.................................................................................................................. 19 
2 Intended Use.......................................................................................................................... 20 
3 Contraindications................................................................................................................... 20 
4 Warnings ............................................................................................................................... 20 
5 Precautions............................................................................................................................ 20 
6 Use and Storage Conditions.................................................................................................... 22 
6.1 Environmental Operating Conditions ........................................................................................................22 
6.2 Environmental Transport and Storage Conditions ....................................................................................22 
7 Location for Use ..................................................................................................................... 23 
0 SOZO Device Assembly .................................................................................................. 24 
1 SOZO Device with SOZOsupport Stand.................................................................................... 24 
1.1 Identify SOZO Device Components............................................................................................................24 
1.2 Assembly Process.......................................................................................................................................25 
1.2.1 Step One: Attach Footplate to SOZOsupport Stand ...........................................................................25 
1.2.2 Step Two: Attach Handplate to SOZOsupport Stand..........................................................................25 
1.2.3 Step Three: Lace SOZOconnect Cable Through SOZOsupport Stand .................................................27 
1.2.4 Step Four: Attach SOZOtouch to Handplate.......................................................................................28 
1.2.5 Step Five: Attach SOZOconnect Cable to SOZOtouch ........................................................................28 
1.2.6 Step Six: Attach SOZOconnect Cable to SOZOstep.............................................................................28 
1.2.7 Step Seven: Connect Power Cord to SOZOstep..................................................................................29 
1.2.8 Step Eight: Attach SOZOstep to the Footplate ...................................................................................30 

 
 
 
 
©  ImpediMed –April 2019 Page 4 LBL-537-en REV B 
1.2.9 Step Nine: Attach SOZOcradle to SOZOtouch ....................................................................................30 
2 SOZO Device without SOZOsupport Stand............................................................................... 31 
2.1 Attach SOZOtouch to SOZOstep with SOZOconnect Cable........................................................................31 
2.2 Connect SOZOcradle..................................................................................................................................32 
2.3 Connect Power Supply...............................................................................................................................32 
0 MySOZO ........................................................................................................................ 33 
1 Introduction........................................................................................................................... 33 
2 All MySOZO Users (Administrators and Clinicians)................................................................... 33 
2.1 First Time Set-Up .......................................................................................................................................33 
2.1.1 Email with Temporary Password........................................................................................................33 
2.1.2 Set New Password..............................................................................................................................34 
2.1.3 User Password Privacy........................................................................................................................34 
2.2 Password Reset..........................................................................................................................................35 
2.3 Password Expiration ..................................................................................................................................37 
3 MySOZO Administrator .......................................................................................................... 38 
3.1 Administrator Home Page .........................................................................................................................38 
3.2 Banner Icons ..............................................................................................................................................38 
3.2.1 Logged in Status .................................................................................................................................39 
3.2.2 Profile of Administrator Logged into MySOZO...................................................................................39 
3.2.3 User List..............................................................................................................................................40 
3.2.4 Help ....................................................................................................................................................41 
3.2.5 Log Out ...............................................................................................................................................41 
3.3 MySOZO Main Menu .................................................................................................................................42 
3.3.1 Create User.........................................................................................................................................42 
3.3.2 Edit User Profile..................................................................................................................................44 
3.3.3 Delete User.........................................................................................................................................44 
3.3.4 Restore User.......................................................................................................................................46 
3.3.5 Export Audit Logs ...............................................................................................................................48 
3.3.6 Settings...............................................................................................................................................50 
4 MySOZO Clinician................................................................................................................... 52 
4.1 Log In..........................................................................................................................................................52 
4.2 Clinician Home Page ..................................................................................................................................52 
4.3 Banner Icons ..............................................................................................................................................53 
4.3.1 MySOZO Icon......................................................................................................................................53 
4.3.1 Clinician User Profile Icon...................................................................................................................53 
4.3.1 Patient List Icon ..................................................................................................................................53 
4.3.2 Help (Question Mark) Icon .................................................................................................................53 
4.3.3 Log Out Icon .......................................................................................................................................53 
4.4 Clinician Main Menu..................................................................................................................................54 
4.4.1 Patient Dashboard..............................................................................................................................54 
4.4.2 Create Patient.....................................................................................................................................55 
4.4.3 Delete Patient.....................................................................................................................................57 
4.4.4 Restore Patient...................................................................................................................................57 
4.4.5 Export .................................................................................................................................................58 
4.4.6 Patient Report: Report/Print..............................................................................................................60 
4.4.7 Settings: Adjusting Measurement Units.............................................................................................60 
4.5 Patient Dashboard .....................................................................................................................................61 
4.5.1 Introduction to Patient Dashboard ....................................................................................................62 

 
 
 
 
©  ImpediMed –April 2019 Page 5 LBL-537-en REV B 
4.5.3 Measurement Results Viewable by Clinician in MySOZO...................................................................70 
4.5.4 Edit Patient Profile..............................................................................................................................76 
4.5.5 Patient Report: Report/Print..............................................................................................................78 
0 Preparing the Patient..................................................................................................... 80 
1 Introduction........................................................................................................................... 80 
1.1 Preparing for All Measurements................................................................................................................80 
1.2 Preparing for Fluid or Tissue Analysis Measurements...............................................................................80 
1.3 Taking Measurements Under Similar Conditions ......................................................................................80 
2 Standing vs. Seated Position................................................................................................... 81 
2.1 Optimal Readings.......................................................................................................................................81 
2.2 Standing Position .......................................................................................................................................81 
2.3 Seated Position ..........................................................................................................................................82 
0 Using the SOZOapp........................................................................................................ 83 
1 Introduction........................................................................................................................... 83 
2 Start-Up................................................................................................................................. 83 
2.1 Pairing the Tablet with the SOZO Device...................................................................................................83 
4 Selecting SOZO Device............................................................................................................ 85 
2.2 Tap SOZOapp .............................................................................................................................................85 
2.3 Enter Email Address ..................................................................................................................................85 
3 SOZOapp Home Screen........................................................................................................... 86 
3.1 SOZOapp Banner Icons .............................................................................................................................86 
3.1.1 User Profile Icon ................................................................................................................................87 
3.1.2 Log Out...............................................................................................................................................87 
3.1.3 Patient List .........................................................................................................................................87 
3.2 Conducting Patient Search........................................................................................................................88 
4 Selecting SOZO Device............................................................................................................ 89 
4.1 Confirming SOZO Device Status.................................................................................................................90 
4.1.1 Using Settings to Confirm Device Status ............................................................................................90 
4.1.2 Using the Self-Test to Confirm Device Status.....................................................................................91 
5 SOZOapp Main Menu ............................................................................................................. 91 
5.1 Create Patient ............................................................................................................................................91 
5.1.1 Patient Details ..................................................................................................................................91 
5.1.2 Assessment Type ..............................................................................................................................92 
5.1.3 Lymphoedema Settings ....................................................................................................................93 
5.2 Delete Patient ............................................................................................................................................93 
5.3 Restore Patient ..........................................................................................................................................93 
5.4 Pairing SOZO Device ..................................................................................................................................95 
5.5 Self-Test .....................................................................................................................................................95 
5.5.1 Optional for Device Status Confirmation..........................................................................................95 
5.5.2 Mandatory Step Before Taking Measurements ...............................................................................95 
5.5 Adjusting SOZO System-Wide Settings from the SOZOapp .......................................................................95 
5.5.1 Adjusting Units of Measure................................................................................................................96 
5.5.2 Firmware Update................................................................................................................................97 
5.5.2 Licencing Status ..................................................................................................................................98 
5.5.3 Check SOZOapp Version .....................................................................................................................98 

 
 
 
 
©  ImpediMed –April 2019 Page 6 LBL-537-en REV B 
6 Taking Measurements ............................................................................................................ 99 
6.1 Select Patient from Patient List ...............................................................................................................100 
6.2 Patient Dashboard ...................................................................................................................................100 
6.2.1 Self-Test............................................................................................................................................100 
6.2.2 Preparing to Take Measurements ....................................................................................................101 
6.2.3 Start Measurement ..........................................................................................................................105 
6.2.4 Reviewing Cole Plots After Measurement........................................................................................108 
6.2.5 History ..............................................................................................................................................110 
6.2.6 Results ..............................................................................................................................................114 
6.2.7 Edit Patient Profile............................................................................................................................119 
0 Assessments.................................................................................................................122 
1 Introduction to Assessments................................................................................................. 122 
2 Choosing the Proper Assessments for the Patient.................................................................. 122 
3 Assessment Specific Instructions for Use............................................................................... 122 
3.1 L-Dex®for Lymphoedema ........................................................................................................................122 
3.1.1 Indications for Use............................................................................................................................122 
3.1.2 Instructions for Use ..........................................................................................................................123 
3.1.3 The Lymphoedema Index (L-Dex).....................................................................................................123 
3.1.4 L-Dex Assessment Results ................................................................................................................124 
3.1.5 Availability of L-Dex Assessment......................................................................................................125 
3.1.7 History of Measurements and Results Trends .................................................................................125 
3.1.8 Recommended Measurement Frequency for L-Dex ........................................................................126 
3.2 Fluid Analysis ...........................................................................................................................................126 
3.2.1 Indications for Use............................................................................................................................126 
3.2.2 Instructions for Use ..........................................................................................................................126 
3.2.3 Fluid Analysis Results........................................................................................................................127 
3.2.4 Recommended Measurement Frequency for Fluid Analysis............................................................128 
3.3 Tissue Analysis .........................................................................................................................................128 
3.3.1 Indications for Use............................................................................................................................128 
3.3.2 Instructions for Use ..........................................................................................................................128 
3.3.3 Tissue Analysis Results .....................................................................................................................129 
3.3.4 Recommended Tissue Analysis Measurement Frequency ...............................................................129 
0 Troubleshooting..........................................................................................................130 
1 SOZOapp Error Messages.................................................................................................... 130 
1.1 Self-Test.................................................................................................................................................130 
1.1.1 Error Message................................................................................................................................130 
1.1.2 Resolutions ....................................................................................................................................130 
1.2 Patient Profile .......................................................................................................................................130 
1.2.1 Assessment Type ...........................................................................................................................130 
1.2.2 Lymphoedema Settings.................................................................................................................132 
1.3 Patient Dashboard ................................................................................................................................133 
1.3.1 Error Message................................................................................................................................134 
1.3.2 Resolution......................................................................................................................................134 
1.4 Losing Connectivity During Measurement ...........................................................................................135 
1.3.4.1 Error Message.............................................................................................................................135 
1.3.4.2 Resolution...................................................................................................................................135 
2 General Troubleshooting Chart........................................................................................... 135 

11.0 Personal Data .............................................................................................................140

12.0 Care and Maintenance................................................................................................141

12.1 The SOZO Device ................................................................................................................ 141

12.1.1 Care........................................................................................................................................................141

12.1.2 Maintenance..........................................................................................................................................141

12.2 Self-Test............................................................................................................................. 141

12.3 Repairs............................................................................................................................... 142

12.4 Tablet Maintenance............................................................................................................ 142

12.5 Technical Support............................................................................................................... 142

12.6 Components and Accessories.............................................................................................. 143

13.0 ImpediMed Product Warranty.....................................................................................144

14.0 Regulatory Statement.................................................................................................145

15.0 Product Specifications.................................................................................................146

16.0 Safety and Electromagnetic Compatibility (EMC) Information......................................147

17.0 Index ..........................................................................................................................151

1.0 Minimum Requirements

1.1 Tablet

The Tablet, a Samsung Galaxy Tab A (Model SM-T580) comes with the SOZO system. It has

Bluetooth®

communication with the SOZO Device.

1.1.1 Tablet Function

The Tablet is the primary user interface for the SOZO Device. Clinicians use the Tablet for all

SOZO functions, including management of patient profiles, and the entry of patient

measurements and data for SOZO Assessments. For product details on the Tablet, review

www.samsung.com and the Tablet user guide.

1.1.2 SOZOapp

The SOZOapp for Android is pre-installed on the Tablet.

1.2 User Devices

Users may access MySOZO with any device, including a PC, laptop, or mobile device, with

internet access and a Google Chrome or Mozilla Firefox web browser. For internet

requirements, see Section 1.3 MySOZO.

1.3 MySOZO

MySOZO communicates with the SOZO system through the internet. The minimum and

recommended requirements for internet access are:

The Bluetooth®word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.

and any use of such marks by ImpediMed is under licence. Other trademarks and trade names

are those of their respective owners.

MySOZO Minimum and Recommended Requirements

Component

Requirements

Internet Speed

Minimum>15 Mbps download, 5 Mbps/ upload

Recommended>25Mbps download, 5 Mbps upload

Web Browser

Google Chrome, Mozilla Firefox

2.0 Glossary

2.0.1 Administrator-MySOZO User authorized to manage Clinician and Administrator

accounts and perform SOZO system-wide administrative functions. The Administrator

has exclusive authority to adjust certain SOZO system-wide settings through MySOZO.

2.0.2 Assessment-An assessment of measurements taken of the patient, which is an output

of the SOZO system. Different types of Assessments are available to the ImpediMed

customer and viewable on the SOZOapp and MySOZO, including L-Dex®, Fluid Analysis

and Tissue Analysis.

2.0.3 Assessment licence-ImpediMed grants a separate licence for each type of

Assessment. Once an Assessment is licenced, the Clinic has access to that Assessment

for all current and previous measurements. The availability of the Assessment licence is

viewable in MySOZO and the SOZOapp.

2.0.4 ATM-Active Tissue Mass. Active Tissue Mass includes all metabolically active tissues in

the body. Also, sometimes referred to as “Body Cell Mass” (BCM), these tissues include

muscle, organs, and nervous tissue. This is expressed as a mass (kg or lb) and as a

percentage of total mass.

2.0.5 At-risk limb-The limb at risk of developing lymphoedema.

2.0.6 Bilateral-A type of L-Dex Assessment for a patient who has both arms or both legs at

risk of lymphoedema. The SOZO system compares each arm with each leg.

2.0.7 Bioimpedance-The measure of impedance of the human body to an alternating electric

current.

2.0.8 Bioimpedance Spectroscopy-The technology used by the SOZO Device to accurately

measure body water volumes of the patient, based upon bioimpedance parameters over

a frequency range of 3 - 1000 kHz using 256 frequencies.

2.0.9 BIS-Bioimpedance Spectroscopy.

2.0.10 BMR-Basal Metabolic Rate. Basal Metabolic Rate is the amount of energy used by a

person’s body when at rest. ImpediMed uses the Mifflin-St. Jeor equation to calculate

BMR. BMR is expressed in calories per day.

2.0.11 Clinic-A customer of ImpediMed, such as a hospital or medical facility, which uses the

SOZO system.

2.0.12 Clinician -The primary User of the SOZO system, and an authorized User of MySOZO

and the SOZOapp. The Clinician uses the SOZO Device to: take and record

measurements of patients; view and evaluate measurements and Assessments over

time; and assess patient progress.

2.0.13 Cole plots -The SOZO measurement data is displayed in the form of a complex

impedance plot, commonly called a Cole plot. The X axis is the resistance value and the

Y axis is the reactance value of the measurement at each of the 256 frequencies

measured. Cole plots are reviewed when determining whether to accept or reject

measurements. The SOZO software helps determine the quality of measurements as

high, medium or low quality.

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