Page 1 SOZO System ® Instructions for Use  ImpediMed – August 2023 Page 1 LBL-537 REV K...
Page 2 Fax : + 61 7 3260 1225 https://www.impedimed.com. For other assistance, or to report product Email : enquiries@impedimed.com issues, please contact ImpediMed by email at ts@impedimed.com or by phone Website : http://www.impedimed.com at + 61 7 3860 3700.
Page 3: Table Of Contents
Clinician Patient List ..................33 4.3.1 Search for Patient .......................... 33 4.3.2 Patient Dashboard ......................... 33 4.3.3 Create Patient ..........................34 4.3.4 Delete Patient ..........................35 4.3.5 Restore Patient ..........................36  ImpediMed – August 2023 Page 3 LBL-537 REV K...
Page 4 Select and Pair Device........................66 5.4.2 Self-Test ............................67 5.4.3 Device Management ........................68 5.4.4 Measurement Units ........................69 5.4.5 Time Zone ............................69 5.4.6 Multi-Factor Authentication ......................69 5.4.7 Technical Support .......................... 69  ImpediMed – August 2023 Page 4 LBL-537 REV K...
Page 5 8.3.4 L-Dex Assessment Results ......................90 ® 8.3.5 Setting the Baseline ........................91 8.3.6 Recommended Measurement Frequency ..................91 8.3.7 Bilateral Arm L-Dex Assessments ....................91 HF-Dex Analysis .................... 94  ImpediMed – August 2023 Page 5 LBL-537 REV K...
Page 6 Restore User ..........................122 Administrator Patient Groups ................ 123 9.3.1 Create a New Group ........................123 9.3.2 Rename/Delete Group ......................... 124 Administrator Patient Tags ................124 9.4.1 Create a New Tag ......................... 125  ImpediMed – August 2023 Page 6 LBL-537 REV K...
Page 7: System Overview
This instructions for use document (IFU) describes the features of the SOZO medical device, including safety, setup, operation, and troubleshooting instructions. It is important to follow the instructions to keep both the hardware and software systems functioning properly.  ImpediMed – August 2023 Page 7 LBL-537 REV K...
Page 8: Bioimpedance Spectroscopy (Bis) Technology
The SOZO System may assist with early detection of lymphoedema by giving an “early warning” of patient fluid status change. It may also be used to track fluid levels in patients living with heart failure or end stage kidney disease.
Page 9: The Sozo ® System Architecture
1.3 The SOZO System Architecture ® The SOZO system is a medical device system made up of hardware and software.  ImpediMed – August 2023 Page 9 LBL-537 REV K...
Page 10: Tablet Function
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.  ImpediMed – August 2023...
Page 11: Minimum Internet Requirements
What you should NOT do. This information is extremely important and should be followed closely.  ImpediMed – August 2023 Page 11 LBL-537 REV K...
Page 12: Intended Use
Notes provide added insight and helpful information which can be useful to the operator. 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 13: Warnings
SOZO 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  ImpediMed – August 2023 Page 13 LBL-537 REV K...
Page 14 SOZO impedance measurements require contact with all four (two hand and two foot) electrodes, therefore patients with partial or full limb amputation cannot have their impedance values measured with SOZO.  ImpediMed – August 2023 Page 14 LBL-537 REV K...
Page 15: Storage Conditions And Use
If the unit has been stored at the extremes of these temperature ranges, allow it to return to within its operating temperature conditions (approximately 35 minutes) before installing or using.  ImpediMed – August 2023 Page 15 LBL-537 REV K...
Page 16: Location For Use
• MySOZO allows the user to access the SOZO system from any user device with internet access and Google Chrome, Mozilla Firefox, or Chromium- based Edge web browsers (“supported browsers”). See MySOZO Minimum Requirements.
Page 17: Mysozo Users (Administrators And Clinicians)
• A MySOZO account must be created before the user can begin using the SOZOapp on the Tablet or access MySOZO.com. • After the Clinic receives and starts the SOZO system setup, ImpediMed will establish the initial authorization and licences and create the first Clinic Administrator.
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Page 20: Password Reset
3. A pop-up notifies the user that a password reset email will be sent from ImpediMed if a valid email has been entered. 4. After the user has received the email with password reset instructions, click the Reset Password link in the email. A new browser window opens and the “Set New Password”...
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Page 22: Password Expiration
A user with a Clinician role has authority to do the following: • Manage patient profiles • Remove patients from groups • View and take patient measurements • Export data or create reports  ImpediMed – August 2023 Page 22 LBL-537 REV K...
Page 23: Mysozo Quick Start Guide
 web browsers to log in to www.mysozo.com. Enter a user email address and password  The SOZO patient list includes specific patients that can be searched by name.   ImpediMed – August 2023 Page 23 LBL-537 REV K...
Page 24 The SOZO patient profile includes specific patient information and demographics.  Notes allows a clinician to provide patient specific information related to in visit  observations. Patient profiles can include up to 10 notes each.  ImpediMed – August 2023 Page 24 LBL-537 REV K...
Page 25 History tracks previous measurements and other data for patient profiles.  Tags allows for patients to be assigned tags that define specific measurements.   ImpediMed – August 2023 Page 25 LBL-537 REV K...
Page 26 Groups allows patients to be aggregated into defined applicable groups.  Merge Patients allows multiple patients profiles to be merged into a single profile.  Restore Patient allows deleted patient profiles to be resurrected.   ImpediMed – August 2023 Page 26 LBL-537 REV K...
Page 27 Other menu items include “Help”, “Info”, “Settings”, and “My Account” which allow  clinicians to access features and .other helpful account settings.  ImpediMed – August 2023 Page 27 LBL-537 REV K...
Page 28: Clinician Home Page
If a Clinician also has Administrator rights, they can toggle between Clinician and Administrator screens by clicking Clinician or Admin. The banner icons enable common administrative functions.  ImpediMed – August 2023 Page 28 LBL-537 REV K...
Page 29: Help Icon
4.2.1 Help Icon For assistance with use of MySOZO, click the Help Icon. The Help page includes contact information for ImpediMed technical support and product Information. 4.2.2 Info Icon For information about MySOZO, click the Info icon. The Information page includes Licensing Status, Software Information and Regulatory Information.
Page 30: Clinician Settings Icon
The clinician can adjust preferred display units of measure (kg vs lb; cm vs ft/in; litres vs pints) here. Once changes have been made, click save. A success confirmation will appear in the top right corner.  ImpediMed – August 2023 Page 30 LBL-537 REV K...
Page 31 Clinician password is required to be entered. Next, a pop-up will show displaying a QR code that can be used to link to a third-party authenticator, and first-time entry of the MFA code.  ImpediMed – August 2023 Page 31 LBL-537 REV K...
Page 32: Clinician User Profile Icon
User profile, click User Profile icon and select My Profile. To sign out of MySOZO at any time, click the User Profile icon then click the Sign Out option in the list.  ImpediMed – August 2023 Page 32 LBL-537 REV K...
Page 33: Clinician Patient List
Search icon. 4.3.2 Patient Dashboard To open the Patient Dashboard, navigate to the Patient List and search for the desired patient. Click on the patient to open the Patient Dashboard.  ImpediMed – August 2023 Page 33 LBL-537 REV K...
Page 34: Create Patient
To leave the patient’s email address blank, click the Not Provided box next to the Email Address field. 2. Select the appropriate Assessment types.  ImpediMed – August 2023 Page 34 LBL-537 REV K...
Page 35: Delete Patient
2. Click on the three dots located next to the patient’s information. 3. Select Delete Patient. 4. Click Delete in the delete patient warning pop-up. 5. A success confirmation will appear in the top right corner.  ImpediMed – August 2023 Page 35 LBL-537 REV K...
Page 36: Restore Patient
Note: the patient will remain in the MySOZO database and may be restored. To permanently remove a patient and all measurement details from the MySOZO database, please contact ImpediMed Technical Support. 4.3.5 Restore Patient MySOZO stores deleted Patient accounts. If a patient is accidentally deleted, the patient may be restored.
Page 37: Edit Patient Profile
Note: if the merged patients have imported L-Dex data from a non-SOZO ImpediMed device such as the L-Dex U400, the imported measurements will not be shown if the patient L-Dex settings are different. For example, if imported U400 data assessed a patient’s leg and the data is merged with a...
Page 38: Export Patient Data
Export. A pop-up will appear, stating that the data export request is in progress. ImpediMed will send the clinician an email containing a secure link to download the Export Data. The link is valid for 48 hours.
Page 39: Report
3. Select the desired assessments and history charts to be included in the report. 4. Input the date range. 5. Click Create. 6. The patient report will automatically download in PDF format.  ImpediMed – August 2023 Page 39 LBL-537 REV K...
Page 40: Measurement Dashboard
The results for one assessment type will initially be displayed, e.g. L-Dex. The Clinician can click on different assessment types, or different measurement dates, from within the displayed record. The selected assessment type and measurement date is highlighted in blue.  ImpediMed – August 2023 Page 40 LBL-537 REV K...
Page 41 The popup will allow the user to select specific outputs to be graphed for each module, by selecting the desired outputs under ‘Select Graphs’ and clicking ‘Apply’:  ImpediMed – August 2023 Page 41 LBL-537 REV K...
Page 42: Setting A Baseline
This is often before treatment has occurred If an incorrect baseline measurement is selected, either de-select the baseline for that measurement, or navigate to the correct measurement and select it as the baseline.  ImpediMed – August 2023 Page 42 LBL-537 REV K...
Page 43: Evaluating Measurements Against A Baseline
These must be created by a Clinic Administrator. The number of Tags linked to a measurement is listed in the top right corner. Multiple Tags can be added to the same measurement.  ImpediMed – August 2023 Page 43 LBL-537 REV K...
Page 44: Cole Plots
To access Group features: 1. Click the Groups List located on the left side panel. This will bring up all current groups within the clinic.  ImpediMed – August 2023 Page 44 LBL-537 REV K...
Page 45 Selecting at least one patient will highlight the Remove button. Click the Remove button to remove patients from the group.  ImpediMed – August 2023 Page 45 LBL-537 REV K...
Page 46: Clinician Analytics
The Controls menu at the top of each tab allows the clinician to display and filter the data as desired. 4.6.1 Lymphoedema Prevention Program (LPP) This program utilizes ImpediMed’s Test, Trigger, Treat ® protocol for early detection and intervention of cancer-related lymphoedema. The LPP is supported by the...
Page 47: Lpp Protocol Compliance Tab
Date of Surgery and the LPP defined frequency within the LPP protocol. Any patient who has taken a measurement in the past 6 weeks is not included in this calculation as they are considered to have already been tested.  ImpediMed – August 2023 Page 47 LBL-537 REV K...
Page 48 LPP Protocol. The Surgery date is an optional field that is specified in the patient profile for individual patients but is required for a patient to be included in the Protocol Compliance analytics.  ImpediMed – August 2023 Page 48 LBL-537 REV K...
Page 49: Program Management
This dashboard provides insight into the usage of SOZO and the L-Dex Analysis for Lymphoedema Assessment. It provides outputs based on all patients with an L-Dex measurement, regardless of if they have a baseline or surgery date set.  ImpediMed – August 2023 Page 49 LBL-537 REV K...
Page 50 This table provides the total number of Patients Measured and Measurements, as defined above, by SOZO serial number. Selecting a device by clicking on it will filter the Patients Measured and Measurements to this device.  ImpediMed – August 2023 Page 50 LBL-537 REV K...
Page 51: Demographics
Note: patients with no measurements will not have a baseline and will not be included in the bar graph output. Bilateral patients will include two measurements, one for each at risk limb.  ImpediMed – August 2023 Page 51 LBL-537 REV K...
Page 52: Patient List
• By default, this is the full list of L-Dex patients contained in the database. Each column can be sorted by ascending or descending order.  ImpediMed – August 2023 Page 52 LBL-537 REV K...
Page 53: Navigation
Measured in Time Period, Serial Number, Bilateral Leg Patients etc) and right click. Select “Go to Patient Details”. This will open the Patient List tab to see the patients associated with that data element.  ImpediMed – August 2023 Page 53 LBL-537 REV K...
Page 54: Mysozo App
5 MySOZO APP 5.1 Introduction to the SOZOapp Clinicians may access the SOZO system through MySOZO and the SOZOapp. The SOZOapp allows Clinicians to conduct most SOZO functions, including: 1) Management of patient profiles, including adding, editing, or selecting patients from a patient list.
Page 55: Reset Password
3. A pop-up notifies the user that a password reset email will be sent from ImpediMed if a valid email has been entered. 4. After the user has received the email with password reset instructions, click the Reset Password link in the email. A new browser window opens and the “Set New Password”...
Page 56 To set and confirm new password, click submit.  ImpediMed – August 2023 Page 56 LBL-537 REV K...
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Page 58: Sozoapp Home Screen
To search for a patient, enter the name of the patient or MRN in the Search field and tap the Search icon. If a complete patient list is desired, simply leave the field blank and tap the Search icon. All patients will be displayed.  ImpediMed – August 2023 Page 58 LBL-537 REV K...
Page 59 • Ascending or descending order • First or Last Name • Date of Birth • Sex • Medical Record Number • Last SOZO Assessment Tap Apply to sort the list.  ImpediMed – August 2023 Page 59 LBL-537 REV K...
Page 60: Patient Dashboard
To go to the Patient Dashboard from the Patients List: 1. Search all patients or enter the patients’ name. 2. Tap the Search icon. 3. Tap on the desired patient.  ImpediMed – August 2023 Page 60 LBL-537 REV K...
Page 61: Create Patient
To leave the patient’s email address blank, tap the Not Provided box next to the Email Address field. 2. Select the appropriate Assessment Types for the patient. 3. When done, tap Create.  ImpediMed – August 2023 Page 61 LBL-537 REV K...
Page 62 Note: adding a new Assessment to the patient profile triggers a Caution about the intended use of that Assessment. Ensure that you understand the instructions for use for L-Dex and HF-Dex.  ImpediMed – August 2023 Page 62 LBL-537 REV K...
Page 63: Delete Patient
List, tap the three dots in the top right corner and select Restore Patient. A list of deleted patients will be displayed. If the desired patient is not in the visible list, conduct a search.  ImpediMed – August 2023 Page 63 LBL-537 REV K...
Page 64: Edit Patient Profile
3. From the Patient Dashboard, a Clinician can tap on the Profile icon. 4. Make updates as needed. 5. Tap Save. 6. A success confirmation will appear in the top right corner.  ImpediMed – August 2023 Page 64 LBL-537 REV K...
Page 65: Sozoapp Settings
The user may also view, but not change, selected Time Zone, Technical Support information, as well as the clinic’s available SOZO licences, the SOZOapp software information, and any applicable regulatory information.  ImpediMed – August 2023 Page 65 LBL-537 REV K...
Page 66: Select And Pair Device
• SOZOconnect cable • SOZOstep housing The Tablet must be paired for any new SOZO System and the pairing process must also be repeated if either the Tablet or Device are replaced. The SOZOapp may only select and work with one SOZO Device at a time.
Page 67: Self-Test
Note: do not pair an Android device (Samsung Tablet) to a SOZO system whose serial number starts with IOS- as the android SOZOapp will not show that device in the Select Device for Use menu. If this occurs, choose a SOZO Device with an identification that does not start with IOS or navigate into the Bluetooth settings menu to unpair the SOZO Device.
Page 68: Device Management
Once the tablet is paired to a device, information about the device can be obtained by tapping update next to “Device Status”. The SOZO system firmware may be updated by tapping update next to “Firmware”. This process may take 2-3 minutes. The Tablet or SOZO Device should not be turned off during this time.
Page 69: Measurement Units
The Clinician can elect to have multi-factor authentication turned on for their account once it has been activated by the Clinic Administrator. 5.4.7 Technical Support For assistance with use of SOZO, the Technical Support page includes contact information for ImpediMed technical support.  ImpediMed – August 2023 Page 69...
Page 70: Licensing Status
Under Settings, users can view the Clinic’s licensing status for various Assessments offered to ImpediMed customers. The licensing status can only be changed by ImpediMed. If desired modules are not available, please reach out to ImpediMed to discuss licensing additional modules for your use.
Page 71: Regulatory Information
MySOZO, the user will be prompted to automatically update upon sign in. If the automatic update process is not successful, contact your IT support or ImpediMed technical support for a compatible version of the SOZOapp.
Page 72: Preparing The Patient
• Avoid exercise for 4 hours prior to measurement. • Avoid caffeine 2 hours prior to measurement. • Avoid alcohol for 8 hours prior to measurement. • Avoid meals for 8 hours prior to measurement.  ImpediMed – August 2023 Page 72 LBL-537 REV K...
Page 73: Measurement Accuracy
After measurement, a patient’s weight may not be modified. 6.3 Positioning the Patient The SOZO system is designed in a Standing Position for patients who can stand and in a Seated Position to accommodate patients who are unable to stand and may exceed the maximum weight limit (up to 170 kg if patient is standing, and up to 340 kg if patient is sitting).
Page 74: Taking Measurements
3. From the Patient Dashboard, tap the Measure icon to begin new patient measurements. 4. After tapping the Measure icon, measurement instructions appear. To optimise measurement quality, ensure patient compliance with these instructions. When done, tap Next.  ImpediMed – August 2023 Page 74 LBL-537 REV K...
Page 75 SOZO measurement. Once started, the SOZO Device measurement will take approximately 30 seconds. The measurement in progress window remains until the measurement is complete.  ImpediMed – August 2023 Page 75 LBL-537 REV K...
Page 76: Accepting And Rejecting Cole Plots After Measurement
Note: surface temperature should not exceed 47° C (117° F) during normal use. Do not use SOZO Device if it is hot to the touch. Disconnect the SOZO Device by unplugging the Power Adaptor and call ImpediMed Technical Support. Note: read Intended Use and Precautions before taking measurements with the SOZO Device.
Page 77: Interpreting Cole Plots
Td corrected data was fitted. Some degree of “scatter” of Measured Data is acceptable. If Td Corrected Data is consistent with the red Fitted Curve the Cole plot is “High Quality.”  ImpediMed – August 2023 Page 77 LBL-537 REV K...
Page 78: Setting A Baseline
7.5 History Graphs The Clinician can view longitudinal measurements of the outputs over time by tapping on “History”.  ImpediMed – August 2023 Page 78 LBL-537 REV K...
Page 79: Measurement Tags
The Tag templates must be created by a Clinic Administrator in MySOZO. The number of Tags linked to a measurement is listed in the Tags icon. Multiple Tags can be added to the same measurement.  ImpediMed – August 2023 Page 79 LBL-537 REV K...
Page 80: Patient Notes
SOZO app. The process for accessing, creation, and update of patient notes is described below. View Notes  Sign into MySOZO as a clinician  Find and select a patient  Near the top of the patient dashboard, select “NOTES”.  ImpediMed – August 2023 Page 80 LBL-537 REV K...
Page 81  Save the note by selecting the save icon on the right of the screen.  Notes can be edited by selecting the edit button (pencil icon) or deleted by selecting the delete button (trashcan icon). Confirm the note deletion.  ImpediMed – August 2023 Page 81 LBL-537 REV K...
Page 82: Deleting Measurements
First navigate to the result screen of the measurement to be deleted and tap the “Delete” icon. Tapping on Delete will bring up a confirmation pop-up. Deleting individual measurements is permanent. The data cannot be recovered.  ImpediMed – August 2023 Page 82 LBL-537 REV K...
Page 83: Licensing
MySOZO and the SOZOapp. Some Assessment types may not be available in certain geographic regions. Contact ImpediMed sales or technical support with any inquiries. Each Assessment has its own instructions for use providing information on how to use the Assessment and outputs, and Assessment-specific precautions, warnings, and contraindications.
Page 84: Assessment Specific Instructions For Use
SOZOapp and MySOZO. Assessment and associated results are only available if licensed. 8.2 Assessment Specific Instructions For Use Below are instructions for use, indications for use and guidance for use of each specific type of Assessment.  ImpediMed – August 2023 Page 84 LBL-537 REV K...
Page 85: L-Dex ® For Lymphoedema
8.3.3 The Lymphoedema Index (L-Dex ® The SOZO system displays L-Dex Assessment results based upon patient measurements taken with the SOZO Device. The L-Dex Assessment produces an L-Dex score, which is based on the ratio of the impedance of the unaffected limb(s) to impedance of the at-risk limb(s).
Page 86 When transitioning from L-Dex devices used in a supine position to use of the SOZO system in a sitting or standing position, there may be a one-time shift in L-Dex scores. The shift has been shown to not be significant.
Page 87 Follow the instructions for use to ascertain the accuracy of the measurements in question. L-Dex Scores >10 L-Dex scores greater than 10 may indicate the early signs of lymphoedema.  ImpediMed – August 2023 Page 87 LBL-537 REV K...
Page 88 Change in L-Dex Scores ≥+6.5 L-Dex scores that have changed +6.5 L-Dex units from the baseline may indicate early signs of lymphoedema.  ImpediMed – August 2023 Page 88 LBL-537 REV K...
Page 89 If a patient has already developed lymphoedema and SOZO is being used to track their progress, do not set the baseline.  ImpediMed – August 2023 Page 89 LBL-537 REV K...
Page 90: L-Dex ® Assessment Results
This shows increases or decreases in the L- Dex score over time. The same patient history information can be accessed from MySOZO through a web browser. For more about accessing MySOZO, see MySOZO.”  ImpediMed – August 2023 Page 90 LBL-537 REV K...
Page 91: Setting The Baseline
Year 6+: Annually 8.3.7 Bilateral Arm L-Dex Assessments ImpediMed has recently confirmed that some patients at unilateral risk of lymphoedema are incorrectly being assessed using the bilateral arm L-Dex assessment and that the bilateral arm L-Dex assessment does not have the same level of sensitivity to help detect early signs of lymphoedema as the unilateral arm L- Dex assessment.
Page 92 L-Dex assessments updated. Heron DE, et al. Risk factors and outcomes for patients with synchronous and metachronous disease. Cancer 2000;88(12):2739-50.  ImpediMed – August 2023 Page 92 LBL-537 REV K...
Page 93 • “Previous surgery date” (if entered) • “Previous LPP Start Date” (if entered), • “Previous Limb Dominance Selection”  ImpediMed – August 2023 Page 93 LBL-537 REV K...
Page 94: Hf-Dex Tm Analysis
Light Blue range: HF-Dex values in the light blue reference range are consistent with healthy individuals who do not have heart failure.  ImpediMed – August 2023 Page 94 LBL-537 REV K...
Page 95: Hf-Dex Tm Assessment Results
• TBW as a % of weight • Extracellular Fluid (ECF) • ECF as a % of TBW • Intracellular Fluid (ICF) • ICF as a % of TBW • Weight history  ImpediMed – August 2023 Page 95 LBL-537 REV K...
Page 96: Setting The Baseline
8.4.6 Recommended Measurement Frequency for HF-Dex Measurement frequency should be based on clinical evaluation of the patient’s monitoring needs. Daily, weekly or monthly measurements may be appropriate using your best clinical judgment.  ImpediMed – August 2023 Page 96 LBL-537 REV K...
Page 97: Esrd
If the SOZO assessment is taken independent of a dialysis treatment session, ‘other’ may be selected. The choice of dialysis status must be made prior to starting a measurement, in a screen similar to the following:  ImpediMed – August 2023 Page 97 LBL-537 REV K...
Page 98: Esrd Assessment Results
The results screen will display the following outputs: • Total Body Water (TBW) • TBW as a % of weight • Extracellular Fluid (ECF) • ECF as a % of TBW  ImpediMed – August 2023 Page 98 LBL-537 REV K...
Page 99: Setting The Baseline
8.5.5 Recommended Measurement Frequency for ESRD Measurement frequency should be based on clinical evaluation of the patient’s monitoring needs. Daily, weekly or monthly measurements may be appropriate using your best clinical judgment.  ImpediMed – August 2023 Page 99 LBL-537 REV K...
Page 100: Body Composition Analysis
When using the SOZO Device’s Tissue and Fluid Analysis assessment modules for body composition measurements, the following indications for use applies: The SOZO system may be used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time: •...
Page 101: Reference Ranges
• Fat Mass, expressed as a % • Hy-Dex • Skeletal Muscle Mass • BMI • Phase Angle For more information on how the reference ranges are derived, please see 10.6.7 Body Composition Parameters.  ImpediMed – August 2023 Page 101 LBL-537 REV K...
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Page 103: Bodycomp Tm Assessment Results (Segmental)
• ECF and ICF distribution (expressed as a percentage of total body water for the limb) • Skeletal Muscle Mass (SMM) • Lean Soft Tissue (a subset of Fat-Free Mass) • Phase Angle  ImpediMed – August 2023 Page 103 LBL-537 REV K...
Page 104: Setting A Baseline
To set a baseline, select the most appropriate measurement by date from the patient’s dashboard, and tap the button next to ‘set as baseline’:  ImpediMed – August 2023 Page 104 LBL-537 REV K...
Page 105: Body Composition Parameters
All the fluid that is contained within the cell membranes of the body. ICF is usually expressed as a volume (litres or pints) and as a percentage of TBW. Reference ranges for ICF are based on internal ImpediMed data. 8.6.7.3 Total Body Water (TBW) All the water within a person’s body, including both intracellular and extracellular...
Page 106 Reference ranges for SMM were established based on data presented in Janssen (2000) 8.6.7.9 Basal Metabolic Rate (BMR) Amount of energy used by a person’s body when at rest. ImpediMed uses the Mifflin-St. Jeor equation to calculate BMR. Expressed in calories per day. 8.6.7.10 Phase Angle The arctangent of reactance divided by resistance at 50 kHz frequency.
Page 107: Mysozo Administrator
• Manage MySOZO user accounts (create, edit, delete, restore users) • Create and edit groups • Create and edit tags • Adjust SOZO system-wide settings which include security, report logo, time zone and multi-factor authentication settings • Export Audit Logs.
Page 108: Help Icon
9.1.1 Help Icon For assistance with use of MySOZO, click the Help icon. The Help page includes contact information for ImpediMed technical support and product Information. 9.1.2 Info Icon For information about MySOZO, click the Info icon. The Information page includes Licensing Status, Software Information and Regulatory Information.
Page 109: Administrator Settings Icon
This includes Clinic Settings - Security Settings, Report Logo Settings, Time Zone, EHR Settings and User Settings - Multi-Factor Authentication. If changes have been made, click Save. A success confirmation will appear in the top right corner.  ImpediMed – August 2023 Page 109 LBL-537 REV K...
Page 110 TOTP standard. Once the authenticator app is is set up, activate the MFA for the Clinic Administrator account using the slider under User Settings, Multi-Factor Authentication (see User Multi-Factor Authentication).  ImpediMed – August 2023 Page 110 LBL-537 REV K...
Page 111 The Clinic Administrator can also set the Sign out Inactivity Time here. This defines the length of time which a user remains signed into the SOZO system from their initial Sign in or last extension. After this time period, the user is automatically signed out or prompted to extend the session.
Page 112 9.1.3.2 Report Logo Settings The Clinic Administrator can upload a logo to the SOZO system. This logo will be printed on reports. The maximum size is 1MB and the supported file format is .png. 9.1.3.3 Time Zone The Clinic Administrator can select the correct time zone here.
Page 113 9.1.3.4 EHR Settings The Clinic Administrator can work with ImpediMed Technical Support during MySOZO setup or contact ImpediMed Technical Support after the system has been installed, to set up the EHR Interface Settings. Full EHR interface configuration will require additional set-up outside of MySOZO to complete.
Page 114 Next, a pop-up will show displaying a QR code that can be used to link to a third-party authenticator, and first-time entry of the MFA code.  ImpediMed – August 2023 Page 114 LBL-537 REV K...
Page 115 MySOZO settings, and requires entry of both the user password and an MFA code. After turning MFA off a success message will appear. The user will then be signed out of the system and return to the sign in screen.  ImpediMed – August 2023 Page 115 LBL-537 REV K...
Page 116: Administrator User Profile Icon
To review or edit the User profile, click the User Profile icon and then select My Profile. To sign out of MySOZO at any time, click the User Profile icon then click the Sign Out option in the menu.  ImpediMed – August 2023 Page 116 LBL-537 REV K...
Page 117: Administrator User List
The remaining fields, including middle name, country code, and phone number, are optional. 2. Under Role select Administrator and/or Clinician. 3. When done, click Create and enter the Administrator password.  ImpediMed – August 2023 Page 117 LBL-537 REV K...
Page 118 Caution will state that the user already exists. The same email address may not be assigned to more than one user, even when the user is acting as both the Administrator and the Clinician.  ImpediMed – August 2023 Page 118 LBL-537 REV K...
Page 119: Audit Logs
3. Click Apply to export logs. 4. A pop-up will appear, stating that the data export request is in progress. 5. ImpediMed will send the user an email containing a secure link to download the Audit Logs. The link is valid for 48 hours.
Page 120: Edit User
3. A success confirmation will appear in the top right corner. Note: only an Administrator may edit a user’s email address. A Clinician may edit their own email address but does not have authority to change another user’s email address.  ImpediMed – August 2023 Page 120 LBL-537 REV K...
Page 121: Delete User
1. On the Users List, click on the three dots located next to the user’s role. 2. Select Delete. 3. Click Delete in the delete user warning pop-up. 4. A success confirmation will appear in the top right corner.  ImpediMed – August 2023 Page 121 LBL-537 REV K...
Page 122: Restore User
3. Search the user list for the user profile to be restored. 4. Click the blue arrow to restore the user. 5. A restore user warning will pop-up, select Restore. 6. A success confirmation will appear in the top right corner.  ImpediMed – August 2023 Page 122 LBL-537 REV K...
Page 123: Administrator Patient Groups
Patient Groups, click the Groups icon to bring up the following screen: 9.3.1 Create a New Group To create a new Patient Group: 1. On the Groups List, click Add New in the top right corner.  ImpediMed – August 2023 Page 123 LBL-537 REV K...
Page 124: Rename/Delete Group
They allow additional information or notes to be linked to the measurement. The tags used within a clinic can only be managed by a user with an Administrator role from the Tags tab.  ImpediMed – August 2023 Page 124 LBL-537 REV K...
Page 125: Create A New Tag
1. On the Tags List, click the blue pencil (edit icon) on the tag to be updated. 2. Update the tag name. 3. Click the blue disk (save icon). 4. A success confirmation will appear in the top right corner. To delete a Tag:  ImpediMed – August 2023 Page 125 LBL-537 REV K...
Page 126: Device Assembly
Device with SOZOsupport Stand Most patients stand during measurement, which requires assembly of the SOZO Device with the SOZOsupport Stand. Follow these steps to assemble the SOZO Device with the SOZOsupport Stand.  ImpediMed – August 2023 Page 126 LBL-537 REV K...
Page 127  ImpediMed – August 2023 Page 127 LBL-537 REV K...
Page 128 Before using the SOZO Device for the first time, make sure to follow all steps for start-up of MySOZO and the SOZOapp. Observe the following warnings while assembling the SOZO Device.  ImpediMed – August 2023 Page 128 LBL-537 REV K...
Page 129: Assembling The Sozo Device Without The Sozosupport Stand
When plugging the Power Cord into the wall outlet, the SOZO system will automatically run a self-test to ensure functionality. Do not touch the stainless-steel electrodes when a self-test is running. For more information on setting up the SOZO system with the SOZOsupport Stand, visit www.impedimed.com...
Page 130: Sozoapp Troubleshooting
Ensure that nothing is in contact with the SOZOtouch or SOZOstep electrodes when applying power. For more information on setting up the SOZO system without the SOZOsupport Stand, visit www.impedimed.com or contact ImpediMed technical support.
Page 131: Lymphoedema Settings Error
3. Unplug the SOZO Device from the wall outlet for 10 seconds and plug back Re-run the self-test function. 11.2 Lymphoedema Settings Error Editing Lymphoedema Settings on the patient profile may trigger an error message. “Please set your L-Dex assessment settings.”  ImpediMed – August 2023 Page 131 LBL-537 REV K...
Page 132: Bilateral Arm Selection
• For patients at bilateral risk for lymphoedema (3-10% of breast cancer patients)1, guidelines suggest routine screening using clinical exam and symptom assessment. Heron DE, et al. Risk factors and outcomes for patients with synchronous and metachronous disease. Cancer 2000;88(12):2739-50.  ImpediMed – August 2023 Page 132 LBL-537 REV K...
Page 133: Patient Dashboard Error
• Unplug the SOZO Device from the wall outlet and plug back in. • Re-run the self-test function. • Ensure that the patient is standing and correctly positioned on the SOZO Device before tapping Measure.  ImpediMed – August 2023 Page 133 LBL-537 REV K...
Page 134: Connectivity Error
The General Troubleshooting chart provides guidance for common issues and error messages. In the event that you need additional help, call +61 7 3860 3700 option 2, ImpediMed technical support, or you may email ImpediMed at ts@impedimed.com or visit https://www.impedimed.com.
Page 135 Segmental, tab is missing from the or licence is not available. the patient and adjust accordingly. history or results. Check available licences and contact ImpediMed technical support if unable to resolve. No SOZO Devices are selectable Device is not licensed. Check licence status. Contact...
Page 136 Ensure that correct patient contact is made for all eight electrodes. If error persists, contact ImpediMed If any physical damage has technical support. occurred to hardware electrode check may also fail.
Page 137 IOS. If Bluetooth is enabled on the Tablet, and SOZO system otherwise appears to be functioning correctly, please call ImpediMed technical support. “Self-test unknown error”...
Page 138 IOS. If Bluetooth is enabled on the Tablet, and SOZO system otherwise appears to be functioning correctly, please call ImpediMed technical support. When attempting to save the Bilateral arms are selected as L- De-select Bilateral and/or arms.
Page 139: Personal Data
Administrator Interfacing with SOZO System Issue/Error Message Potential Cause Resolution “The email entered already exists for When creating a new clinician, the Check the deleted users to see if the another clinician or administrator. selected email address is identical to email was already used and restore The email used must be unique.”...
Page 140: Care And Maintenance
The Tablet may require cleaning and disinfection as well. For the Tablet provided with the SOZO Device, ImpediMed recommends the use of protective disposable Tablet sleeves, to be used and replaced as per your Clinic’s policy. The use of a protective sleeve prevents the need to use potentially damaging chemicals on the Tablet itself.
Page 141: Sozo Device Maintenance
Section 12.1.1 above. The SOZO Device does not require any periodic calibration. 13.3 Self-Test To ensure that the SOZO system is operating correctly, run a self-test from the SOZOapp settings menu. ImpediMed recommends that the self-test be performed at the start of the day on which measurements of the patient will be taken.
Page 142: Technical Support
Tablet 14 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 and accessories will be repaired, or at ImpediMed’s option, replaced.
Page 143: Regulatory Statement
Before returning a product for repair, please contact ImpediMed or their authorised distributor for instructions. In no event will ImpediMed be liable for any direct or indirect damages including incidental, consequential or special damages, arising out of or in connection with the use or performance of the product.
Page 144: Product Specifications
Meets the requirements of IEC 60601-1-2 and 60601- Compatibility 1-11. Minimum service life of Minimum service life and associated warranty of parts device and accessories and accessories is one year.  ImpediMed – August 2023 Page 144 LBL-537 REV K...
Page 145: Safety Information
100 kHz Repetition Freq 100 kHz Repetition Freq Mains power quality Surge ±1kV Differential ±1kV Differential should be that of a typical IEC 61000-4-5 commercial or hospital ±2kV Common ±2kV Common environment.  ImpediMed – August 2023 Page 145 LBL-537 REV K...
Page 146 IEC 61000-4-8 50 or 60 Hz 50/60 Hz hospital environment. NOTE Ur is the AC mains voltage prior to application of the test level.  ImpediMed – August 2023 Page 146 LBL-537 REV K...
Page 147 Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter.  ImpediMed – August 2023 Page 147 LBL-537 REV K...
Page 148 CDMA 1900; Pulse 1700- Modulation 1990 1900; 217Hz DECT; 1 970 LTE Band 1,3,4,25; UMTS Bluetooth, WLAN, 802.11 Pulse 2400- b/g/n, 2450 Modulation 2570 RFID 217 Hz 2450, LTE Band  ImpediMed – August 2023 Page 148 LBL-537 REV K...
Page 149 80 to 800MHz 800MHz to Power 80MHz 80MHz 2.7GHz (Watts) Non-ISM D=(12/E1)(Sqrt D=(3.5/V1)(Sqrt D=(12/V2)(Sqrt D=(23/E1)(Sqrt 0.01 0.116667 0.12 0.12 0.23 0.368932 0.379473 0.379473 0.727324 1.166667 3.689324 3.794733 3.794733 7.273239 11.66667  ImpediMed – August 2023 Page 149 LBL-537 REV K...
Page 150: Glossary
Clinic-A customer of ImpediMed, such as a hospital or medical clinic, which uses the SOZO system. Clinician - The primary User of the SOZO system, and an authorised User of MySOZO and the SOZOapp. The Clinician uses the SOZO Device to take and record measurements of patients;...
Page 151 FFM includes bone, muscle, connective tissue, organs, and body water. FFM is typically measured in mass (kg or lb) or expressed as a percentage of total mass (e.g. 60% fat free mass). Hex Key-A tool which comes with the SOZO system for assembling the SOZOsupport Stand. HF-Dex...
Page 152 Measurements-Measurement data taken by the Clinician of the patient using the SOZO Device. Measurements are the inputs in the SOZO assessment process. MySOZO-The central cloud-based hub for the SOZO system that computes, and stores assessments based on raw measurement data taken from the SOZO Device.
Page 153 ImpediMed, also referred to as the SOZO Digital Health Platform in the SOZOapp, which uses Bioimpedance Spectroscopy to perform various Assessments of patient fluid levels. The SOZO system is comprised of hardware-the SOZO Device and the Tablet, and software - MySOZO and the SOZOapp.

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