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If you have customer service or technical support questions, please contact us:

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tsu@impedimed.com

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+61-7-3860-3700
ts@impedimed.com

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SOZO®

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L-Dex score frequently asked questions

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What is an L-Dex Score?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It was developed by ImpediMed to aid in the clinical assessment of lymphedema in an arm or a leg. It is measured using ImpediMed’s SOZO Digital Health System.

Learn more

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How do I know if an L-Dex Score is normal?

The normal range for an L-Dex score is between -10 and +10. Values greater than +10 can indicate lymphedema. Values which have increased by more than 6.5 units from a baseline measurement can also indicate early stages of lymphedema. The healthcare professional should consider the patient history when interpreting the L-Dex values and use the score as an aid in their clinical assessment of lymphedema.

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How do I know if an L-Dex Score is abnormal?

The normal range for an L-Dex score is between -10 and +10. Values greater than +10 can indicate lymphedema. Values less than -10 are often a sign of a measurement or procedure issue. Values which have increased by more than 6.5 units from a baseline measurement can also indicate early stages of lymphedema. The healthcare professional should consider the patient history when interpreting the L-Dex values and use the score as an aid in their clinical assessment of lymphedema.

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What does it mean to have an abnormal L-Dex Score?

The normal range for an L-Dex score is between -10 and +10. A value greater than +10, or a value which has increased more than 6.5 units from a baseline measurement, indicates an accumulation of excess fluid outside the cells in the at-risk limb which can indicate lymphedema. The healthcare professional should consider the patient history when interpreting the L-Dex values and use the score as an aid in their clinical assessment of lymphedema.

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How does the L-Dex Score aid in the prevention of cancer-related lymphedema?

Like many medical conditions, secondary, cancer-related lymphedema develops in stages and if caught early, progression can be prevented. At Stage 0, lymphedema is typically reversible. The lymphatic system is impaired but there is not enough fluid buildup for patients to notice symptoms. At Stage 1, fluid accumulation usually results in noticeable swelling and discomfort. Treatment at this stage can alleviate symptoms and sometimes reverse progression. At Stages 2 and 3, lymphedema is irreversible. In order to prevent lymphedema, it must be identified and treated at an early stage.

The L-Dex score is a measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It is capable of detecting lymphedema at the subclinical stage, when it is still reversible. If subclinical lymphedema is detected, patients will be instructed on at-home therapy using standard compression garments. Research has shown that early detection using the L-Dex score combined with at-home  compression therapy can reduce the progression of lymphedema by 95%.

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Why not prescribe prophylactic use of compression sleeves instead of proactive monitoring?

Prophylaxis with compression has been recommended for many years but has proven to be highly unsuccessful as demonstrated by continued high incidence rates. The literature on patient compliance to prophylaxis has shown that the burden is better tolerated if the benefit is real and measurable.

An L-Dex score, derived using ImpediMed’s SOZO system, is an effective tool used by a clinician to identify those patients who have subclinical lymphedema. Research has shown that early detection using L-Dex combined with at home compression therapy can reduce the progression of lymphedema by 95%.

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What is the recommended protocol to monitor patients at-risk for lymphedema?

Clinical Practice Guidelines for Bioimpedance Spectroscopy (L-Dex) for Breast Cancer Related Lymphedema Assessment were published in The Breast Journal in 2016. The guidelines recommend the following protocol for monitoring patients at-risk for lymphedema with a clinical assessment using L-Dex:

Pre-treatment baseline

Years 1-3: Every 3 months

Years 4-5: Every 6 months

Years 6+: Annually

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Are there any patient brochures that will help me explain the L-Dex Score?

Yes, ImpediMed offers the SOZO Patient Information Guide and a What You Should Know About Lymphedema and Cancer brochure free of charge to customers. Please contact your ImpediMed representative or customer service to obtain these brochures.

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What parts of the body can be assessed for lymphedema using the L-Dex Score?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It can be used to assess lymphedema in arms or legs. A unilateral measurement will measure an L-Dex score for one arm or one leg. A bilateral measurement will measure an L-Dex score for both arms or both legs. The healthcare professional selects the appropriate measurement based on the individual needs of each patient.

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What if both arms or legs are at-risk of developing lymphedema?

When a patient is at-risk of developing lymphedema in both arms or legs, this is known as a bilateral assessment. When the bilateral assessment is selected, SOZO will measure an L-Dex score either for both arms or for both legs. The healthcare professional selects the appropriate measurement based on the individual needs of each patient.

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Does L-Dex Score work for men and women?

Yes, the L-Dex score using ImpediMed’s SOZO device works for men and women.

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How does an L-Dex Score improve on the tape measure or volumetric bath?

The L-Dex score is an objective and validated metric for lymphedema assessment worldwide, and has excellent repeatability. Tape measure and water displacement measurements are subject to user variability. Unlike L-Dex, tape measure and water displacement measurements are not specific to fluid changes and are impacted by changes in muscle or fat. Research has shown that early detection using L-Dex combined with at-home compression therapy can reduce the progression of lymphedema by 95%.

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Does L-Dex distinguish between lymphedema and other types of edema?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It cannot distinguish the source of fluid between lymphedema and swelling caused by other means such as trauma, infection, or disease. The healthcare professional should consider the patient history when interpreting the L-Dex score and use it as an aid in their clinical assessment of lymphedema.

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Does fibrotic tissue affect the L-Dex Score?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It can monitor increases or decreases in the fluid outside of cells in fibrotic limbs. In patients with advanced cases of fibrosis where there is little excess fluid, the L-Dex score may not correspond to the physical size of the arm or leg.

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Will the L-Dex Score change if a patient develops a new malignancy?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It cannot distinguish the source of fluid between lymphedema and swelling caused by other means such as trauma, infection, or disease. The healthcare professional should consider the patient history when interpreting the L-Dex score and use it as an aid in their clinical assessment of lymphedema.

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Will the L-Dex Score change with chemotherapy or radiation?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It cannot distinguish the source of fluid between lymphedema and swelling caused by other means such as trauma, infection, or disease. Chemotherapy drugs, such as taxanes, which are known to cause swelling in some patients, may impact the L-Dex score. The healthcare professional should consider the patient history when interpreting the L-Dex score and use it as an aid in their clinical assessment of lymphedema.

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How does general weight gain affect the L-Dex Score?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. Normal weight gain due to an increase in muscle or fat will not affect the L-Dex score. The healthcare professional should consider the patient history when interpreting the L-Dex score and use it as an aid in their clinical assessment of lymphedema.

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How does water retention affect the L-Dex Score?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It cannot distinguish the source of fluid between lymphedema and swelling caused by other means. Normal water retention that affects the entire body evenly will not impact the L-Dex score. The healthcare professional should consider the patient history when interpreting the L-Dex score and use it as an aid in their clinical assessment of lymphedema.

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How does dehydration affect the L-Dex Score?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedemas compared to a healthy limb. Dehydration that affects the entire body evenly will not impact the L-Dex score. The healthcare professional should consider the patient history when interpreting the L-Dex score and use it as an aid in their clinical assessment of lymphedema.

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What is an L-Dex baseline?

An L-Dex baseline is a patient-specific reference value for tracking changes of future L-Dex score measurements. For each patient, the SOZO system tracks the change in L-Dex score over time. A healthcare professional can set any measurement as a baseline from which to monitor future changes in the L-Dex score, making the assessment personalized for each patient.

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When should the L-Dex baseline be measured?

The optimal time to measure the L-Dex baseline is before a patient begins any cancer treatment. If the patient is not measured before treatment, the L-Dex baseline can be measured at the first post-operative visit. The patient should be assessed for signs of lymphedema or surgically-related swelling prior to setting the L-Dex measurement as a baseline measurement.

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What should a pretreatment L-Dex baseline be for a patient?

The normal range for an L-Dex score is between -10 and +10. Values greater than +10 can indicate lymphedema. The healthcare professional should consider the patient history when interpreting the L-Dex values and use the score as an aid in their clinical assessment of lymphedema.

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When is the best time to take a post-operative L-Dex baseline measurement?

An L-Dex baseline measurement can be taken at any time post-operatively. However, many practitioners will wait for post-surgical swelling to resolve. If a post-operative L-Dex measurement is used as the baseline, the patient should be assessed for signs of lymphedema or surgically-related swelling a prior to setting the L-Dex measurement as a baseline measurement.

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What is an L-Dex unit?

L-Dex is a ratio that compares the extracellular fluid (fluid in the body that is outside of cells) in a limb at risk for lymphedema to the extracellular fluid in a healthy limb. As a result, an L-Dex score does not have a unit of measure. Instead, it is measured on a scale. The L-Dex scale is centered at 0, which is the mean ratio for a normal, healthy population taking into account gender and limb dominance differences. A change of 10 L-Dex units on the scale is an equivalent of 3 standard deviations (SD) from 0.

L-Dex Scale

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What does an L-Dex Score of 10, 20, or 30 mean?

The normal range for an L-Dex score is between -10 and +10, which is 3 standard deviations from the mean of 0. Values greater than +10 can indicate lymphedema, and values which have increased by more than 6.5 units from a baseline measurement can also indicate early stages of lymphedema. L-Dex scores of +20 and +30 represent 6 and 9 standard deviations from the mean, respectively, which can indicate increasingly severe lymphedema. The healthcare professional should consider the patient history when interpreting the L-Dex values and use the score as an aid in their clinical assessment of lymphedema.

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What is the maximum L-Dex Score?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. Since it is a ratio, there is no theoretical L-Dex score maximum. The normal range for an L-Dex score is between -10 and +10. Values greater than +10 can indicate lymphedema. The healthcare professional should consider the patient history when interpreting the L-Dex values and use the score as an aid in their clinical assessment of lymphedema.

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Can an L-Dex Score be used to grade lymphedema?

No. An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It is intended to aid a healthcare professional in the assessment of lymphedema. Diagnosis and grading of lymphedema should be performed by the healthcare professional.

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Can I compare an L-Dex Scores and a volume measurement?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It is a direct measurement of fluid accumulation outside of the cells and is not affected by changes in weight due to volume changes in muscle or fat. For this reason, exact comparisons of L-Dex scores to volume measurements cannot be made.

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Why does the L-Dex Score go down in a patient who has visible lymphedema and fibrotic changes?

An L-Dex score is a unique measurement of fluid buildup in a limb which is at-risk of developing lymphedema compared to a healthy limb. It will monitor increases or decreases in the fluid in fibrotic limbs. In patients with advanced cases of fibrosis where there is little excess fluid, the L-Dex result may not correspond to the physical size of the arm or leg.

SOZO digital health system frequently asked questions

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What is the SOZO Digital Health System?

The SOZO digital health system is the world’s most advanced, bioimpedance spectroscopy (BIS) medical device. In a single, non-invasive, painless, 30-second assessment, SOZO delivers a precise snapshot of fluid status and tissue composition as well as the L-Dex score to aid in the assessment of secondary, cancer-related lymphedema. The SOZO Digital Health System is commonly referred to as “SOZO”.

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How does SOZO Work?

SOZO uses bioimpedance spectroscopy (BIS), which is the most advanced method of using bioimpedance measurements to assess fluid levels and tissue composition. SOZO sends an electrical current through the body and measures the body’s resistance and reactance to this electrical current at 256 unique frequencies. The measurement is non-invasive, painless, and takes less than 30 seconds to complete.

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What is the meaning of the name “SOZO”?

SOZO is derived from the Greek word for “healed”. The Greek word “sozo” has been translated as: healed, preserve, save or saved, well, and whole.

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Can the patient feel the SOZO measurement when it is taken?

No, the electrical current used is at a very low level and imperceptible.

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Are there any patients I shouldn’t measure with this device?

SOZO has the following contraindications for use:

  • Patients with active implanted medical devices, e.g. cardiac pacemakers, defibrillators or patients connected to electronic life support devices.
  • Patients undergoing external defibrillation

SOZO has the following warnings for use:

  • Pregnant Patients: while the used of bioimpedance technology in pregnant patients has been shown to have no adverse effects, the SOZO device has yet to be clinically validated for use with that population group.
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Can SOZO be used to measure patients with orthopedic implants?

Yes, patients with orthopedic implants may have measurements taken using SOZO. The implants may alter the measurements slightly compared to a patient without orthopedic implants, but the impact on the measurement will be consistent for each subsequent measurement. The implant may affect the initial measurement relative to normal reference ranges, but should not affect trends over time.

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Can a SOZO measurement be performed on a patient with a chemo port?

Yes, the SOZO system may be used to take a measurement on patients with plastic or metal chemo ports.  However, the presence of the port should be noted in the patient’s record as it could impact the measurement.

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What if a patient cannot stand on the device?

The SOZO system can be configured to test patients in either standing and seated positions. It is strongly recommended that patients take readings from the same position each time to enable accurate comparisons over time.

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What are the steps to take a high-quality SOZO measurement?

In order to get a high quality measurement, the following steps should be taken:

  • Ask the patient to remove all metal jewelry and portable electronic devices
  • Dampen the patient’s hands and feet
  • Ask the patient to stay still during the 30 second measurement
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Should you take an additional measurement after you take the first one to make sure they are the same?

Every time a measurement is taken with SOZO, the device records the quality of the measurement. Healthcare professionals have the opportunity to reject the measurement if the results are deemed low-quality. If the healthcare professional rejects the measurement, then a second measurement should be taken. Otherwise, no additional measurements are required.

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Do you have to take the measurement at the same time of day every time you take a measurement?

For L-Dex measurements, it is not required to take the SOZO measurement at the same time of day for a given patient. For Fluid Analysis and Tissue Analysis, however, it is recommended to take measurements with the SOZO system at the same time during the day for a given patient to aid in consistency when comparing results over time.

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Do patients have to remove all jewelry for a SOZO measurement?

Yes. For the most accurate and consistent results, a patient should remove all metal jewelry and electronic devices.

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Can patients wear pantyhose, stockings, or socks during a SOZO measurement?

No. SOZO measurements must be taken with bare hands and feet.

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Does very dry skin affect a SOZO measurement?

Yes. Dry skin can affect the contact between the patient’s hands and feet and the SOZO device. It is recommended to dampen the patient’s hands and feet with water before placing them on the SOZO device. Do not use skin creams prior to measurement on dry skin.

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What if a patient moves during a SOZO measurement?

For the most accurate and consistent results, a patient should remain still during a SOZO measurement. If there is movement during the measurement, and it impacts the measurement quality, then the healthcare professional may reject the measurement and retake it.

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What is a Cole plot?

A Cole plot is a visual representation of the SOZO measurement data that allows a healthcare professional to visually confirm the quality of the measurement. It plots the 256 resistance and reactance measurements for each body segment measured. If the healthcare professional determines that the measurement is low quality, the measurement may be rejected and retaken.

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What is the self-test function?

The SOZO self-test ensures that all electronics are functioning properly before taking patient measurements. It is recommended that a self-test be performed at the start of each day before any measurements are taken.

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How do I purchase SOZO?

SOZO is sold by ImpediMed or authorized ImpediMed distributors. For more information, contact:

 

U.S Sales or Distributors:

info@impedimed.com

+1-877-247-0111 (Toll Free)

 

International Sales:

enquiries@impedimed.com

+61-7-3860-3700

 

Request a quote

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Will I get a tablet with my purchase of a SOZO device?

Yes, a tablet will be provided. The SOZOapp (application) will be pre-loaded on the tablet.

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What kind of tablet will I get with my SOZO purchase?

You will receive a Samsung Android® tablet as part of the SOZO purchase.

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Can I run any other apps on my tablet?

The tablet is a commercially released device and is capable of running other apps. ImpediMed strongly recommends that the tablet be limited to use with the SOZO system, and cannot guarantee the continued use of the SOZOapp or the security of data collected with the SOZO device if other apps are installed.

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Does the tablet support Mobile Device Management (MDM)?

Yes, the SOZO tablet and SOZOapp support typical MDM systems for securing the devices.

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Does the tablet require maintenance?

The supplied tablet comes partially charged and will need to be charged periodically. ImpediMed recommends charging the tablet upon initial receipt of the SOZO system, and maintaining an adequate charge to ensure the system can be used effectively.

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Does the SOZO device use Bluetooth®?

Yes, the SOZO device uses Bluetooth® to communicate with the tablet.

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What are the environmental operating conditions for the SOZO device?

The SOZO device must be operated in the following conditions:

  • A temperature range of +5°C to +40° C (+41°F to +104°F)
  • A relative humidity range of 15% to 93%, non-condensing
  • An atmospheric pressure range of 700 hpa to 1060 hpa
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How should I transport and store the SOZO device?

The SOZO device must be transported (moved) and stored in the following conditions:

  • -25°C (-13°F) without relative humidity control and +70°C (158°F) at a relative humidity up to 93%, non-condensing.

If SOZO has been stored at the extremes of these temperature ranges, please allow it to return to its operating temperature conditions before installing or using.

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What is the warranty and can I buy extended a warranty?

ImpediMed’s warranty is specific to the geographic region or country of the customer. For more information, contact your ImpediMed representative or ImpediMed customer service:

 

U.S. technical support:

tsu@impedimed.com or +1-877-247-0111 (Toll Free)

 

Australia, Asia, and Europe technical support:

ts@impedimed.com or +61-7-3860-3700

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What are the Care and Maintenance instructions for SOZO?

The SOZO device should not be subjected to ingress of liquid or liquid spillage, impact and excessive heat (direct exposure to sunlight). This can cause damage to the device or harm to the patient or give an incorrect reading. The SOZO device should be used in a dry environment. When not in use the SOZO device may remain set up and does not need to be uninstalled. If storage is desired, always keep the SOZO device in its original packaging. There is no periodic maintenance or calibration required of the SOZO device.

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What is the cleaning and disinfecting process?

The external enclosure of the SOZO device should be cleaned between each use with nonbleach based  disinfecting agents such as isopropyl alcohol 70% or Peridox® Concentrate Sporicidal Disinfectant and Cleaner. Cleaning / disinfection should be performed according to manufacturer policy. ImpediMed does not recommend the use of bleaching agents to clean/disinfect the SOZO system as it may cause corrosion of the electrodes. Additionally, ImpediMed does not recommend the use of disinfectants containing aldehydes, phenols and amines as they may cause damage to the plastic housing. The tablet may require cleaning and disinfection as well. For the Samsung Tablet provided with the SOZO unit, ImpediMed recommends the use of protective disposal tablet sleeves, to be used and replaced as per your facility policy. The use of protective sleeves prevents the need to use potentially damaging chemicals on the tablet itself.

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What type of repairs can be done to SOZO device?

There are no user-repairable electronic parts within the SOZO device. Please contact ImpediMed or an authorized agent should service or repair of the SOZO device be required. Do not attempt to use the SOZO device if it does not appear to be functioning correctly or is in need of repair.

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How do I recycle a SOZO device?

Contact ImpediMed to learn about SOZO recycling.

 

Australia:

Phone: +61 7 3860 3700

 

European Union:

All products at the end of their life may be returned to ImpediMed for recycling.  You can also contact ImpediMed at:  impedimedeu@impedimed.com

 

United States:

Phone: +1 (760) 585-2525

SOZOapp frequently asked questions

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Is SOZOapp compatible with apple products?

The SOZOapp does not currently operate on Apple product platforms. This includes, but is not limited to mac, iPad, iPhone, Apple Watch, or any machine running an Apple iOS.

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Do I need to update my SOZOapp?

Customers will be notified of SOZOapp updates when they are available. ImpediMed technical support can help complete the updates if needed.

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Can I download SOZOapp from ImpediMed’s website?

SOZO devices are shipped with a tablet that is pre-loaded with the SOZOapp.

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What languages are supported on SOZOapp?

Danish, Dutch, English, French, German, Italian, Portuguese, and Spanish are currently supported with the international version of SOZOapp.

SOZO software version 3 frequently asked questions

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What is the difference between SOZO Software version 3 and version 2?

SOZO software version 3 is a cloud-based data processing and storage solution, whereas SOZO software version 2 requires installation of a local server and software called SOZOhub, to process and store SOZO measurement data. Each SOZO version 3 customer receives a MySOZO account that is unique to their institution. A single MySOZO account can run multiple SOZO devices in multiple locations with multiple clinical users taking measurements.

 

SOZO Software Version 3 Architecture (U.S.)

SOZO Software Version 3 Architecture (OUS)

SOZO Software Version 3 Release Notes

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Is ImpediMed Business Associate Compliant?

ImpediMed is HIPAA Business Associate compliant and has implemented the following security
and privacy controls:

a. Security Standards (45 C.F.R. § 164.306)
b. Administrative Safeguards (45 C.F.R. § 164. 308)
c. Physical Safeguards (45 C.F.R. § 164.310)
d. Technical Safeguards (45 C.F.R. § 164.312)
e. Organizational Requirements (45 C.F.R. § 164.314)
f. Policies and Procedures (45 C.F.R. § 164.316)
g. Notification to the Secretary (45 C.F.R. § 164.410)
h. General Rules; Uses and Disclosures of PHI (45 C.F.R. § 164.502)
i. Organizational Requirements; Uses and Disclosures (45 C.F.R. § 164.504)

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Where does SOZO store data?

All data are stored on secured infrastructure hosted by ImpediMed through Amazon Web Services. No data are stored in the tablet (SOZOapp) or the SOZO device itself.

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Does SOZO encrypt data?

All data sent between SOZOapp and MySOZO.com and all data at rest are encrypted using SSL/HTTPS. All data sent between SOZOapp and the SOZO device are encrypted using standard Bluetooth® encryption.

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If there is a data breach, what is the breach notification process?

ImpediMed adheres to HIPAA’s breach notification requirements, which in turn adheres to the breach requirements of many other regional regulatory bodies. Upon detection of a breach, immediate mitigation steps are taken to limit the extent of the breach. Affected Business Associates and Covered entities are notified within 5 business days. Notifications to the governing bodies adhere to specific regional requirements.

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Can SOZO use Active Directory FOR user accounts?

At this time, MySOZO does not offer integration into Active Directory or support LDAP. However, creating and maintaining the users accounts are easy and can be done via accessing MySOZO.com.

SOZO software version 2 frequently asked questions

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Do I have to install SOZOhub?

Yes, installation of SOZOhub is required for SOZO software version 2. All data are stored on the SOZOhub. No data are stored in the tablet (SOZOapp) or the SOZO device itself. SOZO software version 3 is a cloud-based solution that does not require installation of SOZOhub.

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Does the SOZOhub have the ability to produce a record of log in’s by user name/password?

SOZOhub does not keep a log of user logins or any user/admin changes to the systems. SOZO software version 3 does provide audit logs with the identity of users who have viewed certain MySOZO.com pages, the identity of users who have retrieved data, and users’ log in and log out dates and times.

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Can I have more than one (1) IT administrator for SOZOhub?

One (1) IT administrator (admin) is allowed for SOZOhub. SOZO software version 3 is a cloud-based solution that permits multiple administrators.

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How is the administrator password reset on SOZOhub?

To reset the administrator password, right click on the installer and select “run as administrator”. Within the installer, you can select the “modify hub” option and reset the administrator password.

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What is MySQL? Can I get more information?

MySQL is a database. For more information, visit: https://www.mysql.com.