MediByte System Home Sleep Testing Common Questions and Answers Nov 2013

I thought BRAEBON was a sleep sensor company? How can BRAEBON help me with Home Sleep Testing (HST)? Yes, we started with sleep sensors but over the past several years BRAEBON has been doing much more than just sleep sensors. In fact, we’ve been in the Home Sleep Testing business much longer than most other companies. We took our famous sleep sensor technology and adapted it to work with our own portable recorders in the home. The result is BRAEBON now sells a complete range of top-notch Level 3 & Level 4 Home Sleep Testing equipment.

What are the BRAEBON HST devices called? BRAEBON offers two HST devices for recording snoring and sleep apnea: the BRAEBON MediByte® is our 12-channel Level 3 HST device and the MediByte® Junior is the 6-channel Level 3 / 4 HST version.

What’s the difference between the MediByte and its sibling, the MediByte Junior? The MediByte is a complete 12-channel Level 3 recorder which exceeds all new home sleep apnea testing guidelines. The MediByte Junior is a 6-channel Level 4 recorder which can be upgraded to a Level 3 device simply by adding one respiratory effort belt. This entry-level Home Sleep Testing device complies with all CMS requirements for either Level 4 or Level 3 Home Sleep Testing. The MediByte records everything the MediByte Junior does, but adds an additional effort channel, a sum channel, an oronasal thermal airflow channel, and an Auxilary port which means you have the option to record more information when using the thermal airflow sensor: ECG, or EMG, or Audio (snoring).

What exactly does the MediByte and MediByte Junior record? MEDIBYTE® Junior 6 Channels ● ● ● ● ● ● ● Optional

Airflow (OroNasal Pressure Cannula) Snoring (OroNasal Pressure Cannula) SpO2 Pulse Rate Body Position CPAP Pressure Event Marker Chest Effort (RIP) Abdominal Effort (RIP) SUM (RIP) Airflow (OroNasal Thermistor) Audio (Microphone) Volume (dB) EKG EMG (PLMs, Bruxism) Number of software installations per recorder Size Weight in grams (including battery) Location worn during recording

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MEDIBYTE® 12 Channels ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● 1

World's Smallest Type 3 3”x2.5”x1” 63x76x25mm

World's Smallest Type 3 3”x2.5”x1” 63x76x25mm

81 (2.6 oz) Chest

84 (2.7 oz) Chest

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What do I get when I buy it? You get everything you need right out of the box. Simply add your own Windows XP or Vista computer with USB port and you are good to go. When you buy the complete MediByte kit you receive a convenient, durable carrying case which includes the MediByte recorder, all needed software with three software licenses, all sensors, USB communication cable, six patient kits and a one-year MediByte warranty. The MediByte Junior comes in a carrying pack about the size of a shaving kit and includes one patient kit.

MediByte carrying case

MediByte Junior carrying pack

How big is the MediByte? The MediByte is the smallest in its class. The small size means better patient comfort and compliance.

How easy is it to use the MediByte? The MediByte is one of the easiest Home Sleep Testing devices to use. Simplicity and ease of use is the key to its success. For example, all connectors are unique. This means the patient training and hook-up is much simpler with no likelihood to plug the wrong sensor into the wrong connector on the MediByte. Attaching the MediByte to the computer is simple and uses a standard USB connection just like your digital camera. The software uses a wizard to prepare the MediByte for a patient recording, and to download the data. The oversized event button makes it easy for the patient to use during the recording. After the recording, the data is automatically analyzed and ready for manual review within our full disclosure software. Quite literally, if you can use a computer mouse you can use the MediByte!

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How long has the MediByte been on the market? BRAEBON has been selling the MediByte since November 2006 and today it is used on five continents.

Are patient instructional videos available? Yes, go to http://www.braebon.com/mp8_demo.html to download the MediByte instructional videos. Go to http://www.braebon.com/medibyte_jr.html to download the MediByte Junior video.

Can the MediByte record multiple nights? Yes, you can record up to two consecutive 9-hour recordings. In fact, you can choose one 9-hour night, two nights, or one continuous 24-hour recording for EKG. You can also choose to start the recording automatically or manually use the On / Off switch. The ability to record two nights minimizes the firstnight effect, and is also useful for evaluating oral appliance treatment with a baseline night and treatment night.

Does the MediByte permit full disclosure? Yes, MediByte software fully complies with new guidelines and permits both full data disclosure and manual scoring.

Can I install the software anywhere I like? Yes, you receive three software licenses with your purchase and you can install a copy on any Microsoft Windows XP or Vista computer. Additional software licenses are available for a small fee.

Is the MediByte compatible with CPAP? Yes, both the MediByte and MediByte Junior can be connected to any CPAP for recording flow, snoring, and CPAP pressure.

Is the technology used in the MediByte the same technology used in sleep laboratories? Yes, because BRAEBON has been selling sleep sensors to sleep laboratories for over ten years, we use the exact same sensors and technology within our family of Home Sleep Testing devices as we supply to world leading sleep laboratories. This means you meet the new Home Sleep Testing guidelines when using the MediByte. It also means the test results can be exchanged and easily understood by any doctor, dentist, or laboratory. With the MediByte, you are practicing medicine at the state-of-the-art.

Can I use sensors from other companies with the MediByte? No, to achieve optimal performance with the MediByte you must use genuine BRAEBON sensors. Remember, BRAEBON started in the sleep sensor business and is a recognized leader in this field – why use something else?

What is the per use cost of running a test with the MediByte? The cost to do a test with the MediByte can be around $8 to $10

Does the MediByte record EEG? No, the MediByte is a snoring and sleep apnea recorder and is not intended for EEG recording. It does not record sleep staging information, but you can record one channel of EKG for up to 24 hours, or one channel of EMG for leg activity or bruxism. Our years of experience have shown us that once EEG is needed for a test, the level of complexity for the patient goes up dramatically.

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Do I need to hook up the patient and send them home? No, because the MediByte is so easy to use most patients hook themselves up at night in the comfort of their own bedroom. Prior to the test, a sleep technologist or dental assistant would prepare the MediByte for the patient before the patient arrives at the laboratory or office. Once the patient arrives, a brief five to ten minute training session is recommended to demonstrate the recorder to the patient and answer any questions. It is also recommended the patient watch the ten minute MediByte video prior to the actual test. Some sleep laboratories also provide their phone number in case the patient has any questions during the evening of the test. On the night of the test, the patient takes the MediByte carrying case home, uses the MediByte and returns the unit the next day where the technologist or assistant downloads the data for analysis.

Can I use rechargeable batteries with the MediByte? No, our experience has been that rechargeable batteries introduce a number of other problems including longer turnaround time, insufficient battery life, and shorter recording time. By using a fresh, new battery for each recording you are improving the likelihood of success.

Can I change the reports? You can change the header and footer on the report templates and add your company information, but we generally do not recommend that reports are altered.

Has the MediByte been validated? Yes, studies have found both high sensitivity and high specificity and have concluded that more than 4 of 5 patients are diagnosed identically when using the MediByte or when using full PSG in a sleep laboratory.

What are some of the billing codes? The following codes are examples where Medicare provides coverage for beneficiaries who use Home Sleep Testing to assist in the diagnosis of sleep apnea: G0398: Home Sleep Testing, Type II portable monitor; minimum 7 channels - $150.00  $100 is recognized for the Professional Component  $50 is recognized for the Technical Component G0399: Home Sleep Testing, Type III portable monitor; minimum 4 channels - $125.00  $85 is recognized for the Professional Component  $35 is recognized for the Technical Component G0400: Home Sleep Testing, Type IV portable monitor; minimum 3 channels - $100.00  $70 is recognized for the Professional Component  $30 is recognized for the Technical Component

What if I still have more questions? Call us at 1-613-831-6690 x218 or toll-free in North America at 1-888-462-4841 x218. We’re here to help.

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What does a sample MediByte Junior report look like? Patient Name:

Smith, Jack

Date of Birth: Weight: Height: BMI: Waist: 32” Comments::no comments

02/19/1966 165.0 lbs 5’ 9” 24.5 Hip: 0”

175 cm Neck Circumference: 16” Waist-Hip Ratio: 0.00

Total Recording Time(TRT): 292.9 minutes Respiratory and Total# Index Snoring Events Central Apneas 10 2.0 Obstructive.Apneas 0 0.0 Mixed Apneas 0 0.0 Hypopneas 0 0.0

Duration (sec.) Mean Min 26.7 9.9 0.0 0.0 0.0 0.0 0.0 0.0

Max 96.4 0.0 0.0 0.0

Apnea + Hypopnea

10

2.0

26.7

9.9

96.4

Desaturations

0

0.0

0.0

0.0

0.0

Snoring

0

0.0

0.0

0.0

0.0

Supine 5.7% 0 2 7.3

Prone 0.4% 0 0 0.0

Avg HR:

48.6

Mean SpO2 Min SpO2 Max SpO2 SpO2 Range 90-100 % 80-89 % 70-79 % 60-69% 50-59% < 50 % Left Side 37.2% 0 8 4.4

Cardiac Min 40.0 HR: Oximetry

Max HR:

95.0

97.3% 94.0% 100.0% % 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% Right Side 56.8% 0 0 0.0

Minutes 292.4 0.0 0.0 0.0 0.0 0.0 Total Non Supine 94.3% 0 8 1.7

BAD

BODYPOS

RESPIRATORY

PULSE

SPO2

Body Position % Time in Position Snoring events Apnea + Hypopnea events Apnea + Hypopnea Index

12345678 0987654321 11/04/08 42 Male

Patient ID: Chart Code: Study Date: Age: Sex: Referring Physician:

Total Recording Time: 292.9 minutes

Patient

Apnea-Hypopnea Index

Jack Smith

2.0

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Severe >30

Moderate 15 to 30

Mild 5 to 15

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Normal <5

What does a sample MediByte report look like? Patient Name: Smith, Mary Date of Birth: 03/14/1954 135.0 lbs Weight: 5’ 4” Height: 23.3 BMI: Waist: 34” Hip: 30” Comments: Respiratory and Snoring Events

162 cm Waist-Hip Ratio: 1.13

7732767863 0987654321 07/12/07 53 Female

Patient ID: Chart Code: Study Date: Age: Sex: Referring Physician: Cardiac

Total#

Index

Central Apneas Obstructive.Apneas Mixed Apneas Hypopneas AH Desaturations Snoring

6 83 1 57 147 56 3430

0.6 8.8 0.1 6.0 15.6 5.9 363.4

Body Position % Time in Position Snoring events AH events AHI

Supine 62.3% 2363 131 22.3

Body Position Min Max Mean

Supine 50.0 99.9 57.6

Mean Heart Rate

Oximetry 68.7

Highest Heart Rate

98.0

Slowest Heart Rate

57.0

93.5%

86.0% Min SpO2 98.0% Max SpO2 % Time SpO2 in Range 99.6% 90-100 % 0.4% 80-89 % 0.0% 70-79 % 0.0% 60-69% 0.0% 50-59% 0.0% < 50 %

Left Side 17.1% 624 5 3.1

Right Side 20.6% 443 11 5.7

Total Non Supine 37.7% 1067 16 4.5

Snoring Volume Table dB(A) Non-Supine Right Side 50.0 50.0 100.0 100.0 55.4 55.1

Left Side 50.0 95.4 55.9

Prone -

BAD

BODYPOS

RESP

PULSE

SPO2

VOLUME

Prone 0.0% 0 0 0.0

Mean SpO2

Total Recording Time: 566.3 minutes

Patient Mary Smith

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Apnea-Hypopnea Index 15.6

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Severe >30

Moderate 15 to 30

Mild 5 to 15

Normal <5

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Here is another example…

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