MediByte User Guide Ver 8.0 March 2016

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BRAEBON Medical Corporation

D.MP8.40600.5 March 2016

Table of Contents Chapter 1: Introduction What’s New in Version 8.0 ... 1-2 Indications for Use ... 1-3 Conventions Used in this Guide ... 1-4 Warnings and Cautions ... 1-5 Contents of the MediByte Kit ... 1-7 Overview of the MediByte Screener ... 1-9

Chapter 2: Specifications Software Requirements ... 2-2 MediByte Recorder Classification and Specifications ... 2-3 Controls ... 2-4 Accessories ... 2-5 Manufacturer’s Declaration ... 2-7

Chapter 3: Installing the Software Installing the MediByte Software ... 3-2 Installing the Hardware Drivers ... 3-4 Security Settings ... 3-5 Activating the MediByte Software and Language Selection ... 3-8

Chapter 4: Preparing for a Study Preparing the MediByte ... 4-2 Insert a fresh Battery into the MediByte® ... 4-2 Connect the MediByte to the Computer ... 4-3 Install the Hardware Drivers... 4-3 Select an Operation ... 4-3 Enter Patient Information ... 4-5 Select an Auxiliary Device... 4-6 Select the Start Time... 4-7 Review the Settings And Configure the MediByte ... 4-8 Prepare a Kit for the Patient... 4-9

Chapter 5: Preparing the Patient Snore Study ... 5-2 Chest and Abdominal Effort Belts ... 5-3 Snore Microphone... 5-5 Pressure Cannula Placement ... 5-6 Pressure Cannula with Thermistor Placement... 5-7 Place the SpO2 Sensor... 5-8 Using a FlexiWrap SpO2 Sensor ... 5-9 EKG Electrode Placement ... 5-10 Bruxism Electrode Placement ... 5-12 EMG Electrode Placement... 5-14 ExG Sleep Staging Electrode Placement... 5-16 Starting the Study ... 5-18 Ending the Study ... 5-18

Chapter 6: Reviewing Data Downloading Data from the MediByte ... 6-2 Data Display Screen ... 6-5 Changing the Language Used in the Software ... 6-6 Reviewing the Data ... 6-7 Assisted Scoring of Events ... 6-22 Manual Scoring of Events ... 6-27 Printing Reports ... 6-46

Chapter 7: Data Management Data Management ... 7-2 File Names and the Directory Structure ... 7-6 Pursuit Outcomes Applications ... 7-8

Chapter 8: File Transfer and Remote Scoring Chapter 9: Maintaining the MediByte Cleaning the MediByte ... 9-2 Maintaining the MediByte and Accessories ... 9-3 Troubleshooting ... 9-4

Chapter 1: Introduction

This user guide describes how to use the MediByte® and the MediByte® Software. The user guide has nine chapters: 1. Introduction 2. Specifications 3. Installing the Software 4. Preparing for a Study 5. Preparing the Patient 6. Reviewing Data 7. Data Management 8. File Transfer and Remote Scoring 9. Maintaining the MediByte®

In this chapter This chapter describes the MediByte® Screener and its components. Included in this chapter:

•

What’s new in version 8.0

•

Indications for use

•

Conventions used in this guide

•

Warnings and cautions

•

Contents of the MediByte® Kit

•

Overview of the MediByte® Screener

1-1

Introduction

What’s New in Version 8.0

1-2

•

Record an EXG channel which will record and display EEG, EOG and EMG waveforms on the data display.

•

The ability to manually add sleep staging tags to the data display.

•

Sleep staging hypnogram drawn in real time as the data is scored.

•

Marking of arousals by dragging the mouse over the EEG waveform.

•

Ten minute display width option.

•

View the Photoplethysmograph (PPG signal) at the bottom of the data display.

•

Pulse rate variability marking and reporting.

Introduction

Indications for Use The MediByte® is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. The data is downloaded after the recording is completed and the assist software enables the trained human professional - typically a Registered Sleep Technologist or Medical Doctor - to review and verify the results of the study and generate a report. Target Population: Children and adult patients who are screened during sleep disorder studies. Environment of Use: The majority of screenings occur either in the home or in a clinical setting. Caution: United States Federal law restricts this device to sale by or on the order of a physician.

1-3

Introduction

Conventions Used in this Guide Conventions for the MediByte These are the safety conventions used on your MediByte®. The table below lists the safety symbol, the name of the symbol and the meaning of the symbol.

BF Protection

Type BF Applied Part: F-Type applied part complying with the specified requirements of the IEC 60601-1 to provide a higher degree of protection against electric shock than that provided by Type B applied parts.

Note: Type BF Applied Parts are not suitable for Direct Cardiac Application.

Conventions for the User Guide Following are document and safety conventions. Each shows the document symbol or safety symbol, the name of the symbol and the meaning of the symbol.

Warning: This symbol flags a serious warning. It is vital that you heed all warnings to prevent injury to yourself or to your patient.

Caution: This symbol flags a caution. Heed all cautions to prevent damage to your equipment.

Note: This symbol flags a note. Notes provide important information about using the MediByte®, its accessories and the software.

1-4

Introduction

Warnings and Cautions Warnings This product is for diagnostic purposes only and is NOT to be used as an apnea monitor or in life sustaining or life supporting applications.

•

MediByte® records signals for use in assessing sleep disorders.

•

To protect the patient, never connect the MediByte® to the computer while the patient is still hooked-up to the MediByte®.

•

Always use a new BRAEBON™cannula and BRAEBON™ hydrophobic (safety) filter with each patient.

•

Do NOT use or attempt to service damaged parts.

•

Unauthorized opening of the MediByte® will void both the safety of the MediByte® and the terms and conditions of the MediByte® warranty.

•

Only trained operators should use the MediByte®.

•

Keep the MediByte® and its components away from flames.

•

Do NOT use the MediByte® in the presence of flammable compounds such as anesthetics.

•

Do NOT immerse the MediByte® in any liquids because damage will result. Advise all patients to keep the MediByte® away from water. Water damage will void the warranty.

•

Do NOT sterilize the MediByte®.

•

Do NOT perform unattended sleep studies on patients who are not physically able to use the MediByte® and its accessories.

•

To prevent strangulation, ensure all leads are taped-down.

Battery Warning Saft LS14250: •

Battery to be replaced by qualified personnel only.

•

Remove the battery if the device is not to be used for a long period of time.

•

Fire, explosion and severe burn hazard. Do not recharge, short circuit, crush, disassemble, heat above 100 OC (212 OF), incinerate or expose contents to water.

1-5

Introduction

Battery Warning BRAEBON Rechargeable: •

Battery to be replaced by qualified personnel only.

•

Remove the battery if the device is not to be used for a long period of time.

•

Fire, explosion and severe burn hazard. Do not short circuit, crush, disassemble, heat above 100 OC (212 OF), incinerate or expose contents to water.

Cautions •

Use only BRAEBON™ sensors and accessories.

•

Use only the BRAEBON™ Respiratory Effort Sensor (Model 8572). Other sensors will NOT function with the MediByte®.

•

Always use a new cannula and BRAEBON™ hydrophobic (safety) filter with each patient.

•

Do NOT set anything on top of the MediByte® and its accessories.

•

Sterilization of the MediByte® is NOT required. Do NOT steam autoclave the MediByte® or damage will occur and void the warranty.

•

Do NOT immerse the MediByte® in any liquids because damage will result. Advise all patients to keep the MediByte® away from water. Water damage will void the warranty.

•

Do NOT drop the MediByte®.

•

Use only 3.6 V 1/2AA battery, models Saft LS14250 (PN 0410-3) or 1/2AA Li-Ion rechargeable battery supplied by BRAEBON.

•

Do NOT recharge the Saft LS14250 (PN 0410); it is non-rechargeable.

•

Ensure the polarity of the battery is correct when inserting, otherwise the device will not operate.

•

Operate and store the MediByte® under the following environmental conditions: Operating Conditions Temperature Relative Humidity

1-6

Storage Conditions

10C–35C

-20C–60C

30%–95% (Without condensation)

10%–100%

Introduction

Contents of the MediByte Kit Verify that you have received the items listed in the MediByte® Kit and that no items were damaged during shipping. If any items are damaged or missing, please contact BRAEBON™ immediately at 1-888-462-4841. Do NOT use damaged items.

MediByte Kit Contents Quantity

Item

1

MediByte® Recorder (Model MP8)

2

BRAEBON Q-RIP Effort belt (Model 8572)

1

MediByte® Electrode Prep Kit (Model 8128)

1

MediByte® Electrode Prep Kit - five piece (Model 8128-5)

6

Self-Adhesive Electrodes, strip of 5 (Model 8501-5)

1

BRAEBON Snore Microphone with Thermistor Input (Model 8541)

1

BRAEBON Electrode Box (Model 8611)

1

24” and 60” lead wire kit (Model 8620)

1

BRAEBON cTherm Cannula Thermistor (Model 8514)

1

BRAEBON Soft Shell SpO2 sensor (Model 8897)

1

MediByte® Carrying case

1

MediByte® Communication Cable (Model 8889.21)

2

Patient Guide to MediByte® (Model 8925)

1

MediByte® User Manual (Model 8920)

1

Hex Screwdriver for MediByte® (Model 8870)

1

MediByte® First Patient Setup Guide

1-7

Introduction

Overview of the MediByte Screener The MediByte® was designed for quick clinician-to-patient turnaround. The clinician prepares the unit for data collection using the MediByte® Software. After the clinician prepares the MediByte®, the patient sleeps with the device and returns it to the clinician for data download and analysis. The data download and data analysis are performed using the MediByte® Software. After reviewing the data, the clinician generates a report using the software.

Description of the MediByte Screener The MediByte® Screener is a compact ambulatory device designed to efficiently aid in the detection of a number of sleep disorders; such as apnea, upper airway resistance and snoring. Because of its small size and portability, clinicians are no longer limited to recording data in an artificial sleep environment. Data collection can occur in the patient’s natural surroundings, over a more extensive period than might otherwise be practical in a sleep lab. The MediByte® Screener records up to twelve channels of physiological signals, including: audio, flow, snoring (volume), snoring (audio), blood oxygen saturation (SpO2), pulse rate, chest effort, abdominal effort, body position, sum and CPAP pressure. The MediByte® Screener consists of the following major components:

1-8

•

the MediByte® unit

•

the communication cable

•

BRAEBON sensors

•

MediByte Software.

Introduction

The MediByte Recorder ®

The MediByte® recorder has a plastic molded case with an Event button and Status LED on the front. On the top portion of the recorder, there is an auxiliary (AUX) port for snoring volume or EKG/EMG sensors, a pressure port and an SpO2 port. On the bottom portion of the recorder, there is a communication port, a chest effort port, an abdominal effort port and a collection on/off switch. See Figure 1.2 on page 1-10 for port locations. The Event button, located on the front of the recorder, permits the patient to record an event by depressing the button. The event marker is defined by the clinician within the software. Common events are lights out, lights on and bathroom break.

Figure 1.1: MediByte

OFF/ON

The Status LED is a small light located on the front of the recorder; it flashes green or red to indicate the current state of the unit. For example, the LED flashes green once every six seconds to show that the recorder is waiting to collect; and it flashes green twice every six seconds to show that the recorder is collecting. Continuous red blinking indicates that the battery is too low to record a study, although it may have enough charge remaining to download data. See Table 2-4 on page 2-4 for a complete list of Status LED indicators. The auxiliary (AUX) port, located on the top of the recorder, attaches the snoring microphone; the Electrode Box which accepts EKG, EMG bruxism, Sleep (EEG), or PLM lead wires. The cTherm thermistor cannula plugs into the white port located on the snoring microphone or the Electrode Box. The pressure port, located on the top of the recorder, attaches the oral/nasal cannula to the recorder. You can also use this port to record CPAP pressure. The SpO2 port, located on the top of the recorder, attaches the SpO2 sensor to the recorder. The communication port, located on the bottom of the recorder, accepts the BRAEBON communication cable. Use this port to attach the recorder to the computer to configure a study and

1-9

Introduction

to download the data from the recorder. Never attach the unit to the computer when it is already attached to the patient. The chest effort port attaches the chest effort (RIP) belt to the recorder. The abdominal effort port attaches the abdominal effort (RIP) belt to the recorder. The collection on/off switch sets the unit to record when in the manual mode. To start the recording, push the switch to the right (white dot). This switch only functions when the unit has been preset to manually record within the software. The collection on/off switch is disabled if the unit is preset to automatically record within the software. It is also disabled when the unit is connected to the computer.

For optimized performance and ease-of-use, BRAEBON recommends the automatic mode.

Figure 1.2: MediByte port locations

Communication Cable The communication cable connects the MediByte® to the computer. Use the communication cable to program the MediByte® for a study and for data download. A green LED on the communication cable displays when the MediByte® is properly connected to the computer.

Figure 1.3: Communication cable

1-10

BRAEBON Sensors The MediByte® Screener uses the following BRAEBON sensors: •

Two respiratory effort belts (Model 8572). The respiratory effort belts, which plug into the chest and abdomen ports on the MediByte®, are used to aid in the diagnosis of sleep apnea.

•

One snore sensor (Model 8541). The snore sensor, which plugs into the AUX port on the MediByte®, detects snore sounds.

•

One Electrode Box (Model 8611). The Electrode Box, which plugs into the AUX port on the MediByte®, attaches electrodes to the MediByte. Use this model for PLM and bruxism studies.

•

One SpO2 finger probe (Model 8897). The SpO2 finger probe, which plugs into the SpO2 port on the MediByte®, measures blood oxygen saturation and pulse. It is used to aid in the diagnosis of sleep apnea.

•

One oral/nasal cannula (Model 8597). The oral/nasal cannula, which plugs into the pressure port on the MediByte®, measures airflow. It is used to aid in the diagnosis of sleep apnea.

•

One cTherm cannula thermistor (Model 8514). The cTherm cannula, which plugs into the white input port on the snoring microphone or either type of Electrode Box, measures airflow with a thermistor. It is used to aid in the diagnosis of sleep apnea.

BRAEBON Batteries The MediByte uses a 3.6 V 1/2AA battery, model Saft LS14250 (PN 0410-3) or 1/2AA Li-Ion rechargeable battery supplied by BRAEBON. The Saft non-rechargeable battery can be used for a two-night study whereas the rechargeable battery is good for a one-night study. To recharge the rechargeable batteries, use the supplied battery charger. Only charge rechargeable batteries; the Saft batteries cannot be recharged. Non-rechargeable batteries will cause the charger to overheat and may cause a fire or explosion. The battery charger has an LED sequence as shown in the following table. LED

Meaning

Red, always on

Battery is charging

Blue, always on

Battery is fully charged

Blue flash, red flash

Battery polarity is incorrect; reverse the direction of the batteries to continue.

1-11 Introduction

Introduction

LED

Meaning

Blue flash, red flash

If the battery polarity is correct, this indicates a voltage of less than 2.7V. Leave the batteries in the charger and after the voltage rises above 2.7V, the LED will change to red to indicate charging.

MediByte® Software MediByte® Software is the software designed to work exclusively with the MediByte®. The software has a handy configuration wizard to help you quickly configure the MediByte® for a study. All you need to do is enter the patient name, patient ID, patient weight and select the type of study you want to perform. The software sends this information to the recorder, telling it what types of channels are to be recorded and with whom to associate the data. After the patient has completed the study, download the data from the recorder onto the computer. The software will assist with data analysis. After you have reviewed the analysis and made any changes, you can enter more information into the Patient Info window and then generate and print a report.

1-12

Chapter 2: Specifications

In this chapter This chapter contains a number of tables which describe the MediByte® Screener. Also included are the manufacturer’s declarations which show how the unit complies to the IEC Standard 60601-1. Included in this chapter: •

Software requirements

•

MediByte® recorder classification

•

MediByte® recorder specifications

•

Pulse oximeter specifications

•

Displays and indicators

•

Controls

•

Accessories

•

Manufacturer’s declarations

2-1

Specifications

Software Requirements The MediByte Software requires Windows Vista SP1 (Service Pack 1) or Windows7, Windows8 or Windows10 operating systems. Microsoft Word® and Excel 2003, 2007 or 2010 are used by MediByte® Software to create reports.

2-2

Specifications

MediByte Recorder Classification and Specifications Table 2-1: MediByte Recorder Classification as per IEC 60601-1 Internally powered Type BF Ingress protection: IPX1 Sterilization not required, refer to cleaning methods Category APG equipment Short-term operation

Table 2-2: MediByte® Recorder Specifications Dimensions

2.5” x 2.25” x 0.75” (66 mm x 60 mm x 19 mm)

Weight

3.3 oz. with battery (93 g)

Case

Plastic (ABS)

Power

1/2 AA 3.6 V Saft LS 14250

Memory

Can store up to 18 hours of data (with audio) or 24 hours (with EMG)

Table 2-3: Pulse Oximeter specifications Oxygen Saturation Range

0 to 100%

Pulse Rate Range

18 to 300 pulses per minute

Measurement Wavelengths Using Nonin Sensors

Red: 660 nanometers @ 3mW Nominal Infrared: 910 nanometers @ 3mW Nominal

Accuracy SpO2 (70-100%) (± 1 SD)

No Motion - Adults, Pediatrics ± 2 digits; Neonates ± 3 digits Motion - Adults, Pediatrics ± 2 digits; Neonates ± 3 digits Low Perfusion- Adults, Pediatrics ± 2 digits; Neonates ± 3 digits

Accuracy Heart Rate

No Motion (18 - 300 BPM) - Adults, Pediatrics, Neonates ±3 digits Motion (40 - 240 BPM) - Adults, Pediatrics, Neonates ±5 digits Low Perfusion (40 - 240 BPM) - Adults, Pediatrics, Neonates ±3 digits

2-3

Specifications

Displays and Indicators Table 2-4: Displays and Indicators LED

Status

At battery insertion, green/red alternating for four seconds

Unit functioning

Not flashing

Battery not inserted, battery dead

Flashing green once every six seconds

Recorder is waiting to collect

Flashing green twice every six seconds

Recorder is collecting

Flashing red once every six seconds

Low battery

Flashing red twice every six seconds

No SpO2/Pulse signal

Blinking red continuously

Battery too low for a study; will not record data but may still work for data download

Controls Table 2-5: Controls

2-4

Control

Function

Event button

When pressed, the event button records the button press. The event is predefined by the clinician.

Collection on/off switch

The MediByte® will start collecting data when the switch is moved to the right (white dot). The switch is de-activated in the automatic mode.