MediByte MedPalm 8 User Guide

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BRAEBON Medical Corporation

D.MP8.40600.1.4.1

Table of Contents Chapter 1: Introduction ... 1-1 Indications for Use ... 1-2 Conventions Used in this Guide ... 1-3 Warnings and Cautions ... 1-4 Contents of the MediByte Kit ... 1-6 Overview of the MediByte Screener ... 1-7

Chapter 2: Specifications ... 2-1 Software Requirements ... 2-2 MediByte Recorder Classification and Specifications ... 2-2 Displays and Indicators ... 2-4 Controls ... 2-4 Accessories ... 2-5 Manufacturer’s Declaration ... 2-7

Chapter 3: Installing the software... 3-1 Installing the Pursuit Sleep Software ... 3-2 Starting Pursuit Sleep™ ... 3-2 Connecting the MediByte to the Computer ... 3-2

Chapter 4: Preparing for a Study... 4-1 Preparing the MediByte ... 4-2 Insert the Battery... 4-2 Connect the MediByte to the Computer ... 4-3 Select an operation ... 4-4 Enter Patient Information ... 4-5 Select an Auxiliary Device... 4-6 Select the Start Time... 4-7 Review the settings and program the MediByte... 4-8

Chapter 5: Preparing the Patient... 5-1 Sensor Placement ... 5-2 Chest and Abdominal Effort Belts ... 5-2 Auxiliary Channel Electrode Placement ... 5-5 Starting the Study ... 5-8 Ending the Study ... 5-8

Chapter 6: Reviewing Data ... 6-1 Downloading Data from the MediByte ... 6-2 Data Display Screen ... 6-5 Reviewing the Data ... 6-6 Assisted Scoring of Events ... 6-16 Manual Scoring of Events ... 6-20 Printing Reports ... 6-31 File Names and the Directory Structure ... 6-34

Chapter 7: Maintaining the MediByte ... 7-1 Cleaning the MediByte ... 7-2 Maintaining the MediByte and Accessories ... 7-3 Troubleshooting ... 7-4 Warranty ... 7-5

Glossary Index

Chapter 1: Getting Started

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

Indications for use

•

Conventions used in this user guide

•

Warnings and cautions

•

Contents of the MediByte® kit

•

Overview of the MediByte® Screener

In this User Guide This user guide describes how to use the MediPalm® 8 PRD commonly referred to as the MediByte®, and the Pursuit Sleep™ software. The user guide has seven chapters: 1. Introduction 2. Specifications 3. Installing the Software 4. Preparing for a Study 5. Preparing the Patient 6. Reviewing Data 7. Maintaining the MediByte®

1-1

Chapter 1: 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.

1-2 Indications for Use

Chapter 1: 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 software note. Notes provide important information about the software.

Conventions Used in this Guide 1-3

Chapter 1: Introduction

Warnings and Cautions Warnings •

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 that all leads are taped-down.

Battery Warning: •

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. 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.

1-4 Warnings and Cautions

Chapter 1: Introduction

Cautions •

Use ONLY BRAEBON™ sensors and accessories.

•

Use ONLY the BRAEBON™ Respiratory Effort Sensor (Model 8528). Other sensors will NOT function with the MediByte®.

•

Always use a BRAEBON™ hydrophobic (safety) filter (Model 0583) when connecting to the MediByte® on-board pressure transducer or damage may occur to 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 Forte ER14250H or Saft LS14250 battery.

•

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

Storage Conditions

Temperature (in degrees Celsius)

10°C–35°C

-20°C–60°C

Relative Humidity

30%–95% (Without condensation)

10%–100%

Warnings and Cautions 1-5

Chapter 1: 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 Respiratory Effort Sensor (Model 8528)

1

Patient Kit with electrodes (Model 8130)

1

BRAEBON Snore Sensor (Model 8540)

1

BRAEBON Leadwire Yoke Adapter (Model 8610)

1

EKG Eliminator (Model 0600)

1

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

1

BRAEBON SpO2 finger probe with a 4-foot cable. (Model 8896)

1

MediByte® Carrying case

1

Patient Kit with electrodes, 5 piece (Model 8130-5)

1

CD-ROM containing Pursuit Sleep Software™(Model 2000)

1

MediByte® Communication Cable (Model 8889)

2

Patient Guide to MediByte® (Model 8925)

1

MediByte® User Manual (Model 8920)

1

Allen key

1-6 Contents of the MediByte Kit

Chapter 1: 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 Pursuit Sleep™ 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 Pursuit Sleep™ 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 eight channels of physiological signals, including: flow, snoring (volume), snoring (audio), blood oxygen saturation (SpO2), pulse rate, chest effort, abdominal effort and body position. One channel of ExG may be exchanged for snoring volume. The MediByte® Screener consists of the following major components: •

the MediByte® unit

•

the communication cable

•

BRAEBON sensors

•

Pursuit Sleep Software™.

The MediByte Unit ®

The MediByte® unit has a plastic molded case with an Event button and Status LED on the front. On the top portion of the unit, 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 unit, there is a communication port, a chest effort port, an abdominal effort port and a collection on/off switch. See Figure 1.1 on page 1-8 for port locations. The Event button, located on the front of the unit, 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.

Overview of the MediByte Screener 1-7

Chapter 1: Introduction

The Status LED is a small light located on the front of the unit. 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 2-2-4 on page 2-4 for a complete list of Status LED indicators. The auxiliary (AUX) port, located on the top of the unit, attaches either the snoring microphone, or the lead wire yoke adapter which accepts EKG lead wires, EMG bruxism lead wires and EMG PLM lead wires (attached to the EKG Eliminator). The pressure port, located on the top of the unit, attaches the oral/nasal cannula to the recorder. The SpO2 port, located on the top of the unit, attaches the SpO2 sensor to the recorder. The communication port, located on the bottom of the unit, accepts the BRAEBON communication cable. Use this port to attach the recorder to the computer to program the recorder and 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 belt to the recorder. The abdominal effort port attaches the abdominal effort 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. If the unit is preset to automatically record within the software, the switch is disabled.

Pressure port

SpO2 port

AUX port

Figure 1.1: MediByte port locations

1-8 Overview of the MediByte Screener

Chest port

Communication port

Abdomen port

Collection on/off switch

Chapter 1: Introduction

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 displays when the cable is connected to the computer and the MediByte® is properly connected.

Figure 1.2: Communication cable

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

Two respiratory effort belts (Model 8528). 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 8540). The snore sensor, which plugs into the AUX port on the MediByte®, detects snore sounds.

•

One leadwire yoke adapter (Model 8610). The leadwire yoke adapter, which plugs into the AUX port on the MediByte®, attaches electrodes to the MediByte®. The three available electrode assemblies are EKG, bruxism and PLM.

•

One SpO2 finger probe (Model 8896). 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 8589). The oral/nasal cannula, which plugs into the pressure port on the MediByte®, measures the flow of oxygen. It is used to aid in the diagnosis of sleep apnea.

•

One EKG Eliminator (Model 0600). The EKG Eliminator, which plugs into the leadwire yoke adapter, removes EKG artifact from PLM signals.

Overview of the MediByte Screener 1-9

Chapter 1: Introduction

Pursuit Sleep™ Pursuit Sleep™ is the software for the MediByte®. You must enter the patient name and patient ID and the study configuration into the software before you can start a study. The software sends the patient name, ID and study configuration to the recorder, telling it what types of channels are to be recorded and with whom to associate the data; this is called programming the MediByte®. After the patient has completed the study, download the data from the recorder into the software. The software will assist with data analysis. After you have reviewed the analysis and made any changes, you need to enter the patient information into the Patient Info window and then generate and print a report.

1-10 Overview of the MediByte Screener

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

Chapter 2: Specifications

Software Requirements The Pursuit Sleep Software™ requires the Windows XP® operating system. Microsoft Word® 2000 or 2003 is used by Pursuit Sleep Software™ to create reports.

MediByte Recorder Classification and Specifications Table 2-1 lists the classification of the MediByte® recorder as defined by IEC 60601-1. 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 lists the specifications of the MediByte® recorder. Table 2-2: MediByte® Recorder Specifications Dimensions

0.9” (L) x 3.0” (W) x 2.9” (H) (2.2 cm x 2.9 cm x 7.3 cm)

Weight

2.9 oz. with battery (82 g)

Case

Plastic (ABS)

Power

1/2 AA 3.6 V Saft LS 14250 or 3.6 V 1/2AA Forte ER14250H

Memory

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

2-2 Software Requirements

Chapter 2: Specifications

Table 2-3 lists the specifications of the internal Nonin pulse oximeter. 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

MediByte Recorder Classification and Specifications 2-3

Chapter 2: Specifications

Displays and Indicators Table 2-4 lists the displays and indicators for the MediByte® recorder. 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 lists the two control buttons on the MediByte® recorder and their functions. Table 2-5: Controls 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.

2-4 Displays and Indicators

Chapter 2: Specifications

Accessories The following table lists the MediByte®accessories. Table 2-6: Accessories Part #

Item

Description

8528

BRAEBON Respiratory Effort Sensor

Use two effort sensors to detect abdominal and chest effort. Plug into the ports labelled Chest and Abdomen.

8896

BRAEBON SpO2 Sensor

Use the SpO2 sensor to measure blood oxygen saturation and pulse. Plug into the port labelled SpO2.

8540

BRAEBON Snore Microphone

Use the snore microphone to record snoring sounds. Plug into the port labelled AUX.

8589

BRAEBON Nasal/ Oral Cannula

Use the nasal/oral cannula to measure airflow. Plug into the port labelled PRESSURE. All nasal cannulas are obtained from a manufacturer that has been legally authorized to distribute nasal cannulas in the United States.

8610

BRAEBON Leadwire Yoke Adapter

Use the leadwire yoke adapter to attach electrode leads to the MediByte® for measuring EKG, PLM, and bruxism. Plug into the port labelled AUX.

8620

BRAEBON Leadwire Kit

Contains 24” and 60” leadwires for performing bruxism, PLM and EKG studies. Plug into the Leadwire Yoke adapter or EKG eliminator (PLM)

8889

BRAEBON Communication Cable

Use the communication cable to attach the MediByte® recorder to the computer for programming and data download. Plug into the port labelled Communication.

8120

Patient Accessory Kit

The patient accessory kit contains one nasal/oral cannula, one battery, one flexiwrap finger sensor, and micropore tape. Use this for a basic patient study without electrodes.

8130

MediByte Electrode Kit

The electrode kit contains one nasal/oral cannula, one 1/2AA Forte ER14250H battery, one flexiwrap finger sensor, micropore tape, one electrode prep pad, five Snap electrodes. Use this for a PLM or bruxism study.

Accessories 2-5

Chapter 2: Specifications

Table 2-6: Accessories Part #

Item

Description

8140

Cardiac Electrode Kit

The cardiac electrode kit contains one nasal/oral cannula, one 1/2 AA 3.6 V Saft LS 14250 battery, one flexiwrap finger sensor, micropore tape, one electrode prep pad, five Snap electrodes. Use this for an EKG study or a two-night study.

0600

BRAEBON EKG Eliminator

Use the EKG Eliminator when performing PLM studies to remove EKG artifact from the signals. Plug the red and black leads from the EKG eliminator into the leadwire yoke adapter.

2-6 Accessories