User Guide
100 Pages
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BRAEBON™ is an ISO 13485 compliant company.
Legal Notices Copyright ©2006-2007 by BRAEBON™ Medical Corporation. All rights reserved. MediByte® is a registered trademark of BRAEBON Medical Corporation. Windows® and Microsoft Word® are registered trademarks of Microsoft® Corporation. All other trademarks are the property of their respective owners
CANADA: 1-120 Walgreen Drive RR#3 Carp, Ontario, K0A 1L0
USA: 102-2981 Ford St. Extension, Ogdensburg, NY. 13669-3474
Technical Support: 1-888-462-4841 (9 am - 5 pm EST)
• E–mail:[email protected] Customer Sales or Service: 1-888-462-4841 • E–mail:[email protected] www.braebon.com
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:
Temperature (in degrees Celsius) Relative Humidity
Operating Conditions
Storage Conditions
10°C–35°C
-20°C–60°C
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
Chapter 2: Specifications
Manufacturer’s Declaration Refer to Tables 2-7 to 2-11 for specific information regarding this device’s compliance to IEC Standard 60601-1-2 Table 2-7: IEC 60601-1-2 Statements Clause 6.8.2.201 a) 1)
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.
Clause 6.8.2.201 a) 2)
Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
6.8.3.201 a) 1)
The use of accessories, transducers, and cables other than those specified by the manufacturer, may result in increased Emissions or decreased Immunity of the System.
6.8.3.201 a) 4)
The System should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the System should be observed to verify normal operation in the configuration in which it will be used.
Table 2-8: Guidance and Manufacturer’s Declaration -Electromagnetic Emissions The MediByte® is intended for use in the electromagnetic environment specified below. The customer or the user of the MediByte® should assure that it is used in such an environment. Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions CISPR 11
Group 1
The MediByte® uses RF energy only for its
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Class B
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Complies
internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The MediByte®is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Manufacturer’s Declaration 2-7
Chapter 2: Specifications
Table 2-9: Guidance and Manufacturer’s Declaration -Electromagnetic Emissions The MediByte® is intended for use in the electromagnetic environment specified below. The customer or the user of the MediByte® should assure that it is used in such an environment. Immunity Test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±6 kV contact
±6 kV contact ±8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4
±2 kV for power supply lines
Not applicable. Battery powered.
Mains power quality should be that of a typical commercial or hospital environment.
Not applicable. Battery powered.
Mains power quality should be that of a typical commercial or hospital environment.
Not applicable. Battery powered.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the MediByte®requires continued operation during power mains interruptions, it is recommended that the MediByte® be powered from an uninterruptible power supply or a battery.
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment
±8 kV air
±1 kV for input/output lines Surge IEC 61000-4-5
±1 kV differential mode ±2 kV common mode
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
3 A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
2-8 Manufacturer’s Declaration
Chapter 2: Specifications
Table 2-10: Guidance and Manufacturer’s Declaration -Electromagnetic Immunity- For Equipment and Systems that are not Life-Supporting The MediByte® is intended for use in the electromagnetic environment specified below. The customer or the user of the MediByte® should assure that it is used in such an environment. Immunity Test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3V
Portable and mobile RF communications equipment should be used no closer to any part of the MediByte®, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2,5 GHz
3V/m
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
Manufacturer’s Declaration 2-9
Chapter 2: Specifications
Table 2-10: Guidance and Manufacturer’s Declaration -Electromagnetic Immunity- For Equipment and Systems that are not Life-Supporting NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an survey should be considered. If the measured field strength in the location in which the MediByte® used exceeds the applicable RF compliance level above, the MediByte®should be normal operation. If abnormal performance is observed, additional measures may be necessary, reorienting or relocating theMediByte®. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
Table 2-11: Recommended separation distances between portable and mobile RF communications equipment and the MediByte® Recommended separation distances between portable and mobile RF communications equipment and the MediByte® TheMediByte® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MediByte® can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MediByte® as recommended below, according to the maximum output power of the communications equipment. Rated maximum output
Separation distance according to frequency of transmitter m
power of transmitter
W
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
2-10 Manufacturer’s Declaration
Chapter 2: Specifications
Table 2-11: Recommended separation distances between portable and mobile RF communications equipment and the MediByte® Recommended separation distances between portable and mobile RF communications equipment and the MediByte® TheMediByte® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MediByte® can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MediByte® as recommended below, according to the maximum output power of the communications equipment. For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Manufacturer’s Declaration 2-11
2-12
Chapter 3: Installing the Software
In this chapter This chapter describes how to install the Pursuit Sleep Software™ onto your computer. After you have installed the software, you can start collecting data with the MediByte®. You cannot collect data until you have installed the software and programmed the MediByte®. When you program the MediByte®, you are telling the recorder the name of the patient and the study parameters. Included in this chapter: •
Installing the Pursuit Sleep™ software
•
Starting the software
•
Connecting the MediByte® to the computer
3-1
Chapter 3: Installing the Software
Installing the Pursuit Sleep Software 1. Close all programs. 2. Insert the CD labeled Pursuit Sleep Software into your CD-ROM drive. If Autorun is enabled on your computer, the installation starts automatically and you can skip steps three and four. 3. On the Start menu, click Run. 4. Type D:\Setup.exe (substitute the appropriate letter of your CD-ROM drive for D). 5. Follow the instructions on the screen to complete the installation. 6. Unless you browse to a different drive, the Pursuit Sleep™ installs in C:\Program Files\Pursuit Advanced Sleep Software by default.
Installing Pursuit Sleep with a previous version installed If you already have Pursuit Sleep Software™ on your computer, the installation consists of the following steps: 1. Uninstall the old software using the Add or Remove Program function. 2. Install the new Pursuit Sleep Software™software.
Caution: Follow the steps outlined above. Failure to do so may result in corrupt data files.
Uninstall the old software
1. From the Start menu, double-click Control Panel. 2. Double-click Add or Remove Program. 3. Double-click Pursuit Advanced Sleep Software and click the Change/Remove button.
3-2 Installing the Pursuit Sleep Software
Chapter 3: Installing the Software
4. In the Installation wizard, click Remove and then OK. Install the new Pursuit Sleep Software™ software.
1. Close all programs. 2. Insert the CD labeled Pursuit Sleep Software into your CD-ROM drive. If Autorun is enabled on your computer, the installation starts automatically and you can skip steps three and four. 3. On the Start menu, click Run. 4. Type D:\Setup.exe (substitute the appropriate letter of your CD-ROM drive for D). 5. Follow the instructions on the screen to complete the installation. 6. Unless you browse to a different drive, the Pursuit Sleep Software™ installs in C:\Program Files\Pursuit Advanced Sleep Software.
Installing the Pursuit Sleep Software 3-3
Chapter 3: Installing the Software
Starting Pursuit Sleep
™
You can start Pursuit Sleep™ in one of two ways: 1. Connect the MediByte® communication cable to the computer and to the MediByte®. Doubleclick the Pursuit Sleep™ icon
on the desktop.
2. Double-click the Pursuit Sleep™ icon on the desktop without connecting the MediByte®. This option only permits the reviewing of previously collected data.
Connecting the MediByte to the Computer 1. Insert the battery into the MediByte®.
Caution: Install the software before you connect the MediByte® to the computer.
2. Using the communication cable, connect the small, type-A Universal Serial Bus (USB) connector to the computer USB port. 3. Connect the SPI connector to the MediByte® communication port. 4. Double-click the Pursuit Sleep™ icon.
3-4 Starting Pursuit Sleep™
Chapter 4: Preparing for a Study
In this chapter This chapter describes how to prepare the MediByte® Screener for a study. To prepare it, you must connect it to the computer and use the MediByte® wizard to program the unit. This chapter includes: 1. Inserting the battery. 2. Connecting the MediByte® to the computer. 3. Selecting an operation. 4. Entering patient information. 5. Selecting an auxiliary device. 6. Selecting the start time. 7. Reviewing the settings and programming the MediByte®.
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Chapter 4:Preparing for a Study
Before You Begin 1. Install the Pursuit Sleep Software™. 2. Ensure that the patient is not connected to the MediByte®.
3. Insert a battery into the MediByte®.
Preparing the MediByte Preparing the MediByte® for a study consists of the following steps:
1. Insert a battery. 2. Connect the MediByte® to the computer. 3. Select an operation. 4. Enter patient name and ID. 5. Select an auxiliary device. 6. Select the start time. 7. Review the settings and program the MediByte®.
1. Insert the Battery The battery lasts for one over-night study using the Forte ER14250H or two over-night studies using the Saft LS14250. To ensure that you don’t lose power during a study, make it a habit to insert a new battery before you program the MediByte®. 1. Using the Allen key provided with your kit, remove the battery compartment screw. 2. Remove the battery compartment cover by pushing it down and away from you. 3. Pull on the fabric strip to remove the used battery. 4. With the ribbon on the bottom of the battery compartment, insert the new battery ensuring the polarity of the battery matches the diagram on the bottom of the battery compartment. 5. Replace the battery compartment cover, reinsert and tighten the screw.
4-2 Preparing the MediByte
Chapter 4:Preparing for a Study
2. Connect the MediByte to the Computer Warning: Do NOT connect the MediByte® to the computer while it is in contact with the patient. This could cause serious injury to the patient.
1. Insert the battery into the MediByte®. 2. Connect the communication cable to the USB port of the computer. 3. Connect the communication cable to the MediByte®. 4. Double-click the Pursuit Sleep™ icon
to activate the MediByte® wizard.
5. The MediByte® wizard requires that you confirm that your patient is not connected to the MediByte® by clicking on the checkbox. Click Next to continue.
Figure 4.1: Opening screen
Preparing the MediByte 4-3
Chapter 4:Preparing for a Study
3. Select an operation 1. In the What do you want to do today? window, select from the list of activities. 2. To start a sleep study, select Configure the Medibyte for a Study and click Next to move to the Patient screen. 3. To retrieve data from the MediByte®, select Download data from the Medibyte and click Next to start the data download. 4. To review a data file stored on the computer, select Review Existing Data File and click Next to open a dialogue box to select the data file. 5. The Renew MediByte license (Unlimited-use device) is not an active button because your device has an unlimited number of uses.
Figure 4.2: What do you want to do today? window
4-4 Preparing the MediByte
Chapter 4:Preparing for a Study
4. Enter Patient Information In the Patient Information window, enter the patient’s name and identification number. It is vital that you enter this information correctly since the patient file is identified by the patient’s last name and patient ID. 1. Type the patient’s last name in the Last Name field. This field is limited to 20 characters. 2. Type the patient’s first name in the First Name field. This field is limited to 12 characters. 3. Type the patient’s unique code in the Patient ID field. This field is limited to ten characters. 4. Click Next to move to the next screen. You cannot use the Next button to move forward until you have entered information into the fields.
Figure 4.3: Patient information window
Preparing the MediByte 4-5
Chapter 4:Preparing for a Study
5. Select an Auxiliary Device The next screen in the MediByte® wizard prompts you to select the function of the auxiliary port. Use this screen to select the external device you want to use for the recording. This is the device that plugs into the AUX port. Choose from the following list: • Snore microphone • EKG • EMG Bruxism • EMG PLM • Do not use AUX channel As each item is selected, the picture corresponding to the selection changes. A similar picture is shown in the Patient Guide as a visual reminder for patient set-up.
Note: You can only select one auxiliary device per study.
1. Select the external device from the list and click Next to move to the start time screen.
Figure 4.4: Auxiliary device screen
4-6 Preparing the MediByte
Chapter 4:Preparing for a Study
6. Select the Start Time In the next screen, select whether the recording will start automatically or manually. Automatically means that the MediByte® will start recording data at the time specified. Manually means that the patient must start the data recording by pushing the collection on/off switch on the unit to the right (white dot).
Note: For an EKG study, the software is programmed to pre-select start automatically and one night study because an EKG study is usually performed for a continuous 24-hour period.
1. Select either the automatic or manual start. If you select automatic, you must select the start date and time. 2. Select either a one-night or two-night study and click Next to move forward to the summary screen.
Figure 4.5: Select the start time
Preparing the MediByte 4-7
Chapter 4:Preparing for a Study
7. Review the settings and program the MediByte
®
Note: When you program the MediByte®, the software sends the patient information and study settings to the MediByte® unit. You must program the unit before you can start a study.
The Summary screen permits you to review the settings before you program the MediByte®. If the settings are correct, start the programming of the MediByte® by clicking Next. If you need to change one of the settings, use the Back button to return to the previous screens.
Figure 4.6: Summary screen
1. Review the summary screen. If the settings are correct, click Next. The software will confirm that you have finished and it is ready to program the unit. 2. Select Finish.
4-8 Preparing the MediByte
Chapter 4:Preparing for a Study
Figure 4.7: Final screen
3. The software will send the patient information and study settings to the MediByte®. This is called programming the MediByte®. Once the unit is programmed, the software closes automatically and you can disconnect the unit from the computer. 4. The MediByte® is now ready to collect data. 5. Disconnect the MediByte® from the computer and prepare the patient for the study.
Preparing the MediByte 4-9
4-10
Chapter 5: Preparing the Patient
In this chapter This chapter describes how to place the sensors on the patient, where to plug the sensors into the MediByte®, how to begin and how to end a study. This chapter includes: • •
Chest and abdominal effort belts SpO2 sensor placement
• • • • • • •
Pressure cannula placement Snore microphone placement EKG electrode placement Bruxism electrode placement PLM electrode placement Starting the study Ending the study
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Chapter 5: Preparing the Patient
Sensor Placement Some of the sensors are used for most studies. These sensors include: • •
Chest and abdominal effort belts SpO2 sensor
• •
Pressure cannula (airflow) Snore microphone
Chest and Abdominal Effort Belts
BRAEBON
The chest and abdominal effort belts record respiratory effort. Respiratory effort is used to diagnose sleep apnea. 1. On the MediByte®, plug the chest belt into the black keyhole input marked Chest and the abdominal belt into the black keyhole input marked Abdomen. BRAEBON
2. Orient both belts with the BRAEBON logo facing upward. 3. On the red MediByte® belt, fasten the male buckle on the Velstretch strap into the female buckle of the black respiratory effort sensor. 4. Wrap the red strap around the back and secure the male buckle on the strap to the female buckle of the black respiratory effort sensor.
BRAEBON
Figure 5.1: Chest and abdominal belts
5. Position the belt above or below the nipple line so that the black sensor is on the right side of the body; this is the chest belt. 6. With the second red belt, attach the second respiratory effort sensor. 7. Wrap the red belt around the abdomen and secure the male buckle on the strap to the female buckle of the respiratory effort sensor. 8. Position the belt over the belly button so that the black sensor is centered on the body; this is the abdominal belt. 9. Tighten both red straps until only two fingers slide between the patient’s body and the belt.
5-2 Sensor Placement
Chapter 5: Preparing the Patient
SpO Sensor Placement 2
FlexiWrap
The SpO2 sensor measures blood oxygen saturation and pulse. It is useful for diagnosing sleep apnea. 1. With the FlexiWrap face down on the table, pull up the tab and peel away the paper backing. The FlexiWrap has cutouts that fit over the finger sensor. 2. Insert the sensor into the cutouts in the FlexiWrap.
Sensor Back View
FlexiWrap
Front View
Sensor
3. Place the index finger on the sensor so that the dotted line on the FlexiWrap is at the tip of the finger, Step a. 4. Wrap the small side flaps around the side of the finger.
Step a
5. Fold the FlexiWrap over the top of the index finger so that the raised parts of the sensor are vertically aligned. 6. Wrap the small side flap around the side of the finger, Step b.
Step b
7. Wrap the long flap around the finger, Step c. 8. Around the base of the index finger, tape the sensor cable with medical tape. 9. On the MediByte®, plug the sensor connector into the input marked SpO2, ensuring that the red dot on the connector aligns with the red dot on the SpO2 input.
Step c
Figure 5.2: SpO2 sensor placement
10. Use medical tape to secure the leads on the patient’s arm.
Warning: Do not wrap the FlexiWrap around the finger too tightly or you may restrict blood flow.
Caution: Ensure that the red dot on the finger probe connector is aligned with the red dot on the MediByte®. Do NOT twist the connector, it will move easily in and out of the port once the dots are aligned.
Sensor Placement 5-3
Chapter 5: Preparing the Patient
Pressure Cannula Placement The pressure cannula measures airflow. It is useful for diagnosing sleep apnea. 1. Position the nasal prongs in the patient’s nostrils and wrap the tubes over the ears and under the chin. 2. Using medical tape, secure the tubes to the patient’s cheeks. 3. Adjust the slider for a comfortable fit under the chin. 4. On the MediByte®, screw the filter on the end of the cannula to the input marked PRESSURE. Do NOT overtighten the filter.
Figure 5.3: Pressure cannula placement
Snore Microphone The snore microphone collects snoring sounds. 1. Position the Snore MicrophoneTM on the patient’s forehead or cheek. The forehead is recommended because it is considered the least intrusive position 2. Secure the Snore MicrophoneTM with medical tape. 3. Plug the Snore MicrophoneTM into the AUX port on the MediByte®, ensuring that the red mark on the connector lines up with the red mark on the port. Figure 5.4: Snore microphone placement
5-4 Sensor Placement
Chapter 5: Preparing the Patient
Auxiliary Channel Electrode Placement There are three possible auxiliary channel electrode settings: • • •
EKG EMG Bruxism EMG PLM
All three electrode settings use peel and snap electrodes which plug into the leadwire yoke adapter. The leadwire yoke adapter is plugged into AUX on the MediByte®. To use these electrodes: 1. Plug the leadwires, according to their colour, into the leadwire yoke adapter. 2. Abrade the area with an alcohol wipe for ten seconds. 3. Peel the back off the adhesive pad.
Figure 5.5: Leadwire yoke adapter
4. Apply the pad to the abraded area. 5. Snap the electrode to the adhesive pad.
EKG 1. Place one adhesive pad on the left rib cage. 2. Attach the black electrode to the pad. 3. Place one adhesive pad on the right shoulder. 4. Attach the red electrode to the pad. 5. Place one adhesive pad on the left shoulder (this is the ground). 6. Attach the green (ground) electrode to the pad. 7. Plug the lead of the leadwire yoke adapter into the AUX port on the MediByte®, ensuring that the red dot on the connector is aligned with the red dot on the port.
Figure 5.6: EKG placement
Auxiliary Channel Electrode Placement 5-5
Chapter 5: Preparing the Patient
EMG Bruxism 1. Place two adhesive pads side by side on the jaw about one inch apart. 2. Attach the red and black electrodes to the pads. 3. Place an adhesive pad on the left shoulder (this is the ground). 4. Attach the green (ground) electrode to the pad. 5. Plug the lead of the leadwire yoke adapter into the AUX port on the MediByte®, ensuring that the red dot on the connector is aligned with the red dot on the port.
5-6 Auxiliary Channel Electrode Placement
Figure 5.7: EMG bruxism placement
Chapter 5: Preparing the Patient
EMG PLM 1. On the right foreleg, place one adhesive pad and attach a red electrode to the pad. 2. On the right foreleg, place a second adhesive pad two inches below the first, and attach a black electrode to the pad.
5
Leadwire Yoke Adapter
7
6
3. On the left foreleg, place one adhesive pad and attach a red electrode to the pad. 4. On the left foreleg, place a second adhesive pad two inches below the first, and attach a black electrode to the pad. 5. Place the one adhesive pad on the left shoulder (this is the ground) and attach the green electrode to the pad.
8 9 EKG Eliminator
6. Plug the lead of the leadwire yoke adapter into the AUX port on the MediByte®, ensuring that the red dot on the connector is aligned with the red dot on the port. 7. Plug the red and black leads from the EKG Eliminator into the red and black ports on the Leadwire Yoke Adapter. 8. Plug the black leads from the left and right legs into the black ports on the EKG Eliminator. 9. Plug the red leads from the left and right legs into the red ports on the EKG Eliminator. 10. Tape down the loose leadwires.
1
3 2
4
Figure 5.8: PLM placement
Auxiliary Channel Electrode Placement 5-7
Chapter 5: Preparing the Patient
Starting the Study Once the patient is wearing all of the sensors and the leads are connected to the MediByte®, the unit is ready to collect data. If the unit is set to automatic start, it will start on its own at the designated start time. If the unit is set to manual start, instruct the patient to slide the collection on/off switch to the ON position (white dot) at bedtime. The event button is used to mark significant events during the night. For example, instruct the patient to press the event button when turning off the lights, when getting up in the middle of the night, upon returning to bed, etc. The data will contain a button press marker which will display on the screen during data analysis.
Ending the Study In the morning, instruct the patient to push the Event button, slide the collection on/off switch to the OFF position and remove the sensors. The unit is now ready for data retrieval.
5-8 Starting the Study
Chapter 6: Reviewing Data
In this chapter This chapter describes how to download data from the MediByte®, review the displayed data, mark it with event tags, mark it with scoring tags, adjust the event tags and scoring tags and print a report. You cannot open the data display screen without data either stored on your computer or downloaded from the MediByte®. This chapter includes: •
Downloading data from the MediByte®
•
Data display screen
•
Reviewing the data
•
Assisted Scoring of Events
•
Manual Scoring of Events
•
Printing a report
•
File and directory structure
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Chapter 6: Reviewing Data
Downloading Data from the MediByte Warning: Do NOT connect the MediByte® to the computer while it is in contact with the patient. This may cause serious injury to the patient.
1. If you have not already done so, disconnect the MediByte® from the patient. 2. Ensure that the battery is still functioning (the status LED will flash green once every six seconds). 3. Plug the communication cable into the computer and then into the MediByte®. 4. In the What do you want to do today? window, select Download data from the MediByte. An information window will appear to inform you that data has been found and the MediByte® is downloading.
Figure 6.1: Downloading data
5. The scoring assist feature will process the data and generate scoring events. 6. The final screen of the wizard appears when the data download is finished. The screen displays Please ensure that the data is reviewed by a qualified professional. 7. Click Finish. The software will display the data on the computer screen.
6-2 Downloading Data from the MediByte