User Guide
140 Pages
Preview
Page 1
For version 6.1 For Version 7.1
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Legal Notices Copyright ©2006-2014 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
1-100 Schneider Road Kanata, Ontario, K2K 1Y2
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.MP8.40600.4.2 February 2014
Table of Contents Chapter 1: Introduction 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 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 Activating the MediByte Software ...................................................... 3-5
Chapter 4: Preparing for a Study Preparing the MediByte ...................................................................... 4-2 Insert a new 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 Starting the Study ............................................................................. 5-16 Ending the Study .............................................................................. 5-16
Chapter 6: Reviewing Data Downloading Data from the MediByte ................................................ 6-2 Data Display Screen .......................................................................... 6-5 Reviewing the Data ............................................................................ 6-6 Assisted Scoring of Events .............................................................. 6-20 Manual Scoring of Events ................................................................ 6-25 Printing Reports ............................................................................... 6-41
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 Warranty ............................................................................................. 9-5
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: •
Indications for use
•
Conventions used in this guide
•
Warnings and cautions
•
Contents of the MediByte® Kit
•
Overview of the MediByte® Screener
1-1
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
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.
1-3
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:
1-4
•
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.
Introduction
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 EEMB ER14250 (PN 0411-3).
•
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 (in degrees Celsius) Relative Humidity
Storage Conditions
10C–35C
-20C–60C
30%–95% (Without condensation)
10%–100%
1-5
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
1-6
Item
1
MediByte® Recorder (Model MP8)
2
BRAEBON Q-RIP Effort belt (Model 8572)
1
MediByte® Electrode Prep Kit (Model 8129)
1
MediByte® Electrode Prep Kit - five piece (Model 8129-5)
6
Self-Adhesive Electrodes, strip of 5 (Model 8501-5)
1
BRAEBON Snore Microphone with Thermistor Input (Model 8541)
1
BRAEBON PLM Leadwire Yoke Adapter (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
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: •
the MediByte® unit
•
the communication cable
•
BRAEBON sensors
•
MediByte Software.
1-7
Introduction
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 1.2 on page 1-9 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.
Figure 1.1: MediByte
ON/OFF
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 2-4 on page 2-4 for a complete list of Status LED indicators. The auxiliary (AUX) port, located on the top of the unit, attaches the snoring microphone; the lead wire yoke adapter which accepts EKG lead wires or EMG bruxism lead wires; or the PLM leadwire yoke adapter which accepts PLM lead wires. The cTherm thermistor cannula plugs into the white port located on the snoring microphone or either type of leadwire yoke adapter. The pressure port, located on the top of the unit, 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 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 configure a study and
1-8
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
1-9
Introduction
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 optional leadwire yoke adapter (Model 8610). The leadwire yoke adapter, which plugs into the AUX port on the MediByte®, attaches electrodes to the MediByte®. Use this model for EKG studies.
•
One PLM leadwire yoke adapter (Model 8611). The PLM leadwire yoke adapter, 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 leadwire yoke adapter, measures airflow with a thermistor. It is used to aid in the diagnosis of sleep apnea.
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.
1-10
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 the Windows XP® SP3 (Service Pack 3), Windows Vista SP1 (Service Pack 1) or Windows7 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.
Specifications
Accessories The following table lists available MediByte®accessories. Table 2-6: Accessories Part #
Item
Description
8119
Patient Accessory Kit
The patient accessory kit contains one nasal/oral cannula, one battery and micropore tape. Use this for a basic patient study without electrodes. For use with SpO2 model 8895 or 8897.
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. For use with SpO2 model 8896.
8129
MediByte Electrode Prep Kit
The electrode prep kit contains one nasal/oral cannula, one 1/2 AA 3.6 V Saft LS 14250 battery, micropore tape, one electrode prep pad, five Snap electrodes. Use this for a PLM or bruxism study. For use with SpO2 model 8895 or 8897.
8130
MediByte Electrode Prep Kit
The electrode prep 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 a PLM or bruxism study. For use with SpO2 model 8896.
8541
BRAEBON Snore Microphone with thermistor input
Use the snore microphone to record snoring sounds. Plug into the port labelled AUX. If you are using the cTherm Cannula Thermistor, plug it into the white port attached to the snore microphone.
8572 8572PED 8572L
BRAEBON Q-RIP Effort belt (regular) BRAEBON Q-RIP Effort belt (pediatric) BRAEBON Q-RIP Effort belt (X-Large)
Use two effort belts to detect abdominal and chest effort. Plug into the ports labelled Chest and Abdomen.
8597
BRAEBON Nasal/ Oral Cannula
Use the nasal/oral cannula to measure airflow. Plug into the port labelled PRESSURE.
8895
BRAEBON SpO2 Sensor, Soft shell medium
Use the SpO2 sensor to measure blood oxygen saturation and pulse. Plug into the port labelled SpO2. Silicone finger cover.
2-5
Specifications
Table 2-6: Accessories
2-6
Part #
Item
Description
8896
BRAEBON SpO2 Sensor
Use the SpO2 sensor to measure blood oxygen saturation and pulse. Plug into the port labelled SpO2. FlexiWrap finger cover.
8897
BRAEBON SpO2 Sensor, Soft shell small
Use the SpO2 sensor to measure blood oxygen saturation and pulse. Plug into the port labelled SpO2. Silicone finger cover.
8898
BRAEBON SpO2 Sensor, Soft shell large
Use the SpO2 sensor to measure blood oxygen saturation and pulse. Plug into the port labelled SpO2. Silicone finger cover.
8610 optional
BRAEBON Leadwire Yoke Adapter
Use the leadwire yoke adapter to attach electrode leads to the MediByte® for measuring EKG. Plug into the port labelled AUX. If you are using the cTherm Cannula Thermistor, plug it into the white port on the 8610.
8611
BRAEBON PLM Leadwire Yoke Adapter
Use the PLM leadwire yoke adapter to attach electrode leads to the MediByte® for measuring periodic limb movements and bruxism. Plug into the port labelled AUX. If you are using the cTherm Cannula Thermistor, plug it into the white port on the 8611.
8620
BRAEBON Leadwire Kit
Contains 24” and 60” leadwires for performing bruxism, PLM and EKG studies. Plug into either of the leadwire yoke adapters.
8889.2
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.
Specifications
Manufacturer’s Declaration 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 internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
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.
Harmonic emissions IEC 61000-3-2
Class B
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Complies
2-7
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
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:
2-9
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, a 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. 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
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.
2-10
Chapter 3: Installing the Software
In this chapter This chapter describes how to install the MediByte® Software onto your computer. After you have installed the software, you can configure the MediByte® and start collecting data. You cannot collect data until you have installed the software and configured the MediByte®. When you configure the MediByte®, you are telling the recorder the name of the patient and the study parameters. This chapter includes: •
Installing the MediByte® Software
•
Connecting the MediByte® to the computer
•
Installing the hardware drivers
•
Activating the MediByte® Software
3-1
Installing the Software
Installing the MediByte Software Windows Vista/ Windows 7 Requirements To use the MediByte® Software with Windows Vista or Windows 7, you must disable the User Account Control for the user account used to run the software. Windows 7:
1. Select Start>Control Panel. 2. Select User Accounts. 3. Select Change User Account Control Settings. 4. Move the slider down to Never Notify. 5. Click OK. 6. Select Restart Now when asked to restart your computer. Vista:
1. Select Start>Control Panel. 2. Select User Accounts and Family Safety. 3. Select User Accounts. 4. Beside Turn User Account Control on or off, uncheck Use User Account Control (UAC) to help protect your computer. 5. Click OK. 6. Select Restart Now when asked to restart your computer.
3-2
Installing the Software
Installing the software The MediByte® Software is installed from the Braebon.com website. After you have installed the software, a MediByte® icon
will be placed on your desktop.
To install the software:
Installing the software is very easy, an installation wizard will guide you through the process. 1. In your web browser (eg., Internet Explorer, Firefox), type braebon.com/setup. 2. Click MediByte. • Click the red Download button beside MediByte Software. The system is designed to start the installation process, but your web browser may not allow this. A new window may open asking whether you want to save the file, click Save File. The software will then download to your computer, usually in the Downloads folder.
Figure 3.1: MediByte Software download
3. Double-click on the MediByte Installer File (MediByte 64bit Small V71082 or MediByte 32bit Small V71082). 4. A security window may open asking you whether you want to run the file. Click Run. The MediByte Installation Wizard will open. 5. Click Next to open the Software License Agreement. 6. Review the software license agreement, and if you accept the terms, click the radio button beside I accept the terms of the license agreement, and click Next. 7. Click Install. 8. Click Finish to exit the Installation Wizard. The software installs in C:\Program Files\MediByte by
Figure 3.2: Installation Wizard
default. You will find the MediByte icon and the MediByte patient Guide on your desktop.
, the MediByte User Guide
3-3
Installing the Software
Connecting the MediByte to the Computer Install the software before you connect the MediByte® to the computer.
1. Insert a battery into the MediByte®. 2. Using the communication cable, connect the larger USB connector to the computer USB port. 3. Connect the smaller connector to the MediByte® communication port. 4. Double-click the MediByte® Software icon
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.
Installing the Software
Installing the Hardware Drivers The first time you plug the MediByte® communication cable into a USB port, a Found New Hardware wizard appears on the computer screen. You must install the hardware drivers before you can prepare the MediByte® for a patient. Every time you plug the MediByte® into a new computer or new USB port, this new hardware wizard appears. 1. On the first screen, click No, not this time. 2. Click Next to move to the next screen.
3. Click Install the software automatically (Recommended). 4. Click Next to move to the next screen.
5. Click Finish.
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Installing the Software
Activating the MediByte Software The first time you use the MediByte® Software, you are required to authorize it. Authorizing the software consists of entering the serial number of your MediByte® and an activation code into the BRAEBON online activation page. The page will generate an authorization code to be typed into the Software Activation page. To activate the MediByte® Software:
1. Connect the MediByte® communication cable to the computer and to the MediByte®. 2. Double-click the MediByte® Software icon Software Activation Page.
on the desktop. This action will open the
3. Make a note of the Activation Code shown on the Software Activation Page. 4. Select the Click Here button to open the BRAEBON online activation page.
116893 73673
Figure 3.3: Activating the MediByte Software online
5. Type the Activation Code into the Activation Code field.
3-6
Installing the Software 6. Type the serial number from the back of your MediByte® into the Serial# field on the online activation page. 7. Click Activate MediByte. You will receive an Authorization Code, enter it into the Enter Authorization Code field on the Software Activation page, and click Authorize. 8. A pop-up window will notify you of your success. You are now ready to use the MediByte® Software.
522 522
Figure 3.4: Entering the Authorization Code
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3-8
Chapter 4: Preparing for a Study
In this chapter This chapter describes how to prepare the MediByte® for a study. To prepare the unit, you must connect it to the computer and use the MediByte® wizard to program it. This chapter includes information about how to: 1. Insert a new battery into the MediByte® 2. Connect the MediByte® to the computer 3. Select an operation 4. Enter patient information 5. Select an auxiliary device 6. Select the start time 7. Review the settings and configure the MediByte® 8. Prepare a kit for the patient
4-1
Preparing for a Study
Preparing the MediByte Before You Begin 1. Install the MediByte Software. 2. Ensure the patient is not connected to the MediByte.® 3. Insert a new battery into the MediByte.® Preparing the MediByte® for a study consists of the following steps:
1. Insert a new battery into the MediByte®. 2. Connect the MediByte® to the computer. 3. Install the hardware drivers (if using for first time or plugging into a new USB port). 4. Select an operation. 5. Enter the patient name, ID and weight. 6. Select an auxiliary device. 7. Select the start time. 8. Review the settings and configure the MediByte®.
1. Insert a new Battery into the MediByte
®
The battery lasts for two over-night studies using the Saft LS14250, PN 0410-3 (recommended for recordings using autostart) or the EEMB ER14250, PN 0411-3. To ensure that you don’t lose power during a study, make it a habit to insert a new battery before you configure the MediByte.® 1. Using the hex screwdriver 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 the ribbon to extract 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. Do not over-tighten as you may strip it.
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Preparing for a Study
2. Connect the MediByte to the Computer Do NOT connect the MediByte® to the computer while it is in contact with the patient. This could cause serious injury to the patient.
To connect the MediByte® to the computer:
1. Connect the large end of the communication cable to the USB port of the computer. 2. Connect the other end of the communication cable to the MediByte®. 3. Double-click the MediByte® Software icon
on your desktop to start the software.
3. Install the Hardware Drivers See Installing the Hardware Drivers on page 3-5.
4. Select an Operation The software features a MediByte® wizard which guides you through the system settings. Selecting an operation means you will choose whether to configure the MediByte® for a study, download data or review an existing data file. 1. The MediByte® wizard requires that you confirm that your patient is not connected to the MediByte® by clicking the checkbox. • Click Next to continue.
Figure 4.1: Opening screen
4-3
Preparing for a Study
2. In the Operation Selection window, select from the list of activities. • To start a sleep study, select Configure the Medibyte for a Study and click Next to move to the Patient screen. • To retrieve data from the MediByte®, select Download data from the Medibyte and click Next to start the data download. • To review a data file stored on the computer, select Review Existing Data File and click Next to open the Load and Review window to select a data file. • The Renew MediByte license (Unlimited-use device) is inactive because your device has an unlimited number of uses.
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Figure 4.2: Operation Selection window
Preparing for a Study
5. Enter Patient Information In the Patient Information window, enter the patient’s name, identification number and weight. Enter this information correctly as the patient file name uses the 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. Type the patient’s weight in pounds. The weight entered determines whether the patient is an adult or pediatric patient; i.e., greater than 55 pounds is considered adult. The default weight is 100 pounds. 5. 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
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Preparing for a Study
6. Select an Auxiliary Device 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. You can only select one auxiliary device (from each list) per study.
1. Select the external device from the list and click Next to move to the start time screen. • Snore microphone • EKG • EMG Bruxism • EMG PLM • Do not use AUX channel Additional Options: • Use Airflow Thermistor • Use CPAP Pressure Figure 4.4: Auxiliary device window
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.
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Preparing for a Study
7. Select the Start Time In the following screen, select whether the recording will start automatically or manually. Automatically means the MediByte® will start recording data at the time specified and the collection on/off switch is disabled. Manually means the collection on/off switch is enabled and the patient must start the data recording by pushing the collection on/off switch on the MediByte® to the right (white dot). For a successful two-night recording, select automatic mode. This mode preserves battery power. 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. If you have opted to perform an EKG study, you will also have the option to select a 24-hour study.
Figure 4.5: Select the start time
4-7
Preparing for a Study
8. Review the Settings And Configure the MediByte The Summary screen permits you to review the settings before you configure the MediByte.® If the settings are correct, start configuring the MediByte® by clicking Next. If you need to change one of the settings, use the Back button to return to the previous screens. When you configure the MediByte,® the software sends the patient information and study settings to the MediByte® screener. You must configure the screener before you start a study. 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 configure the unit.
Figure 4.6: Summary screen
2. Select Finish. The software will send the patient information and study settings to the MediByte.® This action is called configuring the MediByte®. Once the unit is configured, the software closes automatically and you can disconnect the unit from the computer.
Figure 4.7: Final screen
4-8
Preparing for a Study
9. Prepare a Kit for the Patient Pack the MediByte® Kit with only the sensors the patient requires to perform the study. The following kits are illustrated: •
Study with no auxiliary
•
Snore study
•
EKG/Bruxism study
•
PLM study
Table 4-1: Study with No Auxiliary Kit Item
Description
Quantity
A
Patient Accessory Kit (8119)
1
B
SpO2 cable (8897)
1
C
Q-RIP Effort Belt (8572)
2
D
Q-RIP cable
2
E
MediByte (MP8)
1
Figure 4.8: Study with no Auxiliary Kit
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Preparing for a Study
Snore Study Table 4-2: Snore Study Kit Item
Description
Quantity
A
Patient Accessory Kit (8119)
1
B
Snore Microphone (8541)
1
C
Q-RIP Effort Belt (8572)
2
D
Q-RIP cable
2
E
Medibyte (MP8)
1
F
SpO2 cable (8897)
1 Figure 4.9: Snore Study Kit
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Preparing for a Study
EKG Study Table 4-3: EKG/Bruxism Study Kit Item
Description
Quantity
A
PLM leadwire yoke adapter (8611) or optional leadwire yoke adapter (8610)
1
B
EKG leadwires 24” (8620)
1
C
Q-RIP Effort Belt (8572)
2
D
Q-RIP cable
2
E
Medibyte (MP8)
1
F
SpO2 cable (8897)
1
G
MediByte® Electrode Prep Kit (8129)
1
Figure 4.9: EKG Study Kit
PLM/ Bruxism Study Table 4-4: PLM/Bruxism Study Kit Item
Description
Quantity
A
PLM leadwire yoke adapter (8611)
1
B
PLM/Bruxism leadwires 60” (8620)
1
C
Q-RIP Effort Belt (8572)
2
D
Q-RIP cable
2
E
Medibyte (MP8)
1
F
Spo2 cable (8897)
1
G
MediByte® Electrode Prep Kit (8129)
1 Figure 4.10: PLM/Bruxism Study Kit
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4-12
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: •
Snore study • • • • •
•
Chest and abdominal effort belts Snore microphone Pressure cannula placement Pressure cannula with thermistor placement SpO2 sensor placement
Auxiliary channel electrode placement • EKG study • EMG Bruxism study • EMG PLM study
•
Starting the study
•
Ending the study
5-1
Preparing the Patient
Snore Study Snore Microphone
cTherm Cannula Thermistor Pressure Cannula
Chest Belt
Abdominal Belt
SpO2 Sensor
Figure 5.1: Snore study
5-2
Preparing the Patient
1. Chest and Abdominal Effort Belts The chest and abdominal effort belts record respiratory effort.
To place the chest belt The chest belt clips onto the MediByte,® as illustrated. 1. With the MediByte® upright and facing you, clip the black belt onto the right MediByte® clip. 2. Tighten the belt as much as possible. It is much easier to loosen a tight belt on the body than to tighten a loose belt. 3. Wrap the belt around the chest and clip into the remaining MediByte® clip. 4. Ensure the belt is located above or below the nipple line and loosen for a firm but comfortable fit.
Figure 5.2: Placement of the chest belt
5. Take one of the Y-shaped black cables and plug one safety pin connector into the left socket located on the belt (circled) and the other safety pin connector into the right socket. 6. Plug the keyhole connector into the black keyhole input on the bottom right of the MediByte,® labelled CHEST.
5-3
Preparing the Patient
To place the abdominal belt The abdominal belt is placed below the rib cage. 1. As with the chest belt, tighten the belt as much as possible before putting it on. 2. Wrap the belt around the belly and snap closed. Loosen for a firm but comfortable fit. 3. Take the remaining black Y-shaped cable and plug one safety pin connector into the left socket located on the belt and the other safety pin connector into the right socket. 4. Plug the keyhole connector into the black keyhole input on the bottom left of the MediByte,® labelled ABDOMEN. Figure 5.3: Placement of the abdominal belt
5-4
Preparing the Patient
2. Snore Microphone The snore microphone collects snoring sounds. 1. Position the Snore Microphone™ on the patient’s forehead or cheek. 2. Secure the Snore Microphone™ with medical tape. 3. Plug the Snore Microphone™ into the AUX port on the MediByte,® ensuring the red mark on the connector lines up with the red mark on the port. 4. If you are using a cTherm, plug the connector from the cTherm into the white connector on the Snore Microphone™.
Figure 5.4: Snore Microphone placement
cTherm plug
AUX
Figure 5.5: Connect the Snore Microphone to AUX.
5-5
Preparing the Patient
3. Pressure Cannula Placement The pressure cannula measures airflow. 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 5.6: Pressure cannula placement
Figure 5.7: Connect the pressure filter to the Pressure cannula connection
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