Michele Sleep Scoring

User Manual – MICHELE Sleep Scoring System
Revision: 30
Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
Michele
Sleep Scoring System
User Manual
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User Manual – MICHELE Sleep Scoring System
Revision: 30
Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
Table of Contents
Label Information, including Intended Use and Warnings and Cautions
4
Introduction
User Training
5
5

5
5
6
7
8
13
System Overview
1.1.
System Requirements
1.2.
Data Collection Requirements
1.3.
Scoring Rules Used
1.4.
Reported Variables
1.5.
Validation Results
 Viewer Installation
2.1.
Instructions
2.2.
Login Information
2.3.
Software Update Instructions
2.4.
Creating Proper Score File Directories
20
20
28
29
34

35
35
40
44
52
53
54
54
55
57
58
60
Set up and use of the Main Graphical User Interface Window
3.1.
How to Customize the Main Window Layout
3.2.
The Main Menu
3.3.
Setting Up Individual Channels and All Properties Within
3.4.
Filters
3.5.
Referencing
3.6.
Remove R wave
3.7.
Channel Renaming
3.8.
Hypnogram Properties
3.9.
Body Position Channel
3.10. Channel Mapping
3.11. Montages
 Scoring a File
4.1.
Study Review
4.2.
Channel Mapping for Scoring
4.3.
Finalizing User Input Required for Scoring
4.4.
Uploading to the YMT Server
4.5.
Remote File Manager
4.6.
The Scores Window
4.7.
The Graph Window
66
66
66
70
72
72
78
82
 Editing a File
5.1.
Copying a File for Edit
5.2.
How to Edit a Study
5.3.
The editing helper
5.4.
Creating an event
84
84
85
86
91
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User Manual – MICHELE Sleep Scoring System
Revision: 30
Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
5.5.
5.6.
5.7.
5.8.
5.9.
5.10.
The Graph Tray
The View Menu
Additional Information
The Toolbar
Analysis Notes
Print Example
92
93
95
98
100
100
 Generating the Report
102
 The Help Menu
103
 Troubleshooting
8.1.
Error Message
8.2.
Notifying YMT of Perceived Software Failure
105
105
105
 Optional Server Setup
9.1.
Requirements
9.2.
Installation
9.3.
Configuration
9.4.
Miscellaneous
10
106
106
106
106
 Attachments
10.1. Sample Report
107
107
Appendix A – Report Editing
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User Manual – MICHELE Sleep Scoring System
Revision: 30
Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
Younes Medical Technologies (YMT)
Unit 5 – 55 Henlow Bay
Winnipeg, Manitoba R3Y 1G4
Canada
Tel: 1-888-942-6774
EC
REP
Advena Ltd.
Pure Offices
Plato Close
Warwick, CV34 6WE
UK
https://michelesleepscoring.com/
0086
Intended Use
The MICHELE Sleep Scoring System is a computer program (software) intended for use as an aid for
the diagnosis of sleep and respiratory related sleep disorders.
The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and
manual rescoring), display, redisplay (retrieve), summarizing, reports generation and networking of digital data
collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.
The device is to be used under the supervision of a physician. Use is restricted to files obtained from
adult patients.
Warnings and Cautions
The MICHELE Sleep Scoring System does not analyze data that are different from those analyzed by
human scorers. The report generated by the MICHELE Sleep Scoring System contains numerical and graphical
data typical of those generated following manual scoring of polysomnograms. It does not contain any
interpretation, diagnosis, or recommendations for treatment. These decisions are to be made by the treating
physician.
The scoring provided by the MICHELE Sleep Scoring System must be reviewed, edited as necessary
and approved before the report is generated.
Special attention should be paid to confirm the first epoch of REM sleep and of non-REM sleep since,
occasionally, brief periods of either kind can be missed or mistakenly scored resulting in large errors in sleep
latency or REM latency.
Arousals may be underreported in cases where arousal frequency is very high.
Any modification to any component of the MICHELE Sleep Scoring System may result in erroneous
results or failure of the software to operate.
If data files are sent to YMT for processing or troubleshooting, failure to remove confidential patient
information from the file may result in breach of patient privacy if files are lost in transit or accessed by
unauthorized personnel.
Caution: US Federal law restricts this device to sale by or on the order of a physician.
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User Manual – MICHELE Sleep Scoring System
Revision: 30
Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
Introduction
The MICHELE Sleep Scoring System (MICHELE) is a software system that automatically scans
physiological data recorded during sleep studies, referred to as polysomnography (PSG) records, and
applies a variety of analytical approaches to identify the occurrence of certain events that relate to the
presence and type of sleep-state, breathing abnormalities and limb movements. The system is capable of
scoring Sleep Stages, Arousals, Respiratory Events and Leg Movements. At the end of the analysis the
system generates a PSG Report that includes tables and graphs typical of those generated following
manual scoring of PSG records by certified technologists. The results of the automated scoring may be
displayed using the PSG Scoring Viewer (referred to as Viewer in this User Manual) application, which
allows manual editing of the results and generation of a revised PSG Report.
The Autoscoring software package is currently not available to users outside of YMT. The Autoscoring
is currently provided as a service by YMT; users may access the Autoscoring feature remotely via
Hypertext Transfer Protocol (HTTP) using the Viewer software, as described in Section 4.
User Training
This User Manual provides a comprehensive description of the full capabilities of MICHELE, and in
particular of the Viewer. The User Manual – along with descriptions of functions within the Viewer user
interface – comprises the primary training material for use of MICHELE and the Viewer. It is strongly
recommended that users read this User Manual at least once prior to using the Viewer, and that users refer
to the User Manual as often as needed in conjunction with use of the Viewer. Additional training may be
provided on-site and/or via video by YMT personnel, covering both installation and use of the software.
Any user should have a prior understanding of the physiological signals associated with PSG studies, and
should be appropriately qualified in the scoring and interpretation of PSG records, as per a physician in
sleep medicine or a Registered Polysomnographic Technologist (RPSGT). Appropriate qualifications and
training (as described above) will enhance the user’s experience with MICHELE and ensure accuracy in
scoring and report generation.
1.0 System Overview
 System Requirements
1.1.1.
The Viewer has been verified to work with Windows® XP and Windows® 7.
1.1.2.
The Viewer requires a minimum of 4GB of RAM.
1.1.3.
Processor requirement is 1.6 GHz or faster.
1.1.4.
Monitor requirement 19 inch or greater, 1280 X 1024 resolution or greater.
1.1.5.
Keyboard and mouse for control, and a printer if hard copies are required.
1.1.6.
50 MB of free hard drive space.
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User Manual – MICHELE Sleep Scoring System
Revision: 30
Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
1.1.7.
Patient files must be in the .EDF or .YDF format.
1.1.8.
A new directory must be created for each patient file.
1.1.9.
Access to the Internet is required
1.1.10. Outgoing (UDP) traffic on port 53 is allowed to hosts ns1.younessleeptechnologies.com and
ns2.younessleeptechnologies.com. This is required to implement automated failover in the
event of a YMT server outage. For more information, contact YMT Support (contact
information provided in Section 8.2).
 Data Collection Requirements
In order to properly execute the automated scoring module embedded in the Viewer, the PSG data must
meet the requirements described in this section. Section 3.8 elaborates on the signals that the Viewer is
capable of analyzing as well as the signals that are mandatory for data processing.
1.2.1 Electrode positioning and Impedance
Electrode placement should follow the Standard Placement procedures (as per Rechtschaffen and Kales).
Electrode impedance should be <5K.
1.2.2 Sampling rate
The sampling rate should be a minimum of 120 Hz for AC channels (EEG, EOG, EKG, EMG and
Audio), a minimum of 20 Hz for Respiratory signals (Thermister, Flow, Respiratory bands, Airway
pressure, Airway CO2), a minimum of 5 Hz for SpO2 and a minimum of 1 Hz for body position, if
position is recorded directly in the digital file.
1.2.3 Signal filtering of AC channels (EEG, EOG, EKG, EMG and Audio)
Filtering must be performed either in hardware (at the amplifiers) or in the software after recording. If you
use hardware filters, you should export the file into the .EDF format without any additional filtering. If
you do not use the hardware filters, it is recommended that you export the file without additional filters.
You will be asked, as described in Section 4.2, whether the file has been pre-filtered (either by hardware
or during export) before automated scoring begins.
If the signals are to be filtered by hardware or during export, each of the 5 primary AC channels must be
filtered as per the American Academy of Sleep Medicine (AASM) guidelines shown below. In addition, a
60 Hz notch filter must be used where available.
EEG
EOG
EMG
ECG
Audio
Low Frequency Filter
0.3 Hz
0.3 Hz
10 Hz
0.3 Hz
10 Hz
High Frequency Filter
30-35 Hz (preferably 30)
30-35 Hz (preferably 30)
100 Hz
70 Hz
100 Hz
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User Manual – MICHELE Sleep Scoring System
Revision: 30
Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
1.2.4 Signal referencing
As with filtering (Section 1.2.3), referencing of AC signals must be performed either in the hardware (at
the amplifiers) or in the software after recording.
If you use the hardware referencing, you should export the file into the .EDF format without any
additional referencing. If you do not use hardware referencing, it is recommended that you export the file
without referencing. Referencing can be done through the interface provided with the Viewer.
You will be asked, as described in Section 4.2, to confirm that the AC channels have been referenced (by
hardware, during export or through the Viewer interface) before automated scoring begins.
1.2.5 Signal noise
Noise should be kept to a minimum through appropriate cable insulation and connections. Although the
software continuously evaluates the signal quality of certain channels and in those cases uses only signals
that meet minimum quality criteria, as a best practice noise should be minimized as signals that are
damaged or noisy can greatly affect scoring quality. If desired, YMT staff can advise you on ways to
reduce the noise. (Section 8 of this User Manual provides contact information).
1.2.6 Calibration
All AC signals must be calibrated using a 50V calibration switch.
 Scoring Rules Used
The MICHELE Sleep Scoring System adheres to the most recent guidelines of the American Academy of
Sleep Medicine (The AASM Manual for the Scoring of Sleep and Associated Events, 2007). Specifically:
1.3.1 Identification of sleep stages
This is done according to the Rechtschaffen & Kales rules, as modified by the new 2007 AASM
guidelines, from analysis of the frequency profile of the EEG, presence of EEG spindles, k complexes and
delta waves, level of chin EMG, and eye movements. Each 30-second epoch of data will be designated as
being in stage W (awake), REM sleep, N1 Non-REM sleep, N2 Non-REM sleep, or N3 Non-REM sleep.
1.3.2 Detection of arousals
Each 30-second epoch will be searched for the presence of one or more arousals following the guidelines
of the American Sleep Disorders Association (Sleep 15: 174–184, 1992). Whenever an arousal is found, it
will be classified as respiratory-related, leg movement-related or spontaneous, based on the temporal
relation of the arousal to preceding events.
1.3.3 Detection of respiratory events
Each 30-second epoch is searched for the presence of one or more respiratory events characterized by
reduction (hypopnea) or complete cessation (apnea) of airflow in and out of the patient or Respiratory
Effort Related Arousal (RERA). Whenever an apnea is detected, it will be characterized as central,
obstructive or mixed. The software uses the guidelines established by the AASM (The AASM Manual for
the Scoring of Sleep and Associated Events published by the AASM in 2012). The user will have the
choice of identifying hypopneas according to the Recommended or Alternate criteria of the 2012 AASM
guidelines. Recommended criteria is defined as a reduction in airflow of at least 30% accompanied by an
O2 desaturation of at least 3% or an associated sleep arousal. Alternate Criteria is defined as a reduction
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User Manual – MICHELE Sleep Scoring System
Revision: 30
Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
in airflow of at least 30% accompanied by an O2 desaturation of at least 4%. The software continuously
evaluates the signal quality of the various respiratory channels (nasal cannula flow (or CPAP flow),
thermister, and chest and abdomen bands) and uses only signals that meet minimum quality criteria. If
more than one channel is of acceptable quality, the amplitude criteria are assessed from nasal flow (or
CPAP flow if patient is on CPAP), if valid. If not, the thermister is used and if this is not valid also, the
chest and abdomen bands signals are used to assess amplitude changes.
Hypopneas identified by either criterion are further classified into obstructive or undefined. An
obstructive hypopnea is one where there is associated snoring and/or chest wall paradox and/or flow
limitation. An undefined hypopnea is one that lacks these features. It should be emphasized that lack of
these features does not rule out an obstructive basis for the hypopnea. Hence, such hypopneas are called
undefined, meaning they can be obstructive or central.
1.3.4 Detection of leg movements
Each 30-second epoch is searched for the presence of one or more leg movements. Whenever a leg
movement is found, it will be characterized as associated or not with arousal and whether the leg
movements follow a periodic pattern (periodic leg movements (PLMs)) following the guidelines
established by the American Academy of Sleep Medicine (The AASM Manual for the Scoring of Sleep
and Associated Events published by the AASM in 2007).
1.4 Reported Variables
When a file is scored and edited/approved by the technologist, a report will be generated. The report has
two components, numerical and graphical. The default report contains all values and graphs that are
available. The user may choose to omit some values from the report using a procedure described below in
the “Generate Report” Function (Section 6). In the event the study was a split study, there will be two
numerical reports in the same document, one for the pre-CPAP period and one for the On-CPAP period.
1.4.1 Numerical Report
This consists of several sections that relate to the output of the different functions of the software; namely,
sleep variables, arousals detected, periodic leg movements (PLMs) and respiratory events. The following
paragraphs describe how each value is calculated:
1.4.1.1 “SLEEP VARIABLES” Box: This table presents an all-night summary of relevant sleep data (i.e.
it includes pre-CPAP and on-CPAP times in the case of split studies). Each number in this table is
calculated according to the 2007 guidelines of the AASM.
1.4.1.1.1 Lights Off clock time
1.4.1.1.2 Lights ON clock time
1.4.1.1.3 Total Sleep Time (TST): TST is calculated from the sum of all periods scored as N1-N3 and
REM between Lights Off and Lights ON. It is reported in minutes.
1.4.1.1.4 Total Recording Time: Difference between Lights On and Lights Off in minutes.
1.4.1.1.5 Sleep Efficiency: This is calculated from TST *100 / (Total Recording Time - Time with Bad
EEG).
1.4.1.1.6 Sleep Latency: Time from Lights Off to Sleep Onset. Sleep Onset is the first time there is a
change to stage N1, N2, N3 or REM.
1.4.1.1.7 Wake After Sleep Onset (WASO): Total time in stage Awake minus Sleep Latency.
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User Manual – MICHELE Sleep Scoring System
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Effective Date: 03-Oct-17
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1.4.1.1.8 REM Latency: Time when REM sleep first appeared minus Time at which any sleep (N1, N2,
N3, or REM) first appeared.
1.4.1.1.9 Sleep Period Time: Time from Sleep Onset to Lights On minus time with Bad EEG.
1.4.1.1.10 REM Latency Minus Wake Time: REM Latency minus sum of all periods in stage awake
between lights Off and REM Onset.
1.4.1.1.11 Stage 1 Cycles: Number of times patient entered stage N1 sleep.
1.4.1.1.12 Total Awakenings: Number of times sleep-state changed from any sleep stage to stage awake.
1.4.1.1.13 Total Stage Shifts: Total number of shifts from any stage to any other stage.
1.4.1.2 “TIME IN EACH STAGE” box: The time spent in each of the five stages (awake, N1, N2, N3,
and REM) is given in minutes and as % of TST. The latency to entering each stage, provided in the last
column, is the time of first appearance of the stage minus Lights Off. The sum of all times spent in nonREM sleep (sum of stages N1 to N3 in the same table) is reported at the bottom of the table. With split
studies the values in this box and subsequent boxes reflect either the Pre-CPAP or the On-CPAP period,
as indicated in the heading above this box.
1.4.1.3 “AROUSALS” box: The arousal statistics are reported into three categories (Respiratory-related,
PLM-related and Spontaneous):
1.4.1.3.1 Respiratory Arousals: Arousals are attributed to respiratory events if they start within 5
seconds of the end of a respiratory event.
1.4.1.3.2 Arousals with PLMs: As per AASM guidelines, an arousal is attributed to a leg movement if
there is A) overlap between arousal time and PLM time, OR B) an arousal end in the interval PLM onset
to PLM onset –0.5 second, OR C) an arousal onset in the interval PLM end to PLM end +0.5 second. At
times, recurrent respiratory events are associated with recurrent arousals that involve leg movements. In
such cases, the arousal is classified as Respiratory-related.
1.4.1.3.3 Spontaneous Arousals: These are arousals that are not associated with Respiratory events or
with PLMs.
1.4.1.3.4 Total arousals: Sum of all arousals
1.4.1.3.5 Total arousals + awakenings: Sum of arousals and awakenings (from the SLEEP VARIABLES
box).
For each arousal category, arousals are separately reported for REM sleep and non-REM sleep periods.
for each arousal category. All arousal data are reported both as numbers (of arousals) and as an Arousal
Index. The latter index represents the per-hour frequency of occurrence of a certain category of arousals
during a specified sleep-state. For example, the Total Arousal Index for non-REM sleep is given by the
total number of arousals in non-REM sleep divided by total time (in hours) spent in non-REM sleep.
1.4.1.4 “LEG MOVEMENTS” box: The top section of this box reports all leg movements whether they
meet the periodic criteria or not. The lower section reports leg movements that meet the PLM criteria
published in the 2007 AASM guidelines. These criteria exclude leg movements that occur in the interval
between 0.5 seconds before the start of a respiratory event and 0.5 seconds after the end of the respiratory
event. Sections with Bad EEG are considered non-REM for purposes of computing leg movements.
Within each category, the leg movements with and without arousal are reported separately. Both
categories of leg movements (PLMs or Total) are reported separately for REM sleep and for each of the
different stages of non-REM sleep. The Index represents the per-hour frequency of occurrence of a certain
category of leg movements during a specified sleep-state. For example, the PLM index for non-REM
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User Manual – MICHELE Sleep Scoring System
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Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
sleep is given by the total number of PLMs in non-REM sleep divided by total time (in hours) spent in
non-REM sleep.
1.4.1.5 “RESPIRATORY EVENTS BY SLEEP STAGE” box: The first column in this table reports the
total number of each type of Respiratory Event that occurred during sleep, along with the relevant Index
(i.e. number / total sleep time in hours). At the bottom of the first column the total number of apneas
along with relevant index (Apnea Index) are reported. The sum of all apneas and hypopneas, along with
the Apnea + hypopnea index (AHI) are also reported. Finally, the sum of all 6 categories (Apneas +
hypopneas +RERAs) and its index are given. These three Indices are calculated by dividing the relevant
number by TST in minutes and then multiplying by 60. Sections with Bad EEG are considered non-REM
for purposes of computing Respiratory Events.
In the next two columns the total number within each category is broken into numbers occurring in REM
sleep and in non-REM sleep. For each such number the relevant Index is obtained by dividing the number
by total sleep time in minutes of the relevant sleep stage and then multiplying by 60.
The last column shows the average and maximum durations of events in each respiratory event category.
1.4.1.6 “RESPIRATORY EVENTS BY BODY POSITION” box: The first column in this table is
identical to the first column in the preceding table and provides the number, and index, of events in each
category in all body positions. The total numbers are then subdivided by body position. The Indexes are
obtained by dividing the number of events in a given position by the time (in hours) spent asleep in this
body position. Sections with Bad EEG are considered non-REM for purposes of computing Respiratory
Events.
1.4.1.7 “O2 SATURATION STATISTICS” box: This table lists a number of statistics related to SpO2
data (% oxygen saturation of hemoglobin). The following values are reported:
1.4.1.7.1 Maximum: The highest valid SpO2 between Lights Out and Lights On.
1.4.1.7.2 Average: The average of all valid SpO2 data between Lights Out and Lights On.
1.4.1.7.3 Minimum: The lowest valid SpO2 between Lights Out and Lights On.
1.4.1.7.4 # desaturations >2%: Total number of events where SpO2 decreased by >2%.
1.4.1.7.5 Desaturation Index: # desaturations >2% / Total Sleep Time in hours.
1.4.1.7.6 # desaturations >3%: Total number of events where SpO2 decreased by >3%.
1.4.1.7.7 Desaturation Index: # desaturations >3% / Total Sleep Time in hours.
1.4.1.7.8 # desaturations >4%: Total number of events where SpO2 decreased by >4%.
1.4.1.7.9 Desaturation Index: # desaturations >4% / Total Sleep Time in hours.
1.4.1.7.10 % Sleep Time spent in different SpO2 ranges. The table provides this data for six SpO2 ranges.
1.4.1.7.11 % Sleep Time with bad signal.
All of the above values – which pertain to the entire file – are subdivided into values that occur in REM
vs. non-REM sleep as well as being sorted by body position. Sections with Bad EEG are considered nonREM for purposes of computing Oxygen statistics.
1.4.2 Graphical Report
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User Manual – MICHELE Sleep Scoring System
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Effective Date: 03-Oct-17
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To be used with Viewer version 1.03.024
The graphs (see attached Report) are generated by use of the Microsoft® Chart Controls for Microsoft®
.NET Framework 4. The sample report shows the default report format, which includes all seven possible
panels; these can be adjusted to display only the desired values and graphics – see Section 6.0.
1.4.2.1 The Sleep Stage and Arousal Panel: This panel displays the sleep histogram. In addition, a tick is
placed each time an arousal occurs.
1.4.2.2 The Respiratory Panel: There are four groupings in this panel. Within each grouping there are the
six types of respiratory events, central apnea (Ap C), obstructive apnea (Ap O), mixed apnea (Ap M),
obstructive hypopnea (Hyp O), undefined hypopneas (Hyp U), and respiratory effort related arousals
(RERA).
In the first grouping (from top to bottom) a tick is placed in the appropriate row every time there is an
entry in this category, regardless of whether the event was associated with arousal or desaturation. For
example, if there is an obstructive apnea at time X, a tick will be placed in the Ap O row at time X. In the
second grouping, only those events associated with arousal are represented by ticks. In the third grouping,
only those events associated with desaturation are represented by ticks. Finally, in the bottom grouping, a
tick is placed when an event is associated with both arousal and desaturation.
The four groupings to be displayed in the graph can be selected or deselected in the generate report
settings. The height of the Respiratory panel is adjusted automatically based on what groupings are
selected.
1.4.2.3 The Oximetry Panel: This panel shows the instantaneous oxygen saturation values as a function of
time.
1.4.2.4 The Pressure Panel: This panel shows the instantaneous airway pressure values as a function of
time.
1.4.2.5 The Audio Panel: This panel shows the instantaneous Audio level as a function of time.
1.4.2.6 The Legs Panel: There are two rows in this panel. In the top row, a tick is placed for every PLM,
regardless of whether or not it was associated with arousal. In the lower row, a tick is placed only if the
leg movement was associated with arousal. As indicated earlier, when an arousal is associated with both a
PLM and a respiratory event the arousal is classified as related to a respiratory event and thus is displayed
in the top but not the bottom row of the leg movement panel.
1.4.2.7 The Body Position Panel: This panel shows the instantaneous body position as a function of time.
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User Manual – MICHELE Sleep Scoring System
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Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
1.5 Validation Results
The software performance was measured by: A) Determining epoch-by-epoch agreement between
MICHELE’s scoring and the scoring of three technologists with respect to the four scoring functions
(Sleep staging, Arousals, Periodic Leg Movements (PLMs) and Respiratory Events) (Objective 1). B)
Determining the agreement between MICHELE’s results of Clinically Relevant Data, such as Total Sleep
Time, Time in Different Stages, Apnea and Hypopnea Index (AHI…etc) and the results of the three
technologists (Objective 2). MICHELE’s performance, so determined, was compared with the results of
analysis of the same validation files by one of the predicate devices, Alice 5 (510(k) Number K040595),
using the same scoring guidelines (AASM 2007). It was also compared with the published performance
of the two other predicate devices, Somnolyzer (K083620) and Morpheus (K022506).
1.5.1 Files: Software performance was assessed using 30 full night studies recorded in the sleep
laboratory of a tertiary care facility (Foothills Hospital, Calgary, Canada). The files were selected at
random and included 19 patients with sleep apnea. Fifteen of these patients had moderate to severe sleep
apnea (AHI 7338 hr-1) and underwent split studies with one part (pre-CPAP) where sleep was severely
fragmented and a second part (on CPAP) with fairly normal sleep and breathing. The group also included
9 patients with PLMs (8 to183 hr-1; average 3855 hr-1), two patients with severe sleep fragmentation for
no apparent cause (non-organic insomnia) and seven patients with normal sleep. Overall, the quality of
sleep varied considerably among the 30 patients with Total Sleep Time ranging from 2.6 to 7.8 hours
(4.21.1 hours), sleep efficiency ranging from 37 to 99% (6118%) and arousal index ranging from 9 to
97 hr-1 (174 hr-1). A total of 24967 thirty-second epochs were scored.
1.5.2 Technologists: Each of the three scorers is Board certified and has had at least 15 years of hands-on
experience in scoring polysomnograms.
1.5.3 Analytical Methods and Results:
1.5.3.1 Objective 1 testing (epoch-by-epoch agreement): Table 1, left panels, shows results of epoch-byepoch agreement between MICHELE and a consensus (2 of the scorers agree) of the three scorers. The
right panels show the results for a predicate device (Alice 5, referred to as Alice) using the same files and
scoring guidelines. Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), Overall %
agreement and Cohen’s kappa (kappa) were calculated according to Altman DG et al (1). The weighted
average of test and reference scorers was obtained for PPA (i.e. APPA) and NPA (i.e. ANPA).
APPA, ANPA, Overall % agreement and kappa obtained with MICHELE exceeded the corresponding
values obtained with Alice for all comparisons.
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TABLE 1
AGREEMENT BETWEEN AUTO-SCORING AND CONSENSUS (2/3) OF THREE TECHNOLOGISTS
MICHELE
SCORING FUNCTION
Total
by Techs.
ALICE
APPA ANPA Overall % kappa
Agreement
(%)
Total
by Techs.
APPA ANPA Overall %
kappa
Agreement
(%)
SLEEP STAGING
24967
82.5
76.4
24967
30.5
6.1
Awake
6563
88.7 96.8
2.8
99.8
6563
N1
2411
50.6 94.7
2.8
99.1
2411
N2
9846
81.8 90.4
48.4
46.7
9846
N3
2862
92.8 96.0
86.3 59.2
2862
REM
3285
86.9 99.0
4.0
99.8
3285
No Consensus
283
283
AROUSALS
17648
89.9
54.2
17648
57.9
10.0
Yes
2278
60.0 94.1
28.1 70.3
2278
None
15370
15370
No Consensus
104
104
PLMs
18461
95.7
68.7
18461
88.3
38.2
Yes
1741
78.4 97.6
1741
44.7 93.4
None
16720
16720
No Consensus
47
47
RESPRIRATORY EVENTS
Criteria A
17746
94.0
74.2
17746
78.0
24.7
Hypopnea
1513
76.3 96.6
1513
9.3
95.3
Obstructive Apnea
329
57.1 99.2
329
14.8 92.0
Mixed Apnea
214
79.4 99.7
214
34.8 99.1
Central Apnea
174
64.9 99.6
174
16.7 99.1
None
15516
96.9 89.1
15516 90.1 48.0
No Consensus
132
132
Criteria B
17824
93.0
70.4
75.9
23.1
17824
Hypopnea
1822
60.3 97.6
1822
5.1
94.1
Obstructive Apnea
359
55.9 99.3
359
15.5 91.7
Mixed Apnea
214
83.6 99.6
214
34.2 99.1
Central Apnea
177
63.8 99.6
177
16.6 98.9
None
15252
98.1 75.5
15252 89.0 47.7
No Consensus
133
133
Numbers in Sleep Staging rows are number of 30-second epochs. Numbers in Event rows are numbers of events and
not epochs except in the "None" category where the number refers to number of epochs with no events.
APPA, Averaged Positive Percent Agreement; ANPA, Averaged Negative Percent Agreement; N1, N2, and N3, NonREM stages 1, 2 and 3; PLMs, Periodic Limb Movements; No Consensus, all three technologists gave different scores.
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1.5.3.1.1 Comparison with Other Predicate Devices:
There is only one study dealing with the performance of Morpheus (2). These authors reported on the
agreement between Morpheus and two individual (i.e. not a consensus) technologists, M1 and M2, as
well as the agreement between M1 and M2. The paper includes data on all four functions. Data available
for sleep staging include agreement for 5-stage scoring along with PPA for each stage and the overall
%agreement and kappa. They also provided %agreement and kappa, but not PPA, for 4-stage scoring
(Awake, N1+N2, N3, REM) and 3-stage scoring (awake, non-REM and REM). For scoring of arousals,
PLM and respiratory events, they provided overall %agreement and kappa for scoring one event, two
events or no events (3 x 3 matrix). There was no information on agreement for different categories of
respiratory events.
Two studies are available for the Somnolyzer. In one (4), the authors reported on % agreement for sleep
stages only, in comparisons between the Somnolyzer and a 2/3 consensus of technologists. Their subjects
were mostly normal but the study included 25 patients with sleep apnea (severity unspecified). The %
agreement and kappa values for sleep staging by MICHELE (82.5%, Table 1) exceeded the values
reported in this study both for the apnea patients (75.6%) and the normal subjects (80.4%).
The other study on Somnolyzer (3) reported on %agreement and kappa in comparisons between the
Somnolyzer and one scorer. Comparisons were limited to sleep staging, and the subjects were all normal.
In order to compare our results with those cited above (2,3) it was necessary to analyze and report our
data in the same fashion (i.e. one-on-one comparisons between the Auto-score and two technologists and
between the two technologists). This is presented below for our first two scorers (S1 and S2) along with
the agreement indices that correspond to what they reported (Table 2).
Table 2 shows that the agreement between MICHELE and individual technologists equals or exceeds the
corresponding values in the Morpheus study (2). It is to be noted that the criteria for scoring respiratory
events used in the Morpheus study (the Chicago criteria (5)) were different from the criteria used by
MICHELE (6), and that the latter criteria are more complex than the former. It is also notable that the
agreement between MICHELE and each of the two technologists (S1 and S2) is substantially comparable
to the agreement between the two technologists. The other published study dealing with the Somnolyzer
(3) reported a % agreement of 72.3% with a kappa of 59.1% for agreement between the Somnolyzer and
one scorer in staging sleep. The agreement between MICHELE and either technologist (S1 or S2) exceeds
their reported value.
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TABLE 2
COMPARISON OF MICHELE SLEEP SCORING SYSTEM AND MORPHEUS
Scoring
Function
MICHELE Sleep Scoring System
Morpheus (2)
Test reported
Auto vs.S1 Auto vs. S2 S1 vs S2 Auto vs.M1 Auto vs. M2 M1 vs M2
SLEEP (5-stage) %agreement (kappa) 80.9(74.4) 76.7(68.4) 79.6(72.3) 77.7(67.0) 73.3(61.0) 82.1(73.0)
Awake
PPA
94.4
82.6
75.0
68.7
69.6
80.9
N1
PPA
41.4
41.9
53.6
13.1
19.9
21.3
N2
PPA
80.9
76.1
82.9
73.5
68.9
77.1
N3
PPA
89.7
89.2
90.5
58.0
35.3
47.7
REM
PPA
87.3
85.8
94.2
60.7
57.1
79.0
SLEEP (4-stage) %agreement (kappa) 88.0(81.8) 83.3(74.6) 84.9(76.6) 82.6(71.0) 79.9(65.0)
88.7(80)
SLEEP (3-stage) %agreement (kappa) 91.4(83.5) 91.1(81.8) 90.8(82.8) 88.0(75.0) 88.0(74.0) 93.5(87.0)
AROUSALS (3X3) %agreement (kappa) 84.1(38.8) 87.9(49.3) 85.7(46.4) 76.2(28.0) 76.1(30.0) 83.7(57.0)
PLMs (3X3)
%agreement (kappa) 95.0(66.2) 94.6(67.0) 93.8(60.2) 93.1(68.0) 92.2(66.0) 95.6(77.0)
RESPRIRATORY
Chicago (3X3)
%agreement (kappa)
Criteria A (3X3)
%agreement (kappa) 94.8(78.3) 94.6(75.2) 94.9(76.4)
Criteria B (3X3)
%agreement (kappa) 94.3(76.5) 93.9(71.7) 93.8(74.3)
89.7(66.0) 89.7(66.0) 94.9(82.0)
1.5.3.2 Objective 2 testing:
In this section we discuss agreement between automatic and manual scoring for summary variables that
appear in the clinical report used by physicians to assess sleep disorders. Table 3 shows the results for 14
variables. These were selected because they are the most commonly used variables in the clinical
assessment.
The first data column of Table 3 is the average score of the three technologists for each of the 14
variables of interest. The averaging was done on a file-by-file basis. The values and corresponding
standard deviations (SD) given in column 1 are the average and SD of the 30 averages. The second
column contains the average and SD of the values obtained from Automatic analysis with MICHELE
Sleep Scoring System. The third column lists the average and SD of the thirty differences between
MICHELE and the corresponding average of the three technologists (Bland and Altman analysis).
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Table 3: Agreement between Manual and Automatic Scoring for Relevant Scoring Variables
Average
Variable
S1-S3
SD
Michele
Michele - ave.
SD
SD
Alice
Alice
SD
Intra-class Correlation Coefficients
- ave. Michele Alice S1 vs. S2 vs.
SD
vs. Ave. vs.Ave.
Ave. Ave.
S3 vs.
Ave.
Total sleep time (min)
312
74
312
72
0
13
440
66
128
96
0.983
-0.226
0.954
0.978
0.992
Sleep efficiency (%)
74.6
17.0
74.7
16.6
0.1
2.9
97.0
11.0
23.0
21.0
0.985
-0.243
0.957
0.98
0.994
Sleep-onset latency (min)
24
27
24
29
0
9
1
2
-24
27
0.950
-0.118
0.991
0.997
0.995
REM-onset latency
(min)
126
71
126
73
0
28
NA
NA
0.923
NA
0.988
0.966
0.992
Stage wake (min)
108
76
108
74
-1
12
12
43
-97
88
0.986
-0.229
0.958
0.98
0.994
Stage 1 (min)
47
30
42
28
-5
14
3
9
-44
29
0.876
-0.219
0.912
0.864
0.91
Stage 2 (min)
165
54
159
50
-5
20
233
104
69
131
0.922
-0.288
0.983
0.964
0.972
Stage 1+ 2 (min)
212
57
202
62
-10
21
236
107
24
132
0.923
-0.192
0.951
0.935
0.95
Stage delta (min)
47
38
60
46
13
17
193
101
147
100
0.869
-0.132
0.940
0.847
0.948
Stage REM (min)
53
26
51
26
-2
8
3
14
-50
28
0.951
-0.282
0.988
0.977
0.984
Arousal Index (hr-1)
33
23
25
11
-9
15
54
18
21
31
0.566
-0.251
0.937
0.956
0.932
PLM Index (hr-1)
12
29
13
31
1
9
43
42
29
30
0.958
0.589
0.978
0.855
0.867
AHI A (hr-1)
30
41
32
40
2
7
34
22
4
34
0.982
0.369
0.992
0.974
0.988
AHI B (hr-1)
31
42
27
36
-4
8
30
21
-2
35
0.971
0.384
0.99
0.967
0.986
0.918
-0.064
0.966
0.946
0.965
Average
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The fourth and fifth columns are the corresponding results for the predicate device (Alice). Shaded cells
in columns 3 and 5 indicate significant difference (p 0.05) between the Auto-score (MICHELE or Alice)
and the average of the three technologists. The last five columns contain the intra-class correlation
coefficients for comparisons between each of the five scorers and the average score of the three
technologists.
The results show good agreement in general between MICHELE scores and the average of three
technologists. With the exception of the arousal index where concordance (ICC) between the Auto-score
and the average was only modest (ICC = 0.566), concordance was excellent and mostly within the range
observed in comparisons between individual technologists and the average of the three technologists.
Average ICC for MICHELE vs. Average was 0.918 (bottom row, table 3), only marginally below S1
(p=0.03 by ANOVA for repeated measures) and not significantly different from S2 or S3.
The results for analysis with the predicate device (Alice) are also shown in Table 3. It is clear that
MICHELE’s performance is superior in all respects. Alice found no REM sleep in 27 of the 30 files, even
though REM was present in 28 of the files as identified by each of the three technologists and by
MICHELE.
1.5.3.2.1 Comparison with Other Predicate Devices:
Table 4 shows results for MICHELE (left 6 columns) and the only results available in the literature for
another predicate deice (Morpheus) (2). The first three columns in each set are the average results for the
two human scorers (S1 and S2 in the case of MICHELE, and M1 and M2 for Morpheus) and the
corresponding automatic score. The next three columns are intra-class correlation coefficients (ICC) for
the relation between the auto-score and the two technologists as well as the relation between the two
technologists.
As may be expected from comparisons involving a large number of pairs, and as shown in the table by
highlighted cells, there were many significant differences between the three scorers even though the
average differences were small. The results of Morpheus were significantly different from both M1 and
M2 in 8 variables (solid shade and diagonal stripes). MICHELE Auto-scoring was different from both S1
and S2 in five. As in the case of the MICHELE, the authors of the Morpheus study (2) commented on the
occasional inaccuracy of the Morpheus system in estimating REM-onset latency. They indicated that
Morpheus missed the first REM period in 10 patients (32%) whereas MICHELE missed the first REM
period in only one patient. The differences they reported between manual and automatic scoring in the
other variables were in the same range as what we observed with MICHELE. Both systems
underestimated the arousal index. With Morpheus the difference was 11 hr-1 (0.5[30+36]-22) while
MICHELE underestimated the index by 8 hr-1 (0.5[32+33]-25). The correlation coefficients for
comparisons between manual and MICHELE’s scoring (S1 vs.Auto and S2 vs. Auto) exceeded the
corresponding coefficients in the Morpheus study (M1 vs. Auto and M2 vs. Auto) in all categories except
the Arousal Index, where it was only marginally lower. The averages of all correlation coefficients for the
comparisons between Tech.1 & Tech.2, Tech.1 vs. Auto and Tech.2 vs. Auto are given at the bottom of
the table. There were no significant differences (by ANOVA for repeated measures) between the three
averages in the case of MICHELE.
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Table 4
Comparison between Michele and Morpheus for Scoring Clinically Relevant Variables
Michele Auto-Scoring System
Variable
Total sleep time (min)
SD
Sleep efficiency (%)
SD
Sleep-onset latency (min)
SD
REM-onset latency (min)
SD
Stage wake (min)
SD
Stage 1 (min)
SD
Stage 2 (min)
SD
Stage 1+ 2 (min)
SD
Stage delta (min)
SD
Stage REM (min)
SD
Arousal Index (events/h)
SD
PLM Index (events/h)
SD
Resp. Disturbance Index
SD
AHI A (events/h-1)
SD
-1
AHI B (events/h )
SD
Average
S1
330
73
79
16
22
27
131
72
91
72
52
40
167
57
219
62
55
43
55
28
32
18
11
31
30
40
34
43
S2
300
76
72
18
25
27
121
71
120
80
44
29
168
57
212
61
36
36
51
25
33
24
12
32
28
41
31
43
S1
vs.
Auto S2
312 0.876
S1
vs.
Auto
0.934
S2
vs.
Auto
0.968
0.883
0.941
0.968
0.98
0.94
0.95
0.92
0.90
0.92
0.886
0.942
0.969
0.692
0.731
0.804
0.925
0.926
0.822
0.830
0.903
0.811
0.671
0.967
0.548
0.948
0.953
0.915
0.875
0.594
0.461
0.849
0.959
0.738
72
75
17
24
29
126
73
108
74
42
28
159
50
202
62
60
46
51
26
25
11
13
31
32
40
29
37
0.947
0.985
0.930
0.932
0.967
0.926
0.872
0.903
0.838
Morpheus
M1
348
63
83
12
26
24
130
79
85
49
19
15
231
54
250
55
38
26
60
30
30
19
13
19
21
23
M2
345
61
82
11
26
24
127
74
89
46
49
20
222
46
270
53
21
23
53
26
36
17
16
21
23
25
Auto
357
65
85
12
22
21
175
81
76
50
38
27
214
48
252
59
50
26
55
34
22
16
19
25
24
23
M1
vs.
M2
0.980
M1
M2 vs.
vs.
Auto Auto
0.920 0.940
0.960
0.870 0.910
1.000
0.860 0.860
0.990
0.460 0.460
0.960
0.870 0.910
0.220
0.370 0.530
0.800
0.840 0.720
0.860
0.870 0.730
0.570
0.530 0.180
0.920
0.720 0.760
0.810
0.720 0.580
0.930
0.610 0.650
0.990
0.950 0.950
0.845
0.738 0.706
Significantly different from Auto.
Significantly different from Tech.2.
Significantly different from both Tech. 2 and Auto.
18
User Manual – MICHELE Sleep Scoring System
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Effective Date: 03-Oct-17
Document Number: YST-UDoc-USM-30
To be used with Viewer version 1.03.024
REFERENCES:
[1] Altman DG, Machin D, Bryant TN, Gardner MJ. Statistics With Confidence. British Medical Journal
2000.
[2] Pittman SD et al. (2004), “Assessment of Automated Scoring of Polysomnographic Recordings in a
Population with Suspected Sleep-disordered Breathing,” SLEEP 27:1394-1403.
[3] Svetnik V et al. (2007), “Evaluation of Automated and Semi-Automated Scoring of
Polysomnographic Recordings from a Clinical Trial Using Zolpidem in the Treatment of Insomnia.”
SLEEP 30: 1562-1574.
[4] Anderer P et al. (2005), “An E-Health Solution for Automatic Sleep Classification according to
Rechtschaffen and Kales: Validation Study of the Somnolyzer 24 x 7 Utilizing the Siesta Database,”
Neuropsychobiology 51:115-133
[5] Sleep-related breathing disorders in adults: recommendations for syndrome definition and
measurement techniques in clinical research. The report of an American Academy of Sleep Medicine Task
Force. Sleep 22: 667–689, 1999.
[6] The AASM Manual for the Scoring of Sleep and Associated Disorders. American Academy of Sleep
Medicine, Westchester, Illinois. 2007
19
User Manual – MICHELE Sleep Scoring System
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Effective Date: 03-Oct-17
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To be used with Viewer version 1.03.024
2.0 Viewer Installation
2.1 Instructions
Follow the instructions below to install the Viewer. (Instructions on the software update process are
provided in Section 2.3.)
Note 1: During the install process, if a Windows pop-up asking if ‘filename.exe’ is
allowed to make changes to this computer, ‘Yes’ must be selected to enable the
installation.
Note 2: For the Windows XP 64-bit operating system, the following items need to be
installed before successful installation of the Viewer:
•
Microsoft .net Framework 4.5
•
A Microsoft patch entitled ‘wic_x64_enu’, that should look like this:
The patch can be downloaded by pasting this url into your web browser:
http://www.microsoft.com/en-us/download/details.aspx?id=1385
To initiate the software installation process, double click on the “MICHELE_vX_XX_XXX.exe” icon,
shown below, which is provided as part of the Viewer software distribution.
Figure 2.0
Depending on your settings, one or more “Open File – Security Warning” windows such as the one
shown below in Figure 2.1 may appear after initiating the installation process. In each instance, select
Run. A Microsoft Windows message may appear asking if you want to allow the following program
from an unknown publisher to make changes to this computer.
The program is:
“MICHELE_vX_XX_XXX.exe”, where the X represents specific version numbers of the software.
Select Yes if you wish to proceed with the installation.
A window will appear asking if you want to install the MICHELE Data Viewer as shown in Figure 2.1
below. Select Yes to proceed with the installation.
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User Manual – MICHELE Sleep Scoring System
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Figure 2.1
A WinZip Self-Extractor will appear as shown in Figure 2.2 and will begin unzipping the following
programs that are required for Viewer operation:
• Microsoft .NET Framework 4.5;
• Microsoft Visual C++ 2010 x86 Redistributable.
• The MICHELE Sleep Scoring System Viewer (titled “Michele Viewer”)
Figure 2.2
If the target PC has all of the above-listed programs installed, the Viewer Setup Wizard shown in Figure
2.8 will appear. If the target PC does not have all of the above-listed programs installed, the Viewer setup
process will attempt program installation automatically. In each case, the user will be required to read
and accept license terms, and confirm installation. For example, if the target PC does not have
Microsoft® .NET Framework 4.5 and Microsoft® Visual C++ 2010 installed, the following Viewer
Message as shown in Figure 2.3 may appear.
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Figure 2.3
Select Accept. A Microsoft window will appear asking the user to accept the install of the .NET
Framework. Once Accept has been selected, the Viewer Setup window shown in Figure 2.4 will appear.
Figure 2.4
Select Install. This installs the Microsoft® Visual C++ 2010 component libraries. If this does not happen
automatically – i.e. if the window as shown below in Figure 2.5 does not appear – run the installation
manually after completing the Viewer software installation by double clicking on the file
“vcredist_x86.exe” that was included in the Viewer installation package and proceed as described below.
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User Manual – MICHELE Sleep Scoring System
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Figure 2.5
Click on the “I have read and accept the license terms” checkbox, and then click on the Install button.
The installation progress will be displayed as shown below in Figure 2.6.
Figure 2.6
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User Manual – MICHELE Sleep Scoring System
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You will be greeted with a Windows Installer message asking if you want to allow this program to make
changes to the computer at which time you will need to select Yes to continue with the installation.
Another Windows message will appear asking the same question, quoting file
“dotNetFx40_Full_x86_x64.exe.” Select Yes. After the Microsoft® Visual C++ 2010 component
libraries are installed, the installer will automatically install the .NET Framework. The window shown in
Figure 2.7 will be displayed while it is being installed.
Figure 2.7
The Viewer Setup Screen will open up next, as shown in Figure 2.8. Select Next.
Figure 2.8
If a window displaying a License Agreement opens, as shown in Figure 2.9, read the agreement and select
“I Agree” then Next to proceed with the installation. Note that the License Agreement may not be written
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User Manual – MICHELE Sleep Scoring System
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as shown in Figure 2.9, and furthermore, may be provided as a separate document that the end user must
sign and return to YMT prior to being able to complete the installation of the Viewer.
Figure 2.9
For the installation folder dialog, shown in Figure 2.10, it is recommended to choose “Everyone” and to
keep the default location as is for all installations. Choosing “Everyone” will allow any user account on
the computer to access the Michele Data Viewer. Choosing “Just me” will only allow the Michele Data
Viewer to be utilized by the same account used in installation.
Settings for the Michele Data Viewer are kept individually when “Just Me” is selected during the
installation. If the installation is for “Everyone,” the following information will be accessible to all users:
montages; login information; documentation; downloads; report templates; and software update
information including version identification.
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Figure 2.10
After selecting the installation folder, a Confirm Installation dialog will be shown next as per Figure 2.11.
Select Next to proceed.
Figure 2.11
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You will then see a progress bar indicating the installation status as shown in Figure 2.12 below.
Figure 2.12
The Viewer should then appear as an icon on the desktop, as shown in Figure 2.13.
Figure 2.13
Do not attempt to start the Viewer yet. Continue with the installation process described below.
As described earlier, the Viewer setup process will attempt to automatically install each program that is
required to use the Viewer. To determine whether the programs have installed automatically, go to “Add
or Remove Programs” in the Control Panel and review the “Currently installed programs” list to
determine whether all four are listed (as per the list shown earlier, and below). Any program that is not
listed will need to be installed from the Viewer installation disk. If a program needs to be installed in this
manner, it will be necessary to determine whether the operating system on the target PC is 32-bit or 64bit, in order to access the appropriate folder on the installation disk – either the folder labelled “32 Bit”
for a 32-bit system, or the “64 Bit” folder for a 64-bit system. Within the appropriate folder, there will be
additional folders that correspond to the four programs, as follows:
• Folder “DotNetFX40” for Microsoft .NET Framework 4.5;
• Folder “vcredist_x64_x86” for Microsoft Visual C++ 2010 x86 Redistributable.
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In each case, there is either a *.exe or a *.msi file that must be used to install the program. Any file name
referencing “x64” is to be installed on a 64-bit operating system, and a file name referencing “x86” is to
be installed on a 32-bit operating system.
The only way to confirm the correct installation of Microsoft .NET Framework 4.5 and Visual C++
Runtime Libraries is to check “Add or Remove Programs” in the Control Panel and verify that:
• Microsoft .NET Framework 4.5
• Microsoft Visual C++ 2010 x86 Redistributable
are listed under “Currently installed programs”.
The Viewer installation can be confirmed by checking the status of currently installed programs as
described above and by successfully executing it as described in the remainder of this User Manual.
The Viewer is ready to be launched. To launch the Viewer, either double click on the Viewer icon shown
in Figure 2.13 above, or access the Viewer through the Windows Start menu (on the lower left-hand
corner of the desktop screen of any Windows PC), where the Viewer should be contained within a folder
labeled “YMT Limited” which also contains shortcuts to the uninstaller, the release notes, and the User
Manual.
When the Viewer is launched for the first time, you will be prompted to provide a Client ID and a
Password, all of which will be provided by YMT. Figure 2.14 below shows the dialog box where you
enter the information.
2.2 Login Information
Figure 2.14
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If your sleep management facility utilizes a proxy server, click on the box beside “I require connecting
through a proxy server” (shown in Figure 2.14) and the menu box will expand for the user to enter the
relevant information as shown below in Figure 2.15.
Figure 2.15
Once your information has been entered, select the “Verify” option. If “ Do this Later” is selected, the
Viewer will still launch, but an error message will appear from the Remote File Manager within the
Viewer indicating it could not connect to YMT Servers. The Viewer is still functional but features such
as Scoring and Automatic Updates will not function. Scoring is discussed later in this manual.
Automatic Updates are discussed in the following section.
2.3 Software Update Instructions
YMT will update its Viewer software and associated components on a regular basis. Users have the
option of receiving updates automatically or manually checking for updates, via the Preferences Menu
(Figure 2.16) of the Viewer Main Menu as described in Section 3 of this User Manual. The default
selection is to receive automatic updates, as described below.
Figure 2.16
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When new updates are available, you will be notified on the Splash Screen when the Viewer has been
opened as shown in Figure 2.17 below.
Figure 2.17
The update will start downloading automatically and will be indicated by an alert in the user’s bottom
right corner of their monitor, as shown in Figure 2.18 below.
Figure 2.18
Once the update has finished downloading, a window will appear on the user’s monitor as shown in
Figure 2.19 below. Select “OK” and close the Viewer. Users will notice a window appear asking if they
wish to install the new Viewer. Select “Yes”, and the installation of the new Viewer will commence.
Figure 2.19
Figure 2.20 below shows the software gathering information about the current version and tools that are
currently loaded on the computer.
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Figure 2.20
Figure 2.21 below shows the window that will appear when the old version of the software has been
removed and the updated version is being installed.
Figure 2.21
Notice the continuation of the two status windows shown in Figures 2.20 and 2.21 above, and their
progression. This is normal during the upgrade process.
In Windows® 7, Windows Vista® and Windows® XP a window will pop up asking you to approve the
installation of the software. Select Yes to proceed.
Once Yes has been selected, the Viewer Setup Wizard Window will appear as indicated below in Figure
2.8 above. Select Next to proceed. The installation of the new Viewer will follow the steps shown in the
original install procedure, indicated between Figures 2.8 and 2.12 above.
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As shown in Figure 2.22a below, a final status window will appear. This window provides the user the
option of viewing the release notes pertaining to the update installed. When “View Release Notes” is
selected, the release notes will appear as shown in Figure 2.22b below. Referring again to Figure 2.22a,
once Close is selected, the window will disappear (If the Release Notes window shown Figure 2.22b was
open, Close must be selected in that window prior to selecting Close in the status window shown in
Figure 2.22a.).
Note: With respect to release notes, once the Viewer has been installed, the release notes
can be accessed by selecting the appropriate menu items within the Help Menu, as
described in Section 7.
Users will need to restart their Viewer at this point in order to use it. All scored studies and saved
montages will remain intact and available to use again.
Figure 2.22a
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Figure 2.22b
On rare occasions, critical software updates may be required. End users are required to implement these
updates immediately. End users will receive a message that an update is available via the Splash Screen
within the Viewer when a critical update is required. A window will also appear as shown below in
Figure 2.23.
Figure 2.23
If the user decides to ignore this message by selecting the “X” (closing the window) they will notice that
several functions within the main File Menu will be disabled as shown below in Figure 2.24.
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Figure 2.24
The greyed out menu items are no longer functional and will remain disabled until the critical update is
installed. The user may exit the Viewer and reopen it, selecting “OK” to update their version of the
Viewer when the message box shown in Figure 2.19 appears. The normal software update proceeds as
described throughout the Software Update Instructions information of this User Manual (Section 2.3).
The release notes pertaining to the critical update can be reviewed also as described earlier in this section
(Figures 2.22a and 2.22b).
2.4 Creating Proper Score File Directories
It is necessary to store all EDF/REC files in separate folders. Keeping them together in one folder will
corrupt the scoring data.
Create a folder on your hard drive called YMT Data Files. It can be anywhere, as long as it’s NOT under
the newly installed YMT Limited folder. Within the YMT Data Files folder, you will need to create
subfolders for each individual study (using a patient’s name or subject code) to store all of your
individual EDF/REC files.
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3.0 Setup and Use of the Main Graphical User Interface Window
3.1 How to Customize the Main Window Layout
Once the Viewer is launched, the Main Graphical User Interface (GUI) Window will be shown as per
Figure 3.0.
1. Main Menu
2. Toolbar
4. Properties
3. Graph
Window
Window
5. Scoring
Window
6. Hypnogram
Figure 3.0
Note that in Figure 3.0, there is no file open. Subsequent figures (Figure 3.1 and onward) show images
from open, scored files.
The main GUI window has the potential to be customized extensively. There are four main ways to
display the four major windows numbered 3 through 6 in Figure 3.0:
• Docked
• Tabbed
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•
•
Floating
Collapsed (does not apply to Graph Window)
Docked is the term used to indicate that a window has a fixed place on the screen entirely unto itself.
Dragging the edges of a docked window will resize all docked windows that are adjacent to the window
being dragged. In Figure 3.0, all four windows are displayed in the Docked mode.
Tabbed is the term used to indicate that two or more windows share the same fixed place on the screen.
Resizing of the shared space has the same results as resizing a Docked window.
The following Figure 3.1 displays a tabbed window hosting both the Scores Window and the Properties
Window.
Tabs
Figure 3.1
The tabs in the Viewer are located at the bottom of the window. Clicking on a tab will switch the display
in the tabbed window.
Floating is the term used when a window does not have a fixed place on the screen. Resizing a floating
window does not affect any other window. Figure 3.2 below shows an example of a floating window. In
this example, the Scores Window is floating.
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Figure 3.2
A floating window can be placed anywhere on the screen – it is not confined to being located within the
main interface window.
To Collapse a window, click on the pin icon ( ) in the top corner of a docked or tabbed window. Figure
3.3 shows the Hypnogram window collapsed, and Figure 3.4 shows the Hypnogram window docked.
Figure 3.3
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Figure 3.4
To display a collapsed window, the mouse must be placed over top of the tab (in this case, the tab says
“Hypnogram” – bottom left corner of Figure 3.3). This will cause the window to appear. To keep the
window from re-collapsing, dock the window by either clicking on the pin icon or clicking anywhere
within the window.
If the window is not selected or pinned, it will once again become collapsed when the cursor is removed
from the area it occupies.
To change the state of a window (the Selected Window), click on the window name and drag the mouse.
This will detach it from the current Docking point and will present you with many sets of display options.
Figure 3.5 shows the five major docking options. While still holding the mouse down, drag the cursor
over one of these options and then release the mouse. The options are as follows:
Docks the Selected Window above the current window (shares a horizontal boundary)
Docks the Selected Window to the left of the current window (shares a vertical boundary)
Docks the Selected Window below the current window (shares a horizontal boundary)
Docks the Selected Window to the right of the current window (shares a vertical boundary)
Tabs the Selected Window with the current window (shares all boundaries)
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Figure 3.5
The “current window” refers to the window over which Figure 3.5 appears.
illustrates this phenomenon.
Figure 3.6
Figure 3.6
In Figure 3.6, the Properties Window is currently being dragged. Since the mouse is currently being held
over top of the Scores Window, docking options are presented over top of the Scores Window. Selecting
one of these options will apply the docking options described above using the Scores Window as the
current window. Selecting the tabbing option causes both the Selected Window and the current window to
become tabbed.
You will also notice a second set of docking options presented – those located along the edges of the
screen and lacking the tabbing option. Using one of these options will dock using the main interface
window as the current window.
If no docking option is selected, the window switches to the floating state.
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The default layout can be viewed at any time by selecting ’View’ from the main menu and then
selecting ‘Default Layout’.
3.2 The Main Menu
The Main Menu is composed of five sub menus. These are the File Menu, the View Menu, the
Configuration Menu, the Preferences Menu, and the Help Menu. The File Menu is discussed below. The
View Menu is discussed in Section 5.7; the Configuration Menu is accessed as discussed in Sections 3.7,
5.3, and 5.6; and the Help Menu is discussed in Section 7.
The File Menu is used to access and manipulate high-level functionality of the application.
Selecting Open Patient File brings up a dialog box in which a patient file can be selected. The patient file
must be encoded as an EDF file; the file extension is irrelevant provided the EDF syntax is followed.
Opening a patient file automatically opens all .ev (scoring) files located in the same directory as the
selected patient file.
Close Patient File closes the currently opened patient file and provides an opportunity to save changes to
different components of the system.
Channel Information shows a small dialog box that presents three aspects of the opened file, the channel
numbers, names and sample rates. This is displayed in Figure 3.7.
Figure 3.7
The Save function can be utilized to save a montage, an edited file (current working copy), or analysis
notes that accompany a file.
The Score File Manager is described in Section 5.3.
Montage Manager displays a dialog that lists all of the current montages. For more information on
montages, including importing and exporting thereof, see Section 3.9.
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See Section 4.2 for details on selecting Score File from the File Menu.
The Remote File Manager is described in Section 4.5.
How to generate a report using the Generate Report option is covered in detail in Section 6 of this
manual.
The Print option allows printing of any of the Graph Window, Hypnogram, Event List or Analysis Notes.
The Recent File List displays a list of recently opened files. Selecting a file from this list is the equivalent
of utilizing Open Patient File.
Exit attempts to close the application, first prompting to save changes.
3.2.1 Opening a Patient File
To open a file, go to the File Menu and choose “Open Patient File”.
Figure 3.8
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Note: Each EDF file should have a unique file name that does not include any
identifiable patient information. EDF files that have been scored should never be renamed.
You should see a screen similar to the one shown below in Figure 3.9. Note that the hypnogram and
scoring pane are blank as there is no scoring associated with this file yet.
Figure 3.9
Once a study has been opened in the Viewer, it will be necessary to build a new montage by setting
up each individual channel, all properties/settings within, and the Channel Mappings. If channels
numbers are ordered differently between collection systems or rooms/beds, a montage will have to
be built and saved for each configuration of channels. Once a montage has been saved, it will not
have to be built again and can just be chosen for each related study.
Right clicking in the Channel Header Area brings up a channel selection menu shown in Figure 3.10
below.
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Figure 3.10
This menu allows for adding and removing channels from the graph window. Any channel with a
checkmark is currently visible. By selecting a channel from this list, the visibility is toggled: if a
currently hidden channel is selected, it is added at the location of the mouse; if a currently visible channel
is selected, it is hidden and no longer shown in the graph window.
To change the vertical position of a channel, click to select a channel, and then while holding down the
mouse, drag it up and down.
To remove a channel from the graph window, select the channel and then press the delete key. To have
the channel shown again, right click in the Channel Header Area and select the channel.
The bottom of the Channel Header Area displays the time of the cursor both in real time and in seconds
past the start of the file.
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3.3 Setting Up Individual Channels and All Properties Within
Once all desired channels have been selected and displayed according to your preferred layout, you will
need to set the properties for individual channels.
3.3.1 Properties Window
The Properties Window is used to control the properties of all components in the main user interface
window.
The following have properties:
 Graph Window
 Graph Channels
 Individual Events
 Hypnogram
 Hypnogram Channels
To access the properties of any of the above items, they must first be selected. The different properties
windows are placed in the same frame of the user interface (the default layout has the properties window
in the top right portion of the screen), and the contents are changed depending on which item is selected.
3.3.2 Graph Window Properties
Figure 3.11
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To select the Graph, click anywhere in the Graph Window except on a channel name or an event. The
only customizable properties of the Graph Window involve how the graph is colored, as shown above in
Figure 3.11.
The Background color sets the color of the background.
The Primary Line color sets the color of the dashed vertical lines.
The Secondary Line color sets the color of the solid vertical lines.
The Epoch Divider color sets the color of the epoch divider line.
The Sleep Stage color sets the color of the sleep stage lettering.
The Lights Tag, Body Tag, CPAP Tag, BiPAP Tag, Oxygen Tag and Notes Tag colors set the color of the
tags that can be placed in the Graph Tray
Stage Display Type changes the position of the Sleep Display which appears in the background of the
Graph Window, indicating the sleep stage that was scored for the currently viewed 30-second epoch.
Selecting “Top” will allow the sleep stage to appear on the top of the Graph Window, selecting “Bottom”
will display the sleep stage on the bottom of the Graph Window, and selecting “Both” will display the
sleep stage on both the top and bottom of the Graph Window.
To modify sizing of the graph window, the borders may be clicked and dragged.
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3.3.3 Graph Channel Properties
Figure 3.12
To view or change the individual channel properties, click on the channel in the Channel Header Area.
The graph channel properties are separated into seven categories, as shown in Figure 3.12. Those
properties are described below. The Appearance, Channel Data, Numeric Display, Position, and Scale
categories apply specifically to the display of channels in the Main Window and the settings do not have
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an impact on scoring. The Events category will not impact scoring but may be used to set default events
that will allow for Quick Mode editing described in Section 5. Settings made in the General category
will affect autoscoring, and are therefore described in this section as well as Sections 3.4 and 3.5.
The Appearance category allows adjustment of how the channel is graphically represented.
The Color property sets the color of the channel and any events placed on it.
The Visible checkbox is another way to hide a channel. This cannot be used to make a channel visible, as
the channel properties window is only visible when a channel has been selected.
The Channel Data category enables the display of extra-numerical information about the channel in the
Channel Info Area. Often used with the SaO2, CO2 and CPAP pressure channels, the values appear at
the right side of the channel in the Graph Window.
The Display Min checkbox displays the minimum value of the current window.
The Display Max checkbox displays the maximum value of the current window.
The Display Avg checkbox displays the average value of the current window.
The Numeric Display category allows you to modify numeric values displayed within a channel across
the Graph Window. Numeric display modifications are available to all channels within the Viewer.
The Show numerics box activates the numeric entries chosen across the channel horizon within Graph
Window.
The Numerics to show box is where you enter the amount of numerics to show across the channel
horizon. Example: Entering 10 would show 10 numeric values within the current window horizon of the
channel.
The Decimal box is where you would enter the number of decimal places to be shown for the numeric
values.
Figure 3.13
Figure 3.13 shows a Numeric display for the SaO2 channel with 10 values and zero decimals selected.
The Events category allows creation of events on this channel. This may be done for scored files only.
Refer to Section 5.0 for description of the creation of events.
Default Event determines the default event created for the selected channel. Once a default event is
created, it can still be altered manually. The events that can be created using this function are:
• A (Arousal)
• Apnea (unclassified)
• Arrythmia
• Asystole
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•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Atrial Fibrillation
Bad Oxygen (Bad Oxygen Section)
Bradycardia
Bruxism
C (Central Apnea)
Desat (Desaturation)
H (Hypopnea)
HO (Obstructive Hypopnea)
M (Mixed Apnea)
Narrow Complex Tachycardia
O (Obstructive Apnea)
PLM
REM Behavior Disorder
RERA
Rhythmic Movement Disorder
Sinus Tachycardia
Snore
UNKNOWN EVENT
Wide Complex Tachycardia
The Default Duration property allows setting the duration of default events. The default events can be
added to scored files using the Quick Mode of editing described in Section 5.3, and the duration can be
modified (also as described in that section).
The Position category in the graph channel properties window (Figure 3.12) deals with how the channel
is positioned on the screen.
The Height % option allows for specifying how much of the Graph Window, as a percentage of the total
height, the channel should occupy. The value entered here must be greater than 0, and less than or equal
to 100. Invalid entries are rejected.
The Y % option allows for specifying where on the Graph Window, as a percent of the total height, to
place the top of the channel. The value entered here must be greater than 0 and less than 100. Note that if
Y% + Height % is greater than 100, part of the channel will be clipped by the Graph Tray.
Alternatively, dragging the channel up and down as described earlier in the Channel Header section can
modify the Y % option.
The Scale category deals with how the channel data is represented inside the physical space specified by
the Height % and Y % settings.
Note: The descriptions of the Upper Limit and Lower Limit apply to a non-inverted
signal. For an inverted signal, switch the definitions of Upper Limit and Lower Limit.
The description of Auto Scale must also be adjusted by switching Upper Limit with Lower
Limit.
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The Upper Limit option sets the upper limit of the channel, defined as the maximum value that will be
visible in the graphical representation of the channel. Any value that is above the upper limit will be
clipped for display purposes to be equal to the upper limit.
The Lower Limit option sets the lower limit of the channel, defined as the minimum value that will be
visible in the graphical representation of the channel. Any value that is below the lower limit will be
clipped for display purposes to be equal to the lower limit.
Upper and lower limits will need to be entered for all AC channels and for the DC channels that show
numerical values such as SaO2, CO2 and CPAP pressure.
In the Scale category, the Auto Scale checkbox enables and disables auto scaling. When auto
scaling is enabled, the Upper Limit is automatically set to the maximum value in the current
window, and the Lower Limit is automatically set to the minimum value in the current window.
When Auto Scale is checked, the Upper Limit and Lower Limit cannot be modified.
Auto scaling automatically updates the limits each time the displayed data is changed in any way.
It is recommended to check the Auto Scale box only for Chest, Abdomen, Thermistor, Nasal
Pressure and CPAP Flow. Make sure not to check the Auto Scale box for the channels that you
have entered upper and lower limits for, such as the EEG and SaO2 channels. See Figure 3.14
below.
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Figure 3.14
The General category deals with signal processing functionality that can be applied to a specific channel.
The Invert Signal option allows for a signal to be represented as either Positive Up and Negative Down
(non-inverted), or Negative Up and Positive Down (inverted). Clicking on the Invert Signal checkbox
will automatically invert the limits entered (see Scale). Specifying an upper limit that is lower than the
lower limit will automatically invert the signal. While the EEG and EOG channels should be inverted for
every patient file, within individual studies certain signals such as EKG and thermistor may need to be
inverted for correct polarity as well.
The Grid Lines option can be utilized to draw dashed horizontal grid lines on a selected channel. An
example of grid lines, set at 37.5 and –37.5, appears in Figure 3.15. These grid lines enable the user to
easily see the size of a 75uv Delta wave.
Figure 3.15
Selecting the Grid Lines option presents the dialog box shown in Figure 3.16
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Figure 3.16
Here, the levels at which grid lines are displayed are listed in the Level box. To add a new grid line, click
on the Add button, which will display the window shown in Figure 3.17.
Figure 3.17
To delete a grid line, select the level from the list shown in Figure 3.16 and press the Delete button.
Grid lines can be used for other channels besides EEG, like SaO2, CO2 or CPAP pressure. Figure 3.19
provides an example of grid lines on the SaO2 channel.
Figure 3.18
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3.4 Filters
The Filters option allows for different filters to be applied to the selected channel. Low and high filter
settings will need to be applied to all AC channels (i.e. EEG, EOG, EMG and EKG). It is not necessary
to apply filters to the DC channels (e.g. flow). The maximum high frequency filter setting cannot exceed
that of half of the collection sampling rate. Selecting this option in the General category of the graph
channel properties window (see Figure 3.12) opens a filter management dialog box shown in Figure 3.19.
Figure 3.19
Select the box next to the filter frequency you wish to enter and type in the numeric value to be applied. A
Notch Filter can also be selected, with an allowance for either a 50 Hz or 60 Hz setting to accommodate
the variability between geographical regions. Figure 3.20 below displays the end result of entering filter
settings.
Figure 3.20
Note that the green check marks appear if the numeric values you entered are allowed for the frequency
filter selected. If a non-appropriate value is entered, a red X will appear beside the box indicating that the
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values need to be revised. Once entries have been accepted, select OK to save your selections, thereby
applying the filters to the channel selected.
3.5 Referencing
The Reference Channel option in the General category of the graph channel properties window (see Figure
3.12) allows for referencing to be applied to a given channel. Referencing each of the AC channels is
required unless the channels are already referenced when exported. It is recommended to export the
channels unreferenced when possible to allow for re-referencing within a study during subsequent viewing
and editing. Some data acquisition systems such as Alice 5 export all channels referenced automatically.
The channels are displayed in the channel header area. If the channel already has a reference, an example
of the display shown would be C3-A2 (or C3-M2). If C3-A2 is displayed, it is known that the channel was
exported referenced. If each signal is displayed separately, i.e. C3, A2, M2, Right EOG, Chin EMG 1, Chin
EMG 2, etc., that means the channels were exported un-referenced and references will need to be applied
for all AC channels within the montage. When references are applied either during the export or when
setting up the montage, the channel will be displayed showing the reference in the channel header area, i.e.
EMG1-EMG2 or C3-A2. DC channels such as flow do not need to be referenced. By selecting the
Reference Channel option, the referencing dialog box is opened, shown in Figure 3.21. Referencing a
channel to another channel is the equivalent of subtracting the referenced channel from the original channel,
potentially removing common artifacts.
Figure 3.21
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The channel reference dialog is split into two sections. One is the Channel List, which shows a list of all
channels in the opened patient file; the other, the Reference Channels list, shows all the channels that are
currently being used for referencing.
To add a channel to the Reference Channels List, first select it in the Channel List, and then press the
right arrow button [>]. To remove a channel from the Reference Channels List, select it in the Reference
Channels List and press the left arrow button [<]. The up and down arrows can be used to move channels
up and down in the Reference Channels List, although this has no impact on the results.
If more than one channel is selected for referencing, the average of the selected channels is calculated and
used as a single reference channel.
Note: For referencing to function properly, the selected channels must have the same
sampling rate as the current channel. If any channel that is added to the Reference
Channels List does not have the same sampling rate, it is simply ignored.
3.6 Remove R Wave
Occasionally, studies will have an EKG artifact that manifests in channels such as the EEG or EOG,
which would ordinarily disrupt scoring accuracy. To account for this, Michele Sleep Scoring
automatically removes the R-Wave before the scoring is carried out; this is done behind the scenes
however, so to visually remove the R-Wave in the Graph Window for a given channel, the “Remove R
Wave” button can be selected after the given channel is selected.
Another way to remove EKG artifact from selected channels would be to reference A1 and A2
(or M1 and M2) together (refer to Section 3.5 for guidance on this procedure). In other words,
reference C4-A1/A2, as opposed to only referencing C4-A1, thereby averaging the two reference
electrodes; this often removes the EKG artifact.
3.7 Channel Renaming
The Viewer allows you to rename each channel within the Graph Window. The renaming can be either a
temporary or permanent change to the .EDF file. To change a channel name, right-click on the channel
name and a message box will appear as shown in Figure 3.22 below.
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Figure 3.22
By clicking on the dialog box called Rename Channel, another dialog box will be displayed requesting a
new name to be entered (shown below in figure 3.23).
Figure 3.23
Once the name is entered, select OK for the change to take place. You will be presented with a new
dialog inquiring as to whether the change is to be temporary or permanent (see Figure 3.24).
Figure 3.24
Selecting ‘Yes’ will permanently modify the EDF File, while selecting ‘No’ will only modify the current
viewing of the file. Once the file is closed, any temporary name changes will be lost.
3.8 Hypnogram Properties
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Figure 3.25
Selecting the hypnogram is done in a manner similar to selecting the graph. The only configurable
property of the hypnogram is the background color, which functions in the same manner as in the Graph
Window. This is shown in Figure 3.25.
Selecting a hypnogram channel is performed in the same manner as selecting a graph channel. There are
two types of channels that can be displayed in the hypnogram; these are hypnogram-specific channels,
and generic channels.
The hypnogram-specific channels are:
• Hypnogram (shows Sleep Staging)
o Uses a color scheme for displaying sleep stages
▪ Awake and stage transitions: Black
▪ Stage 1: Orange
▪ Stage 2: Red
▪ Stage 3: Green
▪ REM: Purple
• Body Position
• Leg Movements (shows a tick for each event)
• Arousals (shows a tick for each event)
• Respiratory (shows a tick for each event)
Hypnogram-specific channels use the properties window shown in Figure 3.26 (a). Generic channels use
the properties window shown in Figure 3.26 (b).
Additional generic channels can be displayed within the hypnogram such as SaO2. This is done in the
same manner as adding channels and setting the properties within as in the main window channel header
area.
The hypnogram is updated automatically upon making edits to the scoring, but this feature can be
disabled in the Configuration menu (ConfigurationHypnogram Auto Refresh).
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(a)
(b)
Figure 3.26
3.9 Body Position Channel
‘Body Position Channel Levels’ (found under the Configuration Menu in the toolbar) is used to extract
body position information from a body position channel. If the body position information is stored in a
channel, voltage levels must be assigned to the different positions that are extracted from the channel. As
well, a body position channel must be designated in the Channel Mappings discussed later.
Figure 3.27
Selecting a row in the table shown in Figure 3.27 and pressing “Delete” will undo that mapping.
Checking “Disable Voltage Levels” is the equivalent of temporarily deleting all of the entries.
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In order to close the Voltage Ranges dialog box, there must be no conflicts. A conflict is defined as two
or more positions having the same voltage mapping, or two or more voltages being mapped to the same
body position.
Once all channels have been edited to the desired specifications, Channel Mappings need to be assigned.
3.10 Channel Mapping
In order to properly execute the automated scoring module embedded in the Viewer, the Viewer must
know which channels within the currently open EDF file contain the primary signals required for
automated scoring.
To configure the channel mappings, select ConfigurationChannel Mapping in the Main Menu. The
following window will be displayed as shown in Figure 3.28 below.
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Figure 3.28
The Channel Type column lists the fundamental channel types required by the automated scoring. These
are listed and are the names used by YMT. Channel Name corresponds to the specific channel in the
current EDF file. The Viewer cannot automatically correlate specific data channels within the EDF file to
the required channels necessary for scoring; this must be done manually through the process described in
this section. A channel name must be chosen for each individual channel. If this is not done, YMT will
not be able to distinguish the channel type and will not be able to score the file.
There is a minimum selection of channels required to perform the automated scoring for a Level 1 or 2
study. The following channels are required:
1. Two central EEG channels (occipital EEG’s should not be mapped)
2. EKG
3. Right EOG
4. Left EOG
5. Chin EMG
6. O2 Saturation
7. Thermistor
8. Nasal cannula OR CPAP flow signal
9. Chest and abdomen bands
10. Right and Left Leg EMG if PLM scoring is required
However, to improve scoring accuracy, all of the channels in the Channel Type column should be
included in the EDF file used for automated scoring.
Similarly, there is a minimum selection of channels required to perform the automated scoring for a Level
3 study. The following channels are required:
1. Thermistor or Nasal pressure (ideally both)
2. O2 Saturation
3. Chest and abdomen bands
To improve scoring accuracy, the following channels in the Channel Type column should be included in
the EDF file used for automated scoring:
1.
2.
3.
4.
Audio
EKG
Body Position
Pulse Rate
To map a specific channel type to a channel within the EDF file, select the Channel Name text box with
the mouse. When this is done, a drop down box listing all of the channels in the EDF file will be
displayed. If a specific channel type exists with the EDF file, select it with a mouse click. Repeat this
process for all of the channels specified in the Channel Type list. If some channels do not exist within the
EDF file, leave the Channel Name as “None”.
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If the EDF file contains Chest (Thorax) and Abdomen effort bands that use the inductive respitrace to
produce a signal, check off the box in the upper right hand corner (of the dialog box shown in Figure
3.28) labeled “Respitrace Inductive”. Do not check this box if the Chest and Abdomen bands use any
other sensing technology, such as piezoresitive or RIP belts.
If the Audio or Snore signal has been pre-processed such that it is no longer an AC signal and contains a
smoothed waveform representing the recorded audio, select the “Audio Processed” box. If you are
uncertain about the nature of the audio signal leave this box unchecked.
If the Nasal Cannula channel requires processing by the square root function, check the “Process Nasal”
checkbox. This is necessary when the Nasal Cannula is strictly measuring nasal pressure without any
signal processing applied, as the nasal pressure measured is proportional to the square of nasal flow. It is
therefore necessary to take the square root of the pressure signal to get an accurate representation of nasal
flow in such cases. In most cases nasal root is not used and this box should not be checked.
Checking this box will not affect how data is displayed on the screen, only how the autoscoring
algorithms treat the signal for the detection of respiratory events.
If the EDF file contains a signal representing the end tidal CO2 concentration of exhaled air, verify the
CO2 units in the drop down box as either % or mmHg.
Depending on which option your sleep lab employs, select Recommended or Alternate criteria (as per
AASM 2012 guidelines) for the automatic detection of hypopneas. Recommended criteria is defined as a
reduction in airflow of at least 30% accompanied by an O2 desaturation of at least 3% or an associated
sleep arousal. Alternate Criteria is defined as a reduction in airflow of at least 30% accompanied by an
O2 desaturation of at least 4%.
The Desaturation Interval combo box allows for selection between three search intervals that specify the
search range for an O2max after a desaturation has been identified. Changing the search interval may
change the amount of desaturations called.
• [-90, 0] looks up to 90 seconds back from a desaturation, and does not look ahead
• [-60, 0] looks up to 60 seconds back from a desaturation, and does not look ahead
• [-90, +30] looks up to 90 seconds back and up to 30 seconds ahead from a desaturation
Selecting “Save” after configuring all of these parameters will allow them to be saved in the current
montage file when the montage is saved. Section 3.9 describes montages.
3.11 Montages
The montage is a collection of settings, including all channel settings as well as the channel mapping
information described in Section 3.2. By storing the channel settings, the montage effectively stores the
way the Graph Window is organized and how the data are displayed. Montages are handled via the
toolbar through the Montage Selector.
3.11.1 Creating a new Montage
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There are two ways to create a new montage.
The first method involves editing the current montage, and then selecting Save Montage from the File
Menu. This will open the window shown in Figure 3.30. By entering a montage name that does not
currently exist, the edits will be saved into the new montage, and any old montage will remain as it was
before the edits were done.
The second method involves immediately saving a new montage. The new montage can then be edited to
your liking, and saved by selecting Save Montage and selecting the current montage name in the list.
Selecting Save Montage displays Figure 3.30.
Figure 3.30
This prompt allows you to either overwrite a current montage or create a new montage with the current
settings. Creating a montage is done by entering a name in the Montage Name box that does not exist in
the list of current montages.
If all of the data acquisition systems are set up in the exact same way with the same collection system and
the same channel order and numbering, only one montage will be required which will include one channel
mapping. If data acquisition systems are set up differently, different montages/channel mappings will be
required for each setup. If the same collection system is used but the channel order or numbering is
different from one room or system to another, a new montage and new channel mapping within will be
required for each room or system.
Once a montage has been built for each collection system and/or each room (if the channels were
numbered or ordered differently from one room or system to another), saving the montage will store it so
it can be re-opened in the future.
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3.11.2 Importing/Exporting Montages
Users have the ability to copy a Montage for other Users to import and utilize within their operation. This
allows a Sleep lab to create a Montage once and have it used in multiple Viewers within their lab. To
import or export a Montage, select the File menu at the top left corner of the Viewer and a drop down
menu will display as indicated in Figure 3.31 below.
.
Figure 3.31
Select the Import/Export Montages, and a dialog box will appear as shown below in Figure 3.32:
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Figure 3.32
If Export Montage is selected the dialog box will be as shown below in Figure 3.33:
Select the file by clicking on its name, or you can select multiple montages to export by clicking on
multiple names.
Figure 3.33
Select the Next button, and the figure shown in Figure 3.34 below will appear.
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You will need to specify the file location where the montage is to be copied to by clicking on the ‘...’
button next to the montage name. Choose the location and enter the montage file name that you wish to
export in the file name area. Click on save. A box will appear noting that the montage does not exist and
asking if you want to create it. Click on Yes. Once you have selected the location for the montage to be
saved at, you are returned to Figure 3.33 above but the text box will be filled in with the file path you had
specified.
Figure 3.34
Select finish to complete the process.
To import an existing montage, Figure 3.34would still appear, but you would be clicking on the ‘…’
button to search for a montage that already exists on another PC/Network/File location. Once you have
selected that montage file, you are returned to Figure 3.34 again, but with the file path information for the
montage to be imported specified in the text box. Click on next.
Highlight the montage or montages you that you would like to import. Click on next and Figure 3.35 will
be shown as displayed below. Click on finish to complete the process.
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Figure 3.35
Note: If you opt to use the Windows Explorer tool outside of the Viewer operation to see
if the montage files were imported/exported, it will appear that the operation did not
complete. In order to see .mon files, the Viewer is required. Furthermore, if multiple
montage files were imported/exported, it will appear as if only one file was successfully
copied. You should confirm that the transfer was successful by selecting the drop down
Montage Menu in the Viewer toolbar to review the Montage list available to select as
indicated below in Figure 3.36.
Figure 3.36
In addition to importing and exporting montages, they may be downloaded directly after scoring a file.
See section ___ on how to download montages through scoring.
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4.0 Scoring a File
4.1 Study Review
It is recommended to review the patient file prior to engaging the scoring process; if the signal quality is
poor, channels should be re-referenced. Upon opening the study, ensure the correct montage with the
correct channel mapping is used.
4.2 Channel Mapping for Scoring
To initiate the process of scoring an opened patient file, select “Score File” from the File Menu. This will
initiate dialog (shown in Figure 4.0 below) that inquires about the status of pre-filtering.
Figure 4.0
Selecting Yes indicates that the primary channels (EEGs, EOGs, and EMGs) have been filtered either by
hardware filtering, or through software filters applied while exporting the EDF file. If filters have not
been applied to these signals during data collection and/or exporting, then select No.
Most systems do not apply the filters in the hardware and most systems do not allow for applying filters
during the export process. When the option is given to apply filters during the export process, it is
recommended not to do so, and to export the study raw, unfiltered and unreferenced. If these
recommendations are followed, “No”, should always be selected when the dialogue box above appears.
Note that if the filters which have been applied using the Viewer are the only filters that
have been applied, No must be selected. The filters applied within the Viewer are for
viewing purposes only.
Once this question has been answered, the Channel Mapping window is shown (Figure 4.1 below).
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Figure 4.1
This window is identical to the one described in Section 3.9, with the addition of five more options.
The first of these new options is the Valid checkbox located on the right side of the window; the second is
the Referenced checkbox located under the Valid checkbox; the third is the Specify Tags and Lights
button located under the Referenced checkbox; the fourth is the Apply button located beside the Score
button; and the fifth is the Airway Pressure Scaling Factor.
Once this window is open, the procedure for specifying the information required to enable scoring of a
file is as follows:
 Verify that the channel mapping is correct for each individual channel.
a. Edit it if it is not;
 Verify that the correct options on the right side of the window are selected.
;
a. Check the Audio Processed box if audio was used and if it was processed prior to being
loaded into the Viewer;
b. Check Process Nasal if nasal root was used with the Nasal Flow.
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 Select Specify Tags and Lights, which will result in the window shown in Figure 4.2a below.
a. Lights Off and On, as well as CPAP On, can be entered manually in the boxes under the
Set Time category.
b. The information can also be imported from a text file. Select Import Data From File,
click on the text file related to the study that is open, and select Open. Click on “OK”.
All the tags such as lights on/off and body position tags will be included in the scoring.
 The Airway Pressure Scaling Factor feature allows multiplication of the Airway Pressure
channels (both Inspiratory and Expiratory) to allow for alterations in the gain of these channels.
This feature was enabled in case files that are exported from data acquisition systems measure
pressure in units other than cm of water. Where the conversion factor is known, this feature can
implement the required adjustment.
As indicated above, the Import Data From File button in the Body Position and Lights window (Figure
4.2a) can be used to import a text file with position and lights data, which the user has created. This text
file should be created using Microsoft® Notepad (or other software that allows saving as a *.txt file). The
file must be encoded in the following format:
Epoch,Event,[extra]
Each event receives its own line in the file. As long as the first two parameters are present on the line,
[extra] can contain anything and will be ignored.
Epoch is the 30-second epoch in which to insert the marker, and Event is the event name. Accepted
event names are:
• Lights Off
• Lights On
• Out of Bed
• Upright
• Right
• Left
• Prone
• Supine
• Treatment
• Bi-Level (Level1)/(Level2)
• CPAP (Level)
These are not case-sensitive; however, any other spelling or event name is ignored. Spacing is important,
with one space between each word for the multi-word names.
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Figure 4.2a
4.2.1
Body Position/Lights Marker Specifics
a. Body Position channel always overrules supplied tags if it is mapped, as shown in Figure 4.2a
b. Pressure tags will overrule a pressure channel assuming the “Use Pressure Tags” box in the
above window is checked. This box is checked by default if pressure tags are identified in the file
(Figure 4.2b).
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Figure 4.2b
Using a body position channel requires specifying voltage ranges. If voltage ranges are not specified, the
default value of Supine is used for the entire file. See Section 3.8.
 Specifying neither a body position channel nor a body position file will use the markers placed on
the current events file. If no markers are placed, the following default values will be used:
Lights Off will be set to time 0, epoch 1;
 Lights On will be set to the last epoch;
 Body position will be set to Supine for the entire file.
4.3 Finalizing User Input Required of Scoring
Once the process of specifying the body position and lights on/off has been completed, proceed to the
following, remaining steps in the Channel Mapping window (shown in Figure 4.1).
 Verify that the appropriate channels have been referenced (see Section 1.2.4).
a. If this had been done prior to exporting the EDF file, check Referenced after verifying
that no referencing is applied in the Viewer.
b. If this was not done prior to exporting the EDF file, apply the proper referencing in the
Viewer before checking Referenced.
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 Check the Valid checkbox to indicate that everything has been checked and is correct within the
Channel Mapping window. Figure 4.3 shows an example of what the Channel Mapping window
will look like once all information required for scoring has been specified.
It is very important that all aspects of the channel mapping are checked for each individual channel
and for every individual study when sending for scoring. If the channel mapping is wrong the
study will not score
Figure 4.3
 Press Score.
Upon pressing Score, the file will be uploaded to YMT servers for remote autoscoring performed at
YMT. By using the Remote File Manager (described in Section 4.5), you will be able to check the status
of your file and retrieve the scoring results when they are available.
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Reminder: Each EDF file should have a unique file name. EDF files that have been
scored should never be re-named.
4.4 Uploading to the YMT Server
Upon pressing Score (see Figure 4.3), the upload component attempts to automatically connect to the
YMT servers, using the login information specified as described in Section 2.2. The progress of this
process will be indicated by the window shown in Figure 4.4.
Figure 4.4
The file will be compressed during the upload to speed up the uploading process. The progress will be
displayed as shown in Figure 4.5 below.
Figure 4.5
4.5 Remote File Manager
Remote File Manager is used to access the results of patient files scored by YMT. The Remote File
Manager connects to the YMT server using the supplied login information. For the Remote File Manager
to operate, login information must be specified via the Enter Login Information menu item, discussed
next. If the login information is invalid for any reason, the Remote File Manager will display an error
message. When connected, as seen below, a green check mark will be displayed beside connection status.
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Opening the Remote File Manager with correct login information will result in the window shown in
Figure 4.6.
Figure 4.6
The checkboxes located in the Status Filters pane list all potential file statuses and can be used to control
which files are shown in the Remote Files pane. Any file with a status that is not checked will not be
shown. All statuses are checked by default. A user may un-check any status according to their preference
for the display of file statuses. For instance, if a user does not want to see the list of files that have
already been downloaded, the “Downloaded” status may be un-checked.
The File Information pane shows relevant information related to the status of the file. This information
consists of a combination of the following: the time of the upload, the time of scoring, the time of
download, the upload percentage, or an error message. What is displayed is dependent on the status of
the file.
The Remote Files pane lists all of the files that were sent for scoring. The status of each file will be
displayed, such as Uploading, Scoring, Available, Downloaded, New Scoring Available and Error. The
additional status “Previously Downloaded” would be displayed if a second computer logs into the Viewer
and reviews the same files with the Remote File Manager. Since it was not the original computer but
same Login ID and Password, “Previously Downloaded” would appear as a status.
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Multiple files can be uploaded and sent for scoring. The first will upload, and the next will be pending
until the first has uploaded. The files will upload and score in a consecutive manner. See Figure 4.7
below.
Figure 4.7
Each row in the table represents a patient file uploaded to the YMT servers. Each patient file is assigned
a specific status:
• Uploading: the file is currently uploading to the YMT server.
• Pending: the file has been prepared for uploading, but is waiting for another upload to finish.
• Scoring: the file is currently being scored.
• Error: scoring the file has been attempted by YMT, but resulted in an error. Files with this status
will be investigated, and you may contact YMT to obtain further information.
• Unavailable: the file has been uploaded, but has not been scored.
• Available: the file has been uploaded and has been scored by YMT, but the user has not
downloaded the results files. A “Download” button is available for the user to press, to download
the results files.
• Downloaded: the file has been uploaded, scored by YMT, and the user has downloaded the
results files.
• New Scoring Available: the file has been downloaded previously; however, the results files
present on the server are newer than the version that the user has downloaded. A “Download”
button is available for the user to press, to download the updated results files.
• Previously Downloaded: the file has been uploaded, scored by YMT, and the current user was
not the original user that has downloaded the results file
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When there is an error during the scoring process, the file status will show as Error in the Remote Files
pane and there will be information within the File Information pane. An example is shown in Figure 4.8
below.
Figure 4.8
If there is an error in establishing a connection to the server, a notification will appear over top of the
Remote Files pane, as shown in Figure 4.9.
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Figure 4.9
There are three error messages that can appear here:
• Unable to connect to Michele Servers. This message indicates a problem identifying the
Michele Servers. The most common solution to this error is to verify that the computer has
Internet access. This message is also shown during Michele Server downtime.
• Invalid Username and/or password. This message indicates a problem with your login
credentials. Follow the steps described in Section 2.2.
• Unable to set up connection. This message indicates that the Michele Servers are refusing the
connection attempt. If this message is shown, please contact YMT Support for assistance (see
Section 8 for contact information).
Downloading from the Michele Server
If a new automated scoring results file is available, a small YMT icon will appear on your task bar. You
will also see a Download button next to the File Name in your Remote File Manager. Click on the
Download button to download the scoring results file. When the download is complete, you can close the
Remote File Manager.
The Remote File Manager can be used either with a file open, or with no file open. If the automated
scoring results file that corresponds to a currently opened file has been downloaded, the scoring results
are automatically loaded. The results file may require selection from the dropdown box when other
scoring results files are present.
If a results file has been downloaded for a file that is not currently open, the results are automatically
retrieved when the file is opened.
There is no need to specify target directories for the download, or try to seek out the results file
on the computer file system.
The scoring results will be displayed in the Scores Window within the Viewer.
Downloading a Montage
When the scoring results are downloaded from the YMT servers, the montage that was utilized to score
the file is automatically downloaded as well. The user has the option to have the montage automatically
load when the results are downloaded. This feature can be turned on or off in the Configuration Menu
(Auto Select Scoring Montage). If this feature is disabled, the montage that was used to score the file can
be found near the top of the montage list in the toolbar under the Default montage, and will be separated
from the other montages by a horizontal line (see Figure 4.10). If an .ev file (the file that is downloaded
that contains the scoring results) is copied in the Scores window, a new montage will be created bearing
the same name as the copied .ev file; the montage will not be able to be edited and will be stored in the
study folder only – not with the rest of the montages, as it is simply to ensure that you can always
determine the channel mapping that was used to produce that .ev file.
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Figure 4.10
4.6 The Scores Window
The scoring results file is given the name [patient file name]_YMTEvents.ev and is set as read only.
This means that it cannot be modified without first using the copy functionality located in the Scores
Window. The results file is automatically found, but may require selecting it from the dropdown box.
Example: If the patient file is named patient_0030.edf, the output of the autoscoring will be
placed in the same directory and named patient_0030_YMTEvents.ev
The Scores Window is used to show the scoring results for the given file, as well as provide an interface
for handling multiple scoring files, including deleting and renaming events. This window is illustrated
below in Figure 4.11.
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Copy Selected
Score File
Editing Helper
(see section 5.3)
Import Body
Position File
Filter Event
List
Synchronize with
Body Position
Channel
Scoring File
List
Main Window
Figure 4.11
The Main Window displays all scoring events and marker tags that are present in the file. Doubleclicking on a line in the window will jump to the epoch containing the event, and select the event.
Note: If a marker tag event is double-clicked, the display will jump to the epoch but will
not select the event.
The categories shown in the Main Window are as follows.
Epoch displays the 30-second epoch that contains the start of the event.
Event displays the event name.
Start Time displays the event start time.
Duration displays the event duration.
Channel Name displays the name of the channel that the event is currently bound to (located on). Marker
tags are not bound to any specific channel.
The Main Window can be sorted by any of the following categories:
• Start Time/Epoch (same category)
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•
•
Event Name
Event Duration
The Scoring File List allows the selection of which existing scoring file to display. Scoring files located
in the same directory as the patient file are automatically detected by the application and placed in this
list. When a study is scored for the first time, the YMTevents.ev file will be shown. After the study has
been copied and edited, the last score file used will be displayed when opened next. The drop down menu
allows the user to switch between study scores.
The Copy Selected Score File button can be used to copy the current scoring file into a new file. Copying
a file in this manner preserves all settings; however, it does not preserve the read-only tag. Copying may
also be done by choosing to Save the current event file, and then entering a new name.
The Import Body Position File button is used to import a file with position and lights data, which the user
has created in the manner described in Section 4.2 (following item 4.b in that section).
This option does not need to be used prior to executing automated scoring, because the autoscoring allows
a body position file to be specified.
The Synchronize with Body Position Channel button tells the software to read the body position out of an
existing channel. Pressing this button will remove any body position markers already placed. For this
feature to work, a body position channel must be defined in the Channel Mappings window (see Section
4.2), and voltage ranges must be defined and enabled (see Section 3.8). It should be noted that the
autoscoring package automatically extracts information from the body position channel if both it and
voltage ranges are defined. This option does not need to be used prior to executing automated scoring.
The Filter Event List button allows for specification of the type of event that should be displayed in the
Main Window. Clicking this button will display a menu that lists the different categories of events, as
shown in Figure 4.12.
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Figure 4.12
Any item with a check is displayed in Main Window, and any item without a check is not displayed.
Selecting an item will toggle its state. The events included in each category are as follows:
• Arousals
o Arousals
• Respiratory
o All Apneas, Hypopneas and RERAs
• PLMs
o PLMs
• Oxygen Events
o Desaturations and Bad Oxygen Regions
• Markers
o Body Position, Lights On/Off, CPAP On, CPAP Levels, BiPAP Levels, Oxygen Levels
• Sleep
o All Sleep Stages
• Snoring
o All instances where snore signals have been detected
• Cardiac Observations
o All instances where Cardiac Observations have been detected
• General Observations
o Any other observations besides Cardiac
• Custom
o All Notes and Unspecified Events
To delete an event from the scores window, left-click on the event to highlight it, and press “Delete” on
the keyboard. Multiple events can be deleted at one time by left-clicking an event and holding down the
“Ctrl” key while left-clicking on additional events to be deleted.
Note: Sleep or Body Position events cannot be deleted from the Scores Window.
To rename an event from the scores window, right click the event. A menu will appear with events that
the selected event can be renamed to (Figure 4.13). To rename multiple events at once, the user can leftclick an event, hold down the “Ctrl” key while left-clicking other events to be renamed. The user would
then right click one of the selected events and choose the new event name.
Note: This will only rename respiratory events.
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Figure 4.13
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4.7 The Graph Window
View Toggle
Mouse Cursor
Indicator
Sleep Display
Channel Info
Area
Channel Header
Area
Channel Display
Graph Tray
Figure 4.14
Epoch Divider
Epoch Number
The Graph Window consists of the main display for the application. It contains the graphical
representation of all channels, events, key markers, patient information and sleep staging, as shown above
in Figure 4.14.
The View Toggle allows switching between viewing the graphical representation of the current file and
viewing the analysis notes. The currently opened file name is displayed in the left-most (orange) tab of
the Graph Window (file name not shown in Figure 4.14). The analysis notes are discussed in Section
5.10.
The Mouse Cursor Indicator shows a line representation of where the mouse cursor is located on the
screen.
The Epoch Divider is a solid line that can be used to distinguish where the boundaries between 30-second
epochs are located. Epoch dividers are not shown if the compression is set to either 1000 seconds or the
entire file.
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The Epoch Number is placed to the right of any epoch dividers, including the bottom left corner if the
display is aligned to epoch boundaries. This number indicates which epoch starts at a given boundary.
The Channel Header Area displays the name and a value for different channels that are visible. This is
the value at the point in time where the mouse cursor is located.
Selecting a channel is possible by clicking on the channel name in the channel header. Multiple channels
may be selected by holding down the “Ctrl” key and clicking on multiple names.
Figure 4.15
Figure 4.15 shows a selected channel. Dotted lines outline it and two arrows appear beside the name.
The dotted lines show the bounds of the channel, and no part of the channel will appear outside of these
bounds. The arrows beside the channel name are used for quick scaling of the channel. Pressing the “up”
arrow will enlarge the channel by halving the limits about the midpoint, while pressing the “down” arrow
will shrink the channel by doubling the limits about the midpoint. These limits are discussed in more
detail in the Section 3.3 describing the Graph Channels property window.
Example: If a channel is set to display values from 25 to –75, the midpoint is –25 with
±50 on either side. Pressing the “up” arrow changes the limits to –25 ±25. Pressing the
“down” arrow changes the limits to –25 ±100.
The value appearing beside the channel label is the signal value at the cursor location.
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5.0 Editing a File
The results of automated scoring must be edited before the final report can be created. The graph window
will display “UNEDITED” in the background of any file that has not been edited (Figure 5.0). This
section describes the features of the Viewer that allow editing a file.
in
Figure 5.0
5.1 Copying a File for Edit
Before a file can be edited, the results file provided by YMT must be copied. This is done by using the
“Copy Selected Score File” button located in the Scores Window (see Section 4.6). Refer to Figure 5.1
below. It is recommended to re-name the file by adding to the original file name the name of the person
performing the editing, and the word “edit” behind it. For instance, “[original file name] Kris edit.ev”.
Figure 5.1
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5.2 How to Edit a Study
Once the score file has been copied it can be thoroughly edited. Editing a file produces a log file that
records all changes made to the file. This file consists of entries that contain the following information:
[Time of Day of edit]: [Action] [Epoch], changed from [original value] to [new value].
The file name for this file is identical to the name of the scoring file being edited, with the extension
changed to .txt. This file is located within the patient’s subfolder along with the EDF, .txt files and all
else that will be generated.
The following is a summary of the different editing activities that can be done:
1. Events can be deleted by selecting an event and pressing the Delete key.
2. Events can be added in one of two ways:
a. By left clicking on an empty section of a channel, holding the mouse button down and
moving the mouse. This uses the Default Event property of the channel to determine
event type (see Section 3.3 and the section on Creating and Event, below).
b. By right clicking on an empty section of a channel. Uses two properties of the channel to
determine events: Default Event to determine the event type, and Default Duration to
determine the event duration (see Section 3.3 and the section on Creating an Event,
below).
3. Events can be resized by left clicking on either vertical edge of the event, holding the mouse
button down and moving the mouse.
4. Events can be moved by left clicking on the event, holding the mouse button down, and moving
the mouse.
5. Events can be renamed in one of three ways:
a. Selecting an event, and choosing a new event name from the list provided by the Event
Name property.
b. Selecting an event, and pressing one of the key bindings that are set as described below
(see Figure 5.1and the text that corresponds to it).
c. Right clicking an event, and selecting a new event name from the list provided.
6. Event associations can be toggled by using the check boxes provided in the properties window
when an event is selected (see Section 3).
7. Sleep staging can be restaged by using one of the key bindings that are set as described below
(see Figure 5.1 and the text that corresponds to it), if the following conditions are met:
a. Epoch duration is set to 30 seconds;
b. The epoch boundary aligns with the left most edge of the display.
Additional information is provided to help with rescoring: this can be accessed via the
View menu (see Section 5.7).Note: Events are automatically re-associated when they are
moved, renamed, created, or deleted. This can be overridden by setting the associations
manually (Section 5.3 below). Once an association has been toggled, it will never be
changed automatically. To re-enable automatic association for that event, the event will
need to be deleted and a new event placed in its spot.
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Note: Events are automatically deleted when the sleep stage they occurred in is changed
to Awake.
5.3 The Editing Helper
The Michele Sleep Scoring System has a built-in function called the Editing Helper; this feature
is meant to cut down on the editing time required to provide optimal scoring results. It scans the
file and looks at the scoring results to determine if there are any variables that are likely
questionable in terms of accuracy. Clicking on the Editing Helper button (Figure 5.2, circled in
red) will generate a text file listing the suggested edits (Figure 5.3).
Figure 5.2
Figure 5.3
5.4 Creating an Event
There are two modes of event creation: Standard Mode and Quick Mode.
Quick Mode involves right clicking anywhere on a channel. This will create an event of type Default
Event and duration Default Duration with the start being located at the cursor. The creation of default
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events was described in Section 3.3, as part of the description of the Graph Channel Properties window.
Quick mode is disabled if Right Click Adds Event is not selected in the Configuration Menu.
In Standard Mode, events are created by holding the left mouse button down anywhere on a channel and
then dragging the mouse - while still holding down the left button - either forward or backwards. Once
the event is covering the desired area, releasing the mouse button will finalize the event. The created
event will be the default type specified in the Channel properties.
Pressing one of the following keys while an event is selected will change the name of the event as
follows:
• O – Obstructive Apnea
• M – Mixed Apnea
• C – Central Apnea
• H – Hypopnea
• R – RERA
Key Bindings can be customized through the “Set Key Bindings” option in the Configuration menu.
Sleep staging key bindings can be customized as shown in Figure 5.2 below. Event Scoring and Event
Associations key bindings can also be customized through their respective sections in this menu.
Figure 5.2
Pressing one of the function buttons displays Figure 5.3 below. Once this window is open, press a key and
the binding for this function will be modified. If a key is already bound to another function, it cannot be
bound to a new function without first un-binding it.
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Figure 5.3
Pressing one of the invalid keys (shown above in Figure 5.3) will remove the key binding. Key bindings
are stored in the Montage.
Right Click Adds Event is a toggle that, when selected in the Configuration menu, will enable or disable
the ability for right clicking on the graph window to automatically create a default event. Once created,
right clicking on an event allows for the event name to be changed.
The Sleep Display indicates the sleep stage that was scored for the currently viewed 30-second epoch. If
the epoch length is longer than 30 seconds, or a time offset has been added to the window, the sleep
stages of multiple epochs are displayed.
To modify the sleep stage, one of six keys can be pressed:
Pressing “0” sets the sleep stage to Awake (displayed as W).
Pressing “1” sets the sleep stage to stage N1 (displayed as 1).
Pressing “2” sets the sleep stage to stage N2 (displayed as 2).
Pressing “3” sets the sleep stage to stage N3 (displayed as 3).
Pressing “5” sets the sleep stage to REM (displayed as R).
Pressing “6” sets the sleep stage to Movement (displayed as M).
Pressing “7” sets the sleep stage to Bad EEG (displayed as B).
These are the default key bindings. Keys can be re-assigned by using the interface illustrated above in
Figure 5.2.
Modifying the sleep stage can only be done when the epoch duration is set to 30 seconds and the window
is aligned to the epoch boundary. Any arousals in an epoch marked as Bad EEG will be removed.
Reassign Events relocates all events of a specific type (Respiratory, Arousal, Desaturation, or Leg
Movement) to a specified channel. Upon reassigning events from multiple channels onto a single
channel, there is no way to restore events to their previous individual channels. This operation does not
distinguish between Left Leg events and Right Leg events.
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Individual Event Properties
(a)
(b)
(c)
(d)
Figure 5.4
Selecting an individual event is done by clicking on the event box in the Graph Window, or on the marker
in the Graph Tray. The individual event properties deal with all configurable parts of the event. The
figures above show four different states for the event properties window. Figure 5.4a shows a
Desaturation event, Figure 5.4b shows a Respiratory event, Figure 5.4c shows a Leg Movement and
Figure 5.4d shows a Body Position (graph tray marker) event.
Note: If an event cannot be associated with another event, the check boxes for “With
Arousal” and “With Respiratory” will be disabled. This can be seen in Figure 5.4 (a)
and (d). Figure 5.4 (b) and (c) both have potential associations with other events.
• If a PLM event is associated with an arousal or a respiratory event, the
appropriate checkbox should be checked.
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•
If a respiratory event is associated with an arousal or a desaturation, the
appropriate checkbox should be checked.
These data are used for compiling statistics for the final report. The displayed event
name is updated for ease of identification for these associations.
The Start Time property determines when the event starts. This can be changed by entering a new value
in the text box, or by using the mouse to move the event around.
The Duration property determines the length of the event. This can be changed by entering a new value
in the text box, or by using the mouse to drag the edge of the event around.
If the selected event is a Graph Tray marker event, the only modifiable property is the Start Time.
Score File Manager (Figure 5.5) displays a dialog box that allows managing of the score files found for
the currently opened EDF file, allowing you to delete score files as well as choose which score file to
display. Score files deleted by this method cannot be recovered.
Figure 5.5
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5.5 The Hypnogram
The hypnogram (shown in Figure 5.6 below) is equivalent to a leaner form of the Graph Window.
Time Marker
Figure 5.6
The hypnogram contains a Time Marker that, when dragged by the mouse, changes the display of the
Graph Window to the new location of the marker. This functions both ways, and changing the display in
the Graph Window will automatically move the marker.
The hypnogram supports adding channels (in the same manner as the Graph Window), and the ability to
evenly space channels.
The Channel Display displays the visible channels for the specified time window. It also displays all
events at the appropriate start time with the appropriate duration and name of the event. The event name
is displayed on the physical event item. The Channel Display allows the creation of events.
Events can be selected in the same way as a channel, by simply clicking on the event. Multiple events
can be selected by holding down the “Ctrl” key while clicking on events. A selected event will have its
background color inverted.
Events can be modified through the interface. They can be dragged horizontally with the mouse,
modifying the start time but keeping the duration intact. As well, either the left or right boundary of the
event can be dragged.
• Dragging the right boundary will extend the event, preserving the start time but increasing the
duration.
• Dragging the left boundary will also extend the event, moving the start time back while
increasing the duration and preserving the end point.
• Either boundary can be dragged over the other boundary. This will flip the event, turning the end
point into the start point and vice versa.
Events can be removed by selecting them and pressing the Delete key on the keyboard.
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5.6 The Graph Tray
The Graph Tray, shown in Figure 5.7 below, composed of two rows, displays additional information
about the state of the patient and shows global marker events.
Top Row
Bottom Row
Figure 5.7
In the lower row to the left, the Graph Tray displays the patient name, the start time of the file and the end
time of the file.
In the lower row to the far right, the Graph Tray displays the current body position as well as the current
status of CPAP (either Off, On, or On with additional information, which will subsequently be elaborated
on).
In the top row, the Graph Tray displays key global events associated with the patient file. These include
body position changes, lights on/off, CPAP on time, CPAP level changes, BiPAP level changes, oxygen
level changes, and custom notes.
To add one of these global events, a right click on the top row of the Graph Tray brings up a selection
menu that allows a marker to be specified as shown in Figure 5.8 below.
Figure 5.8
When one of these markers has been selected from the menu, an icon with the name of the marker is
placed on the Graph Tray at the location of the mouse. This icon can be selected by clicking on it, and
moved by holding down and dragging the mouse, or deleted by pressing the delete key.
Adding a CPAP Level, BiPAP Level or Oxygen Level event brings up a dialog box that requests
parameters.
• CPAP Level requires a value for the new level
• BiPAP Level requires three values: Inspiratory Level, Expiratory Level and Backup Level
• Oxygen Level requires a value for the new level
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These parameters can be edited at any time by right clicking on the event marker icon.
Adding a note will provide an option to enter some text. These notes should be used only for short notes
or to represent custom markers. Any long or in-depth notes should be added to the analysis notes. Notes
cannot be edited once placed; however, an unlimited amount may be added and deleted. Notes added via
the notes marker are printed with the event list rather than the analysis notes.
Figure 5.9 below shows an example of a Left Body Position marker next to a CPAP level 30 marker. If
any markers overlap each other, the markers will turn red to indicate that there are hidden events, shown
in Figure 5.10
Figure 5.9
Figure 5.10
Several restrictions apply to different types of markers.
•
•
•
The Lights On and Lights Off markers automatically align to the nearest 30-second epoch
boundary.
o Only one of each of these markers can exist at a time. For example, placing a second
Lights Off event will remove the first Lights Off event.
Body Position markers automatically adjust their length based on surrounding body positions.
o The last Body Position marker in the file will stretch to the end.
o Placing two or more consecutive markers of the same Body Position will keep only the
earliest marker.
Only one CPAP On flag may be present in the file. Placing a second one will delete the first.
Adding a CPAP On flag turns the study into a split study. This causes the report to be split into two
sections (pre CPAP and post CPAP). For information on Report Generation refer to Section 6.
5.7 The View Menu
The View Menu is used to access different features related to how the information is displayed on the
screen.
Default Layout re-sizes the different windows (Graph Window, Properties Window, Scores Window and
Hypnogram) to a default size and position on the screen. This should be used to restore windows if one is
accidentally moved off-screen or closed.
Scale Channels scales the selected channels to fit their height entirely in the space assigned to the specific
channels.
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Evenly Space Channels resizes the height and repositions each channel so that all visible channels occupy
the same amount of space without overlap.
Align to Epoch Boundary shifts the start of the currently displayed window to re-align itself with a
multiple of the epoch length.
Show Patient Name, if chosen, will show the patient’s name at the bottom of event window. The patient’s
name is stored within the EDF file which is not shared with YMT. Only the signals are sent to YMT for
scoring, and no patient information is transferred.
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5.8 Additional Information
Show Additional Information opens a window that provides additional information to help with scoring,
as shown in Figure 5.11.
Figure 5.11
This data window shows four categories of information about the current display.
• Breath % High shows the current breath, as a percentage of the nearby reference breath, as well
as the respiratory channel that provided the measurement (the data source).
o Data Sources are as follows:
▪ NC – Nasal Cannula
▪ CPAP – CPAP Flow
▪ Therm – Thermistor
▪ Sum – Represents Respitrace bands when Inductive bands are used
• Flow Limitation indicates if the current inspiration is showing any indication of flow limitation.
Flow limitation applies only when the data source is CPAP or NC.
• Desaturation Percent indicates if there is an oxygen desaturation in the vicinity of the cursor, and
if yes, what percentage the desaturation is. Only desaturations of 2% or more are reported, those
less than 2% being insignificant.
• Duty Cycle - The Duty Cycle is the time of inspiration (Ti) divided by the time of the entire
breath (Ttot).
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The final value is the Delta Wave Duration value. This is provided for both EEG1 and EEG2. Delta
Wave durations are intended to assist scoring and are therefore only shown when the epoch duration is set
to 30 seconds, and the view is aligned to the epoch boundary (the same conditions that allow sleep
staging).
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The Breath % High, Flow Limitation, Desaturation Percent, and Delta Wave Duration can only be viewed
if the autoscoring has already been completed for the opened file, and the generated data file (extension
.rdat) is kept in the same directory as the opened file. The reported values for all fields but Delta Wave
Duration change based on the location of the mouse cursor on the Graph Window.5.9 The Toolbar
The majority of the functionality in the toolbar is also accessible through the menus described earlier.
Figure 5.12 below shows the Toolbar with definitions for the numbered items following it.
1 2 3 4 5 6 7 8
9
10 12
Figure 5.12
11
14
15
The following commands work exactly the same as the menu items described earlier:
1. Open Patient File
2. Save (prompts to save all three of the Montage, Score List and Analysis Notes, assuming there
are unsaved changes)
3. Generate Report
4. Print
5. Import Notes From File
6. Scale Channels
7. Evenly Space Channels
8. Align to Epoch Boundary
The following features are unique to the toolbar:
9. Set Epoch Duration
10. View Previous Epoch
11. View Next Epoch
12. Time of Position in File
13. Current 30-second Epoch Number
14. Animation Controller
15. Montage Selector
The Set Epoch Duration buttons consist of a number of durations which, when clicked, set the currently
displayed window length to that amount of seconds. The exception to this is the ALL button, which
displays the entire file.
Note: Processing can be quite slow when ALL is selected, and it is recommended that
filtering and referencing are disabled when using this display mode.
View Previous Epoch moves the current display back by the Epoch Duration. This button does not adhere
to epoch boundaries if the view has been shifted off the epoch boundary. This functionality can be
accomplished by pressing the Left arrow key. Pressing the minus (-) key either on the numpad or the
main keyboard will move the current display half an epoch backwards in time.
View Next Epoch moves the current display forward by the Epoch Duration. This button does not adhere
to epoch boundaries if the view has been shifted off the epoch boundary. This functionality can be
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accomplished by pressing the Right arrow key. Pressing the plus (+) key either on the numpad or the
main keyboard will move the current display half an epoch forwards in time.
The Time of Position in File controller is used both for informational purposes, showing the current time
of the displayed window, as well as for control purposes.
The time displayed in the controller is in HH:MM:SS AM/PM. Any of the first three fields are selectable,
which is indicated by a highlighting effect. Entering a new value can modify a selected field, or it can be
incremented/decremented through the up and down arrows. This has the potential to remove the
alignment with the epoch boundary, preventing the scoring of sleep. Using Align to Epoch Boundary will
reinstate this alignment and allow scoring to resume. Scrolling the mouse wheel up will advance the
graph window by the number of seconds currently displayed in the graph, while scrolling the mouse
wheel down will move the display back by the number of seconds currently displayed in the graph. Ex.:
If “Display 30 Seconds” is selected as the currently displayed window length, scrolling the mouse wheel
forward will advance the display by 30 seconds, while moving the mouse wheel down will move the
display back by 30 seconds. Pressing the Left and Right arrow keys on the user’s keyboard has the same
effect as scrolling the mouse up (right arrow key) and down (left arrow key).
The Current 30-second Epoch Number displays the current 30-second epoch that is shown earliest in the
displayed window. This number can be modified, and doing so will shift the start of the displayed
window to the beginning of the 30-second epoch number entered.
The Animation Controller allows for continuous scrolling of epochs across the screen at a fixed time
interval, which is set using the drop down box. The time intervals are in increments of 0.25 seconds,
ranging from 0.25 to 3.00 seconds.
Note: When animating large compressions with a fast time interval, this feature may
behave irregularly. If irregular behaviour is observed:
 Stop the animation.
 Select “Align to Epoch Boundary” from the menu or toolbar.
 Select a slower time interval.
The first two steps are vital to guaranteeing proper functionality of any further
operations. The third step is required only if animation is to be attempted again.
To use the Animation Controller, first select a time from the drop down box, then press either Play
scroll forward, or Rewind to scroll backwards.
to
The Montage Selector is used to change the current Montage. Montages are discussed in Section 3.9.
Selecting the Save Scoring File option that is listed under the Save option of the File Menu displays the
window shown in Figure 5.13.
Note: If the software crashes, an option will appear to save your .edited scored file. Please note
that this may corrupt the .ev file if an event was what caused the crash
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Figure 5.13
5.10 Analysis Notes
The Analysis Notes tab should be used to enter additional information about a patient file that cannot be
added through the scoring interface. Only one set of notes is allowed for each patient file, and they are
stored in a specific file (.notes extension) that should not be renamed or modified outside of the
application. The notes, if present, are appended at the end of the generated report. Editing the analysis
notes is done using the provided interface, which functions as a text editor.
Selecting Save Analysis Notes will save the analysis notes. Since there is only one set of analysis notes
per file, no secondary prompt is required.
5.11 Print Example
Print allows printing of any of four windows. These are the Graph Window, the Hypnogram, the
Analysis Notes, and the Event List. All of these windows are printed as they are shown on the screen.
Selecting Print brings up a dialog that allows the selection of which window to print shown below in
Figure 5.14.
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Figure 5.14
Note: Printing the Event List applies the specified event filters.
discussed further in Section 4.6.
Event filters are
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6.0 Generating the Report
Generate Report allows for the user to generate a customized report for the opened patient file and
scoring file using the Report Editor. Please refer to Appendix A – Report Editing for information on
using the Report Editor to create customized reports from scored patient files.
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7.0 The Help Menu
Figure 7.0
In the Help menu, shown in Figure 7.0, About displays a dialog box giving information about the software
version as well as copyright information.
View User Manual displays a PDF formatted current User Manual associated with the current Viewer
Release as shown below in Figure 7.1. The User Manual is available in English as well as other select
languages.
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Figure 7.1
View Release Notes displays a Text box indicating release notes pertaining to the current Viewer in use as
shown below in Figure 7.2.
Figure 7.2
End users can review the release notes or the User Manual at any time by selecting these menu items
within the Help Menu. These documents can be printed if desired.
Regulatory Information displays the Label for the Michele Sleep Scoring software, as well as Instructions
for Use and Younes Medical Technologies contact information. The Label is available in English as well
as other select languages.
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8.0 Troubleshooting
8.1Error Message
In the event of a failure of any part of the Viewer application, an error message will appear shown below
in Figure 8.0.
Figure 8.0
Pressing OK will signal the Viewer to automatically send an email to YMT Support containing critical
information about the error encountered during its use at that particular point. Users do not have to do
anything at this point.
Pressing OK will cause the software to terminate which is a normal event.
8.2 Notifying YMT of Perceived Software Failure
In the event that an error in autoscoring has been incurred or perceived, it is recommended that the user
first consider and verify the following:
a) Correspondence between the list of channels specified prior to data processing, and the order
of channels in the data file (see Section 3.9 above on channel mapping);
b) Specification of times of lights on and lights off (Section 4.2);
c) Use of data collection requirements per Section 1.2 above;
d) File type;
e) Report specifications (see Section 6 above).
If the user is unable to resolve the error, it is recommended that the file causing the failure be sent to
YMT with a full description of the events preceding identification of the error, so that it can be
appropriately investigated (and potentially used to improve the reliability of the software). If the results
of autoscoring have been manually edited, YMT may also request that the user send the results of manual
editing.
Contact Information: Please contact YMT for enquiries, technical assistance, or for reporting complaints.
Please phone toll-free, 1-888-942-6774, or e-mail support@younesmedical.com.
Mailing address:
Unit 5 – 55 Henlow Bay
Winnipeg, Manitoba, Canada
R3Y 1G4
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9.0 Optional Server Setup
9.1 Requirements
•
Microsoft Windows Server 2003 or later (64 bit).
•
6GB of RAM per instance of the viewer.
9.2 Installation
Complete the installation as described in Section 2.0, making sure to install the Viewer for “Everyone”
and not “Just for me” (see Figure 2.10).
9.3 Configuration
Create the 'master' download directory. This is the location that all Viewers, once configured using the
steps below, will download results files to. In this example, C:\downloads will be used.
For each user on the server do the following:
•
Login to the server using the user’s credentials. Run the Viewer once. Close the Viewer. This is
to create the Application Data directory, and the default download directory (which is empty at
this point).
•
Remove the downloads directory located at C:\Users\USERNAME\AppData\Roaming\Ymt
Limited\Michele Data Viewer\downloads. Note that showing hidden folders will be required to
be on to see AppData.
•
Open a command prompt and link the master downloads directory in place of the user specific
one. This can be done with the following command (substituting USERNAME as before):
“mklink
/D
C:\Users\USERNAME\AppData\Roaming\Ymt
Limited\Michele
Data
Viewer\downloads C:\downloads”.
9.4 Miscellaneous
There is a known issue wherein if two instances of the Viewer download the same file and they both
finish within 1 second of each other, one will crash. This is not expected to occur in daily use, and is
being addressed in later revisions.
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10.0 Attachments
10.1 A sample report generated by the MICHELE Sleep Scoring System is attached (nine pages,
including the cover page/label).
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YST-UDoc-USM-30
Michele Sleep Scoring System Report Label
Document Number: YST-Label-001-16
Revision: 16
Effective Date: 03-Oct-17
This report was generated by:
MICHELE Sleep Scoring System
Younes Medical Technologies (YMT)
Unit 5 – 55 Henlow Bay
Winnipeg, Manitoba R3Y 1G4
Canada
Tel: 1-888-942-6774
https://michelesleepscoring.com/
EC
REP
Advena Ltd.
Pure Offices
Plato Close
Warwick, CV34 6WE
UK
Intended Use:
The MICHELE Sleep Scoring System is a computer program (software) intended for use as an aid for the
diagnosis of sleep and respiratory related sleep disorders.
The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual
rescoring), display, redisplay (retrieve), summarizing, reports generation and networking of digital data
collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.
The device is to be used under the supervision of a physician. Use is restricted to files obtained from
adult patients.
Warnings and Cautions:
The MICHELE Sleep Scoring System does not analyze data that are different from those analyzed by
human scorers.
The attached report contains numerical and graphical data typical of those generated following manual
scoring of polysomnograms. It does not contain any interpretation, diagnosis or recommendations for
treatment. These decisions are to be made by the treating physician.
The scoring provided by the MICHELE Sleep Scoring System must be reviewed, edited as necessary and
approved before the report is generated.
Special attention should be paid to confirm the first epoch of Rem sleep and of non-Rem sleep since,
occasionally, brief periods of either kind can be missed or mistakenly scored resulting in large errors in
sleep latency or Rem latency.
Arousals may be underreported in cases where arousal frequency is very high.
Any modification to any component of the MICHELE Sleep Scoring System may result in erroneous
results or failure of the software to operate.
Caution: US Federal law restricts this device to sale by or on the order of a physician.
Identifier of the device:
Viewer Software Version:
Release Date:
Autoscoring Software Version:
Release Date:
1.03.024
12-Oct-17
1.00.107
09-Nov-12
0086
SLEEP ANALYSIS REPORT
Patient Name: Sample
SAMPLE – for User Manual
YST-UDoc-USM-30
Recording Information
Study
Study Date: June 3 2013
Study Type: Split
ID #: 23
Patient
Patient Name: Sample
Gender: M
Date of Birth: April 2 1988
Social Security #: 25651
Healthcare #: 3
Neck Circumference: 20
Weight: 120 kg
Height: 2 m
BMI: 30.0
Epworth Scale: 7
Medications:
Medical Personnel
Referring Doctor: A
Interpreting Doctor: B
Collection Technician: D
Scoring Technician: E
2
SLEEP ANALYSIS REPORT
Patient Name: Sample
SAMPLE – for User Manual
YST-UDoc-USM-30
PRE CPAP
SLEEP VARIABLES
Lights Off
Total Sleep Time (TST)
Sleep Efficiency (%)
Sleep Latency
Sleep Period Time
Stage1 Cycles
Total Stage Shifts
21:28:41
95.0
63.8
38.0
110.9
34
88
Time at CPAP On
Total Recording Time
Wake After Sleep Onset (WASO)
Rem Latency
Rem Latency Minus Wake Time
Total Awakening
23:57:36
148.9
15.9
N/A
N/A
18
TIME IN EACH STAGE
Sleep Stage
Awake
N1
N2
N3
Rem
Total Non-Rem
Time (min)
53.9
35.0
60.0
0.0
0.0
95.0
%TST
56.8
36.8
63.2
0.0
0.0
100.0
Latency
38.0
42.0
N/A
N/A
38.0
AROUSALS
Total
Respiratory
With PLMs
Spontaneous
Total Arousals
Number
110
0
14
124
Rem
Index
69.5
0.0
8.8
78.3
Number
N/A
N/A
N/A
N/A
Index
N/A
N/A
N/A
N/A
Non-Rem
Number
Index
4
2.5
0
0.0
4
2.5
Number
3
0
3
Non-Rem
Number
Index
110
69.5
0
0.0
14
8.8
124
78.3
LEG MOVEMENTS
PLMs
With Arousal
Without Arousal
Total
Number
Index
4
2.5
0
0.0
4
2.5
Rem
Number Index
N/A
N/A
N/A
N/A
N/A
N/A
3
N1
Index
5.1
0.0
5.1
N2
Number
1
0
1
Index
1.0
0.0
1.0
N3
Number
N/A
N/A
N/A
Index
N/A
N/A
N/A
SAMPLE – for User Manual
YST-UDoc-USM-30
SLEEP ANALYSIS REPORT
Patient Name: Sample
RESPIRATORY EVENTS BY SLEEP STAGES
Total
Number
Index
Central Apnea
Obstructive Apnea
Mixed Apnea
Obstructive Hypopnea *
Undefined Hypopnea *
RERA
All Apneas
Apneas + Hypopneas
Apneas + Hypopneas + RERAs
58
78
23
32
3
0
159
194
194
36.6
49.3
14.5
20.2
1.9
0.0
100.4
122.5
122.5
Rem
Number
Index
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Non-Rem
Number
Index
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
58
78
23
32
3
0
159
194
194
Duration
Average Maximum
36.6
49.3
14.5
20.2
1.9
0.0
100.4
122.5
122.5
20.1
19.5
23.0
20.6
19.8
0.0
20.2
20.3
20.3
35.6
32.4
39.1
36.8
26.2
0.0
39.1
39.1
39.1
*Scored by alternate criteria
RESPIRATORY EVENTS BY BODY POSITION
Total
Number
Index
Supine
Number Index
Right
Number Index
Left
Number
Index
Prone
Number Index
Upright
Number Index
Central Apnea
Obstructive Apnea
Mixed Apnea
Obstructive Hypopnea
Undefined Hypopnea
RERA
ALL Apneas
Apneas + Hypopneas
58
78
23
32
3
0
159
194
36.6
49.3
14.5
20.2
1.9
0.0
100.4
122.5
58
78
23
32
3
0
159
194
36.6
49.3
14.5
20.2
1.9
0.0
100.4
122.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Apneas + Hypopneas +
RERAs
194
122.5
194
122.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
O2 SATURATION STATISTICS
Maximum
Average
Minimum
# desaturations > 2% (Index) **
# desaturations > 3% (Index) **
# desaturations > 4% (Index) **
% Sleep Time > 90%
% Sleep Time 80-90%
% Sleep Time 70-80%
% Sleep Time 60-70%
% Sleep Time 50-60%
% Sleep Time <50%
% Sleep Time with Bad Signal
Overall
Rem
N-Rem
Supine **
Lateral **
Prone **
98.0
92.0
78.0
196(79.0)
193(77.8)
193(77.8)
66.6
28.0
0.3
0.0
0.0
0.0
5.1
N/A
N/A
N/A
N/A (N/A)
N/A (N/A)
N/A (N/A)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
98.0
90.9
79.0
196 (123.8)
193 (121.9)
193 (121.9)
56.3
40.8
0.3
0.0
0.0
0.0
2.6
98.0
90.9
79.0
196 (123.8)
193 (121.9)
193 (121.9)
56.3
40.8
0.3
0.0
0.0
0.0
2.6
N/A
N/A
N/A
N/A (N/A)
N/A (N/A)
N/A (N/A)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A (N/A)
N/A (N/A)
N/A (N/A)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
** Only time in sleep considered.
4
SLEEP ANALYSIS REPORT
Patient Name: Sample
SAMPLE – for User Manual
YST-UDoc-USM-30
POST CPAP
SLEEP VARIABLES
Time at CPAP On
Total Sleep Time (TST)
Sleep Efficiency (%)
Sleep Latency
Sleep Period Time
Stage1 Cycles
Total Stage Shifts
23:57:36
217.5
90.6
1.1
239.0
10
32
Time at Lights On
Total Recording Time
Wake After Sleep Onset (WASO)
Rem Latency
Rem Latency Minus Wake Time
Total Awakening
03:57:41
240.1
21.5
24.0
7.5
7
TIME IN EACH STAGE
Sleep Stage
Awake
N1
N2
N3
Rem
Total Non-Rem
Time (min)
22.6
33.0
135.0
0.0
49.5
168.0
%TST
10.4
15.2
62.1
0.0
22.8
77.2
Latency
18.6
1.1
N/A
24.0
1.1
AROUSALS
Total
Respiratory
With PLMs
Spontaneous
Total Arousals
Number
3
0
20
23
Rem
Index
0.8
0.0
5.5
6.3
Number
0
0
3
3
Index
0.0
0.0
3.6
3.6
Non-Rem
Number
Index
10
3.6
0
0.0
10
3.6
Number
2
0
2
Non-Rem
Number
Index
3
1.1
0
0.0
17
6.1
20
7.1
LEG MOVEMENTS
PLMs
With Arousal
Without Arousal
Total
Number
Index
10
2.8
0
0.0
10
2.8
Rem
Number Index
0
0.0
0
0.0
0
0.0
5
N1
Index
3.6
0.0
3.6
N2
Number
8
0
8
Index
3.6
0.0
3.6
N3
Number
N/A
N/A
N/A
Index
N/A
N/A
N/A
SAMPLE – for User Manual
YST-UDoc-USM-30
SLEEP ANALYSIS REPORT
Patient Name: Sample
RESPIRATORY EVENTS BY SLEEP STAGES
Total
Number
Index
Central Apnea
Obstructive Apnea
Mixed Apnea
Obstructive Hypopnea *
Undefined Hypopnea *
RERA
All Apneas
Apneas + Hypopneas
Apneas + Hypopneas + RERAs
1
0
0
2
2
0
5
9
9
Rem
Number
Index
0.3
0.0
0.0
0.6
0.6
0.0
1.4
2.5
2.5
0
0
0
0
0
0
0
0
0
Non-Rem
Number
Index
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
1
0
0
2
2
0
5
9
9
Duration
Average Maximum
0.4
0.0
0.0
0.7
0.7
0.0
1.8
3.2
3.2
13.9
0.0
0.0
39.8
14.7
0.0
15.6
20.8
20.8
13.9
0.0
0.0
68.0
16.2
0.0
17.6
68.0
68.0
*Scored by criteria A
RESPIRATORY EVENTS BY BODY POSITION
Total
Number
Index
Supine
Number Index
Right
Number Index
Left
Number
Index
Prone
Number Index
Upright
Number Index
Central Apnea
Obstructive Apnea
Mixed Apnea
Obstructive Hypopnea
Undefined Hypopnea
RERA
ALL Apneas
Apneas + Hypopneas
1
0
0
2
2
0
5
9
0.3
0.0
0.0
0.6
0.6
0.0
1.4
2.5
1
0
0
2
2
0
5
9
0.3
0.0
0.0
0.6
0.6
0.0
1.4
2.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Apneas + Hypopneas +
RERAs
9
2.5
9
2.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
O2 SATURATION STATISTICS
Maximum
Average
Minimum
# desaturations > 2% (Index) **
# desaturations > 3% (Index) **
# desaturations > 4% (Index) **
% Sleep Time > 90%
% Sleep Time 80-90%
% Sleep Time 70-80%
% Sleep Time 60-70%
% Sleep Time 50-60%
% Sleep Time <50%
% Sleep Time with Bad Signal
Overall
Rem
N-Rem
Supine **
Lateral **
Prone **
100.0
96.9
88.0
24 (6.0)
13 (3.2)
11 (2.7)
97.6
0.2
0.0
0.0
0.0
0.0
2.2
99.0
96.5
94.0
3 (3.6)
0 (0.0)
0 (0.0)
100.0
0.0
0.0
0.0
0.0
0.0
0.0
99.0
97.1
88.0
21 (7.5)
13 (4.6)
11 (3.9)
99.1
0.3
0.0
0.0
0.0
0.0
0.6
99.0
96.9
88.0
24 (6.6)
13 (3.6)
11 (3.0)
99.3
0.2
0.0
0.0
0.0
0.0
0.5
N/A
N/A
N/A
N/A (N/A)
N/A (N/A)
N/A (N/A)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A (N/A)
N/A (N/A)
N/A (N/A)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
** Only time in sleep considered.
6
SLEEP ANALYSIS REPORT
Patient Name: Sample
SAMPLE – for User Manual
YST-UDoc-USM-30
Graphs
Level
7
9
10
DURATION
RESPIRATORY
Total REM NREM Cen. Obs. Mxd. Undef. Hypop A+H
(min.) (min.) (min.) Apnea Apnea Apnea Apnea nea Total
14.8
0.0
0.5
0
0
0
1
0
1
38.3 31.8
6.0
0
0
0
3
3
6
182.7 17.7 160.5
1
0
0
0
1
2
7
OXIMETRY
Max
Min
Avg
SpO2 SpO2 SpO2
119.8 98.0 89.0 96.8
9.5
98.0 88.0 95.4
0.7 100.0 90.0 97.3
AHI
SLEEP ANALYSIS REPORT
Patient Name: Sample
8
SAMPLE – for User Manual
YST-UDoc-USM-30
SLEEP ANALYSIS REPORT
Patient Name: Sample
SAMPLE – for User Manual
YST-UDoc-USM-30
This is an electronically generated secure document
Generated: 2017-10-18 10:51:06 AM
__________________________________________________
E
__________________________________________________
Date
9
Appendix A – Report Editing
Revision: 09
Effective Date: 10-Jan-17
Document Number: YST-UDoc-A1-09
MICHELE
SLEEP SCORING SYSTEM
APPENDIX A - REPORT EDITING
1
Appendix A – Report Editing
Revision: 09
Effective Date: 10-Jan-17
Document Number: YST-UDoc-A1-09
Table of Contents
Introduction
3
1.0 Features of the Report Editor
1.1.
Opening the Report Editor
1.2.
Title Bar
1.3.
Menu Bar
1.4.
File Menu
1.5.
Edit Menu
1.6.
View Menu
1.7.
Insert Menu
1.8.
Format Menu
1.9.
Table Menu
1.10. Toolbar and Button Bar
3
3
3
4
4
4
5
6
6
7
8
2.0 Using the Report Editor
2.1.
Creating a new template
2.1.1.
General Fields
2.1.2.
Data Fields
2.1.3.
Graphs and Tables Fields
2.1.4.
Unique Identifier Keys
2.1.5.
Finalizing and Accessing the New Report Template
2.2.
Uploading a Preexisting Report Template into the Report Editor
2.3.
Using a default template
2.4.
Importing and Exporting Report Templates
2.4.1.
Exporting Reports
2.4.2.
Importing Reports
8
8
9
10
12
12
12
12
13
13
15
17
3.0 Using the Customized Report(s)
3.1.
Sending the file for scoring
3.2.
Downloading and reviewing the scored file
3.3.
Generating the Customized Report
3.4.
Including a Custom Oxygen Threshold
3.5.
Outputting a Sample Channel
3.6.
Selecting a Report Template
3.7.
Opening the Customized Report
3.8.
The Report Manager
18
18
18
19
20
21
21
23
23
2
Appendix A – Report Editing
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Effective Date: 10-Jan-17
Document Number: YST-UDoc-A1-09
Introduction
To suit the individual needs of each user, the Viewer has the ability to create and use report templates to
display the results of autoscoring by MICHELE for both Level 1 and Level 3 studies. To facilitate the
development and deployment of report templates, the Viewer software package includes a Report Editor.
The Report Editor presents users with a free-style word processing interface which allows for the
construction of customized reports. Default templates are included, and can be used as-is, or as a starting
point and modified to suit each user’s requirements. Users are also able to upload a report template
currently being used in their lab, and configure it to display the pertinent information using Unique
Identifier Keys. There is no limit to the number of customized reports users are able to create; users may
wish to create a report template for each type of study their lab performs (Split-night, CPAP only, no
CPAP, etc.).
1.0 Features of the Report Editor
1.1 Opening the Report Editor
To open the Report Editor, from the Viewer Main Menu, select “Report Editor” from the File menu. The
Report Editor will open within the Viewer and present itself as a blank document. The Report Editor
interface looks and functions similarly to most word processing software systems, such as Microsoft®
Word, OpenOffice, or LibreOffice. Please note that while the Report Editor is open all other features
or applications in the Viewer will be inaccessible.
1.2 Title Bar
On the top of the Report Editor window is a long bar called the Title Bar. On the left side of the title bar
there is an icon that represents the application. To use the system menu on the application icon, click the
small icon. A menu will appear, and from this menu you are able to Maximize, Minimize, or Restore the
window to its original size; Move the window; or Close the window. The Report Editor can also be
maximized or minimized by double clicking the blank area inside the Title Bar (Figure A-1).
Title Bar
Figure A-1
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Effective Date: 10-Jan-17
Document Number: YST-UDoc-A1-09
1.3 Menu Bar
Directly under the Title Bar is the Menu Bar, which is composed of several menus (File, Edit, View,
Insert, Format, and Table) (Figure A-2). Each menu on the Menu Bar allows the user to perform many
operations pertinent to word processing. Most users may be familiar with these menus from prior
experience using word processing software; however, they are detailed in sections 1.4 – 1.9 below. If a
particular menu item has a keyboard shortcut, this is indicated beside that item in the menu (e.g. to create
a new report, the user can press Ctrl+N on their keyboard instead of accessing this function through the
File menu). Additionally, certain functions have picture icons beside them in their respective menus.
This is to indicate which functions have shortcuts on the Toolbar menu, further explained in section 1.10
below.
1.4 File Menu
The File menu (Figure A-2) allows users to create a new report, open an existing report, save the current
report, print the current report, view recently opened reports, or exit the Report Editor.
Menu Bar
Figure A-2
1.5 Edit Menu
The Edit menu (Figure A-3) allows users to undo previous actions; redo actions that have just been
undone; cut, copy, paste, or delete text and images; select all text or images; find a particular word; and
find and replace a word with a different word. The Hyperlink function allows users to edit a URL link
that they’ve previously inserted via the Insert menu described in section 1.7 below.
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Appendix A – Report Editing
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Figure A-3
1.6 View Menu
The View menu (Figure A-4) allows users to view the current report in either Page Layout view or in
Draft view, as well as create and edit any existing headers and footers. The Toolbar, Button Bar, Status
Bar, and Horizontal and Vertical Rulers are all shown in the Report Editor by default. The user can
remove any of these from view by de-selecting them in the View menu. The user can also adjust the size
of the report on their monitor by increasing the Zoom % to see a close-up view of the file or decrease the
Zoom % to see more of the page at a reduced size.
Figure A-4
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1.7 Insert Menu
The Insert menu (Figure A-5) allows users to insert files (such as existing report templates), images, text
frames, hyperlinks, or page breaks. When inserting a file or an image, a dialog box will appear and the
user will have to search for the desired file or image in their computer directory. The user will need to be
aware of the format of the desired file or image, and select it from the drop down menu beside the “File
name” drop down menu (Figure A-6).
Figure A-5
Figure A-6
1.8 Format Menu
The Format menu (Figure A-7) allows users to change the font type, attributes, position, and color
through the Character menu item. Changes to paragraph formatting and indents, and frame and page
breaks can be made through the Paragraph menu item. Tab stops, bullets and numbering, borders,
columns, and headers and footers can be customized through their respective menu items. A specific
combination of a font type; paragraph formatting, indents, frame and page breaks; tab stops; and bullets
and numbering can be saved as a particular Style through the Styles menu item and used in future reports.
The text color and background color can be easily changed through their respective menus found at the
bottom of the Format menu.
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Appendix A – Report Editing
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Document Number: YST-UDoc-A1-09
Figure A-7
1.9 Table Menu
The Table Menu (Figure A-8) allows users to insert, delete, or select a table, as well as merge or split
cells found in the table(s). Grid lines in tables can be turned on or off through this menu, and rows and
columns can be added or deleted though the “Insert” and “Delete” menus found within the Table Menu.
Users may highlight several cells in a table and choose “Merge Cells” (either through the Table Menu, or
right click and select “Merge Cells”) to combine those cells together. To split cells that have been
previously merged, left click in the cell that is to be split, and select “Split Cells” (either through the
Table Menu, or right click and select “Split Cells” from the drop-down menu). To customize table
properties, left click anywhere inside the table and select Properties from the Table menu. Alternatively,
users can right click anywhere inside the table and select “Table Properties”. The frame width, table and
background color, cell margins, and text alignment can all be specified through the Properties menu.
Figure A-8
7
Appendix A – Report Editing
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Document Number: YST-UDoc-A1-09
1.10
Toolbar and Button Bar
The Toolbar beneath the Menu Bar (Figure A-9) allows users shortcut access to several frequently-used
features found under menus in the Menu bar. Reports can be created, opened, saved, and printed through
their respective shortcuts in this Toolbar. Images or text can be cut, copied, pasted, or deleted; actions
can be undone and/or redone; words can be searched for; and headers can be formatted through the
Toolbar. The Page Setup menu can also be easily accessed through the Toolbar. To see which shortcut a
button corresponds to, the user may hover their mouse over the button and a description of what the
button does will appear (Figure A-10). The Button Bar allows users to quickly change their paragraph
style, font, font size and attributes; change the alignment of the text; create a bulleted or numbered list;
zoom in or out of the report; view paragraph marks and other formatting symbols; and create or modify
existing tabs.
Toolbar
Figure A-9
Button Bar
Figure A-10
2.0 Using the Report Editor
Users have three options when customizing a report template: Create a new report template, upload a
template that is currently being used in their lab, or use one of the default report templates.
2.1 Creating a new template
To create a new template, open the Report Editor by selecting Report Editor in the Viewer File menu.
The Report Editor will open and the document will be blank. The user can now insert tables, headers and
footers, images, and page numbers, as well as label specific fields that they wish to include in the report,
format font, and use many other features as described in section 1 above.
Once the user has created the report template, they will then have to insert the Unique Identifier Keys
(further explained in 2.1.4) in the report that pertain to each data field. The “Fields” section on the right
8
Appendix A – Report Editing
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Effective Date: 10-Jan-17
Document Number: YST-UDoc-A1-09
side of the Report Editor contains three categories of fields: General Fields, Data Fields, and Graphs and
Tables Fields (Figure A-11).
Figure A-11
2.1.1 General Fields
The General Fields allow for entry of relevant dates and times (Time of Study Start, Time of Study End,
Time of Lights Off, Time of Lights On, Time of CPAP On, Time of Sleep Onset, Time of Sleep End,
Total Recording Time and Today’s Date), general information about the sleep study (Study Date, Study
Type, ID#), patient information (Patient Name, Gender, Date of Birth, Patient Age, Social Security #,
Healthcare #, Neck Circumference, Weight, Height, BMI, Epworth Scale, Medications), names of
medical personnel (Referring Doctor, Interpreting Doctor, Collection Technician, and Scoring
Technician), and miscellaneous information (Page Number and Hypopnea Criteria, which indicates the
Hypopnea Type that was selected in the Channel Mapping window before sending the file for scoring in
the Viewer ). In the final report, the information specified in the General Fields will precede the tables
and graphs that contain results of autoscoring.
The Cover Sheet is a special field that allows importing of patient information into the final report. To
utilize it, drag and drop the code $coversheet$ onto the report; it will then call information from the
Report Generator Options Window (see Figure A-22 below). The information is stored in an .rtf file that
is created prior to generating the report. The .rtf file can be loaded by clicking on the
button.
9
Appendix A – Report Editing
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The .rtf file should look something like this:
2.1.2 Data Fields
The Data Fields section includes fields for Sleep data, Body Position, Respiratory Events, Arousals, Leg
Movements, Oxygen, Heart Rates, and Snoring for Pre- and Post-CPAP as well as the combined results
when needed (e.g. Split Studies).
Sleep data is categorized into General Items, Staging Breakdowns, and ORP. General Items which may
be included are Wake After Sleep Onset, Sleep Period Time, Awake as % of Sleep Period Time, Sleep
Efficiency, and REM Latency Minus Wake Time. The Staging Breakdown field allows users to include
information on Time in Stage, % Total Sleep Time, % Total Study Time, Shifts into Stage, Latency from
Lights Out, and Latency from Sleep Onset for all stages (including awake), all sleep stages, and/or the
individual sleep stages (Stage 1, Stage 2, Stage 3, including REM and NREM, REM/Supine, REM/NonSupine, NREM/Supine and NREM/Non-Supine) ORP allows the user to determine quality of sleep for
Wake, All Sleep Stages including REM, Wake (After Sleep Onset), All, and/or All (After Sleep Onset).
The Body Position field allows users to include data on Total Time Including Awake, Total Time Sleep
Only, % Total Study Time, and % Total Sleep Time for each individual body position the patient was in
(Supine, Prone, Upright, Right, Left, Lateral and Non-Supine).
10
Appendix A – Report Editing
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Document Number: YST-UDoc-A1-09
The Respiratory field allows users to include data collected regarding the Number, Index, Maximum
Duration, Average Duration, Minimum Duration, Total Duration (Minutes) and % Total Sleep Time for
Undefined Apneas, Central Apneas, Obstructive Apneas, Mixed Apneas, Obstructive Hypopneas,
Undefined Hypopneas, All Hypopneas, RERAs, All Apneas, Apneas + Hypopneas, and All Events that
occurred in the sleep-portion of the study. Respiratory event data can also be specified by the stage of
sleep the events occurred in (including REM and NREM), and/or which body position the patient was in
when the event(s) occurred (Supine, Prone, Upright, Right, Left, Lateral, Non-Supine, REM/Supine,
REM-Non-Supine, NREM/Supine, and NREM/Non-Supine).
Arousal data, which include Number and Index of: Respiratory, PLM, Spontaneous, Awakenings, and
Total Arousals, are able to be broken down into the same categories as Respiratory Events as described
above (All Sleep, individual sleep stages (including REM and NREM), and/or body position).
The Leg Movements field allows users to include data on the Number, Average Duration, Total Time, and
% Total Sleep Time of PLM Chains. Users can also include summaries of the Number and Index of all
Leg Movements that occur With Arousal, Without Arousal or Total Movements (with and without
arousal) in All Sleep Stages, individual sleep stages (including REM and NREM) and/or by body
position.
The Oxygen field allows data collected on Oxygen levels to be inserted into the report. Users have the
option of including Desaturations > 2% Count, Desaturations > 2% Index, Desaturations > 3% Count,
Desaturations > 3% Index, Desaturations > 4% Count, or Desaturations > 4% Index, Lowest SpO2 with
Longest Apnea, Lowest SpO2 with Longest Hypopnea, Average Desaturation Amplitude, and/or Lowest
SpO2 with Respiratory for All (entire study), All Sleep Stages, All Awake, individual sleep stages
(including REM and NREM), and/or by body position. Additionally, users have the option of including
Summaries of the Maximum Saturation, Average Saturation, Minimum Saturation, % Sleep Time > 90%,
% Sleep Time 80-90%, % Sleep Time 70-80%, % Sleep Time 60-70%,% Sleep Time 50-60%, % Sleep
Time < 50%, % Sleep Time < CUSTOM% (a custom oxygen threshold the user can define when
generating the report, see “Including a Custom Oxygen Threshold”, section 3.4), % Sleep Time, Bad
Signal for All (entire study), All Sleep Stages, All Awake, individual sleep stages (including REM and
NREM), and/or by body position.
Alternatively, the oxygen times can be reported in minutes.
Note: The custom oxygen threshold will include all the values below, but not including the specified
value (e.g. If a user enters 83% in the report generator, the field would include values from 0-82%).
Heart Rate data (Maximum, Average, Minimum, and 95th Percentile) can be inserted into the report
through the Heart Rates field. Heart Rate data can be included for All (entire study), All Sleep, All
Awake individual sleep stages (including REM and NREM), and/or by body position.
Snoring data (Number of Snores, Epochs with Snoring, Sleep Time with Snoring, Snore Index and %
Sleep Time with Snoring) can be inserted through the Snoring field. Snoring data can also be specified by
the stage of sleep the events occurred in (including REM and NREM), and/or which body position the
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Appendix A – Report Editing
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patient was in when the event(s) occurred (Supine, Prone, Upright, Right, Left, Lateral, Non-Supine,
REM/Supine, REM-Non-Supine, NREM/Supine, and NREM/Non-Supine).
Breaths data (Total Breaths, Flow Limited Breaths, Percent Breaths with Flow Limited) can be inserted
into the report through the Breaths field. Breaths data can also be specified by the stage of sleep the
events occurred in (including REM and NREM), and/or which body position the patient was in when the
event(s) occurred (Supine, Prone, Upright, Right, Left, Lateral, Non-Supine, REM/Supine, REM-NonSupine, NREM/Supine, and NREM/Non-Supine).
2.1.3
Graphs and Tables Fields
The Graphs and Tables fields allow users to include graphs summarizing Sleep Staging, Body Position,
Respiratory Events, Leg Movements, Oximetry, PAP Pressure, Audio, Heart Rate, Average Delta EEG1,
Average Delta EEG 2, Full Graph, Hypnogram Vs O2, Heart Rate Type2 (different version), a sample of
any channel (labelled as “ECG Sample”), an oxygen table (displaying oxygen added during treatment)
and/or a CPAP/BiPAP Summary table. The Full Graph, Hypnogram Vs O2, Heart Rate Type2 and ECG
Sample graphs were specifically made for one user, but are available for useby any user if so desired. For
a full description on how to use the ECG Sample function see Section 3.5 below.
2.1.4
Unique Identifier Keys
Once the user has determined which data, graphs, and/or tables they would like to include in their report,
they can click the particular field, and drag it over into the appropriate column in a table or field in the
report. E.g. if a user wanted to include Time of Lights Off, they would expand the General field by
clicking the + symbol beside “General”, then expand the “Dates and Times” field in the same manner,
click and hold “Time of Lights Off”, and drag the item into the correct place in the report. The data will
appear as a Unique Identifier Key (Figure A-12). This Unique Identifier Key will be replaced with the
appropriate data once the report is generated. Do not delete or modify any of the Unique Identifier
Keys as this will affect how the report is generated and may result in incorrect data being displayed
in the report.
Figure A-12
2.1.5 Finalizing and Accessing the New Report Template
12
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Document Number: YST-UDoc-A1-09
The user may now save the report template by either clicking on the Save shortcut on the Toolbar, or by
selecting “Save As” under the File menu. Users will be prompted to enter a report name (e.g. CPAP
Report).
Once a custom report has been created, it will be available to be opened and modified as needed in the
future. Users may access previously created reports through the Open shortcut in the Toolbar, or by
selecting “Open” under the File menu. Please note that saved report templates are only stored within the
Viewer, and will not be accessible through the user’s hard drive.
2.2
Uploading a Preexisting Report Template Into the Report Editor
To insert a preexisting report template, select “File” from the Insert menu. The user will be presented
with a window in which they can locate the report template on their computer. The report editor can
upload .rtf , .html, .doc, .docx, .xml, .pdf, .txt, and .tx file formats. Please note that the user must be
aware of the format of the document they are uploading, and ensure that this is selected when locating the
file (Figure A-13).
Figure A-13
Once the user has uploaded their template report, they may click the fields that they wish to include in the
report and drag the Unique Identifier Keys into the appropriate fields in the template as described in
section 2.1.4 above.
The report may then be saved as described in section 2.1.5 above.
2.3
Using a default template
There are five template reports that are preloaded into the Report Editor. The five preloaded reports are
titled, “Michele Diagnostic Report”, “Michele CPAP Study”, “Michele Split Study”, “Michele Level 3
Rx Report”, and “Michele Level 3 Dx Report”. These preloaded reports include the data fields that are
most commonly used in reports for those particular types of studies. However, users may add extra fields
to the template reports, or remove fields that they do not want included in their reports. The template
reports may be customized for each lab by adding additional tables, inserting columns and/or rows, or
deleting tables and removing columns and/or rows as described in section 1.9 through the Table menu.
The user would then click and drag the Unique Identifier Keys into the new table cells they have created
13
Appendix A – Report Editing
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as described in 2.1.4. Customized lab information, such as a logo or address, may be added through the
header and footer as described in section 1.6 above.
2.4
Importing and Exporting Report Templates
Users have the ability to copy report templates for other users to import and utilize within their operation.
This allows a sleep lab to create a report template once (or one per study type) and have the report
template(s) used in multiple Viewers within their lab. To import or export a report template, select the
File menu at the top left corner of the Viewer and select “Import/Export Reports” (Figure A-14).
Figure A-14
A dialog box will appear as shown in Figure A-15 below:
14
Appendix A – Report Editing
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Document Number: YST-UDoc-A1-09
Figure A-15
2.4.1
Exporting Reports
If the user wishes to export reports, select “Export Reports”. A dialog box will appear as shown in Figure
A-16. Users will need to specify the file location where the report template(s) is to be copied by clicking
on the ‘...’ button next to the report name. Choose the location through the file directory. By default, the
exported reports are saved as “export.rep”, but users may rename the export if they wish (Figure A-17).
Users will then click “Save”, and a dialog box will appear noting that the exported report file does not
exist and ask if the user wants to create it. Click on Yes. Once the report export has been saved, users are
returned to Figure A-15 above but the text box will now be filled in with the file path that was specified.
Users are now able to click “Next’ to proceed.
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Appendix A – Report Editing
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Figure A-16
Figure A-17
Users will then select which reports they would like to export. A dialog box will appear listing all
customized reports that have been created on the user’s computer (Figure A-18). Select a single report
template by clicking on its name, or select multiple report templates by clicking on multiple file names.
To deselect a report, click on the file name a second time. After selecting the reports to export, click
“Next”. A dialog box will appear confirming that the export was successful (Figure A-19). The dialog
box will indicate that the exported file must be transferred to be imported to another computer.
Transferring the exported file can be done via attachment to e-mail or a usb flash drive; however users
may wish to save the exported reports on a shared network drive that can be accessed by other users
wishing to use the Viewer.
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Figure A-18
Figure A-19
2.4.2
Importing Reports
To import report templates that were previously exported, select “Import Reports” shown in Figure A-15,
and browse for the exported reports using the “…” button to the right of the text box. After the exported
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file has been located, click on it and select “Open”. Users will then be returned to the dialog box shown
in A-16 and can select “Next”.
A dialog box will appear listing the report templates contained in the exported report file (Figure A-20).
Select a single report template by clicking on its name, or select multiple report templates by clicking on
multiple file names. To deselect a report, click on the file name a second time. Select “Next” to continue.
Figure A-20
If a report is being imported that has the same file name as a report already present on the user’s
computer, a dialog box as shown in Figure A-21 will appear. Click the duplicate report name and type a
new file name for the report in the text box below. Select “Rename Report” to continue. Once all
duplicate files have been renamed, users can select “Next”.
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Figure A-21
A dialog box will appear indicating that the import has been successful and the new reports will be
available for use via the report selector. Select “Finish” to close the dialog box.
Users can edit, rename, or delete the imported report templates by selecting “Report Manager” from the
File menu shown in Figure A-14. To open an imported report template, open the Report Editor as
described in section 1.1, select “Open” under the File menu or select the Open shortcut in the Toolbar. A
dialog box will appear, and users may then select the Report they wish to open.
3.0 Using the Customized Report(s)
Once the user has created their customized reports, they can now generate these customized reports from
scored patient files, as described in the following steps.
3.1 Sending the file for scoring
The user sends the file for scoring and downloads the scored file as described in section 4.0 of the User
Manual.
3.2
Downloading and Reviewing the scored file
After downloading the scored file, the user must review and edit the file as necessary as described in
section 5.0 of the User Manual.
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3.3 Generating the Customized Report
Once the user has completed their review and edit of the scored file, they would select “Generate Report”
from the File menu or the Generate Report shortcut icon on the Toolbar of the Viewer. A window will
then pop up prompting them to enter Patient Information (Figure A-22). This Patient Information will
appear in the Report as it is typed in these fields. Patient Information can be imported by clicking the
“Import Patient Info” button near the bottom right of the Report Generator Window. A file directory will
open where users can browse their computer and select the patient information .txt file that pertains to that
particular study. The Report Generator will then ask the user which data collection system was used
(Figure A-23). The user may also enter the patient information manually. Users can enterthe patient’s
weight in pounds or kilograms from the drop-down menu (Figure A-24). Height can be entered as feet
and inches, inches, centimeters, or meters (Figure A-25). Units are automatically added to the Height and
Weight fields in the report. Ex: Entering “200” and selecting “lbs” will appear as “200 lbs” in the report.
If the user would like the Report Generator to calculate the patient’s Body Mass Index (BMI), check the
“Automatically Calculate BMI” box. The BMI value will not appear in the Report Generation Options
window but will be calculated and appear in the report. Alternately, the user can manually enter the
patient’s BMI by unselecting “Automatically Calculate BMI” and typing the data into the text box.
Please be sure to scroll down as there are additional fields to be filled in below what is initally
presented in the Patient Information menu.
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Figure A-22
Figure A-23
Figure A-24
Figure A-25
3.4 Including a Custom Oxygen Threshold
Users may enter a custom oxygen threshold to be included in the report as described in section 2.1.2
above (Oxygen Data Fields). To do this, scroll to the bottom of the Patient Information menu or left click
the “^” button beside “Patient Information” to collapse the menu. A “Reporting Options” menu will
appear, and users can enter in a numerical value that will capture the total % of sleep time and/or minutes
of sleep time that occurred under that specified oxygen level (Figure A-26) (e.g. if a user enters “73” into
this field, the report will display the total % of sleep time and/or minutes of sleep time that occurred when
the patient’s oxygen saturation was anywhere from 0-72.99%). By default, this value is set to 0. If users
do not wish to use this feature they can leave the value as 0.
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Figure A-26
3.5 Outputting a Sample Channel
If desired, the user may display a sample of any of the channels in the EDF file in the report. The start
time of the sample may be selected as seen in Figure A-26, where it shows “Baseline ECG Start (Epoch)”.
The sample may be 30, 60, 90 or 120 seconds in length, and the length of the sample is selected in the
drop-down box shown to the right of the start time. Which channels are displayed (there can be as many
as the user desires) is determined by clicking on “ECG Display Channels”, situated above the “Generate”
box as shown in Figure A-26. For the sample(s) to show up in the report, the corresponding code for ECG
Sample must be present in the report template. The code for ECG Sample is “$ECGSample$”, which can
be found in the Graphs menu.
3.6 Selecting a Report Template
Once the Patient Information has been entered, the user must select the report template they wish to use.
In the drop-down menu, users will see a list of all report templates they have created (Figure A-27).
Default reports described in section 2.3 can be selected through this menu also. Select the appropriate
template as well as the output file format for the report (Figure A-28). Please note that *.rtf reports will
be able to be modified after generation, whereas *.pdf reports will not be modifiable. In order to generate
a report, it must first be confirmed that the scoring data used to generate the report is correct. The scoring
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data that is used is the currently selected file. A report cannot be generated from a read only scoring file
provided by YMT. The scoring data is confirmed by checking the Events have been Verified checkbox,
which in turn enables the Generate button. Users will then select “Generate” and a window will appear
displaying the generation progress (Figure A-29).
Figure A-27
Figure A-28
Figure A-29
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3.7 Opening the Customized Report
The report will automatically open in either Microsoft® Word (for *.rtf reports) or Adobe Reader (for
*.pdf reports). The report can then be printed or saved to the user’s hard drive.
3.8 Using the Report Manager
Users can edit, delete, or rename any custom report template they have created by accessing the Report
Manager found in the File menu of the main Viewer window.
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