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Michele Sleep Scoring System Report Label

Document Number: YST-Label-001-14


Revision: 14
Effective Date: 21-Jun-16
This report was generated by:
MICHELE Sleep Scoring System

Name and address of the manufacturer:


Younes Medical Technologies (YMT)
1 Morley Avenue, Princess Elizabeth Building
Winnipeg, Manitoba R3L 2P4
Canada
Tel: 1-888-942-6774

Name and address of the EU Authorized Representative:


Advena Ltd.
Pure Offices
EC REP 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: CE mark:


Viewer Software Version: 1.03.020
Release Date: 16-Jan-17
Autoscoring Software Version: 1.00.297
Release Date: 08-Mar-17 0086
Interdisziplinäres Zentrum für
Schlafmedizin Telefon 071 494 11 81
Lindenstrasse 52 Fax 071 494 6319
9007 St. Gallen pneumodispo@kssg.ch Seite 2

Polysomnografie vom 25.04.2017 Licht aus: 22:21:50 Uhr Licht an: 04:24:50 Uhr

Bozkaya Mahsum Geburtsdatum: 13.02.1990


Alter [Jahre] 27 Geschlecht: m ESS [Punkte]: 18
Grösse: 1.74 m Gewicht: 105 kg BMI [kg/m2] 34.5
Indikation / Fragestellung:
OSAS?
Bedingungen:
Nativ.

Schlaf Norm Norm Norm

Arousal total
Zeit in Bett [h] 6.2 Schlafeffizienz [%] 96.7 >80 26.5 <20
[Anzahl/h]
10.5 Respiratorisch
Totale Schlafzeit [min] 351.0 Stadium N1+2 [%] 50-60 12.6
+57.7 [Anzahl/h]
Motorisch
Schlaflatenz [min] 3.5 <30 Stadium N3 [%] 13.1 8-20 0.3
[Anzahl/h]
REM Latenz [min] 160.5 Stadium REM [%] 18.7 15-25 Spontan 13.5
[Anzahl/h]

Gasaustausch / Puls
Mittlere SpO2 [%] 96.2 >92 ODI 22.6 <5 max. ptCO2 [kPa] 5.4
[Anzahl/h]
SpO2 < 90% [%] REM ODI
0.1 <20 24.7
[Anzahl/h]
N REM ODI
22.1
[Anzahl/h]
Minimale SpO2 [%] Puls Mittelwert Puls min / max
89.0 90 60 40-80 47-105
[Schläge/min] [Schläge/min]

Atmung / Motorik / Körperposition


Apnoen total 77
AHI total [Anzahl/h] 33.0 <5
[Anzahl/h] [13.2]
Apnoen Obstruktiv Periodische Bein-
REM AHI [Anzahl/h] 43.1 <15 13.2 2
[Anzahl/h] Bewegungen[Anzahl]
Apnoen Gemischt
N REM AHI [Anzahl/h] 30.7 0.0
[Anzahl/h]
Apnoen Zentral Hypopnoen
AHI Supine [Anzahl/h] 22.5 0.0 19.8
[Anzahl/h] [Anzahl/ h]

Auffälligkeiten in Video / EEG / EKG:


Keine Videobeurteilung.
Kardial: Mittlere Pulsrate im Schlaf: 60 bpm.

Bemerkungen:
Präanalyse durch YST-Datamanager für EDF-Files.

Beurteilung vom 27.04.2017


Schwergradige obstruktive Schlafapnoe. Normale Schlaflatenz bei sehr guter Schlafeffizienz.
Herr Bozkaya durchschläft zwei Tiefschlafphasen und zwei REM-Schlafphasen vorwiegend in
Rückenlage.

elektronisch visiert

Franziska Schmidli, Dipl. Pflegefachfrau Dr. med. Jörg Hansen, Oberarzt Pneumologie
Interdisziplinäres Zentrum für
Schlafmedizin Telefon 071 494 11 81
Lindenstrasse 52 Fax 071 494 6319
9007 St. Gallen pneumodispo@kssg.ch Seite 3

Polysomnografie vom 25.04.2017: Bozkaya Mahsum, 13.02.1990, Grafiken


Interdisziplinäres Zentrum für
Schlafmedizin Telefon 071 494 11 81
Lindenstrasse 52 Fax 071 494 6319
9007 St. Gallen pneumodispo@kssg.ch Seite 4

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