Owner's Manual
Table Of Contents
- Quick Installation Guide
- Information Guide
- Indications for use
- Warnings
- Important Notes
- Using the Scan Monitor
- What is an ECG?
- Taking an ECG
- ECG Outputs
- Sharing ECG Results
- What is an SpO2 Measurement?
- Taking an SpO2 Measurement
- SpO2 Outputs
- SpO2 Measurement Information
- Technical specifications
- Wireless information
- Security
- Safety and Performance
- Troubleshooting - Syncing with App
- Troubleshooting - ECG
- Troubleshooting - SpO2
- Cleaning and Disposal
- Equipment symbols
- Warranty
Safety and Performance
33
Scan
Monitor
software's
ability
to
accurately
classify an
ECG
recording
into
Atrial
Fibrillation and normal sinus
rhythm
categories was
tested
according
to
the
IEC 60601-2-47*
standard
and a clinical
study
with
262 subjects.
On
five
public
databases,
the
Scan
Monitor
demonstrated
99.06%
sensitivity
in
classifying
Atrial
Fibrillation and
98.66%
specificity
in classifying
normal
sinus
rhythm
in classifiable recordings. In
the
beat-to-beat
detection
of
QRS complexes, Scan
Monitor
reached a Fl-score
of
at
least 99.19%
on
all
the
datasets,
with
the
exception
of
NSTDB where
the
Fl-score was 90.65% because
of
digitally
added
noise.
Rhythm
classification
by
Scan
Monitor
was
compared
to
ECG
recordings reviewed
by
cardiologists
in a
clinical validation
study
with
262
patients.
19.5%
of
recordings
were
inconclusive. On conclusive recordings,
the
sensitivity
in classifying
Atrial
Fibrillation
was 96.3%
(lower
bound
of
the
95%
confidence
interval: 89.4%)
and
the
specificity
in
detecting
normal
sinus
rhythm
was 100.0%
(lower
bound
of
the
95%
confidence
interval:
96.7%).
These results
reflect
use in a
controlled
environment.
Real-world use
of
Scan
Monitor
may
result in a
greater
number
of
strips being
deemed
inconclusive.
*/EC 60601-2-47:2012:
Requirements
for
the
Basic
Safety
and
Essential
Performance
of
Ambulatory
Electrocardiographic
Systems.