User's Manual
Table Of Contents
- Table of Contents
- Instructions for use
- Getting started
- Using the SEEQ MCT System during the monitoring period
- What to do at the end of monitoring
- Indications for use, contraindications, and precautions
- Services for physicians
- Specifications, compliance, and symbols
- Frequently asked questions
- What is a Wearable Sensor?
- How long will my Wearable Sensor last?
- What information is transmitted to my physician?
- How can I report my symptoms?
- Can I take a shower while wearing my Wearable Sensor?
- Will I need to change the battery in the Transmitter or the Wearable Sensor?
- How close must I be to the Transmitter to ensure that the data collected by my Wearable Sensor is transmitted?
- How often do I need to change the Wearable Sensor device?
- What if the Wearable Sensor causes my skin to itch?
- Should I carry the Transmitter with me when I travel?
- Will I need to notify security screeners about my Wearable Sensor?
- Can I wear a Wearable Sensor through an electronic antitheft system, such as in a store?
- Can I use microwave ovens or TV remotes while wearing a Wearable Sensor?
- Can I be close to wireless phones, WiFi, or other electromagnetic devices?
- Can I carry my cellphone while wearing the Wearable Sensor?
- Will hot or cold environments affect the Wearable Sensor performance?
- Is my medical data protected during transmission?
18 English SEEQ MCT Instructions for use
M958549A001 Rev B
Refer to doc # A73903 for Printing
Instructions.
M958549A_ch.fm 3/12/15 2:34 pm
4" x 8" (101 mm x 203 mm)
Medtronic Confidential
mdvtldct_R1.5
Arrhythmia Detection Algorithms and Automatic ECG Collection
In addition to patient-triggered collection of ECGs using the Patient
Trigger Button, the SEEQ MCT System also uses proprietary
algorithms based on rate, rhythm, and morphology to continuously
analyze rhythm abnormalities and to initiate automatic ECG
transmission. ECGs are automatically transmitted upon detection of
the following conditions:
▪ Heart Rate >= 130 bpm
▪ Heart Rate <= 40 bpm
▪ Pause >= 3 seconds
▪ Atrial Fibrillation
▪ Ventricular Tachycardia/Ventricular Fibrillation
For example, the detection algorithm of the SEEQ MCT System
detects the peak of each R-wave and calculates the interval between
successive R-waves. The RR intervals are then used to calculate
beat-to-beat heart rate values. RR intervals are also aggregated into
5-minute and 24-hour averages to summarize patient heart rate over
the monitoring period. For Pause detection, the algorithm monitors
the time between successive R-wave peaks. A pause trigger is
activated if an internal timer advances to 3 seconds without R-wave
detection.
In order to provide relevant, exception-based arrhythmia reporting,
the SEEQ MCT System proprietary ECG analysis algorithms
proactively manage redundant reporting of ECGs for a select set of
arrhythmias when persistently detected:
▪ Tachycardias with heart rate >= 130 bpm and < 165 bpm
▪ Bradycardias with heart rate >= 30 bpm and < 40 bpm
▪ Atrial Fibrillation
▪ Ventricular Tachycardia < 165 bpm
For these arrhythmias, the Wearable Sensor algorithm detection
sensitivity and positive predictive value results, which are obtained
from the respective databases in strict accordance with EC-57
a
and
with 0% downtime, are as follows:
Test Rhythm Name Sensitivity
(%)
a
a
as measured by EC-57 standards testing on 12NOV2013
Positive
Predictive
Value (%)
a
QRS Detection (average)
Including all Tachycardias with heart rate >=
130 bpm and < 165 bpm, Bradycardias with
heart rate >=30 bpm and <40 bpm
AHA: 98.95
MIT-BIH:
99.83
AHA: 99.34
MIT-BIH:
99.84
AF Duration (gross)
MIT-BIH: 90 MIT-BIH: 85