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?
SEEQ MCT Instructions for use English 19
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
Redundant reporting of ECGs for this select set of arrhythmias is
managed as follows:
▪ The Wearable Sensor will report no more than two (2) ECGs for
each of these arrhythmias each hour.
▪ The Wearable Sensor will wait ten (10) minutes before allowing
a subsequent ECG to be reported for each of these
arrhythmias.
Note: a) ECGs are reported for all Tachycardias with heart rate
>= 165 bpm, all Bradycardias with heart rate < 30 bpm, and all
Pauses >= 3 seconds; b) the Wearable Sensor keeps a complete
count of all arrhythmias that are detected; c) supplemental ECGs are
also reported i) every six (6) hours for prolonged Atrial Fibrillation
episodes and ii) every twenty-four (24) hours, irrespective of the
presence of an arrhythmia.
Transmitter maintenance
Please attempt to keep the Transmitter dust free. If necessary, gently
wipe the Transmitter with a soft dry cloth to clean the surface. The
Transmitter is not waterproof and should be kept dry. This device
does not have user serviceable components inside. Do not
disassemble, crush, puncture, short external contacts or circuits,
dispose of in fire or water, or expose the battery pack to temperatures
higher than 149 ˚F (65 ˚C).
Electromagnetic interference
This equipment complies with International Standard IEC 60601-1-2
for electromagnetic compatibility for medical electrical equipment.
Medical electrical equipment needs special precautions regarding
EMC, and all equipment must be installed and put into service
according to the EMC information provided upon request by calling
Medtronic Customer Support at 1-877-247-7449. Portable and
mobile RF communication equipment can affect nearby medical
electrical equipment.
FCC Compliance Information
Wearable Sensor and Transmitter devices comply with Part 15 of the
Federal Communications Commission (FCC) Rules – Radio
Frequency Devices: Operation is subject to the condition that (1) this
device does not cause harmful interference and (2) this device must
accept any interference received, including interference that may
cause undesired operation. Changes or modifications not expressly
approved by Medtronic could void the user’s authority to operate the
equipment. Note: This equipment has been tested and found to
comply with the limits for a Class B digital device, pursuant to Part 15
of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is
operated in a residential environment. This equipment generates,
uses, and can radiate radio frequency energy and, if not installed and
used in accordance with the instruction manual, may cause harmful
interference to radio communications.