RhythMedix RhythmStar User manual

COMMON QUESTIONS
DO I NEED TO WEAR RHYTHMSTAR AT ALL TIMES?
Yes, unless showering or exposed to water, always wear
your RhythmStar to help ensure the Monitoring Center and
your physician can get your important heart information as
promptly as possible.
CAN I TRAVEL WEARING RHYTHMSTAR?
If you plan to be away for longer than 24 hours, take the
charger and the additional battery with you as well. If you
are traveling by air, the monitor may trigger airport
detectors, but it will not be damaged. Prior to your trip, the
monitoring center can instruct you how to turn off the
cellular radio on the device by placing in “Flight Mode”.
DO I NEED WIRELESS INTERNET ACCESS
OR A CELLULAR DATA PLAN?
No, the RhythmStar has built in cellular technology and
sends your ECG to the Monitoring Center via cellular
network. There is no cost to you for the transmissions.
HOW OFTEN DO I NEED TO CHANGE THE
RECHARGEABLE BATTERY IN THE RHYTHMSTAR?
Several factors, including the cellular network coverage
quality and the amount of data being transmitted can
impact battery life. It is recommended that you place a
fully charged battery into RhythmStar once daily.
HOW LONG DOES IT TAKE TO CHARGE A BATTERY?
3 hours.
WHAT HAPPENS IF THE RHYTHMSTAR GETS WARM
IN TEMPERATURE?
Much like a cell phone or other personal electronic device,
RhythmStar can become warm from time to time.
RhythmStar complies with applicable surface temperature
standards and limits. Placing RhythmStar in a pocket or
unventilated area will increase the temperature and should
be avoided.
Horizon Corporate Center
5000 Atrium Way, Ste. 1, Mt. Laurel, NJ 08054
Tel: [phone] • Fax: (856) 282‐1333
MOBILE CARDIAC
MONITORING SYSTEM
INTENDED USE
The RhythmStar System is intended for use by patients
who either have or are at risk of having cardiac disease
and those that demonstrate intermittent symptoms
indicative of cardiac disease and require cardiac
monitoring on a continuing basis.
The device continuously records ECG data and upon
detection by an ECG analysis algorithm or manually
initiated by the patient, automatically delivers the recorded
cardiac activity to the server where it is presented and can
be reviewed by a medical professional.
The data received from RhythmStar device can be used by
another device for arrhythmia analysis, reporting and
signal measurements. The RhythmStar system is not
intended to sound any alarms.
The device does not deliver any therapy, administer any
drugs, provide interpretive or diagnostic statements or
provide for any life support. RhythmStar is for prescription
use only (Part 21 CFR 801 Subpart D).
CONTRAINDICATIONS
The RhythmStar system is not intended for use under the
following conditions:
• Patients with potentially life-threatening arrhythmias who
require inpatient monitoring.
• Patients who the attending physician believes should be
hospitalized.
• Infants weighing less than 10 kg. (22 lbs.).
CAUTION: Federal law (USA) restricts this device to sale by
or on the order of a physician.
RhythmStar meets current FCC and IC Radio Frequency
Emission Exposure Guidelines.
Ref 10002-052-00-ENG Rev5
QUICK START GUIDE

LOCATE COMPONENTS OF YOUR RHYTHMSTAR
MOBILE CARDIAC MONITORING SYSTEM
ECG CABLE
ADHESIVE ELECTRODES
RECORD
BUTTON
MONITOR
INSERT THE METAL
CONNECTOR OF
ECG CABLE INTO
THE MONITOR
3
INSERT A CHARGED
BATTERY INTO THE
MONITOR
2
The monitor will then prompt you to select the
symptom(s) and the level of activity you were feeling
and doing at the time of pressing the button.
CONFIRM THAT THE MONITOR IS WORKING
6
Insert battery, wait approximately a minute or so.
When the solid green MONITORING message appears,
you are now monitoring and ready to go about your
normal daily activities.
If the green MONITORING message does not display and
you see the message ACTIVATION PENDING in yellow or
any other message, contact the Monitoring Center.
•Once applied, you should change the adhesive electrodes
as needed (electrodes should never be re-used).
• Keep the RhythmStar monitor away from all liquids,
extreme heat, or places that are damp or dusty.
When you shower, you can keep the adhesive
electrodes on, but you must remove the monitor
and ECG Cable before entering water.
• Contact the 24/7 Monitoring Center at any time
if you need assistance using the RhythmStar.
PREPARE YOUR SKIN
4
• Trim hair on chest as needed.
• Clean skin with warm water and let the skin dry.
• Do not use lotions or creams before applying
adhesive electrodes.
APPLY THE ECG CABLE TO YOUR CHEST
5
1
When you see the solid yellow MONITORING COMPLETE
message, you may remove the adhesive electrodes and
discontinue wearing the monitor.
Return the RhythmStar Mobile Cardiac Monitoring System
along with any unused adhesive electrodes, RhythmStar
components and packaging as directed by your physician
or Monitoring Center.
WHENEVER YOU FEEL SYMPTOMS, PRESS AND
HOLD THE RED RECORD BUTTON ON THE MONITOR
7
DURING MONITORING
WHEN YOUR STUDY IS COMPLETE
• Connect the adhesive electrodes to the ECG cable snaps.
• Remove the protective backing from the adhesive electrode.
• Apply the adhesive electrodes to your chest in the
conguration shown below.
CHARGER & BATTERIES