Certification Exhibit FCC ID: QBI-1014 FCC Rule Part: 15.247 ACS Project: 16-2030 Manufacturer: Cardionet Model(s): 100-0025-01, 900-0604-00 User Manual 3998 FAU Blvd.
MOBILE CARDIAC OUTPATIENT TELEMETRY TM CARDIONET MCOT MANUAL TM
We’d know about it. Mobile Cardiac Outpatient Telemetry™ Better Detection. Better Reporting. Validated by Clinical Data.
CARDIONET LIMITED WARRANTY CardioNet products are warranted to be free from manufacturing and material defects for a period of one (1) year from the date of shipment from CardioNet to the original purchaser. This warranty does not apply to any product which CardioNet determines has been modified or damaged by the customer. Excluded from this warranty are expendable supply items including, but not limited to, electrodes, lead wires, and batteries.
TABLE OF CONTENTS 01. 02. 03. 04. 05. 06. 07. 08. 09. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. OVERVIEW....................................................................................... INDICATIONS FOR USE.................................................................. PRECAUTIONS................................................................................ CAUTIONS....................................................................................... WARNINGS.......................................
CARDIONET MCOT TM MANUAL 01. OVERVIEW The CardioNet Mobile Cardiac Outpatient Telemetry TM (MCOT TM) system is an ambulatory ECG Monitor with the capability to detect cardiac arrhythmias and transmit ECG data to a staffed Monitoring center.
2 02. INDICATIONS FOR USE 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g.
CARDIONET MCOT TM MANUAL CONTRAINDICATIONS: 1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring. 2. Patients who the attending physician thinks should be hospitalized. 3. This device should not be used for monitoring of QT interval during the initiation of antiarrhythmic therapy, where in-hospital monitoring is required by the labeling of that drug. 4.
4 03. PRECAUTIONS A. DISPOSE OF BATTERIES PROPERLY Observe all local laws for the disposal of alkaline batteries. B. WHEN NOT IN USE, REMOVE SENSOR BATTERY Do not leave the battery in the Sensor when it is not in use. C. AVOID ELECTROMAGNETIC INTERFERENCE For the best recording results, you should avoid close proximity to heavy equipment or other sources of electromagnetic interference such as electric blankets, heating pads, water beds, etc. D.
CARDIONET MCOT TM MANUAL 04. CAUTIONS A.POWER DOWN MONITOR AND SENSOR BEFORE SHOWERING Power down the Monitor, remove the Sensor, and remove battery from Sensor before showering. The CardioNet Sensor is water resistant, not waterproof. B. DO NOT GET THE MONITOR AND SENSOR WET Make sure the Monitor and Sensor stay dry at all times. C. CLEANING Use a soft cloth to clean the equipment. D.
6 05. WARNINGS A. NOT AN APNEA MONITOR The CardioNet Monitor is not to be used as an apnea monitor. B. NOT AN EMERGENCY RESPONSE SERVICE CardioNet is not an emergency response service. If you experience any symptoms that concern you, seek medical help. C. DO NOT TAMPER WITH DEVICE There are no serviceable parts in the CardioNet MCOT TM System components. Removing the cover of any component may alter device performance. D.
CARDIONET MCOT TM MANUAL 06. MEDICAL PRACTICE INSTRUCTIONS DEPLOYING THE DEVICE 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Receive and store Monitor and Sensor sets in a secure area at practice. To provide devices for a new prescription, retrieve a Monitor and Sensor from available inventory. Turn ON Monitor and insert the battery in Sensor. Note: If there is already a battery in the Sensor, remove it and reinsert it. Go to https://access.cardionet.com and go to Enrollment screen.
8 07.
CARDIONET MCOT TM MANUAL 08. MONITOR AND SENSOR TOUCH SCREEN To operate monitor, touch the screen where indicated. Monitor is still functioning when dark (Screen will go dark after 1 minute). WAKE BUTTON MONITOR If you want to view the screen, press the Wake button.
10 09. ATTACHING THE ELECTRODES TO YOUR SKIN Note: Please do not use the adhesive remover wipes prior to placing electrodes on your skin. These should only be used to remove adhesive from your skin after removing electrodes if needed. 1. Electrodes are placed in the shaded areas; wash and dry these areas. Do not use powder or lotion. If you have chest hair, shave these areas. 2. Remove sensor and neck strap from box. Place the cloth strap over your head around your neck. 3.
CARDIONET MCOT TM MANUAL ITE WH White (Right) Peel the adhesive backing off the White electrode. Place the electrode about 3 fingers width below your right collar bone. BL AC K 4. D RE Black (Left) Peel the adhesive backing off the Black electrode. Place the electrode about 3 fingers width below your left collar bone. Red (Left Side) Peel the adhesive backing off the Red electrode. Place the electrode on the lower left side of your rib cage, in line with the electrode under your left collar bone.
12 10. GETTING STARTED WITH MONITORING 1. The monitor should be powered on (green light above the screen). If it isn’t, please turn it on using the power switch on the right side of the monitor. 2. If the monitor is on, and the screen is dark, touch the Wake button (black button, with white square on it) to light up the screen. 3. Confirm identity. Please verify that your name is correct. If correct, press Yes, and read the monitor screens that follow. If incorrect, including spelling, press No.
CARDIONET MCOT TM MANUAL 11. RECORDING SYMPTOMS Please remember to keep your monitor with you at all times so that you may record any symptoms you feel. 1 Touch Record Symptom to proceed. 2 Yes to proceed. No to return to the Main Menu 3 Touch any symptoms you are feeling. Touch Next for additional symptom options. It is important to use the monitor to record any symptoms you may feel. When you feel a symptom, press Record Symptom and follow the instructions.
14 12. CHARGING THE CARDIONET MCOT™ MONITOR It is important to charge the monitor every night. It may take up to 4 hours to fully charge the monitor. Direct Power Cord Charging DIRECT POWER CORD CHARGING Take the power cord with you if you plan to be away from home all day. To charge the monitor, plug the power cord into the hole on the side of the monitor. Look for the orange light on the top left of the monitor. The “Charge Monitor” alarm will sound when the battery is critically low.
CARDIONET MCOT TM MANUAL 13. RECEIVING TEXT MESSAGES 1 New Message ABOUT TEXT MESSAGES CardioNet may send you text messages during your monitoring. If you hear an alert and see the New Message statement on the screen, you have a new text message. Touch the Messages button to read the message. Follow the instructions on the screen. Press OK when you are finished.
16 14. SKIN CARE & REPLACING ELECTRODES AP SO Change your electrodes every other day. When removing the electrodes, never pull them off quickly. Use soap and water and gently lift the old electrodes from your skin. + If necessary, use the adhesive remover wipes to take the excess adhesive off your skin. Wash and dry the areas thoroughly before putting on new electrodes. When you replace your electrodes, do not put new electrodes in the same locations each time.
CARDIONET MCOT TM MANUAL 15. SHOWERING, BATHING AND SWIMMING Note: The electrodes are water resistant. You may wear them for showering and bathing. BEFORE showering, bathing or other water activities: 2 3 3 4 Unsnap the lead wires from the electrodes. Keep the monitor and sensor out of the bathroom and away from water and steam. BA TT ER Y 1 Remove the sensor battery. Turn off the monitor. AFTER showering, bathing or other water activities: 2 3 4 Dry the electrodes.
18 16. TROUBLESHOOTING Problem Possible Solution Monitor Battery Low Ensure that you recharge the battery every day by correctly by plugging the power cord directly into the side of the monitor. A full recharge takes approximately 4 hours. The orange light shown on page 18 will be lit if the Monitor is charging. The monitor battery life can vary day-to-day depending upon several factors, including cell communication and cell coverage.
CARDIONET MCOT TM MANUAL 17. RETURNING THE UNIT ABOUT DEACTIVATION MESSAGE When your monitoring is complete, a message will appear on your Monitor. It is your responsibility to return the kit back as soon as possible so that other patients can benefit using this valuable service and to avoid being charged for the equipment. Please follow these steps when you receive the message that your monitoring is completed • Take off the Sensor. Remove Sensor battery.
20 18. EQUIPMENT SYMBOLS SYMBOL DESCRIPTION MANUFACTURER NAME AND ADDRESS Manufacturer: Braemar Mfg, LLC Type BF Applied Part 1285 Corporate Center Drive Suite 150 Eagan, MN, 55121 USA Attention: Consult accompanying documents. Phone: 1-800-327-2719 Fax: 1-651-286-8629 E-mail: sales-braemar@gobio.com Web: http://www.GoBio.com Non-Ionizing Radiation Transmitter Contact Braemar Mfg for further technical information.
CARDIONET MCOT 19. SPECIFICATIONS PHYSICAL Sensor 3 inches x 1.9 inches x 0.7 inches; Weight: 3.0 oz. with battery Monitor 4.7 inches x 2.6 inches x 0.9 inches; Weight: 6.0 oz. Display 2.27 inches x 1.7 inches; Touch screen: color FUNCTIONAL Sample Rate 250 samples per second ECG Resolution 12 bits Dynamic range of ECG +/- 5 mV Bandwidth 0.
22 CONNECTIONS Monitor Power in (15V, 1.2A max) WALL ADAPTOR Power In: 100 – 240 VAC; Power Out: 15V, 1.0A; or 15V, 1.67A STANDARDS COMPLIANCE Monitor EN60601-1; AAMI EC-38; FCC Part 15 Sensor EN60601-1; AAMI EC-38; FCC Part 15 AECG Equipment Type I IN HOME REQUIREMENTS 1. Cellular / PCS wireless coverage suitable for data transmission 2. AC powered outlet FCC COMPLIANCE This device complies with part 15 of the FCC Rules.
CARDIONET MCOT TM MANUAL However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver.
24 FCC RADIO FREQUENCY EXPOSURE INFORMATION In August 1996, the Federal Communications Commission (FCC) of the United States, with its action in Report and Order FCC 96-326, adopted an updated safety standard for human exposure to radio frequency (RF) electromagnetic energy emitted by FCC regulated transmitters. Those guidelines are consistent with the safety standard previously set by both U.S. and international standards bodies.
CARDIONET MCOT TM MANUAL 25
1000 Cedar Hollow Road Suite 102 Malvern, PA 19355 Manufactured by Braemar Inc.
