Cardionet 1010 Wireless Modem User Manual
Cardionet Wireless Modem
User manual
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| Document Description | User manual |
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| Date Submitted | 2007-03-29 00:00:00 |
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M O B I L E C A R D I A C O U T PAT I E N T T E L E M E T R Y Patient Education Guide CardioNet Ambulatory ECG System and Arrhythmia Detector Manufactured by CardioNet Inc. 1010 Second Ave., Suite 700 San Diego, CA 92101 Copyright 2006 All rights reserved Document number 101010 Revision B October 2006 TABLE OF I N T R O D U C T I O N . . CO N T E N TS . . . . . . . . . . . . . . . . . . . .1 How the CardioNet Service Works. . . . . . . . . . . . . . . . . . . 2 Your CardioNet Monitoring Supplies . . . . . . . . . . . . . . . . . 4 Your Rights as a Patient. . . . . . . . . . . . . . . . . . . . . . . . . . 6 Your Responsibilities as a Patient . . . . . . . . . . . . . . . . . . . 6 Who to Call with Questions . . . . . . . . . . . . . . . . . . . . . . . . 6 In the Case of an Emergency . . . . . . . . . . . . . . . . . . . . . . 7 What to Do When your Monitoring is Over. . . . .. . . . . . . . 8 G E T T I N G S TA RT E D . . . . . . . . . . . . . . . . . . . .9 Connecting from Home. . . . . . . . . . . . . . . . . . . . . . . . . . 10 How to Install the CardioNet Base . . . . . . . . . .. . . . . . . . 11 About the CardioNet Base. . . . . . . . . . . . . . . . . . . . . . . . 14 How to Activate the CardioNet Sensor. . . . . . . . . . . . . . . . 15 Tips for Wearing the CardioNet Sensor. . . . . . . . . . . . . . . 18 How to Activate the CardioNet Monitor. . . . . . . . . . . . . . . 19 U S I N G T H E M o n i t o r . . . . . . . . . . . . . . . . . . . 25 How to Turn your Monitor On and Off. . . . . . . . . . . . . . . . 26 How to Record an Event . . . . . . . . . . . . . . . . . . . . . . . . . 28 How to Change Monitor Options. . . . . . . . . . . . . . . . . . . . 30 How to Check Battery Power. . . . . . . . . . . . . . . . . . . . . . 34 How to Check Cell Phone Coverage . . . . . . . . .. . . . . . . . 35 Receiving Messages from CardioNet. . . . . . . . . . . . . . . . . 36 How to Read a Text Message . . . . . . . . . . . . . . . . . . . . . 37 ii Table of Contents 4 S E N S O R C A R E . . . . . . . . . . . . . . . . . . . . . . 39 Tips for Changing Electrode Pads . . . . . . . . . . . . . . . . . . 40 How to Change Electrodes and Attach Sensor. . . . . . . . . . 41 Remove Before Showering or Bathing. . . . . . . . . . . . . . . . 44 How to Change the Sensor AA Battery . . . . . . . . . . . . . . . 45 T R O U B L E S H O O T I N G . . . . . . . . . . . . . . . . . . 47 Responding to Monitor Alerts and Alarms . . . . . . . . . . . . . 48 Troubleshooting Device Problems . . . . . . . . . . . . . . . . . . 51 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 S P E C I F I C AT I O N S , C O M PLIANCE & SYMBOLS 57 Specifications . . . . . . . . . . . . . . Equipment Symbols. . . . . . . . . . In Home Requirements. . . . . . . . FCC Compliance. . . . . . . . . . . . . . 58 . 60 . 60 . 62 Table of Contents iii 1 INTRO D U C T IO N In this Chapter: • How the CardioNet Service Works • Your CardioNet Monitoring Supplies • Your Rights as a Patient • Your Responsibilities as a Patient • Who to Call with Questions • In the Case of an Emergency • What to Do When your Monitoring is Over 1. I N T RODUC T ION How the CardioNet Service Works 1 2 Sensor detects and analyses heartbeats When you’re using the CardioNet service, you’ll wear a small, lightweight sensor on your chest. The sensor detects and analyses each heartbeat and sends data to the portable CardioNet monitor. Introduction Monitor transmits events The CardioNet monitor can be tucked away in a pocket or purse. When the sensor detects an event, or when you report an event using the touch screen on the monitor, it transmits the data to the CardioNet Monitoring Center. How the CardioNet Service Works The CardioNet Monitoring Center operates 24 hours a day, 7 days a week. At the Center, specially trained cardiac technicians analyze your heart rhythms and report results to your physician. Your physician reviews your results Your physician reviews the report, discusses results with you and prescribes or adjusts treatment as needed. Introduction 1. I N T RODUC T ION 3 4 CardioNet reports to your physician 1. I N T RODUC T ION Your CardioNet Monitoring Supplies The CardioNet Kit The CardioNet Kit contains the supplies you will need while you are on the CardioNet Monitoring Service. If any items are missing or broken, or if you have any questions about how to use them, please call CardioNet at 1-866-426-4401. When service is ended, follow the detailed instructions in What to Do When Your Monitoring is Over located in this chapter and please return the equipment promptly to the CardioNet Monitoring Center. Picture Kit Photo Here Item and Description CARDIONET SHIPPING KIT The CardioNet shipping kit contains all the items you will need during your monitoring service. You can also reference the inside lid of the kit for information on where each item is located in the kit. CARDIONET SENSOR The sensor can be worn around the neck or on a belt. It detects each heartbeat and sends data to the CardioNet monitor. To communicate with the monitor, the sensor must remain close to the monitor. Walls and other obstructions can interfere with the communications between the sensor and the monitor. If you go out of communications range, the sensor and monitor will beep to alert you. CARDIONET Monitor The monitor constantly analyzes data from the sensor and sends events to the CardioNet Monitoring Center. The monitor uses wireless communication when not in the base and uses the regular phone system when the monitor is placed in the base. You will not be charged by the telephone company for calls made by your monitor. CARDIONET BASE The base recharges the CardioNet monitor and allows the monitor to communicate with the Monitoring Center using your home phone system. The bases are connected to your phone line and plugged into electrical outlets in your bedroom and another room in your home. Introduction Your CardioNet Monitoring Supplies Item and Description ELECTRODES Electrodes are disposable sticky pads that snap onto the three colored lead wires on the CardioNet sensor. You remove the backing and stick them to clean, dry, hairless skin. If you need more electrodes call CardioNet at 1-866-426-4401. AA BATTERIES The AA batteries provide power to the CardioNet sensor. The battery must be replaced each day. Please use only CardioNet-supplied AA batteries. If you need more batteries call CardioNet at 1-866-426-4401. SENSOR NECK STRAP & BELT CLIP Use the neck strap if you prefer to wear the sensor around your neck. Use the belt clip if you prefer to wear the sensor on your belt. POWER PLUG & TELEPHONE CORD Use the black power plug to connect the CardioNet base station to an electrical outlet. Use the telephone cord to connect your CardioNet base station into the telephone wall jack. Detailed information on how to install your base is provided in Chapter 2: How to Install the CardioNet Base. PATIENT EDUCATION GUIDE & VIDEO The Patient Education Guide and Patient Information Video contain helpful information about the CardioNet service and important contact numbers. UPS SHIPPING LABEL Put the kit in the white plastic bag, seal it and stick the UPS pre-paid shipping label to the white plastic bag to return the kit after monitoring is finished. Introduction 1. I N T RODUC T ION Picture Your Rights as a Patient 1. I N T RODUC T ION 1. You have the right to be treated with dignity, courtesy and respect. 2. You have the right to high quality service. 3. You have the right to excellent training on how to use the CardioNet technology and service. 4. You have the right to receive high-quality service regardless of race, religion, political belief, sex, sexual preference or source of payment. 5. You have the right to complain or suggest improvements in service without worrying that CardioNet will stop providing service or provide a poorer quality of service. 6. You have the right to refuse service. Your Responsibilities as a Patient 1. Use the CardioNet equipment with care. 2. Return equipment to CardioNet immediately, when monitoring is completed. 3. Provide CardioNet with the information CardioNet needs to provide you with quality care. 4. Treat CardioNet employees with respect. Who to Call with Questions If you have any questions about your monitoring service or billing, please call one of our toll free numbers. Customer service is available 24 hours a day, 7 days a week. Customer Service: 1-866-426-4401 Monitoring Questions: 1-866-426-4401 Billing Questions: 1-866-426-4402 Introduction In the Case of an Emergency In the course of monitoring your heart, CardioNet may detect cardiac events which are potentially life-threatening and were not anticipated by your physician. As directed in the physician notification criteria, if CardioNet detects such an event, CardioNet will attempt to contact you and your physician as soon as possible. However, CardioNet’s ability to obtain information regarding a cardiac event and to contact you or your physician in a timely manner is limited by a number of factors, including: • Transmission of information about a cardiac event to CardioNet‘s monitoring center is potentially limited by the availability of standard telephone lines and/or cellular phone coverage. • There is an inherent time delay from the time that an event is detected to when the events are analyzed and confirmed by a Certified Cardiac Technician (CCT). • There is an inherent time delay from when the event is analyzed and confirmed by the CCT to when CardioNet is able to make contact with you or your physician. • If you or your physician are not accessible by telephone, CardioNet will not succeed in making contact with you or your physician. When CardioNet does detect a potentially serious cardiac event as defined by your physician, CardioNet will attempt to contact your physician for direction. CardioNet will also attempt to contact you and inform you of any cardiac event that has been received that may require evaluation in the emergency room, per your physician’s notification criteria. You may decide to seek medical help by calling your Emergency Medical Services (EMS) directly or you may ask that CardioNet assist you in contacting EMS. The CardioNet system was designed to help physicians diagnose and treat heart rhythm problems. There are other serious heart conditions that may not be detected by the system. Because of this, and because of the limitations of the CardioNet system described above, you should not delay seeking medical help if you experience symptoms that concern you. Also, you should not rely on CardioNet as an emergency response service. Introduction 1. I N T RODUC T ION CardioNet is not an emergency response service. If you experience symptoms that concern you, seek medical help. 1. I N T RODUC T ION What to Do When your Monitoring is Over When your prescription is over and CardioNet has received data for the number of days your physician has requested, the monitor will be deactivated in the middle of the night. You may hear the monitor beep. If in the morning the screen on your monitor states that your prescription has ended, turn the monitor off and remove the battery in the sensor. Remove the electrodes from your body. Pack items in the kit by following the instructions on the inside of the kit lid. Before you close the kit, complete the Patient Satisfaction Survey and place it with the Patient Education Guide, laminated reminder card and Pocket Guide on the top of the contents of the kit. If you have not returned the Patient Enrollment Form, include a signed copy with these items as well. After everything is in the kit, close the lid and put the kit in the white plastic bag that was included in the kit contents. Seal the white bag. Stick the UPS pre-paid mailing label on the outside of the white plastic bag. The kit is now ready to return and you can choose one of 3 ways to return it to CardioNet: 1. You can call UPS 1-800-742-5877 and UPS will pick it up. If you call UPS you will need to explain that it’s a pre-paid 2nd Day Air package. You will not be charged anything. 2. You can drop off the kit at Staples, the UPS Store, or another location with UPS drop-off. 3. You, or a family member, can bring it to your work if they have daily UPS pick-up. If you do not return the kit CardioNet will bill you for the contents. Please return the kit as soon as you can so other patients can use the equipment. Introduction 2 G ET T ING STA RT E D In this Chapter: • Connecting from Home • How to Install the CardioNet Base • About the CardioNet Base • How to Activate the CardioNet Sensor • Tips for Wearing the CardioNet Sensor • How to Activate the CardioNet Monitor Connecting from Home 2 . GE T T I NG STA RT E D This chapter describes the steps you will need to take in order to set up the CardioNet monitoring system and begin monitoring. You may want to ask for assistance from a family member if you are not comfortable doing these steps on your own. The first step you (or a family member) needs to do is to install the base. The instructions on the next few pages will assist you in completing the installation. The base needs to be installed in the room where you sleep. When setting up a base, you will need a phone jack and an electrical outlet. When your monitor is on the base, your sensor will still be able to communicate with the monitor as long as they are within range of each other. If you go out of communications range, the monitor and sensor will beep to alert you. To ensure good communication, stay close to the monitor while it is in the base or simply take the monitor out of the base and bring it with you when you leave the room. You can go about your normal daily activities - just wear your sensor and bring your monitor with you wherever you go. At night keep the monitor in the base near your bed. The monitor will recharge and it will also transmit your heart data to CardioNet’s Monitoring Center. As you sleep, you can remove the sensor from the neck strap or belt clip and lay it on the bed next to you on the same side of the bed as your monitor. The sensor will move with you as you move. Try not to lie on top of the sensor. The monitor and sensor can not communicate with one another through bodies (your own body, your partner’s, your child’s, your pet’s, etc.) If the monitor beeps at night, sometimes just repositioning the sensor near the monitor will stop the beeping. If the beeping continues, it might be for another reason, like “lead disconnected.” You can read the message on the screen for information on how to resolve the problem. After the base is installed, connect yourself to the sensor using the instructions in this chapter. After you are wearing the sensor, you will need to activate your monitor. Activating the monitor will require a password which you can obtain by calling CardioNet at 1-866-426-4401. 10 Getting Started How to Install the CardioNet Base The table below will help you gather all the items you will need to install each CardioNet base. All items are located in your CardioNet kit. Items You’ll Need for Base Installation Item and Quantity Picture of Item Kit Location Place shipper kit image here CardioNet Base Telephone Cord Place shipper kit image here Power Plug Getting Started 11 2 . GE T T I NG STA RT E D Place shipper kit image here How to Install the CardioNet Base 123 Find your phone cord Plug phone cord into base Find an electrical outlet located close to telephone jack, preferably in your bedroom. Locate the telephone cord plugged into the back of your home phone. Unplug the telephone cord from the back of your telephone. On the CardioNet base, locate the slot labeled “Phone In” on the back of the base. Take the telephone cord you just unplugged from the back of your phone and plug it into the slot on the base labeled “Phone In”. 2 . GE T T I NG STA RT E D Look for outlet and jack Pick up the receiver of your home phone and listen to ensure there is a dial tone. 12 Getting Started How to Install the CardioNet Base Plug in power cord In the CardioNet kit, find the telephone cord. Locate the slot labeled “Phone Out” on the back of the base. Plug one end of this telephone cord into the slot on the base labeled “Phone Out”. Plug the other end of this cord into the back of your telephone. In the kit, locate the power cord. On the back of the base, locate the round hole labeled “Power”. Plug the small, round end of the power cord into the slot on the base labeled “Power”. Plug the other end into an electrical outlet. 2 . GE T T I NG STA RT E D 45 Plug in second phone cord Check your home phone for a dial tone. Getting Started 13 About the CardioNet Base The Base Recharges your Monitor The base functions as a recharging station for your CardioNet monitor. When you insert the monitor into the base correctly, “Monitor is Charging” will appear on the screen. The monitor’s rechargeable battery provides between 12 to 16 hours of use. If you plan to be away from home for more than 12 hours, you should bring one of the black power cords with you. At some point during the day, plug the power cord into an electrical outlet and charge your monitor by inserting the other end of the power cord into the hole on the side of the monitor. 2 . GE T T I NG STA RT E D The Base Transmits Events Using your Home Telephone When your CardioNet monitor is in the base, it uses your home telephone system for communications with the CardioNet Monitoring Center. When you are away from home – or whenever your CardioNet monitor is out of the base station – the monitor uses cell phone technology to contact the CardioNet Monitoring Center and transmit data. You do not need a cell phone. The monitor uses its own cell phone. As with consumer cellular phones, calls can sometimes be delayed or blocked by coverage problems, heavy traffic on cell phone networks, or physical obstructions such as buildings or mountains. If the CardioNet monitor has data to transmit and is unable to communicate with the CardioNet Monitoring Center through cellular communications, the monitor will store the data and transmit it when cell coverage becomes available or through your home telephone system when the monitor is placed in the base. If you pick up your telephone while the monitor is in the base and transmitting data, you will hear static, like the sound a fax machine makes. Hang up the phone and wait a few minutes while the data is sent and then you will get a dial tone. If you must use your phone and the monitor is transmitting data, take the monitor out of the base and make your call. When you are done with the call, however, you should return your monitor to the base right away to complete the transmission. If you are on the phone and the monitor wants to transmit data, you might hear clicking sounds. If you are using a dial-up connection to access the Internet on the same phone line as the base, and the monitor is in the base transmitting data, it may disconnect you from the Internet. Hang up and the monitor will transmit the data. When the monitor is in the base and transmitting data, your telephone line will have a busy signal for incoming calls. You will not be charged for any calls your monitor makes to CardioNet. 14 Getting Started How to Activate the CardioNet Sensor The table below will help you gather all the items you will need to begin using your CardioNet sensor. All items are located in your CardioNet kit. Items You’ll Need to Begin Using your CardioNet Sensor Item and Quantity Picture of Item Kit Location Place shipper kit image here CardioNet Sensor 2 . GE T T I NG STA RT E D Place shipper kit image here AA Battery Place shipper kit image here Pack of Electrode Pads Place shipper kit image here Neck Strap or Belt Clip Getting Started 15 How to Activate the CardioNet Sensor 123 Belt clip or neck strap? Prepare your skin Lift the lid of your sensor and place one AA battery inside. Use the diagram on the inside of the sensor to make sure you insert the battery with the proper positive and negative orientation. If you have inserted the battery correctly, you will hear a chime. Neck strap: unsnap the neck strap and thread it through the loop on the sensor. Snap the ends together and place it over your head. The 2 tabs allow you to adjust the length of the strap. Belt clip: attach the clip to your pants, skirt or belt. Snap the flat side of the sensor into the clip with the wires pointing upward. First make sure you do not have any lotion, powder or hair in the three locations (steps 4-6). If you have lotion or powder on, you should wash off the areas with soap and water and dry the skin completely. If you have any hair in these locations, you must shave it all off before putting the electrodes in place. 2 . GE T T I NG STA RT E D Insert the AA battery 16 Getting Started How to Activate the CardioNet Sensor 456 Black on left Red on ribs Open one pack of electrodes. Snap the 3 leads (from the end of your sensor wires) onto the 3 electrodes. Peel off the electrode from the backing with the WHITE lead attached. Place this electrode just below the center of your right collarbone. Press so that the electrode is adhered to your skin. Peel off the electrode from the backing with the BLACK lead attached. Place this electrode just below the center of your left collarbone. Press so that the electrode is adhered to your skin. Peel off the electrode from the backing with the RED lead attached. Place this electrode on your left side, on the lower part of your rib cage. RED on ribs. Press so that the electrode is adhered to your skin. Getting Started 2 . GE T T I NG STA RT E D White on right 17 Tips for Wearing the CardioNet Sensor How the Electrodes Work The CardioNet sensor uses three electrode pads, carefully placed on your body to detect heartbeats by sensing electrical changes on the surface of your skin. The electrode pads are attached to three leads - a white lead, a black lead and a red lead. The leads can be snapped on and off the electrodes. This allows you to take off the leads and sensor before showering – without removing the electrode pads. 2 . GE T T I NG STA RT E D It is very important that you follow the instructions in Chapter 4: Changing Your Electrodes. By following these instructions carefully you are providing CardioNet with a clear reading of your heartbeats while maintaining the health of your skin. If You Experience Skin Irritation If you experience skin irritation or a rash or at any time you experience discomfort wearing the electrodes, please contact CardioNet at 1-866-426-4401. 18 Getting Started How to Activate the CardioNet Monitor Before proceeding, please contact a CardioNet Customer Service Representative at 1-866-426-4401. The table below will help you gather all the items you will need to activate your CardioNet monitor. All items are located in your CardioNet kit. Items You’ll Need to Activate your CardioNet Monitor Item and Quantity Picture of Item Kit Location Place shipper kit image here CardioNet Monitor 2 . GE T T I NG STA RT E D Sensor Attached The sensor should be attached to your body. Place shipper kit image here Patient Enrollment Form to sign Getting Started 19 How to Activate the CardioNet Monitor 123 Received Privacy Practices Agree to Return Equipment Switch the power switch on the green/on position. Wait for the monitor to power up. Activation screen 1 will appear. Your name should appear on the screen. Activation screen 2 is shown. Activation screen 3 is shown. In the blue folder in your kit, locate “CardioNet’s Notice of Confidentiality and Privacy Practices”. Touch Yes to indicate that you agree to return your CardioNet kit and all its contents immediately after your monitoring is complete. 2 . GE T T I NG STA RT E D Confirm name and sensor Look at the back of your sensor. The 5 digit SNV number should match the number on this screen. Touch Yes to proceed. 20 Getting Started Touch Yes to indicate that you have received this document. How to Activate the CardioNet Monitor 456 Agree to Share Data Call CardioNet Activation screen 4 is shown. Activation screen 5 is shown. Activation screen 6 is shown. In your kit, locate the “Patient Enrollment Form.” Touch Yes to indicate your consent to allow CardioNet to use your data for research purposes. Your identity will not be used and will be kept private. If you are not already speaking with a Customer Service Representative, please call CardioNet at 1-866-426-4401. Touch Yes to indicate that you agree with the Terms and Conditions on the form. 2 . GE T T I NG STA RT E D Agree to terms Touch Continue on your screen to proceed. Getting Started 21 How to Activate the CardioNet Monitor 789 Activating... stand by Activation screen 7 is shown. The Activating Monitor screen appears. 2 . GE T T I NG STA RT E D Enter password While you are talking with our Customer Service Representative, they will give you a password to enter. Enter the password and touch Enter to continue. Place the monitor in the base. You may need to hang up the phone now. 22 Getting Started Activated. When the monitor has connected and activation During this time, your is complete, the Activation monitor is attempting to S u c c e s s f u l s c r e e n i s connect with the center and shown. activate your prescription. To u c h C o n t i n u e t o This could take several proceed and begin the minutes. process of recording a If activation fails, a screen baseline ECG. containing instructions will appear (see page 25). How to Activate the CardioNet Monitor 123 Record baseline Recording... remain still Before you begin recording your baseline ECG, find a comfortable place to sit or lay down. When you are comfortable press Continue on the screen. When you are comfortable and are certain you can remain still for up to 2 minutes, press Record Baseline on the screen. While your baseline ECG is recording the screen will show you a blue bar to indicate your progress. Please wait and remain still unitl this screen changes. Getting Started 2 . GE T T I NG STA RT E D Prepare to record 23 How to Activate the CardioNet Monitor 45 Begin monitoring Once your baseline ECG has been recorded, the Baseline Recorded confirmation screen wil appear. Press Continue to go to the Main Menu. The Main Menu screen is displayed. You are now ready to begin your monitoring session with CardioNet. 2 . GE T T I NG STA RT E D Baseline Recorded 24 Getting Started How to Activate the CardioNet Monitor If Activation Fails If You Disagree Need Assistance? 2 . GE T T I NG STA RT E D If the monitor is unable to connect to the CardioNet center, the activation will fail. If you disagree with any of the Activation screens you may choose No. However, if you do not consent If the “Activation failed” to all of the Activation s c r e e n a p p e a r s , d o screens, CardioNet may not proceed until you not be able to provide have called CardioNet’s monitoring to you. Please Customer Service at 1- call CardioNet at 1-866426-4401 to discuss your 866-426-4401. options. Please do not call your physician. If you have questions or need assistance at any time, call CardioNet toll free at 1-866-426-4401. Getting Started 25 3 USING T H E Mon i tor In this Chapter: • How to Turn your Monitor On and Off • How to Record an Event • How to Change Monitor Options • How to Check Battery Power • How to Check Cell Phone Coverage • Receiving Messages from CardioNet • How to Read a Text Message How to Turn Your Monitor On and Off 123 ON: Flip switch to green OFF: Flip switch to red Powering Down 3. USI NG T H E Mon itor Good bye... With your monitor off, loocate the black toggle switch on the bottom of the device. It show red. Move it to the right. It will show green. With your monitor on, loocate the black toggle switch on the bottom of the device. It show green. Move it to the left. It will show red. The “Good bye” screen indicates that your device is shutting down. Do not move to toggle switch until the screen is blank and the device is completely off. You will hear a start up sound and the CardioNet “C” logo will appear. When the touch screen displays the Main Menu, the monitor is on and awake. The “Good bye...” screen will appear. The only times you will need to turn the monitor off are when you change the sensor battery, change your electrodes, or take a shower or bath. 28 Using the Monitor How to Turn Your Monitor On and Off On & Asleep When the monitor is awake, the touch screen is lit and the LED light at the top right side of the monitor blinks red or green. When the monitor is asleep, the touch screen is blank and not lit. A green blinking LED light means you are being monitored. A red blinking LED light means you are not being monitored. The LED light at the top right side of the monitor is on and blinking red or green. Sleeping helps the monitor save battery power while you are not using the touch screen. Charging When the monitor is charging, the LED light at the top left side of the monitor will illuminate in orange. The monitor battery icon, located on the Main Menu in the uper left corner will blink and will change colors as it recharges. Always leave your monitor on, even when charging. Using the Monitor 29 3. USI NG T H E Mon itor On & Awake How to Record an Event 123 3. USI NG T H E Mon itor Touch Record Event Follow these steps if you are experiencing any symptoms. Touch Yes to confirm Touch symptoms On the monitor’s touch The first of two symptom screen, a confirmation screens appears. screen will appear. Select each symptom that Ensure that your monitor Touch the Yes buton to you feel. The button will is on and awake. continue to step 3. depress and change to a On the Main Menu touch If you have touched the dark blue color. the Record button. Record button by accident Touch Next and repeat and do not wish to record for the second symptom an event, touch No and screen. you will return to the Main When you are finished, Menu. touch Next. 30 Using the Monitor How to Record an Event 456 Touch activity level When you are finished, touch Next. Main menu Your event information When you wish to record has been recorded and another event, press the stored. The monitor will Record button. then attempt to contact and transmit the data to the CardioNet Monitoring Center. Touch OK to return to the Main Menu. Using the Monitor 31 3. USI NG T H E Mon itor Choose the activity level that best reflects your level of exertion when you felt your symptom. Event recorded How to Change Monitor Options 123 3. USI NG T H E Mon itor Touch View Options Ensure the monitor is on and awake. From the Main Menu, touch the Options button. Touch Volume Touch the button labeled Choose a desired volume. Volume. Touching High, Medium or Low places a check mark next to your selection. You will hear a tone for the volume you have chosen. Vibrate disables the audio sounds and you will feel the monitor vibrating. Volume 32 Using the Monitor Choose desired volume Touch Confirm to save. How to Change Monitor Options 123 Touch View Options Touch Display Choose desired brightness Touch the button labeled Choose a desired brightness Display. for the screen. From the Main Menu, touch the Options button. Touching the Bright, Medium or Dim button adjusts the LCD screen brightness and you will see the new setting you have chosen. Display Touch OK to save. Using the Monitor 33 3. USI NG T H E Mon itor Ensure the monitor is on and awake. How to Change Monitor Options 123 3. USI NG T H E Mon itor Touch Options Touch Cell Phone Choose On or Off Ensure the monitor is on and awake. Touch the button labeled Choose either Yes or Cell Power. No. From the Main Menu, touch the Options button. When the cell phone is off, monitoring continues, but no data can be sent unless the monitor is in the base or the cell phone is turned back on. Never turn off your cell phone. The cell phone off feature is ONLY for use when flying. Cell Phone 34 Using the Monitor The cel l icon on the Main Menu now displays “OFF”. How to Change Monitor Options If you enter this screen by accident, exit by touching Back you will return to the Options Menu. Pressing the Service button will display a password screen. This screen allows Cardionet personel to troubleshoot your monitor. These screen can only be accessed while you are speaking with an authorized CardioNet Customer Service Representative. If you enter this screen by accident, exit by touching Enter, then OK and you will return to the Options Menu. Service or Send... Using the Monitor 35 3. USI NG T H E Mon itor Pressing the Record Baseline button will display the first screenin this process. You should only proceed when speaking with an authorized CardioNet Customer Service Representative. How to Check Battery Power A battery icon that is filled with a green color indicates your monitor and / or sensor have full power. A battery icon that is partially filled with a yellow color indicates a low battery in either your monitor or sensor. A battery icon that is minimally filled with a red color indicates either your monitor or sensor battery is empty. 3. USI NG T H E Mon itor The monitor’s rechargeable battery provides 16 hours of use for every 4 hours of recharging. The sensor AA battery should be replaced at the same time every day. Monitor Battery Icon 36 Using the Monitor Sensor Battery Icon If your monitor or sensor battery icon are red in color you, should recharge or replace the battery immediately. How to Check Cell Phone Coverage Four green bars located to the right of the cell icon indicate a very strong cell signal. No bars to the right of the cell icon indicates no cellular signal. The word OFF to the right of the cell signal indicates your cell phone has been turned off. To turn back on, touch the Options button on the Main Menu, select Cell Power, then select Yes. Please remember, the cell phone off feature is only for use when flying. If the icon indicates no cellular coverage and the monitor is not in the base, your data will be stored until the monitor has a cellular connection or is placed in the base. Options Menu Yes for Cell Power Using the Monitor 37 3. USI NG T H E Mon itor You can’t change your cell strength unless you change your current location. Receiving Messages From CardioNet About Text Messages 3. USI NG T H E Mon itor There are times when CardioNet may want to send you a message regarding your monitoring. If you see the blue envelope on the Messages button with the word “NEW” blinking on it, you have received a text message. In order to read the message, touch the Messages button and your message will appear on the screen. When you are done reading and responding to the message, touch OK to return to the Main Menu. The blue envelope will remain on the button and you can read your message again at any time by pressing the button. If you receive another message, the word “NEW” will appear and blink on your envelope. You will need to touch the button again to read your new message. 38 Using the Monitor How to Read a Text Message 123 Touch Messages button If you have received a new text message, an envelope will blink “NEW”. Return to Main Menu The date and time the text The envelope icon no message was sent to you longer reads “NEW”. You is displayed. can regain access to the Read the text message text message by touching and follow any instructions the “Messages” button. provided. From the Main Menu, touch the “Messages” button When you have finished, located at the bottom right touch OK to return to the Main Menu. corner of the screen. If you receive another text message, the envelope icon will change and blink “NEW” again. Using the Monitor 39 3. USI NG T H E Mon itor Ensure the monitor is on and awake. Read text message 4 S ENSO R C A R E In this Chapter: • Tips for Changing Electrode Pads • How to Change Electrodes and Attach Sensor • Remove Before Showering or Bathing • How to Change the Sensor AA Battery 4 . SE NSOR C A R E Tips for Changing Electrode Pads Changing your Electrode Pads and Keeping Your Skin Healthy Change your electrodes every other day. If they come loose before that time, replace them immediately. If you are showering or bathing on the day you need to change them, remove them in the shower or bath. Lather them up with soap and water and pull them off gently. When you are done with your shower, dry your skin and follow the instructions in How to Change your Electrodes. If you do not remove the electrodes in the shower or bath, you will still need to use soap and water to loosen them. The goal is to be gentle with your skin. Never pull the electrodes off quickly like a band-aid. If the electrodes come loose or are moving around before the two days are over, replace them immediately. It is very important that the electrodes adhere to your skin at all times. You may want to press lightly on your electrodes in the morning when you wake up and throughout the day to make sure they are adhered to your skin. Do not put the electrodes in the exact same location each time you change them. It is very important that you rotate the locations near the original sites. This will help preserve your skin. If, at any time, redness or irritation occurs, call CardioNet at 1-866-426-4401. Do not wait until the irritation is severe before you call. The “Skin Prep” in your kit can be used if you experience mild skin irritation. Wipe the 3 areas with one skin prep. Let it dry and then apply the electrodes. The skin prep provides a barrier between the electrodes and your skin. It is usually not necessary to use the skin prep and should only be used if you have sensitive skin or are experiencing mild skin irritation. Adhesive remover is also included in your kit and can be used if you have any adhesive residue left on your skin. The adhesive remover can irritate your skin so make sure you wash it off after using. It is not necessary to use the adhesive remover and should only be used if you can see visible adhesive still on your skin after washing with soap and water. Do not use lotion or powder on your chest while you are being monitored and remove all hair on your chest in the locations of the electrodes. Follow the instructions in the next few pages on How to Change Electrodes. 42 Sensor Care How to Change Electrodes and Attach Sensor Remove sensor battery Remove old electrodes With your monitor on, locate the black toggle switch on the bottom of you monitor. Move the switch from green to red. Open the battery door by pushing the door snap up. Unsnap the three leads from the electrode pads. Using soap and water, Remove the battery by gently lift the old electrode grabbing both sides and pads off your skin. Never The blue “Good bye...” lifing it out. pull them off quickly. screen will appear. Once Throw the old electrode this screen disappears, the pads away. monitor has completely powerd down. Sensor Care 43 4 . SE NSOR C A R E 123 Turn monitor off How to Change Electrodes and Attach Sensor 4 . SE NSOR C A R E 456 Apply new electrodes Placement of the leads Monitor and sensor on It is very important that you place each electrode in another location near the original site to protect your skin. Open one pack of electrodes. Snap the 3 leads to the electrodes. Peel off one electrode at a time from the backing and apply them in the proper location (see step 5) to clean, dry, hairless skin. WHITE ON RIGHT. Place the electrode with the WHITE lead on the right, under your collar bone. Turn the sensor on by inserting one AA battery into the sensor battery compartment. You will hear a chime if the battery is inserted correctly. 44 Sensor Care BLACK ON LEFT. Place the electrode with the BLACK lead on the left, under your collar bone. RED ON RIB. Place the electrode with the RED lead on your lower left rib cage. Turn your monitor on by locating the black toggle switch on the bottom of your monitor. Move the switch from red to green. How to Change Electrodes and Attach Sensor 4 . SE NSOR C A R E 78 If you choose neck strap Skin Irritated? If you choose belt clip If you choose to wear the sensor on your chest, you will need the neck strap. If you choose to wear the If your skin is red or irsensor on your belt, you ritated, you can use the will need the belt clip. “Skin Prep” located in your Unsnap the strap and Attach the clip to your kit. This provides a protecthread it through the loop pants, skirt or belt. Insert tive barrier between your on the sensor. Snap the the end of the sensor skin and the electrode. ends together and place it with the loop pointing Wipe all 3 locations with over your head. The 2 tabs downward into the narrow one skin prep. Allow to allow you to adjust the opening on the clip. Snap dry and place electrodes the other end into the wide on top. If the skin irritation length of the neck strap. opening with the wires continues, call CardioNet at 1-866-426-4401. pointing upward. Sensor Care 45 Remove Before Showering or Bathing 4 . SE NSOR C A R E The sensor is not water proof, but the electrodes are. Therefore, you’ll need to remove your sensor before taking a bath or shower, but you can keep the electrode pads on. To prevent the electrodes from falling off while you are in the shower, avoid soaking the electrode pads. Gently wash the skin around the electrodes. With your monitor on, press the blue power button located on the lower right part of the monitor. 46 On the monitor’s touch screen, a confirmation screen will appear. If your electrodes are 2 Press Yes to turn the moni- days old, remove the old electrodes and apply new tor off. electrodes. Removing the old electrodes during your shower - while they are wet - may be gentler on your skin. 12 Sensor Care While you are drying off, use your towel and press the electrodes onto your skin. This will help dry the electrodes and to ensure a tight surface contact with your skin. How to Change the Sensor AA Battery Press the blue power button located on the lower right part of the monitor. Remove old battery Remove the old battery by placing your finger in the recessed area, wedging your finger underneath On the monitor’s touch the battery and lifting screen, a confirmation upward. screen will appear. Pressing Yes will turn the monitor off. Open the battery door by pushing the door tab up. New battery, monitor on Put in a new AA battery, included in your CardioNet kit. Note the battery direction on the label on the inside of the sensor cover. If properly installed, the sensor will chime. If the sensor doesn’ t chime, recheck the battery direction. Close the sensor cover and turn your monitor on. Sensor Care 47 4 . SE NSOR C A R E 123 Turn monitor off 5 T ROU B L E S H O OT I N G In this Chapter: • Responding to Monitor Alerts and Alarms • Troubleshooting Device Problems • Precautions, Cautions and Warnings Responding to Monitor Alerts and Alarms When the monitor or sensor beeps When the monitor beeps it has nothing to do with the condition of your heart, so don’t become concerned. The monitor will beep to alert you when it is unable to function properly. The touch screen will explain what to do. With both alerts and alarms you can always touch the Help button for further instructions. 5. T ROU BL E SHOOT I NG Alerts display an information screen that will disappear after 15 seconds and have an audio tone of two brief beeps. Alarms display an information screen that persists and alarm tones that grow louder over time. Alerts can sometimes fix themselves, but alarms always require action on your part. For alarms, you can immediately silence the audio tones by touching the Silence button on the touch screen. The table below will help you identify the possible problem and the actions you can take to find a solution for each monitor alert or alarm. Screen Problem NO COMMUNICATIONS Possible Solutions Move closer to your monitor The sensor you are wearing on or move the monitor closer your body and the monitor are to you. not communicating. OR Check if the sensor battery is empty or oriented incorrectly. LEAD DISCONNECTED Check that all leads are One or more leads are unsnapped snapped to the electrodes. from the electrodes. OR OR Check all electrodes to One or more electrodes are not ensure they are stuck to your skin. Apply new electrodes if stuck well to your skin. needed. 50 Troubleshooting Responding to Monitor Alerts and Alarms Screen Problem LOW MONITOR BATTERY Possible Solutions Return the monitor to the The rechargeable battery in the base for recharging. monitor is low. OR Directly recharge the monitor by plugging the base power cable into the monitor. LOW SENSOR BATTERY OR If the battery is new, inspect battery compartment and clean contacts if necessary. INTERNAL MONITOR ERROR Call the CardioNet Patient The monitor is not functioning. Service Center for help. Call Toll free: 1-866-426-4401. INTERNAL SENSOR ERROR The sensor is not functioning. Call the CardioNet Patient Service Center for help. Call Toll free: 1-866-426-4401. Troubleshooting 51 5. T ROU BL E SHOOT I NG The sensor AA battery is low. Install new battery. Responding to Monitor Alerts and Alarms Screen Problem INFORMATION TO SEND Possible Solutions Put the monitor in the base. 5. T ROU BL E SHOOT I NG The monitor needs to transmit OR data but can not establish a con- Move to an area with cell nection to CardioNet. phone coverage. 52 Troubleshooting Troubleshooting Device Problems About Troubleshooting Troubleshooting sometimes involves a bit of detective work, but usually the monitor detects problems for you and can assist you with resolving the problem. The monitor beeps to let you know there is a problem with the equipment. The touch screen shows you a message on how to respond to the alert or alarm. For every alert and alarm the touch screen has a help menu. Any time an alert or alarm appears and you do not know what to do, you can press the Help button to access detailed instructions on how to troubleshoot the problem. If your Problem Can’t be Resolved If you experience additional problems with any components of the CardioNet Monitoring System, review the problems and solutions listed in the troubleshooting section. If additional assistance is required contact customer support toll free at 1-866-426-4401. Most alerts or alarms have a help screen. If you need more information, press the Help button to access detailed instructions on how to troubleshoot the problem. Troubleshooting 53 5. T ROU BL E SHOOT I NG An alert prompts you to resolve a problem by displaying an information screen and beeping an audio tone. With alerts the problem can fix itself and you won’t need to take any action. With alarms you will need to take some action and information on how to resolve the problem will be provided on the touch screen. An alarm persists to let you know that a problem has not been resolved and you must take action. Troubleshooting Problem Monitor battery power drains quickly 5. T ROU BL E SHOOT I NG Monitor screen is blank Possible Solutions Ensure battery is being fully recharged every day. A full recharge takes approximately 4 hours and will last 16 hours. Ensure the monitor is being placed in the base correctly. If the monitor does not make contact with the plug in the base, it may not recharge. It could be that the monitor is not turned on. Ensure the monitor is turned on by confirming that the LED light is flashing red or green. If the monitor is asleep, press the blue button. The screen should light up. If it doesn’t, the monitor may be low on power. Return the monitor to the base for recharging. Monitor beeps while you are in bed It is possible for your body to block communications between the sensor and monitor. This will cause warning beeps. To avoid beeps and maintain the communications link, place the sensor near the monitor on the bed next to you. Try not to lie on top of it or to get between the sensor and monitor while you are sleeping. Your phone line is busy When the monitor is in the base station and sending information it will use your telephone line. If someone calls you while the monitor is using the line, they will get a busy signal. If you try to place a call while the monitor is transmitting data, you will hear a high- pitched sound. This is the sound of monitor data being transmitted. Skin is irritated or reddened If you notice that the skin under or around your electrode pads is becoming sensitive, irritated or painful, or if you develop a rash, please call the CardioNet Patient Service Center immediately at 1866-426-4401. Some people are sensitive or allergic to adhesives. CardioNet will send you another type of electrode pad. Sensor belt If you’re wearing a thicker belt and finding that it is difficult to clip is difficult slide on the Sensor Belt Clip, first remove the CardioNet Sensor to put on from the clip. Slide just the clip onto your belt and then reposition the sensor on the clip. 54 Troubleshooting Precautions PRECAUTIONS DISPOSE OF BATTERIES PROPERLY Observe all local laws for the disposal of alkaline batteries. WHEN NOT IN USE, REMOVE SENSOR BATTERY Do not leave the battery in the sensor when it is not in use. AVOID ELECTROMAGNETIC INTERFERENCE POTENTIAL FOR ELECTROMAGNETIC INTERFERENCE There is a potential for electromagnetic interference to other devices while using the CardioNet Service. USE WITH IMPLANTED PACEMAKERS AND ICDs ( DEFIBRILLATORS) If you have an implanted pacemaker or defibrillator (ICD), the manufacturer may have recommended you take certain precautions when using a cellular phone. Since the CardioNet monitor contains a cellular phone, you should take the same precautions when carrying and using the monitor. In general, most manufacturers recommend the following: • You should keep a distance of at least six inches (15 cm) between the cellular phone and a pacemaker or defibrillator. • You should hold the cellular phone on the opposite side of the body from the pacemaker or defibrillator. • Don’t carry a cellular phone in a breast pocket or on a belt if that would place the phone within six inches of the pacemaker or defibrillator. • You should refer to the manufacturer’s information for guidance regarding your pacemaker or ICD and interference issues. Troubleshooting 55 5. T ROU BL E SHOOT I NG 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. Cautions CAUTIONS POWER DOWN Monitor AND SENSOR BEFORE SHOWERING Power down the monitor and remove the sensor before showering. The CardioNet sensor and monitor are water resistant, not waterproof. DO NOT GET THE Monitor AND SENSOR WET Make sure the monitor and sensor stay dry at all times. 5. T ROU BL E SHOOT I NG LIMITATIONS OF COVERAGE CardioNet’s ability to obtain information regarding a cardiac event and to contact you or your physician in a timely manner is limited by a number of factors including: • Transmission of information about a cardiac event to CardioNet‘s Monitoring Center is potentially limited by the availability of standard telephone lines and/or cellular phone coverage. • There is an inherent time delay from the time that an event is detected to when the events are analyzed and confirmed by a Certified Cardiac Technician (CCT). • There is an inherent time delay from when the event is analyzed and confirmed by the CCT to when CardioNet is able to make contact with you or your physician. • If you or your physician are not accessible by telephone, CardioNet will not succeed in making contact with you or your physician MAINTAIN MINIMUM DISTANCE FROM BASE Due to RF exposure, maintain a minimum distance of 20cm from the base. 56 Troubleshooting Warnings WARNINGS FOR ADULT USE ONLY The CardioNet System is intended for Adult Use only. It shall not be use on infants weighing less than 22 pounds. FOR USE WITH TELEPHONE SYSTEM Any patient whose life may be put at significant risk by the unavailability of the telephone system should not be monitored by the CardioNet System. NOT AN APNEA Monitor USE ONLY WITH CARDIONET ELECTRODES While wearing the CardioNet sensor, use only electrodes provided by CardioNet. NOT AN EMERGENCY RESPONSE SERVICE CardioNet is not an emergency response service. If you experience any symptoms that concern you, seek medical help. DO NOT TAMPER WITH DEVICE There are no serviceable parts in the CardioNet System components. Removing the cover of any component may alter device performance. DO NOT TAMPER WITH Monitor BATTERY The monitor battery can present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 80C (176 F), incinerate, or recharge using any device other than the base or the CardioNet supplied power cord. USE ONLY CARDIONET POWER CORD Do not use any power cord for the base other than the one provided in the CardioNet service kit. DO NOT CONNECT ANY DEVICE TO THE PC PORT ON THE MONITOR The PC port is to be used only by CardioNet personnel. DO NOT USE NEAR FLAMMABLE ANESTHETIC Units are not to be used in the presence of flammable anesthetic. Troubleshooting 57 5. T ROU BL E SHOOT I NG The CardioNet monitor is not to be used as an apnea monitor. 6 S PECI F I C AT I O N S , COMP L I A N C E & S YMB O L S In this Chapter: • Specifications • Equipment Symbols • In Home Requirements • FCC Compliance 6 . SPE CI F IC AT IONS Specifications P H YSICAL Sensor 3 inches x 4 inches x 1 inch ; Weight: 4.0 oz. with battery Sensor Neck Strap Adjustable 20 to 32 inches Monitor 6 inches x 3 inches x 0.8 inches; Weight: 8 oz. LCD 2.27 inches x 1.7 inches; Touch screen: color, backlit Base 7 inches x 4 inches x 2.5 inches; Weight: 12 oz. f U NCTIONAL Sample Rate 250 samples per second Resolution 12 bits Dynamic range +/- 5 mV Bandwidth 0.1 to 40 Hz Channels Battery Life: Monitor Up to 16 hrs (with cleared memory & fully recharged battery) Battery Life: Sensor 24 hrs (1 AA Alkaline) Leakage Current Less than .1 µ A Electrodes T ransmission Sensor to Monitor 900 MHz ISM band RF transmission, digital error corrected. 150 foot range. Retransmission if data is corrupted. Monitor to Center CDMA (PCS and cellular) wireless, digital error corrected. Telephone line modem, digital error corrected. O perating Conditions Operating Tempera- Sensor: 20 - 45 o C; Monitor ; 0 - 45 o C Operating Humidity 10% - 95% noncondensing Storage Temperature -20 - 65 o C noncondensing Storage Humidity 5% - 95% noncondensing Operation Altitude 700 - 1060 millibars 60 Specifications Specifications Base Power in (15V, 1.2A max); Phone in (RJ-11); Phone out (RJ-11) Monitor Power in (15V, 1.2A max) W A LL ADAPTOR Manufacturer Friwo, Inc (15V, 1.0A) Model Number FW755M/15 Note: Both the monitor and sensor are internally powered S T ANDARDS COMPLIANCE Monitor EN60601-1; AAMI EC-38; FCC Parts 2,15,22,24 Sensor EN60601-1; AAMI EC-38; FCC Part 15 Base EN60950; AAMI EC-38; FCC Part 15, 68 AECG Equipment Type I Note: This equipment has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1993, EN60601-1-2:1994, Medical Device Directive 93/42/EEC or the Electromagnetic Compatibility Directive 89/336/EEC (use applicable directive). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, 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 device • Increase the separation between the equipment • Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected • Consult the manufacturer or field service technician for help Specifications 61 6 . SPE CI F IC AT IONS C O NNECTIONS Equipment Symbols 6 . SPE CI F IC AT IONS SN BF Type Equipment Consult Users Manual / Patient Education Guide Serial Number In Home Requirements 1. Touch tone, pulse telephone or cellular / PCS wireless coverage suitable for data transmission 2. AC powered outlet FCC Compliance This device complies with part 15 and 68 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference and, (2) This device must accept interference received including interference that may cause undesired operation. fcc id Sensor ISM QBI-1008 Monitor ISM QBI-1009 Monitor Cell Modem Q9EQ2438F-M Base QBI-1010 62 Specifications FCC Compliance FCC Rules Part 15 The Model 1004 has been tested and complies 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, can cause harmful interference to radio communications. CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY CardioNet Inc. COULD VOID THE USER’S AUTHORITY TO OPERATE THE EQUIPMENT FCC Rules Part 68 REGISTRATION Model 1004 complies with FCC Rules, Part 68. On this equipment is a label that contains, among other information, the FCC Part 68 registration number. REN The Ringer Equivalence Number (REN) is used to determine the quality of devices that may be connected to the telephone line. Excessive RENs on the telephone line may result in the devices not ringing in response to an incoming call. In most, but not all areas, the sum of RENs should not exceed five (5.0). To be certain of the number of devices that may be connected to a line, as determined by the total RENs, contact the local telephone company. NOTE: RENs are associated with loop-start and ground-start ports. It is not used for E&M and digital ports. The REN assigned to the Model 1004 is 0.16. If requested, this information must be given to the telephone company. Service In the event of equipment malfunction, all repairs should be performed by CardioNet, Inc. or an authorized agent. It is the responsibility of users requiring service to report the need for service to CardioNet, Inc. or to one of our authorized agents. Service can be facilitated through our office at: CardioNet, Inc. 1010 Second Avenue, Suite 700 San Diego, CA 92101 619-243-7500. The telephone company can ask you to disconnect the equipment until the problem is corrected or until you are sure that the equipment is not malfunctioning. The Model 1004 interface connects to the Public Switched Telephone Network through a FCC registered NCTE which specifies the type of network jack to be used. Specifications 63 6 . SPE CI F IC AT IONS F C C COMPLIA NCE 6 . SPE CI F IC AT IONS FCC Compliance F C C COMPLIA NCE Disruption of the Network If the Model 1004 disrupts the telephone network, the telephone company can discontinue your service temporarily. If possible, the telephone company will notify you in advance. If advance notice is not practical, they will notify you as soon as possible. You are also informed of your right to file a complaint with the FCC. Telephone Company Facility Changes The telephone company can make changes in its facilities, equipment, operations, or procedures that can affect the operation of your equipment. If they do, you should be notified in advance so you have an opportunity to maintain uninterrupted telephone service. 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. The design of this device complies with the FCC guidelines and these international standards. Use only the supplied antenna. Unauthorized antennas, damaged antennas, modifications, or attachments could impair call quality, damage the device, or result in violation of FCC regulations. Please contact CardioNet if damage to the unit is apparent. BODY-WORN OPERATION This device was tested and was found to comply with the FCC exposure requirements. The device was also tested and found to comply with SAR (Specific Absorption Rate) testing. For more information about RF exposure, please visit the FCC website at www.fcc.gov. 64 Specifications
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