QBI-1009C3 monitor

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 M O B I L E C A R D I A C O U TP AT I E N T T E L E M E T RY 2 1 3 I N T R O D U C T I O N . . . . . . . . . . . . . . . . . . . . . . . .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 . . . . . . . . . . . . . . . . . . . .2 5 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 T A B L E O F C O N T E N T S 4 5 6 S E N S O R C A R E . . . . . . . . . . . . . . . . . . . . . . . .3 9 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 . . . . . . . . . . . . . . . . . . .4 7 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 P L I A N C E & S Y M B O L S 5 7 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Equipment Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 In Home Requirements . . . . . . .. . . . . . . . . . . . . . . . . . 60 FCC Compliance . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Table of Contents iii 1 • 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 I N T R O D U C T I O N In this Chapter:  Introduction 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 p o r t a b l e C a r d i o N e t monitor. 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. 12 Monitor transmits eventsSensor detects and analyses heartbeats How the CardioNet Service Works 1 . I N T R O D U C T I O N Introduction  3 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 the report, discusses results with you and prescribes or adjusts treatment as needed. 4 CardioNet reports to your physician Your physician reviews your results How the CardioNet Service Works 1 . I N T R O D U C T I O N  Introduction PictureItem 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. 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 …

Text truncated - open the document above for the full version.

312 Find an electrical outlet located close to a telephone jack, preferably in your bedroom. Pick up the receiver of your home phone and listen to ensure there is a dial tone. 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”. Locate the telephone cord plugged into the back of your home phone. Unplug the telephone cord from the back of your telephone. Look for outlet and jackFind your phone cordPlug phone cord into base 1 Getting Started How to Install the CardioNet Base 2 . G E T T I N G S T A R T E D 45 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. Check your home phone for a dial tone. 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. Plug in second phone cord Plug in power cord Getting Started 1 How to Install the CardioNet Base 2 . G E T T I N G S T A R T 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. 1 Getting Started 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. About the CardioNet Base 2 . G E T T I N G S T A R T E D Items You’ll Need to Begin Using your CardioNet Sensor Item and QuantityPicture of ItemKit Location 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. Getting Started 1 1 1 1 Pack of Electrode Pads AA Battery CardioNet Sensor 1 Neck Strap or Belt Clip Place shipper kit image here Place shipper kit image here Place shipper kit image here Place shipper kit image here How to Activate the CardioNet Sensor 2 . G E T T I N G S T A R T E D 312 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. Prepare your skin 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. Belt clip or neck strap? 1 Getting Started Insert the AA battery Lift the lid of your sensor and place one AA battery inside. Use the diagram o n t h e i n s i d e o f t h e 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. How to Activate the CardioNet Sensor 2 . G E T T I N G S T A R T E D 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 ad- hered to your skin. Open one pack of elec- trodes. Snap the 3 leads (from the end of your sensor wires) onto the 3 electrodes. Peel off the electrode from the back- ing with the WHITE lead attached. Place this elec- trode just below the center of your right collarbone. Press so th…

Text truncated - open the document above for the full version.

3 U S I N G T H E M o n i t o r 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 312 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 will appear. 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. 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 indicates that your device is shutting down. Do not move to toggle switch until the screen is blank and the device is completely off. 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. OFF: Flip switch to redPowering DownON: Flip switch to green  Using the Monitor Good bye... How to Turn Your Monitor On and Off 3 . U S I N G T H E M o n i t o r On & Awake On & Asleep Charging When the monitor is asleep, the touch screen is blank and not lit. The LED light at the top right side of the monitor is on and blinking red or green. Sleeping helps the moni- tor save battery power while you are not using the touch screen. 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. 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. A green blinking LED light means you are being monitored. A red blinking LED light means you are not being monitored. Using the Monitor 9 How to Turn Your Monitor On and Off 3 . U S I N G T H E M o n i t o r 312 Follow these steps if you a re e x pe r ie nc ing a ny symptoms. Ensure that your monitor is on and awake. On the Main Menu touch the Record button. The first of two symptom screens appears. Select each symptom that you feel. The button will depress and change to a dark blue color. Touch Next and repeat for the second symptom screen. When you are finished, touch Next. On the monitor’s touch screen, a confirmation screen will appear. Touch the Yes buton to continue to step 3. If you have touched the Record button by accident and do not wish to record an event, touch No and you will return to the Main Menu. Touch Record EventTouch Yes to confirmTouch symptoms 0 Using the Monitor How to Record an Event 3 . U S I N G T H E M o n i t o r 456 Your event information has been recorded and stored. The monitor will then attempt to contact and transmit the data to the CardioNet Monitoring Center. Touch OK to return to the Main Menu. Choose the activity level that best reflects your level of exertion when you felt your symptom. When you are finished, touch Next. Touch activity levelEvent recorded Using the Monitor 1 Main menu When you wish to record another event, press the Record button. How to Record an Event 3 . U S I N G T H E M o n i t o r 312 Ensure the monitor is on and awake. From the Main Menu, touch the Options button. Choose a desired volume. Touching High, Medium or Low places a check mark next to your selec- tion. You will hear a tone for the volume you have chosen. Vibrate disables the audio sounds and you will feel the monitor vibrating. Touch Confirm to save. Touch the button labeled Volume. Touch View OptionsTouch VolumeChoose desired volume  Using the Monitor Volume How to Change Monitor Options 3 . U S I N G T H E M o n i t o r 123 Touch the button labeled Display. Choose a desired brightness for the screen. Touching the Bright, Medium or Dim button adjusts the LCD screen brightness and you will see the new setting you have chosen. Touch OK to save. Ensure the monitor is on and awake. From the Main Menu, touch the Options button. Touch View OptionsTouch Display Choose desired brightness Using the Monitor  Display How to Change Monitor Options 3 . U S I N G T H E M o n i t o r 312 Ensure the monitor is on and awake. From the Main Menu, touch the Options button. Choose either Yes or No. 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. T h e c e l l i c o n o n t h e Main Menu now displays “OFF”. Touch the button labeled Cell Power. Touch OptionsTouch Cell PhoneChoose On or Off  Using the Monitor Cell Phone Never turn off your cell phone. The cell phone off feature is ONLY for use when flying. How to Change Monitor Options 3 . U S I N G T H E M o n i t o r 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. Using the Monitor  Service or Send... 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. If you enter this screen by accident, exit by touching Back you will return to the Options Menu. How to Change Monitor Options 3 . U S I N G T H E M o n i t o r 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. The monitor’…

Text truncated - open the document above for the full version.

Problem Possible Solutions Monitor battery power drains quickly 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. Monitor screen is blank 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 1- 866-426-4401. Some people are sensitive or allergic to adhesives. CardioNet will send you another type of electrode pad. Sensor belt clip is difficult to put on If you’re wearing a thicker belt and finding that it is difficult to slide on the Sensor Belt Clip, first remove the CardioNet Sensor from the clip. Slide just the clip onto your belt and then reposition the sensor on the clip.  Troubleshooting Troubleshooting 5 . T R O U B L E S H O O T I N G 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 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. 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 rec- ommended 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 pace- maker 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 pace- maker or ICD and interference issues. Troubleshooting  Precautions 5 . T R O U B L E S H O O T I N G 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. 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  Troubleshooting Cautions 5 . T R O U B L E S H O O T I N G WARNINGS FOR ADULT USE ONLY The CardioNet System is intended for Adult Use only. It shall not be use on infants weigh- ing 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 The CardioNet monitor is not to be used as 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 servic…

Text truncated - open the document above for the full version.

PXA 271 13 MHz XTAL 32.768 KHz XTAL "Whole House" 900 MHz Radio 902-928 Mhz 39MHz XTAL CODEC Audio Subsystem 24.576 MHz XTAL LCD RTC 32.768 KHz XTAL Power Supplies Battery Touch Screen Wavecom CDMA/GPRS Modem 824-849 Mhz 1850-1910 Mhz Charger Vibrator BT 2402 - 2480 MHz MIC SPKR +15 VDC DUART 14.7456 MHz XTAL C3 Gateway Block Diagram 12-19-06

Report No. SC600647-08 Page 52 of 52 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 4.0 ATTESTATION STATEMENT GENERAL REMARKS: Antenna gain is less than 6 dBi. SUMMARY: All tests were performed per CFR 47, Part(s) 15.247(a), 15.247(b), 15.247(c), 15.247(d), 15.107(a), 15.207(a), and 15.209(a) „ - Performed The Equipment Under Test „ - Fulfills the requirements of CFR 47, Part(s) 15.247(a), 15.247(b), 15.247(c), 15.247(d), 15.107(a), 15.207(a), and 15.209(a) Testing Start Date: 15 February 2006 Testing End Date: 16 March 2006 - TÜV AMERICA, INC. - Reviewing Engineer: Test Engineer: Chuck Rickard David Gray (EMC Engineer) (EMC Engineer)

TÜV America Inc. Phone: (651) 631-2487 1775 Old Highway 8 NW Fax: (651) 638-0285 Suite 104 E-mail: [email protected] New Brighton, MN 55112 www.TUVamerica.com Management Service • Product Service • Industry Service • Automotive • BABT TÜV America Inc. is a subsidiary of TÜV SÜD Group. 18 December 2006 American TCB 6731 Whittier Avenue McLean VA 22101 RE: Cardionet Response to 21 November 2006 Comments FCC ID: QBI-1009 In response to your comments on the above submittal from 21 November 2006. 1. ATCB Comments: The Block Diagram is not consistent with the requirements of 2.1033(b)(5). Please review. 2.1033(b) (5) A block diagram showing the frequency of all oscillators in the device. The signal path and frequency shall be indicated at each block. The tuning range(s) and intermediate frequency ( ies) shall be indicated at each block. RESPONSE: Exhibit is pending. 2. ATCB Comments: Please show the front of the device in the external photos. Please revise external photos. RESPONSE: Additional photos have been uploaded. 3. ATCB Comments: Internal photos are blurry please revise internal photos to show components clearly and straight RESPONSE: Additional photos have been uploaded. 4. ATCB Comments: There can be no spaces in the FCC ID number. Please take out the space before and after the dash in the ID number. Please revise ID label. RESPONSE: A letter explaining the spaces and what Cardionet proposes, along with sample revised label have been uploaded. 5. ATCB Comments: The Spectral Power Density plots seem to be very high. Please re-test using a span of 1.5 MHz that has zeroed in on the highest signal and then set the sweep time to the greatest time available on the spectrum analyzer. Please see attachments. RESPONSE: Exhibit has been uploaded. 6. ATCB Comments: Please provide a pseudorandom hopping frequency list showing hopping order of all 26 hopping frequencies. RESPONSE: the device is not a frequency hopping spread spectrum device. 7. ATCB Comments: The FCC requires a 1 year SAR probe calibration cycle. Please have probes calibrated and then retest the EUT with the newly calibrated probes. Do these transmitters transmit simultaneously? If they do they will have to be tested with simultaneous transmissions and the results shown in the SAR report. Please revise SAR report. RESPONSE: Information regarding calibration at the SAR test lab has been uploaded. TÜV America Inc. Phone: (651) 631-2487 1775 Old Highway 8 NW Fax: (651) 638-0285 Suite 104 E-mail: [email protected] New Brighton, MN 55112 www.TUVamerica.com Management Service • Product Service • Industry Service • Automotive • BABT TÜV America Inc. is a subsidiary of TÜV SÜD Group. 8. Portable devise - requires X, Y, Z axis positioning. The test report does not include information on whether this positioning was performed during testing. RESPONSE: Exhibit is pending. Please let us know if anything further is required. Susan L Rupp, Technical Writer TÜV America Inc Tel: 651 638 4585 / Fax: 651 638 0298 [email protected]

Cardionet Gateway Additional External Photos Front Back Side Top Gateway Bottom Gateway Side Gateway Side 2 Gateway Bottom Gateway with Plug Back Gateway

FOR PATIENT QUESTIONS PLEASE CALL: 866-426-4401 = Cardionet Gray = PMS 3125C = White = Die line WARNING: READ PATIENT EDUCATION GUIDE BEFORE USE. PROTECT FROM WATER AND OTHER LIQUID. PATENT NOS. 5,959,529; 6,225,901 15 VOLTS DC, 1.2 AMPS CONTAINS FCC ID: O9EQ2438F-M (CDMA MODEM) FCC ID: Q2331307 (BLUETOOTH RF) FCC ID: QBI-1009 (ISM RF) LI-ION BATTERY CARDIONET IS NOT AN EMERGENCY RESPONSE SERVICE. IF YOU EXPERIENCE SYMPTOMS THAT CONCERN YOU , SEEK MEDICAL HELP. 100-0023-01 220-0047-01 Rev F TBD 1.860” x 3.834” Cardionet Pam Hane Attn: Phil Lamb Cardionet Gray background. PMS 3125C & white graphics. All radius were verified as according to blueprint. Die line will not print. CCARARDDIIOONNEET MONITORT MONITOR AECG TYPE 1 MEDICAL EQUIPMENT IF FOUND PLEASE CALL: CARDIONET, INC. SAN DIEGO, CA 92101 866-426-4404 SPECIFICATIONS NOTES Part Number: P.O. Number: Qty Ordered: GM Number: Finished Size: Customer:11-8-06 Youraccountmanageris: Attn: Please check design, copy, critical placements and specifications carefully. Take note of our "Warranty and Limited Liability" statement below. Check appropriate box below, sign and return so we may proceed with your order. Your signature: Print as is Print with corrections marked Submit corrected proof Approval of this proof is required by to maintain your scheduled ship date. Save time in contacting GM Nameplate, Inc. Phone: 408-435-1666 Fax: 408-435-8121 Customer alterations of original design are not included in quotation. Changes made at this point in production may result in additional charges. Please notify your account manager immediatelyimmediately if there are any changes. Please Note: The colors shown are not for color matching purposes. They are for reference only. Warranty and Limited Liability: GM Nameplate …

Text truncated - open the document above for the full version.