Cardionet 1008 C3 Sensor User Manual 5

Cardionet C3 Sensor Users Manual 5

Users Manual 5

Problem  Possible SolutionsMonitor  battery power drains quicklyEnsure 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 blankIt could be that the monitor is not turned on.  Ensure the monitor is turned on by conrming that the LED light is ashing 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 busyWhen 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 reddenedIf 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 difcult to put onIf you’re wearing a thicker belt and nding that it is difcult to slide on the Sensor Belt Clip, rst remove the CardioNet Sensor from the clip. Slide just the clip onto your belt and then reposition the sensor on the clip.54  TroubleshootingTroubleshooting5.  T ROU BL E SHOO T I NG
PRECAUTIONSDISPOSE OF BATTERIES PROPERLYObserve all local laws for the disposal of alkaline batteries.WHEN NOT IN USE, REMOVE SENSOR BATTERYDo not leave the battery in the sensor when it is not in use. AVOID ELECTROMAGNETIC INTERFERENCEFor 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 INTERFERENCEThere 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 debrillator (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 debrillator.•  You should hold the cellular phone on the opposite side of the body from the pace-maker or debrillator.•  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 debrillator.•  You should refer to the manufacturer’s information for guidance regarding your pace-maker or ICD and interference issues.Troubleshooting  55Precautions5.  T ROU BL E SHOO T I NG
CAUTIONSPOWER DOWN Monitor AND SENSOR BEFORE SHOWERINGPower 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 WETMake sure the monitor and sensor stay dry at all times.LIMITATIONS OF COVERAGECardioNet’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 conrmed by a Certied Cardiac Technician (CCT).•  There is an inherent time delay from when the event is analyzed and conrmed 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 physician56  TroubleshootingCautions5.  T ROU BL E SHOO T I NG
WARNINGSFOR ADULT USE ONLYThe 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 SYSTEMAny patient whose life may be put at signicant risk by the unavailability of the telephone system should not be monitored by the CardioNet System. NOT AN APNEA MonitorThe CardioNet monitor is not to be used as an apnea monitor.USE ONLY WITH CARDIONET ELECTRODESWhile wearing the CardioNet sensor, use only electrodes provided by CardioNet.NOT AN EMERGENCY RESPONSE SERVICECardioNet is not an emergency response service. If you experience any symptoms that concern you, seek medical help.DO NOT TAMPER WITH DEVICEThere are no serviceable parts in the CardioNet System components. Removing the cover of any component may alter device performance.DO NOT TAMPER WITH Monitor BATTERYThe monitor battery can present a re 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 CORDDo 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 MONITORThe PC port is to be used only by CardioNet personnel.DO NOT USE NEAR FLAMMABLE ANESTHETICUnits are not to be used in the presence of ammable anesthetic. Troubleshooting  57Warnings5.  T ROU BL E SHOO T I NG
6SPECIFICATIONS,COMPLIANCE & SYMBOLSIn this Chapter:•  Specications•  Equipment Symbols•  In Home Requirements•  FCC Compliance
60  SpecificationsPHYSICALSensor 3 inches x 4 inches x 1 inch ; Weight: 4.0 oz. with batterySensor Neck Strap Adjustable 20 to 32 inchesMonitor 6 inches x 3 inches x  0.8 inches; Weight: 8 oz.LCD 2.27 inches x 1.7 inches; Touch screen: color, backlitBase 7 inches x 4 inches x 2.5 inches; Weight: 12 oz.FUNCTIONALSample Rate 250 samples per secondResolution 12 bitsDynamic range +/- 5 mVBandwidth 0.1 to 40 HzChannels 2Battery 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 ElectrodesTRANSMISSIONSensor 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. Tele-phone line modem, digital error corrected. OPERATING CONDITIONSOperating  Tempera- Sensor: 20 - 45 o C; Monitor ; 0 - 45 o COperating Humidity 10% - 95% noncondensingStorage Temperature -20 - 65 o C noncondensingStorage Humidity 5% - 95% noncondensingOperation Altitude 700 - 1060 millibarsSpecifications6 .  S PE C I F IC AT IONS
CONNECTIONSBase Power in (15V, 1.2A max); Phone in (RJ-11); Phone out (RJ-11)Monitor Power in (15V, 1.2A max)WALL ADAPTORManufacturer Friwo, Inc (15V, 1.0A)Model Number FW755M/15Note: Both the monitor and sensor are internally poweredSTANDARDS COMPLIANCEMonitor EN60601-1; AAMI EC-38; FCC Parts 2,15,22,24Sensor EN60601-1; AAMI EC-38; FCC Part 15Base EN60950; AAMI EC-38; FCC Part 15, 68AECG Equipment Type INote: 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 eld service technician for helpSpecifications  61Specifications6 .  S PE C I F IC AT IONS
Touch tone, pulse telephone or cellular / PCS wireless coverage suitable for data transmission AC powered outlet 1.2.FCC IDSensor ISM QBI-1008Monitor ISM QBI-1009Monitor Cell Modem Q9EQ2438F-MThis 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. 62  SpecificationsSNBF Type Equipment Consult Users Manual / Patient Education GuideSerial NumberEquipment SymbolsIn Home RequirementsFCC Compliance6 .  S PE C I F IC AT IONS
FCC COMPLIANCEFCC RULES PART 15The 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 harm-ful interference to radio communications.CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY CARDIONET INC. COULD VOID THE USER’S AUTHORITY TO OPERATE THE EQUIPMENTFCC RULES PART 68 REGISTRATIONModel 1004 complies with FCC Rules, Part 68. On this equipment is a label that contains, among other information, the FCC Part 68 registration number.RENThe 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 ve (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.SERVICEIn  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  ofce  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 species the type of network jack to be used.Specifications  63FCC Compliance6 .  S PE C I F IC AT IONS
FCC COMPLIANCEDISRUPTION OF THE NETWORKIf the Model 1004 disrupts the telephone network, the telephone company can discon-tinue 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 le a complaint with the FCC.TELEPHONE COMPANY FACILITY CHANGESThe 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 notied in advance so you have an opportunity to maintain uninterrupted telephone service.FCC RADIO FREQUENCY EXPOSURE INFORMATIONIn 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 regu-lated 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 an-tenna. Unauthorized antennas, damaged antennas, modications, 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 OPERATIONThis device was tested and was found to comply with the FCC exposure requirements. The device was also tested and found to comply with SAR (Specic Absorption Rate) testing.  For more information about RF exposure, please visit the FCC website at www.fcc.gov.64  SpecificationsFCC Compliance6 .  S PE C I F IC AT IONS

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