Cardionet 1006 Monitor User Manual PIM revB

Cardionet Monitor PIM revB

Contents

physicians instruction manual

1CONTENTSContact Information ................................................................................ 2Introduction ............................................................................................. 3Product Description ................................................................................. 4Service Overview ..................................................................................... 6Patient Enrollment ................................................................................... 8Electronic Patient Enrollment ................................................................ 10Indications and Contraindications.......................................................... 11Reports .................................................................................................. 12Physician Notification ............................................................................ 14Billing ..................................................................................................... 15Cautions and Warnings .......................................................................... 17Technical Specifications ......................................................................... 19Sample Forms and Reports ................................................................... 28DRAFT
2Copyright 2004All rights reservedLit Number - 100327 !!!!! Revision E !!!!! February 2004Caution: Federal law restricts this deviceto sale by or on the order of a physician.CONTACT INFORMATIONMain Number (215) 689-7450(866) 426-4404Patient Service Center (866) 727-3397 Physician Notification(866) 426-4401 Patient InquiriesEnrollment (866) 426-4403 FaxBilling (866) 426-4402
3INTRODUCTIONCardioNet: Mobile Cardiac Outpatient TelemetryCardioNet has developed a new, integrated technology andservice – Mobile Cardiac Outpatient Telemetry – which allowsheartbeat-by-heartbeat, ECG monitoring, analysis and response,at home or away, 24/7/365.CardioNet’s Mobile Cardiac Outpatient Telemetry assists physicians inthe diagnosis and management of difficult-to-diagnose arrhythmias.Given the infrequent and asymptomatic nature of some arrhythmias, itis often challenging to capture an actual arrhythmia with conventionalmonitoring technology, such as Holter and cardiac event monitoring.With the CardioNet System, we are able to automatically detect andcapture asymptomatic and symptomatic arrhythmias, based onmonitoring parameters defined by the prescribing physician. Inaddition, the patient can utilize the touch screen on the CardioNetmonitor to entertheir symptoms and activity level at the timeof a documented event. The physician thenreceives a representative ECG strip of theevent; a time and date stamp of the actualevent, including symptoms and activity, and istherefore able to make a more informed andaccurate diagnosis.CardioNet outpatienttelemetry offersphysicians a powerfulnew diagnostic andpatient managementtool for a wide range ofmonitoring indications.Physician ReceivesCardioNet ReportPatient Enters Symptomsand ActivitiesPatient Monitored24/7/365
4PRODUCT DESCRIPTIONCardioNet merges patient monitoring, wireless communications,and the Internet to allow targeted cardiac rhythm related problemsto be identified, quantified, and communicated to the prescribingphysician in a timely and efficient manner.The CardioNet System is comprised of a sensor, monitor, and base.The lightweight sensor is worn by the patient on a lanyard or beltclip, it continuously records two channels of ECG, and transmits theECG by a radio frequency (RF) link to the monitor. The sensor ispowered by a disposable alkaline battery, which typically lasts 24-36hours. While using the sensor, the patient is required to wear (3)disposable electrodes to record their ECG.The monitor is approximately the size of a PDA device. It has apowerful microprocessor, extensive memory, imbedded algorithm,LCD display, wireless modem, and a global positioning system(GPS). The monitor is powered by a rechargeable lithium battery,which typically lasts 18 hours.The monitor’s microprocessor is programmed to identify cardiacrhythm problems within guidelines established by the prescribingphysician. The algorithm detection parameters and physiciannotification criteria are individualized for each patient and physician.Sensor with Lead Wires
5The monitor continuously analyzes the ECG in real time as it istransmitted from the sensor. When an abnormal rhythm has beenidentified based on the monitoring parameters, the data is automaticallysent via a wireless modem to the CardioNet Patient Service Center foradditional review and interpretation by a certified monitoring specialist.In the case of a patient-initiated event, the monitor automaticallyprompts the patient to enter their symptoms and activities from apredetermined list on the touch screen display.When the patient is at home and an event occurs while the monitor is inthe base, the patient’s normal telephone line is used to transmit thedata. If an event occurs when the patient is in an area where cellularcoverage is inadequate, the patient may elect to transmit their ECGdirectly, using a regular telephone.The base utilizes an AC power supply and is connected to the patient’stelephone line. The base also consists of two antennas, which allows thepatient to have an expanded RF range within their home. When thepatient is mobile, the RF range or leash length between the monitor andsensor is estimated to be 25-50 feet. The sensor and monitor aredesigned to alert the patient if and when they are out of RF range orcellular coverage.The CardioNet monitor has sufficient memory to store a minimum oftwenty-four hours of the patient’s ECG. A daily protocol exists to uploadthe patient’s 24-hour ECG data, including related events and trends fromthe monitor to the Patient Service Center.CardioNet Monitor in Base
6SERVICE OVERVIEWFirst, the prescribing physician is registered in the CardioNet service. Allapplicable contact and demographic data is collected and inputted intothe CardioNet Patient Enrollment and Management System (PEMS) by aCardioNet representative. When a physician identifies a patient who isappropriate for CardioNet services, a patient enrollment is initiated byhis/her office, included is patient demographics, insurance information,indications for usage, duration, thresholds, and medical necessity whereapplicable. Upon completion, the enrollment form is submitted to thePatient Service Center – either by fax or Internet.For non Medicare patients, the physician practice may utilize the CPTcode 93799-26 when billing for the professional interpretation,including the narrative description “ECG arrhythmia detection and alarmsystem.” An individual payor may establish or recommend alternativecodes to be used to reflect the professional interpretation for CardioNetrelated services. The physician practice may wish to contact theirprovider representative to establish the appropriate billing requirementsfor CardioNet.Additionally, if you are currently required by the payor to provide areferral through the payor system you should continue to follow thatprocedure. Also if you are required to contact the payor for pre-authorization/authorization to provide professional interpretation fordiagnostic services continue to do so, this will also apply to CardioNet.When speaking to a payor or claims representative, it is important tonote that CardioNet is not a Holter or event monitor. CardioNet mobiletelemetry is a unique, proprietary technology and service offering, andis not the equivalent of any other monitoring technology or service.CardioNet will provide an in-home patient educator to train the patienton the use of the CardioNet System. CardioNet has a wealth ofresources including in-home educators and print and video trainingtools to insure the highest level of patient confidence and compliance.ImportantCardioNet outpatient telemetry is a diagnostic service, not anemergency response service. It is possible, however, that a patient maydevelop a life-threatening arrhythmia while on our service. If we detectsuch an event, CardioNet will attempt to assist the patient in accessingEMS services. Physicians should be aware that our ability to assistambulatory patients is limited by many factors including cell phonecoverage, the inherent limitations of GPS locating technology and localEMS policies.CardioNet provides awealth of educationaltools, including thePatient Education Guide,the Patient Pocket Guide,and a video.
7The CardioNet Patient Service Center is staffedwith highly qualified and experienced cardiacmonitoring specialists. At a minimum, allmonitoring specialists are CCT certified. They have extensiveexperience in cardiovascular monitoring; including the hospital basedC.C.U. and I.C.U. telemetry, emergency medical services, and othercardiac call center environments.As a Medicare provider, CardioNet is licensed as an IndependentDiagnostic Testing Facility (IDTF).The CardioNet monitoring specialists serve a vital role in responding topatient and monitor initiated cardiac events. The monitoring specialistsprovide a thorough preliminary analysis of the patient’s ECG to insurethat the data is accurate and presented in the appropriate time andmanner as requested by the physician.All calls are monitored and recorded for quality assurance. CardioNetrequires that all monitoring specialists participate in additional trainingand educational programs. A continuous QA process has beenestablished for all facets of the service center operation.The monitoring specialists, based on defined physician guidelines,prepare daily patient summary reports for final physician review andinterpretation. In the case of a patient notification threshold event, theprescribing physician is contacted immediately and an urgent report issubmitted for review and interpretation. Reports are tailored to theneeds and requirements of the physician and are sent via the Internet,facsimile, or standard mail.The CardioNet Patient Service Center is fully staffed and available 7x24,365 days of the year.Monitoring Specialists Reviewand Interpret Data to EnsureAccuracy
8PATIENT ENROLLMENTThe Patient Enrollment Form is located in the CardioNet PatientEnrollment and Management System (PEMS). The client can access theCardioNet Patient Enrollment and Management System application atwww.cardionet.com. This is a secure and restricted website and the useris required to be enrolled as a CardioNet client. Forms are also availablefrom the CardioNet Patient Service Center. If you are not a CardioNetregistered user, please contact the Patient Service Center.LoginPasswordPlease enter your username and password to log in.UsernameAfter you have entered your user name and password, click the log inbutton on your screen. You now have access to the CardioNet PatientEnrollment and Management System. The name of the client, physicianor practice should appear on the upper left of the PEMS application.You may also refer to the CardioNet Quick Start Guide for instructionson enrolling a patient.Using the CardioNet navigational tree on the left side, click onDocuments and Forms. A document tab will open with a list ofapplicable forms. Click on Patient Enrollment Form (MON300) and printa copy. Follow the same process and procedure for Patient PrescriptionForm (MON302). Each form must be completed to enroll a patient onCardioNet’s service.The Patient Enrollment Form includes patient demographics,emergency information, primary and secondary insurance, patientwaiver and assignment of benefits. Using this form please input all theappropriate information in the fields listed. In addition to any insuranceinformation that is listed on the form, please provide CardioNet with acopy (front and back) of the patient’s insurance card.The patient’s signature is required on all enrollment forms prior tosubmitting to CardioNet.Log in to access theCardioNet PatientEnrollment andManagement System.
9The Patient Prescription Form includes the patient name, prescribingphysician, physician group name, and duration of monitoring requested,diagnosis and ICD-9 code. Using this form input all the appropriateinformation in the fields listed. The prescribing physician is requiredto sign the CardioNet Patient Prescription Form prior to enrollingthe patient.Please fax both completed forms, including a copy of the patient’sinsurance card to the CardioNet Patient Service Center.The enrollment information will be entered into the CardioNet patientdatabase; the patient’s insurance carrier will be contacted forpreauthorization as required, upon approval, the delivery of theCardioNet System will be scheduled as soon as possible.Please see “Sample Forms and Reports” section of this manual forexamples of reports and forms.
10ELECTRONIC PATIENT ENROLLMENTCardioNet provides an additional method for enrolling patients in ourservice, electronic enrollment. If the user prefers to use CardioNet’selectronic enrollment process, you can access the CardioNet PatientEnrollment and Management System (PEMS) application atwww.cardionet.com. Use the Physician Log In and enter the usernameand password, and then click on Enroll Patient. The application will opento Patient Demographics. Please be advised that all fields andapplicable tabs (Emergency and Insurance Information) must becompleted prior to submitting an electronic enrollment.Note: Electronic Patient Enrollment is not currently an activeapplication in PEMS.Enroll Patient Online
11CARDIONET AMBULATORY ECG MONITORWITH ARRHYTHMIA DETECTORIndications for Use1. Patients who have demonstrated a need for cardiac monitoring andare at low risk of developing primary ventricular fibrillation orsustained ventricular tachycardia2. Patients with dizziness or light-headedness3. Patients with palpitations4. Patients with syncope of unknown etiology5. Patients who require monitoring for non life-threatening arrhythmias,such as atrial fibrillation, other supraventricular arrhythmias,evaluation of various bradyarrhythmias and intermittentbundle branch block. This includes postoperative monitoring forthese rhythms6. Patients recovering from coronary artery bypass graft (CABG) surgerywho require monitoring for arrhythmias7. Patients requiring monitoring for arrhythmias inducing co-morbidconditions such as hyperthyroidism or chronic lung disease8. Patients with obstructive sleep apnea to evaluate possiblenocturnal arrhythmias9. Patients requiring arrhythmia evaluation for etiology of stroke ortransient cerebral ischemia, possibly secondary to atrial fibrillation10. Data from the device may be used by another device to analyzemeasure or report QT interval. The device is not intended to soundany alarms for QT interval changes.Contraindications1. Patients who have a history of sustained ventricular tachycardia or adocumented occurrence of ventricular fibrillation2. Patients who the attending physician thinks will be at risk forventricular tachycardia or ventricular fibrillation as indicatedby the following:!A measured ejection fraction of less than 35% with complexventricular ectopic activity (>= 10 PVCs per hour orrepetitive PVCs)!Unstable angina defined as chest pain at rest, a new onset ofangina, or a change in existing patterns of angina!Patients with a recent (<= 3 months) myocardial infarction (MI)!Patients who are candidates for or have had recent heartvalve surgery3. Patients who the attending physician thinks should be hospitalized.
12REPORTSWhen a physician group and/or physician is enrolled in CardioNet’sservice, preferred reporting methods for different events (Internet,fax, mail or telephone) are established for each physician user.Physicians may elect to modify or change their preferred reportdelivery methods by selecting “Modify Physician” in the CardioNetPatient Enrollment and Management System, or contacting theCardioNet Patient Service Center directly.Fax or mail reports are forwarded to the physician by the CardioNetPatient Service Center. To access Patient Reports using PEMS, the usermust log in to www.cardionet.com. . . . . Use the Physician Log In, and enterthe user name and password. The name of the physician practice orphysician will appear in the top left of your screen. Using thenavigational tool bar on the left side, please click on Active Patients.A list of all active patients will appear under the Patient Reports tab.Included with a list of active patients will be the type of report, date ofreport, report delivery method, time and date the report was sent fromthe Patient Service Center, and a confirmation to indicate that the userhas either read or needs to review the report listed. To select a patientreport you wish to review, click on the patient’s name.Note: The user must have Adobe Acrobat Reader in order to view andprint a CardioNet patient report.CardioNet provides reports for physician review, such as the:Urgent Notification Mobile Telemetry and Daily Mobile Telemetry.An Urgent Report is provided to the physician when a patient has anevent, symptomatic or asymptomatic, that meets the physician definednotification threshold. The Daily Report is provided to the prescribingphysician for each day the patient is on service with CardioNet. TheDaily Report includes a heart rate trend graph and selected patientevents for the previous 24-hour period.
13A Representative ECG for the Urgent ReportThe Urgent Report provides a six second sample of the patient’s ECG,Channel 1 and 2. The report includes a time and date stamp of theactual event, preliminary findings of the CardioNet monitoringspecialist, symptoms and activities reported by the patient, and how theevent was initiated, automatic or patient initiated.Note: The Patient Service Center has an established procedure forcontacting the prescribing physician in advance of receiving anUrgent Notification Mobile Telemetry Report. Escalation and notificationprotocols have been approved by the Patient Center Medical Director todeal with Emergency, Urgent, and Daily patient events. Refer toPhysician Notification Order Form (MON305). Each client or physician aspart of the CardioNet enrollment process is responsible for providingappropriate contact numbers for normal business hours, after hours,weekends and holidays.The client or physician user can request additional ECG data from thePatient Service Center to support a particular event or report.Please see “Sample Forms and Reports” section of this manual forexamples of reports and forms.
14PHYSICIAN NOTIFICATIONAs part of the CardioNet client enrollment process, the PhysicianNotification criteria will be established for the client (physician practice)or individual prescribing physician. The Physician Notification OrderForm (MON305) is to be completed and signed prior to enrolling apatient on CardioNet’s service. CardioNet’s Medical Advisory Boardprovides a set of default values based on established clinical practicemonitoring guidelines.An Emergency notification threshold cannot be downgraded forphysician notification purposes. The physician may elect to changeor modify an Urgent or Daily patient event threshold to a higherpriority notification.Please see “Sample Forms and Reports” section of this manual forexamples of reports and forms.Modifying Physician NotificationA physician may request that the notification criteria be changed ormodified for a particular patient at the time a patient is enrolled orduring the course of monitoring. If the patient is being activelymonitored, the client must complete and sign a Physician NotificationChange Order (MON306). Upon receipt of the form by the PatientService Center, it will be reviewed and approved by a clinical manager.The change will be noted in the patient’s medical record and themonitor will be reconfigured to reflect the change where applicable.The Patient Prescription Form (MON302) should be used when enrollinga new patient on the CardioNet service. Refer to Patient Enrollment.
15BILLINGThe patient is responsible for providing the CardioNet Patient ServiceCenter with all applicable insurance information at the time ofenrollment. CardioNet will bill the patient’s primary insurance company.In addition, CardioNet will also bill the secondary insurance company, ifprovided by the patient. A copy of the patient’s insurance card is to beprovided with the enrollment. The patient/responsible party/legalguardian is required to sign the Patient Enrollment Form.CardioNet will bill the insurance company for only those servicesprovided directly by CardioNet to the patient. In most cases, this isdefined as the technical component, which includes monitoring and allequipment required to monitor the patient. The physician is responsiblefor billing the patient’s insurance carrier for the professional component,which is defined as the physician interpretation.Insurance Verification and BenefitCardioNet requires that a patient’s insurance coverage is confirmed andbenefits are verified. If the insurance verification determines thatservices requires a pre-authorization CardioNet takes the appropriatestep to comply with the insurance company. It is imperative that thePhysician always complies with the requirements of the InsuranceCompany regarding the referral process and subsequent pre-authorization/authorization as determined by the patient/membersbenefit plan. If additional information (certificate of medical necessity,etc.) by the insurance company is required to obtain authorization,CardioNet will immediately contact the prescribing physician. IfCardioNet is not able to obtain authorization from the insurancecompany to provide services for the patient, the prescribing physicianand patient will be notified immediately. The patient may then elect tocontinue on service with CardioNet, and therefore would assume 100%financial responsibility for all related charges.CardioNet has established an appropriate set-up and technical fee forMobile Cardiac Outpatient Telemetry. Medicare in the state ofPennsylvania established a new policy (M-60) on February 11, 2002, toaddress “Real-Time Cardiac Surveillance System.” Please review theLMRP M-60 policy description, indications and limitations, and/ormedical necessity.
16Physician Reimbursement Coding GuidelinesThe LMRP determined that no existing CPT code fully and accuratelydescribes this new technology; therefore services should be reportedby using CPT Code 93799 and include the narrative “ECG arrhythmiadetection and alarm system.” Providers are instructed to bill one (1) unitof procedure code 93799, per day of cardiac surveillance.The TC (Technical) and 26 (Professional) modifiers should be usedwith CPT Code 93799 to identify what component of the monitoringwas performed.The Professional Component includes review and interpretation of each24-hour cardiac surveillance as well as 24-hour availability and responseto surveillance events.CardioNet, based on relevant policies and procedures from all non-Medicare insurance providers, will bill for its services in a similar manner,unless otherwise instructed.Patient ResponsibilityCardioNet has established an initial set-up and technical fee for MobileCardiac Outpatient Telemetry. CardioNet will bill the patient’s insurancecompany for the intended service duration as defined by theprescribing physician. In certain instances, the patient’s insurancecompany may regard CardioNet as an out of network provider. It is notour intent to penalize the patient if their insurance company regardsCardioNet as an out of network provider. CardioNet will continue to billand collect from the patient all applicable co-payments anddeductibles. CardioNet will make every reasonable effort to insure thatthe patient’s financial responsibility will not exceed their normal in planbenefits. With the exception of Medicare, CardioNet will obtaininsurance pre-authorization for all services to be provided by CardioNet.All services will be billed to the applicable parties upon completion ofthe prescribed service period, or upon discontinuation of service asrequested by the physician, patient, or insurance company.
17PRECAUTIONSDispose 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. Damagefrom corrosion could result.Avoid Electromagnetic InterferenceFor the best recording results, you should avoid close proximity to heavyequipment or other sources of electromagnetic interference such aselectric blankets, heating pads, water beds, etc.Potential for Electromagnetic InterferenceThere is a potential for electromagnetic interference to other deviceswhile using the CardioNet service.The CardioNet system with implanted pacemakersand ICDs (defibrillators)If you have an implanted pacemaker or defibrillator (ICD), themanufacturer may have recommended you take certain precautionswhen using a cellular phone. Since the CardioNet monitor contains acellular phone, you should take the same precautions when carrying andusing the monitor. In general, most manufacturers recommend thefollowing:! Keep a distance of at least six inches (15 cm) between the cellularphone and a pacemaker or defibrillator.!Hold the cellular phone on the opposite side of the body from thepacemaker or defibrillator.!Don’t carry a cellular phone in a breast pocket or on a belt if thatwould place the phone within six inches of the pacemaker ordefibrillator.
18CAUTIONS AND WARNINGSCaution: Power Down and Remove Sensor Before ShoweringPower down the monitor and remove the sensor before showering.While the CardioNet sensor and monitor are water resistant, they are notwaterproof. Refer to the Patient Education Guide for completeinstruction on removal and reapplication before showering.Caution: Do Not Get the Monitor and Sensor WetMake sure the monitor and sensor stay dry at all times.Warning: For Adult Use OnlyThe CardioNet Monitoring System is intended for Adult use only. It shallnot be used on infants weighing less than 22 lbs.Warning: Use with Telephone SystemAny patient whose life may be put at significant risk by the unavailabilityof the telephone system should not be monitored by the CardioNetSystem.Warning: Not an Apnea MonitorThe CardioNet monitor is not to be used as an apnea monitor.Warning: Use Only CardioNet ElectrodesWhile wearing the CardioNet sensor, use only electrodes provided byCardioNet.Warning: Do Not TamperThere are no serviceable parts in the CardioNet System. Removing thecover of any of component may alter performance.Warning: Do Not Tamper with Monitor BatteryThe monitor battery can present a fire or chemical burn hazard ifmistreated. Do not disassemble, heat above 80C (176 F), incinerate, orrecharge using any device other than the base.Warning: Use Only CardioNet Wall AdapterDo not use any wall adapter for the base other than the one provided inthe CardioNet Service Kit.Warning: Do Not Connect Any Device to the PC Port on theBack of the BaseThe PC port is to be used only by CardioNet personnel.
19TECHNICAL SPECIFICATIONSPhysicalSensor2.7 in. x 0.9 in heightWeight: 2.2 ozSensor neck strap24 in.Monitor5.8 in x 3.0 in x 1.1 inWeight: 12.8 ozLCD3.0 x 2.3, touch screen, monochrome, backlightBase7.8 in x 4.3 in x 6.1 inWeight: 13.3 ozFunctionalSample Rate 250 samples per secondResolution 12 bitsDynamic Range + / -5 mVBandwidth 0.5 to 40 HzChannels 2Battery Life Monitor: (12-16 hours average with cleared memoryand fully recharged battery), rechargeable Sensor:(24 hr) AA AlkalineLeakage current Less than .1 µ V ElectrodesTransmissionSensor to Monitor 900 MHz ISM band RF transmission, digital error cor-rected. 30 foot range, retransmission if data is corrupted.Monitor to Center CDMA (PCS & cellular) wireless, digital error corrected.Telephone line modem, digital error corrected. Acoustictransmission, 1500 Hz center frequency, 8 bits resolution, 5 mV dynamic range. ECG recording intervals vary bytype of event; the minimum is 15 seconds pre-event and45 seconds post event. Wireless transmission subject tocoverage of cellular network. Data received at MonitoringCenter within minutes with good wireless coverage and/ormodem communications. Urgent reports processed attime of data receipt. Daily reports processed oncea day, by 3 PM.
20Operating conditionsOperating temperature 20 - 45 o COperating humidity 10% - 95%, noncondensingStorage temperature -20 - 55 o C, noncondensingStorage humidity 5% - 95%, noncondensingOperation altitude 700-1060 millibarsFluid Ingress Rating IPX1Note: Please protect the monitor and sensor from water and other fluids. ConnectorsBase Power in (15V, 1.2A max)Phone in (RJ-11)Phone out (RJ-11)Monitor Power in (15V, 1.2A max)Wall AdapterManufacturer Friwo, Inc. (15V, 1.0A)Model number FW7555M/15Note: Both the Monitor and Sensor are internally poweredcontinuous operation devices.
21Standards ComplianceMonitor EN60601-1AAMI EC-38FCC parts 2, 15, 22, 24Sensor EN60601-1AAMI EC-38FCC part 15Base EN60950AAMI EC-38FCC part 15, 68AECG Equipment Class IINote: This equipment has been tested and found to comply with the limitsfor medical devices to the IEC 601-1-2:1993, EN60601-1-2:1994, MedicalDevice Directive 93/42/EEC or the Electromagnetic CompatibilityDirective 89/336/EEC (use applicable directive). These limits aredesigned to provide reasonable protection against harmful interference ina typical medical installation. This equipment generates, uses and canradiate radio frequency energy and, if not installed and used inaccordance with the instructions, may cause harmful interference to otherdevices in the vicinity. However, there is no guarantee that interference willnot occur in a particular installation. If this equipment does cause harmfulinterference to other devices, which can be determined by turning theequipment off and on, the user is encouraged to try to correct theinterference 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 circuitdifferent from that to which the other device(s)are connected. ! Consult the manufacturer or field service technicianfor helpUL ListedThe CardioNet monitor and base have been tested to UL 2601,No. EN60601-1.The CardioNet base is compliant with EN60950.
22EQUIPMENT SYMBOLSSNConsult ManualYear of ManufactureType BF EquipmentSerial Number2000HARDWARE REQUIREMENTSIn Home RequirementsTouch tone telephoneAC powered outletFCC IDSensor QBI-1007Monitor QBI-1006Monitor cell NBZNRM-6832Base CARDT00B42061
23ARRYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSISThe CardioNet System incorporates an arrhythmia analysis algorithmwhose performance is presented below:The algorithm results were obtained from the respective databasesin strict accordance with EC-57 and with 0% downtime onboth databases.Performance Measure MIT Arrhythmia Database AHA DatabaseQRS Detection Sensitivity % 99.93 99.88QRS Detection Positive Predictivity % 99.85 99.89PVC Detection Sensitivity % 95.44 94.07PVC Detection Positive Predictivity % 96.94 97.72PVC Detection False Positive Rate % 0.229 0.222
24HEART RATE MEASUREMENT REPORTThe performance of the analysis algorithm for heart rate detection onstandard databases is shown below. The average RMS errors for theAHA, MIT-arrhythmia, and NST databases are 2.08%, 1.07%, and30.9% respectively.Heart Rate CalculationThe average heart rate is calculated by computing the mean of the actualRR-intervals, in the last 6 seconds or 8 RR-intervals (whatever is shorter).The actual RR intervals are calculated based on the QRS detected events:Actual RR = the time between the last detected QRS complexand the previously detected QRS complex, in millisecondsIn the CardioNet reports, the heart rate displayed on the ECG stripsthemselves is the average of the rate for the beats displayed in that strip.AHA ECG Database (Summary of results from 78 records)ErrSum RefSu Nmeas MeanRefHR RMSerror(%)Sum 130111.6913 2167402.8283 26706Gross 81.15792.7197 2.7197Average 81.4511 2.0762MIT-BIH Arrhythmia Database (Summary of results from 44 records)ErrSum RefSu Nmeas MeanRefHR RMSerror(%)Sum 25694.4788 1016331.6122 13030Gross 77.9994 1.8003Average 78.0769 1.0691NST Database (Summary of results from 12 records)ErrSum RefSu Nmeas MeanRefHR RMSerror(%)Sum 3098725.4772 266364.2826 3576Gross 74.4867 39.5198Average 74.4867 30.8921
25RUN-BY-RUN REPORTAHA ECG DatabaseRecord CTs CFN CTp CFP STs SFN STp SFP LTs LFN LTp LFP CSe C+P SSe S+P LSe L+PSum 904 95 1048 35 379 85 487 12 26 53 75 4Gross 90 97 82 98 33 95Average 72 78 55 97 76 91Total couplets: 999Total short runs: 464Total long runs: 79MIT-BIH Arrhythmia DatabaseRecord CTs CFN CTp CFP STs SFN STp SFP LTs LFN LTp LFP CSe C+P SSe S+P LSe L+PSum 564 84 575 35 32 20 42 5 10 3 15 0Gross 87 94 62 89 77 100Average 78 74 60 87 78 100Total couplets: 648Total short runs: 52Total long runs: 13VENTRICULAR FIBRILLATION EPISODE REPORTAHA VF DetectionRecord TPs FN TPp FP ESe E+P DSe D+P Ref duration Test durationSum 9 0 26 0 1:28:50.140 1:10:59.646Gross 100 100 79 99Average 100 100 77 96Summary of results from 78 recordsMIT-BIH DetectionRecord TPs FN TPp FP ESe E+P DSe D+P Ref duration Test durationSum 1 0 1 0 1:37.900 1:44.032Gross 100 100 91 86Average 100 100 92 86Summary of results from 44 recordsCU DetectionRecord TPs FN TPp FP ESe E+P DSe D+P Ref duration Test durationSum 26 5 28 2 40:38.772 24:55.332Gross 84 93 53 86Average 87 96 52 76Summary of results from 30 recordsPACEMAKER DETECTION RESULTSPacemaker detection: Meets AAMI EC38
26FCC and Industry Canada (CS-03) ComplianceThis device complies with part 15 and 68 of the FCC Rules. Operationis subject to the following two conditions: (1) This device may notcause harmful interference and, (2) This device must acceptinterference received including interference that may cause undesiredoperation.FCC Rules Part 15The Model 1001 has been tested and complies with the limits for aclass A digital device, pursuant to Part 15 of the FCC Rules. Theselimits are designed to provide reasonable protection against harmfulinterference when the equipment is operated in a residentialenvironment. This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with theinstruction manual, can cause harmful interference to radiocommunications.CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BYCardioNet Inc. COULD VOID THE USER’S AUTHORITY TO OPERATETHE EQUIPMENT.FCC Rules Part 68FCC Part 68 RegistrationThe Model 1001 complies with FCC Rules, Part 68. On this equipmentis a label that contains, among other information, the FCC Part 68registration number.RENThe ringer equivalence number (REN) is used to determine the qualityof devices that may be connected to the telephone line. ExcessiveRENs on the telephone line may result in the devices not ringing inresponse to an incoming call. In most, but not all areas, the sum ofRENs should not exceed five (5.0). To be certain of the number ofdevices that may be connected to a line, as determined by the totalRENs, contact the local telephone company.Note: RENs are associated with loop-start and ground-start ports. It isnot used for E&M and digital ports. The REN assigned to the Model1001 is 0.01 B. If requested, this information must be given to thetelephone company.
27ServiceIn the event of equipment malfunction, all repairs should beperformed by CardioNet Inc. or an authorized agent. It is theresponsibility of users requiring service to report the need for serviceto CardioNet Inc. or to one of our authorized agents. Service can befacilitated through our office at:CardioNet Inc.510 Market St.San Diego, CA 92101619-243-7500The telephone company can ask you to disconnect the equipmentfrom the network until the problem is corrected or until you are surethat the equipment is not malfunctioning.The Model 1001 interface connects to the Public Switched TelephoneNetwork through a FCC registered NCTE which specifies the type ofnetwork jack to be used.Disruption of the NetworkIf the Model 1001 disrupts the telephone network, the telephonecompany can discontinue your service temporarily. If possible, thetelephone company will notify you in advance. If advance notice is notpractical, they will notify you as soon as possible. You are alsoinformed of your right to file 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 yourequipment. If they do, you should be notified in advance so you havean opportunity to maintain uninterrupted telephone service.FCC RADIO FREQUENCY EXPOSURE INFORMATIONIn August 1996, the Federal Communication Commission (FCC) of theUnited States, with its action in Report and Order FCC 96-326,adopted an updated safety standard for human exposure to radiofrequency (RF) electromagnetic energy emitted by FCC regulatedtransmitters. Those guidelines are consistent with the safety standardpreviously set by both U.S. and international standards bodies. Thedesign of this device complies with the FCC guidelines and theseinternational standards.Use only the supplied antenna. Unauthorized antennas, damagedantennas, modifications, or attachments could impair call quality,damage the device, or result in violation of FCC regulations. Pleasecontact CardioNet if damage to the unit is apparent.
28BODY-WORN OPERATIONThis device was tested with the softcase sup-plied by CardioNet as an accessory to thisdevice and was found to comply with theFCC exposure requirements.When operating this device, a minimum separation distance of 1.5 cmmust be maintained between the users body and the monitor,including its antenna, to comply with the FCC exposure limits.To maintain compliance with FCC RF exposure requirement, use onlycarrying accessories that maintain a 1.5 cm separation distancebetween the user’s body and the device, including the antenna. Thesecarrying accessories should not containmetallic components in its assembly. The use of carrying accessoriesthat do not satisfy these requirements may not comply with FCC RFexposure requirements, and should be avoided.This particular device has not been designed for held-to-ear use andshould never be used against the ear.For more information about RF exposure, please visit the FCC websiteat www.fcc.gov .
29SAMPLE FORMS AND REPORTSExamples of the forms listed below follow.!Patient Enrollment Form!Physician Enrollment Form!Client Enrollment Form!Patient Prescription Form!Physician Notification Orders Form!Physician Notification Change Orders Form!Daily Mobile Report!Urgent Mobile Telemetry Report!End of Service ReportTo access electronic versions of forms and reports, log onto www.cardionet.com.....

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