Cardionet 1002 User Manual CN Physicians Guide 2001

Cardionet CN Physicians Guide 2001

manual

CardioNet Ambulatory ECG Systemand Arrhythmia DetectorDocument Number - 100008Revision EModel Number 1001Physician’s Operation ManualCAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BYOR ON THE ORDER OF A PHYSICIAN
Table of ContentsCardioNet AECG SystemiSection I - Clinician InstructionsOverviewDescriptionIndications for UseContraindications for UsePrecautionsFeaturesOperation FeaturesPhysical FeaturesPreparing the CardioNet SystemConfiguring the Monitor - Patient ProfileDownloading the Monitor - Patient Profile to the MonitorPreparing the PatientElectrode ApplicationCardioNet Electrode and Lead PlacementEducate the PatientInstruct the PatientReview of FeaturesEntering Symptoms and ActivitiesChanging Monitor OptionsViewing Monitor StatusInstalling the BaseRecharging the MonitorDownloading ECGService and MaintenanceTroubleshootingSpecificationsEquipment SymbolsSection II - Physician InstructionsAutomatic Download PreferencesArrhythmia Detection PreferencesDisclosure of Technical Performance SpecificationDisclosure of Technical Performance Specification (con’t)1223456678889910111212131415161616171819202122232425
CardioNet AECG System1Section IClinicianInstructionsSection I is for clinicians such as nurses and / or technicianswho will be the providing the education and instruction forpatients starting on the CardioNet Service. Included in this section are instructions for preparing andeducating the patient for successful CardioNet Monitoring.Also included in this section are instructions, tools, andhelpful hints to guide clinicians through maintenance andconfiguration of the CardioNet Monitor.
CardioNet AECG System2Overview DescriptionThe CardioNet Monitoring System 1001 is a battery operated,ambulatory arrhythmia detector designed for continuous 24 hour, 7 dayper week ECG monitoring. The CardioNet Monitoring System consists ofthree components; a Sensor, a Monitor and a Base. The CardioNetSystem provides a practical and convenient method for collectingdiagnostic ECGs over an extended period of time. The CardioNet Monitoring System has the capability to record, store andtransmit ECG and event data. The ECG and event data is continuouslyrecorded in digital flash memory within the device. The System containsan on board algorithm, which performs of real time ECG analysis andarrhythmia detection. When an event occurs, whether it is symptomaticor asymptomatic, the Monitor automatically sends the ECG data to theCardioNet Monitoring Center either via the built in cellular phone or theland line telephone connection of the base.The multi-lead design provides enhanced ECG waveform definition andenables a more effective identification of artifact. With a sampling rate of250 measurements per second and 12 bit A to D, the device produces thenecessary amplitude and resolution to detect very fast QRS complexesseen in some atrial arrhythmias.The LCD display with touch panel enables all users to easily control avariety of functions, so that operation of the device is tailored to the needsof the physician, the patient and the clinician.The CardioNet System: Monitor, Sensor and Base
CardioNet AECG System3 Indications for UseThe CardioNet system is for use on low risk arrhythmia patients andspecific indications for use are as follows:1) Patients who have demonstrated a need for cardiac monitoring andare at low risk of developing primary ventricular fibrillation or sustainedventricular tachycardia2) Patients with dizziness or lightheadedness3) 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 ofvarious bradyarrhythmias and intermittent bundle branch block6) 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 possible nocturnalarrhythmias9) Patients requiring arrhythmia evaluation for etiology of stroke ortransient cerebral ischemia, possibility secondary to atrial fibrillation 10) Data from the device may be used by another device to analyze,measure or report QT interval. This device does not sound any alarms forQT interval changes
CardioNet AECG System4 Contraindications for UseThe CardioNet system is for use on low risk arrhythmia patients andis contraindicated for use on the following patients:1) Patients who have a history of sustained ventricular tachycardia or adocumented occurrence of ventricular fibrillation2) Patients the attending physician thinks will be at risk for ventriculartachycardia or ventricular fibrillation as indicated by the following:-A measured ejection fraction (EF) less than 35% with complexventricular ectopic activity (>10 PVCs per hour or repetitivePVCs)- 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 a recent heart valve surgery3) Patients who the attending physician thinks should be hospitalized
PrecautionsCardioNet AECG System5Warnings and CautionsCaution: Power Down and Remove Before ShoweringWhile the CardioNet Sensor and Monitor are water resistant, they arenot water proof. Patients must be instructed to turn the Monitor offand remove both the Sensor and Monitor before showering orswimming. Refer to page 11 for instruction on removal andreapplication. Warning: For Adult Use OnlyThe CardioNet Monitoring System is intended for Adult use only. Itshall not be used on infants weighing less then 22 lbs.Warning: Any patient whose life may be put at significant risk by theunavailability of the telephone system should not be monitored by theCardioNet System.Warning: The CardioNet Monitor is not to be used as an apneamonitor.Warning: Do not use any telephone other than the phone that isconnected to the CardioNet Base while the patient is beingmonitored. If dialing tones are heard in a remote telephone, hang upimmediately to allow the CardioNet Monitor to dial the MonitoringCenter.Warning: There are no serviceable parts in the CardioNet System.Removing the cover of any of component (other than the batterycompartment) may alter performance.Patient leads must be removed before external defibrillation.Observe all local laws for the disposal of alkalinebatteries.Do not leave the battery in the Sensor when it is not in use.Damage from corrosion could result.For the best recording results, the patient should be instructedto avoid close proximity to heavy equipment or other sources ofelectromagnetic interference such as electric blankets, heatingpads, etc.
FeaturesCardioNet AECG System6 Operation FeaturesThe CardioNet Monitor has two separate components: the Sensorand the Monitor. The Sensor is worn by the patient and acquiresECG data from the electrodes. The Monitor can be worn by thepatient or can be located up to 30 feet away. The Monitor receivesthe ECG data from the Sensor and performs real time arrhythmiaanalysis. When an event occurs, (either symptomatic orasymptomatic) the Monitor attempts to call the CardioNetMonitoring Center via either the cell phone or telephone land lineand to transmit the event for review by trained CardioNetpersonnel. CardioNet Sensor without leads CardioNetSensor with leadsCardioNet Monitor
CardioNet AECG System7 Physical FeaturesDuring monitoring, the CardioNet System has several features to ensure ease of use and patient compliance.LED Indicator: Blinks green to indicate Monitor is activelyanalyzing ECG data. Blinks red to indicate Monitor is not collectingand analyzing ECG data.Ear Speaker: Voice communications will be heard through the earspeaker when the Monitor is not in the Base.Touch Screen: Interactive touch screen menus allow patients toenter symptoms, record activities, adjust Monitor settings and view Monitor status. Speaker phone: Voice communications will be heard through thespeaker phone when the Monitor is in the Base. On / Off / Wake: Turns the Monitor on or off and wakes fromstandby mode.
Preparing the CardioNet SystemCardioNet AECG System8 Configure Monitor - Patient ProfileThe Monitor-Patient profile consists of information specific to thepatient. Each profile is determined by the physician prior tomonitor placement as part of the monitoring prescription. AMonitor-Patient profile will contain information regarding Monitorscreen preferences, automatic download time preferences andautomatic threshold levels. Physicians can customize a MonitorPatient profile for a patient or can chose the default settings.Please refer to the physician’s prescription prior to choosing yourpatient’s Profile settings. Download Monitor - Patient Profile to MonitorChoose any Cardionet System for placement on a patient. Placethe Monitor into a Base connected to the computer that has beendesignated as a the CardioNet Utility PC. Open the softwareapplication on the computer’s desktop listed as “CardioNet”. Oncethe Monitor is placed in the Base, the CardioNet software willsupply a list of your physician’s patients waiting to receive aCardioNet Monitoring System. The Software will prompt theclinician to select the patient who will be receiving the System. After the patient selection has been made, the default Monitor -Patient Profile will be displayed. Any changes to the Profile asindicated by the physician on the prescription can be made at thistime (physicians refer Physician Instructions, pg III). Once allchoices have been indicated, the software will display aconfirmation notification indicating the Monitor is ready forplacement on the selected patient.
Preparing the PatientCardioNet AECG System9 Electrode ApplicationWith CardioNet’s on board analysis of ECG, proper electrode andlead placement is imperative to achieve good results. The diagramon the following page demonstrates CardioNet’s recommendedplacement for the electrodes, the leads and the Sensor. However,optimum electrode placement may vary slightly according topatient body shape and size. Verify good quality baseline ECGsignals after placing electrodes.Use only electrodes supplied by CardioNet or ones designed forlonger term monitoring. Proper preparation of the patient’s skin isabsolutely essential for obtaining a quality ECG recording. Referto your electrode provider for instructions on proper skinpreparation.Correct application of the electrodes, demonstrated on thefollowing pages, is imperative for proper ECG analysis. Pleaserefer to the diagram for accurate placement.
CardioNet AECG System10 CardioNet Electrode and Lead PlacementCH 1 -CH 1 +CH 2 -CH 2 +CH 3 -CH 3 +White lead: Center of the right clavicleBlack lead: Center of the left clavicleRed lead: Left anterior axillary line, in the 7th to 8th intercostal space. *Optimum electrode placement may vary slightly according topatient body shape and size. Verify good quality baseline ECGsignals after placing electrodes.* Tape may be used to secure the lead wires in the event ofexcess signal noise on the ECG.
11 Educate the patientExplain the preparation and the position for proper electrode placement.Explain that if any electrode loses contact or dries out during themonitoring process it must be replaced immediately. Additionally, theCardioNet Monitor will recognize when leads are disconnected or wornout and will alert the patient.Explain that new electrodes should be examined prior to application.Electrodes with dried gel should not be used. Show the patient how to install a fresh AA battery into the Sensor. Explain reattachment of the Sensor lead set to the electrodes. Show thepatient how to connect the lead set and secure the lead wires. Explain that the Sensor and the Monitor MAY NOT be worn duringshowering or swimming. The adhesive electrodes ONLY may be worn inthe shower, but they should not get soaked. The skin around theelectrodes should be gently washed and the electrodes repressed to theskin after drying. Power down and remove before showering:1) Press the On / Off / Wake button located on the front of the Monitor. 2) Touch the Options button on the LCD screen.3) Touch the Monitor Power button on the LCD screen.4) Touch the Off button on the LCD screen. 5) At the prompt for confirmation of you choice, press OK on the LCDscreen to turn power off.6) Wait for the Monitor to completely power down. The LCD screen willindicate the Monitor is turning off and then become blank.7) Remove the battery from the Sensor8) Remove the Sensor leads from the electrodes. The patient maychoose to wear the electrodes during a shower or remove the electrodesand apply a new set before reattaching the Sensor. After Showering:1) Re-press electrodes worn during showering or apply new electrodes.2) Reattach the Sensor to the electrodes and replace Sensor battery.3) Turn the Monitor on to resume monitoring by pushing the On/ Off/Wake button located on the front of the Monitor.
Instruct the PatientCardioNet AECG System12Instructing the patient on the operations and functions of theCardioNet Monitoring System is a key component of successfulmonitoring. The following includes instructions for interaction withthe CardioNet Monitor, including entering symptoms and activities,changing Monitor options, and viewing Monitor status. Review of featuresLED Indicator: Blinks green to indicate Monitor is activelyanalyzing ECG data. Blinks red to indicate Monitor is not collectingand analyzing ECG data.Ear Speaker: Voice communications will be heard through the earspeaker when the Monitor is not in the Base.Touch Screen: Interactive touch screen menus allow patients toenter symptoms, record activities, adjust Monitor settings and view Monitor status. Speaker phone: Voice communications will be heard through thespeaker phone when the Monitor is in the Base. On / Off / Wake: Turns the Monitor on or off and wakes fromstandby mode.
CardioNet AECG System13 Entering Symptoms and ActivitiesMain MenuWhen the patient touches the RecordSymptoms area on the screen with theirfingertip, the Symptoms Menu will appearand the patient will be prompted to make aselection. Symptoms MenuPatients have four choices to select forsymptoms on the Symptoms Menu. One ormore symptoms can be selected. The < Back selection will return the patientto the Main MenuThe Next > selection will advance thepatient to the Activity MenuActivity MenuPatients have four choices to select forsymptoms on the Symptoms Menu. Onlyone activity can be selected from theActivity Menu. The < Back selection will return the patientto the Symptoms MenuThe Done > selection will return the patientto the Main Menu
CardioNet AECG System14 Changing Monitor OptionsMain MenuWhen the patient touches the options areaon the screen with their fingertip, theOptions Menu will appear and the patientwill be prompted to make a selection. VolumeThe Volume option allows the patient threeaudible tones: high, medium, and low anda vibrate option.ContrastThe Contrast option allows the patient toadjust the contrast of the screen to high,medium or low when better viewing isnecessary. Cellular PowerThe Cellular Power option allows thepatient to turn the cell phone in the Monitoroff or on. When the cell phone is off, theMonitor is still recording, but no automatictransmissions can be made to theCardioNet Monitoring Center unless theMonitor is placed in the base. Monitor PowerThe Monitor Power option allows thepatient to turn the monitor off. This isrecommended any time the patient wantsto shower, swim or change electrodes.TheMonitor will not record ECG data when thepower is off.
CardioNet AECG System15 Viewing Monitor StatusMain MenuWhen the patient touches the icons area onthe screen with their fingertip, the screenwill provide more in-depth information onbattery power or cell signal strength. Battery PowerThe battery power screenprovides more in-depthinformation on the timeremaining for the Sensorand the Monitor batteries.Cell Signal StrengthThe cell signal strengthscreen provides morein-depth information onhow strong the cellularsignal at the Monitor’slocation.
CardioNet AECG System16 Installing the Base Recharging the MonitorThe CardioNet Monitor contains a rechargeable battery which canbe replenished in the Base. This battery requires a charge of 4hours for each 18 hours of use. When in the Base, the LCD on theMonitor will indicate the battery charge status. To fully charge,leave the Monitor in the Base for four hours. Touching the batteryicon on the screen will indicate how much battery life is remainingon the Monitor.Patients will need to be instructed how to install the Base whenthey return home. Installing the Base properly ensures that theMonitor battery will properly recharge and that the ECG data canbe sent while the Monitor is in the Base. Patients will need tounplug their existing telephone line from the wall. The telephonecable (already attached to the patients telephone) then inserts intothe “Phone In” port of the Base. The additional provided telephonecable then inserts to the Base “Line In” port, then into the tele-phone jack in the wall.CardioNet Base Downloading ECGThe CardioNet Monitor is configured to download ECG dataautomatically at specified times as designated by a physician.Automatic transmission times will be configured during the initialpatient set up, the default is once per 24 hours. Data can also bedownloaded manually by patient activation of the call button.Detailed instructions should be provided by the physician todetermine when patients should use the call button.
Service and MaintenanceCardioNet AECG System17 CleaningDampen a soft cloth with disinfecting solution. Wipe theexternal surfaces of the Sensor, Monitor and Base. Do notspray or submerge any component with liquid or foam. Eachcomponent should be wiped with a soft damp cloth aftercleaning to ensure no fluid has pooled on external surfaces. ServiceIf you experience additional problems with any components ofthe CardioNet Monitoring System, review the problems andsolutions listed in the trouble shooting section. If additionalassistance is required contact customer support via telephoneor fax listed below.Telephone: 619.243.7500Fax: 619.243.7700Call customer support before returning a CardioNet MonitoringSystem to make shipping arrangements.
TroubleshootingCardioNet AECG System18Problem Recommended SolutionNo Display on MonitorLow Battery on SensorBattery does not last18 hoursNo splash screen whenMonitor is turned on. No connection when call button is pressedEnsure Monitor is turned ON.Return Monitor to Base forrecharging.Inspect battery compartment,clean contacts if necessary.Return Monitor to Base for recharging.Ensure battery is being recharged for at least 4 hours per day.Return Monitor to Base forrecharging.Ensure Monitor is in cellular range.Ensure Monitor is turned ON.Check electrode placement and connections.Install new battery.Place Monitor in base.Low Battery on MonitorMonitor displays electrode placement warning.
SpecificationsCardioNet AECG System19 DimensionsSensor Dimensions4.1 x 0.7Weight: 2.1 ozMonitor5.9 x 3.3 x 1.0Weight: 11.0 ozLCD3.0 x 2.3, touch screen, monochrome, EL backlight FunctionalChannelsResolutionRecordingSample RateFrequency ResponseBattery LifeBase Connectors Power in (12V 1.2A)Phone in (RJ11)Phone out (RJ11)Serial RS232 Operating conditionsSensor Immersion resistant (IPx-0)Operating temperature 20 - 45 CStorage temperature -20 - 65 CRelative humidity 10% - 95%, noncondensingMonitor and Base Splash resistant (IPx-0)Operating temperature 0 - 45 CStorage temperature -20 - 65 CRelative humidity 10% - 95%, noncondensing212 BitFull Disclosure250 Samples / sec0.5 hZ - 40 HzMonitor: (18 hr) rechargableSensor: (24 hr) AAA AlkalineSensor neck strap12 x 24 x 0.2Base4.0 x 4.0 x 3.6Weight: 6.1 oz
Equipment symbolsCardioNet AECG System20Symbol DescriptionConsult ManualYear of ManufactureType B EquipmentSerial NumberSN Hardware RequirementsIn Home RequirementsTouch tone telephoneAC powered outletPC RequirementsSerial port installed 2000
CardioNet AECG System21Section IIPhysicianInstructionsSection II is for physicians who will be prescribingpatients for the CardioNet Monitoring Service. Detailed instructions covered in this section:- Monitor Screen Preferences- Automatic Download Preferences- Arrhythmia Detection Preferences- Disclosure of Technical Specifications
CardioNet AECG System22 Automatic Download PreferencesWhen manual measurements of the ECG by CardioNet’s trainedpersonnel are required, the physician can indicate preferences forautomatic transmission of ECG data in the physician’s prescription.This is recommended for patients requiring measurements of thePR interval, the QRS complex, or the QT interval.Options will be listed on the prescription as follows:QD (Once per 24 hours)BID (Two times per 24 hours / every 12 hours)TID (Three times per 24 hours / every 8 hours)QID (Four times per 24 hours / every 6 hours)Q4 (Six times per 24 hours / every 4 hours)The default for automatic download of ECG without a cardiac eventis one time per 24 hours. The physician will receive a strip of ECGdata reviewed by CardioNet personnel that will include allmeasurements indicated by the physician on the prescription.The following options can be listed on the prescription as follows:PR intervalQRS complexQT intervalOne or multiple selections can be made.
CardioNet AECG System23 Arrhythmia Detection PreferencesThe CardioNet System is for use on low risk patients with the followingcontraindications:1) Patients who have a history of sustained ventricular tachycardia or adocumented occurrence of ventricular fibrillation.2) Patients the attending physician thinks will be at risk for ventricular tachycardiaor ventricular fibrillation as indicated by the following:-A measured ejection fraction (EF) less than 35% with complex ventricular ectopic activity (>10 PVCs per hour or repetitive PVCs).- Unstable angina defined as chest pain at rest, a new onset of angina, 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 a recent heart valve surgery.3) Patients who the attending physician thinks should be hospitalized.CardioNet’s on board algorithm continually analyzes ECG for potentialarrhythmias on the following list. Any arrhythmia may be omitted from the list onthe prescription by the prescribing physician. The optional item - Pacer spikedetection - will not be routinely detected unless indicated by the physician.Arrhythmias will be listed on the prescription as follows:CardioNet Event Threshold Table Arrhythmia ValueBradycardia <40 BPM & sustained > 60 secTachycardia >150 BPM & sustained > 60 secIrregular Rhythm to Detect Irregular HR (IRR >25) > 60 secAtrial Fibrillation / Flutter PVC’s >8 occurrences in one minuteVentricular Bigeminy >6 occurrences in one minuteVentricular Trigeminy >6 occurrences in one minuteVentricular Tachycardia >100 BPM & sustained >4 beatsVentricular Fibrillation OnsetPause >2 secondsLong Pause >3 seconds*Irregular R to R is defined as: Standard deviation x 100 [0.01 sec]RR mean
Disclosure of Technical Performance SpecificationCardioNet AECG System241) Analysis of heart rateThe average heart rate is calculated on the basis of the mean R toR interval in the last 6 seconds or 8 R to R intervals (whatever isshorter). For the MIT-BIH ECG database, the average RMS errorfor the calculated HR was 1.07%, and for the AHA ECG database,the RMS error for the HR calculated was 2.08% (see table below).2) Analysis of rhythm DisturbancesThe CardioNet System detects the arrhythmias and other ECGabnormalities shown in the CardioNet Event Thresholds Table.These include the following:- Bradycardia- Tachycardia- Irregular heart rate to detect possible Atrial Fibrillation / Flutter- Frequent PVCs- Ventricular Tachycardia- Ventricular Fibrillation- PausesAHA ECG Database HR measurementsRecord ErrSum RefSum Nmeas MeanRefHR RMSerror(%)___________________________________________________________________Sum 130111.6913 2167402.8283 26706Gross 81.1579 2.7197Average 81.4511 2.0762Summary of results from 78 recordsMIT-BIH ECG Database HR measurementsRecord ErrSum RefSum Nmeas MeanRefHR RMSerror(%)________________________________________________________________________Sum 25694.4788 1016331.6122 13030Gross 77.9994 1.8003Average 78.0769 1.0691Summary of results from 44 records
CardioNet AECG System25Disclosure of Technical Performance Specification (con’t)3) Analysis of ST alterationThe CardioNet System does not currently address ST analysis.4) Recognition and measurement of the QRS morphology anddurationQRS morphology classification (such as labeling of each detectedbeat as normal or ventricular, etc.) is provided by the MortaraArrhythmia Analysis Library, as part of the ECG analysis. TheCardioNet System does not report measurements of the QRSduration.5) Learning PhaseA learning phase occurs for one minute during the initial analysisof the patient’s baseline ECG. A learning phase also occurs for oneminute each time the Monitor is powered up and after a leads offdetection has been detected and reset. 6) Measurement of PR intervalsThe CardioNet System does not provide measurements of PRintervals.7) Recognition of paced rhythmsThe CardioNet supports recognition of pacer pulses. TheCardioNet System detects pacer pulses and calculatespacemaker non-fire, non-capture rates.

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