Biomedical Systems BRHA01 Handheld Mobile Telemetry Device User Manual Physician Operation Manual update pub

Biomedical Systems Corporation Handheld Mobile Telemetry Device Physician Operation Manual update pub

Contents

Operation Manual

Physician’s Operation manual TruVue Mobile Telemetry Outpatient Cardiac ECG Monitoring Biomedical Systems 77 Progress Parkway Saint Louis, MO 63043 www.biomedsys.com 314-576-6800 Toll Free 1-800-877-6334
2 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. This device complies with part 15 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 any interference received, in-cluding interference that may cause undesired operation. Sensor FCC ID: YCVBRSA01 Handheld FCC ID: YCVBRHA01 NOTICE: Changes or modifications made to this equipment not expressly approved by Biomedical Systems may void the FCC authorization to operate this equipment. Radiofrequency radiation exposure Information: For body worn operation, this phone has been tested and meets the FCC RF exposure guidelines when used with the Biomedical Systems accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. USA contact: Biomedical Systems 77 Progress Pakway Saint Louis, MO 63043 (314) 576-6800 (800) 877-6334 Fax: NOTE: This equipment has been tested and found to comply with the limits for a Class B digital de-vice, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radi-ate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is en-couraged to try to correct the interference by one or more of the following measures:  Reorient or relocate the receiving antenna.  Increase the separation between the equipment and receiver.  Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.  Consult the dealer or an experienced radio/TV technician for help.
3 TruVue Mobile Telemetry Monitoring System TABLE OF CONTENTS Indications for Use .......................................................................... 5 System Overview ............................................................................ 6 Patient Devices .......................................................................... 7 Data and Monitoring Center ........................................................ 8 Service Overview ............................................................................ 9 Ordering TruVue ........................................................................ 9 Initiating Monitoring ................................................................ 10 Concluding Monitoring ............................................................. 11 Breaks in Monitoring ................................................................ 11 Operation and Performance Specifications ................................... 10 Sensor Operation ................................................................................ 12 Sensor Performance Specifications .................................................... 15 Handheld Operation.................................................................. 17 Handheld Performance Specifications ......................................... 26 Algorithm Operation and Performance ........................................ 28 Summary of Caution Statements ................................................... 32
4 TruVue Mobile Telemetry Monitoring System TABLE OF CONTENTS
5 TruVue Indications for Use Indications for Use: The TruVue System is intended for use by patients who experience or are suspected of transient events that may suggest cardiac arrhythmia Patients who require monitoring of effect of drugs to control ventricular rate in various atrial ar-rhythmias (e.g. atrial fibrillation) Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath) Patients recovering from cardiac surgery or interventional procedures who are indicated for outpa-tient arrhythmia monitoring ECG data recorded by the device can be analyzed by other processing systems, such as the BMS Century Holter system to provide Holter style reports Contraindications The TruVue System is contraindicated for those patients requiring attended, In-hospital monitoring for life threatening arrhythmias. Note: The TruVue system does not provide interpretative statements. Interpretation and clinical diagno-sis is the responsibility of the physician. PHYSICIAN’S OPERATION MANUAL
6 TruVue System Overview System Overview The TruVue system is a wireless ECG analysis and monitoring system used for the diagnosis of cardiac arrhythmia in ambulatory patients. ECG data is acquired at the patient on a body worn sensor, stored and then transmitted to a data center through a handheld device carried with the patient. No action is re-quired by the patient to transmit ECG data. At the data center, all ECG is stored and then analyzed for arrhythmia. Portions of the ECG containing arrhythmic events are transmitted to monitoring center for human confirmation before being compiled into a report and transmitted to the physician. The system also allows for real time 2-way communications of voice and data between the patient and the monitor-ing center or physician. CAUTION: The TruVue system is not an emergency response device. The patient should call 911 and/or their local emergency medical service if they feel they are having a medical emergency. PHYSICIAN’S OPERATION MANUAL
7 TruVue System Overview Patient Devices The patient devices consist of a body worn Sensor, a Handheld device that provides communication and the patient user interface, and a charger for the Handheld. A modem can optionally be supplied for those patients who lack cellular coverage in their homes. PHYSICIAN’S OPERATION MANUAL TruVue Sensor TruVue Handheld Applied Sensor The sensor acquires and stores 2 channels of full disclosure ECG data covering the entire monitor-ing period (up to 30 days). While acquiring ECG data, the sensor also continuously burst transmits the full disclosure data to the handheld over a radio link with a range up to approximately 30 feet. The handheld continuously burst transmits the full disclosure ECG data over the cellular network to the 24/7 attended BMS monitoring center, where the ECG is analyzed. Any detected arrhyth-mias are confirmed by our certified monitoring technicians before being reported to the physician. If the patient is symptomatic, they can enter their symptoms on the handheld. These symptoms are immediately transmitted to the monitoring center for review and correlation with the ECG data. Text messages and voice calls can be placed to the patient handheld any time the device is in cellu-lar coverage. Real time ECG can also be streamed from the patient device on request.
8 TruVue System Overview Data and Monitoring Center Full disclosure ECG data transmitted from the handheld is stored in the BMS monitoring center, where arrhythmia analysis algorithms analyze for:  Pause / Asystole  Tachycardia  Bradycardia  Atrial Fibrillation  Idioventricular Rhythms  Supraventricular tachycardia  Ventricular tachycardia and runs  Ventricular Fibrillation When one the above arrhythmias is detected, a certified monitoring technician confirms the arrhythmia and prepares and annotates a sample to be included on a physician report. A report is sent immediately to the physician if the arrhythmia meets the immediate report criteria specified for the patient, or sent on a daily summary report per the physicians orders. A daily summary report is prepared per the prescribing physicians preference that can include:  24 hour HR Trend graph  Atrial Fibrillation burden for 24 hours or covering the entire monitoring period  Samples of any arrhythmias detected in the last 24 hours ,or normal ECG samples at the high and low HR for the day if there were no arrhythmias Reports can be faxed, mailed, and/or viewed and printed online. Prior to printing your patients report, you may enter any comments or interpretations on the report. The Truvue system allows you to view your patients monitoring record at any time, including all reports, samples and full disclosure ECG data since the inception of the monitoring period. PHYSICIAN’S OPERATION MANUAL
9 TruVue Service Overview TruVue Service Overview Ordering TruVue The TruVue Mobile Telemetry system is provided as a service by Biomedical Systems. There is no need for the physician to manage an inventory of devices in the office.  You may elect to enroll your patients online through Global Cardio, fax your order, or call us with the patient information. NOTE: To place an order for your patient, call 1-800-000-0000. To fax your order, our fax number is 1-800-000-0000. If you wish to enroll your patients through the Global Cardio system, you will need the software installed in your office and user access set-up. If you do not currently have Global Cardio soft-ware on your office PC’s, call Biomedical Systems to arrange set-up at 1-800-000-0000. NOTE: When ordering TruVue for your patients, all physician orders require the following information to be provided to Biomedical Systems:  Patient first, last, and middle initial  Patient date of birth and social security number  Patient demographics (primary address, telephone number, cell phone number, etc.)  Patient primary and secondary insurance information (ID #, group #, address, telephone #) On receipt of an order for the TruVue service Biomedical Systems will: A) Confirm the insurance coverage for the patient. B) Contact the patient and confirm the delivery address for the device kit C) Configure the device for your patient and ship the device kit and all consumables required for the en-tire monitoring period. Please discuss with your patients:  Reason for ordering mobile telemetry  Importance of proper hook-up and securing electrodes to skin  Change sensor battery every 24-hours and charge handheld unit during times of sleep  Anticipated monitoring time  Instruct them to go to the nearest emergency room or call 911 in the event of a life-threatening Emergency In addition to discussing the above with your patient, we encourage you to provide the patient with contact information for Biomedical Systems. PHYSICIAN’S OPERATION MANUAL
10 TruVue Service Overview TruVue Service Overview Initiating Monitoring When the patient receives the device kit, Biomedical Systems will perform the hook up and verify the proper operation of the system. Our certified monitoring technicians will: A) Confirm the identify of the patient B) Review proper device operation with the patient. C) Instruct the patient on the proper application of electrodes and hook up the patient D) Take a baseline recording and verify proper operation of the device E) Notify you that the patient is on service. Electrode Site Preparation and the Proper Positioning CAUTION: Shave any hair that is in the area the electrodes are placed. 1. Shave area where electrodes (sticky patches) will be placed (if applicable). Wipe each area with alcohol in a circular motion and let dry. (See Figure 1 for electrode placement). 2. Remove the sensor (See Figure 3) from the box. Snap each lead wire onto an electrode. (See Figure 2) 3. Remove backing from the electrode attached to the black snap and place it on the left side of your upper chest just below your clavicle as shown in Figure 1. PHYSICIAN’S OPERATION MANUAL White Electrode (RA) Black Electrodes (LA) Red Electrode (LL) Figure 1 Figure 2
11 TruVue Service Overview 4. Remove backing from the electrode attached to the red snap and place it on the lower left portion of your chest as shown in Figure 1. 5. Remove backing from the electrode attached to the white snap and place it on the right side of your upper chest just below your clavicle as shown in Figure 1. CAUTION: Press firmly all around electrode patches to secure them firmly to skin. Concluding Monitoring When the end-monitoring arrives Biomedical Systems will contact the patient and arrange for the device to be returned to BMS. Our monitoring staff will prepare a summary report for your review. If you reach a diagnosis for your patient prior to the end-monitoring date or wish to extend the monitor-ing period past the date simply inform Biomedical Systems monitoring center. Breaks in Monitoring The monitoring period can be suspended and resumed later if the patient requires a hospitalization or a break in service for any other reason , such as out of the country travel. During a monitoring break you will not receive any daily reports. PHYSICIAN’S OPERATION MANUAL
12 TruVue Sensor Operation Sensor Operation ECG Acquisition and Storage The Sensor acquires two channels of ECG through a three or four wire shielded cable connected to stan-dard Holter monitoring electrodes. Standard leads II and III of the Einthoven triangle are sampled at 1000 samples per second (SPS) with +/- 40 mV of dynamic range with .05 to 150 Hz band pass. The data is then filtered and down sampled to 250 (SPS) before being stored on the sensor. The sensor retains up to 30 days of ECG data. ECG data is stored with the patient ID and an error detecting code. ECG Transmission The Sensor transmits the acquired ECG data to the handheld over an encrypted Bluetooth link with a range of approximately 10 meters. The range of this link can vary depending in environmental factors. If the sensor goes out of range of the handheld the patient will be alerted. The handheld and sensor are paired together prior to providing the kit to the patient and will only communicate with each other. Nei-ther the sensor or handheld will communicate with other devices (they are “non-discoverable” and “non-connectable” per the Bluetooth specification). The ECG is protected from data corruption by an error de-tecting code that “travels” with ECG data throughout the TruVue system, ensuring that no corruption of the data occurs during transmission to and storage at the monitoring center. The Sensor can be placed in “airplane mode” through the handheld user interface. This turns off all ra-dios so the patient can continue to collect ECG data (but not transmit it to the handheld) in areas where wireless devices are not allowed. The stored ECG is transmitted to the monitoring center when the radios are turned back on. If the radios are turned off when the handheld is powered up the patient is prompted to turn them on again. User Interface The Sensor will alert the patient with a speaker tone (or vibration if selected by the patient) and a flashing led when the battery is low, if a lead falls off, or if the sensor is out of range of the handheld. The patient can silence an alert temporarily by using the large pushbutton on the sensor if they choose. Algorithm When communications between the Handheld and the BMS data center are interrupted for any reason the sensor runs a rhythm detector that detects potential significant arrhythmias that have a high heart rate or ventricular rhythm. If a potential arrhythmia is detected then an alert is presented to the patient that instructs them to move to an area with cellular coverage or closer to the modem so the ECG data can be transmitted to the data center for analysis and confirmation of the rhythm. Powering the sensor The sensor is powered by inserting the battery in the battery compartment. It is always on—there is no separated on/off switch. The patient replaces the battery in the sensor once a day with a standard AAA Alkaline battery PHYSICIAN’S OPERATION MANUAL
13 TruVue Sensor Operation Sensor Operation Leadset The lead wires are permanently attached to the sensor hardware and are not user replaceable. CAUTION: Do not attempt to remove the lead wires from the sensor. CAUTION: Inspect the leadwires for any fraying and/or cracking in the insulation prior to use. Note: BMS will perform this check before providing the equipment to the patient. Lanyard A lanyard (neck cord) is attached to the sensor for the convenience of the patient and to prevent the sen-sor and lead wires from dangling. The lanyard can be removed from the sensor if desired Battery The sensor is powered by a 1.5V AAA alkaline battery. 1.5V “advanced lithium” or “Oxyride” batteries can also be used to extend the battery life of the sensor, as long as are rated at 1.5 Volts. CAUTION: Use only AAA alkaline batteries, or the batteries provided with the patient kit, in the sensor. Do not use rechargeable batteries. CAUTION: Do not store sensor with the battery in place for extended periods of time. Remove the bat-tery after each monitoring period Cleaning The sensor may be cleaned with Isopropyl Alcohol. Do not submerse the sensor in any liquid. PHYSICIAN’S OPERATION MANUAL
14 TruVue Sensor Operation Sensor Operation Handling precautions: To ensure proper operation of the sensor please follow these handling precautions CAUTION: Do not drop the sensor or handheld unit. CAUTION: Do not pull or yank on the sensor lead wires CAUTION: Do not expose sensor or handheld to excessive dust or to extreme temperatures CAUTION: Do not immerse or otherwise allow any liquid to enter the sensor or handheld. CAUTION: Do not store the sensor or handheld either unit in direct sunlight or near corrosive liquids When Showering or Bathing  Remove lead wires attached to sensor from the electrodes (patches).  Place sensor (attached to lanyard) in a dry secure place. CAUTION: Do not allow sensor to get wet.  Remove electrodes (patches) from skin even if they have already been changed in past 24 hours.  After showering or bathing, dry skin thoroughly. Do not apply powder or lotion of any kind to chest area.  Wipe skin with alcohol in area where electrodes (patches) will be placed. Replace electrodes (patches) as previously instructed PHYSICIAN’S OPERATION MANUAL
15 TruVue Sensor Performance Specifications Sensor Performance Specifications Standards The sensor complies with the following medical device standards: -AAMI EC 38-1998, Ambulatory Electrocardiographs. -EN60601 -1 Medical electrical equipment, Part 1: General requirements for safety -EN60601 -1 Medical electrical equipment, Part 1-2: Electromagnetic compatibility Sensor Performance Specifications Parameter Notes Min. Typ. Max. Unit Physical: Length 3.1 in. Width 1 in. Thickness .8 in. Weight With AAA Battery 60 gm ECG Cable Lengths Dual channel 3 electrode and Dual channel 4 electrode. 18 in Parameter Test Conditions Min. Typ. Max. Unit Environmental: Complies with AAMI-EC38 and EN60601 -1 Operating Temperature 0 45 °C Storage Temperature -10 60 °C Relative Humidity 10 95 % Shock - Unpackaged Unit 36 in. Water Resistance Not Water Resistant PHYSICIAN’S OPERATION MANUAL
16 TruVue Sensor Performance Specifications Sensor Performance Specifications—Continued PHYSICIAN’S OPERATION MANUAL Parameter Test Conditions Min. Typ. Max. Unit Electrical: Complies with AAMI-EC38 and EN60601 -1 Battery Voltage 1 x AAA Alkalines Eveready E92 or Equivalent 0.9 1.5 3.0 Volts Battery Current At 1.5V Battery Voltage, all circuits turned on 400 mA Lithium Battery Voltage Lithium-Ion Battery Not User Replaceable 2.0 3.1 Volts VREF Voltage Refer-ence 1.22 1.25 1.30 Volts VREFAD Voltage Refer-ence 2.45 2.55 2.60 Volts Input Impedance @ 5 Hz 1.0 1.5 1.6 MW CMRR @ 60 Hz 86 dB CMR Range AC + DC -1.5 +1.5 Volts Differential Range AC DC + 80 mV AC @ 5 Hz -40 -500 +40 +500 mV mV Fast Baseline Reset –3db Frequency After Removing Overloading Signal 0.45 0.5 0.55 Hz Bandwidth + 1 dB - 3 dB referenced to 15 Hz 0.05 150 Hz Low Pass Filter Gain @ 250 Hz -18 -17 dB Pacemaker Pulse De-tection: 1usec max pulse rise and fall times Pacemaker Pulse Width 0.2 2.5 msec Pacemaker Pulse Am-plitude 1.0 250 mV Communications Frequency Bluetooth Class III 2.1 gHz Communications Proto-col Bluetooth SPP Profile, non discoverable 2.2 Ver Output power 0 dB User interface Complies with AAMI-EC38 and EN60601 -1 Pushbutton Used for silencing alerts LED For device alerts Speaker For device alerts 400-2500 Hz
17 PHYSICIAN’S OPERATION MANUAL TruVue Handheld Operation Handheld Operation Communications The Handheld communicates with the sensor over an encrypted Bluetooth link with a range of approxi-mately 10 meters. The range of this link can vary depending in environmental factors. If the sensor and handheld lose communication the patient will be alerted. The Handheld transmits ECG data to the BMS data center over the cellular network. Transmissions are bursted with a maximum latency of 2.5 minutes when the Handheld is in coverage on the network. When out of coverage of either the cellular network or the optional modem, the handheld commands the sensor to run the potential arrhythmia detector algorithm (described under the Sensor Operation section) The Handheld also can transmit data to the BMS data center over a optional modem attached to the pa-tients home phone line. The handheld communicates with the modem over an encrypted Bluetooth link with a range of approximately 100 feet, allowing a single modem to provide coverage for the typical resi-dence. ECG data is transmitted to data center without modification and is protected from corruption by an error detecting code embedded in the ECG data. Text messages can be sent from the BMS monitoring center for display on the patients handheld device. The Handheld can also receive a voice call from the monitoring center in the event that monitoring staff wishes to speak with the patient and they cannot be reached at their regular phone numbers. Only the monitoring center can initiate a voice call, the handheld will only accept incoming calls from the moni-toring center, and the patient cannot initiate an outgoing call. The Handheld can operate as a speaker-phone when desired by the patient. CAUTION: The handheld is a cellular phone. Follow your implantable device manufacturers recom-mendations on the use of the cellular phones with your implant.
18 PHYSICIAN’S OPERATION MANUAL TruVue Handheld Operation Handheld Operation Powering the handheld The handheld is powered by an internal rechargeable LiIon battery. The on/off button is located on the right side of the unit and the handheld is powered on by pressing and holding the power button for ap-proximately 5 seconds. The provided wall charger charges the battery. The handheld can be powered on whenever the wall charger is attached, regardless of whether the battery is depleted or not. The handheld battery will typically power the handheld 16 hours without recharging. The patient should leave the handheld attached to the wall charger while they are sleeping. CAUTION: Do not attempt to replace the handheld battery. CAUTION: Use only supplied wall charger with the handheld. Cleaning The handheld may be cleaned with Isopropyl Alcohol. Do not submerse the handheld in any liquid. Handling precautions: To ensure proper operation of the handheld please follow these handling precautions CAUTION: Do not drop the handheld unit. CAUTION: Do not expose sensor or handheld to excessive dust or to extreme temperatures CAUTION: Do not immerse or otherwise allow any liquid to enter the sensor or handheld. CAUTION: Do not store the sensor or handheld either unit in direct sunlight or near corrosive liquids
19 PHYSICIAN’S OPERATION MANUAL TruVue Handheld Operation User Interface A graphical user interface is incorporated for display of messages to the patient, input of symptoms and control of the system. A 5-way set of navigation keys and two soft keys are used to navigate the user in-terface. An Led is provided to indicate the status of the device when it is on and to indicate the charging status indication when the unit is off . The handheld incorporates a loudspeaker and vibrator for alerting the patient. Operating modes The TruVue device kit operates in two primary modes—monitoring and pre-monitoring. The unit is pro-vided to the patient in pre- monitoring mode and is activated into monitoring mode by a BMS monitor-ing technician during the hook-up call from the patient. In pre-monitoring mode the patient kit does not record, store or transmit ECG data. User Interface in Pre-monitoring mode When the patient receives the unit and turns it on they will proceed the following sets of screens that in-struct the patient to call the BMS monitoring center for the hook-up call: During the hook-up call, the BMS monitoring center technician will perform the hook-up ( see “Initiating Monitoring” in the “TruVue Service Overview” section) and provide the patient with a code the enables the transition of the unit into monitoring mode. At this point the devices are actively monitoring the pa-tient.
20 PHYSICIAN’S OPERATION MANUAL TruVue Handheld Operation User Interface in Monitoring Mode Main screen The main screen is the top level screen for the user interface and is displayed when the device is turned on and whenever the LCD wakes up from power saving mode. It consists of the status bar, the tasks panel and softkey area. The status bar displays various indicators of device operation. The task panels scrolls using the up and down arrow keys and allows the patient to select various tasks to perform by se-lecting the center key. The softkey area contains two indicators that change depending on what state or screen the device is on. Task Wheel Options Status Bar Selection Indicator Softkeys Record symptoms and activity level Read text mes-sages from the monitoring center Turn on or off wireless radios. Place the device in “flight mode” View large battery level indicators for the handheld and sensor Adjust the speaker volume and vibra-tor for both the sensor and hand-held View device infor-mation such as serial number, SW version levels, etc Tasks Wheel
21 PHYSICIAN’S OPERATION MANUAL TruVue Handheld Operation User Interface in Monitoring Mode Status Bar Indicators Sensor Battery Level Sensor Connection Status Upload Activity Network Status Cell Strength Handheld Battery Level Full Connected Uploading 4 Bars Full 3 Bars 2/3 2 Bars 1/3 Empty 1 bar Empty Absent or Unknown No Bars, con-nected Absent or Un-known Off Charging
22 PHYSICIAN’S OPERATION MANUAL TruVue Handheld Operation User Interface in Monitoring Mode Record Symptoms Screens Pressing the center key when the task wheel is on the Record Symptoms task allows the patient to enter both their current symptoms and their current activity level. This information is uploaded to the monitor-ing center and is available for correlation with the patients ECG at the time they recorded the symptoms. Messages Screen Pressing the center key when the task wheel is on the Messages task allows the patient to read text mes-sages sent from the center. Messages can be entered through GlobalCardio. The indicator on the main screen changes to indicate that there are unread messages waiting. Messages are deleted from the hand-held once read Unread message waiting All messages have been read
23 PHYSICIAN’S OPERATION MANUAL TruVue Handheld Operation User Interface in Monitoring Mode Wireless Settings Screens Pressing the center key when the task wheel is on the Wireless Settings task allows the patient to enter turn off all wireless radios in the system for a time. This is a useful feature if the patient is on an airplane or in some other area where cellular phones are not allowed. The sensor will continue to record all ECG data while the handheld radio is off. When the radios are turned back on, all stored data will be transmitted to the monitoring center. When the device is turned back on, the user is always prompted to turn on the radios if the handheld is on flight mode. The user is also prompted every two hours to turn the radios on through an alert message. The potential arrhythmia detection algorithm does not run when the device is in flight mode, since it is assumed that the patient is unable to transmit any data due to their physical location.
24 PHYSICIAN’S OPERATION MANUAL TruVue Handheld Operation User Interface in Monitoring Mode Battery Level Screen Pressing the center key when the task wheel is on the Battery Levels task allows the patient to view the large bat- tery level indicators. Volume Screen Pressing the center key when the task wheel is on the Volume task allows the patient to set the volume and vibrate levels on the handheld and sensor. The sensor volume can only be set when the sensor is con-nected to the handheld. To set to vibrate only, the volume slider is moved to 0 and the vibrate indicator is automatically checked. Vibration can also be selected in addition to volume.
25 PHYSICIAN’S OPERATION MANUAL TruVue Handheld Operation User Interface in Monitoring Mode Device Info Screen Pressing the center key when the task wheel is on the Device Info task allows the patient to view the fol-lowing device information  Handheld Serial Number  Paired Sensor Serial Number  Patient ID  Handheld SW Version  Sensor SW Version  Wireless Setting (Normal or Off)
26 TruVue Handheld Performance Specifications Handheld Performance Specifications Standards The handheld complies with the following medical device standards: -AAMI EC 38-1998, Ambulatory Electrocardiographs. -EN60601 -1 Medical electrical equipment, Part 1: General requirements for safety -EN60601 -1 Medical electrical equipment, Part 1-2: Electromagnetic compatibility Handheld Performance Specifications PHYSICIAN’S OPERATION MANUAL Parameter Notes Min. Typ. Max. Unit Physical: Length 5 in. Width 2.25 in. Thickness .8 in. Weight 150 gm Environmental: Complies with AAMI-EC38 and EN60601 -1 Operating Temperature 0 45 °C Storage Temperature -10 60 °C Relative Humidity 10 95 % Shock – Unpackaged Unit Per AAMI-EC38 36 in. Shock – Packaged Unit Per AAMI-EC38 Water Resistance IPX 0 User interface Display 240X320 QVGA OLED Keypad 5 way navigation + 2 softkeys Receiver / microphone For voice call Loudspeaker For device alerts
27 TruVue Handheld Performance Specifications Handheld Performance Specifications—Continued PHYSICIAN’S OPERATION MANUAL Parameter Lithium Battery Voltage Lithium-Ion Battery Not User Replaceable 4.2 Volts Lithium Battery Cur-rent 1 Amp Charger EN60601 Approved direct plug-in Class II AC adapter power supply rated 100-240V~ Globtek Model GTM41076-0605 100 240 Volts Communications Cellular EGSM/GPRS/EGPRS 900/1800/850/1900 MHz Bluetooth Bluetooth Class I Communications Proto-col Bluetooth SPP and DUN Pro-file, non discoverable 2.2 Ver
28 TruVue Algorithm Operation Algorithm Operation and Performance Specifications Serious Arrhythmia The TruVue arrhythmia detection algorithm continuously process ECG transmitted from the patient de-ices and detects the following rate and rhythm based arrhythmias: When an arrhythmia is detected, it is flagged for immediate review by a BMS certified cardiac technician. The technician confirms the arrhythmia and prepares a report for immediate transmission if the arrhyth-mia meets the Serious Arrhythmia criteria specified by the physician. Representative Samples, Trend and Arrhythmia Burden Once per day, the TruVue algorithm scans all the entire ECG record transmitted from the patient and collates representative samples, HR trend information and Arrhythmia burden information and presents this information the monitoring center staff for review and transmission on the daily report. This infor-mation is also available for review at any time in GlobalCardio. Representative samples are a set of samples that represent the patient’s condition for that day. The algo-rithm identifies the following samples: 1. If no arrhythmia occurred, the algorithm identifies the lowest noise, highest heart rate and lowest noise, lowest heart rate samples 2. If arrhythmias did occur, for each serious arrhythmia class defined above the algorithm identifies the most serious, lowest noise sample. The HR trend graph presents the patient HR represented as a moving average over every 6 beats The arrhythmia burden graph presents the amount of time the patient was in Atrial Fibrillation with 10 minute resolution. If the patient was in Atrial Fibrillation for over 30 seconds during any 10 minute pe-riod then that period is marked as AF. This graph can selectably be presented for the current day or for the entire monitoring period to date. PHYSICIAN’S OPERATION MANUAL Tachycardia Bradycardia Pause/Asystole Atrial Fibrillation Idioventricular rhythm Supraventricular tachycardia Ventricular tachycardia Ventricular Fibrillation
29 TruVue Algorithm Operation Serious Arrhythmia Criteria Any technician confirmed serious arrhythmia will be transmitted immediately to the physician on a seri-ous arrhythmia report by the physicians preferred method of transmission. The default criteria are: The default criteria above can be used or the physician can specify the criteria to be used as long as it falls within the criteria range specified above. The criteria can be specified for a particular patient, for all the physicians patients, for a particular office location or for the entire practice. PHYSICIAN’S OPERATION MANUAL Arrhythmia Default Criteria Criteria range Pause/Asystole > 3 seconds 2-5 seconds Bradycardia < 40 bpm 20-50 bpm Tachycardia > 180 bpm 120-220 bpm Supraventricular tachy-cardia >150bpm,>30 sec 100-200 bpm, 5-60 sec Ventricular tachycardia Rate: > 110 bpm (3 or more beats) Rate: 80-150bpm Beats: 3-10 Idioventricular Rhythm >30 beats 5-50 beats Ventricular Fibrillation Always Atrial Fibrillation First onset for patient Then Vrate >150 or < 40 BPM 1-10 Onsets Vrate: 20-220 bpm Patient Initiated Always sent
30 TruVue Algorithm Operation Beat Detection and Classification The TruVue algorithm can discriminate between normal and ventricular beat morphologies. For each beat complex the algorithm determines the R-point for HR calculation The beat detection performance (as tested under ANSI/AAMI-EC 57:1998, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms) is: Heart Rate Averaging The heart rate is averaged over 6 R-R intervals (HR = 360/duration of 6 consecutive RR intervals ) and becomes the basis for rate based arrhythmia detection following the beat classification step. The HR cal-culation had a mean RMS error of 1.731 as tested per EC-57 on the MIT database. Atrial Fibrillation Detection Algorithm The Atrial fibrillation algorithm detects the irregularity of R-R intervals and examines the signal for flut-ter waves. When a certain irregularity is detected, the algorithm performs additional checks to determine if the underlying rhythm is bigeminy or trigeminy and looks at the presence of flutter waves as a secon-dary indicator. Atrial Fibrillation detection performance as tested per EC-57 is: PHYSICIAN’S OPERATION MANUAL Sensitivity, % Positive Predictivity, % QRS detection (MIT DB) 99.92 99.90 QRS detection (AHA DB) 99.74 99.83 QRS detection (NST DB) 95.00 88.14 V-morphology detection (MIT DB) 91.15 93.25 V-morphology detection (AHA DB) 75.48 92.05 V-morphology detection (NST DB) 88.95 46.09 Sensitivity, % Positive Predictivity, % Atrial Fibrillation detection – all events (MIT DB) 92 100 Atrial Fibrillation detection – events longer than 30 seconds (MIT DB) 100 100
31 TruVue Algorithm Operation Ventricular Fibrillation Detection The TruVue algorithm can detect VF rhythms with the following performance as tested under EC-57 PHYSICIAN’S OPERATION MANUAL Sensitivity, % Positive Predictivity, % Ventricular Fibrillation detection (MIT DB) 100 100 Ventricular Fibrillation detection (AHA DB) 90 100 Ventricular Fibrillation detection (CU DB) 97 73
32 TruVue Algorithm Operation Summary of Caution statements: CAUTION: Do not attempt to remove the lead wires from the sensor. CAUTION: Inspect the leadwires for any fraying and/or cracking in the insulation prior to use. CAUTION: Do not drop the sensor or handheld unit. CAUTION: Do not pull or yank on the sensor lead wires CAUTION: Do not expose sensor or handheld to excessive dust or to extreme temperatures CAUTION: Do not immerse or otherwise allow any liquid to enter the sensor or handheld. CAUTION: Do not get the sensor or handheld wet. CAUTION: Do not store the sensor or handheld either unit in direct sunlight or near corrosive liquids CAUTION: Do not attempt to replace the handheld battery. CAUTION: Use only supplied wall charger with the handheld. CAUTION: The handheld is a cellular phone. Follow your implantable device manufacturers recom-mendations on the use of the cellular phones with your implant. CAUTION: Press firmly all around electrode patches to secure them firmly to skin. CAUTION: Shave any hair that is in the area the electrodes are placed. CAUTION: The TruVue system is not an emergency response device. The patient should call 911 and/or their local emergency medical service if they feel they are having a medical emergency. PHYSICIAN’S OPERATION MANUAL
33 Description of Device Symbols Type BF Electrical Isolation Read Manual First DC Current

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