ALIZEA DR/ ALIZEA SR IMPLANT MANUAL Rate responsive dual-chamber pacemaker / Rate responsive single-chamber pacemaker
Intended audience This manual is intended for use by professionals trained or experienced in device implant and/or follow-up procedures.
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ALIZEA Reminder Leads connection SR DR
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TABLE OF CONTENTS 1. GENERAL DESCRIPTION ...................................................................................... 10 2. INTENDED USE AND TARGETED POPULATION................................................. 11 2.1. Intended use............................................................................................................. 11 2.2. Indications and targeted population ......................................................................... 11 3.
12.1. Necessary equipment............................................................................................... 30 12.2. Packaging contents .................................................................................................. 30 12.3. Optional equipment .................................................................................................. 30 12.4. Opening the package ............................................................................................... 30 12.5.
18.7. Markers and intracardiac ECG ................................................................................. 61 18.8. Temporary programming.......................................................................................... 62 18.9. Memory functions ..................................................................................................... 62 19. PHYSICAL CHARACTERISTICS ............................................................................ 65 20.
1. GENERAL DESCRIPTION 1. GENERAL DESCRIPTION ALIZEA DR is a DDDR-type dual-chamber rate-responsive pacemaker. ALIZEA SR is a single-chamber rate-responsive pacemaker. Both are equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient’s activity. ALIZEA DR and SR models can be programmed and interrogated via bi-directional telemetry using a MicroPort dedicated programmer connected to a MicroPort dedicated programming head.
2. INTENDED USE AND TARGETED POPULATION 2. INTENDED USE AND TARGETED POPULATION 2.1. INTENDED USE The ALIZEA pacemakers are intended to stimulate the bradycardic patient’s heart with electrical impulses as indicated in the guidelines on cardiac pacing(1) in order to maintain or restore a normal heartbeat. SR devices are implantable single chamber pacemakers that must be used with one lead (right atrial or ventricular lead).
2. INTENDED USE AND TARGETED POPULATION ― symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders; ― bradycardia-tachycardia syndrome to prevent symptomatic Bradycardia or some forms of symptomatic tachyarrhythmias; ― vasovagal syndromes or hypersensitive carotid sinus syndromes. ― Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity.
3. CONTRAINDICATIONS AND ADVERSE EVENTS 3. CONTRAINDICATIONS AND ADVERSE EVENTS 3.1. GENERAL CONSIDERATIONS For the DR model, the use of dual chamber pacing mode is contraindicated in patients with chronic atrial fibrillation. In general, the patient's medical and physical condition, as well as age, should always be taken into consideration when choosing the pacemaker and leads. Furthermore, the benefits of pacing to pediatric subjects have not been evaluated.
3. CONTRAINDICATIONS AND ADVERSE EVENTS Events Possible adverse effects Others Venous trauma (e.g.
3. CONTRAINDICATIONS AND ADVERSE EVENTS Events Possible adverse effects Stroke Worsening heart failure Long term Prolonged exposure to fluoroscopic radiation No data available NOTE: Any serious incident in relation to the device should be reported to MicroPort CRM and the local Competent Authority.
4. WARNINGS 4. WARNINGS 4.1. PACEMAKER DEPENDENT PATIENTS Electrograms of the patient’s intrinsic activity should be obtained with care since the patient is without pacing support. Automated threshold testing should be terminated, either by pressing any key or by removing the programming head when capture ceases in order to restore the preprogrammed pulse amplitude and ensure capture.
4. WARNINGS Magnetic Resonance Imaging: When implanted in combination with MR Conditional lead(s), the pacing system constitutes an MR conditional system under specific conditions. When these conditions are not met, MRI is contraindicated. NOTE: Refer to the MRI Solutions manual for the complete instructions for use available at www.microportmanuals.com. Mechanical ventilators: Mechanical ventilators may cause pacing rate changes. Program the pacemaker to a nonrate responsive mode during ventilation.
4. WARNINGS Resulting damage may be immediately undetectable. If irradiation of tissues close to the implantation site is necessary, it is recommended that the pacemaker be moved. As a safety measure, temporary pacemaker back-up should be immediately available. Lithotripsy The risks associated with lithotripsy are limited unless the cardiac pacemaker is implanted in the abdominal position.
5. CLINICAL STUDIES 5. CLINICAL STUDIES ALIZEA SR is limited to single chamber features, but is otherwise the same as ALIZEA DR. ALIZEA DR and SR offer features which have been evaluated during clinical study of Reply DR, whose results are presented in the following paragraph: 5.1. METHODS All patients were implanted with a REPLY DR rate-responsive dual-chamber pacemaker. A variety of marketed atrial and ventricular pacing and sensing leads were used.
5. CLINICAL STUDIES ― absence of unexpected short ventricular cycle The following table presents the percentage of success and its unilateral 95% confidence interval. Number of patients included Number of failures observed % of successes (unilateral 95% confidence interval) 60 0 100% (95.12%) To determine the effectiveness of automatic implantation detection function, the function was activated in all implanted patients.
6. PATIENT SELECTION AND TREATMENT 6. PATIENT SELECTION AND TREATMENT 6.1. SPECIFIC PATIENT POPULATIONS ― Pregnancy: If there is a need to image the device, care should be taken to minimize the radiation exposure to the fetus and the mother. ― Labor and delivery: If minute ventilation mode is enabled breathing patterns associated with birthing may drive the pacing rate to the programmed maximum sensor rate.
7. PATIENT COUNSELING INFORMATION 7. PATIENT COUNSELING INFORMATION Physicians should consider the following points in counseling the patient about this device: ― Provide patient with (temporary) pacemaker ID card – inform them that a permanent ID card will be issued by the pacemaker manufacturer. ― Need to notify other health care providers (e.g., dentist, physical therapist, anesthesiologist, surgeon, etc.) of the presence and type of pacemaker. ― Symptoms of pacemaker syndrome.
8. DECLARATION OF CONFORMITY 8. DECLARATION OF CONFORMITY MicroPort declares that this device is in conformity with the essential requirements of Radio Equipment Directive 2014/53/EU, with the mutual recognition of their conformity (RED). Federal Communication Commission Interference Statement 47 CFR Section 15.19 and 15.105(b) The FCC product ID is : ― ALIZEA DR: YSG1614 ― ALIZEA SR: YSG1311 ALIZEA pacemaker is featuring Bluetooth Low Energy communication capability.
9. PHYSICIAN GUIDELINES 9. PHYSICIAN GUIDELINES 9.1. PHYSICIAN TRAINING Physicians should be familiar with sterile pulse generator. They must apply these procedures according to professional medical training and experience. Physicians should be familiar with follow-up evaluation and management of patients with a pacemaker (or referral to such a physician).
9. PHYSICIAN GUIDELINES 9.4. IMPLANTATION AND DEVICE PROGRAMMING Use only a MicroPort programmer to communicate with the device. Replace the device when the RRT (Recommended Replacement Time*) point (defined by a battery voltage of 2.63 V if Remote monitoring activated or 2.70 V if Remote monitoring deactivated) is reached. Lead System Do not use a lead system other than those with demonstrated compatibility because undersensing cardiac activity and failure to deliver necessary therapy may result.
9. PHYSICIAN GUIDELINES Do not grip the lead with surgical instruments. Do not use excessive force or surgical instruments to insert a stylet into a lead. Use ventricular transvenous leads with caution in patients with either a mechanical or bioprosthetic tricuspid valvular prosthesis. Use the correct suture sleeve (when needed) for each lead, to immobilize the lead and protect it against damage from ligatures. Do not kink leads.
9. PHYSICIAN GUIDELINES 9.8. GENERATOR EXPLANT AND DISPOSAL Interrogate the device prior to explanting. Return all explanted generators and leads to the manufacturer. Never incinerate the device due to the potential for explosion. The device must be explanted before cremation.
10. PATIENT INFORMATION 10. PATIENT INFORMATION Information for the patient is available in the patient booklet, contained in the outer storage package. Additional copies can be obtained by contacting your MicroPort representative. This information should be given to each patient with his or her first pacemaker and offered to the pacemaker patient on each return visit or as deemed appropriate.
11. HOW SUPPLIED 11. HOW SUPPLIED 11.1. STERILITY The ALIZEA pacemakers are supplied one per package in a sterile package. 11.2. WARRANTY AND REPLACEMENT POLICY MicroPort warrants its pacemakers. Refer to the "Warranty" section for additional information. Please see the following labeling sections for information concerning the performance of this device: Indications, Contraindications, Warnings and Precautions, and Adverse Events.
12. IMPLANT PROCEDURE 12. IMPLANT PROCEDURE 12.1.
12. IMPLANT PROCEDURE NOTE:The battery voltage can decrease before the expiration date is reached. However, the battery voltage should be equal to or higher than 3.04V at the time of implant. Devices MUST NOT be interrogated and programmed within the vicinity of other devices. Also check the integrity of the sterile package. The sterility of the contents is no longer guaranteed if the package has been pierced or altered.
12. IMPLANT PROCEDURE 12.6. CHOOSING THE TYPE OF LEAD For the DR model, for optimal use of pacemaker functions, the atrial lead should be bipolar. If a unipolar atrial lead is used, the Autosensing function will not be available. For MRI compatibility, both leads should be bipolar. For the SR model, for optimal use of pacemaker functions, the lead used should be bipolar. If a unipolar lead is used, the following function will not be available: the rate-response function based on minute ventilation.
12. IMPLANT PROCEDURE 4. For the DR model, insert the atrial lead pin all the way into the appropriate port (marked A) of the pacemaker and proceed as in steps 2 and 3. CAUTION: ― Do not tighten the pre-inserted screw when there is no lead connector inserted (this could damage the connector block). ― Do not loosen the screw before inserting the lead into the connector (subsequent risk of being unable to reinsert the screw). ― Use only the screwdriver provided with the pacemaker.
13. PACEMAKER INTERROGATION AND UPGRADE 13. PACEMAKER INTERROGATION AND UPGRADE The pacemaker can be interrogated and programmed via telemetry using a suitable programming head connected to a MicroPort dedicated programmer. Refer to the programmer manual supplied with the programmer for details concerning its use.
14. SPECIAL MODES 14. SPECIAL MODES 14.1. NOMINAL MODE (SAFETY MODE) Safety settings may be rapidly restored by pressing the Emergency button below: via the MicroPort dedicated programmer screen, the programming head or the MicroPort dedicated programmer keyboard. In nominal mode, the pacemaker operates with the parameters from the table of programmable parameters. 14.2.
14. SPECIAL MODES noise is no longer detected.
15. FUNCTIONS AND PARAMETERS 15. FUNCTIONS AND PARAMETERS 15.1. PACING MODES The pacing mode determines pacemaker operation when pacing and sensing. The meanings of the codes (e.g., DDD, VVI, AOO) are provided in Standards EN 45502-2-1 and ISO 14708-2. For the DR model, the SafeR and DPlus modes are described in the section "Therapeutic improvements". Contraindications to the use of specific modes for the both SR and DR models: 1. AAI(R) pacing is contraindicated where AV conduction is impaired. 2.
15. FUNCTIONS AND PARAMETERS Special case: In triggered mode (single or dual chamber), the device may exceed the maximum tracking rate and pace to the rate limit value. 15.2.3. Rate hysteresis Rate hysteresis determines the ability of the patient’s natural sinus rhythm to decrease below the escape rate. After sensing, the pacemaker operates with an escape rate reduced by the programmed percentage of hysteresis. Programming requirements: 1.
15. FUNCTIONS AND PARAMETERS 15.3.3. Sensitivity The sensitivity determines the minimum signal sensing threshold. For example, a sensitivity of 1 mV will allow sensing of only signals with amplitude greater than 1 mV. In order to detect a low-amplitude cardiac signal, a higher sensitivity (lower value) must be programmed. However, if the pacemaker detects extracardiac signals, a lower sensitivity (higher value) must be programmed. Recommendations: 1.
15. FUNCTIONS AND PARAMETERS Programming requirement: The pacemaker cannot be programmed to bipolar configuration if a bipolar lead is not connected (measurement of the impedance determines the type of lead present when programming to bipolar configuration). 15.4. REFRACTORY PERIODS Post R and Post V Atrial Blanking, committed period, automatic AV delay and AVD paced/sensed offset are not available for the SR model. 15.4.1.
15. FUNCTIONS AND PARAMETERS NOTES: The Rest AV delay and the Exercise AV delay are automatically programmed and calculated when Dplus mode is selected. If the basic rate is equal to 30 ppm, the effective AV delay may be shorter than the programmed value. If the basic rate is less than 60 ppm, the rest AV delay is used for all rates between the basic rate and 60 ppm. The effective AV delay following atrial pacing may be longer than the programmed AV delay if an AVD Paced/Sensed Offset is programmed.
15. FUNCTIONS AND PARAMETERS The combination of these two sensors also prevents rate increases due to artifacts through continuous cross-checking of information from each sensor. Any rate increase not confirmed by the second sensor results in a return to the basic escape rate. In dual sensor mode (Twin Trace), the MV sensor is dominant and solely determines the rate response when both sensors detect exercise.
15. FUNCTIONS AND PARAMETERS 15.6. THERAPEUTIC IMPROVEMENTS Features DR model SR model SafeR x Dplus x Rate acceleration x Rest rate x x Smoothing x x Mode switching x 15.6.1. SafeR mode The SafeR mode is intended to minimize unnecessary ventricular pacing and to promote spontaneous atrioventricular conduction. It gives priority to pacemaker operation in AAI(R) mode: the sensed P wave does not trigger the AV delay and recycles an atrial escape interval.
15. FUNCTIONS AND PARAMETERS Adaptation to nocturnal AV blocks: The device switches to DDD(R) mode and remains in DDD(R) mode when it has: ― 45 episodes of AV block or more during the last 24 hours ― 15 episodes of AV block or more per 24 hours during 3 consecutive days ― 50% DDD(R) pacing or more during one hour. In these cases the automatic switch to AAI(R) following every 100 ventricular paced cycles is suspended. It remains in DDD(R) mode until 8:00 am the next morning.
15. FUNCTIONS AND PARAMETERS Limitation: The pacing rate induced by rate acceleration is limited to 120 ppm (or to the maximum rate if the latter is lower). Programming constraints: 1. This function is available when Dplus or DDD mode is programmed. 2. If any of the AA prevention functions is activated, acceleration is forced to 0% and is not programmable. AV delay shortening The Acceleration function (only) may be accompanied by a shortening of the AV delay, intended to increase hemodynamic response.
15. FUNCTIONS AND PARAMETERS Programming at implant: It is not advisable to program the Smoothing function before implantation, since the pacemaker may detect noise and pace at a rate higher than the programmed basic rate. Recommendation: Concomitant use of the Hysteresis function is highly advisable to avoid triggering of pacing for slight variations in the patient’s spontaneous cycle (unless one of the AA prevention functions is activated, for the DR model only). 15.6.6.
15. FUNCTIONS AND PARAMETERS 15.7.1. Automatic detection of implantation Operation: At implantation, once the ventricular lead has been connected to the pacemaker and the case is in contact with the tissue, the device starts the detection of implantation. After five minutes, the device automatically checks if the ventricular lead is still connected to the pacemaker and the case still in contact with the tissue: 1. If yes, the detection of implantation is automatically confirmed. 2.
15. FUNCTIONS AND PARAMETERS 2. For the DR model, when the Overdrive function is activated, the atrial Autosensing function is not programmable. 15.7.3. Ventricular Autothreshold (automatic adjustment of ventricular pacing amplitude) The Ventricular Autothreshold function allows automatic adjustment of the amplitude of ventricular pacing, according to a threshold test performed by the device at regular intervals. Description: ALIZEA searches for the ventricular threshold daily at 0am, 6am, 12am and 6pm.
15. FUNCTIONS AND PARAMETERS Programming constraint: The Ventricular Autothreshold function is not programmable when the basic rate is above 85 ppm. 15.7.4. Atrial Autothreshold (for the DR model only) The Atrial Autothreshold function allows automatic adjustment of the amplitude of atrial pacing, according to a threshold test performed by the device at regular intervals. Description: Once a day (at 2 am by default), ALIZEA searches for the atrial threshold.
15. FUNCTIONS AND PARAMETERS test is successful. 2. When the Atrial Autothreshold function is programmed to "Monitor," the programmed atrial pacing amplitude value is preserved. Programming constraint: The Atrial Autothreshold function is not programmable when the basic rate is above: ― 85 ppm with an atrial autothreshold max rate at 120 ppm, ― 80 ppm with an atrial autothreshold max rate at 110 ppm, ― 70 ppm with an atrial autothreshold max rate at 100 ppm.
15. FUNCTIONS AND PARAMETERS CAUTION: If the Lead Polarity Switch detects out-of-range lead impedance, investigate possible lead system failures. Lead system failures can prevent adequate sensing or full pacing support. NOTE for the DR model: When operating on the atrial lead, the lead polarity switch changes the pacing mode to VVI(R). For optimal use of pacemaker functions, the atrial lead should be bipolar. Programming constraints: 1.
15. FUNCTIONS AND PARAMETERS through the Internet. The SMARTVIEW CONNECT monitor is delivered to the patient who has to install it at home. Preferably, the SMARTVIEW CONNECT monitor will be placed on the nightstand of the patient, as close as possible to the side of the bed where the patient usually sleeps. The SMARTVIEW CONNECT monitor needs to be connected to the power plug.
15. FUNCTIONS AND PARAMETERS ― High pacing threshold (A,V); ― Lead Polarity Switch (A,V); ― AF occurrence with 3 thresholds (for DR only); ― Fast V rate during AF (for DR only); ― Asynchronous mode; ― MRI notifications. The following set of alert triggers (system alerts) cannot be deactivated when the Alerts are programmed “On” and can trigger an alert transmission: ― Battery depletion – RRT; ― System integrity; ― Reset. WARNING: The use of remote monitoring does not replace regular follow-up.
16. PATIENT FOLLOW-UP 16. PATIENT FOLLOW-UP 16.1. RECOMMENDED REPLACEMENT TIME (RRT) The Recommended Replacement Time (RRT), previously known as Elective Replacement Indicator (ERI) is controlled by: ― a battery voltage: ― of 2.63 V if Remote monitoring activated; ― of 2.70 V if Remote monitoring deactivated. When RRT is reached, a magnet rate of 80 ± 1 ppm is applied by the device. As the EOS (End Of Service) approaches, the magnet rate decreases to 70 ± 1 ppm.
16. PATIENT FOLLOW-UP 2. Check for proper sensing (sensitivity for the both SR and DR models, crosstalk for the DR model) and pacing; set the pacing amplitude to twice the pacing threshold. 3. Interrogate the device memories (AIDA) 4. Keep a printout of programmed parameters, test results, and memory data.
16. PATIENT FOLLOW-UP All explanted pacemakers should be returned to your MicroPort representative carefully cleaned of all traces of contamination. Cleaning can be achieved by immersing the pacemaker in an aqueous sodium hypochlorite containing at least 1% chlorine, followed by rinsing copiously with water. The pacemaker should be packaged so as to protect against the mechanical impact and temperature variations that may occur during shipping. 16.4.
16. PATIENT FOLLOW-UP 1. Take an X-ray to identify the name of the manufacturer printed on the device (MLP = MRI Conditional MicroPort Pacemaker model). For the SR model: For the DR model: 2. Interrogate the device using the MicroPort dedicated programmer. The model and serial number of the device are automatically displayed.
17. STANDBY MODE 17. STANDBY MODE Standby is a safety mode of operation that the pacemaker enters in response to a failure of one of the self-tests that are performed periodically. The programmer has the ability to examine the pacemaker by telemetry and restart or, if possible, re-initialize the pacemaker. Test modes, including magnet mode, are disabled and statistics are not incremented.
18. MEDICAL FOLLOW-UP 18. MEDICAL FOLLOW-UP 18.1. MAGNET TEST The magnet test gives an indication of the cell capacity, atrial and/or ventricular capture, amplitude and basic rate programmed without using the programmer. Application of a magnet over the pacemaker makes the pulse generator operate in a simple safety mode. 18.1.1.
18. MEDICAL FOLLOW-UP 18.3. RATE TEST MODE: The purpose of this mode is to measure the programmed amplitude and rate and, in dual chamber pacing, the programmed AV delay.
18. MEDICAL FOLLOW-UP The test begins at user demand in the programmed mode, at the programmed start amplitude (in volts) with the programmed number of spike(s) per amplitude. During the test, atrial pacing (and ventricular if programmed for DR model) is (are) asynchronous. The pacing rate, the pulse width and the polarity are respectively the programmed threshold rate, programmed threshold pulse width and programmed threshold polarity. The atrial amplitude (in volts) sequence is 6V, 5V, 4.5V, 4V, 3.
18. MEDICAL FOLLOW-UP Negative markers: ventricular events Vr marker Small marker Ventricular sensing during a relative refractory period Vs marker Intermediate marker Ventricular sensing outside the refractory periods Vp marker Large marker Ventricular pacing (including pacing initiated in the SST mode) Vn marker Large marker Ventricular pacing inside absolute refractory periods The pacemaker starts transmitting markers when commanded by the programmer (see programmer manual).
18. MEDICAL FOLLOW-UP 18.9.1.
18. MEDICAL FOLLOW-UP 18.9.5. Autosensing histograms and curves If autosensing is programmed in Monitor or Auto mode, P and R waves are continuously recorded and can be displayed through the autosensing histograms. When programmed to Auto mode, curves of the target thresholds determined by the algorithm in each chamber, stored every 8.5 minutes, are also available.
19. PHYSICAL CHARACTERISTICS 19. PHYSICAL CHARACTERISTICS DR model SR model Dimensions 45.5 x 54.3 x 6.1 mm 41.4 x 54.3 x 6.1 mm Weight 24.2 g 23.3 g 3 10.50 cm3 Volume 11 cm Connector IS-1 (2x) IS-1 Active surface area of casing 34.2 cm2 34.
20. ELECTRICAL CHARACTERISTICS 20. ELECTRICAL CHARACTERISTICS Input impedance Unipolar ≥ 40 kΩ Bipolar ≥ 40 kΩ Pulse form 20.1. CURRENT DRAIN AT BEGINNING OF SERVICE Battery condition BOS=3.20 V without Remote monitoring Battery condition BOS=3.10 V with Remote monitoring For the DR model, the current drain at the beginning of service is as follows: Shipment conditions(1) SafeR mode(3) Inhibited: 6.0 µA With pacing: 8.0 µA Shipment conditions (1) DDD mode Inhibited: 6.0 µA 100% pacing: 13.
20. ELECTRICAL CHARACTERISTICS 20.2. CORRESPONDENCE BETWEEN MAGNET RATE AND BATTERY LIFE Table of magnet rate: 20.3. Battery life BOS RRT EOS Magnet Rate (bpm) 96 80 70 BATTERY Manufacturer LITRONIK GmbH Type Lithium manganese dioxide (LiMnO2) Model LiS 3150 MP Total capacity 1.2 Ah Usable capacity Without Remote monitoring, between BOS and RRT = 1.123 Ah, between RRT et EOS = 0.053 Ah. With Remote monitoring, between BOS and RRT = 1.040 Ah, between RRT and EOS = 0.136 Ah.
20. ELECTRICAL CHARACTERISTICS 8.7 years Cenelec conditions and DDD mode, assuming 100% pacing 70 min-1, 2.5 V, 0.5 ms, 500 Ω, Holter ON, sensors ON, Remote OFF 11.1 years ISO14708-2 conditions and DDD mode, assuming 100% pacing 60 min-1, 2.5 V, 0.35 ms, 600 Ω, Holter ON, sensors ON, Remote OFF 12.7 years Shipment conditions and SafeR mode, assuming 5% V pacing & 50% A pacing 60 min-1, 3.5 V, 0.35 ms, 500 Ω, Holter ON, sensors ON, Remote OFF 12.
21. PROGRAMMABLE PARAMETERS 21. PROGRAMMABLE PARAMETERS Measured at 37 °C under a 500 Ω load. The programming of the following parameters can be performed through MicroPort programmer. 21.1.
21. PROGRAMMABLE PARAMETERS Pacing/Sensing Models Values Nominal value "As shipped" value Atrial or ventricular pulse amplitude (V) DR 1-1.5-2-2.5-3-3.5-4-5-6 (± 20 %) 5.0 3.5 5.0 3.5 7.5 (± 30 %) (1) Pulse amplitude (V) SR (1) 1-1.5-2-2.5-3-3.5-4-5-6 (± 20 %) 7.5 (± 30 %) Atrial or ventricular pulse width (ms) (1) DR 0.12-0.25-0.35-0.5-0.6-0.75-0.85 -1 (± 35 µs) 0.5 0.35 Pulse width (ms) (1) SR 0.12-0.25-0.35-0.5-0.6-0.75-0.85 -1 (± 35 µs) 0.5 0.
21.
21. PROGRAMMABLE PARAMETERS Rate responsive parameters Models Values Nominal value "As shipped" value Sensor choice SR, DR Twin Trace-MV-G G MV+G Rate response mode (1) SR, DR Learn-RR auto-RR fixed-No No Learn Physical activity SR, DR Very low-Low-Medium-HighVery high Medium Medium (1) Twenty minutes after the automatic detection of implantation by the device, the as-shipped rate response mode (NO) is automatically reprogrammed to Learn.
21. PROGRAMMABLE PARAMETERS NOTE: The Automatic implant detection function is not available in a SR model when A chamber is selected. 21.2.
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22. NON-PROGRAMMABLE PARAMETERS 22.
23. WARRANTY 23. WARRANTY Warranty duration: 5 Years The ALIZEA implantable cardiac pacemaker is the result of highly advanced research and all components have been selected after exhaustive testing. MicroPort CRM S.r.l.
23. WARRANTY do not have any link to a component failure or a production hazard. The device battery longevity varies with the device settings and pacing operation over time. 23.2. ARTICLE 2: TERMS OF REPLACEMENT 1.
24. EXPLANATION OF SYMBOLS 24.
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MANUFACTURED IN ITALY MicroPort CRM S.r.l. Via Crescentino S.N. 13040 Saluggia (VC) Italy Tel: +39 0161 487095 US Phone: 877.663.7674 www.crm.microport.
