PARADYM RF VR model 9250 Implant Manual March 2011

6.4. Detection characteristics in the presence of electromagnetic fields...19 6.5. Protection against short-circuits...19 7. Main functions...20 7.1. Automatic lead measurements...20 7.2. Ventricular tachyarrhythmia management...20 7.3. Sensing...21 7.4. Pacing...21 7.5. Follow-up functions...22 7.6. Remote Monitoring function...22 8. Patient follow-up...25 8.1. Follow-up recommendations...25 8.2. Elective Replacement Indicator (ERI)...26 8.3. Explantation...27 8.4. Defibrillator identification...28 9. Physical characteristics...29 9.1. Materials used...30 10. Electrical characteristics...30 10.1. Table of delivered shock energy and voltage...31 10.2. Battery...31 10.3. Longevity...32 11. Programmable parameters...33 11.1. Antibradycardia pacing...34 11.2. Ventricular tachyarrhythmia detection...36 11.3. Ventricular tachyarrhythmia therapies...38 11.4. Remote alerts and warnings...43

12. Non programmable parameters...44 13. Declaration of conformity...44 14. Limited warranty...45 14.1. Article 1: Terms of limited warranty...45 14.2. Article 2: Terms of replacement...47 15. Explanation of symbols...48

1. GENERAL DESCRIPTION PARADYM RF VR 9250 is an implantable single-chamber cardioverter defibrillator. It is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity. It is also equipped with the RF wireless technology which enables to remotely monitor the patients who have the Sorin CRM SMARTVIEW Monitor installed at home. PARADYM RF VR 9250 provides a range of therapeutic and diagnostic functions: high energy shocks advanced diagnostic functions PARADYM RF VR 9250 is protected against high-frequency signals emitted by cellular telephones.

2. INDICATIONS Pacing and defibrillation indications are provided by the American College of Cardiology, the American Heart Association and the Heart Rhythm Society: ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices). Circulation 2008;117: 2820-2840; J Am Coll Cardiol 2008 51: 2085-2105.

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3. CONTRAINDICATIONS Implantation of PARADYM RF VR 9250 is contraindicated in patients: whose tachyarrhythmias are induced by drug treatment, electrolyte imbalance, or any other reversible cause, whose tachyarrhythmias are due to acute myocardial infarction or unstable ischemic episodes, who present incessant tachyarrhythmia, whose tachyarrhythmia was due to electrocution. The benefits of pacing to pediatric subjects have not been evaluated. Adverse interactions may occur between the patient's spontaneous rate and device functions.

3.1. POTENTIAL COMPLICATIONS Complications may arise with any implanted pacing or defibrillation system. They may be related to the device itself: early battery depletion, component failure, sensing circuit inhibition, reversion to backup mode, or other failures due to electromagnetic interference, pectoral stimulation, any complication related to failure to detect arrhythmias and terminate detected arrhythmias, to inappropriate delivery of therapy in the absence of arrhythmia, to acceleration of an arrhythmia by therapy, and to pain experienced during or after delivery of therapy. These complications may be life-threatening for the patient. Complications may be related to the pacing and defibrillation leads: improper lead connection, lead displacement, cardiac wall perforation, or tissue reaction at the myocardium-electrode interface, ENGLISH – 7

insulation fracture, conductor fracture, lead fracture. Medical complications may also arise: infection, fluid accumulation at the implant site, casing migration, skin erosion by the defibrillator with possible protrusion of the casing, haematoma.

4. WARNINGS 4.1. WARNINGS TO PATIENTS The patient should be warned of the potential risks of defibrillator malfunction if he is exposed to external magnetic, electrical, or electromagnetic signals. These potential interference sources may cause conversion to inhibited mode (because of noise detection), erratic delivery of VT or VF therapies, nominal programming, or much more rarely, irreversible damage to the device’s circuits. The main sources of high magnitude electromagnetic interference are: powerful radiofrequency equipment (radar), industrial motors and transformers, arc-welding equipment, high power loudspeakers. Electrical equipment: Household electrical appliances do not affect the functioning of the defibrillator, providing they are insulated to current standards. However, patients should avoid using induction ovens and cookers. Antitheft gates: Since antitheft devices at the entrance to stores are not subject to any safety standards, it is advisable to spend as little time as possible in their vicinity. 8 – ENGLISH

Airport detection systems: Since airport detection systems are not subject to any safety standards, it is advisable to spend as little time as possible in their vicinity. Work environment: The patient's work environment may be an important source of interference. In that case, specific recommendations may be required. CAUTION: Do not tap sharply on the ICD can after implant, because the ICD's sensing circuits can detect this as R-waves, and such oversensing could result in inappropriate pacing, inhibition, or therapy. Normal activities after implant do not result in such oversensing.

4.2. RISKS RELATED TO MEDICAL ENVIRONMENT It is advisable to carefully monitor defibrillator operation prior to and after any medical treatment during which an electrical current from an external source passes through the patient's body. Magnetic Resonance Imaging: MRI is strictly contraindicated in cardiac defibrillator patients. Electrocautery or diathermy device: Diathermy and electrocautery equipment should not be used. If such devices must be used: 1. Before procedure, deactivate ATP and shock therapies. 2. During the procedure, keep the electrocautery device as far as possible from the cardiac defibrillator. Set it at minimum intensity. Use it briefly. 3. After the procedure, check for proper implant function. The device should never be exposed directly to the diathermy source. Left Ventricular Assistant Device (LVAD): When implanting an ICD in a patient implanted with a LVAD, it is recommended to place the device as far as possible from the LVAD, as the LVAD may disturb device interrogation. When interrogating the device the programmer head should be kept as far away from the LVAD as possible.

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External defibrillation: PARADYM RF VR 9250 is protected from external defibrillation shocks. Before external defibrillation, deactivate ATP and shock therapies. During external defibrillation, it is advisable to avoid placing the defibrillating paddles directly over the casing or over the lead. The defibrillating paddles should preferably be placed in an anteroposterior position. Avoid any direct contact between the defibrillation paddles and the conductive parts of the implanted leads or casing of the implanted device. After external defibrillation, check for proper device function. Internal pacemaker: Use of the defibrillator is contraindicated in cardiac implantable pacemaker patients. Radiation therapy: Avoid exposure to ionizing radiation. Betatrons are contraindicated. If high doses of radiation therapy cannot be avoided, the defibrillator should be protected from direct exposure with a protection shield. ATP and shock therapies should be disabled during exposure and proper device function should be checked regularly afterwards. Resulting damage may not be immediately detectable. If irradiation of tissues close to the implantation site is necessary, it is recommended that the cardiac defibrillator be moved. As a safety measure, an external defibrillator should be immediately available. Ultrasound therapy (lithotripsy): It is advisable not to administer ultrasound therapy (or lithotripsy) to a patient with a defibrillator implanted in the abdominal position. Concentrating the ultrasonic field over the device could harm the patient and cause damage to the defibrillator. Diagnostic ultrasound (echography): The defibrillator is not affected by ultrasound imaging devices. Transcutaneous Electrical Nerve Stimulation (TENS): TENS may interfere with defibrillator function. If necessary, the following measures may reduce interference: 1. Place the TENS electrodes as close together as possible and as far as possible from the pulse generator and leads. 2. Monitor cardiac activity during TENS use.

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Scales with body fat monitors and electronic muscle stimulators: A patient with an implanted PARADYM RF VR 9250 should not use these devices. Surgical procedure: For safety reasons, it is preferable to not program the Rate Response function before any surgical procedure on the defibrillator patient.

4.3. STORAGE The defibrillator is packaged in sterile packaging inside a cardboard storage box. It is recommended that the device be stored at a temperature ranging from 0 °C to 50 °C. If the packaging or the device itself has been damaged, for example being dropped on a hard floor, the device should not be implanted. Any device subjected to an excessive impact should be returned to your Sorin CRM representative for examination. Devices MUST NOT be interrogated and programmed within the vicinity of other devices.

4.4. CHARACTERISTICS OF THE STERILE PACKAGING The sterile packaging contains: the defibrillator a ratcheting screwdriver a DF-1 defibrillating connector insulating plug All of this equipment is ethylene oxide sterilized and hermetically sealed in two-ply clear packaging compliant international standards.

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5. IMPLANT PROCEDURE 5.1. NECESSARY EQUIPMENT Implantation of PARADYM RF VR 9250 requires the following equipment: Sorin CRM Orchestra Plus programmer, equipped with the SmartView software interface and with the programming head, pacing system analyser, as well as its sterile connecting cables, to evaluate the pacing and sensing thresholds, a ventricular pacing and defibrillation lead, physiological signal monitor capable of displaying simultaneously the surface ECG and arterial pressure, an external defibrillator with sterile external paddles, sterile cover for the telemetry head.

5.2. OPTIONAL EQUIPMENT The following equipment may be required during implantation of PARADYM RF VR 9250: sterile water to clean traces of blood. Any parts cleaned with sterile water must be thoroughly dried. mineral oil to lubricate if necessary a lead cap to isolate a lead which is not used

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5.3. BEFORE OPENING THE PACKAGE Before opening the package, check the “Use Before” date printed on the labels on the box and on the sterile package. Defibrillators that have not been implanted before that date should be returned to Sorin CRM. 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. If the defibrillator is no longer sterile, it should be returned in its packaging to Sorin CRM. Any re-sterilization of the unit is at the discretion of Sorin CRM.

5.4. PRIOR TO IMPLANTATION Use the programmer to verify the defibrillator can be interrogated before implantation. Verify all shock therapies are disabled in order to avoid accidental discharge during implantation. It is not advisable to program the Smoothing function before implantation, since the defibrillator may detect noise and pace at a rate higher than the programmed basic rate. CAUTION: Do not shake or tap sharply on the ICD package with the ICD inside, because the ICD's sensing circuits can interpret this as R-waves and record these as an arrhythmia episode. If unusual shaking or tapping of the package results in a stored arrhythmia episode, erase the recording before using the ICD.

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5.5. DEVICE PLACEMENT The pocket should be prepared in the left pectoral position, either subcutaneously or submuscularly. Subcutaneous device implantation is recommended for optimal RF communication efficacy. Implantation in an abdominal position is not advisable. In its final position, the defibrillator should be no more than 4 cm below the skin surface.

5.6. CHOOSING THE TYPE OF LEAD The defibrillator should be connected to: one ventricular defibrillation lead with sensing/pacing bipolar electrodes, and one or two defibrillation electrodes. The choice of leads and their configuration is left to the implanting physician’s judgment. Connectors: The bipolar pacing/sensing connector is compliant with the IS-1 standard and the defibrillation connectors are compliant with the DF-1 standard.

5.7. MEASUREMENT OF THRESHOLDS AT IMPLANT Pacing and sensing thresholds should be measured at implant. Pacing threshold: Acute thresholds should be lower than 1 V (or 2 mA) for a 0.35 ms pulse width. Sensing threshold: For proper ventricular sensing, the amplitude of the R-wave should be greater than 5 mV. Pacing impedance measurement: Ventricular pacing impedance should range from 200 to 3000 ohms (refer to the lead characteristics, especially if high impedance lead is used).

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5.8. LEAD CONNECTION The lead must be connected to the corresponding connector port. The position of each connector is indicated on the casing. Caution: Tighten only the distal insert. To connect the lead, proceed as follows: 1. Clean the lead terminal pins thoroughly, if necessary (device replacement). 2. Lubricate the lead terminal pins with sterile water, if necessary. 3. Do not insert a lead connector pin into the connector block without first visually verifying that the lead port is not filled with any obstacle. 4. Insert the screwdriver into the pre-inserted screw socket of the appropriate port (in order to allow excess air to bleed out and to make the insertion of the lead pin easier). 5. Insert the lead pin all the way into the port (check that the pin protrudes beyond the distal insert). 6. Tighten, check the tightness and ensure the lead pin still protrudes beyond the distal insert, and did not move. Caution: 1. One single set screw is located on the side of the connection header. 2. Do not tighten the pre-inserted screws when there is no lead (this could damage the connector). 3. Do not loosen the screws before inserting the connector (subsequent risk of being unable to reinsert the screw). 4. Removing the screwdriver: to avoid all risk of loosening screws during removal, hold the screwdriver by its metal part and not by the handle. 5. When mineral oil or sterile water is used to make lead insertion easier, the screwdriver should remain inserted into the pre-inserted screw socket when checking the tightness. As a matter of fact, when the lead port is filled with a liquid, the physics piston effect can give the feeling the lead is properly tightened.

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5.9. DEVICE IMPLANTATION Place the device in the pocket. Carefully wind excess lead and place in a separate pocket to the side of the defibrillator. Suture the casing connector to the muscle using the hole provided for this purpose, in order to avoid potential migration of the device into the pectoral muscle.

5.10. TESTS AND PROGRAMMING During the implant testing procedure, it is recommended that a security margin of at least 10 J be demonstrated between the effective shock energy and maximum programmable energy. Enable shock therapies, then program the defibrillator. Verify that the defibrillation lead impedance for each shock delivered ranges from 30 to 150 ohms. Check the lead connection if the values are outside these boundaries. Save the programming data on the programmer’s hard disk and on an external storage device (if desired).

5.11. DEVICE REGISTRATION Complete the registration form (EURID/Eucomed for Europe). One of the sheets should be given to the patient on discharge from the hospital, to use as an identification and follow-up card. One copy should be returned to Sorin CRM within 30 days after implantation to activate the warranty. The two other copies are for the hospital and for the national registration centre (for Europe).

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6. SPECIAL MODES 6.1. SAFETY MODE (NOMINAL VALUES) Nominal values may be rapidly restored by pressing the following button on the programming head or programmer keyboard:

or via the Emergency button on the SmartView screen. In safety mode, the defibrillator operates with the parameters underlined in the table of programmable parameters.

6.2. MAGNET MODE When the magnet is applied: antiarrhythmia functions are inhibited (detection of rhythm disturbances, charging, and therapy), pacing amplitude is set to 6 V, pulse width is set to maximum, pacing rate is set to the magnet rate, the following functions are disabled: Smoothing, Rate Response. When the magnet is removed: the sensor rate is forced to the basic rate, arrhythmia detection algorithms and sequential therapies are reinitialized, therapies start with the least aggressive program for each area. The other parameters remain at their programmed value. NOTE: The magnet is inactive during telemetry.

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The magnet rate values are as follow: Magnet rate (min-1)

96

94

91

89

87

85

Magnet period (ms)

625

641

656

672

688

703

Magnet rate (min-1)

83

82

80

78

77

Magnet period (ms)

719

734

750

766

781

6.3. RESPONSE IN THE PRESENCE OF INTERFERENCE If the defibrillator senses electrical noise at a frequency above 16 Hz, it switches to an asynchronous mode at the basic rate. The programmed mode is restored as soon as the noise is no longer detected. Ventricular pacing is also inhibited by ventricular noise. It can be restored by setting the parameter V pacing on noise to Yes.

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6.4. DETECTION CHARACTERISTICS IN THE PRESENCE OF ELECTROMAGNETIC FIELDS Per Clause 27.4 of Standard EN 45502-2-2, detection in the presence of electromagnetic fields is characterized as follows: Differential mode:

Common mode rejection ratio: 16.6 Hz Ventricular channel

69 dB

50 Hz 69 dB

60 Hz 69 dB

6.5. PROTECTION AGAINST SHORT-CIRCUITS The defibrillator can undergo a short-circuit if the anode and cathode are not adequately separated. In this case, the shock is aborted to prevent damaging the defibrillator and a warning will indicate that a short circuit (shock impedance < 20 ohms) was detected during the last shock.

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7. MAIN FUNCTIONS 7.1. AUTOMATIC LEAD MEASUREMENTS Automatic pacing lead impedance measurement: A lead impedance measurement is automatically performed on the lead every 6 hours. The daily mean impedance is stored. Shock circuit continuity test: A shock circuit continuity test is automatically performed once a week on RV and SVC coils. The result is stored in the device memory.

7.2. VENTRICULAR TACHYARRHYTHMIA MANAGEMENT Searching for a long cycle (Stability+): Additional arrhythmia classification criterion to improve identification of atrial fibrillation and avoid inappropriate shocks. Automatic adjustment of tachycardia therapies (Autoswitch ATP): This feature enables the device to apply the last successful therapy (ATP only) first, therefore changing the sequence of ATP programs if necessary. Fast VT treatment: Applies detection criteria on fast ventricular tachycardia that are different from those of the VT zone, as well as different therapies. The fast VT zone is included in the VF zone: its lower limit is determined by the programmed value for the VF zone and its upper limit by the programmed value for the fast VT zone. Polarity alternation on Max shock: Reverses the programmed polarity of every second shock set at maximum energy. The number, type, and energy of shocks is independently programmable by detection zone.

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7.3. SENSING Automatic Refractory Periods: Optimize sensing and make the implant progamming easier. These periods are composed of a minimal Refractory Period and a triggerable Refractory Period. The duration of the refractory periods lengthens automatically as needed. Protection against noise: Allows the distinction between ventricular noise and ventricular fibrillation. If the device senses ventricular noise, the ventricular sensitivity is decreased until noise is no longer detected. Ventricular pacing can be inhibited to avoid a potential paced T-wave. Automatic sensitivity control: Optimizes arrhythmia detection and avoids late detection of T-waves and over-detection of wide QRS waves. The device automatically adjusts the sensitivities based on the ventricular sensing amplitude. In case of arrhythmia suspicion or after a paced event, the programmed ventricular sensitivity will be applied. The minimum ventricular sensitivity threshold is 0.4 mV (minimum programmable value).

7.4. PACING BTO (Brady Tachy Overlap): Allows pacing in the slow VT zone, without affecting arrhythmia detection specificity. Post-shock mode: After any automatic shock therapy, the post-shock mode makes it possible to apply different pacing parameters.

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7.5. FOLLOW-UP FUNCTIONS Storage of memory data: AIDA+ (Automatic Interpretation for Diagnosis Assistance) software provides access up to 6 months of patient follow-up with day by day data collection, or up to 24 hours with hourly data collection. Episodes of ventricular tachyarrhythmia are recorded with the programmable EGM channels: either by selecting up to two traces, or by selecting “V-Double” which enables a one-channel recording that is twice as long. Alerts / Warnings: The device routinely performs security self-checks and technical measurements to ensure system integrity. When system integrity is found to be at risk outside a follow-up, alerts are stored in the device memory. When system integrity is found to be at risk during a follow-up, the information is managed as a warning (pop-up message) to notify immediately the user. For example, the following types of event can trigger a warning or an alert: technical problem during a shock, lead impedance or shock continuity measurements out-of-range, battery depletion, …

7.6. REMOTE MONITORING FUNCTION Remote monitoring enables the automatic remote transmission of implant data to the physician thanks to the wireless Radio Frequency (RF) communication ability of the implant in order to provide a comprehensive report to the physician about device functioning and patient cardiac status without having the patient physically in the clinic. The data is transmitted from the implant and the SMARTVIEW monitor, a small transmitter placed in the patient home. Implant data are first transmitted to the SMARTVIEW monitor via RF. Data are then rooted through the phone line to an internet website. This website is responsible for transforming the implant data into a comprehensive report that can be consulted by the physician. 22 – ENGLISH