Implantable cardioverter defibrillator DR models Implant manual
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TABLE OF CONTENTS 1. General description................................................................................................................ 5 2. Indications............................................................................................................................... 6 3. Contraindications.................................................................................................................... 7 4. 4.1. 4.2. 4.3. 4.4. 4.5. Warnings and precautions...............
15.2. 15.3. 15.4. 15.5. Magnet mode.......................................................................................................................... 38 Response in the presence of disturbance...............................................................................38 Detection characteristics in the presence of electromagnetic fields........................................38 Protection against short-circuits......................................................................................
1. GENERAL DESCRIPTION 1. GENERAL DESCRIPTION PLATINIUM DR is an implantable dual-chamber cardioverter defibrillator. It is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity. PLATINIUM DR is also equipped with the RF wireless technology which enables: ─ Remote monitoring of patients who have the Sorin SMARTVIEW Monitor installed at home, ─ wireless interrogation and device programming by Orchestra Plus programmer equipped with ORCHESTRA PLUS LINK accessory.
2. INDICATIONS 2. INDICATIONS PLATINIUM DR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: ─ Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, ─ Recurrent, poorly tolerated sustained ventricular tachycardia (VT). NOTE: The clinical outcome for hemodynamically stable VT patients is not fully known.
3. CONTRAINDICATIONS 3. CONTRAINDICATIONS Implantation of PLATINIUM DR is contraindicated in patients: ─ whose ventricular tachyarrhythmias may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes, ─ who present incessant tachyarrhythmia, ─ who have an internal pacemaker, ─ whose primary disorder is bradyarrhythmias, or atrial tachyarrhythmias.
4. WARNINGS AND PRECAUTIONS 4. WARNINGS AND PRECAUTIONS 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.
4. WARNINGS AND PRECAUTIONS 4.1. 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. Radiofrequency ablation: A radiofrequency ablation procedure in a patient with a generator may cause device malfunction or damage.
4. WARNINGS AND PRECAUTIONS Diagnostic ultrasound (echography): The defibrillator is not affected by ultrasound imaging devices. Scales with body fat monitors and electronic muscle stimulators: A patient with an implanted PLATINIUM DR should not use these devices. 4.2. STERILIZATION, STORAGE AND HANDLING Resterilization: Do not resterilize and re-implant explanted ICDs. "Use Before" Date: A "Use Before" date is printed on the outer storage package and on the sterile package.
4. WARNINGS AND PRECAUTIONS In the event of a warning on a low shock impedance, and after lead replacement or reconnection: it is recommended to check the system integrity (sensing and pacing thresholds and the impedance of the shock electrodes) It is recommended that a security margin of at least 10 J be demonstrated between the effective shock energy and maximum programmable energy.
4. WARNINGS AND PRECAUTIONS Do not place the patch lead over nerve tissue as this may cause nerve damage. Place the patch lead with the conducting coil side facing the heart to ensure delivery of energy to the heart. Place the sutures well outside the coil of the patch lead or in the area between the coils to avoid possible coil fracture. If countershock is unsuccessful using external paddles, adjust the external paddle position (e.g.
5. ADVERSE EVENTS 5. ADVERSE EVENTS Clinical data presented in this section are from the Defender and SafeR (AAI <> DDD) clinical studies. PLATINIUM DR is similar in design and function to the Defender devices. SafeR (AAI <> DDD) operation in PLATINIUMis similar to that in the Symphony pacemaker. The data provided are applicable to PLATINIUM DR. 5.1.
5. ADVERSE EVENTS Ventricular lead migration/dislodgment 2 5.3 2 10.5 * There were 228.7 device months in this study. Table 2: Summary of European Clinical Complications (Including Patient Complaints) All complications, 14 of 38 Defender IV DR 612 patients in Europe Event # of Patients* % of Patients # of Events Events/100 DeviceYears** Change in ventricular sensing threshold 1 2.6 1° 5.2 Device reset*** 1 2.6 1° 5.2 Inappropriate therapy for EMI 1 2.6 1° 5.2 Pneumothorax 1 2.
5. ADVERSE EVENTS Deaths 0 0 0 0 Explants 0 0 0 0 Serious pacemaker related events outside the use of SafeR (AAI <> DDD) 0 0 0 0 Non-serious pacemaker related events outside the use of SafeR (AAI <> DDD) 0 0 0 0 Serious events due to the use of SafeR (AAI <> DDD) 0 0 0 0 Non-serious events related due to the use SafeR (AAI <> DDD) 13 28.9 15 3.2 Serious non-pacemaker related events 6 13.3 9 1.9 Non-serious non-pacemaker related events (a) 8 17.8 8 1.7 4.
6. CLINICAL STUDIES 6. CLINICAL STUDIES Clinical data presented in this section are from the Defender and SafeR (AAI <> DDD) clinical studies. PLATINIUM DR is similar in design and function to the Defender devices. SafeR (AAI <> DDD) operation in PLATINIUM is similar to that in the Symphony pacemaker. The data provided are applicable to PLATINIUM DR. 6.1.
6. CLINICAL STUDIES Pe*N Number of successes 35 Pe Observed experimental proportion 0.95 Ps Null hypothesis success rate 0.76 ES Estimated standard error of Pe 0.04 z´ Test statistic (1) 4.75 p Associated p-value < 0,0001 (1) Statistical test: z´ = (Pe-Ps)/SE where SE = sqrt(Pe(1-Pe)/N) 6.1.2. Rate response European patients only: GROUP Number of patients included Mean slope %SRR on %MR STD of slopes %SRR on %MR SE of mean Lower 95% slope %SRR CI on %MR Upper 95% CI Europe 20 0.
6. CLINICAL STUDIES Event Europe (N=38) Number of events* Number of patients Percent of patients Intent to treat but did not 0 0 0.0 Non-device related death 1 1 2.6 Explant 1 1 2.6 Complication 3 2 5.3 Observation 18 14 36.8 Serious non-related other than death 12 7 18.4 Event All (N=60) Number of events* Number of patients Percent of patients Intent to treat but did not 0 0 0.0 Non-device related death 1 1 1.7 Explant 1 1 1.7 Complication 3 2 3.
6. CLINICAL STUDIES Despite these differences, the data collected on Symphony devices are applicable to PLATINIUM because the principles of SafeR (AAI <> DDD) operation did not change. The criteria for switching from AAI to DDD (or vice versa) did not change. The device’s method for evaluating the presence of AV conduction did not change. Methods: All patients were implanted with a Symphony Model 2550 dual-chamber rate-responsive pacemaker with SafeR (AAI <> DDD) mode.
6. CLINICAL STUDIES In a representative reference group(1) of patients programmed to DDD, none had less than 1 % ventricular pacing and only 10 % had less than 90 % ventricular pacing regardless of AV block indication at implant. The actual reduction of ventricular pacing that SafeR (AAI <> DDD) provides in an individual will depend on the amount of time that the patient spends in AV block. SafeR (AAI <> DDD) cannot and should not provide any decrease in ventricular pacing while the patient is in AV block.
6. CLINICAL STUDIES (a) 4.74 device years Non-serious events due to the use of SafeR 2 (AAI <> DDD) included: delay in switching on 2nd degree AV block, inappropriate classification of a PAC, disagreement between markers and recorded EGM, atrial pacing above the maximum rate, recycling on an R-wave in a refractory period, and disagreement in the statistics for switches to DDD. No patient symptoms were associated with these events.
7. PATIENT SELECTION AND TREATMENT 7. PATIENT SELECTION AND TREATMENT 7.1. INDIVIDUALIZATION OF TREATMENT Exercise stress testing: If the patient’s condition permits, use exercise stress testing to: ─ Determine the maximum rate of the patient’s normal rhythm, ─ Identify any supraventricular tachyarrhythmias, ─ Identify exercise-induced tachyarrhythmias. The maximum exercise rate or the presence of supraventricular tachyarrhythmias may influence selection of programmable parameters.
7. PATIENT SELECTION AND TREATMENT 7.2. SPECIFIC PATIENT POPULATIONS Pregnancy: If there is a need to image the device, care should be taken to minimize radiation exposure to the foetus and the mother. Nursing Mothers: Although appropriate biocompatibility testing has been conducted for this implant device, there has been no quantitative assessment of the presence of leachables in breast milk. Pediatric Patients: This device has not been studied in patients younger than 18 years of age.
8. PATIENT COUNSELLING INFORMATION 8. PATIENT COUNSELLING INFORMATION The physician should consider the following points in counselling the patient about this device: ─ Persons administering CPR may experience tingling on the patient’s body surface when the patient’s ICD system delivers a shock. ─ Advise patients to carry Sorin ID cards and/or ID bracelets documenting their ICD system.
9. DECLARATION OF CONFORMITY 9. DECLARATION OF CONFORMITY Sorin declares that this device is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment, with the mutual recognition of their conformity (R&TTE). Federal Communication Commission Interference Statement 47 CFR Section 15.19 and 15.
9. DECLARATION OF CONFORMITY This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada.
10. PHYSICIAN GUIDELINES 10. PHYSICIAN GUIDELINES 10.1. PHYSICIAN TRAINING Physicians should be familiar with sterile pulse generator implant procedure and familiar with follow-up evaluation and management of patients with an implantable defibrillator (or referral to such a physician). 10.2. DIRECTIONS FOR USE ICD operating characteristics should be verified at the time of implantation and recorded in the patient file.
11. PATIENT INFORMATION 11. 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 Sorin representative. This information should be given to each patient with their first ICD and offered to the patient on each return visit or as deemed appropriate.
12. HOW SUPPLIED 12. HOW SUPPLIED 12.1. STERILITY The PLATINIUM defibrillators are supplied one per package in a sterile package. 12.2. WARRANTY AND REPLACEMENT POLICY Sorin warrants its defibrillators. Refer to the section "Warranty" for additional information. Please see the following labelling sections for information concerning the performance of this device: Indications, Contraindications, Warnings and Precautions, and Adverse Events.
13. DEVICE DESCRIPTION 13. DEVICE DESCRIPTION The PLATINIUM DR ICD device and programming system. The programming system includes the Sorin dedicated programmer with the SMARTVIEW programming software connected to a CPR3 programming head. The programming system is configured and furnished by Sorin. The PLATINIUM DR can serve as a defibrillation electrode (active housing) with a total surface area of 63 cm².
13. DEVICE DESCRIPTION ─ Rescue shock ─ Follow-up tests: ─ Pacing lead impedance, ─ Coil impedance, ─ Capacitor charge time, ─ Pacing threshold tests. ─ Data storage: ─ Therapy History Report, ─ Statistics (pace/sense, therapy, shocks, and battery voltage), ─ Up to 16 complete Holter records with event logs, marker channel notation, and electrogram records.
14. IMPLANT PROCEDURE 14. IMPLANT PROCEDURE 14.1.
14. IMPLANT PROCEDURE 14.4. 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. Interrogate the device: ─ if a warning is displayed, do not implant the device and contact your Sorin representative. ─ if battery voltage is below 3V, and if the last reforming/charge occurred more than one week ago, do not implant the device.
14. IMPLANT PROCEDURE defibrillation coils The choice of leads and their configuration is left to the implanting physician’s judgment. NOTE1: Please note that DF-1 standard compliant lead is not compatible with DF4 connector. In the reverse, DF4 standard compliant lead is not compatible with DF-1 connector. In case of defibrillator replacement, choose the appropriate device compatible with DF-1 or DF4 leads.
14. IMPLANT PROCEDURE 14.9. MEASUREMENT OF THRESHOLDS AT IMPLANT Pacing and sensing thresholds should be measured at implant. Pacing thresholds: Acute thresholds should be lower than 1 V (or 2 mA) for a 0.35 ms pulse width, in the ventricle and in the atrium. Sensing thresholds: For appropriate ventricular sensing, the amplitude of the R-wave should be greater than 5 mV. For appropriate atrial sensing, the amplitude of the P-wave should be greater than 2 mV.
14. IMPLANT PROCEDURE 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. 4. One single set screw is located on the side of the connection header. 5. Use only the screwdriver provided with the defibrillator. Keep the screwdriver's shaft perpendicular to the plane of the defibrillator (see figure below). 6.
14. IMPLANT PROCEDURE 14.12. 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 is within the range of 30 to 150 ohms. Check the lead connection if the values are outside these boundaries.
15. SPECIAL MODES 15. SPECIAL MODES 15.1. 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. 15.2.
15. SPECIAL MODES For DF4 models: ─ Common mode rejection ratio: For DF-1 Models: 16.6 Hz 50 Hz 60 Hz Atrial channel ≥74 dB ≥74 dB ≥74 dB Ventricular channel ≥68 dB ≥68 dB ≥68 dB 16.6 Hz 50 Hz 60 Hz Atrial channel ≥74 dB ≥74 dB ≥74dB Ventricular channel ≥68 dB ≥68 dB ≥68dB For DF4 Models: For atrial sensitivity settings below 0.4mV, the ICD may detect noise lower than the level specified in clause 27.5.1 of standard EN 45502-2-2 for frequencies below 200 Hz.
15. SPECIAL MODES 15.5. 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.
16. MAIN FUNCTIONS 16. MAIN FUNCTIONS 16.1. AUTOMATIC LEAD MEASUREMENTS Automatic pacing lead impedance measurement: A lead impedance measurement is automatically performed on atrial and ventricular leads every 6 hours. The daily mean impedance is stored for each chamber. Automatic coil impedance measurement: A continuity measurement is automatically performed on defibrillation coil(s) once per day. The continuity is stored for each coil.
16. MAIN FUNCTIONS Defibrillation threshold (DFT): Be aware that the changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold (DFT) which may result in non-conversion of the arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no assurance that conversion will occur post-operatively. 16.4.
16. MAIN FUNCTIONS 16.6. FOLLOW-UP FUNCTION 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 one programmable EGM channel which can be selected, in addition to RV EGM. Diagnosis of AV conduction: Automatic diagnosis of AV conduction with graphic displays.
16. MAIN FUNCTIONS are checked daily. ─ the on-demand follow-up transmission is triggered by the patient himself through the use of a specific button on the SMARTVIEW monitor. 16.7.3. Data transmitted The data transmitted are identical to the data available during a standard interrogation with the dedicated programmer.
16. MAIN FUNCTIONS ─ System integrity WARNING: The use of remote monitoring does not replace regular follow-up. Therefore, when using remote monitoring, the time period between follow-ups visits may not be extended.
17. PATIENT FOLLOW-UP 17. PATIENT FOLLOW-UP 17.1. FOLLOW-UP RECOMMENDATIONS Before the patient is discharged and at each subsequent follow-up visit, it is advisable to: ─ check the occurrence of system warnings ─ check the battery status, NOTES: If the last reforming, charge or shock occurred during the week preceding the interrogation, the last battery value may be still impacted by the event. One week post event, the battery will recover its steady state value.
17. PATIENT FOLLOW-UP Stored Tachyarrythmia Episodes: PLATINIUM DR stores up to 16 episodes (VF, VT, Slow VT, SVT/ST, non-sustained) with a total of 25.6 min of high resolution EGM.
17. PATIENT FOLLOW-UP ─ Confirmed malfunction ─ Burial of the patient (for environmental reasons, the local regulation may require the explantation of the devices containing a battery supply) ─ Cremation of the patient (the defibrillator may explode if placed in an incinerator) The explanted defibrillator should not be reused in another patient. All explanted defibrillators should be returned to Sorin, carefully cleaned of all traces of contamination.
18. PHYSICAL CHARACTERISTICS 18. PHYSICAL CHARACTERISTICS 1510 MODEL: Dimensions 73 x 54.3 x 11.1 mm Weight 86 g Volume 33 cm3 Active surface area of casing 62.7cm2 Connector Atrium: IS-1 bipolar. Ventricle: IS-1 bipolar, 2*DF-1. 1540 MODEL: 18.1. Dimensions 72.3 x 54.3 x 11.1 mm Weight 86 g Volume 33 cm3 Active surface area of casing 62.8cm2 Connector Atrium: IS-1 bipolar. Ventricle: DF4.
19. ELECTRICAL CHARACTERISTICS 19. ELECTRICAL CHARACTERISTICS Atrial input impedance 80 kilohms ± 30 % Ventricular input impedance 80 kilohms ± 30 % D.C. capacitance 149 µF ± 8 % Capacitor reformation No reformation required Rate limit 192 ppm ± 10 ppm Pacing waveform Defibrillation waveform 19.1.
19. ELECTRICAL CHARACTERISTICS 19.3. Total capacity 2192 mAh Usable capacity Between BOS and RRT: 1530 mAh. Between BOS and EOS: 1910 mAh. Voltage BOS: 3.24 V. RRT: 2.62 V. EOS: 2.5 V. LONGEVITY The longevities are calculated by taking into account 6 months storage with the following conditions: ─ Basic rate: 60 ppm ─ Pulse width (A, RV, LV): 0.
19. ELECTRICAL CHARACTERISTICS Longevity projection at 700 Ω pacing impedance: Mode DDD DDD DDD DDD DDD SafeR - A pacing (%) 100 100 15 15 15 30 0 V pacing (%) 100 100 1 15 1 6 0 Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 2.5 - Pulse width (ms) 0.35 0.35 0.35 0.50 0.35 0.35 - Sensor OFF ON OFF OFF OFF OFF OFF Max shocks (42J) per year 4 4 4 4 0 4 4 Longevity (years) 9.5 9.3 13.3 12.0 17.1 13.2 13.
20. PROGRAMMABLE PARAMETERS 20. PROGRAMMABLE PARAMETERS Measured at 37 °C under a 500 ohm load Legend: Value in bold: "as shipped" value Underlined value: nominal value 20.1.
20. PROGRAMMABLE PARAMETERS Pacing/Sensing Values Atrial sensitivity (mV) (1) From 0.2 to 4 by steps of 0.2 ; 0.4 (± 50 %) Atrial amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) Atrial pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) Ventricular sensitivity (mV) (1) From 0.4 to 4 by steps of 0.2 ; 0.4 (± 50 %) Ventricular amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) Ventricular pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.
20.
20. PROGRAMMABLE PARAMETERS 20.2.
20. PROGRAMMABLE PARAMETERS 20.3. 20.3.1.
20. PROGRAMMABLE PARAMETERS ATP 2 program Values ATP program OFF-Burst-Burst+Scan-Ramp-Ramp+Scan Number of sequences 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles in first sequence 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles added per sequence 0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 Ramp decrement (per cycle) (ms) 0-4-8-12-16-20-30-40-50-60 Scan decrement (per sequence) (ms) 0-4-8-12-16-20-30-40-50-60 Time limit (min) 0.5-1-1.5-2-2.5-3-3.
20. PROGRAMMABLE PARAMETERS ATP 2 program Values ATP program OFF-Burst-Burst+Scan-Ramp-Ramp+Scan Number of sequences 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles in first sequence 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles added per sequence 0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 Ramp decrement (per cycle) (ms) 0-4-8-12-16-20-30-40-50-60 Scan decrement (per sequence) (ms) 0-4-8-12-16-20-30-40-50-60 Time limit (min) 0.5-1-1.5-2-2.5-3-3.
20. PROGRAMMABLE PARAMETERS Shock program Values Shock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42 Shock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42 Number of Max. Shock (42 J) 20.4. 1-2-3-4 REMOTE ALERTS AND WARNINGS The device routinely performs security self-checks and technical measurements to ensure system integrity.
20. PROGRAMMABLE PARAMETERS Clinical status Values V oversensing ON-OFF High AT/AF burden ON-OFF AT/AF limit (on 24h) (h) 0.5-1-3-6-12-24 Fast V Rate during AT/AF ON-OFF Fast V Rate limit (ppm) 80-90-100-110-120 Fast V Duration limit (h) 0.
21. NON PROGRAMMABLE PARAMETERS 21.
22. LIMITED WARRANTY 22. LIMITED WARRANTY The PLATINIUM implantable cardioverter defibrillator is the result of highly advanced research and all components have been selected after exhaustive testing. The terms of the limited warranty are available upon request from your Sorin representative or on the CD-ROM of the package content.
23. PATENTS 23.
24. EXPLANATION OF SYMBOLS 24.
24. EXPLANATION OF SYMBOLS Temperature limitation Torque wrench Consult instructions for use Instructions for use in the CD-ROM This icon is used to call your attention to a particularly important point. This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon.
BACKCOVER CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN 2015-03 U460A © 2015 Sorin CRM SAS
