sorin Platinum VR 1210 Implant Manual
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sorin Platinum VR 1210 Implant Manual

Implantable cardioverter defibrillator
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Summary of Contents for sorin Platinum VR 1210

  • Page 1 Implantable cardioverter defibrillator VR models Implant manual...
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  • Page 5: Table Of Contents

    14.9. Measurement of thresholds at implant..................30 14.10.Lead connection ........................31 14.11. Device implantation.........................32 14.12.Tests and programming......................32 Special modes........................34 15.1. Safety mode (nominal values)....................34 15.2. Magnet mode.......................... 34 15.3. Response in the presence of disturbance................34 SORIN – PLATINIUM VR – U461A...
  • Page 6 19.2. Battery............................. 44 19.3. Longevity..........................45 Programmable parameters....................47 20.1. Antibradycardia pacing......................47 20.2. Ventricular tachyarrhythmia detection..................49 20.3. Ventricular tachyarrhythmia therapies..................50 20.4. Remote alerts and warnings....................53 Non programmable parameters...................55 Limited warranty........................56 Patents........................... 57 Explanation of symbols......................58 SORIN – PLATINIUM VR – U461A...

  • Page 7: General Description

    PLATINIUM VR 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.

  • Page 8: Indications

    ─ Recurrent, poorly tolerated sustained ventricular tachycardia (VT). NOTE: The clinical outcome for hemodynamically stable VT patients is not fully known. Safety and effectiveness studies have not been conducted. SORIN – PLATINIUM VR – U461A...

  • Page 9: Contraindications

    ─ who present incessant tachyarrhythmia, ─ who have an internal pacemaker, ─ whose primary disorder is bradyarrhythmias, or atrial tachyarrhythmias. SORIN – PLATINIUM VR – U461A...

  • Page 10: Warnings And Precautions

    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. SORIN – PLATINIUM VR – U461A...

  • Page 11: Risks Related To Medical Environment

    Lithotripsy may permanently damage the device if it is at the focal point of the lithotripsy beam. If lithotripsy must be used, keep the defibrillator at least 2.5 to 5 cm (1-2 inches) away from the focal point of the lithotripsy beam. SORIN – PLATINIUM VR – U461A...

  • Page 12: Sterilization, Storage And Handling

    A "Use Before" date is printed on the outer storage package and on the sterile package. Do not implant the device after this date because the battery may have reduced longevity and sterility may be affected. It should be returned to Sorin. If Package is damaged: Do not use the device or accessories if the packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised.

  • Page 13: Lead Evaluation And Lead Connection

    If a thoracotomy is required to place epicardial patches, it should be done during a separate procedure to reduce the risk of morbidity and mortality. SORIN – PLATINIUM VR – U461A...

  • Page 14: Generator Explant And Disposal

    Interrogate the device, and program shock therapy off prior to explanting, cleaning or shipping the device to prevent unwanted shocks. 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. SORIN – PLATINIUM VR – U461A...

  • Page 15: Adverse Events

    (Including Device Failures and Replacements) All complications, 2 of 38 Defender IV DR 612 patients in Europe Event # of Patients % of Patients # of Events Events/100 Device-Years* Hematoma Ventricular lead 10.5 migration/dislodgment SORIN – PLATINIUM VR – U461A...
  • Page 16 ** There were 228.7 device months in this study. ***These observations would not have happened with the currently marketed device and programmer. °Investigator indicated that Defender IV DR did not cause or contribute to the event. SORIN – PLATINIUM VR – U461A...

  • Page 17: Clinical Studies

    26-Jul-99 14-Apr-00 04-May-99 08-Mar-00 14-Apr-00 (Eur), 14-Mar-00 (US) 6.1.1. Complication-free rate Only European patients followed for at least 3 months: Symbol Parameter Defender IV DR 612 Overall number of patients Pe*N Number of successes SORIN – PLATINIUM VR – U461A...
  • Page 18 CI: Confidence Interval 6.1.3. Adverse events Event US (N=22) Number of events* Number of patients Percent of patients Intent to treat but did Non-device related death Explant Complication Observation Serious non-related other than death SORIN – PLATINIUM VR – U461A...
  • Page 19 * A patient can have more than one complication, observation, or serious adverse event, not device-related. Device Failures and Replacements: No device failures or replacements occurred with Defender IV DR 612 during the study. SORIN – PLATINIUM VR – U461A...

  • Page 20: Patient Selection And Treatment

    Changes in a patient’s antiarrhythmic drug or any other medication that affects the patient’s normal cardiac rate or conduction can affect the rate of tachyarrhythmias and/or efficacy of therapy. Direct any questions regarding the individualization of patient therapy to Sorin’s representative. SORIN – PLATINIUM VR – U461A...

  • Page 21: Specific Patient Populations

    Most of the patients receiving this device in clinical studies were over the age of 60 years. Handicapped and Disabled Patients: Special care is needed in using this device for patients using an electrical wheel chair or other electrical (external or implanted) devices. SORIN – PLATINIUM VR – U461A...

  • Page 22: Patient Counselling Information

    ─ 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. SORIN – PLATINIUM VR – U461A...

  • Page 23: Declaration Of Conformity

    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 15.105(b)
  • Page 24 400,150-406,000 MHz, et il doit accepter tout brouillage reçu, y compris le brouillage pouvant entraîner un mauvais fonctionnement du dispositif. SORIN – PLATINIUM VR – U461A...

  • Page 25: Physician Guidelines

    DIRECTIONS FOR USE ICD operating characteristics should be verified at the time of implantation and recorded in the patient file. Complete the Patient Registration Form and return it to Sorin, as it provides necessary information for warranty purposes and patient tracking.

  • Page 26: 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.

  • Page 27: How Supplied

    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.

  • Page 28: Device Description

    13. DEVICE DESCRIPTION 13. DEVICE DESCRIPTION The PLATINIUM VR 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.
  • Page 29 All lead connections pass through the header into the device via feedthroughs. Programming System: The Sorin programmer is used in conjunction with specific programmer software to interrogate and program the implanted device at implant and during patient follow-up procedures.

  • Page 30: Implant Procedure

    14.1. NECESSARY EQUIPMENT Implantation of PLATINIUM VR requires the following equipment: ─ Sorin ORCHESTRA programmer, equipped with the SMARTVIEW software interface and inductive telemetry head, ─ Sorin ORCHESTRA PLUS programmer, equipped with the SMARTVIEW software interface, inductive telemetry head and optionally ORCHESTRA PLUS LINK, ─...

  • Page 31: Before Opening The Package

    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. Any re-sterilization of the unit is at the discretion of Sorin.

  • Page 32: Shock Configuration (+ -> -)

    In case of defibrillator replacement, choose the appropriate device compatible with DF-1 or DF4 leads. For any other lead type that require an adaptor for this device, please contact your Sorin representative for any information on lead / connector compatibility question.

  • Page 33: Lead Connection

    (see figure below). 6. Removing the screwdriver: to avoid all risk of loosening screws during removal, hold the screwdriver by its metal part and not by the handle. SORIN – PLATINIUM VR – U461A...

  • Page 34: Device Implantation

    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. SORIN – PLATINIUM VR – U461A...
  • Page 35 Program Shock Therapy to OFF during surgical implant and explant or post mortem procedures. The device can deliver a serious high energy shock should accidental contact be made with the defibrillation electrodes, the device can deliver a very high energy shock. SORIN – PLATINIUM VR – U461A...

  • Page 36: Special Modes

    V pacing on noise to Yes. 15.4. 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: For DF-1 models: SORIN – PLATINIUM VR – U461A...

  • Page 37: 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. SORIN – PLATINIUM VR – U461A...

  • Page 38: Main Functions

    (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. SORIN – PLATINIUM VR – U461A...

  • Page 39: Pacing

    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. SORIN – PLATINIUM VR – U461A...
  • Page 40 The second one presents the most important IEGM episodes automatically selected based on the degree of severity for the patient. 16.6.4. User website On the website, the physician is able to: SORIN – PLATINIUM VR – U461A...
  • Page 41 ─ Excessive charge time (>25s) ─ 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. SORIN – PLATINIUM VR – U461A...

  • Page 42: Patient Follow-Up

    ─ Up to 16 tachyarrhythmia episodes as well as the therapy history. Stored Tachyarrythmia Episodes: PLATINIUM VR stores up to 16 episodes (VF, VT, Slow VT, SVT/ST, non-sustained) with a total of 25.6 min of high resolution EGM. SORIN – PLATINIUM VR – U461A...

  • Page 43: Recommended Replacement Time (Rrt)

    ─ The Recommended Replacement Time (RRT) point is reached ─ Confirmed malfunction ─ Burial of the patient (for environmental reasons, the local regulation may require the explantation of the devices containing a battery supply) SORIN – PLATINIUM VR – U461A...

  • Page 44: Defibrillator Identification

    ─ 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. Cleaning may be done by immersing them in an aqueous sodium hypochlorite containing at least 1% chlorine, followed by rinsing copiously with water.

  • Page 45: Physical Characteristics

    Active surface area of casing 62.9cm Connector DF4. 18.1. MATERIALS USED 99% pure titanium Active surface area of casing Polyurethane* and silicone elastomer* Connectors *Medical-grade materials that have undergone "in vitro" and "in vivo" qualifications. SORIN – PLATINIUM VR – U461A...

  • Page 46: Electrical Characteristics

    Delivered E: Total (J) 17.4 Tolerances are 12% for voltage (25% at 0.5 J) and 30% for energy. 19.2. BATTERY Manufacturer Greatbatch Type Quasar High Rate (QHR) Model GB 3070 Number of batteries Total capacity 2192 mAh SORIN – PLATINIUM VR – U461A...

  • Page 47: Longevity

    Pacing amplitude (V) Pulse width (ms) 0.35 0.35 0.35 0.50 0.35 0.35 Sensor Max shocks (42J) per year Longevity (years) 11.2 10.9 14.1 13.0 17.6 14.3 14.1 Longevity projection at 700 Ω pacing impedance: SORIN – PLATINIUM VR – U461A...
  • Page 48 The mean longevity as a function of yearly remote follow-ups , with and without pacing, is as follows: 1. An excessive number of remote follow-ups can have a non-negligible impact on device longevity. SORIN – PLATINIUM VR – U461A...

  • Page 49: Programmable Parameters

    (2) The correlation between the programmed amplitudes, the stored amplitudes and the mid-pulse delivered amplitudes under a 500 ohm load are given in the following table: Programmed amplitude (V) Stored amplitude (V) Mid-pulse delivered amplitude 1,11 0,94 1,63 1,38 1,78 3,15 2,67 SORIN – PLATINIUM VR – U461A...
  • Page 50 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) Sensitivity margins Values Ventricular post pacing margin (mV) From 0 to 2 by steps of 0.2 ; 0.8 Response to noise Values Automatic sensitivity on noise ON-OFF V pacing on noise ON-OFF SORIN – PLATINIUM VR – U461A...

  • Page 51: Ventricular Tachyarrhythmia Detection

    VT (ms) Window of RR stability for fast VT 30-45-65 (ms) Acceleration (%) 6-13-19-25-31-38-44-50 Long cycle persistence extension From 0 to 16 by steps of 1 ; 10 (cycles) Long cycle gap (ms) 15-30-45-65-80-95-110-125-140-155-170-190-205 SORIN – PLATINIUM VR – U461A...

  • Page 52: Ventricular Tachyarrhythmia Therapies

    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) 0.5-1-1.5-2-2.5-3-3.5-4 Minimum cycle length (ms) 95-110-125-140-155-170-190-205-220-235-250-265-280- 295-310 SORIN – PLATINIUM VR – U461A...
  • Page 53 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) 0.5-1-1.5-2-2.5-3-3.5-4 Minimum cycle length (ms) 95-110-125-140-155-170-190-205-220-235-250-265-280- 295-310 SORIN – PLATINIUM VR – U461A...
  • Page 54 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 10s-20s-30s-1min-1.5min-2min Minimum cycle length (ms) 95-110-125-140-155-170-190-205-220-235-250-265-280- 295-310 SORIN – PLATINIUM VR – U461A...

  • Page 55: Remote Alerts And Warnings

    200-250-300-350-400-450-500 Abnormal lead high limit (Ohm) 1500-1750-2000-2500-3000 Abnormal RV coil impedance ON-OFF Abnormal SVC coil impedance ON-OFF Abnormal Shock impedance ON-OFF (1) Normal impedance range [20 Ohm-200 Ohm] Clinical status Values V oversensing ON-OFF SORIN – PLATINIUM VR – U461A...
  • Page 56 20. PROGRAMMABLE PARAMETERS Therapy information Values Shock disabled ON-OFF Shocks delivered OFF-All shocks-Inefficient shock-Inefficient max shock ATP delivered ON-OFF SORIN – PLATINIUM VR – U461A...

  • Page 57: Non Programmable Parameters

    7 V (Actual value at 300 ms: 5.3 V ) therapies (1) The device has 50% tilt in each phase thus delivers 94% of stored energy. Each phase is limited to 10 ms duration. SORIN – PLATINIUM VR – U461A...

  • Page 58: 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.

  • Page 59: Patents

    400 922, 7 953 483, US8064992, US8043225, US7792582, US8798748, US7890168, US8195293, US7966068, US8768464, US8874209, US8554313, US8214036, US8233981, US8554319, US7966065, US8253279, US8874210, US8219193, US8391976, US8855764, US8359096, US8494629, US8359091, US8489188, US8712526, US8862230, US8641436, US8718765, US8798771, US8868170, US8678843 , US8694098, US8938286, US8874212. SORIN – PLATINIUM VR – U461A...

  • Page 60: Explanation Of Symbols

    Orchestra Plus programmer equipped with ORCHESTRA PLUS LINK accessory Do not use if the package is DF-1 defibrillating connector damaged insulating plug Do not reuse Do not resterilize Sterilised using ethylene oxide SORIN – PLATINIUM VR – U461A...
  • Page 61 Carefully read the instructions provided with this icon. Eucomed / Advamed Code of Ethical Business Practice Last revision date of this implant manual: 2015-03 SORIN – PLATINIUM VR – U461A...
  • Page 62 BACKCOVER CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN 2015-03 U461A © 2015 Sorin CRM SAS...

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