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sorin Intensia VR 124 Implant Manual

Implantable cardioverter defibrillator
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Implant manual
Implantable cardioverter defibrillator
VR model 124

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Summary of Contents for sorin Intensia VR 124

  • Page 1 Implant manual Implantable cardioverter defibrillator VR model 124...
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  • Page 5: Table Of Contents

    14.9. Measurement of thresholds at implant..................31 14.10.Lead connection ........................31 14.11. Device implantation.........................33 14.12.Tests and programming......................33 Special modes........................34 15.1. Safety mode (nominal values)....................34 15.2. Magnet mode.......................... 34 15.3. Response in the presence of interference................34 SORIN – INTENSIA VR 124 – U153A...
  • Page 6 20.3. Ventricular tachyarrhythmia therapies..................48 20.4. Remote alerts and warnings....................51 Non programmable parameters...................53 Limited warranty........................54 22.1. Article 1 : Terms of limited warranty..................54 22.2. Article 2 : Terms of replacement....................55 Patents........................... 56 Explanation of symbols......................57 SORIN – INTENSIA VR 124 – U153A...

  • Page 7: General Description

    INTENSIA VR 124 is also equipped with the RF wireless technology which enables to remotely monitor the patients who have the Sorin SMARTVIEW Monitor installed at home. INTENSIA VR 124 provides high energy shocks (42 J) for enhanced safety, as well as automatic lead measurements to monitor system integrity.

  • Page 8: Indications

    2. INDICATIONS 2. INDICATIONS INTENSIA VR 124 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, ─...

  • Page 9: Contraindications

    3. CONTRAINDICATIONS 3. CONTRAINDICATIONS Implantation of INTENSIA VR 124 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, ─...

  • Page 10: Warnings And Precautions

    Home appliances that are in good working order and properly grounded do not usually produce enough EMI to interfere with defibrillator operation. There are reports of device disturbances caused by electric hand tools or electric razors used directly over the device implant site. SORIN – INTENSIA VR 124 – U153A...

  • Page 11: Risks Related To Medical Environment

    4. After the procedure, check for proper implant function. The device should never be exposed directly to the diathermy source. External defibrillation: INTENSIA VR 124 is protected from external defibrillation shocks. 1. Before external defibrillation, disable ATP and shock therapies. 2. During external defibrillation, it is advisable to avoid placing the defibrillating paddles directly over the casing or over the lead.

  • Page 12: Sterilization, Storage And Handling

    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 INTENSIA VR 124 should not use these devices. 4.2. STERILIZATION, STORAGE AND HANDLING Resterilization: Do not resterilize and re-implant explanted ICDs.

  • Page 13: Lead Evaluation And Lead Connection

    *: corresponds to ERI (Elective Replacement Indicator) previously used. 4.4. LEAD EVALUATION AND LEAD CONNECTION INTENSIA VR 124 has one DF-4 connector port. DF-4 refers to the international standard for defibrillation lead connectors (ISO 27186:2010). Do not use the device with leads which have not been positively tested.

  • Page 14: Generator Explant And Disposal

    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 – INTENSIA VR 124 – U153A...

  • Page 15: Adverse Events

    5. ADVERSE EVENTS 5. ADVERSE EVENTS Clinical data presented in this section are from the Defender study. INTENSIA VR 124 is similar in design and function to the Defender devices. The data provided are applicable to INTENSIA VR 124. 5.1.
  • 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 – INTENSIA VR 124 – U153A...

  • Page 17: Clinical Studies

    6. CLINICAL STUDIES 6. CLINICAL STUDIES Clinical data presented in this section are from the Defender study. INTENSIA VR 124 is similar in design and function to the Defender devices. The data provided are applicable to INTENSIA VR 124. 6.1.
  • 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 – INTENSIA VR 124 – U153A...
  • 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 – INTENSIA VR 124 – U153A...

  • 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 – INTENSIA VR 124 – U153A...

  • 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 – INTENSIA VR 124 – U153A...

  • 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 – INTENSIA VR 124 – U153A...

  • Page 23: Conformance To Standards

    (frequency range of 30MHz to 6 GHz). This information should not be used as a basis of comparisons among devices since different parts of the standards mentioned may have been used. SORIN – INTENSIA VR 124 – U153A...
  • Page 24 9. CONFORMANCE TO STANDARDS 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 25 400,150-406,000 MHz, et il doit accepter tout brouillage reçu, y compris le brouillage pouvant entraîner un mauvais fonctionnement du dispositif. SORIN – INTENSIA VR 124 – U153A...

  • Page 26: 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 27: 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 or on the Sorin's web site: http://www.sorin.com. 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 28: How Supplied

    The INTENSIA 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 29: Device Description

    The INTENSIA VR 124 can serve as a defibrillation electrode (active housing) with a total surface area of 76 cm². The INTENSIA VR 124 is designed to recognize and treat slow or fast VT and VF by continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
  • Page 30 Remote Monitoring: INTENSIA VR 124 is also equipped with the RF wireless technology which enables to remotely monitor the patients who have the Sorin SMARTVIEW Monitor installed at home. SORIN – INTENSIA VR 124 – U153A...

  • Page 31: Implant Procedure

    PACKAGING 14.2.1 . Contents The INTENSIA VR 124 and its accessories are ethylene oxide sterilized and hermetically sealed in two-ply clear packaging meeting international requirements. The sterile packaging contains a defibrillator and one screwdriver. The non-sterile items contained in the outer storage package are the implant manual, the ICD Registration Form and its envelope, the patient booklet, the ICD ID card and 12 identification labels.

  • Page 32: Prior To Implantation

    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 33: Shock Configuration (+ -> -)

    14.10. LEAD CONNECTION Implant the ventricular lead. 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. SORIN – INTENSIA VR 124 – U153A...
  • Page 34 Do not implant the defibrillator if there is no feeling of solid metallic contact. Do not implant the defibrillator if the wrench does not click when attempting to tighten the setscrew on the lead pin. SORIN – INTENSIA VR 124 – U153A...

  • Page 35: Device Implantation

    14.11. DEVICE IMPLANTATION INTENSIA VR 124 should be implanted with the engraved side facing outwards for optimal communication with the programming head and radiographic identification. Carefully wind excess lead and place in a separate pocket to the side of the defibrillator.

  • Page 36: Special Modes

    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. SORIN – INTENSIA VR 124 – U153A...

  • Page 37: Detection Characteristics In The Presence Of Electromagnetic Fields

    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 – INTENSIA VR 124 – U153A...

  • Page 38: Main Functions

    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. SORIN – INTENSIA VR 124 – U153A...

  • Page 39: Follow-Up Function

    SMARTVIEW monitor will be placed on the nightstand of the patient, as close as possible to the side of the bed the patient usually sleeps. The SMARTVIEW monitor shall be connected to the phone line of the patient and the power plug. Regular transmissions are SORIN – INTENSIA VR 124 – U153A...
  • Page 40 ─ Low or high impedance ─ Abnormal coil impedance (shock lead) ─ Low or High shock impedance ─ Inefficient high energy shock ─ All shocks programmed OFF ─ Shock treated VT/VF SORIN – INTENSIA VR 124 – U153A...
  • Page 41 ─ Suspicion of noise on the V lead 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 – INTENSIA VR 124 – U153A...

  • Page 42: Patient Follow-Up

    The Holter records up to 14 tachyarrhythmia episodes as well as the therapy history. Stored Episodes INTENSIA VR 124 stores up to 14 episodes (VF, VT, Slow VT, SVT/ST, non-sustained). For each episode four levels of details are presented: ─ Tachogram ─...

  • Page 43: Recommended Replacement Time (Rrt)

    For each arrhythmia detection, each therapy delivered (either automatically or during an electrophysiological study) and at the end of each arrhythmia, INTENSIA VR 124 records the type of majority rhythm, the number of ATP sequences delivered, the energy and the number of shocks delivered.

  • Page 44: Defibrillator Identification

    1. Take an x-ray to identify the name of the manufacturer and model, printed on the device (X-ray ID is SDE : S = SORIN ; D = Defibrillator ; E = INTENSIA range). 2. Interrogate the device using the Sorin dedicated programmer. The model and serial number of the device are automatically displayed.

  • Page 45: Physical Characteristics

    Active surface area of casing 76 cm Connector DF-4 18.1. MATERIALS USED Active surface area of casing 99% pure titanium Connectors Polyurethane* and silicone elastomer* *Medical-grade materials that have undergone "in vitro" and "in vivo" qualifications. SORIN – INTENSIA VR 124 – U153A...

  • Page 46: Electrical Characteristics

    37.1 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 2593 Number of batteries Total capacity 1964 mAh SORIN – INTENSIA VR 124 – U153A...

  • Page 47: Longevity

    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 – INTENSIA VR 124 – U153A...

  • Page 48: Programmable Parameters

    Mid-pulse delivered 0.97 1.39 1.79 2.35 2.84 3.25 ampl. (V) Stored amplitude (V) 1.14 1.63 2.76 3.33 3.82 Programmed ampl. (V) Mid-pulse delivered ampl. 3.58 4.23 4.47 5.37 Stored amplitude (V) 4.96 5.25 SORIN – INTENSIA VR 124 – U153A...

  • Page 49: Ventricular Tachyarrhythmia Detection

    VT persistence (cycles) 4-6-8-12-16-20-30-50-100-200 VF persistence (cycles) From 4 to 20 by steps of 1 ; 6 (1) The Slow VT zone should be programmed ON only if the VT zone is programmed ON. SORIN – INTENSIA VR 124 – U153A...

  • Page 50: Ventricular Tachyarrhythmia Therapies

    Atrial coil (SVC) present Yes-No Active case Yes-No Shock configuration (+ --> -) Case to RV-SVC to RV-Case + SVC to RV-RV to Case-RV to SVC-RV to Case + SVC SVC exclusion (shock < 15J) Yes-No SORIN – INTENSIA VR 124 – U153A...
  • Page 51 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 Shock program Values Shock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-9- 10-12-14-16-18-20-22-24-26-28-30-32-34-42 Shock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-9- 10-12-14-16-18-20-22-24-26-28-30-32-34-42 Number of Max. Shock (42 J) OFF-1-2-3-4 SORIN – INTENSIA VR 124 – U153A...
  • Page 52 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 Shock program Values Shock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-9- 10-12-14-16-18-20-22-24-26-28-30-32-34-42 Shock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-9- 10-12-14-16-18-20-22-24-26-28-30-32-34-42 Number of Max. Shock (42 J) OFF-1-2-3-4 SORIN – INTENSIA VR 124 – U153A...

  • Page 53: Remote Alerts And Warnings

    (1) RF and Remote alerts are turned on automatically if Shocks are programmed ON. When Alerts are programmed "On", the following System Alerts are automatically activated: ─ Battery depletion – RRT ─ Device reset ─ Excessive charge time (>25s) SORIN – INTENSIA VR 124 – U153A...
  • Page 54 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 Therapy information Values Shock disabled ON-OFF Shocks delivered OFF-All shocks-Inefficient shock-Inefficient max shock SORIN – INTENSIA VR 124 – U153A...

  • Page 55: 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 – INTENSIA VR 124 – U153A...

  • Page 56: Limited Warranty

    1 and described in article 2 of this section. Sorin makes no claim that the human body will not react unsuitably to the implantation of the INTENSIA device, or that failure will never occur.

  • Page 57: Article 2 : Terms Of Replacement

    ─ or issuing a replacement credit equal to the purchase price for the purchase of any other Sorin replacement device. 2. After a two-year period and up to 4 years after the implantation, Sorin, because of limited warranty terms, will issue a replacement credit to the buyer of an amount equivalent to half of the initial purchase price minus prorata temporis during this two-years period.

  • Page 58: Patents

    912 421, 6 937 898, 6 975 905, 7 065 402, 7 072 716, 7 076 297, 7 113 826, 7 142 924, 7 164 946, 7 251 526, 7 366 566, 7 400 921, 7 400 922, 7 953 483. SORIN – INTENSIA VR 124 – U153A...

  • Page 59: Explanation Of Symbols

    This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon. FCC ID : YSGVR124 IC : 10270A-VR124 Last revision date of this implant manual: 2013-09 SORIN – INTENSIA VR 124 – U153A...
  • Page 60 CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Manufactured in Italy by: Distributed by: Sorin Group Italia S.r.l. Sorin CRM USA, Inc. Via Crescentino s.n. 14401 West 65th Way 13040 Saluggia (VC) - Italy...

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