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Boston Scientific DYNAGEN CRT-D, Technical Manual

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Boston Scientific DYNAGEN CRT-D Technical Manual Download Page 59

Step F: Connect the Leads to the Pulse Generator

To connect leads to the pulse generator, use only the tools provided in the pulse generator sterile tray or
accessory kit. Failure to use the supplied torque wrench may result in damage to the setscrews, seal plugs, or
connector threads. Do not implant the pulse generator if the seal plugs appear to be damaged. Retain the tools
until all testing procedures are complete and the pulse generator is implanted.

NOTE:

Some patients may require pacing therapies immediately upon connecting the leads to the pulse

generator. In such cases, consider programming the pulse generator before continuing.

Leads should be connected to the pulse generator in the following sequence (for pulse generator header and
setscrew location illustrations, refer to "Lead Connections" on page 44):

a.

Right ventricle.

Connect the RV lead

fi

rst because it is required to establish RV-based timing cycles that

yield appropriate sensing and pacing in all chambers, regardless of the programmed con

fi

guration.

•

In models with an IS-1 RV lead port, insert and secure the terminal pin of an IS-1 RV pace/sense
lead.

•

In models with a DF4-LLHH RV lead port, insert and secure the terminal pin of a DF4-LLHH or
DF4-LLHO lead.

b.

Right atrium.

•

In models with an IS-1 RA lead port, insert and secure the terminal pin of an IS-1 atrial pace/sense
lead.

c.

Left ventricle.

•

In models with an IS-1 LV lead port, insert and secure the terminal pin of an IS-1 coronary venous
pace/sense lead.

•

In models with an LV-1 LV lead port, insert and secure the terminal pin of an LV-1 coronary venous
pace/sense lead.

55

Summary of Contents for DYNAGEN CRT-D

Page 1: ...N CRT D ORIGEN X4 CRT D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Model G150 G151 G154 G156 G158 G140 G141 G146 G148 G050 G051 G056 G058 CAUTION Federal law USA restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow up procedures ...

Page 2: ......

Page 3: ...s Electrical Nerve Stimulation TENS 20 Electrocautery and Radio Frequency RF Ablation 22 Ionizing Radiation 23 Elevated Pressures 24 Potential Adverse Events 25 Mechanical Specifications 28 Items Included in Package 31 Symbols on Packaging 31 Characteristics as Shipped 35 X Ray Identifier 37 Federal Communications Commission FCC 38 Pulse Generator Longevity 39 Warranty Information 41 Product Relia...

Page 4: ...t 53 Step F Connect the Leads to the Pulse Generator 55 Step G Evaluate Lead Signals 59 Step H Program the Pulse Generator 61 Step I Test for Ability to Convert Ventricular Fibrillation and Inducible Arrhythmias 62 Step J Implant the Pulse Generator 64 Step K Complete and Return the Implantation Form 65 Bidirectional Torque Wrench 65 Follow Up Testing 67 Predischarge Follow Up 68 Routine Follow Up...

Page 5: ...iologic shape that minimizes pocket size and may minimize device migration They provide a variety of therapies including Ventricular tachyarrhythmia therapy which is used to treat rhythms associated with sudden cardiac death SCD such as VT and VF Cardiac Resynchronization Therapy CRT which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation...

Page 6: ...e IS42 quadripolar left ventricular lead3 One DF 1 IS 14 cardioversion defibrillation lead One DF4 LLHH or DF4 LLHO5 multipolar connector cardioversion defibrillation lead Leads with either a GDT LLHH LLHO or DF4 LLHH LLHO label are equivalent and are compatible with a device containing either a GDT LLHH or DF4 LLHH port The pulse generator and the leads constitute the implantable portion of the p...

Page 7: ...ide a variety of therapy options Access the pulse generator s diagnostic features Perform noninvasive diagnostic testing Access therapy history data RELATED INFORMATION Refer to the lead s instruction manual for implant information general warnings and precautions indications contraindications and technical specifications Read this material carefully for implant procedure instructions specific to ...

Page 8: ...ss I ischemic heart failure CONTRAINDICATIONS There are no contraindications for this device WARNINGS General Labeling knowledge Read this manual thoroughly before implantation to avoid damage to the pulse generator and or lead Such damage can result in patient injury or death For single patient use only Do not reuse reprocess or resterilize Reuse reprocessing or resterilization may compromise the...

Page 9: ...plant explant or postmortem procedures to avoid inadvertent high voltage shocks Do not kink leads Do not kink twist or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage Handling the lead without Connector Tool For leads that require the use of a Connector Tool use caution handling the lead terminal when the Connector Tool is not present on ...

Page 10: ...cing inhibition Slow VT Physicians should use medical discretion when implanting this device in patients who present with slow VT Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates if these rates are in the tachyarrhythmia zones Post Implant Protected environments Advise patients to seek medical guidance before entering environments that could adversely affect th...

Page 11: ...d PRECAUTIONS Clinical Considerations Pacemaker mediated tachycardia PMT Programming minimum PVARP less than retrograde V A conduction may increase the likelihood of a PMT Sterilization and Storage If package is damaged The blister trays and contents are sterilized with ethylene oxide gas before final packaging When the pulse generator and or lead is received it is sterile provided the container i...

Page 12: ...here may be additional factors regarding the patient s overall health and medical condition that while not related to device function or purpose could render the patient a poor candidate for implantation of this system Cardiac health advocacy groups may have published guidelines that may be helpful in conducting this evaluation Lead compatibility Prior to implantation confirm the lead to pulse gen...

Page 13: ...ulse generator connector without taking the following precautions to ensure proper lead insertion Insert the torque wrench into the preslit depression of the seal plug before inserting the lead into the port to release any trapped fluid or air Visually verify that the setscrew is sufficiently retracted to allow insertion Use the torque wrench to loosen the setscrew if necessary Fully insert each l...

Page 14: ...eshold resulting in LV only pacing is not intended for the treatment of heart failure The clinical effects of LV only or RV only pacing for the treatment of heart failure have not been established Pacing and sensing margins Consider lead maturation in your choice of Pacing Amplitude pacing Pulse Width and Sensitivity settings An acute Pacing Threshold greater than 1 5 V or a chronic Pacing Thresho...

Page 15: ...MSR can result in asynchronous pacing during refractory periods since the combination can cause a very small sensing window or none at all Use Dynamic AV Delay or Dynamic PVARP to optimize sensing windows If you are entering a fixed AV Delay consider the sensing outcomes Atrial Tachy Response ATR ATR should be programmed to On if the patient has a history of atrial tachyarrhythmias The delivery of...

Page 16: ...on 2 fast atrial intervals In these instances a short series of premature atrial events could cause the device to mode switch ATR exit count Exercise care when programming the Exit Count to low values For example if the Exit Count was programmed to 2 a few cycles of atrial undersensing could cause termination of mode switching Proper programming without an atrial lead If an atrial lead is not impl...

Page 17: ...uld be advised to contact their physician immediately if they hear tones coming from their device Patient use of patient triggered monitor Determine if the patient is capable of activating this feature prior to being given the magnet and prior to enabling Patient Triggered Monitor Remind the patient to avoid strong magnetic fields so the feature is not inadvertently triggered Patient initiate stor...

Page 18: ...rical smelting furnaces Large RF transmitters such as radar Radio transmitters including those used to control toys Electronic surveillance antitheft devices An alternator on a car that is running Medical treatments and diagnostic tests in which an electrical current is passed through the body such as TENS electrocautery electrolysis thermolysis electrodiagnostic testing electromyography or nerve ...

Page 19: ...h Respiratory Sensor based diagnostics deactivate the pulse generator s Respiratory Sensor by programming it to Off Medical therapies treatments and diagnostic tests that use conducted electrical current e g TENS electrocautery electrolysis thermolysis electrodiagnostic testing electromyography or nerve conduction studies may interfere with or damage the pulse generator Program the device to Elect...

Page 20: ... the pads or paddles in a posterior anterior orientation when the device is implanted in the right pectoral region or an anterior apex orientation when the device is implanted in the left pectoral region Set energy output of external defibrillation equipment as low as clinically acceptable Following external cardioversion or defibrillation verify pulse generator function Post Therapy Pulse Generat...

Page 21: ...uency RF interference RF signals from devices that operate at frequencies near that of the pulse generator may interrupt ZIP telemetry while interrogating or programming the pulse generator This RF interference can be reduced by increasing the distance between the interfering device and the PRM and pulse generator Central line guidewire insertion Use caution when inserting guidewires for placement...

Page 22: ...ellular phones Advise patients to hold cellular phones to the ear opposite the side of the implanted device Patients should not carry a cellular phone that is turned on in a breast pocket or on a belt within 15 cm 6 inches of the implanted device since some cellular phones may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy Follow up Testing Conversion tes...

Page 23: ...oved before cremation Cremation and incineration temperatures might cause the pulse generator to explode Device handling Before explanting cleaning or shipping the device complete the following actions to prevent unwanted shocks overwriting of important therapy history data and audible tones Program the pulse generator Tachy and Brady Modes to Off Program the Magnet Response feature to Off Program...

Page 24: ...aving all patient data Verifying the appropriate final programming prior to allowing the patient to leave the clinic Transcutaneous Electrical Nerve Stimulation TENS CAUTION TENS involves passing electrical current through the body and may interfere with pulse generator function If TENS is medically necessary evaluate the TENS therapy settings for compatibility with the pulse generator The followi...

Page 25: ...ess dizziness or loss of consciousness they should turn off the TENS unit and contact their physician Follow these steps to use the PRM to evaluate pulse generator function during TENS use 1 Program the pulse generator Tachy Mode to Monitor Only 2 Observe real time EGMs at prescribed TENS output settings noting when appropriate sensing or interference occurs NOTE Patient triggered monitoring may b...

Page 26: ...between the electrocautery equipment or ablation catheters and the pulse generator and leads RF ablation close to the lead electrode may damage the lead tissue interface Keep the path of the electrical current as far away as possible from the pulse generator and leads If RF ablation and or electrocautery is performed on tissue near the device or leads monitor pre and post measurements for sensing ...

Page 27: ...diation oncologist and cardiologist or electrophysiologist should consider all patient management options including increased follow up and device replacement Other considerations include Maximizing shielding of the pulse generator within the treatment field Determining the appropriate level of patient monitoring during treatment Evaluate pulse generator operation during and following the course o...

Page 28: ...mple functioned as designed when exposed to more than 1000 cycles at a pressure up to 5 0 ATA Laboratory testing did not characterize the impact of elevated pressure on pulse generator performance or physiological response while implanted in a human body Pressure for each test cycle began at ambient room pressure increased to a high pressure level and then returned to ambient pressure Although dwe...

Page 29: ...e pulse generator operation following high pressure exposure Post Therapy Pulse Generator Follow Up on page 19 The extent timing and frequency of this evaluation relative to the high pressure exposure are dependent upon current patient health and should be determined by the attending cardiologist or electrophysiologist If you have additional questions or would like more detail regarding the test p...

Page 30: ...d accumulation Foreign body rejection phenomena Formation of hematomas or seromas Heart block Inability to defibrillate or pace Inappropriate therapy e g shocks and antitachycardia pacing ATP where applicable pacing Incisional pain Incomplete lead connection with pulse generator Infection including endocarditis Insulating myocardium during defibrillation with internal or external paddles Lead disl...

Page 31: ...ub effusion Pneumothorax Pulse generator migration Shunting current during defibrillation with internal or external paddles Tachyarrhythmias which include acceleration of arrhythmias and early recurrent atrial fibrillation Thrombosis thromboemboli Valve damage Venous occlusion Venous trauma e g perforation dissection erosion Worsening heart failure Patients may develop psychological intolerance to...

Page 32: ...nstruments Prolonged exposure to fluoroscopic radiation Renal failure from contrast media used to visualize coronary veins MECHANICAL SPECIFICATIONS All models have a case electrode surface area of 6192 mm Usable battery capacity is 1 9 Ah and residual usable battery capacity at Explant is 0 15 Ah Mechanical specifications specific to each model are listed below Table 2 Mechanical Specifications D...

Page 33: ...08 x 0 99 72 9 32 0 RA IS 1 RV IS 1 DF 1 LV LV 1 G156 5 37 x 8 08 x 0 99 73 4 32 0 RA IS 1 RV IS 1 DF 1 LV IS4 G158 5 37 x 8 18 x 0 99 73 8 32 5 RA IS 1 RV DF4 LV IS4 Table 3 Mechanical Specifications INOGEN CRT Ds Model Dimensions W x H x D cm Mass g Volume cm3 Connector Type G140 5 37 x 8 18 x 0 99 73 6 32 5 RA IS 1 RV DF4 LV IS 1 G141 5 37 x 8 08 x 0 99 72 8 32 0 RA IS 1 RV IS 1 DF 1 LV IS 1 29...

Page 34: ...S4 Table 4 Mechanical Specifications ORIGEN CRT Ds Model Dimensions W x H x D cm Mass g Volume cm3 Connector Type G050 5 37 x 8 18 x 0 99 73 6 32 5 RA IS 1 RV DF4 LV IS 1 G051 5 37 x 8 08 x 0 99 72 8 32 0 RA IS 1 RV IS 1 DF 1 LV IS 1 G056 5 37 x 8 08 x 0 99 73 4 32 0 RA IS 1 RV IS 1 DF 1 LV IS4 G058 5 37 x 8 18 x 0 99 73 8 32 5 RA IS 1 RV DF4 LV IS4 Models include ZIP telemetry operating with a tr...

Page 35: ... PACKAGE The following items are included with the pulse generator One torque wrench Product literature NOTE Accessories e g wrenches are intended for one time use only They should not be resterilized or reused SYMBOLS ON PACKAGING The following symbols may be used on packaging and labeling Table 5 on page 31 Table 5 Symbols on packaging Symbol Description Reference number Package contents 31 ...

Page 36: ...Table 5 Symbols on packaging continued Symbol Description Pulse generator Torque wrench Literature enclosed Serial number Use by Lot number Date of manufacture 32 ...

Page 37: ...able 5 Symbols on packaging continued Symbol Description Sterilized using ethylene oxide Do not resterilize Do not reuse Do not use if package is damaged Dangerous voltage Consult instructions for use 33 ...

Page 38: ...e 5 Symbols on packaging continued Symbol Description Temperature limitation Place telemetry wand here Open here Authorized Representative in the European Community Manufacturer Investigational use only 34 ...

Page 39: ...RT D RA RV LV ICD RA RV ICD RV Uncoated device CHARACTERISTICS AS SHIPPED Refer to the table for pulse generator settings at shipment Table 6 on page 35 Table 6 Characteristics as shipped Parameter Setting Tachy Mode Storage Tachy Therapy available ATP Shock 35 ...

Page 40: ...ipolar Models The pulse generator is shipped in a power saving Storage mode to extend its shelf life In Storage mode all features are inactive except Telemetry support which allows interrogation and programming Real time clock Commanded capacitor re formation STAT SHOCK and STAT PACE commands The device leaves Storage mode when one of the following actions occurs however programming other paramete...

Page 41: ...is identifier provides noninvasive confirmation of the manufacturer and consists of the following The letters BSC to identify Boston Scientific as the manufacturer The number 140 to identify the Model 2868 PRM software application needed to communicate with the pulse generator The x ray identifier is embedded in the header of the device For a left side pectoral implant the identifier will be visib...

Page 42: ...plies with Title 47 Part 15 of the FCC rules Operation is subject to the following two conditions This device may not cause harmful interference and This device must accept any interference received including interference that may cause undesired operation This transmitter is authorized by rule under the Medical Device Radiocommunication Service in part 95 of the FCC Rules and must not cause harmf...

Page 43: ...ton Scientific could void the user s authority to operate the equipment PULSE GENERATOR LONGEVITY Based on simulated studies it is anticipated that these pulse generators have average longevity to explant as shown below The longevity expectations which account for the energy used during manufacture and storage apply at the conditions shown in the table along with the following Assumes 70 ppm LRL D...

Page 44: ...ly for in clinic follow up checks b Assumes standard use of the LATITUDE Communicator as follows Daily Device Check on monthly Full Interrogations scheduled remote follow ups and quarterly patient initiated interrogations NOTE The energy consumption in the longevity table is based upon theoretical electrical principles and verified via bench testing only The pulse generator longevity may increase ...

Page 45: ...y 16 days An additional 6 months in Storage mode prior to implant will reduce longevity by 39 days Assumes implanted settings of 70 ppm LRL DDDR mode 15 atrium pacing 100 biventricular pacing 0 4 ms pacing Pulse Width 500 Ω pacing Impedance 2 5 V pacing pulse Amplitude RA RV 3 0 V pacing pulse Amplitude LV Device longevity may also be affected by Tolerances of electronic components Variations in p...

Page 46: ...standing the overall reliability of these types of products Sometimes device malfunctions result in the issuance of product advisories Boston Scientific determines the need to issue product advisories based on the estimated malfunction rate and the clinical implication of the malfunction When Boston Scientific communicates product advisory information the decision whether to replace a device shoul...

Page 47: ...e Minimum heart rate lower rate limit of the pulse generator Frequency of follow up Travel or relocation Follow up arrangements should be made in advance if the patient is leaving the country of implant Patient ID card the patient should be advised to carry their patient ID card at all times a temporary patient ID card is provided with the device and a permanent ID card will be sent to the patient...

Page 48: ...in potential adverse consequences such as undersensing of cardiac activity or failure to deliver necessary therapy CAUTION If the Lead Configuration is programmed to Bipolar when a unipolar lead is implanted pacing will not occur 6 4 5 7 IS 1 BI DF4 LLHH RV RA IS4 LLLL LV 3 2 1 1 RA White 2 LV Green 3 RV Red 4 RA 5 LV 6 Suture Holes 7 RV Figure 2 Lead connections and setscrew locations RA IS 1 RV ...

Page 49: ... RA DF 1 DF 1 IS 1 BI 1 2 3 4 5 LV 1 UNI BI 1 Defib Red 2 Defib Blue 3 RA White 4 LV Green 5 RV White 6 Defib 7 Defib 8 RA 9 RV 10 LV 11 Suture Hole Figure 3 Lead connections and setscrew locations RA IS 1 RV IS 1 DF 1 LV LV 1 45 ...

Page 50: ...6 4 5 7 IS 1 BI DF4 LLHH RV RA LV IS 1 UNI BI 1 2 3 1 RA White 2 LV Green 3 RV Red 4 RA 5 LV 6 Suture Holes 7 RV Figure 4 Lead connections and setscrew locations RA IS 1 RV DF4 LLHH LV IS 1 46 ...

Page 51: ...LL LV RV RA DF 1 DF 1 IS 1 BI 1 2 3 4 5 1 Defib Red 2 Defib Blue 3 RA White 4 LV Green 5 RV White 6 Defib 7 Defib 8 RA 9 RV 10 LV 11 Suture Hole Figure 5 Lead connections and setscrew locations RA IS 1 RV IS 1 DF 1 LV IS4 LLLL 47 ...

Page 52: ...fibrillating electrode unless the pulse generator has been programmed to the Distal Coil to Proximal Coil or Cold Can Shock Vector IMPLANTING THE PULSE GENERATOR Implant the pulse generator by performing the following steps in the sequence provided Some patients may require pacing therapies immediately upon connecting the leads to the pulse generator In such cases consider programming the pulse ge...

Page 53: ...nches During the implantation procedure always have a standard transthoracic defibrillator with external pads or paddles available for use during defibrillation threshold testing Step B Interrogate and Check the Pulse Generator To maintain sterility test the pulse generator as described below before opening the sterile blister tray The pulse generator should be at room temperature to ensure accura...

Page 54: ... a sutureable steroid eluting pace sense epicardial lead or sutureless epicardial pace sense lead is recommended CAUTION The absence of a lead or plug in a lead port may affect device performance If a lead is not used be sure to properly insert a plug in the unused port and then tighten the setscrew onto the plug CAUTION Do not suture directly over the lead body as this may cause structural damage...

Page 55: ...ctor Tool is not present on the lead Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA alligator clips ECG connections forceps hemostats and clamps This could damage the lead terminal possibly compromising the sealing integrity and result in loss of therapy or inappropriate therapy such as a short within the header Pace sense lead measure...

Page 56: ... 3 0 V endocardial 3 5 V epicardial Pacing Threshold left ventricle 2 5 V coronary venous 2 0 V epicardial 3 5 V coronary venous 3 5 V epicardial Pacing Threshold atrium 1 5 V endocardial 3 0 V endocardial Lead impedance at 5 0 V and 0 5 ms atrium and right ventricle e programmed Low Impedance Limit 200 500 Ω programmed High Impedance Limit 2000 3000 Ω programmed Low Impedance Limit 200 500 Ω prog...

Page 57: ...erator s refractory period may result in inaccurate cardiac rate determination inability to sense a tachyarrhythmia or in the misinterpretation of a normal rhythm as abnormal d This measurement is not inclusive of current of injury e Changes in the defibrillation electrode surface area such as changing from a triad configuration to a single coil configuration can affect the impedance measurements ...

Page 58: ...e DF4 LLHH or DF4 LLHO lead terminal other than the terminal pin even when the lead cap is in place Do not contact any other portion of the IS4 LLLL lead terminal other than the terminal pin even when the lead cap is in place If a compatible tunneler is not used cap the lead terminal pins A Penrose drain large chest tube or tunneling tool may be used to tunnel the leads For DF4 LLHH or DF4 LLHO le...

Page 59: ...lowing sequence for pulse generator header and setscrew location illustrations refer to Lead Connections on page 44 a Right ventricle Connect the RV lead first because it is required to establish RV based timing cycles that yield appropriate sensing and pacing in all chambers regardless of the programmed configuration In models with an IS 1 RV lead port insert and secure the terminal pin of an IS ...

Page 60: ...e or nonconversion of the arrhythmia post operatively may result if the polarity is switched physically Connect each lead to the pulse generator by following these steps for additional information about the torque wrench refer to Bidirectional Torque Wrench on page 65 a Check for the presence of any blood or other body fluids in the lead ports on the pulse generator header If fluid inadvertently e...

Page 61: ...ed to allow insertion Use the torque wrench to loosen the setscrew if necessary Fully insert each lead into its lead port and then tighten the setscrew onto the terminal pin Figure 7 Inserting the torque wrench d With the torque wrench in place fully insert the lead terminal into the lead port The lead terminal pin should be clearly visible beyond the connector block when viewed through the side o...

Page 62: ...d to confirm that the terminal pin is fully inserted into the lead port e Apply gentle downward pressure on the torque wrench until the blade is fully engaged within the setscrew cavity taking care to avoid damage to the seal plug Tighten the setscrew by slowly turning the torque wrench clockwise until it ratchets once The torque wrench is preset to apply the proper amount of force to the captive ...

Page 63: ...reflect those above Table 8 on page 51 CAUTION Take care to ensure that artifacts from the ventricles are not present on the atrial channel or atrial oversensing may result If ventricular artifacts are present in the atrial channel the atrial lead may need to be repositioned to minimize its interaction 3 Evaluate all lead impedances CAUTION If total shocking lead impedance during implant is less t...

Page 64: ...ow Impedance Limits Pacing dependence of the patient Recommended impedance range for the lead s being used if available The Shock Low Impedance Limit is fixed at 20 Ω The Shock High Impedance Limit is nominally set to 125 Ω and is programmable between 125 and 200 Ω in 25 Ω increments Consider the following factors when choosing a value for the High Impedance Limits For chronic leads historical imp...

Page 65: ...integrity including electrogram analysis X ray or fluoroscopic image review or internal visual inspection NOTE Because this device uses a subthreshold test pulse to conduct shock lead impedance measurements it can be difficult to measure responses to test signals when electrical interference or noise e g electrocautery or external monitoring equipment attached directly to the patient is present du...

Page 66: ...consists of inducing the arrhythmia and then attempting to convert the arrhythmia with a preselected energy level Demonstrating conversion of ventricular fibrillation is suggested before implanting a pulse generator because a shock delivered during ventricular tachycardia has the potential to accelerate the arrhythmia Intraoperative testing may be minimized by performing only VF testing at time of...

Page 67: ...ocket enough to ensure that the pulse generator will remain in position during conversion testing Make sure the pulse generator has good contact with surrounding tissue flush the pocket with saline solution if necessary to avoid a dry pocket CAUTION Do not allow any object that is electrically conductive to come into contact with the lead or device during induction because it may shunt energy resu...

Page 68: ...ccessful VF conversion NOTE Since the results of any single test may be an example of statistical variation a one time conversion of a rhythm disturbance at a particular energy level does not guarantee or assure that the energy level is reliable for conversion As a safety margin it is recommended that you perform the conversion test at the DFT two times if the DFT is 31 J or one time if the DFT is...

Page 69: ... ten days of implantation complete the Warranty Validation and Lead Registration form and return the original to Boston Scientific along with a copy of the patient data saved from the PRM This information enables Boston Scientific to register each implanted pulse generator and set of leads and provide clinical data on the performance of the implanted system Keep a copy of the Warranty Validation a...

Page 70: ...tracting these setscrews stop turning the torque wrench when the setscrew has come in contact with the stop The additional counterclockwise torque of this wrench may cause these setscrews to become stuck if tightened against the stop Loosening Stuck Setscrews Follow these steps to loosen stuck setscrews 1 From a perpendicular position tilt the torque wrench to the side 20º to 30º from the vertical...

Page 71: ...TING It is recommended that device functions be evaluated with periodic follow up testing by trained personnel Follow up guidance below will enable thorough review of device performance and associated patient health status throughout the life of the device WARNING Ensure that an external defibrillator and medical personnel skilled in CPR are present during post implant device testing should the pa...

Page 72: ...reen Tachy Counters screen or Brady Counters screen Routine Follow Up You should conduct routine follow up examinations one month after the predischarge check and every three months thereafter to evaluate device programming therapy effectiveness lead status and battery status Office visits may be supplemented by remote monitoring where available NOTE Because the duration of the device replacement ...

Page 73: ...rs and leads can provide information for continued improvement in system reliability and warranty considerations WARNING Do not reuse reprocess or resterilize Reuse reprocessing or resterilization may compromise the structural integrity of the device and or lead to device failure which in turn may result in patient injury illness or death Reuse reprocessing or resterilization may also create a ris...

Page 74: ... Modes to Off Program the Magnet Response feature to Off Program the Beep when Explant is Indicated feature to Off Program the Beep When Out of Range feature to Off Clean and disinfect the device using standard biohazard handling techniques Consider the following items when explanting and returning the pulse generator and or lead Interrogate the pulse generator and print a comprehensive report Dea...

Page 75: ... Use a Boston Scientific Returned Product Kit to properly package the pulse generator and or lead and send it to Boston Scientific 71 ...

Page 76: ...72 ...

Page 77: ......

Page 78: ... com ifu Boston Scientific 4100 Hamline Avenue North St Paul MN 55112 5798 USA www bostonscientific com 1 800 CARDIAC 227 3422 1 651 582 4000 2013 Boston Scientific Corporation or its affiliates All rights reserved 359049 002 EN US 2013 07 FCC ID ESCCRMG17912 359049 002 ...

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