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Cardiac Resynchronization Therapy Defibrillators

COGNIS 100-D Physicians Technical Manual

Physicians Technical Manual

53 Pages

PHYSICIAN’S TECHNICAL MANUAL  COGNIS™ 100–D CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR REF N106, N107, N108   CONTENTS New or Enhanced Features... evice Description...  Related Information ... ndications and Usage ...  Contraindications... Warnings ... Precautions... Potential Adverse Events ... Mechanical Specifications ... ead Connections... Items Included in Package ...  Symbols on Packaging ...  Characteristics as Shipped...  X-Ray Identifier...  Pulse Generator Longevity ...  Warranty Information ...  Product Reliability... Patient Counseling Information ... Patient Handbook...  Setscrew Locations ...  1 2 5 6 6 6 8 26 29 31 33 33 37 39 40 43 43 45 46 47
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Page 1

PHYSICIAN’S TECHNICAL MANUAL

COGNIS™ 100–D

CARDIAC RESYNCHRONIZATION THERAPY HIGH

ENERGY DEFIBRILLATOR

REF N106, N107, N108

Page 3

CONTENTS

New or Enhanced Features........................................................................................

Device Description......................................................................................................

Related Information ....................................................................................................

Indications and Usage ................................................................................................

Contraindications........................................................................................................

Warnings ....................................................................................................................

Precautions.................................................................................................................

Potential Adverse Events .........................................................................................

Mechanical Specifications ........................................................................................

Lead Connections.....................................................................................................

Items Included in Package .......................................................................................

Symbols on Packaging .............................................................................................

Characteristics as Shipped.......................................................................................

X-Ray Identifier.........................................................................................................

Pulse Generator Longevity .......................................................................................

Warranty Information ................................................................................................

Product Reliability.....................................................................................................

Patient Counseling Information ................................................................................

Patient Handbook.............................................................................................

Setscrew Locations ..................................................................................................

1

2

5

6

6

6

8

26

29

31

33

33

37

39

40

43

43

45

46

47

Page 5

NEW OR ENHANCED FEATURES

These pulse generator systems include additional features as compared to previous

products.

Ease of Use

•

•

ZOOMVIEW Programmer Software: the new user interface offers the following

benefits:

–

Clinical focus—features such as patient diagnostic trends and

indications-based programming emphasize the patient’s clinical condition

over device status and parameters.

–

Consistency—ZOOMVIEW software will be available on future pulse

generators, providing the same screens whether you are following a brady,

tachy, or heart failure device.

–

Simplicity—screen complexity is reduced through the use of progressive

disclosure (displaying the information you use frequently and minimizing the

information you only rarely access) and exception-based reporting.

Indications-Based Programming (IBP): the new ZOOMVIEW feature allows you

to quickly set up programming parameters based on the patient’s clinical needs

and indications.

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Tachy Therapy

•

Rhythm ID and Onset/Stability detection: the selection between detection

enhancements provides you the opportunity and flexibility to adjust for individual

patient conditions.

•

QUICK CONVERT ATP: in an attempt to avoid an otherwise scheduled charge

and painful shock for a pace-terminable fast ventricular tachycardia (VT), the

pulse generator delivers one rapid burst of antitachycardia pacing (ATP) for an

episode detected in the ventricular fibrillation (VF) zone.

•

Programmable Shock Vectors: this capability allows you to electronically change

the shocking vectors for added flexibility in treating high defibrillation thresholds

(DFTs).

Sensing

•

Sensing is designed to combine the strengths of both implantable cardioverter

defibrillator (ICD) and pacemaker sensing capabilities to improve detection and

therapy by reducing inappropriate mode switching, pacing inhibition, and shocks.

DEVICE DESCRIPTION

This manual contains information about the COGNIS 100 family of cardiac

resynchronization therapy defibrillators (CRT-Ds) (specific models are listed in

"Mechanical Specifications" on page 29).

2

Page 7

Therapies

This family of pulse generators has a small, thin, physiologic shape that minimizes

pocket size and may minimize device migration. Pulse generators within this family

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

•

Bradycardia pacing, including adaptive rate pacing, to detect and treat

bradyarrhythmias and to provide cardiac rate support after defibrillation therapy

Cardioversion/defibrillation therapies include:

•

A range of low- and high-energy shocks using a biphasic waveform

•

The choice of multiple shock vectors:

–

Distal shock electrode to proximal shock electrode and pulse generator case

(TRIAD electrode system)

–

Distal shock electrode to proximal shock electrode (RV Coil to RA Coil)

–

Distal shock electrode to pulse generator case (RV Coil to Can)

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Leads

The pulse generator has independently programmable outputs and accepts the

following leads:

•

One IS-11 atrial lead

•

One IS-1 coronary venous pace/sense lead

•

One LV-1 coronary venous pace/sense lead

•

One DF-1/IS-12 cardioversion/defibrillation lead

•

One GDT-LLHH multipolar connector cardioversion/defibrillation lead

CAUTION: The GDT-LLHH multipolar connector cardioversion/defibrillation lead is

intended for use only with pulse generators that are configured with the GDT-LLHH

connector.

The pulse generator and the leads constitute the implantable portion of the pulse

generator system.

PRM System

These pulse generators can be used only with the ZOOM LATITUDE Programming

System, which is the external portion of the pulse generator system and includes:

1.

2.

4

IS-1 refers to the international standard ISO 5841.3:2000.

DF-1 refers to the international standard ISO 11318:2002.

Page 9

•

Model 3120 Programmer/Recorder/Monitor (PRM)

•

Model 2868 ZOOMVIEW Software Application

•

Model 6577 Accessory Telemetry Wand

You can use the PRM system to do the following:

•

Interrogate the pulse generator

•

Program the pulse generator to provide 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 the chosen lead

configurations.

The Physician’s Technical Manual is packaged with the pulse generator. It provides the

technical information needed at implant.

Refer to the PRM system Operator’s Manual for specific information about the PRM

such as setup, maintenance, and handling.

5

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INDICATIONS AND USAGE

Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are

indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain

symptomatic despite stable, optimal heart failure drug therapy and have left ventricular

(LV) dysfunction (EF ” 35%) and QRS duration • 120 ms.

CONTRAINDICATIONS

There are no contraindications for this device.

WARNINGS

General

•

Labeling knowledge. Read this manual thoroughly before implanting the pulse

generator to avoid damage to the system. Such damage can result in patient

injury or death.

•

Avoid shock during handling. Program the pulse generator Tachy Mode(s) to

Off during implant, explant, or postmortem procedures to avoid inadvertent high

voltage shocks.

•

Backup defibrillation protection. Always have sterile external and internal

defibrillation protection available during implant. If not terminated in a timely

fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.

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•

Resuscitation availability. Ensure that an external defibrillator and medical

personnel skilled in CPR are present during post-implant device testing should the

patient require external rescue.

•

Protected environments. Advise patients to seek medical guidance before

entering environments that could adversely affect the operation of the active

implantable medical device, including areas protected by a warning notice that

prevents entry by patients who have a pulse generator.

•

Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to

MR device scanning. Strong magnetic fields may damage the device and cause

injury to the patient.

•

Diathermy. Do not subject a patient with an implanted pulse generator to

diathermy since diathermy may cause fibrillation, burning of the myocardium, and

irreversible damage to the pulse generator because of induced currents.

Programming and Device Operations

•

Atrial tracking modes. Do not use atrial tracking modes in patients with chronic

refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in

VT or VF.

•

Atrial-only modes. Do not use atrial-only modes in patients with heart failure

because such modes do not provide CRT.

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•

Ventricular sensing. Left ventricular lead dislodgement to a position near the

atria can result in atrial oversensing and left ventricular pacing 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.

Implant Related

•

Do not kink leads. Kinking leads may cause additional stress on the leads,

possibly resulting in lead fracture.

•

Patch leads. Do not use defibrillation patch leads with the pulse generator

system, or injury to the patient may occur.

•

Separate pulse generator. Do not use this pulse generator with another pulse

generator. This combination could cause pulse generator interaction, resulting in

patient injury or a lack of therapy delivery.

PRECAUTIONS

Clinical Considerations

•

8

Pacemaker-mediated tachycardia (PMT). Retrograde conduction combined

with a short PVARP might induce PMT.

Page 13

Sterilization, Storage, and Handling

•

For single use only; do not resterilize devices. Do not resterilize the device

or the accessories packaged with it because the effectiveness of resterilization

cannot be ensured.

•

If package is damaged. The pulse generator blister trays and contents are

sterilized with ethylene oxide gas before final packaging. When the pulse

generator is received, it is sterile provided the container is intact. If the packaging

is wet, punctured, opened, or otherwise damaged, return the device to Boston

Scientific.

•

Storage temperature and equilibration. Recommended storage temperatures

are 0°C–50°C (32°F–122°F). Allow the device to reach a proper temperature

before using telemetry communication capabilities, programming or implanting the

device because temperature extremes may affect initial device function.

•

Device storage. Store the pulse generator in a clean area away from magnets,

kits containing magnets, and sources of EMI to avoid device damage.

•

Use by date. Implant the device system before or on the USE BY date on the

package label because this date reflects a validated shelf life. For example, if the

date is January 1, do not implant on or after January 2.

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Implantation and Device Programming

•

Lead system. Do not use any lead with this device without first verifying

connector compatibility. Using incompatible leads can damage the connector

and/or result in potential adverse consequences, such as undersensing of cardiac

activity or failure to deliver necessary therapy.

•

Telemetry wand. Make sure the telemetry wand is connected to the programmer

and that it is available throughout the session. Verify that the wand cord is within

reach of the pulse generator.

•

STAT PACE settings. When a pulse generator is programmed to STAT PACE

settings, it will continue to pace at the high-energy STAT PACE values if it is not

reprogrammed. The use of STAT PACE parameters will decrease device longevity.

•

Biventricular pacing therapy. This device is intended to provide biventricular or

left ventricular pacing therapy. Programming the device to provide RV-only pacing

is not intended for the treatment of heart failure.

10

Page 15

•

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 threshold

greater than 3 V can result in loss of capture because thresholds may

increase over time.

•

An R-wave amplitude less than 5 mV or a P-wave amplitude less than 2 mV

can result in undersensing because the sensed amplitude may decrease

after implantation.

•

Pacing lead impedance should be within the range of 200 Ÿ and 2000 Ÿ.

•

Line-powered equipment. Exercise extreme caution if testing leads using

line-powered equipment because leakage current exceeding 10 µA can induce

ventricular fibrillation. Ensure that any line-powered equipment is within

specifications.

•

Proper programming of the lead configuration. If the Lead Configuration is

programmed to Bipolar when a unipolar lead is implanted, pacing will not occur.

•

Proper programming of the shock vector. If the shock vector is programmed to

RVcoil>>RAcoil and the lead does not have an RA coil, shocking will not occur.

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•

Replacement device. Implanting a replacement device in a subcutaneous pocket

that previously housed a larger device may result in pocket air entrapment,

migration, erosion, or insufficient grounding between the device and tissue.

Irrigating the pocket with sterile saline solution decreases the possibility of pocket

air entrapment and insufficient grounding. Suturing the device in place reduces

the possibility of migration and erosion.

•

Defibrillation power surge. Defibrillation that causes a power surge exceeding

360 watt-seconds can damage the pulse generator system.

•

Programming for supraventricular tachyarrhythmias (SVTs). Determine if the

device and programmable options are appropriate for patients with SVTs because

SVTs can initiate unwanted device therapy.

•

AV Delay. To ensure a high percentage of biventricular pacing, the programmed

AV Delay setting must be less than the patient’s intrinsic PR interval.

•

Adaptive-rate pacing. Adaptive-rate pacing should be used with care in patients

who are unable to tolerate increased pacing rates.

12

Page 17

•

Ventricular refractory periods (VRPs) in adaptive-rate pacing. Adaptive-rate

pacing is not limited by refractory periods. A long refractory period programmed in

combination with a high 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 CRT is compromised

because AV synchrony is disrupted if the ATR mode switch occurs.

•

Threshold test. During the LV threshold test, RV backup pacing is unavailable.

•

Left ventricular pacing only. The clinical effect of LV pacing alone for heart

failure patients has not been studied.

•

Do not bend the lead near the lead-header interface. Improper insertion can

cause insulation damage near the terminal end that could result in lead failure.

•

Shock waveform polarity. For IS-1/DF-1 leads, never change the shock

waveform polarity by physically switching the lead anodes and cathodes in the

pulse generator header—use the programmable Polarity feature. Device damage

or nonconversion of the arrhythmia post-operatively may result if the polarity

is switched physically.

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Page 18

•

Absence of a lead. 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.

•

Electrode connections. Do not insert a lead into the pulse generator connector

without first visually verifying that the setscrew is sufficiently retracted to allow

insertion. Fully insert each lead into its lead port and then tighten the setscrew

onto the electrodes.

•

Tachy Mode to Off. To prevent inappropriate shocks, ensure that the pulse

generator’s Tachy Mode is programmed to Off when not in use and before handling

the device. For tachyarrhythmia therapy, verify that the Tachy Mode is activated.

•

Atrial oversensing. 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.

•

Defibrillation lead impedance. Never implant the device with a lead system that

has less than 15 Ÿ total shock lead impedance. Device damage may result. If a

shocking lead impedance is less than 20 Ÿ, reposition the shocking electrodes to

allow a greater distance between the shocking electrodes.

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•

ATR entry count. Exercise care when programming the Entry Count to low

values in conjunction with a short ATR Duration. This combination allows mode

switching with very few fast atrial beats. For example, if the Entry Count was

programmed to 2 and the ATR Duration to 0, ATR mode switching could occur 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.

•

Left ventricular lead configuration. Proper programming of the LV coronary

venous lead configuration is essential for proper LV lead function. Program the

lead configuration in accordance with the number of electrodes on the LV lead;

otherwise, erratic LV sensing, loss of LV pacing, or ineffective LV pacing might

occur.

•

Left Ventricular Protection Period (LVPP). Use of a long LVPP reduces the

maximum LV pacing rate and may inhibit CRT at higher pacing rates.

•

Shunting energy. 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,

resulting in less energy getting to the patient, and may damage the implanted

system.

15

Page 20

•

Expected benefits. Determine whether the expected device benefits outweigh

the possibility of early device replacement for patients whose tachyarrhythmias

require frequent shocks.

•

Device communication. Use only the designated PRM and software application

to communicate with this pulse generator.

Environmental and Medical Therapy Hazards

•

16

Avoid electromagnetic interference (EMI). Advise patients to avoid sources of

EMI because EMI may cause the pulse generator to deliver inappropriate therapy

or inhibit appropriate therapy. Examples of EMI sources are:

•

Electrical power sources, arc welding equipment, and robotic jacks

•

Electrical 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

Page 21

•

Radio and Telecommunications Terminal Equipment (RTTE). Boston Scientific

declares that this device is in compliance with the essential requirements and

other relevant provisions of the current RTTE directive.

NOTE: As with other telecommunications equipment, verify national data privacy

laws.

•

Elevated Pressures. Elevated pressures due to hyperbaric chamber exposure of

SCUBA diving may damage the pulse generator. The pulse generator has been

tested to function normally at 1.5 Atmospheres Absolute (ATA) pressure or 15 ft

(4.6 m) depth in sea water. For specific guidelines prior to hyperbaric chamber

exposure, or if the patient is planning scuba diving activity, contact Technical

Services at the number shown on the back cover of this manual.

Hospital and Medical Environments

•

Mechanical ventilators. During mechanical ventilation, respiration rate trending

may be misleading; therefore, the Respiratory Sensor should be programmed

to Off.

•

Internal defibrillation. Do not use internal defibrillation paddles or catheters

unless the pulse generator is disconnected from the leads because the leads

may shunt energy. This could result in injury to the patient and damage to the

implanted system.

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•

External defibrillation. Use of external defibrillation can damage the pulse

generator.

•

Transcutaneous electrical nerve stimulation (TENS). TENS may interfere

with pulse generator function. If necessary, the following measures may reduce

interference:

1.

Place the TENS electrodes as close to each other as possible and as far

from the pulse generator and lead system as possible.

2.

Monitor cardiac activity during TENS use.

For additional information, contact Technical Services at the number shown on

the back cover of this manual.

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•

Electrocautery. The use of electrocautery could induce ventricular arrhythmias

and/or fibrillation, cause asynchronous or inhibited pulse generator operation, or

cause the pulse generator to deliver an inappropriate shock. If electrocautery

cannot be avoided, observe the following precautions to minimize complications:

•

Select Electrocautery Protection Mode. Avoid direct contact with the pulse

generator or leads.

•

Monitor the patient and have temporary pacing equipment, external

defibrillation equipment, and knowledgeable medical personnel available.

•

Position the ground plate so that the current pathway does not pass through

or near the pulse generator system.

•

Use short, intermittent, and irregular bursts at the lowest feasible energy

levels.

•

Use a bipolar electrocautery system where possible.

Remember to reactivate the Tachy Mode after turning off the electrocautery equipment.

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•

Ionizing radiation therapy. Ionizing radiation therapy may adversely affect

device operation. During ionizing radiation therapy (e.g., radioactive cobalt,

linear accelerators, and betatrons), the pulse generator must be shielded with

a radiation-resistive material, regardless of the distance of the device to the

radiation beam. Do not project the radiation port directly at the device. After

waiting a minimum of one hour following radiation treatment (to allow for a device

memory check to occur), always evaluate device operation, including interrogation

and sensing and pacing threshold testing.

At the completion of the entire course of treatments, perform device interrogation

and follow-up, including sensing and pacing threshold testing and capacitor

re-formation.

•

Lithotripsy. Lithotripsy may permanently damage the pulse generator if the

device is at the focal point of the lithotripsy beam. If lithotripsy must be used, avoid

focusing near the pulse generator site.

The lithotriptor is designed to trigger off the R-wave on the ECG, resulting in shock

waves being delivered during the VRP.

20

•

If the patient does not require pacing, program the pulse generator Brady

Mode to Off.

•

If the patient requires pacing, program the pulse generator to the VVI mode

because atrial pacing pulses can trigger the lithotriptor.

Page 25

•

Ultrasound energy. Therapeutic ultrasound (e.g., lithotripsy) energy may damage

the pulse generator. If therapeutic ultrasound energy must be used, avoid focusing

near the pulse generator site. Diagnostic ultrasound (e.g., echocardiography) is

not known to be harmful to the pulse generator.

•

Radio frequency ablation. Exercise caution when performing radio frequency

ablation procedures in device patients. If the pulse generator Tachy Mode

is programmed to Monitor + Therapy during the procedure, the device may

inappropriately declare a tachycardia episode and deliver therapy. Pacing therapy

may also be inhibited unless the device is programmed to Electrocautery mode.

RF ablation may cause changes in pacing thresholds; evaluate the patient’s

thresholds appropriately.

Minimize risks by following these steps:

•

Program the Tachy Mode(s) to Electrocautery Protection to avoid inadvertent

tachycardia detection (sensing) or therapy.

•

Monitor the patient and have external defibrillation equipment and

knowledgeable medical personnel available.

•

Avoid direct contact between the ablation catheter and the implanted lead

and pulse generator.

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•

Keep the current path (electrode tip to ground) as far away from the pulse

generator and leads as possible.

•

Consider the use of external pacing support for pacemaker-dependent

patients (i.e., using internal or external pacing methods).

•

Monitor pre- and post-measurements for sensing and pacing thresholds and

impedances to determine the integrity of the lead-patient function.

Remember to reactivate the pulse generator after turning off the radio frequency

ablation equipment.

•

22

Electrical interference. Electrical interference or “noise” from devices such

as electrocautery and monitoring equipment may interfere with establishing or

maintaining telemetry for interrogating or programming the device. In the presence

of such interference, move the programmer away from electrical devices, and

ensure that the wand cord and cables are not crossing one another. If telemetry is

cancelled as a result of interference, the device should be re-interrogated prior to

evaluating information from pulse generator memory.

Page 27

•

Radio frequency (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. Examples of devices that may cause interference include:

•

Cordless phone handsets or base stations

•

Certain patient monitoring systems

•

Remote control toys

Home and Occupational Environments

•

Home appliances. Home appliances that are in good working order and properly

grounded do not usually produce enough EMI to interfere with pulse generator

operation. There have been reports of pulse generator disturbances caused

by electric hand tools or electric razors used directly over the pulse generator

implant site.

23

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