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ADDENDUM TO: 002-1362, Rev. D, US

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ICD Systems from Boston Scientific –TELIGEN

ICD Indications and Usage

ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. ICDs (i.e. Vitality AVT) with atrial therapies

are also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias.

Contraindications

Use of ICD systems are contraindicated in: Patients whose ventricular tachyarrhythmias may have reversible cause, such as 1) digitalis intoxication, 2) electrolyte imbalance, 3) hypoxia, or 4) sepsis, or

whose ventricular tachyarrhythmias have a transient cause, such as 1) acute myocardial infarction, 2) electrocution, or 3) drowning. Patients who have a unipolar pacemaker.

Warnings

Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the ICD system. For single patient use only, Do not reuse, reprocess, or resterilize. Program the pulse

generator ventricular Tachy Mode to Off during implant, explant or post-mortem procedures. Always have external defibrillator protection available during implant and electrophysiologic testing. Ensure

that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing. Patients should 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.

Do not expose a patient to MRI scanning. Do not subject a patient with an implanted pulse generator to diathermy. Do not use atrial tracking modes (or an AVT device) in patients with chronic refractory

atrial tachyarrhythmias. Do not use this pulse generator with another pulse generator. Do not kink, twist or braid lead with other leads. For Patient Triggered Monitor (PTM) feature, make sure the feature

is enabled prior to sending the patient home with a magnet. Once the PTM feature has been triggered and the magnet response programming is set to inhibit therapy, the patient should not reapply the

magnet.

Precautions

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization and storage; implantation; device programming; environmental and

medical therapy hazards; hospital and medical environments; home and occupational environments follow-up testing; explant and disposal; supplemental precautionary information. Advise patients to

avoid sources of electromagnetic interference (EMI).

Potential Adverse Events

Potential adverse events from implantation of the ICD system include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias,

lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, psychologic intolerance to

an ICD system – patients susceptible to frequent shocks despite antiarrhythmic medical management/imagined shocking, and component failure. In rare cases severe complications or device failures can

occur.

Refer to the product labeling for specific indications, contraindications, warnings/ precautions and adverse events. Rx only.

(Rev. Q)

Pacing Systems from Boston Scientific – INGENIO

and ADVANTIO

Indications

Ingenio and Advantio indications include: symptomatic paroxysmal or permanent second- or third-degree AV block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient sinus

node dysfunction with or without associated AV conduction disorders; bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias;

neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased

pacing rates concurrent with increases in minute ventilation and/or level of physical activity. Pacemakers’ dual-chamber and atrial tracking modes are also indicated for patients who may benefit from

maintenance of AV synchrony. Dual-chamber modes are specifically indicated for: conduction disorders that require restoration of AV synchrony, including varying degrees of AV block; VVI intolerance

(eg, pacemaker syndrome) in the presence of persistent sinus rhythm or low cardiac output or congestive heart failure secondary to bradycardia.

Contraindications

Pacemakers are contraindicated for the following patients under the circumstances listed: patients who have a separate implanted cardioverter-defibrillator (ICD); use of Minute Ventilation in patients with

both unipolar atrial and ventricular leads; single-chamber atrial pacing in patients with impaired AV nodal conduction; atrial tracking modes for patients with chronic refractory atrial tachyarrhythmias (atrial

fibrillation or flutter), which might trigger ventricular pacing; dual-chamber and single-chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias; asynchronous pacing in the presence

(or likelihood) of competition between paced and intrinsic rhythms.

Warnings

Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. For single use only. Do not reuse, reprocess or resterilize. Always have external defibrillation

protection available during implant and electrophysiologic testing. Do not use this pulse generator with another pulse generator. In response to applicable nonrecoverable or repeat fault conditions, the

pulse generator will switch irreversible to Safety Core operation. Do not kink, twist, or braid leads. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. In devices with

the lead safety switch programmed to On, the lead polarity will switch to unipolar in the presence of a lead impedance of ≤ 200 or ≥ 2000 Ω. If programmed to a fixed atrial sensitivity value of 0.15 mV, the

pulse generator may be more susceptible to electromagnetic interference. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active

implantable medical device. Do not expose a patient to MRI scanning. Do not subject a patient with an implanted pulse generator and/or lead to diathermy.

Precautions

medical therapy hazards; hospital and medical environments ; home and occupational environments; follow up testing; explant and disposal; supplemental precautionary information. Advise patients to

avoid sources of electric or magnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

Potential Adverse Events

Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, lead or accessory breakage (fracture/insulation/lead tip),

hematoma/seroma, inappropriate or inability to provide therapy (pacing/sensing), infection, procedure related, and component failure. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.

(Rev. A)

Pacing Systems from Boston Scientific ALTRUA

and INSIGNIA

Indications

Pacemaker indications include: symptomatic paroxysmal or permanent second- or third-degree AV block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient sinus node

dysfunction with or without associated AV conduction disorders; bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; neurovascular

(vaso-vagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients who may benefit from increased pacing rates concurrent with increases in minute

ventilation and/or level of physical activity. Pacemakers’ dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual-chamber modes

are specifically indicated for: conduction disorders that require restoration of AV synchrony, including varying degrees of AV block; VVI intolerance (eg, pacemaker syndrome) in the presence of persistent

sinus rhythm.

Contraindications

Pacemakers are contraindicated for the following patients under the circumstances listed: patients with unipolar pacing leads or in MV mode with an implanted ICD because it may cause unwanted

delivery or inhibition of ICD therapy; use of the MV sensor in patients with only unipolar leads, because a bipolar lead is required in either the atrium or the ventricle for MV detection (INSIGNIA® Plus,

ALTRUA® 20/40); MV mode in patients with both unipolar atrial and ventricular leads (INSIGNIA® Ultra, ALTRUA® 60); single-chamber atrial pacing in patients with impaired AV nodal conduction; atrial

tracking modes for patients with chronic refractory atrial tachyarrhythmias, which might trigger ventricular pacing; dual-chamber and single-chamber atrial pacing in patients with chronic refractory atrial

tachyarrhythmias; asynchronous pacing in the presence (or likelihood) of competition between paced and intrinsic rhythms.

Warnings

Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. For single use only-do not resterilize devices. Inappropriate sustained high-rate pacing occurred

in the PULSAR™ MAX clinical study in 5 out of 130 patients with MV ON, 4 to 14 days after implant. If sustained high-rate pacing could be of concern, consider programming a reduced Max Sensor Rate

or MV to Passive. These programming recommendations are intended to assure that MV calibration is evaluated and, if necessary, recalibrated (4 →ON) when the patient and pacing system have

stabilized post implant. Continued monitoring of the MV sensor performance should be performed at all follow-up visits until implant stabilization has occurred.

Precautions

For specific information on precautions, refer to the following sections of the product labeling: MV sensor calibration at implant; clinical considerations; sterilization, storage and handling; lead evaluation

and connection; implantation; programming and pacemaker operation; MV initialization; environmental and medical therapy hazards; elevated pressure; explanted pacemakers. Advise patients to avoid

sources of electric or magnetic interference (EMI). If the pacemaker inhibits or reverts to asynchronous operation at the programmed pacing rate or at the magnet rate while in the presence of the EMI,

moving away from the source or turning it off will usually allow the pulse generator to return to its normal mode of operation.

Potential Adverse Events

Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, lead or accessory breakage (fracture/insulation/lead tip),

hematoma/seroma, inappropriate or inability to provide therapy (pacing/sensing), infection, procedure related, and component failure. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.

(Rev. Q)