Medtronic KSR703 Technical Manual

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KAPPA® SR700 SERIES

197882003A_view.pdf

Pacemaker Models KSR701/703/706

Product Information Manual

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

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Medtronic Kappa® 700 Series Pacemaker Product Information Manual

Models KSR701, KSR703, KSR706

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This Product Information Manual is primarily intended as an implantation manual. For programming information see the Pacemaker Reference Guide that accompanies the programmer software. It is primarily intended as a follow-up manual, and contains further information on therapeutic and diagnostic features, troubleshooting information, follow-up precautionary information, and complete reference information.

The following are trademarks of Medtronic:

Capture Management, FAST, Implant Detection, Kappa, Key Parameter History, Marker Channel, Medtronic, Medtronic Kappa, Medtronic Vision, Rate Profile Optimization, Remote Assistant, Sensing Assurance, and Vision.

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Chapter 1 - Prescribing the Pacemaker 7

Device Description 8 Indications and Usage 9 Contraindications 9 Warnings and Precautions 10 Co-implantation with an Implantable Defibrillator 19 Adverse Events 21 Clinical Studies 25

Chapter 2 - Implanting the Pacemaker 29

Implantation Procedures 30 Implant Documentation 40 Parameter Programming at Implant 41 Medical Therapy Interactions 45 Assistance 48

Chapter 3 - Description 49

Pacing Mode Operations 50 Rate Responsive Pacing 51 Timing Operations 53 Pacing and Sensing Operations 54 Special Therapy Options 62

Chapter 4 - Pacemaker Follow-up 63

Pacemaker Telemetr y 64 Other Operations 67

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Diagnostics 70 General Recommendations 72

Appendix 73

NBG Codes 74 Special Notice 75

Pacemaker Specifications 77

Lead Requirements, Compatibility 78 Radiopaque Identification 79 Emergency Parameter Settings 80 Shipping and Nominal Parameter Settings 81 Electrical Reset Parameter Settings 84 Elective Replacement Indicator 87 Magnet Mode Conditions 87 Longevity Projections 88 Programmable Parameters 90 Nonprogrammable Parameters 97 Temporary Parameters 98 Tel e m e t r y Ma r k e r s 98 Electrograms 99 Automatic Diagnostics 99 Clinician-Selected Diagnostics 100 Patient Information 100 Battery and Lead Telemetered Information 101 Battery Parameters 102 Mechanical Dimensions 102

Index 103

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Chapter 1 - Prescribing the Pacemaker

Device Description 8

Indications and Usage 9

Contraindications 9

Warnings and Precautions 10

Co-implantation with an Implantable Defibrillator 19

Adverse Events 21

Clinical Studies 25

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Device Description

Medtronic Kappa 700 Series pacemakers (KSR700 Series) are multiprogrammable, rate responsive, implantable pacemakers, intended for a variety of bradycardia pacing applications. Rate response is controlled through an activity-based sensor. The following models are available:

Model Polarity Primary Leads

SR701 Bipolar/Unipolar IS-1

KSR703 Bipolar/Unipolar Low-profile 3.2 mm bipolar

SR706 Unipolar Unipolar 5 or 6 mm

IS-1 refers to an International Connector Standard (see Document No. ISO 5841-3;

1992).

SR700 Series pacemakers are programmed using the

K Medtronic.Vision software Model 9953 and a Medtronic Model 9790 programmer. For programming instructions refer to the Pacemaker Programming Guide that accompanies Medtronic Kappa 700 Series software.

or IS-1

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Indications and Usage

KSR700 Series pacemakers are indicated for the following:

■

Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity.

■

Accepted patient conditions warranting chronic cardiac pacing which include:

– Symptomatic paroxysmal or permanent second or

third-degree AV block. – Symptomatic bilateral bundle branch block. – Symptomatic paroxysmal or transient sinus node

dysfunctions with or without associated AV conduction

disorders. – Bradycardia-tachycardia syndrome to prevent

symptomatic bradycardia or some forms of symptomatic

tachyarrhythmias.

Contraindications

KSR700 Series pacemakers are contraindicated for the following applications:

■

Asynchronous pacing in the presence (or likelihood) of competitive paced and intrinsic rhythms.

■

Unipolar pacing for patients with an implanted cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of ICD therapy. See “Coimplantation with an Implantable Defibrillator” on page 19.

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Warnings and Precautions

■

Rate responsive modes – Do not use rate responsive modes in those patients who cannot tolerate pacing rates above the programmed Lower Rate.

■

Single chamber atrial modes – Do not use single chamber atrial modes in patients with impaired AV nodal conduction because ventricular capture cannot be assured.

Pacemaker Dependent Patients

■

Diagnostic modes – Never program diagnostic modes (OVO and OAO) for pacemaker-dependent patients. For such patients, use the programmer’s inhibit function for brief interruption of outputs.

■

Electrogram (EGM) of the patient’s intrinsic activity should be obtained with care since the patient is without pacing support when using the programmer’s inhibit function.

■

Polarity override – Overriding the bipolar verification prompt with bipolar polarity when a unipolar lead is connected results in no pacing output. See “Manually Programming Polarity” on page 57 for further information.

■

A false bipolar pathway on a unipolar lead, a possible occurrence with bipolar 3.2 mm connector pacemakers, may result in a loss of output. See the warning on “Automatic Polarity Configuration” on page 54 for further information.

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Warnings and Precautions

■

Loss of capture during threshold margin test (TMT) at a 20% reduction in amplitude indicates that the stimulation safety margin is inadequate. Consider increasing the pacing amplitude and/or pulse width. See “Magnet Operation” on page 67 for further information on the Threshold Margin Test.

■

Capture Management will not program ventricular outputs above 5.0 V or 1.0 ms. If the patient needs a pacing output higher than 5.0 V or 1.0 ms, program Amplitude and Pulse Width manually. See “Capture Management” on page 60 for further information.

Medical Therapy

■

Therapeutic Diathermy can cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator due to induced currents.

■

Magnetic resonance imaging of pacemaker patients has resulted in significant adverse effects. See “Magnetic Resonance Imaging (MRI)” on page 15 for further information.

Storage and Resterilization

Medtronic pacemakers are intended for single use only. Do not resterilize and re-implant explanted pacemakers.

The chart below gives recommendations on handling and storing the package. Medtronic has sterilized the pacemaker with ethylene oxide prior to shipment. Resterilizing the pacemaker is necessary if the seal on the sterile package is broken. Resterilization does not affect the “Use Before” date.

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Warnings and Precautions

Handling and Storage: Acceptable Unacceptable

Store and transport within Environmental Temperature limits:

°F (- 18°C) to + 131°F (55°C).

0 Note: A full or partial electrical reset

condition may occur at temperatures below 0°F (- 18°C). See “Electrical Reset Parameter Settings” on page 84.

Resterilization: Acceptable Unacceptable

Do not implant the device if it

has been dropped on a hard surface from a height of 12 inches (30 cm) or more.

Resterilize if the sterile package seal is broken. Place the device in an ethylene oxide permeable package and resterilize with ethylene oxide. Allow the device to aerate ethylene oxide residues. Refer to sterilizer instructions for details. Use an acceptable method for determining sterility, such as biological indicators.

Do not resterilize the device or the torque wrench using:

• an autoclave,

• gamma radiation,

• organic cleaning agents, e.g., alcohol, acetone, etc.,

• ultra-sonic cleaners.

Do not exceed 140 17 psi (103 kPa) when sterilizing.

Do not resterilize the device more than twice.

°F (60°C) or

Lead Evaluation and Lead Connection

■

Connector compatibility – Do not use any lead with this pacemaker without first verifying connector compatibility. Using incompatible leads can damage the connector or result in a leaking or intermittent connection.

■

Pacing and sensing safety margins – Consider lead maturation when choosing pacing amplitudes, pacing pulse widths, and sensing levels. See “Manual Programming” on page 42.

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Warnings and Precautions

■

Hex wrench – Do not use a hex wrench with a blue handle or a right-angled hex wrench. These wrenches have torque capabilities greater than is designed for the lead connector. See “Connecting Leads to the Pacemaker” on page 33 for lead connection instructions.

Programming and Pacemaker Operation

■

Epicardial leads – Ventricular epicardial leads have not been determined appropriate for use with the Capture Management feature. Therefore, Capture Management should be programmed Off if epicardial leads are implanted with

SR700 Series pacemakers.

■

Shipping values – Do not use shipping values for pacing amplitude and sensitivity without verifying that they provide adequate safety margins for the patient.

■

Constant current devices – To test the performance of the lead, Medtronic recommends using a constant voltage device such as the Medtronic Model 5311B (or equivalent) Pacing System Analyser (PSA). Medtronic does not recommend using a constant current device such as the Medtronic Model 5880A or 5375 External Pacemaker because the Kappa SR pacemaker has constant voltage output circuits.

■

Elective Replacement Indicator (ERI) – When ERI is set, the pacemaker must be replaced within three months. See “Elective Replacement Indicator” on page 69 for more information.

■

Full electrical reset is indicated by VVI pacing at a rate of 65 ppm without the elective replacement indicator set. See “Electrical Reset” on page 69 for more information.

■

Lead Monitor – If the Lead Monitor detects out-of-range lead impedance, investigate lead integrity more thoroughly.

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Warnings and Precautions

Rate Increases

■

Twiddler’s syndrome, i.e., patient manipulation of the device after implant, may cause the pacing rate to increase temporarily if the pacemaker is programmed to a rate responsive mode.

■

Muscle stimulation, e.g., due to unipolar pacing, may result in pacing at rates up to the Upper Sensor Rate in rate responsive modes.

Unipolar Sensing

■

Continuous myopotentials cause reversion to asynchronous operation when sensed in the refractory period. Sensing of myopotentials is more likely when atrial sensitivity settings of

0.5 through 1.0 mV and ventricular sensitivity settings of

1.0 and 1.4 mV are programmed.

Environmental and Medical Therapy Hazards

Patients should be directed to exercise reasonable caution in avoidance of devices which generate a strong electric or magnetic field. If the pacemaker inhibits or reverts to asynchronous operation at the programmed pacing rate or at the magnet rate while in the presence of electromagnetic interference (EMI), moving away from the source or turning it off will allow the pacemaker to return to its normal mode of operation.

Hospital and Medical Environments

■

Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may cause asynchronous or inhibited pacemaker operation. If use of electrocautery is necessary, the current path and ground plate should be kept as far away from the pacemaker and lead as possible. See “Electrosurgical Cautery” on page 47 for more information.

■

External defibrillation may damage the pacemaker or may result in temporary and/or permanent myocardial damage at

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Warnings and Precautions

the electrode-tissue interface as well as temporary or permanent elevated pacing thresholds. Attempt to minimize current flowing through the pacemaker and lead system by following these precautions when using external defibrillation on a pacemaker patient:

– Position defibrillation paddles as far from the pacemaker as

possible (minimum of 5 inches [13 cm]). Attempt to minimize current flowing through the pacemaker and leads by positioning the defibrillation paddles perpendicular to the implanted pacemaker/lead system.

– Use the lowest clinically appropriate energy output (watt

seconds).

– Confirm pacemaker function following any defibrillation.

■

High energy radiation sources such as cobalt 60 or gamma radiation should not be directed at the pacemaker. If a patient requires radiation therapy in the vicinity of the pacemaker, place lead shielding over the device to prevent radiation damage and confirm its function after treatment.

■

Lithotripsy may permanently damage the pacemaker if the device is at the focal point of the lithotripsy beam. If lithotripsy must be used, program the pacemaker to a nonrate responsive mode (VVI/AAI or VOO/AOO) prior to treatment; and keep the pacemaker at least 1 to 2 inches (2.5 to 5 cm) away from the focal point of the lithotripsy beam.

■

Magnetic resonance imaging (MRI). Pacemaker patients subjected to MRI should be closely monitored and programmed parameters should be verified upon cessation of MRI. MRI of pacemaker patients should be carefully weighed against the potential adverse affects. Clinicians should carefully weigh the decision to use MRI with pacemaker patients. Limited studies of the effects of MRI on pacemakers have shown that:

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Warnings and Precautions

– Magnetic and radio frequency (RF) fields produced by MRI

may adversely affect the operation of the pacemaker and may inhibit pacing output.

– Magnetic fields may activate magnet mode operation and

cause asynchronous pacing.

– Reported1 effects of MRI on pacing include increased

ventricular pacing beyond the rate limit.

■

Radiofrequency ablation procedure in a patient with a

SR700 Series pacemaker may cause any of the following:

K – Asynchronous pacing above or below the programmed

rate. – Reversion to an asynchronous operation. – Pacemaker electrical reset. – Premature triggering of the elective replacement indicator.

RF ablation risks may be minimized by:

1. Programming a non-rate responsive, asynchronous pacing mode prior to the RF ablation procedure.

2. Avoiding direct contact between the ablation catheter and the implanted lead or pacemaker.

3. Positioning the ground plate so that the current pathway does not pass through or near the pacemaker system, i.e., place the ground plate under the patient's buttocks or legs.

4. Having a Medtronic programmer available for temporary pacing.

5. Having defibrillation equipment available.

Holmes, Hayes, Gray, et al. The effects of magnetic resonance imaging on implantable pulse generators. PA C E. 1986; 9 (3): 360-370.

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Warnings and Precautions

Home and Occupational Environments

■

High voltage power transmission lines may generate enough EMI to interfere with pacemaker operation if approached too closely.

■

Communication equipment such as microwave transmitters, linear power amplifiers, or high-power amateur transmitters may generate enough EMI to interfere with pacemaker operation if approached too closely.

■

Commercial electrical equipment such as arc welders, induction furnaces, or resistance welders may generate enough EMI to interfere with pacemaker operation if approached too closely.

■

Home appliances which are in good working order and properly grounded do not usually produce enough EMI to interfere with pacemaker operation. There are reports of pacemaker disturbances caused by electric hand tools or electric razors used directly over the pacemaker implant site.

■

Electronic article surveillance (EAS) equipment such as retail theft prevention systems may interact with pacemakers. Patients should be advised to walk directly through and not to remain near an EAS system longer than is necessary.

Cellular Phones

SR700 Series pacemakers have been tested to the frequency

K ranges used by the cellular phones included in Table 1. Based on this testing, these pacemakers should not be affected by the normal operation of such cellular phones.

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Warnings and Precautions

These pacemakers contain a filter that allows usage, without interaction, of all cellular phones having one of the transmission technologies listed in Table 1. These transmission technologies represent most of the cellular phones in use worldwide. Patients can contact their local cellular phone service provider to confirm that the provider uses one of these technologies.

Table 1. Cellular Phone Transmission Technologies

Transmission Technology Frequency Range

Analog

FM (Frequency Modulation) 824 - 849 MHz

Digital TDMA

North American Standards

TDMA - 11 Hz 806 - 821 MHz

NADC

PCS

International Standards

GSM

DCS

(TDMA - 50 Hz)

1900

1800

824 - 849 MHz

1850 - 1910 MHz

880 - 915 MHz

1710 - 1785 MHz

Digital CDMA

CDMA - DS

Time Division Multiple Access

North American Digital Cellular

Personal Communication System

Global System for Mobile Communications

Digital Cellular System

Code Division Multiple Access - Direct Sequence

824 - 849 MHz

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Co-implantation with an Implantable Defibrillator

■

An implantable defibrillator may be implanted concomitantly with a bipolar pacemaker.

– The use of unipolar-only Model KSR706 and the KSR700

Series bipolar models implanted with unipolar leads is contraindicated for patients having an implantable defibrillator.

– Follow implant protocol and precautions for pacemaker

and defibrillator lead placement. Ensure the pacemaker is configured to be compatible with the defibrillator.

Programming Considerations

Note the following programming considerations for patients who have an implantable defibrillator.

■

Only bipolar pacing should be used with these patients. In some cases, pacing in the unipolar configuration may cause the defibrillator either to deliver inappropriate therapy or to withhold appropriate therapy.

■

Polarity is automatically configured during Implant Detection (see “Automatic Polarity Configuration” on page 3-14 of the Product Information Manual). If lead integrity is suspect, confirmation of the automatically programmed polarities should be made after completion of Implant Detection in order to assure that bipolar polarities have been programmed appropriately.

■

The implantable cardiac defibrillator (ICD) should be turned off during pacemaker implantation procedures until lead polarities have been configured and confirmed. This is to prevent possible back-up unipolar paces from triggering the ICD.

■

Lead Monitor should not be programmed to Adaptive. When a prevalence of out-of-range lead impedance paces is detected,

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Co-implantation with an Implantable Defibrillator

the monitor automatically reprograms the selected lead(s) to unipolar polarity. Pacing in the unipolar configuration may cause the defibrillator either to provoke inappropriate therapy or to withhold appropriate therapy.

■

Transtelephonic Monitor should be programmed to Off. If it is programmed On, the pacing polarity is temporarily set to unipolar when the magnet is applied. Pacing in the unipolar configuration may cause the defibrillator either to provoke inappropriate therapy or to withhold appropriate therapy.

■

Although these pacemakers are designed to be compatible with implantable defibrillators, the potential does exist for a defibrillation pulse to reset them.

– If a partial electrical reset occurs, these pacemakers

implanted with bipolar leads will retain atrial and ventricular bipolar pacing polarities.

– If a full electrical reset occurs, these pacemakers

implanted with bipolar leads will reset to Implant Detection. If lead integrity is suspect, confirmation of bipolar polarity should be made after completion of Implant Detection.

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Adverse Events

The Medtronic Kappa 700 Series devices were evaluated in a multicenter prospective study (43 investigational centers, 15 centers in the US) of the adaptive features and rate response of the device. Clinical study of the Medtronic Kappa 700 Series of pacemakers included 288 devices implanted in 285 patients worldwide.

Note: Clinical studies were not performed on the single chamber

SR700 Series models due to similarity in design and function to the

DR700 Series models. The clinical data collected for the KDR700

K Series models therefore supports the safety and efficacy claims for

SR700 Series models and is included here for reference

the K purposes.

There were a total of six deaths in the study; all were reviewed and judged to be non-device related by a clinical events committee comprising clinical investigators and Medtronic clinical evaluation managers. Two were attributed to ventricular arrhythmia, one to respiratory failure, the fourth to respiratory insufficiency due to chronic obstructive pulmonary disease, the fifth to a mesotelioma, and the sixth to multi-system organ failure.

Eight devices were explanted: three due to pocket infection, one due to infection of the electrode, one from lead/connector mismatch, one patient had a psychosomatic disorder, one patient required the implant of a dual chamber ICD, and one patient continued with vasovagal symptoms and the therapy did not provide sufficient benefit.

Observed Adverse Events

A total of 355 adverse events were reported. The device-related events (182 events) are listed in descending order of frequency in Ta bl e 2 .

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Adverse Events

Tab le 2. Adverse Events Reported in Four or More Patients- Complicationsa

(Comps) and Observations

(Obs)

All patients implanted (n=288 devices in 285 patients, 133 device years)

% of

Patients

with Comps (n=285)

Comps

per

Device-

Year

(n=133)

% of

Patients

with Obs

(n=285)

Obs per

Device-

Year

(n=133)

Event Total

Number

Events

(Patients)

Any adverse

355 (168) 17.2% 0.45 52% 2.22

events

Any device-related

182 (118) 10.9% 0.31 34% 1.06

events

Pain at pocket site 32 (31) — — 10.9% 0.24

Other 23 (21) 1.1% 0.02 6.3% 0.15

Inappropriate

11 (11) — — 3.9% 0.08

programming

Atrial lead

11 (10) 3.6% 0.08 — —

dislodgment

Programmer/ software anomaly

11 (8) — — 2.8% 0.08

Pocket infection 7 (6) 0.7% 0.02 1.4% 0.03

Intermittent

6 (6) 0.7% 0.02 1.4% 0.03

undersensing

Palpitations 6 (6) — — 2.1% 0.05

Pocket hematoma 6 (6) 0.4% 0.01 1.8% 0.04

Ventricular lead

6 (6) 2.1% 0.05 — —

dislodgment

Elevated pacing

4 (4) 0.7% 0.02 0.7% 0.02

thresholds

Syncope 4 (4) — — 1.4% 0.03

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Adverse Events

Complications included those adverse events which required invasive measures to correct (e.g., surgical intervention), and were related to the presence of the pacing system or procedure.

Observations included those adverse events which did not require invasive measures to resolve, and were related to the presence of the pacing system or procedure.

Where present, a number in parentheses indicates the number of patients with the event.

Programmer software anomalies observed: screen lock-ups while saving data to diskette (8); problems printing reports outside of a patient session (2); and an incorrect parameter setting on a printout (1), which occurred in an earlier version of the software—software changes were made to eliminate reoccurrence.

The following other adverse events were reported, but occurred in three or fewer patients: angina pectoris; atrial flutter (paroxysmal)/ atrial fibrillation; bipolar short circuit pathway; chest pain; chest pain (non-specific); dizziness; dyspnea/shortness of breath; exit block; failure to capture/loss of capture; false negative capture detection; far field R-wave sensing; fatigue/tiredness; hypotension; inadequate lead/pacemaker connection; infection of electrode; lead/connector mismatch; lead insertion route problem; lead insulation failure; migration of pulse generator; myopotential interference; other oversensing; pacemaker mediated tachycardia; pacemaker syndrome; pectoral muscle stimulation; penetration of myocardium by lead; phrenic nerve/diaphragm muscle stimulation; pneumothorax; swelling pocket site; tachycardia (atrial); thrombus formation at lead; ventricular ectopy; ventricular tachycardia (non-sustained); ventricular tachycardia (sustained).

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Adverse Events

The following adverse events were deemed not device related (173 events were reported): angina pectoris; atrial fibrillation; atrial flutter (paroxysmal); atrial flutter (persistent); atrial tachycardia; chest pain; chest pain (non-specific); congestive heart failure; dizziness; dyspnea/shortness of breath; fatigue/tiredness; hypertension; hypotension; insufficient cardiac output; myocardial infarction (acute); palpitations; syncope; ventricular ectopy; ventricular fibrillation; ventricular tachycardia (non-sustained); ventricular tachycardia (sustained).

Potential Adverse Events

Adverse events (in alphabetical order), including those reported in Table 2, associated with pacing systems include:

■

Cardiac perforation

■

Cardiac tamponade

■

Death

■

Erosion through the skin

■

Hematoma/seroma

■

Infection

■

Myopotential sensing

■

Nerve and muscle stimulation

■

Rejection phenomena (local tissue reaction, fibrotic tissue formation, pulse generator migration)

■

Threshold elevation

■

Transvenous lead-related thrombosis

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Clinical Studies

The Medtronic Kappa 700 Series devices were evaluated in a multicenter prospective study (43 investigational centers, 15 centers in the US) of the adaptive features and rate response of the device.

Note: Clinical studies were not performed on the single chamber

SR700 Series models due to similarity in design and function to the

K KDR700 Series models. The clinical data collected for the KDR700 Series models therefore supports the safety and efficacy claims for

SR700 Series models and is included here for reference

the K purposes.

Methods

This study compared the following features of the Medtronic Kappa 700 Series pacemakers to historical controls:

■

Rate Response

■

Capture Management

■

Automatic Polarity Configuration

■

Sensing Assurance

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Clinical Studies

Patient data were collected at implant, pre-discharge, two weeks, one month, two and/or three months, and six months post implant. Patients were evaluated utilizing a modified version of the Minnesota Pacemaker Response Exercise Protocol (MPREP

) at their one month visit. Evaluation of rate response performance for the Medtronic Kappa 700 Series pacemaker was conducted using the Metabolic Chronotropic model described by Wilkoff as applied by

. Automatic polarity configuration data were collected at implant.

Kay Sensing Assurance and Capture Management data were collected at each follow-up.

Description of Patients

Patients enrolled in the study represented a general dual chamber pacing population.

Results of the Study

Table 3 summarizes the results of the clinical study. The incidence of complications was found to be similar to that experienced by similar devices. The performance of the automatic polarity configuration, Capture Management, Sensing Assurance, and rate response features were found to meet study objectives.

The slope of the exercise rate response (1.0 target slope) was less than 0.65 for 26 of 87 (30%) of patients.

Benditt, David G. M, Editor, Rate Adaptive Pacing, Blackwell Scientific Publications, Boston. 1993: 63-65.

Kay, Neal G., “Quantitation of Chronotropic Response: Comparison of Methods for Rate-Modulating Permanent Pacemakers”, JACC 20(7):1533-41, Dec 1992.

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Clinical Studies

All patients implanted (n=288 devices in 285 patients, 133 device years)

Primary Objectives

Automatic Polarity Configuration (n with loss of output / N leads)

Total Leads 0% (0/546) [0%, 0.55%] ≤5%

Unipolar 0% (0/107) [0%, 2.8%] ≤5%

Bipolar 0% (0/439) [0%, 0.7%] ≤5%

Sensing Assurance

(n with loss of sensing or oversensing / N device years)

Atrial 13.5% (18/133) [8.8%, 20.5%] ≤35.7%

Ventricular 0.8% (1/133) [0.2%, 4.1%] ≤9.2%

Capture Management (n with all causes loss of capture / N device years)

Loss of capture 5.3% (7/133) [2.6%, 10.5%] ≤10.7%

Slope of MPREP rate response at 1 month (n=87 patients)

Mean 0.81 [0.76, 0.86] [0.65, 1.35]

Table 3. Effectiveness Analysis

Percent of

events

% (n/N)

95%

Confidence

interval

Criteria:

Upper

95% CI

The Medtronic Kappa 700 Series pacemaker’s Rate Profile Optimization (RPO) governs sensor indicated rate (SIR) output. Figure 1 shows the SIR vs. the Wilkoff predicted heart rate achieved using the RPO feature during the MPREP tests at 1 month.

Page 28

Clinical Studies

All patients reaching Anaerobic Threshold, N=87

Expected (Wilkoff) rate, mean and 95% CI

100

SIR (normalized)

0 204060

Lower 95% CI

)

(

MPREP Workload (normalized)

Figure 1. Sensor Indicated Rate (SIR) vs. Expected Rate at One Month

)

(

100

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Chapter 2 - Implanting the Pacemaker

Implantation Procedures 30

Implant Documentation 40

Parameter Programming at Implant 41

Medical Therapy Interactions 45

Assistance 48

Page 30

Implantation Procedures

Testing Leads and Pacemaker

Equipment to Test the Pacemaker and Lead

To test the performance of the lead, Medtronic recommends using a constant voltage device such as the Medtronic Model 5311B (or equivalent) Pacing System Analyzer (PSA).

Caution: Do not use constant current devices (such as the Medtronic external pacemaker Models 5880A, 5375, 5348, or 5346) to test lead performance. They may damage the pacemaker’s constant voltage output circuits.

For further procedures on determining thresholds and analyzing pacemaker operation, consult the PSA technical manual.

Note: Wait at least 15 minutes after implanting screw-in leads (nonsteroid) before measuring final stimulation thresholds and intracardiac sensing potentials.

Determining Stimulation Threshold

While testing the lead system prior to implant, Medtronic recommends taking and verifying threshold measurements in both the unipolar and bipolar polarities for all of the pacemaker models. Stimulation thresholds less than 1.0 V at a 0.5 ms pulse width are recommended for acute ventricular leads. Atrial leads may have slightly higher stimulation thresholds.

Test for the following configurations:

■

Lead tip to case (for unipolar pacing and sensing).

■

Lead tip to lead ring (for bipolar pacing and sensing).

If the stimulation threshold of a mature chronic lead exceeds 2.5 V at a pulse width of 0.5 ms, consider replacing the lead.

Note: Low-profile 3.2 mm bipolar and IS-1 BI leads can be connected to the pacemaker in only one way, i.e., distal (tip)

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Implantation Procedures

electrode to the negative terminal. Because of this, the negative clip of the PSA connecting cable must be connected to the lead connector pin for correct threshold measurement. (See PSA technical manual for more information.)

Determining Lead Impedance

Acute lead impedance or pacing impedance for standard leads should typically fall between 250 and 1000 ohms, although it may fall outside this range for short periods of time.

Acute lead impedance for leads designed with impedance at or greater than 1000 ohms should typically fall between 500 and 2500 ohms. High impedances with these leads are acceptable as long as stimulation and sensing thresholds are acceptable.

If the lead or pacing impedance remains outside of the recommended range, reposition or replace the lead.

Determining Intracardiac Sensing Potentials

The intracardiac signal must be of sufficient strength to be sensed by the pacemaker. Intracardiac signals on chronic leads have a lesser magnitude and slew rate.

Note: Acceptable stimulation thresholds are not an indication of adequate sensing potentials.

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Implantation Procedures

Analyzing Pacemaker Operation

Before connecting the leads, check the pacemaker for proper operation with a Medtronic Model 5311B (or equivalent) Pacing System Analyzer (PSA). Note that specifications for device operation apply at body temperature. As a result, some variance may occur if measurements are taken at room temperature.

During this test, the setscrew(s) in the connector assembly must contact the PSA’s cable probes. Use the appropriate cable probes to match the connector ports for K

SR700 Series models.

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Implantation Procedures

Connecting Leads to the Pacemaker

The Model KSR701 connector assembly accepts IS-1 BI leads. The Model K IS-1 BI leads. The Model K or IS-1 leads with the appropriate sizing sleeves.

K aligned behind one another. (See Figure 2.)

SR703 accepts either low-profile 3.2 mm bipolar leads or

SR706 accepts 5 or 6 mm unipolar leads

SR700 Series pacemakers have a tip and ring connector contact

Tip Electrode

Ring Electrode

Figure 2. Example of Bipolar Connector Assembly for

Model K

SR701

Model KSR701 uses a setscrew to contact the lead tip electrode, but does not use a setscrew to contact the ring electrode. Model K

SR703

contacts the lead with setscrews at the tip and ring electrodes.

Page 34

Implantation Procedures

Connection Procedure

Lead connection consists of three steps:

1. Insert the provided torque wrench into the bisected grommet as shown in Figure 3.

a. Check that the setscrew is retracted from the connector

port by visual inspection of the opening. If a setscrew is obstructing the pathway, rotate the setscrew counterclockwise one or two revolutions until the opening is no longer obstructed.

Note: Counterclockwise rotation beyond this point may

disengage the setscrew from the connector block.

b. Eliminate the “piston effect” (difficulty in inserting the lead

due to compression of trapped air in the connector port) when the lead is inserted by leaving the torque wrench in the distal grommet until the lead is secure. This allows a pathway for venting trapped air when the lead is inserted. The rubber connector seal maintains the torque wrench in position.

Page 35

Implantation Procedures

Figure 3. Connector Port Setscrew Preparation

2. Push the lead into the connector port until the lead pin is clearly visible in the pin viewing area as indicated by arrows in Figure 4 and described in the table below.

Note: Lubricating the lead end with sterile water may ease lead insertion.

Lead-Pin Tip Placement In Pin Viewing Area

SR701 IS-1 BI Visible at end of area

Model K

SR703 IS-1 BI Just becomes visible

Low-profile

3.2 mm bipolar

Model K

SR706 5 or 6 mm unipolar Visible at end of area

Visible at end of area

Page 36

Implantation Procedures

KSR701

SR706

SR703

(IS-1 BI leads)

Figure 4. Lead Insertion Viewing Area

(with 3.2 mm bipolar leads)

SR703

3. Tighten the setscrew by turning clockwise until the torque wrench clicks as indicated in Figure 5. The setscrew(s) must

be engaged for pacing to begin. Do not pull on the lead until all setscrews have been tightened.

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Implantation Procedures

KSR706 KSR703

SR701

Figure 5. Tightening Setscrews

Caution: Do not overtighten the setscrew(s). Do not use blue handled or right angled hex wrenches, since they have torque capabilities greater than is designed for this connector. The torque wrench supplied with the pacemaker is designed to slip when overtorqued to prevent damage to the socket or the setscrews. Bending the wrench may break it.

Pacemaker Implantation

Proper placement can help facilitate lead wrap and prevent muscle stimulation and device migration.

Pacemaker Orientation

The pacemaker may be used in either right or left pectoral implants. Either side of the shield can face the skin to facilitate excess lead wrap. However, pacemakers with an insulative coating must be implanted with the uncoated side facing the patient’s skin.

Page 38

Implantation Procedures

Avoiding Muscle Stimulation

If the patient experiences muscle stimulation while being paced in the unipolar configuration, program the device to lower output settings, such as a lesser Amplitude and/or narrower Pulse Width, without compromising the patient’s stimulation safety margin.

Securing the Pacemaker (Suture Hole)

A suture placed through the suture hole located in the connector assembly area helps secure the pacemaker in the subcutaneous pocket, thus minimizing post-implant rotation and migration of the device. Use normal surgical needles to penetrate the suture hole.

Replacing an Implanted Pacemaker

When replacing a pacemaker:

1. Program the pacemaker to a nonrate responsive mode prior to explantation if previously programmed to a rate responsive mode. This avoids any potential rate increase while handling the pacemaker.

2. Insert the proper wrench through each slit in the rubber grommet and loosen each setscrew by turning counterclockwise.

3. Gently retract the lead from the pacemaker connector.

4. If the lead pin shows signs of pitting or corrosion, the entire

lead should be discarded and replaced with a new lead to assure the integrity of the pacing system.

5. Measure stimulation thresholds and sensing potentials.

6. Pacemaker-dependent patients will be without pacing support when the lead is disconnected. Therefore, have a temporary external pacing instrument available for use.

Page 39

Implantation Procedures

Caution: Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may cause asynchronous or inhibited pacemaker operation. Refer to “Electrosurgical Cautery” on page 47 for information on electrocautery use.

When replacing a Medtronic pacemaker or a pacemaker from another manufacturer, the physician may require a lead adaptor kit to connect the pacemaker to the chronic lead. Use the appropriate hex wrench or screwdriver to disconnect the chronic lead. Medtronic provides such wrenches in adaptor kits for use with pacemakers manufactured by Biotronik, Coratomic, CPI, Intermedics, Pacesetter, Telectronics/Cordis, and Vitatron. See the Medtronic publication Pacemaker and Connector Encyclopedia under “Adaptors and Accessories” for the appropriate adaptor kits.

For questions about lead and pacemaker compatibility, consult your Medtronic representative, or call Medtronic Technical Services.

Disposal of Pacemaker

When replacing the pacemaker (due to battery depletion or explanting the pacemaker at the death of the patient who is to be cremated), return the pacemaker to Medtronic for analysis and disposal. Medtronic recommends cleaning and sterilizing the pacemakers before returning. See the back cover for mailing addresses.

Page 40

Implant Documentation

Pacemaker Registration

A registration form is included in the shipping package for each Medtronic implantable pacemaker. Upon completion of the registration form by the clinician, this form serves as a permanent record of facts related to the implanted device. A copy of this form should be returned to Medtronic, where vital information will be transferred to a wallet-size, plastic-coated pacemaker Identification Card which will be mailed directly to the patient. A temporary identification card is included in the shipping package for use by the patient until the permanent card arrives. Refer to the back cover for mailing addresses.

Establishing a Patient Record

At the time of implant the clinician should establish a record of the patient’s pacemaker programmed parameter settings for later reference. A patient record can give the clinician an accurate account of the patient’s medical history at subsequent follow-ups when evaluating the pacemaker’s performance. The registration form should not serve this purpose since the form is intended for registering the patient and pacemaker with Medtronic.

Page 41

Parameter Programming at Implant

Shipping Parameters

The pacemaker is configured to a set of shipping parameters at the time of manufacture. At implant the device operates at these settings unless reprogrammed prior to implant. Refer to“Shipping and Nominal Parameter Settings” on page 81 for specific shipping parameter settings.

In the event that the pacemaker is not configured to shipping settings at implant, the device may have changed to partial or full electrical reset settings due to extreme temperatures or intense electromagnetic interference.

Caution: If, at implant, a programmer interrogation indicates the pacemaker has been reset to VVI, 65 ppm full electrical reset settings, use the programmer to reset the device and reprogram the previous mode and pacing operations. If, after a reset, a message appears on the programmer screen/printout indicating the Date/Time memory has been altered, contact your Medtronic representative for further information.

Implant Detection

Implant Detection is a 30-minute period, beginning at lead insertion, during which the pacemaker verifies that a lead has been connected by measuring lead impedance. After 30 minutes of continuous lead connection, the pacemaker completes Implant Detection and activates the pacemaker’s automatic features mentioned in “Automatic Operation” on page 41.

Automatic Operation

At the completion of Implant Detection, these features are automatically enabled or begin adaptation from their shipping settings.

Page 42

Parameter Programming at Implant

■

Operating polarities, which are determined during Implant Detection, are confirmed at its completion.

■

Mode becomes VVIR (though shipped in the VVIR mode, the device effectively operates in the VVI mode until Implant Detection is completed).

■

Rate Profile Optimization is enabled.

■

Capture Management is enabled, and Ventricular Amplitude and Pulse Width become adaptive.

■

Sensing Assurance is enabled, and Sensitivity becomes adaptive.

■

Diagnostics are enabled.

If the physician manually programs Implant Detection to Off/ Complete during the 30-minute detect time, the automatic operation of the above features will be activated at that time. If a programming session is initiated at any time during Implant Detection, the pacemaker will reset Implant Detection.

Manual Programming

If pacing rates, pacing outputs, and sensitivities are manually programmed at implant, the physician should be aware of the following programming considerations:

Pacing Rates

Program the Lower Rate to a setting that permits the patient to sleep comfortably or program the Sleep Function On. Program the ADL Rate to provide adequate cardiac output during typical patient activity. Program the Upper Sensor Rate to provide cardiac output that meets the patient’s metabolic demand during exercise without provoking symptoms (e.g., angina, palpitations, etc.).

Note: For patients with stable angina, program the Upper Sensor Rate to a value below the rate at which angina occurs.

Page 43

Parameter Programming at Implant

Pacing Outputs

Strive for acute ventricular stimulation thresholds of 1.0 V amplitudes at 0.5 ms pulse widths. Atrial stimulation thresholds may be slightly higher. Do not use a chronic atrial or ventricular lead if the stimulation threshold exceeds 2.5 V amplitude at 0.5 ms pulse width.

The clinician should consider programming the pacemaker’s atrial or ventricular output to allow a 2:1 voltage safety margin above the measured stimulation threshold values. Capture Management can also be programmed to provide ongoing ventricular capture monitoring and adjustment. (Programming to an atrial mode disables Capture Management.)

Sensitivity

Intracardiac signal amplitudes and slew rates decrease during the lead maturation process. The clinician should consider 2:1 or 3:1 atrial or ventricular sensitivity safety margins when selecting sensitivity settings, especially with acute leads. After establishing the intracardiac sensing thresholds, the clinician may wish to program atrial or ventricular sensitivity to a more sensitive setting (i.e., a lower numerical setting than the measured sensing threshold). Weigh this lower setting against the possibility of oversensing noise and electromagnetic interference, especially with unipolar sensing.

Note: Adequate intracardiac signals should be present in both the unipolar and bipolar polarities when using bipolar leads. Measure sensing potentials in the unipolar polarity (lead tip to case) and bipolar polarity (lead tip to lead ring) prior to connecting the leads.

Self-Inhibition

Self-inhibition results from the sensing of the pacing output pulse. This is more likely to occur with high amplitudes, wide pulse widths, and low sensitivity settings. Reprogramming the Sensitivity to a less sensitive setting (higher numeric value) will usually resolve the situation.

Page 44

Parameter Programming at Implant

In addition, inhibition can occur when far-field R-waves are sensed in AAIR and AAI modes. This can be prevented by proper programming of the Atrial Refractory Period and Atrial Blanking.

Muscle Stimulation with Unipolar Pacing

Under certain circumstances (e.g., high output settings, etc.), pacemaker-induced muscle stimulation may occur at the pocket site with the pacemaker programmed to ventricular unipolar pacing. Pacemaker-induced muscle stimulation may be effectively controlled and/or eliminated by programming Pulse Width to a narrower setting or programming a lower Amplitude.

Adapting Other Parameters

In addition to programming those parameters discussed above, the physician should consider adjusting other nominal parameters based on the patient’s history, medical condition, lifestyle, and hemodynamic potential and need.

■

Rate response parameters: Rate Profile Optimization (ADL Response and Exertion Response), Activity Threshold, Activity Acceleration, and Activity Deceleration.

■

Refractory and blanking periods: Ventricular Refractory Period, Atrial Refractory Period, and Atrial Blanking.

In addition, the physician should consider programming Sleep Function and Single Chamber Hysteresis for other pacing operations during inactivity.

Page 45

Medical Therapy Interactions

This section provides details on possible interactions between pacemaker therapy and other medical therapies.

Implantable Defibrillators

Some pacemaker patients may also require therapy from an implantable defibrillator. Only bipolar pacing should be used with these patients. In some cases, pacing in the unipolar configuration may cause the defibrillator either to deliver inappropriate therapy or to withhold appropriate therapy.

Regarding use of K implantable defibrillator, note the following:

■

The unipolar-only Model KSR706 and the bipolar Models

SR701, KSR703 implanted with a unipolar lead should not be

K used in patients having an implantable defibrillator.

■

The Models KSR701, KSR703 implanted with a bipolar lead may be used in patients having an implantable defibrillator. With these pacemakers, however, polarity is automatically configured during Implant Detection. (See “Automatic Polarity Configuration” on page 54.) If lead integrity is suspect, confirmation of the automatically programmed polarity should be made after completion of Implant Detection in order to assure that bipolar polarity has been programmed appropriately.

■

Although these pacemakers are designed to be compatible with implantable defibrillators, the potential does exist for a defibrillation pulse to reset them.

SR700 Series models in patients having an

Page 46

Medical Therapy Interactions

– If a partial electrical reset occurs, these pacemakers

implanted with a bipolar lead will retain atrial or ventricular bipolar pacing polarity.

– If a full electrical reset occurs, these pacemakers

implanted with a bipolar lead will reset to Implant Detection. If lead integrity is suspect, confirmation of bipolar polarity should be made after completion of Implant Detection.

■

Follow implant protocol and precautions for pacemaker and defibrillator lead placement. Ensure the pacemaker is configured to be compatible with the defibrillator.

Warnings :

■

Lead Monitor should not be programmed to Adaptive. When a prevalence of out-of-range lead impedance paces is detected, the monitor automatically reprograms the selected lead(s) to unipolar polarity. Pacing in the unipolar configuration may cause the defibrillator either to provoke inappropriate therapy or to withhold appropriate therapy.

■

Programming Transtelephonic Monitor On is contraindicated for patients with implantable defibrillators. When it is programmed On, the pacing polarity is temporarily set to unipolar when the magnet is applied. Pacing in the unipolar configuration may either cause the defibrillator to provoke inappropriate therapy or to withhold appropriate therapy.

Page 47

Medical Therapy Interactions

Electrosurgical Cautery

Electrocautery may cause permanent loss of output prior to explanting the pacemaker and can induce ventricular fibrillation. The electrocautery tip should never be used within 6 inches (15 cm) of an implanted pacemaker/lead system.

The use of electrocautery may cause any of the following: triggered or inhibited output, a temporary pause in output, permanent loss of output, a rate in excess of the 200 ppm rate limit, reversion to asynchronous operation, an electrical reset, or premature triggering of the elective replacement indicator.

Because of these potential complications, alternatives to electrocautery should be used when available.

Effects to the pacemaker vary considerably based on the type of electrocautery unit, coagulation and cutting current settings, current pathway from the cautery tip to the indifferent plate, and the pacemaker/lead system. Electrocautery units could also interfere with ECG monitoring equipment. Monitor cardiac activity via blood pressure or pressure pulses when using electrocautery.

If electrocautery cannot be avoided, follow these steps to minimize complications:

1. Program the device to the VOO/AOO (non-rate responsive) mode beforehand and avoid direct contact with the pacemaker or leads to avoid induction of tachyarrhythmias and/or fibrillation.

2. Position the ground plate so that the current pathway does not pass through or near the pacemaker system, i.e., place ground plate under the patient’s buttocks or legs during abdominal surgery.

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

4. Use a bipolar electrocautery system, where possible.

5. Have temporary pacing and defibrillation equipment available.

Page 48

Assistance

X-ray and Fluoroscopy

X-ray and fluoroscopy testing of pacemakers similar to the KSR700 Series pacemakers by exposure to diagnostic X-ray or fluoroscopic radiation has not affected those pacemakers.

Assistance

Assistance Information

Medtronic employs highly trained representatives and engineers located throughout the world to serve you and, upon request, to provide training to qualified hospital personnel in the use of Medtronic products. Medtronic also maintains a professional staff to provide technical consultation to product users. For medical consultation, Medtronic can often refer product users to outside medical consultants with appropriate expertise. For more information, contact your local Medtronic representative or call or write Medtronic at the appropriate address or telephone number listed on the back cover.

Page 49

Chapter 3 - Description

Pacing Mode Operations 50

Rate Responsive Pacing 51

Timing Operations 53

Pacing and Sensing Operations 54

Special Therapy Options 62

Page 50

Pacing Mode Operations

A brief description of programmable mode operations is given below.

Warnings :

■

Do not use rate responsive modes in those patients who cannot tolerate pacing rates above the programmed Lower Rate.

■

Do not use single chamber atrial modes in patients with impaired AV nodal conduction because ventricular capture cannot be assured.

VVIR / AAIR Modes

The ventricle is paced at the sensor-indicated rate (VVIR) in the absence of intrinsic ventricular events. The atrium is paced at the sensor-indicated rate (AAIR) in the absence of intrinsic atrial events.

VVI / AAI, VVT / AAT Modes

The ventricle is paced at the programmed Lower Rate (VVI) in the absence of intrinsic ventricular events. The atrium is paced at the programmed Lower Rate (AAI) in the absence of intrinsic atrial events.

Sensed ventricular events in the VVT mode trigger pacing pulses. Sensed atrial events in the AAT mode trigger pacing pulses.

Note: Programmed triggered pacing will not occur faster than 300 ms (200 ppm) from the previous paced event. Temporary programmed triggered pacing is not limited to 300 ms (200 ppm).

Page 51

Rate Responsive Pacing

VOO / VOOR, AOO / AOOR Asynchronous Modes

The VOOR mode paces the ventricle at the sensor-indicated rate, whereas the VOO mode paces at the programmed Lower Rate. The AOOR mode paces the atrium at the sensor-indicated rate, whereas the AOO mode paces at the programmed Lower Rate.

OVO / OAO Diagnostic Modes

The OVO mode senses only intrinsic ventricular events, whereas the OAO mode senses only intrinsic atrial events.

Warning: These modes should never be programmed for pacemaker-dependent patients. For such patients, the programmer’s “Inhibit” function may be used for brief interruption of outputs.

Rate Responsive Pacing

The KSR700 Series pacemakers use activity-based pacing, which varies the pacing rate in response to the patient’s detected physical motion. In rate responsive modes, the pacing rate varies between the Lower Rate and Upper Sensor Rate limits and is dependent on the following programmable parameters:

■

Activity Threshold establishes the minimum signal amplitude above which activity signals are detected by the activity circuit.

■

Activity Acceleration and Deceleration times determine how quickly the rate will rise and fall as a result of changes in patient physical activity. Deceleration can also extend the rate fall by providing up to 20 minutes of rate deceleration based on the intensity and duration of exercise.

Rate response is initialized and VVIR pacing becomes effective upon completion of Implant Detection.

Page 52

Rate Responsive Pacing

Rate Profile Optimization

Rate Profile Optimization controls how rapidly and to what level the sensor-indicated rate increases and decreases within submaximal and maximal rate ranges:

■

Submaximal rates are moderate pacing rates achieved during typical daily patient activities. These rates are at or near the ADL (Activities of Daily Living) Rate.

■

Maximal rates are rates at or near the Upper Sensor Rate achieved during vigorous activities.

Rate response for rates below the submaximal rate range (i.e., at or near the Lower Rate) are also controlled by Optimization.

Rate response function is optimized in the submaximal and maximal rate ranges by a daily comparison of data in two rate profiles:

■

Sensor rate profile is an actual rate distribution of the patient’s averaged sensor-indicated rates.

■

Target Rate Profile is a programmable rate distribution of the patient’s desired rates. The ADL Response and Exertion Response parameters define the time spent pacing in the submaximal and maximal ranges, respectively.

Once each day, the pacemaker evaluates the percent of time spent pacing in both the submaximal and maximal rate ranges by comparing the sensor rate profile against the target rate profile. From this comparison, the pacemaker automatically adjusts rate response in both rate ranges.

Page 53

Timing Operations

Rates

The KSR700 Series pacemakers have three rates that determine the patient's pacing rate.

■

The programmable Lower Rate is the minimum pacing rate for a given mode.

■

ADL Rate (Activities of Daily Living Rate) is the average target rate that the patient’s heart rate is expected to reach during moderate exercise.

■

Upper Sensor Rate provides the upper limit for the sensordriven rate during physical activity, particularly during vigorous exercise.

Refractory and Blanking Periods

The pacemaker has several refractory periods to avoid inappropriate restarting of certain timing intervals.

■

The programmable Ventricular Refractory Period (VRP) prevents sensing of T-waves or PVCs. The VRP occurs after paced, sensed, and refractory sensed ventricular events in ventricular modes.

The first portion of the VRP is a nonprogrammable Ventricular Blanking period in which ventricular sensing is disabled after paced, sensed, and refractory sensed ventricular events. The Ventricular Blanking period varies dynamically from 50 to 100 ms based on the strength and duration of the ventricular event.

Page 54

Pacing and Sensing Operations

■

The programmable Atrial Refractory Period (ARP) prevents atrial inhibition due to sensed far-field R waves or noise. The ARP occurs after paced, sensed, and refractory sensed atrial events in atrial modes.

The first portion of the ARP is a programmable Atrial Blanking period that disables atrial sensing after paced, sensed, and refractory sensed atrial events.

Pacing and Sensing Operations

Polarity

Unipolar polarity uses the lead tip as the active electrode and the pacemaker case as the common electrode. Bipolar polarity uses the lead tip as the active electrode and the lead ring as the common electrode.

With the bipolar Model K sensing polarities are automatically or manually programmable. The Model K

SR706 provides unipolar pacing and sensing only.

Automatic Polarity Configuration

With bipolar pacemakers, polarity settings are selected automatically during the pacemaker’s 30-minute Implant Detection period that begins at lead insertion. During Implant Detection, with either a bipolar or unipolar lead implanted, and with the Configure or Adaptive parameter under Lead Monitor active, the pacemaker continuously measures impedance as follows:

■

The pacemaker issues a bipolar pace and immediately checks the pace for high impedance.

– If the pace is within range, it is considered an acceptable

bipolar pace.

– If high impedance is found, the pacemaker immediately

follows the bipolar pace with a backup unipolar pace.

SR701, KSR703 pacemakers, pacing and

Page 55

Pacing and Sensing Operations

■

If a unipolar backup pace is issued, the pacemaker checks it for high impedance.

– If the pace is within range, it is considered an acceptable

unipolar pace.

– If high impedance is found, the pacemaker assumes a lead

is not attached and restarts Implant Detection.

Note: During polarity configuration, the pacemaker also checks for low impedance paces but does not follow them with unipolar backup paces. To avoid possible loss of capture due to continuous low impedance pacing, the pacemaker sets unipolar polarity when 3 of 16 paces are detected as low impedance during the first phase of configuration (described below).

Warning: If the Implant Detection feature identifies a bipolar, high-impedance path, backup unipolar pacing will be delivered. This may be inappropriate for patients with an implantable defibrillator (ICD). See “Notes” on page 3-10.

Polarity configuration for bipolar pacemakers takes place in two phases:

■

Initial Configuration Phase – Five minutes after lead connection, if a high impedance unipolar pace has not reset Implant Detection, the pacemaker issues three asynchronous paces at magnet rate and determines if they are bipolar or unipolar.

– Two of three paces must be bipolar for initial pacing and

sensing polarities to be determined bipolar for the Confirmation Phase.

– Two of three paces must be unipolar for initial pacing and

sensing polarities to be set to unipolar and remain unipolar during and after Implant Detection.

Page 56

Pacing and Sensing Operations

■

Confirmation Phase – If bipolar polarity is determined at five minutes, the remaining 25 minutes of Implant Detection is used to confirm bipolar polarity.

– The pacemaker continues to monitor each pace as

described above, providing backup unipolar paces for high impedance bipolar paces.

– The pacemaker checks for a programmed number of out-

of-range (high or low impedance) paces that indicate bipolar pacing is in jeopardy.

– The pacemaker confirms bipolar pacing and sensing

polarity at the end of 25 minutes by examining three asynchronous paces as described above for the Initial Configuration Phase.

Note: If a prevalence of out-of-range bipolar paces is detected during the Confirmation Phase, the pacemaker reconfigures pacing and sensing polarities to unipolar and the asynchronous paces are not delivered.

Warning: When implanting a Model K

SR703 pacemaker, ensure that

both the tip and ring setscrews are properly engaged and all electrical contacts are sealed in order to prevent possible electrical leakage between the tip and ring contacts. Such leakage may cause the pacemaker to falsely identify a unipolar lead as bipolar, resulting in a loss of output. For the same reason, ensure that electrical contacts are sealed when using lead extenders or adaptors with all bipolar models.

Notes:

■

During Implant Detection, the unipolar-only Model KSR706 pacemaker examines unipolar pacing impedance to determine lead connection.

■

When implanting a bipolar pacemaker in a patient with an implantable defibrillator, the physician has the option to manually program polarities to avoid the possible occurrence of unipolar backup paces during Implant Detection.

Page 57

Pacing and Sensing Operations

Manually Programming Polarity

Pacing and Sensing Polarities for the Models KSR701, KSR703 can also be manually programmed. However, the Configure selection under Lead Monitor, which controls automatic configuration, must be “turned off” by programming the Monitor Only selection instead.

When pacing and/or sensing polarity is manually programmed from unipolar to bipolar, the pacemaker verifies whether a functioning bipolar lead is connected by measuring lead impedance. If lead impedance is outside the accepted programmed impedance range for bipolar polarity (between 200 and 4000 ohms), the lead is assumed to be unipolar and pacing and/or sensing polarity remains set to unipolar.

Warning: If the clinician overrides the bipolar lead verification and programs bipolar polarity when a unipolar lead is connected to the pacemaker, no pacing output results.

Lead Monitor

The Lead Monitor feature enables the pacemaker to monitor lead integrity and adapt bipolar pacing and sensing to unipolar when bipolar lead integrity is in doubt. It also controls automatic configuration of lead polarities at implant. Lead Monitor is available in all pacing modes.

The Lead Monitor feature monitors lead integrity by looking for high and low impedance on each pace. The Atrial or Ventricular Lead Monitor can be programmed to operate as follows:

■

Configure – provides automatic polarity configuration of bipolar pacemakers (bipolar pacemakers are shipped in Configure).

Page 58

Pacing and Sensing Operations

■

Adaptive

– monitors bipolar paces and provides backup unipolar

paces when impedance is high

– switches pacing and sensing polarities from bipolar to

unipolar when a prevalence of out-of-range (high and low impedance) paces is detected

– provides automatic polarity configuration if the pacemaker

is programmed to Adaptive prior to implant

■

Monitor Only – monitors unipolar and bipolar paces to determine if they are out of range (high and low impedance). Unipolar-only Model K

SR706 is shipped in and only

programmable to Monitor Only.

When Lead Monitor is set to Adaptive or Monitor Only, and the pacemaker determines a lead is out of range, the pacemaker issues a status warning that appears on the programmer screen at the next interrogation. However, a status warning is not issued at any time during the configuration process.

After automatic polarity configuration is complete, Lead Monitor is automatically set to Monitor Only for bipolar and unipolar configurations. If, however, the Adaptive setting was programmed prior to implant, bipolar configurations are set to Adaptive, but unipolar configurations are set to Monitor Only.

Warning: Lead Monitor should not be programmed to Adaptive for patients with an implantable defibrillator. When a prevalence of outof-range lead impedance paces is detected, the monitor automatically reprograms the selected lead(s) to unipolar polarity. Pacing in the unipolar configuration may cause the defibrillator either to provoke inappropriate therapy or to withhold appropriate therapy.

Caution: If the Lead Monitor detects out-of-range lead impedance, investigate lead integrity more thoroughly.

Page 59

Pacing and Sensing Operations

Sensitivity

Sensitivity determines the minimum intracardiac signal that the pacemaker can detect when intrinsic atrial or ventricular events occur. With K or manually programmable.

Sensing Assurance, the pacemaker's automatic sensing feature, adjusts sensitivities within defined limits. At the completion of Implant Detection, the pacemaker enables Sensing Assurance and begins continual monitoring of the peak amplitude of sensed signals. In response to monitoring, it automatically increases or decreases Sensitivity to maintain an adequate sensing margin with respect to the patient's sensed P and R waves.

During provocative myopotential testing of the Medtronic Kappa 700 Series pacemakers having Sensing Assurance On, 56% (28/50) of patients experienced atrial oversensing while 7.3% (4/55) experienced ventricular oversensing. The atrial oversensing rate is comparable to that experienced by Medtronic’s Thera devices which had an atrial oversensing rate of 52.4% (75/143) during provocative testing. The ventricular oversensing rate of Medtronic Kappa 700 Series pacemakers compared favorably to the ventricular oversensing rate experienced by Medtronic Thera pacemakers –

44.1% (63/143).

For guidelines regarding manually programming Sensitivity settings, refer to “Parameter Programming at Implant” on page 41.

Atrial or Ventricular Sensitivity can also be programmed on a temporary basis.

Note: Atrial Sensitivity with unipolar sensing polarity is restricted to

0.5 mV to limit oversensing of muscle noise or electromagnetic interference.

SR700 Series pacemakers, sensitivity is automatically

Page 60

Pacing and Sensing Operations

Pacing Output

Amplitude and Pulse Width determine the pacing pulse strength necessary to capture the atrium or ventricle. Amplitude and Pulse Width are both manually programmable for the atrial and ventricular channels or automatically programmable for the ventricular channel through the Capture Management feature. Amplitude and Pulse Width can also be programmed on a temporary basis. Refer to “Parameter Programming at Implant” on page 41 for pacing output guidelines.

Capture Management

The Capture Management feature provides automatic monitoring of ventricular pacing thresholds and automatic adjustment of Amplitude and Pulse Width to maintain capture.

When Capture Management is programmed to Monitor Only, the pacemaker periodically causes paces to be delivered (affecting pacemaker timing temporarily if necessary). The pacemaker then monitors the paces by changing first amplitude and then pulse width to find two points that lie on the strength duration curve that define the boundary between settings that capture and those that do not. How often the pacemaker performs this pacing threshold search is determined by the programmable Capture Test Frequency parameter. This parameter determines how often the pacing threshold search will be initiated and provides for retry if the test is delayed.

Page 61

Pacing and Sensing Operations

When Capture Management is programmed to Adaptive, the pacemaker responds to monitoring by adapting ventricular amplitude and pulse width using the following programmable parameters:

■

Amplitude Margin and Pulse Width Margin – the pacemaker- determined threshold multiplied by the selected safety factor.

■

Minimum Adapted Amplitude and Minimum Adapted Pulse Width – the lower limit to which Amplitude and Pulse

Width can be set by the pacemaker during adaptation.

■

Acute Phase Days Remaining – time in days during which the pacemaker will not decrease output settings below the initially programmed settings. This parameter is used during the lead maturation period.

Capture Management becomes operational automatically when Implant Detection is completed.

Warning: Capture Management will not program ventricular outputs above 5.0 V or 1.0 ms. If the patient needs a pacing output higher than 5.0 V or 1.0 ms, program Amplitude and Pulse Width manually.

Note: In the event of partial or complete lead dislodgment, Capture Management may not prevent loss of capture.

Page 62

Special Therapy Options

Sleep Function

Sleep Function is a programmable On or Off feature that reduces the paced rhythm during sleep. It replaces the programmed Lower Rate with a slower Sleep Rate during a programmable sleep period. At the programmed Bed Time, the pacemaker gradually lowers the operating lower rate from the programmed Lower Rate to the programmed Sleep Rate over a 30 minute period. The Sleep Rate becomes the operating lower rate until the programmed Wake Time occurs, when the pacemaker gradually raises the operating lower rate from the Sleep Rate to the Lower Rate over a 30 minute period.

Note: For rate responsive modes, the Sleep Rate becomes the minimum rate during the sleep period. However, in the presence of sensor-detected activity, the sensor-indicated rate overrides the Sleep Rate.

Single Chamber Hysteresis

Single Chamber Hysteresis allows tracking of an appropriate intrinsic rhythm below the Lower Rate during extended periods of inactivity such as sleep. When a nonrefractory sensed event occurs, sensed events that follow are allowed to occur below the programmed Lower Rate to the programmed Hysteresis Rate. As long as the intrinsic rate is above the Hysteresis Rate, pacing is inhibited. When the intrinsic rate drops to the Hysteresis Rate, escape pacing results and the programmed Lower Rate returns as the operating lower rate until the next nonrefractory sensed event occurs.

Page 63

Chapter 4 - Pacemaker Follow-up

Pacemaker Telemetry 64

Other Operations 67

Diagnostics 70

General Recommendations 72

Page 64

Pacemaker Telemetr y

Pacemaker Telemetry

Pacemaker telemetry is established by placing the programming head over the implant site and moving the head along the axis shown in Figure 6 until the head lights indicate telemetry is possible. Pacemaker telemetry can be used for routine monitoring. A brief description of the types of telemetry is given below.

Axis

Figure 6. Positioning the Programming Head

Parameter Summary

Upon interrogation by the programmer, the pacemaker telemeters the programmed parameter settings along with battery status and device identification.

Note: The parameters may change due to a full or partial electrical reset, elective replacement indication, Rate Profile Optimization, automatic Sensitivity, Capture Management, or Lead Monitor operation. See the appropriate topic for more information.

Page 65

Pacemaker Telemetry

Battery and Lead Information

The pacemaker provides Battery and Lead Information for both measured and calculated values of the pacing output pulse, the lead, and the battery. The pacemaker’s Battery and Lead Information is accessed via the programmer.

Telemetry Markers (Extended Markers)

Telemetry markers depict cardiac events that are useful in evaluating pacemaker operations.

■

Standard Markers (Marker Channel Telemetry) annotate pacemaker paced, sensed, and refractory sensed events in any mode.

■

Therapy Trace Markers provide depictions of therapy interventions that alter timing intervals.

Electrogram (EGM)

The Electrogram (EGM) is a real-time intracardiac waveform detected by the atrial or ventricular lead. The waveform is accompanied by standard Marker Channel telemetry annotation.

Warning: An EGM of the patient’s intrinsic activity should be obtained with care since the patient is without pacing support when using the programmer’s inhibit function.

Notes:

■

The simulated pacing pulses on the EGM should not be interpreted as representing the actual timing or amplitude of paced events. Use an ECG to determine such events.

■

Intracardiac amplitudes measured on the EGM should not be used to assess the adequacy of the programmed Sensitivity setting. Use the sensing test instead.

Page 66

Pacemaker Telemetr y

Transtelephonic Monitor

The Transtelephonic Monitor is a programmable On or Off feature intended for use with remote pacemaker monitoring services. When the Transtelephonic Monitor is programmed On, the Threshold Margin Test is delayed for five seconds upon magnet application to enhance communication with transtelephonic equipment. If the pacing polarity is programmed to bipolar, it is temporarily set to unipolar to provide improved ECG artifact detection for the remote monitoring equipment. (The programmed polarity is restored when the magnet is removed.) When Transtelephonic Monitor is programmed Off, the Threshold Margin Test is not delayed upon magnet application, and conventional transtelephonic monitoring can occur.

Warning: Programming Transtelephonic Monitor On is contraindicated for patients with implantable defibrillators. When it is programmed On, the pacing polarity is temporarily set to unipolar when the magnet is applied. Pacing in the unipolar configuration may cause the defibrillator either to provoke inappropriate therapy or to withhold appropriate therapy.

Extended Telemetry

Extended Telemetry provides frequent patient monitoring in the programmed mode. When Extended Telemetry is programmed On, the pacemaker automatically transmits the programmed telemetry type (i.e., Electrogram, Marker Channel telemetry) when the programmer head or monitoring receiver (with or without a magnet) is positioned over the pacemaker. Extended Telemetry is automatically programmed Off after 48 hours or can be programmed Off via the programmer.

Page 67

Other Operations

Magnet Operation

Magnet operation includes an initial capture safety margin test, an automated self test, and magnet mode operation with telemetry:

■

The Threshold Margin Test (TMT) provides a check for loss of capture. It is performed at 100 ppm with pulse amplitude reduced by 20% on the third pulse.

Warning: Loss of capture during TMT may indicate that the stimulation threshold safety margin is inadequate. Perform a pacing threshold test and reprogram output to establish a 2:1 voltage safety margin, if necessary.

■

The Fully Automated Self Test (FAST) is a pattern of pacing pulses that indicates either of the following events has occurred:

– Lead Monitor has detected an out-of-range lead, and, if

programmed to Adaptive, has switched polarities from bipolar to unipolar.

– Capture Management has measured unusually high

ventricular thresholds.

Beginning on the cycle following TMT, the pacemaker delivers two pacing pulses at 85 ppm followed by two pulses at 65 ppm and then repeats the same sequence once again.

■

Magnet Mode forces the pacemaker’s programmed operation to an asynchronous mode (VOO or AOO). Magnet Mode rate is 85 ppm, however, the rate is 65 ppm if an electrical reset occurs or the elective replacement indicator is set.

Page 68

Other Operations

Magnet Operation Using the Transtelephonic Magnet

When a transtelephonic magnet is placed over the pacemaker, a TMT is automatically initiated. A FAST, if programmed On, immediately follows the TMT if any of the events mentioned above that initiate the test have occurred. When the FAST (or TMT when a FAST is not initiated) is completed, pacing is forced to Magnet Mode operation until the magnet is removed.

Magnet Operation Using the Programming Head

The programming head does not initiate a TMT when placed over the pacemaker. The clinician must perform a Magnet Test in order to obtain a TMT. A FAST, if programmed On, will follow the TMT if initiated by any of the events described above. When the FAST (or TMT when a FAST is not initiated) is completed, pacing is forced to Magnet Mode operation until the Magnet Test is terminated or the programming head is removed.

FAST Reporting Using the Remote Assistant

The FAST is available with the patient-activated hand-held Remote Assistant when the Remote Assistant diagnostic is off, and FAST has been programmed On.

With the Remote Assistant, the FAST results indicating a lead or threshold problem are reported by two beeps in a low tone, and a yellow light appears on the underside of the activator. When no problems exist, the FAST results are reported by three beeps, and a green light appears instead.

FAST with the Remote Assistant also reports if the ERI has been set or an electrical reset has occurred (indicated by two beeps and a yellow light from the activator).

Temporary Parameters

Several pacemaker parameters can be programmed temporarily during a patient session. These include: Mode, Rate, Amplitude, Pulse Width, and Sensitivity.

Page 69

Other Operations

Electrical Reset

A partial Electrical Reset can occur when the pacemaker is exposed to cold temperatures, electrocautery, internal or external defibrillation. Under these conditions, the pacemaker resumes pacing at the previously programmed mode and preserves many of the primary pacing parameter settings in operation prior to the partial reset. See “Electrical Reset Parameter Settings” on page 84 for a complete list of the preserved settings as well as full Electrical Reset settings.

If the temperature or electrical disturbance is severe enough, the pacemaker can reset to full Electrical Reset settings, in which case the pacemaker reverts to VVI mode at a pacing rate of 65 ppm and restarts Implant Detection. To restore the pacemaker to its previous mode and pacing operations, it must be reset and manually reprogrammed via the programmer.

Note: If after a reset a message appears on the programmer screen or printout indicating the Date/Time memory has been altered, contact your Medtronic representative for further information.

Elective Replacement Indicator

The Elective Replacement Indicator (ERI) forewarns when the battery is nearing depletion. When the pacemaker detects that the battery voltage has dropped below 2.59 V, the pacemaker sets the ERI status and reverts to VVI operation at a rate of 65 ppm. Pacing

is maintained, in VVI mode, even in pacemakers previously programmed to the AAIR, ADIR, AAI, ADI, AAT, AOOR, or AOO mode.

Caution: When ERI is set and verified, the pacemaker must be

replaced within three months.

High-rate pacing over several years, or with the battery partially depleted, may trigger the ERI prematurely.

Continuous pacing at high rates (i.e., greater than 100 ppm) and high output settings (i.e., pulse width greater than 1.0 ms and/or

Page 70

Diagnostics

amplitude greater than 5.0 V) may cause the battery to deplete rapidly and set ERI. While operating at ERI, the battery voltage may rise above 2.59 V, allowing the pacemaker to be reset and reprogrammed.

Before and after the use of high-rate pacing, the clinician should interrogate the pacemaker to determine the battery status and ERI condition.

Emergency Pacing

Emergency pacing provides VVI pacing at high output settings in emergency situations for pacemaker-dependent patients. See “Emergency Parameter Settings” on page 80.

Rate Limit

In the event of a single component failure, the absolute rate limit is held to 200 ppm. Rate limit is automatically overridden in temporary single chamber modes for high rate pacing.

Diagnostics

The pacemaker has automatic data summary diagnostics, some of which have an accompanying clinician-selected diagnostic to collect further detailed data. At the completion of Implant Detection, the pacemaker enables diagnostic collection.

Automatic Diagnostics / Clinician-Selected Diagnostics

■

Heart Rate Histogram – Automatically collects short and long term heart rate and percent-paced data for the atrium or ventricle.

■

Sensor Indicated Rate Profile – Automatically collects sensor rate data.

■

High Rate Episode – Automatically collects basic data on atrial or ventricular high rates and, optionally, clinician-selected

Page 71

Diagnostics

detailed data of atrial or ventricular electrogram with a rate trend.

■

Lead Diagnostics – Chronic Lead Impedance Trend automatically collects long-term chronic lead impedance data. The automatic Lead Monitor Counters present the impedance status of every beat. Chronic lead impedance data is collected in all pacing modes except for triggered pacing modes (AAT and VVT). This data is not collected in non-pacing modes (OAO and OVO).

■

Key Parameter History – Automatically records the status of key parameters pertaining to the last eight programming sessions.

■

Sensitivity Trend – Automatically collects the minimum and maximum sensitivities used to operate automatic sensitivity.

■

Capture Management Trend – Automatically collects information about the range of ventricular thresholds and outputs over the life of the device and, optionally, clinician-selected detailed data reporting the results of pacing threshold tests.

■

Custom Rate Trend – Clinician-selected collection of heart rate and percent-paced trends over a beat-to-beat or 24-hour period.

■

Lead Monitor Impedance Trend – Provides trend data on lead integrity.

■

Sensitivity Detail – Provides a detailed view of Sensing Assurance operation by recording sensitivity values at 1-hour intervals.

If you selected Sensitivity Detail as one of the setup options for Capture Management Detail, the recording interval is 2 hours rather than 1 hour.

Page 72

General Recommendations

■

Remote-Assistant Symptoms – Data for symptom diagnosis is collected by the clinician-selected atrial or ventricular beat-to-beat rate trend with optional EGM.

Data collection is initiated by the patient using the Remote Assistant patient activator. The patient will hear a clicking sound from the Remote Assistant when initiating a telemetry link with the pacemaker. If the link is successful, the Remote Assistant responds with three beeps, and a green light appears on the underside of the activator. If communication is unsuccessful, it responds with two beeps in a lower tone, and a yellow light appears instead.

■

Remote-Assistant Exercise – Records heart rate data for a trend graph during a particular exercise activity.

General Recommendations

During the first few months after receiving a new pacing system the patient may require close monitoring. In the U.S.A., the physician may wish to use the individual state’s or Medicare’s maximum frequency table for dual chamber pacemakers under Guideline I, i.e., every two months from the second month through three years post-implant, and monthly thereafter (Ref. Carriers Manual, Part 3, Claims Process, Transmittal No. 1051, or a later publication, if available). Note that Guideline I applies to those pacing systems (i.e., the pacemaker and the lead used) for which 5 years of clinical data are not yet available.

Page 73

Appendix

NBG Codes

Special Notice 75

Page 74

NBG Codes

The KSR700 Series pacemakers may be described as VVIR pacemakers using the NBG

code (NBG code stands for “The North American Society of Pacing and Electrophysiology [NASPE] and the British Pacing and Electrophysiology Group [BPEG] Generic”). The five-letter code, which supersedes the ICHD Code, describes the operation of implantable pacemakers. For simplicity, this manual uses only the first three or four letters, e.g., AAI, VVI, VVIR, etc. The following chart describes the first four letters of the NBG code.

CHAMBER PACED

Ventricle

Atrium

Dual Chamber

Single Chamber

None

CHAMBER SENSED

Ventricle

Atrium

Dual Chamber

Single Chamber

None

VVIR

MODE OF RESPONSE

Triggered

Inhibited

Double (Both)

None

PROGRAMMABLE/ RATE RESPONSE

Programmable

Multiprogrammable

Communicating

Rate Responsive

None

Bernstein A., et al., The NASPE/BPEG Pulse Generator Code, Pace, 10 (4), Jul-Aug 1987.

Page 75

Special Notice

Medtronic implantable pacemakers and leads are implanted in the extremely hostile environment of the human body. This environment places severe limitations on the design and function of the pacemaker and lead. These limitations unavoidably reduce the potential performance and longevity of the pacemaker and lead despite the exercise of due care in design, component selection, manufacture and testing prior to sale. Reference is hereby made to published data on predictable failure rates of the pacemaker and lead and their implantation which have either been furnished by Medtronic or are otherwise available to physicians. The pacemaker includes an inseparable power source which will ultimately cease to function due to exhaustion or premature failure thereby necessitating removal of the pacemaker. The lead is necessarily very small in diameter and very flexible, which unavoidably increases the likelihood of breakage or breach of its insulation. Other reasons for failure of the pacemaker or lead include, but are not limited to: body rejection phenomena; change in performance characteristics due to component changes or failures; unusual physiological variations in patients; lead displacement; lead fracture; fibrotic tissue formation; elevated thresholds; medical complications, such as myocardial infarction occurring at the site of the electrode; erosion of the pacemaker or lead through body tissue or interference from transmitters, tools, appliances, instruments, equipment or other devices which use electricity or electromagnetic wave transmission. Consequently, no representation or warranty is made that failure or cessation of function of the pacemaker or lead will not occur, that the body will not react adversely to the implantation of the pacemaker or lead, that medical complications will not follow the implantation of the pacemaker or lead or that the pacemaker and lead will, in all cases, restore adequate cardiac function.

Page 76

Page 77

Pacemaker Specifications

Lead Requirements, Compatibility 78

Radiopaque Identification 79

Emergency Parameter Settings 80

Shipping and Nominal Parameter Settings 81

Electrical Reset Parameter Settings 84

Elective Replacement Indicator 87

Magnet Mode Conditions 87

Longevity Projections 88

Programmable Parameters 90

Nonprogrammable Parameters 97

Temporary Parameters 98

Telemetry Markers 98

Electrograms 99

Automatic Diagnostics 99

Clinician-Selected Diagnostics 100

Patient Information 100

Battery and Lead Telemetered Information 101

Battery Parameters 102

Mechanical Dimensions 102

Page 78

Lead Requirements, Compatibility

The chart below lists the available models by polarity type with the required lead for proper operation. Refer to “Connecting Leads to the Pacemaker” on page 33.

Model Polarity Primary Leads

SR701 Bipolar/Unipolar IS-1

KSR703 Bipolar/Unipolar Low-profile 3.2 mm bipolar

SR706 Unipolar Unipolar 5 or 6 mm

IS-1 refers to an International Connector Standard (see Document No. ISO 5841-3;

1992) whereby pulse generators and leads so designated are assured of meeting the electrical and mechanical parameters specified in the IS-1 International Standard.

or IS-1

Page 79

Radiopaque Identification

Listed below are the pacemaker’s radiopaque identifications, which are used to identify the pacemaker with fluoroscopy. An X-ray showing the location of the radiopaque for Model K Figure 7.

Models Radiopaque

SR701 PHT

SR703 PHW

SR706 PHU

PHT

SR701 is given in

Figure 7. Model KSR701 X-Ray

Page 80

Emergency Parameter Settings

Listed below in Table 4 are the pacemaker’s emergency parameter settings.

Table 4. Emergency Settings

Mode VVI

Pacing Rate 70 ppm

Ventricular

Amplitude 7.5 V

Pulse Width 1.5 ms

Sensitivity 2.8 mV

Pacing Polarity Unipolar

Sensing Polarity Unipolar

Lead Monitor Monitor Only

Capture Management Off

Ventricular Refractory Period 330 ms

Single Chamber Hysteresis Off

Page 81

Shipping and Nominal Parameter Settings

Listed below in Table 5 are the pacemaker’s shipping and nominal parameter settings.

Note: “Adaptive” indicates that the parameter value is adapted during operation. “Unchanged” indicates that the parameter setting is unchanged by nominal programming.

Table 5. Shipping and Nominal Settings

Parameter Shipping Medtronic

Mode VVI (VVIR

)VVIR

Lower Rate 60 ppm 60 ppm

Upper Sensor Rate 120 ppm 120 ppm

ADL Rate 95 ppm 95 ppm

Rate Profile Optimization On

ADL Response 3-Mod. Active 3-Mod. Active

Exertion Response 3-Mod. Frequent 3-Mod. Frequent

Activity Threshold Med. Low Unchanged

Activity Acceleration 30 sec Unchanged

Activity Deceleration Exercise Unchanged

Nominal

Unchanged

Ventricular Lead

Amplitude 3.5 V (Adaptive

Pulse Width 0.4 ms (Adaptive

Sensitivity 2.8 mV (Adaptive

Sensing Assurance On

Pace Polarity Configure

Sense Polarity Configure

Unipolar

)3.5V

)0.4msb (Adaptive)

)2.8mVb (Adaptive)

Unchanged

(Adaptive)

Page 82

Shipping and Nominal Parameter Settings

Tab le 5. Shipping and Nominal Settings (Continued)

Parameter Shipping Medtronic

Lead Monitor Configured or

Monitor Only

Notify if < 200 ohms Unchanged

Notify if > 4000 ohms 4000 ohms

Monitor Sensitivity 8 8

Capture Management Adaptive

Amplitude Margin 1.5x (times) 1.5x (times)

Pulse Width Margin 1.5x (times) 1.5x (times)

Minimum Adapted

2.5 V 2.5 V

Amplitude

Minimum Adapted

0.4 ms 0.4 ms

Pulse Width

Capture Test

Day at Rest Day at Rest

Frequency

Acute Phase Days

112 days Unchanged

Remaining

Refractory Period 330 ms 330 ms

Sleep Off Off

Single Chamber

Off Unchanged

Hysteresis

Implant Detection On/Restart Unchanged

Transtelephonic Monitor Off Unchanged

Extended Telemetry Off Unchanged

Extended Marker Standard Unchanged

FAST Indicators On Unchanged

Nominal

Unchanged

Adaptive

Page 83

Shipping and Nominal Parameter Settings

Tab le 5. Shipping and Nominal Settings (Continued)

Parameter Shipping Medtronic

Serial Number Factory Set Unchanged

Clinician-Selected Diagnostic

At the completion of the 30-minute Implant Detection period: – Mode becomes VVIR – Rate Profile Optimization is enabled – Polarities are automatically configured for Models K – Capture Management is enabled, and Ventricular Amplitude and Pulse Width

become adaptive

– Sensing Assurance is enabled, and Sensitivity becomes adaptive

Value from which adaptive adjustment begins when nominals are programmed

Unipolar-only Model KSR706

Models KSR701 and KSR703l

Capture Management Detail

Nominal

Unchanged

SR701 and KSR703.

Page 84

Electrical Reset Parameter Settings

Listed below in Table 6 are the pacemaker’s full and partial electrical reset parameter settings.

Note: “Unchanged” indicates that the parameter setting is unchanged by a reset.

Table 6. Electrical Reset Parameter Settings

Parameter Partial Electrical

Reset

Mode Unchanged VVI

Lower Rate Unchanged 65 ppm

Upper Sensor Rate Unchanged 120 ppm

ADL Rate Unchanged 95 ppm

Rate Profile Optimization Unchanged Off

ADL Response 3-Mod. Active

Exertion Response 3-Mod. Frequent

Activity Threshold Med. Low Med. Low

Activity Acceleration 30 sec 30 sec

Activity Deceleration Exercise Exercise

Ventricular Lead

Amplitude Unchanged 5.0 V

Pulse Width Unchanged 0.4 ms

Sensitivity Unchanged 2.8 mV

Sensing Assurance Unchanged Off

Pace Polarity Unchanged Configure

Full Electrical Reset

Unipolar

Page 85

Electrical Reset Parameter Settings

Table 6. Electrical Reset Parameter Settings (Continued)

Parameter Partial Electrical

Reset

Sense Polarity Unchanged Configurea or

Lead Monitor Unchanged Configure

Notify if < 200 ohms 200 ohms

Notify if > 4000 ohms 4000 ohms

Monitor Sensitivity 8 8

Capture Management Unchanged Off

Amplitude Margin Unchanged

Pulse Width Margin Unchanged

Minimum Adapted

Unchanged

Amplitude

Minimum Adapted

Unchanged

Pulse Width

Capture Test

Day at Rest

Frequency

Acute Phase Days

112 days

Remaining

Refractory Period 330 ms

Sleep Off Off

Full Electrical Reset

Unipolar

Monitor Only

330 ms

Single Chamber

Unchanged Off

Hysteresis

Implant Detection Unchanged On/Restart

Transtelephonic Monitor Unchanged Off

Extended Telemetry Off Off

Extended Marker Standard Standard

Page 86

Electrical Reset Parameter Settings

Table 6. Electrical Reset Parameter Settings (Continued)

Parameter Partial Electrical

Reset

FAST Indicators On On

Serial Number Unchanged Zeros

Clinician-Selected Diagnostic

Bipolar Models KSR701 and KSR703 revert to Implant Detection during which polarity is automatically configured.

Unipolar-only Model KSR706

If the pacemaker is programmed to an atrial mode, parameter value is 400 ms.

Capture Management Detail

Full Electrical Reset

Capture Management Detail

Page 87

Elective Replacement Indicator

Listed below in Table 7 are the pacemaker’s Elective Replacement Indicators for nonmagnet and magnet modes.

Table 7. Elective Replacement Indicator Conditions

Nonmagnet Mode VVI mode at 65 ppm rate

Magnet Mode VOO mode at 65 ppm rate

Telemetry Replacement message on programmer

Battery/Lead Information Replacement message and displayed

battery voltage on programmer

Magnet Mode Conditions

The pacemaker’s magnet mode is VOO or AOO at 85 ppm.

Page 88

Longevity Projections

Listed below in Table 8 are the longevity projections from implant to the Elective Replacement Indicator (ERI) for the Model K

SR703 and KSR706 pacemakers. The estimated time varies based

SR701,

on the lead impedance and the percent paced.

Table 8. Projected Longevity from Implant to ERI

Programmed Settings Percent

Mode: VVIR Lead Impedance

Lower Rate: 60 ppm 500

Nominal Outputs

Amplitude: 3.5 V Pulse Width: 0.4 ms

Low Outputs

Amplitude: 2.5 V Pulse Width: 0.4 ms

Lower Outputs

Amplitude 1.5 V Pulse Width: 0.4 ms

Paced

100%

50%

100%

50%

100%

50%

Projected Longevity

(Years)

ohms

6.5

7.5

7.4

7.9

8.4

8.8

600

ohms

6.8

7.7

7.6

8.1

8.5

8.9

1000

ohms

7.5

8.2

8.0

8.3

8.8

9.1

Warning: When the Elective Replacement Indicator (ERI) is set, the pacemaker will continue to operate at ERI conditions for a minimum of three months until the battery depletes.

Page 89

Longevity Projections

Note: The values above are based on calculations using deliverable battery capacity. These values are estimates of longevity projections from implant to ERI and are intended to assist the clinician in understanding the effects of various pacing conditions on battery longevity. These values should not be interpreted as precise projections.

Listed below in Table 9 are the longevity projections from ERI to erratic pacing for the Model K

SR701, KSR703 and KSR706

pacemakers. At most programmed settings, virtually all (i.e., 99.9%) of these pacemakers will achieve a minimum of three months longevity after ERI is set.

Note: The average time in the table below refers to the projected mean longevity of pacemakers at the stated conditions.

Table 9. Longevity from ERI to Erratic Pacing

Previous Programmed Settings Before ERI

Lower Rate: 60 ppm Amplitude: 3.5 V Pulse Width: 0.4 ms

Mode: VVIR/AAIR 100% 3.5 8.5

Mode: VVI/AAI 100% 3.5 8.5

Programmed settings which lead to increased current demands in VVI, 65-ppm operating condition after ERI may slightly decrease average projections. Increased current demands post-ERI could be caused by an increase in the percent paced and/ or the increase in pacing rate.

Current data show that combinations of extreme pacing conditions (high output values [≥ 5.0 V] and high pulse widths, and /or low impedance values [300 ohms] may decrease the average projection in the AAI/AAIR and VVI/VVIR modes.

Percent

Paced

Projected Longevity

(Months)

Lead Impedance

500 ohms

Minimum Average

a,b

Page 90

Programmable Parameters

Listed below in Table 10 through Table 16 are the pacemaker’s programmable modes and parameters.

Table 10. Pacing Modes and Rates

Parameter Capability Notes

Pacing Mode VVIR, VVI, VVT, VOOR,

Lower Rate 30, 35, 40, … 175 ppm

Upper Sensor Rate 80, 90, 95, … 180 ppm

VOO, AAIR, AAI, AAT, AOOR, AOO, OVO, OAO

(except 65 and 85 ppm)

Rate responsive modes

Page 91

Programmable Parameters

Table 11. Rate Response Parameters

Parameter Capability Notes

ADL Rate 60, 65, 70, … 180 ppm Rate responsive

modes

Rate Profile Optimization

ADL Response 1-Inactive

Exertion Response 1-Infrequent

ADL Setpoint 5, 6, 7, … 40,

UR Setpoint 15, 16, 17, … 40,

Activity Threshold Low, Medium Low,

Activity Acceleration 15, 30, 60 sec

Activity Deceleration 2.5, 5.0, 10 min, Exercise

On, Off Rate responsive

2-Less Active 3-Mod. Active 4-More Active 5-Very Active

2-Less Frequent 3-Mod. Frequent 4-More Frequent 5-Very Frequent

42, 44, 46, … 80

42, 44, 46, … 80, 85, 90, 95, … 180

Medium High, High

modes

Programmable from the Exercise test only

Page 92

Programmable Parameters

Table 12. Outputs, Sensitivity, and Polarity

Parameter Capability Notes

Amplitude

0.5, 0.75, 1.0, … 4.0 V

4.5, 5.0, 5.5, 6.0 V, 7.5 V

0.625, 0.875, 1.125,

1.375, 1.625, and

1.875 V can be set by Capture Management. Values are displayed but not selectable.

Pulse Width 0.12, 0.15, 0.21, 0.27,

0.34, 0.40, 0.46, 0.52,

0.64, 0.76, 1.00, 1.25,

1.50 ms

Ventricular Sensitivity 1.0, 1.4, 2.0, 2.8, 4.0, 5.6,

8.0, 11.2 mV

Sensing Assurance On, Off

Atrial Sensitivity 0.25, 0.35, 0.5, 0.7, 1.0,

1.4, 2.0, 2.8, 4.0 mV

Sensing Assurance On, Off

Pacing Polarity Bipolar, Unipolar,

Configure

Sensing Polarity Bipolar, Unipolar,

Configure

0.25 and 0.35 mV apply to atrial bipolar sensing only

SR706 is

Model K unipolar only. Configure is displayed but is not selectable.

SR706 is

Model K unipolar only. Configure is displayed but is not selectable.

Page 93

Programmable Parameters

Tabl e 1 2 . Outputs, Sensitivity, and Polarity (Continued)

Parameter Capability Notes

Lead Monitor Configure, Monitor Only,

Adaptive, Off

Notify if < 200 ohms Nonprogrammable

Notify if > 1000, 2000, 3000,

4000 ohms

Monitor Sensitivity 2, 3,4, … 16

Tolerance for amplitudes from 0.5 V through 6.0 V is ± 10%, and for 7.5 V is

-20/+0%. Tolerances are based on 37°C and a 500-ohm load.

Model KSR706 only operates in Monitor Only

Page 94

Programmable Parameters

Table 13. Capture Management

Parameter Capability Notes

Ventricular Capture Management

Amplitude Margin 1x, 1.25x, 1.5x, 2x,

Pulse Width Margin 1x, 1.5x, 2x, 2.5x, 3x,

Minimum Adapted Amplitude

Minimum Adapted Pulse Width

Capture Test Frequency

Test Capture Every 15, 30 minutes

At 12:00 am, 12:15 am,

Retry if Test Delayed?

Acute Phase Days Remaining

Off, Adaptive, Monitor Only

2.5x (times)

4x, 5x (times)

0.5, 0.75, 1.0, … 4.0 V

4.5, 5.0 V

0.12, 0.15, 0.21, 0.27, 0.34,

0.40, 0.46, 0.52, 0.64, 0.76,

1.00 ms

1, 2, 4, 8, 12 hours, Day at Rest, Day at …, 7, 14, 28, 42 Days at …

12:30 am, … 11:45 pm

Ye s , No

Off, 7, 14, 21, … 84 days 112, 140, 168, … 252 days

Applicable only for Day(s) at … parameters

Page 95

Programmable Parameters

Parameter Capability Notes

Table 14. Refractory / Blanking Periods

Ventricular Refractory Period

150, 160, 170, … 500 ms Ventricular modes,

except VOOR and VOO

Atrial Blanking 110, 120, 130, … 350 ms AAIR, AAI, AAT

Atrial Refractory

150, 160, 170, … 500 ms AAIR, AAI, AAT

Period

Table 15. Special Therapy Features

Parameter Capability Notes

Sleep On, Off All pacing modes

Sleep Rate 30, 35, 40, … 90 ppm

(except 65 and 85 ppm)

Bed Time 12:00 am, 12:15 am,

12:30 am, … 11:45 pm

Wake Time 12:00 am, 12:15 am,

12:30 am, … 11:45 pm

Single Chamber Hysteresis

40, 50, 60 ppm, Off VVI, VVT, AAI, and

AAT modes

Page 96

Programmable Parameters

Table 16. Additional Features

Parameter Capability Notes

Implant Detection On/ Restart, Off/Complete All modes

Telemetry Features

Transtelephonic Monitor On, Off

Extended Telemetry On, Off

Extended Marker Standard, Therapy Trace

FAST Indicators On, Off

Page 97

Nonprogrammable Parameters

Listed below in Table 17 are the pacemaker’s nonprogrammable parameters.

Table 17. Nonprogrammable Parameters

Parameter Capability Notes

Ventricular Blanking Period

Rate Limit 200 ppm

50-100 ms Blanking for Ventricular

(± 20 ppm)

Refractory Period; pacemaker-determined

Atrial and ventricular rates

Page 98

Temporary Parameters

Listed below in Table 18 are the pacemaker’s temporary parameters.

Table 18. Temporary Parameters

Parameter Capability Notes

Pacing Mode

Pacing Rate 30, 35, 40, … 180 ppm

Amplitude 0.25, 0.375, 0.5, 0.625,

Pulse Width 0.03, 0.06, 0.09, … 0.15 ms

Atrial Sensitivity 0.25, 0.35, 0.5, 0.7, 1.0, 1.4,

Ventricular Sensitivity

Programmer displays atrial or ventricular values, depending on the chamber of the operating pacing mode.

VVI, VVT, VOO, AAI, AAT, AOO, OVO, OAO

(except 65 and 85 ppm), 190, 200, 210, … 280, 300, 310, 320, 330, 350, 370, 380, 400 ppm

0.750, … 2.0 V

2.25, 2.50, 2.75, … 4.0 V

4.5, 5.0, 5.5, 6.0 V, 7.5 V

0.21, 0.27, 0.34, 0.40, 0.46,

0.52, 0.64, 0.76, 1.00, 1.25,

1.50 ms

2.0, 2.8, 4.0 mV

1.0, 1.4, 2.0, 2.8, 4.0, 5.6, 8.0,

11.2 mV

Rates above 180 ppm are available by selecting the enable button

The amplitude values in 0.125 V increments apply only to the Capture Management and Temporary tests.

0.25 and 0.35 mV not available with Model

SR706

Telemetry Markers

Standard (Marker Channel telemetry) Therapy Trace

Page 99

Electrograms

Atrial Ventricular

Automatic Diagnostics

Heart Rate Histogram Sensor Indicated Rate Profile High Rate Episode Chronic Lead Impedance Trend Lead Monitor Counters Sensitivity Trend Key Parameter History Capture Management Trend

Electrograms

Page 100

Clinician-Selected Diagnostics

High Rate Detail Capture Management Detail Custom Rate Trend Lead Monitor Impedance Trend Sensitivity Detail Remote-Assistant Symptoms Remote-Assistant Exercise

Patient Information

Patient Identification Indication for Implant Leads Implanted Device Implanted Physician Information

100

Medtronic KSR703 Technical Manual

Table of contents

Device Description

Indications and Usage

Contraindications

Warnings and Precautions

Pacemaker Dependent Patients

Medical Therapy

Storage and Resterilization

Lead Evaluation and Lead Connection

Programming and Pacemaker Operation

Environmental and Medical Therapy Hazards

Co-implantation with an Implantable Defibrillator

Programming Considerations

Adverse Events

Observed Adverse Events

Potential Adverse Events

Clinical Studies

Methods

Description of Patients

Results of the Study

Implantation Procedures

Testing Leads and Pacemaker

Connecting Leads to the Pacemaker

Pacemaker Implantation

Replacing an Implanted Pacemaker

Disposal of Pacemaker

Implant Documentation

Pacemaker Registration

Establishing a Patient Record

Parameter Programming at Implant

Shipping Parameters

Implant Detection

Automatic Operation

Manual Programming

Medical Therapy Interactions

Implantable Defibrillators

Electrosurgical Cautery

Assistance

X-ray and Fluoroscopy

Assistance Information

Pacing Mode Operations

VVIR / AAIR Modes

VVI / AAI, VVT / AAT Modes

Rate Responsive Pacing

VOO / VOOR, AOO / AOOR Asynchronous Modes

OVO / OAO Diagnostic Modes

Rate Profile Optimization

Timing Operations

Rates

Refractory and Blanking Periods

Pacing and Sensing Operations

Polarity

Lead Monitor

Sensitivity

Pacing Output

Capture Management

Special Therapy Options

Sleep Function

Single Chamber Hysteresis

Pacemaker Telemetr y

Parameter Summary

Battery and Lead Information

Telemetry Markers (Extended Markers)

Electrogram (EGM)

Transtelephonic Monitor

Extended Telemetry

Other Operations

Magnet Operation

Temporary Parameters

Electrical Reset

Elective Replacement Indicator

Diagnostics

Emergency Pacing

Rate Limit

Automatic Diagnostics / Clinician-Selected Diagnostics

General Recommendations

Appendix

NBG Codes

Special Notice