sorin PARADYM RF DR 9550 User manual

Implant manual
Implantable cardioverter defibrillator
DR model 9550
ELECTRONIC COPY OF THE ORIGINAL APPROVED AND SIGNED DOCUMENT

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ELECTRONIC COPY OF THE ORIGINAL APPROVED AND SIGNED DOCUMENT

ELECTRONIC COPY OF THE ORIGINAL APPROVED AND SIGNED DOCUMENT

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ELECTRONIC COPY OF THE ORIGINAL APPROVED AND SIGNED DOCUMENT

TABLE OF CONTENTS
1. General description.......................................................................6
2. Indications.....................................................................................6
3. Contraindications..........................................................................7
3.1. Potential complications..........................................................7
4. Warnings........................................................................................8
4.1. Warnings to patients..............................................................8
4.2. Risks related to medical environment....................................9
4.3. Storage................................................................................11
4.4. Characteristics of the sterile packaging...............................12
5. Implant procedure.......................................................................12
5.1. Necessary equipment..........................................................12
5.2. Optional equipment.............................................................13
5.3. Before opening the package................................................13
5.4. Prior to implantation.............................................................13
5.5. Device placement................................................................14
5.6. Choosing the type of lead....................................................14
5.7. Measurement of thresholds at implant................................15
5.8. Lead connection .................................................................15
5.9. Device implantation.............................................................16
5.10. Tests and programming.......................................................16
5.11. Device registration...............................................................17
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6. Special modes.............................................................................17
6.1. Safety mode (nominal values).............................................17
6.2. Magnet mode.......................................................................18
6.3. Response in the presence of interference...........................19
6.4. Detection characteristics in the presence of
electromagnetic fields..........................................................19
6.5. Protection against short-circuits..........................................20
7. Main functions.............................................................................20
7.1. Automatic lead measurements............................................20
7.2. Atrial tachyarrhythmia management....................................20
7.3. Ventricular tachyarrhythmia management...........................21
7.4. Sensing................................................................................22
7.5. Pacing..................................................................................22
7.6. Follow-up functions..............................................................23
7.7. Remote Monitoring function.................................................24
8. Patient follow-up.........................................................................27
8.1. Follow-up recommendations...............................................27
8.2. Elective Replacement Indicator (ERI)..................................28
8.3. Explantation.........................................................................29
8.4. Defibrillator identification.....................................................30
9. Physical characteristics.............................................................31
9.1. Materials used.....................................................................31
10. Electrical characteristics............................................................31
10.1. Table of delivered shock energy and voltage......................32
10.2. Battery.................................................................................33
10.3. Longevity.............................................................................33
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11. Programmable parameters.........................................................35
11.1. Antibradycardia pacing........................................................35
11.2. Ventricular tachyarrhythmia detection.................................40
11.3. Ventricular tachyarrhythmia therapies.................................42
11.4. Remote alerts and warnings................................................48
12. Non programmable parameters.................................................49
13. Declaration of conformity...........................................................50
14. Limited warranty..........................................................................50
14.1. Article 1 : Terms of limited warranty.....................................51
14.2. Article 2 : Terms of replacement..........................................52
15. Explanation of symbols..............................................................54
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1. GENERAL DESCRIPTION
PARADYM RF DR 9550 is an implantable dual-chamber cardioverter
defibrillator. It is equipped with an accelerometer to allow adaptation of
pacing to suit the patient’s activity.
It is also equipped with the RF wireless technology which enables to
remotely monitor the patients who have the Sorin CRM SMARTVIEW
Monitor installed at home.
PARADYM RF DR 9550 provides a range of therapeutic and diagnostic
functions:
high energy shocks
atrial tachyarrhythmia prevention
advanced diagnostic functions
PARADYM RF DR 9550 is protected against high-frequency signals
emitted by cellular telephones.
2. INDICATIONS
Pacing and defibrillation indications are provided by the American
College of Cardiology, the American Heart Association and the Heart
Rhythm Society: ACC/AHA/HRS 2008 Guidelines for Device-Based
Therapy of Cardiac Rhythm Abnormalities (Writing Committee to Revise
the ACC/AHA/NASPE 2002 Guideline Update for Implantation of
Cardiac Pacemakers and Antiarrhythmia Devices). Circulation
2008;117: 2820-2840; J Am Coll Cardiol 2008 51: 2085-2105.
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3. CONTRAINDICATIONS
Implantation of PARADYM RF DR 9550 is contraindicated in patients:
whose tachyarrhythmias are induced by drug treatment, electrolyte
imbalance, or any other reversible cause,
whose tachyarrhythmias are due to acute myocardial infarction or
unstable ischemic episodes,
who present incessant tachyarrhythmia,
whose tachyarrhythmia was due to electrocution.
The use of the dual-chamber pacing mode is contraindicated in patients
with chronic atrial fibrillation.
The benefits of pacing to pediatric subjects have not been evaluated.
Adverse interactions may occur between the patient's spontaneous rate
and device functions.
3.1. POTENTIAL COMPLICATIONS
Complications may arise with any implanted pacing or defibrillation
system. They may be related to the device itself:
early battery depletion,
component failure,
sensing circuit inhibition, reversion to backup mode, or other
failures due to electromagnetic interference,
pectoral stimulation,
any complication related to failure to detect arrhythmias and
terminate detected arrhythmias, to inappropriate delivery of therapy
in the absence of arrhythmia, to acceleration of an arrhythmia by
therapy, and to pain experienced during or after delivery of therapy.
These complications may be life-threatening for the patient.
ENGLISH –7
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Complications may be related to the pacing and defibrillation leads:
improper lead connection,
lead displacement, cardiac wall perforation, or tissue reaction at
the myocardium-electrode interface,
insulation fracture,
conductor fracture,
lead fracture.
Medical complications may also arise:
infection,
fluid accumulation at the implant site,
casing migration,
skin erosion by the defibrillator with possible protrusion of the casing,
haematoma.
4. WARNINGS
4.1. WARNINGS TO PATIENTS
The patient should be warned of the potential risks of defibrillator
malfunction if he is exposed to external magnetic, electrical, or
electromagnetic signals.
These potential interference sources may cause conversion to inhibited
mode (because of noise detection), erratic delivery of VT or VF
therapies, nominal programming, or much more rarely, irreversible
damage to the device’s circuits.
The main sources of high magnitude electromagnetic interference are:
powerful radiofrequency equipment (radar), industrial motors and
transformers, arc-welding equipment, high power loudspeakers.
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Electrical equipment: Household electrical appliances do not affect the
functioning of the defibrillator, providing they are insulated to current standards.
However, patients should avoid using induction ovens and cookers.
Antitheft gates: Since antitheft devices at the entrance to stores are
not subject to any safety standards, it is advisable to spend as little time
as possible in their vicinity.
Airport detection systems: Since airport detection systems are not
subject to any safety standards, it is advisable to spend as little time as
possible in their vicinity.
Work environment: The patient's work environment may be an important
source of interference. In that case, specific recommendations may
be required.
CAUTION: Do not tap sharply on the ICD can after implant, because the
ICD's sensing circuits can detect this as P-waves or R-waves, and such
oversensing could result in inappropriate pacing, inhibition, or therapy.
Normal activities after implant do not result in such oversensing.
4.2. RISKS RELATED TO MEDICAL ENVIRONMENT
It is advisable to carefully monitor defibrillator operation prior to and
after any medical treatment during which an electrical current from an
external source passes through the patient's body.
Magnetic Resonance Imaging: MRI is strictly contraindicated in
cardiac defibrillator patients.
Electrocautery or diathermy device: Diathermy and electrocautery
equipment should not be used. If such devices must be used: 1. Before
procedure, deactivate ATP and shock therapies. 2. During the
procedure, keep the electrocautery device as far as possible from the
cardiac defibrillator. Set it at minimum intensity. Use it briefly. 3. After
the procedure, check for proper implant function. The device should
never be exposed directly to the diathermy source.
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Left Ventricular Assistant Device (LVAD): When implanting an ICD in
a patient implanted with a LVAD, it is recommended to place the device
as far as possible from the LVAD, as the LVAD may disturb device
interrogation. When interrogating the device the programmer head
should be kept as far away from the LVAD as possible.
External defibrillation: PARADYM RF DR 9550 is protected from
external defibrillation shocks. Before external defibrillation, deactivate
ATP and shock therapies. During external defibrillation, it is advisable to
avoid placing the defibrillating paddles directly over the casing or
over the leads. The defibrillating paddles should preferably be placed in
an anteroposterior position. Avoid any direct contact between the
defibrillation paddles and the conductive parts of the implanted leads or
casing of the implanted device. After external defibrillation, check for
proper device function.
Internal pacemaker: Use of the defibrillator is contraindicated in
cardiac implantable pacemaker patients.
Radiation therapy: Avoid exposure to ionizing radiation. Betatrons are
contraindicated. If high doses of radiation therapy cannot be avoided,
the defibrillator should be protected from direct exposure with a
protection shield. ATP and shock therapies should be disabled during
exposure and proper device function should be checked regularly
afterwards. Resulting damage may not be immediately detectable.
If irradiation of tissues close to the implantation site is necessary, it is
recommended that the cardiac defibrillator be moved. As a safety
measure, an external defibrillator should be immediately available.
Ultrasound therapy (lithotripsy): It is advisable not to administer
ultrasound therapy (or lithotripsy) to a patient with a defibrillator implanted
in the abdominal position. Concentrating the ultrasonic field over the
device could harm the patient and cause damage to the defibrillator.
Diagnostic ultrasound (echography): The defibrillator is not affected
by ultrasound imaging devices.
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Transcutaneous Electrical Nerve Stimulation (TENS): TENS may
interfere with defibrillator function. If necessary, the following measures
may reduce interference: 1. Place the TENS electrodes as close
together as possible and as far as possible from the pulse generator
and leads. 2. Monitor cardiac activity during TENS use.
Scales with body fat monitors and electronic muscle stimulators:
A patient with an implanted PARADYM RF DR 9550 should not use
these devices.
Surgical procedure: For safety reasons, it is preferable to not program
the Rate Response function before any surgical procedure on the
defibrillator patient.
4.3. STORAGE
The defibrillator is packaged in sterile packaging inside a cardboard
storage box. It is recommended that the device be stored at a
temperature ranging from 0 °C to 50 °C.
If the packaging or the device itself has been damaged, for example
being dropped on a hard floor, the device should not be implanted. Any
device subjected to an excessive impact should be returned to your
Sorin CRM representative for examination.
Devices MUST NOT be interrogated and programmed within the vicinity
of other devices.
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4.4. CHARACTERISTICS OF THE STERILE
PACKAGING
The sterile packaging contains:
the defibrillator
a ratcheting screwdriver
a DF-1 defibrillating connector insulating plug
All of this equipment is ethylene oxide sterilized and hermetically sealed
in two-ply clear packaging compliant international standards.
5. IMPLANT PROCEDURE
5.1. NECESSARY EQUIPMENT
Implantation of PARADYM RF DR 9550 requires the following equipment:
Sorin CRM Orchestra Plus programmer, equipped with the
SmartView software interface and with the programming head,
pacing system analyser, as well as its sterile connecting cables, to
evaluate the pacing and sensing thresholds,
a complete set of leads with corresponding introducers,
physiological signal monitor capable of displaying simultaneously
the surface ECG and arterial pressure,
an external defibrillator with sterile external paddles,
sterile cover for the telemetry head.
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5.2. OPTIONAL EQUIPMENT
The following equipment may be required during implantation
of PARADYM RF DR 9550:
an IS-1 insulating plug to close the atrial port
sterile water to clean traces of blood. Any parts cleaned with sterile
water must be thoroughly dried.
mineral oil to lubricate if necessary
a lead cap to isolate a lead which is not used
5.3. BEFORE OPENING THE PACKAGE
Before opening the package, check the “Use Before”date printed on
the labels on the box and on the sterile package. Defibrillators that have
not been implanted before that date should be returned to Sorin CRM.
Devices MUST NOT be interrogated and programmed within the vicinity
of other devices.
Also check the integrity of the sterile package. The sterility of the contents is
no longer guaranteed if the package has been pierced or altered. If the
defibrillator is no longer sterile, it should be returned in its packaging to Sorin
CRM. Any re-sterilization of the unit is at the discretion of Sorin CRM.
5.4. PRIOR TO IMPLANTATION
Use the programmer to verify the defibrillator can be interrogated before
implantation.
Verify all shock therapies are disabled in order to avoid accidental
discharge during implantation.
It is not advisable to program the Smoothing function before
implantation, since the defibrillator may detect noise and pace at a rate
higher than the programmed basic rate.
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CAUTION: Do not shake or tap sharply on the ICD package with the
ICD inside, because the ICD's sensing circuits can interpret this as
P-waves or R-waves and record these as an arrhythmia episode. If
unusual shaking or tapping of the package results in a stored
arrhythmia episode, erase the recording before using the ICD.
5.5. DEVICE PLACEMENT
The pocket should be prepared in the left pectoral position, either
subcutaneously or submuscularly. Subcutaneous device implantation is
recommended for optimal RF communication efficacy.
Implantation in an abdominal position is not advisable.
In its final position, the defibrillator should be no more than 4 cm below
the skin surface.
5.6. CHOOSING THE TYPE OF LEAD
The defibrillator should be connected to:
one bipolar atrial sensing/pacing lead
one ventricular defibrillation lead with sensing/pacing bipolar
electrodes, and one or two defibrillation electrodes.
The choice of leads and their configuration is left to the implanting
physician’s judgment.
Note: In case no atrial lead is implanted, the atrial port should be plugged
with IS-1 insulating plug and a single chamber mode (VVI-VVIR) should
be programmed. PARAD and PARAD+ should not be used.
Connectors: The bipolar pacing/sensing connectors are compliant with
the IS-1 standard and the defibrillation connectors are compliant
with the DF-1 standard.
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5.7. MEASUREMENT OF THRESHOLDS AT IMPLANT
Pacing and sensing thresholds should be measured at implant.
Pacing thresholds: Acute thresholds should be lower than 1 V (or
2 mA) for a 0.35 ms pulse width, both in the ventricle and in the atrium.
Sensing thresholds: For proper ventricular sensing, the amplitude of
the R-wave should be greater than 5 mV. For proper atrial sensing, the
amplitude of the P-wave should be greater than 2 mV.
Pacing impedance measurements: Ventricular and atrial pacing
impedances should range from 200 to 3000 ohms (refer to the lead
characteristics, especially if high impedance leads are used).
5.8. LEAD CONNECTION
Each lead must be connected to the corresponding connector port. The
position of each connector is indicated on the casing.
Caution: Tighten only the distal inserts.
To connect each lead, proceed as follows:
1. Clean the lead terminal pins thoroughly, if necessary (device
replacement).
2. Lubricate the lead terminal pins with sterile water, if necessary.
3. Do not insert a lead connector pin into the connector block without
first visually verifying that the lead port is not filled with any obstacle.
4. Insert the screwdriver into the pre-inserted screw socket of the
appropriate port (in order to allow excess air to bleed out and to
make the insertion of the lead pin easier).
5. Insert the lead pin all the way into the port (check that the pin
protrudes beyond the distal insert).
6. Tighten, check the tightness and ensure the lead pin still protrudes
beyond the distal insert, and did not move.
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Caution: 1. One single set screw is located on the side of the
connection header. 2. Do not tighten the pre-inserted screws when
there is no lead (this could damage the connector). 3. Do not loosen the
screws before inserting the connector (subsequent risk of being unable
to reinsert the screw). 4. Removing the screwdriver: to avoid all risk of
loosening screws during removal, hold the screwdriver by its metal part
and not by the handle. 5. When mineral oil or sterile water is used to
make lead insertion easier, the screwdriver should remain inserted into
the pre-inserted screw socket when checking the tightness. As a matter
of fact, when the lead port is filled with a liquid, the physics piston effect
can give the feeling the lead is properly tightened.
5.9. DEVICE IMPLANTATION
Place the device in the pocket.
Carefully wind excess lead and place in a separate pocket to the side of
the defibrillator.
Suture the casing connector to the muscle using the hole provided for
this purpose, in order to avoid potential migration of the device into the
pectoral muscle.
5.10. TESTS AND PROGRAMMING
During the implant testing procedure, it is recommended that a security
margin of at least 10 J be demonstrated between the effective shock
energy and maximum programmable energy.
Enable shock therapies, then program the defibrillator.
Verify that the defibrillation lead impedance for each shock delivered
ranges from 30 to 150 ohms. Check the lead connection if the values
are outside these boundaries.
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Save the programming data on the programmer’s hard disk and on an
external storage device (if desired).
5.11. DEVICE REGISTRATION
Complete the registration form (EURID/Eucomed for Europe). One of
the sheets should be given to the patient on discharge from the
hospital, to use as an identification and follow-up card. One copy should
be returned to Sorin CRM within 30 days after implantation to activate
the warranty. The two other copies are for the hospital and for the
national registration centre (for Europe).
6. SPECIAL MODES
6.1. SAFETY MODE (NOMINAL VALUES)
Nominal values may be rapidly restored by pressing the following button
on the programming head or programmer keyboard:
or via the Emergency button on the SmartView screen.
In safety mode, the defibrillator operates with the parameters underlined
in the table of programmable parameters.
ENGLISH –17
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6.2. MAGNET MODE
When the magnet is applied:
antiarrhythmia functions are inhibited (detection of rhythm
disturbances, charging, and therapy),
hysteresis and AVD paced/sensed offset are set to 0,
pacing amplitude is set to 6 V,
pulse width is set to maximum,
pacing rate is set to the magnet rate,
the following functions are disabled: atrial arrhythmia prevention,
ventricular arrhythmia prevention, Mode Switch, Anti-PMT,
Smoothing, Rate Response.
When the magnet is removed:
the sensor rate is forced to the basic rate,
arrhythmia detection algorithms and sequential therapies are
reinitialized,
therapies start with the least aggressive program for each area.
The other parameters remain at their programmed value.
NOTE: The magnet is inactive during telemetry.
The magnet rate values are as follow:
Magnet rate (min-1) 96 94 91 89 87 85
Magnet period (ms) 625 641 656 672 688 703
Magnet rate (min-1) 83 82 80 78 77
Magnet period (ms) 719 734 750 766 781
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