sorin REPLY DR User manual

Implant manual Manuel d'implantation
Anwenderhandbuch Manuale d'impianto
Manual de implante
Rate responsive dual-chamber pacemaker
Stimulateur cardiaque double chambre à
fréquence asservie
Frequenzadaptiver Zweikammerschrittmacher
Elettrostimolatore cardiaco bicamerale con
adattamento di frequenza
Marcapasos cardiaco bicameral con
adaptación de frecuencia

Implant manual
Rate responsive dual-chamber pacemaker

**Information from the manufacturer**
The Dplus mode, Rate acceleration and AV delay
shortening features indicated here in this manual are
available only in REPLY devices marked with the following
serial number: xxxZUxxx

TABLE OF CONTENTS
1. General description....................................................................6
2. Indications...................................................................................6
3. Contraindications.......................................................................7
3.1. Generalities........................................................................7
3.2. Potential complications ......................................................7
4. Warnings to patient....................................................................8
4.1. Risks related to medical environment................................8
4.2. Storage.............................................................................10
4.3. Characteristics of the sterile package..............................10
5. Implant procedure ....................................................................10
5.1. Before opening the package ............................................10
5.2. Preparing the pocket........................................................11
5.3. Choosing the type of lead ................................................11
5.4. Measurement of thresholds at implant.............................11
5.5. Lead connection...............................................................12
5.6. Functioning test at implant ...............................................13
6. Special modes ..........................................................................14
6.1. Nominal mode (Emergency mode) ..................................14
6.2. Standby mode..................................................................14
6.3. Magnet mode ...................................................................15
6.4. Response in the presence of interference .......................15
7. Functions and parameters ......................................................16
7.1. Pacing modes ..................................................................16
DDTA(R) Mode...........................................................16
DDTV(R) Mode...........................................................17
DDTAV(R) Mode ........................................................17
7.2. Rates................................................................................17
Basic rate....................................................................17
Maximum tracking rate ...............................................18
Rate hysteresis...........................................................18
7.3. Pacing and sensing parameters ......................................18
Pulse amplitude..........................................................18

Pulse width .................................................................19
Sensitivity ...................................................................19
Pacing and sensing polarities.....................................19
7.4. Refractory periods............................................................20
Absolute refractory periods ........................................20
Committed period .......................................................20
Automatic AV delay ....................................................20
AVD Paced/Sensed Offset .........................................21
7.5. Rate response..................................................................21
7.6. Therapeutic improvements ..............................................22
SafeR mode................................................................22
Dplus mode ................................................................22
Rate acceleration........................................................23
AV delay shortening ...................................................23
Rest rate.....................................................................23
Rate smoothing ..........................................................24
7.7. Managing atrial arrhythmias (AA) ....................................25
Preventing AA: Overdrive...........................................25
Preventing AA: Post extrasystolic pause suppression25
Preventing AA: Acceleration on PAC .........................26
Protecting the ventricles against AA: Mode switching26
7.8. Optimizing operation ........................................................27
Automatic detection of implantation ...........................27
Autosensing................................................................28
Ventricular Auto-threshold..........................................29
Anti-PMT protection....................................................29
8. Patient follow-up ......................................................................30
8.1. Follow-up recommendations............................................30
8.2. Elective Replacement Indicator (ERI)..............................30
8.3. Explant .............................................................................31
8.4. Programmer tests ............................................................32
8.5. Interrogating the memories (AIDA+) ................................32
8.6. Pacemaker identification..................................................33

9. Physical characteristics ..........................................................34
10. Electrical characteristics .........................................................34
10.1. Current drain at beginning of life......................................35
10.2. Correspondence between magnet rate and battery
impedance........................................................................35
10.3. Battery..............................................................................36
10.4. Longevity..........................................................................36
11. Programmable parameters......................................................37
12. Non-programmable parameters..............................................41
13. Warranty....................................................................................42
13.1. Article 1: Terms of warranty..............................................42
13.2. Article 2: Terms of replacement .......................................44

6 – ENGLISH
1. GENERAL DESCRIPTION
REPLY DR is a DDDR-type dual-chamber rate-responsive
pacemaker.
It is equipped with a physiological sensor (minute ventilation) and an
accelerometer to allow adaptation of pacing to suit the patient’s
activity.
REPLY DR provides a range of highly effective therapeutic functions:
!Prevention of atrial arrhythmias
!Protection of ventricles against atrial arrhythmias (Fallback Mode
Switching)
!Preservation of atrioventricular conduction (SafeR mode and
Dplus mode)
!Preservation of circadian cardiac rhythm (Rest rate)
!Prevention of vasovagal syncope (acceleration)
!Automatic adjustment of amplitude of ventricular pacing (Auto-
threshold)
!Automatic adjustment of atrial and ventricular sensitivity
(Autosensing)
!Protection against Pacemaker-Mediated Tachycardia (Anti-PMT)
2. INDICATIONS
Pacing indications are provided by the American College of
Cardiology and the American Heart Association (see "ACC/AHA/HRS
2008 Guidelines for Device-Based Therapy of Cardiac Rhythm
Abnormalities", J Am Coll Cardiol 2008 May 27;51(21):e1-62).

ENGLISH – 7
3. CONTRAINDICATIONS
3.1. GENERALITIES
There are no known contraindications to the use of cardiac
pacemakers as a therapeutic method for controlling heart rate.
Nevertheless, the patient's medical and physical condition, as well as
age, should be taken into consideration when choosing the
pacemaker and leads.
The benefits of pacing to pediatric subjects have not been evaluated.
Adverse interactions may occur between the patient's spontaneous
rate and pacemaker functions.
3.2. POTENTIAL COMPLICATIONS
Complications may arise with any implanted pacing system. They
may be related to the device itself:
!Early battery depletion
!Component failure
!Circuit inhibition, reversion to standby mode, or other failures due
to electromagnetic interference
!Pectoral stimulation
Complications may be related to the pacing leads:
!Poor connection to the pacemaker leads
!Lead displacement, cardiac wall perforation, or tissue reaction at
the myocardium-electrode interface
!Insulation fracture
!Conductor fracture
Medical complications may also arise:
!Infection
!Fluid accumulation at the implant site

8 – ENGLISH
!Casing migration
!Skin erosion by the pacemaker with possible protrusion of the
casing
4. WARNINGS TO PATIENT
The patient should be warned of the potential risks of pacemaker
malfunction if he/she is exposed to external magnetic, electrical, or
electromagnetic signals.
Electrical equipment: Household electrical appliances do not affect
the functioning of the pacemaker, 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.
Work environment: The patient's work environment may be an
important source of interference. In that case, specific
recommendations may be required.
Cellular phones: Radiofrequency signals can interfere with the
functioning of REPLY DR if the handset is placed too close to the
pacemaker. It is advisable to maintain a minimum distance of 15 cm
(6 inches) between the cellular telephone and the implanted device,
when the telephone is turned on.
4.1. RISKS RELATED TO MEDICAL ENVIRONMENT
Pacemaker operation should be carefully monitored 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 pacemaker patients.

ENGLISH – 9
Electrocautery or diathermy device: Diathermy and electrocautery
equipment should not be used. If such devices must be used:
1. Keep it as far as possible from the pacemaker. 2. Set it at
minimum intensity. 3. Use it briefly.
External defibrillation: If the patient must be defibrillated, it is
recommended that the paddles be placed at least 10 cm from the
pacemaker, along a line perpendicular to the axis formed by the line
connecting the leads to the pacemaker.
Internal defibrillator: Use of the pacemaker is contraindicated in
implantable defibrillator patients.
Radiation therapy: Avoid exposure to ionizing radiation. Betatrons
are contraindicated. If high doses of radiotherapy cannot be avoided,
the pacemaker should be protected from direct exposure, and
pacemaker operation should be monitored continuously. Resulting
damage may be immediately undetectable. If irradiation of tissues
close to the implantation site is necessary, it is recommended that
the pacemaker be moved. As a safety measure, temporary
pacemaker back-up should be immediately available.
Lithotripsy: The risks associated with lithotripsy are limited if the
cardiac pacemaker is not implanted in the abdominal position.
However, in order to avoid all risk of ventricular or atrial fibrillation,
shocks should be administered synchronously with pacing.
Ultrasound: The pacemaker should not be exposed to therapeutic
levels of ultrasound.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS may
interfere with pacemaker 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.

10 – ENGLISH
4.2. STORAGE
The pacemaker is packaged in a sterile pack contained within a
cardboard storage package. It is recommended that the pacemaker
be stored at a temperature ranging from 0 °C to 50 °C.
The cardboard package protects the pacemaker from impact during
shipping.
Devices subjected to excessive impact, such as those that have
been dropped on a hard floor, should not be implanted. Any device
subjected to such an impact should be returned to your Sorin CRM
representative for examination.
Devices MUST NOT be interrogated and programmed within the
vicinity of other devices.
4.3. CHARACTERISTICS OF THE STERILE
PACKAGE
The pacemaker and its ratchet screwdriver are sterilized with
ethylene oxide and hermetically sealed in a transparent dual package
in accordance with international standards.
5. IMPLANT PROCEDURE
5.1. 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. Pacemakers not implanted before the “use
before” date should be returned to your Sorin CRM
representative.

ENGLISH – 11
!Interrogate the device: if a warning is displayed or if battery
impedance is too high (> 2 kilohms), do not implant the device
and contact your Sorin CRM representative.
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 pacemaker is no longer sterile, it should be returned in
its packaging to your Sorin CRM representative. Any re-sterilization
of the unit is at the discretion of Sorin CRM.
5.2. PREPARING THE POCKET
Because of the orientation of the pacemaker connector, it is
advisable to create the pocket in a left pectoral position.
In its final position, the pacemaker should be no more than 4 - 5 cm
below the skin surface.
5.3. CHOOSING THE TYPE OF LEAD
For optimal use of pacemaker functions, the atrial lead should be
bipolar. If a unipolar atrial lead is used, the Autosensing function will
not be available.
Use of a high polarization ventricular lead interferes with normal
operation of the Auto-threshold function.
Connections: The pacing/sensing connectors are IS-1
compatible. Low profile type leads are not compatible.
5.4. MEASUREMENT OF THRESHOLDS AT
IMPLANT
Pacing and sensing thresholds should be measured at implant.

12 – ENGLISH
Pacing thresholds: Acute thresholds should be lower than 1 V for a
0.5 ms pulse width, both in the ventricle and in the atrium. Chronic
thresholds should be less than 3 V for a 0.5 ms pulse width.
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.
5.5. LEAD CONNECTION
It is imperative that each lead be properly connected to the
corresponding pacemaker connector (the position of each connector
is indicated on the case).
Caution: Only both distal inserts must be tightened.
To connect each lead, proceed as follows:
1. Insert the ventricular lead pin all the way into the appropriate
pacemaker port (marked V) of the pacemaker.
2. Insert the screwdriver in the centre of the prominent screwdriver
slot contour on the distal insert, then into the pre-inserted screw.
The ventricular screwdriver slot is positioned above the axis of
the ventricular lead and the atrial screwdriver slot is positioned
below the axis of the atrial lead.
3. Tighten the screw until the screwdriver clicks. Check the
tightness by pulling the lead (the lead should remain in the
pacemaker when pulling to check the tightness).
4. Insert the atrial lead pin all the way into the appropriate port
(marked A) of the pacemaker.
5. Proceed as in steps 2 and 3.

ENGLISH – 13
Caution: 1. Do not tighten the pre-inserted screws when there is no
lead connector inserted (this could damage the connector block).
2. Do not loosen the screws before inserting the lead connector
(subsequent risk of being unable to reinsert the screw). 3. Use only
the screwdriver provided with the pacemaker. Maintain the
screwdriver's shaft perpendicular to the plane of the pacemaker (see
figure below).
Warning: Ensure that the screwdriver's tip is fully inserted in the
setscrew; otherwise the screwdriver can damage the setscrew
and prevent connection with or disconnection from the lead.
To ensure full insertion, push the screwdriver's hex tip smoothly into
the setscrew until it reaches the bottom of the hex chamber in the
screw, which could be felt as a solid metallic contact. Do not implant
the pacemaker if there is no feeling of solid metallic contact. Do not
implant the pacemaker if the wrench does not click when attempting
to tighten the setscrew on the lead pin.
5.6. FUNCTIONING TEST AT IMPLANT
After placing the device in its pocket, check the pacemaker
functioning using an ECG.

14 – ENGLISH
6. SPECIAL MODES
6.1. NOMINAL MODE (EMERGENCY MODE)
A safety function may be rapidly restored by pressing the following
button:
In nominal mode, the pacemaker operates with the parameters
underlined in the table of programmable parameters.
6.2. STANDBY MODE
In the event of self-test failure, the pacemaker switches
automatically to a safe mode of operation known as standby mode.
In most cases, normal pacemaker operation may be re-established (if
the pacemaker is at a stabilized temperature of approximately 37°C)
by validating the reinitialization function suggested by the
programmer. If this is not the case, contact your Sorin CRM
representative.
In standby mode, the pacemaker operates with the following
parameters: VVI, 70 min-1, 5 V, 0.5 ms, sensitivity 2.2 mV, unipolar.
Programming is then impossible and test modes, including magnet
mode, are ineffective.

ENGLISH – 15
6.3. MAGNET MODE
When a magnet is applied, the pacemaker terminates the cycle in
progress and operates using the following parameters:
Mode DOO (if mode programmed: Dxx or SafeR)
VOO (if mode programmed: Vxx)
AOO (if mode programmed: Axx)
Rate Magnet rate
Pulse amplitude 5 V (or greater if the programmed amplitude value is
greater)
Pulse width 0.5 ms (or greater if the programmed pulse width
value is greater)
AV delay Rest AV delay
On exiting magnet mode, the device operates:
!for 6 cycles by pacing at the magnet rate, with an AV delay of
95 ms (if applicable) and with the programmed amplitude,
!then for 2 cycles with the programmed parameters, in
asynchronous mode.
6.4. RESPONSE IN THE PRESENCE OF
INTERFERENCE
If the pacemaker senses electrical noise at a frequency above 20 Hz,
it switches to an asynchronous mode at the basic rate. The
programmed mode is restored as soon as the noise is no longer
detected.

16 – ENGLISH
7. FUNCTIONS AND PARAMETERS
7.1. PACING MODES
The pacing mode determines pacemaker operation when pacing and
sensing. The meanings of the codes (e.g., DDD, AOO) are provided
in Appendix DD to Standard EN 45502-2-1. The SafeR mode is
described in the section "Therapeutic improvements." The DDTA,
DDTV, and DDTAV modes are special modes developed by Sorin
CRM (see description below).
Contraindications: 1. AAI(R) pacing is contraindicated where AV
conduction is impaired. 2. Asynchronous pacing is contraindicated
when there is competition between the patient's intrinsic rhythm and
the pacemaker. 3. DDD pacing is contraindicated in patients with
chronic atrial fibrillation or flutter, or in those with slow retrograde
conduction, which may induce Pacemaker- Mediated Tachycardia.
DDTA(R) Mode
Dual-chamber DDD(R) pacing with triggered atrial pacing.
Both chambers are paced at the basic rate (DDTA) or at the sensor-
driven rate (DDTAR) in the absence of intrinsic activity. A sensed P
wave triggers atrial pacing and ventricular pacing after the
programmed AV delay. A sensed R wave inhibits ventricular pacing if
it occurs during the AV delay and inhibits atrial and ventricular pacing
if it occurs outside the AV delay.
In this mode, atrial pacing may be triggered while maintaining
atrioventricular synchronization.
This mode is not intended to be programmed permanently.