© BIOTRONIK GmbH & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. 2009-D-xx Cardiac Rhythm Management Bradycardia therapy Technical Manual ® BIOTRONIK Home Monitoring and Entovis are registered trademarks of BIOTRONIK GmbH & Co.
Evia DR-T, DR, SR-T, SR Pacemaker Bradycardia therapy Technical manual for the implant Doc. Id.
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3 Table of Contents Table of Contents Table of Contents Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Implant Variants and NBG Codes . . . . . . . . . . . . . . . . . . . . . . 8 Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . .
4 Table of Contents Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Pacing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Timing DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Timing SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Pacing and Sensing DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . .
5 1 Product Description Intended Medical Use Product Description1365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Intended use Evia is a family of implantable pacemakers that may be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested.
6 Product Description System Overview Parts Implant The implant system consists of the following parts: • Implant with connections for unipolar or bipolar sensing and pacing • Suitable leads and approved accessories • Programmer • Current implant programs The implant's housing is made of biocompatible titanium, welded from outside and thus hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral muscle area.
7 BIOTRONIK Home Monitoring® Technical manuals Product Description In addition to effective pacing therapy, BIOTRONIK provides a complete therapy management system: • With Home Monitoring, diagnostic and therapeutic information and technical data are sent via an antenna in the implant header to a mobile or stationary transmitter. The encrypted data are sent from the transmitter to the BIOTRONIK Service Center via the cellular phone network. • The received data are deciphered and evaluated.
8 Product Description Implant Variants and NBG Codes Evia family The following implant variants are available: Implant type Variant with Home Monitoring Variant without Home Monitoring Dual-chamber Evia DR-T Evia DR Single-chamber Evia SR-T Evia SR Note: The setting of the pacing mode depends on the individual diagnosis; the modes are listed in the section pertaining to adjustable parameters.
9 Product Description Diagnostic and Therapy Functions General overview Diagnostic functions Antibradycardia pacing All the systems have extensive features that allow quick diagnosis and delivery of safe therapy for bradycardia conditions. • Automatic functions make it easy and fast to implant, configure, and check the pacemaker. • Auto-initialization after implantation: the implant automatically detects the implanted leads, sets the polarity and activates the automatic functions after 10 min.
10 Home Monitoring Product Description The implant automatically sends information to the transmitter once a day. Additionally, the test messages can be initiated using the programmer.
11 Product Description Scope of Delivery Standard The storage package includes the following: • Implant in sterile packaging • Patient's manual • Serial number label • Patient ID card • Warranty card • Technical manual The sterile container contains the following: Order numbers Evia Accessories • Implant • Screwdriver The implants can be obtained as follows: Implant Order number: uncoated Order number: coated DR-T 359529 359530 DR 359524 359528 SR-T 359533 359534 SR 359531
12 Product Description
13 2 General Safety Instructions General Safety Instructions2365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Possible Medical Complications General information on medical complications Complications for patients and implant systems generally recognized among practitioners also apply to BIOTRONIK implants. • Normal complications may include fluid accumulation within the implant pocket, infections, or tissue reactions.
14 General Safety Instructions Possible Technical Complications Technical malfunctions Technical implant malfunctions cannot entirely be excluded.
15 General Safety Instructions Possible Electromagnetic Complications Electromagnetic interference (EMI) Any implant can be sensitive to interference, for example, when external signals are sensed as intrinsic rhythm or if measurements prevent rate adaptation. • BIOTRONIK implants have been designed so that their susceptibility to EMI is minimal. • Due to the intensity and variety of EMI, there is no guarantee for safety.
16 General Safety Instructions Possible Risks Risky diagnostic and therapeutic procedures If electrical current from an external source is conducted through the body for diagnostic or therapeutic purposes, then the implant can be subjected to interference and the patient placed at risk. Therefore the following always applies: • External defibrillation The implant is protected against the energy that is normally induced by external defibrillation.
17 3 Prior to Implantation Prior to Implantation3365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Indications and Contraindications Guidelines of cardiologic societies Generally approved differential diagnostics methods, indications, and recommendations for pacemaker therapy apply to BIOTRONIK implants. The guidelines provided by cardiology associations offer decisive information.
18 Prior to Implantation Ambient Conditions Temperature Storage location Storage period Extremely low and high temperatures affect the service time of the battery in the implant. • The following temperatures are permitted for transport, storage, and use: – 10°C to 45°C (50°F to 113°F) • Implants are not to be stored close to magnets or sources of electromagnetic interference. The duration of storage affects the service time of the battery of the implant (see battery data).
19 Prior to Implantation Sterility Delivery Sterile container Single use only The implant and the accessories have been gas sterilized. Sterility is guaranteed only if the plastic container and quality control seal have not been damaged. The implant and accessories are packaged respectively in two separately sealed plastic containers. The inner plastic container is also sterile on the outside so that it can be transferred in a sterile state during implantation.
20 Prior to Implantation Preparing the Implantation Have parts ready • Ensure that sterile spare parts are available for all parts that are to be implanted.
21 4 Implantation Implanting Implantation4365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Implantation site Sequence In general the pacemaker is implanted subcutaneously or subpectorally on the right depending on the lead configuration as well as the anatomy of the patient. Proceed as follows: 1 Shape the implant pocket and prepare the vein. 2 Implant the leads and perform measurements. 3 Connect implant and leads. The implant starts auto-initialization on its own.
22 Implantation Connecting PM Leads Connection options BIOTRONIK pacemakers are designed for leads with unipolar or bipolar IS-1 connection. A unipolar or bipolar lead can be connected to Evia for sensing and pacing: DR-T and DR Atrium SR-T and SR IS-1 unipolar or bipolar Ventricle Note: Use only adapters approved by BIOTRONIK for leads with different connections. • Connection schemes If you have any questions concerning the compatibility of other manufacturers' leads, please contact BIOTRONIK.
23 Auto-initialization Implantation Auto-initialization begins automatically once the first connected lead is detected. Auto-initialization is terminated 10 minutes after connection of the first lead. If no other program has been transferred in the meantime, the implant subsequently works with active automatic functions in the standard program. Manual setting of the lead polarity or measurement of lead impedances is not necessary.
24 Implantation Precautionary Measures while Programming Checking the implant system Monitoring the patient Manually setting lead polarity • After auto-initialization perform follow-up to see if the implant system is functioning properly. • Perform a pacing threshold test to determine the pacing threshold. The patient could be subjected to critical states if, for example, inadequate parameters are set or due to telemetry interference during a temporary program.
25 Information on magnet response Implantation Applying a magnet or the programming head can result in an unphysiological rhythm change and asynchronous pacing.
26 Implantation
27 5 After Implantation Follow-up After Implantation 5365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Follow-up intervals Follow-ups must be performed at regular agreed intervals. • Follow-up with the programmer Follow-ups with the programmer should take place in intervals between 6 to 12 months considering the expected service life of the implant. Proceed as follows: 1 Record and evaluate the external ECG. 2 Check the pacing function. 3 Interrogate the implant.
28 After Implantation Notes for the Physician Notes for patients Possible sources of interference Using cellular phones Magnet application by patients A patient brochure and a patient ID card are supplied with the device. • Provide the patient with the patient brochure and patient ID card. • Draw the patient's attention to prohibitory signs: places with prohibitory signs must be avoided.
29 After Implantation Replacement Indications Pacemaker operational status indications The time span from the beginning of service (BOS) to elective replacement indication (ERI) is determined by, among others, the following: • Battery capacity • Lead impedance • Pacing program • Pacing to inhibition ratio • Pacemaker circuit properties The following are the defined pacemaker operational statuses: ERI activation ERI display Change of the pacing mode with ERI Deactivated functions with ERI B
30 Rate decrease Magnet response at ERI After Implantation The decrease of basic rate and magnet rate is defined as follows: • In the following pacing modes the pacing rate decreases by 11%: DDD(R); DDT(R); DOO(R) VDD(R); VDI(R); VVI(R), VVT(R) AAI(R); AAT(R); AOO(R). • In the pacing modes DDI(R) and DVI(R), only the VA interval is extended by 11%. This reduces the pacing rate by 4.5 to 11%, depending on the configured AV delay.
31 After Implantation Explantation and Implant Replacement Explantation Implant replacement • Disconnect the leads from the header. • Remove the implant and, if necessary, leads using state-of-the-art technology. • Explants are biologically contaminated and must be disposed safely due to risk of infection. • Implanted leads of a predecessor implant must be checked before they are connected to a new implant.
32 After Implantation
33 6 Parameters Pacing Modes Parameters6365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Evia family The following pacing modes are available: Implant type Pacing mode Standard DR(-T) • DDD-CLS, VVI-CLS DDDR • DDDR, DDIR, DVIR, DOOR VDDR, VDIR, VVIR, VVTR, VOOR AAIR, AATR, AOOR • DDD, DDT, DDI, DVI, DOO VDD, VDI, VVI, VVT, VOO AAI, AAT, AOO OFF SR(-T) • VVI-CLS • VVIR, VOOR AAIR*, AATR*, AOOR* • VVI, VVT, VOO AAI*, AAT*, AOO* OFF *depends on the programmer software Not
34 Parameters Timing DR(-T) Basic rate day/night Parameter Range of values Standard Basic rate 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... (5) ... 200 ppm 60 ppm Night rate OFF; 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... (5) ... 200 ppm OFF Night begins 00:00 ... (10 min) ... 23:59 hh:mm 22:00 hh:mm Night ends 00:00 ... (10 min) ... 23:59 hh:mm 06:00 hh:mm Rate hysteresis Parameter Range of values Standard Rate hysteresis OFF; -5 ... (-5) ...
35 Parameters Ventricular pacing suppression Parameter Range of values Standard Vp suppression OFF; ON OFF Pacing suppression after consecutive Vs 1 ... (1) ... 8 6 Pacing supports after X-out-of-8 cycles 1; 2; 3; 4 3 Upper rate Parameter Range of values Standard Upper rate 90 ... (10) ... 200 ppm 130 ppm Atrial upper rate OFF; 240 ppm 240 ppm Mode switching Parameter Range of values Standard Mode switching OFF; ON ON Intervention rate 100 ... (10) ...
36 Parameters Blanking periods Parameter Range of values Standard Far-field protection after Vs 100 ... (10) ... 220 ms 100 ms Far-field protection after Vp 100 ... (10) ... 220 ms 150 ms Ventricular blanking after Ap 30 ... (5) ... 100 ms 30 ms Parameter Range of values Standard PMT detection/termination OFF; ON ON VA criterion 250 ... (10) ...
37 Parameters Timing SR(-T) Basic rate day/night Parameter Range of values Standard Basic rate 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... (5) ... 200 ppm 60 ppm Night rate OFF 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... (5) ... 200 ppm OFF Night begins 00:00 ... (10 min) ... 23:59 hh:mm 22:00 hh:mm Night ends 00:00 ... (10 min) ... 23:59 hh:mm 06:00 hh:mm Parameter Range of values Standard Rate hysteresis OFF -5 ... (-5) ...
38 Parameters Pacing and Sensing DR(-T) Pulse amplitude and pulse width Parameter Range of values Standard Pulse amplitude A 0.2 ... (0.1) ... 6.2; 7.5 V 3.0 Pulse width A 0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms 0.4 ms Pulse amplitude V 0.2 ... (0.1) ... 6.2; 7.5 V 3.0 V Pulse width V 0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms 0.4 ms Parameter Range of values Standard Sensitivity A AUTO 0.1 ... (0.1) ... 1.5 ... (0.5) ... 7.5 mV AUTO Sensitivity V AUTO 0.5 ... (0.5) ... 7.
39 Parameters Lead configuration Parameter Range of values Standard Pacing polarity A Unipolar; bipolar Unipolar Pacing polarity V Unipolar; bipolar Unipolar Sensing polarity A Unipolar; bipolar Unipolar Sensing polarity V Unipolar; bipolar Unipolar Parameter Range of values IEGM recordings 20 (quantity); each max. 10 s Types of IEGM recordings High atrial rate (HAR) IEGM recordings Mode switching (MSW) High ventricular rate (HVR) Patient triggered (Pt.
40 Parameters Pacing and Sensing SR(-T) Pulse amplitude and pulse width Parameter Range of values Standard Pulse amplitude 0.2 ... (0.1) ... 6.2; 7.5 V 3.0 V Pulse width 0.1; 0.2; 0.3; 0.4; 0.5; 0.75; 1.0; 1.25; 1.5 ms 0.4 ms Parameter Range of values Standard Sensitivity AUTO 0.5 ... (0.5) ... 7.5 mV AUTO Parameter Range of values Standard Ventricular capture control ON; ATM (monitoring only) OFF ON Min. amplitude 0.7 V 0.7 V Threshold test start 2.4; 3.0; 3.6; 4.2; 4.8 V 3.
41 Parameters Rate Adaptation Closed Loop Stimulation rate adaptation Rate adaptation via accelerometer CLS modes: Parameter Value range Standard Max. CLS rate 80 ... (5) ... 160 ppm 120 ppm CLS response Very low; low; medium; high; very high Medium Resting rate control OFF; +10 ... (10) ... +50 ppm +20 ppm CLS required Yes; no No R modes: Parameter Range of values Standard Sensor gain 1 ... 23 4 Max. activity rate 80 ... (5) ...
42 Parameters Preset Programs DR(-T) Standard and safe program Only the auto-initialization function is activated as a factory setting. All the other functions of the standard program are deactivated.
43 Parameters Parameter Standard program Safe program Lead configuration, automatically determined and set: Pacing polarity Unipolar Unipolar Sensing polarity Unipolar Unipolar Automatic lead check A/V ON ON Active capture control ATM OFF IEGM recording (HAR) ON OFF Home Monitoring OFF OFF
44 Parameters Preset Programs SR(-T) Standard and safe program Only the auto-initialization function is activated as a factory setting. All the other functions of the standard program are deactivated. Parameter Standard program Safe program Mode (after auto initialization: VVI) VVI VVI In the AAI mode, the safe program is also AAI. Basic rate 60 ppm 70 ppm Night program OFF OFF Rate hysteresis OFF OFF Magnet response AUTO AUTO Pulse amplitude 3.0 V 4.8 V Pulse width 0.4 ms 1.
45 Parameters Tolerances of Parameter Values DR(-T) Parameter Range of values Tolerance Basic rate 30 ... 100 ppm +/-1.5 ppm 102 ... 195 ppm +/-2.0 ppm 200 ppm +0.0/-3.0 ppm Basic interval 1000 ms +/-20 ms Magnet rate 90 ppm +/-1.5 ppm Magnet interval 664 ms +/-20 ms AV delay 15 ... 350 ms +20/-5 ms A/V pulse amplitude 0.2 V +/-0.10 V 0.3 ... 7.5 V +20/-25% 0.1 ... 0.4 ms +/-0.04 ms 0.5 ... 1.0 ms +/-0.10 ms 1.25 ... 1.5 ms +/-0.
46 Parameters SR(-T) Parameter Range of values Tolerance Basic rate 30 ... 100 ppm +/-1.5 ppm 102 ... 195 ppm +/-2.0 ppm 200 ppm +0.0/-3.0 ppm Basic interval 1000 ms +/-20 ms Magnet rate 90 ppm +/-1.5 ppm Magnet interval 664 ms +/-20 ms Pulse amplitude 0.2 V +/-0.10 V 0.3 ... 7.5 V +20/-25% 0.1 ... 0.4 ms +/-0.04 ms 0.5 ... 1.0 ms +/-0.10 ms 1.25 ... 1.5 ms +/-0.15 ms Sensitivity 45502-2-1 Delta pulse 0.5 ... 7.5 mV +/-20% Refractory period 200 ...
47 7 Technical Data Technical Data7365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Mechanical Characteristics Measurements for the housing The measurements refer to the housing without header. Implant W x H x D [mm] Volume [cm3] Mass [g] DR-T 53 x 44.5 x 6.5 12 25 DR 53 x 43 x 6.5 11 26 SR-T 53 x 39 x 6.5 11 24 SR 53 x 39 x 6.
48 Technical Data Electrical Characteristics Components and input values Housing shape Electrically conductive surface Pulse form Electrical characteristics determined at 37°C, 500 Ohm Circuit Hybrid electronics with VLSI-CMOS chip Input impedance > 10 kOhm Pulse form Biphasic, asymmetric Polarity Cathodic The implant housing has the following shape: Implant type DR(-T), SR(-T) Uncoated Flattened ellipsoid Coated Ellipse The implant housing has the following surface: Implant type DR(-T)
49 Technical Data Battery Data Battery type characteristics Power consumption The following data is entered by the manufacturer: Manufacturer GREATBATCH, INC. Clarence, NY 14031, USA LITRONIK GmbH 01796 Pirna, Germany Battery type GB 8431 GB 2596 LiS 3150 LiS 3150M System LiJ Ag/SVO/CFx QMR® LiJ LiMn02 Implant DR SR DR-T SR-T DR SR DR-T SR-T Battery voltage at BOS 2.8 V 3.0 V 2.8 V 3.1 V Open-circuit voltage 2.8 V 3.0 V 2.8 V 3.1 V Nominal capacity 1.3 Ah 1.3 Ah 1.3 Ah 1.
50 Service times SR(-T) Technical Data For single-chamber implants, the following times (in years) result: Amplitude 1.5 V 2.5 V 3.0 V 3.5 V 5.0 V Shortening of the service time after long storage period Impedance [Ohms] Pacing 10% 50% 100% SR-T SR SR-T SR SR-T SR 500 23.3 21.3 21.7 19.8 19.9 18.3 1000 23.6 21.5 22.7 20.7 21.6 19.8 500 22.1 20.3 17.8 17.3 14.3 14.6 1000 22.8 21.0 20.2 19.2 17.5 17.2 500 21.7 19.8 16.8 15.5 13.2 12.2 1000 22.7 20.7 19.
51 Technical Data Country-Related Information International certification Industry Canada Other notes specific to each country will follow in the course of international product certification. Telemetry data • This device may not interfere with stations operating in the rate range of 400.150 - 406.000 MHz in the meteorological aids, meteorological-satellite, and earth exploration-satellite services and must accept any interference received, including interference that may cause undesired operation.
52 Technical Data Legend for the Label The label icons symbolize the following: Manufacturing date Expiration date: Use by Storage temperature BIOTRONIK order number Serial number Product identification number Sterilization with ethylene oxide 2 Resterilization prohibited STERILIZE Not for reuse Non-sterile NON STERILE Usage information Contents Do not use if packaging is damaged.
53 Technical Data Transfer sheath for leads with PIN-lock PE lead connector (5 mm) to connect to pacemakers with PEC sockets (6 mm) Implant with NBG encoding and name of compatible leads (example) Silicone-coated implant with NBG encoding and designation of the compatible leads (example) Screwdriver DDDR Position of connector ports in the header (example) A IS-1 Unipolar IS-1 connector Bipolar IS-1 connector A Atrium V Ventricle UNI/BI Unipolar/bipolar configuration Vp Vs Ventricular pace Vent
54 Technical Data
