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© BIOTRONIK mbH & o K
All r ghts reserved Spec cat ons
sub ect to mod cat on, rev s on
and mprovement
2009-D-xx
® BIOTRONIK Home Mon tor ng and
Entov s are reg stered trademarks of
BIOTRONIK mbH & o K
Th s product conforms w th the
d rect ves 90/385/EE relat ng to
act ve mplantable med cal dev ces
and 99/5/E on rad o equ pment and
telecommun cat on term nal equ p-
ment It was approved by ndependent
Not ed Bod es and s therfore
des gnated w th the E mark The
product can be used n all European
Un on countr es as well as n countr es
that recogn ze the above-ment oned
d rect ves
9
BIOTRONIK mbH & o K
Woermannkehre 1
12359 Berl n
ermany
Tel+49 (0) 30 68905–0
Fax+49 (0) 30 6852804
sales b otron k com
www b otron k com
Ev a
Pacemaker w th automat c Funct ons
and BIOTRONIK Home Mon tor ng
ard ac Rhythm Management
Bradycard a therapy
Techn cal Manual
®
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Table of Contents
Related Manuals for BIOTRONIK EVIA
Summary of Contents for BIOTRONIK EVIA
- Page 1 Bradycard a therapy and mprovement 2009-D-xx Techn cal Manual ® BIOTRONIK Home Mon tor ng and Entov s are reg stered trademarks of Ev a BIOTRONIK mbH & o K Pacemaker w th automat c Funct ons...
- Page 2 Evia DR-T, DR, SR-T, SR Pacemaker Bradycardia therapy Technical manual for the implant Doc. Id.: 365353-A Index 365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR sbiotronik...
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Page 4: Table Of Contents
Table of Contents Table of Contents Table of Contents Product Description..........5 Intended Medical Use . - Page 5 Table of Contents Parameters..........33 Pacing Modes .
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Page 6: Product Description
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 bradycar- dia arrhythmia indications. The primary objective of the therapy consists of improv- ing patients' symptoms that can be clinically manifested. -
Page 7: System Overview
The housing serves as an antipole in the case of unipolar lead configuration. BIOTRONIK provides silicone-coated implants to avoid muscle twitching near the implanted pacemaker in the case of unipolar pacing. The labeling provides information about the implant type and arrangement of the connections. - Page 8 Product Description BIOTRONIK In addition to effective pacing therapy, BIOTRONIK provides a complete therapy ® Home Monitoring 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.
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Page 9: Implant Variants And Nbg Codes
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. NBG-Code for Evia DR(-T) The NBG code for dual-chamber implants is DDDR: Pacing in both chambers... -
Page 10: Diagnostic And Therapy Functions
Product Description Diagnostic and Therapy Functions General overview 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. - Page 11 Product Description Home Monitoring The implant automatically sends information to the transmitter once a day. Addi- tionally, the test messages can be initiated using the programmer. Important med- ical information include, among others, the following: • Ongoing atrial and ventricular arrhythmia •...
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Page 12: Scope Of Delivery
359529 359530 359524 359528 SR-T 359533 359534 359531 359532 Accessories All BIOTRONIK products correspond to the requirements of the EC Directive 90/385/EEC: • BIOTRONIK leads • BIOTRONIK programming and monitoring devices • Permanent magnet • For Home Monitoring: BIOTRONIK transmitters... - Page 13 Product Description...
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Page 14: General Safety Instructions
General information Complications for patients and implant systems generally recognized among prac- on medical complications titioners also apply to BIOTRONIK implants. • Normal complications may include fluid accumulation within the implant pocket, infections, or tissue reactions. Primary sources of complication infor- mation include current scientific and technological knowledge. -
Page 15: Possible Technical Complications
General Safety Instructions Possible Technical Complications Technical malfunctions Technical implant malfunctions cannot entirely be excluded. Possible causes can include the following: • Lead dislocation • Lead fracture • Insulation defects • Implant component failures • Battery depletion... -
Page 16: Possible Electromagnetic Complications
(EMI) 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. It is gen- erally assumed that EMI produces only minor symptoms in patients - if any. -
Page 17: Possible Risks
General Safety Instructions Possible Risks Risky diagnostic and If electrical current from an external source is conducted through the body for diag- therapeutic procedures nostic or therapeutic purposes, then the implant can be subjected to interference and the patient placed at risk. Therefore the following always applies: •... -
Page 18: Prior To Implantation
Guidelines of Generally approved differential diagnostics methods, indications, and recommen- cardiologic societies dations for pacemaker therapy apply to BIOTRONIK implants. The guidelines provided by cardiology associations offer decisive information. Indications We recommend observing the indications published by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC... -
Page 19: Ambient Conditions
Prior to Implantation Ambient Conditions Temperature 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) Storage location •... -
Page 20: Sterility
Prior to Implantation Sterility Delivery 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. Sterile container The implant and accessories are packaged respectively in two separately sealed plastic containers. -
Page 21: Preparing The Implantation
• Only use products that correspond to the requirements of the EC Directive 90/385/EEC: — BIOTRONIK implant and blind plugs — BIOTRONIK leads and lead introducer — BIOTRONIK programmer with approved cable and adapter accessories — External multi channel ECG recorder — External defibrillator and paddles or adhesive electrodes WARNING... -
Page 22: Implantation
Implantation Implanting Implantation4365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Implantation site 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. Sequence Proceed as follows: Shape the implant pocket and prepare the vein. -
Page 23: Connecting Pm Leads
Implantation Connecting PM Leads Connection options BIOTRONIK pacemakers are designed for leads with unipolar or bipolar IS-1 con- nection. A unipolar or bipolar lead can be connected to Evia for sensing and pacing: DR-T and DR SR-T and SR Atrium... - Page 24 Implantation Auto-initialization 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.
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Page 25: Precautionary Measures While Programming
Implantation Precautionary Measures while Programming Checking the • After auto-initialization perform follow-up to see if the implant system is func- implant system tioning properly. • Perform a pacing threshold test to determine the pacing threshold. Monitoring the patient The patient could be subjected to critical states if, for example, inadequate param- eters are set or due to telemetry interference during a temporary program. - Page 26 The magnet response is set as follows in the standard program of BIOTRONIK pacemakers: • Asynchronous: for the duration of the magnet application – mode D00 (possibly V00 / A00) without rate adaptation; magnet rate: 90 ppm •...
- Page 27 Implantation...
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Page 28: After Implantation
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-ups with the programmer should take place in intervals between 6 to 12 months considering the expected service life of the implant. Follow-up with Proceed as follows: the programmer... -
Page 29: Notes For The Physician
• Strong electromagnetic fields • Cellular phones and transmitters Using cellular phones Electromagnetic interference has a temporary effect only. Generally, BIOTRONIK implant functions return to normal when the respective cellular phone is removed from the proximity of the implant. • Patients are advised to hold cellular phones to the ear opposite the side on which the device is implanted. -
Page 30: Replacement Indications
After Implantation Replacement Indications Pacemaker operational The time span from the beginning of service (BOS) to elective replacement indica- status indications tion (ERI) is determined by, among others, the following: • Battery capacity • Lead impedance • Pacing program • Pacing to inhibition ratio •... - Page 31 After Implantation Rate decrease 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.
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Page 32: Explantation And Implant Replacement
BIOTRONIK takes back used products for the purpose of environmentally safe dis- posal. • Clean the explant with an at least 1% sodium-hyperchlorine solution. • Rinse off with water. • Fill out explantation form and send to BIOTRONIK together with the cleaned implant. - Page 33 After Implantation...
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Page 34: Parameters
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 •... -
Page 35: Timing Dr(-T)
Parameters Timing DR(-T) Basic rate day/night Parameter Range of values Standard Basic rate 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 60 ppm ... (5) ... 200 ppm Night rate OFF; 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... - Page 36 Parameters Ventricular pacing suppression Parameter Range of values Standard suppression OFF; ON Pacing suppression after 1 ... (1) ... 8 consecutive V Pacing supports after 1; 2; 3; 4 X-out-of-8 cycles Upper rate Parameter Range of values Standard Upper rate 90 ...
- Page 37 Parameters Blanking periods Parameter Range of values Standard Far-field protection after V 100 ... (10) ... 220 ms 100 ms Far-field protection after V 100 ... (10) ... 220 ms 150 ms Ventricular blanking after A 30 ... (5) ... 100 ms 30 ms PMT protection Parameter...
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Page 38: Timing Sr(-T)
Parameters Timing SR(-T) Basic rate day/night Parameter Range of values Standard Basic rate 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 60 ppm ... (5) ... 200 ppm Night rate 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... -
Page 39: Pacing And Sensing Dr(-T)
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 Pulse width A 0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms 0.4 ms Pulse amplitude V 0.2 ... - Page 40 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 IEGM recordings Parameter Range of values IEGM recordings 20 (quantity);...
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Page 41: Pacing And Sensing Sr(-T)
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; 0.4 ms 1.5 ms Sensitivity Parameter Range of values... -
Page 42: Rate Adaptation
Parameters Rate Adaptation Closed Loop Stimulation CLS modes: rate adaptation Parameter Value range Standard Max. CLS rate 80 ... (5) ... 160 ppm 120 ppm CLS response Very low; low; medium; high; Medium very high Resting rate control OFF; +20 ppm +10 ... -
Page 43: Preset Programs Dr(-T)
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. Parameter Standard program Safe program Mode (after auto initialization: DDDR DDD-CLS) Basic rate 60 ppm 70 ppm Night program... - Page 44 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 Active capture control IEGM recording (HAR) Home Monitoring...
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Page 45: Preset Programs Sr(-T)
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) In the AAI mode, the safe program is also AAI. -
Page 46: Tolerances Of Parameter Values
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... - Page 47 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...
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Page 48: Technical Data
Technical Data Mechanical Characteristics Technical Data7365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Measurements for The measurements refer to the housing without header. the housing Implant W x H x D [mm] Volume [cm Mass [g] DR-T 53 x 44.5 x 6.5 53 x 43 x 6.5 SR-T 53 x 39 x 6.5... -
Page 49: Electrical Characteristics
With increasing pacing duration (tb), the pulse amplitude is reduced dependent on the pacing impedance. Resistance to interference All variants of BIOTRONIK implants comply with the requirements of prEN 45502-2-2: 2006, Section 27.5.1 at the highest sensitivity. Telemetry Telemetry data for Home Monitoring:... -
Page 50: Battery Data
Technical Data Battery Data Battery type characteristics The following data is entered by the manufacturer: Manufacturer GREATBATCH, INC. LITRONIK GmbH Clarence, NY 14031, USA 01796 Pirna, Germany Battery type GB 8431 GB 2596 LiS 3150 LiS 3150M System Ag/SVO/CFx LiMn0 ®... - Page 51 Technical Data Service times SR(-T) For single-chamber implants, the following times (in years) result: Amplitude Impedance Pacing [Ohms] 100% SR-T SR-T SR-T 1.5 V 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 2.5 V 22.1 20.3 17.8 17.3...
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Page 52: Country-Related Information
The following provides information according to the ordinance no. 39 issued by the 'Ministry for Industry and Information Technology' of the People's Republic of China pertaining to the materials which are contained in BIOTRONIK's pacemak- ers, ICDs and external devices:... -
Page 53: Legend For The Label
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 Resterilization prohibited STERILIZE Not for reuse Non-sterile STERILE... - Page 54 Technical Data Transfer sheath for leads with PIN-lock PE lead con- nector (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 des- ignation of the compatible leads (example) Screwdriver Position of connector ports in the header (example)
- Page 55 Technical Data...
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