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Summary of Contents for BIOTRONIK Amvia Stellar UDI-DI
- Page 1 Amvia Stellar Pacemaker | Bradyarrhythmia Therapy | Cardiac Resynchronization Therapy Technical Manual 462977 Revision: A (2022-04-27)
- Page 2 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany ® All product names in use may be trademarks or Tel +49 (0) 30 68905-0 registered trademarks held by BIOTRONIK or the Fax +49 (0) 30 6852804 sales@biotronik.com respective owner. www.biotronik.com...
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Page 3: Table Of Contents
Table of Contents Table of Contents About this Technical Manual ..................Objective ............................Technical manuals..........................Conventions............................Product Description....................Intended Medical Purpose........................ System Overview ..........................Diagnostic and Therapy Functions....................General Safety Instructions..................General Information on Safe Handling of the Device ..............Operating Conditions ........................ -
Page 4: About This Technical Manual
About this Technical Manual Objective About this Technical Manual Objective In this technical manual, you will find information for physicians and medical professionals regarding the device, the implantation, programming, and follow-up of an implantable pacemaker as well as information on safe handling of the device. -
Page 5: Technical Manuals
Technical manuals Technical manuals Technical manuals are either included in hard copy form in the storage package or available in digital form on the internet: https://manuals.biotronik.com. Consult all relevant technical manuals. Keep the technical manuals for future reference. To ensure safe operation, in addition to this technical manual, please also consult the following manuals: •... -
Page 6: Conventions
About this Technical Manual Conventions Conventions Identification of Safety Warnings The following symbol draws attention to potential hazards: Follow all safety warnings indicated by this symbol to avoid possible serious or fatal injury or damage to the system. Safety warnings are also indicated by a signal word. •... -
Page 7: Product Description
(CRT-Ps, e.g. biventricular pacing). Diagnosis and therapy forms The device monitors the heart rhythm and automatically detects and treats bradycardia and atrial tachycardia. BIOTRONIK Home Monitoring® enables physicians to supervise therapy management at any time. Intended user group In addition to having basic medical and cardiological knowledge, the user must be thoroughly familiar with the operation of a device system. - Page 8 Generally approved differential diagnostic methods, indications, and recommendations for pacemaker therapy apply to BIOTRONIK devices. See the current guidelines of cardiology associations for guidance. We recommend observing the indications published by the European Society of Cardiology (ESC).
- Page 9 Product Description Intended Medical Purpose The pacemakers are not intended for neonates or infants. As there are no randomized clinical trials of bradycardia pacing in pediatric or pregnant patients, the level of evidence for guideline recommendations is consensus based. Contraindications •...
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Page 10: System Overview
The ellipsoid shape facilitates ingrowth into the pectoral muscle area. The housing serves as an antipole in the case of unipolar lead configuration. Lead connections BIOTRONIK provides pacemakers with headers for different standardized lead connections: • IS‑1 •... - Page 11 Only quadripolar leads may be connected to the HF-T QP device type with IS4 connector port. Note Use only adapters approved by BIOTRONIK for leads with different connections. • If you have any questions concerning the compatibility of other manufacturers' leads, please contact BIOTRONIK.
- Page 12 Steroid-eluting leads reduce inflammatory processes. The fractal design of the leads allows for low pacing thresholds, high pacing impedance, and a low risk of oversensing. BIOTRONIK provides a series of adapters to connect a variety of already implanted leads to new devices.
- Page 13 With Home Monitoring, diagnostic and therapeutic information as well as technical data of the device are automatically and wirelessly sent to a transmitter via an antenna in the device header. The data is encrypted and sent from the transmitter to the BIOTRONIK Service Center via the cellular phone network.
- Page 14 Note The technical manual pertaining to the device is either included in hard copy form in the storage package or is available in digital form on the internet: https://manuals.biotronik.com Note The warranty booklet for this device is either included in hard copy form in the storage package or is available in digital form on the internet: https://www.biotronik.com/warranty-booklet...
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Page 15: Diagnostic And Therapy Functions
Product Description Diagnostic and Therapy Functions 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 16 Product Description Diagnostic and Therapy Functions Physiological pacing The device enables therapy through physiological stimulation, thereby improving the hemodynamic function of the heart. • For His-bundle pacing, a lead can be implanted in the His bundle. In triple-chamber devices, an additional lead can be implanted in the left ventricle or as backup lead in the right ventricle.
- Page 17 Product Description Diagnostic and Therapy Functions ProMRI devices recognize magnetic resonance imaging scanners The static magnetic field of an MRI scanner is reliably recognized with the aid of a sensor. The sensor can be activated after the implantation or during a follow-up using the MRI Guard 24/7 function. If the patient is in the vicinity of an MRI scanner, the device recognizes the scanner’s static magnetic field and automatically activates the preset MRI program.
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Page 18: General Safety Instructions
General Safety Instructions General Information on Safe Handling of the Device General Safety Instructions General Information on Safe Handling of the Device Observe notes and follow instructions WARNING Risk to patient, risk to physician and interferences of device Cardiac electrotherapy is subject to specific conditions. From the transport to the storage, in terms of sterility, concerning technical complications, what requires special care during implantation or what needs to be observed regarding risky therapies with persons wearing a pacemaker: The device system is sensitive and must not be damaged, in order not to harm patients. -
Page 19: Operating Conditions
General Safety Instructions Operating Conditions Operating Conditions WARNING Risk to patient and interferences of device Cardiac electrotherapy is subject to special operating conditions. If these are not fulfilled, the functionality of the device may be impaired; if the functionality of the device is impaired, the patient may be at risk. -
Page 20: Possible Complications
General information on medical complications Complications for patients and device systems generally recognized among practitioners also apply to BIOTRONIK devices. It is impossible to guarantee the efficacy of antiarrhythmia therapy, even if the programs have proven successful during tests or subsequent electrophysiological studies. In some cases the set parameters may be ineffective. - Page 21 Any device can be sensitive to electromagnetic interference, for example, when external signals are sensed as intrinsic rhythm: • BIOTRONIK devices have been designed so that their susceptibility to EMI is minimal. • Due to the intensity and variety of EMI, safety around sources of EMI cannot be guaranteed. In general, there are many sources of EMI that will produce minor or no symptoms in patients.
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Page 22: Possible Risks
General Safety Instructions Possible Risks Possible Risks WARNING Risk to patient and interferences with the device Cardiac electrotherapy is subject to special risks. They must be considered so that the functionality of the device is not impaired and, as a result, put the patient at risk. •... - Page 23 BIOTRONIK devices with the "MR conditional" function display the identification ProMRI. Magnetic resonance imaging (MRI) should only be performed while following mandatory precautions to protect the device system and the patient.
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Page 24: Implantation
Triple-chamber device: an additional unipolar, bipolar, or quadripolar LV lead or a unipolar or bipolar backup lead for the right ventricle • Approved connections are IS-1 and IS4: Use only adapters approved by BIOTRONIK for leads with different connectors or leads from other manufacturers. •... - Page 25 Avoiding damage to the header Set screws must be tightened or loosened with care. • Loosen set screws with the supplied torque wrench. Use only BIOTRONIK torque wrenches! • If lead repositioning is necessary, reorder sterile torque wrenches from BIOTRONIK.
- Page 26 Implantation Implantation Procedure Close the device pocket. Prior to testing and configuration, wait for the successful completion of automatic device initialization. Note If necessary, the device can also be programmed before or during auto-initialization. Preventing short circuits in the header WARNING Short circuit due to open lead connector ports Connector ports in the header which are open and thus not electrolyte-proof may cause undesired...
- Page 27 Implantation Implantation Procedure If the lead connector cannot be inserted completely, the set screw may be protruding into the drill hole of the set screw block. Carefully loosen the set screw without completely unscrewing it, so that it does not become tilted upon retightening. Use the torque wrench to perpendicularly pierce through the slitting in the center of the silicone plug until it reaches the set screw.
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Page 28: Precautionary Measures While Programming
Implantation Precautionary Measures while Programming Precautionary Measures while Programming WARNING Safety information The programming of devices requires special precautionary measures. • Please take all the following precautionary measures carefully into account. Checking the device system • After auto-initialization, perform a follow-up to see if the device system is functioning properly. •... - Page 29 Program VA criterion: The aim is to set a VA criterion that is longer than the longest measured retrograde conduction time. Preventing conduction of atrial tachycardia BIOTRONIK devices feature several functions to prevent conduction of atrial tachycardia to the ventricle(s): •...
- Page 30 Implantation Precautionary Measures while Programming Phrenic nerve stimulation that cannot be terminated With LV pacing, chronic phrenic nerve stimulation can in rare cases not be terminated by reprogramming the available left ventricular pacing configurations or by other measures. • Possibly set a right ventricular mode both in the permanent program and for Mode Switching. Avoiding risks in the case of exclusive LV pacing Lead dislodgement in the case of exclusive left ventricular pacing could pose the following risks: loss of ventricular pacing as well as induction of atrial arrhythmia.
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Page 31: Magnet Response
RF telemetry contact. Magnet response in standard program Applying a magnet or the programming head can result in an unphysiological rhythm change and asynchronous pacing. The magnet response is set as follows in the standard program of BIOTRONIK pacemakers: • Asynchronous: For the duration of the magnet application –... -
Page 32: Follow-Up
(in-office follow-up). • Subsequent in-office follow-up intervals may be extended up to 12 months, taking into account current medical guidelines and the use of BIOTRONIK Home Monitoring. Follow-up with BIOTRONIK Home Monitoring Monitoring using the Home Monitoring function is not intended to replace regular in-office appointments with the physician required for other medical reasons. -
Page 33: Patient Information
Information for patients is written in a language understandable to laypersons. Anatomy, technology, and living with an implanted device are the topics discussed here. This information is available in digital form on the internet: https://patients.biotronik.com. • Request that patients contact their physician in case of uncertainties. -
Page 34: Replacement Indications
Implantation Replacement Indications Replacement Indications Possible charging status 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 •... - Page 35 Implantation Replacement Indications • Home Monitoring • MRI Guard 24/7 • Statistics • Atrial and ventricular capture control Magnet response at ERI After reaching ERI, pacing is performed as follows after applying the magnet or programming head: Magnet response Cycles 1 to 10 After 10th cycle Synchronous with basic rate Automatic...
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Page 36: Explantation And Device Replacement
BIOTRONIK takes back used products for the purpose of environmentally safe disposal. • Clean the explanted device with an at least 1% sodium hypochlorite solution. • Rinse off with water. • Fill out the explantation form and send it to BIOTRONIK together with the cleaned device. -
Page 37: Parameter
Parameter Bradycardia/CRT Parameter Note Unless described separately, information for device type HF also applies to device type HF QP. Bradycardia/CRT Timing: basic rate day/night and rate hysteresis Timing: Basic rate day/night and rate hysteresis Parameter Range of values Standard 60 bpm 30 ... (5) ... 100 ... (10) ... 200 Basic rate 50 bpm OFF;... - Page 38 Parameter Bradycardia/CRT Parameter Range of values Standard Rate increase 1; 2; 4; 8 bpm/cycle 2 bpm/cycle Rate decrease 0.1; 0.2; 0.5; 1.0 bpm/cycle 0.5 bpm/cycle Rate fading OFF; ON Timing: Upper rate Parameter Range of values Standard Upper rate 90 ... (10) ... 200 bpm 130 bpm Atrial upper rate OFF;...
- Page 39 Parameter Bradycardia/CRT Pacing: Ventricular pacing Parameter Range of values Standard Ventricular pacing BiV; RV; LV Triggering OFF; RVs; RVs+PVC LV T-wave protection OFF; ON Maximum trigger rate: DDD- UTR + 20, 90...(10)...160 bpm UTR + 20 CLS, DDD(R), VDD(R) Maximum trigger rate: DDI(R), VDI(R), VVI‑CLS, 90...(10)...160 bpm 130 bpm...
- Page 40 Parameter Bradycardia/CRT Timing: AV delay Note If His-bundle pacing is used, the parameter names on the programmer change from AV to AH. Parameter Range of values Standard Low; Medium; High; AV dynamics Fixed With HBS: Fixed 180 ms (DR); 150 ms 40…(5)…300 ms (HF (QP)) AV delay 1 after pacing...
- Page 41 Parameter Bradycardia/CRT Parameter Range of values Standard 0.1 ... (0.1) ... 0.5 ... (0.25) ... Pulse width RV 0.4 ms 1.5 ms 0.5…(0.25)…4.0…(0.5)…6.0; Pulse amplitude LV 3.0 V 7.5 V 0.1 ... (0.1) ... 0.5 ... (0.25) ... Pulse width LV 0.4 ms 1.5 ms Pacing: Atrial capture control...
- Page 42 Parameter Bradycardia/CRT Lead configuration Parameter Range of values Standard Atr. pacing polarity UNIP; BIPL UNIP Atr. sensing polarity UNIP; BIPL UNIP Pacing polarity RV With HBS: Pacing polarity UNIP; BIPL UNIP Sensing polarity RV With HBS: Sensing polarity UNIP; BIPL UNIP LV1 →...
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Page 43: Tachycardia
Parameter Tachycardia Tachycardia AT/AF detection and termination Parameter Range of values Standard HAR limit 100 ... (10) ... 250 bpm 200 bpm HVR detection and termination Parameter Range of values Standard HVR limit 150 ... (5) ... 200 bpm 180 bpm 4 ... -
Page 44: Sensing
Parameter Sensing Sensing Atrial sensing parameters Parameter Range of values Standard OFF; AUTO; 0.1 ... (0.1) ... Sensing A AUTO 1.5 ... (0.5) ... 7.5 mV 121 ... (2) ... 145; 146 ... (2) ... Detection hold-off period 188; 189 ... (2) ... 229; 230 ... 121 ms (2) ... -
Page 45: Home Monitoring
Parameter Home Monitoring Home Monitoring Setting options on the programmer Parameter Range of values Standard Home Monitoring OFF; ON Std.; 00:00 ... (01:00) ... 23:00 Time of transmission Std. hh:mm Ongoing atrial episode OFF; 6 h; 12 h; 18 h 12 h Event-based IEGM OFF;... -
Page 46: Diagnostics
Parameter Diagnostics Diagnostics Recording parameters Parameter Range of values Standard High atrial rate OFF; ModeSw; AT High ventricular rate OFF; ON For nsT OFF; ON Patient trigger OFF; ON Pre-trigger recording 0 ... (25) ... 100 % 75 % When Home Monitoring is deactivated: Periodic recording 90 days... -
Page 47: Mri Program
Parameter MRI program MRI program Parameter Range of values Standard MRI program ON; OFF; AUTO Today ... (1) ... Today + Expiration date Today + 14 days 14 days D00; V00; A00; AUTO AUTO D00/BiV; D00; V00/BiV; AUTO V00; A00; AUTO Mean rate + 15 bpm;... -
Page 48: Technical Data
33.3 cm 14.6 cm HF-T QP 33.0 cm 19.8 cm X-ray identification All device types receive the BIOTRONIK logo for X-ray identification. It can be found centrally between the circuitry and the battery inside of the housing and is visible in an X-ray image. -
Page 49: Electrical Characteristics
The pulse amplitude reaches its maximum value at the beginning of the pulse (Ua). With increasing pacing duration (tb), the pulse amplitude is reduced dependent on the pacing impedance. Resistance to interference All variants of BIOTRONIK devices comply with the requirements of EN 45502-2-1: 2003, Section 27.5.1 at the highest sensitivity. -
Page 50: Battery Data
Technical Data Battery Data Battery Data Battery characteristics The following data is provided by the manufacturers: Manufacturer LITRONIK Batterietechnologie GmbH Birkwitzer Strasse 79 01796 Pirna, Germany Battery type Li3150MK System LiMnO Device type DR-T; HF-T; HF-T QP Battery voltage at BOS 3.1 V Open-circuit voltage 3.1 V Nominal capacity... -
Page 51: International Radio Certification
Technical Data International radio certification International radio certification Telemetry information for Australia: This device is in compliance with the Australian "Radiocommunications Act 1992" and, therefore, it is labeled according to the "Radiocommunications (Compliance labeling – Devices) Notice". Telemetry information for Canada: This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s). - Page 52 Technical Data International radio certification The said legal communications means radio communications is operated in compliance with the Telecommunications Act. The low power radio-frequency devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices.
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Page 53: Legend For The Label
Meaning Manufacturing date Manufacturer Use by Temperature limit Observe the information on temperatures during shipping and storage in this technical manual. Medical device BIOTRONIK order number Serial number Product identification number Unique device identifier CE mark UKCA mark Contents Device Torque wrench manuals.biotronik.com... - Page 54 Technical Data Legend for the Label Symbol Meaning Single sterile barrier system with protective packaging inside Do not resterilize Do not reuse Do not use if packaging is damaged and consult the technical manual MR conditional IS-1 Uncoated device: NBG code and compatible leads VVIR/AAIR Example Examples of the header configuration: IS-1, IS-1/IS4...
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