Inlexa 1 VR-T, DR-T, HF-T ICD-Familie | Tachyarrhythmietherapie | Kardiale Resynchronisationstherapie Gebrauchsanweisung 420651 Revision: A (2015-12-09) © BIOTRONIK SE & Co. KG Alle Rechte vorbehalten. Technische Änderungen vorbehalten. ® Alle verwendeten Produktnamen können Marken oder eingetragene Marken von BIOTRONIK oder dem jeweiligen Eigentümer sein. Index 420651GebrauchsanweisungInlexa 1 VR-T, DR-T, HF-T, BIOTRONIK SE & Co.
1 1 Product Description Product Description1403736Technical Manual Intended Medical Use Intended use Inlexa 1 is part of a family of implantable cardioverter-defibrillators (ICDs). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing.
2 Contraindications Known contraindications: • Tachyarrhythmia caused by temporary or reversible irritation, e.g.
3 Telemetry Programmer Telemetric communication between the device and the programmer can be carried out following initialization either by applying the programming head (PGH) to the device or by using wireless radio frequency (RF) telemetry in the programmer. BIOTRONIK calls this function SafeSync®. Implantation and follow-up are performed with BIOTRONIK's portable programmer: Programmer software PSW version N.N.
4 BIOTRONIK Home Monitoring® In addition to effective pacing therapy, BIOTRONIK provides a complete therapy management system: • With Home Monitoring, diagnostic and therapeutic information as well as technical data are automatically sent to a stationary or mobile transmitter via an antenna in the device header. The data are encrypted and sent from the transmitter to the BIOTRONIK Service Center via the cellular phone network. • The received data are deciphered and evaluated.
5 Therapeutic and Diagnostic Functions Diagnostic functions • • • • Antitachycardia pacing • • Cardioversion, defibrillation • • Antibradycardia pacing and CRT • • • • • • Storing programs Data from implantation and the most recent interrogations and follow-ups are recorded as well as arrhythmia episodes; they are stored together with other data to assess both the patients' and the device's state at any time.
6 Home Monitoring functions • • • The device automatically sends information to the transmitter once a day. It also sends messages related to events, which are immediately forwarded to the Service Center. In addition to this, test messages can be initiated using the programmer. Appointments for Home Monitoring-supported follow-ups can be scheduled via the HMSC.
7 2 General Safety Instructions General Safety Instructions2403736Technical Manual Operating Conditions Technical manuals The following technical manuals provide information about usage of the device systems: — Technical manual for the device — Technical manual for the HMSC — Technical manual for the electrodes — Technical manuals for the programmer and its accessories — Technical manuals for the user interface — Technical manuals for cables, adapters and accessories • Technical manuals are either incl
8 Possible Complications General information on medical complications Complications for patients and device systems generally recognized among practitioners also apply to BIOTRONIK devices. • Normal complications may include fluid accumulation within the device pocket, infections, or tissue reactions. Primary sources of complication information include current scientific and technological knowledge.
9 Possible Risks Procedures to avoid Risky therapeutic and diagnostic procedures The following procedures must be avoided, as they may cause harm to the patient or damage the device and, as a result, put the system functionality at risk: • Transcutaneous electrical nerve stimulation • Hyperbaric oxygen therapy • Applied pressures higher than normal pressure If electrical current from an external source is conducted through the body for diagnostic or therapeutic purposes, then the device can be subjected
10 3 Implantation Implantation3403736Technical Manual Implantation Procedure Having parts ready The following parts that correspond to the requirements of the EC Directive 90/385/ EEC are required: • BIOTRONIK device with blind plug and screwdriver • BIOTRONIK leads and lead introducer set — Single-chamber device: one bipolar ICD lead with 1 or 2 shock coils for the ventricle — Dual-chamber device: one bipolar lead for the atrium and one bipolar ICD lead for the ventricle with 1 or 2 shock coils — Trip
11 Implantation site Preventing leakage currents • Depending on lead configuration and the patient's anatomy, the ICD is generally implanted subpectorally on the left side. Leakage currents between the tools and the device must be prevented during implantation. • Electrically insulate the patient. Preventing unintentional shock delivery ! WARNING Shock delivery with activated ICD There is a risk of unintended shock delivery when handling an activated ICD.
12 3 DF-1/IS-1 connection: • Connect the bipolar IS-1 connector for the atrium to RA. • Connect the bipolar IS-1 connector for the right ventricle to RV. • Connect the unipolar or the bipolar IS-1 connector for the left ventricle to LV. 4 Push the lead connector into the header without twisting or bending the connector or conductor until the connector tip (on the DF-1 connector) becomes visible behind the set screw block. This indicator can vary depending on the manufacturer of the lead used.
13 Precautionary Measures while Programming Performing standard tests and monitoring the patient Critical conditions can occur for the patient even during standard tests due to inadequate parameter settings or interrupted telemetry. • Ensure sufficient patient care even during tests. • After the threshold test, check to determine whether the threshold is clinically and technically justifiable. • Continuously monitor the ECG and the patient's condition. • Cancel testing if necessary.
14 Note the reduced pulse amplitude due to a battery voltage drop If the rate and amplitude are set very high and the pulse width is set too long at the same time, the battery voltage may temporarily drop so low that the actual pulse amplitude drops well below the selected level. • Continuously check the pacing efficiency using ECG monitoring.
15 Recognizing lead failure Considering power consumption and service time Automatic impedance measurement is always switched on. • Impedance values that indicate technical failure of a lead are documented in the event list. RF telemetry requires somewhat more power: Consumption during implantation corresponds to approximately 10 days of service time and consumption during a 20-minute follow-up corresponds to approximately 3 days. • Do not establish unnecessary RF telemetry.
16 Follow-up Follow-up intervals Follow-up with BIOTRONIK Home Monitoring® Follow-ups must be performed at regular, agreed intervals. • The first follow-up should be carried out by the physician using the programmer (in-office follow-up) approximately 3 months after implantation following the lead ingrowth phase. • The next in-office follow-up should be carried out once a year and no later than 12 months after the last in-office follow-up.
17 Patient Information Patient ID card Prohibitory signs Possible sources of interference A patient ID card is included in delivery. • Provide the patient with the patient ID. • Request that patients contact the physician in case of uncertainties. Premises with prohibitive signs must be avoided. • Draw the patient's attention to prohibitory signs. Electromagnetic interference should be avoided in daily activities. Sources of interference should not be brought into close proximity with the device.
18 Replacement Indications Possible battery levels • • • • • Elective Replacement Indication (ERI) BOS: Beginning of Service: > 90% charge MOS 1: Middle of Service: 90% to 40% residual charge MOS 2: Middle of Service: < 40% residual charge ERI: Elective Replacement Indication (i.e. RRT: Recommended Replacement Time) EOS: End of Service Elective Replacement Indication can be detected by Home Monitoring.
19 Explantation and Device Replacement Explantation • • • • Interrogate the device status. Deactivate VT and VF therapies prior to explantation. Remove the leads from the header. Do not simply cut them loose. Use state-of-the-art techniques to remove the device and, if necessary, the leads. Note: Normal oxidation processes may cause ICD housing discolorations. This is neither a device defect nor does it influence device functionality.
20 4 Parameters Parameters4403736Technical Manual Bradycardia / CRT General ICD therapy Timing: Basic rate day/night and rate hystereses Parameter Range of values Standard VR DR HF ICD therapy OFF; ON ON x x x Programs Display standard program; Display safe program; Display first interrogated program; Individual 1, 2, 3; Program Consult — x x x Parameter Range of values Standard VR DR HF Basic rate 30 ... (5) ... 100 ... (10) ... 160 bpm 40 bpm Night rate OFF; 30 ... (5) ...
21 Timing: Post-shock pacing Parameter Range of values Standard VR DR HF Post-shock duration OFF; 10 s; 30 s; 1 min; 2 min; 5 min; 10 min 10 s x x x Post-shock basic rate 30 ... (5) ... 100 ... (10) ... 160 bpm 60 bpm x x x x x AV delay post shock 50 ... (10) ... 350 ms 140 ms Ventricular post-shock pacing RV; BiV RV Parameter Range of values Standard VR DR HF x Timing: Upper rate Upper rate 90 ... (10) ...
22 Timing: Refractory periods and blanking periods Parameter Range of values Standard VR DR HF PVARP AUTO; 175 ... (25) ... 600 ms 225 ms x x PVARP extension OFF; ON ON x x Blanking after atrial pacing 50 ... (10) ... 100 ms 50 ms x x LV blanking after RV pacing 80 ms x RV blanking after LV pacing Far-field protection after Vs OFF; 25 ... (25) ... 225 ms 75 ms x x Far-field protection after Vp 50 ... (25) ...
23 Pacing: Ventricular capture control Lead configuration LV on IS-1 connection Parameter Range of values Standard VR DR HF Ventricular capture control OFF; ATM ON x x x Threshold test start 2.5 ... (0.5) ... 5.0 V 3.
24 Tachycardia Detection Parameter Range of values Standard VR DR HF Interval AT/AF 240 ... 600 ms 300 ms Interval VT1 OFF; 270 ... (10) ... 600 ms OFF x x x x x x x x x x x x x x ON x x x x x x x Interval VT2 OFF; 270 ... (10) ... 500 ms Interval VF OFF; 240 ... (10) ... 400 ms 300 ms Detection counter VT1 10 ... (2) ... 100 28 Detection counter VT2 10 ... (2) ...
25 Therapy: ATP Parameter Range of values Standard VR DR HF Attempts OFF; 1 ... (1) ... 10 OFF x x x ATP type for VT1/VT2 Burst; Ramp Burst x x x ATP type for VF OFF; Burst; Ramp Burst x x x ATP optimization OFF; ON OFF x x x Number S1 for VT1/VT2 1 ... (1) ... 10 5 x x x Number S1 for VF 8 S1 decrement for VT1/VT2 5 ... (5) ... 40 ms and for VF 10 ms x x x Scan decrement OFF; 5 ... (5) ...
26 Sensing Sensitivity and thresholds Parameter Range of values Standard VR DR HF Sensing A STD; OFF STD Sensing RV STD; TWS; VFS; IND STD Sensing LV STD; OFF; IND STD Upper threshold RV 50; 75% 50% Upper threshold LV 50; 75% 50% Upper threshold duration 110; 150 ... (50) ...
27 Home Monitoring Parameter Range of values Standard VR DR HF Home Monitoring OFF; ON OFF x x x Time of transmission STD; 00:00 ... (1:00 AM) STD ... 23:00 hh:mm x x x IEGM for therapy episodes OFF; ON ON x x x Ongoing atrial episode OFF; 6; 12; 18 h 12 h x x Transmission date XX.XX.XXXX Follow-up + 91 days x x x Cycle duration 20 ... (1) ...
28 5 Technical Data Technical Data5403736Technical Manual Mechanical Characteristics Housing Materials in contact with body tissue X-ray identification Devices with header for DF-1 connector: Type Lead connector W x H x D in mm Volume cm3 Mass g VR DF-1 69 x 55 x 12,5 38 71 DR DF-1 69 x 55 x 12,5 39 71 HF DF-1 69 x 58.
29 Electrical Characteristics Standards Measuring conditions The specifications are made according to EN 45502-2-2:2008.
30 Pulse form The pacing pulse has the following form: 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. Common mode rejection ratio ATP amplitude Rate Common mode rejection ratio Atrium: DR, HF V right: VR, DR, HF V left: HF 16.6 Hz 72 dB 59 dB 57 dB 50 Hz 73 dB 66 dB 57 dB 60 Hz 71 dB 66 dB 62 dB A burst was measured at 500 Ω, an amplitude of 7.
31 Battery Data Battery characteristics Storage period Calculation of service times The following data is provided by the manufacturers: Manufacturer LITRONIK Batterietechnologie GmbH & Co 01796 Pirna, Germany Battery type LiS 3410 RR System LiMnO2 Battery ID number shown on the programmer 6 Device type VR-T, DR-T, HF-T Battery voltage at ERI 2.
32 Inlexa 1 DR-T Service times with LiS 3410 RR battery: Service time [in years] at number of shocks per year Pacing Inlexa 1 HF-T 4 8 12 16 20 0% 9.4 7.7 6.5 5.7 5.0 15% 9.0 7.4 6.3 5.5 4.9 50% 8.1 6.8 5.9 5.2 4.6 100% 7.1 6.1 5.3 4.7 4.3 Service times with LiS 3410 RR battery: Service time [in years] at number of shocks per year Pacing 4 8 12 16 20 0% 8.9 7.4 6.3 5.5 4.9 15% 8.3 7.0 6.0 5.2 4.7 50% 7.2 6.1 5.4 4.8 4.3 100% 6.0 5.3 4.7 4.2 3.
33 Legend for the Label Label on the package The label icons symbolize the following: Manufacturing date Use by Storage temperature Order number Serial number Product identification number Dangerous voltages! CE mark Contents Follow the instructions for use Sterilized with ethylene oxide 2 Do not resterilize Single use only.
