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BIOTRONIK Enitra 8 HF-T, Техническое руководство

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Product Description

System Overview

Package contents

The storage package includes the following:

•

Sterile packaging with device

•

Serial number label

•

Patient ID card

•

Warranty booklet

Note: 

The technical manual pertaining to the device is either included in hard copy 

form in the storage package or in digital form on the internet.

The sterile packaging includes the following:

•

Device

•

Screwdriver

Содержание Enitra 8 HF-T

Страница 1: ...ved Specification subject to modification revision and improvement All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner Index 417804Technical M...

Страница 2: ...s 13 Possible Risks 14 Implantation 15 Implantation Procedure 15 Precautionary Measures while Programming 18 Magnet Response 21 Follow up 22 Patient Information 23 Replacement Indications 24 Explantat...

Страница 3: ...r features Resynchronization of ventricular chamber contraction via biventricular pacing Diagnosis and therapy forms The cardiac rhythm is automatically monitored and bradycardia arrhythmias are treat...

Страница 4: ...re indicated Pacing modes For the following symptomatic the following pacing modes are indicated Symptom expectation SR DR HF Disorientation due to bradycardia x x x Presyncope x x x Benefit from resy...

Страница 5: ...t of facts Contraindicated pacing mode Additionally implanted ICD Unipolar pacing Set of facts Inappropriate pacing mode Chronic atrial tachycardia chronic atrial fibrillation or flutter Atrial contro...

Страница 6: ...with different connec tions IS 1 The device labeling provides information pertaining to the connection assignment Device type Variant with Home Monitoring Variant without Home Monitoring Single chamb...

Страница 7: ...e programmer Programmer Using the programmer the pacing thresholds can be determined and all tests can be performed during implantation and in office follow up In addition to this the programmer is us...

Страница 8: ...nfigure the time of notification via e mail SMS or fax A clear overview of the results of this analysis is displayed for the attending physicians on the protected internet platform Home Monitoring Ser...

Страница 9: ...ng Sterile packaging with device Serial number label Patient ID card Warranty booklet Note The technical manual pertaining to the device is either included in hard copy form in the storage package or...

Страница 10: ...veraged and the trend can be displayed Pacing thresholds Pacing thresholds are automatically identified in the device in single and dual chamber devices the right ventricular in triple chamber devices...

Страница 11: ...that the optimal pacing polarity can be set The short RV LV conduction test supports also the selection An additional diagnostic function with biventricular pacing Variability of the heart rate patien...

Страница 12: ...nt technical manuals Keep technical manuals for later use Care during shipping and storage Devices are not to be stored close to magnets or sources of electromagnetic interference Note the effects of...

Страница 13: ...ay result in undesirable pacing of the diaphragm in the case of an initial or permanent high setting of the pulse amplitude Possible technical failures Technical failure of a device system cannot be e...

Страница 14: ...Specifically the current induced in the implanted leads may result in necrotic tissue formation close to the electrode tissue interface As a result sensing properties and pacing thresholds may change...

Страница 15: ...In order to be able to respond to unforeseeable emergencies or possible technical failures of the device Keep an external defibrillator and paddles or adhesive electrodes ready WARNING Inadequate ther...

Страница 16: ...y cause undesired current flows to the body and penetration of body fluid into the device WARNING Inadequate therapy Insufficient lead spacing or inappropriate lead positioning may lead to far field s...

Страница 17: ...ual setting of the lead polarity or measurement of lead impedances is not necessary Behavior during auto initialization During transmission of a permanent program Auto initialization is terminated and...

Страница 18: ...be operated due to a program error or a defective touch screen and therefore the temporary program cannot be terminated Under these circumstances it is helpful to cancel telemetry in which case the d...

Страница 19: ...entricular mode both in the permanent program and for Mode Switching Avoiding risks in the case of exclusive left ventricular pacing Lead dislodgement in the case of exclusive left ventricular pacing...

Страница 20: ...rly because the service time of the battery may be reduced to less than 1 year Home Monitoring The CardioMessenger should be relatively close to the patient if it is too far away the device constantly...

Страница 21: ...t rate adaptation Magnet rate 90 bpm Automatic For 10 cycles mode D00 subsequently mode DDI without rate adaptation Magnet rate 10 cycles with 90 bpm subsequently set basic rate Synchronous Note See a...

Страница 22: ...hysician decides whether the data transmitted via Home Monitoring with regard to the patient s clinical condition as well as the technical state of the device system are sufficient If not an in office...

Страница 23: ...ces of interference Electromagnetic interference should be avoided in daily activities Sources of interference should not be brought into close proximity of the device Draw the patient s attention to...

Страница 24: ...By a defined decrease in the basic rate as well as the magnet rate Rate decrease The decrease of basic rate and magnet rate is defined as follows In the following modes the pacing rate decreases by 1...

Страница 25: ...ogram with both high and low pacing energy Data of the battery manufacturer see the battery data Magnet response Cycles 1 to 10 After 10th cycle Automatic Asynchronous with 80 bpm Synchronous with bas...

Страница 26: ...device If upon replacing the device already implanted leads are no longer used but left in the patient then an additional uncontrolled current path to the heart can result Isolate unused lead connecto...

Страница 27: ...ues Standard SR DR HF Hysteresis OFF 5 5 25 20 65 bpm OFF x x x Repetitive search cycles OFF ON OFF x x x Parameter Range of values Standard SR DR HF AV delay Low Medium High Fixed Individual Low x x...

Страница 28: ...kebach response 2 1 rate Automatically set x x Atrial upper rate OFF 175 200 240 bpm 240 bpm x x Parameter Range of values Standard SR DR HF Mode switching OFF ON ON x x Intervention rate 100 10 250 b...

Страница 29: ...x LV refractory period 200 ms 200 ms x AUTO PVARP OFF ON ON x x PVARP 175 25 600 ms 225 ms x x PVARP after PVC PVARP 150 ms max 600 ms Automatically set x x Parameter Range of values Standard SR DR HF...

Страница 30: ...8 V 1 0 V x x Threshold test start 2 4 0 6 4 8 V 3 0 V x x Safety margin 0 5 0 1 1 2 V 1 0 V x x Search type Interval time of day Time of day x x Interval 0 1 0 3 1 3 6 12 24 h 24 h x x Time of day 0...

Страница 31: ...ip LV2 ring LV4 ring LV2 ring RV ring LV2 ring housing LV3 ring LV2 ring LV3 ring LV4 ring LV3 ring RV ring LV4 ring LV2 ring LV4 ring RV ring LV1 tip LV2 ring x Parameter Range of values Standard SR...

Страница 32: ...Medium High Very high Medium x x x CLS resting rate control OFF 10 10 50 bpm 20 bpm x x x Vp required Yes No No When BiV is set Yes x x x Parameter Range of values Standard SR DR HF Sensor gain AUTO...

Страница 33: ...SR DR HF Basic rate 60 bpm 60 bpm 70 bpm x x 50 bpm 50 bpm x Night rate OFF OFF OFF x x x Rate hysteresis OFF OFF OFF x x x Upper rate 130 bpm 130 bpm x x AV dynamics Low Low x x AV hysteresis mode O...

Страница 34: ...DDIR DDIR x x The basic rate with mode switching 10 bpm 10 bpm x x Rate stabilization with mode switching OFF OFF x x PVARP AUTO Start 250 ms 225 ms x x PVARP after PVC 400 ms Automati cally set x x...

Страница 35: ...gnet rate magnet interval 90 bpm 664 ms 20 ms Pulse amplitude 0 2 7 5 V The greater value of 50 mV or 20 25 Pulse width 0 1 1 5 ms 10 Sensitivity A EN 45502 2 1 triangle pulse 0 1 0 2 mV 0 05 mV 0 3 7...

Страница 36: ...BIOTRONIK logo for X ray identification It can be found centrally between the circuitry and the battery Materials in contact with body tissue Housing Titanium Header Epoxy polysulfone IS4 seal Silasti...

Страница 37: ...nts for Industry Canada are met Telemetry information for Japan In accordance with Japanese law this device has been assigned an identification number under the Ordinance concerning certification of c...

Страница 38: ...itude 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 vari...

Страница 39: ...hamber devices of the 4 series the following times result when set to AAI R or VVI R with a basic rate of 60 bpm and a pulse width of 0 4 ms at an impedance of 500 For single chamber devices of the 8...

Страница 40: ...when set to DDDR with a basic rate of 60 bpm 100 biventricular pacing and a pulse width of 0 4 ms at an impedance of 500 Amplitude Pacing Average service time A 2 5 V RV 2 5 V 100 9 years 10 months 50...

Страница 41: ...w the instructions for use Sterilized with ethylene oxide Do not resterilize Single use only Do not re use Do not use if packaging is damaged Non sterile Transmitter with non ionizing radiation at des...

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