C-series. Pacemaker Manual Manual de los marcapasos Manual do pacemaker

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1 C-series C60 DR C50 D C20 SR C10 S C60A1 C50A1 C20A1 C10A1 Pacemaker Manual Manual de los marcapasos Manual do pacemaker

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3 Contents 1 Device description Features Programmer About this manual 5 2 Indications and contraindications Indications Contraindications Side effects 6 3 Handling and disposal Storage Use by date Opening the sterile pack Registration Handling Explant and disposal 7 4 Suggested implant procedure Lead compatibility and polarity Lead connection Securing the pacemaker Post-implant configuration 9 5 Measuring methods 9 6 Warnings Effects of extreme conditions Area restrictions Sterilization Environmental and medical therapy hazards 11 7 Technical information 13 8 Terms of Limited Warranty 19 9 Explanation of symbols 20 3 English

4 English 4

5 1 Device description The Vitatron C-series consists of two dual chamber (C60 DR, C50 D) and two single chamber (C20 SR, C10 S) pacemakers. 1.1 Features Beat-to-Beat mode switching Atrial synchronization pacing Therapy Advisor Extensive diagnostics EGM with annotated markers 1.2 Programmer Two Medtronic/Vitatron programmers are available: the Vitatron CareLink and the Medtronic/Vitatron 9790c. Other programmers are not compatible. The Vitatron CareLink and the Medtronic/Vitatron 9790c can be used for the following: to program the full range of parameters and therapies to monitor the pacemaker battery status to perform follow-up measurements and diagnostics The software needed to program the Vitatron C-series pacemakers is Vitatron C-series software. 1.3 About this manual This manual is intended primarily as an implant manual. Regular patient follow-ups should be scheduled after implant. The Reference Manual describes follow-up procedures and programming instructions and gives more extensive descriptions on how the pacemaker operates. 2 Indications and contraindications 2.1 Indications Vitatron C-series pacemakers are intended for use in patients for whom permanent cardiac pacing is indicated for the treatment of disorders in impulse formation or conduction. Rate responsive modes can help patients who have a requirement for an increase in pacing rate, in response to physical activity. Single chamber ventricular pacing can help patients with permanent atrial tachyarrhythmias, including atrial fibrillation and flutter. Single chamber atrial pacing can help patients with symptomatic bradyarrhythmias and normal AV conduction. 2.2 Contraindications There are no known contraindications to the use of pacemakers as a means to control the heart rate. The patient s individual medical condition dictates which particular pacing system and mode of operation is chosen by the physician. 5 English

6 Rate responsive modes may be contraindicated for those patients who cannot tolerate pacing rates above the programmed lower rate. Pacemakers are contraindicated in the following situations: dual chamber permanent supraventricular tachyarrhythmias, including atrial fibrillation and flutter expected aggravation of clinical symptoms (for example, angina pectoris) or congestive heart failure caused by fast heart rates inadequate intracavitary atrial complexes single chamber AAI(R) AV conduction disturbances inadequate intracavitary atrial complexes single chamber VVI(R) known pacemaker syndrome a need for AV synchrony expected aggravation of clinical symptoms (for example angina pectoris) or congestive heart failure caused by fast heart rates 2.3 Side effects Possible side effects include, but are not limited to, device rejection phenomena, muscle stimulation, nerve stimulation, infection, lead-related thrombosis, erosion of the skin caused by the pacemaker or the lead, embolism, effects of electromagnetic interference and cardiac tamponade. 3 Handling and disposal 3.1 Storage The ambient temperature limits for pacemaker storage and handling are 5 C to 40 C. Store the pacemaker package in a dry place away from direct sunlight. The operating temperature range is 22 C to 45 C. 3.2 Use by date Check the Use by date shown on the pacemaker package before opening the sterile pack. The pacemaker loses approximately 10% of the available battery capacity for every 12-month storage period. 3.3 Opening the sterile pack Before shipment the pacemaker was sterilized as shown on the package. The sterile pack cover carries an illustration of the opening instructions. Before opening the sterile pack, check for any signs of damage that might invalidate the sterility of the contents. If there is any uncertainty about the sterility, do not implant the pacemaker. Non-sterile pacemakers should be returned to Vitatron. 3.4 Registration When completing the European Pacemaker Patient Identification Card, print all relevant details with a ballpoint pen (black is preferred). All the required codes are on the inside of the first sheet. Use the enclosed stickers to identify the pacemaker serial number. When completed, please ensure that the sheet marked National Registry Centre is sent to the appropriate national registration centre (addresses are on the first sheet). English 6

7 3.5 Handling Normal handling is unlikely to damage the pacemaker, but do not implant the pacemaker under the following circumstances: The pacemaker has been dropped on a hard surface from a height of 30 cm or more. This could damage the pacemaker components. The storage package has been pierced or altered. This could render the pacemaker non-sterile. The Use by date has expired. This could adversely affect the pacemaker longevity and sterility. 3.6 Explant and disposal Remove the pacemaker before burial or cremation. In some countries, removal of battery-operated implantable devices is mandatory because of environmental concerns; please check local regulations. In addition, the cremation process could cause the battery to explode. Dispose of depleted batteries and worn-out devices according to local regulations. Notes: Vitatron implantable devices are for single use only. Do not resterilize and reimplant explanted devices. Please return explanted devices to Vitatron for analysis and disposal. 4 Suggested implant procedure Implant techniques vary according to the physician s preference, the patient s anatomy and the patient s physical condition. For a more extensive description of implant procedures and methods, please refer to the professional literature on the subject. 4.1 Lead compatibility and polarity Vitatron C-series pacemakers are compatible with unipolar or bipolar IS-1 leads (acute or chronic). The programmed polarity is specified on the pacemaker package. When unipolar leads are connected to the pacemaker the polarity should not be programmed to bipolar. When the pacing polarity is reprogrammed from unipolar to bipolar the pacemaker checks if a bipolar lead is actually implanted by measuring the bipolar lead impedance. When the measured lead impedance is below 200 Ω or above 2 kω the programmer assumes that no bipolar lead is connected and displays a warning. Warning: Pacemakers co-implanted with an ICD device must be set to bipolar pacing. 4.2 Lead connection Refer to the lead manual for information on how to implant the lead and test its performance. Connect the leads in the following way: 1. If implanting a dual chamber pacemaker, correctly identify the atrial and ventricular leads and the corresponding pacemaker connector holes (see Figure 1). A single chamber pacemaker is shown in Figure 2. 7 English

8 Figure 1. Dual chamber lead connection Figure 2. Single chamber lead connection 2. If implanting a dual chamber pacemaker, start by connecting the ventricular lead. 3. Make sure that the lead connector is clean. 4. Push the lead firmly into the pacemaker connector. The lead connector can be lubricated with saline solution or sterile water, if required. 5. If lead insertion is difficult, check to see if the setscrew is blocking the lead. If so, insert the torque wrench and loosen the setscrew with one or two counterclockwise revolutions, until the connector hole is unobstructed. 6. Make sure that the lead connector has been fully inserted and that the terminal pin is visible behind the connector block (see Figure 3). Figure 3. Lead insertion 1 Dual chamber connection 2 Single chamber connection 7. Carefully push the torque wrench through the self-sealing plug without damaging the plug (see Figure 4). English 8

9 Figure 4. Tightening the setscrews 1 Dual chamber 2 Single chamber 8. Tighten the setscrews by turning the torque wrench clockwise until it begins to click. 9. Again check that the lead connector has been fully inserted and that the terminal pin completely fills the hole behind the connector block (see Figure 3). 10. Make sure that the lead is securely fastened by gently pulling it. 11. Now repeat steps 3 to 10 for the atrial lead. Warning: The use of silicone grease or medical adhesive is strictly prohibited. Cautions: Only use the torque wrench supplied with this pacemaker. The torque wrench is designed to slip when overtorqued to prevent damage to the socket or the setscrews. Care should be taken when there is a need to loosen a setscrew because if unscrewed too far it may disengage from the connector block. Bending the wrench may break it. The torque wrench is designed for single use only. If the torque wrench is dropped onto the floor it should not be used. 4.3 Securing the pacemaker Use the suture hole to secure the pacemaker to the underlying tissue to minimize rotation and migration of the device after implant. Use normal surgical needles to penetrate the suture hole. Caution: When using the suture hole, take care not to damage the connector, or the self-sealing plugs, with the needle tip. 4.4 Post-implant configuration When the pacemaker detects the connection of an implanted lead, post-implant configuration starts automatically. Once configuration has ended, after about two hours, the pacemaker automatically programs the implant date. Setting the implant date activates the diagnostic features. 5 Measuring methods Important parameters such as pulse duration, pulse amplitude and sensitivity are factory measured at the standard conditions of 37 C, 60 min -1, 3.75 V, 0.4 ms, 2.0 mv, VVI, 100% pacing, 500 Ω load. 9 English

10 Pulse duration Pulse duration is measured at one third of peak voltage according to standard EN (2003) (see Figure 5). Figure 5. Pulse duration and amplitude 1 V peak 2 Pulse duration 10 µs 3 Pulse amplitude Pulse amplitude The pulse amplitude is defined as the voltage deflection from the base line measured 10 µs into the pulse (see Figure 5). The amplitude according to standard EN (2003) is 0.90 x this value at a pulse duration of 0.4 ms and with a 500 Ω load. Sensitivity The atrial and ventricular sensitivity are defined as the voltage amplitude of a standard EN (2003) test signal that is just sufficient to be sensed by the pacemaker (see Figure 6). Figure 6. P-wave and R-wave test signal 15 ms 2 ms 1 Amplitude Notes: When measuring the pacing and sensing parameters with pacing systems analyzers it should be realized that considerable differences may be observed when the results are compared with the specifications presented in this manual, because the measuring methods employed by such systems may differ from those described here. Lead impedance measurement results may be disturbed by electrocardiogram monitoring equipment. English 10

11 6 Warnings 6.1 Effects of extreme conditions The pacemaker may be affected by abnormal impacts, such as those that can occur in contact sports, and high ambient pressures, such as those that can occur when scuba diving. Note: The maximum absolute pressure that the pacemaker can withstand is 300 kpa. 6.2 Area restrictions Patients should consult a physician before entering an area where there are signs placed prohibiting patients with an implanted pacemaker. 6.3 Sterilization Vitatron has sterilized the package contents with ethylene oxide before shipment. This device is for single use only and is not intended to be resterilized. 6.4 Environmental and medical therapy hazards Pacemakers use spontaneous cardiac signals to inhibit or trigger pacemaker output. There are some signals existing in the environment, and during some forms of medical treatment, that have similar characteristics. Certain types of electromagnetic interference (EMI) can damage the pacemaker and could interfere with its operation, possibly leaving the patient without pacing therapy. In some circumstances, these signals can interfere with the pacemaker function. Contact Vitatron if there is concern about any particular patient Home and occupational environment High voltage power transmission lines can generate enough EMI to interfere with pacemaker operation if approached too closely. Communication equipment such as microwave transmitters, linear power amplifiers, or high-power amateur transmitters can generate enough EMI to interfere with pacemaker operation if approached too closely. Commercial electrical equipment such as arc welders, induction furnaces, or resistance welders can generate enough EMI to interfere with pacemaker operation if approached too closely. Home appliances that are in good working order and properly grounded do not usually produce enough EMI to interfere with pacemaker operation. There are reports of pacemaker disturbances caused by electric hand tools or electric razors used directly over the pacemaker implant site. Electronic Article Surveillance (EAS) Some types of EAS equipment, such as those found at store entrances and exits, can temporarily inhibit the pacemaker or cause the pacemaker to partially restore. Vitatron pacemaker wearers should walk through theft prevention systems, preferably through the middle, and not linger close to the theft prevention system. If a pacemaker wearer feels weak or dizzy, move away from the system. Cellular phone Keep the cellular phone 15 cm away from the pacemaker. Cordless phones Short range phones intended for domestic use are safe to use. For cordless phones that can transmit up to 8 km, keep the phone 30 cm from the pacemaker. Portable and cellular phones transmitting above 3 W Keep the antenna 30 cm from the pacemaker by doing the following actions: Hold the phone to the ear opposite the side of the pacemaker. Carry the phone in a pocket away from the pacemaker. (In standby or listen mode the phone is still capable of transmitting.) 11 English

12 Note: Patients experiencing dizziness or palpitations while using a cellular or cordless phone, should move the phone antenna further from the pacemaker. Similar symptoms may occur in close proximity to radio or radar transmitters, and in the presence of strong magnetic fields. Moving away from the source will restore normal pacemaker function Hospital and medical therapy hazards The influence of medical equipment on pacemaker performance varies considerably according to the type of unit and the energy levels employed. It is advisable in all cases to monitor the pacemaker function during the procedure and to check the pacemaker after the procedure. The following medical devices are likely to be a source of interference. Defibrillation (external) Do not defibrillate with the paddles placed on the skin above the pacemaker. Place the paddles at least 15 cm away from the pacemaker and afterwards check that it is functioning properly. Defibrillation currents may cause changes in myocardial tissue with a subsequent loss of capture (increased stimulation threshold) and possibly, a loss of sensing (decreased amplitude of the intracardiac signal). Such changes are usually only temporary. Following defibrillation, perform a normal patient follow-up. Diathermy People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and the diathermy can cause tissue damage, fibrillation, or damage to device components, which could result in serious injury, loss of therapy, and the need to reprogram or replace the device. Electrosurgical cautery If possible, do not use an electrocautery unit when replacing a pacemaker. Currents generated from such units can cause a permanent loss of output. Spontaneous changes in the programmable parameter values may be observed following cauterization. Electrosurgical cautery could induce ventricular arrhythmias or fibrillation, and may cause asynchronous or inhibited pacemaker operation. If use of electrocautery is necessary, keep both the current path and ground plate as far from the pacemaker and leads as possible. In addition, program the pacemaker to an asynchronous mode (DOO/VOO/AOO). High radiation source Large doses of therapeutic and diagnostic radiation can adversely influence pacemaker function. Therefore shield the pacemaker during exposure, and carefully monitor pacemaker function after exposure to large radiation doses. Continue to monitor the pacemaker function for several weeks, since changes induced by radiation may not be immediately apparent. Lithotripsy Lithotripsy can permanently damage the pacemaker if the pacemaker is at the focal point of the lithotripsy beam. If lithotripsy is required, follow these procedures: Program the pacemaker to single chamber, non-rate responsive mode VVI/AAI or VOO/AOO before treatment. Keep the focal point of the lithotripsy beam at least 5 cm away from the pacemaker. Magnetic resonance imaging (MRI) Do not use magnetic resonance imaging (MRI) on patients who have this device implanted. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias. MRI may also cause damage to the device. Computed tomographic x-ray (CT scan) If the patient undergoes a CT scan procedure and the device is not directly in the CT scan x-ray beam, the device is not affected. If the device is directly in the CT scan x-ray beam, oversensing may occur for the duration of the time in the beam. If the duration of the time in the beam is longer than 4 s, take appropriate measures for the patient, such as enabling an asynchronous mode for pacemaker-dependent patients or enabling a non-pacing mode for non-pacemaker-dependent patients. These measures prevent false inhibition and false tracking. After completing the CT scan, restore the desired parameters. English 12

13 Radiofrequency ablation The radiofrequency ablation procedure in a pacemaker patient may cause any of the following events: The pacemaker will pace asynchronously above or below the programmed rate. The pacemaker will revert to asynchronous operation. The pacemaker will reset. The pacemaker will prematurely trigger Replace PM indicators. Reduce the risks with the following procedures: Program the pacemaker to a non-rate responsive, asynchronous pacing mode prior to RF ablation. Avoid direct contact between the ablation catheter and the implanted lead or pacemaker (the advised minimum distance is 1.3 cm between catheter and lead tip). Position the ground plate so that the current pathway does not pass through or near the pacing system (place the ground plate under the patient s buttocks or legs). Manage the risks with the following precautions: Have a Vitatron programmer available for emergency programming. Have defibrillation equipment available. Transcutaneous Electrical Nerve Stimulators (TENS) The effects of TENS used in close proximity to the pacing system are dependent on the type of pulse train employed. The most probable effect is a temporary switch, by the pacemaker, to its interference mode (fixed rate pacing at the programmed rate). Temporary inhibition of the pacemaker is, however, also possible. Vitatron recommends closely monitoring the pacemaker function during nerve stimulation. Note: Because of the possible effects on pacemaker function, pacemaker patients should not be allowed to use TENS at home without adequate medical supervision. 7 Technical information Table 1. Mode Vitatron C60 DR Vitatron C50 D Vitatron C20 SR Vitatron C10 S DDDR DDIR DDD a a DDI DOO VDDR VDD VVIR b VVI a a VVT VOO AAIR b AAI 13 English

14 Table 1. Mode (continued) Vitatron C60 DR Vitatron C50 D Vitatron C20 SR Vitatron C10 S AAT AOO OOO c a Delivery setting. b Limited rate response. c In the OOO mode the pacemaker is effectively switched off. Table 2. Physical characteristics Model number Vitatron C60 DR Vitatron C50 D C60A1 C50A1 Vitatron C20 SR Vitatron C10 S C20A1 C10A1 Dimensions 50.9 x 45.9 x 7.25 a mm 46.8 x 45.9 x 7.25 a mm Mass 28.6 (±0.5) g 27.3 (±0.5) g Volume 12.7 (±0.5) cm (±0.5) cm 3 Surface area 33.1 cm cm 3 X-ray identification b VF VF Connector IS-1 dual chamber IS-1 single chamber a Connector thickness may vary. b See Figure 7 for exact location. Figure 7. Location of x-ray identification 1 Dual chamber pacemaker 2 Single chamber pacemaker English 14

15 Table 3. Pacing and sensing parameters Parameter name Range Delivery settings per model Vitatron C60 DR Vitatron C50 D Lower rate 40 (5) 130 min min min -1 Vitatron C20 SR Vitatron C10 S Maximum pacing rate 90 (5) 170 a min min min -1 Maximum tracking rate 90 (5) 190 min min -1 Pulse amplitude 0.5 (0.25) 4.0 (0.5) 8.0 V 3.75 V 3.75 V Pulse duration 0.1 (0.05) 1.0 ms 0.4 ms 0.4 ms Atrial sensitivity Uni: 0.5 (0.1) (0.5) 7.5 mv Bi: 0.25, 0.3 (0.1) (0.5) 7.5 mv 0.7 mv 0.7 mv Ventricular sensitivity 1.0 (0.5) 10.0 mv 2.0 mv 2.0 mv Sensing/pacing polarity unipolar, bipolar The programmed polarity is specified on the pacemaker package. Atrial blanking on VP 50 (25) 300 ms 150 ms Atrial blanking on VS 25 (25) 150 ms 50 ms Ventricular blanking on AP 20 (5) 50 ms 30 ms Ventricular Safety Pacing On, Off On Atrial refractory period 250 (10) 500 ms 330 b ms 330 ms Ventricular refractory period 250 (10) 500 ms 260 ms 330 ms Maximum sensed AV delay 40 (5) 260 ms 120 ms Maximum paced AV delay 80 (5) 300 ms 160 ms SAV/PAV offset 20 (5) 50 ms 40 ms Adaptive AV delay Off, Median c, Fast d Median Conditional hysteresis e 0-(5)-30 min -1 0 min -1 a 130 min -1 for the C10 S. b Applies only to atrial-only modes. c Median = 5 ms per atrial rate change of 10 min -1. d Fast = 10 ms per atrial rate change of 10 min -1. e Conditional hysteresis is only applicable in VVI, VVT, AAI and AAT modes. Table 4. Tolerances (valid between 22 C and 45 C throughout the pacemaker lifetime) Parameter Tolerance Lower rate [min -1 ] Programmed value ±15 ms Maximum pacing rate [min -1 ] Programmed value ±15 ms Maximum tracking rate [min -1 ] Programmed value ±15 ms 15 English

16 Table 4. Tolerances (valid between 22 C and 45 C throughout the pacemaker lifetime) (continued) Parameter Tolerance Pulse amplitude [V] Programmed value 1.0 : +40%/ 10% Programmed value > : +20%/ 10% Programmed value > : +10%/ 10% Programmed value > 7.0 : +10%/ 20% Pulse duration [ms] Programmed value -0.02/+0.04 Atrial sensitivity [mv] Programmed value ±(10% +0.16) at 37 C a Ventricular sensitivity [mv] Programmed value ±(20% +0.16) at 37 C a Blanking period [ms] Programmed value ±15 Refractory period [ms] Programmed value ±15 Sensed or paced AV delay [ms] Programmed value ±15 SAV/PAV offset [ms] Programmed value ± 15 Lead impedance [Ω] Measured value ±(20% +20) Conditional hysteresis [ms] Programmed value ± 15 Battery voltage [V] Measured value ±0.03 a Add ±10% over temperature range 22 C to 45 C. Table 5. Exposed materials Item Can Connector Material Titanium Polyether-Urethane (PUR) and silicone rubber Table 6. Magnet mode Parameter Magnet pacing mode Magnet rate, battery status Good Magnet rate, battery status Ageing Magnet rate, battery status Replace PM Rate Fixed rate pacing in programmed mode. 100 min -1 (600 ms) 95 min -1 (630 ms) 86 min -1 (700 ms) Warning: In magnet mode the pacemaker operates in an asynchronous pacing mode. If the intrinsic rate is higher than the magnet rate, this may induce ventricular tachycardia or ventricular fibrillation. Table 7. Electrical specifications Characteristic Value Output capacitor 3.4 µf Input impedance: atrium 100 kω English 16

17 Table 7. Electrical specifications (continued) Characteristic Value Input impedance: ventricle 100 kω Current/Energy consumption DDDR DDD VVIR VVI Pacing a 25.2 µa 24.2 µa 16.2 µa 15.3 µa Inhibited 13.8 µa 12.8 µa 10.3 µa 9.3 µa a 100% pacing at 60 min -1, 3.75 V, 0.4 ms, 500 Ω. Table 8. Power source Characteristic Value Cell type Pi 223 lithium iodine Voltage 2.8 V (RRT a 2.6 V) Capacity 1.4 Ah (RRT a 0.1 Ah) Battery manufacturer MECC a RRT = Recommended Replacement Time. Table 9. Calculated lifetime Model Pacing mode Calculated lifetime (years) 100% pacing 50% pacing 100% inhibited c 70 a min b min a min b min a min -1 Vitatron C60 DR DDDR Vitatron C50 D DDD Vitatron C20 SR VVIR Vitatron C10 S VVI a Conditions: 2.5 V, 0.5 ms, 500 Ω. b Conditions: 2.5 V, 0.4 ms, 500 Ω. c During periods in which the pacemaker senses high frequency atrial rhythms, especially AF, there will be an increase in power consumption. This will result in a reduction in battery lifetime. As an example, battery life could be reduced by 15% if the pacemaker were to sense an AF rhythm of 300 min -1 through 25% of the pacemaker lifetime. Table 10. Emergency settings Mode a VVI AAI Lower rate 60 min min -1 Pulse duration 1.0 ms 1.0 ms Pulse amplitude 7.5 V 5.0 b V Sensitivity 2.0 mv 0.7 mv 17 English

18 Table 10. Emergency settings (continued) Mode a VVI AAI Refractory period 400 ms 400 ms Polarity (pacing and sensing) unipolar unipolar a Mode is VVI, except for single chamber pacemakers programmed to AXX mode. b Keeps value if greater than 5 V. Table 11. Minimum partial restore settings a Mode b VVI AAI Lower rate 60 min min -1 Magnet rate 90 min min -1 Pulse duration 1.0 ms 1.0 ms Pulse amplitude 7.5 c V 7.5 c V Sensitivity 2.0 d mv 2.0 d mv Refractory period 350 ms 350 ms Polarity (pacing and sensing) unipolar unipolar a If pacemaker operation is interrupted, the pacemaker tries to restore the programmed settings. The figures in this table represent the minimum settings after a partial restore. b Mode is VVI, except for single chamber pacemakers programmed to AXX mode. c Tolerance ±20%. d Tolerance ±80%. Warning: Emergency and partial restore pacing polarity are unipolar. This can cause an undesirable interaction with a co-implanted ICD (Implantable Cardioverter Defibrillator). Table 12. Interference and high rate protection Parameter Value Interference detection frequency 15.4 ±0.5 Hz (923 ±29 min -1 ) Pacing rate during interference Pacing mode during interference Ventricular high rate protection a 205 ±10 min -1 Pacemaker behaves as if no spontaneous cardiac activity is present. If interference continues, the eventual pacing rate is either the sensorindicated rate or the lower rate, whichever is the higher. DOO(R) if programmed to a dual chamber pacing mode. VOO(R) if programmed to a ventricular mode. AOO(R) if programmed to an atrial mode. OOO if programmed to the OOO mode. a Atrial high rate protection for single chamber pacemakers programmed to AXX mode. English 18

19 8 Terms of Limited Warranty A. This Limited Warranty provides the following assurance to a patient who receives a Vitatron pulse generator: (1) Should the pulse generator fail to function within normal tolerances at any time due to a defect in materials or workmanship, Vitatron will issue a credit as defined in Subsection A.3. Battery depletion will occur with time and, as used in Subsection A.2., is not considered a defect in material or workmanship. (2) A credit as defined in Subsection A.3. will be issued if the pulse generator is explanted within 60 months due to battery depletion, in accordance with the pulse generator s Recommended Replacement Time Indicator. Each warranty period commences on the implant date. The warranty on battery depletion is made void if the pulse generator has been programmed to output values higher than the standard factory output settings for an accumulated period of longer than 3 months. (3) The credit is equal to the purchase price and is issued against the purchase of any Vitatron pulse generator requested as a replacement, or, at the discretion of Vitatron, is a functionally comparable replacement Vitatron pulse generator at no charge. Normally the credit will be issued only to the hospital or physician purchasing the replacement pulse generator. B. To qualify for this Limited Warranty, the following conditions must be met: (1) The pulse generator must be implanted prior to its Use By date. (2) The pulse generator for which credit is sought must be returned to Vitatron in a shockproof package within 30 days of its removal and shall then become the property of Vitatron. Furthermore, a Request for analysis form should be completed and returned with the pulse generator. C. This Limited Warranty is limited to its express terms. In particular: (1) Vitatron shall not be liable to any person for any medical expenses or any direct or consequential damages resulting from implant or removal of any pulse generator or caused by any defect, failure or malfunction of any pulse generator, whether a claim for such damage is based upon warranty, contract, tort or otherwise. The exclusive remedy for any defect, failure or malfunction of any pulse generator shall be as stated. (2) This Limited Warranty is made only to the patient in whom the pulse generator was originally implanted and is expressly in lieu of any and all representations, conditions, and warranties express or implied, including any implied warranty or merchantability or fitness for a particular purpose, whether arising from statute, common law, custom or otherwise. The remedies set forth in this Limited Warranty shall be the exclusive remedies available to any person. No person has any authority to bind Vitatron to any representation, condition or warranty except as contained in this Limited Warranty. (3) This Limited Warranty is only valid as to the pulse generator and is not applicable, in whole or part, to any other Vitatron product including, but not limited to, Vitatron pacing leads. (4) Vitatron shall inspect the returned pulse generator and determine whether credit is due under the terms of this warranty. No credit will be issued if Vitatron finds evidence of improper handling or of material alteration to the pulse generator. (5) This Limited Warranty is only applicable to pulse generators sold through a sales organization authorized by Vitatron. Vitatron as used in this warranty shall mean Vitatron B.V. in The Netherlands. (6) The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. Users may benefit from statutory warranty rights under the legislation governing the sales of consumer goods. If any part or term of this Limited Warranty is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining portion of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. 19 English

20 9 Explanation of symbols Symbol Explanation The NASPE/BPEG generic pacemaker code Model number Serial number Implantation date Date of manufacture Use by Sterilized using ethylene oxide Sterilized using gas plasma Storage temperature Product identification number Do not reuse Open here Caution: see instructions for use English 20

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