These Frequently Asked Questions (FAQs) cover Pacemakers and Leads from Dextronix, manufactured by BIOTRONIK. The most common and shortest questions are listed first. Topics requiring a longer explanation (e.g., graphs and photos) may be found in the Appendix at the end of this document.
Dextronix handles all technical support for BIOTRONIK pacemaker products used in veterinary medicine. For more information contact Dextronix Technical Support at (866) 744-3427 or techsupport@dextronix.com. Please do NOT contact BIOTRONIK directly, they will redirect to us.
Download the complete FAQ shown below
1. SUPPORT DOCUMENTATION ON THE INTERNET:
Question: Can I look up technical aspects of the Dextronix pacemakers, leads, and programmer on the Internet?
Answer: Extensive support links are on the Dextronix web site at:
https://dextronix.com/support/
For further information or support call Dextronix Technical Support at (866) 744-3427.
2. NO PACING, NO CAPTURE - AUTOMATIC LEAD CHECK:
Question: I implanted the lead and checked the threshold, R wave, and impedance – all looked very good. But after tunneling and reinserting the lead into the pacemaker, we have no capture, no pacing at all. The lead has not moved as seen in fluoroscopy, and the connection inside the header looks okay. What is wrong?
Answer: The pacemaker has activated AUTOMATED LEAD CHECK and reverted to unipolar mode. The quickest solution is to put the edge of the pacemaker into the pocket, you will see immediate pacing and capture on the ECG. This is a safety feature, designed to continue pacing in case of a lead fracture. You can easily program the pacemaker back to Bipolar mode or turn off LEAD CHECK before the implant. If it still fails to capture after placement in the pocket, trying both unipolar and bipolar, there is another problem, please call Technical Support. For more information on this topic Dextronix’s technical support document at the following link:
3. NO RATE RESPONSE (RR) IN THE O.R. – HOW TO TURN OFF RADIO FREQUENCY VERSUS THE WAND:
Question: Why is there no rate response (RR) or rate increase seen in the Operating Room (O.R.) when jiggling the pacemaker or patient?
Answer:
4. RENAMIC ICONS ON THE TOP RIGHT OF THE PROGRAMMER
Question: On the Renamic programmer, what are the icons on the top right of the programmer?
Answer: In the top right corner, above the clock, is the familiar Bluetooth® Symbol. That function will be activated in the future, it is presently dormant. Just to the left of that is a radar-signal appearing symbol, with the letter “H”, indicating the Head (Wand) is active. It should have two (2) or greater bars when communicating with the pacer. To the left of that is a circle, empty or grayed-out. It will be replaced by a green bar graph showing the signal strength of the RF connection. At this point the RF is active, you may move the wand and programmer to another table or across the room. You can also operate the built-in Pacing System Analyzer (PSA) via this RF connection, without the wand. To turn off the RF connection and return to the wand, refer to NO RATE RESPONSE (FAQ# 3, above).
5. VERY LITTLE RATE RESPONSE (RR) FOR STANDARD VVIR WITH ACCELEROMETER:
Question: At follow-up while in standard VVIR mode with an accelerometer, the rate histogram shows very little rate response in the middle and fast ranges. How can I get it to go faster?
Answer:
6. FASTER PACING IN CLOSED LOOP STIMULATION (CLS) MODE:
Question: At follow-up in CLS mode, the rate histogram shows very little rate response in the middle and fast ranges. How can I get it to go faster?
Answer:
7. TURN THE PACEMAKER COMPLETELY OFF:
Question: How can I turn the Pacemaker completely off?
Answer: This varies with different Pacemaker models. Go to PARAMETERS > MODE > ALL MODES, select OFF > PROGRAM (blue button in bottom row). If OFF is not available, programming the pacemaker to the lowest possible amplitude and pulse width (e.g., 0.2V / 0.1ms) will prevent pacing and capture, in most cases. Contact Dextronix if this does not solve the problem.
8. INCREASE BATTERY LONGEVITY ON THE SHELF (SHELF LIFE):
Question: How can I increase the battery longevity on the shelf?
Answer: Ensure the rate response (VVIR) is not on, it should be programmed to VVI. Program it to the lowest outputs, as described in the FAQ answer for TURN THE PACEMAKER COMPLETELY OFF (FAQ# 6, above). Be sure to re-program the pacemaker back to normal outputs (4.0V / 0.4ms) before implanting.
9. INCREASE BATTERY LONGEVITY WHEN IMPLANTED:
Question: How do I increase the battery longevity when the pacemaker is implanted?
Answer: Standard in the industry is to set the amplitude at two-times (2x) the threshold, at 0.4ms or 0.5ms. For example, if the threshold is 0.9V at 0.4ms, you would set the Output to 1.8V. In the case of a high threshold, increase the pulse width (not the output in Volts) to the next available setting. Doubling the pulse width will double (2x) the energy but doubling the amplitude will quadruple (4x) the energy and deplete the battery faster. Use of the Automatic Capture Control (ACC) where the output hovers slightly over the threshold and increases the output if loss of capture occurs, can greatly increase the longevity, see AUTOMATIC CAPTURE CONTROL (ACC) (FAQ# 9, below).
10. AUTOMATIC CAPTURE CONTROL (ACC):
Question: What is Automatic Capture Control (ACC)?
Answer: Once activated, this algorithm looks to ensure capture on every single beat, while programmed slightly above threshold. The factory setting for ACC is ON, but it only works with a pulse width of 0.4ms. A pulse width of 0.5ms might gain more consistent capture than 0.4ms, but ACC will not work with 0.5ms. When active, ACC searches for an evoked response (capture) right after the output pulse. If none is seen within 100ms, the device emits an output pulse 0.5V higher than the current threshold, along with a pulse width of 1.0ms to ensure capture.
A more detailed version can be found in the following article:
When signal analysis is successful, voltage step-down occurs at every elicited beat, firstly in large (0.6V) and secondly in smaller (0.1V) steps, until an ineffective stimulus (loss of capture) is delivered. The last effective pulse is defined as the threshold, and the programmed safety margin (default 0.5V) is added to determine the current output. ACC works at 0.4ms pulse width only. EVERY paced beat is checked for ER detection, and a pack-up pulse at 1.0ms is delivered in the instance of loss of capture. In the event three (3) consecutive beats require delivery of the back-up pulse, signal analysis occurs again, and a new threshold measurement is triggered to update the current pacing output; if test start amplitude equals the current threshold, VCC reverts to a safety output as test start voltage +1.2V.
Reference: EP Europace, Vol 18, Issue 10, Oct 2016, p 1551-1560
In contrast to other companies, the BIOTRONIK algorithm works on a beat-to-beat basis, and again runs a threshold every day, at midnight. This is shown to be 97% effective in the Ventricle – the best in the industry.
In addition to being a great safety feature, the ACC adds significant longevity to the battery, usually increasing battery life by one (1) or two (2) years. This can be visualized on the programmer parameter page, in the lower right corner when you activate the ACC. The longevity is calculated at 100% pacing at the programmed output. If the patient has any intrinsic activity the pacer will inhibit, and the battery will last longer.
11. CHANGING PARAMETERS OR RUNNING TESTS IF A PACEMAKER IS NOT AVAILABLE:
Question: Can I practice changing parameters or run tests if a pacemaker is not available?
Answer: Yes. On both the Renamic and ICS-3000 programmers, from the MAIN screen, before you interrogate, and before the FOLLOW UP tab appears, go the very bottom row, click on the DEVICE LIST tab. From there, select the pacemaker model you are working with. This will allow you to enter patient data, change parameters, view diagnostics, etc. You can also partially run threshold, sensing and impedance tests, but they will be incomplete as there is no lead attached.
12. FUNCTIONS MISSING WHILE PROGRAMMING THE PACEMAKER WHILE IT IS STILL IN THE PACKAGE:
Question: While practicing programming the Pacemaker while it is still in the package, it appears some functions are not active?
Answer: This is because the pacemaker is in “Shipment Mode” to conserve battery. The pacemaker stays this way until the leads are inserted, then the pacemaker automatically “wakes up” fully.
13. COMPATIBILITY WITH OTHER MANUFACTURER’S LEADS:
Question: Are Dextronix Pacemakers compatible with other manufacturer’s leads?
Answer: Yes. All the pacemaker companies meet the VS1 (Voluntary Standard), or IS1 (International Standard),
3.2mm, which are identical nomenclature for the same connector specifications. This means the sealing rings are on the body of the lead, not inside the pacer header. One company had leads labeled “3.2mm”, but not VS1/IS1, where the rings were part of the header, and therefore not compatible with the VS1/IS1 standard. It is worth noting, but unlikely you would encounter one of those leads today. If there is a question on the lead being VS1/IS1, you should contact the manufacturer or Dextronix.
Dextronix pulse generators will automatically recognize the lead type and configuration of any modern pacing lead with IS-I connector (all current Biotronik, Medtronic, St. Jude Medical, Boston-Scientific, and Sorin products are IS-I equipped and acceptable).
WARNING: Using leads from Pacetronix, or any other brand not listed above, in combination with Dextronix devices will void all warranties made by Dextronix and will not be supported. Proper pacemaker therapy depends on lead quality, and it is of outmost importance that the implanted lead is new, unused, and not re-sterilized (which may damage the steroid coating).
14. COMPATIBILITY WITH OTHER MANUFACTURER’S TORQUE WRENCH:
Question: Is it okay to use another manufacturer’s torque wrench on Dextronix pacemakers (or when is a #2 torque wrench not a #2 torque wrench)?
Answer:
APPENDIX A14: BIOTRONIK Torque Wrench or (When is a #2 Wrench not a #2?)
Dextronix pacemakers are manufactured by BIOTRONIK to very tight, exacting specifications, more so than some other companies. It was noted that inserting a BIOTRONIK lead into a BIOTRONIK lead port would compress air, tending to push the lead back out. This was eliminated by having a hole all the way through the set screw, allowing air to escape. But doing so allowed the torque wrench to pass all the way through the screw, down into the port, and blocking the lead. This issue was alleviated by adding a slight “shoulder” or “bevel” to the shaft of the wrench (see Figure A14-1, below)
15. BUILT-IN PACING SYSTEM ANALYZER (PSA):
Question: Does my programmer have a built-in pacing system analyzer (PSA)?
Answer: Most of the Renamic (white) programmers, and some of the ICS-3000 (blue) programmers have a PSA incorporated inside of the Programmer. For the ICS-3000 with the PSA, you will see an attached component labeled “ICS3000 IMPLANT MODULE” at the very bottom right corner of the programmer. Programmers with the PSA will show “PSA Docking Station” in the bottom right corner. For the Renamic, rotate the unit around so you are looking at the right side of the case. At the far right, above the small ECG symbol, there is a round receptacle (for surface ECG cable), followed by 3 USB Ports. If the area to the left of the round receptacle is smooth, there is no PSA in this programmer. If you see a small panel 4.5 inch wide with another round receptacle and a small round spring-loaded cover, that is the PSA. Cables for the PSA are included with the Renamic and available from Dextronix.
16. USING THE BUILT-IN PACING SYSTEM ANALYZER (PSA):
Question: How do I use the built-in pacing system analyzer (PSA)?
Answer: The PSA, whether built-in or free standing, connects as follows:
17. SOME OF THE SETTINGS WILL NOT PROGRAM OR OPERATE BEFORE THE IMPLANT:
Question: Why doesn’t the rate increase when I wiggle the dog in the operating room (O.R.)?
Answer: This answer is similar to NO RATE RESPONSE (RR) (FAQ# 3) with more specifics. Dextronix/BIOTRONIK pacemakers need to have a lead inserted to be able to take an impedance measurement, and for all the functions to operate. Until the lead is inserted, the device is still in the “Shipment Mode”, waiting to be activated. This is to extend battery longevity while on the shelf. So, when you plug in the lead, all functions will be activated automatically – you do not have to do anything else.
Some newer Dextronix pacemakers, in conjunction with the Renamic programmer, can communicate wirelessly (even from across the room) once it has been interrogated. You need to interrogate with the wand like you normally do, then you can remove the wand.
Note that the sensor input is suspended while the device is in the Interrogation mode. The normal fix for this is to remove the wand, but with the wireless communication you would have to move the wand FAR AWAY (e.g., down the hallway). The solution is to turn OFF the wireless (radio frequency or RF) communication. When that is done, the pacemaker will revert to standard communication through the wand. To restore RF just replace the wand over the device, wait for the small bar graph to appear, then remove the wand, and the Rate Response will become active.
To turn off RF (temporarily or permanently), also see NO RATE RESPONSE (RR) (FAQ# 3):
18. FINDING A FUNCTION OR PARAMETER FOR A DEXTRONIX PACEMAKER ON THE INTERNET:
Question: How do I find online information from BIOTRONIK?
Answer: The best source for online information (NOT technical support) may be found at the following link:
19. VERIFICATION OF THE FIXATION OF THE HELIX/SCREW INTO THE ENDOCARDIUM:
Question: How do I know the lead is screwed into tissue?
Answer: Just because the helix is extended as viewed per fluoroscopy does not mean it is properly fixated. The best way to verify proper fixation is to gently pull back about an inch on the lead, while observing the L shape at the junction of the superior vena cava and right atrium. If the curve starts to disappear (i.e., “flatten out”) then it is fixated properly. Do not pull back anymore, but gently advance the lead until the “L” shape is restored. You are now ready to test threshold, R wave, and impedance.
20. CLOSED LOOP STIMULATION (CLS):
Question: What is Closed Loop Stimulation (CLS)?
Answer: Closed-loop stimulation (CLS) is a proven sensor concept for rate adaptive pacing that measures changes in the unipolar right ventricular impedance, which correlates to changes of the right ventricular contractility known as inotropic change and reflects the autonomic nervous innervation of the heart. It can mimic heart rate changes due to emotion, stress, and REM sleep. A more detailed description may be found in Appendix A23 at the end of this document.
21. REMAINING BATTERY LIFE:
Question: How much battery life is remaining?
Answer: Touch Parameters, then see bottom right corner to see how many years are left. If no programmer is available, see MAGNET RESPONSE (FAQ# 26, below)
22. MAGNET RESPONSE FOR DEXTRONIX PACEMAKERS:
Question: What is the response of Dextronix pacemakers to an external magnet?
Answer: All Dextronix pacemakers have 3 programmable options for the Magnet Response, indicated as AUTO, SYNCHRONOUS, and ASYNCHRONOUS. The nominal/default setting from the factory is AUTO, which will pace VOO (Asynchronous) at a rate of 90 beats per minute for a strong battery, and 80 beats per minute for a pacer that has reached the Elective Replacement Time (ERT). When ERT is reached, there is a minimum of 6 months remaining, and often more, depending on output settings and percentage pacing. The final indicator shown on the programmer is EOS (i.e., End of Service), formerly known as EOL (i.e., End of Life). If EOS/EOL is seen on the programmer, battery failure is imminent, urgent replacement is recommended. (Editor’s note: when patients heard the nurse or tech tell the doctor that the pacer was at End of Life, they thought they were talking about the patient’s life and became upset. Thus, the industry changed the terminology to End of Service to lessen the patient’s anxiety.)
23. VDD PACEMAKERS AND LEADS:
Question: Does Dextronix have a VDD pacemaker and lead?
Answer: Dextronix does not make a dedicated VDD Lead. However, all Dextronix pacemaker models have a VDD mode available.
24. HOW TO CHANGE OR RESET LOGIN PASSWORDS ON RENAMIC PROGRAMMERS:
Question: How do I set up the Primary Password and Recovery Password on a Renamic programmer?
Answer: Use the following steps:
1. Launch and select Guest Access.
2. Touch MORE (in the right column).
3. Touch RELEASE (upper middle).
4. Keyboard pops up, type in: “erasePassWD”.
5. Press the Enter Key.
6. The system will restart and prompt you to set the Primary Password and Recovery Password.
It is the sole responsibility of the user to keep a record after changing or resetting the Recovery Password. Dextronix
is not responsible and cannot assist customer to regain access to their Renamic after the Recovery Password has
been changed.
25.UNEXPECTED THRESHOLD RISE IN PACING LEADS WITH MEDTRONIC AND OTHER MANUFACTURER’S LEADS:
Question: Does the threshold rise when using Medtronic or another manufacturer’s leads?
Answer: All modern endocardial pacing leads come with Dexamethasone steroid coating to reduce the inflammatory effects raising the thresholds in the first weeks after implantation. We suspect re-sterilization of pacing leads with methods other than ETO may impair or even damage the Dexamethasone coating rendering it dysfunctional and possibly cause a rise of the threshold values over time. Re-sterilization of pacing leads and then use in combination with Dextronix or Biotronik pulse generators will void all warranties made by Dextronix.
WARNING: We highly discourage the reuse of explanted pacing leads or use of new but expired pacing leads that
have been re-sterilized. Dexamethasone coatings degrade over time and their ability to perform properly in an
implant when past their expiration date is unknown to us.
Customers mixing Dextronix/Biotronik pulse generators with Medtronic (or other manufacturer’s) pacing leads must
ensure that the Medtronic pacing lead is new, not past its expiration date, and not re-sterilized to avoid unexpected
threshold rises after implantation.
PDA Occluder