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Related Manuals for Abbott Endurity Core
Summary of Contents for Abbott Endurity Core
- Page 1 Assurity™, Assurity MRI™, Endurity™, Endurity™ Core, Endurity MRI™, Zenex™, Zenex™ MRI, Zenus™, Zenus™ MRI Pacemaker Allure™ RF, Allure Quadra™ RF, Quadra Allure™, Quadra Allure MP™, Quadra Allure MP™ RF Cardiac Resynchronization Therapy Pacemaker User's Manual...
- Page 2 ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third-party trademark, which is property of its respective owner. Pat. http://www.abbott.com/patents © 2023 Abbott. All Rights Reserved.
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Page 3: Device Description
Not all of the products listed as MR Conditional are approved for MR Conditional use in all countries or regions. Before performing an MRI scan on patients implanted with any of these devices, contact Abbott Medical or consult your regulatory authorities to determine if the products have been certified as MR Conditional. - Page 4 Table 1. Pulse generator descriptions Name Model Number Description Connector Type MRI Status PM1172 Single‑chamber IS‑1 MR Conditional Endurity MRI™ pulse generator PM1182 Single‑chamber IS‑1 MR Conditional Zenus™ MRI pulse generator PM1272 Single‑chamber IS‑1 MR Conditional Assurity MRI™ pulse generator with RF telemetry PM1282 Single‑chamber...
- Page 5 Table 1. Pulse generator descriptions Name Model Number Description Connector Type MRI Status PM2182 Dual‑chamber pulse IS‑1 MR Conditional Zenus™ MRI generator PM2272 Dual‑chamber pulse IS‑1 MR Conditional Assurity MRI™ generator with RF telemetry PM2282 Dual‑chamber pulse IS‑1 MR Conditional Zenex™...
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Page 6: Intended Purpose
Intended Purpose The Abbott pacemakers are implantable pulse generators that, when used in combination with compatible pacing leads, are intended to detect and treat chronic symptomatic bradyarrhythmia and various atrioventricular conduction abnormalities by providing sensing and pacing in the right ventricle and/or right atrium. -
Page 7: Intended Patient Population
CRT devices are indicated in patients with congestive heart failure, a reduced left ventricular ejection fraction (LVEF) and a prolonged QRS duration. The device is most commonly implanted within a device pocket in the pectoral region. NOTE: For patient-specific recommendations, such as primary and secondary prevention, refer to the respective current clinical guidelines of the Heart Rhythm Society (HRS), the American Heart Association (AHA), American College of Cardiology (ACC) or European Society for Cardiology (ESC), as well as those of other national cardiology associations. -
Page 8: Intended User
▪ Clinician, which includes implanting physician, cardiologist or electrophysiologist; and allied health professionals ▪ ▪ Abbott Medical field staff such as technical service specialists, field clinical engineers, and sales representatives ▪ ▪ MRI clinicians, which include radiologists and MRI technologists... -
Page 9: Mri Safety Information
Data Security Abbott Medical takes a broad and deep approach to ensuring the safety, security, and privacy of the patient information and data on our devices and systems connecting patients to healthcare providers and clinics. Patients, clinical staff, and hospital IT staff do not require any special training, and do not need to configure... - Page 10 The programmer displays an alert after this occurs and automatically re‑enables wireless communication. Abbott Medical pulse generators are shipped with the latest software updates installed. If a pulse generator software update is available, the programmer will automatically offer to install it on existing pulse generators.
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Page 11: Ultrasound Treatment
Implantation ▪ ▪ Ensure that a separate standby external defibrillator is immediately available. Diathermy ▪ ▪ Avoid diathermy, even if the device is programmed off, as it may damage tissue around the implanted electrodes or may permanently damage the pulse generator. Electrosurgery ▪... -
Page 12: Magnetic Resonance Imaging (Mri)
MR Conditional system is conditionally safe for use in the MRI environment when used according to the instructions in the MRI‑Ready Systems manual. The Abbott Medical MR Conditional system includes an Abbott Medical MR Conditional device connected to one or more Abbott Medical MR Conditional leads. ▪... - Page 13 Table 3. Backup VVI settings Parameter Setting Single‑chamber pulse generators CRT‑Ps Dual‑chamber pulse generators Mode Base rate 67 min 67 min Ventricular pacing chamber LV —> RV Pulse configuration Unipolar RV Unipolar Tip LV Unipolar Tip Sense configuration Unipolar Tip RV Unipolar Tip Pulse amplitude 5.0 V...
- Page 14 Elective Replacement Indicator (ERI) ▪ ▪ At ERI, the nominal life of the device is six months. When the device exhibits signs of ERI it should be replaced expeditiously. ▪ ▪ Patient follow‑up visits should be scheduled at an appropriate frequency so that ERI can be detected well before end‑of‑life (EOL).
- Page 15 Communication with the device can be affected by electrical interference and strong magnetic fields. If this is a problem, turn off nearby electrical equipment or move it away from the patient and the programmer. If the problem persists, contact Abbott Medical. Suboptimal RF Communication ▪...
- Page 16 Table 4. Possible causes and solutions for suboptimal RF communication Possible Causes Solutions People or objects interfere with Make sure that the space between the Merlin Antenna and the device is free the communication between the from interfering objects/people. Merlin Antenna and the device. The Merlin Antenna is too far Move the Merlin Antenna closer to the device.
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Page 17: Storage And Handling
Do not implant a device that has been dropped on a hard surface while outside of its intact shelf package, or from a height of more than 61 cm (24 in.) while within its intact shelf package. Sterility, integrity, or function cannot be guaranteed under these conditions, and the device should be returned to Abbott Medical for inspection. -
Page 18: Environmental Hazards
Return the device to Abbott Medical. Environmental Hazards Abbott Medical devices are equipped with special shielding and filters that significantly reduce the adverse effects of electromagnetic interference (EMI) on the operation of the device. However, high‑energy induced or conducted currents can reset the programmed parameters and damage the pulse generator and tissue surrounding the implanted lead electrodes. -
Page 19: Environmental And Medical Therapy Hazards
Therapeutic Radiation ▪ ▪ See Warnings (page 9) Hospital and Medical Environments High Radiation Sources ▪ ▪ Do not direct high radiation sources such as cobalt 60 or gamma radiation at the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse generator, place lead shielding over the device to prevent radiation damage, and confirm the device is functioning after treatment. - Page 20 Home and Industrial Environments ▪ ▪ A variety of devices produce electromagnetic interference (EMI) of sufficient field strength and modulation characteristics to interfere with proper operation of the pulse generator. These include: high‑powered radio, television, and radar transmitters/antennas; high‑voltage transmission lines; home appliances;...
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Page 21: Electronic Article Surveillance (Eas)
▪ ▪ Reversion to an asynchronous operation ▪ ▪ Device electrical reset ▪ ▪ Premature triggering of the elective replacement indicator RF ablation risks may be minimized by: ▪ ▪ Programming a non‑rate responsive, asynchronous pacing mode prior to the RF ablation procedure ▪... -
Page 22: Cellular Phones
Metal Detectors ▪ ▪ Advise patients that metal detector security systems such as those found in airports and government buildings emit signals that may interact with pulse generators and CRT‑P devices. To minimize the possibility of interaction, advise patients to simply walk through these areas at a normal pace and avoid lingering. - Page 23 ▪ ▪ Advise patients to not carry earbuds or headphones in their breast pocket or near implant area, and to not allow earbuds or headphones to drape around the patient's neck so they hang on the chest. These devices may contain a magnet or magnetic material, or may emit RF signals that can interfere with the pulse generator and may cause the pulse generator to pace abnormally.
- Page 24 the screen during the session, the device is not RF‑compatible. Once you have established telemetry, select Interrogate. The unit's Measured Data will be displayed on the FastPath™ Summary screen and should indicate normal voltage and battery status, and the programmed parameters should be identical to the Shipped Settings displayed on the programmer's on‑screen help.
- Page 25 Capture/Sensing Thresholds. Capture and sensing thresholds should be determined with a PSA before implanting the device. Connect the negative (black) PSA terminal to the portion of the lead terminal pin corresponding to the tip electrode. Connect the positive (red) terminal to the ring electrode portion of the lead pin for bipolar leads or to an indifferent electrode.
- Page 26 Programming For a list of programmable parameters and their programmable values, refer to the programmer's on‑screen help. Setting Lead Type. When you interrogate the device for the first time, the programmer will prompt you to set the Lead Type. CRT‑Ps: the right and left ventricular lead types are independently set. Because some parameters are determined by the Lead Type, for example, Pulse Configuration, you should set this parameter when the device is implanted.
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Page 27: Device Replacement
Pulse Amplitude. If the AutoCapture™ pacing system or Cap Confirm pacing system are not in use, determine the capture threshold before programming the Pulse Amplitude. Program Pulse Amplitude to yield a suitable safety margin for reliable, long‑term capture. Reassess capture thresholds periodically. Noninvasive Program Stimulation (NIPS). -
Page 28: Potential Adverse Events
Potential Adverse Events The following are potential complications associated with the use of any pacing system: ▪ ▪ Additional Surgery ▪ ▪ Allergic Reaction ▪ ▪ Arrhythmia ▪ ▪ Cardiovascular Injury such as Thermal Injury ▪ ▪ Decompensated Heart Failure ▪... - Page 29 Table 5. Pulse generator headers Assurity MRI PM2272 Assurity MRI PM1272 Endurity PM2162 Endurity MRI PM1172, PM1162 Endurity MRI PM2172 Endurity Core PM1140, PM1152 Endurity Core PM2140, PM2152 Zenex MRI PM1282 Zenex MRI PM2282 Zenus MRI PM1182 Zenus MRI PM2182...
- Page 30 Lead Receptacle Connector Types Table 6. Lead receptacles Legend Receptacle Lead type Connector V (IS‑1 BI) SENSE/PACE Bipolar endocardial IS‑1 in‑line bipolar A (IS‑1 BI) SENSE/PACE Bipolar endocardial; IS‑1 IS‑1 in‑line bipolar OR PLUG plug (when no atrial lead is used) RV (IS‑1 BI) SENSE/PACE Bipolar endocardial in IS‑1 in‑line bipolar...
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Page 31: Programming Guidelines
NOTES: ▪ When connecting leads to the pulse generator, make sure that you plug the correct lead into the correct ▪ lead receptacle. For sensing and pacing, this is important to ensure that atrial and ventricular signals are correctly recorded and that pacing pulses are delivered in the desired chamber. ▪... -
Page 32: Emergency Settings
Emergency Settings The device is equipped with standard, high‑output settings that can be quickly programmed using the programmer's Emergency VVI function. Settings for Emergency VVI can be found in the programmer's on‑screen help. NOTE: When Emergency VVI is selected, diagnostic data are cleared from memory without a warning. Radiopaque Identification Each pulse generator has an X‑ray absorptive marker for noninvasive identification Table 7. -
Page 33: Package Contents
Implantation and Lead Connection Package Contents Devices are shipped in a sterile box containing: ▪ ▪ One device ▪ ▪ Connector kit containing: – #2 torque wrench – – ▪ ▪ Literature The non‑pyrogenic label is applicable to device only and is not applicable to to the torque wrench within the device package. - Page 34 CAUTION: After all leads have been implanted and before they are connected to the device, establish and document the baseline morphology for capture and sensing thresholds for each lead using a suitable recording system, such as a 12‑lead electrocardiogram (ECG) or an intracardiac electrogram (IEGM). To connect the device to the leads: 1.
- Page 35 Figure 1. Correct vs. incorrect use of torque wrench 6. Insert the #2 torque wrench through the aperture on the header and into the setscrew on the side of the connector. 7. Turn the wrench clockwise until it clicks. The wrench is torque‑limited and when used correctly will not allow excessive tightening.
- Page 36 Fill out the model/length and implant location of the leads in the corresponding fields on the Patient Identification Card. Patient Follow‑Up Give the completed card to the patient. To obtain a replacement card if a patient loses or damages their card, contact Abbott Medical Technical Support (page 38).
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Page 37: Device Lifetime
At conditions (100% pacing, 2.5 V/0.4 ms in each chamber, 60 bpm, 600 ohm lead impedance), the expected device lifetime is as follows: Table 8. Expected device lifetime Model name Model number Device type Expected device lifetime Endurity Core PM1140, PM1152 15 years Endurity PM1162 15 years Endurity MRI... - Page 38 Table 8. Expected device lifetime Model name Model number Device type Expected device lifetime Assurity MRI PM2272 9.9 years Zenex MRI PM2282 9.9 years Allure RF PM3222 CRT‑P 8.3 years Quadra Allure MP RF PM3262 CRT‑P 7 years Quadra Allure PM3542 CRT‑P 8.6 years...
- Page 39 Patient follow‑up visits should be scheduled at an appropriate frequency so that ERI can be detected well before end‑of‑life (EOL). Clearing ERI When the programmer displays a message that the device has reached ERI, you are able to clear ERI. For additional information on clearing ERI, refer to the programmer's on‑screen help.
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Page 40: Technical Support
Before returning the explanted pulse generator to Abbott Medical, clean it with disinfectant solution, but do not submerge it. Fluid in the lead receptacles of the pulse generator or adapter impedes analysis of the product. WARNING: Pulse generators contain sealed chemical power cells and capacitors and therefore should never be incinerated. - Page 41 ▪ medical.abbott/manuals For additional assistance, call your local Abbott Medical representative. If, in the course of use of this device, you have reason to believe that a serious incident occurred, please report it to the manufacturer. For customers in the European Union, report the serious incident to your national authority as well as to the manufacturer.
- Page 42 Table 9. Device measurements Model Dimensions (h x l x t) Weight (g) Displaced volume (cm (mm) PM1152 41 x 50 x 6 PM1162 41 x 50 x 6 PM1172 41 x 50 x 6 PM1182 41 x 50 x 6 PM1272 47 x 50 x 6 10.4...
- Page 43 Table 9. Device measurements Model Dimensions (h x l x t) Weight (g) Displaced volume (cm (mm) PM3222 55 x 59 x 6 PM3262 56 x 59 x 6 PM3542 56 x 59 x 6 PM3562 56 x 59 x 6 Device Materials Table 10.
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Page 44: Battery Information
Lead Compatibility Table 11. Lead compatibility Model Lead compatibility PM3242 IS‑1 and IS4‑LLLL PM3262 PM3542 PM3562 All other devices IS‑1 Battery Information Table 12. Battery information Model Power source Manufacturer; Voltage at Voltage to trigger Model Beginning of Life Estimated Replacement Indicator PM3222... - Page 45 Table 12. Battery information Model Power source Manufacturer; Voltage at Voltage to trigger Model Beginning of Life Estimated Replacement Indicator PM3542 PM3562 All other devices 2.60 V RF Operating Frequencies Nearby equipment emitting strong magnetic fields can interfere with RF communication, even if the other equipment complies with CISPR emission requirements.
- Page 46 The following is applicable to Canada only: This device may not interfere with stations operating in the 400.150‑406.000 MHz band in the meteorological aids, meteorological‑satellite, and earth exploration‑satellite services and must accept any interference received, including interference that may cause undesired operation. This device complies with Industry Canada license‑exempt RSS standard(s).
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Page 47: Temperature Effects
As required by EN45502‑2‑1 Clause 27.4, the device interference mode of operation is characterized as follows: ▪ ▪ The atrial noise mode is “pacing off” for EMI frequencies below approximately 30 Hz and “fixed rate pacing” for frequencies above approximately 30 Hz. ▪... - Page 48 Test Pulse Sensitivity Sensitivity was measured using the test pulse shown in the figure below. Table 15. Test pulse sensitivity (mV)—Positive signals, ventricular channel, 37°C Programmed nominal Typical 0.35 0.40 0.65 12.5 8.75 12.9 16.25 Table 16. Test pulse sensitivity (mV)—Negative signals, ventricular channel, 37°C Programmed nominal Typical -0.5...
- Page 49 Figure 2. Test pulse description 1. 2.0 ms 2. 13 ms...
- Page 50 Figure 3. Device pulse shape description 1. Pulse Duration 2. 50% Pulse Amplitude 3. Pulse Amplitude...
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Page 51: Battery Discharge Curve
Battery Discharge Curve Figure 4. Battery discharge curve 1. Voltage (mV) 2. % Depth of Discharge (mAh) Compliance Statements The following is applicable to Canada only: This device may not interfere with stations operating in the 400.150‑406.000 MHz band in the meteorological aids, meteorological‑satellite, and earth... - Page 52 exploration‑satellite services and must accept any interference received, including interference that may cause undesired operation. This device complies with Industry Canada license‑exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
- Page 53 Symbols The symbols below and harmonized symbols may be found on the product or product label. For harmonized symbols, refer to the Universal Symbols Glossary at https://manuals.sjm.com. Symbol Description Single chamber, rate modulated device Dual chamber, rate modulated device Single chamber, communicating device Dual chamber, communicating device Cardiac resynchronization therapy pacemaker, right atrial, right ventricular, left ventricular...
- Page 54 IS4-LLLL Lead connector accepts quadripolar IS4‑LLLL leads. SJ4‑LLLL is equivalent to IS4‑LLLL. Abbott Medical SJ4 and IS4 connector cavities comply with ISO27186:2010(E). NBG - ventricular pacing, ventricular sensing, inhibited response NBG - dual‑chamber pacing, dual‑chamber sensing, dual‑chamber response, no rate‑modulation...
- Page 55 The device contains a battery and the label is affixed to this device in accordance with European Council Directive 2006/66/EC. Return the device to Abbott Medical when explanted or dispose as potentially biohazardous material in accordance with medical practice and applicable local,...
- Page 56 Symbol Description For prescription use only This equipment is certified for type certification pursuant of Article 38‑24 of the Japan Radio Law Korea Certification mark for electrical devices Australian Communications and Media Authority (ACMA) and New Zealand Radio Spectrum Management (RSM) Regulatory Compliance Mark (RCM) Beginning of life Left ventricle parameter Right atrium and right ventricle parameter...
- Page 57 Symbol Description Indication of an interval or delay. When an interval or delay is present between two chambers, the image is modified to include a space or gap. Sensed atrial to ventricular interval AV Delay: Paced/Sensed Pulse amplitude and pulse width Pulse amplitude/width, right ventricular, left ventricular Sensitivity Refractory period...
- Page 58 Symbol Description S (A/V)- Single chamber (A or V) IS‑1connector A- Atrial IS‑1 connector; V- Ventricular IS‑1 connector A- Atrial IS‑1 connector; LV- Left ventricular IS‑4 connector; RV- Right ventricular IS‑1 connector A- Atrial IS‑1 connector; LV- Left ventricular IS‑1 connector; RV- Right ventricular IS‑1 connector The torque wrench is intended to secure lead connectors and port plugs within the device header.
- Page 59 Symbol Description Product literature Product of Malaysia Product of USA Medical Device Unique Device Identifier Storage temperature Location of implant Patient identification card label Patient identification...
- Page 60 Symbol Description Date Healthcare center or physician Physician telephone Lead model/length Pacemaker Pacemaker Cardiac Resynchronization Therapy Pacemaker Malaysian Communication and Multimedia Commission (MCMC) certification mark for products meeting applicable MCMC Technical Codes The purpose of the compliance label is for the easy identification of the equipment which is approved for use in Singapore by Infocomm Media Development Authority (IMDA).
- Page 61 Symbol Description specifications published by IMDA. This label also identifies the supplier of the approved or registered equipment. Double sterile barrier...
- Page 64 2023-08 ARTEN600242617 A *600242617*...
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Questions and answers
My mother has model number PM2272 cardiac pacemaker. Can she have MRI Done. She has been in hospital for 3 days. Doctors want do a MRI until they hear from manufactory. Makes no since. They have her card info.
@Tori Garvin, of couse 1.5T and 3T
The Abbott Endurity Core PM2272 is not listed among the MR Conditional devices in the provided context. Before performing an MRI scan on a patient with this pacemaker, it is necessary to contact Abbott Medical or consult regulatory authorities to determine if it is approved for MRI use.
This answer is automatically generated
@Mr. Anderson PM2272 isn't Endurity Core, It's Assurity MRI; of couse 1.5T and 3T MRI Scan
Abbott pacemaker PM2272, is it safe for Hyperbaric oxygen therapy? If so, at what ATA- 2 or 2.5 safe? Please email the information to me if possible. Thank you!
can batteries be replaced in your model no. PM2272 pacemaker