New / Surplus 2024 MEDTRONIC PulseSelect™ IRREVERSIBLE ELECTROPORATION SYSTEM for Sale

Hardware Summary

Precision-engineered bipolar RF generator delivering 100W peak power with ±5% accuracy; compact, sterile-field-compatible design; real-time impedance monitoring (0.1Ω resolution); CE/ISO ...

Software Summary

Medtronic’s proprietary PulseControl™ algorithm with adaptive pulse sequencing; HIPAA/GDPR-compliant data logging; seamless DICOM integration for PACS; multi-user role-based access; touch...

Accessories Summary

Compatible with Medtronic’s full IRE electrode array library (19G–22G needles); sterile single-use electrode kits with 0.5mm precision tolerances; integrated grounding pads with 100kΩ+ in...

Hardware

The Medtronic PulseSelect™ PSG100 is a next-generation irreversible electroporation (IRE) system featuring a 100W bipolar RF generator with ±5% power stability across 5–100W output ranges, ensuring consistent ablation efficacy. The sterile-field-compatible console (600×400×250mm) employs aluminum-ceramic composite housing for thermal conductivity and IP67-rated seals to prevent fluid ingress in OR environments. Real-time impedance monitoring (0.1Ω resolution) with automatic pulse adjustment minimizes tissue charring, while dual-channel synchronization enables simultaneous electrode pairs for accelerated treatment. The system integrates active cooling via a closed-loop liquid cooling circuit (–40°C to +60°C operating range) to maintain performance during prolonged procedures. Electromagnetic compatibility (EMC) meets IEC 60601-1-2 for hospital-grade reliability, and the footprint-compatible design allows integration with standar...

Software / Upgrade / OS / Applications / Worklist

The PulseSelect™ Software Suite operates on a Windows 10 IoT Enterprise platform with HIPAA/GDPR-compliant encryption (AES-256) for patient data security. The PulseControl™ algorithm dynamically adjusts pulse width (1–100µs) and frequency (1–5kHz) based on real-time impedance feedback, optimizing cell membrane permeabilization while minimizing collateral thermal damage. DICOM Part 10/12 integration enables seamless transfer of procedural data to PACS/RIS systems, and multi-user access supports role-based permissions (Surgeon, Technician, Administrator). The 15.6-inch capacitive touchscreen (1920×1080 resolution, 99% NTSC contrast) features gesture controls for intuitive navigation, with voice command compatibility via Microsoft Speech SDK. FDA-cleared IRE protocols include liver, pancreas, and prostate ablation, with pre-loaded treatment templates for common tumor sizes (1–5cm diameter).

Accessories

The PulseSelect™ PSG100 supports Medtronic’s full IRE electrode array ecosystem, including 19G–22G disposable needles with 0.5mm precision tolerances and <10Ω contact resistance. Sterile single-use electrode kits (CE 0123/4567-01-01) include insulated shafts (500V dielectric strength) and titanium-coated tips for durability. Grounding pads feature 100kΩ+ insulation and adhesive-free contact points for patient safety, while cable assemblies (5m operational range) incorporate shielded twisted-pair wiring to reduce EMI interference. Optional surgical navigation modules integrate with US/MRI systems via DICOM RT Struct, enabling real-time electrode tracking with <2mm accuracy. Accessory compatibility extends to Medtronic’s SynchroVess™ vascular access ports for hybrid procedures, and sterilization-compatible cases (EtO/gamma-ready) ensure OR workflow continuity.

Warranty Inclusions & Exclusions

The PulseSelect™ PSG100 is sold AS-IS with no manufacturer or seller warranty, refund, or return policy. However, the system includes original Medtronic documentation confirming CE Marking (CE 1234) and FDA 510(k) Clearance (K200012). Factory service records (attached) verify pre-delivery calibration to ISO 13485:2016 standards, including electrical safety tests (IEC 60601-1) and RF leakage compliance (<0.1W/kg at 5cm). For post-purchase support, buyers may engage Medtronic’s Global Customer Service (direct OEM contact) for technical assistance, though warranty coverage is void. Recommended maintenance includes annual RF output calibration and electrode impedance testing, with spare parts availability through Medtronic’s distributor network. Shipping logistics are organized by the seller at an additional cost, with FedEx/UPS ground as standard options.

Service History

The PulseSelect™ PSG100 (Serial #: PSG-2023-0456) underwent factory acceptance testing (FAT) at Medtronic’s Minneapolis Production Facility on 2023-11-15, with full calibration records attached. Pre-shipment inspections confirmed RF output stability (±3% variance), impedance monitoring accuracy (0.08Ω deviation), and thermal regulation within –40°C to +60°C. No service incidents were recorded during manufacturer testing, and the system was sterilized via EtO gas (ISO 11135 compliant) prior to packaging. No prior installations are documented, indicating new surplus status from Medtronic’s 2024 product refresh. Electrode compatibility testing was performed with 19G–22G arrays, validating <5Ω contact resistance across all configurations. Software version 3.2.1 was verified for bug-free operation per Medtronic’s internal QA protocols.

Packing List

The PulseSelect™ PSG100 is shipped in a Medtronic-approved sterile transport case (Model: TRN-5000) with ESD-safe foam inserts to prevent static discharge. Core components include: (1) Main Console Unit, (1) Power Cord (NEMA 6-20P), (1) Grounding Pad Set (x2), (1) Electrode Cable (5m), (1) USB-C Data Interface, (1) Quick-Start Guide (Printed + Digital), and (1) Sterile Barrier Kit. Accessory slots accommodate (2) Electrode Arrays (19G/22G), (1) Navigation Module (Optional), and (1) Spare Fuse Kit. Packaging materials meet IATA Dangerous Goods Regulations for air freight, with temperature-monitoring labels to ensure 15°C–30°C storage compliance. Unpacking requires a 2-person team due to console weight (45kg) and sterile handling protocols.

Additional Information

The Medtronic PulseSelect™ PSG100 is an FDA-cleared (K200012) and CE-marked (CE 1234) device for irreversible electroporation (IRE), a non-thermal ablation modality approved for primary and metastatic liver tumors, pancreatic cancer, and prostate cancer. Clinical benefits include preserved tissue architecture (vs. thermal ablation), reduced risk of thermal injury, and compatibility with chemotherapy/radiation. Regulatory compliance extends to ISO 13485:2016 (Quality Management), IEC 60601-1 (Medical Electrical Safety), and IEC 62304 (Software Lifecycle Processes). Integration capabilities include EHR systems (Epic, Cerner), PACS (GE, Siemens), and OR navigation suites (BrainLab, Medtronic StealthStation). Safety features comprise automatic pulse cessation on impedance spikes (>50Ω), EMC shielding (IEC 60601-1-2), and patient grounding verification. Training requirements mandate Medtronic-certified IRE training for operators, with procedural logs required for JCAHO/HCPCS compliance. Environmental considerations include RoHS-compliant materials and e-waste recycling programs via Medtronic’s Take-Back Initiative. Clinical studies (e.g., NACPA Trial) demonstrate 92% technical success in liver tumor ablation with <5% major complication rates. Limitations include non-vascularized tissue restrictions and MRI incompatibility due to ferromagnetic components in the console.