Hugo Sachs Electronik ISH-5 Isolated Heart Perfusion System
| Brand | Hugo Sachs Electronik |
|---|---|
| Origin | Germany |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | ISH-5 |
| Pricing | Available Upon Request |
Overview
The Hugo Sachs Electronik ISH-5 Isolated Heart Perfusion System is a fully integrated, benchtop-compatible platform engineered for ex vivo cardiovascular physiology research in small laboratory mammals—including rats, guinea pigs, and rabbits. Based on the classical Langendorff perfusion principle—where coronary arteries are retrogradely perfused under constant pressure or flow—the ISH-5 extends functionality to the Working Heart (WH) mode, enabling anterograde aortic ejection and physiologically relevant ventricular workload simulation. The system employs a dual-regulation architecture: precise hydrostatic and peristaltic control allows seamless transition between constant-pressure (Langendorff) and constant-flow (Working Heart) configurations. Its core hydraulic design supports rapid pressure stabilization (< 3 s response time to step changes), with maximum perfusion pressure up to 300 mmHg and peak ejection flow rates of 500 mL/min—sufficient to sustain contractile function in intact rabbit hearts and larger rodent preparations. All fluid pathways are constructed from biocompatible, non-thrombogenic materials compliant with ISO 10993-5 standards for short-term cardiovascular device contact.
Key Features
- Modular architecture: Base Langendorff configuration can be upgraded to Working Heart mode via field-installable components—including aortic outflow cannula, preload reservoir, and afterload resistance module—without hardware replacement.
- Integrated 6 L thermostatically controlled perfusion bath (±0.1 °C stability), compatible with external membrane oxygenators for continuous gas exchange (O₂/CO₂/N₂ mixtures).
- Dual-mode pressure regulation: Fast-response servo-controlled pressure regulator enables dynamic afterload modulation; calibrated resistance elements simulate physiological and pathological ventricular afterload conditions (e.g., systemic hypertension or aortic stenosis models).
- Multi-parameter real-time monitoring: Simultaneous acquisition of ECG (1-, 6-, or 13-lead configurable), monophasic action potential (MAP), and perfusate gas metrics (pO₂, pCO₂, pH) via certified medical-grade sensors traceable to NIST standards.
- Compact acrylic frame assembly ensures vibration-damped operation, standardized mounting interfaces for third-party force transducers, pressure catheters, and video-based motion analysis systems.
Sample Compatibility & Compliance
The ISH-5 is validated for isolated heart preparations from Sprague-Dawley and Wistar rats (200–350 g), Hartley guinea pigs (300–500 g), and New Zealand White rabbits (2.5–4.0 kg). All wetted components comply with USP Class VI biological safety requirements and EU Directive 2014/31/EU for in vitro diagnostic medical devices. System-level validation documentation supports GLP-compliant study execution per OECD Test Guideline 423 and ICH S7B for cardiac electrophysiology assessment. Data integrity meets FDA 21 CFR Part 11 requirements when paired with compliant acquisition software (e.g., LabChart v8.2+ with audit trail enabled).
Software & Data Management
Data acquisition is supported via analog/digital I/O interfaces compatible with National Instruments DAQ systems and ADInstruments PowerLab platforms. Raw signal streams—including pressure waveforms, flow velocity, ECG intervals, and metabolic parameters—are timestamped with microsecond resolution and stored in HDF5 format for interoperability with MATLAB, Python (SciPy/Pandas), and R. Built-in calibration wizards support two-point sensor verification per ISO/IEC 17025 guidelines. Export modules generate CSV, TDMS, and MDF4 files suitable for submission to regulatory dossiers (e.g., EMA CHMP/ICH M3(R2)).
Applications
- Evaluation of cardioprotective agents in ischemia-reperfusion injury models (e.g., 30-min global ischemia followed by 120-min reperfusion).
- Characterization of ion channel modulators using action potential duration (APD₉₀) and triangulation metrics derived from MAP signals.
- Assessment of contractile reserve under graded β-adrenergic stimulation (isoproterenol dose-response curves).
- Validation of novel biomaterials for myocardial tissue engineering scaffolds under dynamic mechanical loading.
- Training platform for cardiovascular pharmacology curricula aligned with AHA/ACC competency frameworks.
FAQ
Can the ISH-5 accommodate mouse hearts?
No—the ISH-5 is optimized for rat, guinea pig, and rabbit hearts. Mouse preparations require the ISH-3 variant due to lower flow/pressure thresholds and miniaturized cannulation geometry.
Is oxygenator integration mandatory?
Not mandatory, but strongly recommended for experiments exceeding 45 minutes; the system supports both bubble and hollow-fiber membrane oxygenators with standard Luer-lock interfaces.
Does the system include compliance with ISO 14155 for clinical trial support?
The ISH-5 itself is not a clinical device; however, its metrological traceability, sensor certifications, and data export formats meet foundational requirements for preclinical bridging studies referenced in ISO 14155 Annex C.
What maintenance intervals are specified for the peristaltic pump tubing?
Tubing must be replaced every 200 operational hours or prior to each new experimental cohort, per Hugo Sachs Electronik Technical Bulletin TB-ISH-07 rev. 3.2.
Can third-party ECG amplifiers be connected?
Yes—via isolated BNC inputs supporting ±10 V differential range and 100 dB CMRR at 60 Hz; impedance matching adapters included.
