Model note · Urodynamics System
Andromeda Ellipse urodynamic system
The Andromeda Ellipse is a compact, mini trolley urodynamic system made in Germany and first sold in 1996. It records pressure, uroflow and EMG, converts the signals to digital form, shows them on a built in LCD screen, prints on a thermal printer and stores studies in memory for later transfer to a PC over a network. Pressures are taken with microtip (catheter tip) transducers rather than water filled lines. It supports flowmetry, cystometry, pressure flow studies, urethral pressure profiles and EMG. The original manufacturer website is no longer online, so support now depends on distributors.
The model
Maker, model and type.
- Maker
- Andromeda medizinische Systeme GmbH (Taufkirchen, Germany)
- Model
- Ellipse urodynamic system
- Device type
- Urodynamics System
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Tests supported | Flowmetry, cystometry, pressure flow, urethral pressure profile and EMG | Source |
| Pressure sensing | Microtip catheters (MTCs) for pressure; surface electrodes for EMG | Source |
| Maximum pressure channels | 8 (NHS CEP 2009 table) | Source |
| Uroflowmeter type | Weight sensor | Source |
| Monitor size | 15 cm | Source |
| Display, printing and storage | LCD screen, thermal printer and internal memory; data can be downloaded to a PC over a network | Source |
| Options listed in 2009 | Profilometer, EMG amplifier, video capture and user calibration | Source |
| Report and export formats | PDF and Word reports, text and ICS export, all via laptop | Source |
| Configuration and warranty (UK, 2009) | Mini trolley; 2 year warranty; supplied in the UK by Mediplus | Source |
| Pump and power (reseller listing for a refurbished unit, not manufacturer data) | H2O pump 1 to 200 ml/min; 230 V, 50/60 Hz, 160 W; 22 kg | Source |
| FDA clearance | K964522 for Ellipse 4, 21 CFR 876.1620, Class II, cleared 21 March 1997 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Reading from a catheter tip sensor depends on where the tip lies; the top of the bladder can read about 10 cmH2O lower than the bottom, and this cannot easily be corrected. Source
- Transducers calibrated at room temperature must stay accurate at body temperature, so check readings after the catheter has warmed in the patient. Source
- Denser fluids such as contrast medium make a weight based flowmeter over read flow and volume unless the density setting is changed. Source
- Electrical safety tests and repairs should only be done by competent technicians. Source
Sources
Where this note comes from.
- FDA 510(k) K964522 summary of safety and effectiveness, Ellipse 4
- NHS Centre for Evidence-based Purchasing, Urodynamic systems evaluation report CEP09038 (December 2009)
- Gammie et al., ICS Guidelines on Urodynamic Equipment Performance, Neurourol Urodyn 2014
- Praiston reseller listing, reconditioned Andromeda Ellipse (used for pump and power figures only)
- openFDA MAUDE search, manufacturer Andromeda (no matches)
Not covered: Sources are thin. The former manufacturer website (andromeda-ms.de) no longer hosts Andromeda content, and no operator or service manual was found, so there are no error codes, part numbers or model specific calibration routines; first checks and failing parts rely on general ICS and NHS urodynamic guidance. The FDA 510(k) covers the earlier Ellipse 4 and is a scanned 1997 summary without numeric specs. Channel count, display and options come from a 2009 NHS evaluation. Pump, power and weight come only from a used equipment reseller and need confirming. No FDA recalls or MAUDE reports were found for Andromeda.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Urodynamics System
Other models of this device.
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