Model note · Autoclave
Tuttnauer Elara11 pre and post vacuum Class B tabletop autoclave
The Elara11 is a countertop steam sterilizer for dental, ophthalmic and medical clinics and small laboratories. It removes air with vacuum pulses before sterilising, dries with heat and vacuum, and makes steam electrically from distilled water held in a built in reservoir. It has five sterilisation programs plus a Bowie and Dick test and a vacuum test, a built in printer, and a double safety door lock.
The model
Maker, model and type.
- Maker
- Tuttnauer Ltd. (Tuttnauer USA Co. Ltd.)
- Model
- Elara11 pre and post vacuum Class B tabletop autoclave
- Device type
- Autoclave
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Chamber | 280 mm diameter, 504 mm deep, 28.5 L (7.5 gal) | Source |
| Maximum allowable working pressure | 2.8 bar (40 psi); steam generator safety relief valve also 2.8 bar | Source |
| Electrical | 230 VAC plus or minus 5%, 60 Hz, 2300 W, 10 A, dedicated circuit with 15 A breaker recommended | Source |
| Maximum instrument load per tray | 1.58 kg (3.5 lb) | Source |
| Shipping weight | 78 kg (171 lb) | Source |
| Programs (2009 clearance) | 134 degrees C for 4 min (flash and wrapped with dry) and 121 degrees C for 20 min (unwrapped, wrapped, delicate); Bowie and Dick at 134 degrees C for 3.5 min; vacuum test | Source |
| Vacuum test | Pulls down to 0.17 bar, holds 5 min to equalise, then measures for 10 min without heating | Source |
| Main components | Pressure vessel with steam jacket, heating elements, clean and waste water reservoirs, vacuum pump and water pump | Source |
| FDA clearance | K090783, cleared August 2009, product code FLE, 21 CFR 880.6880, validated to AAMI/ANSI ST55:2003 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Only qualified technicians with the technician manual may service the unit; the user troubleshooting chart covers minor faults only. Source
- Fit a ground fault protection device in the supply panel to reduce electrical shock risk. Source
- FDA noted that no cleared wraps, pouches or indicators existed for the specific parameters of programs 1 to 5, which are not standard FDA cycles. Source
- Clean and replace the gasket only when the autoclave and door are cold, to avoid burns. Source
Sources
Where this note comes from.
- Tuttnauer Elara11 Operation and Maintenance Manual MAN205-0497002EN Rev H
- FDA 510(k) K090783 summary, Tuttnauer Elara11
Not covered: Error messages come from the operator manual's troubleshooting chart, which extracts as a jumbled table; each mapping was checked but should be confirmed against the printed manual. Service level codes, calibration and part numbers sit in the technician manual, which was not read. No FDA recall or MAUDE records matched the Elara brand. Cycle times listed are from the 2009 clearance and current firmware may differ.
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.
Autoclave