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T-EDGE Autoclaves 10|11

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T-EDGE Autoclaves 10|11

So much more than just an autoclave
23 and 27 litre chamber capacities

Overview

Get peace of mind with the T-Edge autoclave.

This space-saving, fully automatic tabletop autoclave gives you high speed Class B performance saving you time so you can assist your patients, while meeting current international standards and regulatory requirements to protect your staff and patients. The T-Edge10|11 autoclaves will operate without interruption on a daily basis, offering efficiency and safety.

  • Compliance with the strictest international standards
  • Clinically proven sterilization capabilities
  • High-resolution tactile touchpad
  • Innovative technology
  • Easy-to-use interface
  • Perfected cycle programs for effective cycle times that ensure the safe and complete sterilization of all your instruments
  • Traceability technology that monitors all relevant process parameters. The program logs provide you certainty
  • Flexibility, with integrated water reservoir, the stand-alone autoclave operates independent of location and is easy to install
T-Edge tabletop autoclave - Tuttnauer
T-Edge-10-11-control-panel

Data & Software

As simple to use as your smartphone, the T-Edge 10|11 autoclaves are easy to use and give you easy access to cycle data and status.

  • User-friendly touchpad and control panel. Quickly see programs, cycles times, water levels and more
  • Automatic one-button programs, including test programs
  • Control panel displays programs, cycles times, water levels, and more
  • Advanced documentation and traceability options. For safety and regulatory purposes, scan barcode data (including expiration date) for the patient file during treatment

Technical Specifications

 

T-EDGE10 T-EDGE11
Chamber Dim. ø x L (mm) 250 x 460 280 x 460
Chamber Volume 23 liters 27.2 liters
Dimensions W x H x D (mm) 480 x 500 x 580 mm 421 x 207 x 20.5 mm
Tray Dimensions (W x H x D) 421 x 189x 20.5 mm Wrapped delicate instruments
Weight 53 kg 56 kg
Power Supply 50/60Hz, 230V-1Ph+N+GND 50/60Hz, 230V-1Ph+N+GND
Number of Trays 5 5
Connections 1 Ethernet port, 2 USB ports, WIFI, integrated automatic water filling and drain connection 1 Ethernet port, 2 USB ports, WIFI, integrated automatic water filling and drain connection
Items Supplied Drain tube, tray holder Drain tube, tray holder
T-edge Automatic Autoclave - Tuttnauer

Sterilization Programs

The T-Edge10|11 autoclaves come with 4 pre-set cycle programs, as well as 3 standard diagnostic tests.

Preset Cycles

Cycle Program Temp. Load Type
Unwrapped 134 134 °C Unwrapped Instruments
Wrapped 134 134 °C Wrapped instruments
Unwrapped 121 121 °C Unwapped delicate instruments
Wrapped 121 121 °C Wrapped delicate instruments

Test Cycles

Program Name Temp. Load Type Type of Use
Prion 134 134 °C Solid/porous load For storage
Bowie and Dick 134 °C Chemical indicator in a product challenge device Periodic testing as referred to in ISO 17665-1
Vacuum Test N/A Empty Not applicable

Standards and directives

(a partial list)

Standards

  • EN 13060: 2004+A2: 2010 – Small Steam Sterilizer / ANSI/AAMI ST55
  • EN 61010-1: 2010 Safety Requirements for measurement control
    and laboratory use
  • EN 61326-1 for EMC Requirements for electrical software
  • EN 61010-2-40: 20015 Safety requirements for sterilizers used
    to treat medical materials
  • EN 62304, FDA guidance – Software validation
  • IEC 62366-1 – Usability (User Experience, Human Factor Engineering)

Pressure Vessel

  • All pressure vessels and boilers are certified according to ASME Code section I and section VIII. Div.I, PED 2014/68/EU – Pressure Equipment Directive

Quality Standards

  • EN ISO 13485:2016 Quality Management System – Medical Devices

Directives

  • 93/42/EEC Council Directive concerning Medical Devices

Download Brochure

For more information dowload brochure here