Product Description

This VIOGRAPHY™ STERLY series is designed to cover a large field of applications for hospitals,
Central Sterilizer Supply Department(CSSD), Dental Clinics, Plastic Surgery Clinics, Gastro Clinics and Medical Centers.

This VIOGRAPHY™ STERLY series has a chamber volume range from 30 liters to 100 liters.
The sterilizer operates with H2O2 and Plasma Inverter system as the sterilizing agent at a temperature of 50 °C.

Feature Summary

  • Chamber volume: 30 liters to 100 liters
  • Temperature range: 50°C ~ 55°C
  • No utilities needed except electricity
  • User friendly control system with touch screen display
  • Built-in printer
  • Stainless steel chamber
  • Safety Glass door
  • Conforms to standards: NP EN ISO 9001:2000,EN ISO 13485:2003, EN ISO 14937, EN 61010-2-040,EN 61010-2-042, 73/23/EEC • 89/336/EEC  • 98/37/EEC • 93/42/EEC

Applications

  • Central Sterilizing Supply Department(CSSD)
  • Dental Clinic
  • Plastic Surgery Clinic
  • Operating Theater
  • Gastro Clinic
  • Out Patient Clinic

Features and Benefits

1. Intelligent System

  • Direct Plasma Sterilization System
  • One Touch & One Stop Interface
  • E.U.I.S. (Easy User Interface System)
  • 7-inch Touch Screen Display
  • Emergency Manual System
  • Medical embedded Software System
  • USB Memory & Embedded Printer
  • Plug-In Ready3. VIO ECO-Friendly Sterilizer
  • Low Temperature System
  • Non-Toxic Poison
  • Low Concentration Sterilization Agent

2. Applications

  • Simple & Compact Design
  • Sterilization Cabinet
  • Easy Mobility

3. VIO ECO-Friendly Sterilizer

  • Low Temperature System
  • Non-Toxic Poison
  • Low Concentration Sterilization Agent

4. Safety

  • One Touch Door System
  • Double Door System
  • Over Current and Over Temperature Protectors

Low Temperature Plasma Sterilization Process

 

 

CONTROL SYSTEM

The control system runs through Software Operating System.It controls and monitors the physical parameters of the sterilization process.
It also performs the operation sequence of the machine, according to the selected
program, and features:

  • Data acquisition
  • Digital inputs and outputs for sterilizer control
  • Measures chamber pressure and temperature
The control system controls all system functions, monitors system operations and audibly alerts the operator of cycle malfunctions.

Temperature Sensors

The temperature measuring circuits are both linear and designed with components having a high precision.

CONTROL PANEL

The control system operates with an easy to use full color touch screen(7” TFT LCD) found on the operator control section.
The touch screen control panel supports English language only.

The Following Information is displayed:

  • Program Mode
  • Cycle Name
  • Power Failure
  • Door On/Off
  • Temperature
  • Operation Time
  • Cycle Time Parameter

Alarms

The control system provides automatic process checking and failure detection.
The protected process informs with both audible and screen messages.

The range of alarms includes:

  • Temperature sensor failure
  • Phase time-outs
  • Door(s) not properly closed
  • Power failure
  • Over temperature sensor failure

Sterilization Program

COMMON Program (P1)
COMMON Program provides fast turn around for instruments which need surface sterilization.
It includes telescopes used in laparoscopic, orthopedic or ophthalmology procedures.

COMMON Program (P2)
REGULAR program is designed to sterilize general surgical instruments with flexible and rigid lumens.
This program is designed to handle Single Channel Flexible Lumens/Endoscopes.

COMMON Program (P3)
MASTER Program is designed to sterilize general rigid (not-flexible) surgical instruments which has long rigid lumens.

Cycle Documentation Printer and USB Memory

With an embedded printer, it prints a detailed history of each cycle performed by the instrument.
The following information and set parameters
are printed when the sterilization cycle begins:

  • Sterilizer serial number, load number, name
  • Software version
  • Real time
  • Selected program
  • Sterilization temperature and time
  • Alarms

Thereafter, the sterilizer starts performing the sequence of the cycle operations.
The measured values of temperature are printed at fixed time intervals, according to various phases of the sterilization process.
The printed data contains the following:

  • Date
  • “OK”, for a complete cycle
  • “FAIL”, for an aborted cycle

Loading Equipment

Pull Out Trays Stainless steel trays (2) Trays are equipped with tracks for easy loading and unloading.
Materials: AISI 304 stainless steel.

Sterilizer Documentation

A number of copies of the manuals are provided. Operator and service manuals are in English.
Furthermore, the sterilizer is provided containing the following:

  • Operators manual
  • Technical manual
  • Serial number for specific sterilizer
  • Factory test report prior to shipping

Chamber Construction

Chamber Materials

Standard Configuration Materials: Chamber: Stainless steel

Chamber Heating

The chamber is pre-heated by heaters to 50 °C.

Safety Features

  • Door Safety Systems
  • Chamber door cannot be opened when the cycle is active
  • H2O2 is not allowed into the chamber when the door is open
  • A cycle cannot start if the door is open or not properly locked
  • Double-door safety is implemented through interlocks which prevent both doors from being opened simultaneously

Emergency Shut-Off:

Easily accessible emergency switches for immediate cycle shut-off.

Standards and Codes

This products meet the following provisions and standards:

  • ISO 9001:2008 – Quality Management Systems
  • ISO 14001:2004 – Environmental Management Systems
  • EN ISO 13458:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes

Directives

  • Eu Directive 2006/95/EC – Low Voltage Directive
  • 93/42/EEC
  • EU Directive 2004/108/Ec – Electromagnetic Compatibility

Maintenance / Service Plan

Skilled service special provide periodic inspections and adjustments for low-cost performance.
A detailed service and maintenance plan is included in the operator manual.

Packaging For Shipment

The sterilizer is packed in a wooden crate for shipping/transportation.

Warranty

VIOGRAPHY™ STERLY warrants that each device is carefully tested, inspected, and that leaves the factory in proper working condition.
VIOGRAPHY™ STERLY certifies that the device is guaranteed to be free from defects in material and workmanship, for one year from installation date but not more than 18 months from shipping date, against faulty components and assembly.
Extended warranty periods are optional. The warranty does not include and does not replace routine treatment and preventive maintenance to be performed according to “Preventive and Periodical Maintenance” instructions mentioned in the device’s accompanying manual.

Sterilant

Hydrogen Peroxide is an sterilizing agent.
The sterilizing agent is for single use only, this should not be used multiple times.

Utility Data / Requirements

All utilities used must meet all the specifications mentioned in the operator manual.
The user is subject to the full warranty statement found in the documentation delivered with the equipment.

 

 

 
 

Certification


VGS-30 model CB Certificate

VGS-50 model CB Certificate

ISO 13485 N.B DNVGL

GMP

Medical Instrument Certificate

Medical Instrument Production Certificate
 
 

Exhibition

SINCE 2016

MEDICA 2016, 2017
Dusseldorf, Germany

         
 

SINCE 2017

IDS 2017
International Dental Show
Cologn, Germany

         
 

SINCE 2017

Arab Health 2017, 2018
Dubai

     
 

KIMES 2017, 2018
Korea International Medical& Hospital Equipment Show
Seoul, Korea