Tuttnauer T-Edge VET-11 User manual

Table Top Steam Sterilizer
Models T-Edge VET-11
Cat.No. MAN205-0504003EN Rev. B
Tuttnauer. Ltd., Har Tuv Industrial Zone, B P.O. Box 170, Beit
Shemesh, 9910101, Israel. )Tel: [phone], ÊFax: 972 2 9904730
+Tuttnauer U.S.A. Co, Ltd., 25 Power Drive Hauppauge, NY, 11788, U.S.A.
)Tel: [phone], ÊFax: [phone]
Operation and Maintenance Manual

Operation and Maintenance
Manual
Table Top Steam Sterilizer
Models T-Edge VET-11
This device is not a medical device and not intended for medical use
Cat. No. MAN205-0504003EN Rev. B January 2023
Tuttnauer. Ltd., Har Tuv Industrial Zone, B P.O. Box 170, Beit Shemesh, 9910101, Israel. )Tel: 972
2 9904611, ÊFax: 972 2 9904730
+Tuttnauer U.S.A. Co, Ltd., 25 Power Drive Hauppauge, NY, 11788, U.S.A. )Tel: [phone], (800)
624-5836, ÊFax: [phone]

Table of Contents
Paragraph Page No.
1. GENERAL INFORMATION 1
1.1 Manufacturer and US Official Correspondence Information 1
1.2 Applicable Regulation and Quality Standards 1
1.3 Legend for Symbols appearing on the Labels and in this Manual 3
1.4 General Description of the Device 5
1.5 Intended Use 6
1.6 Intended Users 6
1.7 Warranty Description 6
1.8 Warranty Statement 7
1.9 Customer Inspection Upon Receival of the Device 7
1.10 Device Specifications 8
1.11 Device Environmental Information 11
1.12 Requirements with concern to Water Quality 12
2. SAFETY 13
2.1 Safety Notes 14
2.2 Safety features incorporated in the device 14
3. CONTENT OF THE DEVICE PACKAGE 15
4. DEPICTION OF SYSTEM PARTS 16
4.1 Front View 16
4.2 Rear View 17
5. INSTALLATION INSTRUCTIONS 18
5.1 Lifting and Carrying 18
5.2 Device Placement and Operating Conditions 18
5.3 Connections to Utility Supplies 19
5.4 Storage 19
5.5 Initial Operation of the Device 20
5.6 Before starting the Autoclave 22
6. PRE-STERILIZATION CLEANING AND DISINFECTION OF INSTRUMENTS AND THEIR LOADING INTO THE DEVICE 26
7. OPERATING INSTRUCTIONS 29
7.1 Turning on the Device 29
Page I

7.2 Filling Water 29
7.3 Filling water in the reservoir 31
7.4 See the requirements concerning Water Quality, in Section 1.12 32
7.5 Setting Date and Time 33
7.6 Class S and Class B 34
7.7 Setting Class S and Class B 36
8. CONTROL PANEL 38
8.1 Home screen Description and Functions 40
8.2 Opening the Device Door 42
8.3 Starting a Cycle 43
8.4 Virus Protect program 46
8.5 Available Sterilization Programs and Test Programs 48
8.6 Cycle Succeeded / Cycle Failed Notifications and Follow-on 51
8.7 Aborting a cycle 52
8.8 Custom Programs 53
8.9 Cycles history 54
8.10 Opening the door and Unloading 55
8.11 Checking Waste Water Level 55
8.12 Draining the Reservoirs 56
9. PREVENTIVE AND SCHEDULED MAINTENANCE TO BE PERFORMED BY THE OPERATOR 58
9.1 Daily Maintenance 58
9.2 Weekly Maintenance 58
9.3 Monthly Maintenance 59
9.4 Periodic Maintenance 59
10. FULL LIST OF INFORMATIVE SCREEN DISPLAY SYMBOLS, OPERATING MESSAGES, ERROR MESSAGES AND
TROUBLESHOOTING 63
10.1 Symbols 63
10.2 Error Messages & Troubleshooting 64
11. TSC PRINTER INSTALLATION (OPTIONAL) 71
11.1 General printer information 71
11.2 Safety instructions 73
11.3 Setting printer definitions 74
12. SYSTEM CLEAN PROGRAM 76
12.1 General 76
Page II

12.2 System Clean Cleaning Procedure 76
Page III

1. General Information
1.1 Manufacturer and US Official Correspondence Information
T-Edge VET-11 Autoclave is manufactured by Tuttnauer Ltd., Located Har – Tuv B Industrial Zone,
P.O. Box 170, Beit Shemesh 9910101, Israel.
)Tel: [phone]
The US Official Correspondence is:
+Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA.
)Tel [phone], ÊFax: [phone]
1.2 Applicable Regulation and Quality Standards
The life cycle of Tuttnauer's T-Edge VET-11 is in compliance with the following regulation and quality
standards:
Global Unique Device Identification
Database (GUDID)
Guidance for Industry and Food and Drug
Administration Staff
ISO 9001: Quality Management System
ISO 14001: Environmental management system
ISO 17025: General requirements for the competence of testing
and calibration laboratories
EN ISO 14971: Medical devices – Application of risk management
for medical devices
ASME Code Section I and Section VIII. Div. I
PED 2014/68/EU
Chinese Regulations Special Equipment Licensing Office
*EN 13060: Small Steam Sterilizer
*ANSI/AAMI/ST55: Tabletop Steam Sterilizer
*ANSI/AAMI/ST79: Comprehensive guide to steam sterilization and
sterility assurance in health care facilities
Page 1

IEC 61010-1 / UL 61010-1:
Safety requirements for electrical equipment for
measurement, control, and laboratory use – Part 1:
General requirements
IEC 61010-2-040:
Safety requirements for electrical equipment for
measurement, control, and laboratory use – Part 2-
040: Requirements for sterilizers and washer-
disinfectors used to treat medical materials
EN 613261-1: EMC Requirements for Electrical Equipment
IEC 62304: Medical Device Software – Software life cycle
processes
*Applicable for medical devices.
Page 2

1.3 Legend for Symbols appearing on the Labels and in this Manual
Manufacturer
Year of Manufacturing
Model Number
Serial Number
Consult the Operation and Maintenance Manual (User Manual) before use
Keep away from sunlight and protect from heat.
For Indoor Use Only
Keep dry
Disposal according to electronic scrap ordinance
This side up (during transport and shipment)
Page 3

Fragile (during transport and shipment)
OR A warning or precaution as detailed in the Operation and Maintenance Manual
(User Manual)
OR Caution! Hot Surface
Page 4