Tuttnauer T-Edge 11 User manual

Table Top Steam Sterilizer
Models T-Edge 11
Cat.No. MAN205-0502003EN Rev. C
+Tuttnauer U.S.A. Co, Ltd., 25 Power Drive Hauppauge, NY, 11788, U.S.A.
)Tel: [phone], ÊFax: [phone]
Tuttnauer. Ltd., Har Tuv Industrial Zone, B P.O. Box 170, Beit Shemesh, 9910101,
Israel.)Tel: [phone], ÊFax: 972 2 9904730
REF: AMS11-120-T, AMS11-120-W-T
Operation and Maintenance Manual

Operation and
Maintenance Manual
Table Top Steam Sterilizer
Models T-Edge 11
REF: AMS11-120-T, AMS11-120-W-T
Cat. No. MAN205-0502003EN Rev. C June 2021
+Tuttnauer U.S.A. Co, Ltd., 25 Power Drive Hauppauge, NY, 11788, U.S.A.
)Tel: [phone], ÊFax: [phone]
Tuttnauer. Ltd., Har Tuv Industrial Zone, B P.O. Box 170, Beit Shemesh,
9910101, Israel.)Tel: [phone], ÊFax: 972 2 9904730

https://www.tuttnauerusa.com

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 2
1.3 Legend for Symbols appearing on the Labels and in this Manual 4
1.4 General Description of the Device 6
1.5 Intended Use 7
1.6 Intended Users 7
1.7 Warranty Description 7
1.8 Warranty Statement 7
1.9 Customer Inspection Upon Receival of the Device 8
1.10 Device Specifications 9
1.11 Device Environmental Information 13
1.12 Requirements with concern to Water Quality 13
2. SAFETY 15
2.1 Safety Notes 16
2.2 Safety features incorporated in the device 17
3. CONTENT OF THE DEVICE PACKAGE 18
4. DEPICTION OF SYSTEM PARTS 19
4.1 Front View 19
4.2 Rear View 20
5. INSTALLATION INSTRUCTIONS 21
5.1 Lifting and Carrying 21
5.2 Device Placement and Operating Conditions 21
5.3 Connections to Utility Supplies 22
5.4 Storage 22
5.5 Initial Operation of the Device 23
5.6 Before starting the Autoclave 25
6. PRE-STERILIZATION CLEANING AND DISINFECTION OF INSTRUMENTS AND THEIR LOADING INTO
THE DEVICE 28
7. OPERATING INSTRUCTIONS 32
Page I

7.1 Turning on the Device 32
7.2 Filling Water 32
7.3 Filling water in the reservoir 34
7.4 See the requirements concerning Water Quality, in Section 1.12 35
7.5 Setting Date and Time 36
7.6 Class S and Class B 37
7.7 Setting Class S and Class B 39
8. CONTROL PANEL 43
8.1 Home screen Description and Functions 44
8.2 Opening the Device Door 46
8.3 Starting a Cycle 47
8.4 Virus Protect program 50
8.5 Available Sterilization Programs and Test Programs 52
8.6 Cycle Succeeded / Cycle Failed Notifications and Follow-on 55
8.7 Aborting a cycle 56
8.8 Custom Programs 58
8.9 Cycles history 59
8.10 Opening the door and Unloading 61
8.11 Checking Waste Water Level 62
8.12 Draining the Reservoirs 62
9. PREVENTIVE AND SCHEDULED MAINTENANCE TO BE PERFORMED BY THE OPERATOR 64
9.1 Daily Maintenance 64
9.2 Weekly Maintenance 64
9.3 Monthly Maintenance 65
9.4 Periodic Maintenance 65
10. FULL LIST OF INFORMATIVE SCREEN DISPLAY SYMBOLS, OPERATING MESSAGES, ERROR
MESSAGES AND TROUBLESHOOTING 70
10.1 Symbols 70
10.2 Error messages & Troubleshooting 72
11. TSC PRINTER INSTALLATION (OPTIONAL) 77
11.1 General printer information 77
11.2 Important safety instructions 80
11.3 Installation for the first time 81
11.4 Open the printer top cover 82
Page II

11.5 Loading thermal printer paper roll/ Label roll 82
11.6 Connecting the interface cables to the printer 85
11.7 Connecting power and interface cables 86
11.8 Starting the printer 86
11.9 Setting Printer definitions 87
12. CHAMBER CLEAN PROGRAM 90
12.1 General 90
General 90
12.2 Chamber Clean cleaning procedure 91
13. FACTORY CODES FOR END USER 96
Page III

1. General Information
1.1 Manufacturer and US Official Correspondence
Information
T-Edge 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]
Page 1

1.2 Applicable Regulation and Quality Standards
The life cycle of Tuttnauer's T- Edge 11 is in compliance with the following
regulation and quality standards:
Medical Device Directive 93/42/EEC as amended by 2007/47/EC
Medical Device Single Audit
Program
companion document, doc# MDSAP AU
G0002.1.004 rev. 13-04-2017Ft
MDSAP audit approach doc# MDSAP AU P0002.005
FDA QSR 21 CFR part 820 & part 11
Australian Therapeutic Goods (Medical Devices) Regulations 2002
Brazilian Good Manufacturing
Practices
(RDC ANVISA 16/2013, 67/2009,
56/2001, 23/2012)
Japanese QMS Ordinance (MHLW MO 169)
Canadian MDR (CMDR) SOR/98-282 (2018), consolidated
Global Unique Device
Identification Database (GUDID)
Guidance for Industry and Food and Drug
Administration Staff
ISO 9001: Quality Management System
EN ISO 13485: Quality Management System – Medical
Devices
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
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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
ISO 17665: Sterilization of health care products –
Moist heat
ANSI/AAMI/ST79:
Comprehensive guide to steam
sterilization and sterility assurance in
health care facilities
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
Page 3