Tuttnauer T-Edge 10 User manual

Pre-vacuum B and S -Class Steam Sterilizer
Models T-Edge 10
Cat.No. MAN205-0502015EN Rev.H
+Tuttnauer U.S.A. Co, Ltd., 25 Power Drive Hauppauge, NY, 11788, U.S.A.
)Tel: [phone], ÊFax: [phone]
REF: AMS10-120-T, AMS10-120-W-T
Operation and Maintenance Manual

Operation and
Maintenance Manual
Pre-vacuum B and S -Class Steam
Sterilizer
Models T-Edge 10
REF: AMS10-120-T, AMS10-120-W-T
Cat. No. MAN205-0502015EN Rev.H January 2021
+Tuttnauer U.S.A. Co, Ltd., 25 Power Drive Hauppauge, NY, 11788, U.S.A.
)Tel: [phone], ÊFax: [phone]

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 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 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 27
7. OPERATING INSTRUCTIONS 31
Page I

7.1 Turning on the Device 31
7.2 Filling Water 31
7.3 Filling water in the reservoir 33
7.4 See the requirements concerning Water Quality, in Section 1.12 34
7.5 Setting Date and Time 35
7.6 Class S and Class B 36
7.7 Setting Class S and Class B 38
8. CONTROL PANEL 42
8.1 Home screen Description and Functions 43
8.2 Opening the Device Door 45
8.3 Starting a Cycle 46
8.4 Virus Protect program 49
8.5 Available Sterilization Programs and Test Programs 51
8.6 Cycle Succeeded / Cycle Failed Notifications and Follow-on 54
8.7 Aborting a cycle 55
8.8 Custom Programs 57
8.9 Cycles history 58
8.10 Opening the door and Unloading 60
8.11 Checking Waste Water Level 61
8.12 Draining the Reservoirs 61
9. PREVENTIVE AND SCHEDULED MAINTENANCE TO BE PERFORMED BY THE OPERATOR 63
9.1 Daily Maintenance 63
9.2 Weekly Maintenance 63
9.3 Monthly Maintenance 64
9.4 Periodic Maintenance 64
10. FULL LIST OF INFORMATIVE SCREEN DISPLAY SYMBOLS, OPERATING MESSAGES, ERROR
MESSAGES AND TROUBLESHOOTING 69
10.1 Symbols 69
10.2 Error messages & Troubleshooting 71
11. TSC PRINTER INSTALLATION (OPTIONAL) 76
11.1 General printer information 76
11.2 Important safety instructions 79
11.3 Installation for the first time 80
11.4 Open the printer top cover 80
Page II

11.5 Loading thermal printer paper roll/ Label roll 81
11.6 Connecting the interface cables to the printer 84
11.7 Connecting power and interface cables 85
11.8 Starting the printer 85
11.9 Setting Printer definitions 86
12. CHAMBER CLEAN PROGRAM 89
12.1 General 89
General 89
12.2 Chamber clean Cleaning procedure 90
13. FACTORY CODES FOR END USER 95
Page III

1. General Information
1.1 Manufacturer and US Official Correspondence
Information
T-Edge 10 Autoclave is manufactured by Tuttnauer Ltd., Located Har – Tuv B
Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel. Tel: +972-2-
9904611
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 10 is in compliance with the following
regulation and quality standards:
l93/42/EEC, Council Directive, concerning medical devices
l2014/68/EU, Directive, concerning pressure equipment.
l2006/42/EC Machinery Directive.
l2014/35/EU, Directive, Low Voltage Directive (LVD)
l2014/30/EU, Electromagnetic compatibility.
l2012/19/EU WEEE and EU Restriction of the use of certain hazardous
substances (RoHS Directive)
lCanadian MDR (CMDR) SOR/98-282, consolidated.
lISO 9001Quality Management System.
lEN ISO 13485 Quality Management System – Medical devices.
lISO 14001 environmental management system
lEN ISO 14971 Medical devices – Application of risk management.
lChinese Regulations on Safety Technology for Pressure Vessel.
lMEDDEV 2.12-1 Medical Devices Vigilance System
lMEDDEV 2.12/2 Post Market Clinical Follow Up
lMEDDEV 2.7.1 Rev 4 Clinical Evaluation
lMEDDEV 2.5.2 Reporting of design changes of the quality system
lASME Code section I and section VIII. Div.I
lANSI/AAMI ST55 Tabletop steam sterilizers
lIEC 61010- 1 Safety Requirements for electrical equipment for
measurement control and laboratory use.
lEN 61010- 2- 40 Safety requirements for sterilizers and washer-
disinfectors used to treat medical materials.
Page 1

lEN ISO 15223-1 Symbols for use in the labeling of medical devices.
lEN1041+ A1 Information to be supplied by the manufacturer of medical
devices
lEN 60529 Degrees of protection provided by enclosures (IP Code)
lEN 61326-1 EMC Requirements for Electrical Equipment.
lIEC62304 + A1 Medical Device Software – Software life cycle processes.
lIEC 62366- 1– Part1: Application of Usability Engineering to Medical
Devices
lEN 62366 - Application of Usability Engineering to Medical Devices
lANSI/AAMI ST55
1.2.1 And in consideration with:
FDA QSR 21 CFR part 820 & part 11
Page 2

1.3 Legend for Symbols appearing on the Labels and in
this Manual
Table 1 - Device labeling
Manufacturer
Year of Manufacturing
Catalog Number
Serial Number
Consult the Operation and Maintenance Manual (User
Manual) before use
IP31 Ingress Protection
Keep away from sunlight and protect from heat.
For Indoor Use Only
Keep dry
Page 3