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
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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
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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

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
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Disposal according to electronic scrap ordinance
This side up (during transport and shipment)
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 5

1.4 General Description of the Device
The autoclave is fully automatic (a computerized control unit ensures a fully
automatic sterilization cycle, control and monitoring of physical parameters and
a clear documentation of the sterilization cycle. Drying is performed with the
door closed)
This autoclave uses steam as a sterilizing agent.
The steam is produced by warming up a controlled amount of water inserted to
a pipe heating element, and then to the chamber. This technique saves energy
and water consumption.
The autoclave is equipped with a Pipe heating element and with chamber
heaters to maintain the steam inside the chamber.
The autoclave is equipped with a vacuum system, which supports and
improves:
lRemoval of residual air from packs and porous load and most kinds of
tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle.
lSteam penetration into the load; resulting in effective sterilization.
lTemperature uniformity.
lPost sterilization drying phase
A touchscreen is used for monitoring and control purposes.
The device has a built -in USB port to enable the operation of an external
optional barcode printer:
lThe barcode printer can print labels with a unique cycle ID barcode,
operator name, sterilization and expiry dates
lOne barcode printer can be connected to the machine.
lThe printer connection to the machine, by using a USB socket, with a
dedicated cable.
lBarcode printer power supply voltage can range between 100-240V.
lA barcode printer is an optional addition to the autoclave
The device features built-in memory to record up to 999 sterilization cycles.
These can be exported to a USB device to be transferred to a PC.
The device has a built-in Network Port for use with optional Tuttnauer’s R.PC.R
software when connected to your local network.
The autoclave has two optional configurations (available upon request):
Page 6

lBasic: Demineralized water is supplied by a manually filled reservoir,
demineralized water overflow outlet on the rear cover:
(device catalog number: AMS11-120-T - T-Edge 11)
lAutomatic: Demineralized water direct inlet from the water supply
system, demineralized water overflow, and waste water outlet on the
rear cover:
(device catalog number: AMS11-120-W-T - T-Edge 11-W)
1.5 Intended Use
The T-Edge 11 tabletop autoclave is designed for sterilization of medical and
surgical goods such as wrapped and unwrapped solid, hollow, and porous
loads used in dental and medical clinics, first aid rooms, hospitals, and
laboratories etc.
1.6 Intended Users
The T-Edge 11 tabletop autoclave is intended for use by hospital personnel and
other medical personnel as well as laboratory personnel.
All autoclave users must receive training in proper usage from an experienced
employee. Every new employee must undergo a training period under an
experienced employee.
1.7 Warranty Description
This warranty does not include routine cleaning and preventive
maintenance, to be performed according to instructions in chapter 8.
Tuttnauer warranties all new autoclaves to be free from defects in material and
workmanship for a period of two (2) years, covering the parts (except door
gaskets and air filters – they are considered wear items).
Tuttnauer warranties all chambers for a period of ten (10) years against defects
in materials and workmanship.
This warranty does not apply to any product that has been subjected to misuse,
neglect, accident or improper installation or application, nor shall it extend to
autoclaves that have been repaired or altered outside the factory without prior
authorization from Tuttnauer.
Tuttnauer’s obligation is limited to the repair or replacement of parts for the
autoclave. This warranty will be void if the unit is not purchased from an
authorized Tuttnauer dealer. No other warranties or obligations are expressed
or implied.
1.8 Warranty Statement
The warranty registration must be completed and returned to our service
departments; within fourteen (14) days of purchase or the warranty will be void.
Page 7

Our American Representative’s Technical Service Department can be reached
at:
+Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA.
)Tel [phone], ÊFax: [phone]
Note: If there is any difficulty with this autoclave, and the solution is not covered
in this manual, contact our representative or us first. Do not attempt to service
this autoclave yourself. Describe the difficulty as clearly as possible so we may
be able to diagnose the problem and provide a prompt solution.
If replacement parts are needed, stipulate the model and serial number of the
machine.
No autoclaves will be accepted for repair without proper authorization from us.
All transportation charges must be paid both ways by the owner.
For technical information or service please contact us at:
+Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA.
)Tel: [phone], ÊFax: [phone]
Tuttnauer Ltd., Har – Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh
9910101, Israel )Tel: [phone]
1.9 Customer Inspection Upon Receival of the Device
Upon receiving your Tuttnauer Autoclave, carefully inspect the outside of the
shipping carton for signs of damage. If any damage to the carton is found, note
the location with respect to the autoclave and check that area of the autoclave
carefully once it is fully unpacked. Observe packing method and retain packing
materials until the unit has been inspected. Mechanical inspection involves
checking for signs of physical damage such as: scratched panel surfaces,
broken knobs, damaged gasket etc.
If any damage is found, contact your dealer as soon as possible
so that they can file a claim with the shipping carrier and also
notify Tuttnauer.
All Tuttnauer products are carefully inspected prior to shipment and all
reasonable precautions are taken in preparing them for shipment to assure safe
arrival at their destination.
Page 8

1.10 Device Specifications
1.10.1 Overall Dimensions:
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1.10.2 T-Edge11 fit into sterilization center cabinet - recommended
dimensions:
To allow adequate cooling & ventilation of the autoclave placed inside the
sterilization center cabinet, the following T-Edge11 cabinet sizes are
recommended:
Width - 23.65”- 24.40”/60-62cm; Height – 22.25”- 22.65”/56.5-57.5cm; Min.
Depth - 24.9”-25.2”/63.2-64cm
Note:The imperial dimensions in inches/lbs are approximated to less than 3
percent.
1.10.3 Device Properties
Table 2 - Properties of the device
Property Dimension
External size
Width ~19.7"(50cm)
Height ~19.7"(50cm)
Depth ~22.8" (58 cm) supporting common install base
carry a ~23" (60 cm) counter top
Chamber
Diameter ~11"(28 cm)
Depth ~18"(46 cm)
Volume ~913 Ounces (27.2lit)
Usable chamber
space 75% (~685 Ounces / ~20.5 L)
Max. Allowable Working Pressure
(MAWP) ~40.6PSI (2.8 bar)
Maximum load per item ~0.45 lbs. (0.2kg)
Maximum
load per tray
Unwrapped ~4 lbs. (1.8kg)
Wrapped ~2.4 lbs (1.08kg)
Maximum
Solid load
Unwrapped ~19.8 lbs (9kg)
Wrapped ~11.9 lbs (5.4kg)
Maximum textile load ~4.4 lbs (2kg)
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Property Dimension
Tray dimensions ~16.6" x~8.1"x~0.8" (42.1cm x 20.7cm x2.05cm)
No. of trays 5
Net weight ~124lbs (56kg)
Shipping weight ~152lbs (69kg)
Floor loading requirements ~165 lbs(75kg).
Mineral-free
water
reservoir
Max. water
volume
Overflow (up to the float) – ~155 Ounces
(4.6lit)
Min. water
volume ~33.8 Ounces (1lit)
The volume used
by the sterilization
cycle/load having
the highest steam
consumption
Recorded ~30 Ounces (~900ml) for "Wrapped
273F" + Virus Protect
Used (waste)
water
reservoir
Max. water
volume
Max vol. –./~135 Ounces /(4.0 lit)
Float – ~125 Ounces (3.7lit.) max allowed for start
cycle
Safety relief valve ~40 PSI (2.8 bar)
Load No. counter Counting from 0 to 999 and nullifies.
Page 11

1.10.4 Device Electrical Data
Table 3 - Electrical data
Property Value
Total Power 1500W
Voltage 1Ph / 120 VAC
Amperage 12.5A
Protection against
electrical shock IEC 61010-1
Mains supply fluctuation +/- 10%
Frequency (Hz) 60Hz
1.10.5 Utility Requirements
Table 4 - Requirements pertaining the utilities
Property Value
Mineral-free water See table in Water Quality
Mineral-free water inlet Optional - 1/2" automatic
Drain Optional - 3/4", withstanding temp. of
80°C
Power supply * 1 phase /120VAC ±10%, 60Hz, 15A.
Recommended circuit
breaker 15A
* According to the local network.
Page 12

Caution!
In order to avoid any injury by electrical hazard, it is
recommended that a ground fault protection device (GFCI) be
installed in the electrical panel feeding the autoclave (local codes
may make this mandatory).
The electrical network must comply with local rules and
regulations.
Verify that there is an easy access to the main power switch and
to the current leakage safety relay (GFCI). The voltage supplied to
the device must comply with the label ± 10%.
1.11 Device Environmental Information
lThe peak sound level generated by the autoclave is 67dBa with
background noise of 48dBa during sterilization stage, and 65dBa during
drying stage.
lThe total heat per hour transmitted by the autoclave is <200Wh.
1.12 Requirements with concern to Water Quality
The distilled or mineral-free water supply to the autoclave shall be according to
the table below:
Suggested Maximum Limits of Contaminants in Water for Steam
Sterilization per EN13060
Table 5 - Water Quality
Substance Feed Water Condensate
Evaporate residue ≤ 10 mg/l ≤ 1.0 mg/l
SiO2≤ 1 mg/l ≤ 0.1 mg/l
Iron ≤ 0.2mg/l ≤ 0.1mg/l
Cadmium ≤ 0.005 mg/l ≤ 0.005 mg/l
Lead ≤ 0.05 mg/l ≤ 0.05 mg/l
Rest of heavy metals
except iron,
cadmium, lead
≤ 0.1 mg/l ≤ 0.1 mg/l
Page 13