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
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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
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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.
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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
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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 4

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):
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lBasic: Demineralized water is supplied by a manually filled
reservoir, demineralized water overflow outlet on the rear cover
(device catalog number: AMS10-120-T)
lAutomatic: Demineralized water direct inlet from the water supply
system, demineralized water overflow, and waste water outlet on
the rear cover (device catalog number: AMS10-120-W-T)
1.5 Intended Use
The T-edge10 Table-top 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 10 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.
Page 6

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 one full year, 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.
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]
Page 7

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 Device Overall Dimensions:
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1.10.2 T-Edge10 fit into sterilization center cabinet - recommended
dimensions:
To allow adequate cooling & ventilation of the autoclave placed inside the
sterilization center Cabinet, the following T-Edge10 Cabinet sizes are
recommended:
Width - 22.85”- 23.65”/58-60cm; 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"(49 cm)
Depth ~22.8" (58 cm) supporting common install base carry
a ~23" (60 cm) counter top
Chamber
Diameter ~10"(25 cm)
Depth ~18"(46 cm)
Volume ~778 Ounces (23lit)
Usable chamber
space 75% (~575 Ounces / ~17 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 ~2.67 lbs. (1.2kg)
Wrapped ~1.6 lbs (0.72kg)
Maximum
Solid load
Unwrapped ~13 lbs.(6kg)
Wrapped ~7.7 lbs.(3.5kg)
Maximum textile load ~3.3 lbs.(1.5kg)
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Property Dimension
Tray dimensions ~16.6" x~7.4"x~0.8" (42.1cm x 18.9cm x2.05cm)
No. of trays (5) ~13 lbs (6 kg )
Net weight ~110lbs (50kg)
Shipping weight ~132lbs (60kg)
Floor loading requirements ~165 lbs(75kg).
Mineral-free
water
reservoir
Max. water
volume
Overflow (up to the float) – ~128 Ounces
(3.8lit)
Min. water
volume ~33.8 Ounces (1lit)
The volume used
by the
sterilization
cycle/load having
the highest
steam
consumption
Recorded 27 Ounces (800ml) were required to
sterilize full load of porous type using "wrapped 121".
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.
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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 Class I (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