Tuttnauer T-Top 10 User manual

Table Top Steam Sterilizer
Models T-Top 10
Cat.No. MAN205-0502033EN Rev. E
Tuttnauer Europe b.v.Hoeksteen 11, 4815 PR Breda,
P.O. Box 7191, 4800 GD Breda, Netherlands)Tel: [phone], ÊFax: +31/76-5423540
Operation and Maintenance Manual

Operation and Maintenance
Manual
Table Top Steam Sterilizer
Models T-Top 10
Cat. No. MAN205-0502033EN Rev. E June 2023
Tuttnauer Europe b.v.Hoeksteen 11, 4815 PR Breda,
P.O. Box 7191, 4800 GD Breda, Netherlands)Tel: [phone], ÊFax: +31/76-5423540

Table of Contents
Paragraph Page No.
1. GENERAL INFORMATION 1
1.1 Manufacturer and Authorized Representative Information 1
1.2 Applicable Regulation and Quality Standards 1
1.3 Legend for Symbols appearing on the Labels and in this Manual 2
1.4 General Description of the Device 4
1.5 Intended Use / Intended Purpose 5
1.6 Intended Users 5
1.7 Warranty Description 5
1.8 Warranty Statement 6
1.9 Customer Inspection Upon Receival of the Device 6
1.10 Device Specifications 7
1.11 Requirements with concern to Water Quality 10
2. SAFETY 12
2.1 Principle Safety Warnings and Precautions 12
2.2 Safety Features Incorporated in the Device 13
2.3 Cybersecurity 13
3. DEPICTION OF SYSTEM PARTS 16
3.1 Front View 16
3.2 Top View 17
3.3 Rear View 18
4. INSTALLATION INSTRUCTIONS 19
4.1 Lifting and Carrying 19
4.2 Device Placement and Operating Conditions 19
4.3 Connections to Utility Supplies 20
4.4 Storage 20
4.5 Initial Operation of the Device 21
4.6 Before starting the Autoclave 22
5. PRE-STERILIZATION CLEANING AND DISINFECTION OF INSTRUMENTS AND THEIR LOADING INTO THE DEVICE 25
6. OPERATING INSTRUCTIONS 27
6.1 Turning on the Device 28
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6.2 Filling Water 28
6.3 Filling water in the reservoir 30
6.4 See the requirements concerning Water Quality, in Section 1.11 30
6.5 Setting Date and Time 31
7. CONTROL PANEL 32
7.1 Home screen Description and Functions 34
7.2 Opening the Device Door 36
7.3 Starting a Cycle 37
7.4 Available Sterilization and Test Programs 40
7.5 Cycle Succeeded / Cycle Failed Notifications and Follow-on 42
7.6 Aborting a cycle 43
7.7 Custom Programs 44
7.8 Cycles history 45
7.9 Opening the door and Unloading 46
7.10 Checking Waste Water Level 46
7.11 Draining the Reservoirs 47
8. PREVENTIVE AND SCHEDULED MAINTENANCE TO BE PERFORMED BY THE OPERATOR 49
8.1 Daily Maintenance 49
8.2 Weekly Maintenance 49
8.3 Monthly Maintenance 50
8.4 Periodic Maintenance 50
9. FULL LIST OF INFORMATIVE SCREEN DISPLAY SYMBOLS, OPERATING MESSAGES, ERROR MESSAGES AND
TROUBLESHOOTING 54
9.1 Symbols 54
9.2 Error Messages & Troubleshooting 55
10. TSC PRINTER INSTALLATION (OPTIONAL) 62
10.1 General printer information 62
10.2 Safety instructions 64
10.3 Setting printer definitions 65
11. SYSTEM CLEAN PROGRAM 67
11.1 General 67
11.2 System Clean Cleaning Procedure 68
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1. General Information
1.1 Manufacturer and Authorized Representative Information
T-Top 10 Autoclave is manufactured by Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR Breda, P.O.
Box 7191, 4800 GD Breda, Netherlands.
)Tel: [phone], ÊFax: +31/76-5423540
1.2 Applicable Regulation and Quality Standards
The life cycle of Tuttnauer's T-Top 10 is in compliance with the following regulation and quality standards:
Regulation (EU) 2017/745 (MDR)
EN ISO 13485 Quality Management System – Medical Devices
EN ISO 14971 Medical devices – Application of risk management for medical devices
PED 2014/68/EU
EN 13060 Small Steam Sterilizer
ISO 17665 Sterilization of health care products – Moist heat
IEC 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
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1.3 Legend for Symbols appearing on the Labels and in this Manual
Manufacturer
Year of Manufacturing
European Authorized Representative
Medical Device
Model Number
Serial Number
Consult the Operation and Maintenance Manual (User Manual) before use
European compliance Mark of compliance with the European Medical Device
Regulation (Number xxxx identifies the Notified Body that performed the
examination)
Keep away from sunlight and protect from heat.
For Indoor Use Only
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Keep dry
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
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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 2 built -in USB ports 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 (external power supply - not from
the USB socket).
lA barcode printer is an optional addition to the autoclave
The device features built-in memory to record up to 500 sterilization cycles. These can be exported to a
USB device to be transferred to a PC.
The device is Wi-Fi compatible, enabling remote tracking and monitoring by technicians and HQ services.
Tuttnauer's R.PC.R software can be connected to the device via Wi-Fi or the Network Port.
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1.5 Intended Use / Intended Purpose
The T-Top 10 tabletop autoclave is designed for the sterilization of medical and surgical goods such as
wrapped and unwrapped solid, hollow, and porous loads used in healthcare facilities (e.g. hospitals,
nursing homes, extended care facilities, freestanding surgical centers, clinics and medical & dental clinics)
and laboratories.
1.6 Intended Users
The T-Top 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.
1.7 Warranty Description
This warranty does not include routine cleaning and preventive maintenance, to be performed
according to instructions in chapter 8 .
This product is sold with a limited warranty and specific remedies are available to the original purchaser in
the event that the product fails to conform to the limited warranty.
In general, and in a non-limited manner, Tuttnauer shall not be responsible for product damages caused
by natural disasters, fire, static discharge, misuse, abuse, neglect, improper handling or installation,
unauthorized repair, alteration or accident.
Tuttnauer’s obligation is limited to the repair or replacement of parts for the device. 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.
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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 Technical Service Department can be reached at:
Tuttnauer Europe B.V.,
)Tel: [phone], ÊFax: 31 (0) 765423540, Email: [email protected]
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 Europe B.V.,
)Tel: [phone], ÊFax: 31 (0) 765423540, Email: [email protected]
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.
Manufacturer Sterilization Performance Validation
The sterilization performance validation of all sterilization programs and test programs were performed by
the manufacturer according to EN 13060.
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