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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1.10 Device Specifications
1.10.1 Device Overall Dimensions - T-Top 10
1.10.2 T-Top 10 fit into sterilization center cabinet - required dimensions:
To allow adequate cooling & ventilation of the autoclave placed inside the sterilization center Cabinet, the
following are the minimum dimensions required for the cabinet :
Width - 482 mm; Height – 510 mm; Depth - 595 mm
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1.10.3 Device Properties
Property Dimension
External size
Width 462 mm
Height 460 mm
Depth 585 mm supporting common install base carry a 605 mm counter
top
Chamber
Diameter 249 mm
Depth 450 mm
Volume 23 lit
Usable chamber
space 75% (~17 L)
Max. Allowable Working Pressure
(MAWP) 2.8 bar
Maximum
load per tray
Unwrapped 1.2 kg
Wrapped 0.72 kg
Maximum
Solid load
Unwrapped 6 kg
Wrapped 3.5 kg
Maximum textile load 1.5 kg
Tray dimensions 375 mm x 185 mm x 15 mm
No. of trays 4
Net weight 45 kg
Shipping weight 51 kg
Floor loading requirements 75 kg
Mineral-free
water
reservoir
Max. water volume 3.6 lit
Min. water volume 1.35 lit (up to the float)
Used (waste)
water Max. water volume Up to float: 3.75 lit Overflow: 5.75 lit
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Property Dimension
reservoir
Safety relief valve 2.8 bar
Load No. counter Counting from 0 to 500.00 and nullifies.
1.10.4 Device Electrical Data
Property Value
Total Power 1800W
Voltage 1Ph / 230 VAC
Amperage 10A
Protection against electrical
shock IEC 61010-1
Mains supply fluctuation +/- 10%
Frequency (Hz) 50Hz
Pollution degree Pollution degree 2
Over-voltage category Category II
Pollution degree of the intended environment
1.10.5 Utility Requirements
Property Value
Mineral-free water See table in Water Quality
Drain Optional - 10mm, withstanding temp. of 80°C
Power supply * 1 phase, 230VAC ±10%, 50Hz
Recommended circuit breaker 16A
* According to the local network.
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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%.
Check and verify that the electrical net is protected by a current leakage safety relay.
1.11 Requirements with concern to Water Quality
Warnings:
The use of water for autoclaves that do not comply with the table below may have severe impact on the
working life of the sterilizer and can invalidate the manufacturer’s warranty.
In the case of a generator:
lUse only water having the characteristics stated in the table below. Using tap water will clog the
system and invalidate the manufacturer's warranty.
lUse only deionized water, having a maximum conductivity of 15 µs/cm. Conductivity greater than
15 µs/cm may cause failures.
lThe range of hardness value 0.7-2.0 mmol/l (70- 200 mg/l CaCO3). The use of soft water is strictly
forbidden! Please consult a water specialist!
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
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
Chloride (Cl) ≤ 2 mg/l ≤ 0.1 mg/l
Phosphate ≤ 0.5 mg/l ≤ 0.1 mg/l
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Substance Feed Water Condensate
Conductivity (at 20°C) ≤15 µs/cm ≤ 3 µs/cm
pH value 5 to 7.5 5 to 7
Hardness ≤ 0.02 mmol/l ≤ 0.02 mmol/l
Appearance Colorless, clean, without sediments
Compliance with the above data should be tested in accordance with acknowledged analytical methods,
by an authorized laboratory.
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2. Safety
2.1 Principle Safety Warnings and Precautions
lNEVER operate a new autoclave or steam generator before the safety, licensing, and authorization
department has approved it for use.
lAlways operate the autoclave strictly as instructed in this user manual.
lThe device is designed to carry safeguards against cybersecurity threats. If you fear the device has
been compromised, immediately contact the authorized representative.
lThe instructed Steam Sterilization Program should be verified against the programs available in
this autoclave. Verify that you have chosen the appropriate sterilization program. When sterilizing
materials, make sure that the item can withstand the sterilization temperature.
lA written procedure should be established to ensure safe autoclave operation, including: Daily
safety tests; seal inspection and door hinge inspection; smooth action of the closing mechanism;
chamber cleaning; prevention of clogging; preservation from corrosion; and finally, what is
permitted and what is prohibited for sterilization and choosing a sterilization program.
lIf there is a steam generator – drain it daily.
lIf there is an air compressor – drain it daily.
lBefore use, check the autoclave chamber to ensure that no items have been left from a previous
cycle.
lBefore loading the autoclave, clean the strainer on the chamber floor.
lLoad trays in a manner that enables steam to move freely among all items.
lBe careful: the surfaces may be hot! Before withdrawing trays, wear heat resistant gloves and
avoid touching hot loads and surfaces.
lDuring loading and unloading, use safety gloves and glasses in accordance with local safety
regulations and good practice.
lIf applicable: Do not remove the top cover during a running cycle. Hot water / steam may exit!
lOnly technical personnel having proper qualifications and holding technical documentation
(including a Technician Manual), and adequate information are authorized to install and serve the
apparatus.
lMind the power socket. Keep it and its vicinity dry. Danger of electrocution.
lIf applicable: Before moving the autoclave, make sure that the electrical cord is disconnected from
the power and there is no pressure in the chamber.
lFor devices that weigh less than 75Kg – The device is not designed for use on any standard slide
out shelf. If necessary, it must be tested and/or rated for 75Kg or more.
lOnce a month, ensure that the safety valves are operating.
lOnce a year, or more frequently, effective tests must be performed by a certified technician, i.e.,
calibration and validation.
lMake sure there are no leaks, breaks, blockages, whistles or strange noises.
lNotify the person in charge immediately of any deviation or risk of proper function of the device or
with the shipping carrier, and also notify the Tuttnauer representative.
lInsufficient space for ventilation may result in malfunction or damage due to overheating.
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lIn order to assure proper operation of the autoclave, it should not be placed in the vicinity of
electrical equipment which is not certified for Electromagnetic Compatibility according to IEC/EN
61326-1.
lThe user shall report any serious incident that occurred in relation to the sterilizer, to the
manufacturer and the authority having jurisdiction in their locale.
lDisposal of the device should be done in accordance with local laws.
2.2 Safety Features Incorporated in the Device
The pressure vessel chamber door has the following features protecting personnel from hazards:
lThe door switch indicates that the door is closed. Without this indication steam is not introduced into
the chamber.
lAn electrical door locking pin that blocks door opening during operation.
The following safety devices are installed in the autoclave to optimize its safe operation:
lSafety thermostat, to prevent over-heating of the jacket heating elements.
lSafety thermostat to prevent over-heating of the pipe heating element.
lSafety pressure valve to prevent over-pressurizing of the chamber.
Warning! Mind the power socket. Keep it and its vicinity dry. Danger of electrocution.
2.3 Cybersecurity
1. Autoclave Connectivity
Product specifications:
The autoclave includes connectivity capabilities used for:
lExporting the autoclave’s cycles data.
lImporting and exporting the device settings.
lInstalling new software updates.
lRemote monitoring .
lPrinting data from the device on paper or labels.
The autoclave includes a USB, Ethernet and Wi-Fi connection, used for:
a. USB
lPrinting.
lImporting and exporting settings.
lInstalling a new software version.
lExporting cycles data.
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b. Ethernet and Wi-Fi connection
lImporting and exporting settings by the internet.
lExporting settings by the local network.
lInstalling new software versions from the internet.
lExporting cycles data by the local network, or by the internet.
lMonitoring the devices from a local network or from the internet.
Recommended instructions for cybersecurity controls:
lUse known source USB for exporting data.
lOnly a qualified technician is allowed to update the software version.
lSoftware updating requires authentication.
lUpdate the autoclave software to the latest version as recommended by the manufacturer.
Note: The autoclave software is stand-alone and does not require connecting to the internet.
2. Protective features
The autoclave control system includes the autoclave main application and a dedicated agent for
cybersecurity and IoT (remote connection capabilities).
The autoclave application contains functionalities for cybersecurity such as: data integrity, electronic
signature check, data encryption and decryption, file structure checks, authentication, and authorization
mechanism.
A dedicated agent for cybersecurity is used for security, detection & prevention, software updates and data
exports. The agent reports to an external secured dashboard server.
3. Backup
The following information will be displayed per each recorded event:
Username, Time and Date, machine + software details, cycle name, sensor reading during the cycle
stages + time stamp, end status of the cycle. · Cycle (data *.cyc file) should be saved during cycle
operation.
The device will save cycles history. The cycle files are encrypted and signed and can only be opened by a
dedicated software.
4. Infrastructure requirements and secure configuration
The agent for cybersecurity and IoT is installed on the device control system. This agent can prevent
detection and cybersecurity threats, as well as, a secure channel with the internet. The secure channel is
used to enable remote software installation, device monitoring, exporting and importing settings, and
exporting cycles data. The secure channel connects between the device's secured web-server, and the
user website on the internet. The user can monitor the device from this website and exchange data as
described above. The sterilizer is connected to the internet using Wi-Fi connection.
The connection from the website to the autoclave requires correct authorization and authentication
credentials.
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The user can monitor the machine and download cycles from the local network.
Network Diagram
5. Instructions for users on how to respond upon detection of a cybersecurity vulnerability
or incident
If you detect a cybersecurity vulnerability or incident, it is important to take immediate action to minimize
the impact and prevent further damage. Here are some steps to follow:
lDisconnect the affected device or system from the network. This will prevent the vulnerability or
incident from spreading to other devices or systems.
lInform the manufacturer and your IT or cybersecurity team as soon as possible. They will be able
to assess the situation and determine the appropriate course of action.
lFollow any instructions provided. This may include running scans or performing other actions to
secure the affected device or system.
lChange any passwords that may have been compromised. Use strong, unique passwords and
different factory codes.
lKeep all software and devices up to date, ensuring that any known vulnerabilities are patched.
lUpdates shall be done only by a qualified technician.
lRegularly back up important data to ensure that it is not lost in the event of a cybersecurity incident.
It is important to remain vigilant and take steps to prevent future vulnerabilities or incidents from occurring.
This may include implementing security best practices, such as using strong passwords and factory code
authentication, as well as regularly updating the software and devices to patch any known vulnerabilities.
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3. Depiction of System Parts
3.1 Front View
No. Description No. Description
1Door switch (close) 7Chamber
2ON/OFF switch (beneath the service
panel) 8 Door gasket
3Clean water drain (beneath the service
panel) 9 Air filter
4 USB port (beneath the service panel) 10 Touch screen
5Used water drain (beneath the service
panel) 11 Door handle
6 Door switch (lock)
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