Tuttnauer T- Edge 10 User and maintenance manual [gb]

1

Operation and Maintenance

Manual

Pre-vacuum B and S -class Steam

Sterilizer

T- Edge 10

REF: AMS10-230-T, AMS10-230-W-T

Cat. No. MAN205-0502005EN Rev D July 2020

 Tuttnauer Ltd. Har – Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel
 Tel: [phone],  Fax:[phone]

 Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA.  Tel (631) 737

4850, [phone],  Fax: [phone]

2

Web site: http//www.tuttnauerUSA.com

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Table of Contents

1 GENERAL INFORMATION ............................................................................................................. 6

MANUFACTURER AND EUROPEAN AUTHORIZED REPRESENTATIVE INFORMATION ........................................ 6

APPLICABLE REGULATION AND QUALITY STANDARDS ............................................................................ 6

1.2.1 And in consideration with: ..................................................................................................... 7

LEGEND FOR SYMBOLS APPEARING ON THE LABELS AND IN THIS MANUAL .................................................. 8

GENERAL DESCRIPTION OF THE DEVICE ............................................................................................... 9

INTENDED USE ............................................................................................................................ 10

INTENDED USERS ......................................................................................................................... 11

WARRANTY DESCRIPTION .............................................................................................................. 11

WARRANTY STATEMENT ................................................................................................................ 11

CUSTOMER INSPECTION UPON RECEIVAL OF THE DEVICE ..................................................................... 12

TYPICAL PRESSURE AND TEMPERATURE VERSUS TIME DIAGRAMS FOR THE OPERATING CYCLES .................... 12

THE DIAGRAMS ARE SHOWN IN THE APPENDIX A ................................................................................ 12

DEVICE SPECIFICATIONS ................................................................................................................. 13

1.11.1 Device Overall Dimensions: ................................................................................................ 13

1.11.2 T-Edge10 fit into sterilization center cabinet - recommended dimensions: ......................... 14

1.11.3 Device Properties ................................................................................................................ 14

1.11.4 Device Electrical Data ......................................................................................................... 15

1.11.5 Utility Requirements ................................................................ ............................................ 15

DEVICE ENVIRONMENTAL INFORMATION .......................................................................................... 16

REQUIREMENTS WITH CONCERN TO WATER QUALITY .......................................................................... 16

1.13.1 Tap water supply ................................................................................................................. 17

2 SAFETY ....................................................................................................................................... 18

PRINCIPLE SAFETY WARNINGS AND PRECAUTIONS .............................................................................. 18

SAFETY NOTES ............................................................................................................................. 19

3 CONTENT OF THE DEVICE PACKAGE ........................................................................................... 20

4 DEPICTION OF SYSTEM PARTS ................................................................................................... 21

FRONT VIEW ............................................................................................................................... 21

REAR VIEW ................................................................................................................................. 22

5 INSTALLATION INSTRUCTIONS ................................................................................................... 23

LIFTING AND CARRYING ................................................................................................................. 23

DEVICE PLACEMENT AND OPERATING CONDITIONS ............................................................................. 23

CONNECTIONS TO UTILITY SUPPLIES ................................................................................................. 24

STORAGE .................................................................................................................................... 24

INITIAL OPERATION OF THE DEVICE .................................................................................................. 24

6 PRE-STERILIZATION CLEANING AND DISINFECTION OF INSTRUMENTS AND THEIR LOADING INTO

THE DEVICE ........................................................................................................................................ 26

7 OPERATING INSTRUCTIONS ....................................................................................................... 29

TURNING ON THE DEVICE ............................................................................................................... 29

FILLING WATER ........................................................................................................................... 30

4

FILLING WATER IN THE RESERVOIR.................................................................................................... 31

SEE THE REQUIREMENTS CONCERNING WATER QUALITY, IN SECTION 1.14 .............................................. 32

SETTING DATE AND TIME ............................................................................................................... 32

SET DATE AND TIME ..................................................................................................................... 33

CLASS S AND CLASS B ................................................................................................................... 35

SETTING CLASS S AND CLASS B ........................................................................................................ 37

8 CONTROL PANEL ........................................................................................................................ 41

HOME SCREEN DESCRIPTION AND FUNCTIONS ................................................................................... 42

OPENING THE DEVICE DOOR .......................................................................................................... 43

STARTING A CYCLE........................................................................................................................ 44

AVAILABLE STERILIZATION PROGRAMS AND TEST PROGRAMS ............................................................... 49

8.4.1 List of available Sterilization and Test Programs (refer to sec.8.4.2 for maximal allowed

weight of load) .................................................................................................................................. 49

8.4.2 Maximum Load Weight per Load type ................................................................................. 50

8.4.3 Description of the Sterilization Cycle Stages ....................................................................... 50

8.4.4 Description of the Vacuum Test Stages .............................................................................. 50

8.4.5 Description of Bowie-Dick Test Stages ............................................................................... 51

CYCLE SUCCEEDED / CYCLE FAILED NOTIFICATIONS AND FOLLOW-ON ..................................................... 51

8.5.1 Cycle Succeeded ................................................................................................................ 51

8.5.2 Cycle Failed ........................................................................................................................ 52

ABORTING A CYCLE ....................................................................................................................... 53

OPENING THE DOOR AND UNLOADING ............................................................................................. 54

CHECKING WASTE WATER LEVEL .................................................................................................... 55

DRAINING THE RESERVOIRS ............................................................................................................ 55

8.9.1 Waste water draining .......................................................................................................... 56

9 PREVENTIVE AND SCHEDULED MAINTENANCE TO BE PERFORMED BY THE OPERATOR ............. 57

DAILY MAINTENANCE ................................................................................................................... 57

WEEKLY MAINTENANCE ................................................................................................................ 57

MONTHLY MAINTENANCE ............................................................................................................. 58

PERIODIC MAINTENANCE ............................................................................................................... 59

9.4.1 Replacing the Air Filter ........................................................................................................ 59

9.4.2 Cleaning the Drain Filter...................................................................................................... 61

9.4.3 Replacing the Drain Filter ................................................................................................ .... 62

10 FULL LIST OF INFORMATIVE SCREEN DISPLAY SYMBOLS, OPERATING MESSAGES, ERROR

MESSAGES AND TROUBLESHOOTING ................................................................................................. 64

SYMBOLS .................................................................................................................................... 64

ERROR MESSAGES & TROUBLESHOOTING .......................................................................................... 65

11 TSC PRINTER INSTALLATION (OPTIONAL) ................................................................................... 70

GENERAL PRINTER INFORMATION .................................................................................................... 70

11.1.1Printer Output: ...................................................................................................................... 70

IMPORTANT SAFETY INSTRUCTIONS .................................................................................................. 72

INSTALLATION FOR THE FIRST TIME ................................................................................................... 73

OPEN THE PRINTER TOP COVER ....................................................................................................... 74

LOADING THERMAL PRINTER PAPER ROLL/ LABEL ROLL ......................................................................... 75

CONNECTING THE INTERFACE CABLES TO THE PRINTER ......................................................................... 77

12 CHAMBER CLEAN PROGRAM ..................................................................................................... 82

GENERAL ............................................................................................................................ 82

5

CHAMBER CLEAN CLEANING PROCEDURE .......................................................................................... 83

13. FACTORY CODES FOR END USER ................................................................................ 89

List of Tables

Table 1 - Device labeling ............................................................................................................................. 9

Table 2 -Device Properties ........................................................................................................................ 14

Table 3 - Device Electrical Data ................................................................................................................ 15

Table 4 - Utility Requirements .................................................................................................................. 15

Table 5 - Water Quality ............................................................................................................................ 16

Table 6 - Safety Warnings and Precautions .............................................................................................. 18

Table 7 - Device Package .......................................................................................................................... 20

Table 8 - Front View .................................................................................................................................. 21

Table 9 - Rear View ................................................................................................................................... 22

Table 10 - Home screen Description and Functions .................................................................................. 42

Table 11 - Home screen Description and Functions .................................................................................. 49

Table 12 - Maximum Load Weights .......................................................................................................... 50

Table 13 - Error messages & Troubleshooting .......................................................................................... 69

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1 General Information

Manufacturer and European Authorized Representative

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: +972-2­9904611

The American Authorized Representative is:
 Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA. 

Tel [phone],  Fax: [phone]

Applicable Regulation and Quality Standards

The life cycle of Tuttnauer's T- Edge 10 is in compliance with the following
regulation and quality standards:

93/42/EEC, Council Directive, concerning medical devices
2014/68/EU, Directive, concerning pressure equipment.
2006/42/EC Machinery Directive.
2014/35/EU, Directive, Low Voltage Directive (LVD)
2014/30/EU, Electromagnetic compatibility.
2012/19/EU WEEE and EU (2017/2102 Restriction of the use of certain

hazardous substances (RoHS Directive)
Canadian MDR (CMDR) SOR/98-282 (2018), consolidated.
ISO 9001: 2015 Quality Management System.
EN ISO 13485:2016 Quality Management System – Medical devices.
ISO 14001:2015 environmental management system
EN ISO 14971:2012 Medical devices – Application of risk management.
Chinese Regulations on Safety Technology for Pressure Vessel.
MEDDEV 2.12-1 Rev 8 Medical Devices Vigilance System
MEDDEV 2.12/2 Rev 2 Post Market Clinical Follow Up
MEDDEV 2.7.1 Rev 4 Clinical Evaluation
MEDDEV 2.5.2 Rev 8 Reporting of design changes of the quality system
ASME Code section I and section VIII. Div.I
EN 13060:2014 Small steam sterilizer

7

ANSI/AAMI ST55:2016 Tabletop steam sterilizers
IEC 61010-1 3.1 Edition, January 2017 Safety Requirements for electrical

equipment for measurement control and laboratory use.
EN 61010-2-40: 2015 Safety requirements for sterilizers and washer-

disinfectors used to treat medical materials.
EN ISO 15223-1: 2016 Symbols for use in the labeling of medical devices.
EN 1041: 2008 + A1:2014 Information to be supplied by the manufacturer

of medical devices
EN 60529:1992 + A2:2013 Degrees of protection provided by enclosures

(IP Code)
EN 61326-1: 2013 for EMC Requirements for Electrical Equipment.
IEC 62304:2014 + A1: 2015 – Medical Device Software – Software life

cycle processes.
EN 62304:2006/AC:2008– Medical Device Software – Software life cycle

processes.
IEC 62366-1: 2015 – Part1: Application of Usability Engineering to Medical

Devices
EN 62366:2008 - Application of Usability Engineering to Medical Devices
ANSI/AAMI ST55:2016

1.2.1 And in consideration with:

FDA QSR 21 CFR part 820 & part 11

8

Legend for Symbols appearing on the Labels and in

this Manual

Manufacturer
European Authorized Representative

Year of Manufacturing

Catalog Number

Serial Number

Consult the Operation and Maintenance Manual (User
Manual) before use

IP31

Ingress Protection

European compliance Mark of compliance with the European
Medical Device Directive (Number xxxx identifies the Notified
Body that performed the examination)

European compliance Mark of compliance with the European
Pressure Equipment Directive (Number xxxx identifies the
Notified Body that performed the examination)

Keep away from sunlight and protect from heat.
For Indoor Use Only

Keep dry

9

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

Table 1 - Device labeling

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.

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The autoclave is equipped with a vacuum system, which supports and
improves:

 Removal 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.

 Steam penetration into the load; resulting in effective sterilization.
 Temperature uniformity.
 Post 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:

 The barcode printer can print labels with a unique cycle ID barcode,

operator name, sterilization and expiry dates

 One barcode printer can be connected to the machine.
 The printer connection to the machine, by using a USB socket, with a

dedicated cable.

 Barcode printer power supply voltage can range between 100-240V.
 A 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):

 Basic: Demineralized water is supplied by a manually filled reservoir,

demineralized water overflow outlet on the rear cover (device catalog
number: AMS10-230-T)

 Automatic (optional): Demineralized water direct inlet from the water

supply system, demineralized water overflow, and waste water outlet
on the rear cover (device catalog number: AMS10-230-W-T)

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.

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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.

Warranty Description

This warranty does not include routine cleaning and preventive
maintenance, to be performed according to instructions in chapter 8.

Tuttnauer warrantees 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 warrantees all chambers for a period of ten (10) years against
defects in materials and workmanship. This chamber warranty went into effect
January 1997.

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.

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],  Fax: [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.

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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],  Fax: [phone]

Tuttnauer Ltd., Har – Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh
9910101, Israel

Tel: [phone]

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.

Typical Pressure and Temperature versus Time Diagrams

for the Operating Cycles

The diagrams are shown in the Appendix A

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Device Specifications

1.11.1 Device Overall Dimensions:

Front view Side view

Top View

Dimensions:

Front view: W-18 "(480mm), H-22" (580mm); 21" (536mm), D-(536mm)
Side view: W-18"(580mm), 21" (536mm)
Top view: W-18"(480mm), D-22 "(580mm), 21" (536mm)

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1.11.2 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

1.11.3 Device Properties

Property

Dimension

External size
Width

18.9"(48cm)

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)

aximum Solid load
Unwrapped

13 lbs.(6kg)

Wrapped

7.7 lbs.(3.5kg)

Maximum textile load

3.3 lbs.(1.5kg)

Tray dimensions

16.6" x7.4"x0.8" (42.1cm x 18.9cm x2.05cm)

No. of trays

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.

Table 2 -Device Properties

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1.11.4 Device Electrical Data

Property

Value

Total Power

2000W

Voltage

1Ph / 230 VAC

Amperage

10A

Protection against

electrical shock

Class I (IEC 60601-1)

Mains supply fluctuation

+/- 10%

Frequency (Hz)

60Hz

Table 3 - Device Electrical Data

1.11.5 Utility Requirements

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, /230VAC ±10%, 60Hz, 10 A.

Recommended circuit breaker

16A

Table 4 - Utility Requirements
* According to the local network.

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%.

16

Device Environmental Information

 The peak sound level generated by the autoclave is 67dBa with background noise

of 48dBa during sterilization stage, and 65dBa during drying stage.

 The total heat per hour transmitted by the autoclave is <200Wh.

Requirements with concern to Water Quality

The distilled or mineral-free water supply to the autoclave shall be according to
the table below:

TABLE1: 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

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

Table 5 - Water Quality
Compliance with the above data should be tested in accordance with

acknowledged analytical methods, by an authorized laboratory.

Caution:

The use of water for autoclaves that do not comply with the table above
may have severe impact on the working life of the sterilizer and can
invalidate the manufacturer’s guarantee.

Use only deionized water, having a maximum conductivity of 15 µs/cm.
Conductivity greater than 15 µs/cm may cause failures.

17

1.13.1 Tap water supply

The 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!

Note: We recommend testing the water quality once a month. The use of water

for autoclaves that does not comply with the table above may have severe
impact on the working life of the sterilizer and can invalidate the manufacturer’s
guarantee.

18

2 Safety

Principle Safety Warnings and Precautions

Caution!

Always operate the autoclaves strictly as instructed in this
user manual.

Caution!

Instruments should not be loaded into the autoclave to be
sterilized unless Steam Sterilization is instructed in their User
Manual. The instructed Steam Sterilization Program should
be verified against the programs available in this autoclave.

Caution!

Never use the autoclave to sterilize corrosive products
(acids, bases, or phenols) volatile compounds or solutions
(ethanol, methanol or chloroform), or radioactive substances.

Warning!

Always wear heat resistant gloves before unloading and
avoid touching hot load and hot surfaces.

Warning!

Don't place your hand or head, etc. above the door while
opening it as hot steam is escaping the chamber.

Warning!

Do not stand near the back panel of the autoclave while the
device is operating as the pressure safety valve may release
steam.

Warning!

Do not touch hot surfaces, such as the top enclosure and
area adjacent to the chamber opening! Hot surfaces are
indicated with a label (see sec. 1.3 above)

Caution!

Only technical personnel having proper qualifications and
holding technical documentation (including a technician
manual) and adequate information are authorized to install
and serve the apparatus

Caution!

In 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.

Table 6 - Safety Warnings and Precautions

19

Safety Notes

 All new autoclave users must undergo a period of training in proper usage under an

experienced employee.

 Before initial use, check the autoclave chamber to ensure that no packaging

materials have been left inside.

 Before use, check inside the autoclave chamber to ensure that no items have been

left from the previous cycle.

 Always verify that you have chosen the appropriate sterilization program
 After the cycle, open the door slowly to allow steam to escape and wait 20 seconds

before you remove the load.

 A certified inspector must perform a periodic pressure chamber safety test

according to the local regulations.

 Once a year, or more frequently, effectiveness tests must be performed, i.e.,

calibration and validation.

 Make sure there are no leaks, breaks, blockages, whistles or strange noises.
 Perform maintenance operations as instructed. The owner of the autoclave is

responsible to perform the maintenance operations.

 Notify the person in charge immediately of any deviation from the normal

functioning of the device.

 Protective equipment and clothes and other safety instructions shall be

implemented in accordance with local and national regulations and/or rules.

2.3 Safety features incorporated in the device

The pressure vessel chamber door has the following features protecting
personnel from hazards:

 Two door switches indicate that the door is closed. Without this indication steam is

not introduced into the chamber.

 An electrical door locking pin that blocks door opening during operation.

The following safety devices are installed in the autoclave to optimize its safe
operation:

 Safety thermostat, to prevent over-heating of the chamber heating elements.
 Safety cut-off switch to prevent over-heating of the pipe heating element.
 Safety pressure valve to prevent over-pressurizing of the chamber.

Warning!

Mind the Power socket. Keep it and its vicinity dry. Danger
of electrocution.

20

3 Content of the Device Package

Table 7 - Device Package

Part Number

Part Description

Quantity

Supplied

AMS10-230-W-T

T-Duke23 Autoclave

1

0663-DEV000

Aluminum Tray for 10”

5

TRH511-0001

Wire Tray holder for trays or

Cassettes

1

TRH511-0004

tray stoppers (to be assembled

on tray holder)

8

CMT240-0002

Tray Handle

1

PIP411-0042

Tube for Reservoir Drain

2

PIP511-0029

Tube for Auto reservoir drain+

1

WIR040-0005 Power cable

15A, 250V, USA

Power cable

1

THE002-0117

Blank labels roll for barcode

printer

1

MAN205-0502005EN Rev. B

Operation and Maintenance

Manual (USA)

1

21

4 Depiction of System Parts

Front View

No.

Description

No.

Description

1

Touch screen

7

Door switches

2

On/off switch

8

Air filter

3

Chamber Door

9

USB socket

4

Door Gasket

10

Door Handle

5

Mineral-free (left) and
waste water (right)
reservoir drains Chamber

11

Mineral-free water reservoir opening
6

Chamber

Table 8 - Front View

2

7

6

5

1

4

3

9

8

10

11

22

Rear View

No.

Description

No.

Description

1

USB ports

6

Waste outlet

2

LAN socket

7

Mineral-free inlet (available in AMS10­230-W-T)

3

Cut-off Thermostat

8

Safety valve

4

Circuit breaker on off
switch

9

Aeration Ventilation opening

5

Power socket

Table 9 - Rear View

Warning!

Mind the Power socket. Keep it and its vicinity dry. Danger of
electrocution.

3

1 5 7

2

4

6

8

9

23

5 Installation Instructions

Lifting and Carrying

Cautions!

Before moving the autoclave, make sure that the electric cord is
disconnected from the power, and there is no pressure in the chamber.

Drain the water from the reservoir (see draining the reservoir, 8.9)
Do not drop the device!

To avoid injuries, lifting and carrying should be done with at least two people or
by using a fork-lift or any other mechanical aid.

Device Placement and Operating Conditions

1. The autoclave is intended for indoor use only.

2. Check and verify that the counter carrying the autoclave is a rigid and
leveled surface and can carry a load of 165 lbs (75kg).

Caution! The device is not designed for

use on any standard slide out shelf. If it is
necessary to use a slide out shelf, it must be
tested and/or rated for 165 lbs (75Kg) or more.

3. Check and verify that the dimensions of the surface of the counter are at
least 21"(55cm) x 23"(60cm).

4. Keep the back and the sides of the autoclave approximately 10cm away
from the wall to allow ventilation and facilitate the device disconnection.

5. If placed in a cabinet, verify that the rear of the cabinet is open to allow
ventilation.

Caution! Insufficient space for
ventilation may result in malfunction or
damage due to overheating.

6. It is recommended that enough space be left around the autoclave to
give a technician access for servicing the machine.

7. Check and verify that the ambient temperature range is 41ºF (5ºC)­104ºF(40ºC), it is preferable not to exceed 86 ºF (30ºC).

24

8. Check and verify that the ambient relative humidity does not exceed
80%

9. The operational altitude shall not be over 13123 ft (4000 meters).

10. Ambient pressure shall not be lower than 8.8 psi (60.5 KPa) (if the
altitude and temperature are kept in the manufacturer's instructed
ranges above, and no forced extreme negative pressure is applied near
the autoclave, then ambient pressure of 8.8 psi (60.5 KPa) or higher is
guaranteed, as it is a function of altitude and temperature).

11. Operate the autoclave only in the manner specified in the manual. If the
equipment is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired.

Connections to Utility Supplies

1. Check and verify that the power supply is a 1 phase, 110Vac ±10%,
60Hz, 10A supply.

2. Check and verify that the electrical net is protected by a current
leakage safety relay.

Storage

After the removal of the autoclave from the package, we recommend the
following:

Keep the device dry.
Keep the device away from sunlight and protect it from heat.

Initial Operation of the Device

1. Plug the power cord into the power socket.

Warning!

Mind the Power socket. Keep it and its vicinity dry. Danger
of electrocution.

25

2. Turn ON the semi-automatic ON/ OFF button switch located on the
bottom left side of the back panel of the autoclave (see the rear view),
and then.

3. Turn on the ON/ OFF Switch mounted on the bottom left side of the
front panel (see the front view).

4. When you turn on the autoclave, it will automatically warm up.

Warning!

Be careful the surfaces may be hot!

5. Fill the Mineral Free Water Reservoir with water meeting the quality
specs (see Water Quality and Filling the Mineral-Free Water Reservoir).

6. Set date and time (see Set date and time).

Semi- automatic ON/OFF Switch

26

6 Pre-sterilization Cleaning and Disinfection of

Instruments and their Loading into the Device

Caution!

Instruments should not be loaded into the autoclave to be
sterilized unless Steam Sterilization is instructed in their User
Manual. The instructed Steam Sterilization Program should be
verified against the programs available in this autoclave.

Caution!

Never use the autoclave to sterilize corrosive products (acids,
bases, or phenols) volatile compounds or solutions (ethanol,
methanol or chloroform), or radioactive substances.

The most important stage begins with removing debris by cleaning and rinsing.
Effective cleaning is affected by several factors: water quality, type,
concentration and quality of a cleaner, effective washing method, and
adequate rinsing and drying.

Cleaning dried blood is especially difficult because it flows and dries in difficult­to-clean locations. It shall be washed away. Mechanically scrubbing, high pH
detergents, enzymatic solutions, and water spray at high pressure will clean
this contamination.

Note: Consult the Medical Device manufacturer relating adequate and most
effective cleaning method and cleaning agents.

Instruments which are composed of several components shall be dismantled.
Disinfection is the next step. It is important for safe handling. There are

various methods and means for disinfection like soaking in liquid chemical
disinfectants or hot water disinfection.

Packaging. The target in packing medical items is to assure that the contained
goods are sterile and maintaining them sterile till opening the package.

There are various methods and techniques used in preparation and packaging
of surgical instruments.

Check the instructions of the item manufacturer as to the proper procedure for
cleaning and sterilizing each item. The item manufacturer’s instructions always
supersede any other instructions.

 Clean instruments immediately after use to remove any residue. It is recommended

that all instruments be ultrasonically cleaned using Tuttnauer’s Clean & Simple

enzymatic cleaning tablets or other suitable solution.

 After cleaning, rinse instruments under tap water for 30 seconds and pat or air dry

to remove residual minerals. If your tap water has a high mineral content, then rinse
a second time in a bath of distilled water to remove minerals and pat dry.

27

 Launder textile wraps prior to sterilization, thoroughly rinse wraps laundered in

chlorine bleach. Chlorine bleach can harm your stainless-steel instrument and the
sterilizer.

 Follow the instrument manufacturer’s instructions on the use of products for

cleaning and lubricating instrument that have been ultrasonically cleaned.

 Be sure that instruments of dissimilar metal (stainless steel, carbon steel, etc.) are

separated. Carbon steel instruments should be bagged or placed on autoclavable
towels and not directly on stainless steel trays (mixing will result in damage to the
instruments or trays from the oxidation of these materials).

 Load items within the boundaries of the tray so that they do not touch the chamber

walls or fall off when the tray is moved. Items should not be allowed to touch the
walls of the Chamber as the hot metal can damage the item.

 Don’t overload the Sterilizer trays (see Specification). Overloading will cause

inadequate sterilization & drying.

 Make sure that all instruments remain apart during the sterilization cycle. Surfaces

that are hidden because items are covering other items will not be exposed to the
steam and will not be sterilized.

 Disassemble or sufficiently loosen multiple-part instruments prior to packaging to

permit the sterilizing agent to come into direct contact with all parts of the
instrument.

 Verify that packaging methods are in accordance with the good practice approach

and the packaging materials used are in agreement with applicable standards.0

 Tilt on edge items prone to entrap air and moisture, e.g. hollowware, so that only

minimal resistance to air removal exist, the passage of steam and condensate will
be met.

 Wrapped instruments should be placed in material which will allow steam

penetration and promote drying, such as autoclave bag, autoclave paper, or muslin
towels.

 When loading pouches on the tray, put them with paper side up, nylon side towards

the tray (see the figure below)

 Tubing should be rinsed after cleaning. When placed in the tray, make sure that

both ends of the tubing are open and there are no sharp bends or twists.

28

 Cassettes should be placed on the tray rack in place of the trays. They should not

be touching each other or the Chamber walls. There should be about 2.5cm
between cassettes or packs for proper steam circulation.

 If spotting is detected on the instruments it is necessary to determine if the spot is

dirt or rust. The first step would be to use an ordinary eraser to remove the spot. If
there is no pitting under the spot, then the spot is only dirt. Dirt spots on an
instrument may be an indication that the autoclave needs to be cleaned or that the
instruments were not adequately cleaned or dried prior to sterilization. If removal of
the spot reveals pitting, then the spot is most likely rust. Rust spots on an
instrument are not uncommon on inexpensive instruments. It may also be an
indication that the instruments were rinsed in tap water with a high mineral content.
These minerals when exposed to high temperature and steam will accelerate the
oxidation of the metal. One suggestion would be to final rinse the instruments in a
distilled water bath and pat dry to absorb residual water and minerals.

 If the instruments exhibit a discoloration this can be due to the mixing of carbon

steel and stainless steel. When these two metals come into contact with each other
electrolysis occurs that breaks down the metal. The best solution is to separately
wrap the carbon steel instrument to insulate it from other instruments on the tray
and the tray itself.

29

7 Operating Instructions

The following are the operation instructions.

Turning on the Device

Plug the power cord into the socket on the rear panel of the autoclave (see
the rear view) and into the wall outlet.

Turn ON the semi-automatic ON/ OFF bottom Switch located on the rear panel of
the autoclave (see the rear view).

Semi-automatic ON/OFF Switch

Turn on the ON/OFF switch mounted under the cover on the front of
the autoclave (see below)

30

Filling Water

Cautions!

In the beginning of each day, check water level in the reservoir.

Note: Improper Water level icon appears when the water reservoir needs to be
filled. See the ‘filling procedure’ (7.3 below) and ‘Draining the Reservoir’ (8.9).

A general alarm symbol will appear.

Proper Water level icon appears when the water reservoir is properly
filled. See the ‘filling procedure’ below and ‘draining procedure’ (8.9).

The water level icon appears when the water level in the reservoir is full.
See the ‘filling procedure’ (7.3 below) and ‘Draining the Reservoir’s (8.9).

When this icon appear, do not fill water!
Note: A new icon was added to the row of icons for the dirty water reservoir

The following screen shows that the Waste water tank is full.

31

The following screen shows that the Waste water tank is empty.

Caution!

Before filling the reservoir, verify that the autoclave is idle and there is no
pressure in the chamber.

Filling water in the reservoir

Note: Use only water having the characteristics stated in Water Quality.

Using tap water will clog the system and invalidate the manufacturer’s
guarantee.

To fill water in the reservoir:

Lift up the water reservoir cover (see below).

Pour water into the reservoir through the water filter on top of the autoclave
unit.

In case you fill too much water, it will spill on the counter.

32

The clean water level indicator will change from a red water droplet
symbol to a blue water droplet, as shown below:

See the requirements concerning Water Quality, in

Section 1.14

Setting Date and Time

Note: The Initial log-in including setting of drying time as well as other initial

parameters will be performed only by a qualified technician upon installation

On the main screen, press the menu symbol to open the settings screen.

Note: The only functionality to be performed by the user (on a regular basis) is
set of date and time.

33

Set Date and Time

Press the Set Date and Time icon to open the Set Date and Time
screen.

This quick option enables the operator to set the machine date and time.
Select day, month and year, as depicted:

After adjusting the date and time, the system will automatically restart.

34

This page is left intentionally blank

35

Class S and Class B

Class B: general description

Class B (that conform to European standard) mainly provides deeper vacuum in the
autoclave chamber than Class S, and therefore include more complete air removal
from the most difficult load types. It allows the system to perform vacuum in difficult
hollow or porous instruments and perform effective sterilization of these materials.

Class S: general description

Class S used in the USA obtain weaker vacuum level and is less effective than class B
in the sterilization of hollow instruments.

The following tables provide:

Table1 for types of sterilization cycles
Table 2 provides the T-EDGE 10, Class B sterilization programs.
Table 3 provides the T-EDGE 10, Class S sterilization programs.

Table 1 — Types of sterilization cycles
Class B

The sterilization of products as represented by the test loads in the standard.
For products that lie within the limits specified for the relevant test loads, this includes solid
products, porous products and lumen devices, wrapped (single- and multiple-layer) or
nonwrapped.

Class S

The sterilization of products as specified by the manufacturer of the sterilizer including
nonwrapped
Solid products
And at least one of the following:
Porous products, small porous items,
Lumen devices, bowls and receivers, single-layer

wrapped products, multiple-layer
wrapped products

36

Table 2 — Class B: sterilization cycles

Cycle Name

Sterilization Temp.

1

Pre / Post Vac Unwrapped Instr. 273F

273F

2

Pre / Post Vac Wrapped Pouches 273F

273F

3

Pre / Post Vac Unwrapped Delicate 250F

250F

4

Pre / Post Vac Wrapped Delicate 250F

250F

5

Chamber Clean

6 Bowie and Dick

273 F

7

Vacuum test

Table 3 — Class S: sterilization cycles

Cycle Name

Sterilization Temp.

1

Unwrapped Instr. 270F

270 F

2

Wrapped Pouches 270 F

270F

3

Unwrapped Delicate 250F

250 F

4

Handpieces 270F

270F

5

Chamber Clean

N/A

37

Setting class S and class B

Your autoclave contain class S as a standard. If you (the customer) would like to
upgrade your system to a class B, please contact Tuttnauer USA representatives or
your dealer. Tuttnauer will ask you for the autoclave serial number. In return Tuttnauer
will provide you with a code/password.

After entering the new code password by the customer user, the autoclave will contain
now the class B features.

The following details the procedure to access to Class B and how to switch from class
S to B, and from class B to S.

1. Press on menu.

2. Press on to select class B

Note: The autoclave presently is in Class S,

38

3. Press on the required class type.

4. Enter Password.

5. Click on set.

6. Class setting is in progress, press OK.

39

The autoclave is now converted to Class B and the screens displayed will have a class
B identification.

Note: the Class B sign are on screen header.
The entire autoclave is now in class B system, a sample of the screens after the

conversion to class B, are shown below:

40

Note: It is possible to switch back from class B to class S if desired, following the steps
above, by selecting S in step 3.above instead of B. Entering the code password is
required.

41

8 Control Panel

The display is a graphic Touch screen LCD panel used to display the autoclave current
status, any Operational or Error Messages and for operating the machine.

Image 1: Home screen –Program Select Screen
This screen will be presented when the autoclave is switched on:

Additional programs are accessible by paging using the side arrows:

10

1 3 2 6 4 7 5

11

12

15

16

13

14

17

18

42

Home screen Description and Functions

#

Icon

Name

Description

1 Home icon

immediate use only

2 Menu

Menu selection icon

3 Unwrapped 273F

Exposed Unwrapped 273F load program

4

Pressure

Momentary Pressure in the chamber

5 Temperature

Momentary temperature in the chamber

6 Load no. ID

Load cycle number

7 Date and time

It enables the operator to set the machine date and time screen

8 Water full

The Water is full in the reservoir

9 Waste water

The Water is empty in the waste reservoir

10 Door condition

Door is locked

11 Wrapped Pouches 273F

Wrapped Pouches 273F sterilization program

12 Side arrow right

Paging forward to the next program will display the next screen
item 17, and 18

13 Wrapped Delicate 250F

Wrapped Delicate 250F load prgram

14 Warnings

It indicate the Alerts

15 Unwrapped Delicate 250F

Unwrapped Delicate 250F program

16 Side arrow left

Paging backward to the previous programs

17 Bowie and Dick Test

periodic testing as referred to in ISO 17665-1.See the screen in
the top next page

18 Vacuum Test

See the screen in the bottom previous page

Chamber clean program

Chamber clean program cleans the autoclave chamber

Table 10 - Home screen Description and Functions

43

Opening the Device Door

This machine is equipped with an electronic door lock. The door is locked
when either the system is running a sterilization cycle, or there is pressure in
the chamber, or the power is off.

If you need to open the door after cycle completes, press the confirm button:
Showing Class S

In any case, if the door is not locked, it can be opened as illustrated below.
Turn the handle counterclockwise and pull out to open the door.

Closed position Opened position

Green Light

44

Starting a Cycle

It is recommended to perform B&D test cycle at the beginning of each working
day.

1. Before each cycle, check visually that the gasket is intact, not loose and
clean.

2. Load the autoclave properly (see chapter 6).

3. Choose the appropriate sterilization program.

Note: The program can only be selected when the door is open.

4. The selected program will be highlighted in red, as depicted here:

See section 8.4 for available sterilization and test programs.

5. The next screen will prompt the selected program information.

45

6. Close the door by both:

Pushing the door gently;
Turning the handle clockwise while pushing the door until it comes to the

closed position, then releasing the handle.

When the door is closed, the open-door symbol .

is replaced with the closed-door symbol .

46

Press the Start button to start the cycle.
For cycle process description, see Sterilization Cycle Description.

Warning!

Do not remove the top plastic cover during a running cycle. Hot water /
steam may exit!

After pressing start, the sterilization process starts

Image 3: screen display while "Unwrapped 134" sterilization program is in progress

47

Showing the

time left until
the end of the
process

48

Note: For the results of the cycle, see description in paragraph 8.5.

Program/ test description:

 Program icon & name

Program/ test description:



Sterilization temperature

 Sterilization time

Chamber
temperature

Chamber
pressure

 System status

 Name of stage


Error and operational messages

 Progress bar

Stop button

49

Available Sterilization Programs and Test Programs

8.4.1 List of available Sterilization and Test Programs (refer to sec.8.4.2 for

maximal allowed weight of load)

#

Icon

Name

Temp

Sterili-

zation

time

(min.)

Dry time

(minutes)

Load type

Type of use

Cycle

type

1

Unwrapped
Instr. 373F

273°F

4

1 (default)
Range: 1-99

Unwrapped
Instruments
(Unwrapped
Solid)

immediate
use only

S

2

Wrapped
Pouches 273F

273°F

4

23 (default)
Range: 30-99

Handpieces,
Wrapped
Instruments
(wrapped
solid), Textile
(fabric packs),
porous

for storage

B

3

Unwrapped
Delicate 250F

250°F

20

1 (default)
Range: 1-99

Unwrapped
Instruments
(Unwrapped
Solid)

immediate
use only

S

4

Wrapped
Delicate 250F

250°F

20

35 (default)
Range: 30-99

Wrapped
Instruments
(wrapped
solid),
Textile (fabric
packs),
porous

for storage

B

6

Bowie and Dick

273.2°F

3.3

2 (default)
Range: 0-99

Chemical
Indicator in a
product
challenge
device

periodic
testing as
referred to in
ISO 17665-1

B
7 Vacuum test

NA

Vac. Stable Time 1 =
5min

Vac. Time stable 2
=10min

Empty

Not
Applicable

N/A

8 Chamber clean

273.2°F

N/A

Empty

Periodic
cleaning

Chamber
clean

Table 11 - Home screen Description and Functions

Notes:

1

The sterilization program can be used for sterilizing lumen device of no longer than 230mm

and no smaller than 3.4mm.

2

This sterilization program can be used in sterilizing up to five dental handpieces.

50

8.4.2 Maximum Load Weight per Load type

Load type

Maximum
Load Weight

Suitable for programs

Textile, porous

3.0 lbs (1.5kg)

Wrapped

Solid Unwrapped

13 lbs ( 6.0kg)

Unwrapped

Solid Wrapped

7 lbs (3.5kg)

Wrapped

Table 12 - Maximum Load Weights

8.4.3 Description of the Sterilization Cycle Stages

Air-removal stage: Pre vacuum pulses are performed. For wrapped

cycles, there are 2-3 pulses and the vacuum are deeper.

Heating stage: steam is inserted into the chamber until the sterilization

temperature is reached

Sterilization: sterilization temperature is maintained constant during

the sterilization time.

Fast exhaust: steam is exhausted out of the chamber at a fast rate

until pressure decreases to ambient pressure.

Drying: performed with the door closed by pulling vacuum and using the

accumulated heat in the chamber and the load to remove leftover
moisture from the instruments and wraps.

8.4.4 Description of the Vacuum Test Stages

Vacuum is produced in the chamber, down to P1=2.17 psi (15 kPa.) At this
stage all the valves close. The autoclave remains in this stage for 5 minutes.
This period enables the condition in the chamber to reach equilibrium. After the
5 minutes have elapsed, the cycle ‘history record’ records the pressure that is
referred to as P2. At this point the test begins and lasts 10 minutes. At the end
of the test, the cycle ‘history record’ records the results. The pressure at the
end of the test is referred to as P3.

Notes: During the test period the autoclave is not heated. Even if the vacuum
test is completed, the operator shall check the test results and consider
whether the test results are acceptable or not.

51

8.4.5 Description of Bowie-Dick Test Stages

Air-removal stage: vacuum pulses are performed.
Heating stage: steam is inserted into the chamber until the sterilization

temperature and pressure are reached.
Sterilization stage: temperature and pressure are maintained constant at the

pre-set level for sterilization time.
Fast exhaust stage: steam is exhausted out of the chamber at a fast rate until

pressure decreases to ambient pressure.
Drying stage: heating of chamber followed by a vacuum break (air inlet) to

remove leftover moisture from the instruments and wraps. Air inlet to reach
atmospheric pressure.

Cycle Succeeded / Cycle Failed Notifications and

Follow-on

8.5.1 Cycle Succeeded

When the cycle has ended successfully, the following "Successful" message is
displayed:

Push the confirm button to confirm the "Successful" message.
Proceed to chapter "Opening the door and Unloading".

52

8.5.2 Cycle Failed

In the event of a failure at any stage, the exhaust valve will be opened to
release pressure from the chamber, the message "Fail" and a relevant failure
message will be displayed on the screen:

Warning!

The load has not completed a sterilization cycle; therefore, it is not
sterile. Handle it as a contaminated load.

Any failure means that the load is not sterile.

53

Aborting a cycle

It is possible to stop the cycle while the autoclave is operating. Press

the Stop button at any stage (except exhaust) of
the process to stop the operation.

If the cycle is aborted, the load is not sterile. A “fail” message will be displayed

with an error message explaining the reason for the failure. An alternating
buzzer signal will sound to notify the user.

Press the button to confirm the displayed message.

Warning!

The load has not completed the cycle; therefore, it is not sterile. Handle it
as a contaminated load.

54

Opening the door and Unloading

1. Push the button to confirm the "Successful" or the "error"
message to unlock the door.

2. Open the door.

Caution!

Open the door a little to release the steam from the chamber. Only after
the steam escaped, open the door widely.

Warning!

To avoid severe injuries from hot steam and condensed hot water that
may drip out when opening the door, it is strictly forbidden to lean on the
autoclave. It is strictly forbidden to place your hand or any part of your
body over or under the door.

3. Use the tray handle or wear heat-resistant gloves to remove the load
from the autoclave.

4. After unloading, visually inspect the load to ascertain that it is dry, and
that sterilization indicators have made the required color change.

Caution:

Water droplets and visible signs of moisture on sterile packaging or the
tape used to secure it, may compromise sterility of processed loads or be
indicative of a sterilization process failure. Visually check outside
wrapper for dryness. If there are water droplets or visible moisture on the
exterior of the package or on the tape used to secure it, the pack or
instrument tray is considered unacceptable.

Warning!

The sterility of the instruments processed in unwrapped cycles cannot be
maintained if exposed to non-sterile environment.

55

Checking Waste Water Level

When the waste water level is high, the general alarm symbol will appear.
A relevant text alarm will appear in the alarms list. This situation is normal, but
the operator cannot run a new cycle before draining the waste water reservoir
(see ‘Draining the Reservoir’ 8.9).

Draining the Reservoirs

This procedure applies to the mineral-free water reservoir (left) and to the
waste-water reservoir (on the right).

Note: Improper Water level icon appears when the water reservoir needs
to be filled or drained.

The drain valves are located on the front right side of the autoclave after the
door is opened.

56

To drain the reservoir:

1. See item (5) with the plastic hose (6) attached to it (supplied with the autoclave).

2. Put the other end of the hose into a drain bucket.

3. Insert part (5) into valve (3) and press it until you hear a click. The drain valve opens
immediately.

4. When the water reservoir is empty, press part (4). Item (5) will pop out approx. 3mm
and the drain valve will be closed. Remove item (6) with the plastic tube.

Caution!

Never reuse waste water.

5. If the drained reservoir is the clean-water reservoir, fill reservoir with distilled water
until it reaches the full level. (Approximately 6.5 liters).

The autoclave is now ready for use.

8.9.1 Waste water draining

Caution!
Waste water should be brought into the public net in accordance with the local
rules or requirements i.e ONLY NON-HAZARDOUS LIQUIDS SHALL BE
DISPOSED IN PUBLIC SEWAGE!

Connect the autoclave's drain to the building’s drainage pipe. The drainage shall be of an open
type, withstanding temperature of, at least, 60ºC. (Applicable for device with automatic water
inlet system only).

Waste Water

Clean Water

3

4

5

6

57

9 Preventive and Scheduled Maintenance to be

performed by the Operator

The maintenance operations described in this chapter need to be followed as
indicated to keep the device in good working condition and to keep any
breakdown time to a minimum.

The instructions that follow can easily be carried out by the operating
personnel and do not require a service technician.

Note: Technician manual describes the maintenance operations required from
qualified technician, every two months and once a year.

Should the need arise, technical assistance or a service technician can be
requested by either calling your dealer or Tuttnauer Europe.

Daily Maintenance

Caution!

Make sure the autoclave is not hot before cleaning it.

 Turn the unit on momentarily to allow the door to be opened. Open the door, unplug

the autoclave again, and proceed with cleaning.

 Clean door gasket with a mild detergent, water and a soft cloth or sponge. Check

visually that the gasket is intact, not loose and clean.

Weekly Maintenance

Caution!

Make sure the autoclave is not hot before cleaning it.

 Turn the unit on momentarily to allow the door to be opened. Open the door, unplug

the autoclave again, and proceed with cleaning.

 Clean the outer parts of the autoclave with a soft cloth.

9.2.1 Chamber Clean
Once a week perform chamber clean process per section 12

58

Monthly Maintenance

Caution!

Make sure the autoclave is not hot before cleaning it.

 Turn the unit on momentarily to allow the door to be opened. Open the door, unplug

the autoclave again, and proceed with cleaning.

 Clean and descale the chamber.
 If the autoclave is only used occasionally, drain the water from the mineral free

water reservoir once a week, and refill with fresh mineral-free water or distilled
water.

 Once a week or if a text alarm of ‘full waste water reservoir’ appears (whichever

comes first) drain the water from the waste water reservoir.

 Clean the outer parts of the autoclave with a soft cloth.
 Clean the Drain filter of the autoclave.

59

Periodic Maintenance

Caution!

Make sure the autoclave is not hot before cleaning it

1. Replace the air filter, every 6 months or after 1000 cycles
(whichever comes first) according to 12.3.

2. Every 3 months check the door gasket for any signs of physical
damage and ask the technician to replace it if there is tear or
leakage.

9.4.1 Replacing the Air Filter

Cautions!
Before proceeding, make sure that the electric cord is

disconnected and there is no pressure in the chamber.
Use scissors to open the filter bag and not sharp blades or

pointed instrument.
Check that the new filter has not exceeded the maximum

shelf life.
Carefully un-pack the new filter and examine it for any signs

of damage.
Remove any protective packaging before inserting the filter

into place.
Carefully Insert the new filter into the housing. Do not force.

The AIR filter is located under the mounted under the cover (see below).

1. Unscrew the filter (see below).

60

2. Disconnect the pipe.

3. Connect the new filter.

4. Screw in the new filter.

5. Ensure the new filter is all the way in and seated properly.

Note: make sure that the arrow on the filter body points inwards, toward the
chamber. Make sure that you don’t bend the filter pipe when reattaching it.

Note: It is recommended to replace the air filter every 6 months or after 1000
cycles (whichever is the shorter period).

61

9.4.2 Cleaning the Drain Filter

Caution!

Make sure the autoclave is not hot before cleaning it

Cautions!
Before proceeding, make sure that the electric cord is

disconnected and there is no pressure in the chamber.

1. Clean the drain filter, every month.

The DRAIN filter (1) is located inside the autoclave chamber at the

bottom far end, to reach the filter open the autoclave chamber door,
remove the tray (see below).

2. Open the autoclave chamber door, remove the tray (2), (see above).

3. Clean with a soft cloth the filter and the area around the filter.

4. Check that the autoclave function normally after the drain filter cleaning.

Note: If by cleaning the filter the result is not satisfactory, proceed to the replacement
of the drain filter (paragraph 9.4.3 below).

1

2

62

9.4.3 Replacing the Drain Filter

Note: If after successive cleaning of the filter the result is not

satisfactory proceed to the replacement of the drain filter
(paragraph 9.4.3 below).

Cautions!
Before proceeding, make sure that the electric cord is

disconnected and there is no pressure in the chamber.
Use scissors to open the filter bag and not sharp blades or

pointed instrument.
Check that the new filter has not exceeded the maximum

shelf life.
Carefully un-pack the new filter and examine it for any signs

of damage.
Remove any protective packaging before inserting the filter

into place.
Carefully Insert the new filter into the housing. Do not force.

Caution!

Make sure the autoclave is not hot before cleaning it

The DRAIN filter (1) is located inside the autoclave chamber at the bottom far
end, to reach the filter open the autoclave chamber door, remove the tray (see
below). (See below).

1. Replace the old DRAIN filter, by the new DRAIN filter (P/N: CMT511-

0048).

2. Open the autoclave chamber door, remove the tray (2), (see below).

1. Drain filter assembly–

P.N :CMT511-0048

1

2

63

3. Unscrew the old Drain filter assembly, using M14 wrench.

4. Remove the old Drain filter assembly.

5. Screw the new Drain filter assembly, (P/N: CMT511-0048) to its place in
the chamber bottom, tighten it with the M14 wrench.

6. Ensure the new filter is all the way in and seated properly.

7. Place the shelf (2) back.

64

10 Full List of Informative Screen Display Symbols,

Operating Messages, Error Messages and
Troubleshooting

The troubleshooting section is provided in order to enable the user to solve
minor malfunctions, prior to contracting our service department.

However, only technical personnel having proper qualifications and holding
technical documentation (including a technician manual) and adequate
information are authorized to serve the apparatus (See TABLES 13 & 14 below).

Symbols

Symbol / Message

Symbol / Message Description

Required
Action (if
applicable)

Sym­100

This symbol is displayed when
the door is open.

Note: The inherent safety feature
of the machine enables the user
to choose a cycle only when the
door is open.

Informative

symbol ----

Sym­110

This symbol is displayed when
the door is locked.

Note: The machine has an
inherent safety feature that
prevents the cycle from starting if
the door is not locked.

Informative

symbol ----

Sym­120

Good Water level (Clean water
tank)

Informative

symbol ----

Sym­125\

Full Water level

Informative

symbol

Sym­130

Low clean Water level

fill the mineral free water
reservoir until this symbol
change to Good level symbol.

65

Symbol / Message

Symbol / Message Description

Required
Action (if
applicable)

Sym­132

Good Water level (Waste water tank)

Sym­134

Full Water level (Waste water tank)

Sym­140

Alert

Press to watch the alert description

When cycle is selected it is
highlighted in red

----

The "cycle succeeded" message
and symbol are displayed when
the cycle ends successfully.

----

The "cycle Failed" message and
symbol are displayed when the
cycle failed either due to intended
cycle abort action by the user, or
due to a run-time error.

Try Perform a new cycle in order to
sterilize the load.

Error messages & Troubleshooting

Req ID

Message

Description

Msg-100

“Door is Open”

In STBY stage, when Door switch (DI 1) Open AND Door
lock DO 2 is ON

Msg-110

Canceled

Msg-120
"Analog Input
Error"

This message is displayed when any Temperature sensor
or Pressure sensor is disconnected or out of range.

* The name of the input should appear in the message

(Task 4642: If one of the analog inputs disconnected - the
name of the input should appear in the message (Now its­Analog inputs error))

66

Req ID

Message

Description

Msg-130

"Chamber
temperature not
in range"

This message is displayed if the temperature in the
chamber > End temperature (120C) or < 2C

Msg-140

"Chamber
pressure not in
range"

This message is displayed if Chamber pressure <ATM
pressure-40kPa or >ATM Pressure +10kPa).

Msg-150

Canceled.

Msg-160

"I/O card is not
connected"

This message is displayed if I/O card is disconnected (both
while cycle is running or not).

Msg-170

"Low Temp"

This message is displayed if the temperature drops for
more than 1 second below the sterilization temperature
during sterilization cycle.

Msg-180

"High Temp"

This message is displayed if the temperature raises 3°C
above sterilization temperature during the sterilization
stage for 2 seconds during sterilization cycle.

Msg-190

"High Temp.
(Ending)"

This message is displayed if the system cannot reach the
required temperature, in the chamber, within 10 minutes.

Msg-200

"Heat Time Error"

This message is displayed if the system cannot reach the
required temperature, in the chamber, within the preset
time.

Msg-210

"Low Pressure"

This message is displayed if Chamber Pressure drops
below the sterilization pressure for 2 seconds during the
sterilization stage.

Msg-220

"High Pressure"

This message is displayed if Chamber Pressure raises 29
kPa above sterilization pressure for 2 seconds during the
sterilization stage.

Msg-230

"High Pressure
(Ending)"

This message is displayed if the system cannot reach
atmospheric pressure ± 5kPa during the ending stage.

Msg-240

"High Pressure
(Exhaust)"

This message is displayed if the system cannot reach
preset pressure within 10 minutes from the beginning of
the exhaust stage.

Msg-250

Canceled.

67

Req ID

Message

Description

Msg-260

"Pressure Time
Error"

This message is displayed if the system cannot reach the
required pressure conditions in the chamber, after preset
time, during the air removal stage.

Msg-270

N/A

N/A

Msg-280

"Time Error"

This message is displayed if the real time clock is faulty.

Msg-290

"Door is open
(During the
cycle)"

This message is displayed when the door is open: During
the cycle.

Msg-300

"Canceled By
User"

This message is displayed after the STOP button is pressed
and cycle aborted.

Msg-310

This message and symbol are displayed if an error occurs
before sterilization cycle is completed.

Msg-320

"Air Error"

This message is displayed at the end of the cycle if the
autoclave does not reach the atmospheric pressure after
10 minutes.

Msg-330

Canceled.

Msg-340

If the water level is low in the clean water reservoir and
not sufficient for at least one cycle, this symbol will be
displayed.

Mineral free water reservoir empty will appear in the
error messages.

Msg-350

"Routine cycle
service is
recommended
Please call your
service provider."

Number of cycles, since last periodical maintenance,
exceeded the "cycle service counter" parameter Or time
elapsed exceeded the "time service counter" parameter.

Msg-360

"Power Down"

This message is displayed if power down has occurred
during the cycle. (this message will print out in the printer
after the autoclave will turn on).

Msg-370

Vacuum time
error”

Vacuum pressure fails to reach the required value within
the required time (in Vacuum test and Pre-vacuum stage)

Msg-380

Water fill Error

If DO10 is On for timer > Parameter Water fill time out
and DI2 (Max. float switch) is not On

68

Req ID

Message

Description

Msg-390

Water tank filling,
Please wait

If high water demand cycle is chosen (e.g. Prion) and
Parameter>0 (Auto fill) - Then before enabling Start
message presented on GUI

Msg-400
Please fill water

tank to full for
start

For prion cycle in manual water filling configuration, when

the water tank is not full the “Start” button will not

appear, instead this error message will appear in the
Active alarms screen.

Prion cycle, in manual water filling and the water tank is
not full

Msg-410

Unrecognized
printer

If printer is not recognized an error will appear in the UI.

Msg-420

Low Quality
Water

1. Read the water level from analog sensor.

2. Translate the digital value to micro siemens

according to the attached table.

3. Compare the value system parameter (water

quality reference, default 10).

4. if value is less than 10 show error - Low Quality

Water

Msg-430

Set Atmosphere
Pressure is Active

Present when Reset Atmospheric pressure is requested
from Technician screen

Msg-440

“No Water”

Chamber clean cycle, If Float switch (DI 2) doesn’t change
from 1 to 0 during water pump time On.

Msg-450

“Analog Input

Error - Jacket
Temperature”

Msg-460

Utility issue #1 –
Please switch OFF
and ON

machine’s power

switch

If windows card disconnects

Msg-470

Utility issue #2 –
Please switch OFF
and ON

machine’s power

switch

If WIN application crash/not start up

69

Req ID

Message

Description

Msg-480

Utility issue #3 –
Please switch OFF
and ON

machine’s power

switch

If I/O card disconnected during power on

Msg-500

Time jumped
during the cycle

If main system clock changed during the cycle
Msg-510

No-user log-in

If CFR-11 on and no user login

Table 13 - Error messages & Troubleshooting

70

11 TSC Printer Installation (optional)

The following is a user's set up guide that explains describe:

 General printer information.
 Safety instructions
 How to install TSC printer and connect it to the T Edge autoclave for the first time.

(Shall be performed by qualified personnel).

 How to set, operate, use and maintain the printer after the first installation.

General printer information

The printer(s) are optional and can be purchased/ordered from Tuttnauer by the customer,
the printers can easily be installed and connected to the autoclave following the
instructions below.

The options includes:

 One printer connected to the autoclave, and can be loaded with thermal paper roll,

or with label roll. The user can direct the printer to switch between printing on
thermal paper roll or label roll.

 Two printers connected to the autoclave, one loaded with thermal paper roll, and

the second printer is loaded with label roll.

11.1.1Printer Output:

The autoclave is equipped with a character printer, which prints a detailed history of
each cycle performed. (This can be used for the record or for subsequent
consideration.)

The printing is on thermal paper with a defined set of characters per line and contains
important information such as some of the main following details:

 Date:, Time: , Ser. Num:, Model:, Version:,
 Cycle Num:, Cycle Name:, Ster Temp:, Ster Time:, Dry Time:,End Temperature

When the sterilization cycle begins the printer starts printing the above data.
After the preliminary printing, the autoclave starts performing the sequence of operations

of the cycle. The measured values of temperature and pressure are printed at time
intervals, according to the phase of the process, as shown in the table on the next page.

The data is printed from the bottom up, beginning with the date and ending
with "Cycle Ended". For an aborted cycle, "Cycle Failed" and the Error
message are printed (refer to "Displayed Error Messages/Symbols").

The printer can also print labels when loaded with label roll and printer1 is
selected.

For an example of a typical printout, see next page.

71

72

Important safety instructions

1. Read all the instructions and keep them for future use.

2. Follow all warnings and instructions on the product.

3. Disconnect the power plug from the AC outlet before cleaning or if fault
happened. Do not use liquids or aerosol cleaners. Using a damp cloth is
suitable for cleaning.

4. The mains socket shall be installed near the equipment and easily accessible.

5. The unit must be protected against moisture.

6. Handle the equipment with care. Ensure the stability when installing the
device, tipping or dropping could cause damage.

7. Make sure to follow the correct power rating and power type indicated
on the marking label provided by the manufacturer.

8. Please refer instructions and to the user manual for maximum operation
ambient temperature.

Warning!

Hazardous moving parts, keep fingers and other body parts away.

Caution!
(For equipment with RTC (CR2032) battery or rechargeable battery pack)
Risk of explosion if battery is replaced by incorrect type. Dispose of used

batteries according to the instructions as below.

Caution!

The print head may be hot and could cause severe burns. Allow the print
head to cool.

Please, refer to the printer manufacturer safety instructions

73

Installation for the first time

Unpacking the printer:

1. Carefully open the printer box (1) and remove the printer packing.

2. Place the printer (2) on the table, and remove the two tapes (3).

3. Remove the rest of the box content which includes USB communication cable (6),
electrical power cable (7), CD (5), adapter (8), blue cable (9), and the printer
instructions (4).

Note: the USB communication cable or other cables may come in another additional box.

1

2

3

8 7 6

5

4

9

74

Open the printer top cover

1. Remove the two tapes bonding the printer body to its cover (1) on each opposite sides
of the printer.

2. Pull the two handles left and right (2) simultaneously together forward as shown by the arrows
in figure 1.

3. The top printer cover will lift as shown in the figure indicated by 2.

1

2

75

Loading thermal printer paper roll/ Label roll

You can either load a thermal paper roll, or label roll on the printer roll
compartment opening.

You can also connect two printers to the autoclave, one loaded with thermal
paper roll, and the second printer loaded with label roll.

1. Slide switch (item 1) forward shown in fig 2, it will allow to move the roll holders (2)
apart as shown in fig 1 below, allowing to put the paper roll on the holders.

2. Adjust the roll holder (2) as shown in (item 3) in figure 3 depending if a thermal or label roll
is installed.

3. Place the thermal paper roll or label paper roll as shown in (item 4) figure 3.or,

4. Place the label roll as shown in (item 5) figure 4.

1

2

Figure 2

76

5. Insert the paper under the two paper guides (item 6) in figure 3 for the paper roll, pull the
paper to extend it beyond the printer. Do the same for the label roll (item 6) figure 4.

6. Push the printer cover down (fig 5) until you can hear a click indicating that the cover is
connected to the printer bottom.

3

Figure 3

Figure 4 Label roll.

4

Figure 3 paper roll

5

6

Figure 5 Printer

77

Connecting the interface cables to the printer

1. Connect the adapter male (1) to the RC-232 Output Port blue cable female plug
connection (2), tighten and secure the 2 screws (3) to the adapter.

2. Plug the adapter connected with the blue cable (8) to the printer adapter connection,
Tighten the 2 screws (4). To the printer (5) using screwdriver shown below.

3. Connect the Power cable (6) to the printer back port.

1. Adapter

2. RC-232 Output Port blue cable

3. RC-232 Output Port screws

4. Adapter 2 screws

5. Printer

6. Power cable

4. Connect the power cable connector of cable (6) coming from the printer to the electrical
power source on the wall.

1

2 3 4 5 1

6

7

Figure 5 Connecting the interface cables.

8

6

78

11.7 Connecting power and interface cables

1. Connect the RC-232 Output Port blue cable (6) to the back of the autoclave (4).

2. Connect the power cable plug connector of cable (6) coming from the printer to the
electrical power source on the wall.

3. Turn on the printer power

6

4

79

11.8 Starting the printer

1. Press on the button in the front of the printer cover, keep pressing the finger while
switching on the printer power at (1) the printer back. (Step 1 and 2 shall be done
simultaneously).

2. Switch on the printer power (1) at the printer back, keep pressing the finger in
step 1 until the red light bulb in front start flashing.

3. Ensure that the green bulb lights.

The printer will run and feed the roll until the end of calibration process, approximately
half meter for paper roll, and 3 labels for label roll.

1

80

11.9 Setting Printer definitions

The following are the login procedures for new user:

1. Press on the quick options menu

2. . Press on icon.

3. Enter administration password Select from drop down list.

4. Press Login Enter administration password Select from drop down list

5. Press on the quick option

6. Press on new

81

7. Press on system parameters

8. Select for paper roll printer type 6. Select for label roll label 1.

9. If only the one printer is connected to the autoclave, local=0 or
printer=1.

The following table gives the various printer possibilities

Printer Type

Local

Only paper roll 6

0

Only Label roll 1

1

Both paper roll and label roll are connected 6

1

.

82

12 Chamber Clean Program

General

The Chamber Clean is a cleaning and descaling process. It is using a tablet agent
designed specifically for cleaning and removal of water deposit oxides and other
sediments found in steam sterilizers.

The tablet material is a combination of acidic salts and additional cleaning materials.
Use one prepacked chamber clean tablet for all T-Edge10 Tuttnauer Autoclave models.
Perform chamber clean every week.
Chamber Clean Program-Icon Picture

The Chamber Clean cleaning program for class B and S for T-Edge10 autoclaves is
described below:

83

Chamber clean Cleaning procedure

Important

The Chamber Clean cleaning program for class B and S for T-Edge10 autoclaves is
described below:

The chamber must be cold.

1. All steps in this procedure must be completed without interruption.

2. Open the autoclave chamber door.

3. Remove instruments and any load, trays from the autoclave chamber.

4. Place the trays and tray holder in the sink to be cleaned with a
stainless steel Safe cleaner.

5. Place one 6g cleaning tablet (1) from the tablet packing (2) inside the
sterilization chamber at the back bottom of the cold chamber.(see
figure below). Under the 132°C program conditions. Chamber clean
program 6g Tablet position

1. Tablet

2. Tablet from packing

6. Close the autoclave door.

7. Fill fully (Approx. 23 liters for T-Edge 10, and 28 Liters for T-Edge 11)
clean water reservoir with distilled water only. (Either Automatic or
manual filling). For manual filling, select 0, Global select 1 for
automatic filling. Fill the reservoir full until the screen indicate full.

1

2

84

8. Chamber Clean Program-Manual fill clean water tank.

9. Chamber Clean Program-Water tank clean & waste

85

10. Select Chamber Clean Program

11. Chamber Clean Program -Start Cycle

86

12. Chamber Clean Program-Water tank alarm

13. Chamber Clean Program -Set manuel mode fill clean water tank

87

14. Please fill water tank to full for start.Chamber Clean Program-Alarm
water fill before start,

15. Chamber clean program Stage Cleaning-insert water

The chamber clean process last 45 minutes

The warming up to 80ºC and hold for 10 minutes at 80ºC, (This stage uses

500ml of water from the clean water reservoir) .Exhaust water from the
chamber, goes to air removal , pass to plateau of 3 minutes at 132 ºC and
1 minute drying time.

88

16. Chamber clean program Stage Cleaning-keep

17. After 45 minutes the chamber clean process is completed, the
chamber is clean, and the following screen is displayed.

Chamber Clean Program-cycle confirm by operator

89

13. Factory Codes for end user

Notice: Please, find below Factory Codes for end user.

These codes are similar to all T-Edge 10 machines from version

1.0.

Level 1 Factory Code 010 7N613IOJT6 Admin - for User Manual

Level 1 Factory Code 011 4YFBH5G597 Admin - for User Manual

Level 1 Factory Code 012 KX4D3O2IZ0 Admin - for User Manual

Level 1 Factory Code 013 E6QS7RCBF4 Admin - for User Manual

Level 1 Factory Code 014 UC3VUOCEGD Admin - for User Manual

Level 1 Factory Code 015 KQTPXJT37P Admin - for User Manual

Level 1 Factory Code 016 PGU318IXEZ Admin - for User Manual

Level 1 Factory Code 017 3F0ENI3ISP Admin - for User Manual

Level 1 Factory Code 018 LYBVQXMB4X Admin - for User Manual

Level 1 Factory Code 019 8JDZPNRA4W Admin - for User Manual

Level 1 Factory Code 020 GPAQKFZPCO Admin - for User Manual

Level 1 Factory Code 021 PKKSD0F9MD Admin - for User Manual

Level 1 Factory Code 022 WG2Q1UBBY9 Admin - for User Manual

Level 1 Factory Code 023 03O6I6YUKL Admin - for User Manual

Level 1 Factory Code 024 868PHX8VVZ Admin - for User Manual

Level 1 Factory Code 025 ISX099WTZ0 Admin - for User Manual

Level 1 Factory Code 026 DY0CYW6OJH Admin - for User Manual

Level 1 Factory Code 027 BUYBFZIMJE Admin - for User Manual

Level 1 Factory Code 028 VQP91IFY6J Admin - for User Manual

Level 1 Factory Code 029 JF5THJF61U Admin - for User Manual

Level 1 Factory Code 030 1ULOXX3VUJ Admin - for User Manual

Level 1 Factory Code 031 1KKUEWI1LP Admin - for User Manual

90

Level 1 Factory Code 032 QHR976ZE46 Admin - for User Manual

Level 1 Factory Code 033 TMUYMBFBLE Admin - for User Manual

Level 1 Factory Code 034 OTEWS95KOU Admin - for User Manual

Level 1 Factory Code 035 AOUMETCLQ1 Admin - for User Manual

Level 1 Factory Code 036 7Z1X0PZVHD Admin - for User Manual

Level 1 Factory Code 037 RGQHB6D4R7 Admin - for User Manual

Level 1 Factory Code 038 APZJ5F1IT3 Admin - for User Manual

Level 1 Factory Code 039 93VTGY2Q6C Admin - for User Manual

Level 1 Factory Code 040 KJCLC48NKH Admin - for User Manual

Level 1 Factory Code 041 QI3S1S9S2U Admin - for User Manual

Level 1 Factory Code 042 XRCOEYV6AM Admin - for User Manual

Level 1 Factory Code 043 EW7PX1MNGB Admin - for User Manual

Level 1 Factory Code 044 HO7MM19C2Y Admin - for User Manual

Level 1 Factory Code 045 ZKYMO2HXHO Admin - for User Manual

Level 1 Factory Code 046 IBM8C3KO49 Admin - for User Manual

Level 1 Factory Code 047 FWL0NJTZCN Admin - for User Manual

Level 1 Factory Code 048 YSEMX48VA4 Admin - for User Manual

Level 1 Factory Code 049 TYG12FB9JT Admin - for User Manual

Level 1 Factory Code 050 QVH2SC878F Admin - for User Manual