Tuttnauer 2840 ELG-D Скачать руководство пользователя страница 13

Страница: 13 / 95

Page 11

3.3 Directives and Standards

Tuttnauer. Ltd

. company meets the provisions of the following standards:

EN ISO

13485:2012 (Quality Systems for Medical Devices)

ISO

9001:2008 (Quality Systems)

MDD

93/42/EEC (Medical Device Directive)

Tuttnauer. Ltd. company also works in conjunction with and refers to:

AAMI/ANSI-ST8

Hospital sterilizers

ASME

American Society of Mechanical Engineers

Section VIII, Division 1, for unfired pressure vessels

EN 13060

Small Steam Sterilizers

UL 61010-1

PED

97/23EEC

IEC

IEC 61010-2-040 Safety

IEC

IEC 61326-1 EMC

ISO

17665-1:2006 (Validation and Routine Control)

3.4

Electrical Data

Property

Value

Total Power

9000W

Voltage

230VAC / 1ph

Amperage

10A

Protection

against

electrical shock

Class I (IEC 60601-1)

Mains

supply

fluctuation

+/- 10%

Degree of protection

by enclosure

IP31

Note:

In order to avoid any injury by electrical hazard, it is recommended that

a ground fault protection device be installed in the electrical panel

feeding the autoclave (local codes may make this mandatory).

3.5 Environment Emission Information

Peak sound level generated by the sterilizer is « 70 / dBA with a back

sound level of 60 dBA.

Total heat transmitted by the sterilizer is < 150 W/h

3.6 Water Quality

Содержание 2840 ELG-D

Страница 1: ...rd autoclave C optional system for fast cooling PV optional vacuum pump BH optional bio hazard filtration F optional fan for super fast cooling Cat No MAN205 0480000EN Rev I Tuttnauer Europe B V Hoeks...

Страница 2: ...https tuttnauer com...

Страница 3: ...onstruction 15 3 13 Safety Features 16 3 14 Stickers Description 16 3 15 Front View 18 3 16 Rear View 19 4 Control Panel 20 4 1 Control Panel Drawing 20 4 2 Description and Functions of the Front Pane...

Страница 4: ...ing aborted cycles after complete sterilization stage 49 6 3 Screens following a fail cycle 49 7 Printer 51 7 1 Printer Output 51 7 2 Printer Handling 53 8 Installation 56 8 1 Placing 56 8 2 Lifting a...

Страница 5: ...nce Instructions 79 12 1 Preventive and Scheduled Maintenance 79 12 2 Draining the Reservoirs 80 12 3 Cleaning the Air Jet 82 12 4 Replacing the Door Gasket 82 12 5 Checking the Safety Valve 83 12 6 C...

Страница 6: ...ting in effective sterilization Better temperature uniformity Better drying of materials with closed doors due to the vacuum achieved in the chamber at the end of the sterilization cycle In BH bio haz...

Страница 7: ...is provided with a pressure gauge that is used as guide only Should there be a power failure during the operation of the autoclave the pressure gauge indicates to the operator that there is pressure...

Страница 8: ...d preventive maintenance to be performed according to instructions in sec 12 1 Preventive and Scheduled Maintenance Our obligation is limited to replacing the instrument or parts after our examination...

Страница 9: ...us All transportation charges must be paid both ways by the owner This warranty will be void if the unit is not purchased from an authorized full service Tuttnauer dealer 1 5 Accessories Basket acces...

Страница 10: ...the safety licensing and authorization department has approved it for use 2 All autoclave users must receive training in proper usage from an experienced employee Every new employee must undergo a tra...

Страница 11: ...st conduct pressure chamber safety tests 12 Once annually or more frequently effective tests must be performed i e calibration and validation 13 Examine the condition of assemblies on a regular basis...

Страница 12: ...ver 2000 meters 6561 feet ambient pressure shall not be lower than 80 kPa 11 6 psi The autoclave shall not be used in a manner not specified in this manual Do not use the autoclave in the presence of...

Страница 13: ...1010 2 040 Safety IEC IEC 61326 1 EMC ISO 17665 1 2006 Validation and Routine Control 3 4 Electrical Data Property Value Total Power 9000W Voltage 230VAC 1ph Amperage 10A Protection against electrical...

Страница 14: ...ue degree of acidity 5 to 7 5 5 to 7 Hardness ions of alkaline earth 0 02 mmol l 0 02 mmol l Appearance Colorless clean without sediments Compliance with the above data should be tested in accordance...

Страница 15: ...h 1090mm Distance between supporting legs Width 315mm front legs 400mm rear legs Length 532mm Weight per support area max load According to overall weight and floor loading requirements Net weight 78k...

Страница 16: ...tion against electrical shock Class I IEC 60601 1 Mains supply fluctuation 10 Degree of protection by enclosure IP31 Note In order to avoid any injury by electrical hazard it is recommended that a gro...

Страница 17: ...ipment within easy reach of the operator and marked as the disconnecting device for the equipment The electrical net must be protected with a current leakage safety relay The electrical network must c...

Страница 18: ...peration to be started only when the door is closed Water level safety device Excess temperature protection 3 14 Stickers Description Symbol Meaning Part Number Location Caution Hot steam LAB048 0058...

Страница 19: ...Page 17 ON OFF On Off LAB048 0018 Near the Power switch...

Страница 20: ...ption 1 Main switch circuit breaker 10 Door switch 2 Operating keyboard 11 Door closing device 3 Printer cover 12 Water reservoir funnel 4 Rear Leg 13 Water level gauge 5 Printer option 14 Autoclave c...

Страница 21: ...cover 3 16 Rear View No Description No Description 1 Water reservoir cover 7 Tap water inlet 2 Compressed air inlet 8 Overflow drain 3 Compressed air pressure gauge 9 Chamber water strainer 4 Air pre...

Страница 22: ...Page 20 4 Control Panel 4 1 Control Panel Drawing No Description 1 Display 2 Keypad Up Button 3 Keypad Start Stop Button 4 Keypad Down Button 5 Printer 3 5 1 2 4...

Страница 23: ...d below UP key This key has the following functions In the menu directories o This key enables the operator to browse through the cycles In the directories available o When the cursor is blinking on a...

Страница 24: ...the ERROR message displayed on the screen and opens the electric door lock In the menu directories o When the cursor is blinking on a number the START STOP key enables moving to the next position o W...

Страница 25: ...y Clock mode is performed Enter the Admin menu as described in this manual to change the time or to cancel this option Cycle by clock This message is displayed if the user presses START STOP key while...

Страница 26: ...reached the timed sterilization cycle begins 4 5 4 Cooling Optional The autoclave is designed to operate two liquid cooling cycles as follows Sealed bottles cooling with compressed air On completion...

Страница 27: ...ssure at the end of the test is referred to as P3 The rate of change of P3 P2 shall not exceed 0 13 kPa min If P3 P2 exceed 0 13 kPa min the printer will print FAIL If P3 P2 is within the required val...

Страница 28: ...Time minutes C models only PV models only BH models only Icon No Name Glass 134 C 273 F 3 1 Plastic 121 C 250 F 15 1 Liquid A 121 C 250 F 15 Liquid B Waste 121 C 250 F 30 Liquid A Cooling 121 C 250 F...

Страница 29: ...F 45 Vacuum test PV only 5 1 0 Bowie and Dick 134 C 273 F 3 5 1 Warm Up 80 C 176 F 20 Isotherm al 80 C 176 F 20 Air Mixture 121 C 250 F 15 Glass Test 121 C 250 F 20 Durham 121 C 250 F 15 These progra...

Страница 30: ...Page 28 The stages names are as follows Start Pulse Low PV models only Pulse High PV models only Heating Sterilization Cooling C models only Exhaust Drying PV model only Ending...

Страница 31: ...ly Pulse low Pulse high at one pulse it will build vacuum down to 25 kPa Heating Steam enters the chamber and heats it up until the sterilization temperature is reached Sterilization Sterilization tem...

Страница 32: ...m models only Pulse low Pulse high at one pulse it will build vacuum down to 25 kPa Heating Steam enters the chamber and heats it up until the sterilization temperature is reached Sterilization Steril...

Страница 33: ...s only Pulse low Pulse high at one pulse it will build vacuum down to 25 kPa Heating Steam enters the chamber and heats it up until the sterilization temperature is reached Sterilization Sterilization...

Страница 34: ...e vacuum models only Pulse low Pulse high at one pulse it will build vacuum down to 25 kPa Heating Steam enters the chamber and heats it up until the sterilization temperature is reached Sterilization...

Страница 35: ...pre vacuum models only Pulse low Pulse high at one pulse it will build vacuum down to 25 kPa Heating Steam enters the chamber and heats it up until the sterilization temperature is reached Sterilizati...

Страница 36: ...sequence PV pre vacuum models only Pulse low Pulse high at one pulse it will build vacuum down to 25 kPa Heating Steam enters the chamber and heats it up until the sterilization temperature is reache...

Страница 37: ...perations sequence Pulse low Pulse high four vacuum pulses remove air by drawing the chamber down to 25kPa Heating Steam enters the chamber and heats it up until the sterilization temperature is reach...

Страница 38: ...s Drying time 15 minutes Operations sequence Pulse low Pulse high four vacuum pulses remove air by drawing the chamber down to 25 kpa Heating Steam enters the chamber and heats it up until the sterili...

Страница 39: ...high at one pulse it will build vacuum down to 25 kPa All exhaust from the chamber is performed through the bio hazard filter Heating Steam enters the chamber and heats it up until the sterilization t...

Страница 40: ...ons sequence PV pre vacuum models only Pulse low Pulse high at one pulse it will build vacuum down to 25 kPa All exhaust from the chamber is performed through the bio hazard filter Heating Steam enter...

Страница 41: ...rature sensors must be inside the bottles For proper sterilization fill the bottles with approximately the same amount of liquid Nominal parameters default settings Sterilization temperature 121 C 250...

Страница 42: ...eases the door 5 12 Program 12 Vacuum Test PV pre vacuum models only Vacuum Test is a test program with the following parameters Nominal parameters default settings Vacuum pressure 17 0 kPa Vacuum tim...

Страница 43: ...nce Pulse low Pulse high Four vacuum pulses will build vacuum down to 25 kPa Heating Steam enters the chamber and heats it up until the sterilization temperature is reached Sterilization Temperature a...

Страница 44: ...0 minutes Operations sequence Pulse low Pulse high N A Heating Steam enters the chamber and heats it up until the warm up temperature is reached Warm up Warm up temperature is maintained constant for...

Страница 45: ...ion program Put one PT100 inside the bottle leave the second one hanging in the chamber outside the bottle see below Nominal parameters default settings Heating temperature default 80 C 176 F Heating...

Страница 46: ...inutes Sterilization is controlled in a way that the sterilization pressure remains approx 30 above the theoretical pressure corresponding to the same temperature according to the steam table These in...

Страница 47: ...checks that End temperature and End pressure have been reached and then releases the door 5 17 Program 17 Glass Test This cycle is intended to check the durability of the bottles for liquids when the...

Страница 48: ...ge of the cooling take approximately 21 minutes This is to check the durability of the bottles Fast Exhaust The steam is exhausted out of the chamber at a fast rate until pressure decreases to ambient...

Страница 49: ...ization time Slow Exhaust Steam is exhausted from the chamber at a slow rate until chamber temperature reaches 105 C Cooling Forced cooling to the required end temperature chamber pressure remains at...

Страница 50: ...6 1 Screens following a completely successful cycle Cycle Ended 1 System Ready 2 Pulse Low PV model only 3 Pulse High 1 1 PV model only 5 Heating 6 Sterilization 7 Exhaust 8 Drying PV model only 9 End...

Страница 51: ...erilization stage The cycle ended successfully the reason for aborted cycle is displayed 6 2 2 Pressure Time Error Failure occurrence after complete sterilization stage The cycle ended successfully th...

Страница 52: ...age When Cycle Failed appears on the screen the user shall press START STOP key in order to delete the Cycle Failed message An example for all displayed warnings according to Cycle Failed Cycle Failed...

Страница 53: ...e date and ending with Cycle Ended For an aborted cycle Cycle Failed and the Error message are printed refer to Displayed Error Messages Symbols For an example of a typical printout see next page Note...

Страница 54: ...rature and pressure during heating A 00 08 48 089 6 077 1 The time temperature and pressure during air removal A 00 05 48 091 3 049 4 The time temperature and pressure during air removal W 00 03 22 09...

Страница 55: ...k H Heating stage E Exhaust stage K Keep Heat Optional D Drying Stage ELPV Model only C Cooling stage for ELVC only 7 2 Printer Handling 7 2 1 Maintenance Wipe off the soiling on the printer surface w...

Страница 56: ...the paper and re close the cover as shown see Fig 3 3 the printer cover is locked 5 Tear off the exceeding paper using the jagged edge see Fig 3 4 Fig 3 6 Close the printer s cover door 3 by pressing...

Страница 57: ...liquids If any liquids get into the printer it could lead to fire electric shock or other serious accidents Never touch the thermal head immediately after printing because it becomes very hot Make su...

Страница 58: ...o allow ventilation and to facilitate the device disconnection If placed in a cabinet verify that the rear of the cabinet is open to allow ventilation Insufficient space for ventilation may result in...

Страница 59: ...h instruments with an ultrasonic cleaner using detergent and mineral free water 4 Launder textile wraps prior to reuse 5 After cleaning rinse instruments for 30 seconds Follow manufacturer s instructi...

Страница 60: ...uate separation of packaged instruments 9 Load trays in such a way as to allow steam to move freely among all items 10 Once a week use a biological spore test indicator in any load to make sure steril...

Страница 61: ...packs of folded operating room drapes with layers vertical allowing air to be removed from the packs rapidly 6 Do not place packs of hollowware and trays of instruments above textile packs or soft goo...

Страница 62: ...ressure build up 3 The PT100 temperature sensors se are used to control the program temperature and ensure the safety of the operating cycle Note For isothermal cycles insert one PT100 temperature sen...

Страница 63: ...oclave 10 2 Opening the door 1 Place your thumb on the plastic door cover 1 and the other fingers in the handle 3 2 Pull the handle 2 until the locking of the door is released 3 Open the door When the...

Страница 64: ...5 2 10 4 1 Closing the door 1 Hold the opening handle in open position while pushing the door until it comes to closed position then release the handle 2 The open door symbol is replaced by the messa...

Страница 65: ...oor is not completely closed the process will not start and the DOOR indicator will flash twice then turn off and the buzzer will sound four times Caution Do not touch the strainer s cover mounted on...

Страница 66: ...are displayed on the screen Refer to Displayed Error Messages Symbols Pressing the START STOP key cancels the displayed message and enables opening the door If the door is not opened the vacuum pump...

Страница 67: ...or detailed loading instructions see sec 9 Preparation before sterilization 10 9 3 Unloading On completion of the cycle take out the load immediately from the sterilizer Do not remove the load from th...

Страница 68: ...u will learn how to browse through the folders When you read the Directories and subdirectories chapter with links to specific menus you will need to know how to browse through the folders using the a...

Страница 69: ...owsed through the menus and reached the parameter changing screen as explained above Now you can change the required parameter as desired To do so 1 Enter the required value as follows Press the Up an...

Страница 70: ...e note the maximum and minimum values for this parameter shown on the screen Your value must be within these boundaries Below is the example of changing the Dry time parameter on the screen used in th...

Страница 71: ...P and DOWN keys simultaneously 11 3 Quick options screen When the autoclave is on and no cycle is running press Up and Down keys simultaneously to enter the Quick options screen Most of the options re...

Страница 72: ...some Quick Options 11 3 1 Version Information This directory allows viewing information of the current factory default and previous software versions 1 Enter the Version information screen 11 3 2 Sta...

Страница 73: ...ing the time to start the cycle 1 Move the cursor to the Time field 2 Set the required time Enabling the Start Cycle by Clock 1 Set the starting time 2 Move the cursor to Enabled Press Up or Down key...

Страница 74: ...art Cycle by Clock 11 3 3 Set date and time This subdirectory enables the operator to set date and time On the Set date and time screen the time is displayed in the upper row in the form HH MM SS The...

Страница 75: ...11 2 explains how to change a parameter When the autoclave is on and no cycle is running press the up and down keys simultaneously to enter the Quick Options screen see 11 3 On this screen you can ei...

Страница 76: ...ptions available to user on the Main Menu 11 5 Changing parameters Bacsoft control panel provides an interface that consists of control screens available through an easy scrollable menu tree To learn...

Страница 77: ...llowing folder Main menu System parameters You will see the following screen 11 6 1 Screen Saver In this menu you can define the screensaver delay time i e how long the keyboard will be untouched befo...

Страница 78: ...for autoclave s maintenance menu 11 7 1 Reset atmospheric pressure In this menu you can reset the atmospheric pressure value To do so 1 Browse to the following folder Maintenance Reset atmospheric pr...

Страница 79: ...done See the printout shown in the Printer handling chapter of the user manual 11 8 Cycle parameters The Cycle parameters menu includes parameters of a specific sterilization program cycle Browse to t...

Страница 80: ...ameter as desired Drying stage is divided into two stages For each stage you can set the total time on time and off time So during the Dry First Stage the heating elements are on for the time set in D...

Страница 81: ...y by the operator Clean door gasket with a soft cloth The gasket should be clean and smooth A mild soapy solution may be used 12 1 2 Weekly by the operator 1 Check the interior of the autoclave If the...

Страница 82: ...ions Calibrate the temperature and pressure Perform validation of the autoclave Checking the precise operation of the earth leakage relay Checking that the autoclave is leveled Checking the safety ele...

Страница 83: ...into valve 3 and press it until you hear a click The drain valve is open 3 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...

Страница 84: ...clean out wire inserted in it wire is permanently installed and will not come out It is required that the air jet be cleaned once per week or more often if necessary to remove any accumulated dirt and...

Страница 85: ...s check while the autoclave is cold 1 For the autoclave safety valve operate the sterilization cycle for the generator safety valve operate the generator 2 Allow a pressure of approximately 200 kPa 29...

Страница 86: ...Page 84 ASME approved type safety valve 2 4 3 No Description 1 water reservoir cover 2 Safety valve 3 Pulling device 4 Pressure relief ring 1...

Страница 87: ...ted on the exhaust line during and shortly after operation Touching the hot strainer s cap may cause severe injuries 2 If maintenance operation is performed while strainer cap is hot use heat resistan...

Страница 88: ...y reported to the microprocessor all during the cycle The water sensor is located in the rear of the chamber It is easily cleaned using a damp cloth or sponge you may use a mild soapy solution if you...

Страница 89: ...Page 87...

Страница 90: ...d Message is displayed and FAIL indicator lights if in the air removal stage a vacuum level of 25kPa is not reached during 20 minutes after the cycle is started Perform a new cycle Call the technician...

Страница 91: ...Heat Time Error Keep This message is displayed if the system cannot reach the required temperature in the chamber during the optional Keep Heat stage within the preset time Verify that the autoclave i...

Страница 92: ...ror This message is displayed at the end of the cycle If the autoclave does not reach the atmospheric pressure after 10 minutes Wait until the autoclave reaches the atmospheric pressure and perform a...

Страница 93: ...the autoclave turns on condition and perform a new cycle No Water This message is displayed if the electrode in the chamber did not sense water within the preset time 1 check and fix the mineral free...

Страница 94: ...NTAINERS Stainless steel wire baskets Stainless steel container for waste products L x D x H mm Capacity L x D x H mm Capacity 400 x 180 x 160 1 400 x 190 x 160 1 Pouch Rack ACS215 0008 Container for...

Страница 95: ...Filter Air 0 2 Micron Model 50mm D THE002 0066 Thermal paper for CUSTOM PLUSII printer roll 57mm d 50mm 15 Accessories Part number Description GAS084 0007 Drain P V C Tube 8x12 THE002 0052 Printer PLU...

Результаты поиска

Содержание 2840 ELG-D

Отзывы:

Похожие инструкции для 2840 ELG-D

Бренды по названию

Популярные бренды

Tuttnauer 2840 ELG-D, Руководство по эксплуатации и обслуживанию

Результаты поиска

Содержание 2840 ELG-D

Отзывы:

Похожие инструкции для 2840 ELG-D

Бренды по названию

Популярные бренды