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Page 4 of 57 

1.

 

GENERAL 

 

Read the Operating Instructions carefully, before beginning any 

operation on the autoclave! 

1.1.

 

Incoming Inspection 

 

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, 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.  

 

 Note

: Lifting and carrying should always be done by two people. 

 

1.2.

 

Warranty  

 

We certify that this instrument is guaranteed to be free from defects in 

material and workmanship for one year against faulty components and 

assembly. 

 

This warranty does not include routine cleaning and preventive 

maintenance which needs to be performed according to instructions 

in section 11 (Preventive and Scheduled Maintenance). 

 

 

Tuttnauer warrantees all new autoclaves for a period of one full year, 

covering both parts and labor. This one year warranty covers defects in 

materials and workmanship on every part in the autoclave except the 

HEPA filter and the door gasket.  

 

This warranty does not apply to any instrument 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. 

 

Warning 

Sterilization programs 1-5 are not considered by the Food and Drug 

Administration to be standard sterilization cycles.  In the United States, 

use only sterilizer accessories that have been cleared by the Food and 

Drug Administration for the selected sterilization cycle parameters 

(time and temperature).  Users should only use sterilizer accessories 

(such as sterilization wraps, sterilization pouches, chemical indicators, 

biological indicators, and sterilization cassettes) that have been cleared 

for use in their markets. 

The Autoclave should not be used in a manner not described in this 

manual! 

Summary of Contents for Elara 11

Page 1: ...ELARA 11 Cat No MAN205 0342001EN Rev Q Manufactured by Tuttnauer Co Ltd Har Tuv Industrial zone B P O Box 170 Beit Shemesh 99000 Israel Tel 972 2 9904611 Fax 972 2 9904730 Tuttnauer U S A Co Ltd 25 Po...

Page 2: ......

Page 3: ...PTION 14 4 10 WATER QUALITY 15 4 11 DIRECTIVES AND STANDARDS 16 5 KEYBOARD 19 5 1 DESCRIPTION AND FUNCTIONS OF THE FRONT PANEL KEYBOARD 20 5 2 DISPLAYED ERROR AND OPERATIONAL MESSAGES 22 6 STERILIZATI...

Page 4: ...G 46 10 8 STOPPING THE PROCESS 46 10 9 CANCELING THE ERROR MESSAGE 46 10 10 SLEEP MODE 46 11 MAINTENANCE INSTRUCTIONS 47 11 1 PREVENTIVE AND SCHEDULED MAINTENANCE 47 11 2 DRAINING THE RESERVOIRS 49 11...

Page 5: ...Page 3 of 57 T A B L E O F I L L U S T R A T I O N S FRONT VIEW 17 REAR VIEW 18 TRAY HANDLE 56 POUCH RACK 56 TRAY 56 TRAY HOLDER 56...

Page 6: ...needs to be performed according to instructions in section 11 Preventive and Scheduled Maintenance Tuttnauer warrantees all new autoclaves for a period of one full year covering both parts and labor T...

Page 7: ...nd from Tuttnauer must be paid by the owner of the autoclave During the first 90 days after purchase of an autoclave Tuttnauer will pay shipping costs on an individually evaluated basis and ONLY with...

Page 8: ...to allow steam to move freely among all items 4 When sterilizing plastic materials make sure that the item can withstand sterilization temperature Plastic that melts in the chamber is liable to cause...

Page 9: ...until the unit has been inspected Mechanical inspection involves checking for signs of physical damage such as scratched panel surfaces broken knobs etc To avoid injuries lifting and carrying of the...

Page 10: ...adjusting parameters ATMPressure sec 7 2 6 in the Technicians Manual 3 1 6 Operating the autoclave 1 Plug the power cord into the power socket 2 Turn on the Main Switch Circuit Breaker see front view...

Page 11: ...ws use the operation manual as reference 9 1 Operation principals of the autoclave 9 2 Preparation for sterilizing instruction including loading instructions 9 3 Intended use of each cycle 9 4 Selecti...

Page 12: ...he pressure in the chamber and the pressure in the steam generator Temperature can be displayed in either F or C according to the operators needs The advantages of the prevacuum sterilizer are as foll...

Page 13: ...shall not exceed an ambient temperature range of 41 F 104 F 5 C 40 C and a relative humidity of 85 respectively The operation altitude shall not be over 6500 feet 2000 meters ambient pressure shall n...

Page 14: ...530 mm 20 8 Height B 444 mm 17 4 Length C 645 mm 25 4 Length with open door D 997 cm 39 25 Distance between supporting legs F Front legs F1 Rear legs K 452 mm 17 8 F 315 mm 12 4 F1 400 mm 15 7 Maximum...

Page 15: ...ording to the local network Attention The electrical net must be protected with a current leakage safety relay The electrical network must comply with local rules or regulations 4 6 Environment Emissi...

Page 16: ...eel 316 L Door is made of stainless steel 316 Trays are made of stainless steel 304 Water reservoir is made of polyethylene Door handle is made of hard plastic material which is safe to touch and ther...

Page 17: ...esidue 15 miligrams liter mg l Silica 2 mg l Iron 0 2 mg l Cadmium 0 005 mg l Lead 0 05 mg l Rest of heavy metals 0 1 mg l Chloride 3 mg l Phosphate 0 5 mg l Conductivity 50 s cm pH value 6 5 to 8 App...

Page 18: ...irements for sterilizers and washer disinfectors used to treat medical materials The following standards were taken in consideration 5 ANSI AAMI ST79 Comprehensive guide to steam sterilization and ste...

Page 19: ...r standard 4 Mineral free water reservoir cover 13 Legs 5 Chamber and steam generator safety valves 14 Mineral free water reservoir drain valve 6 Waste water reservoir cover 15 Waste water reservoir d...

Page 20: ...REAR VIEW No Description 1 Mineral free water reservoir cover 2 Waste water reservoir cover 3 Ventilation grills 4 Air filter service cover 5 Opening for calibration 6 Main power electric cable socket...

Page 21: ...Page 19 of 57 5 KEYBOARD No Description 1 Display 2 Keypad 3 Printer 2 3 1...

Page 22: ...reen The display is a graphical screen used to display the current status of the autoclave and any Operational Messages or Error Messages Time display Clock Time countdown Chamber temperature Chamber...

Page 23: ...DOWN key decreases its value o When the cursor is blinking on menu selection the DOWN key allows browsing forward through the menu o When adjusting a parameter and the cursor is blinking on SET or EXI...

Page 24: ...10 seconds Check that the autoclave is not overloaded or perform a new cycle If the problem persists call the technician Err 005 High Gen Press This error is displayed when the Generator pressure is m...

Page 25: ...t overloaded If the problem persists call the technician Err 016 Press Sensor Cutout This error and symbol are displayed if the chamber pressure sensor is disconnected or out of range Call the technic...

Page 26: ...mbol is displayed if the waste water reservoir is full Drain the reservoir This symbol is displayed while the chamber is preheating Wait for the autoclave to reach the proper operating conditions befo...

Page 27: ...ram 4 Wdry 121 Program 5 Delicate 121 Tests programs Test 1 B D Test Test 2 VacTest During the process the graph of the cycle will be displayed on the screen This graph shows the different steps of th...

Page 28: ...s Operation Sequence Air removal phase two vacuum pulses as described in the diagram below Saturated steam is introduced into the chamber until the sterilization temperature is reached Sterilization p...

Page 29: ...134 C 273 F Sterilization time 4 minutes Dry time 20 minutes Max cycle time 50 minutes Average cycle time 42 minutes Operation Sequence Air removal phase three vacuum pulses as described in the diagr...

Page 30: ...ed 8kg 17 6 lb Nominal Parameters Sterilization temperature 121 C 250 F Sterilization time 20 minutes Max cycle time 40 minutes Average cycle time 35 minutes Operation Sequence Air removal phase two v...

Page 31: ...121 C 250 F Sterilization time 20 minutes Dry time 20 minutes Max cycle time 70 minutes Average cycle time 60 minutes Operation Sequence Air removal phase three vacuum pulses as described in the diagr...

Page 32: ...ilization time 20 minutes Max cycle time 55 minutes Average cycle time 45 minutes Operation Sequence Air removal phase two vacuum pulses as described in the diagram below Saturated steam is introduced...

Page 33: ...vacuum pulses as described in the diagram below Saturated steam is introduced into the chamber until the sterilization temperature is reached Sterilization phase temperature and pressure are maintain...

Page 34: ...est the printer records the results The pressure 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 1 3 kPa the printer will print TE...

Page 35: ...splayed on the screen with the cursor blinking under the right digit 3 To increase the right digit press the UP key 4 After changing the code to 0001 move the cursor to SET by pressing the START STOP...

Page 36: ...the minimum allowable value It is possible to increase the time value up to a maximum of 99 minutes However cycles of this length have not been tested and there is no guaranty that they will be succes...

Page 37: ...date use the UP and DOWN keys 2 To move the curser from one digit to another press the START STOP key 3 After changing the time and the date move the curser to SAVE 4 Confirm the new time and date by...

Page 38: ...STORY directory 1 Choose the required cycle according to its number Log Load Nu with the UP and DOWN key 2 The words Log Load Nu are replaced by printing and the required cycle data is printed by the...

Page 39: ...ature and chamber pressure Date finished Time finished Operator Initials When the sterilization cycle begins the printer starts printing the cycle details for the program that was selected After the p...

Page 40: ...ng heating H 00 12 28 158 4 014 7 The time temperature and pressure during heating V 00 12 28 156 6 014 7 The time temperature and pressure during air removal Prints sterilization data every 3 minute...

Page 41: ...r open button 4 and open the printer s paper cover Handle the paper cutter 8 carefully not to cut your hand as shown on Fig 2 3 Set a paper roll 5 as shown on Fig 2 The loose end of the paper roll mus...

Page 42: ...ric shock overheating or burning of the printer which may lead to fire Never use the printer in a place of extreme humidity more than 85 or any place where it can possibly be splashed by any liquids I...

Page 43: ...aned using Tuttnauer s CLEAN AND SIMPLE enzymatic cleaning tablets or other suitable solution 2 After cleaning rinse instruments under tap water for 30 seconds and pat or air dry to remove residual mi...

Page 44: ...lizer trays Overloading will cause inadequate sterilization drying 16 Allow a distance of approximately 1 between trays to permit steam circulation 17 Wrapped instruments should be placed in material...

Page 45: ...n indication that the instruments were rinsed in tap water with a high content of minerals These minerals when exposed to high temperature and steam will accelerate the oxidation of the metal One sugg...

Page 46: ...dicates that the water level in the reservoir is too high To assist the operator to detect the water level the sight gauge is equipped with a yellow float 5 Caution Under no circumstance should water...

Page 47: ...rator is ready Sterilization cycles cannot be started until the unit is ready NOTE If the unit is in the Vacuum Test mode the heaters are turned off When the unit is ready the pre heating symbol is re...

Page 48: ...esistant gloves or use the tray handle to remove the load from the autoclave On completion of the cycle the load shall be visually inspected to ascertain that the load is dry and that sterilization in...

Page 49: ...water and a mild soapy solution The gasket should be clean and smooth 2 Check the interior of the autoclave If the autoclave is dirty it requires cleaning as follows Remove the tray holder and trays C...

Page 50: ...ator and refill with mineral free water Once a year Check the grounding continuity Calibrate the temperature and pressure Perform validation of the autoclave Check the precise operation of the earth l...

Page 51: ...o a bucket 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 5 with the plastic tube 4 If the drained reservoir is the clea...

Page 52: ...e filter proceed as follows 1 Remove the filter cover 2 by turning the cover counterclockwise until it is released 2 Remove the filter 3 from the filter cover by unscrewing the filter from the filter...

Page 53: ...cold Pull off the gasket from the door groove and install the new gasket referring to the drawings as above points 1 2 and 3 Apply a mild and diluted soapy solution to the door gasket to ease its inst...

Page 54: ...lve 1 Operate the sterilization cycle according to the manual but with no instruments 2 Allow a pressure of approximately 300 kPa 29 psig to build up in the generator and the chamber 3 Remove water re...

Page 55: ...e heat resistant gloves to avoid injuries 1 Turn the unit on momentarily to allow the door to be opened Then turn the unit off to stop the chamber from preheating 2 Remove the trays and the tray holde...

Page 56: ...ed to open the door follow this procedure 1 Turn the power switch off 2 Wait at least one hour until the autoclave cools down 3 Verify that there is no pressure in the autoclave chamber by pulling the...

Page 57: ...e sure the power cord is properly connected to the machine and the power source Verify that there is electrical power in the main source If the problem persists contact your dealer or Tuttnauer USA fo...

Page 58: ...Page 56 of 57 TRAY HANDLE CT530020 POUCH RACK AR910 TRAY CT520010 TRAY HOLDER TRH411 0004...

Page 59: ...n Model 50mm D 01610406 Paper Roll Printer DPU30 14 ACCESSORIES PART NUMBER DESCRIPTION AR910 Pouch rack CT530020 Handle Tray CT520010 Tray GAS084 0007 Drain P V C Tube 13mm OD x 10mm ID THE002 0022 P...

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