Statim 2000 & 5000 Operating Manual - rev7
Contents
1. Statim 5000S Statim 2000S Congratulations on your selection of the STAT M Cassette Autoclave We are confident that you have purchased the finest equipment of its type The Statim is a compact counter top unit that features a number of sterilizing cycles designed to meet your needs and suitability for steam sterilization The Statim S Cassette Autoclaves are fully compliant with EN13060 The details of installing operating and servicing your Statim are all contained within this operators manual To ensure years of safe trouble free service please read these instruc tions before operating this unit and keep them for future reference Operational maintenance and replacement instructions should be followed for the product to perform as designed Contents of this manual are subject to change without notice to reflect changes and improve ments to the Statim product The Statim is suitable for the sterilization of dental and medical instruments designed to withstand steam sterilization The Statim has not been designed to sterilize liquids cloth loads biomedical waste or materials not compatible with steam sterilization The processing of such loads may result in incomplete sterilization and or damage to the autoclave For more information about instrument suitability for steam sterilization consult the manufacturers reprocessing i2. gt Water Quality CD conductivity XX micro S value CD XXpS yyy z z ppm yyy engineering value z z parts per million value STAT M 2000S 5000S 5 Maintenance con t a 5 10 Preventative Maintenance Schedule To ensure trouble free performance both the operator and the dealer must follow a preventative maintenance schedule NOTE Please refer to your National Regional State or Safety laws for any additional reoccurring user testing that may be required The schedules below describe the necessary actions Operator Water Reservoir e Replace water as needed For opthalmic use drain at the end of every workday leave empty and refill at the start of the next workday Waste Bottle Empty the waste bottle every time you refill the water reservoir Fill the bottle with water up to the MIN line marking You may also add some chlorine free disinfectant Cassette e Wash the interior of the cassette with dishwashing soap or a mild detergent that does not contain chlorine e Scrub the inside with a cleaning pad designed for use with Teflon coated surfaces e After removing all traces of the detergent treat interior surfaces of the cassette with the STAT DRI Plus drying agent to enhance the drying process Order more STAT DRI Plus from SciCan quoting 20OZPLUS 80ZPLUST or 320ZPLUS Biological and or e Check the filter for dirt and moisture Replace if dirty Call for service if wet Air Filter Water Filter
3. Check the unit leveling Clean the inside of the cassette and treat with Stat Dri drying agent Refer to section 5 1 Cleaning the Cassette Examine the exhaust tube tube to the waste bottle for kinks STAT M 2000S 5000S 7 Troubleshooting con t If kinked straighten the tube If the tube cannot be straightened remove it from the push in fitting attached to the Statim Depress the collar on the fit ting and with the other hand pull firmly on the tube Once the tube is free of the fitting cut the damaged section of tubing away using a sharp instrument Be sure that you leave enough tube to reach the unit when you re attach the tube to the exhaust fitting If the tube is too short to remove a section contact your SciCan dealer fora replacement Make sure the compressor is working To check remove the exhaust tube from the waste bottle Start the Air Drying Only Cycle and place the free end into a glass of water If there is not a strong steady flow of bubbles the compressor is not functioning properly Contact your SciCan dealer Cycle interrupted NOT STERILE Wait a few minutes and attempt another cycle before Cycle aborted NOT STERILE and proceeding to the next solution Remove the cas CYCLE FAULT messages sette Be careful The metal parts will be hot and the cassette will contain hot steam Inspect the cassette to ensure that the holes in the back of the seal are perfectly aligned and that the flexible l
4. Never pull the paper backwards through the printer This will damage the printer mechanism To install the paper into the printer follow these steps 1 Power the Statim 5000S ON 2 Open the printer door El by pushing on the top half of the door 3 Power the printer ON 4 Unroll some paper from the thermal paper roll E and trim the corners using the paper cutting template included with each box 5 Move the paper roll arm El into the loading position Place the paper roll E on the arm so the paper strip feeds from the top of the roll and then carefully insert it into the paper feed slot E until it stops If the paper does not feed from the top the heat sensitive side of the paper will not be in con tact with the print head and the printer will not print 6 With one hand continue to gently feed the paper strip into the paper feed slot With the other hand press the paper advance button until the paper feeds by itself Keep the paper straight when feeding it into the printer or it may jam Do not force the paper into the slot If the paper will not feed into the slot pre cut the end of the roll again and reload the paper STAT M 2000S 5000S 6 The Communication Port con t 7 Continue to press the paper advance but ton until the paper feeds through the paper exit slot on the front of the printer Then move the paper roll E and arm into the operating position and close the printer door W The printer is now
5. 5 Repack the unit in the original packing materials and include all accessories originally included with the unit 6 Specify heated and insured shipping STAT M 2000S 5000S 4 Instructions For Use 4 1 Statim 2000S Using the Cassette When removing the cassette after a cycle exercise caution as the metal areas will be hot and the cassette may contain hot steam To open the cassette 1 Hold the cassette handle with your thumbs facing inward on the cassette latch 2 Push downward on the cassette latch cassette latch 3 Raise the cassette lid upwards and disengage the hinge 4 Rest the lid on its outer surface To close the cassette 1 Align the hinge tab on the cassette lid with the hinge slot on the rear of the bottom tray 2 As you begin to close the lid the hinge tab and slot will engage Inserting the cassette into the Statim 2000S 1 Place the end of the cassette into the unit 2 Gently push inward until you hear a click sound Never push the cassette into the Statim with force as the interior components could be damaged e Removing the cassette 1 Grasp the handle with two hands and pull away from the unit 2 Pull the cassette clear of the unit and set down on a firm surface Disengaging the cassette handle and pull the cassette out until there is a 15 mm to 20 mm 1 2 to 3 4 gap between When not in use the cassette should be disengaged To d
6. all four feet should be secure ly in contact with the counter surface This will prevent the unit from moving freely STAT M 2000S 5000S 3 Installation Con t 3 3 Connecting the Waste Bottle The waste bottle Ell is used to collect the wastewater after it has been converted to steam and then drained from the cassette To connect the waste bottle to the Statim follow these steps see figure 4 1 Insert the exhaust Ell tube into the fitting EI Oo on the back of the unit and connect tightly 2 Cut the tube to length and slide the waste bot tle fitting El into place 3 Place the free end of the tube into the hole in the lid of the waste bottle and hand tighten the fitting Do not coil the exhaust tube 4 Unscrew the lid and copper condenser coil i assembly from the waste bottle The lid and coil should come out together 5 Fill the waste bottle with water to the MIN line and replace the lid and copper condenser assembly Empty the waste bottle often to avoid unpleasant odors and discoloration of the contents A low level disinfectant pre pared according to the manufacturer s instructions may be added to the waste bottle to remedy this situation As a mini mum empty the waste bottle each time you refill the reservoir 6 Place the waste bottle near the unit Store th
7. from the paper roll arm El and leave the arm in the loading position 4 Using a 1 Phillips screwdriver remove the three G screws E from the printer cover E and remove the cover 5 Note the orientation of the exposed printed wiring board and the paper roll arm Elassem bled on the printer door El 6 Gently lift the printed wiring board upwards and away from the printer door Exercise care while handling the board The printer is integral to the wiring board Do not place strain on the connections of the ribbon cable soldered to the board Do not remove the connector of the flexible cable from the connector header on the board The paper drive mechanism on the underside of the wiring board is now exposed 7 Using a pair of tweezers or fine needle nosed pliers carefully remove the paper from the mechanism When the paper is removed reassemble the printer 1 Carefully snap the paper roll holder in the loading position back into the clips on the printer door El STAT M 2000S 5000S 6 The Communication Port con t 2 Place the printed wiring board back into position on the printer door Note the alignment of the mounting holes E in the wiring board and the mounting bosses IE on the printer door The black plastic printer body rests between the locating ribs on the inside of the printer door 3 Ensure that the flexible cables W are not pinched between the printer door and the wiring board pinched bet
8. or clean ing agents is not reccommended and could cause the unit damage 5 4 Cleaning the Exterior Surfaces Use a soft cloth moistened with soap and water to clean all exterior surfaces Do not use harsh cleaning chemicals or disinfectants 5 5 Changing the Statim 2000S Air Filter The filter should be replaced every six months in order to maintain an adequate supply of clean air during the air drying cycle To change the filter follow these steps 1 Turn the power switch at the back of the unit OFF 2 Remove and discard the old foam air filter El 3 Install the new filter Zl SciCan part no 01 1002078 4 Secure the filter plate El to the back of the compressor using the screw El retained during the disassembly procedure STAT M 2000S 5000S 5 Maintenance 5 6 Changing the Bacteria Retentive Air Filters The filters should be replaced every six months or after 500 cycles to maintain an adequate supply of clean air during the air drying cycle To change the bacteria retentive air filter on the Statim 2000S and 5000S follow these steps 1 Power the Statim OFF 2 Disconnect tube A Ell from the bacteria retentive filter Zl and remove the filter from the filter bracket El As you remove the filter from the bracket note the orientation of the arrow mark on the filter 3 When the filter is free of the bracket carefully discon nect tube B El from the filter 4 Before installing
9. or close to a heat source e g vents or radiators The recommended operating temperatures are 15 25 C with humidity of 25 70 Spacing The vents and openings on the Statim should remain uncovered and unobstructed Leave a minimum of 50 mm between the top sides and back of the unit and any wall or partition Venting The Statim should be operated in a clean dust free environment Work Surface The Statim should be placed on a flat level water resistant surface Never install and operate the unit on a sloped surface Electromagnetic Environment The Statim has been tested and meets applicable standards for electromagnetic emissions While the unit does not emit any radiation it may itself be affected by other equipment which does We recommend that the unit be kept away from potential sources of interference e Electrical Requirements Use properly grounded and fused power sources with the same voltage rating as indicated on the label at the back of your Statim Avoid multiple outlet receptacles If using a surge suppressor power bar plug in one Statim only 3 2 Unit Placement When placing the unit on a counter top ensure the following The level indicator bubble El on the front panel should be balanced in the front right quadrant of the target This will ensure that the unit drains properly Adjusting the three lev eler feet will help you move the bubble if necessary e The unit should be stable and
10. roll This means that the treated surface of the coated thermal paper will be in contact with the ther mal print head The time and date have not been set See section 3 6 Setting the Time and Date STAT M 2000S 5000S 7 Troubleshooting con t Message MSD NOT CONNECTED lt gt Check the serial cable connection INSERT MSD FLASH Check the power connection Ensure the lower red LED is lit Check that the Mass Storage Device is properly inserted Repeat the instructions for Installing the SciCan Data Logger on your Statim Message MSD FLASH FULL lt gt The MSD is full Export the data REPLACE MSD Message Missing lines of Refer to the STATIM screen to confirm successful Data on MSD FLASH sterilization Reset the Data Logger by unplugging its power dis connecting the MSD and waiting 10 seconds Then re connect the power adapter and insert the MSD into the Data Logger If the problem persists contact the SciCan Service Center Message The file or directory in the Refer to the STATIM screen to confirm successful MSD is corrupted or unreadable sterilization The MSD may have been unplugged while data was being written to it The MSD should not be unplugged until after SAFELY REMOVE MSD lt gt MSD FLASH DETECTED is displayed The corrupted files or directories may be lost Reformat the MSD on your computer STAT M 2000S 5000S 8 Spare Parts List 01 100204S Exhaust Tube 01 100724S Condenser Bottle
11. the replacement bacteria retentive filter El SciCan order no 01 102119S check that the arrow mark on the filter matches the direction 2020209 of the arrow on the bracket Push the left 02099 hand filter fitting into tube B E o o0 o0 0 o o 0 0 0 o ooo o o o 0 o 0 0 0 o Q Q 0 O o ooo o M oo 5 Gently press the replacement filter into the filter bracket El The arrow mark of the filter should be facing out and pointing to the left Figure 12 6 Re connect tube A Hl to the right hand filter fitting 5 7 Replacing the Cassette Seal To ensure optimum performance of your Statim cassette autoclave change the cassette seal every 500 cycles or every six months whichever comes first Replacement seals are available from SciCan order number 01 100028S for Statim 2000S and 01 101649S for Statim 5000S To change the cassette seal follow these steps Place the cassette lid and the new seal on a clean work surface Examine the position of the old seal in the cassette lid and arrange the new seal in the same orientation next to the lid STAT M 2000S 5000S 5 Maintenance con t Remove the old seal and discard Clean any residue out of the seal channel and flush out the channel with distilled water Lubricate the new seal with the liquid seal lubricant provided Insert the rounded edge of the seal under the round lip of
12. 5 cm 5 cm 5 cm 57 cm 57 cm 550 mL 43 5 PSI 220 240 V 50 60 Hz 6 A AC l covered 5 C 40 C Mean 57 dB Peak 65 dB 80 Max 2000 m Thermal Printer 20 characters per line 1 line per second 80 sterilization cycles per roll
13. Kit Printer 5000S Container Endoscope Complete 5000S 20ZPLUS STAT dri 2 oz 8O0ZPLUST STAT dri 8 oz 32OZPLUS STAT dri 32 oz 99 108332 Chemical Emulator 134 C 3 5 min Statim PCD Final Assembly Kit oO oO O cO N ojo _ _ ojo GO cO O RO oO 1 O cO 1 104701 ojoj lojo O N J i Q O w N ol 01 108341 STAT M 2000S 5000S 9 Warranty Limited Warranty For a period of one year SciCan guarantees that the Statim 2000S 5000S when manu factured by SciCan in new and unused condition will not fail during normal service due to defects in material and workmanship that are not due to apparent abuse misuse or acci dent The one year warranty will cover the performance of all components of the unit except con sumables such as the cassette seal the compressor filter and the microbiological filter pro vided that the product is being used and maintained according to the description in the user s manual A two year warranty will be applied specifically to the water pump steam generator and printed circuit board PCB provided that the product is being used and maintained according to the description in the user s manual In the event of failure due to such defects during this period of time the exclusive remedies shall be repair or replacement at SciCan s option and without charge of a
14. STATIM 2000S 5000S C a ss e ave e Operator s Manual LEE EENS gt O STATIM 2000S 5000S Operators Manual 95 108430 Rev 6 0 www scican com Copyright 2006 SciCan All rights reserved Table of Contents 1 Introduction 7 2 Important Information 8 2 1 Disclaimers 2 2 Statim 2000S Unit Overview 2 3 Statim 5000S Unit Overview 3 Installation 11 3 1 Environmental Considerations 3 2 Unit Placement 3 3 Connecting the Waste Bottle 3 4 Filling the Reservoir 3 5 Priming the Statim Pump 3 6 Setting the Time and Date 3 7 Language Selection 3 8 Assigning Unit Identifier Number 3 9 Shipping the Unit 4 Instructions for Use 4 1 Statim 2000S Cassette 4 2 Statim 5000S Cassette 4 3 Statim 5000S STAT DRI Plates 4 4 Preparing and Loading Instruments 4 5 Instrument Weight Table 4 6 Selecting a Cycle 4 7 Running a Cycle 4 8 Stopping a Cycle 5 Maintenance 5 1 Cleaning the Cassette 5 2 Cleaning the Water Reservoir Filter 5 3 Cleaning the Reservoir 5 4 Cleaning the Exterior Surfaces 5 5 Changing the Statim 2000S Air Filter 5 6 Changing the Bacteria Retentive Air Filters 5 7 Replacing the Cassette Seal 5 8 Maintaining Fluid Levels 5 9 Rea
15. TOP button to access the User Setup menu 2 Using the UNWRAPPED and WRAPPED buttons scroll to the Unit ID Setup and press the RUBBER AND PLASTIC button to select it 3 From the Setup Unit ID menu use the UNWRAPPED and WRAPPED buttons to change the displayed values and the RUBBER AND PLASTIC button to select and move to the next digit Press the STOP button when completed Step 4 Connecting the SciCan Data Logger 1 Ensure that both the Statim unit and the SciCan Data Logger are off 2 Connect the SciCan Data Logger to the Statim unit by using the serial cable 3 Power up the SciCan Data Logger HH MM DD MM YYYY 4 Power up the Statim unit estes ae MSD NOT DETECTED INSERT 5 The LCD will display the following MSD FLASH SELECT A CYCLE sequence of messages Insert USB Flash Drive or SD memory card HH MM DD MM YYYY 7 After a few seconds the LCD will display USB FLASH DETECTED SAFELY the following sequence of messages REMOVE MSD SELECT A CYCLE STAT M 2000S 5000S 6 The Communication Port con t 6 3 Installing Paper on the Internal Printer Use only paper approved for use with the optional internal printer on the Statim 5000S The D use of any other paper will damage the printer and will void the warranty Thermal paper is available from SciCan SciCan order no 01 101657S Q Do not operate the printer without paper If you run out of thermal paper or if you do not wish to use the printer turn it OFF
16. ased 20 on cycle selection this is a 21 one purge cycle activity 22 within B phase 23 10 Lowest Temp Press amp Time of conditioning purge for each purge number of lines based on cycle selection this is a one purge cycle activity within B phase STATIM 2000 S2S2R4180 Unit f 323 CYCLE NUMBER 000009 15 38 147 04 7 2005 SOLID UNWRAPPED N 134 C 7 3 5 min CYCLE START 0 00 CONDITIONING 2 07 132 9 C 294KPa 3 06 115 0 C 15 0KPa 3 06 PRESSURIZING 5 21 STERILIZING 4 12 135 6 C 3135KPa 4 12 Min steri Values 135 1 C 308KPa Max Steri Ualues 136 7 C 3235KPa 135 9 C 316KPa 7 43 UENTING 7 43 STERILIZING COMPLETE AIR DRYING 8 07 STOP BUTTON PRESSED CHECK FOR DRYNESS STAT M 2000S 5000S 6 The Communication Port con t 12 13 14 15 16 17 18 19 20 21 22 23 Start Time of Pressurization 3 21 start of C phase Start Time of Sterilization 4 12 start of D phase Temp Press amp Time at start of sterilization D phase Min Temp Press during the sterilization phase lower limits of D phase 135 1 C 308 kPa Max Temp Press during the sterilization phase upper limits of D phase 136 7 C 323 kPa Temp Press amp Time of end of sterilization phase end of D phase Time Venting started 7 43 start of E phase Sterilization was successfully completed Time Air Drying started 8 07 start o
17. clean is good clinical practice and assists in the function of the unit SciCan recommends that the interior surface be cleaned at least once a week Use dishwashing soap or a mild detergent that does not contain chlorine Scrub the inside of the cassette with a cleaning pad designed for use with Teflon coated surfaces After scouring rinse thoroughly with water to remove all traces of the detergent Cleaning the inside of your cassette is very important if you regularly sterilize lubricated instruments Coating the entire inside surface with STAT DRI drying agent induces water to form an even coat on the inside surface without beading The water in contact with the hot cassette surfaces also evapo rates much more efficiently Spotting is minimized and instruments dry much better STAT DRI should be applied every 10 cycles and after every cassette cleaning 5 2 Cleaning the Water Reservoir Filter This water reservoir filter should be cleaned at least once a week or when required The filter can easily be removed and cleaned by placing the filter upside down under running water to wash away the particles until clean and then placed back into the reservoir opening If a replacement water reservoir filter is required order part number 01 109300S 5 3 Cleaning the Reservoir Check the reservoir for dirt or particles The reservoir may be cleaned by draining followed by cleaning and rinsing with steam process distilled water ONLY Use of chemicals
18. dicator power switch El power cable port Ell leveler feet Figure 1 E cassette EB biological filter E exhaust tube port El compressor E RS232 port The following symbols i A situation which appear in the margins A ee Oo may lead toa tah ae of this book mechanical failure m The following symbols UNWRAPPED RUBBER Caution Hot Surface appear on the unit cycles W PLASTIC and or Hot Steam cycles Caution Risk of electrical START WRAPPED massa shock Disconnect supply button cycles y ony before servicing STOP y Power Active Indicator AN Caution Refer to button x Indicator LED LED manual for details When you receive your Statim 2000S packing carton the items listed below will be included If any of the items are missing contact your dealer immediately so the situation can be corrected Cassette Tray and Lid Dower Cord Unwrapped Instrument z Operator s Manual f Rack bs 10 Easy Maintenance Tips Waste Bottle u Exhaust Tube Bottle Lid Fitting P C D 20 SciCan Tube Mounting Hardware Sterilization Emulators STAT M 2000S 5000S 2 Important Information Con t 2 3 Statim 5000S Unit overview level indicator keypad a n reservoir cap water filter LCD power indicator active indicator power switch power cable port leveler feet E exhaust tube port HI biological filter m optional internal printer not on all models E cassette MW RS232 port not
19. ding Water Quality 5 10 Preventative Maintenance Schedule Statim is a registered trademark and STAT DRI is a trademark of SciCan Ltd All other trademarks referred to in this manual are the property of their respective owners For all service and repair inquiries In Canada 1 800 870 7777 United States 1 800 572 1211 International 416 446 4500 Email techservice ca scican com Manufactured by SciCan 1440 Don Mills Road Toronto ON M3B 3P9 CANADA Phone 416 445 1600 Fax 416 445 2727 Toll free 1 800 667 7733 STAT M 2000S 5000S 6 The Communication Port 29 6 1 The RS232 Communication Port 6 2 Installing the Statim Data Logger 6 3 Installing Paper on the Internal Printer 6 4 Removing Internal Printer Paper Jams 6 5 Internal Printer Output Overview 7 Troubleshooting 39 8 Spare Parts List 43 9 Warranty 44 10 Test Protocol 45 10 1 Type Test 11 Specifications 47 11 1 Statim 2000S Specifications 11 2 Statim 5000S Specifications EU REPRESENTATIVE BHT Hygienetechnik GmbH Messerschmilttstr 11 D 86368 Gersthofen GERMANY Phone 49 0821 278 930 Fax 49 0821 78 40 99 SciCan Medtech AG Alpenstrasse 16 6300 Zug Switzerland Phone 41 41 727 70 27 Fax 41 41 727 70 29 1 Introduction
20. e Check the water reservoir filter every week and clean if necessary Replace only if necessary Cassette Seal Replace every 500 cycles or six months whichever is first or whenever necessary Biological and or e Replace every 500 cycles or six months whichever is first Air Filter Technician e Clean the filters replace if dirty Check Valve e Remove the exhaust tube from the back of the unit during the air drying phase Check for air coming from the fitting e Remove the air compressor tube from the check valve inlet while running a cycle Make sure no steam is leaking from the valve Replace if there are any leaks e Check the reservoir for dirt Clean and rinse with steam process distilled water if necessary Calibration e Calibrate the unit oe gt we oOo Once a year STAT M 2000S 5000S 6 The Communication Port 6 1 The RS232 Communication Port All Statim units that do not have an internal printer will have an RS232 communication port that will allow you to connect to an external printer or to a SciCan Data Logger For printing aD you will need to purchase a recommended printer see list below from your local computer or electron ics store For data storage you can purchase SciCan s USB Data Logger to record and store cycle information onto a mass storage device MSD such as a USB Flash Drive or SD memory card Printer Model End Of Line Serial Port Printer user CR LF Bitrate charact
21. e bottle below the unit The tube can be routed through a hole 8 mm in diameter ay in the counter top and secured with the Figure 4 provided nylon clamps 3 4 Filling the Statim Reservoir When filling the reservoir ensure you only use steam processed distilled water containing less than 5 ppm total dissolved solids having conductivity of less than 10 uS cm The impurities and additives in other water sources will cause an error reading on the LCD If you D have a water conductivity meter available from SciCan order number 01 103139S check each new water container before filling the reservoir To fill the reservoir follow these steps see figure 5 STAT M 2000S 5000S 3 Installation Con t 3 3 5 Priming the Statim Pump To prime the Statim pump Remove the reservoir cap 2 Pour steam process distilled water into the reservoir until almost full a maxi mum of 4L Use a funnel to avoid spillage Replace and secure the cap follow these steps Figure 5 1 Make sure the plug in the drain tube is secured Move the unit to the edge of the work surface The front leveler feet should be approximately 12 mm from the edge Lift the front left corner of the unit upward and remove the drain tube E from the clip located on the underside of the unit Pull the drain tube outward so the free end can be positioned over a water container Fill the reservoir with steam process distilled water Remove
22. em to avoid overlap Ensure that all wrapped loads are dry before handling and or storage to maintain sterility The use of cloth wraps in the Statim is not recommended SciCan recommends the use of paper paper and plastic paper autoclave bags manufac tured in accordance to EN 868 Loosely pack instruments in the bags to allow steam pene tration to all instrument surfaces Rubber and Plastic Instruments W The following materials can be sterilized in the Statim nylon polycarbonate Lexan polypropylene PTFE Teflon acetal Delrin polysul fone Udel polyetherimide Ultem silicone rubber and polyester When loading rubber and plastic instruments in the tray leave a space between the instru ments and the cassette walls This ensures that steam reaches all surfaces and will pro mote drying The following materials cannot be sterilized in the Statim polyethylene ABS styrene cellulosics PVC Acrylic Plexiglas PPO Noryl latex neo prene and similar materials Use of these materials may lead to instrument or equipment damage If you are unsure of your instrument s material or construction do not load into your Statim until you have checked with the instrument manufacturer STAT M 2000S 5000S 4 Instructions For Use Con t e All Instruments The Statim is NOT intended for sterilizing textiles liquids or biomedical waste Instruments m will remain sterile after a succ
23. er Epson TM U220D C31C515603 CR LF 9600 248 OxF8 Citizen IDP 3110 40 RF 120B CR 9600 N A Star Micro SP212FD42 120 CR 9600 210 Oxd2 Star Micro SP216FD41 120 CR LF 9600 210 Oxd2 Star Micro SP512MD42 R CR LF 9600 210 0xd2 SciCan Data Logger End Of Line Serial Port Printer user CR LF Bitrate character For Mass Storage Device 9600 32 Oxd2 Due to a variety of software programs viewers that can be used to view the data files stored on a mass storage device such as a USB memory stick we recommend the above settings Printer For your Statim to communicate to a specific device you must enable this function through the User Setup menu Follow the instructions in section 6 2 Installing the SciCan Data Logger below to enable communication to either an external printer or the SciCan Data Logger STAT M 2000S 5000S 6 The Communication Port con t 6 2 Installing the SciCan Data Logger SciCan s USB Data Logger can record and store cycle information onto a mass storage device MSD such as a USB Flash Drive or SD memory card These instructions are for units with a 9 pin communication RS232 port located at the back of the unit Follow the steps below before connecting the Data Logger User Mode gt Time Date Setup User Setup Menu To install the SciCan Data logger access the user setup menu by powering up the unit while pressing
24. er as shown in Figure 8 2 Place the end of the cassette into the unit and drop the carry handle into its closed position 3 Gently push the cassette inward until you hear a click sound Never push the cassette into the Statim with force as the interior components could be damaged STAT M 2000S 5000S 4 Instructions For Use Con t e Removing the cassette 1 Grasp the cassette handle with one hand and pull out from the unit 2 As the cassette emerges from the unit grasp the carry handle with your free hand and lift it upwards 3 Pull the cassette clear from the unit and set down on a firm surface Disengaging the cassette handle and pull the cassette out until there is a 15 mm to 20 mm 1 2 to 3 4 gap between Q When not in use the cassette should be disengaged To disengage the cassette grasp the the front of the Statim 5000S and the cassette handle 4 3 Statim 5000S STAT DRI Plates The Statim 5000S cassette uses STAT DRI plates to enhance the drying process for wrapped instruments The adjustable plates are designed for the unwrapped instruments rack and eliminate the need for a separate wrapped instrument rack Up to ten plates can be arranged along the length of the rack Each unit is shipped with five STAT DRI plates Additional plates may be ordered from SciCan SciCan part number 01 103935 To install and adjust a STAT DRI plate follow these steps 1 Hold a plate over the desired positi
25. essful cycle until the cassette is disengaged from the unit Unwrapped instruments once exposed to ambient or external conditions cannot be main tained in a sterile state If sterile storage is desired wrap the instruments to be sterilized in autoclave bags according to the instrument manufacturer s instructions Then allow the wrapped cycle to run until the air dry phase is complete Best Practice Allow instruments wrapped or unwrapped to dry completely prior to han dling Wrapped or pouched instruments must not touch each other to promote drying and enable effective sterilization Note for Ophthalmology Use In the field of ophthalmology proper wrapping or pouching of surgical instruments will reduce the exposure of instruments to any process residues during the sterilization process Due to the highly sensitive nature of some types of surgery particularly in ophthalmology SciCan recommends that all instruments be routinely packaged or wrapped and processed through the wrapped cycle of the sterilizer This practice is the suggested approach for the majority of sterile surgical procedures and is referenced in most leading infection control publications and guidelines e Routine Monitoring Chemical process indicators suitable for steam sterilizers should be included in or on each package or load being sterilized In addition the weekly use of biological indicators which allow you to ascertain whether the instruments have been expo
26. f F phase Cycle was stopped by user Drying cycle aborted prior to completion load may not be dry STAT M 2000S 5000S 7 Troubleshooting Unit does not power ON There is water under the machine Instruments do not dry Check that the unit is plugged into a properly grounded outlet and that the power cord is firmly seated at the rear of the machine Try another circuit Power unit OFF for 10 seconds and then power ON again Check the condition of the line circuit breaker or fuse Check that water was not spilled when refilling the reservoir Make sure the plug in the exhaust tube is secured Remove and reinsert the cassette Attempt another cycle Be careful The metal parts will be hot and the cas sette will contain hot steam The cassette is leaking If water drips from the under side of the unit during operation check the cassette seal for misalignment or damage and replace the seal if required Be careful The metal parts will be hot and the cas sette will contain hot steam Attempt another cycle If it still leaks attempt another cycle using a different cassette if possible If the leak persists turn the unit OFF remove and unload the cassette unplug the unit and call your dealer Best drying occurs when the cycle continues to com pletion Allow the cycle to finish Make sure the instru ments are loaded correctly in the cassette Refer to section 4 4 Preparing and Loading Instruments
27. if required Be careful as the metal parts will be hot and the cas sette will contain hot steam If the leak persists turn the unit OFF remove and unload the cassette and contact your SciCan dealer You have used water which is not steam process dis tilled or is improperly distilled Empty the reservoir and refill with steam process dis tilled water containing less than 5 ppm total disolved solids having conductivity of less than 10 uS cm If you have the water conductivity meter check the quality of the water before refilling the reservoir Refer to the steps described in section 3 9 Shipping the Unit to empty the reservoir The level of the water in the reservoir is low Refill the reservoir Refer to the steps described in section 3 4 Filling the Reservoir Check for a paper jam If the paper is jammed follow the paper removal procedures outlined in section 6 4 Power unit OFF for 10 seconds and then power ON again If the paper is still jammed follow the dis assembly procedures outlined in section 6 4 Removing Paper Jams Make sure that the printer cable is connected securely with the connector on the back of the Statim and the Statprinter Make sure that the printer is pow ered ON Power unit OFF for 10 seconds and then power ON again Ensure that the paper is loaded properly refer to sec tion 6 3 Installing Paper on the Internal Printer Check to see that the paper leaves the paper roll from the top of the
28. ip of the seal is completely free Check the exhaust tube for kinks or obstructions If kinked straighten the tube If the tube cannot be straightened remove it from the push in fit ting attached to the Statim Depress the collar on the fitting and with the other hand pull firmly on the tube Once the tube is free of the fitting cut the damaged section of tubing away using a sharp instrument Be sure that you leave enough tube to reach the unit when you re attach the tube to the exhaust fitting If the tube is too short to remove a section contact your SciCan dealer for a replacement Check that the Statim has not inadvertently been exposed to any electrical interference Refer to the Installation section dealing with Environmental Considerations Section 3 1 Try running another cycle If the problem persists record the cycle fault message number and contact your dealer STAT M 2000S 5000S 7 Troubleshooting con t Excessive steam issuing from the front of the machine Message WATER QUALITY IS NOT ACCEPT ABLE Machine will not start Message REFILL RESERVOIR Machine will not start Message PRINTER FAULT displayed on LCD Printer is not printing The printer does not work The printer appears to work but nothing is printed on the paper Time and date are incorrect Remove and reinsert the cassette Attempt another cycle Remove and check the cassette seal for mis alignment or damage Replace the seal
29. isengage the cassette grasp the the front of the Statim 2000S and the cassette handle STAT DRI Treatment of the interior surfaces of the cassette with the Stat Dri drying agent provided with your unit will enhance the drying process Replacement bottles are available from SciCan order number 2OZPLUS 80ZPLUST 32O0ZPLUS STAT M 2000S 5000S 4 Instructions For Use Con t 4 2 Statim 5000S Using the Cassette When removing the cassette after a cycle exercise caution as the metal areas will be hot and the cassette may contain hot steam To open the cassette 1 Push the carry handle Hl into the open position 2 Put your hands on either side of the cas sette handle 3 Insert your forefingers in the slots and place your thumbs on the thumb pads 4 Press down with your thumbs and pull up with your forefingers until the lid opens 5 Raise the cassette lid and disengage from the tray Rest the lid on its outer surface To close the cassette 1 Align the hinge tab on the lid with the hinge slot on the tray 2 As you begin to close the lid the hinge tab and slot will engage 3 Place the carry handle into the closed position Inserting the cassette into the Statim 5000S 1 Hold the cassette handle in one hand Figure 8 and the carry handle in the oth
30. jiene uoleoyioeds qOd l sseO p pu lxd S000S WEIS 10 000S WEIS u YIM SN JO JOU SI dJOd ul s Age 9oln S0009 WNES pue S000 Z wes y ul sn Jo Ajanisnjoxe p uBis p sem oS A q Bu j jeuS ss 5oiq GOd YL L uw S OYE S GaddVHYMNN MOTIOH uw S E O vEL S GaddVHMNN MOTIOH uw S E O vE S GAaddVHYMNN MOTIOH uW S E D vEb S GaddVHYMNN MOTIOH uw S E 3 EL S GAaddWHYMNN MOTIOH uw S E 9 p L S Gadd VHMNN MOTIOH ulw S E 9 81 S GaddVHYMNN MOTIOH uw S E 9 81 S GaddVHYMNN MOTIOH uw S E Otel S GAaddVYMNN MOTIOH uw S E 9 tEL S GAaddVHYMNN MOTIOH uw S E 9 r L S GAaddVHYMNN MOTIOH uw S E 9 tEL S GAaddVHYMNN MOTIOH uw S E 3 tEL S GAaddVWHYMNN MOTIOH uw S E 9 p8L S GAaddVHYMNN MOTIOH uw S E Otel S GaddVYMNN MOTIOH uw S E 9 r L S GAaddVHYMNN MOTIOH uw S E 9 EL S GAaddVYMNN MOTIOH uw S E 9 EL S GAaddVHYMNN MOTIOH uw S E 9 r L S GaddVHMNN MOTIOH ulw S E D vEb S GaddVHYMNN MOTIOH uw S E 9 EL S GAaddWYMNN MOTIOH uw S E 9 EL S GAaddVHYMNN MOTIOH ulw S E D veb S GaddVHYMNN MOTIOH uw S D vEL S GaddVHMNN MOTIOH uw S E 9 tEL S GaddVHMNN MOTIOH uw S 39 tE l S GaddVHMNN MOTIOH uw S D veL S GaddVHMNN MOTIOH SZ6L mw Buljeed uesqw wu sdeoio4 YIS O YIOH doysyio IPe3ID W LD0 Ip N uosumi a uol15 g OSI gL lp u sdoiquluBu W SShrOl Z qnluonmons JaneyueA 029 6 qn
31. lected press the START button A NKU X N The unit memory remembers the last cycle run and then displays this first when l l l l l l l l l l the unit is powered on i l l C E F 100 C 101 kPa Sterilizing 1 purge Conditioning 134 C 304 kPa peak at 133 C 295 kPa 138 C 341 kPa vent to 115 C 169 kPa E Venting Pressurizing F Air Drying Type N STAT M 2000S 5000S 4 Instructions For Use Con t I 2 Hollow Wrapped Cycles The Statim 2000S and 5000S feature two WRAPPED 134 C type S ster ilization cycles To select one of these S Cycles Press the WRAPPED button to scroll through the available cycles Am NKU mt lt gt Q 18 min A 100 C 101 kPa D Sterilizing B 6 purges Conditioning 134 C 304 kPa 7 3 peak at 133 C 295 kPa 138 C 341 kPa HOLLOW WRAPPED S 134 C 3 5 min vent to 115 C 169 kPa E Venting C Pressurizing F Air Drying HOLLOW WRAPPED S 134 C 18 min Once the desired cycle has been selected press the START button Am WK U XU lt Q The unit remembers the last cycle run and then displays this first when the unit is powered on A Process Challenge Device PCD is available for validation of HOLLOW WRAPPED S 134 C 3 5 min cycle W 3 Rubber and Plastics Cycle The Statim 2000S and 5000S feature two 121 C type S sterilization cycles To select one of these S Cycles Press the RUBBER PLASTIC button to scroll thro
32. nstructions STAT M 2000S 5000S 2 Important Information 2 1 Disclaimers Use only steam process distilled water in your Statim Deionized demineralized or specially filtered water should not be used Never use tap water Do not permit any person other than certified personnel to supply parts for service or main tain your Statim SciCan shall not be liable for incidental special or consequential damages caused by any maintenance or services performed on the Statim by a third party or for the use of equipment or parts manufactured by a third party including lost profits any commer cial loss economic loss or loss arising from personal injury Never remove the cover of the unit and never insert objects through holes or openings in the cabinetry Doing so may damage the unit and or pose a hazard to the operator All elements of this book are common to both Statim 2000S and Statim 5000S except when noted IMPORTANT Follow local guidelines governing verification of the sterilization procedure SciCan SciCan Medtech AG 1440 Don Mills Road Alpenstrasse 16 6300 Zug Toronto ON M3B 3P9 SWITZERLAND CANADA Phone 416 445 1600 Fax 416 445 2727 Toll free 1 800 870 7777 Email customer_servicecanada scican com STAT M 2000S 5000S 2 Important Information Con t 2 2 Statim 2000S Unit overview EN level indicator El keypad El reservoir cap water filter El LcD E power indicator O active in
33. ny defected part s except gasket provided SciCan is notified in writing within thirty 30 days of the date of such a failure and further provided that the defective part s are returned to SciCan prepaid This warranty shall be considered to be validated if the product is accompanied by the origi nal purchase invoice from the authorized SciCan dealer and such invoice identifies the item by serial number and clearly states the date of purchase No other validation is acceptable After one year all SciCan s warranties and other duties with respect to the quality of the product shall be conclusively presumed to have been satisfied all liability therefore shall ter minate and no action or breach of any such warranty or duty may thereafter be commenced against SciCan Any express warranty not provided hereon and any implied warranty or representation as to performance and any remedy for breach of contract which but for this provision might arise by implication operation of law custom of trade or course of dealing including any implied warranty of merchantability or of fitness for particular purpose with respect to all and any products manufactured by SciCan is excluded and disclaimed by SciCan If you would like to learn more about SciCan products and features visit our website at www scican com STAT M 2000S 5000S 10 Test Protocol 1s nb i uodn ajqerene jeuoye jqesdde jou s3 V peol AojioH Y ysenbas uodn ajqe
34. on tilted slightly for ward with the tabs down 2 Insert the tabs between the mesh of the unwrapped instrument rack 3 Each tab has an elongated slot Slide the plate until the wire is at the end of each slot 4 Release the plate to the resting position 5 Prepare and load instruments for sterilization 4 4 Preparing and Loading Instruments Before loading any instruments into the Statim consult the manufacturer s reprocessing instructions e Clean Instruments Clean and rinse all instruments before loading them into the cassette Disinfectant residues and solid debris may inhibit sterilization and damage the instruments the cassette and the Statim Lubricated instruments must be wiped thoroughly and any excess lubricant should be removed before loading STAT M 2000S 5000S 4 Instructions For Use Con t e Unwrapped Instruments Arrange unwrapped instruments on the instrument rack in the tray so that they do not touch one another This ensures that steam reaches all surfaces and will promote drying Instruments must not be stacked or piled in the cassettes as this will impede the sterilization process Wrapped Instruments Place the instruments into autoclave bags according to the manufacturer s instructions Orient the instrument rack in the cassette to ensure that wrapped instruments rest approxi mately 6 mm 0 25 above the cassette base Place the wrapped instruments on the rack and arrange th
35. on all models The yan symbols A potential hazard A ee which I Important appear in the margins to the operator may lead to a information of this book mechanical failure E The following symbols UNWRAPPED RUBBER appear on the unit cycles PLASTIC START cycles Caution Risk of electrical WRAPPED l i button N cycles Air dry only f shock Disconnect supply before servicing STOP X Power Active Indicator button xx Indicator LED LED When you receive your Statim 5000S packing car ton the items listed below will be included If any of E the items are missing contact your dealer immedi Ww Drying Enhancement Plates ately so the situation can be corrected gt Figure 2 EDISI Co Caution Hot Surface and or Hot Steam Caution Refer to manual for details Cassette Tray and Lid Power Cord Unwrapped Operator s Manual Instrument Rack 10 Easy Maintenance Tips Waste Bottle Exhaust Tube Bottle Lid Fitting P C D 20 SciCan Tube Mounting Hardware Sterilization Emulators STATIM 2000S 5000S 3 Installation 3 1 Environmental Considerations There are several factors that may affect the performance of your Statim Please review these factors and select a suitable location in which to install the unit Temperature and Humidity Avoid installing your Statim in direct sunlight
36. ready to oper ate When you see a red line on one side of the paper it is time to replace the roll If a paper jam occurs and the paper cannot be removed by pressing the paper advance button E do not pull the paper backwards through the printer Never put a utensil or tool into the paper exit slot For full instructions on how to remove paper jams see section 6 4 Removing Internal Printer Paper Jams To replace the paper roll E follow these steps 1 With scissors cut the paper between the roll and the paper feed slot B 2 Remove the roll from the arm and discard the unused portion 3 Press the paper advance button I to feed the paper that remains in the printer out of the slot at the front of the printer 4 Install the new thermal paper roll by following the instructions described in this section STAT M 2000S 5000S B Figure 15 2 6 The Communication Port con t 6 4 Removing Internal Printer Paper Jams If paper jams in the printer and cannot be removed by pressing the paper advance button the printer must be disassembled Do not pull the paper back wards through the printer and never put utensils or tools into the paper exit slot When paper is jammed in the printer follow these steps to remove the jam 1 Power the Statim 5000S OFF and unplug the unit 2 Using scissors cut the paper between the roll and the paper feed slot B 3 Remove the paper roll El
37. s is the normal functioning of the unit 108 C Y VENTING 134 kPa Y STAT M 2000S 5000S 4 Instructions For Use Con t The buzzing noise during the air drying stage is the compressor operating The air drying phase of the cycle may be interrupted at any time by pressing the STOP button The display will read PLEASE WAIT CYCLE COMPLETE When the automatic 60 minute air drying stage is finished the display reads REMOVE CASSETTE CYCLE COMPLETE If a sterilization cycle is successful the reminder tone sounds and the amber light flashes until the STOP button is pressed or the cassette is removed from the unit 4 8 Stopping a Cycle To stop a cycle press the STOP button If the STOP button is pushed the cassette is removed or the unit detects a problem while operating the cycle will stop and the amber active light will flash Once a cycle has been stopped the STOP button must be pressed before another cycle can be started The display reads any of the following messages CYCLE FAULT xxx NOT STERILE or CASSETTE REMOVED NOT STERILE If the display shows the message CYCLE FAULT or NOT STERILE the cassette contents are not sterile See section 7 Troubleshooting for more information If the air drying stage of the cycle is interrupted do not store wrapped instruments that were in the cassette unless they are dry STAT M 2000S 5000S 5 Maintenance 5 1 Cleaning the Cassette Keeping the Statim cassette
38. sed to sterilization conditions is recommended 4 5 Instrument Weight Guide Instrument si Typical Instrument Weight Scissors 30 g 0 96 oz NOTE The above weights are to be used as reference only For exact weights of your instruments consult the manufacturer s specifications STAT M 2000S 5000S 4 Instructions For Use Con t 4 6 Selecting a Cycle The Statim 2000S and 5000S have seven sterilization cycles each designed to sterilize using the parameters specified Each cycle can be selected by pressing the UNWRAPPED WRAPPED or RUBBER PLASTIC cycle buttons The types of instruments sterilization requirements and a graph depicting each cycle charac teristics are described over the following pages 1 Unwrapped Cycles h The Statim 2000S and 5000S feature two 134 C type S and one 134 C type N UNWRAPPED sterilization cycles At the end of the cycle s sterilization phase air drying will commence for one hour Air drying can be interrupted at any time by pressing the STOP button To select one of these cycles Press the UNWRAPPED cycle button to scroll through the available cycles A B D E F HOLLOW UNWRAPPED S 134 C 3 5 min 3 5 min 18 min A 100 C 101 kPa D Sterilizing HOLLOW UNWRAPPED S 134 C 18 min B 3 purges Conditioning 19A CSOT KEA vent to 115 C 169 kPa E Venting SOLID UNWRAPPED N 134 C 3 5 min Pressutizing F Air Drying Type S Once the desired cycle has been se
39. t OFF 2 Press and hold the WRAPPED cycle button ENGLISH 3 While depressing the WRAPPED _ ee switch at Display when scrolling through languages 4 Press the UNWRAPPED cycle button to scroll to the next language selection 5 Press the WRAPPED cycle button to scroll to the previous language 6 When the desired language is displayed press the STOP button to save the selection and return to the regular operating mode 3 8 Assigning Unit Identifier Number 1 Power the Statim OFF STATIM 2000 S2S2R601 323 2 Press and hold the RUBBER PLASTIC cycle button Display when assigning unit number 3 While pressing the RUBBER PLASTIC cycle button power the Statim ON 4 Using the cycle buttons select a maximum of 3 digits to be used as the unit s identifier The UNWRAPPED button will increase the selected value and the WRAPPED cycle button will decrease it Use the RUBBER PLASTIC to move to the next digit 5 To save changes and return to the regular operating mode press the STOP button 3 9 Shipping the Unit Before you move the unit you will need to drain the reservoir To do so follow these steps 1 Place a water container below the unit 2 Using the drain tube see section 3 5 Priming the Pump Figure 6 empty the contents of the reservoir into the water container 3 Remove any remaining water from the reservoir with a non linting absorbant towel 4 Screw in the three leveler feet found underneath the unit
40. t value by ten enter the value 32 0x20 and press the RUBBER AND PLASTIC button to accept and return to the User Setup menu Save and Exit gt Save and Exit A Save and Exit must be performed after the above settings are completed If this is not done the information will revert to its prior settings 1 From the User Setup menu use the UNWRAPPED and WRAPPED buttons to scroll to Save and Exit 2 Select it by pressing the RUBBER AND PLASTIC button The LCD will display time and date HH MM DD MM YYYY information and a sequence of messages MSD NOT DETECTED INSERT MSD FLASH SELECT A CYCLE STAT M 2000S 5000S 6 The Communication Port con t Step 2 Selecting the Time and Date gt Time Date HH MM DD MM YYYY Note If the time and date were set according to section 3 6 this does not have to be per formed again 1 Power up unit while pressing the STOP button to access the User Setup menu 2 Using UNWRAPPED and WRAPPED buttons scroll to Time Date Setup and press the RUBBER AND PLASTIC button to select it 3 From the Time Date Setup menu set the time and date using the UNWRAPPED and WRAPPED buttons to change the displayed values and the RUBBER AND PLASTIC but ton to select Press the STOP button when completed Step 3 Setting Unit ID gt Unit ID 001 Note If the unit ID was set according to section 3 8 this does not have to be performed again 1 Power up unit while pressing the S
41. ter Clearance required Top Sides Back Front Clearance required for movement of the door s Minimum charge in the water reservoir PRV value pressure relief valve Electrical Rating Current Protection Class Protection Ambient Operating Temperature Sound levels Humidity Max Altitude STAT M 2000S 5000S 48 5 cm 41 5 cm 15 cm 41 cm includes handles 19 5 cm 4 cm 28 cm 18 cm 4 cm 1 8 L 4 0 L 21 kg 5 cm 5 cm 5 cm 48 cm 48 cm 550 mL 43 5 PSI 220 240 V 50 60 Hz 6 A AC l covered 5 C 40 C Mean 56 dB Peak 65 dB 80 Max 2000 m 11 Specifications con t 11 2 Statim 5000S Specifications Machine Dimensions Length Width Height Cassette Size External Length Width Height Cassette Size Internal Length Width Height Sterilization Chamber Volume Reservoir Volume Weight Without water Clearance required Top Sides Back Front Clearance required for movement of the door s Minimum charge in the water reservoir PRV value pressure relief valve Electrical Rating Current Protection Class Protection Ambient Operating Temperature Sound levels Humidity Max Altitude Optional Internal Printer Specifications Type Print Print Speed Paper Roll Capacity approx STAT M 2000S 5000S 55cm 41cm 19 cm 49 5 cm includes handles 19 5 cm 8 cm 38 cm 18 cm 8 cm 5 1 L 4 0 L 33 kg
42. the STOP button Follow the instructions below to complete installation steps STEP 1 Selecting the USB Flash MSD Option gt RS232 USB Flash MSD 1 Power up unit while pressing the STOP button to access the User Setup menu 2 Using the UNWRAPPED and WRAPPED buttons scroll to RS232 and select it by press ing the RUBBER AND PLASTIC button 3 From the RS232 menu use the UNWRAPPED and WRAPPED buttons to scroll down to the USB FLASH MSD option and press the RUBBER AND PLASTIC button to select and return to the User Setup menu STAT M 2000S 5000S 6 The Communication Port con t the Serial Port Bitrate to 9600 gt Serial Port Bitrate Serial Port Bitrate 9600 From the User Setup menu use the UNWRAPPED and WRAPPED buttons to scroll to the Serial Port Bitrate menu and select it using the RUBBER AND PLASTIC button 2 From the Serial Port Bitrate menu use the UNWRAPPED and WRAPPED buttons to scroll down to 9600 and press the RUBBER AND PLASTIC button to select and return to the User Setup menu the Printer user Character example 134 C gt Prnteruser char Printer user char 32 32 0x20 From the User Setup menu use the UNWRAPPED and WRAPPED buttons to scroll to the Printer user char menu and select it using the RUBBER AND PLASTIC button 2 From the Printer user char menu using the UNWRAPPED button to increase the dis played value by one and the WRAPPED button to increase tha
43. the lid Align the holes in the new seal with the holes in the lid NOTE At every corner and at the holes in the lid two square nibs should be visible The nibs should fit flush with the lid s outer surface Ensure the seal is completely inserted Feel around the periphery to ensure the seal is securely in place NOTE During a cycle steam may appear between the lid and the tray If this persists remove the cassette and check that the seal is correctly installed Figure 13 Be careful The metal parts will be hot and the cassette may contain hot steam 5 8 Maintaining Fluid Levels Use only steam process distilled water containing less than 5 ppm total dissolved solids having conductivity of less than 10 uS cm in the Statim To fill the reservoir remove the cap from the top of the unit and fill the reservoir We recommend using a funnel to minimize spills Each time you refill the reservoir empty the waste bottle and refill with water to the MIN line Empty the waste bottle often to avoid unpleasant odors and discoloration of the contents A low level chlorine free disinfectant prepared according to the manufacturer s instructions may be added to the waste bottle to remedy this situation 5 9 Reading Water Quality 1 Power up unit while pressing the STOP button to access the User Setup menu 2 Using the UNWRAPPED and WRAPPED buttons scroll to Water Quality and select it by pressing the RUBBER AND PLASTIC button
44. the plug El from the end of the drain tube and allow water to drain from the tube into a container for 30 seconds When the water flows in a steady stream replace the stopper Lift the front left corner of the unit upward and reinsert the tube into the clip on the underside of the unit Push the excess length of tubing back into the space provided 3 6 Setting the Time and Date To set the time and date follow these steps and watch the blinking cursor on the LCD 1 Power the Statim OFF 11 15 2006 Press and hold the UNWRAPPED cycle button DD MM YYYY While pressing the UNWRAPPED cycle button Display when setting the Date Time power the Statim ON The LCD display reads wed 3 Use the cycle buttons to select and change the selected field s value To increase a field s value press the UNWRAPPED cycle button Hold the button down to increase the value To decrease the value press the WRAPPED cycle button STAT M 2000S 5000S 3 Installation Con t 6 To select the next field press the RUBBER AND PLASTICS cycle button 7 To save changes and return to the regular operating mode press the STOP button 8 To quit without making changes power the Statim OFF 3 7 Language Selection The messages displayed on the LCD can be changed to a number of different languages To change the current language selections follow these steps 1 Turn the power switch at the back of the uni
45. tte is opened the instruments must be handled in an aseptic manner for immediate use or resterilized To start press the Air Dry Only Cycle button then press the START button Om 0 Q gt When started independently this cycle will run for 1 hour STATIM 2000S 5000S 4 Instructions For Use Con t 4 7 Running a Cycle To operate each cycle follow these steps and watch the LCD 1 Turn the power switch at the back of the unit to ON 14 23 _ 11 15 2006 The LCD display reads Is 2 Press the appropriate cycle button on the keypad to scroll through the available cycles A The display will read either HOLLOW UNWRAPPED or HOLLOW WRAPPED S or RUBBER PLASTIC S S 134 C 3 5 min 134 C 3 5 min 121 C 15 min HOLLOW UNWRAPPED HOLLOW WRAPPED S RUBBER PLASTIC S S 134 C 18 min 134 C 18 min 121 C 30 min SOLID UNWRAPPED N 134 C 3 5 min As the button is released the display reads DOOM PRESS START 2 2222 25 es2c essees e 5e5 5 The unit s cycle counter is displayed at the start after the start button is depressed Cycle you selected CYCLE NUMBER 000000 The amber indicator light comes on To indicate that the cycle is in progress the following messages are displayed as the cycle runs Cycle you selected WARMING UP _ CONDITIONING Bm 110 C 143kPa PRESSURIZING 125 C 232 kPa As the cycle is running gt 136 sae various sounds will be heard gt Thi
46. u 08 O LZL s OltSv1d d3ggntu uu SL O LZL s OlLSv1d d3ggnu uw 8L Opel S GaddVHM MOTIOH uw S O r8L S GaddVHM MOTIOH S3 TOAD S GaddVHMNN MOTIOH S GaddVHMNN_ MOTIOH DS S gt lt gt lt gt lt gt gt gt lt gt lt gt lt gt lt gt lt gt lt gt lt gt lt gt lt uw 8L r L uw S E 3 pEL J quueu2 3Iuueu q uu S OPEL N GaddVYMNN anos WoL odAL 000S S0002 WILVLS O LO gt O N lt H V 10 Test Protocol con t STATIM 2000S STATIM 5000S Cold Unit With Max Load Cold Unit With Max Load Drying Phase Drying Phase Warm Unit Without Load Warm Unit Without Load Drying Phase Drying Phase SOLID UNWRAPPED N 9 15 60 00 13 15 60 00 134 C 3 5 min 6 45 60 00 8 45 60 00 fare UNWRAPPED 11 45 60 00 17 30 60 00 134 C 3 5 min 8 05 60 00 10 50 60 00 HOLLOW UNWRAPPED S 26 15 60 00 32 00 60 00 ee HOLLOW WRAPPED S 15 35 60 00 HOLLOW WRAPPED S 30 05 60 00 ceases RUBBER PLASTIC S 35 15 60 00 37 50 60 00 121 C 30 min 33 40 60 00 35 20 60 00 STAT M 2000S 5000S 11 Specifications 11 1 Statim 2000S Specifications Machine Dimensions Length Width Height Cassette Size External Length Width Height Cassette Size Internal Length Width Height Sterilization Chamber Volume Reservoir Volume Weight Without wa
47. ugh the available cycles Am NK U X lt gt Q D E F 15 min 30 min A 100 C 101 kPa D Sterilizing B 3 purges Conditioning 121 C 205 kPa peak at 120 C 199 kPa 124 c 225 kPa RUBBER PLASTIC S 121 C 15 min vent to 110 C 143 kPa E Venting C Pressurizing F Air Drying RUBBER PLASTIC S 121 C 30 min STAT M 2000S 5000S 4 Instructions For Use Con t Once the desired cycle has been selected press the START button A KU NKU al lt gt Q The unit remembers the last cycle run and then displays this first when the unit is powered on 4 Air Dry Only Cycle This is not a sterilization cycle The Air Dry Only Cycle starts automatically after each sterilizing cycle and runs for 60 minutes Air drying may be interrupted by pressing the STOP button To ensure that the contents of the cassette are dry the cycle should run for the full 60 minutes Dryness is important for unwrapped instruments for corrosion prevention For wrapped instruments a dry wrap is required to maintain sterility If the STOP button is pressed during the air drying stage of the sterilization cycle and the cassette has not been removed from the autoclave the Air Dry Only Cycle may be used to complete the sterilization cycle If the cassette has been removed from the autoclave it may not be reinserted for the Air Dry Only Cycle If the cassette contains wrapped instruments and the wraps are not dry when the casse
48. uosn6Bi 3 lJ Zel13 P66L 8L in Buoiuosui y uonoins i zis luo yun S000S u sd 21oj uguuo A t08 8Z yeys Bulo yim sd oloj Asdoiq uewosy 824 97 lp u Jalze14 siu uunulsu Ie3Ip ui x ll IN 5 idpueu ooeUd XIUOSO N dpuey Sluu gu1udo uosjy 00 6r00 0L UB5u l ww ZOE x eip ww Z 4909 dols p x yyeeys oNsoubelp AdoosoJaysAy anva s 1E9011 00 8000 01 umu l ww pO X ep ww sy900 dojs Bulyejol z Adoososyye adajs 12901 saliossaooe do5sopu3 HAWY y uuS lulzIp N Jlopny O98901 SAW S ldpueu Buneuidse B5uneBiu H levva B9Z elnuueo uonsassoipAy ulweyoin Ze6ra emuues Buneuidse 6BuneBi so 6863 elnuueo y Se1 vesra Bog elnuueo Buelna aquo s u wn su BolouiIgu1udo 1 g way IP9ID NW uollIpe11 1S ADIN EOL lonuoO L L euolsS 1 Op S 91sse O L BUdIIS IMS 08r uV1S OvOSLLTLY MSN HIY VNVd MSN 90002 89910 J311N39S 0AP3 H7 02 Xn1 WEWYYLNI OAey g or9 xn1 enbiol sadns ojey NWHS6 21 SH PUaIL HZM 9S GA S1 pue11 H9 A way Ie1u q alah I PON SHEN peo winwixey M0739 LSI 33S S 9JA Q Ie9ID N oyloeds 104 S S 1 12316001Q LYE8OL L0 x dOd 000S S0002 WILYLS S1s 1 IeuonIppV are yenpisoy peddeim lBuis peo pijos ss u iq peddeimun peo pijos ssauAiq 10 1 Type test g peol MO lOH peddeim lBuls peol piloS peddeimun peol piloS Jaquieyo dwg u
49. w o Condenser 01 1007355 01 1007808 01 1007828 01 1008128 01 1008345 01 1016495 01 1010575 01 1016588 01 1017095 01 1017558 01 1017575 01 1017668 01 1017685 01 1017695 01 1017798 01 106030S Handle 5000S 01 1040935 01 101783S 01 101970S 01 1021195 01 1031398 01 103475S Tray 2000S 01 103557S Power Cord Repl Denmark det 01 103865S Seal Lubricant 01 103945S Rack Tray Unwrapped Instr Kit 2000S 01 104343S Plug Drain Tubing 5000S 01 104472S Extended Cassette Handles 5000S 01 104696S Handpiece Adapter 01 104697S Adapter Cassette Seal 2000S 01 104698S Adapter Cassette Seal 5000S 01 104699S Seal Insert 01 100207S Compressor Filter 2000S 01 104700S Adapter Cassette O Ring Kit 01 104702S Adapter Cassette Lid 2000S 01 104704S Adapter Cassette Lid 5000S 01 104786S Instrument Holder 4 mm 5000S 01 100028S Cassette Seal 2000S 01 106438S Cassette Lid Extended 2000S 01 108340S Statim PCD spare parts 01 109300S Water Reservoir Filter Kit ACCESSORIES 01 100008A Kit Cassette Final 2000S 01 100271A Kit Tray Cassette w Mesh 2000S 01 101613S Cassette Complete 5000S 01 101614S Tray Complete 5000S with Box 3 Condenser Additional Bottle STATDRI Plates 5000S Extended Length Cassette 5000S Extended Cassette Instrument Rack 5000S Adapter Cassette 2000S 1 104703 1 106101 1106653 1 210000
50. ween the cover and the door The power button and the paper advance but 4 Place the printer cover on the printer door Ensure that the flexible cables are not ton must protrude through the openings in the cover and operate freely 5 Using a 1 Phillips screwdriver secure the printer cover to the printer door with the three screws retained during the disassembly procedure Do not over tighten these screws 6 Plug your Statim 2000S 5000S into the wall receptacle Reconnect the printer if it was previously disconnected Turn the power switch to the ON position 7 Press the printer power button to the ON position Load paper into the printer following the procedures in section 7 3 Installing Paper on the Internal Printer STATIM 2000S 5000S 6 The Communication Port con t 6 5 Cycle Printout Overview 1 Model STATIM 2000 software S2S2R410 1 2 Unit Identifier autoclave has 2 been set up as number 323 3 3 Cycle counter the number of ic cycles having been run on the 5 unit 9 6 4 Time Date 1 38 pm 14th 7 April 2003 8 5 Cycle Name SOLID 9 UNWRAPPED N 10 6 Cycle Name cont d parame 11 ters 134 C 12 3 5 min 1P 13 7 Cycle clock starting at 0 00 14 8 Warm up complete start of 15 the conditioning phase is 2 07 16 see cycle graph A phase 17 complete start of B phase I5 9 Peek Temp Press amp Time of 19 conditioning purge for each purge number of lines b
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