STATIM 2000/5000 • Operator’s Manual • Manuel de l’utilisateur • Manual del Operador • Manual do Operação • STATIM 2000/5000 Operator’s Manual 95-108027 Rev 7.0. Copyright 2012 SciCan Ltd . All rights reserved.
Table of Contents 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . 2 2. Important Information . . . . . . . . . . . . . . . 3 2.1 Disclaimers 2.2 Statim 2000 - Unit Overview 2.3 Statim 5000 - Unit Overview 3. Installation . . . . . . . . . . . . . . . . . . . . . . . . 6 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.
1. Introduction Statim 5000 Statim 2000 Congratulations on your selection of the STATIM 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 details of installing, operating and servicing your Statim® are all contained within this operator’s manual.
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 maintain your Statim.
2. Important Information 2.2 Statim 2000 — Unit overview 1 level indicator n 2 keypad n 3 reservoir cap/ n 3 n 4 n 2 n water filter 4 LCD n 5 power indicator n 6 active indicator n 7 power switch n 8 power cable port 6 n n 5 n 9 n leveler feet 10 exhaust tube port 12 cassette n 13 biological filter n n 11 14 n compressor n RS232 port (not on all models) The following symbols appear in the margins of this book.
2. Important Information 2.3 Statim 5000 — Unit overview n level indicator 2 keypad n 3 n reservoir cap/ 1 3 n 4 n water filter 4 LCD n 5 power indicator n 6 active indicator n 7 power switch n 8 power cable port n 6 n 9 leveler feet n 12 5 n n 10 exhaust tube port n 11 biological filter n 12 optional internal printer (not on all models) n The following symbols appear in the margins of this book.
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 • Spacing • Venting • Work Surface • Electromagnetic Environment • Electrical Requirements Avoid installing your Statim in direct sunlight or close to a heat source (e.g. vents or radiators).
3. Installation 3.3 Connecting the Waste Bottle 2 is used to collect the wastewater after it has been converted The waste bottle n to steam and then drained from the cassette. To connect the waste bottle to the Statim, follow these steps (see Figure 4): 5000 3 tube into the 1. Insert the exhaust n 4 on the back of the unit and fitting n connect tightly. 2. Cut the tube to length and slide the waste 5 into place. bottle fitting n 3.
3. Installation To fill the reservoir, follow these steps (see Figure 5): n2 2 1. Remove the reservoir cap n 2. Pour steam-process distilled water into the reservoir until almost full (a maximum of 4L/1 U.S. gal). Use a funnel to avoid spillage. 3. Replace and secure the cap. 3.5 Priming the Statim Pump Figure 5 To prime the Statim pump, follow these steps (see Figure 6): 1. Move the unit to the edge of the work surface. The front leveler feet should be approximately 12 mm/0.5˝ from the edge.
3. Installation 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 unit OFF. N.A. ENGLISH 2.
3. Installation 3.10 Preparing Unit for Use Once the unit is installed and before any instruments are sterilized, run two Wrapped Cycles (see Section 4.8 Statim 2000 - Running a Cycle and 4.10 Statim 5000 - Running a Cycle). Remove the cassette once it has cooled. Clean the top (lid) and bottom (tray) sections using a soft cloth to wipe the inside surfaces and then rinse thoroughly with tap water. Once the cassette is clean and dry, coat the inside surfaces with STAT-DRI. 3.
4. Instructions For Use 4.1 Statim 2000 — 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. 3. Raise the cassette lid upwards and disengage the hinge. cassette latch 4. Rest the lid on its outer surface. • To close the cassette: 1.
4. Instructions For Use 4.2 Statim 5000 — 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 into the 1. Push the carry handle n open position. 2. Put your hands on either side of the cassette handle. n1 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. n1 5.
4. Instructions For Use • 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 When not in use, the cassette should be disengaged.
4. Instructions For Use • 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 (single wrapped) Place the instruments into single layer autoclave bags according to the manufacturer's instructions.
4. Instructions For Use • All Instruments The Statim is NOT intended for sterilizing textiles, liquids or biomedical waste. Instruments will remain sterile after a successful cycle until the cassette is disengaged from the unit. Unwrapped instruments, once exposed to ambient or external conditions, cannot be maintained in a sterile state.
4. Instructions For Use 4. Recover the biological and / or chemical indicator and process further according to the literature that accompanied the indicator. At the first indication of a potential sterilization failure: 1. Do not process any more instruments until favourable test results have been returned. 2. Ensure the correct indicator type was chosen. 3. Ensure the cassette was not overloaded. Consult the earlier portion of this section for proper loading instructions. 4.
4. Instructions For Use 4.7 Statim 2000 — Selecting a Cycle The Statim 2000 has three sterilization cycles, each designed to sterilize a specific type of instrument. The instruments will remain sterile after a successful cycle until the cassette is removed from the autoclave. At the end of each sterilization cycle, microbiologically filtered air-drying will commence for 1 hour. Air-drying can be interrupted at any time.
4. Instructions For Use 2. Wrapped Cycle The Wrapped Cycle is used to sterilize up to 1.0 kg (2.2 lbs) of solid and hollow metal instruments which have been sealed in paper / paper, or paper / plastic autoclave bags. Dental handpieces may be sterilized in this cycle. To select the Wrapped Cycle, press the Wrapped Cycle button, then press the START button. A A B B C Warming up Conditioning C D 10 MIN.
4. Instructions For Use 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 runs for up to 60 minutes, depending on the desired Cycle Drying Time. Dryness is important for unwrapped instruments for corrosion prevention.
4. Instructions For Use 4.8 Statim 2000 — Running a Cycle To operate each cycle, follow these steps and watch the LCD . Turn the power switch at the back of the unit to ON. The LCD Display reads: SELECT A CYCLE Press the appropriate cycle button on the keypad. or 14:23 3/11/2001 SELECT A CYCLE (if optional printer is installed) UNWRAPPED 134˚C for 3.5 min. The display will read either: or or WRAPPED 134˚C for 10 min. RUBBER AND PLASTICS 121˚C for 15 min.
4. Instructions For Use As the cycle is running, an intermittent buzzing sound will be apparent as the pump injects water into the steam generator. A random clicking sound will also be heard as the exhaust valve opens and closes. Once the sterilization cycle is complete, a reminder tone will sound and the amber light will flash as the cycle moves into the Air Drying phase. The buzzing noise during the air drying stage is the compressor operating.
4. Instructions For Use 4.9 Statim 5000 — Selecting a Cycle The Statim 5000 has four sterilization cycles, each designed to sterilize a specific type of instrument. It is important not to overload the chamber as this can inhibit steam access to all instrument surfaces. The instruments will remain sterile after a successful cycle until the cassette is removed from the autoclave housing.
4. Instructions For Use 1. Unwrapped Cycle The Unwrapped Cycle is used to sterilize light loads (less than 0.5 kg or 1.1 lbs) of solid metal instruments such as pliers, burrs, scalers, and forceps. 3.5 MIN.* To select the Unwrapped Cycle, press the D Sterilizing Warming up A Unwrapped Cycle button, then press the START B Conditioning E Venting F Air Drying C Pressurizing button.
4. Instructions For Use 3. Rubber and Plastics Cycle The Rubber and Plastics Cycle is used to sterilize up to 0.4 kg (0.9 lbs) of solid or hollow unwrapped instruments constructed of metal or the materials listed in Section 4.4 Preparing and Loading Instruments. To select the Rubber and Plastics Cycle, press the Rubber and Plastics Cycle button, then press the START button.
4. Instructions For Use 4.10 Statim 5000 — Running a Cycle To operate each cycle, follow these steps and watch the LCD. Turn the power switch at the back of the unit to ON. The LCD Display reads: SELECT A CYCLE The display will read either: UNWRAPPED 134˚C for 3.5min. Press the appropriate cycle button on the keypad. or or or or 14:23 3/11/2001 SELECT A CYCLE (if optional printer is installed) WRAPPED 134˚C for 6 min. RUBBER AND PLASTICS 121˚C for 15 min. HEAVYDUTY UNWRAPPED 134˚C for 6 min.
4. Instructions For Use The sterilizing cycle ends when the reminder tone sounds, the amber light flashes and the message CYCLE COMPLETE is displayed. The display appears similar to: AIR DRYING 60:00 CYCLE COMPLETE You may interrupt the automatic Air Drying phase at any time, or let it run to the end. To ensure that Wrapped Instrument loads are dry, allow this cycle to run to completion.
4. Instructions For Use 4.11 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.
5. Maintenance 5.1 Cleaning the Cassette Keeping the Statim cassette 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.
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 2000 and 5000, follow these steps: 1. Power the Statim OFF. 1 from the bacteria 2. Disconnect tube A n 2 and remove the filter from retentive filter n 3 .
5. Maintenance 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 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.
5. Maintenance 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. Daily Water Reservoir Waste Bottle Weekly Cassette Every 6 months • Replace water as needed.
6. The Communication Port (Not on all models) 6.1 The RS232 Communication Port Some models without an internal printer may be equipped with an 9-pin RS232 communication port that will allow you to connect to an external printer or to a SciCan Data Logger. Printer For printing, you will need to purchase a recommended printer (see list below) from your local computer or electronics store.
6. The Communication Port (Not on all models) 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.
6. The Communication Port (Not on all models) Setting the Serial Port Bitrate to 9600 Serial Port Bitrate 9600 1. 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.
6. The Communication Port (Not on all models) Step 2 Selecting the Time and Date 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 performed 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.
6. The Communication Port (Not on all models) 6.3 Cycle Printout Overview 1. Model: STATIM 2000 software: S201R604 2. Unit Identifier: autoclave has been set up as number 000 3. Cycle counter: the number of cycles having been run on the unit = 2 4. Time / Date: 10:47 am 25th October 2007 5. Cycle Name: UNWRAPPED 6. Cycle Name cont'd - parameters: 135°C / 3.5 min 1 2 3 4 5 6 7 8 9 7. Cycle clock: starting at 0:00 10 8.
7. Internal Printer (Not on all models) 7.1 Installing Paper on the Internal Printer Use only paper approved for use with the optional internal printer on the Statim 5000. The use of any other paper will damage the printer and will void the warranty. Thermal paper is available from your dealer (SciCan order no. 01-101657S). 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. Never pull the paper backwards through the printer.
7. Internal Printer (Not on all models) 7. Continue to press the paper advance 6 until the paper feeds through button n the paper exit slot on the front of the 3 and printer. Then, move the paper roll n arm into the operating position and close 1 . The printer is now the printer door n ready to operate. When you see a red line on one side of the paper, it is time to replace the roll.
7. Internal Printer (Not on all models) 7.2 Removing Internal Printer Paper Jams If paper jams in the printer and cannot be removed by pressing the paper advance 6 , the printer must be disassembled. button n Do not pull the paper backwards through the printer and never put utensils or tools into the paper exit slot. n7 n8 When paper is jammed in the printer, follow these steps to remove the jam: n9 1. Power the Statim 5000 OFF and unplug the unit. 2. Using scissors, cut the paper between the 5.
7. Internal Printer (Not on all models) 2. Place the printed wiring board back into position on the printer door. Note the 9 in the wiring board and the mounting bosses n 13 alignment of the mounting holes n 10 on the printer door. The black plastic printer body rests between the locating ribs n on the inside of the printer door. 11 , n 14 are not pinched between the printer door 3. Ensure that the flexible cables n and the wiring board. 4. Place the printer cover on the printer door.
8. Troubleshooting Problem Unit does not power ON. Solution 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. There is water under the machine. Check the condition of the line circuit breaker or fuse. Check that water has not spilled when refilling the reservoir. Make sure the plug in the exhaust tube is secured.
8. Troubleshooting 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 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.
8. Troubleshooting Excessive steam issuing from the front of the machine. Message WATER QUALITY IS NOT ACCEPTABLE. 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 misalignment or damage.
8. Troubleshooting Message MSD NOT CONNECTED <> INSERT MSD/FLASH Check the serial cable connection. 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 <> REPLACE MSD The MSD is full. Export the data. Message Missing lines of Data on MSD/FLASH Refer to the STATIM screen to confirm successful sterilization.
9.
10. Warranty Limited Warranty For a period of one year, SciCan guarantees that the Statim 2000 / 5000, when manufactured 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 accident.
11. Specifications 11.1 Statim 2000 — Specifications Machine Dimensions: Length: Cassette Size (External): Length: Cassette Size (Internal): Sterilization Chamber Volume: Reservoir Volume: Weight (Without water): Clearance required: Maximum Steam Temperature: Maximum Operating Pressure: 485 mm (19") Width: 415 mm (16.3") Width: 195 mm (7.67") Height: 150 mm (5.9") 410 mm (16") includes handles Height: 40 mm (1.6") Length: 280 mm (11") Width: 180 mm (7.1") Height: 35 mm (1.4") 1.
11. Specifications 11.2 Statim 5000 — Specifications Machine Dimensions: Cassette Size (External): Length: Width: Height: Length: Width: Height: Extended Cassette Size (External): Length: Width: Height: Cassette Size (Internal): Extended Section (L x W x H): Sterilization Chamber Volume: Reservoir Volume: Weight (Without water): Clearance required: Maximum Steam Temperature: Maximum Operating Pressure: Length: Width: Height: 550 mm (22") 410 mm (16") 190 mm (7.5") 495 mm (19.
