Operator Manual Dokument ID: T60003J Page 1of 44 Issue J / 2011-11-01
Table of contents Page 1 Introduction 3 2 Installation 4 3 Water filter 5 4 Getting started 6 5 Using the C-10 Probetester 7-9 6 Program settings 10-14 7 Setting the sensors 15-18 8 Temperature sensor 19-20 9 Threshold values 21-22 10 Manual mode 23-25 11 Other Settings 26-33 12 Log 34 13 Printer information 35-36 14 Cleaning & maintenance 37 15 Self disinfection 38 16 Troubleshooting 39-40 17 Technical specifications 41 18 Accessories & spare parts 42 19 Certificate of Conformance 43 20 Contact information 44 Dokument ID: T60003J Page 2of 44 Issue J / 2011-11-01
1. Introduction The C-10 Probetester is designed with the following intended use: To measure occurring leakages through the outer isolation layer in ultrasound probes and to indicate if by the user set values are exceeded. The measuring is done during a disinfection process, which is specified by the user. C-10 Probetester is a CE-marked product certified to the Medical Device Directive 93/42/EEC, annex II as a class IIb medical device which in applicable parts follows ISO 15883-4:2008. The quality management system of Optima Scandinavia AB Hospital Equipment Division is certified to SS-EN ISO 13485:2003. It is important to follow the probe manufacturer s instructions regarding what disinfection solution to use and to follow the instructions from the manufacturer of the disinfection solution for appropriate settings for disinfecting and rinsing. It is also important to follow instructions on how to clean the probe before it is connected to the C-10. The C10-probetester will not replace the safety-test according to your hospital standards. If the C10-probester indicates an electrical leakage on the probe it is important that further tests are being carried out by certified engineers. If the instructions in this operator s manual are not followed, the warranty will not be valid. Optima can not be held responsible for any damage to the probes. In case of malfunction be aware that only certified personnel are allowed to service the equipment. C-10 Probester is tested and validated for use with the following disinfection fluids: Cidex OPA Gigasept FF Gigasept Forte Vircon Perasafe Korsolex Extra, Sekusept Plus Before using any other disinfection fluids Optima must be consulted. The C-10 Probetester is designed and manufactured by Optima Scandinavia AB. If problems should occur please contact your local distributor or Optima Scandinavia AB. Please refer to the following information about your C-10 Probetester when corresponding to Optima Scandinavia or your local distributor. Part. No: Serial No: Dokument ID: T60003J Page 3of 44 Issue J / 2011-11-01
2. Installation The C-10 Probetester is designed to be mounted onto a wall by two bolts. The equipment weighs 40 kg so make sure to use the appropriate bolts. Use stoppers if needed. Recommended distance from the floor level to the mounting brackets on the equipment is 1800 mm. It is important to connect the air filter to the exhaust ventilation system of the room. If there is no existing exhaust ventilation system available it is recommended to connect the hose to outside air. If the dimensions do not match, use an adaptor. Water and drains must be connected by a professional or a certified plumber. Caution! Make sure that main power is turned off before installation. Connect fresh water to the inlet on the equipment (marked inlet). Use a suitable hose of 8 mm inside diameter. The inlet is located inside the door at the bottom of the equipment (see fig. 1). Connect a suitable hose for drainage with an inside diameter of 22 mm (marked drain). The drainage is located at the bottom of the equipment (see fig. 1). Connect a suitable hose to drain single-use with an inside diameter of 22 mm (marked single-use). The single-use drainage is located at the bottom of the equipment (see fig. 1). Consult the local hygienic department where to connect the single-use drainage. Connect the exhaust filter (HK22) to the transparent vent pipe on the top of the equipment. Connect the filter to the ventilation system. The supplied electrical mains cable should be connected to the 220-250V electrical power inlet. The power inlet is located on the right hand side of the equipment. Fig. 1 Vatten to drain Single use Water inlet to drain Dokument ID: T60003J Page 4of 44 Issue J / 2011-11-01
3. Water filter The equipment ihas a water filter installed. The sterilisation level of the filter is 0,2 um and it has to be replaced every three months. The filter has a quick-connect design and is easy to change. If the water is unusually unclean the equipment will alarm for filling time exceeded in the rinsing process and the filter has to be replaced, even before three months time has passed. This is displayed on the screen as described below. To turn off the alarm, press Ok. To print out a receipt press Receipt, if no receipt is desired press Ok again. 11-06-27 14:35:01 11- Fill time exceeded Ok Receipt Dokument ID: T60003J Page 5of 44 Issue J / 2011-11-01
4. Getting started Fill the container with disinfection solution. Use only disinfection solution approved and tested by the manufacturer of the probes. Follow the instructions from the manufacturer of the disinfection solution regarding concentration. Program the equipment with the appropriate settings for disinfecting and rinsing according to the manufacturer of the disinfection solution (see page 7 for program settings). It is important that the disinfection process also follows any national standards deviating from SS-ISO 15883-4. When handling disinfection solution carefully follow the safety instructions from the manufacturer of the disinfection solution. Verify that there is at least 2 litres of disinfection solution in the container before each use. Also check that the solution has not passed the best-before date. It is important to clean the probe according to the probe manufacturers instructions before the probe is connected to the C-10 Probetester. If the probe is not properly precleaned there is a possibility that blood/mucus may cause a malfunction. Note! It is the users responsibility to make sure the equipment is properly programmed for the disinfection solution that is being used. The disinfection solutions concentration, effectivity and durability must be verified (ie. test stripes). Note that the plastic tube may get miscoloured from the disinfection fluid after long use! When using the standard program (Std) the disinfection solution is reused. It is important to follow the instructions from the manufacturer of the disinfection solution when reusing disinfection solution. Settings for number of days or cycles to change canister should be done according to instructions (see page 28). In case of an alarm during the process, make sure to control and correct the error and inform responsible personnel about the alarm code (see page 40). To turn off the sound from the alarm press any of the buttons. Then, press OK or Receipt to restore the alarm. In case of main power failure the equipment will automatically pump out the fluid to the preset drain and will indicate with an alarm message on the display when the main power is restored. This process has been developed to protect the probe from over exposion from the disinfection solution. Note! After a disrupted cycle following an alarm or power failure the testand disinfection process must be performed again. Dokument ID: T60003J Page 6of 44 Issue J / 2011-11-01
5. Using the C-10 Probetester Turn ON the equipment by pressing the main switch key on the upper front, the display will then start-up. After switching the equipment OFF, it is important that you wait at least 10 seconds before switching it on again. While showing C-10 probetester on the display the equipment will automatically perform a self-test. During the self-test the software version number is shown on the display (important information for service) and after a successful self-test the following is shown on the display: 2011-06-06 15:23:00 Place probe Standard Selfdes. Single use Menu First enter the menu and set the values according to the instructions from the manufacturer of the disinfection solution (see chapter 6 Program settings). Carefully place the probe in the transparent plastic tube. Caution! Contamination can be transferred from an earlier used probe if the probe gets in contact with the edges on top of the tube or the stainless steel nozzles. It is therefore very important to manually disinfect these parts after connecting the probe. Use a wipe only with disinfection solution that is compatible with acrylic. Adjust the probe handle above the transparent plastic tube. It is important that the tip of the probe is able to move freely 360 degrees. Connect the probe connector to the equipment. Some probes have a locking device which in such cases should be used. To start the measuring process press either the Standard program key or the Single-use program key. The Standard program will return the disinfection solution to the container and the Single-use program will send the disinfection solution directly to the drains or to an installed separate container. The selected program will be shown on the display. Dokument ID: T60003J Page 7of 44 Issue J / 2011-11-01
5.1 Standard program To start the standard program press Standard followed by Start. To return to menu press Stop. Standard program Start Stop The equipment will now start to measure the electrical leakage while the probe is in the disinfection solution. The display will indicate the electrical leakage in µa as well as ongoing process and remaining time for the complete process. Measure/disinf 20:00 250 μa 15% Stop After the measuring process the rinsing process starts automatically. Rinsing 08:00 Stopp 59% Dokument ID: T60003J Page 8of 44 Issue J / 2011-11-01
When the process is finished the result of the leakage test is indicated on the display. Print a receipt for documentation by pressing Receipt. Process ready Probe OK Acknowledge w. receipt Receipt Stop 5.2 Single use To start the single use program press Single use followed by Start. To return to menu press Stop. Thereafter the process will be the same as for standard program but the used disinfection fluid is pumped to drain. att använd desinfektionsvätska pumpas till avloppet After finished process the probe should be removed from the plastic tube to dry. If there is a leakage of more than the set threshold value the probe has failed the electrical safety test. In such case contact technical personnel for further testing. Dokument ID: T60003J Page 9of 44 Issue J / 2011-11-01
6. Program settings In order to change the program settings press the menu key. To access the menu enter the password code. Caution! Changing the program settings may affect the outcome of the process. Before changing any settings, please consult the responsible personnel. The equipment should be programmed with the appropriate settings for disinfecting and rinsing according to the manufacture of the disinfection solution. The probe testing device timer is programmed by the manufacturer accordingly: Filling time disinfection solution: 35 seconds Filling time H 2 O: 35 seconds Measuring process: 20 minutes Empty time: 35 seconds Rinse time: 10 minutes Pause rinsing time: 3 seconds Test level: 50-5000 SensorU (upper): 60 SensorL (lower): 80 Min. temp: 18 C Max. temp: 26 C Trim temp: 22 C Pump effect: 8 Printer: ON Pressure regulator: 1,5-2 bar Changes made in the settings will be saved and it will not return to the manufacturer program settings. To go to the menu, press Menu. 2011-06-06 15:23:01 Place probe Standard Self des Single use Menu Dokument ID: T60003J Page 10of 44 Issue J / 2011-11-01
Password To enter the menu press the code. If no code is registered within 15 seconds, the menu for changing canister will appear. Password 5 1 2 3 4 After entering correct password the menu appears. To change program settings, press Program. Menu Program Other Log Values Delete log To go back one step in the menus, press. To go forward one step in the menus, press. Dokument ID: T60003J Page 11of 44 Issue J / 2011-11-01
6.1 Changing disinfection filling time To change the disinfection filling time press or. Prg fill dis 40s 6.2 Changeing water filling time To change the water filling time press or. Prg fill water 35s Dokument ID: T60003J Page 12of 44 Issue J / 2011-11-01
6.3 Changing measuring process time To change the measuring process time (time in disinfection solution) press or. Prg measuring time 15m 6.4 Changing self disinfection time To change the self disinfection (SD) time press or. Prg SD time 15m 6.5 Changing emptying time To change the emptying time press or. Prg emptying time 35s Dokument ID: T60003J Page 13of 44 Issue J / 2011-11-01
6.6 Changing rinsing time To change the rinsing time press or. Prg rinsing time. 10m 6.7 Changing pause time To change the pause time press or. Prg pause time 2s Dokument ID: T60003J Page 14of 44 Issue J / 2011-11-01
7. Setting the sensors As a safety measue the C-10 Probetester is equipped with two separate sensors in the plastic tube that must be calibrated to adjust to different disinfection solutions. Before using the C-10 Probetester the sensitivity of the sensors must be set. To go to menu, press Menu. 2011-06-06 15:23:01 Place probe Standard Self dis. Single use Menu Password To enter the menu press the code. If no code is registered within 15 seconds, the menu for changing canister will appear. Password 5 1 2 3 4 After entering correct password the menu appears. Since the measuring is performed in disinfection fluid, the plastic tube must first be filled with water. The differences between measuring in water or disinfection fluid are To go back one step in the menus, press. To go forward one step in the menus, press. Dokument ID: T60003J Page 15of 44 Issue J / 2011-11-01
7.1 Manual filling of water To fill the plastic tube manually, press Program. Menu Program Other Log Values Delete log Press or to go to the program for Manual rinsing valve. To open the rinsing valve and fill water manually, press On. Fill water a few millimetres over the metal top of the small white sensor in the upper plastic cup. Stop filling by pressing Off. Man rinsing valve OFF On Off Dokument ID: T60003J Page 16of 44 Issue J / 2011-11-01
7.2 Sensor sensitivity To change the sensors sensitivity go to the menu and press (threshold) Values. Menu Program Other Log Values Del. log 7.2.1 Adjusting the lower sensors sensitivity The measured value is shown on the left side. Set the right hand value to appr. 80% of the measured value. The manufacturer setting is 60. To change the value press or. LowerL 290 230 - Caution! If the sensor is not set correctly this can result in a malfunction. Dokument ID: T60003J Page 17of 44 Issue J / 2011-11-01
7.2.2. Adjusting the upper sensors sensitivity. The measured value is shown on the left side. Set the right hand value to appr. 60% of the measured value. The manufacturer setting is 80. To change the value press or. UpperL 275 220 Caution! If the sensor is not set correctly this can result in a malfunction. 7.3 Manual water drain To manually drain the water, press On or Off. Man drain water OFF On Off Dokument ID: T60003J Page 18of 44 Issue J / 2011-11-01
8. Temperature sensor The C-10 Probetester is equipped with a temperature sensor in the disinfection solution canister. The temperature sensor checks that the temperature of the disinfection solution is within the limits recommended by the disinfection solution manufacturer. The temperature sensor does not regulate the temperature, it only indicates if the temperature of the disinfection is out of the set values. Note! Check the disinfection fluid manufacturers advices regarding operating temperature of the disinfection fluid. 8.1 Adjusting the lower limits for the disinfection solution temperature Check the lowest useable temperature that is permitted with the used disinfection fluid. To change the value press or. If the temperature of the disinfection fluid is lower than the set value, the process will not start. Min Temp. 18C 8.2 Adjusting the upper limits for disinfection solution temperature Check the highest useable temperature that is permitted with the used disinfection fluid. To change the value press or. If the temperature of the disinfection fluid is higher than the set value, the process will not start. Max Temp. 25C Dokument ID: T60003J Page 19of 44 Issue J / 2011-11-01
8.3 Calibration of the temperature sensor Calibrate the temperature sensor in relation to room temperature by entering the actual room temperature. A press on or will change the temperature with 1/10 degree, but the display will only show the integer. Trimtemp. 22C Dokument ID: T60003J Page 20of 44 Issue J / 2011-11-01
9. Threshold values The C-10 Probetester can be equipped with up to four different connectors for ultrasound probes. Every connector can be set to an individual threshold value for the electrical leakage level. Password To enter the menu press the code. If no code is registered within 15 seconds, the menu for changing canister will appear. Password 5 1 2 3 4 After entering correct password the menu appears. To change program settings, press Program. Menu Program Other Log Values Delete log Dokument ID: T60003J Page 21of 44 Issue J / 2011-11-01
9.1.1 Changing test level 1 To change the threshold value for electrical leakage measured in μa för probe connector 1, press or. Test level 1 5000 9.1.2 Changing test level 2 To change the threshold value for electrical leakage measured in μa för probe connector 2, press or. Test level 2 5000 9.1.3 Changing test level 3 FTo change the threshold value for electrical leakage measured in μa för probe connector 3, press or. Test level 3 5000 Dokument ID: T60003J Page 22of 44 Issue J / 2011-11-01
10. Manual settings The manual settings enable the operator to manually control the filling and emptying of the plastic process tube for maintenance work and after a malfunction. It is highly recommended that the operator has sufficent skills of operating the C-10 Probetester before using the manual settings as the automatic overflow and alarm systems are bypassed. 10.1 Opening of the rinsing valve To manually open the rinsing valve, press On or Off. Man rinsing valve OFF On Off 10.2 Filling the rinsing tube To fill the plastic tube with disinfection fluid manually, press On or Off. Man Fill des OFF On Off Dokument ID: T60003J Page 23of 44 Issue J / 2011-11-01
10.3 Manual emptying of disinfection fluid To empty the disinfection fluid back to the container manually, press On or Off. Man empty dis OFF On Off 10.4 Manual water drain To manually drain water press On or Off. Man drain water OFF On Off Dokument ID: T60003J Page 24of 44 Issue J / 2011-11-01
10.5 Manual single use disinfection solution drain To manually drain single use disinfection solution press On or Off. Man drain single use OFF On Off Dokument ID: T60003J Page 25of 44 Issue J / 2011-11-01
11. Other settings C-10 Probetester has an automatic function to remind the user of changing the disinfection solution canister. To manually set the time for canister replacement, press Menu and enter the password. If no code is registered within 15 seconds, the menu for changing canister will appear. Password 5 1 2 3 4 After entering correct password the menu appears. To change time setings for canister change, press Other. Menu Program Other Log Values Delete log To manually set the canister change to cycles, days or - press or. When selecting cycles or days the C-10 Probetester will alarm when canister is to be changed. When selecting - the C-10 will not alarm. Dokument ID: T60003J Page 26of 44 Issue J / 2011-11-01
11.1 Canister change days Canister change DAYS To manually change the number of days the disinfection solution can be used, press or. Max days 14 Dokument ID: T60003J Page 27of 44 Issue J / 2011-11-01
11.2 Canister change hours Canister change HOURS To manually change the number of hours the disinfection solution can be used, press or. Max hours 14 Dokument ID: T60003J Page 28of 44 Issue J / 2011-11-01
11.3 Canister change cycles Canister change CYCLES To manually change the number of cycles the disinfection solution can be used, press or. Max cykles 14 10.4 Canister change - To manually shut of the canister change function choose -. Canister change - Dokument ID: T60003J Page 29of 44 Issue J / 2011-11-01
11.5 Changing disinfection solution This menu below will appear on the display when it is time to change disinfection solution. Press Receiptto see when the latest canister change was performed. Press New and then Receipt to verify that the canister is changed. New canister11-06-06 OK Receipt New 11.6 Changing language To change language, press or. Language English Dokument ID: T60003J Page 30of 44 Issue J / 2011-11-01
11.7 Setting the date To set the date press or to move through year/month/day. To change the date press or. To move one step in the menu press again after day. Date 11-06-06 11.8 Setting the time. To set the time press or to move through hours/minutes/seconds. To change the time press or. To move one step in the menu press again after seconds. Time 15:21:00 Dokument ID: T60003J Page 31of 44 Issue J / 2011-11-01
11.9 Changing the pump effect To change the pump effect, press or. The range goes from 0-15 where 0 is the lowest and 15 the highest pump effect setting. Note! A high pump effect value gives a low noise level and vice versa. Pump effect 15 11.10 Printer settings To turn the printer On or Off, press or. Printer ON Dokument ID: T60003J Page 32of 44 Issue J / 2011-11-01
10.11 Bar code reader settings To turn the bar code reader (scanner) printer On or Off, press or. Bar code reader ON 11.12 Setting the MAC-address To change the MAC-address, cycle with or and change with or. MAC 00-00-00 2 10.13 Setting the IP-address To change the IP-address, cycle with or and change with or. IP 192.168.000.099 Dokument ID: T60003J Page 33of 44 Issue J / 2011-11-01
12. Log C-10 Probetester is equipped with a log that saves the test results from the latest runs. The log cam be printed or transferred to other equipment through IP- and MAC settings. To access the log, press Log. The same resullts as on the receipt will be shown. A list of error messages can be found in chapter 16 of this manual. Menu Program Other Log Values Delete log C-10 Probetester Disinfection: Passed Test results Disinfections time: Date: 11-06-6 20m Time: 15:23:01 Rinsing: Passed Rinsing time: 10 min Prob no: Probe test: Passed (5000 µa) 246 µa Dokument ID: T60003J Page 34of 44 Issue J / 2011-11-01
13. Printer information Introduction Printouts are available to fully document the process and to facilitate traceability. The printer is a 50 mm, 5V, Easy Loading Printing Module. The printer will indicate with a red line on the paper when it is time to change the paper roll. If paper is missing the red light will start blinking (3 short, paus, 3 short etc.). To deactivate the printer press the right button (pause) and the LED will indicate pause by blinking. To reactivate press the right button again (pause) and the LED will indicate with a constant red light. To feed paper press the left button (feeding). Notice! The printer paper is not of a permanent archival type. Stability over long time archiving can not be guaranteed. Available printouts Available printouts are; date, time, measuring/disinfection pass/fail, rinsing pass/fail, probe test pass/fail, change of disinfection solution and alarmcodes. The sections that form the printer are described in the following image. 1. Printer mechanism, easy loading type 2. Paper roll housing 3. Cover, with Lever and Roller 4. Tear Bar, for paper cutting 5. Control panel with two push buttons and one LED 6. Electronic Control Board Dokument ID: T60003J Page 35of 44 Issue J / 2011-11-01
Opening the cover Pull the lever until the cover is released from its locking position. To avoid damages to the lever do not use excessive force. Loading paper rolls Step 1 Step 2 Closing the cover correctly Press on both sides of the cover simultaneously Cutting the paper correctly Pull the paper towards the Tear Bar from one side to the other. Dokument ID: T60003J Page 36of 44 Issue J / 2011-11-01
14. Cleaning and maintenance The outer case of the C-10 Probetester is made of stainless steel and can be cleaned using a wipe or cloth with a mild soap solution. Please be aware that the plastic tube and the keypad must not be exposed to any alcohol based products or any other strong cleaning detergents. If the plastic tube is repeatedly exposed to alcohol there is a risk that cracks will appear as a function of time. The tube does not tolerate alcohol based solutions with an alcohol content over 12%. Caution! If the keypad or the plastic tube is cleaned with alcohol based products the surface may be damaged. To prevent possible malfunction maintenance should be performed periodically. Personnel operating the equipment should control the following before every use: 1) Check that the level of disinfection solution in the container is at least 2 litres. 2) Make sure that the plastic tube is not cracked. 3) Check for obvious leakage. Within a 12 month interval or in case of suspected malfunction the following should be controlled: 1) An Electrical Safety Test should be performed by certified hospital/clinic personnel. 2) Test of electrical leakage with the 1MΩ test device delivered together with the equipment. The test device is connected between the inside of the upperplastic cup (make sure that the it is in contact wit the fluid) and with the metal tongue of one of the the probe connectors. Should be performed periodically by personnel certified by Optima or an Optima representative. Within a 24 month interval the following maintenance should be performed: 1) Cleaning of the pump membranes. Should be performed periodically by personnel certified by Optima or an Optima representative. 2) Cleaning of the valves. Should be performed periodically by personnel certified by Optima or an Optima representative. 3) Changing the plastic tube, if needed. Should be performed periodically by personnel certified by Optima or an Optima representative. Caution! Contamination can be transferred from an earlier used probe if the equipment is not properly cleaned. Dokument ID: T60003J Page 37of 44 Issue J / 2011-11-01
15. Self disinfection The C-10 Probetester is designed to be able to perform self disinfection (SD). This should be done periodically in consultation with the hospital hygiene department that will decide what solution to use as well as disinfection time to guarantee an approved process. The procedure is to use another disinfection solution for self disinfectin the equipment than normally used to disinfect the probes. This is done to prevent resistent bacteria to grow in the equipment. Connect a canister with self disinfection solution and press SD in the menu to start the self disinfection process. The equipment will select the preset time settings. If other settings are required the equipment must be reprogrammed by the user before the self disinfection process. Self disinfection started 08:52 Stop 15% The parts that will be disinfected are all the parts that will normally be in contact with the disinfection solution; hoses, pumps, vents and the disinfection tube. If bacteria should grow in the rinse water pipes in the equipment, the water pipes should be flushed with disinfection solution and thereafter rinsed. This means that the inlet water should be disconnected and the solution flushed manually through the pipes with valve V1 open. Optima can not be held responsible for any water filtration systems outside the C-10 Probetester. Dokument ID: T60003J Page 38of 44 Issue J / 2011-11-01
16. Troubleshooting & alarm codes Alarm codes/fault Possible cause Solution 10 Fill time (filling Filling time too short. the fill up time time exceeded in the measuring process). Level of disinfections Fill up or change solution is too low. disinfection solution. Hoses are kinked or Adjust the hoses. jammed. Membrane pump out of function. Turn off the equipment and contact certified personnel. Solenoid valve does not open. Turn off the equipment and contact certified personnel. Major leakage Turn off the water inlet and contact certified personnel. 11 Fill time (filling time exceeded in the rinsing process). 12 Empty time (emptying time exceeded in the measuring process). 13 Empty time (emptying time exceeded in the rinsing process). Filling time too short. Incoming flow rate too low. Incoming water pressure too low. Hoses are kinked or jammed. Solenoid valve does not open. Major leakage Emptying time too short. Hoses are kinked or jammed. Membrane pump out of function. Solenoid valve does not open. Major leakage Emptying time too short. Hoses are kinked or jammed. Membrane pump out of function. Solenoid valve does not open. Major leakage the fill up time. Turn the needle valve anticlockwise. Turn the pressure regulator clockwise. Adjust the hoses. Turn off the equipment and contact certified personnel. Turn off the water inlet and contact certified personnel. the emptying time. Adjust the hoses. Turn off the equipment and contact certified personnel. Turn off the equipment and contact certified personnel. Turn off the water inlet and contact certified personnel. the emptying time. Adjust the hoses. Turn off the equipment and contact certified personnel. Turn off the equipment and contact certified personnel. Turn off the water inlet and contact certified personnel. Dokument ID: T60003J Page 39of 44 Issue J / 2011-11-01
Alarm codes/fault Possible cause Solution 16 - Leakage (leakage in Major leakage. Turn off the equipment and the measuring process). contact certified personnel. 17 Leakage (leakage in the rinsing process). 18 Power failure (power failure in the measuring process). 19 Power failure (power failure in the rinsing process). 20 No probe Major leakage. Failure in main power supply. Failure in main power supply. The probe is not connected. Turn off the water inlet and contact certified personnel. The equipment will automatically start when the power is back on. The equipment will automatically start when the power is back on. Connect the probe. 21 Temperature out of range The temperature of the disinfection solution is either too high or too low. Connect the probe. Caution! A leakage or a broken hose may cause leakage of hazardous disinfection fluid. Dokument ID: T60003J Page 40of 44 Issue J / 2011-11-01
16. Technical specifications for C-10 Probetester Dimensions: Weight: Electrical supply: Noise level: Height 1650 mm Width 510 mm Depth 250 mm 40 kg 220-250V AC, 50-60 HZ, 50 W Appr. 60db Applied Standards: EN 61010-1:2001 IEC 61326-1:2006 SS-EN ISO15883-4:2008 93/43/EEC Annex II (Class IIb, rule 15) Operating temp.: Disinfection solution volume: Water consumption: Water pressure: Room temperature 1,4 litres per cycle 1,4 litres per cycle 2-6 BAR Dokument ID: T60003J Page 41of 44 Issue J / 2011-11-01
17. Accessories & Spare parts Options: T8000X Extra probe connector Spare parts T10019 T10028 T30002 T30008 T50012 T80001 T10025 T10026 Control board C-10 Touch Tank connector Membrane pump Solenoid valve Tubing set Transparent plastic tube Sensor, upper Sensor, lower Consumables: T50001 Printer paper Dokument ID: T60003J Page 42of 44 Issue J / 2011-11-01
19. DECLARATION OF CONFORMITY C-10 Probetester Operator manual The undersigned, representing the following manufacturer Name: Optima Scandinavia AB Address: Gunstagatan 16, SE-753 24 Uppsala, Sweden Telephone no: +46 (0)18 183020 Telefax no: +46 (0)18 143040 e-mail info@optima.se herewith declares that the product Type of equipment: Probetester for ultrasound probes Brand name: C-10 Probetester Model/Type: Serial number: 0904001 and higher complies with LVFS 2003:11 which is the Swedish implementation of the Medical Device Directive 93/42 EEC. The following standards (or parts thereof) and/or technical specifications have been applied - harmonized standards: No Issue Subject EN 61010-1 2001 Electrical safety testing for measurement and laboratory devices IEC 61326-1 2006 Electrical equipment for measurement, control and laboratory us EMC requirements - Part 1: General requirements EN ISO 15883-4 2008 Washer desinfectors- Part 4:Requirements and test for washer-disinfectors employing chemical disinfection for thermolabile endoscopes Product category: Disinfection of other medical devices Class: II b The Declaration of conformity is issued according to the Medical Device directive 93/42 EEC Annex II (Full quality assurence system). Uppsala 2011-03-14 --------------------------------------------------- ----------------------- place date --------------------------------------------------- signature /Jens Pettersson, CEO ----------------------------------------------------------------------------------------------- name and function Dokument ID: T60003J Page 43of 44 Issue J / 2011-11-01
20. Contact information Sales & service Optima Scandinavia AB Gunstagatan 16 SE-753 24 Uppsala Sweden +46 18 183020 +46 18 143040 info@optima.se www.probetester.com Dokument ID: T60003J Page 44of 44 Issue J / 2011-11-01