User Manual - washwell STRIP - 3.21.DOC
Contents
1. 26 Version No 03 21 Page No 3 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP The contents of this manual with all figures tables and graphics are intellectual property of ROBONIK INDIA PVT LTD Unauthorized commercial or non commercial excerption or copying of contents and use of this manual in total or in parts are strictly forbidden unless the editor gives written permission for it Wash Well manual was written and produced with the utmost care However errors cannot be fully excluded Robonik does not take any responsibility and accepts liabilities of any kind that may occur because of errors in the manual Manufacturer INDIA PVT LTD 374 MIDC Mumbai 400710 District INDIA Tel 491 22 67829700 491 22 67829701 Email sales robonikindia com Website www robonik in washwell STRIP Version 3 21 Version No 03 21 Page No 4 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 1 GENERAL INFORMATION 1 1 Warranty Information Each Instrument is completely tested and guaranteed for twelve months from delivery The warranty applies to all the mechanical and electrical parts It is valid only for proper installation use and maintenance in compliance with the instructions given in this manual ROBONIK will at its discretion repai2. 8 3 2 SPECIAL FEATURES Z 8 3 3 20 9 4 PACKING TRANSPORT AND 10 E 10 4 2 INSTRUMENT TRANSPORTATION essscesessseesseeeeeeeseesseeesnenaeeeseeeneeenseseenenenanses 10 4 3 STORAGE OF THE INSTRUMENT 10 5 INSTRUMENT DESCRI PTI 222 2 2 11 51 PERSPECTIVE VIEW 11 5 2 REAR PANEL VIEW 22 11 5 3 2 225 12 5 4 ea aE aea aaa 13 5 5 PRIMING AREA 13 5 6 MICRO STRIP CARRIAGES 13 5 7 PRIMING AND RINSING 14 5 8 2 saxtcccieecndeaiennstuwasnnctuascauccteduncedhsaskwudveponsussdsccastuuasnndaaiennts 14 6 INSTALLATION
3. 20 8 2 1 Recalling saved test 20 8 3 PRIME 20 8 4 RINSE REY 20 8 5 TIMER KE Y 2 nanara aeara kaupan 20 9 21 9 1 STRIP WASH aana raa aae Aeaaeai 21 9 2 WELL WASH 22 9 3 23 9 4 PRIMING 23 92 5 23 10 TROUBLESHOOTI NG 2200 24 11 2 25 11 1 DECONTAMINATION PROCEDURE 2 25 11 2 PURPOSE OF DECONTAMINATION sesesseeeseeeeeesnseeseeeesseseeeeeeeenenereeseesenees 25 11 3 GENERAL CONSIDERATIONS 2s ssececseesssseersseeensnseneseeoenseaeansneenserseseeneees 25 11 4 DECONTAMINATION PROCEDURE 2 ssesessseessscesesneeseeeesseeeeseeeesneeaeseeeeeenens 25 12 SAFETY CLEARANCE CERTI FI
4. ROBONIK INDIA PVT LTD A 374 TTC MIDC Industrial Area MAHAPE NAVI MUMBAI 400710 INDIA Tel 91 22 67829700 Fax 491 22 67829701 Email sales robonikindia com Website www robonik in Version No 03 21 Page No 5 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 2 GENERAL SAFETY WARNINGS 2 1 Danger Warning symbols The following symbols are used to inform the user of the safety rules This symbol indicates generic danger It means that serious damage can occur to the operator if described precautions are not observed This symbol indicates HIGH ELECTRIC VOLTAGE It is dangerous to touch any part having this label Only qualified operators can access these components after unplugging the instrument from the Supply gt gt This symbol indicates that the instrument makes use of chemical reagents and other dangerous Corrosive irritant or harmful CHEMICAL SUBSTANCES which can cause damage to people or materials When this label is found pay attention to the manufacturer s recommendations This symbol indicates that the instrument involves the handling of samples which can be infected urine or human serum In this condition infection or contamination might occur Pay attention to the general safety warnings when in presence of such biological substances Use Protective clothes gloves and glasses This symbol in the user manual indicates that damages to the instrument or erroneou
5. correct washing Version No 03 21 Page No 12 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 5 4 Keyboard 5 5 Priming Area Carriage Strip has a built in priming area Priming is essential immediately after starting the instrument and before shutting down the instrument It helps smooth flow of buffer and prevents crystallization 5 6 Micro Strip Carriage Movement of Strip is precisely controlled by stepper motor and timing belt to position the Strip exactly below the manifold for washing Ref Fig a Priming Version No 03 21 Page No 13 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 5 7 Priming and Rinsing Area Carriage Strip has built in priming and rinsing area priming and rinsing is essential immediately after starting the instrument and before shutting down the instrument It helps smooth flow of buffer solution and prevents crystallization Ref Fig a 5 8 Manifold Instrument has a specially designed 1 way manifold The manifold has a provision to clean the liquid path conveniently hence avoiding common clogging problem because of crystallization etc Manifold is moved vertically up and down by well controlled stepper motor for proper placement Manifold needles are laboratory grade steel smooth ends to prevent scratching of the well bottom Version No 03 21 Page No 14 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 6 I
6. instrument before packaging and shipment 11 2 Purpose of Decontamination Decontamination minimizes the risk to all who come in contact with the instrument during shipping handling and servicing 11 3 General Considerations e Any laboratory instrument that has been used for clinical analysis is considered a bio hazard and should be decontaminated prior to handling Intact skin is generally considered an effective barrier against infectious organisms however small abrasions and cuts may not be always visible Prophylactic gloves must be worn when handling instruments that have not been decontaminated Gloved hands should be considered contaminated and must be kept away from eyes mouth and nose at all times e Mucous membranes are considered as the prime entry routes for infectious agents Wear eye protection and a surgical mask when there is a possibility of aerosols e Eating and or drinking while decontaminating instruments is not advisable 11 4 Decontamination procedure A solution of 0 5 Sodium Hypo Chlorite NaOCL solution Bleach is used Commercial bleach is 5 NaOCL household bleach is 3 NaOCL When using commercial bleach use a 10 1 mixture if using household bleach a 6 1 mixture is required This is a caustic solution It is important to wear gloves and eye protection when handling it e Wipe down the carrier and all exposed surfaces of the unit with the bleach solution Remove the top shroud of the instr
7. sec should be gt 50 Soak Time in Seconds secs and Press ENTER No of Cycles Eer of wash cycles required min 1 max 999 and press ENTER WASH VOLUME 25ul Y N Select required volume of wash buffer volumes available 25 400 ul Flat Well Y N Select the type of the well to be washed Select the type of the well to be Round Well Y N EA of Wells nnn Enter number of wells to be washed min 1 amp max 12 amp press ENTER Load Strip and press ENTER ee _LOad Strips Strip and press ENTER Instrument aspirates the waste solution from the well Dispenses the programmed volume in to the micro strip well Aspiration is continuously kept on to prevent the over flow After completing dispensing cycle depending on soak time it starts aspirating the solution After this the instrument transports the micro Strip back to home position Version No 03 21 Page No 22 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 9 3 Incubation WASH WELL consists of a One Plate incubator which can be programmed individually After the set time elapses the instrument gives an audible alarm as well as notification on display indicating the elapse of time Both the timers can be programmed separately Incubator is activated when the instrument is in power on condition It takes 10 15 minutes to attain 37 C Temperature This temperature is factory set Procedure to program incuba
8. AND START UP INSTRUCTIONS 15 6 1 PLACING THE INSTRUMENT cscssssesessecrscssenrseesenesseersersenenaeanenenenseorsneesnensearses 15 6 2 POWER 15 6 3 PROTECTIVE 15 6 4 START UP INSTRUCTIONS 15 6 5 SETTING DATE TIME 16 6 6 WASTE BOTTLE 6 16 7 PRECAUTIONS tots suuasaveaecdepnadecasudeoneabetanceenninanias 17 Version No 03 21 Page No 2 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 8 GENERAL KEY OPERATI 5 222 18 8 1 18 8 1 1 Deleting test 19 8 1 2 Setting Date and aah 19 8 1 3 Storing the Test tee eet 19 8 2 MENU KEY
9. NSTALLATION AND START UP INSTRUCTIONS While installing and setting up the instrument the safety warnings and general precautions described in section 8 must be observed 6 1 Placing the instrument e The instrument has to be placed on a level bench Amin distance of 1m should be maintained from the rear panel to avoid damage to power cord and instrument e Room temperature has to be between 18 C and 35 C with a relative humidity below 85 e Protect it from direct sunshine 6 2 Power supply Once the instrument has been placed plug it into a power source by the locally available approved plug in cable Power cord should be CE CSA and UL marked Voltage 115 230 Volts 10 50 60 Hz 6 3 Protective Grounding Warning Please make sure that electrical power source is properly grounded 6 4 Start up Instructions Instrument Starting Procedure 1 Switch on the instrument The instrument will display WASH WELL 2 The instrument carries out a Power on Self Test to check all the internal parameters 3 It displays ROBONIK and the time indicating that initialization is complete 4 If the date and time are not correctly displayed switch off the instrument and switch it on once again The instrument is now ready for use Version No 03 21 Page No 15 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 6 5 Setting date and time Setting of date and time can be done with the help of FUNC key Dis
10. Time Y N Ref 8 1 2 NO Modify Time Option Exit Y N Version No 03 21 Page No 18 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 8 1 1 Deleting test Display How to operate Press FUNC Key Delete Test Y N Test No Press YES Key Enter the Test No of the test to be Deleted Deleting Test Yes Test Deleted 8 1 2 Setting Date and Time Refer point No 6 5 8 1 3 Storing the Test To save the programmed test under any programming Mode Display How to operate Save Test Y N Yes YES Name Tests Y N Press YES Key to Enter Name Save Test Test Number will be without name printed on the paper ABCDEFGHIJKL Sc a een Select Arrow Keys to select Alphabets Yes Press Enter after selection and proceed Press Enter twice after completing selection Version No 03 21 Page No 19 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 8 2 MENU KEY 2 This key is used to recall the test number to be performed 8 2 1 Recalling the saved test Press MENU Key Choose Test Enter the test No to be recalled And Press ENTER 8 3 PRIME KEY Pressing the Prime key Peristaltic pump 1 operates continuously for few seconds Wash buffer from wash bottle primes the tubing and manifold needles 8 4 RINSE KEY Pressing Rinse key peristaltic pump 2 operates continuously for few seconds Distilled water from rinse bottle rinses the
11. User Manual WASHWELL STRIP washwell STRIP ELISA Strip Washer User Manual Version No 3 21 R 2030NiI lt ROBONIK India Pvt Ltd A 374 TTC MIDC Mahape Navi Mumbai 400 710 INDIA Tel 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No 03 21 Page No 1 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP TABLE OF CONTENTS 1 GENERAL 22242 1 1 WARRANTY INFORMATION 5 1 9 lt 5225 5 1 3 DISPOSAL INSTRUCTION 2 5 WA CONTACTS E E 5 2 GENERAL SAFETY WARNI NGS nnne 2 1 DANGER WARNING SYMBOLSG sssccecessseesseeeesseeeseeeenseseseseeeenenereeeeeeeneeanses 6 2 2 USE OF THE INSTRUMENT 7 sent 3
12. coustic signal for bottle full indication Ability to wash U V and Flat bottom wells Overflow protection through continuous aspiration Cross wash facility Auto detection of bottom of well and collision prevention Optional built in Incubator 37 C Factory set with programmable timer Version No 03 21 Page No 8 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 3 3 Specifications High quality stainless steel co axial probe Dispensing Method Specially designed Peristaltic pump Volume 25 to 400 ul Aspirating Method Continuous through diaphragm pump Residual Volume lt 3 ul Washing Method Well Wash Short Wash Strip Wash Long Wash Cross Wash Rinsing Priming Incubator Optional For One ELISA Plate 37 C Version No 03 21 Page No 9 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 4 PACKING TRANSPORT AND STORAGE 4 1 Packing Packaging of the instrument is needed whenever to be transported or shipped by courier or other means To pack the instrument please follow the instructions as below described Decontaminate the instrument as explained on chapter 11 of this manual e Put the instrument into the original packaging box Instrument has to be properly protected by plastic protective material Put copy of safety clearance certificate copy of Safety clearance certificate is attached at the end of this manual e Mark the package with address instrument identi
13. fication and warning labels 4 2 Instrument transportation The transportation of the instrument in unpacked condition must be limited within the room where it is used to avoid damage 4 3 Storage of the instrument Before storing the instrument for a long period please pack it carefully as described above and store indoors Version No 03 21 Page No 10 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 5 INSTRUMENT DESCRI PTI ON Components of different views of the instrument in picture below 5 1 Perspective View Front view Display Alphanumerical key pad Wash Bottle Waste Bottle Rinse Bottle Rinse bottle Waste bottle Keyboard amp Dis play Micro Strip Manifold 5 2 Rear Panel View Please refer diagram of point No 5 3 Ensure that the main power switch is in OFF position before connecting e Plug the instrument to the A C mains Confirm proper grounding for trouble free operation The washwell STRIP is provided with an inbuilt voltage stabilizer to take care of voltage fluctuations Version No 03 21 Page No 11 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 5 3 Tubing Diagram REAR PANEL TUBING CONNECTIONS 2 Power Supply Rinse Wash W Washer Washer Waste Washer O Knob MANIFOLD TUBING CONNECTIONS Green Wash Manifold Red Wash Note Load Elisa Strip carefully in the slot provided for
14. ons to the instrument by unauthorized personnel strictly prohibited The user is liable amp solely responsible for any improper modification to the instrument and for the consequences derived as a result gt Should the instrument need extraordinary maintenance please contact Robonik service or an authorized service center Specialized technicians equipped to repair the instrument using original spare parts will carry out the maintenance gt An advisory that the electromagnetic environment should be evaluated prior to operation of the device gt Warning Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded international RF sources as these may interfere with the proper operation Version No 03 21 Page No 7 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 3 INTRODUCTION 3 1 Description Washwell STRIP is an automatic ELISA strip washer with optional built in Incubator amp programmable timer Its unique co axial probe allows user to wash single well or a strip with user defined number of wash cycles soak time wash volume etc It is designed to be used to wash single or multiple wells by automated procedure Hence eliminating errors in assays rising due to cumbersome manual wash method It is intended for in vitro diagnostic use 3 2 Special Features Built in stabilizer Ability to wash single well Multiple wells Waste bottle with a
15. play How to operate Set TIME Y N Press YES Key Enter Date in Same format Press ENTER key Date DD MM YY Enter Time in same format Time HH MM SS Press ENTER key 6 6 Waste Bottle connections Please refer point No 5 3 Tubing Diagram Version No 03 21 Page No 16 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 7 PRECAUTIONS Always check for proper grounding during installation Never operate the instrument with ground wire removed Do not attempt to open the instrument make repair without proper technical training Do not allow unauthorized persons to operate or repair the instrument Place the ELISA Strip carefully on the tray Ensure that the main power switch is in OFF position before connecting Prime manifold before and after use Always Prime immediately after switching ON the instrument Always rinse before switching OFF Keep wash waste and rinse bottles clean Disconnect the tubing before opening wash waste and rinse bottle caps Version No 03 21 Page No 17 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 8 GENERAL KEY OPERATIONS Check whether all the tubing is properly connected Switch on the instrument 8 1 FUNC KEY Idle Mode Programming Mode Load wash Strip Y N YES Place Strip amp press Enter Save Test Y N NO YES Ref 8 1 1 Ref 8 1 3 Delete Test Y N Delete Option Save Option NO YES Set
16. r or replace parts which may be found defective in the warranty period The warranty does not include any responsibility for direct or indirect personal and material damages caused by improper use or maintenance of the instrument Parts that are inherently subject to deterioration are excluded from the warranty In case of defects due to misuse of the instrument any travel and man hour expenses will be charged extra 1 2 Technical Service ROBONIK is always accessible to the customers for any kind of information about installation use maintenance etc When asking for service please refer to this manual and report the data reported on the identification label Serial No and Model Name Only qualified technicians are entitled to fix the instrument the user as described in this manual should carry out ordinary maint enance ROBONIk s technical service an authorized service center with specialized technicians with suitable instrumentation and original spare parts are always available for extraordinary maintenance repair under an annual maintenance contract or on specific demand 1 3 Disposal instruction In case of removal or disposal of instrument following instructions need to be followed Do not dispose in municipal waste follow local regulations for instrument disposal Plastic parts Electronic PCBs and components can be recycled so return back the instrument to manufacturer 1 4 Contacts Manufacturer
17. s results could occur if the given warnings are not followed This symbol indicates a portion which is particularly important and should be studied carefully This symbol indicates a Protective Earth or Ground terminal YSS General Symbols Symbol for Manufacturer VD Symbol for IN VITRO DIAGNOSTIC MEDICAL DEVICE Version No 03 21 Page No 6 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 2 2 Use of the instrument gt The instrument should be used for the designed purposes only and under specified conditions by qualified personnel following proper procedures and safety rules provided in this manual gt THIS MANUAL CONTAINS INSTRUCTIONS FOR OPERATION BY QUALIFIED PERSONNEL ONLY gt A qualified user has to make sure that environmental condition is suitable the installation correct the use and maintenance is proper according to the general safety rules as well as to the particular precautions described in the manual However the user is not entitled to repair the instrument gt A qualified technician only is entitled to maintain and fix the instrument according to the instructions given in this manual using the original spare parts only gt The room temperature and humidity should be maintained as specified in the manual gt The instrument has to be used as described in this manual If it is not use the protection provided by the instrument may be impaired gt Alterati
18. tor time is as follows Please refer point No 8 5 9 4 Priming Please refer point No 8 3 9 5 Rinsing Please refer point No 8 4 Version No 03 21 Page No 23 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 10 TROUBLESHOOTING PROBLEM SOLUTION The Manifold does not dispense Clean the path of the steel tubes using needle cleaner provided Check Wash bottle tubing connections Check valve direction The Manifold does not aspirate Clean the path of the steel tubes using needle cleaner provided Check the Waste bottle cap and tighten them properly Check waste bottle tubing connections The Instrument beeps Check the Sensor cable continuously connection Check whether waste bottle is full Check the waste bottle cap and clean the cap Movement Jam Reset the instrument by pressing the CLEAR key twice or Switch OFF and Switch ON the instrument Insert the Strip properly and return Memory Full If Number of saved tests exceeds 35 tests then delete the unwanted test and save the test Version No 03 21 Page No 24 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 11 DECONTAMINATION Check whether all the tubing is properly connected Switch on the instrument 11 1 Decontamination procedure If the instrument is to be shipped after being exposed to potentially hazardous material it should be decontaminated The following procedure outlines the method to decontaminate the
19. tubing and manifold needles 8 5 TIMER KEY Press Timer Key Set timer Y N YES Reset timer Y N YES Timer Resets Version No 03 21 Page No 20 of 26 Effective Date Nov 2011 User Manual 9 PROGRAMMING 9 1 Strip Wash S WASH Display Soak Time in Seconds No of Cycles WASH VOLUME 25 ul Y N Flat Well Y N No Round Well Y N No of Wells Load Strip and press ENTER Instrument aspirates the waste solution from the WASHWELL STRIP How to operate Press S wash key Enter soak time in sec should be gt 50 secs and Press ENTER Enter no of wash cycles required min 1 max 999 and press ENTER Select required volume of wash buffer volumes available 25 400 ul Select the type of the well to be washed Select the type of the well to be washed Enter number of Wells to be washed min 1 max 12 amp press ENTER Load Strips Strip and press ENTER well Dispenses the programmed volume in to the micro strip well Aspiration is continuously kept on to prevent the over flow After completing dispensing cycle depending on soak time it starts aspirating the solution After this the instrument transports the micro Strip back to home position Version No 03 21 Page No 21 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 2 9 2 Well Wash zoa Display How to operate Press W wash key Soak Time Y N 1 Enter soak time
20. ument and wipe down the top surface of the instrument base as well as the inside of the top shroud e Reassemble the unit and discard the used gloves and towels Version No 03 21 Page No 25 of 26 Effective Date Nov 2011 User Manual WASHWELL STRIP 12 SAFETY CLEARANCE CERTIFICATE Please complete all information requests on this form prior to returning the instrument to the manufacturer or your local distributor for servicing repairs or return Thank you for your co operation Customer Address Country Post Code Model No Accessories Returned Date of Purchase if known Complaint Has the equipment been exposed to any of the following a Blood body fluids pathological specimens If YES please specify b Other Biohazard if YES Please specify Version No 03 21 Effective Date Nov 2011 Contact Position Dept Tel Fax Serial No delete as applicable YES NO YES NO Page No 26 of 26
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