Pall Biotech RDUA007BT Instructions For Use Manual Download Page 5 | Manualshive

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1.2

Safety Symbols Within This IFU

Table 2

Safety signs and symbols within this document.

Symbol

Definition / Meaning

Prior to operating, the instructions must be read in entirety.

Highlights important information regarding instructions for use.

Protected earth; Ground.

Identifies a dangerous prohibited situation that may result in personal injury or death.

Caution should be taken. Potential risk to equipment. Refer to instructional text.

Caution possibility of electric shock.

Caution risk of entanglement.

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Summary of Contents for Biotech RDUA007BT

Page 1: ...BIOTECH Instructions For Use USD 3557 Wand Mixer Single Use Mixing System Model RDUA007BT Model RDUA008FB ...

Page 2: ...Disconnecting the Bag 15 10 Maintenance 15 10 1 Preventative Maintenance 15 10 2 Troubleshooting 16 10 3 Procedures 16 10 3 1 Power Cord Replacement 16 10 3 2 SD Micro Card Replacement 17 10 3 3 Speed Calibration Verification 18 11 Cleaning and Decontamination Guide 19 12 Operator Control Interface 20 12 1 Navigating the Wand Mixer Control Screen 20 12 1 1 Common default Functions 20 12 1 2 Operat...

Page 3: ...13 10 Stopping a Manual Mode Job Timed Run 26 13 11 Pausing and Resuming a Manual Job 26 14 Failure Detection 28 14 1 Types of Failure 29 14 1 1 Manual E Stop 29 14 1 2 Speed Off Range 29 14 1 3 Motor Failure 29 14 2 Finishing Mixing Run 33 14 3 Initial Settings 33 15 Spare Parts and Accessories 34 16 Electrical Schematic 35 17 Service 36 ...

Page 4: ...nal bar with black symbol on white background Specifies behavior that is prohibited because it would result in an immediate or potential risk of personal injury or threat to health life Yellow Warning Caution Yellow triangle with black border and black symbol Warns of hazards which could result in personal injury or threat to health Blue Mandatory Information Blue circle with white symbol Specifie...

Page 5: ...ons must be read in entirety Highlights important information regarding instructions for use Protected earth Ground Identifies a dangerous prohibited situation that may result in personal injury or death Caution should be taken Potential risk to equipment Refer to instructional text Caution possibility of electric shock Caution risk of entanglement ...

Page 6: ...stributor for qualified technical service assistance Do not use flammable liquids substances Do not use non Pall rotational wands or heavy duty frames Do no t Submerge drive unit in water Cut ground plug Disconnect the protective earth connector Do not allow loose clothing or parts of the body to come near the rotating drive unit shaft shaft adaptor Power supplied to this instrument must match the...

Page 7: ...ntrol TURCK RSFPV61 RSFPV579 Functions available from remote control panel Motor start stop Speed adjustment indication Alarm indication Mode of control remote local indication Signal type s for remote output control Wand speed out 4 20 mA motor control in 0 10 VDC discrete I O signals relay contact type Alarms generated Motor failure speed off range failure E stop activation Method for RPM measur...

Page 8: ...tions available from remote control panel Motor start stop Speed adjustment indication Alarm indication Mode of control remote local indication Signal type s for remote output control Wand speed out 4 20 mA motor control in 0 10 VDC discrete I O signals relay contact type Alarms generated Motor failure speed off range failure E stop activation Method for RPM measurement Direct measurement of motor...

Page 9: ...tom designed single use mixing biocontainers available from Pall Corporation 4 Principle of Operation The Wand Mixer single use biocontainer mixing technology provides non invasive mixing inside sterile plastic biocontainers The technology is based on rotating a rod of predetermined shape introduced in the sleeve of the mixing biocontainer The rod is separated from the processed sterile fluid by a...

Page 10: ...h top Wand Mixer drive unit The above image shows the 5 L 10 L and 20 L containers Both the 5 L and 10 L containers are on stand RESA003A 5 2 RDUA008FB Figure 3 Floor based Wand Mixer drive unit The above image shows the 200 L container on a stainless steel dolly RDOC2005 ...

Page 11: ...ed by motor shaft adaptor It is very important to only use each wand with its designated nominal biocontainer size Failure to use the proper wand can result in damage to the biocontainer and or the equipment See Table 6 for each wand s designated biocontainer size Table 6 Wand part numbers and nominal biocontainer volume Part Number Nominal Biocontainer Volume L RWAA005A 5 RWAA006A 10 RWAA014A 20 ...

Page 12: ...can be operated in one of three modes selected by the operator from the Main Menu Manual Mode Automatic Mode and Remote Mode Each mode includes a specific set of functions to support processing requirements In case of emergency the operator can stop rotation of the motor by pressing the E Stop button on the face panel This can be done during any mode of operation Doing so halts motor rotation and ...

Page 13: ...in the flange of the shaft adaptor decouples the rotation of the shaft from the biocontainer Clamp The clamp secures the connection between the mating flanges of coupler and shaft adaptor Properly assembling the biocontainer starts by placing the mixing biocontainer into appropriate retaining tank and filling it with fluid by using the appropriate tube line Make sure that retaining tank is compati...

Page 14: ...wand in the receiving hex cavity inside the adaptor Bring the mating surfaces of two the flanges together and secure the flanges of the coupler and shaft adaptor against each other with the clamp as shown on the next page in Step 2 of 8 Tighten the screws on the clamp Lastly increase the motor height slightly up by turning the handle of the motor positioner until noticeable biocontainer tension is...

Page 15: ...restore of software resets the runtime counters and recipe content to zero 20 RPM The Wand Mixer is designed to operate with minimal maintenance However to minimize wear it is recommended that the drive be unplugged if it is not in use for more than 24 hours Recipes can be transferred between Wand Mixer units including the whole recipe library using external media micro SD card If user defined lib...

Page 16: ...ox Make sure the key on the receptacle and keyhole in the plug are aligned and the connector plug is pushed all the way in 5 Secure the connector holding cap by rotating it clockwise Tighten the cap firmly to seal the connection Problem Description Possible Reason Corrective Action Unit does not start when power button is pressed Main power fuse is burned out Contact service personnel No white lig...

Page 17: ...ng a flat head screwdriver 3 Open the Control Box door and locate the memory slot on the upper side of the PLC see 10 4 To insert the SD card a Align the card so that the 8 pin gold edge connector is facing upwards on the SD card b Push the Micro SD card in all the way into the memory slot ensuring that it clicks into place 5 To remove the Micro SD card a Push down on the top of the card gently to...

Page 18: ... write into the second column of Table 9 4 Calculate and write down in the third column the difference between set point and measured in c speed value 5 Compare the reading recorded in column 2 with corresponding allowable range in the third column of Table 9 then record the result in column 6 6 RPM Reading from panel screen record into the fourth column of Table 9 7 Compare the reading recorded i...

Page 19: ...n Allowable Range Y N 20 19 21 19 21 40 39 41 39 41 60 59 61 59 61 80 79 81 79 81 100 99 101 99 101 120 119 121 119 121 140 139 141 139 141 160 159 161 159 161 180 179 181 179 181 200 199 201 199 201 220 219 221 219 221 240 239 241 239 241 250 249 251 249 251 Calibration verification is successful if all rows in columns 6 and 7 of Table 9 have result Y 11 Cleaning and Decontamination Guide The sys...

Page 20: ...in the left upper corner of each screen except informational screens All passwords are group passwords with a minimum of six uppercase lower case or numeric characters In total three group logins are available Operator Supervisor and Maintenance Maintenance login is only available while the system is in power up mode The login time period is controlled via a program setup parameter Access is autom...

Page 21: ...hen choose Password Figure 12 to open the password entry screen 3 When the keypad entry screen appears enter the passcode for the desired user access level and then press Enter Figure 13 4 You will now return to the previous screen press Login Youare now loggedin under the selected user access level Figure 11 User login screen Figure 12 Supervisor user password screen Figure 13 Password entry scre...

Page 22: ... values of zero and speed of rotation set to 20 RPM Any recipe with all mixing phase durations set to zero considered an empty recipe If the operator tries to run such a recipe a notification is displayed on screen To simplify exchange of recipes between drive units a Migration function is available at the Supervisor level The feature allows Import Export of the entire library from to a removable ...

Page 23: ...n failure reset Unscheduled Finish is displayed with a time stamp run duration and name of the recipe after finishing the recipe run To resume to the Auto Mode screen press the OK button 13 4 Aborting a Recipe Supervisor and Maintenance user levels can abort running recipes To abort a recipe that is currently running press and hold the Abort button When a routine is aborted the Unscheduled Finish ...

Page 24: ...en opens 2 Use the arrow buttons at the top of the screen to scroll through the list of recipes until you find the name you want to edit 3 Press Edit The Recipe Editor screen opens 4 If needed press the Back andNext buttons on the right side of the screen to scroll through the list of instructions for that recipe 5 Press the button with the recipe name in it An entry screen opens 6 Use the onscree...

Page 25: ... opens 2 Press the Set Point box to set the RPM set point 3 In the Entry screen enter the RPM set point and then press Enter 4 Set the time period for prospective run 5 The status PERMANENT indicated on a switch means it will run indefinitely until manually stopped 6 To have manual run stopped automatically specify the length of run Press the switch to toggle it to TIMED status to allow time perio...

Page 26: ...ob stops the screen will display Unscheduled Finish with a time stamp and run duration To resume to the Manual Mode screen press the OK button When failure mode is activated during a run the job is paused automatically and can be resumed upon failure reset Unscheduled Finish is displayed with a time stamp and net mixing time after manually stopping or automatic finishing of the run To resume to th...

Page 27: ...orrectly connected to the Wand Mixer and powered up Finally press and hold the Switch Control to Remote button on the Remote Mode screen When the control is switched to a remote panel the Remote Control status is indicated in the window status bar To switch control back to the Wand Mixer press and hold the Switch Control Back to Local button on the Remote Mode screen The system will switch to Manu...

Page 28: ...e detection screen Figure 25 which is opened after pressing the Alarm button Figure 24 Alarm screen Figure 25 Failure detection screen Manual Mode idle condition Moment of alarm the mixer is in Remote mode or idled in Manual mode Manual Mode pause condition Moment of alarm the mixer is in Manual mode Automatic mode idle condition Moment of alarm the mixer is idled in automatic mode Recipe run paus...

Page 29: ...f the failure event is indicated on this screen Press the RESET button to return the unit to operation 14 1 3 Motor Failure If the mixer s drive motor experiences an error it signals the PLC The mixer then stops rotation and displays ALARM on the screen The operator should do the following steps Press the ALARM button The failure detection screen will then open On the failure detection screen iden...

Page 30: ... system as Supervisor Press the setup button on the Main Menu screen Select the Date Time function using the up and down arrows Press the curved arrow to go to the next screen Press the button with the date adjust the date to current then press Enter Press button with the time adjust time to current then press Enter Press to return to the Settings list 3 Change password for supervisor and operator...

Page 31: ... runtime separately for both system and motor rotation Press to return to the Settings list 6 Export of recipe library to memory card Insert a SD card into the Memory slot Login to the system as Supervisor Press the setup button on the Main Menu screen Select the Recipe Imp Exp function using the up and down arrows Press the curved arrow to open the next screen Press the File number button to go t...

Page 32: ...en the next screen Press the File number button to go to the entry screen On the entry screen input the file number 0 9 you wish to Import and press Enter Press the Import recipes button and confirm when prompted The whole library will be imported from the file on the Micro SD card named LIBRARYX BAK where X is the file number entered on the previous step A confirmation notice will appear after th...

Page 33: ...Successful Actual duration of recipe run time includes pauses Pause resumed Failure Alarm Unscheduled Aborted 14 3 Initial Settings Default settings are the factory preinstalled parameters as listed in Table 11 The parameters can be adjusted through the corresponding editor screens Table 11 Default initial settings Description of Parameter Units Factory Setting Manual mode speed of rotation RPM 20...

Page 34: ...SP365 Assembly US power cord included in tool box 1100025 Shaft adaptor assembly 500 11381 00 Medium acting fuse 3 A 5 mm X 20 mm LT SVSP367 Assembly Australian power cord LT SVSP368 Assembly Swiss power cord LT SVSP369 Assembly UK power cord LT SVSP480 Assembly Chinese power cord LT SVSP414 White illuminated push button switch assembled LT SVSP415 White LED bulb CBG401B Basic Control box CE optio...

Page 35: ...35 16 Electrical Schematic Figure 30 Electrical schematic ...

Page 36: ...he analog output 4 20 mA pins 2 and 3 of analog I O connector the MAX load resistance should not exceed 500 Ohm For equipment safety and to avoid possible excess noise on the speed control input signal pins 4 5 of Analog I O connector it is recommended to include an Isolation Amplifier in the design of the 0 10 VDC remote control external circuitry 17 Service The Wand Mixer system was developed ex...

Page 37: ...010 1 2010 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 general requirements EN61010 2 051 2013 Wide band transmission systems Data transmission equipment operating in the 2 4 GHz ISM band and using wide band modulation techniques Harmonised standard covering essential requirements of article 3 2 of the RED 2014 53 EU Warning This is a class A prod...

Page 38: ... for Measurement Control and Laboratory Use Part 1 General Requirements Valid without technical revision 01Jan2022 UL 61010 1 2012 Ed 3 R 29Apr2016 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requirements R2017 Valid without technical revision 01Jan2022 CSA C22 2 61010 1 12 2012 Ed 3 U1 U2 Wand mixer WMG403 RDUA200 RDUA007BT RDUA008FB Cont...

Page 39: ...istributor orcontact Pall directly Copyright 2021 Pall Corporation Pall and are trademarksof Pall Corporation Indicates a trademark registered in the USA All product and company namesare trademarks or registered trademarks of their respective holders Use of them does not imply any affiliation with or endorsement by them All specifications are subject tochange without notice USD 3557 SEPTEMBER 2021...

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