INSTALLATION QUALIFICATION
Contents
1. Present Missing Not Requested n n n n n n n n n Unstirred Water Bath SUB Aqua Plus Installation and Operational Qualification SAMPLE COPY 29570 Version 1 March 2010 5 Installation Qualification Instrument Safety Manufacturer s Safety Recommendations Allow enough space for the instrument Position on level non combustible surface indoors Area free from aggressive explosive chemical mixtures Ensure correct power supply and all power switches easily accessible Beware hot surfaces and hot water both during and after use For 18 and 26 litre baths empty the bath before moving it Do not use to heat material that could cause fire or other hazard Use safety goggles during high temperature operation DODO COCOON DOOD Read Operator Manual before use Comments Unstirred Water Bath SUB Aqua Plus SAMPLE COPY 29570 Version 1 March 2010 Installation and Operational Qualification 6 Installation Qualification Assembly and Installation Assembled and Installed By Use Q Specialised Engineer L Installation Procedure OK Discrepancy N A Q Unpack and retain packaging OM4 1 Assembly OM4 2 Site and connect to power supply OM4 3 4 4 Bath fluid filled correctly OM5 1 1 OO WoO vo D O ow DOODO Base tray fitted OM5 1 3 Comments including discrepancies Unstirred Water Bath SUB Aqua Plus SAMPLE COPY 29570 Version 1 March 2010 Installati2. OUD OD TEL Comments Unstirred Water Bath SUB Aqua Plus Installation and Operational Qualification SAMPLE COPY 29570 Version 1 March 2010 13 Operational Qualification Summary Report Serial Number Instrument Manufacturer Grant Instruments Assessment of Complete Operational Qualification No Deviations L Deviations 1 list below Deviation Impact on Operation Justification for Acceptance Successful completion of the preceding activities and checks indicates that this instrument is operating satisfactorily following delivery and installation The instrument has passed the Operational Qualification procedure and may now be released for use OQ Completed By Date Deviations Date Approved By OQ Approved By Date Unstirred Water Bath SUB Aqua Plus Installation and Operational Qualification SAMPLE COPY 29570 Version 1 March 2010 14
3. also known as Operating Instructions Operating Parameters Specified Range Conditions Met Ambient Temperature 540 C L 8096 up to 31 C decreasing linearly Maximum Relative Humidity to 50 at40 C Maximum Altitude 2 000 m 6 500 ft Supply Voltage amp Frequency 230V 50 60Hz or 120V 50 60Hz D DUO O Model 230V 110V SUB Aqua2 Plus 10 LJ os LJ SUB Aqua 28 Plus 26 LJ 13 LJ SUB Aqua5 Plus 26 LJ 13 Ld GE SUB Aqua12 Plus 53 LJ 27 LL J SUB Aqua18 Plus 7 9 LJ 5 3 LJ SUB Aqua 26 Plus 7 9 Ld 5 3 LJ SUB Aqua Dual Plus 7 9 LJ 4 0L SUB Aqua 34 Plus 1344 ssl Comments Unstirred Water Bath SUB Aqua Plus SAMPLE COPY 29570 Version 1 March 2010 Installation and Operational Qualification 4 Installation Qualification Instrument Delivery and Documentation Unpack the instrument carefully Are any items missing against the Packing List Yes LJ If yes state missing items No LJ Is there any damage to the instrument or accessories Yes LJ If yes Corrective action Manufacturer informed Description of damage No L Yes L No LJ Is all standard documentation included Operator Manual OM Certificate of Conformity Quick Start Guide Warranty Card UK only Present Missing n n D DL D DHL Is all additional documentation included Calibration Certificate Service Manual SM Performance Qualification PQ Requested
4. Grant 29570 SUB Aqua Plus IQOQ document Unique Product Serial number label placed here To purchase a full bound copy of this document contact Grant Instruments Cambridge Ltd Shepreth Cambridgeshire SG8 6GB England Tel 44 0 1763 260811 Fax 44 0 1763 262410 Email service grant co uk www grant co uk Contents Installation Qualification Instrument Origin and Identification ce rry err Ere RE FEE EY eU UE FERE EE Ee SEE EE de eee ERE 2 Instrument SPSCMCAM OM RR 3 Environment and Siting eS ee 4 Instrument Delivery and Documentation 9B 5 Instrument SOU ieee entente ZAM 6 Assembly and Installation NM 7 Summary Report dB NER eenen 8 Operational Qualification Safety Tests A MR eeneeenneenneenneennaenen 9 Pre Run Checks 4 A A 10 Functional Cee AA IB oomen entente 11 Calibrati gE SID nennen 12 Eje We UK E E 13 Summary Reports OE sy Merde een 14 Unstirred Water Bath SUB Aqua Plus SAMPLE COPY 29570 Version 1 March 2010 Installation and Operational Qualification 1 Installation Qualification Instrument Origin and Identification Instrument Series Unstirred Water Bath Model SUB Aqua Plus Instrument Description Digital thermostatic unstirred water bath Manufacturer Grant Instruments Cambridge Ltd Shepreth Cambridgeshire SG8 6GB England http www grant c
5. ld just above temperature sample protection Remember tonasel Wes with greater sample protection ation thermostat back above set point afterwards 1 Display shows Pr then Water heats to the OM5 3 4 preset temperature when preset tempearture OM5 3 5 Preset Key 1 is pressed n n 2 Water reaches preset temp 1 Dot will flash on the display 2 Alarm sounds at the end Countdown timer OM5 3 6 of countdown period L L 3 Alarm stops when enter is pressed Comments Unstirred Water Bath SUB Aqua Plus Installation and Operational Qualification SAMPLE COPY 29570 Version 1 March 2010 11 Operational Qualification Calibration This instrument is supplied fully calibrated by the manufacturer using equipment traceable to national standards Calibration by the user directly following standard installation is not usually required Calibration Step Refer to OK Not Done Single Point Calibration OM5 3 9 L LJ Twin Point Calibration OM5 3 10 L L Traceable Reference Thermometer Serial Number Comments Unstirred Water Bath SUB Aqua Plus SAMPLE COPY 29570 Version 1 March 2010 Installation and Operational Qualification 12 Operational Qualification Training Date Instrument Released for Use Trained Operators Read Operator Manual Practical Training Authorising Signature a D D D DD OW D O
6. o uk Service Contact Tel 44 0 1763 260811 Fax 44 0 1763 262410 E mail service grant co uk Serial Number Condition When Received New LJ Used L Reconditioned D Date Received Installed Location Purchase Order Number Identification Asset Number Unstirred Water Bath SUB Aqua Plus Installation and Operational Qualification SAMPLE COPY 29570 Version 1 March 2010 2 Installation Qualification Instrument Specification Instrument Parameter Specified Range Acceptable Output Temperature 5 C above ambient to 99 C L Temperature Stability at 37 C 0 2 C Temperature Setting Resolution Qed C Fixed thermal fuse and adjustable Over Tempra eut user defined sample protection n n n a Bath Fluids Water only SUB Aqua 2 Plus 2 litre SUB Aqua 2S Plus 2 litre SUB Aqua 5 Plus 5 litre SUB Aqua 12 Plus 12 litre Bath C it a apacity SUB Aqua 18 Plus 18 litre DODCDLDLU SUB Aqua 26 Plus 26 litre SUB Aqua Dual Plus 5 amp 12L LJ SUB Aqua 34 Plus 34 lite LJ Comments Unstirred Water Bath SUB Aqua Plus SAMPLE COPY 29570 Version 1 March 2010 Installation and Operational Qualification 3 Installation Qualification Environment and Siting Has the instrument been adequately acclimatised since transport or storage Yes LJ No L refer to OM1 2 OMX denotes section X of the Operator Manual
7. on and Operational Qualification 7 Installation Qualification Serial Number Summary Report Instrument Manufacturer Grant Instruments Assessment of Complete Installation Qualification No Deviations LJ Deviations J list below Justification for Deviation Impact on Operation Acceptance Successful completion of the preceding activities and checks indicates that this instrument has been satisfactorily delivered and installed The instrument has passed the Installation Qualification procedure and may now be submitted for Operational Qualification IQ Completed By Date Deviations Approved By Date IQ Approved By Date Unstirred Water Bath SUB Aqua Plus SAMPLE COPY 29570 Version 1 March 2010 Installation and Operational Qualification 8 Safety Tests Operational Qualification This instrument conforms to the following standards and is supplied fully tested by the manufacturer e BS EN 61326 2006 Electrical equipment for measurement control and laboratory use EMC requirements e BS EN 61010 Part 2 010 2003 Safety requirements for electrical equipment for measurement control and laboratory use particular requirements for laboratory equipment for the heating of material The following electrical safety tests should also be carried out by a competent person after installation Safety Te
8. st Referto Pass Fail Date Signed Earth Bonding OM923 J LJ Insulation Resistance OMe m Comments Unstirred Water Bath SUB Aqua Plus Installation and Operational Qualification SAMPLE COPY 29570 Version 1 March 2010 9 Operational Qualification Pre Run Checks Pre Run Check Refer to OK Discrepancy N A Bath fluid filled correctly OM5 1 1 L L L Lid polypropylene spheres in place OM5 1 2 L L L Base tray fitted OM5 1 3 L E n All power switches easily accessible OM4 3 W L LJ Comments including discrepancies Unstirred Water Bath SUB Aqua Plus Installation and Operational Qualification SAMPLE COPY 29570 Version 1 March 2010 10 Operational Qualification Functional Tests Functional Test Refer to Acceptance Criteria Pass Fail 1 Display illuminates and Powers up j shows fluid temperature E n Heats fluid to reach 1 Display shows fluid set point OMS5 3 2 temperature increase and L L temperature rising bar Controls fluid 1 Display shows fluid temperature when OMS5 3 2 temperature at set point and L L set point reached rising bar disappears Controls fluid temperature when sample protection thermostat level 1 Display alternates reached Test by between fluid temperature setting sample qu c protection and BEc and audible alarm ds thermostat slightly OM5 3 3 SOUncs LJ LJ lower than set point 2 Fluid he
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