STD813 - Stericool Sterilizer Range Installation Qualification Report v9
Contents
1. may now be submitted for Operational Qualification IO Completed By Date Deviations Approved By Date IO Approved By Date2. ONAL DOCUMENTATION REQUESTED PRESENT Production OQ PQ Test YES NO YES NO Certificate Service Manual YES NO YES NO IQ Device Safety MANUFACTURER SAFETY RECOMENDATIONS CONFIRMATION Allow enough space for the Device See installation Manual YES NO Position on level Surface YES NO Heavy load surface indoor to carry 450Kg YES NO Mobility on Wheels YES NO Water supply accessible in case of emergency YES NO Read User Manual before operating YES NO Comments IQ Assembly and Installation STERICOOL Assembled and Installed By Trained Technician Engineer Yes No Name of the Engineer or Technician Installation Procedure STATUS Discrepancy Unpack and retain Packing YES NO Assembly done as per the YES NO Installation Manual Connected to Power supply YES NO Quick Guide poster and User manual YES NO available by the sterilizer Comments Installation Oualification Summary Report Device Manufacturer Assessment of Complete Installation Qualification Is there a Deviation YES NO IF YES LIST THE DEVIATIONS BELOW SA Justification for Deviation Impact on Operation acceptance Successful completion of the preceding activities and checks indicates that this Device has been satisfactorily delivered and installed The Device has passed the Installation Qualification procedure and
3. STERICOOL INSTALLATION QUALIFICATION REPORT for STERICOOL Hydrogen Peroxide Plasma Sterilizer Range A160S A160D A160SF A160DF A110S A110D A110SF A110DF GOA Teknoloji A S Ivedik OSB 1436 Sok No 14 Ostim Yenimahalle 06378 ANKARA TURKEY Tel 90 312 387 3940 Fax 90 312 387 3948 www stericool com info stericool com IQ Device Origin and Identification Device Series and Model Serial Number Device Description GOA TEKNOLOJI A S Ivedik OSB 1436 Sok No 14 Ostim Yenimahalle 06378 Ankara TURKEY Service Contract Condition Date Received Installed Installed Location Purchase Order Number Identification Asset Number STERICOOL IQ Device Specification DEVICE PARAMETER ACCEPTABLE Chamber Size 110Lt 160lt YES NO Single Door Double door YES NO Front Loaded Side loaded YES NO 240ml 30ml Cartridge YES NO Stainless Aluminum Chamber YES NO RFID Barcode Sterilant reader YES NO Mobility Wheels Feet YES NO Other Technical Specs YES NO IQ Environment and Site Check OPERATING PARAMETERS SPECIFIED RANGE CONDITIONS MET Air Exchanges 10 per Hour YES NO Operating Temperature 18 C 35 C YES NO Storage Temperature 29 C 70 C Heat Generation Max at Advance cycles 10 KW YES NO Maximum Relative Humidity 80 up to 30 C decreasing linearly YES NO to 70 at 40 C non conden
4. sing Maximum Altitude 3000m YES NO Supply Voltage amp Frequency Single Phase 220 240V 50 60H YES NO Phase 220 240V 50 60H Maximum Current 16Amp YES NO Earth Leakage protection Yes and Max difference between live YES NO and earth 0 5V STERICOOL IQ Device Delivery and Documentation Packaging Crate Inspection Is there any damage to the packaging crate Yes No If Yes please circle the appropriate location Comments Packaging List PRESENT MISSING 24 Trays Caster Wheels 2x with lock 2x without Lock Oil Return Valves Solenoids Catalytic Converter Trap Gate Valve Thermal Printer Paper Vacuum Pump Oil Independent Monitoring System IMS For compliance with ISO 14937 The Independent Monitoring System IMS is an optional feature thatmay be purchased and installed on the sterilizer It is an independent data collection system that can be used for system validation or requalification Madge Temp sensor and T Junction with Edwards pressure sensor and reader Is there any damage to the Device or accessories YES NO If yes Description of damage STERICOOL Documentation Checklist PRESENTED MISSING User Manual YES NO YES NO Quick Guide Wall Poster YES NO YES NO Installation Manual YES NO YES NO Certificate of Conformity YES NO YES NO Warranty Document YES NO YES NO ADDITI
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