^Equipment (ERBA XL_1000) Documents and Records^^^
| Requirement | Type and Location | Help |
|---|---|---|
| a.identity of the equipment | Erba XL-1000 HOSP-EQ-P-8: | Use Equipment Name and Hospital Register page Number to create ID. It is same as in LIS cl_general.equipment.equipment upload pdf of orders |
| b.manufacturer’s name, model and serial number or other unique identification | Transasia Fully Automated Chemical Analyser ERBA XL 1000, Sr No-110021 ,Modal No XL-1000 xl-1000_serial_no.jpeg, Provisional no-07/19, ASW Version-2019.01, ESW Version- 2019_o0.02 | |
| c.contact information for the supplier or the manufacturer | TRANSASIA BIO-MEDICALS Ltd, MR.JITESH-9327110049, MR.Manoj-9327110109, Mr.Sidhdharth-9327012201 To register complain call: 1800 103 8226 or 8451048434 complaint_format_xl_1000.jpeg | |
| d.date of receiving and date of entering into service | 25/04/2020 and 15/05/2020 | Same as in register |
| e.location | Clinical Biochemistry Laboratory,NCH,Surat | Lab section/room etc |
| f.condition when received (e.g. new, used or reconditioned) | New | |
| g.manufacturer’s instructions | -User manual Host Manual ASTM Host manual(.chm) | As per User Manual |
| h.Procedural document for and records that confirmed the equipment’s initial acceptability for use when equipment is incorporated in the laboratory | Procedure for Performance Qualification. Records in LIS | Procedure may be in user manual. In that case write chapter/page numbers for easy reference |
| i.Record of maintenance carried out and the Procedural(schedule) document for preventive maintenance | •••Procedural(schedule) document for preventive maintenance is performa_monthly_maintenance_sheet_document_.ods Information about Preventive Maintenence is in User Manual Page Number 512,Under the headinf of 11.6 PREVENTIVE MAINTENANCE. •••Record of maintenance carried out are in LIS in the form of monthly maintenance sheet in Equipment Record Menu. | |
| j.Procedural document and records that confirm the equipment’s ongoing acceptability for use;Such records include copies of reports/certificates of all calibrations and/or verifications | •••Procedure For Instrument Acceptibility •••Records at LIS, Performance records- Records of Calibrations of various Tests done in XL_1000 are in LIS, IQC and EQC also kept in LIS, EQA reports are uploaded chronologically in Docs_in subtitle 5.06.3 | |
| k.Documented Procedure for repair and Records of damage to, or malfunction, modification, or repair of the equipment | Documented Procedure for repair and Records of damage to, or malfunction, modification, or repair of the equipment as per user manual and records are in LIS in Equipment Menu |
