1^Equipment(TOSOH automated glycohemoglobin analyzer HLC- 723 GX) Documents and Records^^^
| Requirement | Type and Location | Help |
|---|---|---|
| a.identity of the equipment | TOSOH automated glycohemoglobin analyzer_SR NO-1182094_MODEL NO-HLC- 723 GX_HOSP-EQ-PG-04 | 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 | TOSOH automated glycohemoglobin analyzer HLC- 723 GX_HOSP-EQ-PG-04 | Unique ID of equipment in manufacturer's context |
| c.contact information for the supplier or the manufacturer | supplier- Optima Biocare Contact person-1st person-Mr Siddhesh-8408902546,2nd person-Mr Tanuji-9924477355,3rd person-Vijaybhai contact no-9377294150and Pranavbhai contact no-9377294160. | Address, company/local sale/engineer phone/email, number for automated complaint registration etc |
| d.date of receiving and date of entering into service | 31-05-2021 | Same as in register |
| e.location | Clinical Biochemistry lab | Lab section/room etc |
| f.condition when received (e.g. new, used or reconditioned) | New | |
| g.manufacturer’s instructions | prep_of_hb_control.pdfhb_liquid_prep.pdfhlc-723gx_operators_manual_eng_rev.f.pdfhlc-723g8host_connect_spec_rev.4.pdfep1103812b1_best_hba1c_three_reagent.pdf | User manual pdf |
| 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 (HPLC) hplc_installation_report.pdftosoh_gx_calibration_report.pdf it was received in biochemistry lab on 31-05-2021, opened and installed by company person on 31-05-2021. and it is working properly. | It 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_daily_monthly_maintenance_sheet_document_hplc.odsInformation about Preventive Maintenence is in User Manual Page Number 137,Under the headinf of chapter 5 MAINTENANCE PROCEDURE. •••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 | ||
| 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 |
Summary of Analytical Performance —> 2020_certificate_tosoh_hlc-723gx.pdf
Tracebility Certificate —→ 8.2020certification_gx_zs9002.pdf
Summary of Certification Criteria —–> ngsp_criteria_summary.pdf