PRE PURCHASE QUESTIONNAIRE PPQ Nippy ST Jan17
User Manual: PPQ-nippy-ST-Jan17
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PRE-PURCHASE QUESTIONNAIRE EXTENDED FORM PPQ – June 2003 Produced by NHS Purchasing and Supply Agency, Scottish Healthcare Supplies, Northern Ireland CSA Regional Supplies Service and Welsh Health Supplies in conjunction with the Association of British Healthcare Industries This form is intended to supply prospective purchasers with information about equipment being considered for purchase. It is intended principally for pre-purchase information on electrical medical, dental, ophthalmic and laboratory equipment. The form may also be used for other products, including non-electrical items, and to give information prior to equipment being supplied on loan, in which case not all the questions will be relevant. Please ensure all relevant questions are answered. For issue and completion by purchaser: PPQ Master Reference: A unique reference (preferably ten characters maximum) must be given by the supplier: Supplier's Reference: 0926 Generic Device Type: Ventilator Equipment Model: Nippy ST+ Country of Origin: England Manufacturer: B and D Electromedical Supplier: B and D Electromedical Telephone No: 01789 293460 Fax No: 01789 262470 e-mail: quality@nippyventilator.com CE MARKING 1. a) Does the product carry the CE marking? b) If YES, to which EC Directive(s): i) Active Implantable Medical Devices Directive (90/385/EEC) YES ii) Medical Devices Directive (93/42/EEC) YES In Vitro Diagnostic Medical Devices Directive (98/79/EC) If YES, is the device: For self-testing? YES X YES Covered by Annex II: List A? YES List B? YES NO 0086 For ii) and iii) above, Identification No. of Notified Body, if applicable 2. NO 2b If YES, state classification of device (93/42/EEC Annex IX) iii) X YES iv) EMC Directive (89/336/EEC or superseding directive)) YES v) Low Voltage Directive (73/23/EEC) YES vi) Other Directive(s) (please specify) a) Is the product a ‘custom-made device’ (93/42/EEC)? YES NO X b) Is the product intended for ‘clinical investigation’ (93/42/EEC) or ‘performance evaluation’ (98/79/EC)? YES NO X If YES to a) or b) above, does the device comply with the UK Medical Devices Regulations? YES NO MANAGEMENT SYSTEM STANDARDS 3. a) Is the manufacturer currently registered to any management system standards (eg ISO 9001, ISO 14001, ISO 13485)? YES If YES, please state the standard(s) and certification body: b) Is the supplier's service and repair organisation currently registered to any management system standards? If YES, please state the standard(s) and certification body: X NO X NO ISO 13485, BSI YES ISO 13485, BSI SAFETY STANDARDS 4. For products not CE marked to 1 b) I), ii) or iii) above, with which safety standard(s) does the product comply? Standard Test House Certificate Number Date SERVICE / SPARES / INSTALLATION 5. Is service/repair information available? (Please state YES, NO or N/A) YES a) If NOT f.o.c. please state current price Fault finding procedure YES Preventative maintenance YES Repair information YES Spare parts listing YES List of special tools/test equipment/etc N/A Website If Web, please state address In addition to the service/repair information/manual, will training be required before competent technical personnel can provide: First-line maintenance YES Calibration YES Planned preventative maintenance YES Repair YES Is the supplier able to provide this training for the purchaser’s or a third party’s technical personnel? If YES, will this be free of charge? NO Or chargeable? YES X NO YES If NO, please indicate if details of an organisation that is able to provide this training are available on request? Page 1 of 2 Indicate contents below: YES (Please state YES, NO or N/A) b) NO Full circuit diagrams If YES, please state whether also available on: Disk 6. X YES NO 0926 Supplier's Reference: 7. c) Is the provision of service/repair information conditional upon completion of training? YES NO X d) In order to undertake maintenance/repair/calibration, is any special software/test equipment/tooling required? YES NO X If YES, please indicate that details of special software/test equipment/tooling are provided on a separate sheet: YES a) Is the supplier able to provide an 'as required' repair/maintenance service in the UK? YES b) Is the supplier able to provide a contract repair/maintenance service? YES If YES, please confirm that details of repair/maintenance contracts are provided on a separate sheet. YES c) i) If repairs are normally performed by the supplier on the purchaser's site, please state typical response time: ii) If repairs are performed off-site, where will these be carried out? Company: iii) 8. B and D Electromedical Stratford on Avon Location: YES If YES, is the supply of repair parts conditional upon acquisition of repair information? YES YES Or training? Please indicate when this model was first placed on the market: 10. a) For how many years from the date of last manufacture is the supply of spare parts guaranteed? 12. 1 week NO X X NO NO X 2007 9. 11. X NO YES Please state if repair parts will be available to the purchaser’s or a third party’s suitably trained and equipped personnel: X NO Typical turnround time: Is free of charge loan equipment normally available? b) Is the product still in current production? YES X NO 7 If NO, indicate year of last manufacture: Is installation necessary? YES If YES, please confirm that details of all services required are provided on a separate sheet: YES Will software upgrades be notified? N/A YES NO X NO X NO X IONISING RADIATION 13. Does the product contain a source of ionising radiation or is it capable of emitting ionising radiation? YES DECONTAMINATION / REPROCESSING 14. a) b) YES x i) Is the item intended to be processed/reprocessed? ii) If YES, is the item intended to be: Non-sterile for single use iii) Is there a recommended maximum number of uses? iv) Are decontamination/reprocessing instructions supplied? YES x NO v) Are instructions available for safe disposal? YES x NO i) Is manual cleaning the only cleaning method specified before further reprocessing? YES x ii) What is the maximum temperature that can be used for thermal disinfection? iii) Are there any restrictions on detergent/disinfectant types? YES iv) Can the item withstand autoclaving at 137 oC for 3 mins? Is the item compatible with other sterilization methods? vi) Does reprocessing require the use of specified equipment? x NO x YES If NO, go to Question 15. Disinfected x Sterilized YES v) NO Other If YES, please state: NO n/a Temp: NO If YES, please state: NO x If YES, please state: Use Chlorine based or 70% isopropyl YES NO x YES NO x If YES, please state equipment type (eg containers, processors, etc) and, where appropriate, parameters of operation (eg temp, pressure, etc): c) i) Are tools required to aid dismantling/reassembly, or are lubricants required? ii) If YES, are they supplied with the device or available optionally? YES Supplied d) Is decontamination/reprocessing training available? YES NO x e) Are reprocessing instructions available on the Web? YES NO x NO Optional If YES will this be: Free of charge? If YES, please state address: x Neither Chargeable? WARRANTY 15. Please confirm that a copy of the warranty is provided on a separate sheet: YES X DECLARATION When reference is made to this form and its attachments within the process of obtaining the item, we agree that the purchaser will be entitled to rely upon the contents and subsequent non-compliance with the statements contained herein will entitle the purchaser to seek redress. Name: Position: Alison Speechly Company/Address: B and D Electromedical Unit A2, The Bridge Business Centre Timothy’s Bridge Road, Stratford upon Avon, CV37 9HW Page 2 of 2 Compliance Manager Date: 30/01/2017
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