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:
Country of Origin:
England
Manufacturer:
Supplier:
B and D Electromedical
Telephone No:
Fax No:
01789 262470
e-mail:
CE MARKING
1.
a)
Does the product carry the CE marking?
YES
X
NO
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
X
If YES, state classification of device (93/42/EEC Annex IX)
2b
iii)
In Vitro Diagnostic Medical Devices Directive (98/79/EC)
YES
If YES, is the device:
For self-testing?
YES
Covered by Annex II: List A?
YES
List B?
YES
NO
For ii) and iii) above, Identification No. of Notified Body, if applicable
0086
iv)
EMC Directive (89/336/EEC or superseding directive))
YES
v)
Low Voltage Directive (73/23/EEC)
YES
vi)
Other Directive(s) (please specify)
2.
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
X
NO
If YES, please state the standard(s) and certification body:
ISO 13485, BSI
b)
Is the supplier's service and repair organisation currently registered to any management system standards?
YES
X
NO
If YES, please state the standard(s) and certification body:
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?
YES
X
NO
If NOT f.o.c. please state current price
Indicate contents below:
(Please state
YES, NO or N/A)
Full circuit diagrams
YES
Fault finding procedure
YES
Preventative maintenance
YES
Repair information
YES
Spare parts listing
YES
List of special tools/test equipment/etc
N/A
If YES, please state whether also available on:
Disk
Website
If Web, please state address
6.
a)
In addition to the service/repair information/manual, will training be required before competent technical personnel can provide:
(Please state YES, NO or N/A)
First-line maintenance
YES
Calibration
YES
Planned preventative maintenance
YES
Repair
YES
b)
Is the supplier able to provide this training for the purchaser’s or a third party’s technical personnel?
YES
X
NO
If YES, will this be free of charge?
NO
Or chargeable?
YES
If NO, please indicate if details of an organisation that is able to provide this training are available on request?
YES
NO
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Supplier's Reference:
0926
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
7.
a)
Is the supplier able to provide an 'as required' repair/maintenance service in the UK?
YES
X
NO
b)
Is the supplier able to provide a contract repair/maintenance service?
YES
NO
X
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:
B and D Electromedical
Location:
Stratford on Avon
Typical turnround time:
1 week
iii)
Is free of charge loan equipment normally available?
YES
NO
X
8.
Please state if repair parts will be available to the purchaser’s or a third party’s suitably trained and equipped personnel:
YES
X
NO
If YES, is the supply of repair parts conditional upon acquisition of repair information?
YES
Or training?
YES
NO
X
9.
Please indicate when this model was first placed on the market:
2007
10.
a)
For how many years from the date of last manufacture is the supply of spare parts guaranteed?
7
b)
Is the product still in current production?
YES
X
NO
If NO, indicate year of last manufacture:
11.
Is installation necessary?
YES
NO
X
If YES, please confirm that details of all services required are provided on a separate sheet:
YES
12.
Will software upgrades be notified?
N/A
YES
NO
X
IONISING RADIATION
13.
Does the product contain a source of ionising radiation or is it capable of emitting ionising radiation?
YES
NO
X
DECONTAMINATION / REPROCESSING
14.
a)
i)
Is the item intended to be processed/reprocessed?
YES
x
NO
If NO, go to Question 15.
ii)
If YES, is the item intended to be:
Non-sterile for single use
Sterilized
Disinfected
x
Other
iii)
Is there a recommended maximum number of uses? YES
NO
x
If YES, please state:
iv)
Are decontamination/reprocessing instructions supplied?
YES
x
NO
v)
Are instructions available for safe disposal?
YES
x
NO
b)
i)
Is manual cleaning the only cleaning method specified before further reprocessing?
YES
x
NO
ii)
What is the maximum temperature that can be used for thermal disinfection?
Temp:
n/a
iii)
Are there any restrictions on detergent/disinfectant types?
YES
x
NO
If YES, please
state:
Use Chlorine based or 70% isopropyl
iv)
Can the item withstand autoclaving at 137 oC for 3 mins?
YES
NO
x
v)
Is the item compatible with other sterilization methods?
YES
NO
x
If YES, please
state:
vi)
Does reprocessing require the use of specified equipment?
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?
YES
NO
x
ii)
If YES, are they supplied with the device or available optionally?
Supplied
Optional
Neither
d)
Is decontamination/reprocessing training available?
YES
NO
x
If YES will this be:
Free of charge?
Chargeable?
e)
Are reprocessing instructions available on the Web?
YES
NO
x
If YES, please state
address:
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:
Alison Speechly
Position:
Compliance Manager
Company/Address:
B and D Electromedical
Unit A2, The Bridge Business Centre
Timothy’s Bridge Road, Stratford upon Avon, CV37 9HW
Date:
30/01/2017

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