Medical Devices -Touch Controller
55
| Annexes
Questionnaire
S.No
Question/Request
Answer/Evaluation
1
Have you already used an identical or similar device, of the
same or different brand?
Yes
No
2
Have the users intended to use the MD been properly trained
about the "good use" of blood and blood related products?
(blood sampling, processing and storage)
Yes
No
3
Have the users intended to use the MD been properly trained
about the "good use" of breast milk? (sampling, processing
and storage)
4
Is there in the chosen medical staff intended to use the MD a
person informed and updated on the current regulations for
MD?
Yes
No
5
Has the Use and Maintenance manual been read?
Yes
No
6
Was the installation carried out in compliance with the
indications listed in the manual?
Yes
No
7
The provided documentation is clear, and it provides all the
useful information for the usage of the device.
1
2
3
4
5
8
The instructions stick on the packaging for its removal are clear
and comprehensive.
1
2
3
4
5
9
The installation instructions displayed in the manual are clear
and don’t give margin for interpretation.
1
2
3
4
5
10
Taking into account the instructions provided in the manual by
the manufacturer, can the MD be used improperly or
incorrectly?
Yes
No
11
If you answered "YES" to the question above, provide details/reasons:
12
The device display (Touch screen or keyboard) is intuitive and
easy to be used.
1
2
3
4
5
13
The access to user panel interface is easy.
1
2
3
4
5
14
The alarms described in the manual and shown in the display
are adequate to grant the safety of the stored product.
1
2
3
4
5
15
The accessories supplied for the storage of "products" are
easy to be used (for example, shelves or drawers with dividers).
1
2
3
4
5
Stamp and signature
DATE:
