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DAYmate S Installation Qualification

Instrument :

Serial Number:

HMI SW Version:

SMART SW Version:

Customer Site: Customer Name:

Department:

Tel: Email:

Distributor in charge:

Name of service Engineer:

Tel: Email:
IQP-TF Test Form IQ -TF01
DAYmate S PRE-REQUIREMENTS

Pre-requirements of test form

Passed / Date & Finding


Description Expected Result Obtained result
N° Failed Visa number

The person in charge The concerned


of the installation of person is
1 a DAYmate S is from competent and has
DAY medical or has the permission to
been trained by DAY perform the
medical (certified installation of the
technician). the DAYmate S.

A preventive
2 maintenance plan is Date of the next
or will be available maintenance
each 6 months

The DAYmate S is The surface is even


3 placed on an even and the maximal
surface which is able charge is more
to support its weight than 200 kgs
IQP-TF Test Form IQ -TF01
DAYmate S DELIVERY INSPECTION

Test case reference: IQ-DAYmate S-TC01 Description: Delivery Inspection


N° Passed / Date & Finding
Instruction Test Expected results Obtained results
Failed visa number
The tilt watch is
The packaging has normal (silver) and
1 not been damaged there is no visual
during transport. damage on the
packaging.
Ext. result: no visible
Result ext : __________________
defects
2 Visual check of the
instrument
Int. result: no visible
Result int : __________________
defects
The following items
are present in the
3 instrument:
All items are present
- Power cable
- Waste
- Cartridge holder
The serial number
4 of the machine
matches to the
SN_______________ SN_______________
serial numbers
mentioned on the
QC certification
The quality control
certification (form HMI
HMI v.______________
5 02011) is complete v.______________
and the HMI and
SMART software SMART
SMART v._____________
are in the latest v._____________
versions.

The completeness of
The packaging list is
6 the checklist has
complete.
been confirmed with
(form 02310)
date and signature.
IQP-TF Test Form IQ -TF01
DAYmate S SECURITY INSPECTION

Test case reference: IQ-DAYmate S-TC02 Description: Security (safety) Inspection


N° Passed / Date & Finding
Instruction Test Expected results Obtained results
Failed visa number
The instrument is
1 installed inside and
OK
not in proximity to
the patients.
Voltage:
· Voltage: ________
The DAYmate S is 100 - 240 VAC
2 connected to an Frequency:
· Frequency: _______
appropriate power 50/60 Hz
supply. Available power:
· Available power: ________
600 VA
The DAYmate S is
located in a place
The power supply is
where a
3 nearby the machine
disconnection from
and easily accessible.
the power supply is
always possible.

The DAYmate S is
located in a place Around the machine
with enough place is a minimal place of
4 for ventilation to 150 mm.
avoid overheating.
All software and
The products are
accessories used
delivered and/or
5 with the DAYmate S
officially approved
are approved from
from DAY medical.
DAY medical.
Every PC, which will An antivirus and
be connected to firewall is installed
6 the DAYmate S, is on the PC.
protected against (only if connected to
Virus and Malware. internet)
All sources of
The DAYmate S is
electromagnetic
not under influence
7 emissions with high
of electromagnetic
intensity are not in
waves of high
proximity of the
intensity.
DAYmate
Connect the · A green check
DAYmate S to a appears above in the
8 power outlet and middle on the HMI.
start the machine · No error messages
completely (both / warnings appear in
power switches) the fixed-bar.
IQP-TF Test Form IQ -TF02
DAYmate S RESULTS

Results of the execution of the test forms

All the Finding are under control (fill out the table “List of finding”)  Yes  No

All the tests are documented and proofs available  Yes  No

Date and Visa are presents.  Yes  No

List of all Finding  Number of Finding : ______________________

N° Finding Finding Status Comments


number
 blocking

 Non-blocking

 N/A
 blocking

 Non-blocking

 N/A
 blocking

 Non-blocking

 N/A
 blocking

 Non-blocking

 N/A
 blocking

 Non-blocking

 N/A
IQP-TF Test Form IQ -TF02
DAYmate S RESULTS

Final Result

The Installation Qualification (IQ) is All Findings are non-blocking

passed   Yes

Failed   No

Go in Operational Qualification (OQ)?

 Yes

 No

Remarks: ……..……………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………………….

………………………………………………………………………………………………………………………………………………………….

………………………………………………………………………………………………………………………………………………………….

………………………………………………………………………………………………………………………………………………………….

Name & function Date Signature Visa

DAY medical (only


for 1st installation)

Distributor

Final customer