Protocol, PRT-76-xxx

INSTALLATION QUALIFICATION OF MEMERT INCUBATOR

DCN: 2019-xxx Rev: A Pg. 1 of 2

1. PURPOSE
This qualification serves for the inspection of the appliance designated as the "test object" for
completeness of the delivery and operational readiness.

2. SCOPE
This qualification protocol is intended to be used with MEMERT incubator which are new or relocated.

3. RESPONSIBILITY
Quality Control Team Leader is owner this protocol.

4. CONTENT
4.1. Unit description
Manufacturer MEMMERT GmbH + Co. KG, 91107 Schwabach, Germany
Designation Incubator
Type IN series
Voltage 230 V, 50/60 Hz
Nominal temperature 5-80oC
Serial number ………………………………………………………………….

4.2. Installation qualification

Check the following item by viewing and hearing when installing the equipment.
A form which attaches to this instruction: check sheet for Installation Qualification.
4.2.1. Packaging/appliance
Inspection Item Judgment
Yes No
Packaging undamaged? □ □
All appliance parts undamaged as far as externally visible? □ □
Completeness of the scope of delivery, according to the order and order □ □
confirmation (e.g. steel grids/thermo-shelve)

4.2.2. Documentation/accessories
Inspection Item Judgment
Yes No
Operating manual included? □ □
Calibration certificate included? □ □

4.2.3. Appliance installation

Inspection Item Judgment
Yes No
Ambient conditions
Ambient temperature: +5oC to +40oC □ □
Rel. humidity max 80%, non-condensing □ □
Mains voltage
Does the local mains voltage match the information on the nameplate? □ □

This document is subject to control by MEDICAL DEVICES AND BIOMATERIAL PLANT JOINT STOCK COMPANY (MEDEP). Controlled copies of this document are
on MEDEP Local Area Network or on paper with CONTROLLED stamp by the Quality Assurance Department. Use of uncontrolled documents is strictly prohibited.
 Protocol, PRT-76-xxx
INSTALLATION QUALIFICATION OF MEMERT INCUBATOR
DCN: 2019-xxx Rev: A Pg. 2 of 2

Mains voltage connected according to manufacturer specifications? □ □

4.2.4. Qualification assessment

 Damaged or missing parts
………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………
Yes No
The appliance is operational □ □
Corrective action necessary □ □

4.2.5. Judgement result

□ Pass: As a result of the installation qualification, we certify that this equipment is manufactured
and install, and the aforementioned inspection items are satisfied.
□ Fail: As a result of the installation qualification, we judge that this equipment is a disqualified
product, because it is not manufactured or installed properly.

5. REFERENCES / THAM KHẢO:

Equipment Qualification for generation 2012 appliances. IN series. B614.0312. MEMMERT GmbH + Co. KG,
91107 Schwabach, Germany.

Test performed by Date Signature

QC Engineer
Test performed by Date Signature

ME Engineer
Review by Date Signature

QC Team Leader
Review by Date Signature

QA Engineer
Approve by Date Signature

QA Deputy Manager

DOCUMENT REVISION HISTORY

Rev DCN No Initiated date Effective date Requestor Reason(s) for change
A 2019 - xxx Triet Nguyen Initial release.

This document is subject to control by MEDICAL DEVICES AND BIOMATERIAL PLANT JOINT STOCK COMPANY (MEDEP). Controlled copies of this document are
on MEDEP Local Area Network or on paper with CONTROLLED stamp by the Quality Assurance Department. Use of uncontrolled documents is strictly prohibited.