Gima SEAL CHECKER User guide

Gima S.p.A.

ITALIANO

Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

www.gimaitaly.com

PROFESSIONAL MEDICAL PRODUCTS

SEAL CHECKER

User manual

ATTENTION: The operators must carefully read and completely understand the present manual before using the product.

ENGLISH

Seal Check manual

Introduction

The ISO 11607 - 2 is describing the IQ, OQ and PQ procedures
which are applicable to Medical Heat sealers. For Operational
Qualication (OQ) and daily testing of your sealing device
in accordance with EN ISO 11607-2 the Seal Checker can be used
as a indicator placed in between the layers of medical pouches
and seal it. By its unique printed pattern of the black area the
inspection of the seal and the detection of minor or bigger
problems are easily detected.

Procedure

Place the Seal Check inside a 20 cm wide pouch in between the
paper and the lm. The printed side should be facing the lm to be
visable at all times. Only the black printed area should be inside the
pouch enabling the operator to make notes on the designated area.

Switch on the heat sealer and let it heat up till the pre-set value.
(In most cases the heat sealer will be set in between 160 and
180 degrees Celsius depending on the pouch manufacturers
recommendations).

Heat seal the combination in a normal way once the heat sealer
has indicated it reached the pre-set temperature. Make sure the
seal is made over the dark part of the seal check.

Inspect the dark seal part of the seal check. The seal made should
be:

- Uniform without any distortion

- Without gabs or spots

In case of low sealing temperature, pressure or interruptions
of the seal the Seal Check will show it clearly by a lighter area
at the sealing area.

When the seal is been tested and ok, please ll in the related data
on the Seal check and place it in a folder for future references.

Now the heat sealer can be released for usage for the day.

Restrictions for use:

The Seal Check can only be used for Paper/Film pouches and rolls
to be tested. The Seal Check is not suitable for testing the Heat
sealer in combination with a Tyvek Pouch.

M-35957-M-Rev.0.12.17

35957

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy
Made in Turkey