Page 11 - DUOKOPT BIBLIOBOOK

USABILITY
EFFICACY

USABILITY TESTING REPORT FOR MEDICAL DEVICE.

TIM (TRANSPARENCE ET INFORMATION DU MÉDICAMENT)

(According to ISO IEC 62366:2007) Jun 2013

ABSTRACT

PURPOSE: Easiness of use and easy handling of the bottle.

METHODS: 40 participants (20 French and 20 English), 40% of men and 60% of women. 10% < 40
years old; 30% > 40 and < 60; 60% > 60 years old. Face to face interviews with a questionnaire after
test of the Duokopt® bottle.

STUDY CRITERIA: Handling.

RESULTS: 92% of the participants considered that the opening was easy or very easy.
The participants handled the medical device correctly. They didn’t meet any difficulties to place their
fingers and they expressed a feeling of natural position of the fingers and the facility to manipulate
the device.

Difficult 8% Difficult 0%

Easy Easy
25% 35%

Very easy Very easy
67% 65%

Figure 2: General perception on the Figure 3: General perception on the
opening of the bottle handling of the bottle

Most of the right‐handed participants considered the application into the left eye as easy as into the
right eye. Only 1 participant experienced difficulty to administer the drops into the left eye.

CONCLUSIONS: The opening of bottle is easy. The 2 tabs helped the patients to put the fingers cor-
rectly on the device. Participants handle the device and apply the drops correctly and easily into both
eyes.

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