Directions For Use - Sibelmed S3000 Mode D'emploi

research centers, and by manufacturers of respiratory systems.
SIBELMED syringes are used by trained staff to perform the
calibration procedures on the spirometers or other equipment
under test.
Warning: It's very important that the operator performing the
calibration with the syringe is trained. Otherwise measurement
errors can be introduced in the spirometer.

Directions For Use

For detailed information contact SIBEL S.A.U.
The SIBELMED syringe is typically used to calibrate spirometers
and has a volumen of 3 liters. Its accuracy is +-0.5%.
Standards and recomendations:
• Medical device regulation (EU) 2017/745: CE Mark Class I
• ATS / ERS 2005: Miller et al. Task force: Standardisation
of Lung Function Testing. Standardisation of Spirometry.
Eur Respir J 2005: 26:319-338
• EN 15223-1:2016: Medical devices - Symbols to be used
with medical device labels, labelling and information to be
supplied
- Part 1: General requirements.
• EN 1041:2008 + A1:2013 Information supplied by the
manufactures of Medical Devices.
• S I B E L
EN ISO 13485:2016+AC:2018, EN ISO 9001:2015 and
EN ISO 14971:2019
Three liters are confirmed when the piston rod pulled all the way
out and it stops at the zero position.
SIBELMED syringe has been calibrated sealing the locking collar.
Therefore, it must never be moved under normal use.
Confirm that the connection between the syringe output port
and the device under test is leak free.
Volume calibration of the spirometer is performed with the syringe
by actuating !he piston rod from the zero position to the output
volume. The output volume is confirmed when the locking collar
stops at zero position.
User's manual S3000 User's manual S3000
s y s t e m q u a l i t y
EN 16 EN 16
c o n f o r m s
512-300-MUM • REV. 2.02
w i t h