Reprocessing Lnstructions; Scope; Product Classification; Decontamination - Sibelmed S3000 Manual Del Usuario

With the gray syringe model (Option 2), and for your calibration
of Sibelmed spirometers, use the included calibration adapter
(code 09497), as shown in the previous figure.
When the syringe is not in use, place the plug provided in the
outlet port to keep the syringe internal volume clean and free of
contaminants.

Reprocessing lnstructions

Scope

This guidance is directed to personnel responsable Cleaning and
mantaining SIBELMED calibration syrynges.

Product classification

The syringe is considered Class I according to Medical Device
Directive 93/42/EEC.
SIBELMED calibration syringes are supplied clean, non sterile.
Calibration syringes fall into the non-critical device category based
on potential risk of infection. Non-critical equipment should be
kept visibly clean with soap and water or an intermediate level
disinfectant. This device will not come into contact with patients
therefore disinfection or sterilization is no required.

Decontamination

SIBELMED calibration syringes are not required to be disassembled
in the field for cleaning or disinfection. Without proper training
and equiprnent the precise components of these syringes could
be damaged in the disassembly/reassembly process. These
calibration syringes should be returned to SIBEL S.A.U. once a
year for maintenance and recalibration.
lt is the responsibility of the user (health care personnel) for
ensuring that: the cleaning methods recommended by SIBEL
S.A.U. can be duplicated in their environment, that appropriate
tools, and replacement parts are available and that instructions
provided in this user's manual are followed correctly.
User's manual S3000 User's manual S3000 EN 16 EN16
512-300-MUM • REV. 2.01