Use Instructions

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MasterScope - Instructions for Use
Version 03.00 • Date 19FEB2020
General Safety Precautions
Contraindications and possible adverse effects:
According to ‘‘ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION
TESTING’’ (ERS Journals Ltd 2005) performing lung function tests can be physically
demanding for a minority of subjects. It is recommended that subjects should not
be tested within 1 month of a myocardial infarction.
In the S2 guideline “Spirometry” (German Airway League, German Respiratory
Society and German Society of Occupational and Environmental Medicine,
2015), contraindications of spirometry are divided into absolute and relative
contraindications:
Absolute contraindications for Forced Maneuvers
Acute, life threatening diseases of every description, e.g.
• Acute Myocardial Infarction
• Acute Fulminant Pulmonary Embolism
• Large Ascending Aortic Aneurysm
• Tension Pneumothorax
Relative contraindications for Forced Maneuvers
• Massive Pneumothorax (within the first weeks)
• Abdominal or Thoracic Surgery (depending on the findings 1 to 4 weeks
post-operatively)
• Surgery of the Eyes, Brain, or Ears (variable, consultation with the surgeon)
• Special care must be taken when dealing with Hemoptysis of unknown origin
Cleaning and Hygiene
Prior to every application, all parts which come in contact with the subject and
which are intended for reuse must be cleaned or disinfected (unless otherwise
instructed).
Prior to taking measurements on a subject, his/her medical history is to be
checked in order to avoid a contamination of the device and a resulting cross-
contamination of the next subject.
While performing a calibration check, a new disposable Pneumotach must be used
to prevent cross-contamination between the calibration syringe and the parts. This
will prevent contamination of the syringe and allow for its reuse.
Always be sure to disconnect the devices/systems from the mains power before
cleaning or disinfecting. The Charging Station corresponds to protection class IP21,
the Wireless Spirometry Sensor Unit to class IP20.
The device may not be soaked in liquid of any kind. Liquid inside the device/system
may lead to harm of the user and can destroy the device. The device can be
cleaned with a damp (but not soaked) cloth, which does not produce lint.
More detailed information can be found under “Hygiene“ in this Instructions for
Use. Chemicals required for operation or care of the unit must always be stored,
prepared, and made available in specially marked vessels to prevent any accidental
use.