Use Instructions

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MasterScope - Instructions for Use
Version 03.00 • Date 19FEB2020
Maintenance
No part of the medical device may be replaced by the customer.
Use only ERT approved accessories and spare parts for this medical device.
If applied parts (e.g. handle/Sensor Unit) have been exposed to extreme
mechanical stress, a function test (e.g. calibration check) has to be performed. If
function is lost, the defective part is to be replaced. Damaged parts, e.g. frayed
plugs, receptacles, pressure regulators, a damaged handle, and defective cables
should be replaced immediately by an authorized specialist or engineers of the
ERT Customer Care. The device must not be opened. If it is opened without
authorization the guarantee entitlement expires. The ERT Customer Care is always
at your disposal with help and assistance in case of
problems.
Before turning on the device/system you should always check whether power
cable, power plug, outlet and power input of the device as well as modem cable
are free from defects.
Additional preventive inspection/maintenance except the daily visual check before
turning on the device/ system is not required. The ERT PT is precalibrated by the
manufacturer and therefore it is not required to perform a volume calibration
before starting a spirometry measurement. Further safety-related checks are not
necessary to be performed within the product life-cycle of 7 years if the following
is assured:
• the unit has not been mechanically stressed in the extreme (e.g. the cable is
made defective by running over it with a heavy object or dragging it)
• no liquid got inside the unit
• the handle and its cable are not damaged/the Sensor Unit is not damaged
• cables and/or multiple connectors are not defective
• coverings are not broken
• rubber connectors don’t show cracks
If there are any technical problems or doubts regarding the reliability of the
product contact ERT Customer Care. Additional national regulations have to be
considered where appropriate.
Children should not get into contact with disposables, accessories and packing
material and cleaning and disinfection substances.
Recurrent Test
Medical Electrical equipment needs a recurrent testing and testing after repair of
the equipment according to EN 62353.
The calibration syringe itself has to be calibrated at regular intervals as determined
by the manufacturer and as indicated on the syringe. The calibration syringe must
be checked for an accuracy of ± 12 mL.
Recycling
Adhere to the national law of the country when disposing the medical device and
its accessories.
Improper disposal of the device and/or its accessories can result in serious
environmental hazards.
General Safety Precautions