Use Instructions

Page 216/233
MasterScope - Instructions for Use
Version 03.00 • Date 19FEB2020
Portable RF communication equipment (transmitters) (including their accessories,
such as antenna cables and external antennas) should be operated with a
minimum distance of 30 cm (21 inch) to the MasterScope’s components and cables
specified by the manufacturer. Non-observance may lead to a reduction of the
device’s performance.
Ambient Conditions
The medical device must not be operated in rooms or in the presence of flamm-
able anaesthetic mixture with air or flammable anaesthetic mixture with oxygen or
nitrous oxide. The medical device must be operated in rooms where only non-
conductive pollution occurs; however, occasional temporary conductivity due to
condensation is to be expected. The medical device is designed for operation in
medically used rooms.
The medical device has to be effectively protected against moisture. Ventilation
slots must be kept free of obstructions in order to enable air circulation.
Interfaces
Only optional devices or external devices approved by ERT are allowed to be
connected to the interfaces.
The physician/operator must not touch any voltage-carrying parts and the subject
at the same time.
Only connect the ethernet cable (RJ-45) of the device to the network connection.
Only connect the modem of the device to an analog telephone network (max.
60V).
Putting the Unit into Operation
Always consult the nameplate on the device/system for compliance of the unit’s
own data with those of the local power supply system (mains voltage and mains
frequency) before actually connecting the unit.
Connect only if all data comply!
Inspect the mains connection cable, plug, and receptacle for visible damages prior
to establishing the connection. Damaged cables or plugs must be replaced
immediately. Installation and assembly of the device must be done only in
compliance with this Instructions for Use.
After the first setup or if the setup has been changed (e.g. exchanging of the
pneumotach), a function test (e.g. calibration) has to be performed.
To separate the device from power supply, disconnect the plug from electricity grid.
The device contains no unit to separate it from the power supply.
It must be ensured that no risk of stumbling/tripping is caused by cables connected
to the device.
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
Medical Supervision
A qualified physician must reassess all measurements. An interpretation by the
medical device is significant only when considered together with other clinical
findings. During the measurement the subject must not be unattended. The
performance of the spirometer can be affected by the subject spitting or coughing
into the spirometer during expiration or by extremes of temperature, humidity and
altitude.
General Safety Precautions