Operation Manual MA 25/MA 25e
MA 27/MA 27e
8104818 Rev. 4
9
19/10/2017
To transfer data to a PC, establishing a PC-connection via USB
is required. See section 4.2.5 on how to safely establish a
connection with a power supplied PC or laptop (medical
device/non-medical device) or to a battery-driven laptop.
This equipment is intended to be connected to other
equipment thus forming a Medical Electrical System.
External equipment intended for connection to signal input,
signal output or other connectors shall comply with the
relevant product standard e.g. IEC 60950-1 for IT equipment
and the IEC 60601-series for medical electrical equipment.
In addition, all such combinations
– Medical Electrical
Systems
– shall comply with the safety requirements stated
the general standard IEC 60601-1, edition 3, clause 16. Any
equipment not complying with the leakage current
requirements in IEC 60601-1 shall be kept outside the
patient environment i.e. at least 1.5 m from the patient
support or shall be supplied via a separation transformer to
reduce the leakage currents. Any person who connects
external equipment to signal input, signal output or other
connectors has formed a Medical Electrical System and is
therefore responsible for the system to comply with the
requirements. If in doubt, contact qualified medical
technician or your local representative. If the device is
connected to a PC (IT equipment forming a system) ensure
not to touch the patient while operating the PC.
If the device is connected to a PC (IT equipment forming a
system) assembly and modifications shall be evaluated by
qualified medical technician according to safety regulations
in IEC 60601.
The device is not intended for operation in areas with an
explosion hazard.
Never short-circuit the terminals.
To avoid the risk of electric shock, this equipment must only
be connected to the medical power supply originally
delivered by MAICO. Using another power supply can also
lead to electrical damage on the device.
In order to maintain a high level of safety and to ensure the
device works properly, it is necessary to have the device and
its power supply checked according to the medical electrical
safety standard IEC 60601-1 by a qualified service technician
at least once a year. For more information see section 3.2.
The use of non-calibrated devices can lead to incorrect test
results and is not advisable.
Prevent cable breakage: cables must not be bent or buckled.
WARNING
WARNING
WARNING
CAUTION