To transfer data to a PC, establishing a PC-connection via USB
is required. See section 4.2.3 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 connect to
a PC (IT equipment forming a system) ensure not to touch the
patient while operating the PC. Do not touch the patient and the
printer at the same time.
If the device is connect 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-series.
The device is not intended for operation in areas with an
explosion hazard. Do NOT use the device in a highly oxygen-
enriched environment, such as a hyperbaric chamber, oxygen
tent, etc. If the device is not used switch it off and disconnect
it from the power supply.
Never short-circuit the terminals.