Service manual

iv Service Manual BSM-4100
In IEC 60601-1-2 Medical Electronic Equipment, Part 1: General Requirements for Safety, 2. Collateral
Standard: Electromagnetic compatibility-Requirements and test. Section 36. 202. 2 Radiated radio-frequency
electromagnetic fields, PATIENT COUPLED EQUIPMENT and/or SYSTEMS applicable IMMUNITY test
methods are under consideration at SC62A/WG13. The 3 V/m IMMUNITY level may be inappropriate
especially when measuring SpO
2
because physiological signals can be much smaller than those induced by
a 3 V/m electromagnetic field.
When measuring SpO
2
, various interference may produce false waveforms which look like pulse waveforms.
SpO
2
value and pulse rate may be measured from these false waveforms, causing the alarm to function
improperly.
When installing the monitor, avoid locations where the monitor may receive strong electromagnetic
interference such as radio or TV stations, cellular phone or mobile two-way radios.
WARNING
Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic
Equipment*
The bioelectric impedance measurement sensor of a minute ventilation rate-adaptive implantable pacemaker
may be affected by cardiac monitoring and diagnostic equipment which is connected to the same patient. If
this occurs, the pacemaker may pace at its maximum rate and give incorrect data to the monitor or
diagnostic equipment. If this occurs, disconnect the monitor or diagnostic equipment from the patient or
change the setting on the pacemaker by referring to the pacemaker’s manual. For more details, contact your
pacemaker distributor or Nihon Kohden distributor.
* Minute ventilation is sensed in rate-adaptive pacemakers by a technology known as bioelectric impedance measurement
(BIM). Many medical devices in addition to pacemakers use this technology. When one of these devices is used on a
patient with an active, minute ventilation rate-adaptive pacemaker, the pacemaker may erroneously interpret the mixture
of BIM signals created in the patient, resulting in an elevated pacing rate.
For more information, see the FDA web site.
http://www.fda.gov/cdrh/safety.html
NOTE about Waste Electrical and Electronic Equipment (WEEE) directive 2002/96/EEC
For the member states of the European Union only:
The purpose of WEEE directive 2002/96/EEC is, as a first priority, the prevention of waste electrical and
electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such
wastes so as to reduce the disposal of waste.
Contact your Nihon Kohden representative for disposal at the end of its working life.