3. CLASSIFICATION AND COMPLIANCE
1) FT-500(R/L) is classified as ;
- Class 1 type-BF against electric shock
- Ordinary equipment without protection against ingress of water
- Equipment not suitable for use in presence of a flammable anesthetic mixture by standard of
IEC 60601-1(Safety of Medical Electrical Equipment)
2) FT-500(R/L) are complied with Class A for Noise-Emission, Level B for Noise-immunity, by
standard of IEC 60601-1-2(Electromagnetic Compatibility Requirements).
3) This blood pressure meter complies with the EN 1060-1 : 1995 Non-invasive
Sphygmomanometers general requirements as well as EN 1060-3 : 1997 supplementary
requirements for electro-mechanical blood pressure measuring systems.
4. SAFETY PRECAUTIONS
FT-500(R/L) is designed and manufactured with consideration given to the safety of the
operator and subject and also to the reliability of the unit.
The following precautions must be observed for additional safety ;
1) The unit must be operated only by, or under supervision of, a qualified person by JAWON
or his distributor.
2) FT series are specified as Class 1 type BF unit under the standard of IEC 60601-1(Safety
of Medical Electrical Equipment).
Therefore, patients must not touch or handle inner side of the system at any time.
3) Do not modify the unit. If any modification is desired, ask JAWON or its authorized dealer
for service.
4) The unit has been factory-adjusted for optimum performance.
Do not attempt to adjust any pre-controls or switches except those specified in this
manual for operation.
5) If you have experienced any trouble with the unit, switch it off immediately, and contact
JAWON or its authorized dealer for assistance.
6) If you plan to connect any device of other manufacturers electrically or mechanically to
this unit, contact JAWON or its authorized dealer for instructions before doing so.
When you connect computer or other system to the unit(RS-232C), the attached systems
should be certified by IEC 950 or equivalent standards for data processing equipment.
Configurations shall comply with the system standard IEC60601-1-1.
Everybody who connects additional equipment to the signal input part or signal output part
configures a medical system standard IEC 60601-1-1.
If in doubt, consult the A/S department of local distributor.
