6
3. CLASSIFICATION AND COMPLIANCE
1) This device 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
EN 60601-1:2006(Safety of Medical Electrical Equipment)
2) This device is complied with Class A for Noise-Emission, Level B for Noise-immunity, by
standard of IEC 60601-1-2:2007(Electromagnetic Compatibility Requirements).
3) This device is complies with the EN 1060-1: 1995+A2:2009 Non-invasive
Sphygmomanometers general requirements as well as EN 1060-3: 1997+A2:2009
supplementary requirements for electro-mechanical blood pressure measuring systems.
4. SAFETY PRECAUTIONS
This device is designed and manufactured with consideration of safety of the operator and
subject and also to the reliability of the unit.
The following precautions must be observed for additional safety;
This device is designed and manufactured with consideration of 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 with our
company or our distributors.
2) This device is specified as Class 1 type BF unit under the standard of EN 60601-
1:2006 (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 needed, ask our company or its authorized
dealer for service.
4) The unit has previously been adjusted in the factory for optimum performance.
Do not attempt to adjust switches or any other things except those specified in this
manual for operation.
5) If you have experienced any trouble with the unit, switch it off immediately, and contact
our company or its authorized dealer for assistance.
6) If you plan to connect any device of other manufacturers electrically or mechanically to
the unit, contact our company 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 those certified by IEC 950 or equivalent standards for data
processing equipment.
Configurations shall comply with the system standard EN 60601-1:2006.
Everybody who connects additional equipment to the signal input part or signal output
part configures a medical system standard EN 60601-1:2006.
If in doubt, consult the A/S department of local distributor.
7) Avoid the following environments for storage;
- Where the ambient temperature falls -20°C or exceeds 60°C.
- Where the atmospheric pressure falls below 70kPa (700mbar) or exceeds 106kPa
(1060mbar).
- Where the humidity is over 95% non-condensing.
- Where the unit is exposed to spray or splashing water.
