English 3
2. Preliminary Remarks
Compliance
Compliance with European Directive 93/42 EEC for Medical Products
The device conforms to the following requirements: European Directive 93/42
EEC for Medical Products; Medical Products Act; European Standards for
Electrical Medical Equipment EN 6060-1 (General Safety Provisions), EN
60601-2-30 (Particular Requirements for the Safety of Automatic Cycling
Indirect Blood Pressure Monitoring Equipment), EN 60601-1-2 and EN 55011
(Electromagnetic Compatibility); European Standards pertaining to Non
Invasive Blood Pressure Instruments EN 1060-1(General Requirements),
prEN 1060-3(Supplementary Requirements for Electrome-chanical Blood
Pressure Measuring Systems). The above is evidenced by the
mark
of conformity accompanied by the reference number to the involved notified
body. This device is designed for adults only.
Definitions
SYS
Systolic Blood Pressure
DIA
Diastolic
Blood
Pressure
PUL
Pulse
Exhaust
This means “releasing the cuff air as soon as possible”.
Constant exhaust
This means, “releasing the cuff air at a constant
depressurization rate”.
Batteries
Use alkaline batteries (LR6 type, AA type, Mignon) or equivalent batteries.
Do not mix new and used batteries.
Remove the batteries if the device will not be in use for a prolonged period of
time as the batteries may leak and cause a device malfunction.
A Defective Sphygmomanometer
Stop the examination immediately if the device does not work properly. Please
attach a note with the following "Do not use this sphygmomanometer " to
prevent any further use. This defective device should be stored in a safe place
to avoid any misuse until it has been sent for repair.
