LOGIKODIGIT DM490, User Manual

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ENGLISH
EC REP
0197
S N
IIa Class Medical Device
According to directive 93/42/EEC and further modifications
1. CODES
DM490
Digital sphygmomanometer desk type, LCD display 3”
DM491 Digital sphygmomanometer desk type, LCD display 4”
DM492S Digital sphygmomanometer desk type, LCD display 4,8”
2. INTRODUCTION
Thank you for purchasing LOGIKO sphygmomanometer by Moretti S.P.A. product range. This user’s
manual provides some suggestions as how to correctly use the product you have chosen and gives
some valuable advice for your safety. Please read through the manual carefully before using the
product. Should you have any queries, please contact your retailer for advice and assistance.
In case of doubts, we recommend to contact the dealer who can help and advice you properly.
WARNING!
• Do not use the product for a purpose not indicated in this manual
• Moretti S.P.A declines all responsibilities for any consequences resulting from an
incorrect use of this product and from unauthorized alteration to the frame of the product.
• The manufacturer reserves the right to change the information contained in this
document without previous notice.
• This device is intended for non-invasive measuring of an adult individual's systolic,
diastolic blood pressure and heart rate using the oscillometric method.
• The device is not intended to use on infants and children.
• The device is designed for home or clinical use.
• All values can be read out in one LCD Display.
• Measurement position is on adult wrist only.
3. INTENDED USE
The digital sphygmomanometer wrist type is measurement device for systolic and diastolic blood
pressure.
4. REGULATIONS AND DIRECTIVE OF REFERENCE
The LOGIKO sphygmomanometer by Moretti S.p.A are in accordance to the following regulations:
This Blood Pressure Monitor complies with the European regulations.This blood pressure monitor
also complies with mainly following standards (included but not limited):
Safety standard:
EN 60601-1 Medical electrical equipment part 1: General requirements for safety
EMC standard:
EN 60601-1-2 Medical electrical equipment part 1-2: General requirements for safety- Collateral
standard: Electromagnetic compatibility- Requirements and tests
Performance standards:
EN ISO 81060 -1 Non-invasive sphygmomanometers - General requirements
EN 1060-3 Non-invasive sphygmomanometers - Supplementary requirements for
electromechanical blood pressure measuring systems.
EN ISO 81060 - 2 Non-invasive sphygmomanometers - Test procedures to determine the overall
system accuracy of automated non-invasive sphygmomanometers