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DANA AUTO SETTER DUAL Manual

DANA AUTO SETTER DUAL Manual

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Summary of Electromagnetic Compatibility Test
Basic EMC standard
Phenomenon
or test method
Electrostatic
EN 61000-4-2: 2009
Discharge
IEC 61000-4-2: 2008
Immunity
EN 61000-4-3: 2016+
Radiated RF
A2:2010
Electromagnetic
IEC 61000-4-3: 2006+
Field Immunity
A1:2007+A2:2010
Immunity to
Proximity Fields
EN 61000-4-8: 2010
from RF wireless
IEC 61000-4-8: 2009
Communications
Equipment
Power Frequency
EN61000-4-8: 2010
Magnetic Field
IEC 61000-4-8: 2009
Immunity
Explanation of Universal Symbols
Follow Instruction for Use
Caution! Refer to safety-related notes in
the manual accompanying this instrument
Manufacturer
Date of manufacture
Lot Number
Keep dry
Sooil Development co., Ltd
IFU-390-EN (rev.9_230313)
62, Yonggu-daero 2325 beon-gil, Giheung-gu,
Yongin-si, Gyeonggi-do, 16922, Republic of Korea
Tel: +82 2 3463 0041 / Fax: +82 2 3463 7707
MT Promedt Consulting GmbH
Ernst-Heckel-Straße 7, 66386 St. Ingbert, Germany
8
809220
582929
>
Tel: + 49 6894 581020 / Fax: +49 6894 581021
Port
Test
Operating
Test level/requirement
tested
Voltage
mode
±8Kv/ Contact
Injection
±2, ±4, ±8,
Enclosure
DC 3.6V
mode
±15Kv/Air
10V/m
Injection
Enclosure
DC 3.6V
80MHz – 2.7GHz
mode
80% AM at 1kHz
Injection
Table 9 in
Enclosure
DC 3.6V
mode
IEC 60601-1-2:2014
30 A/m
Injection
Enclosure
DC 3.6V
mode
50Hz & 60Hz
CE Marking
European Authorized
Representative
Disposal (WEEE marking)
Direct current
International Protection code
Dustproof degree: 2
Waterproof degree: 0
Medical Device

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Summary of Contents for DANA AUTO SETTER DUAL

  • Page 1 Summary of Electromagnetic Compatibility Test Basic EMC standard Port Test Operating Phenomenon Test level/requirement or test method tested Voltage mode Electrostatic ±8Kv/ Contact Injection EN 61000-4-2: 2009 Discharge ±2, ±4, ±8, Enclosure DC 3.6V mode IEC 61000-4-2: 2008 Immunity ±15Kv/Air EN 61000-4-3: 2016+ Radiated RF 10V/m...
  • Page 2 It must be used with DANA Diabecare Insulin Pump. Enter the“Refill”menu on your ※The “DANA Auto Setter Dual” is referred to as “Auto Setter” in this Instructions for Use. Cannot transfer the value insulin pump to get the value from to the insulin pump.