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Doc. No.
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P30001PE0101-07
Other’s symbol
This symbol indicates a caution message (including danger
and warning). The mark inside the triangle specifies the type
of caution (the example on the left illustrates electric shock).
This symbol indicates actions that you should not perform.
Details are illustrated inside the symbol or near the symbol.
This symbol is used to restrict operations or to illustrate what
action should be performed. Details are illustrated inside the
symbol (the example on the left shows unplugging of an AC
plug from the wall outlet).
⚫
Do not use kits other than the MagDEA Dx reagent kits.
⚫
The magLEAD 12gC CANNOT be used as an accessory for any of following
diagnostic applications:
1) Determination of:
◆
blood groups: ABO system, rhesus (C, c, D, E, e), anti-Kell, anti-Duffy or
anti-Kidd
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irregular, anti-erythrocytic antibodies
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human cytomegalovirus and human chlamydia
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HLA tissue groups DR, A, or B
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PSA tumor marker
2) Detection, confirmation, or quantification of:
◆
markers of HIV infection (HIV-1 and 2), HTLV-I and II, and hepatitis B,
C, and D in human specimens
◆
congenital infections: rubella or toxoplasmosis in human samples
3) Diagnosis of the hereditary disease phenylketonuria
4) Evaluation of the risk for trisomy 21
5) Self-diagnosis from blood sugar measurements, including related
calibrations or controls.
6) Any other applications listed on the latest version of Class A(Sterile), B , C
and D of Annex VIII of Regulation (EU)2017/746.
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Do not use this instrument in a strong electric field or magnetic field.
⚫
Use of this instrument in a dry environment may cause erroneous results due to damage
from static discharge.
Caution