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Mindray DPM 1 Manual de servicio Pagina 24

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Specifications
Pulse oximeter Service Manual 3-4
Spillage and
ingress of liquid:
The oximeter meets the requirements of IEC 60601-1-1, clause 44.3 and
of IEC 60601-27, clauses 30 and 34. It shall also meet the IEC 529
requirements for IPX0 devices.
Surface
temperature:
The oximeter meets the requirements of IEC 60601-1, clauses 42.1，
42.2 and 42.3.
The oximeter meets the requirements of FDA Reviewer Guidance for
Premarket Notification Submission, November 1993, paragraph i7.
Mechanical
stability:
The oximeter meets the requirements of IEC 60601-1, clause 24.1.
Incompatibility with
external connectors
The oximeter meets the requirements of IEC 60601-1, clause 56.3 and
of FDA Reviewer Guidance for Premarket Notification Submission
November1993, i2.
Enclosure rigidity
and strength
The oximeter meets the requirements of IEC 60601-1, clause 21a，16a
and 21b.
The oximeter meets the requirements of UL 2601-1, clause 55.
Deterioration of
heat radiation
conditions
The oximeter meets the requirements of IEC 60601-1, clause 52.5.5.
Leakage current The oximeter meets the requirements of IEC 60601-1/EN 60601-1,
Clause 19.
Dielectric strength The oximeter meets the requirements of IEC 60601-1/EN 60601-1,
Clause 20.
3.9 EMC
The oximeter shall meet the requirements of IEC 60601-1-2.
Radiated emission The oximeter meets the requirements of CISPR 11 （EN 55011:1998）
Group 1, Class A.
Conducted
emission
The oximeter meets the requirements of IEC 61000-4-6, Level 2,
150KHz to 80MHz, 3V
rms
, 80% AM @ modulation frequency significant
for the equipment under test
Immunity to
radiated RF
electromagnetic
fields
The oximeter meets the requirements of IEC 61000-4-3, 80MHz to
2.5GHz, 3V/m, 80% AM @ 2 Hz or modulation frequency significant for
the equipment under test.
ESD The oximeter meets the requirements of IEC 61000-4-2.
Immunity to Power
frequency magnetic
fields
The oximeter meets the requirementsIEC 61000-4-8.
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