Mesis PressoMedical 3.0 ZAM-03 Manual De Usuario página 53

j) The ISM (industrial, scientific and medical) bands between 0,15MHz and 80MHz are 6,765MHz to
6,795MHz; 13,553MHz to 13,567MHz; 26,957MHz to 27,283MHz; and 40,66MHz to 40,70MHz.
The amateur radio bands between 0,15MHz and 80MJz are 1,8MHz to 2,0MHz, 3,5MHz to 4,0MHz,
5,3MHz to 5,4 MHz, 7MHz to 7,3MHz 10.,1MHz to 10,15MHz, 14MHz to 14,2MHz, 18,07MHz
18,17MHz, 21,0MHz to 21,4MHz, 24,89MHz to 24,99MHz, 28,0MHz to 29,7MHz and 50,0MHz to
54,0MHz.
Table 8 – Patient coupling PORT
Phenomenon
ELECTROSTATIC
DISCHARGE c)
Conducted
diturbances induced
by RF fields a)
a) The following apply:
- All PATIENT-COUPLED cables shall be tested, either individually or bundled
- PATIENT-COUPLED cables shall be tested using a current clamp unless a current clamp is not suitable.
In cases were a current clamp is not suitable, an EM clamp Shall be used.
- No international decoupling device shall be used between the injection point and the PATIENT
COUPLING POINT IN any case.
- Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT
PROCESS.
- Tubes that are intentionally filled with conductive liquids and intended to be connected to a PATIENT
shall be considered to be PATIENT-COUPLED cables.
- If the frequency stepping skips over an ISM or amateur radio band, This applies to each ISM and amateur
radio band within the specified frequency range.
- The ISM(industrial, scientific and medical) bands between 0,15MHz and 80MHz are 6,765MHz to
6,795MHz; 13,553MHz to 13,567MHz; 26,957MHz to 27,283MHz; and 40,66MHz to 40,70MHz. The
amateur radio bands between 0,15MHz and 80MHz are 1,8MHz to 2,0MHz, 3,5MHz to 4,0MHz,
5,3MHz to 5,4MHz, 7MHz to 7,3MHz, 10,1MHz to 10,15MHz, 14MHz to 14,2MHz, 18,07MHz to
18,17MHz, 21,0MHz to 21,4MHz, 24,89MHz to 24,99MHz, 28,0MHz to 29,7MHz and 50,0MHz to
54,0MHz.
b) r,m,s., before modulation is applied
c) Discharges shall be applied with no connection to an artificial hand and no connection to PATIENT
simulation. PATIENT simulation may be connected after the test as needed in order to verify BASIC
SAFETY and ESSENTIAL PERFORMANCE.
Basic EMC standard
or test method
IEC 61000-4-2
IEC 61000-4-6
IMMUNITY TEST LEVELS
Professional healthcare facility environment
Not applicable
±8kV contact
±2kv, ±4kV, ±8kV, ±15kV air
Not applicable
3V b)
0,15MHz – 80MHz
6V b) in ISM bands between
0,15MHz and 80MHz
805 AM at 1kHz
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