Instructions for Use MPR1 DATALOGGER
Manufacturer:
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
Page 86 of 98
10 Electromagnetic compatibility
The MPR1 devices fulfil the EMC requirements in accordance with IEC 60601-1-2:2007, if the use of the
mains adapter REF 284007-002 is specified on their type plate. If the mains adapter REF 284027-001 is
used, the requirements of IEC 60601-1-2: 2007 continue to be fulfilled.
The MPR1 devices fulfil the EMC requirements according to IEC 60601-1-2:2014, if the use of the mains
adapter REF 284027-001 is specified on their type plate and this is also specified is used. If the mains
adapter REF 84007-002 is used differently, only the requirements of IEC 60601-1-2:2007 are fulfilled.
10.1 Manufacturer's declaration on the EMC requirements according to IEC 60601-1-2:2014
The device meets the requirements of IEC 60601-1-2:2014. The essential performance will be fulfilled.
10.1.1 Accuracy under the influence of electromagnetic interference phenomena
Essential performance under the influence of electromagnetic interference phenomena is defined as
follows:
Port
Measuring
point
Display parameter
Allowable variation
Additional display
parameter
P1, P2, P3*)
ICP
ICP
±2 mmHg
ICPA
ART
SAP, DAP, MAP
-40 ... 100 mmHg: ± 4
mmHg
100 … 360 mmHg: ± 4 %
---
T1, T2*)
T
Temp
15 ... 25 °C: ±0.4 K
25 ... 37 °C: ±0.2 K
37 ... 39 °C: ±0.1 K
39 ... 45 °C: ±0.2 K
---
*) The catheter is placed in the water and dimmed during the tests.
10.1.2 General information
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operating normally.
Use of accessories other than those specified in chapter 0 could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the MPR1, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Avoid therapeutical microwave devices or similar units in the vicinity of the device.
Interference frequencies of 14 and 27 MHz can trigger interruptions in the communication between RFID
reader and pressure measuring implant.
Simultaneous operation with other devices connected to the patient may cause mutual influences which
may have an effect on the measuring results.
If the amplitude of the physiological signal from the patient lies below the minimum amplitude and/or the
values given in section 11.1 Technical data, device use could lead to inaccurate results.
This
document
is
for
information
only
