Instructions for Use MPR1 DATALOGGER
Manufacturer:
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
Page 6 of 98
1 Safety-related information
Prior to using the DATALOGGER, please attentively read the entire instructions for use and familiarise
yourself with the operation of the appliance.
Prevent longer direct skin contact between patient and housing of the DATALOGGER.
In order to ensure safety, reliability and performance of the system, the following notes shall have to be
observed carefully:
Changes and modifications of the unit are not permitted.
•
The MPR1 DATALOGGER (hereinafter referred to as MPR1 for short) may be operated by qualified
staff only.
•
The MPR1 may be operated only with the specified mains power adapter, see chapter 11.1
•
Select only such wall outlet for the mains power adapter that is accessible to the user without difficulty.
Do not place the mains power adapter in a way that makes it difficult to disconnect the adapter from
the wall outlet.
•
To completely disconnect the MPR1 from the mains, disconnect the mains power adapter from the wall
outlet.
•
Prior to using the MPR1, you have to be completely familiar with the operation of the system.
•
The MPR1 may be used on one patient at a time only.
•
When the apparatus is switched on, a signal is sounded which is intended to check the alarm sounding
unit. If the signal is not sounded, the apparatus must not be used.
•
If two or more apparatuses with separate mains connections are used on the same patient, the
apparatus leakage current adds up which may cause a potential hazard. In this case, use shall be
permitted only, if it has been secured that patient and operator are safe, and that the requirements of
standard IEC 60601-1-1 are fulfilled.
•
Every person who connects an additional unit to the signal input or signal output configures a medical
system, and thus he / she shall be responsible for the fact that this system meets the requirements of
standard IEC 60601-1-1.
•
Simultaneous operation with other apparatuses connected to the patient may cause mutual influences
which may have an effect on the measuring results.
•
Note that in the event of different alarm pre-settings for the same or similar devices, which are used in
different hospital areas (e.g. ITS or the operating suite), the interchanging of settings can cause a
potential danger to patients. Therefore always check that the alarm settings are suitable for the patients
concerned prior to starting monitoring. (see chapter 4.3 Alarm limit selection)
•
If and when a defibrillator is used, short-time interferences of the signal shapes and values measured
may occur.
•
The apparatus can forward up to two invasive pressure signals to a downstream redundant monitoring
system. By means of the downstream system, it is possible to easily integrate the datalogger into a
central monitoring system. In the process special attention has to be given to the fact that only approved
systems from the listed accessories are connected. In case of every signal relaying, proceed as
rendered in the instructions for use of the MPR1: Establish the cable connection; check the signal
transmission; and set the alarm limits to the foreign system.
•
Prior to using the MPR1, the correct condition of the apparatus and any accessories shall have to be
checked. Check the plausibility of the readings before using the apparatus for monitoring. The
apparatus and the accessories must not be damaged or soiled; otherwise the apparatus must not be
used. Do not use the apparatus, if it reveals obvious signs of a wrong function; in this case forward the
unit to the after-sales service of the manufacturer.
•
In questions of servicing, please always get in touch with the manufacturer. The manufacturer will give
you a list of authorised service partners, if and when required.
This
document
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information
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