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Chapter 12: Specifications
Installation altitude
Stability
12.7 Storage conditions
Temperature
Relative humidity
Atmospheric pressure
Maintenance of the built-in
battery
12.8 External connection options
12-10
Maximum installation altitude up to 3000 m
Maximum admissible inclination 5°
The device must be stored upright in a well-ventilated room with low
variations in temperature.
–20 °C to 60 °C
30% to 75%, temporarily 95%
500 hPa to 1060 hPa
On receipt of the device, charge the battery as follows:
– Use the power cable to connect the device to the power supply.
– Actuate the power switch to turn the device on.
– Leave the device on for 10 hours.
If the device is not used, repeat this procedure every six months.
Other additional equipment connected to this device must comply with
the applicable IEC or ISO standards (e.g., IEC 60950-1 for information
technology equipment).
Furthermore, all device configurations must comply with the
requirements specified by medical system standards (see chapter 16
and appendix I to EN 60601-1:2006).
Connecting the device to an IT network that contains components not
installed and validated by the manufacturer can introduce unknown
risks for patients, operators, or third parties. These risks must be
identified, analysed, evaluated, and monitored by the responsible
organisation. For assistance, refer to IEC 80001-1:2010 and
annexes H5 and H6 of EN 60601-1:2006.
Any modifications to an IT network that has been installed and validated
by the device manufacturer can introduce new risks and therefore
require a repeat analysis. Especially problematic activities include:
– Changes to the IT network configuration
– Connection of additional components and devices to the IT network
– Removal of components and devices from the IT network
– Updates or upgrades of components and devices in the IT network
Note that local laws take priority over the above-mentioned normative
requirements. Please address any queries to the local service support
organisation.
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
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