Specifications Concerning Alarms - Sophysa PRESSIO 2 PSO-4000 Manual De Instrucciones

Externalization specifications to a PC
Item Specification
Refreshing
Output range
Unit
ICT output to a PC
Resolution
Refreshing
Internal history specifications
Item Specification
Mode1
Mode2
History format
Real time data
Average data
Data saved ICP, ICT, events
Max number of
characters
Event
Max number of
events
History of exports and imports specifications
Item Specification
USB stick
Media Format
Max. output voltage
PDF file
History of averages
Exportable internal
history format
History of real time
data
Exported data ICP, ICT, events
History of averages
Importable history
format
History of real time data
Specifications for pole clamp fixation
Item Specification
Orientability 4 positions, engaging at 90-degree intervals
Vertical pole
Fixation Support
Horizontal rail
Vertical pole: diameter of 10 mm to 60 mm
Fixation diameter
Horizontal rail: diameter of 20 mm to 60 mm
Material Aluminum
Safety specifications
Item Specification
Class I
Page 30 of 174
10 ms
+20.0 °C to +45.0 °C
+68.0 °F to +113.0 °F
Celsius/Fahrenheit
0.01 °C/0.01 °F
1 s
24 h of data in real time +
14 days of average data
15 days of data in real time
Interval of 10 ms
Interval of 1 s (Storage of the
displayed value)
50 characters per event
200 events per history life
FAT32 format
+5 Vdc
Interval of 20 s for the
ICP and ICT. Encrypted
file
Interval of 10 ms. En-
crypted file
Example: IV pole
Example: bed rail
Safety specifications
Item Specification
Input Type BF
IP41
Protection index
Operation mode Continuous
History of averages
Importable history
format
History of real time data
High cut-off capacity fuse: LITTELFUSE
Protection against
021502.5MXESPP (215SP T2.5A/250V, single
short-circuits
cap pigtail, axial leaded, 5 x 20 mm)
The Monitor complies with the following standards:
– IEC60601-1:2005/AMD1:2012
– IEC60601-1-8:2006/AMD1:2012
– IEC60601-1-6:2010
– IEC60601-2-49:2016
– NF EN ISO 80601-2-56:2017
– IEC 60601-1-2:2014 4th Edition (EN 60601-1-2:2015)
– CAN_CSA-22.2 No.60601-1:2008
– CAN_CSA-22.2 No.601.1.2
– IEC62304:2006
– UL 60601-1_1:2006
– IATA DGR – International Air Transport Association Dan-
gerous Goods Regulation
Restarting monitoring following a power cut or powering off
Battery ICP and
status ICT moni-
toring
Power OK Conserved Conserved Conserved Conserved
cut
Power Flat Stopped
cut
Monitor OK or Stopped
powered flat
off

17.2. SPECIFICATIONS CONCERNING ALARMS

The Monitor generates two types of visual/audible alarms:
– Physiological alarms which alert the personnel that the
average ICP or/and the average ICT has exceeded the
alarm thresholds.
– Technical alarms which warn the personnel there is a prob-
lem with the Monitor itself or the Catheter.
ICP/ICT
4: Protected against solid
bodies of more than 1 mm
1: Protected against drip-
ping water equivalent to
1 mm rainfall per minute.
Restarting Restarting Restarting
ICP and ICP moni- ICT moni-
ICT moni- toring on toring on
toring patient patient
monitor monitor
Yes No. Reca- Yes
libration
necessary
Yes No. Reca- Yes
libration
necessary