Warnings And Precautions; Warnings; Precautions; Precautions For Monitoring The Patient During Transport - Sophysa PRESSIO 2 PSO-4000 Manual De Instrucciones

4. Warnings and Precautions

4.1. WARNINGS

– Only use the Monitor with Sophysa-supplied cables, Cath-
eters, and accessories from the Pressio
ucts.
– Do not use the Monitor if there are no trained personnel
available to provide continuous observation.
– Do not leave the Catheter in contact with conductive ele-
ments, including the ground.
– The Monitor must be correctly grounded to ensure the
safety of the patient and the operator. Reliability of the
grounding can only be achieved if the Monitor is connec-
ted to a ground electrode.
– There is a risk of explosion if used in the presence of in-
flammable anesthetics.

4.2. PRECAUTIONS

– The patient should only be monitored by trained and quali-
fied personnel.
– Move the patient with care in order to avoid disconnecting
any cables, or causing any movement of the implanted
Catheter.
– After moving the patient, check the connection of the
Catheter to the catheter extension cable, and the connec-
tion of the catheter extension cable to the Monitor.
– Do not perform maintenance or service operations during
monitoring.
– Do not use a Monitor that is damaged or has fallen. Return
it to Sophysa for analysis and repair.
– Do not use the Monitor beyond the period for which its
calibration is valid, which is displayed on the calibration la-
bel on the bottom panel of the Monitor.
– Do not access the battery when the Monitor is being used
on a patient.
– Do not place the Monitor or its cables in an MRI magnetic
field.
– Do not use a Monitor and the implanted Catheter at the
same time as a high frequency electro-surgical instrument
or a defibrillator. The Catheter and/or the Monitor could be
damaged or have their operation disrupted.

5. Description

The Monitor is packaged with the following items:
®
– Pressio 2 ICP Monitor (PSO-4000)
– Pole clamp (integrated into rear panel)
– Catheter extension cable (PSO-EC30)
– Power cable
– Battery
– Instructions for Use (NT500)
– Screwdriver for opening the battery cover
When unpacking, confirm that package contains all of the
above items, and that none of these items has been dam-
aged during shipping.
To monitor the patient's ICP and ICT, the Monitor must be
connected to a Catheter (supplied separately) using the cath-
eter extension cable.
The Monitor may be connected to a patient bedside monitor
(not supplied by Sophysa) which centralizes the measure-
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®
2 range of prod-
– The Monitor has been tested and is compliant with the
standard IEC 60601-1-2. However, electromagnetic inter-
ference could occur in specific situations. If the Monitor
causes electromagnetic interference or is subject to it, the
user may be able to resolve the situation in the following
manner:
– Power off the Monitor and power it on again.
– Reorient or move the Monitor in relation to other equip-
ment.
– Connect the Monitor to a mains power source that is not
connected to the other equipment.
– Contact Sophya Customer Service at contact@sophy-
sa.com, or contact your local distributor.
– The USB stick can only be used in the patient's environ-
ment (within reach of the patient) if it is compliant with one
of the following standards: IEC60601-1, IEC60950-1 or
IEC62368-1.
4.3. PRECAUTIONS FOR MONITORING THE PATIENT
DURING TRANSPORT
To monitor the patient during transport, disconnect the ca-
bles between the Monitor and the patient bedside monitor.
The Monitor may be transported with the patient for continu-
ous monitoring during transport without a patient bedside
monitor.
The Monitor automatically switches to battery power when it
is disconnected from mains power.
NOTICE
Firmly attach the Monitor to the patient's bed during
transport to minimize the risk of the Monitor falling, to
avoid disconnecting any cables, or causing any move-
ment of the implanted Catheter.
After transport, reconnect the Monitor to the patient bedside
monitor using the appropriate cables (temperature and pres-
sure), and then recalibrate the patient bedside monitor.
ments from various medical devices. If the Monitor is con-
nected to a patient bedside monitor, the ICP and ICT meas-
urements are transmitted to the patient bedside monitor via
the pressure cable (PSO-MCxx) and the temperature cable
(PSO-MCT-y) (supplied separately).
The Monitor must only be used in a professional healthcare
facility (intensive care unit, resuscitation room and operating
room).