Reporting Of Serious Incidents; Danger Safety Messages; Warnings; System Warnings - GE Portrait Hub01 User Manual

Safety and intended use
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Reporting of serious incidents

Any serious incident related to the use of this product should be reported to both the
manufacturer and the health authority/competent authority where the product is
installed.
To report to GE, contact your local service representative or report to
In-box.complaints@ge.com.
Please provide the following information:
The catalogue number or the model designation of the product as stated on its
●
identification plate affixed on the product
The SystemID/serial number/lot number of the product
●
Date of incident
●
Description of incident, including any patient or user impact/injury
●
Your contact information (facility, address, contact name, title, and telephone
●
number)

Danger safety messages

No danger safety messages apply to this system.

Warnings

System warnings

WARNING
WARNING
WARNING
WARNING
22
Explanation
Type BF (IEC 60601–1) defibrillator-proof protection against electric shock.
Isolated (floating) applied part suitable for intentional external and internal
application to the patient, excluding direct cardiac application.
Type CF (IEC 60601-1) defibrillator-proof protection against electric shock.
Isolated (floating) applied part suitable for intentional external and internal
application to the patient including direct cardiac application.
BURN INJURY. To avoid burn injuries, do not disconnect the
sensor battery and leave the Wearable SpO
attached to the patient while performing defibrillation.
Keep sensor batteries connected to sensors or remove the
Wearable SpO
2
Do not allow defibrillation patches to come into contact with
conductive portions of the Wearable SpO
EXPLOSION. Do not use this system in the presence of
flammable anesthetics, vapors or liquids.
EXCESSIVE LEAKAGE CURRENT. Do not use a multiple socket
outlet or extension cord in a medical electrical system.
FIRE. To avoid the risk of fire, do not expose the Hub or sensor
batteries to high temperatures.
Portrait ™ Mobile Monitoring Solution
or RR Parameters completely from the patient.
or RR Parameter
2
or RR Parameters
2
5815148-01