GE Portrait Hub01, User Manual

Page: 22 / 198

Safety and intended use
Symbol 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.
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
BURN INJURY. To avoid burn injuries, do not disconnect the
sensor battery and leave the Wearable SpO
2
or RR Parameter
attached to the patient while performing defibrillation.
Keep sensor batteries connected to sensors or remove the
Wearable SpO
2
or RR Parameters completely from the patient.
Do not allow defibrillation patches to come into contact with
conductive portions of the Wearable SpO
2
or RR Parameters
WARNING
EXPLOSION. Do not use this system in the presence of
flammable anesthetics, vapors or liquids.
WARNING
EXCESSIVE LEAKAGE CURRENT. Do not use a multiple socket
outlet or extension cord in a medical electrical system.
WARNING
FIRE. To avoid the risk of fire, do not expose the Hub or sensor
batteries to high temperatures.
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Portrait ™ Mobile Monitoring Solution
5815148-01