Requirements For Life Supporting Treatment - Breas Vivo 45 LS User Manual

Ensure that the cooling air intake vents are not blocked. If the vents are blocked,
especially in hot use environments, the surface temperature of the patient circuit may
rise above 41°C (106°F). In a 40°C (104°F) environment and with the cooling air
intake vents blocked, surface temperatures as high as 50°C (122°F) can occur. Before
an unsafe temperature is reached, the "High Patient Air Temp" alarm will occur. If
this alarm occurs, assure that the ventilator cooling air intake path is free of obstruc-
tion and that the patient circuit surface is not heating the patient's skin.
WARNING!
Risk of Electric Shock
Modifying or using the ventilator with accessories that are not specified or approved
by Breas may cause cardiac arrhythmia.
The Vivo 45 LS must only be used in original and unmodified shape and only with
accessories specified or approved by Breas Medical.
Inadequate use of device or accessories may cause loss of treatment or decreased
performance.
CAUTION!
The Remote Start/Stop accessory is not to be used in Pediatric mode. Ensure that
the Remote Start/Stop is disconnected when entering Pediatric mode.
2.1.1

Requirements for Life Supporting Treatment

Life supporting-supporting treatment requires that:
• An emergency equipment (e.g. resuscitation bag) is available.
• One of the following means of surveillance is used:
– Using the EtCO
This surveillance method can be used for ventilation with active exhalation valve
circuits as well as leakage port circuits.
The CO
or leakage port to be able to measure exhaled gases. If using an external CO
monitor, it shall fulfil the ISO 80601-2-55 standard (Medical electrical equipment
– Particular requirements for the basic safety and essential performance of respi-
ratory gas monitors).
– Supervising the ventilator's monitoring of exhaled volume. This surveillance
method can be used for ventilation with leakage circuits only.
22 Safety Information
User manual
sensor accessory, or an external EtCO
2
sensor must be connected between the patient and the exhalation valve
2
monitor (capnometer).
2
2
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