SAVe II+ OPERATOR’S MANUAL > Page 4
Device Warnings
G
ENERAL
ALTERNATIVE VENTILATION –
Always have immediate access to an alternative
means of ventilation, which is ready to use, to reduce the possibility of patient death or
serious deterioration of health.
PATIENT MONITORING
– This ventilator is intended to be continuously attended by
an operator. Failure to be in close proximity to this ventilator can contribute to patient
death or serious injury. Such personnel should be prepared to troubleshoot alarms,
address equipment malfunctions and circumstances where equipment experiences
problems.
EXPIRED VOLUME & EXPIRATORY END-TIDAL CO
2
MONITORING
–This device
is not equipped with expired volume monitoring or CO
2
monitoring equipment for
measurement of the expiratory carbon dioxide concentration. The device must be
equipped with suitable expired volume monitoring or CO
2
monitoring equipment
(complying with ISO 80601-2-55) before being put into service.
EQUIPMENT COMPATIBILITY
- Do not add any attachments or accessories to the
ventilator that are not listed as intended for use in combination with the ventilator in the
instructions for use of the ventilator or accessory, as the ventilator might not function
correctly leading to the risk of patient death or additional serious deterioration of health.
For more information refer to www.automedx.com/accessories
PREVENTATIVE MAINTENANCE
- Failure to follow preventative maintenance
procedures could result in device malfunction. For more information refer to
NOT MRI COMPATIBLE
- Do not put the SAVe II+, any components, or accessories
inside an MRI machine.
STORAGE ENVIRONMENT -
Storage of the SAVe II+ outside the specified storage
environment may materially impact device performance and permanently damage
and/or shorten the life of the device.
TRANSPORT OF LITHIUM-ION BATTERIES
- Regulations govern the transportation
of lithium-ion batteries and devices that have lithium-ion batteries. Check the
appropriate statutes to ensure compliance before transporting the device and / or the
batteries.
UNCERTAIN POWER SOURCES / AUTOMOBILE POWER OUTLETS -
Verify the
SAVe II+ internal battery is in good condition and fully charged before connecting the
SAVe II+ AC power supply to uncertain power input sources. Connecting to an
improperly rated power source may damage the AC power supply, preventing the
SAVe II+ battery from charging.