8 Safety Information
Vivo 40 clinician’s manual
Doc. 003886 En-Us A-1e
2 Safety Information
2.1 General User Precautions
• The Vivo 40 must be switched off and on at least once a day. This is neces-
sary in order for the Vivo 40 to perform a self test.
• U.S. Federal law restricts this device for sale by or on order of a physician.
• The Vivo 40 should not be used for any kind of total ventilatory require-
ment.
• The Vivo 40 shall only be used by patients with spontaneous breathing.
• Advice contained in this manual should not supersede instructions given by
the prescribing physician.
• If the patient is admitted to a hospital or is prescribed any other form of
medical treatment, always inform the medical staff that the patient is on
mechanical ventilation treatment.
• Vivo 40 must only be used:
– for the intended treatment in accordance with this operating manual and
with the instructions given by the responsible clinical personnel;
– in accordance with the operating conditions specified in this operating
manual;
– in original and unmodified shape and only with accessories specified or
approved by Breas Medical AB.
• Do not use the Vivo 40 in the event of suspected damage to the device,
unexplainable or sudden pressure, performance or sound changes during
operation, or if the delivered air from the Vivo 40 is abnormally hot or
emits an odor. Contact your responsible care provider for an inspection.
• Inadequate use of device or accessories may cause loss of treatment or
decreased performance.
• The Vivo 40 therapy settings must always be based on medical supervision
and must be changed by authorized clinical personnel only. Blood gas
measurement should be performed when changing settings or changing to
another device.
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