Smiths Medical Pneupac babyPAC 100, User Manual

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504-2056A 5
SECTION 1 SUMMARY STATEMENT
The babyPAC 100 portable ventilator is designed for use in and outside hospitals. It is particularly
suitable for ventilation during transportation and for the resuscitation of neonates and infants up to a
bodyweight of 20 kg.
The babyPAC ventilator consists of a single compact control module with a conventional Y patient
circuit. It is a gas powered pressure generator ventilator with pneumatic and electronic alarm
systems.
Before use for the first time, all potential users should familiarise themselves with the machine and
its operation to enable them to use it effectively. They should study the contents of this Manual to
the extent required to supplement their training. Special attention must be paid to warnings and
precautions which are summarised in section 1(b). Failure to observe these warnings and
precautions could compromise patient safety. Special guidance on the operation and use of the
ventilator is given in section 4 of this manual and basic operating instructions are provided on the
label affixed to the control module.
WARNING:
The equipment should only be used by medical personnel who have a full
understanding of the techniques required for its use, or paramedical personnel who
have received full and proper initial and 'refresher' instruction from a qualified
person on detailed use of the equipment in the situations in which it is likely to be
employed. Information given in this manual beyond the basic operation of the
ventilator is only intended as a guide to supplement proper medical training and to
indicate the specific operational requirements of the babyPAC ventilator.
The babyPAC ventilator is intended only for use in transport and emergency situations where the
patient is being constantly monitored by the carer. The integrated alarm unit is intended to alert the
carer to changes in the patient’s ventilation but it cannot ensure that the patient’s blood gases are
maintained at the required level. Therefore, patient monitoring devices e.g. a pulse oximeter and
other recommended devices, should additionally be used where appropriate.
(b) Warnings and Precautions
The following Warnings and Precautions highlight aspects of the use of the babyPAC ventilator that
require particular emphasis. The section of this manual referenced in each clause provides the
relevant context.
WARNINGS
1. Warning: Operator skill and training (Section 1(a))
The equipment should only be used by medical personnel who have a full understanding of
the techniques required for its use, or paramedical personnel who have received full and
proper initial and 'refresher' instruction from a qualified person on detailed use of the
equipment in the situations in which it is likely to be employed. Information given in this
manual beyond the basic operation of the ventilator is only intended as a guide to supplement
proper medical training and to indicate the specific operational requirements of the babyPAC
ventilator.
2. Warning: Use of Oxygen (Section 3(a))
Oil, grease or combustible lubricants, other than those approved for oxygen service, must
never be allowed to come into contact with the parts of the ventilator, oxygen regulator or
cylinder. Particular care should be taken to avoid any trace of contamination around the
oxygen inlet and outlet ports. Oil or Grease readily oxidise and in the presence of oxygen will
violently burn.