2 Prima 451 – User Manual
1. Warnings and Cautions
The following WARNINGS and CAUTIONS must be read and
understood before using this anaesthetic apparatus.
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The
Prima 451 MRI System* is validated for use in
proximity to the 1000 gauss line, with scanners rated at
1.5 tesla and 3 tesla, when used in compliance with user
instructions.
Users should, as a precautionary measure, make an
individual check of MRI suitability of any device within their
particular MRI facility before use.
*A typical Prima 451 MRI System is supplied only with the
following Penlon products:
A200SP MRI absorber (without heater), Sigma Delta MRI
vaporizer (Selectatec compatible), SC760 MRI suction
controller (high suction model), MRI anaesthetic gas
scavenging system (AGSS) receiver, AV-S MRI ventilator,
and Nuffield 200 MRI ventilator.
Special operational conditions apply to Prima 451 systems
with the AV-S MRI ventilator - see section 5.13 and
Appendix 5.
1. Although the Prima 451 MRI System is designed to
minimise the effects of ambient radio-frequency
interference, system functions may be adversely
affected by the operation of other equipment in the
vicinity.
If abnormal performance is observed, additional
measures may be necessary, such as using a shielded
location, or relocating the equipment.
2. The Prima 451 MRI has been designed for use in an
MRI environment only as a system (as listed above).
Objects placed on or in this machine that are not
designed for use with this anaesthesia system may
be strongly attracted to the magnet and may cause
serious injury or death when the machine is used in a
MRI scanning room.
3. It is the user’s responsibility to ensure that the MR
status of the Prima 451 MRI System is not compromised
by any modification:
a) Do not use an A200SP absorber that is fitted with a
heater unit
b) If a third-party accessory or device is mounted on
the machine (e.g. patient monitoring, or an AGSS
receiver, suction controller, or vaporizer from another
manufacturer) the user must check that:
(1) it is specifically labelled to be used in an MRI
scanning room, and MR compliant for your facility,
(2) it is securely mounted, and (3) it is installed by
trained engineering personnel.
c) In addition, do not assume that any individual
component of the Prima 451 MRI System (including
any Penlon accessories), can be safely used in a MR
facility when it is used on any other anaesthesia
system.
d) Contact Penlon Ltd for further information.
4. Always lock the front castors on this anaesthetic
machine when it is stationary in the MRI scanning
room.
a) Movement of the machine during an MRI procedure
may affect the image.
b) Magnetic forces between the scanner magnet and
the anaesthesia machine may cause unintentional
movement of the anaesthesia machine if the
castors are unlocked.
5. Use only non-magnetic cylinders with this machine.
Steel cylinders can cause serious injury or death if
brought into an MRI scanning room. See also Warning
13.
6. Pre-use checks:
a) As part of the pre-use check procedure (see also,
Warning 18), always check that the vaporizer,
ventilator, absorber, anaesthetic gas scavenging
system receiver, suction equipment, etc. are
securely mounted.
b) Remove test equipment from the MRI facility after
completion of the pre-use tests
c) On machines fitted with a drawer unit (section 3.1),
empty the drawer. Check all items and remove
anything metallic or with metallic content from the
MRI scanning room.
7. Maintenance or repair:
a) Remove the machine from the MRI facility before
commencing any service or repair procedure.
b) When contacting Penlon for technical advice or when
ordering spares, always state if the unit is used in a
MRI environment.
c) Do not fit replacement components from third-
party suppliers - use Penlon spares only.
d) After completion of service or repair work, check
that all tools, test/monitoring equipment, and
unused/replaced components are removed from
the machine before it is returned to the MRI facility.
e) If an individual device (e.g. ventilator, vaporizer,
absorber, AGSS receiver, suction controller) must
be removed for service or repair, make a note of the
serial number. When the device is refitted, check
the serial number against your recorded data.
8. Refilling the vaporizer in the MRI facility:
a) Do not bring any bottle or container of anaesthetic
agent into the MR facility unless it is specifically
labelled to be used in an MRI scanning room.
b) For Key-fill vaporizers (see section 5.1 in the Delta
vaporizer user manual) check that the key filler
adaptor is labelled MR Conditional.
c) Do not use an unlabelled, early-type key filler
adaptor that may have been brought to the MRI
facility from your hospital’s operating theatre.
If in doubt, refill the vaporizer in a suitable location
outside the MRI facility.
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