SP3 USA User Manual_SP 2 User Manual.qxd

SP3 USA User Manual_SP 2 User Manual.qxd
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Prima SP3
Anaesthetic Machine Range
User Manual
Partnership for Life
IMPORTANT
Servicing and Repairs
In order to ensure the full operational life of
this anaesthetic machine, servicing by an
engineer trained by the manufacturer should
be undertaken periodically.
The machine must be serviced to the
schedule detailed in section 6.4.
Details of these service operations are given
in the Prima SP3 Service Manual, available
only for engineers trained by the
manufacturer.
For any enquiry regarding the servicing or
repair of this machine, contact Penlon Inc.:
Penlon Inc.
11515 K-Tel Drive
Minnetonka
MN 55434
Always give as much of the following
information as possible:
1.
2.
3.
4.
5.
Type of equipment
Product name
Serial number
Approximate date of purchase
Apparent fault
(i)
FOREWORD
This manual has been produced to provide
authorised personnel with information on the
function,
routine
performance
and
maintenance checks applicable to the Prima
SP3 anaesthetic machine range.
The Importance of
Patient Monitoring
WARNING
Anaesthetic systems have the capability to
deliver mixtures of gases and vapours to the
patient which could cause injury or death
unless controlled by a qualified anaesthetist.
Information contained in this manual is
correct at the date of publication.
The policy of the manufacturer is one of
continued improvement to its products.
Because of this policy, the manufacturer
reserves the right to make any changes
which may affect instructions in this manual,
without giving prior notice.
There can be considerable variation in the
effect of anaesthetic drugs on individual
patients so that the setting and observation
of control levels on the anaesthesia systems
does not in itself ensure total patient safety.
Anaesthesia system monitors and patient
monitors are very desirable aids for the
anaesthetist but are not true clinical
monitors as the condition of the patient is
also dependent on his respiration and the
functioning of his cardio-vascular system.
Personnel must make themselves familiar
with the contents of this manual and the
machine’s function before using the
apparatus.
IT IS ESSENTIAL THAT THESE ELEMENTS
ARE MONITORED FREQUENTLY AND
REGULARLY
AND
THAT
ANY
OBSERVATIONS ARE GIVEN PRECEDENCE
OVER MACHINE CONTROL PARAMETERS
IN JUDGING THE STATE OF A CLINICAL
PROCEDURE.
Before using any monitoring system or
device with the anaesthetic machine, the
user must check that it conforms to the
relevant standard, as listed in the table
below.
Parameter / Device
Relevant Standard
Pressure Measuring
Pressure Limitation Device
Exhaled Volume Monitor
Breathing System Integrity Alarm System
Continuing Pressure Alarm
Oxygen Monitor
Carbon Dioxide Monitor
Breathing Circuit
Gas Scavenging
Vaporizers
Ventilators
Agent Monitor
ISO 8835-2
EN 60601-2-13:2006
EN 60601-2-13:2006
EN 60601-2-13:2006
EN 60601-2-13:2006
ISO 7767
ISO 9918
ISO 8835-2
ISO 8835-3
ISO 8835-4
ISO 8835-5
ISO 11196
-
51.101.1
51.101.4
51.101.5
51.101.6
For information on installing and connection of any of these systems or devices, please refer to the relevant manufacturer’s instructions.
(ii)
CONTENTS
Page No.
USER RESPONSIBILITY
1
1.
WARNINGS AND CAUTIONS
2
2.
PURPOSE
4
DESCRIPTION
Framework and General Construction
Gas Circuit
Gas Circuit Schematic
5
5
5
6
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
Gas Supply Safety Devices
Mechanical Anti Hypoxic Device (AHD)
Pressure Gauges
Flowmeters and Controls
Vaporizers
Common Gas Outlet (CGO)
Electrical Power Supply
Auxiliary Gas Outlets
A200SP Absorber
AV-S Ventilator
7
8
8
9
10
10
11
13
13
13
4.
SPECIFICATION
14
4.1
Physical Dimensions
14
4.2
Gas Supplies
15
4.3
Flowmeters
15
4.4
Gas Pressures
16
4.5
Auxiliary Gas Outlets
16
4.6
Oxygen Failure Warning Devices
16
4.7
Oxygen Flush
16
4.8
Mechanical AHD System
17
4.9
Environmental
17
4.10
Electrical Supply
17
4.11
Device Classification and Labelling
18
5.
PRE-USE CHECKS
19
5.1
Pre-use Check List
19
5.2
Pre-use Checks - Gas Supply
21
5.2.1
Gas Pipeline Supplies
21
5.2.2
Gas Cylinder Supplies
21
5.2.3
Flowmeters
22
5.3
Vaporizers
23
5.4
Electrical Supply
24
3.
3.1
3.2
(iii)
CONTENTS
5.5
Patient Breathing System
25
5.6
Leak Rate Check - Low pressure gas System
28
5.7
Oxygen Flush
28
5.8
Anaesthetic Gas Scavenge System (AGSS)
28
5.9
Ventilator
29
5.10
Alarm System Testing
30
6.
6.1
6.2
6.3
USER MAINTENANCE
Cleaning and Sterilisation
A200SP Absorber
Service Schedule
31
32
33
APPENDIX
Disposal at end of useful life: risk assessment
Accessories
34
35
(iv)
USER RESPONSIBILITY
This anaesthetic machine has been built to
conform with the specification and operating
procedures stated in this manual and/or
accompanying labels and notices when
checked, assembled, operated, maintained
and serviced in accordance with these
instructions.
Statements in this manual preceded by the
following words are of special significance:
To ensure the safety of this device it must be
checked and serviced to at least the
minimum standards laid out in this manual.
A defective, or suspected defective, product
must not under any circumstances be used.
The user must accept responsibility for any
malfunction which results from noncompliance with the servicing requirements
detailed in this manual.
WARNING
means there is a
possibility of injury to
yourself or others.
CAUTION
means there is a possibility
of damage to the apparatus
or other property.
NOTE
indicates points of
particular interest for more
efficient and convenient
operation.
Always take particular notice of the
warnings, cautions and notes provided
throughout this manual.
Additionally, the user must accept
responsibility for any malfunction which may
result from misuse of any kind or noncompliance with other requirements detailed
in this manual.
Worn, broken, distorted, contaminated or
missing components must be replaced
immediately. Should such a repair become
necessary it is recommended that a request
for service advice be made to Penlon Inc.
This device and any of its constituent parts
must be repaired only in accordance with
written instructions
issued by the
manufacturer and must not be altered or
modified in any way without the written
approval of the manufacturer. The user of
this equipment shall have the sole
responsibility for any malfunction which
results from improper use, maintenance,
repair, damage or alteration by anyone other
than the manufacturer or Penlon Inc.
USA and Canadian Federal Law restricts the
sale and use of this device to, or on the order
of, a licensed practitioner.
1
1. WARNINGS AND CAUTIONS
Free-standing vaporizers may be
accidentally
tipped,
resulting
in
excessive and uncalibrated volumes of
anaesthetic drug entering the breathing
system
The
following
WARNINGS
and
CAUTIONS must be read and
understood before using this anaesthetic
apparatus.
Do not install or connect any vaporizers
of any description between the Common
Gas Outlet (CGO) and the breathing
system unless they are specifically
designed for such use.
(If this is done, the oxygen flush flow will
pass through the vaporizer and may
result in gross overdosage when the
flush valve is operated.)
WARNINGS
1.
This apparatus is designed for use only
with non flammable anaesthetic agents.
It must not be used with or in close
proximity to flammable anaesthetic
agents, due to a possible fire or
explosion hazard.
2.
Exterior panels must not be removed by
unauthorised personnel and the
apparatus must not be operated with
such panels missing.
7.
On machines with an electrical power
supply, unauthorised personnel must
not attempt to access fuses or other
electrical components. There is a
possible electric shock hazard.
3.
4.
Because breathing systems require
frequent cleaning and disinfection they
are not a permanent part of the
anaesthetic machine and therefore
cannot be directly under the control of
the anaesthetic machine manufacturer.
No oil, grease or other flammable
lubricant or sealant must be used on any
part of the machine in close
proximity to medical gas distribution
components.
There is a risk of fire or explosion.
However, we strongly recommend that
only breathing systems which have been
approved and authorised by Penlon for
use with the Prima SP range should be
employed.
This is particularly important when
mechanical ventilation is employed.
When attaching cylinders of medical
gases ensure that the machine yoke and
cylinder faces are dust free and clean
and that the sealing washer provided is
in position between the cylinder valve
and the yoke.
Tighten the yoke securely before
opening the cylinder valve. Dust and dirt
presents a fire hazard in the presence of
high pressure gas.
Leakage of high pressure gas
cause serious injury.
5.
8.
When
mechanical
ventilation
is
employed the patient breathing system
must be connected directly to an overpressure relief valve to prevent the
possibility of barotrauma.
9.
Always perform a pre-use check of the
machine,
including
vaporizers,
ventilator, circle absorber and monitors
before clinical use. Follow the pre-use
checklist (see section 5) as a minimum
requirement.
Many clinical incidents occur because of
a failure to check for correct function.
10.
The machine must not be used if any of
the alarm, monitoring or protection
system devices are not functioning
correctly.
11.
The gas supply failure systems within
the anaesthetic machine will not
necessarily operate as indicated in the
user manual during any procedures that
are outside the scope of the indications
for use of the machine:
can
Anaesthesia
apparatus
must
be
connected to an anaesthetic gas
scavenging system (AGSS) to dispose of
waste gas and prevent possible health
hazards to operating room staff.
This requirement must be observed
during test procedures as well as
during use with a patient.
6.
The breathing system which conveys
gases from the anaesthetic machine to
the patient and disposes of expired
gases is a vital part of the anaesthetic
delivery system.
Prima SP series machines must only be
used with Delta vaporizers (or other
vaporizers
approved
by
the
manufacturer) installed by means of the
Cagemount or Selectatec system.
2
WARNINGS AND CAUTIONS
(A) Machine set to deliver Air only
When the machine is operated with an Air
flow only, note that there may still be
retained oxygen in the system, and that the
visual O2 alarm will continue to indicate
green, even though oxygen is not being
delivered.
17.
CAUTIONS
(B) Machine set to deliver Oxygen only
through Auxiliary Outlets
The oxygen failure alarm is designed to
operate during normal use of the machine,
i.e. when providing controlled
concentrations and flows of gases to a
patient breathing system, as described in
Section 2 (Purpose).
Do not use the machine solely to provide
large flows of oxygen, via the anaesthetic
machine auxiliary outlets, to external
devices which may not be equipped with a
supply failure alarm.
12.
13.
The machine must not be fitted with
more than four operator accessible
mains socket outlets. There is a risk of
an excessive leakage current.
The use of antistatic or electrically
conductive breathing hoses is not
recommended
when
using
high
frequency electrical surgery equipment
(e.g. Diathermy). Burns
may
be
caused.
14.
Before any electrically powered machine
is used clinically for the
first time,
check that the hospital engineering
department has carried out an earth
continuity test.
15.
Before using any additional electrical
equipment powered by the auxiliary
sockets on the machine, check that the
additional equipment is correctly wired
and is earthed through its plug.
A missing or defective protective earth
conductor may increase earth leakage
currents to the patient to values
exceeding the allowable
limits,
resulting in ventricular fibrillation, or
interference with the pumping action of
the heart.
16.
Prima
SP2/3
series
anaesthetic
machines are not MRI compatible.
Additional equipment placed on the top
shelf must be securely attached.
Take care when moving a fully loaded
machine, particularly when negotiating
ramps.
Check that hoses or power leads are not
trailing on the floor.
3
1.
Flowmeter needle valves are designed to
seal with light torque and may be damaged
if tightened excessively.
Do not force the control knob past either the
fully open or fully closed positions.
2.
Open cylinder valves slowly to avoid
damage to pressure reducing valves.
Ensure that cylinder valves are at least one
full turn open when in use.
3.
Under no circumstances should anaesthetic
agents be used for cleaning purposes.
4.
After use, always disconnect the machine
from the piped gas supply and/or close the
gas cylinder valves.
5.
Mechanical AHD system - The oxygen flow
control is restricted to prevent the needle
valve from fully closing. This ensures a
minimum basal flow of oxygen.
DO NOT attempt to close the flow to zero.
Do not overtighten.
6.
Compressed gas supplies must be clean
and dry.
7.
When the auxiliary gas outlets are in use on
a machine with cylinder supply only, or if
the pipeline supply is not in use, check flow
rate requirements, and ensure that
adequate back-up cylinders are available.
8.
The requirements of IEC 60601-1-1 apply to
any device connected to the auxillary
sockets. Users must be aware of the risks of
increased
leakage
currents
when
equipment is connected to the auxillary
power sockets
9.
In the event of malfunction of any device
powered by the auxiliary sockets, check if
the circuit breaker has tripped.
10.
On machines with pipeline connections,
note that a malfunction of the central gas
supply within your facility may cause
immediate cessation of gas delivery and
total anaesthesia system failure.
2. PURPOSE
The Prima SP3 anaesthesia workstation
range is intended to provide controlled
concentrations and flows of anaesthesia
gases into a patient breathing system, from
where the anaesthesia ventilator and
breathing circuit will then deliver this fresh
gas mixture to the patient
Use the Prima SP3 in conjunction with
anaesthetic vaporizers, breathing hoses and
patient connection fittings which comply with
the relevant ISO standard or equivalent.
Depending upon the patient circuit selected,
the machines can be used in open, semiopen, semi-closed or closed circuit
configurations.
The range has been designed to give a wide
choice of configurations and accessories,
including:
Gas supplies
Up to four gases - oxygen, nitrous oxide, and
air, with optional fourth gas (see section 4).
Pin-index cylinder yokes, and provision for
up to three pipeline supply inlets.
Vaporizer mounting systems
Backbar manifold for Selectatec Compatible,
or Cagemount type vaporizers.
Anti-hypoxic Device (AHD)
The mechanical AHD system is designed to
minimise the risk of a hypoxic mixture
reaching the patient (see section 3).
4
3. DESCRIPTION
3.1 General Construction
Frame
The machine has a cast aluminium base,
extruded aluminium uprights, with aluminium
and plastic panels.
1
Mobility
Four castors are fitted, with a brake on each
of the front castors. The castors are five
inches diameter.
A footrest is built into the front of the
machine and, to aid manoeuvrability, two
handles are provided.
Pipeline Inlets (1)
Up to three, rear mounted pipeline gas inlets
can be fitted.
Pipeline supply hoses are connected by
non-interchangeable,
screw
threaded
unions.
Mounting posts and brackets
A mounting system is built into each side
upright, to allow the use of pole-mount
brackets, V-brackets, and ventilator
mounting brackets.
The pole mount upright can be used to
mount an A200SP Absorber assembly.
CAUTION
A malfunction of the central gas supply within
your facility may cause immediate cessation of
gas delivery and total anaesthesia system failure.
Work surfaces
The work surface has raised edges to retain
instruments, vials etc.
A pull-out writing tablet is mounted under the
work surface.
3.2
Filters
To prevent dirt entering the gas system,
cylinder yokes and pipeline inlets are fitted
with filters.
Gas Circuit
Gas Inlet Block
Each individual cylinder or pipeline supply,
is routed through a separate gas block.
Each gas block has an integral high
pressure gauge tapping for direct mounting
of a pressure gauge, and a non-return valve
to prevent back flow of gas.
In addition, cylinder gas blocks have a
diaphragm pressure regulator to reduce the
pressure of the compressed gas supply, and
a pressure relief valve, factory set to 517
kPa (75 psi). This prevents pressure build up
under the diaphragm should any leakage
develop across the reducing valve seat.
Gas Circuit Schematic
A gas circuit schematic is shown on the
following page.
Gas Supplies
A variety of cylinder and pipeline
combinations can be added to the basic
specification of oxygen and nitrous oxide
cylinder and pipeline supply.
For example, two extra gas cylinders
(choose from one additional oxygen, one
additional nitrous oxide, one air), and one
extra pipeline supply - Air.
Cylinder Yokes
The yokes are rear mounted and conform
with ISO standards for pin-index fitting.
To ensure that only cylinders of the
appropriate gas may be installed the yokes
are designed so that the retaining latch
cannot be closed unless the index pins are
fully engaged.
Secondary Pressure Regulator
A second stage regulator reduces the
pressure supplied to each flowmeter control
(see section 4).
The fitment of a secondary regulator for
oxygen and nitrous oxide enhances the
performance of the mechanical AHD system.
Secondary regulation of the air supply aids
the stabilisation of the output at the
flowmeter.
5
USA specification threegas machine with dual
cascade oxygen and
nitrous oxide flowmeters.
Air
O2
N2O
Flowmeter
Assembly
Gas Tray
O2
Pneumatic pressure
source
N 2O
Air
Gas cut-off valve
(normally open)
Flowmeter
Vaporizer
Pressure gauge
Reservoir
Pressure regulator
Pressure relief valve
Oxygen flush valve
Pneumatic on/off
switch
Audible alarm
Flow control valve
(variable)
Restrictor
Filter
Non-return valve
Power take-off point
(or test point)
Visual indicator
6
DESCRIPTION
3.3 Gas Supply Safety Devices
3.3.1
Gas Supply Cut-off Device
A gas cut-off device, triggered by low oxygen
supply pressure, cuts the supply of nitrous
oxide, and carbon dioxide or other fourth gas
(if fitted).
The cut-off operates when the oxygen
pressure falls to 200 ± 14 kPa (29 ± 2 psig).
1
Gas supplies are reinstated only when the
oxygen supply pressure rises above 227
kPa (33 psig).
3.3.4
3.3.2
Oxygen Supply Failure Warning
Whistle
Oxygen Supply Visual Indicator
WARNING: Refer to WARNING 11 (section 1).
The indicator (1) is mounted on the front of
the machine and is operated from the
oxygen supply and shows GREEN when the
supply is at working pressure, and RED if the
pressure falls.
WARNING: Refer to WARNING 11 (section 1).
A whistle gives an audible warning when
there is a reduction of oxygen supply
pressure.
Operated solely by the remaining oxygen in
the machine system, the warning whistle is
prolonged by an oxygen reservoir built into
the gas circuit, allowing a minimum warning
whistle of 7 seconds duration.
3.3.5
Mechanical AHD
A mechanical link between the oxygen
control valve and a needle valve in the
nitrous oxide flow ensures that the machine
delivers a fresh gas mixture with a minimum
30% (±3%) oxygen, irrespective of the flow
of nitrous oxide set by the anaesthetist.
With the nitrous oxide control valve fully
open, the oxygen and nitrous oxide flows are
then both controlled by the oxygen control
valve.
The whistle will start to sound when the
pressure falls to 200 ± 21 kPa (29 ± 3 psig),
and will continue to sound until the pressure
falls to approximately 70 kPa (10 psig).
Oxygen consumption of the whistle is
approximately 2 L/min when sounding and
nil at other times.
See section 3.4 for a full description
3.3.6
Low Pressure Gas Tubing
Diameter-indexed tubing is used for the low
pressure gas system - see section 4.
3.3.3 Fresh Gas Pressure Relief Valve
A pressure relief valve is mounted between
the vaporizer back bar and the common gas
outlet (CGO) on the inside face of the
machine right hand upright.
It is designed to prevent fresh gas being
delivered to the breathing system at
pressures exceeding 41 kPa (6 psi).
This valve also protects machine
components against excessive pressure in
the event of a total blockage of the CGO.
7
DESCRIPTION
3.4 Mechanical AHD
limits the flow of nitrous oxide relative to the
flow of oxygen set by the user.
Note that this needle valve acts as the
primary nitrous oxide valve, and is actuated
only by movement of the oxygen control.
(Anti Hypoxic Device)
3.4.1 Introduction
The Mechanical AHD is housed within the
flowmeter module and comprises a gear
linkage between the oxygen control valve
and a needle valve in the nitrous oxide flow.
The nitrous oxide control knob on the
flowmeter module operates a secondary
needle valve in the nitrous oxide flow. It is
positioned downstream of the primary valve
and therefore is used only to restrict the flow
already set by the primary valve, which itself
has been determined by the position of the
oxygen control knob.
Therefore, for any oxygen flow set by the
user, the mixture delivered will still contain a
minimum 30% ±3% oxygen even with the
nitrous oxide control knob fully open.
As the nitrous oxide knob is progressively
closed, the oxygen content of the mixture
increases to 100%.
The system controls the relative flow rates of
oxygen and nitrous oxide.
A
predetermined
minimum
oxygen
concentration of 30% ±3% in the oxygen /
nitrous oxide mixture is maintained over the
flow range to prevent delivery of a hypoxic
mixture.
3.4.4
Oxygen Basal Flow
To allow the system to function correctly, an
oxygen basal flow is continuously supplied.
1
Single Flow Tubes:
3.4.2
Gas Delivery Switch (1)
Dual Cascade System Flow Tubes:
50 - 75 ml/min
The Gas Delivery Switch (1) operates on the
oxygen supply and must be in the ‘On’
position for normal operation of the
anaesthetic machine.
Switch labelling:
1
0
100 - 200 ml/min
This basal flow can only be turned on and off
by using the Gas Delivery Switch.
CAUTION
The oxygen control is restricted to prevent the
needle valve from fully closing. This ensures a
minimum oxygen basal flow.
DO NOT attempt to close the flow to zero. Do not
overtighten the knob.
Indicates On
Indicates Off
The switch consequently controls the supply
of all gases provided with a gas cut-off
triggered by a predetermined pressure level
within the oxygen supply (see section 3.3.1).
A whistle (oxygen failure warning whistle)
will sound briefly whenever the gas delivery
switch is turned on or off. Note that the
whistle functions continuously if the oxygen
supply fails (see section 3.3.2).
3.5
Pressure Gauges
Pressure gauges (50 mm diameter) are
located on the front panel below the
flowmeter bank.
The gauge for Air is positioned between
oxygen and nitrous oxide. Unused gauge
positions are blanked out.
All pressure gauges are colour coded and
labelled for the gases whose pressures they
are indicating.
Cylinder gauges are marked: CYLINDER.
Pipeline gauges are marked: PIPELINE.
The gauges are calibrated in kPa x 100.
NOTE
The switch also controls the electrical supply to
the optional flowmeter lighting unit.
3.4.3
Gear Linkage and Nitrous Oxide
Control Valves
A gear linkage connects the oxygen control
knob on the flowmeter module and a needle
valve in the nitrous oxide flow. This linkage
8
DESCRIPTION
3.6
Flowmeters and Controls
3.6.1
All models
The flowmeters, mounted behind the perspex
cover on the left hand side of the machine, are
length-indexed to prevent inadvertent, incorrect
installation.
Read flow at
this level
All floats indicate flow rate in line with the upper
surface as shown below.
Each flow control valve is positioned directly
underneath the flow tube assembly to which it
corresponds, and the control knob is colour-coded
for the gas which it controls.
The oxygen flow control knob is made physically
distinguishable from the other flow controls for
identification by touch in accordance with ISO
standards.
When fitted, air and carbon dioxide flowmeters are
always installed in the inner positions on the
flowmeter assembly. These positions are blanked
out if air or carbon dioxide are not specified for the
machine.
The gas delivery switch (see 3.4.2), positioned on
the front panel controls the supply of oxygen and
must be in the ON position for normal operation of
the machine.
Flow control of each gas is achieved by a needle
valve comprising a polished stainless steel needle
mounted concentrically in a common manifold
block. To minimise wear and material pick-up the
needle seat is manufactured from silver. The flow
control knob is turned counter-clockwise to
increase the gas flow.
CAUTION
Needle valves are designed to seal with light torque and
may be damaged if tightened excessively.
DO NOT USE EXCESSIVE FORCE.
3.6.2
Dual Cascade Flow Tubes
The flow of gas through dual cascade system flow
tubes always flows through the low-flow tube first.
The high-flow tube should not show any flow until
more than 1 L/min is set.
At flows above 1 L/min, the high-flow tube reading
indicates the rate of flow for that gas.
3.6.3
Auxiliary Oxygen Flowmeter
An oxygen flowmeter (1), with outlet, is mounted to
the left of the machine flowmeter bank.
9
1
DESCRIPTION
3.7
3.7.3
Vaporizers
Vaporizers fitted with cagemount tapers
have the male taper (inlet port) on the left,
and the female taper on the right (viewing
the front of the vaporizer).
CAUTION
Read the instruction manual supplied with the
vaporizer before clinical use.
3.7.1
Vaporizer Mounting Systems
Vaporizers for the administration of volatile
anaesthetic agents can be fitted as follows:
(a)
(b)
Cagemount Vaporizer
It is recommended that detachable
cagemount connectors are retained with a
safety clip (catalogue number 52275) to
prevent inadvertent disconnection.
Penlon Delta Selectatec compatible
vaporizers, mounted on a Selectatec
compatible universal backbar.
Penlon Delta Cagemount vaporizers
mounted on a Modura rail (check that
relevant national standards for your
country allow fitment of more than one
cagemount type vaporizer).
3.8
WARNING
Vaporizers must always be securely mounted,
and never used free-standing.
Unmounted vaporizers may be accidentally
tipped resulting in uncalibrated and excessive
volumes of liquid anaesthetic drug entering
the breathing system.
Common Gas Outlet (CGO)
1
Vaporizers of any description must not be
installed or connected between the Common
Gas Outlet (CGO) and the Breathing
System, unless they are specifically
designed for such use. (If this is done, the
oxygen flush flow will pass through the
vaporizer, and severe overdosage may
result).
The outlet (1) can be located at the front or
rear of the machine, and has a 22 mm male
taper and concentric 15 mm female taper.
The male taper incorporates the Penlon
Safelock system designed
to prevent
accidental disconnection of the breathing
system.
3.7.2 Selectatec Compatible Vaporizer
Selectatec compatible vaporizers, (e.g. the
Delta with the Selectatec connector block),
may be mounted on a universal back bar
manifold.
Two- and three-station
manifolds are
available, with each station fitted with two
valve capsule assemblies for vaporizer
connector block attachment.
2
When a vaporizer is installed on a station the
valves on that station open automatically to
allow gas flow into and out of the vaporizer.
Removal of the vaporizer from the station
closes the valves on that station.
Selectatec compatible vaporizer interlock
systems are described in the literature
supplied with the vaporizer.
Oxygen Flush
An emergency oxygen flush valve button (2)
is mounted at the font of the machine and is
marked ‘O2 FLUSH’.
Depressing the button provides a delivery of
between 35-75 litres/min of oxygen through
the common gas outlet (1).
Releasing the button allows the springloaded valve to return to its normal position.
10
DESCRIPTION
3.9
Electrical Power Supply
3.9.1 Mains Power Supply
Power is fed to the machine via the mains
lead, to power an optional auxiliary output
panel, and/or lighting system.
Mains Power Indicator
The warning lamp (1) is illuminated, when
mains power is connected.
NOTE
a) It is the user’s responsibility to ensure that the
total sum of leakage currents from additional
equipment plugged into the auxiliary sockets plus
the leakage current from the machine does not
exceed the values specified in any relevant
national standards that may apply in the country
where the machine is in use (see also, below)
b) Each socket is protected with a 5 A fuse in both
the live and neutral wire.
3.9.2
C A B
Auxiliary Power Supply Sockets
CAUTION
The requirements of IEC 60601-1-1 apply to any
device connected to the auxiliary sockets. Users
must be aware of the risks of increased leakage
currents when equipment is connected to the auxiliary power sockets.
2
The optional mains electricity outlet panel is
fitted to the rear of the machine.
The supply is controlled by an ON/OFF
switch (2), which also incorporates a circuit
breaker.
Switch labelling:
I indicates On
0 indicates Off
CAUTION
In the event of malfunction of any device powered
by the auxiliary sockets, check if the circuit breaker has tripped.
3.9.3
1
3
Current Leakage
Flowmeter Bank Lighting
The lighting system is controlled by a threeway switch (3).
The three positions denote:
A: Off
B: Bright light
C: Dim light
11
DESCRIPTION
3.9.4
Ventilator Power Supply
The mains lead for an AV-series ventilator
can be plugged into one of the auxiliary
power sockets on the rear of the machine.
AV-S with interface link to Prima SP3
a)
b)
c)
Turn the machine Gas Delivery Switch (1)
ON.
The ventilator will power-up.
While the Prima SP3 power is ON, the
Ventilator can be turned OFF and ON, using
the ventilator On/Off switch.
Turn the Gas Delivery Switch to OFF.
The ventilator will power-down.
1
For further information, refer to section 3.6 in the
AV-S user manual.
AV-S Ventilator Back-up Battery
If the power supply to the ventilator fails, the
ventilator back-up battery will power the
ventilator for 30 minutes, if the battery has
been maintained in a fully charged condition.
Refer also to the user instruction manual
supplied with the ventilator
Battery charging takes place automatically
when the ventilator mains lead is connected
to a ‘live’ mains supply.
The OFF indicator on the ventilator front
control panel will show a yellow light during
charging.
NOTE
The stated battery back-up period will only be
available if the battery is kept fully charged.
If the battery has been allowed to discharge
below the LOW BATTERY condition, the
ventilator will not function correctly until the
voltage raises above the LOW BATTERY level.
A fourteen hours recharge will be necessary to
bring the battery to full charge.
3.9.5
Monitor and other Accessories
The mains lead (or adaptor) for a monitor
system or other accessories requiring an
electrical supply can be plugged into one of
the auxiliary sockets on the rear of the
machine.
12
DESCRIPTION
3.10
Auxiliary Gas Outlets
CAUTION
When the auxiliary gas outlets are in use on a
machine with cylinder supply only, or if the
pipeline supply is not in use, check flow rate
requirements, and ensure that adequate back-up
cylinders are available.
1
Oxygen and Air
Auxiliary outlets (1) are mounted on the rear
of the machine.
Supply pressure
See section 4.5
3.11
A200SP Absorber
The A200SP Absorber and ventilator bellows
assembly is mounted on a polemount
bracket attached to the machine frame
upright.
Refer to the user instruction manual for
A200SP for detailed information on
installation and operation.
3.12
AV-S Ventilator
Interface to Prima SP3
An interface cable links the gas delivery
switch on the anaesthetic machine, via a
socket (1) on the rear panel of the machine
to the socket (2) marked ‘Prima Master’ on
the rear of the ventilator control unit.
1
Ventilator ON/OFF function
a)
b)
c)
Turn the machine Gas Delivery Switch (see
3.4.2) ON.
The ventilator will power-up.
While the Prima SP3 power is ON, the
Ventilator can be turned OFF and ON, using
the ventilator On/Off switch (refer to
ventilator user manual.
Turn the Gas Delivery Switch to OFF.
The ventilator will power-down.
2
Refer to the user instruction manual for AV-S
for detailed information on installation and
operation.
13
4. SPECIFICATION
4.1
Physical Dimensions
Overall frame size:
Height x Width x Depth (cm)
139 x 71 x 70
Work surface
Height:
86 cm
Size:
Loading:
58 cm x 25 cm
30 kg (66 lb) - evenly distributed.
Writing tablet:
30 x 22 cm
Top shelf:
Loading:
71 cm x 35 cm
30 kg (66 lb) - evenly distributed.
Drawers:
Loading:
12 x 54.5 x 35 cm
10 kg (22 lb) - evenly distributed
Castors:
Diameter: 127 mm (5 inches)
Front pair braked
Ventilator bellows post
Bushed to accept 25.4 mm (1 inch) or 22
mm (7/8 inch) poles.
30 kg (66 lb)
Loading:
Gas scavenging fixing
Loading:
Bracket on frame upright
30 kg (66 lb)
Common gas outlet:
22 mm male taper with coaxial 15 mm
female taper connections, Safelock fitting
Weight:
75 kg (165 lb)
(approximate, depending on specification)
14
SPECIFICATION
4.2
Gas Supplies
Cylinders:
A maximum of four cylinder fittings can be specified
All cylinder yokes are pin-indexed
Fourth Gas Options:
Carbon dioxide, Helium, Xenon
Pipeline:
Maximum of three (oxygen, nitrous oxide, air).
All specifications to relevant national standards.
Medical gas colour codes:
Oxygen
Nitrous oxide
Medical air
Carbon dioxide
Helium
Xenon
Green or White*
Blue
Yellow or Black/White*
Grey
Brown
Green (bright)
*To comply with relevant national standards.
Internal pipework is diameter indexed for each gas:
Oxygen
Nitrous oxide
Air
Mixed gas
8 mm
6 mm
5 mm
10 mm
Carbon Dioxide
Helium
Xenon
4 mm
4 mm
4 mm
4.3 Flowmeters
Flow ranges:
Single flow tubes:
Oxygen:
Nitrous Oxide:
Air
Helium
Cascade flow tubes:
Oxygen / Air / Nitrous Oxide
0 - 10
0 - 10
0 - 10
0 - 10
(1)
(2)
L/min
L/min
L/min
L/min
0 - 1000 ml/min
0 - 10 L/min (graduated 1 - 10 L/min)
Flowmeter Accuracy
The accuracy of the flowmeter tubes is ± 2.5% of full scale reading.
Flowmeter construction and dimensions
Tubes and floats are matched, and must not be interchanged.
Flowmeter tubes have antistatic coatings.
Tubes are length indexed:
Oxygen
Nitrous oxide
Other gases
260 mm (10.24 inch)
250 mm (9.84 inch)
240 mm (9.45 inch) (see 3.12)
Scale length
152 mm (6 inch) minimum
(all tubes except carbon dioxide)
15
SPECIFICATION
4.4
Gas Pressures
USA/
Canada/Japan
Pipeline supplies:
340 kPa
(50 psig)
Cylinder supplies:
Reduced pressure from regulator
(at 5 L/min flow)
310 kPa +15 kPa / -35 kPa
(45 psig +2 psig / -5 psig)
Regulator diaphragm bursting pressure
2800 kPa
(406 psig)
Reduced pressure system safety valve
600 kPa
(87 psig)
Safety valve (protects flowmeter, vaporizer etc.)
41 kPa ±10%
(6 psi ±10%)
Reduced pressure from secondary regulators (at 5 L/min flow)
Oxygen and Nitrous Oxide
152 - 241 kPa (22 - 35 psi)
Air
207 - 283 kPa (30 - 41 psi)
4.5
Auxiliary Gas Outlets
Pipeline supply:
Gas is supplied at pipeline supply pressure (see above)
Cylinder supply:
Gas is supplied at reduced pressure from cylinder regulator (see above)
Oxygen
Two self sealing connections on rear of machine
Total flow rate: not less than 100 L/min to free air
80 L/min against 243 kPa (36 psig) resistance
70 L/min against 270 kPa (40 psig) resistance
50 L/min against 297 kPa (44 psig) resistance
Air (on machines with Air supply option)
One self sealing connection on rear of machine.
4.6
Oxygen Failure Warning Devices
1.
Gas system whistle
2.
Visual indicator, direct pressure operated
4.7
Oxygen Flush
Button on front edge of worksurface
The system supplies 35 - 75 L/min when the button is fully depressed.
16
SPECIFICATION
4.8
Mechanical AHD System
Minimum oxygen concentration:
30% ± 3% (of total O2 + N2O flow)
Basal Flow
Cascade flow tubes
Oxygen basal flow
50-75 ml/min
Single Flow tubes
Oxygen basal flow
100-200 ml/min
Reduced pressure from secondary regulators:
See section 4.4.
4.9
Environmental
Operating Conditions
+10 to 38oC (50 to 100oF)
70 kPa to 106 kPa
2438 m (8000 ft) maximum
10 - 95% R.H. non-condensing.
Temperature
Atmospheric Pressure range
Altitude
Humidity
Transport and storage temperature:
-5 to 40oC (23 to 112oF)
-5 to 50oC (23 to 122oF )
Basic machine
Oxygen monitor option
Cleaning
Wipe external surfaces with dry or damp cloth.
Use mild soap, or disinfectant solution if necessary.
Please refer to section 6.1.
4.10 Electrical Supply
Power Input
NOTE: The internal power circuit feeds the machine lighting systems only.
Option 1: Internal power / auxiliary power sockets
US/CSA specification machines:
110 - 120 VAC, 60 Hz, 1350 VA maximum
Non-US/CSA specification machines:
100 - 240 VAC, 50 - 60 Hz, 1100 - 2500 VA maximum
Option 2: Auxiliary power outlets / No internal power
US/CSA specification machines:
110 -120 VAC, 60 Hz, 1200 VA maximum
Non-US/CSA specification machines:
100 - 240 VAC, 50 - 60 Hz, 1000 - 2400 VA maximum
Option 3: Internal power / No power outlets
Non-US/CSA specification machines only: 100 - 240 VAC, 50 - 60 Hz, 100 VA maximum
Fuses (internal power):
T2AH ceramic (¼ x 1¼ inch) high breaking capacity fuses
Power cable:
Permanently attached lead (3 m), with stowage hooks on rear.
17
SPECIFICATION
Power Outlets
Auxiliary power outlets
Four outlets:
5 A per outlet
10 A maximum total
Fuses
T5AH ceramic (¼ x 1¼ inch) high breaking capacity fuse on
Live and Neutral on each outlet
Overload Protection
10 A thermal circuit breaker incorporated within the power
outlet On/Off switch
Electromagnetic Compatibility
The Prima SP3 meets the requirements of EN 60601-1-2
(electromagnetic compatibility - requirements and tests)
4.11 Device Classification and Labelling
Type B Applied Part
Degree of protection against electric shock
This symbol denotes:
Type B equipment
Class 1 Classification
Type of protection against electric shock:
Class 1
IPX0 Ingress Protection
Classification according to the degree
of protection against ingress of water:
IPX0 (not protected)
Labelling
This symbol denotes:
Refer to the User Manual
18
5. PRE-USE CHECKS
5.1
Pre-use Checklist
A pre-use checklist for the Prima SP3
machine is printed on the next page.
This checklist is also supplied with the
machine.
Where necessary, subsequent sections in this
manual provide an explanation and procedure
for setting up the machine and ancillary
equipment and the various checks that must
be carried out before clinical use.
WARNING
Pre-use checks must be performed before each
period of clinical use.
These checks must be supplemented by
periodic Function Testing, and full Service
Testing by a engineer trained by the
manufacturer to the Service Schedule given in
the Prima SP2/3 Service Manual.
Note that these checks will not in themselves
ensure the safe use of the apparatus, which
remains the responsibility of the qualified
practitioner in charge of it.
19
PRE-USE CHECKS
PRE-USE CHECKLIST
The machine must be carefully inspected and checked as follows.
An incorrectly functioning machine must be repaired by a suitably
qualified person before use.
1.
Check for visible damage, machine stability, and condition of gas
supply hoses.
2.
Check for labelling which may indicate status of machine, including
faults or recent servicing.
3.
Check correct connection of electrical supply.
4.
Check correct connections of gas supplies.
5.
Check adequate pipeline supply and back-up cylinder supply.
6.
Switch on gas delivery switch, and note special operating system:
Check functioning of flowmeters.
Check function of Mechanical AHD
7.
Check correct connection and functioning of the vaporizers.
8.
Check functioning of oxygen flush.
9.
Check leak rate of low pressure gas system.
10.
Check the integrity of the patient circuit.
11.
Test the alarm system.
Refer to Section 5 for further information.
12.
Ancillary equipment
Check operation of the AGSS.
13.
Check functioning of ventilator, including disconnect alarm.
14.
Check that the oxygen analyser and other patient monitoring
equipment functions correctly.
Refer to the relevant user manual for further information.
20
PRE-USE CHECKS
5.2 Pre-use Checks - Gas Supply
5.2.1
Gas Pipeline Supplies
Oxygen supply:
1. Connect the oxygen pipeline hose only.
Check that the correct pressure gauge
reading is obtained.
2. Turn on the Gas Delivery switch (1).
Check that the warning whistle sounds
briefly, and that the correct basal flow of
oxygen is delivered (see section 3.8).
3. Open both oxygen and nitrous oxide
flowmeter valves.
Check that flow is only shown in the oxygen
flowmeter.
4. Close both valves.
Turn off the Gas Delivery switch.
Check that the warning whistle sounds
briefly, and that the oxygen basal flow is
stopped.
Nitrous Oxide supply:
5. Connect the Nitrous Oxide pipeline hose.
Check the gauge reading.
Turn on the Gas Delivery switch (1).
Check for a flow of nitrous oxide when the
flowmeter needle valve is operated.
NOTE: cylinder supply can be used if necessary
for this test.
Air supply:
6. Connect the Air pipeline hose.
Check the gauge reading.
Check for a flow of air when the flowmeter
needle valve is operated.
5.2.2
Gas Cylinder Supplies
CAUTION
Open the cylinder valves slowly to avoid damage to the
pressure reducing valve and pressure gauges. Ensure
that valves are at least one full turn open when in use.
1.
Fit the gas cylinders to their respective
yokes, open the cylinder valves one at a
time and check the pressure on each gauge.
NOTE
a) When two cylinders are provided for a single gas,
test each separately, clearing pressure after each
test by opening the flowmeter valve.
b) Turn off the reserve cylinders during normal use.
c) N2O: cylinder pressure does not indicate cylinder
content.
2.
Ensure that all flowmeters are kept closed
until gas supplies are required.
21
CAUTION
The mechanical AHD system
requires that the oxygen flowmeter
control is restricted to prevent the
needle valve from fully closing.
This ensures a minimum oxygen
basal flow.
DO NOT attempt to close the flow
to zero.
Do not overtighten the knob.
1
PRE-USE CHECKS
5.2.3
Flowmeters
1.
Turn on the Gas Delivery switch (1) and
check that the warning whistle sounds
briefly briefly, and that the correct basal
flow of oxygen is delivered (see section 4).
2.
Open the nitrous oxide flowmeter needle
valve and check that there is no nitrous
oxide flow.
3.
Operate the oxygen flowmeter needle
valve.
Check that full scale of flow of oxygen and
nitrous oxide can be achieved, and that
the floats in both tubes move freely and
rotate when at a steady flow.
4.
Check that the nitrous oxide flow can be
turned off by gentle rotation of the oxygen
knob.
Check also that the nitrous oxide float
reseats on the bottom stop, and that the
oxygen basal flow continues to flow.
5.
Operate the other flowmeter control knobs
in turn to check:
the full scale of flow can be obtained;
the floats move freely and rotate at a
steady flow;
the flow can be turned off by gentle
rotation of the knob; and that
the floats reseat on the bottom stop.
6.
Dual cascade flow tubes:
Check that gas flow is through the low flow
tube initially until full flow is achieved, then
through the high flow tube.
7.
Auxiliary flowmeter (2)
Rotate the flowmeter control and check
that a gas flow can be obtained.
22
2
1
PRE-USE CHECKS
5.3
5.3.1
5.3.4
Vaporizers
Pre-use Checks
WARNING
Only
vaporizers with the Selectatec
compatible interlock function will interlock if
installed on a two station or three station
manifold.
The installation of non-interlock vaporizers
allows the possible operation of more than
one vaporizer at the same time.
If two vaporizers only are mounted on a three
station manifold, they must be installed on
adjacent stations (i.e. the middle station must
be occupied).
On ALL vaporizers, before use:
1.
Check all joints for gas tightness.
2.
Check vaporizer agent level.
3.
Check for correct agent delivery
concentrations - use an agent analyser.
Always follow the procedures and checklist
given in the instruction manual supplied with
the vaporizer, particularly when filling the
vaporizer with anaesthetic agent.
5.3.2
Selectatec Compatible
Vaporizers with Interlock
Check that the interlock mechanisms of all
the vaporizers on the manifold are working
correctly, i.e. check that only one vaporizer
at a time can be turned on.
General Information
WARNING
Vaporizers must always be mounted, never
used free-standing.
Free standing vaporizers may be accidentally
tipped resulting in excessive and uncalibrated
volumes of anaesthetic drug entering the
breathing system.
5.3.5
Cagemount Vaporizer
Some international standards demand that
this type of vaporizer should only be used on
machines with a single mounting station.
In addition, use safety clip (Cat. No. 52275)
to retain the cagemount taper cones in position on the vaporizer.
Do not install or connect any vaporizer of any
description between the CGO and the
breathing system, unless it is specifically
designed for such use. (This allows the
oxygen flush flow to pass through the
vaporizer, and severe overdosage may result).
5.3.3 Selectatec Mounting System
Up to two Selectatec compatible vaporizers
may be fitted (up to three on SP3 models).
To install the vaporizer:
a) Carefully offer the vaporizer up to the
manifold.
b) Check that the gas connection ports on
the vaporizer are aligned with the valves
on the manifold.
c) Carefully lower the vaporizer onto the
manifold and lock the vaporizer into
position by clockwise rotation of the
locking lever through 90o.
NOTE Do not use excessive force to lock
the vaporizer onto the manifold. Damage to
the locking fastener will result.
CAUTION
To prevent damage to the locking shaft, ensure
that the gas connection ports are aligned with the
valves on the manifold, and are correctly
engaged, before tightening the locking lever.
23
PRE-USE CHECKS
5.4
1.
Electrical Supply
Connect the machine power lead to a
suitable mains supply socket.
Check that the mains indicator light (1)
is on.
2.
Set the auxiliary power supply switch
(2) to ON.
Check for correct function of each
auxiliary power outlet
3.
Check all electrical equipment,
including devices powered by the
auxiliary power outlets on the rear of
the machine.
4.
Machines with optional flowmeter
lighting (3):
Check for correct operation (section
3.9.3).
3
2
24
1
PRE-USE CHECKS - All models
5.5 Patient Breathing System
5.5.1 Hose Connections
Check that all hoses are secure.
5.5.2
Breathing System Hose, Reservoir
Bag, Ventilator
Connectors for the Inspiratory hose and
Expiratory hose, and the reservoir bag connector
are 22 mm male.
All connectors comply with ISO 5356/1.
The ventilator connection point is also 22 mm
male.
Hose and bag connections are fitted with Penlon
Safelock high security fittings.
Check all connections for gas tightness.
5.5.3
Fresh Gas Supply
The fresh gas hose assembly supplied with the
machine has a Penlon connector at the absorber
inlet and a 22 mm Safelock taper at the other
end.
This should be connected to the common gas
outlet of the anaesthetic machine.
Check all connections for gas tightness.
5.5.4
A200SP Absorber
Always follow the pre-use check procedures given
in the instruction manual supplied with the
absorber.
The use of an oxygen monitor (and a carbon dioxide
analyser) is highly recommended when using any
partial rebreathing anaesthetic system.
3
A200SP Connections
2
1.
2.
3.
Inspiratory connector
Expiratory connector
Bag connector
4.
Inlet - from DRIVE GAS outlet on ventilator
control unit.
5.
Inlet - fresh gas hose from Common Gas Outlet
6.
Exhaust outlet from APL Valve - connect to
Anaesthetic Gas Scavenge System
7.
Oxygen monitor sensor
8.
Outlet - sample line to Pressure Monitor Port on
ventilator
Interface cable - Bag/Vent switch and spirometer
(connects internally to Prima SP On/Off Switch
interface, then to connector on ventilator control
unit rear panel).
9.
1
7
9
6
4
5
8
25
PRE-USE CHECKS
25
3
31
23
24
2
20
26
19
30
18
12
1
4
11
10
21
16 27
14
29
26
28
15
13
5
17
22
12
6
Note
9
7
8
1. AV-S has spirometry
and oxygen monitor.
2. Interface cabling is
shown for Prima SP3
On/Off switch and
A200SP Bag/Vent
switch.
1.
Bellows
18.
Drive Gas Inlet - Ventilator
2.
Ventilator Control Unit
19.
Drive gas Outlet - ventilator control unit to bellows
3.
Outlets to Anaesthetic Gas Scavenging System (AGSS)
20.
Outlet - Exhaust Valve
4.
Bacterial Filter
21.
Inlet - Bellows Drive Gas
5.
Absorber valve block
22.
Outlet - to breathing system
6.
Heat and moisture exchanger
23.
Input socket - Oxygen monitor sensor
7.
Patient
24.
Input socket - Prima SP3 interface
8.
CGO Block on anaesthetic machine (Fresh Gas Supply)
9.
Auxiliary Outlet on anaesthetic machine (Drive Gas Supply)
25.
Input socket:
10.
Flow sensor - expiratory
(i) A200SP Absorber Bag/Vent control position
11.
Flow sensor - inspiratory
(ii) Spirometer sensor signal
12
Connectors - sensor - pressure monitor
26.
Interface connections on Prima SP3 and A200SP
13.
Expiratory Valve - Absorber
27.
APL Valve
14.
Inspiratory Valve - Absorber
28.
Outlet from APL Valve to AGSS
15.
Inlet - from Ventilator Bellows
29.
Oxygen sensor
16.
Connector - Reservoir Bag
30.
AV-S remote screen
17.
Inlet - Absorber - Fresh Gas Supply
31.
Cable (AV-S control unit to remote screen)
(SP on/off switch)
26
PRE-USE CHECKS
5.5.5
Breathing Circuit Schematic
NOTE
1.
To protect the expiratory limb of the
breathing circuit, and the spirometer, use a
breathing circuit bacterial filter (4), and a
heat and moisture exchanger (6) at the
patient Y-piece.
CAUTION
Replacement/Disposal - always follow the
instructions supplied with the filter or heat
and moisture exchanger.
Always renew components at the
recommended interval.
2.
Follow the instructions in the relevant user
manual for connection to analysers and
monitors.
3.
Ventilator connections shown are for AV-S
with spirometry and oxygen monitor.
4.
For A200SP, refer also to the user
documentation supplied with the absorber.
5.5.6
System Low Pressure Leak Test
Connect the CGO outlet on the machine to
the fresh gas inlet of the A200SP absorber.
3
NOTE
This machine must be fitted with a breathing
system complying with approved design
parameters, at the selection of the qualified
practitioner.
4
The breathing system components do not
constitute part of the machine but
connections between the machine and
breathing system should be verified as
follows:
1.
1
Fit a patient circuit to the inspiratory
connector (1) and expiratory connector
(2) on the absorber, and a breathing
bag to the bag arm connector (3).
2.
Set the bag/ventilator switch (4) on the
absorber to ‘Bag’
3.
Close the adjustable pressure limiting
(APL) valve (5), and occlude the patient
connection port on the patient circuit.
Press the oxygen flush valve button on
the front of the machine briefly.
Check that the reservoir bag inflates
and the manometer (6) indicates
approximately 40 cmH2O.
6
2
27
5
4.
Release the oxygen flush valve.
Check that the pressure is maintained
in the system with less than 200 ml/min
fresh gas delivered into the breathing
system, showing that no leaks are
present.
5.
If this test fails, check the low pressure
system on the machine (section 5.6).
If the low pressure test on the machine
is successful, check the ventilator and
absorber, referring to the relevant user
instruction manual.
PRE-USE CHECKS
5.6 Machine Low Pressure Leak Test
NOTE
This test is necessary if the system fails the low pressure test
5.5.6.
1.
Attach a side branch connector to the CGO outlet.
Connect
the
side
branch
tube
to
a
sphygmomanometer.
2.
Turn on a flow of 150 ml/min of oxygen. Block the
open port of the connector with a finger.
The pressure in the low pressure gas system will
rise and be displayed on the sphygmomanometer.
3.
Check that the pressure rises to at least 100 mmHg.
Release the finger seal immediately the pressure is
reached.
CAUTION
Do not maintain closure of the open port longer than necessary
to perform the test.
This test should be performed:
(a) With all vaporizers ‘off’ and isolated.
(b) With each vaporizer in turn set to 1%.
NOTE
This test is equivalent to (and in some cases exceeds) the
requirements for system leakage rates quoted in national
standards worldwide.
5.7
Oxygen Flush
Check for a high flow of oxygen through the CGO outlet
when the flush valve button is pressed and that the flow
ceases when the button is released.
This test is most conveniently done after the breathing
system has been attached, using the reservoir bag as an
indicator of gas flow.
5.8
Anaesthetic Gas Scavenge System
(AGSS)
By inspection, check that all sources of expired
anaesthetic gases, e.g. the absorber APL valve, and the
ventilator bellows patient gas exhaust port,
are
connected to an approved collection system leading to
an AGSS.
WARNING
Vacuum systems must not be connected directly to the
APL valve on the absorber. A receiving system with a
positive and negative pressure control function must be
interposed.
Systems must comply with standard ISO 8835 part 2.
28
PRE-USE CHECKS
5.9
Ventilator
Always follow the pre-use check procedures
given in the ventilator instruction manual.
Check all hose and tubing connections for
gas tightness.
Check all wiring connections for correct
fitment and security.
AV-S Ventilator Interface
1
Check the Interface Cable
Check for correct fitment of the interface
cable at the socket (1) on the rear panel of
the Prima SP3, and the connection on the
AV-S control unit, marked ‘Prima master’.
Check the interface system function
a)
b)
c)
Turn the Gas Delivery Switch ON.
The ventilator will power-up.
While the Prima SP3 power is ON, the
ventilator can be turned off and on, using the
ventilator On/Off switch.
Turn the Gas Delivery Switch to OFF.
The ventilator will power-down.
29
PRE-USE CHECKS
5.10
Alarm System Test
WARNING
The anaesthetic machine must not be used if any alarm
is not functioning correctly.
Primary Oxygen Failure Alarm
The machine is fitted with a warning whistle and a
visual indicator (1).
These components act as oxygen supply failure
devices and constitute the primary alarm system,
powered only by the residual oxygen supply, as
described in section 3.
The system can be checked whenever the low
pressure oxygen system is first pressurised by
turning on a cylinder or connecting a pipeline.
a) The whistle will sound briefly as pressure
increases, and,
b) The visual indicator will turn from red to green.
Whistle, Visual Indicator, and Gas Cut-off Device
Test
A formal test (including the action of the internal gas
cut-off device) is performed as follows:
1.
Connect oxygen, nitrous oxide and air supplies.
2.
Set the Gas Delivery switch (2) to ON, and
check that the warning whistle sounds briefly.
3.
Set a flow of 2 L/min on both flowmeters.
4.
Disconnect the oxygen supply at the wall socket
or close the oxygen cylinder valve and check:
a) that as the oxygen flow slows down, the
whistle starts to sound and continues for at least
7 seconds.
b) that the flow of nitrous oxide is cut off
completely before the oxygen flowmeter shows
zero flow.
c) that the visual indicator (1) turns red before
the oxygen flow is entirely stopped.
d) air continues to flow.
NOTE.
All gases must be included in the pre-use check.
5.
Reinstate the oxygen supply.
Check that the flow of nitrous oxide is
reinstated, and that the visual indicator turns
green again.
30
2
1
6. USER MAINTENANCE
IMPORTANT
User Maintenance is restricted to cleaning the external
surfaces of the machine (see section 6.1).
All other maintenance and servicing must be carried out only
by an engineer trained by the manufacturer.
The Prima SP3 must be only be serviced according to the
schedule and procedures given in the Service Manual.
WARNING
Exterior panels must not be removed by unauthorised
personnel and the apparatus must not be operated with such
panels missing.
On machines with an electrical power supply, unauthorised
personnel must not attempt to access fuses or other electrical
components. There is a possible electric shock hazard.
Ensure that all panels are secure after any work by authorised
personnel. Fuseholders must be carefully tightened using an
appropriate tool, e.g. flat-blade screwdriver.
Ancillary Equipment
Follow the instructions given in the relevant user manual for
detailed information on maintenance and service
requirements for the ancillary equipment used with the
anaesthetic machine:
Vaporizers
Ventilator
Absorber
AGSS
Monitoring
6.1
Cleaning and Sterilisation
CAUTION
a) Check that the unit is disconnected from the electrical supply
before cleaning.
b) Care must be taken not to allow liquids to run into enclosed
areas; serious damage may result.
c) Do not use harsh abrasive cleaning agents.
To clean outside surfaces, use a damp cloth that has been
immersed in a cleaning solution and thoroughly wrung out.
Use cleaning agents as recommended by your hospital
infection control department:
Use a warm, mild detergent solution to remove resistant
grime.
To remove blood etc, clean as above then use an antiseptic
solution, or anti-microbial wipes.
Make sure that all cleaning agent residues are fully removed
after cleaning.
Always allow the machine to dry off thoroughly before clinical
use.
Breathing system hoses and other components must be
sterilised to the manufacturer’s recommended methods.
31
USER MAINTENANCE
6.2
A200SP Absorber
6.2.1 Removing the Absorber
Assembly
CAUTION
The canister (1) may contain condensate.
Before removing the absorber from the polemount assembly, refer to the A200SP user
manual for instructions on draining the canister
and disposing of absorbent.
1.
Set the brakes on the anaesthetic
machine front castors.
2.
Refer to the A200SP user manual
and disconnect all cable connectors
and hoses, including the mains lead
from the heater unit (2) (if fitted).
3.
3
2
1
Slacken the knob (3), and lift the
absorber assembly from the polemount.
32
USER MAINTENANCE
6.3
Service Schedules
6.3.1 Prima SP3
The anaesthetic machine must be serviced to the following
service schedule:
6 months
Inspection and Function Check
12 months
Annual service which includes routine
replacement of seals, etc. as preventive
maintenance
2 and 4 years
Additional tests and component replacement
Details of these service operations are given in the Service
Manual, available only to engineers trained by the
manufacturer.
6.3.2
Delta Vaporizer
Follow the instructions given in section 8 of the vaporizer
user instruction manual.
Servicing includes a periodic leak test and calibration test,
and a major overhaul at 10 years (5 years for Halothane
models).
On vaporizers with interlock, the system must be tested
during the vaporizer calibration test.
6.3.3
Monitoring Systems
Follow the service recommendations detailed in the monitor
user instruction manual.
6.3.4
AV-S Ventilator
If the anaesthetic machine was supplied with an AV- series
ventilator, refer to section 7 of the ventilator user instruction
manual, for servicing requirements.
These include:
6 months
12 months
Inspection and Function Check
Replace bellows
Replace O seals and drive gas inlet
filter, etc.
24 and 48 months Additional component replacement
6.3.5
A200 Absorber
6 months
12 months
Inspection and Function Check
Component replacement.
6.3.6
Anaesthetic Gas Scavenging System
Follow the service recommendations detailed in the AGSS
user instruction manual.
33
APPENDIX
APPENDIX 1
Disposal at end of useful life: risk assessment
There are no risks associated with disposal of this product.
Do not dispose of in landfill, refer to an approved recycling facility.
Follow your hospital, local, state and federal regulations.
34
APPENDIX
APPENDIX 2
Approved Accessories
WARNING
Only use accessories approved by the manufacturer.
Contact:
Penlon Inc.
11515 K-Tel Drive
Minnetonka
MN 55434
35
36
Penlon Inc.
11515 K-Tel Drive
Minnetonka
MN 55434
Cat No 53012
Doc No PRSP3 0110 (PI)
January 2010
Manufactured by:
Penlon Limited
Abingdon
UK
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