Penlon Prima SP User manual
Prima SP Anaesthetic
Machine Range
User Manual
Quality and Assurance in Anaesthesia
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.
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.
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.
IMPORTANT
Servicing and Repairs
In order to ensure the full operational life of
this anaesthetic machine, servicing by a
Penlon-trained engineer should be
undertaken periodically.
The machine must be serviced to the
schedule detailed in section 8.
Details of these operations are given in this
Service Manual, available only for Penlon
trained engineers.
For any enquiry regarding the servicing or
repair of this machine, contact the nearest
accredited Penlon agent:
or communicate directly with:
Service Department
Penlon Limited
Radley Road
Abingdon
OX14 3PH
UK
Tel: +44 (0) 1235 547063
Fax: +44 (0) 1235 547062
E-mail: service@penlon.co.uk
Always give as much of the following
information as possible:
1. Type of equipment
2. Product name
3. Serial number
4. Approximate date of purchase
5. Apparent fault
(i)
FOREWORD
This manual has been produced to provide
authorised personnel with information on the
function, routine performance, maintenance
checks and repair procedures applicable to
the Prima SP anaesthetic machine range.
Information contained in this manual is
correct at the date of publication.
The policy of Penlon Limited is one of
continued improvement to its products.
Because of this policy, Penlon Limited
reserves the right to make any changes
which may affect instructions in this manual,
without giving prior notice.
Personnel must make themselves familiar
with the contents of this manual and the
machine’s function before using the
apparatus.
Copyright © Penlon Limited, 2002.
All rights reserved.
(ii)
CONTENTS
Page No.
USER RESPONSIBILITY 01
1. WARNINGS AND CAUTIONS 02
2. PURPOSE 05
3. DESCRIPTION 06
3.1 Framework and General Construction 06
3.2 Gas Circuit NON-AHD MACHINES 07
3.3 Gas Circuit Schematic 07
3.4 Gas Supply Safety Devices 10
3.5 Mechanical AHD 11
3.6 Pressure Gauges 12
3.7 Flowmeters and Controls 13
3.8 Vaporizers 14
3.9 Common Gas Outlet (CGO) Block 15
3.10 Electrical Power Supply 16
3.11 Third/Fourth Gas Options 17
3.12 Auxiliary Gas Outlets 17
3.13 Oxygen Monitor 18
3.14 A100 Absorber 23
3.15 Prima SP Anaesthetic System - MRI Compatibility 23
4. SPECIFICATION 24
4.1 Physical Dimensions 24
4.2 Gas Supplies 25
4.3 Flowmeters 25
4.4 Gas Pressures 26
4.5 Auxiliary Gas Outlets 27
4.6 Oxygen Failure Warning Devices 27
4.7 Oxygen Flush 27
4.8 Mechanical AHD Systems 27
4.9 Environmental 28
4.10 Third and Fourth Gas Options 28
4.11 Electrical Supply 28
4.12 Oxygen Monitor 29
5. PRE-USE CHECKS 31
5.1 Pre-use Check List 31
5.2 Pre-use Checks (Non-AHD Machines) 33
5.3 Pre-use Checks (Machines with Mechanical AHD) 35
5.4 Leak Rate Check 37
5.5 Electrical Supply 37
5.6 Patient Breathing System 38
5.7 Oxygen Flush 42
5.8 Anaesthetic Gas Scavenge System (AGSS) 42
5.9 Alarm System Testing 43
5.10 Vaporizers 44
5.11 Ventilator 44
5.12 Oxygen Monitor 45
(iii)
CONTENTS
6. FUNCTION TEST 49
6.1 Introduction 49
6.2 Machine Frame 50
6.3 Electrical Safety Tests 50
6.4 Pipeline Gas Supply and Non-Return Valve 51
6.5 Cylinder Gas Supply and Pressure Reducing Valves 52
6.6 Flowmeter Unit 54
6.7 Gas Safety Devices 56
6.8 Vaporizers and Back Bar Manifold Assembly 57
6.9 Reduced Pressure Gas Circuit Leakage 58
6.10 Emergency Oxygen Flush Control Test 58
7. FAULT FINDING 59
7.1 Introduction 59
7.2 Fault Diagnosis Table 60
8. SERVICE SCHEDULE 69
8.1 Service Schedule 69
8.2 Six Month Service Checks 69
8.3 Twelve Month Service Checks 72
8.4 Twenty-four Month Service Checks 75
8.5 Seventy-two Month Service Checks 78
9. SERVICING PROCEDURES 82
9.1 Servicing 82
9.2 Ancillary Equipment 82
9.3 Cleaning and Sterilisation 84
9.4 Gas System Components 85
9.5 Internal Gas Pipework 85
9.7 Front Cover - Remove and Refit 88
9.7 Flowmeter Cover 89
9.8 Gear Linkage - Reset 90
9.9 Control Valve Capsule Removal/Replacement 92
9.10 Oxygen Reservoir - Removal/Replacement 93
9.11 Secondary Regulators 94
9.12 Gas Block - Remove and Refit 95
9.13 Selectatec Compatible Manifold Block 96
9.14 Gas Delivery Switch 97
9.15 Air/N2O Interlock Switch 98
9.16 Oxygen Failure Visual Indicator 99
9.17 CGO - Clippard Valve Replacement 100
9.18 Flowmeter Tubes - Removal 101
9.19 Flowmeter Assembly - Removal 102
9.20 Flowmeter Lighting - Removal 103
9.21 Oxygen Monitor - Battery Replacement 104
9.22 Oxygen Monitor Sensor 105
9.23 A100 Circle System Absorber 106
10. SPARE PARTS LIST 107
11. APPENDIX 130
Care of Back-up Battery 130
Product Classification and Labelling Terminology 131
Wiring Diagram - Lighting 132
Wiring Diagram - General 133
(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.
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.
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.
Statements in this manual preceded by the
following words are of special significance:
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.
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 the nearest
Penlon accredited agent.
This device and any of its constituent parts
must be repaired only in accordance with
written instructions issued by Penlon
Limited and must not be altered or modified
in any way without the written approval of
Penlon Limited. 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 Penlon or its
appointed agents.
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
The following WARNINGS and
CAUTIONS must be read and
understood before using this
anaesthetic apparatus.
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.
On machines with an electrical
power supply, there is a possible
electric shock hazard.
during test procedures as well as
during use with a patient.
6. Prima SP machines must only be
used with Sigma Delta vaporizers
(or other vaporizers approved by
Penlon Limited) installed by means
of the Cagemount or Selectatec
system.
Free-standing vaporizers may be
accidentally tipped, resulting in
excessive and uncalibrated
volumes of anaesthetic drug
entering the breathing system
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.)
3. 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.
4. 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 can
cause serious injury.
5. 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
7. 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.
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.
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.
8. When mechanical ventilation is
employed the patient breathing
system must be connected directly
to an over-pressure relief valve to
prevent the possibility of
barotrauma.
2
WARNINGS AND CAUTIONS
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 accidents 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 machine must not be fitted with
more than four operator accessible
mains socket outlets. There is a
risk of an excessive leakage
current.
12. 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.
Take care when moving a fully
loaded machine, particularly when
negotiating ramps.
Check that hoses or power leads
are not trailing on the floor.
CAUTIONS
1. Flowmeter needle valves are
designed to seal with light torque and
may be damaged if tightened
excessively.
Take particular care with the carbon
dioxide flowmeter control (if fitted); 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.
16. Additional equipment placed on the
top shelf must be securely
attached.
3
WARNINGS AND CAUTIONS- O2 Monitor
Oxygen Monitor
WARNINGS
1. We recommend calibration of the
oxygen monitor every time the
system is turned on, as a safety
precaution.
2. Do not attempt to open the fuel
cell. The sensor contains a small
quantity of electrolyte, classified as
a harmful irritant which is
potentially hazardous.
3. ALWAYS check the integrity of the
sensor assembly before use. See
section 3.4.
4. Once exhausted, the sensor must
be disposed of according to
hospital, local, state and federal
regulations.
5. The sensor measures oxygen
partial pressure, and its output will
rise and fall due to pressure
change.
An increase in pressure of 10% at
he sensor inlet will produce a 10%
increase in sensor output.
Using the oxygen monitor
6. When the battery voltage has fallen to the minimum safe level, the
oxygen monitor will automatically
shut down to avoid permanent
damage to the battery.
7. If the internal battery is fully discharged, the oxygen monitor will
not function in the event of mains
power failures.
The battery must be recharged
before the oxygen monitor is used
clinically, otherwise back-up time
can not be guaranteed.
See section 3.13.
CAUTIONS
1. Do not sterilise the oxygen sensor or
control unit components.
These components are not
compatible with sterilisation
techniques and damage may result.
2. Do not autoclave or expose the
sensor to high temperatures.
3. If the sensor shows signs of being
affected by condensation, dry the
sensor with soft tissue.
Do not use heat to dry the sensor.
NOTES
1. The O2 SENSOR FAULT alarm
indicates that one of the following
conditions has occurred.
a) Internal electrical fault
b) Software/electronics fault
c) Oxygen sensor fault.
2. The concentration read-out may, in
certain conditions of excess pressure,
show a value above 100%.
To accommodate these conditions it is
possible to set the high alarm value up
to 105% (see section 5).
3. To maintain maximum sensor life,
always remove the unit from the
breathing circuit after use.
4
2. PURPOSE
The Prima 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 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, as
follows:
Machine size
Prima SP101 Induction machine with a
single vaporizer on the backbar manifold,
and up to three gas cylinders.
Anti-hypoxic Device (AHD)
Machines can be specified with a
mechanical AHD system, designed to
minimise the risk of a hypoxic mixture
reaching the patient, see section 3.
Oxygen monitor (optional)
The Oxygen Monitor is intended to continuously measure and display the concentration
of oxygen in breathing gas mixtures used in
anaesthesia, and is intended for adult, paediatric and neonatal patients.
The oxygen monitor is a module within an
anaesthesia machine.
The oxygen monitor is intended for use by
health care providers, i.e. Physicians,
Nurses and Technicians for use with patients
during general anaesthesia.
Prima SP102 Medium width machine with
capacity for two vaporizers on the backbar
manifold, and up to four gas cylinders.
Gas supplies
SP101 Up to three gases
SP102 Up to four gases (oxygen,
nitrous oxide, carbon
dioxide, and air, with pinindex cylinder yokes (see
above), and provision for up
to three pipeline supply
inlets.
Vaporizer mounting systems
Back bar manifold for Selectatec
Compatible, or Cagemount type vaporizers.
5
3. DESCRIPTION
3.1 Framework and General
Construction
Frame
The machine has a cast base, extruded
aluminium uprights, and aluminium panels.
Mobility
Trolley models have four castors, with a
brake on each of the front castors. The
castors are five inches diameter with antistatic rubber.
A footrest is mounted on the front of the
machine.
To aid manoeuverability, two side handles
are provided.
Mounting posts and brackets
A ‘T-slot’ 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 (see illustration) can
be used to mount a complete AV-series
Ventilator, or bellows unit only.
V brackets can be used to mount a gas
scavenging system, suction units, and
accessories.
Draw units and work surfaces
The machine can be fitted with a base
drawer unit (as illustrated) plus two
additional smaller drawers.
The work surface has has raised edges to
prevent instruments, vials etc. from rolling
off.
The Prima SP 102 illustrated is equipped
with a standard full-width top shelf unit
suitable for a large monitor, and a pull-out
writing tablet mounted under the work
surface.
Options available include a CPU tray
mounted above the drawer unit.
Prima SP 102 with
standard top shelf
and base drawer unit
Pole mount system
fitted to frame upright
6
DESCRIPTION
3.2 Gas Circuit
Gas Supplies
For each size machine, 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, the Prima SP102 can be supplied with an extra two gas cylinders (choose
from one additional oxygen, one additional
nitrous oxide, one carbon dioxide, one air),
and one extra pipeline supply - Air.
Note a) Kits are available for fitment to
existing machines - see section
9 (Ordering Information).
b) Carbon dioxide is not available
on US specification machines.
Cylinder Yokes
The cylinder 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.
Pipeline Inlets
Machines can be fitted with up to three
pipeline gas inlets mounted on the rear of
the machine.
Pipeline supply hoses are connected by
non-interchangeable, threaded unions.
Filters
To prevent dirt entering the gas system,
cylinder yokes and pipeline inlets are fitted
with filters.
pressure gauge tapping for direct mounting
of a pressure gauge, and a non-return valve
to prevent back flow of gas.
In addition, gas blocks for cylinder supplies
have a diaphragm pressure regulator to
reduce the pressure of the compressed gas
supply, and a pressure relief valve, factory
set to prevent any pressure build up under
the diaphragm should any leakage develop
across the reducing valve seat.
Secondary Pressure Regulator
For oxygen, nitrous oxide, and air, a second
stage regulator reduces the pressure
supplied to the flowmeter controls (see
section 4.4).
The fitment of a secondary regulator for
oxygen and nitrous oxide enhances the
performance of the mechanical AHD system
fitted to some models.
Secondary regulation of the air supply is
utilised to allow connection to high pressure
air pipeline supplies.
Carbon Dioxide Flow Restrictor
On machines with a carbon dioxide supply,
an integral, factory set, flow valve is fitted to
restrict the flow of carbon dioxide to 500
ml/min.
3.3 Gas Circuit Schematics
Gas circuit schematics for:
a) Non-AHD machines
b) Mechanical AHD machines
are shown on the following pages, and both
show a four-gas machine.
All available gas supply options are shown.
Gas Inlet Block
Each individual gas supply, from a cylinder
or pipeline, is routed through a separate gas
block.
Each gas block has an integral high
Note that carbon dioxide is not available for
US specification machines.
7
Prima SP Non-AHD Machine
UK specification four-gas machine
Note: US spec. machines are not fitted with CO
Air
N2O
facility
2
CO
O
2
2
Pneumatic pressure
source
Filter
Pressure gauge
Pressure regulator
Pressure relief valve
Pneumatic on/off
switch
Gas cut-off valve
(normally open)
Gas cut-off valve
(normally closed)
Gas cut-off valve
(open/closed)
Reservoir
Audible alarm
Flow control valve
(variable, but note
that valve 1 is not
user-adjustable)
1
Flowmeter
Vaporizer
Oxygen flush valve
Non-return valve
Power take-off point
(or test point)
Gas reference
connection
Visual indicator
8
Prima SP Mechanical AHD Machine
UK specification four-gas machine
Note: US spec. machines are not fitted with CO
Air
N2O
facility
2
CO
O
2
1
2
Pneumatic pressure
source
Filter
Pressure gauge
Gas cut-off valve
(normally open)
Gas cut-off valve
(normally closed)
Gas cut-off valve
(open/closed)
Flowmeter
Vaporizer
Oxygen flush valve
Non-return valve
Pressure regulator
Pressure relief valve
Pneumatic on/off
switch
Reservoir
Audible alarm
Flow control valve
(variable, but note
that valve 1 is not
user-adjustable)
9
Power take-off point (or
test point)
Gas reference
connection
Mechanical connection
Visual indicator
DESCRIPTION
3.4 Gas Supply Safety
Devices
3.4.1 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 (if fitted).
The cut-off operates when the oxygen
pressure falls below 172 kPa (25 psi).
Gas supplies are reinstated only when the
oxygen supply pressure rises above 227
kPa (33 psi).
3.4.2 Oxygen Supply Failure
Warning Whistle
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.
The whistle will start to sound when the
pressure falls to approximately 172 kPa (25
psi), and will continue to sound until the
pressure falls to approximately 70 kPa (10
psi).
3.4.4 Air/N
(Machines with Air option)
The user can switch
between Air and
Nitrous Oxide (A).
NOTE
a) The machine will
NOT deliver a
mixture of Air and
nitrous oxide.
b) On machines with
Mechanical AHD, the
2/N2O linkage
O
continues to operate.
2O Interlock
B
A
3.4.5 Oxygen Supply Visual
Indicator
The indicator (B) is operated from the
oxygen supply and shows GREEN when the
supply is at working pressure, and RED if
the pressure falls.
3.4.6 CO2 Flow Restriction
The maximum flow of carbon dioxide is
restricted to 500 ml/min by a pre-set flow
control valve.
This valve is not user-adjustable.
Note that carbon dioxide is not available for
US specification machines.
Oxygen consumption of the whistle is
approximately 2 L/min when sounding and
nil at other times.
3.4.3 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 39 kPa (5.4 psi).
This valve also protects machine
components against excessive pressure in
the event of a total blockage of the CGO.
3.4.7 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
oxygen concentration of 30% ±3%,
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.
See section 3.5 for a full description
3.4.8 Low Pressure Gas Tubing
Diameter-indexed tubing is used for the low
pressure gas system - see section 4.
10
DESCRIPTION
3.5 Mechanical AHD (Anti
Hypoxic Device)
3.5.1 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 system is designed to control 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 ensure that a hypoxic mixture
is not supplied from the anaesthetic
machine.
3.5.2 Gas Delivery Switch
The Gas Delivery Switch (A) operates on the
oxygen supply and must be in the ‘On’
position for normal operation of the
anaesthetic machine.
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 3.4.1).
A whistle (oxygen failure warning whistle)
will sound briefly whenever the gas delivery
switch is turned on or off. Note that the
whistle functions normally if the oxygen
supply fails (see section 3.4.2).
The switch also controls the electrical supply
to the optional Flowmeter Lighting unit and
2 Monitor (see section 3.13.2).
O
A
B
NOTE
Machines with an Air supply option are fitted
with an Air/N2O Interlock switch (B).
The machine will NOT deliver a mixture of
Air and nitrous oxide - see section 3.4.4) .
This switch must be in the N
allow a flow of Nitrous Oxide.
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%.
2O position to
3.5.3 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 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.
3.5.4 Oxygen Basal Flow
To allow the system to function correctly, an
oxygen basal flow is continuously supplied
(see section 4.8). This basal flow can only
be turned on and off by using the Gas
Delivery Switch (A).
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.
11
DESCRIPTION
3.6 Pressure Gauges
Pressure gauges (50 mm diameter) are
located on the front panel below the
flowmeter bank.
The gauges for the third and fourth gases (if
fitted) are 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 contents are marked CYLINDER
and pipeline pressure gauges are marked
PIPELINE.
The gauges are calibrated in kPa x 100.
12
DESCRIPTION
3.7 Flowmeters and
Controls
3.7.1 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.
All floats indicate flow rate in line with the
upper surface as shown below.
Read flow at
this level
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.
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.
3.7.2 Optional 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 will 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.
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.
NOTE
Machines with an Air supply option are fitted
with an Air/N
machine will NOT deliver a mixture of Air
and nitrous oxide - see section 3.4.4) .
This switch must be in the N
allow a flow of Nitrous Oxide.
The gas delivery switch, positioned to the
right of the flowmeter bank, controls the
2O Interlock switch (The
2O position to
3.7.3 Carbon Dioxide Flow
Restriction
The maximum flow of carbon dioxide (if
fitted) is restricted to 500 ml/min.
13
DESCRIPTION
3.8 Vaporizers
CAUTION
Read the instruction manual supplied with
the vaporizer before clinical use.
3.8.1 Vaporizer Mounting
Systems
Vaporizers for the administration of volatile
anaesthetic agents can be fitted to
customer’s requirements as follows:
(a) Up to two Penlon Sigma Delta
Selectatec compatible vaporizers
(interlock or non-interlock), mounted
on a Selectatec compatible backbar.
(b) One or two Penlon Sigma 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).
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.
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).
3.8.2 Selectatec Compatible
Vaporizers
Selectatec compatible vaporizers, e.g. the
Sigma Delta with the Selectatec
compatibility block, may be mounted on a
universal back bar manifold built onto the
Prima range as an option.
Single and two-station manifolds are
available, with each station fitted with two
valve capsule assemblies for vaporizer
connector block attachment.
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.
3.8.3 Cagemount Vaporizer
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).
It is recommended that detachable
cagemount connectors are retained with a
safety clip (catalogue number 52275) to
prevent inadvertent disconnection.
14
DESCRIPTION
3.9 Common Gas Outlet
(CGO) Block
The CGO block is mounted on the rail on the
front of the machine, and can be moved
along the rail.
Slacken the securing screw under the block
and carefully slide the block along the rail to
the required position.
Tighten the screw to hold the block in place.
The fresh gas outlet is located on the front
face of the block, with 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.
A high mounting position for the CGO is
available as an option for induction
machines.
Oxygen Flush
An emergency oxygen flush valve button is
mounted on the top front of the CGO block
and is marked ‘O
Depressing the button provides a delivery of
between 35-75 litres/min of oxygen into the
common gas outlet.
Releasing the button allows the springloaded valve to return to its normal position.
2 FLUSH’.
15
DESCRIPTION
3.10 Electrical Power
Supply (if specified)
3.10.4 AV900 or AV800 Ventilator
(if fitted) Power Supply
3.10.1 Mains Power Supply
Power is fed to the machine via the mains
lead, to power an auxiliary output panel, and
optional flowmeter bank light.
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.
b) Each socket is protected with a 5 Amp
fuse.
3.10.2 Auxiliary Power Supply
Sockets (if fitted)
An optional mains electricity auxiliary panel
with three or four sockets can be specified,
and fitted to the rear of the machine.
A
The mains lead for an AV-series ventilator
can be plugged into one of the auxiliary
power sockets on the rear of the machine.
Should the electrical power supply to the
ventilator fail, the ventilator has a battery
back up system to power the ventilator for 60
minutes, if the battery has been maintained
in a fully charged condition.
Reference must be made to the separate
user instruction manual supplied with the
ventilator
Charging of the back-up battery 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. After the back-up power supply has
been run down, the ventilator will not
function until the battery is in a fully charged
state.
A fourteen hours recharge will be necessary
to bring the battery to full charge.
The supply to the sockets is controlled by an
ON/OFF switch (A).
3.10.3 Flowbank Lighting
(optional)
The lighting system is controlled by the
main ON/OFF switch (A).
3.10.5 Monitor and Other
Accessories (if fitted)
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.
See 3.13.17.
16
DESCRIPTION
3.11 Third/Fourth Gas
Options
3.11.1 Air
When air is requested as the third/fourth gas,
the machine specification is modified as stated
in 4.10.1.
NOTE
Machines with an Air supply option are fitted
with an Air/N
will NOT deliver a mixture of Air and nitrous
oxide - see section 3.4.4).
This switch must be in the N2O position to
allow a flow of Nitrous Oxide.
3.11.2 Carbon Dioxide
When carbon dioxide is requested as the
third/fourth gas, the machine specification is
modified as stated in 4.10.2.
2O Interlock switch (The machine
Gas supply cut-off devices operate on carbon
dioxide in all machines.
An integral, factory-set flow valve is fitted to
restrict the flow of carbon dioxide to 500
ml/min.
Note that carbon dioxide is not available on US
specification machines.
3.12 Auxiliary Gas Outlets
Oxygen
Auxiliary oxygen outlets are mounted on the
right hand side frame upright.
Air
On machines with an air cylinder/pipeline
supply, an auxiliary air outlet is fitted above the
oxygen outlets.
17
DESCRIPTION - O2 Monitor
3.13 Oxygen Monitor (Optional)
The oxygen monitor continuously measures and
indicates the concentration of oxygen in the breathing
system, and triggers an alarm when the concentration
varies from the set levels.
CAUTION
If your machine is fitted with an AV900 Ventilator with
a built-in Oxygen Monitor, please refer to the AV900
user manual for instructions on setting up and
operation.
3.13.1 System Description
The Oxygen Monitor uses a fast-responding, oxygenspecific, self powered sensor that achieves 90% of
final value in less than 10 seconds.
Sensor life:
approximately 1 500 000 O
20oC
(minimum one year in most normal applications).
2 percent hours at
An external probe is supplied with a 2 m (6 ft)
extendable cable and diverter fitting for a standard 15
mm Tee adaptor. The probe has a safety lock.
The system has user-adjustable high-level and lowlevel alarms with visual and audible indication of
alarm conditions.
Easy-to-read, seven segment LED display for highset, low-set, and oxygen concentration readings.
The monitor is controlled by the machine gas system
master On/Off switch (A).
A back-up battery provides a minimum of 60 minutes
operation in the event of mains failure.
The battery is charged when the machine is
connected to the mains supply.
3.13.2 System On/Off Switch
The switch controls gas delivery from the anaesthetic
machine, and electrical power to the oxygen monitor.
The switch must be in the On position to use the
oxygen monitor and anaesthetic machine.
A
When switched to On, the monitor will always default
to previous settings.
18
DESCRIPTION - O2 Monitor
5
3
2
10
9
1
6
7
8
4
Oxygen monitor control panel
1. O2 Concentration display 6. High set key
2. Low alarm set display 7. Low set key
3. High alarm set display 8. Calibrate key
4. Alarm LEDs 9. Low alarm set / Calibration control
5. Alarm mute key 10. High alarm set control
3.13.3 Displays
Oxygen Percentage Readout
The display provides direct readout of oxygen concentrations in the range of 0-100%.
If the oxygen concentration exceeds 100%, the display will flash.
Low Alarm Set Readout
The indicated value represents the oxygen percentage at which the low alarm will be activated.
The low alarm set value is limited within 18-99%.
To set the low oxygen concentration alarm, see section 3.3.2.
High Alarm Set Readout
The indicated value represents the oxygen percentage at which the high alarm will be activated.
The high alarm set value is limited within 19-105% (Note that in certain conditions of excess pressure,
the readout may show a value above 100%.)
To set the high oxygen concentration alarm, see section 3.3.1.
19
DESCRIPTION - O2 Monitor
3.13.4 Alarm Conditions
HIGH O2 ALARM
The high O
oxygen concentration is 1% above the
setting.
In this alarm condition, a red HIGH O
ALARM LED will flash at a 0.5 second rate,
accompanied by a high priority sound.
To cancel this alarm, the high alarm setting
must be equal to, or above the oxygen
concentration.
LOW O
The low alarm is triggered when the oxygen
concentration is 1% below the setting.
In this alarm condition, a red LOW O
ALARM LED will flash at a 0.5 second rate,
accompanied by a high priority sound.
To cancel this alarm, the low alarm setting
must be equal to, or below the oxygen
concentration.
2 MONITOR INOP (inoperative)
O
This alarm indicates when the oxygen
monitor is in malfunction condition.
It could be triggered by electronic
components failure or software malfunction.
In this alarm condition, a red O
ALARM LED will flash at a 0.5 second rate,
accompanied by a high priority sound.
If this mode occurs you can reset the system
by pressing the ALARM MUTE and LOW
ALARM SET buttons simultaneously for 3
seconds.
2 alarm is triggered when the
2 ALARM
2 MONITOR
will fall very quickly to zero within two to
three weeks of normal usage.
See section 5 for sensor replacement.
NOTE
always remove from breathing circuit after use.
2
LOW BATTERY
To maintain maximum sensor life,
The low battery alarm indicates that the
battery is disconnected or the battery
voltage has dropped below acceptable
limits.
If the monitor is in use under battery power,
and the battery voltage is less than 11.5
volts, a low priority alarm is triggered, to
indicate that the battery has less than 20
2
minutes life left.
If the battery voltage falls to less than 10.8
volts a flashing medium priority alarm is
triggered to indicate there is less than 5
minutes power left in the battery.
To cancel this alarm, mains power must be
On.
NOTE
Penlon Service Centre, or Penlon Customer
Service Department in the UK.
At the end of the final 5 minute warning
period, the oxygen monitor will shut down, to
prevent damage to the battery.
If this condition persists, contact your
MAINS FAILURE
This alarm indicates mains power failure or
cut-off. The yellow MAINS FAILURE LED will
illuminate, and a low priority sound will be
triggered.
2 SENSOR FAULT
O
The alarm is triggered
a) when either the oxygen sensor is
disconnected or approaching the end of its
life.
b) if the the oxygen concentration exceeds
110%.
In the alarm condition, a red O
2 SENSOR
ALARM LED will flash at a 0.5 second rate,
accompanied by a high priority sound.
To cancel this alarm, check the sensor
connection or replace the sensor.
2 SENSOR LOW
O
This alarm indicates the sensor has
approached the end of its life.
The yellow O
2 SENSOR LOW LED will light
up, and a low priority sound will be triggered.
The sensor must be replaced as the output
3.13.5 Alarm Mute
In an alarm condition, pressing the ALARM
MUTE button will deactivate the alarm
sounder but the alarm LED will continue to
flash. The yellow MUTE ALARM LED will
illuminate, accompanied with a SINGLE
‘beep’ sound.
The alarm mute can not be operated:
a) until the mute time is over, or the alarm
condition has been rectified.
b) when the oxygen concentration drops
below 18%.
In high priority and medium alarm conditions
the alarm mute deactivates the sounder for
30 seconds and 120 seconds respectively.
20
DESCRIPTION - O2 Monitor
3.13.6 The MOX-3 Oxygen Sensor
The MOX-3 oxygen sensor offers quick
response, linear output over the entire 0-100%
oxygen range, and long service life.
The MOX-3 is a self-powered galvanic cell that
generates current, and the current is
proportional to the rate of oxygen consumption.
The cell has a highly stable output over its
operating life. Significant output loss is only
shown at the very end of its life.
Typical sensor drift rates are less than 1% per
month when the sensor is exposed to gas in
typical applications.
Sensor lifetime is governed by the mass of lead
available to react with the oxygen and its rate of
consumption. High oxygen partial pressure and
high temperature will increase the sensor
output current, thus shortening the operation
life.
Nevertheless, average sensor life will still
exceed one year.
At the point where all lead has been consumed,
the output will fall very quickly to zero over a
period of two to three weeks.
NOTE
To maintain maximum sensor life, always
remove from breathing circuit after use.
Typical Sensor Installation on
Machine CGO
The sensor assembly consists of an
external probe and 2 m (6 ft) cable and
diverter on a standard 15 mm Tee
adaptor.
On machines with an A100 Absorber,
the probe can also be mounted on the
dome of the inspiratory valve (see section 5).
21
DESCRIPTION - O2 Monitor
3.13.7 Power Supply
Mains Power Supply
Power is fed to the machine via the mains lead to a switching mode power
supply, and the oxygen monitor will be powered up by 14.2 v.
The monitor is controlled by the machine gas system master On/Off switch
(see 3.13.2).
Back-up Battery
Should the electrical power supply to the machine fail, the emergency battery
supply for the unit comes into action automatically.
This is indicated by the illuminated yellow ‘MAINS FAILURE’ LED alarm,
accompanied with a ‘beep’ sound.
The battery is maintained in a fully charged state during normal use (i.e. the
machine connected to the mains power supply).
A fully charged battery will power the unit for a minimum of 60 minutes.
Low Priority Battery Low Alarm
When the battery is discharged, and the mains power supply is not restored,
the ‘BATTERY LOW’ LED alarm will illuminate, accompanied with a low priority alarm sound.
Medium Priority Battery Low Alarm
When the battery is further discharged, and the mains power supply is not
restored, the ‘BATTERY LOW’ LED will flash at a two second rate and a
medium priority audible warning will be given when the minimum safe level of
voltage is reached.
Low Battery Shut Down
WARNING
When the battery voltage has fallen to the minimum safe level, the oxygen monitor will automatically shut down to avoid permanent damage
to the battery.
Recharging the Battery
Charging of the back-up battery takes place automatically when the mains
power supply is on, irrespective of the position of the machine gas system
On/Off switch position.
NOTE
The stated battery back-up period will only be available if the battery is kept
fully charged. After the back-up power supply has been run down, the oxygen monitor will not function until the battery is in a fully charged state. An
eight hours recharge will be necessary to bring the battery to full charge.
22
DESCRIPTION
3.14 A100 Absorber
In-board Mounting
The canister and valve block assemblies are
mounted under the work surface and can be
detached separately for cleaning (see section 7).
3.15 Prima SP Anaesthetic
System - MRI Compatibility
The following Prima SP system components are
MRI compatible:
Prima SP basic* machine
*A 'basic' machine includes any variant of
Back Bar
Flowmeter Bank
Drawers
Monitor Shelves
Additional Gases
A100 Absorber (In-board and pole-mounted)
Nuffield 200 Ventilator
Delta Vaporizer
The following components are currently not
MRI compatible:
Oxygen Monitor
Flowmeter lighting
Electrical power outlets
AV-series ventilator
NOTE
a) MRI Compatible Plastic Laryngoscopes -
see section 3.9 in the Price List.
b) The IDP Pressure Failure Alarm is MRI
compatible when used with appropriate batteries - see section 1.5.3 in the Price List.
23
4. SPECIFICATION
4.1 Physical Dimensions
Overall size: Height x Depth x Width (mm)
SP 101 1475 x 620 x 450
SP 102 1475 x 620 x 570
Work surface height: 890 mm
Work surface size: 690/570/450 x 370 mm
Loading: 30 kg (66 lb) - evenly distributed.
Writing tablet: 300 x 220 mm
Loading: 10 kg (66 lb) - evenly distributed.
Top shelf: 690/570/450 x 370 mm
Loading: 30 kg (66 lb) - evenly distributed.
Mid shelf: 690/570/450 x 370 mm
Loading: 25 kg (55 lb) - evenly distributed
Drawers: 150 x 325 x 500 mm.
Loading: 10 kg (22 lb) evenly distributed
Castors: Front pair braked
Absorber posts: Swivels on a 254 mm radius around the left
hand side frame upright:
Height adjustment 300 to 760 mm
Loading 30 kg (66 lb)
Ventilator bellows post Bushed to accept 25.4 mm (1 inch) or 22
mm (7/8 inch) poles.
Loading 30 kg (66 lb)
Gas scavenging fixing Dovetail clip on frame upright
Loading 30 kg (66 lb)
Common gas outlet: 22 mm male taper with coaxial 15 mm
female taper connections Safelock fitting
Weight:
SP 101 70 kg (154 lb)
SP 102 75 kg (165 lb)
24
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