Penlon Prima SP2 Service Manual

Prima SP2 Anaesthetic Machine Range

Service Manual

Partnership for Life

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 and methods detailed in sections 8
and 9.

For any enquiry regarding the servicing or
repair of this machine, contact the nearest
accredited Penlon agent:

or communicate directly with:

Technical Support
Penlon Limited
Abingdon Science Park
Abingdon
OX14 3PH
UK

Tel: [phone]
Fax: [phone]

E-mail: [e-mail]

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

IMPORTANT

(i)

This manual has been produced to provide
authorised personnel with information on the
function, routine performance, maintenance
and repair 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, 2008
All rights reserved.

FOREWORD

(ii)

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.

Page No.

USER RESPONSIBILITY 1

1. WARNINGS AND CAUTIONS 2

2. PURPOSE 4

3.

DESCRIPTION 5

3.1 Framework and General Construction 5

3.2 Gas Circuit 5

Gas Circuit Schematic 6

3.3 Gas Supply Safety Devices 7

3.4 Mechanical Anti Hypoxic Device (AHD) 8

3.5 Pressure Gauges 8

3.6 Flowmeters and Controls 9

3.7 Vaporizers 10

3.8 Common Gas Outlet (CGO) 10

3.9 Electrical Power Supply 11

3.10 Auxiliary Gas Outlets 12

3.11 A200SP Absorber 12

3.12 AV-S Ventilator 12

3.13 MRI Compatibility 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 17

4.7 Oxygen Flush 17

4.8 Mechanical AHD System 17

4.9 Environmental (including MRI compatibility) 17

4.10 Electrical Supply 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

5.5 Patient Breathing System 25

CONTENTS

(iii)

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 28

5.10 Alarm System Testing 29

6.

FUNCTION TEST

6.1 Introduction 30

6.2 Machine Frame 31

6.3 Electrical Supply 31

6.4 Pipeline Supply and Non-return Valve 32

6.5 Cylinder Supply and Pressure Reducing Valves 33

6.6 Flowmeter Unit 35

6.7 Gas Safety Devices 36

6.8 Vaporizers and backbar Manifold 37

6.9 Reduced Pressure Gas Circuit Leakage Test 38

6.10 Oxygen Flush Control 38

6.11 Auxiliary Outputs 38

7. FAULT FINDING 40

8. SERVICE SCHEDULE 49

9. SERVICE PROCEDURES 53

9.1 Servicing Information 53

9.2 Ancillary Equipment, including A200SP Absorber 51

9.3 Cleaning and Sterilisation 54

9.4 Internal Gas System 55

9.5 Front Cover - Removal 58

9.6 Flowmeter Cover - Removal 59

9.7 Mechanical AHD System 60

9.8 Gas Control Valve Capsule Replacement 65

9.9 Secondary Regulators 66

9.10 High Pressure (cylinder) Gas Block 67

9.11 Selectatec Compatible Manifold Block 68

9.12 Flowmeter Tubes 69

9.13 Flowmeter Assembly 70

9.14 Oxygen Monitor Sensor 71

10.

PARTS LISTS 72

APPENDIX

Product Classification and Labelling Terminology 98

Disposal at end of useful life - risk assessment 98

CONTENTS

(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.

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.

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.

1

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.

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
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
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.)

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 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 machine must not be fitted with
more than four operator accessible
mains socket outlets. There is a risk of
an excessive leakage current.

2

1. WARNINGS AND CAUTIONS

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.

13. 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.

14. 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.

15. 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.

CAUTIONS

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.

3

WARNINGS AND CAUTIONS

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.

The Prima SP2 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 SP2 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:

Gas supplies

Up to three gases

Oxygen, nitrous oxide, and air, with pin­index cylinder yokes, and provision for up to
three pipeline supply inlets.

Vaporizer mounting systems

Backbar manifold for Selectatec compatible
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

2. PURPOSE

3.1 General Construction

Frame

The machine has a cast aluminium base,
extruded aluminium uprights, with aluminium
and plastic panels.

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.

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.

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 Gas Circuit

Gas Circuit Schematic

A gas circuit schematic is shown on the
following page.
All available gas supply options are shown.

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.

5

3. DESCRIPTION

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
(DISS - diameter indexed safety system).

Filters

To prevent dirt entering the gas system,
cylinder yokes and pipeline inlets are fitted

with filters.

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 factory set pressure relief valve. This
prevents pressure build up under the
diaphragm should any leakage develop
across the reducing valve seat.

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.

1

6

Prima SP2

Models built from March 2007

(see Appendix for earlier models)

Three-gas machine with dual cascade

oxygen and nitrous oxide flowmeters.

O2 N2O Air

O

2 Air N2O

Gas Tray

Flowmeter
Assembly

Pneumatic pressure
source

Pressure gauge

Pressure regulator

Pressure relief valve

Audible alarm

Restrictor

Gas cut-off valve
(normally open)

Reservoir

Pneumatic on/off
switch

Flow control valve
(variable)

Flowmeter

Vaporizer

Oxygen flush valve

Non-return valve

Power take-off point
(or test point)

Visual indicator

Filter

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 (if fitted).

The cut-off operates when the oxygen
pressure falls to 186 ±14 kPa (27 ±2 psig).

Gas supplies are reinstated only when the
oxygen supply pressure rises above 227
±14 kPa (33 ±2 psig).

3.3.2 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 200 ±21kPa (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.

WARNING
Gas supply failure systems will not
necessarily operate as indicated during any
procedures that are outside the scope of the
indications for use of the machine (see
section 2).

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.
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.

3.3.3 Fresh Gas Pressure Relief Valve

The valve 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.

3.3.4 Oxygen Supply Visual Indicator

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

Gas supply failure systems within the anaesthetic
machine will not necessarily operate as indicated
during any procedures that are outside the scope
of the indications for use of the machine (see
section 2).

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.

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.

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.

7

DESCRIPTION

1

3.4 Mechanical AHD

(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 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.

3.4.2 Gas Delivery Switch

The Gas Delivery Switch (1) 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 3.3.1).

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).

NOTE
The switch also controls the electrical supply to
the ventilator and 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
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.

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%.

3.4.4 Oxygen Basal Flow

To allow the system to function correctly, an
oxygen basal flow is continuously supplied.

Single Flow Tubes: 100 - 200 ml/min
Dual Cascade System Flow Tubes:

50 - 75 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.

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.

8

DESCRIPTION

1

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.

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, 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 auxiliary oxygen flowmeter (1) is
mounted to the left of the machine flowmeter
bank.
Flow range: 0 - 10 L/min

9

DESCRIPTION

Read flow at
this level

1

3.7 Vaporizers

CAUTION

Read the instruction manual supplied with the
vaporizer before clinical use.

3.7.1 Vaporizer Mounting Systems

Selectatec compatible vaporizers for the
administration of volatile anaesthetic agents
can be mounted on the compatible universal
backbar.

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).

3.7.2 Selectatec Compatible Vaporizer

Selectatec compatible vaporizers, (e.g. the
Sigma Delta with the Selectatec connector
block), may be mounted on a universal
compatible back

bar manifold.

Two and three-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 Common Gas Outlet (CGO)

The outlet (1) is at the 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.

Note - front mounted CGO available as an option.

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

2

1

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.

Current Leakage

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 two 5 A fuses.

3.9.2 Auxiliary Power Supply Sockets

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.

3.9.3 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

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.

11

DESCRIPTION

2

1

3

B A C

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 SP

(See section 3.15)

a) Turn the machine Gas Delivery Switch ON.

The ventilator will power-up.

b) While the Prima SP power is ON, the

Ventilator can be turned OFF and ON, using
the ventilator On/Off switch.

c) Turn the Gas Delivery Switch to OFF.

The ventilator will power-down.

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

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.

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 SP2/3

An interface cable links the rear of the
ventilator control unit to the gas delivery
switch on the anaesthetic machine.

Ventilator ON/OFF function

a) Turn the machine Gas Delivery Switch (C)

ON.
The ventilator will power-up.

b) While the Prima SP2 power is ON, the

Ventilator can be turned OFF and ON, using
the ventilator On/Off switch (refer to
ventilator user manual.

c) Turn the Gas Delivery Switch to OFF.

The ventilator will power-down.

Refer to the user instruction manual for AV-S
for detailed information on installation and
operation.

13

DESCRIPTION

1

4.1 Physical Dimensions

Overall frame size: Height x Width x Depth (cm)

139 x 71 x 70

Work surface
Height: 86 cm
Size: 58 cm x 25 cm

Loading: 30 kg (66 lb) - evenly distributed.

Writing tablet: 30 x 22 cm

Top shelf: 71 cm x 35 cm

Loading: 30 kg (66 lb) - evenly distributed.

Drawers: 12 x 54.5 x 35 cm

Loading: 10 kg (22 lb) evenly distributed

Castors: Diameter: 5 inches

Front pair braked

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 Bracket 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

(approximate, depending on specification): 75 kg (165 lb)

14

4. SPECIFICATION

4.2 Gas Supplies

Cylinders: A maximum of four cylinder fittings can be specified

All cylinder yokes are pin-indexed

Special order options: Helium, Xenon

Pipeline: Maximum of three (oxygen, nitrous oxide, air).

All to relevant national standards.

Medical gas colour codes:

Oxygen green or White*
Nitrous oxide Blue
Medical air Yellow or Black/White*
Carbon dioxide Grey

Helium Brown
Xenon Green (bright)

*To comply with relevant national standards.

Internal pipework is diameter indexed for each gas:

Oxygen: 8 mm Carbon Dioxide: 4 mm
Nitrous oxide 6 mm Helium 4 mm

Air 5 mm Xenon 4 mm

Mixed gas 10 mm

4.3 Flowmeters

Flow ranges:

Single flow tubes

Oxygen: 0 - 10 L/min
Nitrous Oxide: 0 - 10 L/min

Air 0 - 10 L/min

Helium 0 - 10 L/min

Cascade flow tubes

Oxygen /Air /Nitrous Oxide (1) 0 - 1000 ml/min

(2) 0 - 10 L/min

Flowmeter Accuracy

The accuracy of the flowmeter tubes is ± 2.5% of full scale reading.

15

SPECIFICATION

Flowmeter construction and dimensions

Tubes and floats are matched, and must not be interchanged.
Flowmeter tubes have antistatic coatings.

Tubes are length indexed:
Oxygen 260 mm (10.24 inch)
Nitrous oxide 250 mm (9.84 inch)
Other gases 240 mm (9.45 inch) (see 3.12)

Scale length 152 mm (6 in) minimum
(all flow tubes except carbon dioxide)

4.4 Gas Pressures

USA/ UK

Canada/Japan

Pipeline supplies: 340 kPa 400 kPa

(50 psig) (58 psig)

Cylinder supplies:

Reduced pressure from regulator 310 kPa +15 kPa / -35 kPa 380 kPa +15 kPa / -35 kPa
(at 5 L/min flow) (45 psig +2 psig / -5 psig) (55 psig +2 psig / -5 psig)

Regulator diaphragm 2800 kPa 2800 kPa
bursting pressure (406 psig) (406 psig)

Reduced pressure system 600 kPa 600 kPa
safety valve (87 psig) (87 psig)

Safety valve 41 kPa ±10% 41 kPa ±10%
(to protect flowmeter, (6 psi ±10%) (6 psi ±10%)
vaporizer etc.)

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.

16

SPECIFICATION

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 fully depressed.

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

Temperature +10 to 38oC (50 to 100oF)

Atmospheric Pressure range 70 kPa to 106 kPa

Altitude 2438 m (8000 ft) maximum

Humidity 10 - 95% R.H. non-condensing.

Transport and storage temperature:

Basic machine -5 to 60oC (23 to 140oF)

Oxygen monitor option -5 to 50oC (23 to 122oF )

Cleaning Wipe external surfaces with dry or damp cloth.

Use mild soap, or disinfectant solution if necessary.

17

SPECIFICATION

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 3 metre lead

Stowage hooks for cable on rear.

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 SP2 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

SPECIFICATION

5.1 Pre-use Checklist

A pre-use checklist for the Prima SP2 range of
machines 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 Penlon-trained engineer to the
Service Schedule given in this manual.

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

5. 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 in the User Manual for further information.

Ancillary equipment

12. 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, and that
the oxygen valve is open.

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.

PRE-USE CHECKS

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

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

PRE-USE CHECKS

1

2

5.3 Vaporizers

5.3.1 Pre-use Checks

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 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.

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

Dependent on choice of backbar manifold
system, up to three Selectatec compatible
vaporizers may be fitted.
To install the vaporizer, carefully offer the
vaporizer up to the manifold.
Check that the gas connection ports on the
vaporizer are aligned with the valves on the
manifold.
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.

5.3.4 Selectatec Compatible
Vaporizers with Interlock

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.

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.

23

PRE-USE CHECKS

5.4 Electrical Supply

1. Connect the machine power lead to a
suitable mains supply socket.

2. Set the switch (1) 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:
Check for correct operation.

24

PRE-USE CHECKS

1