Penlon Prima SP2 User Manual

Prima SP2
Anaesthetic Machine Range

User 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 detailed in section 6.4.

Details of these service operations are given
in the Prima SP2 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:

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 and
maintenance checks 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.

Before using any monitoring system or
device with the anaesthetic machine, the
user must check that it conforms to the
relevant standard, as listed in the table
below.

Parameter / Device Relevant Standard

Pressure Measuring ISO 8835-2
Pressure Limitation Device EN 60601-2-13:2006 - 51.101.1
Exhaled Volume Monitor EN 60601-2-13:2006 - 51.101.4
Breathing System Integrity Alarm System EN 60601-2-13:2006 - 51.101.5
Continuing Pressure Alarm EN 60601-2-13:2006 - 51.101.6
Oxygen Monitor ISO 7767
Carbon Dioxide Monitor ISO 9918
Breathing Circuit ISO 8835-2
Gas Scavenging ISO 8835-3
Vaporizers ISO 8835-4
Ventilators ISO 8835-5
Agent Monitor ISO 11196

For information on installing and connection of any of these systems or devices, please refer to the relevant manufacturer’s instructions.

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 13

3.11 A200SP Absorber 13

3.12 AV-S Ventilator 13

4.

SPECIFICATION 14

4.1 Physical Dimensions 14

4.2 Gas Supplies 15

4.3 Flowmeters 15

4.4 Gas Pressures 16

4.5 Auxiliary Gas Outlets 16

4.6 Oxygen Failure Warning Devices 16

4.7 Oxygen Flush 16

4.8 Mechanical AHD System 17

4.9 Environmental 17

4.10 Electrical Supply 17

4.11 Device Classification and Labelling 18

5.

PRE-USE CHECKS 19

5.1 Pre-use Check List 19

5.2 Pre-use Checks - Gas Supply 21

5.2.1 Gas Pipeline Supplies 21

5.2.2 Gas Cylinder Supplies 21

5.2.3 Flowmeters 22

5.3 Vaporizers 23

5.4 Electrical Supply 24

CONTENTS

(iii)

5.5 Patient Breathing System 25

5.6 Leak Rate Check - Low pressure gas System 28

5.7 Oxygen Flush 28

5.8 Anaesthetic Gas Scavenge System (AGSS) 28

5.9 Ventilator 29

5.10 Alarm System Testing 30

6.

USER MAINTENANCE

6.1 Cleaning and Sterilisation 31

6.2 A200SP Absorber 32

6.3 Service Schedule 33

APPENDIX

Disposal at end of useful life: risk assessment 34
Accessories 35

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, unauthorised personnel must
not attempt to access fuses or other
electrical components. 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 series 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.)

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 gas supply failure systems within
the anaesthetic machine will not
necessarily operate as indicated in the
user manual during any procedures that
are outside the scope of the indications
for use of the machine:

2

1. WARNINGS AND CAUTIONS

(A) Machine set to deliver Air only

When the machine is operated with an Air
flow only, note that there may still be
retained oxygen in the system, and that the
visual O2 alarm will continue to indicate
green, even though oxygen is not being
delivered.

(B) Machine set to deliver Oxygen only
through Auxiliary Outlets

The oxygen failure alarm is designed to
operate during normal use of the machine,
i.e. when providing controlled
concentrations and flows of gases to a
patient breathing system, as described in
Section 2 (Purpose).

Do not use the machine solely to provide
large flows of oxygen, via the anaesthetic
machine auxiliary outlets, to external
devices which may not be equipped with a
supply failure alarm.

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

13. The use of antistatic or electrically
conductive breathing hoses is not
recommended when using high
frequency electrical surgery equipment
(e.g. : Diathermy). Burns may be
caused.

14. Before any electrically powered machine
is used clinically for the first time,
check that the hospital engineering
department has carried out an earth
continuity test.

15. Before using any additional electrical
equipment powered by the auxiliary
sockets on the machine, check that the
additional equipment is correctly wired
and is earthed through its plug.
A missing or defective protective earth
conductor may increase earth leakage
currents to the patient to values
exceeding the allowable limits,
resulting in ventricular fibrillation, or
interference with the pumping action of
the heart.

16. Additional equipment placed on the top
shelf must be securely attached.
Take care when moving a fully loaded
machine, particularly when negotiating
ramps.
Check that hoses or power leads are not
trailing on the floor.

3

WARNINGS AND CAUTIONS

17. Prima SP2 series anaesthetic machines
are not MRI compatible.

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.

5. Mechanical AHD system - The oxygen flow
control is restricted to prevent the needle
valve from fully closing. This ensures a
minimum basal flow of oxygen.
DO NOT attempt to close the flow to zero.
Do not overtighten.

6. Compressed gas supplies must be clean
and dry.

7. When the auxiliary gas outlets are in use on
a machine with cylinder supply only, or if
the pipeline supply is not in use, check flow
rate requirements, and ensure that
adequate back-up cylinders are available.

8. The requirements of IEC 60601-1-1 apply to
any device connected to the auxillary
sockets. Users must be aware of the risks of
increased leakage currents when
equipment is connected to the auxillary
power sockets

9. In the event of malfunction of any device
powered by the auxiliary sockets, check if
the circuit breaker has tripped.

10. On machines with pipeline connections,
note that a malfunction of the central gas
supply within your facility may cause
immediate cessation of gas delivery and
total anaesthesia system failure.

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,
including:

Gas supplies

Up to four gases - oxygen, nitrous oxide, and
air, with optional fourth gas (see section 4).

Pin-index cylinder yokes, and provision for
up to three pipeline supply inlets.

Vaporizer mounting systems

Backbar manifold for Selectatec Compatible,
or Cagemount type vaporizers.

Anti-hypoxic Device (AHD)

The mechanical AHD system is designed to
minimise the risk of a hypoxic mixture
reaching the patient (see section 3).

4

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.

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.

CAUTION

A malfunction of the central gas supply within
your facility may cause immediate cessation of
gas delivery and total anaesthesia system failure.

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 pressure relief valve, factory set to 517
kPa (75 psi). This prevents pressure build up
under the diaphragm should any leakage
develop across the reducing valve seat.

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

USA specification 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)

Filter

Flowmeter

Vaporizer

Oxygen flush valve

Non-return valve

Power take-off point
(or test point)

Visual indicator

3.3 Gas Supply Safety Devices

3.3.1 Gas Supply Cut-off Device

A gas cut-off device, triggered by low oxygen
supply pressure, cuts the supply of nitrous
oxide, and carbon dioxide or other fourth gas
(if fitted).

The cut-off operates when the oxygen
pressure falls to 200 ± 14 kPa (29 ± 2 psig).

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

3.3.2 Oxygen Supply Failure Warning
Whistle

WARNING: Refer to WARNING 11 (section 1).

A whistle gives an audible warning when
there is a reduction of oxygen supply
pressure.
Operated solely by the remaining oxygen in
the machine system, the warning whistle is
prolonged by an oxygen reservoir built into
the gas circuit, allowing a minimum warning
whistle of 7 seconds duration.

The whistle will start to sound when the
pressure falls to 200 ± 21 kPa (29 ± 3 psig),
and will continue to sound until the pressure
falls to approximately 70 kPa (10 psig).

Oxygen consumption of the whistle is
approximately 2 L/min when sounding and
nil at other times.

3.3.3 Fresh Gas Pressure Relief Valve

A pressure relief valve is mounted between
the vaporizer back bar and the common gas
outlet (CGO) on the inside face of the
machine right hand upright.

It is designed to prevent fresh gas being
delivered to the breathing system at
pressures exceeding 41 kPa (6 psi).
This valve also protects machine
components against excessive pressure in
the event of a total blockage of the CGO.

3.3.4 Oxygen Supply Visual Indicator

WARNING: Refer to WARNING 11 (section 1).

The indicator (1) is mounted on the front of
the machine and is operated from the
oxygen supply and shows GREEN when the
supply is at working pressure, and RED if the
pressure falls.

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 (1)

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 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