Prima 465

Prima 465 Anaesthetic Machine User Manual
A N A E S T H E S I A S O LU T I O N S
IMPORTANT
Servicing and Repairs

In order to ensure the full operational life of this device,
servicing by an engineer trained by the manufacturer should
be undertaken periodically.
The machine must be serviced to the schedule detailed in
section 7.
Details of these service operations are given in the Prima 465
service manual, available only for Penlon-trained engineers.
For any enquiry regarding the servicing or repair of this device,
contact the nearest accredited Penlon agent:
or communicate directly with:

UK and ROW, except USA
Technical Support
Penlon Limited
Abingdon Science Park
Abingdon, OX14 3NB, UK
Tel: +44 (0) 1235 547060
Fax: +44 (0) 1235 547061
E-mail: tech.support@penlon.com
USA
Penlon Inc.
11515 K-Tel Drive
Minnetonka
MN 55434
USA
Toll Free: 800-328-6216
Tel: 952-933-3940
Fax: 952-933-3375
E-mail: customer.service@penlon.com
Always give as much of the following information as possible:

1. Type of equipment
2. Product name
3. Serial number (refer to the device ID label)
4. Approximate date of purchase
5. Apparent fault
Prima 465 Anaesthetic Machine i User Manual

Foreword
This manual has been produced to provide authorised IMPORTANCE OF PATIENT MONITORING
personnel with information on the function, routine,
performance and maintenance checks applicable to the Prima WARNING
465 anaesthetic machine. Anaesthesia systems have the capability to deliver mixtures
of gases and vapours to the patient which could cause injury
Information contained in this manual is correct at the date of or death unless controlled by a qualified anaesthetist.
publication. The policy of the manufacturer is one of continued
improvement to their products. Because of this policy the There can be considerable variation in the effect of
manufacturer reserves the right to make any changes which anaesthetic drugs on individual patients so that the setting
may affect instructions in this manual, without giving prior and observation of control levels on the anaesthesia system
notice. does not in itself ensure total patient safety.
Personnel must make themselves familiar with the contents Anaesthesia system monitors and patient monitors are very
of this manual and the machine function before using the desirable aids for the anaesthetist but are not true clinical
apparatus. 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, the user must
check that it conforms to the relevant standards.
Prima 465 Anaesthetic Machine ii User Manual

Contents
1. Warnings and Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2. Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3. Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.1 General construction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.2 Gas circuit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.3 Gas supply safety devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.4 Gas circuit components and controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.5 Vaporizer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.6 Communications ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.7 Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.8 Electrical Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.9 Alarm system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.10 Absorber. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.11 Anaesthetic gas scavenge system (AGSS). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.12 Ventilator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.13 Patient monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4. Specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.1 Physical dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.2 Gas supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.3 Gas supply pressure and flow rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.4 Auxiliary gas outlets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.5 Oxygen flush. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.6 Fresh gas mixture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.7 Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.8 Electrical supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.9 Ventilator and breathing system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.10 Device classification and labelling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5. Installation and Pre-use Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

5.1 Installation and Commissioning before first clinical use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.2 Pre-use test before each clinical procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.3 Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.4 Start up test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.5 Pipeline gas supply tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.6 Oxygen fresh gas supply check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.7 Cylinder gas supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.8 Vaporizers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.9 Alarm tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.10 Breathing circuit tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.11 Oxygen flush test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.12 Preoperative procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6. Operating the Anaesthesia System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

6.1 Ventilation modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6.2 Standby mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6.3 Home screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.4 Function fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
6.5 Ventilator setting fields. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
6.6 Fresh gas fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Prima 465 Anaesthetic Machine iii User Manual

Contents
6.7 Waveform field displays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

6.8 Measured values fields - key parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
6.9 Measured values fields - general parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
6.10 Anaesthetic Gas fields (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
6.11 Alarm silence status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
6.12 Alarm message field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
6.13 System prompt message and icons field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
6.14 System start-up procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
6.15 Ventilation mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
6.16 Monitoring parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
6.17 Absorber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
6.18 System shut-down procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
7. Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
7.1 Service schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
7.2 Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
7.3 Absorber and breathing system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
7.4 Anaesthetic gas scavenging system - Receiver unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
7.5 Breathing system sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
7.5 Flowmeter zero calibration procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
7.7 Oxygen monitor calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
7.8 Water trap - sidestream anaesthetic gas monitoring module (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
7.9 Battery replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
7.10 Fault diagnosis and troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
8. Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Appendix 1. References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Appendix 2. Disposal at end of useful life: risk assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Appendix 3. Optional extras and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Appendix 4. Labelling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Appendix 5. Gas circuit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Appendix 6. Optional sidestream anaesthetic gas monitoring module - single agent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Appendix 7. Electromagnetic compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Prima 465 Anaesthetic Machine iv User Manual

User Responsibility
This device has been built to conform with the specification and Statements in this manual preceded by the following words
operating procedures stated in this manual and/or accompanying are of special significance:-
labels and notices when checked, assembled, operated,
maintained and serviced in accordance with these instructions. WARNING
To ensure the safety of this device it must be checked and Means there is a possibility of injury to yourself or others.
serviced to at least the minimum standards laid out in this
manual. A defective, or suspected defective, product must not CAUTION
under any circumstances be used. Means there is a possibility of damage to the apparatus
The user must accept responsibility for any malfunction which or other property
results from non-compliance with the servicing requirements
detailed in this manual. NOTE
Indicates points of particular interest for more efficient
Additionally, the user must accept responsibility for any
and convenient operation.
malfunction which may result from misuse of any kind,
or non-compliance with other requirements detailed in The reader must take particular notice of the warnings,
this manual. 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 Penlon Limited or the nearest Penlon Service Centre.
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 Limited 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.
Prima 465 Anaesthetic Machine 1 User Manual

1. Warnings and Cautions
The following WARNINGS and CAUTIONS must be read and they are not a permanent part of the anaesthetic
understood before using this anaesthesia system. machine and therefore cannot be directly under the
control of the anaesthetic machine manufacturer. When
Warnings mechanical ventilation is employed the patient breathing
1. This anaesthesia system is designed for use only with system must be connected directly to an over-pressure
non-flammable anaesthetic agents. It must not be used relief valve to prevent the possibility of barotrauma.
with or in close proximity to flammable anaesthetic
agents, due to a possible fire or explosion hazard. 10. Always perform a pre-use check of the machine,
including vaporizers, ventilator, absorber and monitors
2. Exterior panels must not be removed by unauthorised before clinical use. Follow the pre-use checklist (see
personnel and the anaesthesia system must not be section 5.2) as a minimum requirement.
operated with such panels missing. Unauthorised Many clinical incidents occur because of a failure to
personnel must not attempt to access fuses or other check for correct function.
electrical components. There is a possible electric shock
hazard. 11. The system start-up test (section 5.4) includes an
automatic system test. This test includes system
3. To isolate the machine from the mains power supply, calibration tests. If the screen displays a ‘Fail’ for the
disconnect the mains cable from the hospital power Pressure sensor, Flow sensor, or Flowmeter zero
outlet. calibration tests, follow the instructions given in
Always use a mains power outlet socket that can be sections 7.5.1, 7.5.2, and 7.6.
easily accessed. DO NOT use any other procedures.
If a ‘Fail’ error is still displayed, contact a Penlon-trained
4. No oil, grease or other flammable lubricant or sealant
service engineer.
must be used on any part of the machine in close
proximity to medical gas distribution components. 12. The machine must not be used if any of the alarm,
There is a risk of fire or explosion. monitoring, or protection system devices are not
functioning correctly.
5. Attaching or removing a medical gas cylinder:
13. Auxiliary gas outlets: Flow rates greater than 60 L/min
a) Follow appropriate manual handling guidelines
could affect the fresh gas flow to the patient.
when lifting.
14. When the auxiliary gas outlets are in use on a machine
b) Check that the machine yoke and cylinder faces are
using cylinder supply only (i.e. if the pipeline supply is
dust free and clean and that the sealing washer
not in use), check flow rate requirements, and check that
provided is in position between the cylinder valve
adequate back-up cylinders are available.
and the yoke.
15. Do not use the machine solely to provide large flows of
c) Tighten the yoke securely before opening the
oxygen, via the anaesthetic machine auxiliary outlets,
cylinder valve. Dust and dirt presents a fire hazard in
to external devices which may not be equipped with a
the presence of high pressure gas. Leakage of high
supply failure alarm.
pressure gas can cause serious injury.
16. On machines with pipeline connections only, note that a
6. The anaesthesia system must be connected to an
malfunction of the central gas supply within your facility
anaesthetic gas scavenging system (AGSS) to dispose
may cause immediate cessation of gas delivery and total
of waste gas and prevent possible health hazards to
anaesthesia system failure.
operating room staff.
This requirement must be observed during test 17. To avoid the risk of electric shock, this system must only
procedures as well as during use with a patient. be connected to a mains supply with a protective earth.
Before any electrically powered machine is used
7. This machine must only be used with Selectatec-
clinically for the first time, check that the hospital
compatible vaporizers installed on the backbar.
engineering department has carried out an earth
Free-standing vaporizers may be accidentally tipped,
continuity test.
resulting in excessive and uncalibrated volumes of
anaesthetic drug entering the breathing system. 18. Before using any additional electrical equipment
powered by the auxiliary sockets on the machine, check
8. Only vaporizers with the Selectatec-compatible interlock
that the additional equipment is correctly wired and is
function will interlock if installed on the backbar.
earthed through its plug.
The installation of non-interlock vaporizers allows the
possible operation of more than one vaporizer at the 19. A missing or defective protective earth conductor may
same time. increase earth leakage currents to the patient to values
exceeding the allowable limits, resulting in ventricular
9. The breathing system which conveys gases from the
fibrillation, or interference with the pumping action of
anaesthetic machine to the patient and disposes of
the heart.
expired gases is a vital part of the anaesthetic delivery
system.
Because breathing systems require frequent cleaning

Warnings and Cautions
20. Portable RF (radio frequency) communications 34. Ventilating neonates (infants)

equipment (including peripherals such as antenna
a) Use only Pressure Control Ventilation or Volume
cables and external antennas) should be used no
Control ventilation for mandatory ventilation of
closer than 30 cm (12 inches) to any part of this device, neonates.
including cables specified by the manufacturer.
Otherwise, degradation of the performance of this b) Always set a low target pressure first and then
equipment could result. increase to the required level.
21. Additional equipment placed on the top shelf must be c) Use breathing circuits and filters specifically designed
securely attached. for paediatric/neonatal use
22. The following conditions must apply before the machine d) Do not ventilate pre-term babies with birth weights
is transported. below 2.4 kg.
a) Detachable parts removed 35. Patient monitoring:
b) The drawers must be empty a) Always use an anaesthetic agent monitor that
complies with the latest relevant standard.
c) All gas cylinders must be removed.
b) Always monitor oxygen concentrations
23. MRI compatibility - Prima 465 models are not MRI
compatible. c) Always check that the monitors are functioning
correctly before starting the clinical procedure.
24. To prevent patient injury in the event of total anaesthesia
system failure, an alternative means of ventilation must d) An external anaesthetic gas monitoring device,
be available whenever the device is in use. complying with ISO/IEC 80601-2-55 must be
connected to the breathing circuit. Use the
25. Obstruction of the breathing system can restrict or manufacturer’s instructions to correctly connect the
stop gas flow to the patient, and can cause injury or device.
death. Make sure that there are no obstructions in the
breathing system. 36. When connecting other equipment to the auxiliary sockets a
medical electrical system is created and the whole system
26. Keep very small components/parts/plugs away from the should be re-evaluated to the requirements of BS EN
breathing system. 60601-1.
27. Use non-conductive breathing system hoses. 37. Gas analyser (N2O, O2, CO2) measurements are intended
only to assist in patient assessment. These devices must
28. Do not touch any electrical device connector at the same
be used in conjunction with other patient physiological
time as the patient, when the machine is connected to
indications and in the assessment of the overall patient
the mains supply.
condition.
29. This machine is not suitable for use in oxygen-rich
38. When any accessory is installed on the shelf or attached
environment.
to an arm mount, you must check the stability of the
30. This device must not be altered or modified in any way anaesthetic machine before use.
without the written permission of Penlon limited.
39. When the machine is in operation, the alarm message
31. Make sure that the absorber canister sensor is clean and field must be visible to the operator at all times.
unobstructed by cables or tubing etc, at all times.
40. Sidestream anaesthetic gas monitoring module (if
32. Communication ports should not be subjected to fitted): Check the water trap for damage (cracks, etc.) and
voltages greater than 7 V DC. Damage to internal replace if damaged.
circuitry may occur. To maintain adequate levels of hygiene, the water trap must
be replaced every four weeks.
33. In the event of a mains failure or operation of the mains Note that the sample tubing is a single-use component.
circuit breaker, the auxiliary mains outlet sockets will
not function. Make sure that any equipment connected to
the auxiliary mains outlet sockets are protected against
mains failure.

Warnings and Cautions
Cautions
1. Open cylinder valves slowly to avoid damage to

pressure reducing valves.
Check that cylinder valves are at least one full turn
open when in use.
2. Under no circumstances should anaesthetic agents be

used for cleaning purposes.
3. After use, always disconnect the machine from the

piped gas supply and/or close the gas cylinder valves.
4. Compressed gas supplies must be clean and dry.
5. The requirements of IEC 60601-1 apply to any device

connected to the auxiliary electrical sockets. Users
must be aware of the risks of increased leakage
currents when equipment is connected to the auxiliary
power sockets
6. In the event of malfunction of any device powered by

the auxiliary sockets, check if the circuit breaker has
tripped.
7. Do not apply excessive pressure to the display screens.
8. Connect the external RS232 outlet only to approved

devices using protocol provided by Penlon Ltd. Contact
Technical Support Department for details.
9. Vaporizers: Read the instruction manual supplied with

the vaporizer before clinical use.
Note
1. Screen displays and waveform displays shown in this
manual are given as examples only.
Settings and the parameter values shown may not be
replicated on your system.
2. Refer to Appendix 4 for labelling and symbols

2. Purpose
Intended use
The Prima 465 anaesthesia system is for use by a professional

operator in a professional healthcare environment, and must
be continually attended when in use.
Application
The device 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 device in conjunction with anaesthetic vaporizers,
breathing hoses and patient connection fittings which comply
with the relevant ISO standard or equivalent.
Depending upon the specification, the system can be used in
open or closed circuit configurations.
Intended patient population
This product is intended to be used for a patient population
from neonatal (infants) to adult.
Intended part of the body or type of tissue applied to or
interacted with
No direct interaction with any part of the human body. The
system is used to transmit ventilated gas to and from a patient
whilst absorbing CO2 in the patient expired gas.
Contraindications
The Prima 465 is not suitable for use in an MRI environment.
Contact Penlon Limited for details of the Prima 451 MRI
anaesthetic machine.

3. Description
3.1 General construction
3.1.1 Frame
The machine has a cast aluminium base, extruded aluminium
uprights, with aluminium and plastic mouldings.
4
3.1.2 Mobility
Castors (125 mm diameter), with a brake (1) on each.
A footrest is built into the front of the machine and, to aid
manoeuvrability, a handle is provided at the front of the
machine.
3.1.3 Mounting posts and brackets

A mounting system is built into each pair of side uprights (2),
to allow the use of pole-mount brackets and V-brackets
3
3.1.4 Work surfaces and lighting
The work surface has raised edges to retain instruments, vials 2
etc.
An optional pull-out writing tablet (3) is mounted under the
work surface.
An LED lighting unit, mounted under the top shelf (4), provides
work-area lighting. A three-position switch (Off, On: dim light,
On: bright light) is mounted next to the light unit.
3.1.5 Extractor fan outlet

1
Caution
Do not obstruct the extractor fan outlet (5).
3.2 Gas circuit
3.2.1 Cylinder Yokes

The yokes (6) conform with ISO standards for pin-index fitting.
7
To ensure that only cylinders of the appropriate gas may be
installed the yokes are designed so that the retaining latch 5
cannot be closed unless the index pins are fully engaged.
3.2.2 Pipeline Inlets 6

Three pipeline gas inlets (7) are fitted.
Pipeline supply hoses are connected by territory-specific, non-
interchangeable, screw threaded unions (see section 4.2).
CAUTION
A malfunction of the central gas supply within your facility
may cause immediate cessation of gas delivery and total
anaesthesia system failure.
A schematic is included in Appendix 5.

Description
3.2.3 Gas inlet filter

To prevent dirt entering the gas system, a filter is fitted to each
cylinder yoke and pipeline inlet.
3.2.4 Gas inlet block

Each individual cylinder or pipeline supply, is routed through a
separate gas block.
Each gas block has a pressure gauge, and a non-return valve
to prevent back flow of gas.
In addition, cylinder gas blocks have:
(a) A diaphragm pressure regulator to reduce the pressure of
the compressed gas supply.
(b) A pressure relief valve, factory set to 517 kPa (75 psi). This
prevents pressure build up under the diaphragm if a leak
develops across the seat of the reducing valve.
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.
The supply of nitrous oxide is reinstated only when the oxygen
supply pressure rises above the cut-off value.
3.3.2 Fresh gas pressure relief valve

A valve is fitted to prevent fresh gas being delivered to the
breathing system at pressures exceeding 90 cmH2O.

Description
3.4 Gas circuit components and controls
3.4.1 Anaesthesia system switch

The anaesthesia system switch (1) controls the operation of
the anaesthesia machine.
1. Switch labelling:
I indicates On
0 indicates Off
2. Pneumatic function
The switch operates on the oxygen supply and must be in
the ‘On’ position for normal operation of the system. 1
NOTE
When the switch is in the ‘Off’ position, note that there
may still be retained oxygen in the system, even though
oxygen is not being delivered.
3. Electrical function
The switch controls the anaesthesia system internal
electrical circuit.
3.4.2 Electronic flow mixer

1
3.4.2.1 Fresh gas flow
Pre-set flows
The display (1) shows the range of default fresh gas flows
available.
User-set flow
Fresh gas flow values (2) can be set using the touchscreen
buttons (3 and 4), and the multifunction control knob (5).
Note that a minimum oxygen flow of 200 ml/min is
automatically delivered. Fresh gas
0.08
O
0.05
2
16
3.4.2.2 Oxygen / nitrous oxide mixture 2
O2/Air
8.0
The software maintains a fresh gas mixture with a minimum 4.0 5
of 25% +5%/-4% oxygen throughout the delivery range. Flow 2.0 O2/N2O
values and oxygen concentration values that have been set by 1.0
the user will be automatically applied. 0.5 O2
0
Nitrous oxide flows are automatically calculated by the O2 Gas mix
software and can not be set by the user. 3 60
21 % 100 O2/Air
See section 5.1.7.3 for settings when the user set a low oxygen 4
FG FLOW
flow. 21
0.2
% 100
Note
In Standby mode a minimum oxygen concentration of 30%
must be set, and a minimum flow of 300 ml.

Description
1
3.4.3 Auxiliary CGO control (if fitted)
The auxiliary common gas outlet (ACGO) system allows the
user to select either the system closed breathing circuit
configuration or an open circuit configuration.
Closed circuit configuration
When the switch (1) is in the upper position (as illustrated)
fresh gas is delivered to the absorber circle system and the
system operates in a closed circuit configuration.
Open circuit configuration
When the switch is in the lower position, fresh gas is delivered
to the outlet (2) for use with other delivery systems, e.g. Magill
circuit.
2
Note
1. The switch and the outlet assembly are both illuminated.
2. The legend ‘ACGO’ (3) is displayed on the screen.
3
3.4.4 Alternate O2 supply control and flowmeter

The system provides an alternate O2 flow into the breathing
3
system.
The ON/OFF switch (1) is illuminated when the switch is in the
ON position.
When set to ON: the software controlled fresh gas flow, gas 2
mixture and oxygen concentration displays are disabled.
The O2 control knob (2) varies the flow, as indicated on the flow 1
tube (3).
1
2
3.4.5 O2+ flush button and Common gas outlet (CGO)
The O2+ flush button (1) directs a high flow of oxygen into the
selected breathing circuit.
1. If the auxiliary common gas outlet (ACGO, see section
3.4.3)) switch is ON (see section 3.4.3), the oxygen flow is
directed to the common gas outlet port (2).
2. If the ACGO switch is OFF, the oxygen flow is directed to
the absorber circle system.

Description
3.4.6 Cylinder and pipeline pressure gauges

Pressure gauges (1) for oxygen, air, and nitrous oxide are
located on the front panel .
Cylinder gauges have a red zone that indicates a reduced
delivery pressure.
3.4.7 Auxiliary oxygen flowmeter

The auxiliary oxygen flowmeter (1) is supplied directly from the
O2 supply, and will continue to deliver oxygen if there is a total
power failure. 1
Output is set by the control knob (2) and delivered through the
outlet (3).
3.4.8 Auxiliary gas outlets

Caution
When the auxiliary gas outlets are in use with a cylinder
supply only, or if the pipeline supply is not in use, check the
flow rate requirements, and make sure that adequate back-
up cylinders are available.
Oxygen and air
Auxiliary oxygen and air outlets (1) are mounted on the rear of
the machine.
1
WARNING
Flow rates greater than 60 L/min could affect the fresh gas
flow to the patient - see section 4.4.

Description
3.5 Vaporizer
CAUTION
Read the instruction manual supplied with the vaporizer
before clinical use.
3.5.1 Vaporizer mounting system

Selectatec compatible vaporizers for the administration of
volatile anaesthetic agents can be fitted to the universal
backbar manifold (1). 1
WARNING
All 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.
Do not install or connect any vaporizer of any description
between the alternate common gas outlet (ACGO) and the
breathing system, unless it is specifically designed for such
use. Note that the oxygen flush flow will pass through the
vaporizer, and severe overdosage may result.
2
3.5.2 Selectatec compatible vaporizer

Two Selectatec compatible vaporizers (e.g. the Sigma Delta)
may be fitted to a Prima 465.
Each station is fitted with two valve capsule assemblies (2)
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.
Vaporizer interlock system
Selectatec compatible vaporizer interlock systems are
described in the literature supplied with the vaporizer.
See also, section 5.1.
3.6 Communications ports

3
warning 2 1
Communications ports should not be subjected to voltages
greater than 7 VDC. Damage to internal circuitry may occur.
1. RS232 interface:
The RS232 interface (1) is designed for use with the
Masimo mainstream gas module only.
2. Calibration port (Cal. Port) (2) and the VGA socket (3):
The user must not attempt to access or connect any device
to these ports.
Contact Penlon technical support department
(tech.support@penlon.com) for additional information.

Description
3.7 Control panel

Multifunction control knob (1)
The multifunction control knob is used to select and adjust the
parameters displayed on screen.
1. Rotate the control to navigate between dialogue boxes, or
to increase or decrease values within a selected dialogue
box.
2. Push the multifunction control to select the set value.
3. A dialogue box with three circles next to the title, indicates
that more than one value is associated with the dialogue
box.
Press the control to move between the foreground and
background value. 1
Note
Always confirm the new setting before adjusting another
parameter. If confirmation is not given, the ventilator reverts to
the pre-set value.
4 5 6
Alarm silence button (2) 2 3
The alarm silence button is used to mute the alarm tone for
120 seconds.
Information on the alarms is given in section 6.12.
Alarm reset button (3) 7
The alarm reset button clears any cancelled alarms that are
displayed on the screen.
Home page button (4)
The button returns the displayed screen to the home page.
9
8
Start/Standby button (5)
The start/standby button allows the operator to switch
between standby mode and operational mode
Battery in-use LED (6)
The battery in-use LED is illuminated when there is no mains
power and the machine is switched on.
Battery charging LED (7)
The LED is illuminated when mains power is applied to the
machine and the battery is receiving charge.
Mains power LED (8)
The mains power LED is illuminated when mains power is
applied to the machine.
Alarm indicators (9)
High priority alarm: Three red LEDs
Low or medium priority alarm: Three amber LEDs
All six alarm indicators also illuminate as part of the
anaesthetic machine pre-use checks.

Description
3.8 Electrical Power Supply 4 5 1
3.8.1 Mains Power Supply

WARNING
Always use a mains power outlet socket that can be
easily accessed.
To isolate the machine from the mains power supply,
disconnect the mains cable from the power outlet
socket.
Power is supplied to the machine via the non-detachable
mains cable (1) at the rear upper panel.
Mains power indicators

The LEDs (2) on the control panel and top shelf illuminate
when mains power is connected. 2
4
The LED (3) on the control panel indicates that the back-
up battery is being charged.
Current leakage
NOTE
3
1. It is the user’s responsibility to ensure that the total
sum of leakage currents from additional equipment
plugged into the auxiliary sockets (4) 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. 2
2. Each socket is protected with a 2 A fuse in both the

live and neutral circuits.
3.8.2 Mains inlet circuit breaker

A 10 A circuit breaker (5) provides protection to all the
electronic devices connected to the system.
NOTE
The circuit breaker cannot be reset by the user.
If the circuit breaker trips; contact a Penlon-trained
engineer to reset and test the anaesthetic machine.
3.8.3 Auxiliary mains power supply sockets

CAUTION
1. The requirements of IEC 60601-1 apply to any device
connected to the auxiliary sockets (4). Users must
be aware of the risks of increased leakage currents
when equipment is connected to the auxiliary mains
power sockets.
2. If any device powered by the auxiliary sockets
malfunctions, a Penlon-trained engineer should
check if the circuit breaker has tripped.

Description
3.8.4 Battery
3.8.4.1 Specification
A back-up battery provides power to the machine in the event 1
of an AC mains power failure.
The battery in-use LED (1) is illuminated when there is no

mains power and the machine is switched on.
LED (2) is illuminated when there is mains power applied to
the machine and the battery is receiving charge. 2
If the AC power supply fails, the system will automatically
switch to battery supply.
Backup time: Approximately 1.5 hours
Note that the backup time depends on system configuration

and operation.
For example, frequent use of monitoring modules will shorten
the backup time available.
A suitable warning is given prior to total battery discharge.
Battery recharge
The battery is charged automatically when the machine is
connected to an AC power source.
Recharge time: Approximately 4 hours from total discharge.
3.8.4.2 Battery charge indicator

Ventilation will still be possible when a low battery alarm is
triggered.
When the indicator (1) shows empty display sectors, and the
battery total discharge alarm is triggered, automatic shutdown 1
will occur unless mains power is restored.
Caution
1. If a battery has been stored in a discharged state,
charging may take longer than the time stated above.
2. If the machine is in storage, charge the batteries every
two months.
3.8.4.3 Battery life

Battery life depends on frequency and period of use.
Penlon recommends replacement every two years.
3.8.4.4 Battery replacement

Warning
Battery replacement must be undertaken by a competent,
1
trained engineer, see section 7.9.
The battery compartment (1) is located at the rear of the
machine.

Description
3.9 Alarm system
Warning
When the machine is in operation, the alarm message field
(1) must be visible to the operator at all times.
1
3.9.1 Alarm message field
The alarm message field (1) is displayed at the top of the
display screen.
Alarms displayed in the alarm message field are classified as
Clinical or Technical.
Clinical alarms are related to patient condition, see section
6.12.5.
Technical alarms are related to the functioning of the
anaesthesia system, see section 6.12.6..
Alarms are displayed as long as the condition that caused the
alarm remains.
High level alarms are displayed on a red background.
Medium and low alarms are displayed on a yellow background
All alarms displayed in the alarm message field are
accompanied by an audible alarm.
3.9.2 Alarm silence

The alarm silence button (2) mutes the audible alarm for a 2 3
maximum of 120 seconds.
3.9.3 Alarm reset

The alarm reset button (3) removes visual alarms that are no
longer active.
3.9.4 Alarm indicators

The alarm indicators (4) consist of two rows of LEDs.
The upper row are coloured red and flash when a high level 4
alarm occurs.
The lower row are coloured amber and flash when a medium
or illuminate (without flashing) when a low level alarm occurs.
3.9.5 Limits display - Alarm log

The Limits display includes the Alarm Log page.
The latest 100 alarms are listed, with the time and date of
their appearance.
The alarm log will only display the latest 100 alarms with
newer alarms overwriting the oldest logged alarm.

Description
3.10 Absorber
3.10.1 Bag/Ventilator switch

The Bag/Ventilator switch (1) facilitates switching between 1 2
ventilator mode and manual bag mode.
14
Ventilator mode: move the switch to the right.
Bag mode: move the switch to the left. 13
Automatic ventilator mode switching

With the system operating in mechanical ventilation mode,
moving the switch from Ventilator to Bag position will trigger 12
an automatic ventilator mode change to Manual ventilation.
11
Moving the switch from Bag to Ventilator position triggers a
return to the previous mode.
9
10
3.10.2 Adjustable pressure limiting valve
The APL valve (2) provides breathing system pressure control,
and excess pressure relief. 8
Turn the dial clockwise to increase the pressure limit up to a 6

maximum of approximately 70 cmH2O. 3
3.10.3 Absorber canister
The absorber canister (3) contains 1.5 litres of carbon dioxide
absorbent. Do not overfill. Do not exceed the ‘MAX’ line
marked on the canister, refer to section 6.17. 7 4
Warning
A gradual colour change of the soda lime absorbent indicates
approximately the level of absorption of carbon dioxide.
Check the instructions supplied with the absorbent.
Canister ‘not fitted’ alarm
A sensor (4) triggers an alarm when the canister is removed.
CAUTION
Do not obstruct the sensor - do not route any hoses or cables
(including the oxygen monitor sensor cable (5) in front of the 5
canister sensor.
3.10.4 Oxygen monitor sensor

NOTE
If a sidestream gas monitoring module is installed (with
optional paramagnetic oxygen monitoring) the oxygen sensor
shown (6) is not required and the sensor port is blanked off.
The oxygen sensor (6) measures the O2 content of the circle
system. The sensor cable (5) connects to an input socket (7) on
the side of the machine.
CAUTIONs
Check the sensor calibration during the start-up tests
whenever the system is switched on.
Do not route the cable (5) in front of the canister sensor (4).

Description
3.10.5 Inspiratory and expiratory ports

1 2
The inspiratory (8) and expiratory (9) ports are connected to the
patient breathing circuit.
14
A differential pressure flow sensor is located within each
port. The sensors measure flow and volume within the patient 13
circuit.
3.10.6 Inspiratory and expiratory non-return valves 12

The inspiratory (10) and expiratory (11) valves control the
direction of the gas flow through the system. 11
Each valve consists of a disc located over a valve seat.
9
WARNING
10
The discs operate by gravity. The absorber must be securely
mounted in an upright position.
8
The valve discs are visible, and the operation of each valve can
be visually checked as the patient breathes in and out.
3.10.7 Airway pressure gauge

The pressure gauge (12) displays airway pressure in the
inspiratory circuit.
Pressure is displayed in cmH2O and kPa. 6
3
3.10.8 Bellows housing

The bellows housing (13) provides an airtight compartment for
the breathing system bellows.
3.10.9 Breathing bag arm

The bag arm (14) can be rotated so that the bag is positioned
for ease of use when manual ventilation is applied.
5
1
3.11 Anaesthetic gas scavenge system (AGSS)
The AGSS receiver (1) is mounted on the side of the machine 2 4
(2), see section 5.1.9.
All sources of expired anaesthetic gases (e.g. directed from
the absorber APL valve, and the ventilator bellows patient gas
exhaust), are directed internally to the outlet (3) at the right-
hand-side of the rear of the machine. A hose (4) connects the
outlet to the receiver unit inlet port.
The output hose (5) connects to the hospital disposal system.
WARNING
1. Do not connect any vacuum system directly to the
outlet (3).
2. The receiving system (1), with a positive and negative
pressure control function, must be used.
3. Systems must comply with ISO 80601-2-13. 3

Description
3.12 Ventilator
The ventilator is a pneumatically driven, microprocessor-
controlled device, with multiple ventilation modes. Drive gas is
provided through the anaesthesia system. The drive gas can be
oxygen or air.
If the drive gas in use fails, the alternate supply can be selected.
Support-mode waveforms are displayed in colour - see section
6.1.4.
3.12.1. Volume control ventilation (VCV)

The ventilator delivers a mandatory set volume of gas at preset,
fixed breath intervals.
The patient is making no respiratory effort
3.12.2. Pressure control ventilation (PCV)

The ventilator delivers a variable flow of gas to achieve a set
pressure at fixed breath intervals. The patient is making no
respiratory effort
3.12.3. Pressure-regulated volume controlled ventilation

(PRVC)
In PRVC a tidal volume is set and the ventilator delivers that
volume at a constant pressure. The ventilator will adjust the
inspiratory pressure breath-by-breath, so that the lowest pressure
is used to deliver the set tidal volume.
3.12.4. Synchronised intermittent mandatory ventilation -

volume control (SIMV-V)
The ventilator delivers volume controlled breaths which are
synchronised with the patients inspiratory efforts. The ventilator
also allows spontaneous breaths with pressure support.
3.12.5 Synchronised intermittent mandatory ventilation -

pressure control (SIMV-P)
The ventilator delivers pressure controlled breaths which are
synchronised with the patients inspiratory efforts. The ventilator
also allows spontaneous breaths with pressure support.

pressure-regulated volume controlled (SIMV-PRVC)
The ventilator delivers synchronised pressure controlled breaths
at the lowest possible pressure in order to deliver the set tidal
volume. The ventilator also allows spontaneous pressure support
breaths.
3.12.7 Spontaneous / Pressure support ventilation

(SPONT/PSV)
The ventilator allows spontaneous breaths and delivers pressure
support at a pre-set trigger level. In the event of an apnea
condition, the ventilator enters a backup mode - either VCV or PCV,
whichever the user has selected.

Description
3.13 Patient monitoring
3.13.1 Parameters
Measured parameters are grouped on-screen into two
displays - Values 1 and Values 2.
Values 1
Note Values 1 Values 2 X
O2 monitoring is not shown in the illustration. VTI 0 mL Ppeak 0 cmH2O Rst -- cmH2O/L/S
VTE 0 mL Pmean 0 cmH2O Cdyn 10 mL/cmH2O

• Inspiratory tidal volume (VTI)
MV 0 L Pplat 0 cmH2O FiO2 -- %
• Expiratory tidal volume (VTE) MVspn 0 L PEEP 0 cmH2O SpO2 -- %
• Minute ventilation (MV) ftotal 15 bpm Pmin -0.1 cmH2O Pulse -- bpm
fspn 0 bpm I : E 1 : 2.01 PI -- %

• Spontaneous minute ventilation (MVspn)
• Respiratory rate (ftotal)
• Spontaneous breathing frequency (fspn)
• Peak airway pressure (Ppeak)
• Mean airway pressure (Pmean)
• Inspiratory plateau pressure (Pplat)
• Positive end expiratory pressure (PEEP)
• Minimum airway pressure (Pmin)
• Respiratory ratio (I:E)
• Airway resistance (Rst)
• Compliance (Cdyn)
• Fraction of inspired oxygen (FiO2)
• Peripheral oxygen saturation (SpO2)
• Pulse rate (bpm)
• Perfusion index (PI)
Values 2 (available with optional gas monitoring)
Values 1 Values 2 X
Note MAC 0 FiAA1 -- --
Paramagnetic O2 monitoring is not shown in the illustration. FiCO2 0 % EtAA1 -- --
• Minimum alveolar concentration (MAC) EtCO2 0 % FiAA2 -- --
FiN2O 0 % -- --
• Fraction of inspired carbon dioxide (FiCO2)
EtAA2
EtN2O 15 % --
• End tidal carbon dioxide (EtCO2) -- --
• Fraction of inspired nitrous oxide (FiN2O)

• End tidal nitrous oxide EtN2O
• Fraction of inspired anaesthetic agent 1 (FiAA1)
• End tidal anaesthetic agent 1 (EtAA1)
• End-tidal anaesthetic agent 2 (EtAA2)

4. Specification
Note
Gas flow rates, volume and leakage specifications for the breathing circuit are displayed as BTPS values (body temperature and
pressure saturated).
Other gas specifications are given as STPD values (Standard temperature and pressure dry)
4.1 Physical dimensions
Note
All data is approximate
Overall frame size Height 131 cm

Width 79 cm
Depth 70 cm
Work surface Height 86 cm
Size 58 x 25 cm
Loading 30 kg (66 lb) (evenly distributed)
Writing tablet (optional) Size 30 x 22 cm
Top Shelf Size 71 x 35 cm
Loading 30 kg (66 lb.) (evenly distributed)
Drawers Size 12 x 54.5 x 35 cm
Castors Diameter 12.5 cm (5 inches)
Bracket on frame upright
Gas scavenging receiver fixing
Loading 30 kg (66 lb)
Auxiliary common gas outlet 22 mm male taper with coaxial 15 mm female taper connections
Mass 125 kg (275 lb)
4.2 Gas supplies
Cylinders Three (oxygen, air, nitrous oxide)

Pin-indexed cylinder yokes
Pipeline Three pipeline inlets (oxygen, air, nitrous oxide).
UK and Europe: NIST
USA: DISS
Australia: SIS
Medical gas colour codes
Oxygen Green or White*
Nitrous oxide Blue
Medical air Yellow or Black*
* to comply with relevant national standards

Specification
4.3 Gas supply pressure and flow rate
USA/Canada/Japan UK
Pipeline supplies:
Supply Pressure 280-600 kPa (40.6-87.0 psig) 280-600 kPa (40.6-87.0 psig)
Pipeline flow rate
Air/Oxygen 40-100 L/min 40-100 L/min
Nitrous Oxide ≤15 L/min ≤15 L/min
Cylinder supplies:
Supply pressure 19 985 kPa (2900 psig) 19 985 kPa (2900 psig)
Reduced pressure from regulator 310 kPa + 15 kPa/-35 kPa 380 kPa + 15 kPa/-35 kPa
(at 5 L/min) (45 psig +2 psig/-5 psig) (55 psig +2 psig/-5 psig)
Regulator diaphragm bursting pressure 2800 kPa (406 psig) 2800 kPa (406 psig)
Reduced pressure from secondary regulators (at 5 L/min)
Oxygen and nitrous oxide 152-241 kPa (22 - 35 psig) 152-241 kPa (22 - 35 psig)
Air 207-283 kPa (30 - 41 psig) 207-283 kPa (30 - 41 psig)
Fresh gas supply pressure
Safety valve 90 cmH2O 90 cmH2O
4.4 Auxiliary gas outlets
Oxygen
Two self-sealing connections on rear of machine
Air
Two self-sealing connections on rear of machine
Supply pressure
Pipeline supply in use: Gas is supplied at pipeline supply pressure
Cylinder supply Gas is supplied at reduced pressure from the cylinder supply secondary regulator
Flow rate
Flow rate for each gas: 60 L/min maximum
WARNING
Flow rates greater than 60 L/min could affect the fresh gas flow to the patient.
4.5 Oxygen flush

Flush button on the front edge of the work surface.
The system supplies 25-75 L/min when the button is fully depressed.
For more information refer to 3.4.5.
4.6 Fresh gas mixture
Minimum oxygen concentration :25% +5%/-4% (of total O2 + N2O flow) - a minimum
Anti-hypoxic fresh gas mixture
of 21% oxygen
Barometric compensation Compensated to 101.3 kPa
Electronic mixer response time 500 msec (10% to 90% flow step)

Specification
4.7 Environmental
Operating conditions
Temperature +10 to 40° (50 to 104°F)
Atmospheric pressure range 70 to 106 kPa
Altitude 2438 m (8000 ft) maximum
Humidity 5-95% R.H. non-condensing
Transport and storage conditions
Temperature -5 to 40°C (23 to 104°F)
Atmospheric pressure 50 to 106 kPa
Humidity 10-85% RH non-condensing
Cleaning
Wipe external surfaces with dry or damp cloth. Use mild soap, or disinfectant solution if necessary (see section 7.4)
4.8 Electrical supply
Power Input:
US/CSA specification machines: 100-130 VAC, 50/60 Hz, 1000-1300 VA maximum
Non US/CSA specification machines: 120-240 VAC, 50/60 Hz, 2000-2400 VA maximum
Overload protection: 10 A Thermal circuit breaker
Permanently attached lead (3 m). Stowage hooks are fitted at the rear of the
Power cable:
machine.
Internal power distribution

T2AH 250 V ceramic (5 x 20 mm) high breaking capacity (On live and neutral on each
Fuses - Internal power
outlet)
Power outlets:
1. Rear auxiliary power outlets Three outlets: 2 A per outlet maximum
T2AH 250 V ceramic (5 x 20 mm) high breaking capacity (on live and neutral on each
Fuses
outlet)
2. Front power outlet One outlet (IEC socket), 2 A maximum.
Fuses T2AH 250 V ceramic (5 x 20 mm) high-breaking capacity (on live and neutral)
Electromagnetic compatibility
The Prima 465 meets the requirements of EN 60601-1-2 (electromagnetic compatibility - requirements and tests). Refer to
Appendix 8.
Battery
Back-up battery specification NiMH, 12 V 8.4 Ah. (20X GRPH-18670 8400P 12 V)

Specification
4.9 Ventilator and breathing system
Display 12.1 inches, TFT with touch screen

800 x 600 pixels
Gas type O2 or Air
Drive gas Inlet pressure 280-600 kPa
Max flow ≤ 120 L / min (max flow = inspiratory flow + fresh gas flow)
VCV, PCV, SIMV-V, SIMV-P, PSV, backup mode, Manual, standby mode.
Operating mode
Optional: SIMV-PRVC, PRVC, ACGO
Pressure, Flow rate, Volume, P-V loop, F-V loop, P-F loop,
Waveform
Pleth (optional), anaesthetic agent (optional), CO (optional),
Safety pressure System pressure does not exceed 12.5 kPa
Parameter setting range Description

Range: 10 - 1600 ml
Tidal volume Increment: 10 ~ 100 mL: 5 mL;
100 ~ 1600 mL: 10 mL
Respiratory rate Range: 1 ~ 100 bpm; increment: 1 bpm
Inspiratory time Range: 0.1 ~ 10.0 s; increments: 0.1 s
Respiratory ratio Range: 4:1 to 1:10; increments: 0.5
Percentage of inspiratory pause Range: 0 to 60%; Increment: 5%
PEEP Range: OFF, 3 ~ 30 cmH2O; Increment: 1 cmH2O
Pressure support Range: 0 ~ 70 cmH2O; Increment: 1 cmH2O
Pressure control Range: 5 ~ 70 cmH2O; Increment: 1 cmH2O
Flow trigger Range: 1 ~ 20 L/min; increments: 0.1 L/min
Pressure trigger Range: 1 ~ 20 cmH2O; increments: 1 cmH2O
Insp termination level (Esens) Range: 5 ~ 80%; increments: 5%
Monitored parameters
Parameters Description
Inspiratory tidal volume (VTI) Range: 0 ~ 2500 mL;
Resolution: 1 mL. Error of ± 20 mL or actual value ± 15%, whichever is greater
Expiratory tidal volume (VTE) Range: 0 ~ 2500 mL;
Resolution: 1 mL. Error of ± 20 mL or actual value ± 15%, whichever is greater
Minute ventilation (MV) Range: 0 ~ 60 L / min;
Resolution: 0.1 L / min. Error of ± 1 L/min or actual value ± 15%, whichever is greater
Spontaneous minute ventilation (MVspn) Range: 0 ~ 60 L / min;
Resolution: 0.1 L / min. Error of ± 1 L/min or actual value ± 15%, whichever is greater
Respiratory rate (ftotal) Range: 0 ~ 100 bpm;
Resolution: 1 bpm. Error of ± 2 bpm or actual value ± 10%, whichever is greater
Spontaneous breathing frequency (fspn) Range: 0 ~ 100 bpm;
Resolution: 1 bpm. Error of ± 2 bpm or actual value ± 10%, whichever is greater
Respiratory ratio (I:E) Range: 30:1 to 1:150;
Resolution: 0.1. Error of ± 20%
Peak airway pressure (Ppeak) Range: 0 ~ 100 cmH2O;
Resolution: 1 cmH2O. Error of ± (2% + 4% of full scale actual reading)
Mean airway pressure (Pmean) Range: 0 ~ 100 cmH2O;
PEEP Range: 0 ~ 100 cmH2O;

Specification
Monitored parameters
Inspiratory plateau pressure (Pplat) Range: 0 ~ 100 cmH2O;
Minimum airway pressure (Pmin) Range: -20 ~ 100 cmH2O;
FiO2 (optional) Range: 15 to 100%;
Resolution: 1%. Error is ± (2.5% +2.5% of full scale actual reading)
Compliance (Cdyn) Range: 0 ~ 300 mL/cmH2O; resolution: 1 mL/cmH2O. Error of ± 20% or ± 5 mL/
cmH2O, whichever is greater
Airway resistance (Rst) Range: 0 ~ 600 cmH2O / (L / S);
Resolution: 1 cmH2O / (L / S). Error of ± 20% or ± 5 cmH2O, whichever is greater
EtCO2 (optional) Range: 0 ~ 100 mmHg;
Resolution: 1 mmHg. Error is ± (0.43% of the volume percentage + 8% of the gas
concentration) - equivalent to the optional units used to monitor kPa and mmHg.
Inhalation of carbon dioxide (optional) Range: 0 ~ 100 mmHg;
Resolution: 1 mmHg. Error is ± (0.43% of the volume percentage + 8% of the gas
concentration) - equivalent to the optional units used to monitor kPa and mmHg.
MAC values (optional) Range: 0 to 10; resolution: 0.01
Fresh gas flow of oxygen Range: 0.2 ~ 15 LPM;
Resolution: 0 ~ 1 LPM: 0.01 LPM
1~15 LPM: 0.1 LPM
Fresh gas flow of nitrous oxide Range: 0 ~ 12 LPM
1~12 LPM: 0.1 LPM
Fresh gas flow rate of air Range: 0 ~ 15 LPM
1~15 LPM: 0.1 LPM
Alarm settings
Alarm type Range
Tidal volume High 10 ~ 2000 mL, OFF
Low OFF, 10 ~ 1600 mL
Minute ventilation High 1 ~ 99 L
Low 0 ~ 98 L
Respiratory rate High 1 ~ 100 bpm
Low 0 ~ 99 bpm
FiO2(optional) High 19 ~ 100%, OFF
Low 18 ~ 99%
Airway pressure High 10 ~ 99 cmH2O
Low 1 ~ 98 cmH2O
ETCO2 (optional) High 0.1 to 13.3%
Low 0 to 13.3%
FiCO2 (optional) High 0.1 to 13.3%
Inhalation anaesthetic Halothane, Isoflurane, Enflurane: 0.1 ~ 7.9%, OFF;
Upper limit
gas (optional) Sevoflurane: 0.1 ~ 9.9%; Desflurane: 0.1~ 19.9%, OFF
Halothane, Isoflurane, Enflurane: 0 to 7.8%,
Lower limit
Sevoflurane: 0 to 9.8%; Desflurane: 0.1~ 19.8%

Specification
Alarm settings
Alarm type Range
End tidal anaesthetic Halothane, Isoflurane, Enflurane: 0.1 ~ 7.9%, OFF;
Upper limit
gas (optional) Sevoflurane: 0.1 ~ 9.9%, OFF; Desflurane: 0.1~ 19.9%, OFF
Halothane, Isoflurane, Enflurane: 0 to 7.8%;
Lower limit
Sevoflurane: 0 to 9.8%; Desflurane: 0.1~ 19.8%
Pulse (optional) Upper limit 31~250 bpm
Lower limit 30~249 bpm
SpO2 (optional) Upper limit 50~99%, OFF
Lower limit 49~99%
PI (optional) Upper limit 0.1~20%
Lower limit 0~19.9%
Airway pressure greater than (PEEP +15) cmH2O.

Continuous pressure high
15 cmH2O is sustained when an alarm is triggered
Negative pressure alarm Airway pressure is less than -10 cmH2O
Apnea alarm Setting time is 10 ~ 60 s, in increments of 1 s
Oxygen low pressure alarm Oxygen pressure is less than 280 ±28 kPa
AC power failure alarm The mains breaks down or the power cord disconnects
Low battery alarm More than 10 minutes
Alarm battery is exhausted More than 5 minutes
Alarm silence period ≤ 120 s
Flow rate (l/min) Pressure drop (kPa) Pressure drop (cmH2O)

Inspiratory breathing resistance in mechanical mode
5 0.05 0.5
30 0.23 2.3
60 0.56 5.6
Inspiratory breathing resistance in manual mode
5 0.05 0.5
30 0.21 2.1
60 0.50 5.0
Expiratory breathing resistance in mechanical mode
5 0.05 0.5
30 0.22 2.2
60 0.49 4.9
Expiratory breathing resistance in manual mode
5 0.05 0.5
30 0.21 2.1
60 0.46 4.6
Pressure and flow data (APL valve completely open)
Flow rate (l/min) APL pressure (cmH2O STPD) APL pressure (cmH2O BTPS)
3 0.95 1.03
30 1.86 2.1
40 2.08 2.45
50 2.29 2.72
60 2.57 3.14
70 3.02 3.41

Specification
4.10 Device classification and labelling

The Prima 465 is classified as Medical Electrical (ME) equipment as defined in BS EN 60601-1.
Labelling
Refer to Appendix 4
Equipment classification
Protection against electric shock Class 1
Ingress protection IPX0
Oxygen compatibility Not suitable for use in an Oxygen rich environment
Mode of operation Continuous
All patient types: No residual risks from phthalates that are
Patient
carcinogenic, mutagenic, or toxic to reproduction.
Applied parts
Patient hoses/masks Type BF, defibrillator proof
Sidestream multigas sensor
Sidestream CO2 sensor
SpO2 Sensor (optional)
Mainstream multigas sensor
Accessories
Refer to Appendix 3

5. Installation and Pre-use Checks
5.1 Installation and Commissioning before

first clinical use
5.1.1 Warnings and cautions

Warnings
1. Installation and commissioning must be carried out by a
Penlon-trained engineer
2. To avoid the risk of electric shock, this system must only
be connected to a mains supply with a protective earth.
clinically for the first time, the hospital engineering
department must carry out an earth continuity test.
3. Additional equipment placed on the top shelf must be
securely attached.
4. Before the machine is transported.
a) Remove all detachable devices.
b) Empty the drawers.
c) Remove the gas cylinders.
5. MRI compatibility - Prima 465 models are not MRI
compatible.
6. This machine must only be used with Selectatec-
compatible vaporizers installed on the backbar.
Free-standing vaporizers may be accidentally tipped,
resulting in excessive and uncalibrated volumes of
anaesthetic drug entering the breathing system.
7. The anaesthesia system 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.
CAUTION
1
1. Connect the external RS232 outlet (1) only to approved
devices using protocol provided by Penlon Ltd. Contact
Technical Support Department for details.

Installation and Pre-use Checks
5.1.2 Absorber assembly
5.1.2.1 Absorber assembly installation

Warning 3
1 1
When the absorber is lifted or carried by hand, always
support the weight of the unit under the base.
Do not lift the absorber by gripping any of the components
attached to the manifold block.
1. Remove all packing materials before installation.
2. Make sure that the eight silicon inserts (1) on the 2
breathing circuit adapter plate (2) are in place and are not
damaged.
3. Use BG87 or Fomblin grease to lightly lubricate the eight
silicon inserts (1).
4. Lift and turn the locking catch (3) to the unlocked position. 1 1
5 5
5. Align the two connector pins (4) on the absorber with the
matching holes (5) on the circuit adapter plate.
6. Push the absorber assembly into the circuit adapter plate
with moderate force.
7. Reset the locking catch (3) to the locked position.
Warning
Always set the locking catch to the locked position after the
absorber assembly is installed.
Before use, to prevent a serious fresh gas leak and
inaccurate tidal volume measurement, always check that the
4
assembly is locked in position.
5.1.2.2 Absorbent canister filling and installation

1
Warning
To prevent dust and particles from entering the breathing
circuit, the filter (1) must be fitted in the correct position as
illustrated.
Before installation, clean the rim of the canister perimeter,
the canister support, and the seal to prevent breathing
system leakage.
1. Fill with new soda lime to the MAX line (2).

Remove any soda lime that has collected on the filter (1).
2 3 4
2. Wipe the dust from the absorber canister support.
3. Position the canister, ensuring that the threads are
engaged.
Make sure that the triangular marks (3) are aligned.
4. Tighten counterclockwise until the ‘locked’ symbol (4) and
the triangular mark on the canister are aligned.

5.1.3 Bag arm installation

1. Fit the bag support arm (1) to the port in front of the
absorber bellows canister on the top of the absorber.
1
2. Turn the locking nut clockwise to secure.
3. Check that the bag arm can be rotated.
5.1.4 Oxygen sensor installation

Caution
1. Before installing the oxygen sensor (1), check that the
O-ring (2) is in good condition.
Fit a new sensor if the O-ring is missing or damaged.
2
2. Tighten the sensor manually, do not use a wrench or
other tool. 1
1. Align the threads of the oxygen sensor (1) with the port on 5
the side of the absorber.
2. Turn the sensor (1) clockwise to tighten. 3
3. Fit the cable (3) to the sensor.
Warning
Make sure that the absorber canister position sensor (4)
is unobstructed by cables or tubing etc, at all times. 4
Do not route the oxygen sensor cable in front of the 5
canister sensor
4. Connect the cable (3) to the socket (5) on the side of the
anaesthetic machine.
Note
If a sidestream gas monitoring module is installed (with
optional paramagnetic oxygen monitoring) the oxygen sensor
shown (1) is not required and the sensor port is blanked off.
2 4
5.1.5 Connecting an optional sidestream multigas
module
1. Connect the elbow (1) to the Y-piece (2) 1
2. Connect the sampling tube (3) to the sample port (4) on

the elbow (1) and to the inlet connector on water trap (5).

5.1.6 Installing the vaporizer 1 1
Note
1. Read the vaporizer instruction manual before clinical use.
2. Up to two Selectatec-compatible vaporizers may be fitted,
see section 3.5.1.
Install the vaporizer
1. Carefully align the vaporizer with the valves (1) on the
backbar manifold.
CAUTION
Check that the gas connection ports (2) on the vaporizer
are aligned with the valves (1) on the manifold and are
correctly engaged. 3
2. Carefully lower the vaporizer onto the manifold
3. Lock the vaporizer into position by clockwise rotation of the
locking lever (3) through 90°.
NOTE
Do not use excessive force to lock the vaporizer onto the
manifold. Damage to the locking shaft (4) will result.
5.1.7 Gas supplies

4 2
5.1.7.1 Medical gas pipeline installation
Warning
Gas connections are not interchangeable, check the label,
symbol, and colour code while connecting.
Use medical grade gas supplies only. Other types of gas

supplies may contain water, oil, or other contaminants.
Check that cylinders are available as a backup in case of a

central gas supply failure.
1. Connect oxygen, air, and nitrous oxide medical gas hoses 1
between the central gas supply terminals and the correct
inlet (1) on the anaesthesia workstation.
5.1.7.2 Gas cylinder installation 2
CAUTION
Open the cylinder valves slowly to avoid damage to the
pressure reducing valve and pressure gauges. Ensure that 3
valves are at least one full turn open when in use.
1. Fit the gas cylinders to their respective yokes (2):
2. Follow appropriate manual handling guidelines when lifting.
3. Check that the machine yoke and cylinder faces are dust
free and clean and that the sealing washer (3) provided is in
position between the cylinder valve and the yoke.
4. 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. Open the cylinder valves one at a time and check the
pressure on each gauge.

5.1.7.3 Electronic gas mixer operating system
Oxygen / nitrous oxide mixture at low oxygen flows

The software controls N2O concentrations in the fresh gas
flow, as follows:
1. If the user sets a oxygen flow of 0.2 to 2.0 L/min.
An alarm message is displayed:
‘Before accepting this O2% setting be aware that F.G Flow
will increase to X.X L/min’
‘X.X’ represents the value that will be displayed
2. If the user sets a combination of O2 and N2O flows that
results in an O2 concentration of less than 30% in the fresh
gas flow.
An alarm message is displayed:
‘Before accepting this F.G flow setting be aware that O2%
will increase to X.X %’
‘X.X’ represents the value that will be displayed
The tables below give the approximate concentration levels
of that will be delivered for (a) Standy mode and (b) Ventilator,
Bag, and ACGO modes.
Standby mode
Fresh gas flow % O2 % N2O
(L/min)
0.3 100 0
0.4 75 25
0.5 60 40
0.6 50 50
0.7 43 57
0.8 38 62
0.9 34 66
1.0-2.0 30 70
Note that in Standby mode a minimum oxygen concentration

of 30% must be set, and a minimum flow of 0.3 L/min.
Ventilator, Bag, and ACGO modes

Fresh gas flow (L/ % O2 % N2O
min)
0.2 100 0
0.3 66 34
0.4 50 50
0.5 40 60
0.6 33 67
0.7 29 71
0.8 25 75
0.9 25 75
1.0-2.0 25 75

5.1.8 Electrical power supply 3 1
WARNING
1. To avoid the risk of electric shock, this system must only
be connected to a mains supply with a protective earth.
clinically for the first time, the hospital engineering
department must carry out an earth continuity test.
2. Always use a mains power outlet socket that can be
easily accessed.
To isolate the machine from the mains power supply,
disconnect the mains cable from the power outlet
socket.
1. Connect the power cable (1) to the hospital mains supply.
2. Check that the mains indicator LEDs (2) on the control
panel and top shelf illuminate when mains power is 2
3
connected.
3. Check all electrical equipment, including devices powered
by the auxiliary power outlets (3).
5.1.9 Anaesthetic gas scavenging system (AGSS)

WARNING
1. Read the AGS receiver instruction manual for installation
instructions and for instructions for clinical use. 5
2. Use an anaesthesia gas scavenging system that complies
with ISO 80601-2-13. 2
3. Do not connect any vacuum system directly to the outlet
port. A receiving system with a positive and negative 3 4
pressure control function must be interposed.
The anaesthetic gas scavenging (AGS) outlet port (1) is located
at the right rear of the machine.
Note that the illustration shows the hose adaptor that must be
fitted when commissioning a new anaesthetic machine before
clinical use.
The receiver (2) is fixed to the mounting system built into the
side upright (3) of of the anaesthetic machine.
A hose (4) connects the outlet port (1) to the receiver unit inlet
port.
The output hose (5) connects to the hospital disposal system.

5.2 Pre-use test before each clinical

procedure
Caution
1. Before use, read this user manual, and understand the
function and operation of each component.
2. If the system fails a test, do not use the device. Contact a
Penlon-trained engineer.
5.2.1 Pre-use test schedule

Recommended testing schedule
Daily, Each
before the patient,
first patient before use
Visual inspection Section 5.3
Start up test Section 5.4
Pipeline gas supply tests Section 5.5
O2 supply check Section 5.6
Cylinders gas supply tests Section 5.7
Vaporizer Section 5.8
Alarm tests Section 5.9
Breathing circuit tests Section 5.10
O2 flush test Section 5.11
SpO2 and AG monitoring tests Section 5.12
Preparing for system operation Section 5.13
5.3 Visual Inspection
Warning
1. Additional equipment placed on the top shelf must be
securely attached. Do not install additional equipment
heavier than 30 kg or above 450 mm in height.
2. Obstruction of the breathing system can restrict or
stop gas flow to the patient, and can cause injury or
death. Make sure that there are no obstructions in the
breathing system.
3. Keep very small components away from the breathing
system.
Caution
Check that the absorber and breathing system are not
damaged and are correctly connected.
1. Check that the anaesthesia machine is undamaged.
2. Make sure that all components are correctly attached.
3. Make sure that the absorber is correctly connected
and locked in position, and that the breathing tubes are
undamaged.
4. Make sure that the vaporizers are locked in position and
contain sufficient agent.

5. Make sure that the gas supplies are connected and check
that the pressures are between 280 kPa (40.6 psig) and
600 kPa (87.0 psig).
6. Make sure that the cylinder valves are closed.
7. Make sure that the necessary emergency equipment, and
equipment for airway maintenance and tracheal intubation
is available and in good condition.
8. Make sure that the applicable anaesthetic and emergency
drugs are available.
9. Check that the castors are not damaged or loose and the
brakes are set and function correctly.
5.4 Start up test

1. Connect the machine to the mains supply
2. Set the anaesthesia system switch to the ON position.
3. Check that the amber and red alarm LEDs (1) illuminate.
4. Check that audible beep sounds are heard.
1
5. Check that the start-up screen (2) is displayed.
6. When the standby screen is shown, press the on-screen
CANCEL button (3) or wait for the screen to default to the
patient set-up screen.
Start pre-use Test?
Cancel Accept
2 3
7. Check that the patient set up screen is shown after

approximately 10 seconds.
8. Check that audio and visual alarm indicators are triggered.
9. Press the on screen CONFIRM button.
10. When the CLEAR TREND DATA? dialogue box is shown,
press the on-screen CANCEL button (4).

11. Disconnect the machine from the mains power supply.

12. Check that the mains indicator is extinguished √.Pass x.Fail --.Skip
Last Manual Leak Test Last Automatic System Test
2000-00-00 00:00 2017-03-16 13:07
13. Check that the battery indicator light illuminates. √.00 x.00 --.10
14. Check that the message MAINS FAILURE is displayed. Manual √. Pass Baromter √. Pass
Gas Supply O2
15. Reconnect the machine to the mains electrical supply.

N2O
Air
Circuit Flow Sensor --. Skip
Pressure Sensor --. Skip
16. Check that mains indicator is illuminated.

FG Flow Sensor --. Skip
Oxygen Sensor --. Skip
Circuit Compliance --. Skip
Circuit Leakage --. Skip
Battery --. Skip
17. Check that the bellows is inflated.
18. Press the System Test button.

5
19. Select the Manual Leak Test button (5) from the pre-use Quit Manual Leak Test Automatic System Test 7
test screen.
20. Follow the on-screen instructions before you press the
Start button (6).
21. Check that the Last Manual Leak Test dialogue box is √.Pass x.Fail --.Skip
updated with the current date. Manual Leak Test
22. Make a note of the result of the Manual Leak Test as

shown on the Last Manual Leak Test progress screen.
1. Set Bag/Vent switch to Bag
23. Push the Quit button. 2. Connect the patient circuit and seal the Y-Piece by test block;
3. Install Manual Bag;
4. Connect gas pipeline, valid the supply pressure in regulated range;
5. Check absorber canister and water trap are installed correctly;
24. Select the Automatic System Test button (7) from the 6. Set Alternate O2 switch to OFF;
7. Turn off the vaporizers;
pre‑use test screen (5). 8. Set ACGO switch to OFF (double circuit position);
9. Adjust APL valve limited pressure to 70 cmH20;
25. Follow the on screen instructions. 10. Push 02 flush button until PAW gauge pressure is between 25-35 cmH20;
11. Verify that bellows did not inflate (If bellows moved or inflated, contact service);
12. Click start button to perform Manual Leak Test
26. Press the Start button (8).
Note Quit Start 6

If the Oxygen sensor test fails, calibrate the sensor.
27. Observe the Automatic System Test progress screen (9);
make a note of tests that Fail or Skip.
Warning
If the screen displays a ‘Fail’ for the Pressure sensor, Flow
sensor, or Flowmeter zero calibration tests, DO NOT attempt
manual calibration.
Contact a Penlon-trained service engineer.
28. When the test has completed, press Finish, then Quit. 9

5.5 Pipeline gas supply tests

1. Use the system Settings screen to set Air and N2O to On.
2. Connect the O2 pipeline to the main gas supply.
3. Do not connect the N2O and Air pipelines.
Caution
Close the gas cylinder valves if the pipeline supply is in use.
Cylinder supplies could be depleted, leaving an insufficient
reserve supply in case of a failure of the pipeline supply.
5.5.1 Oxygen pipeline supply test

1. Check that the O2 pipeline gauge indicates a pressure
within the range 280-600kPa.
4
2. Set the alternate O2 ON/OFF switch (1) to the ON position.
Check that the switch is illuminated.
3. Check that that prompt ‘Alternate O2 control has been
opened’ is displayed at the top of the screen. 3
4. Check that that the FG FLOW, Gas Mix and O2 buttons are
inactive (2). 1
5. Turn the alternate O2 control (3) counterclockwise. Check
that the flowmeter (4) indicates an increase in O2 flow.
6. Turn the alternate O2 control clockwise and check that the
flowmeter ball indicates a decrease in O2 flow.
7. Turn the alternate O2 control clockwise to the minimum
flow position.
8. Set the alternate O2 ON/OFF switch to the OFF position.
Check that the switch is not illuminated
9. Check that the prompt ‘Alternate O2 control has been
opened’ is no longer displayed at the top of the screen.
10. Check that the FG flow, and O2 , and Gas mix buttons (2)
are now active.
5.5.2 Nitrous oxide pipeline supply test 2
1. Connect the N2O pipeline to the main gas supply.
2. Check that the N2O pipeline gauge indicates a pressure
within the range 280-600kPa.
3. Set the Gas mix button to O2/N2O.
4. Set FG flow to 2.0 L/min.
5. Disconnect the N2O pipeline.
6. Check that N2O SUPPLY DOWN warning is shown at the
top of the Alarm Log. Make a note of the time of the last
warning.
7. Check that the on-screen prompt ‘Oxygen concentration
increased to 100%!’ is shown.
8. Connect the N2O pipeline to the main gas supply.
9. Check that the on-screen prompt is no longer shown.
10. Check that there are no new N2O SUPPLY DOWN warnings
shown in the alarm log.

5.5.3 Air pipeline supply test

1. Connect the Air pipeline to the main gas supply.
2. Check that the Air pipeline gauge indicates pipeline pressure.
3. Set the Gas Mix on screen button to O2/Air.
4. Disconnect the Air pipeline.
5. Check that AIR SUPPLY DOWN warning is shown at the top of
the Alarm Log.
6. Make a note of the time of the last AIR SUPPLY DOWN warning.
7. Check that the on screen prompt ‘Oxygen concentration
increased to 100%!’ is shown.
8. Connect the Air pipeline to the main gas supply.
9. Check that the on screen prompt is no longer shown.
10. Check that there are no new AIR SUPPLY DOWN warnings
shown in the alarm log.
5.6 Oxygen fresh gas supply check

1. Set FG flow to display O2/N2O.
2. Set FG flow to 2 L/min.
3. Disconnect the O2 supply.
4. Check that the O2 and the N2O gas flows reduce to 0 (zero).
5. Check that the O2 SUPPLY DOWN warning is shown.
6. Reconnect the O2 supply.
7. Check that the FG flow returns to its original O2 and N2O values.
8. Check that the O2 SUPPLY DOWN warning is no longer shown.
5.7 Cylinder gas supplies
CAUTION
1. 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.
2. Fit the gas cylinders to their respective yokes, open the
cylinder valves one at a time and check the pressure on each
gauge.
Cylinder contents test
2. Check that the O2 cylinder is installed correctly.
3. Disconnect all gas pipeline supplies.
4. Open each cylinder valve and check each cylinder pressure.
5. Replace the cylinder if necessary, refer to Section 5.1.7.2.
6. Close the N2O cylinder.

Oxygen cylinder high pressure leak test

1. Set the anaesthesia system switch to the OFF position
2. Make a record of the current cylinder pressure.
3. Close the O2 cylinder valve.
4. Make a record of the cylinder pressure after two minutes.
5. If the cylinder pressure decreases more than 700 kPa (100
psi), install a new cylinder seal.
6. Repeat steps 1 through 5.
If the leak continues, contact a Penlon-trained engineer.
Do not use the cylinder supply system.
Nitrous oxide cylinder high pressure leak test
1. Open the N2O cylinder.
2. Make a record of the current N2O cylinder pressure.
3. Close the N2O cylinder valve.
4. Make a record of the N2O cylinder pressure after one
minute.
5. If the cylinder pressure decreases more than 700 kPa (100
psi), install a new cylinder seal (see section 5.1.7.2).
6. Open the N2O cylinder valve and repeat steps 1 through 5.
If the leak continues, contact a Penlon-trained engineer.
Do not use the cylinder supply system.
7. Connect the N2O pipeline.
8. Connect the O2 pipeline.
Oxygen verification
1. Set the anaesthesia system switch to the ON position
2. Exit the patient screen.
3. Connect the y-piece to the test lung.
4. Set the bag/vent switch to the vent position.
5. Use the O2 flush button to fill the bellows.
6. Press the Start/Standby button.
7. Make sure that the system is in Ventilation mode.
8. Set the Gas mix display to show O2/N2O.
9. Set the concentration to 50.
10. Set the FG Flow to 5 L.
11. Observe the FIO2 value: Check that FIO2 reduces to
between 45 and 55.
12. If FIO2 does not reduce, calibrate the O2 sensor (section
7.6).

5.8 Vaporizers
5.8.1 Vaporizer back pressure test

Warning
1. Use only Selectatec-compatible interlock vaporizers.
Check that each vaporizer is securely mounted - refer to
Section 5.1.6.
2. The machine must be connected to an anaesthetic gas
scavenging system (AGSS).
1. Connect the patient y-piece to the test lung.
2. Fill the bellows.
3. Use the start/standby button to start operational mode.
4. Set the alternate O2 button to the ON position.
5. Check that the button is illuminated.
6. Turn the alternate O2 flow to approximately 6 L/min.
7. Check that the O2 flow stays constant.
8. Set a vaporizer concentration of 1%.
Caution
Do not test the vaporizer when the vaporizer
concentration control is between “0” and the first
graduation.
9. Check that the alternate O2 flow does not decrease more
than 1 L/min.
10. If the vaporizer fails this test:
a) Install a different vaporizer and repeat the test
b) If the problem persists, do not use the system
Contact a Penlon-trained technician.
11. Repeat the back pressure test for each vaporizer and
backbar manifold station..
12. Set the alternate O2 button to the OFF position
13. Check that the alternate O2 button is no longer
illuminated.
5.8.2 Vaporizer interlock system test

1. Fit two vaporizers (with interlock).
2. Make sure that the interlock mechanism of each vaporizer
is working correctly:
a) Check that only one vaporizer at a time can be turned
on.
b) Refer to the vaporizer user manual for additional
pre‑use checks.

5.9 Alarm tests

Preparation for the alarm test
1. Set the ventilator control setting as follows:
a) Ventilation mode VCV
b) Tidal volume [VT] 500 mL
c) Respiratory frequency [f] 12 BPM
d) Breathing ratio [I: E] 1:2.0
e)
PEEP OFF
2. Push the O2 flush button to fill the bellows.
3. Set the FG Flow to 1 L/min.
4. Use the Start/Standby button to enter operational mode.
5. Check that the bellows inflates and deflates normally.
6. Check that the displayed value of VTE is 500 mL ± 50.
7. Check that the displayed values of ftotal and I:E are as set in step 1.
Oxygen concentration monitoring and alarm test
NOTE
This test applies to systems with an O2 sensor (1) fitted to the absorber.
1. Use the Start/Standby button to enter standby mode.
2. Set the APL valve to the MIN position.
1
3. Calibrate as follows:
a) Press the SYSTEM button
b) Press the CALIBRATION tab
c) Press the OXYGEN CELL CAL button
d) Press the 100% button
e) Follow the on-screen instructions.
f) Press the confirm button and wait for the test to finish.
4. Reconnect the breathing tubes.
5. Set the bag/vent switch to Vent.
6. Attach the Y-piece to the test lung.
7. Fill the bellows.
8. Set the FiO2 low alarm limit to 75%.
9. Use the Start/Standby button to enter operational mode.
10. Set FG Flow to 4.0 L/min.
11. Set gas mix to O2/N2O, and set O2 concentration to 25%.
12. Check that after a period of time; a LOW FiO2 alarm is triggered.
13. Reset the FiO2 low alarm limit to 20%. Check that the alarm is
cancelled.
14. Set the FiO2 high alarm limit to 50%.
15. Set the O2 concentration to 60%.

16. Check that after a short period; the HIGH FIO2 alarm is
triggered.
17. Set the FiO2 high alarm limit to OFF, and check that the
alarm is cancelled.
Minute volume (MV) low alarm test
1. Set the MV low alarm limit to a minimum of 7 L/min.
2. Check that a MV LOW!!! alarm is triggered.
3. Set the MV low alarm limit to 2.0 L/min.
4. Check that the MV LOW!!! alarm is cancelled.
High airway pressure (Paw) alarm test
1. Set the pressure high alarm limit to 15 cmH2O.
2. Check that a High Pressure alarm is triggered.
3. Set the pressure high alarm limit to 40 cmH2O.
4. Check that the alarm is cancelled.
Apnea alarm test
1. Use the start/Start/Standby button to select standby mode.
2. Set the bag/vent switch to vent.
3. Set the ventilation mode to SPONT/PSV.
4. Use the Start/Standby button to start operational mode.
5. Check that an APNEA warning is shown.
6. Check that ventilation begins.
7. Set the ventilation mode to VCV.
Continuous high positive airway pressure alarm test
1. Set the bag/vent switch to Bag (bag fitted to bag arm).
2. Set the APL valve to 30 cmH2O.
3. Press and hold the O2 flush button to fill bag until the
reading on the airway pressure gauge is approximately 30
cmH2O.
4. After 15 seconds, check that a CONTINUOUS HIGH
PRESSURE alarm is triggered.
5. Set the APL valve to MIN.
6. Check that the alarm is cancelled.
Airway pressure low alarm test
1. Set the Bag/Vent switch to Vent.
2. Set the pressure low alarm limit to 5 cmH2O.
3. Disconnect the Y piece from the test lung.
4. Check that a PRESSURE LOW alarm is triggered.
5. Connect the Y piece to the test lung.
6. Press the O2 flush button
7. Check that the PRESSURE LOW alarm is cancelled.

5.10 Breathing circuit tests

APL valve test
1. Make sure that the system is in Standby mode.
3. Connect the Y-piece to the absorber test block (1).
5. Push the O2 flush button until the airway pressure gauge
rises to approximately 35 cmH2O.
7. Check that the gauge shows 15 to 25 cmH2O.
8. Set the APL valve to the minimum position.
9. Set the anaesthesia system switch to the OFF position 1
10. Check that the gauge shows less than 5 cmH2O.
Non-return valve test
1. Set the bag/vent switch to Vent and set the anaesthesia
system switch to the ON position
3. Make sure that the breathing system is not damaged and
correctly installed.
4. Connect the Y-piece to the absorber test lung.
5. Use the manual bag to complete a series of breathing
cycles.
6. Check that the non-return valves in the breathing system
work as follows:
a) The inspiratory non-return valve opens during
inspiration and closes at the start of expiration.
b) The expiratory non-return valve opens during
expiration and closes at the start of inspiration.
Bellows test
1. Set the Bag/Vent switch to the vent position.
3. Deflate the bellows.
4. Connect the Y-piece to the absorber test block.
5. Press and hold the O2 flush button to fill the bellows.
6. Check that the airway pressure gauge indicates less than
15 cmH2O.
7. Release the O2 flush button.
8. If the bellows deflates within one minute:
a) Remove the bellows - Turn the bellows housing
counterclockwise, and lift from the base , and
reinstall.
b) Repeat the bellows test.

Breathing system leak test

3. Press the O2 flush button until the airway pressure gauge reads
25 cmH2O.
4. Check that the pressure gauge reading does not reduce.
Caution
a) If a leak is suspected, check the bellows, breathing tube,
absorber, and connectors for correct function and security.
b) Retest the system. Do not use the machine if the circuit
continues to leak. Contact a Penlon-trained engineer.
5. Turn the APL valve counterclockwise to the Min position.
6. Disconnect the hose from the absorber test block.
5.11 Oxygen flush test

1
Auxiliary common gas outlet test
1. Turn the ACGO control (1) to the lower position
2. Press the O2 Flush button (2)
3. Check that there is a flow of fresh gas from the auxiliary
common gas outlet (3).
4. Release the O2 Flush button, and check that the flow of O2 from
the outlet (3) stops.
2
5. Turn the ACGO control to the OFF position
3
5.12 Preoperative procedure

1. Set the anaesthesia system switch to the ON position.
2. Make sure that the ventilator parameters and alarm limits are
set to applicable clinical levels. See to Section 6.
3. Make sure that the system is in Standby.
4. Make sure that equipment for airway maintenance, manual
ventilation, and tracheal intubation are available.
5. Connect the manual bag to the bag port.
Set the Bag/Vent switch to Bag.
6. Turn off all vaporizers.
7. Turn the APL valve control counterclockwise to the MIN
position.
9. Check the breathing system for damage and correct connection.
Warning
Before connecting a patient, flush the anaesthesia machine with
5 L/min of O2 for at least one minute. This removes unwanted gas
mixtures from the system.
10. Set the anaesthesia system switch to the OFF position.

6. Operating the Anaesthesia System
6.1 Ventilation modes
WARNING
Ventilating neonates (infants):
1. Use ONLY Pressure Control Ventilation or Volume Control
ventilation for mandatory ventilation of Neonates.
2. Always set a low target pressure first and then increase to the
required level.
3. Use breathing circuits and filters specifically designed for
Paediatric/Neonatal use
4. Do not ventilate pre-term babies with birth weights below 2.4 kg.
6.1.1 Volume control ventilation (VCV)
6.1.1.1 Description
In VCV mode, gas is delivered to the patient at a constant flow, to
deliver the preset VT within the gas delivery time.
To achieve the preset VT, the resulting airway pressure (Paw)
changes, based on patient pulmonary compliance and airway
resistance.
In VCV mode, as long as Paw is less than the pressure high limit and
the gas delivery flow is kept constant, expiration starts immediately
after the high pressure limit is reached.
Set the Pressure high limit to prevent injury to the patient from high
airway pressure.
In this mode, select [Pause] to improve patient pulmonary gas
distribution and [PEEP] to improve expiration of end-tidal carbon
dioxide and to increase oxygenation.
6.1.1.2 VCV mode waveforms A

Paw waveform and flow waveform in VCV mode are shown. In VCV
mode, the flow waveform is at a constant flow during inspiration and
the Paw waveform rises in the same period.
B
Key
A: Airway pressure
C
B: Inspiratory pressure
D E
C: Flow
D: Time: inspiration
E: Time: Expiration
6.1.1.3 Parameter range and default values in VCV mode
Parameter Range Step Default

Infant: 10 to 100 ml 35 ml
20 to 100 ml: 5 ml
VT Paediatric: 50 to 360 ml 120 ml
100 to 1500 ml:10 ml
Adult: 100 to 1600 ml 510 ml
I:E 4:1 to 1:10 0.5 1:2
f 1 to 100 bpm 1 bpm 15 bpm
PEEP OFF, 3 to 30 cmH2O 1 cmH2O OFF
Pause 0% to 60% 5% 0%
Sigh OFF, 50 to 150 25 OFF

Operating the Anaesthesia System
6.1.2 Pressure control ventilation (PCV)
6.1.2.1 Description
Pressure control ventilation (PCV) mode is a basic fully-
mechanical ventilation mode.
In PCV mode, Paw rises rapidly to the preset pressure control
value. Then gas flow slows down through the feedback system
to keep Paw constant until expiration starts.
The tidal volume delivered in PCV mode changes, based on
patient pulmonary compliance and airway resistance.
In addition, the user can select PEEP to improve expiration of
end-tidal carbon dioxide and to increase oxygenation.
6.1.2.2 PCV waveforms A

PCV mode waveforms for Paw and flow are shown.
B
In PCV mode:
1. The Paw waveform rises sharply during inspiration and
stays at the plateau for a relatively long time without peak.
C C D E D
The flow waveform declines in the same period.
2. Tidal volume is measured instead of preset.
F
Key
A: Airway pressure D: PEEP
B: Pmax E: Pressure support breath
C: SIMV breath F: Flow
6.1.2.3 High airway pressures

The system will prevent the selection of high airway pressures.
The high pressure alarm (Ph) sets a limit on airway pressure,

above which the machine will not allow a pressure to be set.
To facilitate this, two notifications are displayed:
1. Pinsp + PEEP < Ph
This notification indicates that no further increase in
pressure is permitted.
2. Pinsp > ** cmH2O ? Confirm
The notification, where ** is a value of 30 or 50, indicates
that pressure is increasing through the 30 cmH2O and 50
cmH2O thresholds.
To continue to increase airway pressure through a
threshold, a positive press of the multifunction control is
required.
6.1.2.4 PCV mode parameter range and default values

Pinsp 5 to 70 cmH2O 1 cmH2O 15 cmH2O
I:E 4:1 to 1:10 0.5 1:2
Tslope 0 to 2 s 0.1 s 0.2 s

6.1.3 Pressure-regulated volume control (PRVC)
6.1.3.1 Description
In PRVC a tidal volume is set and the ventilator adjusts the
inspiratory pressure needed to deliver the set tidal volume so
that the lowest pressure is used.
The pressure range is between the PEEP +2 cmH2O level and
5 cmH2O below pressure high limit.
The inspiratory pressure change between breaths is a
maximum of +/- 3 cmH2O.
This mode delivers breaths with the efficiency of pressure
controlled ventilation, yet still compensates for changes in the
patient’s lung characteristics.
PRVC mode initially delivers a VCV breath. Patient compliance
is determined from this volume breath.
The inspiratory pressure level is then set for the next breath. A
6.1.3.2 PRVC Waveforms

Key
A: Airway pressure B
B: Flow
6.1.3.3 Parameter range and default values in PRVC

mode
Infant: 10 to 100 ml 20 - 100 ml: 5 ml 35 ml
VT Paediatric: 50 to 360 ml 100 - 1500 ml: 10 ml 120 ml
Adult: 100 to 1600 ml 510 ml
I:E 4:1 to 1:10 0.5 1:2
6.1.4 Support mode waveforms - colour codes

Support mode waveforms are displayed in colour.
Mandatory (inspiratory phase) Blue

Expiratory phase Red
Synchronised breath Green
Spontaneous breath Yellow

6.1.5 Synchronised intermittent mandatory

ventilation - volume control (SIMV-V)
6.1.5.1 Description
SIMV-V delivers volume controlled breathing to the patient,
and waits for the patient’s next inspiration, based on the set
time interval. Sensitivity is dependent on trigger level (optional
flow and pressure).
If the trigger level is reached within the trigger waiting time
(synchronous trigger window), the ventilator delivers volume
controlled breathing synchronously with the preset tidal
volume and inspiratory time.
If the patient does not inspire within the trigger window, the
ventilator delivers volume-controlled breathing to the patient
at the end of trigger window.
Spontaneous breathing outside of the trigger window can
acquire pressure support.
F
6.1.5.2 SIMV-V waveforms B
Key
A: Within the trigger window C
B: Outside of the trigger window
D
C: SIMV cycle A A B
D: Flow
E: VCV applied (no ventilation within the trigger window)
F: Airway pressure
G: Inspiratory time
G E
6.1.5.3 Parameter range and default values in SIMV-V

mode
20 to 100 ml: 5 ml
100 to 1500 ml: 10 ml
Adult: 100 to 1600 ml 510 ml
Tinsp 0.1 to 10.0 s 0.1 s 1:2
Psupp 0 to 70 cmH2O 1 cmH2O 15 cmH2O
Fsens: 1 to 20.0 L/min Fsens: 0.1 L/min Fsens: 3 L/min
Fsens/Psens
Psens: 1 to 20 cmH2O Psens:1 cmH2O Psens: 2 cmH2O
Esens 5% to 80% 5% 25%


pressure control (SIMV-P)
6.1.6.1 Description
SIMV-P delivers pressure-controlled breathing. The ventilator
waits for the patient’s next inspiration, based on the specified time
interval. If the patient does not inspire within the trigger window, the
ventilator delivers pressure controlled breathing to the patient at
the end of the trigger window.
Sensitivity depends on the trigger level (optional flow and pressure).
If the trigger level is reached within the trigger waiting time (called
synchronous trigger window), the ventilator delivers pressure B
controlled breathing synchronously with the preset tidal volume and A C
inspiratory time.
Spontaneous breathing outside the trigger window can trigger
pressure support. If the trigger level is reached outside of the D
trigger window, the ventilator delivers pressure-supported
ventilation based on the preset value [Psupp].
6.1.6.2 Esens (expiratory trigger sensitivity)

Esens is expressed as a percentage of peak flow. It is used to
determine the end of the inspiratory phase, allowing the expiratory F
phase to be synchronised. Esens allows the clinician to adjust the E
ventilators onset of expiration to match the patient’s breathing G
pattern. Use the Esens button on the Controls page to set Esens.
6.1.6.3 SIMV-P waveforms

Q
Key H: Within trigger window
H J
A: Normal J: Outside of the trigger window
K: Trigger level, triggered by
B: PS exceeds target
pressure
K L K
C: Problem resolved L: SIMV cycle
D: Pressure M: Trigger level, triggered by flow
G
E: Esens fixed (25%) N: Inspiratory termination level
H J
P: Pressure-supported ventilation N
F: Esens adjusted to 50% (no ventilation within the trigger M
window)
G: Flow Q: Airway pressure
6.1.6.4 Parameter range and default values in SIMV-P mode P

Pinsp 5 to 70 cmH2O 1 cmH2O 15 cmH2O
Tinsp 0.1 to 10.0 s 0.1 s 1:2

Fsens 1.0 to 20.0 L/min 0.1 L/min 3 L/min
Psens 1.0 to 20 cmH2O 1 cmH2O 2 cmH2O
Esens 5% to 80% 5% 25%

6.1.7 Synchronised intermittent mandatory

ventilation - pressure-regulated volume
controlled (SIMV-PRVC)
6.1.7.1 Description
SIMV-PRVC delivers pressure controlled breathing to the
patient and the ventilator waits for patient’s next inspiration
based on the specified time interval.
Sensitivity depends on trigger level (flow and pressure).
If the trigger level is reached within the trigger waiting time
(called synchronous trigger window), the ventilator delivers
pressure guaranteed ventilation - volume control breathing
synchronously with the preset tidal volume and inspiratory
time.
If the patient does not inspire within the trigger window the
ventilator delivers pressure controlled breathing to the patient
at the end of trigger window.
Spontaneous breathing outside of the trigger window can
acquire pressure support.
If trigger level is reached outside of the trigger window, the
ventilator delivers pressure-supported ventilation based on
the preset [Psupp].
6.1.7.2 SIMV-PRVC waveforms A

B B
F: If no ventilation occurs
Key
within the trigger window C
G
A: Paw G: Time (s)
D E F E
B: Trigger window H: SIMV cycle
H
C: Pressure support level J: Flow
J
D: Within the trigger window K: Flow trigger
K K
E: Outside the trigger window L: PRVC ventilation G
L L
6.1.7.3 Parameter range and default values in SIMV-

PRVC mode
20 to 100 ml: 5 ml 100
to 1500 ml: 10 ml
Adult: 100 to 1600 ml 510 ml
Tinsp 0.1 to 10.0 s 0.1 s 1:2
Esens 5% to 80% 5% 25%

6.1.8 Spontaneous / pressure support ventilation (SPONT/PSV)
6.1.8.1 Description
Spontaneous/pressure support ventilation mode (SPONT/PSV) is an
auxiliary breathing mode.
When the patient’s spontaneous inspiration reaches the preset trigger
level, the ventilator begins to deliver gas and Paw rises to the preset
Psupp rapidly. The ventilator then reduces the flow to keep Paw constant.
When the inspiration flow drops to the preset level, the ventilator stops
delivering gas and the patient is allowed to expire, and the ventilator
waits for the next inspiration trigger.
If inspiration is not triggered within the set time (Backup Mode Active),
the system automatically switches to the backup ventilation mode
(Volume or Pressure). The backup mode should be selected in advance.
In SPONT/PSV mode, VT does not need to be set. VT depends on the
patient’s inspiratory force and pressure support level, and compliance
and resistance of the patient and breathing system.
PSV mode is used only when the patient is breathing spontaneously.
When PSV mode is applied alone, PCV and VCV backup modes are
available. If within the preset time (Backup Mode Active), no spontaneous
breathing occurs or spontaneous breathing is not strong enough to reach
the Trigger Level, backup mode ventilation is triggered automatically
when the time period for Backup Mode Active ends.
If an apnea situation occurs, and there is no spontaneous breathing,

or spontaneous breathing and an inspiratory trigger condition is
not reached, the system in accordance with the set ‘Apnea time’,
automatically enters a backup ventilation mode.
6.1.8.2 SPONT/PSV mode waveforms

Airway pressure (Paw) and flow waveforms in SPONT/PSV mode. B
A
C D
Key K
H
A: Airway pressure (Paw) G: Flow trigger E F J
B: Pressure trigger H: Backup mode - active period G
C: Pressure support level J: PCV (if triggered) - backup time K
D: Pressure control level K: Time (seconds)
E: Flow
F: Expiratory trigger
6.1.8.3 Parameter range and default values in SPONT/PSV mode

SPONT/PSV mode can be used jointly with SIMV-V or SIMV-P.

Esens 5% to 80% 5% 25%

6.2 Standby mode
6.2.1 Standby mode

1. Set the Anaesthesia system switch to ON.
After the power-up self test, the system enters standby
mode automatically.
2. In standby mode, press the Start/Standby button, the
system enters operating mode.
3. To return to standby mode during mechanical ventilation,
press the Start/Standby button, and in the pop up menu
select the ‘Activate Standby Mode’ button.
4. If the system is not in use, select standby to save power.
Monitored parameters and waveforms are not shown.
Ventilation stops
6.2.2 Standby mode features

• Parameters can be set and the system will operate based
on those settings when standby is exited.
• Physiological alarms are cleared automatically
• Technical alarms function normally.
• The monitor module enters standby status.
• Service modes are activated.

The standby page allows access to two page displays:
System Test
See section 5.4.
Patient
1. New Patient
a) New Adult
b) New Paediatric
c) New Infant (neonatal)
d) Gender options:
2. Previous Patient - data displayed from previous patients.

6.3 Home screen

11
1. Function fields (refer to section 6.4)
2. Ventilator setting fields (refer to section
6.5)
3. Fresh gas fields (refer to section 6.6)
8 9 10
4. Waveforms fields (refer to section 6.7)
5. Anaesthetic agent (AG) fields (optional)
(refer to section 6.10)
6. Measured values fields (refer to section
6.8)
7
7. Key parameter measured values fields 5
8. Ventilation mode (refer to section 6.15)
9. Alarm silence status (refer to section 6.11)
10. Alarm message fields (refer to section
6.12) 4
11. System prompt message and icons field

6
3
Caution
Confirm the new setting before adjusting
another parameter. If confirmation is not
given, the ventilator reverts to the pre-set
value.
Note
1. The software is primarily controlled using 2
the multifunction control (12).
Turn the control to move between dialogue 1
boxes, or to increase or decrease values
within a selected dialogue box.
Press the control to confirm the set value.
2. A dialogue box with three circles next to
the title indicates that more than one page
can be accessed. Press the control to
move between pages.
12

6.4 Function fields

The function fields give the user access to the following six
menu structures:
6.4.1 Ventilation Modes

Warning
Use ONLY Pressure Control Ventilation or Volume Control
ventilation for mandatory ventilation of infants (neonates).
Touch the MODE button to view the mode setting screen.
Depending on the configuration, there are seven ventilation
modes available.
When a mode is selected the display will show the
CONTROLS screen that is associated with the selected mode.
6.4.2 Controls
The controls buttons gives the user access to the control
panels for each of the seven ventilation modes.
Note
Only permitted ventilator settings may be confirmed by
the control, if a parameter is out of delivery range for the
selected ventilator mode, the parameter value cannot be
set.
6.4.2.1 Volume Control Ventilation (VCV) VCV X
To set ventilator parameters in VCV mode, select the desired Ttotal 4.00 s FlowPattern + SIGH
button in the ventilator settings fields. Parameters to be set Tinsp 1.33 s OFF
are shown below. Texp 3.34 s
Off 150
Pause %
PeakFlow 18.43 s
VT Tidal volume
MV 6.1 s 0
0 60
I:E Respiratory ratio
VT I:E f PEEP
f Respiratory rate 510
300 ml 1600
1:2.0
0.10 s 10.00 1
15 OFF
bpm 100 Off cmH2O 30
Pause Inspiratory pause
Cancel Accept
PEEP Positive end expiratory pressure
Modes Controls Monitoring Trends Alarms System
Flow pattern: Decelerating or constant flow
+Sigh: Sigh interval
6.4.2.2 Pressure Control Ventilation (PCV) PCV X
To set ventilator parameters in PCV mode, select the desired Ttotal 5.00 s
buttons in the ventilator settings fields. Parameters to be set Tinsp 1.66 s
are shown below. Texp 3.34 s
Tslope
Pinsp Pressure control level
0.3
I:E Respiratory ratio 0 s 2.00
Pinsp I:E f PEEP

f Respiratory rate
15 1:2.0
5 cmH2O 70 0.10 s 10.00
15 OFF
Tslope Pressure rise time
1 bpm 100 Off cmH2O 30
Cancel Accept
PEEP Positive end-expiratory pressure

6.4.2.3 Pressure Guaranteed - volume control

ventilation (PRVC) X
PRVC
To set ventilator parameters in PRVC mode, select the desired Ttotal 5.00 s
button in the ventilator settings fields. Parameters to be set
Tinsp 1.66 s
are shown below.
Texp 3.34 s
VT Tidal volume Pressure Limit
Tslope
40 0.3
f Respiratory rate
cmH2O
0 s 2.00
VT I:E f PEEP
510 1:2.0 12 OFF
Tslope Pressure rise time 300 ml 1600 0.10 s 10.00 1 bpm 100 Off cmH2O 30
Cancel Accept
6.4.2.4 Synchronized Intermittent Mandatory

Ventilation - volume control (SIMV-V) X
SIMV-V
To set ventilator parameters in SIMV-V mode, select the
Ttotal 5.00 s
desired button in the ventilator settings fields.
I:E 1 : 2.01
Texp 3.34 s
VT Tidal volume Tslope Esens Psens
Tinsp Inspiratory time 0

0.3
s 2.00 5
25
% 80
3
0 cmH2O 20
f Respiratory rate VT Tinsp Psupp f PEEP
510 1.66 15 12 OFF

Psupp Pressure support level 100 ml 1600 0.10 s 10.00 0 cmH2O 70 1 bpm 40 Off cmH2O 30
Cancel Accept
Psens/Fsens Pressure trigger / Flow trigger Modes Controls Monitoring Trends Alarms System

Esens Expiratory trigger sensitivity
6.4.2.5 Synchronized Intermittent Mandatory

Ventilation - pressure control (SIMV-P)
To set the ventilator parameters in SIMV-P mode, select the SIMV-P X
desired button in the ventilator settings fields. Ttotal 5.00 s
Pinsp Pressure control level I:E 1:2.01

Texp 3.34 s
Tinsp Inspiratory time Tslope Esens Psens
0.3 s 2.00 5
25
% 80
3
0 cmH2O 20
Psupp Pressure support level Pinsp Tinsp Psupp f PEEP
Tslope Pressure rise time 15 1.66

5 cmH2O 70 0.10 s 10.00
15
5 cmH2O 70 1
12
bpm 40
OFF
Off cmH2O 30
Psens/Fsens Pressure trigger / Flow trigger Cancel Accept


6.4.2.6 Synchronized Intermittent Mandatory Ventilation

- pressure guaranteed - volume control
ventilation (SIMV-PRVC) X
SIMV - PRVC
To set the ventilator parameters in PRVC mode, select the Ttotal 5.00 s
desired button in the ventilator settings fields.
I:E 1:2.01
VT Tidal volume Texp 3.34 s

Tslope Esens Psens
Pressure Limit
Tinsp Inspiratory time 0.3 25 3
40 cmH2O
0 s 2.00 5 % 80 0 cmH2O 20
Psupp Pressure support level
VT Tinsp Psupp f PEEP

300 ml 1600
1.66 15
5 cmH2O 70 1
12 OFF
bpm 100 Off cmH2O 30
0.10 s 10.00
Cancel Accept
Psens/Fsens Pressure trigger / Flow trigger
6.4.2.7 Spontaneous/Pressure Support Ventilation

(SPONT/PSV)
To set the ventilator parameters in SPONT/PSV mode, select
the desired button in the ventilator settings fields. SPONT/PSV X
In SPONT/PSV mode, the backup parameters should be set. Ttotal 4.00 s

The backup ventilation mode can be volume mode or pressure Tinsp 1.66 s
Backup
- VC
Backup
- PC
mode. Texp 3.34 s
Psupp Pressure support level

Tslope Esens Psens
PeakFlow 18.43 LPM
MV 6.1 L
0.3 25 3
Psens/Fsens Pressure trigger / Flow trigger 0 s 2.00 5 % 80 0 cmH2O 20
VT I:E Psupp f PEEP

510 1:2.0 15 12 OFF
PEEP Positive end-expiratory pressure 300 ml 1600 0.10 s 10.00 0 cmH2O 70 1 bpm 100 Off cmH2O 30
Cancel Accept
Esens: Expiratory trigger sensitivity
To set backup modes: Modes Controls Monitoring Trends Alarms System
1. Select the [Modes] shortcut button-> [Backup].

2. Touch [Volume] or [Pressure] to set desired backup mode.
Volume selected: the following parameters are available:
VT Tidal volume
f Respiratory rate
Pressure selected: the following parameters are available:
Pinsp Pressure control
f Respiratory rate

6.4.3 Monitoring
When the MONITORING function button is pressed the
monitoring screen shows two pages that display 27 set
parameters.
The parameters are divided between the two pages, titled
Values 1 and Values 2, as follows:
Values 1
Note
Values 1 Values 2 X
O2 monitoring is not shown in the illustration.
VTI 0 mL Ppeak 0 cmH2O Rst -- cmH2O/L/S
• Inspiratory tidal volume (VTI) VTE 0 mL Pmean 0 cmH2O Cdyn 10 mL/cmH2O
• Expiratory tidal volume (VTE) MV 0 L Pplat 0 cmH2O FiO2 -- %
MVspn 0 L 0 --
• Minute ventilation (MV)
PEEP cmH2O SpO2 %
ftotal 15 bpm Pmin -0.1 cmH2O Pulse -- bpm

• Spontaneous minute ventilation (MVspn) fspn 0 --
bpm I : E 1 : 2.01 PI %
• Respiratory rate (ftotal)

• Spontaneous breathing frequency (fspn)
• Peak airway pressure (Ppeak)
• Mean airway pressure (Pmean)
• Inspiratory plateau pressure (Pplat)
• Positive end expiratory pressure (PEEP)
• Minimum airway pressure (Pmin)
• Airway resistance (Rst)
• Compliance (Cdyn)
• Fraction of inspired oxygen (FiO2)
• Peripheral oxygen saturation (SpO2)
• Pulse rate (bpm)
• Perfusion index (PI)
Values 2 (available with optional gas monitoring)
Values 1 Values 2 X
Note MAC 0 FiAA1 -- --
Paramagnetic O2 monitoring is not shown in the illustration. FiCO2 0 % EtAA1 -- --
• Minimum alveolar concentration (MAC) EtCO2 0 % FiAA2 -- --
FiN2O 0 % -- --
• Fraction of inspired carbon dioxide (FiCO2)
EtAA2
EtN2O 15 % --
• End tidal carbon dioxide (EtCO2) -- --
• Fraction of inspired nitrous oxide (FiN2O)

• End tidal nitrous oxide EtN2O
• End tidal anaesthetic agent 1 (EtAA1)
• End-tidal anaesthetic agent 2 (EtAA2)

6.4.4 Trends
A trend graph is used to review the trend of parameter values
within a specific time period. The trend is reflected through a
curve.
Every point on the curve corresponds to the parameter value
at a specific time point. You can review parameter data within
a maximum of 24-hour operating time.
Select the [Trends] menu to access the display
1. Time Scale button
2. Parameter selection button
3. Trend graph
4. Cursor time
5. Cursor
6. Parameter and Parameter value
6.4.4.1 Setting trends

1. Select [Time Scale] button.
Select the desired scale from 1, 4, 12 or 24 hours.
2. Select the [Parameter selection] button.
Select the desired parameter.
3. Use the multifunction control to adjust the position of the
cursor to view the corresponding time point parameter
values
Caution
1. When the anaesthesia machine is used to set the system
time the trend graph is recorded again.
2. When the anaesthesia machine is used to set the type of
patient, select save or record again.
6.4.5 Alarms
Alarms are triggered (a) by a vital sign that appears abnormal
or set limits that have been exceeded or (b) by technical
problems within the anaesthesia machine.
The user can set upper and lower limits for the parameters in
the following sub-sections.
When setting alarm limits, touch the button, turn the
multifunction control knob to the value that you want to set,
and push the knob to confirm.
NOTE
Alarm message fields - see section 6.12.

6.4.5.1 Limits 1 display

In Limits 1, alarms are generally related to mechanical
ventilation.
Upper limits (1) and lower limits (2) are displayed for the 1
following parameters:
Pressure 2
MV Minute ventilation
FREQ Respiratory rate
FiO2 Fraction of inspired oxygen
VTE Expiratory tidal volume
Apnea time
In the SPONT/PSV mode, you can set the [Apnea Time] for
Apnea alarm, and if the patient failed to trigger, anaesthesia
ventilator will automatically convert to Backup mode,
[BACKUP] will be displayed in the mode display fields.

In Limits 2, alarms are related to anaesthesia gas and CO2
monitoring (if installed)
End-tidal carbon dioxide
Fraction of inspired carbon dioxide
Fraction of inspired nitrous oxide
End-tidal anaesthetic agent
Fraction of inspired anaesthetic agent

In Limits 3, alarms are related to SpO2 monitoring (if
installed)
Pulse rate
Pulse oximeter oxygen saturation
Perfusion Index
6.4.5.4 Alarm Log

The alarm log, the system displays up to 100 events, stored
in chronological order. When a new event occurs after 100
events are already stored, the new event overwrites the
current earliest event.

6.4.6 System Info Settings Date & Time Calibration

When the SYSTEM function button is pressed the SYSTEM
pages are shown. Software Version Supply Pressure Option
GUI 1.00.02 O2 - - PSI
• Info PRVC CO2
BDU 1.00.25 N2O - - PSI
• Settings PMU 1.00.08 Air - - PSI
SpO2
EGM 1.00.01
• Date & Time
Run Time Barometric Pressure
• Calibration. 102 Hours 1013 hPa
6.4.6.1 Info page VT ml I:E f bpm PEEP cmH2O
The Info page lists: 510

100 ml 1600
1:2.0
4.1 1.10
15 OFF
OFF 30
4 100
• Software version Modes Controls Monitoring Trends Alarms System
• Supply Pressure
• Run Time
• Barometric Pressure.
6.4.6.2 Settings page

Caution
When MONITOR switches are set to OFF, pressure alarms
related to those gases will be non-functional.
The SETTINGS page provides access to controls for :
• MONITOR
-- ON/OFF control for the O2 and AA Monitor
-- ON/OFF control for the SpO2 Monitor
• GAS SUPPLY
-- ON/OFF control for the Air supply
-- ON/OFF control for the N2O supply
• Alarm volume, Language and Units
-- Alarm volume control: The Alarm volume can be set to
20% (minimum); 40%; 60%; 80% or 100% (maximum).
-- Language selection controls
-- Units of measure selection controls.
»» CO2: %, mmHg or kPa Info Settings Date & Time Calibration
»» Airway pressure: cmH2O or mbar

Date Format Year Month Day Hour Minute
»» Height: cm or inches
YYYY-MM-DD
ON
▼ 2017 3 16 13 16
»» Barometric pressure: mmHg or hPa
»» Gas supply : kPa or psi
»» Weight: kg or lb (pounds).
Apply
6.4.6.3 Date & Time page VT ml I:E f bpm PEEP cmH2O

The DATE & TIME page provides a facility to set the system 510 1:2.0 15 OFF
time and date. 100 ml 1600 4.1 1.10 4 100 OFF 30

Date can be set using the UK or US date display systems.

6.4.6.4 Calibration page

Warning
The user must not attempt manual calibration of the
Pressure sensor, Flow sensor, or Flowmeter zero. Contact a
Penlon-trained service engineer.
The Calibration button allows access to the following
functions:
• Service Modes
• Oxygen Cell Cal
• Touchscreen Cal.
• Pressure Sensor Cal - Access for service engineer only
• Flow Sensor Cal - Access for service engineer only
• Flowmeter Zero Cal - Access for service engineer only
6.5 Ventilator setting fields

Ventilator setting fields give quick access to ventilator settings.
Ventilator setting fields are available in both standby and
ventilation modes. Values can be adjusted using the touch
screen or the multifunction control.
• Tidal volume (VT)
• Inspiration pressure (Pinsp)
• Breathing frequency (f)
• PEEP
1
6.6 Fresh gas fields
The Fresh Gas (FG) fields show the current flow of fresh gases
and the oxygen concentration of the fresh gas.
Preset (1) and user-set flows(2) can be displayed
The FG fields has a gas mix button (3 that is used to control
the display. The Gas mix button allows the display of a single
O2 display or a dual O2/Air or O2/N2O display.
Fresh Gas flow and O2 concentration are displayed. Fresh gas
0.08
O
0.05
2
16 O2/Air
2 8.0
4.0
2.0 O2/N2O
1.0
0.5 O2
0
O2 Gas mix
60 3
21 % 100 O2/Air
FG FLOW
21
0.2
% 100

6.7 Waveform field displays

Waveform field displays are shown in sections 6.7.1 to 6.7.8.
The measured range corresponding to the waveform scales
can be adjusted automatically. The sweep time is fixed.
Greyed-out icons indicate that the display is not available (the
monitor module is not installed, or the sensor may not be
connected).
Default waveforms:
1. Airway pressure (Paw)
2. Flow
3. Volume.
To access the following waveforms, press the waveform icon.
1. Paw: Airway pressure
2. Flow: Flow rate
3. Volume: Tidal volume
4. P-V Loop: Pressure - volume loop
5. V-F Loop: Volume-flow loop
6. P-F Loop: Pressure -flow loop
7. CO2: Carbon dioxide
8. N2O: Nitrous oxide
9. AA1: Anaesthetic agent in use
10. Pleth: Pleth.
6.7.1 Airway pressure waveform cmH2O

50
The airway pressure waveform shows the airway pressure,
measured in cmH2O, in the breathing circuit.
0
12 sec
-10
6.7.2 Flow waveform LPM

120
The flow waveform shows the flow of gases in the breathing
circuit.
0
12 sec
120
mL
600
6.7.3 Volume waveform
The volume waveform shows the volume of gas in the
breathing circuit.
0
12 sec

6.7.4 Pressure-Volume loop

Select [Monitoring] -> [Graphics]
A Pressure-Volume Loop and Volume-Flow loop will displayed
as shown.
6.7.5 Volume-Flow loop
6.7.6 Pleth waveform

On machines with an SpO2 module, a Pleth waveform is
displayed as shown.
6.7.7 EtCO2 waveform

On machines with CO2 monitoring, an EtCO2 waveform is
displayed as shown.
LPM
60
6.7.8 Pressure-Flow loop
An example of a Pressure-Flow (P-F) loop is shown.
0
0 25 cmH2O
-60

6.8 Measured values fields - key parameters Ppeak cmH2O
The key parameters listed below are displayed at the top of the
right-hand column at all times.
0
MV
40
5
L
• Ppeak: Peak airway pressure

0 10
5
• MV: Minute ventilation VTE ml
• VTE: Expiratory tidal volume 0

ftotal
670
350
bpm
• ftotal: Total respiratory rate
15 100
5
6.9 Measured values fields - general

parameters
The values fields are divided into two groups that are shown on PEEP cmH2O
two interchangeable pages.
The page number (1) that is currently active is shown in a
2.6 cmH O
Pmean
6.0 L
2
highlighted circle.
Note MVspn
1. Each list of parameters displayed will vary, depending on
the ventilator and monitoring settings chosen by the user. 0 bpm
fspn
0 mL
2. If an AG module is fitted, a third page can be selected.
6.10 Anaesthetic Gas fields (optional) VTI

For details, refer to Appendix 6.
The Anaesthetic Gas (AG) fields are displayed in the upper
502
LH display column. The fields are automatically configured to 1 1 2
reflect the Anaesthetic in use and the ventilation mode in use.
• MAC: Minimum alveolar concentration
• FiAA: Fraction of inspired anaesthetic agent
• EtAA: End-tidal anaesthetic agent
• FiN2O: Fraction of inspired nitrous oxide
• EtN2O: End-tidal nitrous oxide.
6.11 Alarm silence status

Press the alarm silence button (1). 1 2
’Alarm silenced’ status will be set. The audio alarm will be
disabled for 120 seconds.
The alarm silence symbol and the 120 seconds countdown
time will be displayed in the upper right-hand corner of the
screen.
If another alarm occurs, the current silenced status is
cancelled automatically and the audible alarm is restored.
When the countdown time period ends, the audible alarm is
restored. The alarm message will be displayed continually
until the Alarm Reset button (2) is pushed.
In the alarm silence period, press the alarm silence button
again if the system does not respond.

6.12 Alarm message field

Alarms are triggered by a vital sign that appears abnormal, or
by a technical condition within the anaesthesia machine.
Alarms are indicated to the user by visual and audible alarm

indicators.
WarningS
1. Do not rely exclusively on the audible alarm system.
2. Decreasing the alarm volume may result in a hazard to
the patient.
Caution
1. At start-up, the system self-test checks if the alarm lamp
and audible alarm tones function normally.
If the self-test confirms normal function, the alarm
system triggers an audible beep and the alarm lamp
flashes yellow and red once in turn.
2. If a failure is detected, do not use the equipment. Contact
a Penlon-trained engineer.
3. When multiple alarms of different levels occur
simultaneously, the system will select the highest priority
alarm and give visual and audible alarm indications for
that alarm.
4. Values for all technical alarms and some physiological
alarms are preset and cannot be changed.
6.12.1 Alarm indicators

Alarms trigger visual or audible indicators:
Alarm lamp
Alarm message
Flashing numeric
Audible alarm tones
6.12.2 Visual indicator

If an alarm occurs, the alarm indicators will illuminate.
Colour and frequency match the alarm level as follows:
High level alarms The red indicators flash quickly.

Medium level alarms The yellow indicators flash slowly.
Low level alarms The yellow indicators are is lit,
without flashing
6.12.3 Audible indicator

Different alarm tone patterns are used to match the alarm
level:
High priority: 10 note sequence, repeated every 10
seconds
Medium priority: 3 note sequence, repeated every 2 seconds
Low priority: 2 note sequence, does not repeat.

6.12.4 Alarm message

When an alarm occurs, a message appears in the alarm area.
The alarm area background colour matches the alarm level:
High level alarms: red
Medium level alarms: yellow
Low level alarms: yellow

For physiological alarms, the symbol (!) identifies alarm level:
High level alarm: !!!
Medium level alarm: !!
Low level alarm: !
6.12.5 Clinical alarms

Message Priority Cause Action
Check patient’s spontaneous breathing
Breathing or ventilation has ability.
APNEA!!! High
stopped. Check for blockages in the breathing
circuit
Airway pressure greater than Check for blockages in the breathing
Continuous Pressure High!!! High
(PEEP +15) cmH2O for 15 seconds. circuit.
Decrease tidal volume or increase Paw
Ppeak is higher than the Paw high high alarm limit value.
PRESSURE HIGH!!! High
alarm limit setting.
Check for blockages in the patient circuit
Recalibrate the O2 cell.
FiO2 < 18%!!! High FiO2 is lower than 18%.
Set the alarm limits appropriately.

FiHAL HIGH!!! High FiAA is greater than alarm limit.
Check agent setting.
FiENF HIGH!!! High
FiISO HIGH!!! High
FiSEV HIGH!!! High
FiDES HIGH!!! High
EtHAL HIGH!!! High EtAA is greater than alarm limit.
Check agent setting
EtENF HIGH!!! High
EtISO HIGH!!! High
EtSEV HIGH!!! High
EtDES HIGH!!! High
MV is lower than the low alarm Increase tidal volume or breath rate, or
MV LOW!!! High
limit setting. decrease low alarm limit.
MV is higher than the high alarm Decrease tidal volume or breath rate, or
MV HIGH!!! High
limit setting. increase high alarm limit.
Check for blockages in the breathing
circuit.
Increase fresh gas flow.
PRESSURE < -10 cmH2O!!! High Paw is less than -10 cmH2O Check that there is high flow gas flowing
through the AGSS. If yes, check the
negative pressure relief valve on the
receiver.


Set the alarm limits appropriately or
RATE LOW!! High Rate is less than low alarm limit.
adjust the Rate setting
FiO2 is greater than high alarm
FiO2 HIGH!!! High Check the O2 setting.
limit.
Recalibrate the O2 cell
Check the O2 setting.
FiO2 LOW!!! High FiO2 is less than low alarm limit. Check for leaks or blockages in the patient
circuit.
Recalibrate the O2 cell
Check the patient settings.
EtCO2 is greater than high alarm
EtCO2 HIGH!!! High Set the alarm limits appropriately.
limit.
Check if absorbent needs to be changed.
FiCO2 HIGH!!! High FiCO2 is greater than alarm limit.
Check if absorbent needs to be changed.
FiN2O HIGH!!! High FiN2O is greater than alarm limit.
Check the N2O setting.
Ppeak is lower than the Paw low Increase tidal volume setting or decrease
PRESSURE LOW!!! High
alarm limit setting. Paw low alarm limit setting.
SpO2 is lower than the low alarm Check patient’s condition!

SpO2 LOW!!! High
limit setting. Set the alarm limits appropriately.
Pulse rate is lower than the low Check patient’s condition!

PULSE RATE LOW!!! High
alarm limit setting. Set the alarm limits appropriately.
VTE is higher than the high alarm Decrease tidal volume setting or increase
VTE HIGH!!! High
limit setting. high alarm limit.
VTE is lower than the low alarm Increase tidal volume setting or decrease
VTE LOW!! Medium
limit setting. low alarm limit.
Rate is greater than high alarm Set the alarm limits appropriately or
RATE HIGH!! Medium
limit. adjust the Rate setting.
Pulse rate is greater than high Check patient’s condition!

PULSE RATE HIGH!! Medium
alarm limit. Set the alarm limits appropriately.
SpO2 is greater than high alarm Check patient’s condition!

SPO2 HIGH!! Medium
limit. Set the alarm limits appropriately.
Check that patient is properly intubated.
Check for leaks or blockages in the
EtCO2 LOW!! Medium EtCO2 is less than alarm limit.
patient circuit.
Set alarm limit appropriately.
FiHAL LOW!!
FiENF LOW!! Check the fill level of the vaporizers.
FiISO LOW!! Medium FiAA is less than alarm limit. Set alarm limit appropriately.
FiSEV LOW!! Check agent setting.
FiDES LOW!!


EtHAL LOW!!
EtENF LOW!! Check the fill level of the vaporizers.
EtISO LOW!! Medium EtAA is less than alarm limit. Set alarm limit appropriately.
EtSEV LOW!! Check agent setting.
EtDES LOW!!
Set the required alarm limits.
FiN2O LOW!! Medium FiN2O is less than alarm limit.
Check the N2O setting
Two different agents are detected Make sure only one vaporizer is on.
Mixed Agent and MAC > =3!! Medium and the MAC calculation is greater Wait approximately two minutes for the
than or equal to 3. first agent to wash out of the system.
Two different agents are detected Make sure only one vaporizer is on. Wait
Mixed Agent and MAC < 3! Low and the MAC calculation is less approximately two minutes for the first
than 3. agent to wash out of the system
6.12.6 Technical alarms

O2 pipeline pressure is less than Check the O2 pipeline and cylinder are
O2 SUPPLY DOWN!!! High
280 kPa. properly connected.
Plug in the power cable.
Remaining battery power is
BATTERY DISCHARGED!!! High Check that the system circuit breaker is
between five and fifteen minutes.
on.
Switch to alternate O2 control.
EGM FAILURE !!! High Electronic gas mix hardware error Restart anaesthetic workstation.
Contact your service personnel.
Restart anaesthetic workstation.
EGM communication failure!!! High Hardware error
Contact your service personnel.
Breath delivery unit hardware Restart anaesthetic workstation.
BDU communication failure!!! High
error Contact your service personnel.
Gas Module Software Error!!! High Gas Module Software Error Contact your service personnel.
Gas Module Hardware Error!!! High Gas Module Hardware Error Contact your service personnel.
Gas Module Motor Overspeed!!! High Gas Module Motor Overspeed Contact your service personnel.
Gas Module Factory calib lost!!! High Gas Module Factory calib lost Contact your service personnel.
Gas Module Replace Adapter!!! High Gas Module Replace Adapter Contact your service personnel.
Gas Module No Adapter!!! High Gas Module No Adapter Contact your service personnel.
CO2 Unspecified Accuracy!!! High CO2 Unspecified Accuracy Contact your service personnel.
N2O Unspecified Accuracy!!! High N2O Unspecified Accuracy Contact your service personnel.
AA Unspecified Accuracy!!! High AA Unspecified Accuracy Contact your service personnel.
Gas Module Temp Out Of
High Gas Module Temp Out Of Range Contact your service personnel.
Range!!!
Pressure Out Of Range!!! High Pressure Out Of Range Contact your service personnel.
AA ID Unreliable!!! High AA ID Unreliable Contact your service personnel.
Remaining battery power is
BATTERY LOW!!! High Check that the system circuit breaker is
between ten and thirty minutes.
on


No battery detected Check battery cable or replace battery
Battery failure Replace battery
BATTERY FAILURE!!! High
Battery disconnected Check battery cable
Power controller board failure Contact your service personnel
Air pipeline pressure is less than Check that the air pipeline is properly
AIR SUPPLY DOWN!! Medium
280 kPa. connected.
Check the N2O pipeline.
N2O pipeline pressure is less than
N2O SUPPLY DOWN!! Medium Check that the cylinder is properly
280 kPa.
connected.
NO ABSORBER ? !! Medium No connected Absorber canister Installation Absorber canister
An error or occlusion occurred to
ETCO2 LINE OCCLUSION!! Medium Check the CO2 sampling line.
the sampling line.
Gas Module Inaccurate Gas Gas Module Inaccurate Gas Calibrate the Gas Module Zero.
Medium
Zeroing!! Zeroing Contact your service personnel.
MAINS FAILURE! Low AC power disconnected or failure Check that the system circuit breaker is
on.
SPO2 SENSOR DISCONNECT?! Low SPO2 sensor is not connected Connect the SpO2 sensor.
Press the “Alarm Reset”
EtCO2 OFF! Low CO2 switch is turned off To monitor CO2 concentration, open the
CO2 switch
AA OFF! Low AA switch is turned off To monitor Anaesthetic agent
concentration, open the AA switch.
SPO2 OFF! Low SpO2 switch is turned off To monitor SpO2, set the SpO2 switch to
on.
O2 OFF! Low O2 switch is turned off To monitor O2 concentration, set the O2
switch to on.

6.13 System prompt message and icons field
NOTE
Prompt messages are not alarm messages.
Clinical and technical alarm messages and system status
messages are also displayed in the prompt message area.
1 2
6.13.1 Patient type icon

The display (1) shows an icon relevant to the selected patient
type. 4
6.13.2 Power status display field 3

The power status display indicates mains power (2) and battery
power (3) .
6.13.3 System time field

The time field (4) displays system time data.
6.14 System start-up procedure

1. Plug the power cord into an AC mains power outlet.
The mains indicator is lit when the AC power is connected.
The battery will be charged (if it is not already fully
charged).
2. Check that the breathing system is properly connected.
3. Turn the Anaesthesia system switch (1) to the ON position.
4. The self test will start and the indicator lights will be
illuminated.
The self-test screen will be displayed and the self test will
start.
5. The self-test will continue for about 10 seconds. The
1
device will prompt the user to perform a pre-use test.
Press the ACCEPT button to access the pre-use test
screen.

6.15 Ventilation mode
Warning
Before clinical use, check that all connections are secure
and that the pre-operation tests are completed.
If any tests failed, do not use the system. Refer the
workstation to a Penlon-trained service engineer for repair.
6.15.1 Bag ventilation mode

A C D
1. Turn the APL valve control to adjust the pressure in the
breathing system within the appropriate range.
2. Set the bag/mechanical ventilation switch to the Bag
position. The ventilation mode prompt area displays the
icon for manual ventilation mode.
Note: Automatic mode switching between manual and
mechanical ventilation is described in section 3.10.1.
B
3. Press the O2 flush button to inflate the bag if necessary.
In manual ventilation mode, you can use the APL valve
to adjust the breathing system pressure limit and gas
volume in the manual bag.
When the pressure in the breathing system reaches the
pressure limit set for the APL valve, the valve opens to
release excess gas.
4. The figures show the Paw waveform and flow waveform in
the manual ventilation mode. Key
A: Airway pressure
B: Flow
6.15.2 Mechanical ventilation mode
1. Check that the system is in Standby mode. C: Time: inspiration
D: Time: Expiration
2. Set the appropriate pressure high alarm value in the
parameter setup.
3. Set the bag/mechanical ventilation switch to the
Ventilator position.
4. If necessary, press the O2 flush button to inflate the
bellows.
Caution
Check the parameters are set to appropriate values before
starting ventilation.
5. To start mechanical ventilation, press the Start/Standby
button.

6.16 Monitoring parameters
6.16.1 FiO2 monitoring

If the system is configured with an O2 module or an oxygen
sensor (1), FiO2 values are displayed.
Caution
Note that the oxygen sensor test is part of the daily alarm 1
system test procedure (section 5.9). If the sensor fails the
test, refer to section 7.7 and recalibrate.
6.16.2 Pressure monitoring

Pressure related parameters are measured as shown below.
Ppeak Peak airway pressure
Pplat Inspiratory plateau pressure
Pmean Mean airway pressure
6.16.3 Tidal volume monitoring

Caution
The tidal volume values on the bellows housing give an
approximate indication, and may be inconsistent with the
actual measured volumes.
Tidal volume related parameters are shown below.
VTI Inspiratory tidal volume

VTE Expiratory tidal volume
MV Minute ventilation
MVspn Spontaneous minute ventilation
6.16.4 Respiratory rate monitoring

Breath rate related parameters are shown below.
ftotal Respiratory rate

fspn Spontaneous breathing frequency
6.16.5 Pulmonary function

The system displays dynamic compliance monitoring, static
resistance, and spirometry loops to reflect the patient’s
pulmonary function.
The system provides two spirometry loops: Paw-V (Paw-
volume) loop and V- Flow(volume-flow) loop.
The scales of volume flow and Paw are adjusted automatically.
Paw-V loop and V- Flow loop are shown in section 6.7.

6.17 Absorber
6.17.1 Drain the condensate from the canister

Warning
1. Condensate is caustic. Avoid skin contact when draining.
2. If the water is drained during a clinical procedure,
reinstall the drain plug (1) immediately to prevent gas
leakage 1
The drain plug allows condensation drainage without the need

to remove the soda lime.
1. Wear protective gloves
2. Hold the canister over a drain or collection bowl.
3. Carefully pull out the drain plug (1).
6.17.2 Changing the CO2 Absorbent

WARNINGS
1. If the absorbent is to be changed during clinical use,
adequate fresh gas flow must be maintained to prevent
excessive build up of CO2.
2. Anhydrous soda lime is known to react with some
anaesthetic agents. Do not continue to use the absorbent
if it has been allowed to dry out (or if you suspect it has
dried out). Always replace dried-out absorbent with a
fresh supply.
3. Condensation, which may collect in the bottom of the
absorber canister, is caustic. Avoid skin contact when
draining.
4. Soda lime and condensate are caustic and strong
irritants to eyes, skin and respiratory system. Affected
areas should be flushed with water. If irritation
continues after flushing with water, seek medical
assistance immediately.
5. During a clinical procedure, refit the canister as soon as
possible.
Removing the canister

1. Hold the handle, rotate the canister clockwise and remove.
NOTE
If the system is in use an alarm is triggered:
’No absorber!?’ is shown in the alarm message area.
Bypass mode is activated.
The breathing circuit is bypassed and the patient re-
breaths exhaled gases until the canister is refitted.
2. If necessary, Drain the condensate from the canister, see
section 6.17.1.
3. Dispose of the absorbent in compliance with your local
facility disposal procedures.

Refilling and refitting 1
Warning
To prevent dust and particles from entering the breathing
circuit, the filter (1) must be fitted in the correct position as
illustrated.
Before installation, clean the rim of the canister perimeter,
the canister support, and the seal to prevent breathing
system leakage.
1. Fill with new soda lime to the MAX line (2).

Remove any soda lime that has collected on the filter (1).
2 3 4
2. Wipe the dust from the absorber canister support.
3. Position the canister, ensuring that the threads are
engaged.
Make sure that the triangular marks (3) are aligned.
4. Tighten counterclockwise until the ‘locked’ symbol (4) and
the triangular mark on the canister are aligned.
Before clinical use, carry out the relevant pre-use checks listed
in section 5 of this manual.
6.18 System shut-down procedure

When a clinical procedure is completed, carry out the following
procedure.
1. Check that the vaporizer is in the OFF position.
2. Turn the anaesthesia system switch to the OFF position.
3. Disconnect electrical power.
4. Disconnect all gas pipelines.
5. Close the cylinder valves..

7. Maintenance
IMPORTANT
User maintenance
User Maintenance is restricted to cleaning the external
surfaces of the machine (see section 6.1).
All other maintenance and servicing must be carried out
only by Penlon-trained engineers.
Servicing and Repair
Prima 465 machines must only be serviced or repaired by
Penlon-trained engineers, according to the schedule and
procedures given in the Service Manual.
WARNINGS
1. Exterior panels must not be removed by unauthorised
personnel and the apparatus must not be operated with
such panels missing. Ensure that all panels are secure
after any work.
2. Electrical power supply
a) Unauthorised personnel must not attempt to access
fuses or other electrical components. There is a
possible electric shock hazard.
b) Replacement of the mains lead must be carried out
only by a Penlon-trained engineer.
Ancillary Equipment
Follow the instructions given in the relevant user manual for
detailed information on maintenance and service requirements
for the ancillary equipment used with the anaesthetic machine
7.1 Service schedule

The operational life of the Prima 465 is eight years.
The anaesthetic machine must be serviced to the following
service schedule:
6 months
Inspection and Calibration
Clean the bellows and diaphragm valve.
Service engineers checklist
12 months
Carry out the operations listed for the 6-month service.
Calibrate the CO2 and AG modules (if installed)
2 years
Carry out the operations listed for the 6-month service.
Calibrate the CO2 and AG modules (if installed)
Fit the components supplied in the preventive maintenance kit.
Service engineers tests
Further information is given in the Prima 465 service manual,
available only to engineers trained by the manufacturer.

Maintenance
7.2 Cleaning and disinfection
WARNING
1. Read the cleaning agent data sheet, and the user manual for all disinfection equipment.
2. Wear gloves and safety glasses. The O2 sensor contains a small quantity of electrolyte,
classified as a harmful irritant, which is potentially hazardous.
3. Reuse of a non-disinfected breathing system or reusable accessories may cause cross-
contamination.
4. To prevent leaks, avoid damaging any breathing system components when disassembling
and reassembling. Ensure the correct installation of the system, especially component
seals.
5. Disconnect the electrical supply before cleaning.
6. Do not allow liquids to run into enclosed areas; serious damage may result.
7. Pre-use checks must be performed before patient use after cleaning and disinfection.
CAUTION
1. Cleaning and disinfection is required before a new machine is used for the first time.
2. Do not use organic, halogenated, or petroleum based solvents, anaesthetic agents, glass
cleaners, acetone, or other harsh cleaning agents. Cleaning solutions must have a pH of
7.0 to 10.5.
3. Do not use harsh abrasive cleaning agents (such as steel wool, silver polish or cleaner).
4. Do not allow liquid to go into the machine or onto any electronic components.
5. Do not soak synthetic rubber components for more than 15 minutes. Swelling or faster
aging can occur.
Anaesthetic workstation
Clean all surfaces with an appropriate disinfectant, on a daily basis, or immediately if visibly
contaminated. All surfaces, especially those areas which are likely to have been touched by the
gloved hand that has been in contact with blood or secretions, will be contaminated. Clean at
the earliest opportunity, between patients. Appropriate disinfectants are isopropyl alcohol, or
alcohol wipes.
Anaesthetic gas scavenging system
Clean with a damp cloth soaked in mild detergent. Wipe off the remaining detergent with a dry
lint free cloth.
After cleaning
Make sure that all cleaning agent residues are removed after cleaning. Allow all surfaces to dry
thoroughly before clinical use.
Breathing system
The table shows the methods of cleaning, disinfecting or sterilisation of individual components.
Part Method Details Life cycles

Wipe with mild detergent, dry with
O2 sensor Cleaning
a lint-free cloth
Wash with mild detergent, soak for
All parts of the breathing circuit
Disinfecting 30 minutes in 30-41°C detergent
except the O2 sensor
(PH 7.0-10.5
Autoclave at a maximum
All parts of the breathing circuit
temperature of 121°C for a
except O2 sensor, airway pressure Sterilisation 25 minimum
minimum of 15 minutes and a
gauge and relief valve assembly.
maximum of 30 minutes.

Maintenance
Disinfection
Breathing system hoses and other components must be
disinfected to the manufacturer’s recommended methods.
An effective, new HME (heat and moisture exchanger) with a
bacterial filter should be used for every patient.
Display screen surface
CAUTION
Do not apply excessive pressure to the display screens.
Clean the display screen with soap-based sanitising wipes.
Use a soft cloth only. Do not use harsh abrasive cleaning
agents.
7.3 Absorber and breathing system
CAUTION
Removal and refitting must only be carried out by qualified
service personnel. Always support the weight of the unit
under the manifold block. Do not lift the absorber by gripping
any of the components attached to the manifold block.
The canister may contain condensate. Before removal, drain
the canister and dispose of the absorbent - see section 7.4.8.
1. Set the brakes on the anaesthetic machine castors.
2. Disconnect all cable connectors and hoses.
2
3. Remove the components as described in sections 7.3.1 to
7.3.10.
1
7.3.1 Remove the oxygen sensor

1. Unplug the cable (1) from the sensor (2).
2. Unscrew the oxygen sensor (1).
7.3.2 Remove the breathing hoses

1. Disconnect the inspiratory and expiratory hoses from the
absorber.
2. Separate the Y-piece from the two breathing tubes.
Caution
Do not reuse the filter. Follow local regulations regarding
disposal of hospital waste when the filter is discarded.
7.3.3 Remove the bag

Remove the bag from the bag arm.

Maintenance
7.3.4 Differential pressure flow sensors

Remove
1. Unscrew the inspiratory and expiratory connectors (1), and
disconnect the breathing hoses.
8
2. Withdraw each differential pressure flow sensor and tube
assembly (2) from the absorber. 2
3. Detach each flow sensor (3) from the tube (4). 5
Install (after cleaning)
1. Align the lugs on the tube with the slots (5) in the flow
sensor (2).
1
2. Push the tube into the sensor until the lugs engage the
slots.
3. Turn the tubing clockwise until the lugs are fully engaged 4 5 3
in the slots (6).
4. Align the flow sensor and tube assembly with the
absorber.
Caution
a) Make sure that the arrow (8) and the word ‘UP’
(9) are aligned uppermost as shown in the top
illustration .
b) The direction of the arrow (9) indicates expiratory 6 8 9
sensor (top illustration) and inspiratory sensor (lower
illustration) on the sensor.
5. Push the differential pressure flow sensor into the
absorber assembly. 1
7.3.5 Remove the bellows assembly components

2
1. Turn the bellows housing (1) counterclockwise, and lift
from the base
2. Remove the bellows (2) from the base (3).
3. Remove the bellows base (3)
4. Remove the locking tabs (4) and ring (5) from the bellows
base.
4 5

Maintenance
7.3.6 Remove the non-return valve assemblies

1. Turn each non-return valve cover counterclockwise to
remove.
2. Remove the non-return valve assemblies.
7.3.7 Remove the absorber canister

Warning
Soda lime and condensate are caustic and strong irritants to
eyes, skin and respiratory system. Affected areas should be
flushed with water. If irritation continues after flushing with
water, seek medical assistance immediately.
During a clinical procedure, refit the canister (1) as soon as
possible.
1
1. Hold the canister handle, rotate the canister clockwise and
remove.
7.3.8 Drain the condensation from the canister

Warning
If the water is drained during a clinical procedure, reinstall
the drain plug immediately to prevent gas leakage
The drain plug allows condensation drainage without the need
to remove the soda lime. 1
1. Wear protective gloves
2. Hold the canister over a drain or collection bowl.
3. Carefully pull out the water drain plug (1).
4. Dilute the drained condensate before disposal.
5. Refit the plug and empty the canister.
Dispose of the absorbent in line with local regulations.
7.3.9 Remove the water container

1
WarningS
1. Removing the water collection container (1) will not
cause gas leakage, but reinstall as soon as possible
during a clinical procedure.
2. Dilute the condensate with water before disposal.
1. Wear protective gloves, and turn clockwise to remove
7.3.10 Remove the airway pressure gauge
Carefully pull the airway pressure gauge from the port on the
top of the absorber.

Maintenance
7.3.11 Remove the absorber assembly

1. Lift and rotate the locking catch (1) through 90 degrees.
2. Use both hands to remove the absorber assembly.
1
7.3.12 Absorber and breathing system - cleaning and
disinfection
Cleaning
Rinse and dry all parts of the breathing system, except the O2 sensor.
Use a mild detergent (pH ranging from 7.0 to 10.5).
Sterilising
Metal, glass and autoclavable moulded parts can be steam autoclaved
at a maximum temperature of 121°C.
Warning
1. To avoid patient injury, do not use talc, zinc stearate, calcium
carbonate, corn starch or equivalent materials.
2. Inspect all parts for deterioration and replace if necessary.
All parts of the breathing system must be cleaned and disinfected.
Recommended disinfection methods
Patient breathing hoses and Y-piece (reusable)

Check the manufacturer’s instructions
Differential pressure flow sensor
Do not autoclave.
Flush with water, then soak in a soap solution for 30 minutes, at a
temperature of 30-41°C. Rinse with clean water. Dry and wipe, using
70% medical-use alcohol.
Bellows assembly
The relief valve assembly is not autoclavable and must be cleaning
with 70% medical-use alcohol.
Flush with water, then soak it in a solution of water and detergent for
30 minutes at a temperature of 30-41°C. Rinse with clean water, and
wipe with 70% medical-use alcohol.
Non-return valve assemblies
Flush with water, then soak in a soap solution for 30 minutes at a
temperature of 30-41°C. Rinse with clean water, and wipe with 70%
medical-use alcohol.
Alternatively, autoclave at a maximum temperature of 121°C for a
minimum of 15 minutes.
Oxygen sensor
Do not immerse in liquid, do not autoclave.
Clean with a damp cloth soaked in mild detergent. Wipe off the
remaining detergent with a dry lint free cloth.
Absorber canister assembly
Flush with water, then soak it in a soap solution for 30 minutes at a
temperature of 30-41°C. Rinse with clean water, and wipe with 70%
medical-use alcohol.
maximum of 15 minutes.

Maintenance
Reusable manual bag

Check the manufacturer’s instructions
Absorber assembly, APL valve and bag arm
Flush with water, then soak it in soak it in a soap solution for 30
minutes at a temperature of 30-41°C. Rinse with clean water, and
wipe with 70% medical-use alcohol.
The bag arm may be removed before the bag arm, APL valve, and
the absorber assembly are autoclaved.
Note
Set the APL valve to the MAX position before autoclave.
Condensate collection container
Flush with water, then soak it in a soap solution for 30 minutes, at a
temperature of 30-41°C. Rinse with clean water, then wipe by using
70% medical use alcohol.
Airway pressure gauge
Do not autoclave.
Flush with water, then soak it in a soap solution for 30 minutes, at a
temperature of 30-41°C. Rinse with clean water, then wipe by using
70% medical use alcohol.
7.3.13 Reassemble the absorber and breathing system

1. All components must be fully dried before assembly and
installation.
3
2. Replace any parts that are visibly damaged or worn. 1 1
3. Reverse the dismantling procedures given in sections 7.3.1 to
7.3.10.
7.3.14 Reinstall the absorber and breathing system

1. All components must be fully dried before assembly and 2
installation. Refer to Section 5, Installation and Pre-Use Checks
2. Check that the eight silicon inserts (1) on the breathing circuit
adapter plate (2) are in place and are not damaged.
3. Use BG87 or Fomblin grease to lightly lubricate the eight silicon
inserts (1). 1 1
4. Lift and turn the locking catch (3) to the unlocked position. 5 5
5. Align the two connectors (4) on the absorber with the matching
holes (5) on the circuit adapter plate.
6. Carefully push the absorber assembly into the circuit adapter
plate with moderate force.
7. Reset the locking catch (3) to the locked position.
Warning
Set the locking catch to the locked position after the absorber
assembly is installed. Always check that the assembly is locked in
position. 4

Maintenance
7.4 Anaesthetic gas scavenging system -

Receiver unit
Follow the cleaning and service recommendations detailed in

the AGSS user instruction manual.
7.5 Breathing system sensors

7.5.1 Pressure sensor zeroing
Caution
1. Do not calibrate while the unit is connected to a patient.
2. During calibration, do not move or compress the
breathing tubes.
Procedure
1. Stop ventilation.
If a breathing tube is connected, open the breathing tube
patient connection to air.
Check that the bellows falls to the bottom of the canister.
2. Set gas flows to minimum.
3. In standby mode, touch the [System] button (1) ->
[Calibration] button (2) ->[Pressure Sensor Cal] button (3).
Pressure sensor zero calibration will start automatically.
Do not touch the breathing system tubing during
calibration.
1
Caution
If zeroing fails, contact a Penlon-trained engineer.
2
7.4.2 Flow sensor zeroing
3
1. Stop manual or mechanical ventilation. If a breathing
tube is connected to the breathing system, then open the
breathing tube patient connection to air.
Check that the bellows falls to the bottom of the canister.
2. Turn off the flowmeter.
3. In standby mode, touch the [System] button (1) ->
[Calibration] button (2) ->[Flow Sensor Cal] button (3).
Flow sensor zero calibration will start automatically.
Do not touch the breathing tubes during calibration.
Caution
If zeroing fails, contact a Penlon-trained engineer.
1
7.5 Flowmeter zero calibration procedure
1. Press the ‘System’ button (1), located in the function fields 2
2. Select the Calibrations page (2).
DO NOT press the Flowmeter Zero Cal. button.
3

Maintenance
3. Press the Alternate O2 supply switch (3).

4. Check that the switch is illuminated.
5. Press the Flowmeter Zero Cal button (4) to start the
1
calibration.
6. Wait for the test to finish - ‘Calibration Success!’ (5) will be
displayed. 2
7. Press the calibration window exit button (6).
8. The system will enter Standby.
9. Press the Alternate O2 supply switch (3). Check that the 4
flow of O2 stops, and the switch is not illuminated.
10. Press the start/standby button (7) on the control panel.
11. Reapply the original flow settings.
12. After approximately two minutes check that the measured
O2 is within 5% of the set value.
Caution
If the measured error is still displayed, contact a Penlon-
trained engineer.
3
6
7.7 Oxygen monitor calibration
Caution
Calibrate at the same ambient pressure in which it will be
used to monitor oxygen delivery in the breathing system.
1. Remove the O2 sensor (1).
2. Check for water build-up in the sensor and its installation.
Dry if necessary, then refit. 5
3. Check that the oxygen sensor cable is connected correctly.
7
7.7.1 O2 calibration at 21%

Maintenance
Caution
1. Calibrate when the measured value of O2 concentration
is outside specification range, or when the O2 sensor is
replaced.
2. If calibration fails: 1
a) Check for a technical alarm, then repeat the
calibration.
b) In case of repeated calibration failures, replace the
O2 sensor. Follow your hospital biohazard disposal
procedure, do not incinerate the sensor.
c) Repeat the calibration. If it still fails, contact a Penlon-
trained service engineer.
Calibration procedure at 21% O2
1. Select standby mode.
2. Turn off all gas flows.
3. Touch the [System] buttons -> [Calibration] -> [Oxygen Cell
Cal]->[21%].
4. Check that the test lung is disconnected from the system.
5. Follow the prompts:
Before O2 21% calibration, flush with 10 L/min of air, or
expose in air for two minutes minimum.
6. Remove the O2 sensor from the breathing system and expose
to room air for three minutes.
7. Push the [Enter] button to start calibration.
8. After a successful calibration, the screen will display
[Calibration Completed!].
If [Calibration Failure! ] is displayed, repeat the calibration.
7.7.2 O2 calibration at 100% O2

Caution
1. If the calibration fails, check for a technical alarm.
Repeat the calibration.
2. In case of repeated calibration failures, replace the O2
sensor and repeat the 21% O2 calibration.
3. Calibrate at 100% O2 after a 21% O2 calibration is
completed. If it still fails, contact a Penlon trained engineer.
Calibration at 100% O2:
1. Check that the 21% O2 calibration is completed successfully
and that the O2 Supply Failure alarm is not triggered.
2. Select standby mode.
3. Turn off all of gas flows.
4. Touch [System] buttons -> [Calibration] -> [Oxygen Cell
Calibration]->[100%].
5. Check that the test lung is disconnected from the system.
6. Follow the prompts [e.g. before O2 100% calibration, set a
supply of 10 L/min of O2].
7. Turn the bag/vent switch to the bag position

Maintenance
8. Connect the bag to the bag arm.

Set the APL valve to the 30 cmH2O position.
9. Push and hold the O2 flush button for 20 seconds.
10. Connect the Y-piece with a test plug on the breathing
system and set the O2 flow to 10 L/min.
11. Press the [Enter] button to start calibration.
12. After a successful calibration, the screen will display
[Calibration Completed!].
Repeat the procedure if [Calibration Failure! ] is displayed.
7.8 Water trap - sidestream anaesthetic gas

monitoring module (optional)
Check the water trap for damage (cracks, etc.) and replace if
damaged.
To maintain adequate levels of hygiene, the water trap (1) must be
replaced every four weeks.
NOTE
The sample tube (2) is a single-use component.
7.9 Battery replacement
Warning
Installing or replacing batteries must be undertaken by a
competent, trained engineer.
1. Switch the workstation off and disconnect the mains cable
from the mains supply.
2. Undo the screws and remove the battery cover (1) at the
rear of the machine.
1
3. Fit new batteries into the holder.
Check the polarity.
2
4. Refit the cover and tighten the four screws.
7.10 Fault diagnosis and troubleshooting
Fault Possible cause Action

Ventilation system leak APL is not closed during manual mode Turn the valve to the appropriate setting
Absorber canister is not installed correctly Reinstall
Damaged or loose breathing tube connector Refit or renew the breathing tube
A loose non-return valve Reinstall
Bag/vent switch failure Contact a Penlon-trained engineer 1
Bellows does not Respiratory rate is set too fast and expiratory time is too Set respiratory rate to a reasonable value
inflate completely short.
The breathing system leaks Carry out a system leak test
Flowmeter is closed Reset the flowmeter

Maintenance
During the inspiratory Bag/vent switch is still in the manual position. Turn the switch to mechanical ventilation
phase, the bellows is Flow control valve has failed; no drive gas is delivered. Contact a Penlon-trained engineer
not compressed
Bellows housing is damaged Replace the bellows housing
During inhalation, the PEEP valve can not be closed. Contact a Penlon-trained engineer
Airway pressure APL valve is set too high Reset the APL valve.
too high (Manual
breathing)
Power indicator is not Power cord is not connected Connect the power cord.
lit System and ventilator switch is not turned on Turn the switch to On
Power cord is damaged Replace the power cord.
Mains power outlet is faulty Switch to another power outlet.
Fuse has blown Contact a Penlon-trained engineer.
Replace the fuse and check the circuit
No power at auxiliary Fuse has blown Contact a Penlon-trained engineer.
outlet Replace the fuse and check the circuit
No airway pressure There is a disconnect between the pressure sensor and Reconnect.
waveform the sample tube.
Gas source is exhausted Check the gas supply
Abnormal flow Water build-up: check the flow sensors for moisture Dry the flow sensors
waveforms or Check the water container and absorber
unstable tidal volume canister for condensation and drain if
fluctuation
necessary.
Fit a filter between the flow sensor and the
patient.
Measured O2 1. O2 cell calibration required 1. Calibrate the O2 cell - see section 7.7.
concentration
error (+/-5% error, 2. Electronic flowmeter error. 2. Refer to section 7.6 and carry out a
Flowmeter zero calibration.
compared to the set
WARNING
value) The instructions in section 7.6 must be
followed. Do not use any other procedure.

8. Appendix
Appendix 1. References
Standards
The Prima 465 anaesthesia system complies with the
requirements of ISO 80601-2-13.
Trademarks
Penlon and InterMed are trademarks of Penlon Limited.
Selectatec is a GE trademark.
All other trademarks are the property of their respective
owners.
Appendix 2. Disposal at end of useful life: risk

assessment
Disposal of anaesthesia system
Do not dispose of in landfill, refer to an approved recycling
facility. Follow your hospital, local, state and federal
regulations.
EC territories: follow the requirements of Directive 2002/96/EC
Disposal of used batteries
facility. Follow your hospital, local, state and federal
regulations.
Note
Removal/replacement of the battery must only be undertaken
by a trained technician.
Appendix 3. Optional extras and accessories

Accessories
WARNING Hose - Air / O2 / N2O Contact Sales Department
Only use accessories approved by Penlon Ltd.
Exhalation diaphragm valve 5008688
Please contact Penlon Ltd (see below), or your local Penlon Bellows - Latex free 5006441
Distributor.
O2 sensor (MOX-3) 102714
UK Sales Mainstream AG module Contact Sales Department
Tel: 01235 547036
a) Adult adapter 5008685
E-mail: uk.sales@penlon.com
b) Infant adapter 5008686
International Sales
Multi-gas monitor module Contact Sales Department
Tel: +44 1235 547001
E-mail: international.sales@penlon.com a) Sample tube (single use) 5008679
USA b) Water trap 5008678

Penlon Inc. Back-up battery 5008160
11515 K-Tel Drive, Minnetonka, MN 55434, USA SpO2 monitor (optional) Contact Sales Department
Tel: Toll Free: 800-328-6216 SpO2 probe 5008690
Tel: 952-933-3940 Adult face mask 50244
Fax: 952-933-3375
E-mail: customer.service@penlon.com Paediatric face mask 50240
Manual bag 3 L 2830000
Bacterial filter 1541197
Breathing circuit - silicon 2000000
Breathing circuit - paediatric
2142000
- silicon

Appendix
Appendix 4. Labelling
Fuse symbol and specification, plus

Operating instructions (this user manual)
orientation of Neutral and Live fuses
Refer to user manual (White and blue symbol) Protective earth
General Warning (yellow background) On
Manufacturer
Caution (white background)
Defibrillation proof part, Type BF
Oxygen flush valve button

Electrostatic device
Gas inlet pressure (pipeline or cylinder

supply) Serial Number
Do not sit
Do not push above 1.1 metres
Rotation (controls output)
1. Transport conditions
Mute (alarm)
2. Mass (weight) is indicated
Mark of conformity to European Medical

Device Directive 93/42/EEC
Backbar leak check

Auxiliary Gas Outlet label
Input connector - Gas monitoring (multi-gas)

Appendix
Common gas outlet selector
IEC Outlet Socket rating
Electrical safety label

Internal Power indicates the position of fuses for internal
electrical circuits.
IEC indicates position of fuses for IEC socket.
Battery hatch label
Input Label O2%
Circuit Breaker Label
Battery Label

facility. Follow your hospital, local, or state and federal
regulations.
Fuse: T2AH No L-N, non-polarized mains plugs

Appendix
Fuse: T2AH L-N, polarized mains plug
Input applied label
Input sample label
Do not obstruct
Bag
Ventilator
Bag port
Unlock
Lock
Use by date (YYYY-MM-DD)
Do not reuse
IP classification indicating degree of protection against ingress

of solid foreign objects and water

Appendix
Appendix 5. Gas circuit
4
16
3 7 31
23 24
22
14
10
17
11 21
1
2 12 13 15 34 32
40
35 33
10 25
18 19
36
5
38 37
6 39
26
10
28
8 27
9
29
20
30 30
1. O2 pipeline inlet 17. Exhalation diaphragm valve 31. Anaesthetic gas scavenge outlet
(bellows base) port
2. O2 cylinder inlet
18. O2 flush control 32. Absorber expiratory port
3. Auxiliary O2 outlets
19. Alternate O2 flowmeter 33. Expiratory flow sensor
4. Auxiliary O2 outlet flowmeter
20. Electronic gas mixer module 34. Expiratory non-return
5. Air pipeline inlet
21. Absorber assembly 35. Airway pressure gauge
6. Air cylinder inlet
22. Bag/ventilator switch 36. Patient airway pressure sensor
7. Auxiliary air outlets
23. Rebreathing bag 37. Inspiratory flow sensor
8. N2O pipeline inlet
24. Adjustable pressure limiting valve 38. Inspiratory non-return
9. N2O cylinder inlet
25. Absorbent canister 39. Absorber inspiratory port
10. Pressure sensor - gas supplies
26. Oxygen sensor (inspiratory) 40. Patient
11. Drive gas selector switch
27. Alternate common gas outlet switch
12. System master on/off switch
DP: Flow sensor
28. Alternate common gas outlet (if
13. Ventilator module fitted) P: Pressure sensor
14. Drive valve 29. Backbar manifold
15. PEEP valve 30. Vaporizer
16. Bellows

Appendix
Appendix 6. Optional sidestream anaesthetic

gas monitoring module - single agent
1. General Warnings and Cautions
Warning
1. Do not expose the sidestream anaesthetic gas monitoring
module to heat.
2. The sample gas must not be exhausted to ambient air.
To prevent contamination of ambient air and inaccurate
measurement values during zeroing and calibration,
exhaust gas from the anaesthesia machine must be
removed by an anaesthetic gas scavenging system. This
requirement must be observed during test procedures as
well as during use with a patient.
3. Always use the water trap to avoid cross-infection and
damage to the gas module.
4. Check the water trap for damage (cracks, etc.) and replace if
damaged.
To avoid cross-infection, the water trap must be replaced
every four weeks.
5. The operator must be familiar with and strictly follow the
guidelines detailed in the user manual for the Prima 465
and accessories.
6. The user manual for the Prima 465 must be available at
all times.
7. You must disconnect the sample line and seal the Luer
lock on the patient Y-piece during cardiopulmonary
bypass operations.
You must use only the Penlon recommended sample line.
Do not use a standard pressure line or an intravenous
catheter line instead of the Penlon recommended sample
line.
To avoid cross-infection, always use a new sample line
for each patient.
8. The anaesthetic gas module is not MRI compatible.
9. Use only accessories approved for use with the
anaesthetic gas module.
caution
1. Before use, you must make sure that the sample line is
correctly attached to the patient and the equipment.
2. The water trap must be emptied every two days.
3. Do not use the anaesthetic gas module without a water
trap.
4. The anaesthetic gas module must be disposed of in
accordance with local regulations.

Appendix
2. Preface
Intended use
The monitoring module is for use by a by a professional
operator in a professional healthcare environment, and must
be continually attended when in use.
The device is intended to monitor concentrations of
anaesthesia gases in the patient breathing system.
Intended patient population
This product is intended to be used for a patient population
from neonatal (infants) to adult.
Intended part of the body or type of tissue applied to or
interacted with
No direct interaction with any part of the human body.
3. Description
warning
You must be aware of the limitations of gas measurement
accuracy as shown in the specifications.
Anaesthetic gas module options
The installed anaesthetic gas module is displayed on the
Systems-Settings page as illustrated.
• This module is a single agent type anaesthetic gas bench

plus a paramagnetic oxygen sensor.
• This module is a single agent type anaesthetic gas bench

without a paramagnetic oxygen sensor.
4. Specification
warning
You must be aware of the limitations of gas measurement
accuracy as shown below.
Gas measurement
Method Sidestream gas measurement
Sampling rate 200 ±20 mL/min
Automated cyclical zeroing and duration Zeroing: Once per day (first zeroing 35 minutes after power on,
then once every 24 hours)
Duration: ≤20 s
O2 (paramagnetic ) if fitted
Range 0 to 100 Vol.%
Accuracy ±(2.5 Vol.% +2.5 % rel.)
Rise time (t10 ... 90) <500 ms

Appendix
CO2
Range 0 to 13.6 Vol.%
Accuracy ±(0.43 Vol.% +8 % rel.)
Rise time (t10 ... 90) <300 ms
N2O
Range 0 to 100 Vol.%
Accuracy ±(2 Vol.% + 8% rel.)
Rise time (t10 ... 90) <300 ms
Anaesthetic gases
Range
Halothane 0 to 8.5 Vol.%
Isoflurane 0 to 8.5 Vol.%
Enflurane 0 to 10 Vol.%
Sevoflurane 0 to 10 Vol.%
Desflurane 0 to 20 Vol.%
Accuracy ±(0.20 Vol.% +15 % rel.)
Rise time (t10 ... 90) <450 ms
MAC value calculation algothrim MAC = %Et(AA1) + %Et(AA2) + %Et(N2O)
X(AA1) X(AA2) 100
X(AA1):
Halothane = 0.75%
Enflurane = 1.7%
Isoflurane = 1.15%
Sevoflurane = 2.05%
Desflurane = 6%
Automatic detection (dual agent units only)

Primary gas At least 0.3 Vol.%
Secondary gas At least 0.4 Vol.%
Complied standards
ISO 80601-2-55, IEC 60601-1
Operational characteristics
Voltage input range 12.0 V to 32.0 V -5 % +10 %
Power consumption
Steady state <= 6 W (depending on variant)
Warm up <= 18 W (depending on variant)
Warm-up time (module temperature: 10 °C) <450 ms (duration from power on to transmission of
measurements with the specified accuracies listed in this
table)
Data sample rate 20 ms (depending on setting)
Data transfer rate 19200 kB/s (configurable)
Operating conditions
Ambient temperature +10 to +40 °C (50 to 104 °F)
Ambient relative humidity 5 to 95% (without condensation)
Atmospheric pressure 70 to 106 kPa (10.0 to 15.4 psi)
Barometric compensation Compensated to 101.3 kPa

Appendix
Transport and storage conditions

Temperature -5 to +40 °C (-4 to 158 °F)
Relative humidity 10 to 85%, without condensation
Atmospheric pressure 50 to 106 kPa (7.25 to 15.4 psi)
Device classification
Mode of operation Continuous
Patient class Neonatal (infants) to adult.
5. Pre-use tests
warningS
Environment
1. Make sure that the anaesthetic gas module operates in
room air at all times.
2. You must not use RF emitting equipment near the
anaesthetic gas module.
3. Do not use the anaesthetic gas module near a strong
magnetic field.
2 1
4. Before you use the anaesthetic gas module after a period
of storage in a cold environment, make sure that there is
no condensation in the system.
5. Do not use the anaesthetic gas module near to liquids.
6. The anaesthetic gas module must not be placed closer
than 25 cm to an ignition source.
7. Do not use the anaesthetic gas module:
a) In an environment containing greater than 25%
oxygen.
b) In an environment containing combustible gas
mixtures.
c) If a leakage of oxygen is suspected.
d) If drugs or substances that are based on flammable
solvents are used.
e) With explosive anaesthetic agents.
8. Make sure that the operating environment is suitably
ventilated.
9. The sample gas must not be exhausted to ambient air.
To prevent contamination of ambient air and inaccurate
measurement values during zeroing and calibration,
exhaust gas from the anaesthesia machine must be
removed by an anaesthetic gas scavenging system. This
requirement must be observed during test procedures as
well as during use with a patient.
Water Trap and Sample Line
1. The sample line (1) must be positioned so that it does
not interfere with the operation of the Prima 465 and the
position of any switches

Appendix
2. Do not apply pressure to the sample line or water trap (2)

beyond that of the patient breathing circuit pressures.
3. Do not disconnect the water trap with a connected sample
line.
If you remove the water trap when connected to the patient
circuit via the sample line, contaminated liquid may be
expelled.
4. Replace the water trap at a maximum interval of four weeks.
5. Always use the water trap to avoid cross-infection of patients
and damage to the gas module.
6. The water trap and sample line may contain contaminated
liquids. The liquid in the water trap must be disposed of
according to hospital regulations.
7. The sample line may be reused if a bacterial filter is
installed.
8. Check that the sample line is not damaged.
9. Check that the water trap is not damaged.
You must replace the water trap:
• When the water trap has been in use for a maximum of four
weeks
• If a relevant error message is displayed and emptying the
water trap does not remove the error message
• If the water trap is dirty
• If the self-sealing filter elements positioned in the gas stream
close and turn blue.
Breathing System
1. Do not use nebulizers or aerosols in the breathing system
when the anaesthetic gas module is connected.
Nebulizers or aerosols can have an affect on gas
measurements and can damage the water trap and
measuring system. Disconnect the sample line whilst
nebulizers are used in the breathing system.
2. Make sure that the anaesthetic agent ID has been correctly
set.
Alarm system pre-use checks

CO2, N2O, and agent concentration alarms
1. For each parameter: Check the alarm limit settings, and adjust
if necessary.
2. For each parameter: To test the alarm function, simulate alarm
conditions by setting upper and lower alarm limits to levels that
are certain to trigger an alarm.

Appendix
6. Operating the anaesthetic gas module

warning
Fresh gas flow must be increased when you use the
anaesthetic gas module with low flow anaesthesia.
2
cAution
Before you use the Anaesthetic Gas Module:
3
1. Make sure that you have an additional means of
monitoring the patient
2. Make sure that the sample line and water trap are not
damaged or blocked
3. Make sure that the components of the Anaesthetic Gas
Module have been replaced at the prescribed intervals.
4
Connect the sample line
Connect the sampling tube (1) to the sample port (2) on the
patient Y-piece elbow (3) and to the inlet connector on the 1
water trap (4).
Enabling the gas module and selecting anaesthetic

agent
Warning
Do not apply more than one anaesthetic agent.
1. Select ‘System’ (1).
2. Select ‘Setting’ (2)
3. Switch ‘AA&O2’ or ‘AA’ to ‘On’ (3).
3 2 1
4. Exit this menu.
5. Note that the screen upper left field will display the button
‘Set AA type’ (4) when ventilation is started.
6. Selecting this field will show the anaesthetic agents that
are available for selection.
7. Select the required agent.
CAUTION
1. It is important to select the correct anaesthetic agent.
Incorrect selection will result in the wrong agent and
concentration being displayed.
Check the name of the agent on the vaporizer that has
been turned on. 4
2. Mixed anaesthetic agent in the circle breathing system
will cause an incorrect agent concentration to be
displayed.

Appendix
Anaesthetic gas fields

The anaesthetic gas (AG) fields are displayed in the upper left-
hand display column. The fields are manually configured to
reflect the anaesthetic agent in use.
The fields listed below are displayed when the anaesthetic gas
module is connected and operating:
• MAC: Minimum alveolar concentration
• FiAA: Fraction of inspired anaesthetic agent
• EtAA: End-tidal anaesthetic agent
• FiN2O: Fraction of inspired nitrous oxide
• EtN2O: End-tidal nitrous oxide.
Alarms
AA Module Failure !!!
AA Module Water Trap Full !!! High Water trap is full Empty the water trap
AA Module Dehydrator Almost Medium Water trap is nearly full Empty the water trap
Full!!
Check AA Module Water Trap or Low Sample line is blocked or Remove the blockage from the sample
Sample Line disconnected line.
Reconnect the sample line.
Information
Message Cause Action

Gas Module Unspecified Anaesthetic gas module is in warm-up state. Allow the gas module to warm up and
Accuracy! achieve operational status.
Zero process is in progress.
7. Maintenance
warning
1. Do not use silicon spray on the water trap O-rings.
2. The anaesthetic gas module must be clean and
disinfected before maintenance or repair is carried out.
Scheduled maintenance includes component replacement.
Details are given in the Prima 465 Service manual, available
for Penlon-trained service engineers.
Cleaning
warning
1. The water trap must be in its installed position during
cleaning.
2. Do not wash, disinfect or sterilize the inside of the
sample line and water trap.
Cleaning must be carried out in accordance with the
requirements stated in section 7.2.

Appendix
Appendix 7. Electromagnetic compatibility (EMC)
Electromagnetic environment
This device is suitable for use in the specified electromagnetic environment. The user should assure that it is used in an
electromagnetic environment as described below.
Changes or modifications to this device, not expressly approved by Penlon Limited, could result in EMC issues with this device.
Contact Penlon Limited for more information.
The use of phones or RF emitting equipment near this anaesthetic machine may cause interference.
Always monitor anaesthetic machine operation before and during use on a patient.
The essential performance of this device is to provide controlled concentrations and flows of anaesthesia gases into a patient
breathing system.
WARNING
The device should not be used adjacent to or stacked with other manufacturer’s equipment. If adjacent or stacked use is
necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
Cables, Transducers, and Accessories

WARNING
The device is EMC-compliant with all cables, transducers and accessories supplied by Penlon Limited.
The use of cables, transducers and accessories other than those specified may result in increased emissions or decreased
immunity of this device.
The use of cables, transducers and accessories supplied by Penlon Limited on non-Penlon equipment may also result in
increased emissions or decreased immunity of that equipment.
Cables supplied by Penlon Limited

Category Function Length (m)
AC mains supply input/output ports Hospital mains supply to the input port (cable is ≤3.9
fixed to the Prima 465.
Oxygen sensor cable (Prima 465 with an oxygen Connects the oxygen sensor on the absorber to 0.6
sensor on the absorber). the Prima 465
Guidance and manufacturer’s declaration – electromagnetic emissions

This device is intended for use in the electromagnetic environment specified below.
The customer or user should assure that it is used in such an environment.
Required test Compliance Comments

RF emissions Group 1 Class A equipment is suitable for use in all locations other than
CISPR 11 Class A those allocated in residential environments and those directly
Harmonic emissions Complies connected to a low voltage power supply network which supplies
IEC 61000-3-2 buildings used for domestic purposes, and may be used in domestic
establishments and those directly connected to the public low-
Voltage fluctuations/ Complies voltage power supply network that supplies buildings used for
flicker emissions domestic purposes provided the following warning is heeded
IEC 61000-3-3
NOTE: The EMISSIONS characteristics of this equipment make it
suitable for use in industrial areas and hospitals (CISPR 11 class A).
If it is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-
orienting the equipment.

Appendix
Guidance and manufacturer’s declaration - electromagnetic immunity

This device is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure
that it is used in such an environment.
Required test 60601 test levels for equipment used Compliance level
in a professional healthcare facility
environment only
Electrostatic discharge (ESD) ± 8 kV contact ± 8 kV contact
IEC 61000-4-2 ± 2, 4, 8, 15 kV air ± 2, 4, 8, 15 kV air
Radiated RF EM Fields 3 V/m 10 V/m

IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz
Proximity fields from RF Frequency - Test level Frequency - Test level

wireless communications
385 MHz - 27 V/m 385 MHz - 27 V/m
IEC 61000-4-3
450 MHz - 28 V/m 450 MHz - 28 V/m
710 MHz – 9 V/m 710 MHz – 9 V/m
745 MHz – 9 V/m 745 MHz – 9 V/m
780 MHz – 9 V/m 780 MHz – 9 V/m
810 MHz - 28 V/m 810 MHz - 28 V/m
870 MHz - 28 V/m 870 MHz - 28 V/m
930 MHz - 28 V/m 930 MHz - 28 V/m
1.72 GHz - 28 V/m 1.72 GHz - 28 V/m
1.845 GHz - 28 V/m 1.845 GHz - 28 V/m
1.97 GHz - 28 V/m 1.97 GHz - 28 V/m
2.45 GHz - 28 V/m 2.45 GHz - 28 V/m
5.24 GHz – 9 V/m 5.24 GHz – 9 V/m
5.50 GHz – 9 V/m 5.50 GHz – 9 V/m
5.875 GHz – 9 V/m 5.875 GHz – 9 V/m
Electrical fast transient / ± 2 kV for power supply lines ± 2 kV for power supply lines
burst
IEC 61000-4-4 ± 1 kV for input / output lines
Surge ± 0.5, 1, 2 kV line(s) to earth, ± 0.5, 1, 2 kV line(s) to earth,

IEC 61000-4-5
± 0.5, 1 kV line(s) to line(s) for power supply ± 0.5, 1 kV line(s) to line(s) for power supply
lines lines
± 2 kV line(s) to earth for input / output lines
Conducted RF 3 V - 150 kHz to 80 MHz 3 V - 150 kHz to 80 MHz
IEC 61000-4-6 6 V - ISM bands between 150 kHz to 80 MHz 6 V - ISM bands between 150 kHz to 80 MHz
Voltage dips and interruptions 0% UT (100 % dip in UT) for 0.5 cycle 0% UT (100 % dip in UT) for 0.5 cycle
IEC 61000-4-11
0% UT (100 % dip in UT) for 1 cycle 0% UT (100 % dip in UT) for 1 cycle
70% UT (30% dip in UT) for 25/30 cycles 70% UT (30 % dip in UT) for 25/30 cycles
0% UT (100% dip in UT) for 250/300 cycles 0% UT (100 % dip in UT) for 250/300 cycles
Power frequency (50 Hz) 30 A/m 30 A/m
Magnetic field
IEC 61000-4-8

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REF Doc. No. 5008647-en Rev G
Part of the InterMed Group © Penlon Ltd. 2020 All rights reserved
Penlon and InterMed are trademarks of Penlon Limited. All other trademarks are the property of their respective owners.
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Abingdon Science Park t +44 (0) 1235 547060 t +44 (0) 1235 547001 t +44 (0) 1235 547036
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OX14 3NB, UK e tech.support@penlon.com

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Prima 465 Anaesthetic Machine User Manual

Servicing and Repairs

or communicate directly with:

Always give as much of the following information as possible:

Prima 465 Anaesthetic Machine i User Manual

Prima 465 Anaesthetic Machine ii User Manual

1. Warnings and Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

5. Installation and Pre-use Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

6. Operating the Anaesthesia System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Prima 465 Anaesthetic Machine iii User Manual

6.7 Waveform field displays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Prima 465 Anaesthetic Machine iv User Manual

Prima 465 Anaesthetic Machine 1 User Manual

Prima 465 Anaesthetic Machine 2 User Manual

20. Portable RF (radio frequency) communications 34. Ventilating neonates (infants)

a) Detachable parts removed 35. Patient monitoring:

Prima 465 Anaesthetic Machine 3 User Manual

1. Open cylinder valves slowly to avoid damage to

2. Under no circumstances should anaesthetic agents be

3. After use, always disconnect the machine from the

4. Compressed gas supplies must be clean and dry.

5. The requirements of IEC 60601-1 apply to any device

6. In the event of malfunction of any device powered by

7. Do not apply excessive pressure to the display screens.

8. Connect the external RS232 outlet only to approved

9. Vaporizers: Read the instruction manual supplied with

Prima 465 Anaesthetic Machine 4 User Manual

The Prima 465 anaesthesia system is for use by a professional

Prima 465 Anaesthetic Machine 5 User Manual

3.1 General construction

3.1.3 Mounting posts and brackets

3.1.5 Extractor fan outlet

3.2 Gas circuit

3.2.1 Cylinder Yokes

3.2.2 Pipeline Inlets 6

A schematic is included in Appendix 5.

Prima 465 Anaesthetic Machine 6 User Manual

3.2.3 Gas inlet filter

3.2.4 Gas inlet block

3.3 Gas supply safety devices

3.3.1 Gas supply cut-off device

3.3.2 Fresh gas pressure relief valve

Prima 465 Anaesthetic Machine 7 User Manual

3.4 Gas circuit components and controls

3.4.1 Anaesthesia system switch

3.4.2 Electronic flow mixer

Prima 465 Anaesthetic Machine 8 User Manual

3.4.4 Alternate O2 supply control and flowmeter

Prima 465 Anaesthetic Machine 9 User Manual

3.4.6 Cylinder and pipeline pressure gauges

3.4.7 Auxiliary oxygen flowmeter

3.4.8 Auxiliary gas outlets

Prima 465 Anaesthetic Machine 10 User Manual

3.5.1 Vaporizer mounting system

3.5.2 Selectatec compatible vaporizer

3.6 Communications ports

Prima 465 Anaesthetic Machine 11 User Manual

3.7 Control panel

Prima 465 Anaesthetic Machine 12 User Manual

3.8 Electrical Power Supply 4 5 1

3.8.1 Mains Power Supply

Mains power indicators

2. Each socket is protected with a 2 A fuse in both the