Sigma Alpha Vaporizer

User Manual

IMPORTANT
The Sigma Alpha is
specifically designed
for use with a circle
system type breathing
circuit

To ensure the accuracy of

calibration checks, always
follow the test procedures
detailed in section 12 of
this User Manual

Partnership for Life

IMPORTANT

Servicing and Repairs For any technical enquiry regarding

the service or repair of this
In order to ensure the full vaporizer, contact the nearest
operational life of the Sigma Alpha accredited Penlon agent* or
vaporizer, we recommend that a contact Technical Support
service check should be performed Department at Penlon Limited.
every three months, by a Penlon
trained engineer. This comprises a *Agent's name and address:
vaporizer Calibration Check and
Leak Check.
Record the results of each test in
section 12.3. Successive sets of
figures will indicate that vaporizer
performance is maintained.

WARNING Technical Support

The calibration check must be Penlon Ltd
performed as described in section
Abingdon Science Park
12.2.
Barton Lane
Always measure output at the
Abingdon
inspiratory port of the circle
system, or use an agent analyser OX14 3PH
system that incorporates a mixing UK
chamber of the correct size.
The analyser must be of an Tel: +44 (0) 1235 547076
approved type, e.g. a Riken Fax: +44 (0) 1235 547062
refractometer or infrared analyser. E-mail: [email protected]

Service the vaporizer if the

calibration check shows that the Always give as much of the
unit is outside the specified following information as possible:
performance requirement (see 1. Type of equipment
section 12.3). 2. Product name
3. Serial number
This may be done on site by: 4. Software revision number
(a) A trained user. 5. Approximate date of
(b) An authorised Penlon agent. purchase
6. Apparent fault
(c) A Penlon service engineer.

(i)
FOREWORD

This manual has been produced to

provide authorised personnel with WARNING
information on the function, routine
performance and maintenance Anaesthetic systems have the
capability to deliver mixtures of
checks, applicable to the Penlon
gases and vapours to the
Sigma Alpha vaporizer.
patient which could cause
Information contained in the
injury or death unless
manual is correct at the date of controlled by a qualified
publication. The policy of Penlon anaesthetist.
Limited is one of continued
improvement to its products. There can be considerable
Because of this policy Penlon variation in the effect of
Limited reserves the right to make anaesthetic drugs on individual
any changes, which may affect patients so that the setting and
instructions in this manual, without observation of control levels on
giving prior notice. the anaesthesia systems does
Personnel must make themselves not in itself ensure total patient
familiar with the contents of this safety.
manual before using the vaporizer. Anaesthesia system monitors
and patient monitors are very
desirable aids for the
Terminology anaesthetist but are not true
This manual complies with ISO clinical monitors as the
4135, Anaesthetic Apparatus condition of the patient is also
Terminology. dependent on his respiration
The following additional definitions and the functioning of his
should be noted: cardio-vascular system.
Vol.% - shortened form of
volumetric percentage. IT IS ESSENTIAL THAT THESE
ELEMENTS ARE MONITORED
FREQUENTLY AND REGULARLY
The commonly used method of
AND THAT ANY OBSERVATIONS
expressing vapour concentrations ARE GIVEN PRECEDENCE OVER
so that they can be compared with MACHINE CONTROL PARAMETERS
concentrations of true gases. IN JUDGING THE STATE OF A
100 Vol.% is equivalent to 100% CLINICAL PROCEDURE.
partial pressure in a mixture.

Copyright © Penlon Ltd, 2008

All rights reserved.

(ii)
CONTENTS
USER RESPONSIBILITY 1
1. WARNINGS AND CAUTIONS 2
2. PURPOSE 8

3. DESCRIPTION
3.1 Operating Principles 9
3.2 Controls 10

4. SPECIFICATION
4.1 Physical Dimensions 13
4.2 Weight 13
4.3 Capacity 13
4.4 Filling System 13
4.5 Concentration Control Dial Scale 13
4.6 Patents 13
4.7 Environmental 14
4.8 Flow Range 14
4.9 Pressure Range 14
4.10 Electrical Power 14
4.11 Warm Up 15
4.12 Installation 15
4.13 Device Classification 15

5. FILLING
5.1 Desflurane Filler System 16
6. INSTALLATION
6.1 New Vaporizers 19
6.2 Selectatec Compatible Models (with interlock) 20
6.3 Cagemount (23 mm) Taper Models 22
6.4 Penlon Off-line System 23
6.5 Drager 'Plug-in' Compatible 24
6.6 North American Drager Compatible 25
6.7 Electrical Power Supply 27

7. OPERATING THE VAPORIZER

7.1 Using the Vaporizer 28
7.2 Controls 31
7.3 Alarms and Display Messages 33
7.4 Pre-use Checklist 35
7.5 Output Check 35

(iii)
 CONTENTS

8. PERFORMANCE CHARACTERISTICS
8.1 Vaporizer Output Graph 36
8.2 Temperature Compensation 37
8.3 Pressure Effects 37
8.3.1 Ambient Pressure 37
8.3.2 Barometric Pressure 37
8.3.3 Back Pressure 37
8.3.4 Intermittent Back Pressure 37
8.4 Summary of Performance Specifications 38
8.4.1 Factors Affecting Output Accuracy 38
8.4.2 Resistance to Gas Flow 39
8.5 Effect of IPPV on Output 39
8.6 Effect of Gas Composition on Output 39
8.7 Output when Control is at 0 (Zero) 40
8.8 Effect of Flush Valve Operation 40
8.9 Effect of Sub-atmospheric Pressure 40

9. USER MAINTENANCE
9.1 Servicing 41
9.2 Cleaning 42
9.3 Training Course 42
9.4 Returning the Vaporizer for Service or Repair 43
9.5 End of Product Service Life 43

10. REFERENCES 44

11. ORDERING INFORMATION 45

12. CALIBRATION RECORDS 46

12.1 Calibration Policy 46
12.2 Calibration Procedure 47
12.3 Calibration Check Records 53

13. SERVICE AND REPAIR RECORDS 63

(iv)
USER RESPONSIBILITY

This vaporizer has been built to only in accordance with written

conform with the specification and instructions issued by Penlon
operating procedures stated in this Limited, and must not be altered or
manual and/or accompanying modified in any way without the
labels and notices when checked, written approval of Penlon Limited.
assembled, operated, maintained The user of this equipment shall
and serviced in accordance with have the responsibility for any
these instructions provided. malfunction which results from
To ensure the safety of this improper use, maintenance, repair,
vaporizer it must be checked and damage or alteration by anyone
serviced to at least the minimum other than Penlon Limited or its
standards laid out in this manual. appointed agents.
A defective or suspected defective,
product must not, under any This vaporizer must only be
circumstances be used. supplied to, and used by, suitably
qualified medical practitioners.
The user must accept In the USA and Canada:
responsibility for any Caution: Federal Law restricts this
malfunction which results from device to sale by or on the order of
mishandling, or non-compliance a physician.
with the requirements and
procedures detailed in: Statements in this manual
preceded by the following words
Section 1 (Warnings and Cautions)
are of special significance.
Section 4 (Specification)
Section 5 (Filling) WARNING - means there is a
Section 7.4 (Pre-use Checklist) possibility of personal injury to
Section 9 (Servicing) yourself or others.
Non-compliance invalidates the CAUTION - means there is a
warranty. possibility of damage to the
instrument or other property.
Worn, broken, distorted, NOTE - indicates points of particular
contaminated or missing interest for more efficient and
components must be replaced convenient operation.
immediately. Should such a repair
become necessary it is The reader must take particular
recommended that a request for notice of the warnings, cautions,
service advice is made to the and notes printed throughout the
nearest Penlon service centre. manual.

This vaporizer and any of its

constituent parts must be repaired
1
1. WARNINGS AND CAUTIONS

The following Warnings and 5. Before the vaporizer is used

Cautions must be read and clinically for the first time, verify
understood before using this that the hospital engineering
vaporizer department has carried out an
earth continuity test.
If the integrity of the protective
WARNINGS
earth is in doubt, do not use the
General Information vaporizer.

1. The vaporizer is designed for 6. Accessories:

use only in a circle breathing Only use accessories approved
system, as described in section by Penlon Ltd.
2.
Anaesthetic Agent
2. The user must read and be
familiar with the contents of this 7. Use only Desflurane. Do not use
instruction manual, and the the vaporizer with any other
product, before using the anaesthetic agent.
vaporizer.
In addition, read the instruction 8. The vaporizer is designed for
manuals for the anaesthetic use only with the specific
machine and other devices that anaesthetic agent named on the
are used as part of the filler block (and further indicated
anaesthetic workstation. by colour coded labelling).
Misdosage may occur if the
3. This vaporizer must not be vaporizer is filled with the wrong
modified or disassembled by an drug.
unauthorised person. Do not use with flammable
The vaporizer must be regularly agents, there is a fire or
serviced by a Penlon-authorised explosion hazard.
service agent, trained technician
or engineer and by no other 9. The user is responsible for
person. confirming that any drug with a
different trade name is
4. The vaporizer must be stored equivalent to the registered
and operated in line with the name.
information listed in Section 4
(Specification). 10. It is not necessary to refrigerate
Note that the vaporizer may Desflurane prior to filling the
malfunction if exposed to vaporizer.
excessively high temperatures,
e.g. by storage above a radiator. Filling the vaporizer
This may affect the calibration. 11. The filling procedure must only
Storage temperature range: be carried out in a well-ventilated
area.
-5oC to 40oC (23oF to 104oF)
12. The filler system must be
Operating temperature range: maintained in accordance with
18 to 30oC (64 to 86oF) the instructions given in section
9 (User Maintenance).

2
WARNINGS AND CAUTIONS

13. The vaporizer must be filled only Before using the vaporizer
by suitably skilled and trained
personnel. 22. Do not use the vaporizer:
a) if the agent level is not visible
14. Anaesthetic drugs are on the display when the
poisonous and there is evidence vaporizer is turned on, or
that there is a health hazard to b) if the agent level is outside the
personnel due to prolonged maximum and minimum
inhalation of trace concentration indicators.
in the atmosphere.
23. Purge the vaporizer before
Care must be taken to avoid
clinical use:
spillage of anaesthetic drugs
when filling or draining the a) when the vaporizer is first
vaporizer. turned on after filling from
EMPTY,
15. Do not inhale anaesthetic agent b) after a period of not being
vapour. used.
Set the control dial to 5% output
16. The vaporizer must be upright
and run/flush for a minimum of
during filling.
30 seconds at 5 L/min. Return
the dial to zero after purging.
17. If a new bottle of anaesthetic
agent is to be used, check that Note that purging may cause a
the tamper-evident packaging is temporary increase in vaporizer
undamaged. output. See also, Warning 51.

18. Do not use the bottle if it is 24. Movement during transport can
cracked or the filler connector is result in over-dosage.
loose / broken. Allow time for the liquid to regain
its normal position.
19. Do not tamper with the filling If a vaporizer has been
system valve. This may cause transported it must be purged
vapour and/or liquid to be before clinical use.
ejected from the filler receiver. Set the control dial to 5% output
and run/flush for a minimum of
20. Do not overfill. 30 seconds at 5 L/min. Return
A vaporizer that has been the dial to zero after purging.
overfilled must be withdrawn Note that purging may cause a
from use. temporary increase in vaporizer
Contact Technical Support at output.
Penlon for advice.
25. The vaporizer must not be tipped
21. Anaesthetic drugs must be or inverted during installation.
treated as a pharmaceutical If the vaporizer has been tipped
product. or inverted, it must be set to 5%
Do not reuse agent that has been and flushed at 5 L/min for a
drained from a vaporizer into an minimum of 30 seconds. Return
open container. Contamination the control dial to zero after
is likely. Always dispose of such purging.
drained liquid as a hazardous Check for stable output before
chemical. clinical use.

3
WARNINGS AND CAUTIONS

26. Do not user a vaporizer that has cord into the same electrical wall
been dropped. outlet or adaptor strip into which
an electrocautery unit is
27. The vaporizer must be securely connected.
fixed, and in an upright position In addition, radio communication
before use. equipment can interfere with the
There is a danger of overdosage function of the vaporizer
if sudden inadvertent movement
occurs during use. 31. Connect the vaporizer power
supply unit to a ‘hospital grade’
28. Anaesthetic machine designs mains electrical supply outlet.
are constantly evolving, and new If used with a mains extension
models may differ dimensionally cord, the unit may be subject to
from existing equipment. electro-magnetic interference.
The user must ensure that the
32. Do not use the vaporizer in an
configuration of the anaesthetic
MRI environment.
machine allows correct
installation of the vaporizer.
33. Installation:
(Check for clearance between
If two vaporizers are to be used
the Selectatec manifold and the
on a three station backbar, one
rear frame panelling of the
of the vaporizers must be
machine to allow the vaporizer
installed on the centre station to
connector block to seal correctly
ensure that the interlock system
on the manifold.
can function correctly.
29. Before use:
34. Before use, always carry out:
a) Test all joints for gas (a) the pre-use checks listed in
tightness, and perform back bar section 7.4.
function tests as detailed in the
manual supplied with the (b) a basic output check (7.5).
anaesthetic machine.
Using the vaporizer
b) Interlock System - check that
35. The anaesthetic machine and
only one vaporizer at a time can
other devices that are used as
be turned on. A defective
part of the anaesthetic
interlock system may result in
workstation must be operated in
the delivery of excessive
line the specifications and
concentrations of anaesthetic
instructions detailed in the
agent.
relevant user instruction
manuals.
30. Excessive electronic noise
caused by a poorly regulated 36. Check that breathing system
device (e.g. an electrocautery components are compatible with
unit) may adversely interfere anaesthetic gas mixtures.
with the functioning of the
vaporizer. 37. The vaporizer must not be used
in the presence of flammable
To avoid this problem, do not
substances, e.g. cyclopropane,
connect the vaporizer power
ether

4
WARNINGS AND CAUTIONS

38. Do not use the vaporizer during 47. As stated in section 2, the
transportation. vaporizer is of relatively high
resistance and must not be
39. Exterior panels must not be incorporated within a breathing
removed by unauthorised system.
personnel and the vaporizer
must not be operated with such 48. Warm up and Standby:
panels missing. Do not set an output
There is a possible electric concentration until warm up is
shock hazard. complete.
If the concentration control dial
40. Do not use the vaporizer if the
has been rotated inadvertently
backup battery is faulty and can
before or during warm up, return
not hold its charge.
the dial to zero in Standby mode,
and then reset to the desired
41. The vaporizer can not be
concentration.
operated if the VAP INOP alarm
The vaporizer will not deliver
message is displayed.
agent unless the correct
42. Check the liquid level frequently procedure is followed.
when using the vaporizer and
49. Always use an anaesthetic gas
maintain the level between the
scavenging (AGS) system to
minimum and maximum marks.
extract expired anaesthetic
43. The output of the vaporizer is vapours from the operating
sensitive to barometric pressure. theatre.
A correction factor may be The AGS system must comply
with ISO 8835-3.
necessary when assessing the
output using an analyser, for 50. Patient monitoring:
example at high altitude. a) Always use an anaesthetic
Barometric pressure effects are agent monitor that complies with
not usually of clinical ISO 11196.
importance (see section 8.3). b) Always monitor oxygen
concentrations.
44. The vaporizer is a flow- c) Always check that the
direction-sensitive apparatus. monitors are functioning
The direction of gas flow correctly before starting the
towards the patient must be as clinical procedure.
indicated by the arrow on the top
label. 51. Anaesthesia system monitors
Reversal of flow will trigger a and patient monitors are very
vaporizer alarm. desirable aids for the
anaesthetist. However, they are
45. The vaporizer must not be used not true clinical monitors, as the
downstream of the common gas condition of the patient is also
outlet. dependent on his respiration
and the functioning of his
46. During use, the vaporizer must cardiovascular system.
not be subjected to tilting in
excess of 5o.

5
WARNINGS AND CAUTIONS

52. Do not set the control dial 59. After any cleaning or
between 0 and the lowest maintenance operation, and
graduation. before clinical use, carry out:
A pre-use check (section 7.4),
53. High concentrations of and a vaporizer output check
Desflurane reduce the (section 7.5).
concentration of oxygen in the
60. If the vaporizer is drained,
fresh gas delivered to the
dispose of the drained agent as a
patient.
hazardous chemical. Do not
reuse.
54. If a high agent concentration has
been set, the use of high fresh Output check and calibration
gas flow rates will result in a
vaporizer output below the set 61. The output of the vaporizer must
concentration (see section 8.1) be checked every 3 months, and
a record kept of the measured
55. In some territories the vaporizer figures.
must not be used unless the
accompanying user manual is The calibration check must be
printed in the language used in performed as described in
that territory. section 12.2.
Always measure output at the
User Maintenance inspiratory port of the circle
system, or use an agent analyser
56. Always stand the vaporizer on a
system that incorporates a
firm, level surface when it is
mixing chamber of the correct
removed from the anaesthetic
size.
machine.

57. Follow the instructions for The analyser must be of an

cleaning in section 9.2 approved type, e.g. a Riken
Do not immerse the vaporizer in refractometer or infrared
any liquid. analyser.
Do not autoclave. The vaporizer must be serviced
Do not allow any liquids to enter if the figures are outside the
the inlet and outlet ports, or the tolerance ranges shown in
filler block. section 12.3, calibration check
Do not pour water, or any records.
cleaning solutions into the
vaporizer. Servicing
Do not allow liquids to get under
62. The vaporizer must be serviced
the filler cover or control dial.
to the schedule detailed in
Do not spray aerosol-based
section 9.1.
cleaning agents onto the
Clean and disinfect the vaporizer
vaporizer.
before each service.
58. Cleaning materials:
Use a dry cloth, or proprietary
cold sterilised wipes.
Do not use use solvents or
cleaning agents.
6
WARNINGS AND CAUTIONS

CAUTIONS
1. Anaesthetic machine and
anaesthetic workstation standards
require that means be provided to
ensure that gas cannot pass
through more than one vaporizer
chamber.
Vaporizers without interlock
devices or systems must only be
used on machines which only have
one vaporizer mounting station.
2. Contact Penlon Ltd if the vaporizer
has been inadvertently filled with
any anaesthetic agent other than
Desflurane.

3. Inlet and outlet ports are sealed at

the factory for delivery transit.
Ensure that the seals are removed
from the vaporizer before
installation on an anaesthetic
machine.

4. This symbol denotes:

‘’Refer to the User
Manual’’

7
2. PURPOSE

WARNING
The vaporizer is designed for use
only in a circle breathing system.

The Sigma Alpha Vaporizer is

designed for incorporation in the
fresh gas supply system of
continuous flow anaesthetic
machines, delivering fresh gas
through a circle system.
The vaporizer is designed for
continuous operation and must be
directly connected between the
flowmeter unit and the common
gas outlet of the machine.

The vaporizer is unsuitable for use

within a breathing system 'in circuit'
because of the relatively high
internal resistance.

Its purpose is the provision of

accurate concentrations of
anaesthetic drug in the fresh gas
supply, in accordance with the
setting of the control dial, when the
fresh gas supply flow is between
0.5 and 10 litres/min.
Refer to section 8 (Performance
Characteristics), which shows the
extent of modifications to the
control calibration.

8
3. DESCRIPTION

3.1 Operating Principles

The Sigma Alpha is uniquely designed
and tested for use only with Desflurane
anaesthetic agent.
1
The vaporizer must be mounted on an
anaesthetic machine and used with a
circle breathing system. 2
3
The vaporizer is powered by mains
electricity, and has a backup battery.
When the battery is in a fully charged
state, it provides a minimum of 5 minutes
operation, depending on fresh gas flow
and the set agent concentration.

Control System
The vaporizer has a unique, software 1. Control dial
driven control system. 2. On-Off switch
Liquid agent is delivered from the 3. Display
pressurised reservoir into a vaporizing
chamber. Here the liquid agent is
vaporized. A heated element ensures a
constant temperature to maintain
vaporization. The vapour flow out of the
chamber is controlled to provide the
required concentration as set on the
control dial.
The vaporized agent then passes through
to the fresh gas flow.

If the fresh gas flow alters, or if the agent

concentration is reset, the control system
automatically adjusts the volume through
the system, maintaining the correct
desired agent concentration.

Operating status, agent level, agent

consumption and alarm conditions are
shown on the vaporizer display screen.

9
DESCRIPTION

1 2
4

5
STANDBY
DES USED: 0

3.2 Controls
Status Indicator and On/Off
Switch
When connected to mains power the
amber ‘power’ indicator (1) will be
illuminated, and the battery charger
circuit will be powered.
Switch on the vaporizer by pressing the
On/Off switch (2).
The green ‘in use’ indicator (3) will be
illuminated, and the power indicator will
be extinguished.
The LCD display will indicate "WARM
UP". Note that during this period the
vaporizer will not deliver agent.
Warm up lasts for approximately two
minutes, and when completed the
vaporizer switches to standby mode (The
LCD display indicates ‘’STANDBY’’).
When mains power is lost during use, a
low priority alarm is shown on the
display, indicating ‘Mains Failure’.

10
DESCRIPTION

Agent Concentration Control Dial

The vaporizer has a single, forward
facing calibrated control (4) to regulate
vapour concentration.
The dial is locked at zero when not in
use.
To set a concentration level, push the
dial assembly in and rotate anti-
clockwise.
Align the required concentration
graduation with the mark at the top of the
bezel.
The vaporizer display will indicate "IN
USE" and the vaporizer will deliver
agent.
On returning the dial to zero, the dial
assembly will automatically spring
outwards into the locked 'off' position.
The vaporizer will return to "Standby"
mode.
A
Alarm Mute / ‘DES USED’ zero
control (5)
Press the button to mute any audible
alarm (see also, section 7.3).
The control also activates the agent STANDBY
consumption facility (‘DES USED’).
When an output is first set, the user will DES USED: 0
be prompted for two seconds to zero the
"DES USED" count by pressing the
button (5). 5
This gives the user the option of
quantifying the volume of Desflurane that
will be used during the next clinical
procedure, or over a particular period.

Agent Level
The display indicates agent level (vertical
band ‘A’).

11
DESCRIPTION

Interlock Models
When the vaporizer is mounted on the
anaesthetic machine back bar with
other interlock vaporizers, initial oper-
ation of the concentration control dial
activates the interlock system ensuring
that only one of the vaporizers can be
in use at any time. 1

The interlock deactivates as soon as

the control dial is returned to the
locked out zero position.

NOTE
The Sigma Alpha Selectatec Compatible
Vaporizer with Interlock can be used on a
Selectatec Universal Series Manifold
back bar in conjunction with other types
of Selectatec compatible vaporizers (i.e. Selectatec Compatible
from other manufacturers) fitted with the Vaporizer with Interlock
interlock function. Bolt (1)

WARNING
The Drager compatible model with
interlock must only be used with other
Drager-compatible interlock vaporiz-
ers, to maintain the integrity of the
interlock system.

WARNING
When installing two vaporizers only
on a three station manifold, the centre
station must be occupied by one of
the vaporizers.

12
4. SPECIFICATION

4.1 Physical Dimensions

Width Height Depth
Size (Selectatec compatible model) 120 250 220
Dimensions given above are in millimetres

4.2 Weight
Approximate weight: 6 kg

4.3 Agent Capacity

Volume at display maximum mark 330 ml (nominal)
Volume at low agent alarm display 70 ml (nominal)
Agent consumption display Yes

4.4 Filling System

For use with Saf-T-Fill™ Desflurane bottle.

4.5 Concentration Range and Control Dial Scale

Concentration Range 1% to 18%
The control dial is marked as follows:
From 1 to 10% by intervals of 1.0% vol
From 10% to 18% by intervals of 2.0% vol
The control dial is marked '0' at zero

WARNING
Do not set a concentration between 0 (zero) and the lowest graduation.

4.6 Patents
The Sigma Alpha is protected by UK and foreign patents.

13
SPECIFICATION

4.7 Environmental
Operating Temperature Range 18 to 30oC (64 to 86oF)
Storage Temperature Range -5oC to 40oC (23oF to 104oF)

Operating Humidity Range 30 to 75% relative (non-condensing)

Storage Humidity Range Do not exceed 95% relative humidity
(non-condensing)

Electro-magnetic compatibility:
The vaporizer meets the requirements of EN60601-1-2 (Electromagnetic
compatibility - requirements and tests).

MRI compatibility: The vaporizer is not suitable for use

in an MRI environment

4.8 Flow Range

Operating Flow Range 0.5 to 10 L/min.
Maximum Flow 12 L/min
(high fresh gas alarm is triggered)
See section 8.4.1 for output accuracies at extreme conditions.

4.9 Pressure Range

Operating Pressure Range 0 to 5 kPa (0 to 0.7 psi)
Maximum Manifold Pressure 38 kPa (5.5 psi)
Maximum Test Pressure 38 kPa (5.5 psi)

4.10 Electrical Power

Mains supply 110 V & 220/240 V (dual), 50/60 Hz
Power consumption (warm up) 50 W
Power consumption (normal use) 25 W
Power Supply Type Penlon Power Supply, part number
411227
Fuse Type 4 A, Mini-blade, fast acting
Fuse is not user serviceable

14
SPECIFICATION

Battery back up Minimum of 5 minutes.

(when the battery is in a fully
charged state it provides a min-
imum of 5 minutes operation,
depending on fresh gas flow
and the set agent concentra-
tion.)
Battery Type 12 v, 600 mAh, Ni-Mh
Battery is not user-serviceable

4.11 Warm Up
Warm up time Approximately 5 minutes

4.12 Installation
The vaporizer must be mounted on a backbar on an anaesthetic machine
Maximum allowable tilt from vertical plane: 5o

4.13 Device Classification

Protection Class Class 1
(when used in conjunction with
power supply, Penlon part number
411227)

Type B applied part

Ingress protection designation IPX0

(The vaporizer is not protected
against water ingress)

15
5. FILLING

5.1 Filler System 6. The filler system must be main-

tained in accordance with the
- Desflurane Specific instructions given in section 9
WARNINGS (User Maintenance).
Anaesthetic Agent 7. The vaporizer must be filled
only by suitably skilled and
1. Use only Desflurane. Do not use
trained personnel.
the vaporizer with any other
anaesthetic agent. 8. Anaesthetic drugs are poison-
Contact Penlon Ltd if the vaporizer ous and there is evidence that
has been inadvertently filled with there is a health hazard to per-
any anaesthetic agent other than sonnel due to prolonged inhala-
Desflurane. tion of trace concentration in
the atmosphere.
2. The vaporizer is designed for Care must be taken to avoid
use only with the specific spillage of anaesthetic drugs
anaesthetic agent named on the when filling or draining the
filler block (and further indicat- vaporizer.
ed by colour coded labelling).
Check that the drug name on the 9. Do not inhale anaesthetic agent
vaporizer and the supply bottle vapour.
are the same before commenc-
ing the filling process. 10. The vaporizer must be either
Misdosage may occur if the secured to the anaesthetic
vaporizer is filled with the wrong machine or free-standing on a
drug. level table so that in either case
Do not use with flammable it is upright during the filling
agents, there is a fire or explo- process.
sion hazard.
11. If a new bottle of anaesthetic
3. The user is responsible for con- agent is to be used, check that
firming that any drug with a dif- the tamper-evident packaging is
ferent trade name is equivalent undamaged.
to the registered name.

4. It is not necessary to refrigerate 12. Do not tamper with the filling

Desflurane prior to filling the system valve. This may cause
vaporizer. vapour and/or liquid to be eject-
ed from the filler receiver.
Filling the vaporizer 13. Do not overfill.
5. The filling procedure must only A vaporizer that has been over-
be carried out in a well-ventilat- filled must be withdrawn from
ed area. use. Contact Technical Support
at Penlon for advice.

16
FILLING
14. Anaesthetic drugs must be treated
as a pharmaceutical product.
Do not reuse agent that has been
drained from a vaporizer into an
open container. Contamination is
likely. Always dispose of such
drained liquid as a hazardous
chemical.

15. Gas may continue to be delivered

from the anaesthetic machine to a
patient during the filling process.
16. Do not use if the bottle is cracked
or the filler connector is loose or
broken. This may result in
overfilling or contaminated agent
entering the vaporizer.
17. Ensure that the bottle neck is
fitted with an O-ring.
18. After filling, remove the bottle and
refit the filler block cover before
using the vaporizer. 2

Filling the Vaporizer

NOTE 1
The vaporizer may be filled on or off the
anaesthetic machine backbar.
The vaporizer may be filled with power
on or off.
Push in, until the bottle engages
1. If power is On, check that the fully.
vaporizer is in Standby mode.
Note that the display indicates 4. Slowly rotate the filler locking
the agent level. ring (3) clockwise.
The locking ring will ‘click’ into
2. Remove the cap from the bottle the ‘bottle secure’ position.
of Desflurane. Rotate further clockwise and the
Ensure that the bottle neck is locking ring will click into ‘filling’
fitted with an O-ring (1) . position and the system will fill
automatically.
3. Lift the filler cover (2), align the
NOTE The vaporizer may
bottle with the filler receiver, and momentarily pressurise the filling
insert the bottle. system during this operation.
17
FILLING

5. Allow the agent to fill the

vaporizer:
a) If power is on - fill the
vaporizer to the level desired
as indicated on the LCD
display (4). 2
b) If power is off, fill the
vaporizer until the flow of air
3
bubbles (5) has stopped.

6. Slowly rotate the filler locking

ring (3) anti-clockwise.
The locking ring will click into
‘filler valve closed’ position.
Rotate further anti-clockwise to
release the bottle 4
Withdraw the bottle, and close
the filler cover (2).
NOTE A small amount of
liquid may spill when the bottle
is removed from the receiver.
DO NOT REUSE THIS AGENT.
STANDBY
7. Replace the cap on the bottle.
DES USED: 0

Overfilling
WARNING
DO NOT OVERFILL.
Do not use a vaporizer that has been
overfilled.
If the vaporizer has been
inadvertently overfilled, excess
liquid agent will fill the filling
chamber and may spill from the
vaporizer.
DO NOT REUSE THIS AGENT.

18
6. INSTALLATION

WARNING
The vaporizer must not be tipped or inverted
during installation.
If the vaporizer has been tipped or inverted,
it must be set to 5% and flushed at 5 L/min
for a minimum of 30 seconds, before
returning the control dial to zero. Check for
stable output before clinical use.

During use, the vaporizer must not be

subjected to tilting in excess of 5o.

6.1 New Vaporizers

6.1.1 Electrical Continuity Check
WARNING
Before the vaporizer is used clinically for
the first time, verify that the hospital engi-
neering department has carried out an earth
continuity test.
If the integrity of the protective earth is in
doubt, do not use the vaporizer.

6.1.2 Gas Port Transit Seals

CAUTION
Inlet and outlet ports are sealed at the
factory for delivery transit. Ensure that the
seals are removed from the vaporizer before
installation on an anaesthetic machine.

19
INSTALLATION

6.2 Selectatec
Compatible Models 1
with Interlock
These vaporizers are designed for 2
installation on a Selectatec type
manifold back bar.
2
WARNING 3
When installing two vaporizers only on a
three station manifold, the centre station
must be occupied by one of the
vaporizers.

WARNING
Anaesthetic machine designs are
constantly evolving, and new models 1. Locking Lever
may differ dimensionally from existing 2. Interlock Bolts
equipment. 3. Back Bar Manifold Locking Shaft

It is the user's responsibility to ensure

that the configuration of the
anaesthetic machine allows correct
installation of the vaporizer. 3. Carefully lower the vaporizer
There must be sufficient clearance onto the manifold.
between the Selectatec manifold and CAUTION
the rear panelling/frame of the Recheck that the gas ports are
machine to allow the vaporizer correctly engaged with the valve
connector block to seal correctly on the capsules on the manifold.
manifold. 4. Lock into position by pushing
the locking lever (1) downwards
Installation and rotating clockwise through
1. Carefully offer the vaporizer up 90o.
to the manifold.
2. Align the gas connection ports CAUTION
with the valve capsules on the To prevent damage to the locking shaft (3) ,
manifold. (The capsules are always recheck that the gas ports on the
referred to as the valve vaporizer are correctly engaged with the
valve capsules before tightening the locking
‘cartridges' in some user
lever.
literature).

20
INSTALLATION

Pre-use Checks
Interlock System - check that only
one vaporizer at a time can be
turned on. 1

Observe the WARNING below and

carry out the check list procedure
given in section 7.4.
2

WARNING
Test all joints for gas tightness 2
before using the anaesthetic 3
machine.

The locking lever MUST be in the

locked position before the
vaporizer is operated.

Removal 1. Locking Lever

NOTE 2. Interlock Bolts
The concentration control dials of all 3. Back Bar Manifold Locking Shaft
the vaporizers linked by the interlock
system must be turned to zero before
removing the vaporizer from the
manifold.

To remove the vaporizer, rotate the

locking lever 90o anti-clockwise
and carefully lift the unit vertically
until clear of the back bar.

21
INSTALLATION

6.3 Cagemount (23 mm)

Taper Models
WARNING
This type of vaporizer is not fitted
with an interlock system. It should
only be used on anaesthetic
machines with a single vaporizer
mounting station.

Vaporizers fitted with cagemount 4

tapers have the male taper (1) (Inlet
port) on the left and the female taper
on the right (viewing the front of the
vaporizer). 1
Two M6 studs with nuts (2), washers
and a clamp plate (3) are provided
to fix the vaporizer to the back of the
anaesthetic machine. See next
page for installation with a Modura 2
claw assembly on a Modura rail 3
system.
Taper Connectors
It is essential that the taper cone
joints should be engaged axially and
not sideways loaded.

1. Adjust the distance from the

back bar to the taper joint by
adding or removing the
shims (4) .

2. The cone joints should be

lightly smeared with an
oxygen compatible lubricant
such as Fomblin.

3. Engage the taper joints by

applying axial pressure.

4. Tighten the fixing nuts (2).

22
 INSTALLATION

Cagemount Taper Models

Installation on Modura Rail
1. Remove the M6 nuts and
washers, the clamp plate and 3
the shims from the vaporizer.
2. Fit the Modura claw (1) to the
backplate (2), using the two 2
M6 screws.
3. Fit the Modura claw
backplate assembly to the
studs (3) on the rear of the
vaporizer, and secure with
the M6 nuts and washers.
4. Attach the vaporizer to the
Modura rail on the 1
anaesthetic machine and
secure in place by moving
the lever into its 'locked on'
position.
Pre-use Check
Observe the WARNING below and
carry out the check list procedure
given in section 7.4.
WARNING
Test the joints for gas tightness
before using the machine.

The flexible hoses attached to the

block are connected to the inlet
6.4 Penlon Off-line and outlet of the vaporizer.
Mounting System Use a Safety Clip (Part Number
A vaporizer with cagemount tapers 52275) to retain the detachable
may be fitted with a Penlon cagemount connectors, to prevent
mounting clip, Part No. 58090, in inadvertent disconnection.
place of the backbar clamp. The WARNING
vaporizer may then be fitted to a Test the joints for gas tightness
Penlon off-line block, as used on before using the machine.
Penlon Anaesthetic Machines with
Cagemount option.
23
INSTALLATION

6.5 Drager 'Plug-in'

Compatible (interlock)
1
Installation 3
WARNING
When installing two vaporizers only on a
three station manifold, the centre station
must be occupied by one of the
vaporizers.
2
1. Carefully offer the vaporizer up
to the manifold.

2. Align the gas connection ports

with the valve capsules on the
manifold. 1. Locking lever
(The capsules are referred to as 2. Back bar manifold
the valve ‘cartridges' in some locking shaft
user literature) 3. Interlock shaft

3. Carefully lower the vaporizer

onto the manifold.
Recheck that the gas ports are
correctly engaged with the valve
capsules on the manifold.

4. Lock into position. Pre-use Checks

Push the locking lever (1) Interlock System - check that only
downwards and rotate clockwise one vaporizer at a time can be
through approximately 100o. turned on.

WARNING Observe the WARNING above,

To prevent damage to the locking shaft and carry out the check list
(2), and to ensure that the gas procedure given in section 7.4.
connection ports are correctly engaged,
check that the vaporizer is firmly
positioned on the manifold before
Removing the Vaporizer
tightening the locking lever.
The locking lever (1) MUST be in the Rotate the locking lever fully
locked position before the vaporizer is anticlockwise and carefully lift the
used. vaporizer from the manifold.

24
 INSTALLATION

6.6 North American

Drager Compatible
(Interlock) 3

WARNING
1
The anaesthesia workstation
interlock system may require
periodic adjustment as a result of
normal use, to maintain system
2
integrity.1
In addition, adjustment may be
necessary when installing a new
vaporizer. 1

Installation
Installation and adjustment to be
carried out by suitably trained
Pre-use Checks
technicians only.
Interlock System - check that only one
1. Check that each gas port is fitted vaporizer at a time can be turned on.
with the correct O seal (1) If the vaporizer fails this check, carry
(Penlon Part No. 041126). out the adjustment procedure detailed
on the next page.
2. Carefully offer the vaporizer up to
the manifold. Observe the WARNING below and
carry out the check list procedure given
3. To secure the vaporizer to the in section 7.4.
manifold, use two M4 x 30 screws
WARNING
(Penlon Part No. 01267) and fan- Test all joints for gas tightness before
type lock washers. using the anaesthetic machine.
From the rear of the anaesthetic
machine fit the two screws Removing the Vaporizer
through the manifold block holes 1. Support the vaporizer, and
(2), and screw into the threaded remove the securing screws (2).
holes in the vaporizer. 2. Detach the vaporizer from the
manifold.
4. Tighten the screws to a torque of 3. Check that the O-seals are
3.0 Nm. retained in the gas ports (1).
1Anesthesiology, 104 (4), April 2006, p.891

25
INSTALLATION

4
3

Interlock Function Check and

Adjustment
Check that only one vaporizer at a
time can be turned on.
If necessary, adjust the position of the
interlock screw (3) on the vaporizer to
ensure that the system functions
correctly (see 1 and 2, below):

Adjustment to be carried out by

suitably trained technicians only.
1. If the Alpha vaporizer, or any 2. If the vaporizer is on, and
vaporizer on the machine, is another vaporizer can also be
difficult to turn on (or can not turned on:
be turned on at all): i) Turn the vaporizer off.
i) Remove the vaporizer from the ii) Remove the vaporizer from the
machine to enable adjustment machine to enable adjustment
(refer to the sub-section (refer to the sub-section
‘Removing the Vaporizer’ on ‘Removing the Vaporizer’ on
previous page). previous page).
ii) Carefully pull the interlock screw iii) Carefully pull the interlock screw
(3) and sleeve (4) outwards, and (3) and sleeve (4) outwards, and
hold the sleeve. hold the sleeve.
iii) Use a 2.5 mm Allen Key to iv) Use a 2.5 mm Allen Key to
adjust the position of the screw adjust the position of the screw
(3) inwards. (3) outwards.
iv) Refit the vaporizer and recheck v) Refit the vaporizer and recheck
the interlock system. the interlock system
WARNING WARNING
The anaesthesia workstation interlock The anaesthesia workstation interlock
system may also require adjustment to system may also require adjustment to
maintain system integrity. maintain system integrity.
26
INSTALLATION

2
1

6.7 Electrical Power

Supply
WARNING Connecting the Power Supply
Connect the vaporizer power supply
unit to a ‘hospital grade’ mains
1. Insert the power supply unit
electrical supply outlet.
If used with a mains extension cord, cable connector (1) into the
the unit may be subject to electro- electrical socket (2) on the
magnetic interference. top of the vaporizer.
WARNING
Excessive electronic noise caused 2. Connect the power supply
by a poorly regulated device (e.g. an unit to the mains electrical
electrocautery unit) may adversely supply.
interfere with the functioning of the The amber light (3) will
vaporizer.
illuminate. This indicates
To avoid this problem, do not that power is available.
connect the vaporizer power cord
In addition, the recharging
into the same electrical wall outlet or
adaptor strip into which an
system for the back-up
electrocautery unit is connected. battery is automatically
In addition, radio communication switched on and remains on
equipment can interfere with the until the battery is fully
function of the vaporizer. charged.

27
7. OPERATING THE VAPORIZER

7.1 Using the Vaporizer Set the control dial to 5% output

and run/flush for a minimum of 30
WARNINGS seconds at 5 L/min. Return the dial
1. The user must read and be familiar to zero after purging.
with the contents of this Note that purging may cause a
instruction manual before using temporary increase in vaporizer
the vaporizer. output. See also, Warning 51.
In addition, read the instruction 7. Movement during transport can
manuals for the anaesthetic result in over-dosage.
machine and other devices that Allow time for the liquid to regain
are used as part of the anaesthetic its normal position.
workstation. If a vaporizer has been transported
In some territories the vaporizer it must be purged before clinical
must not be used unless the use.
accompanying user manual is Set the control dial to 5% output
printed in the language used in and run/flush for a minimum of 30
that territory. seconds at 5 L/min. Return the dial
to zero after purging.
2. The vaporizer will not operate if
Note that purging may cause a
VAP INOP is displayed.
temporary increase in vaporizer
3. The vaporizer must be stored and output.
operated in line with the 8. The vaporizer must not be tipped
information listed in Section 4. or inverted during installation.
Note that the vaporizer may If the vaporizer has been tipped or
malfunction if exposed to inverted, it must be set to 5% and
excessively high temperatures, flushed at 5 L/min for a minimum of
e.g. by storage above a radiator. 30 seconds. Return the control dial
This may affect the calibration. to zero after purging.
Check for stable output before
4. The vaporizer must be mounted
clinical use.
on a backbar (see 6.2 to 6.8), and
connected to the mains electrical 9. Do not user a vaporizer that has
supply (see 6.7), before use. been dropped.
5. Do not use the vaporizer: 10. The vaporizer must be securely
a) if the agent level is not visible fixed, and in an upright position
on the display when the vaporizer before use.
is turned on, or There is a danger of overdosage if
b) if the agent level is outside the sudden inadvertent movement
maximum and minimum occurs during use.
indicators. 11. Anaesthetic machine designs are
6. Purge the vaporizer before clinical constantly evolving, and new
use: models may differ dimensionally
a) when the vaporizer is first from existing equipment.
turned on after filling from EMPTY. The user must ensure that the
configuration of the anaesthetic
b) after a period of not being used.
machine allows correct installation
of the vaporizer.
28
OPERATING THE VAPORIZER

Check for clearance between the 16. The anaesthetic machine and
Selectatec manifold and the rear other devices that are used as
frame panelling of the machine part of the anaesthetic
to allow the vaporizer connector workstation must be operated in
block to seal correctly on the line the specifications and
manifold. instructions detailed in the
relevant user instruction
12. Before use: manuals.
a) Test all joints for gas
tightness, and perform back bar 17. Check that breathing system
function tests as detailed in the components are compatible with
manual supplied with the anaesthetic gas mixtures.
anaesthetic machine.
18. The vaporizer must not be used in
b) Interlock System - check that the presence of flammable
only one vaporizer at a time can substances, e.g. cyclopropane,
be turned on. A defective ether
interlock system may result in
the delivery of excessive 19. Do not use the vaporizer during
concentrations of anaesthetic transportation.
agent.
20. Exterior panels must not be
13. Connect the vaporizer power removed by unauthorised
supply unit to a ‘hospital grade’ personnel and the vaporizer
mains electrical supply outlet. must not be operated with such
If used with a mains extension panels missing.
cord, the unit may be subject to There is a possible electric shock
electro-magnetic interference. hazard.
14. Do not use the vaporizer in an 21. Do not use the vaporizer if the
MRI environment. backup battery is faulty and can
not hold its charge.
15. Excessive electronic noise
caused by a poorly regulated 22. Check the liquid level frequently
device (e.g. an electrocautery when using the vaporizer and
unit) may adversely interfere maintain the level between the
with the functioning of the minimum and maximum marks.
vaporizer.
To avoid this problem, do not 23. The output of the vaporizer is
connect the vaporizer power sensitive to barometric pressure.
cord into the same electrical wall A correction factor may be
outlet or adaptor strip into which necessary when assessing the
an electrocautery unit is output using an analyser, for
connected. example at high altitude.
Note also: radio communication Barometric pressure effects are
equipment can interfere with the not usually of clinical importance
function of the vaporizer.
(see section 8.3).
29
OPERATING THE VAPORIZER

24. The vaporizer is a flow- dependent on his respiration

direction-sensitive apparatus. and the functioning of his
The direction of gas flow cardiovascular system.
towards the patient must be as 31. Do not set the control dial
indicated by the arrow on the between 0 (zero) and the lowest
top label. graduation.
Reversal of flow will trigger a
vaporizer alarm. 32. High concentrations of
25. The vaporizer must not be used Desflurane reduce the
downstream of the common gas concentration of oxygen in the
outlet. fresh gas delivered to the
26. During use, the vaporizer must patient.
not be subjected to tilting in
33. If a high agent concentration
excess of 5o. has been set, the use of high
27. As stated in section 2, the fresh gas flow rates will result
vaporizer is of relatively high in a vaporizer output below the
resistance and must not be set concentration (see section
8.1).
incorporated within a breathing
system.

28. Always use an anaesthetic gas

scavenging (AGS) system to
extract expired anaesthetic
vapours from the operating
theatre.
The AGS system must comply
with ISO 8835-3.
29. Patient monitoring:
a) Always use an anaesthetic
agent monitor that complies
with ISO 11196.
b) Always monitor oxygen
concentrations.
c) Always check that the
monitors are functioning
correctly before starting the
clinical procedure.

30. Anaesthesia system monitors

and patient monitors are very
desirable aids for the
anaesthetist.
However, they are not true
clinical monitors, as the
condition of the patient is also
30
OPERATING THE VAPORIZER

3
1

WARM UP
DES USED: 0

7.2 Controls
Switch On
Switch on by pressing the On/Off button
(1).
The green light (2) will illuminate and the
internal battery charging circuit remains in
operation.
Warm Up
The LCD display will indicate "WARM UP".
During this period the vaporizer will not
deliver agent. Do not set a concentration.
The "Warm up" period lasts for
approximately two minutes.
WARNING
Do not set an output concentration until
warm up is complete
If the concentration control dial has been
rotated inadvertently before or during
warm up, return the dial to zero in
Standby mode, and then reset to the
desired concentration.
The vaporizer will not deliver agent
unless the correct procedure is followed.

Before clinical use, carry out a Pre-use

Check (section 7.4), and a basic output
check (7.5).

31
OPERATING THE VAPORIZER

Standby
When warm up is complete the dis-
play indicates that the vaporizer is in
"Standby" mode.
The "Des Used" display will indicate
zero.
STANDBY
DES USED: 0
In Use
The vaporizer display will indicate "In
Use" when the vapour concentration
control is rotated from the zero posi-
tion.
The control dial is locked at zero when 1
not in use.
To set a concentration level, push the
dial assembly (1) in and rotate anti-
clockwise. Align the required concen- 2
tration graduation with the mark at the
top of the bezel.

Desflurane consumption
When an output is set the user will be
prompted (for two seconds) to zero 3
the "Des Used" count by pressing the
alarm mute button (2).
This gives the user the option of
quantifying the volume of Desflurane
that will be used during the next
clinical procedure, or over a particular
period. IN USE
Off DES USED: 250.5ml
When the control dial is set to zero,
the dial assembly will automatically
spring outwards into the locked 'off'
position and the display will return to
"Standby".
Press the On/Off button to switch off
the vaporizer.
If the vaporizer is still connected to the
mains electricity supply, the amber
light (3) will illuminate.
32
OPERATING THE VAPORIZER

7.3 Alarms and

Message Displays
When an alarm condition occurs,
the control system triggers a
mutable audible alarm and a
display message as detailed in the
table on the next page.

Mute Control
Press the mute button (1) to
LOW BATTERY
silence the audible alarm for 120
seconds.
If a new alarm condition occurs, IN USE
the alarm sounder will reset. DES USED: 250.5ml

1
Vaporizer Inoperative
WARNING
The vaporizer can not be operated if VAP INOP
the VAP INOP alarm message is NO OUTPUT
displayed.
If Vap Inop is displayed on screen
DES USED: 250.5ml
the vaporizer must not be used.
The fault must be investigated by a
Penlon-trained technician.

33
OPERATING THE VAPORIZER

Alarm Conditions

Alarm Priority Mode Details

level

Vap Inop High All modes Vaporizer inoperative - no output, do not use
(vaporizer
inoperative)

Mains Failure Medium All modes No connection to external mains supply.

Note that the backup battery provides a
minimum of 5 minutes power if in a fully-
charged state.

Low Battery High All modes The alarm is triggered approximately 5

minutes before vaporizer shuts down
(vaporizer is operating on battery power)

No Battery Backup Medium All modes Battery is disconnected, or not fitted

Low agent level Low Standby Liquid level less than 70 ml, more than 50 ml
+ In Use
No more agent High All modes Liquid level less than 50 ml

Delivery system High In Use Pre-vaporization cycle checks have failed

not active

Low fresh gas Medium In Use Measured fresh gas is less than 200 ml/min
supply

High fresh gas Medium In Use Measured fresh gas is greater than 12 L/min

Low concentration Medium In Use Measured output concentration is

output considerably less than set concentration
value

High concentration Medium In Use Measured output concentration is

output considerably higher than set concentration
value

34
OPERATING THE VAPORIZER

7.4 Pre-Use Check List 7.5 Output Check

In addition to the pre-use warnings listed 1. Set a fresh gas flow of 5 L/min.
for different models in sections 6.2 to
2. Set a concentration of 5%.
6.6, the following check list procedure
must be carried out on ALL vaporizers 3. Use a patient monitor in the
before use. breathing system to check that
adequate agent is being delivered
1. Investigate any alarm conditions. into the breathing system.
2. Check that the vaporizer Note that there may be a delay
concentration control is in the 0 before a reading is displayed, due to
(zero) position. the volume of the breathing circuit.
3. Check that the anaesthetic liquid
level is between the minimum
and maximum marks on the
display, and that adequate
volume remains for the
anticipated clinical procedure.
4. Check that the filler cover is
securely closed.
5. Perform a back bar manifold leak
test as detailed in the relevant
anaesthetic machine user
instruction manual.
6. Interlock system (if fitted) - check
that only one vaporizer at a time
can be turned on.
7. Perform a basic output check
(see section 7.5).

WARNING
Anaesthetic machine designs are
constantly evolving and new models
may differ dimensionally from existing
equipment.
It is the user's responsibility to ensure
that the configuration of the anaesthetic
machine allows correct installation of the
vaporizer.

35
 8. PERFORMANCE CHARACTERISTICS

NOTE
Concentration output figures quoted and shown graphically in this section
were compiled from average test results from a number of vaporizers.
The output from individual units may vary from these average figures.

8.1 Vaporizer Output

Variation of output with flow rate

Temperature: 22oC
20 Carrier gas: Oxygen

18% set

16 B 16% set

14% set

12 12% set

A 10% set
9% set
8 8% set
Output Vol%

7% set
6% set
5% set
4 4% set
3% set
2% set

0 2 4 6 8 10

Flow Rate L/min

NOTE
Within area A, the Alpha Vaporizer delivers output concentrations
within the tolerance specified in ISO 8835.4 / IEC 60601-2-13.
Within area B, at high flow rates and agent concentration levels,
vaporizer output will be lower than the set concentration.

For further information, see section 8.4.1.

36
PERFORMANCE CHARACTERISTICS

8.2 Temperature 8.3.2 Barometric Pressure

Compensation Changes in barometric pressure
can be ignored clinically.
NOTE
Within the operating range of 18 -
Changes in barometric pressure
30oC, the device is compliant must be considered when checking
with the requirements of outputs with an analyser.
ISO8835-4. Some analysers include automatic
barometric pressure correction.
The use of an agent analyser is Check the instructions provided with
the analyser.
recommended if the vaporizer is
used in temperatures outside the
above range. 8.3.3 Back Pressure
Back pressures imposed on the
vaporizer by ventilators or other
8.3 Pressure Effects parts of the anaesthetic apparatus
8.3.1 Ambient Pressure are usually relatively small, but
certain ventilators can impose back
NOTE pressures of 10 to 15 kPa (100 to
The output of the vaporizer is 150 cmH2O) which will produce a
referenced to atmospheric reduction of the output
pressure. concentration.
Ambient pressure effects are not
normally of clinical significance but 8.3.4 Intermittent Back
the following rules apply:
The control is graduated in units of Pressure
vol% at 101.3 kPa (14.7 psi). At Intermittent back pressure imposed
any other pressure the true output on the vaporizer by a ventilator
will be modified according to the may result in some change in
equation: output. The effect is greatest at low
settings of the control and low flow
C = S% x 101.3 rates, and the Sigma Alpha
P vaporizer is designed to comply
with the tests laid down in various
P is absolute pressure in kPa. Standards in this respect (see
C is delivered concentration vol%, section 10).
S% is the set value.

37
PERFORMANCE CHARACTERISTICS

8.4 Summary of Performance Specifications

8.4.1 Factors Affecting Output Accuracy
Under calibration conditions (temperature at 21oC, flow rate of 4 L/min) the
output will not deviate from the set concentration by more ±10% of scale reading,
or ±0.5% vol% (whichever is greater).

Outside these conditions the device is compliant with the requirements of

ISO8835-4 (+30%/-20% of set concentration, or +7.5%/-5% of the maximum
setting, whichever is greater).

See below for conditions and settings for normal use.

Conditions and Settings defined as Normal Use

Gas composition: O2, Air + N2O mixture

Liquid level: Between minimum and maximum marks on display

Temperature: 18 to 30oC

Flow rate range: 0.5 to 10 L/min

Altitude: -100 m to 3000 m

Intermittent back pressure: As defined in the standards listed in section 10 (a)

Movement: Do not agitate during use

Inversion or tipping: Do not tip or invert

38
PERFORMANCE CHARACTERISTICS

8.4.2. Resistance to Gas 8.6 Effect of Gas

Flow Composition on
Resistance to gas flow, measured Output
at: The vaporizer is calibrated with
22oC (72oF) pure oxygen and the scale is
101.3 kPa therefore most accurate with this
(1013 mbar or 14.7 psi) gas.
Carrier gas : Air The effect of other gases normally
used in anaesthesia is as follows:
Flow Rate Resistance
using Air (cmH2O) Nitrous oxide
(L/min) Nitrous oxide, added to oxygen, will
produce a minimal change in
1.0 0.2 output, as the vaporizer is gas
2.5 0.9 mixture compensated.
5.0 3.0
7.5 5.8 Carbon dioxide
10 10.6 Carbon dioxide is not usually
added in high concentrations and is
Resistance varies from these usually limited to 5%. At this
nominal values at other control concentration the effect on
positions, and changes with vaporizer output is negligible.
temperature.
Air
Air will produce a minimal change
8.5 Effect of IPPV on in output, as the vaporizer is gas
Output mixture compensated.

When tested in accordance with Helium

ISO 8835-4*, output will not deviate The vaporizer is not designed for
from the set concentration by more use with Helium and will give
than +30% / -20%. uncontrolled concentrations with
helium-enriched mixtures.
*Tested at:
a) 2 kPa IPPV / flow rate of 2 L/min
b) 5 kPa IPPV / flow rate of 8 L/min

39
PERFORMANCE CHARACTERISTICS

8.7 Output when Control is at

0 (zero)
Output vapour concentration when the
control is in the ‘Off’ position (i.e. set at 0)
will not exceed 0.05% vol., when tested in
accordance with ISO 8835-4.

8.8 Effect of Flush Valve

Operation
When tested in accordance with ISO
8835-4 the operation of the flush valve on
the anaesthetic machine will not affect
anaesthetic agent output concentration by
more than 20%.

8.9 Effect of Sub-atmospheric

Pressure
When tested in accordance with ISO
8835-4 sub-atmospheric pressure will not
affect anaesthetic agent output
concentration by more than 20%.

40
9. USER MAINTENANCE

WARNING Calibration Check and Leak Test

This vaporizer must not be modified a) The calibration should be
or disassembled by an unauthorised checked every 3 months
person. under controlled conditions
The vaporizer must be serviced by a
The output of the vaporizer
Penlon-authorised service agent,
trained technician or engineer and should be checked every 3
by no other person. months, either:
Clean and disinfect the vaporizer (i) as part of the Penlon Service
before each service. Contract (UK only)
(ii) by a Penlon certified engineer
CAUTION Do not attempt to
(iii) by a suitably qualified hospital
dismantle the vaporizer or make any
technician if agent analysis
adjustment to it which is outside the
apparatus is available.
scope of the following instructions.
NOTE The user must accept Follow the procedure detailed
responsibility for any malfunction in section 12.2 and record the
which results from non-compliance measured values in the
with the following requirements. relevant page in section 12.3.

(b) Successive sets of figures

9.1 Servicing should be compared to
NOTE A label is fixed on the determine if performance is
vaporizer bearing the words: maintained. If deterioration is
detected, a service must be
GENUINE PART carried out to restore normal
LABEL TAMPERING operation.
VOIDS WARRANTY
(c) A major overhaul must be
When the vaporizer is dismantled performed every five years to
this label will be damaged beyond maintain performance within
repair as permanent evidence of the specification.
unauthorised servicing, repair or
modification.
Selectatec Mounting System
If this label (or other labels) is
The Selectatec compatible
missing, do not use the vaporizer
vaporizer locking system must be
until it has been serviced (see
inspected during the vaporizer
below).
calibration test.
If damage to the locking shaft is
The Sigma Alpha must only be
suspected, the device must be
serviced at an authorised service
referred to a Penlon certified
centre or by Penlon-trained
engineer.
technicians in accordance with the
following procedures.
41
USER MAINTENANCE

Interlock System • Do not pour water, or any

Function test the interlock system cleaning solutions into the
during the vaporizer calibration vaporizer.
test. • Do not allow liquids to get under
the filler cover or control dial.
Filler System • Do not spray aerosol-based
Filling must be checked, under cleaning agents onto the
controlled conditions, during the vaporizer.
vaporizer calibration test.
After any cleaning or maintenance
operation, carry out a pre-use check
9.2 Cleaning and (section 7.4) and an output check
(section 7.5) before clinical use.
Sterilisation
WARNING Display Screen
Always stand the vaporizer on a firm, Use a soft cloth.
level surface when it is removed
Do not use a harsh abrasive
from the anaesthetic machine.
cleaning agent.
WARNING
Do not pour water, or any cleaning
solutions into the vaporizer.
The process of filling and emptying will
9.3 Training Courses
clean the internal passageways of the A training course is available to
vaporizer filler block satisfactorily. engineers and hospital staff who
wish to carry out routine
Exterior maintenance on vaporizers.
The exterior of the vaporizer should
be kept clean and dust free with a The course covers:
dry cloth, or, if necessary use - leak testing
proprietary cold sterilised wipes.
- replacement of seals
Important: - internal maintenance
• Do not use water or other - replacement of major
liquids. sub-assemblies
• Do not use use solvents or - regulation of output
cleaning agents.
• Do not immerse the vaporizer in A manual describing this work is
any liquid. available to personnel who have
• Do not autoclave. completed this course.
• Do not allow any liquids to enter
the inlet and outlet ports or the
filler block.
42
USER MAINTENANCE

9.4 Service or Repair

Keep a record of any service or
repair work in section 13.

Returning the unit to Penlon Ltd

The vaporizer must be drained
before packing.

Drain the vaporizer into an empty

Desflurane bottle:
1. Remove the cap from the
bottle of Desflurane.
Ensure that the bottle neck is
2
fitted with an O-ring (1).

2. Lift the filler cover (2), align the

bottle with the filler receiver,
and insert the bottle. 1
Push in, until the bottle
engages fully.

3. Tilt the vaporizer forward until

agent ceases to flow into the 9.5 End of Product
bottle.
Do not use the bottle to
Service Life
support the weight of the The vaporizer must be drained and
vaporizer during the drain purged.
procedure. Dispose of the drained agent as a
hazardous chemical. Do not reuse.
Dispose of the drained agent as a
hazardous chemical. Do not reuse. Disinfect/sterilise the vaporizer if
necessary, before disposal.
Packaging
Dispose of the vaporizer in
Always use the original packaging, compliance with the relevant
to prevent damage during transit. WEEE statutory requirement
If the original packaging is not and/or national and local
available, use a strong carton and regulations for disposal of
pack tightly before despatch. medical devices.

43
10. REFERENCES

Standards
The Sigma Alpha vaporizer has been designed in accordance with the
following Standards.

(a) General

EN ISO 8835-4
IEC 60601-2-13
EN 60601-1
EN 60601-1-2
ISO 5356-1

(b) Agent Specific (Keyed) Filling System

ISO 5360

Trademarks
Selectatec is a GE trademark.

44
11. ORDERING INFORMATION

Contact Customer Service at Penlon Ltd.

UK:
Tel: 01235 547036
Fax: 01235 547023
E-mail: [email protected]
International
Tel: +44 1235 547001
Fax: + 44 1235 547021
E-mail: [email protected]

Accessories
WARNING
Only use accessories approved by Penlon Ltd.

52275 Safety clip for cagemount tapers (Off-line system only)

58090 Mounting clip for cagemount tapers (Off-line system only)

45
12. CALIBRATION CHECK

12.1 Calibration and Service Policy

a) The calibration of the vaporizer must be checked

every 3 months under controlled conditions, and a leak
test performed.
Record the measured figures in section 12.3.
For further information, Penlon-trained engineers
should refer to the relevant section in the service
manual.
WARNING
The calibration check must be performed as
described in section 12.2.
Always measure output at the inspiratory port of the
circle system, or use an agent analyser system that
incorporates a mixing chamber of the correct size.
The analyser must be of an approved type, e.g. a
Riken refractometer or infrared analyser.

At the completion of each Five or Ten Year Overhaul,

a copy of the completed calibration records must be
faxed to Penlon Limited (Fax No: 44 1235 547062).
b) By comparing several sets of successive figures, a
trend in performance can be established and a
service performed before the standard tolerance is
exceeded.

c) If the calibration check shows a departure from the

standard performance or a trend towards predicted
failure, the vaporizer must be serviced as described
in the service manual.
d) All vaporizers must be overhauled every five years,
and certain items replaced even if the performance
appears satisfactory.
This is a preventive maintenance requirement.

e) Repair and servicing work must be recorded in

section 13.

46
CALIBRATION CHECK

12.2 Calibration Procedure

12.2.1 Checking Vaporizer Output

The output of the vaporizer should be checked
every 3 months, either:
(i) as part of the Penlon Service Contract (UK
only)
(ii) by a Penlon certified engineer
(iii) by a suitably qualified hospital technician if
agent analysis apparatus is available.

To be comparable with the master calibration,

such tests must conform to the following.

(a) The carrier gas should be oxygen.

(b) The vaporizer must be filled, and fixed
upright and stationary, at a temperature
between 18 and 22oC (64 and 72oF) for at
least 2 hours.
(c) A mixing chamber must be attached to the
outlet of the vaporizer to ensure that a
homogeneous mixture is sampled (see
12.2.2).
This is particularly necessary at low gas
flow rates.
Note : The volume of the mixing chamber
must be equivalent to the volume of the
anaesthetic machine internal pipework,
between the vaporizer and the CGO block,
plus the volume of the circle system.

(d) The sampling system must be of non-

absorbent material such as nylon.
(Rubber, etc., absorbs vapour to a
substantial extent.)
(e) Flow rates, etc., must lie within the range
covered by the master calibration charts.

47
 CALIBRATION CHECK

(f) The analysis apparatus must be of an

approved type, e.g. a Riken refractometer.
However, if the calibration check is
undertaken by a hospital technician, it is
permissible to use a commercially
available agent analyser, but only if:
i) the analyser is calibrated to the
manufacturer’s specification and
schedule.
ii) output failures are confirmed by a
Penlon certified engineer using a
refractometer.
g) Output values must be recorded in section
12.3.
Ensure that there is a 30 seconds interval
between each reading.
Add comments at the foot of each page.

48
CALIBRATION CHECK

12.2.2 Calibration Test Equipment

3
9
7
1 2 4 6

1. Oxygen supply
2. Pressure regulator 0 - 400 kPa (0 - 60 psi)
3. Pressure gauge 0 - 400 kPa (0 - 60 psi)
4. Flowmeter 0 - 10 L/min
5. Pressure gauge 0 - 10 kPa (0 - 100 cmH2O)
6. Alpha Vaporizer
7. Analyser mixing chamber
Note : The volume of the mixing chamber must be equivalent to
the volume of the anaesthetic machine internal pipework,
between the vaporizer and the CGO block, plus the volume of
the circle system.
Alternatively, take readings with the vaporizer fitted on an
anaesthetic machine, with a circle system connected.
Readings must be taken at the inspiratory port of the circle
system (absorber bypass ON, to isolate the absorbent)
8. Analyser
9. Exhaust tubing
10. Additional components (not illustrated):
Pressure gauge connector T piece
Nylon catheter (analyser connector)
Test connection block

49
CALIBRATION CHECK

12.2.3 Using the Riken Analyser

The Riken Model 1F-18 is normally calibrated by the manufacturer for

measuring up to 8% vol. Halothane, or up to 9% Sevoflurane, either in
air or in oxygen.
Service checks on the vaporizer must be performed with oxygen if the
vaporizer is checked on an anaesthetic machine.
Use air or oxygen if the vaporizer is checked in a test laboratory.

CAUTION
A) It is essential that the gas used during service checks is recorded,
B) The reference cell of the Riken must be purged with the appropriate gas
before measurements are made.

Using the Riken Analyser with Desflurane

The Riken gas analyser measures the refractive index of gases and
vapours and, although normally calibrated for measuring halothane, the
instrument can also measure other vapours if an appropriate correction
factor is applied.
To obtain the true concentration of Desflurane multiply the reading
shown on the Riken analyser by the correction factors given below.

Carrier Gas
The refractive index of oxygen is higher than that of air so that,
(a) the unit must be re-zeroed if the carrier gas is changed, and
(b) the scale must be adjusted by a correction factor, applied by
multiplying the Riken scale reading to obtain the true concentration.

Correction Factors:
Halothane in Air Riken
Factor (using air) Factor (using oxygen)
Desflurane 1 1.06

Halothane in Oxygen Riken

Factor (using air) Factor (using oxygen)
Desflurane 0.95 1.34

50
CALIBRATION CHECK

Temperature and Barometric Pressure

Calibration checks must be performed at a temperature between 19 and
21oC.

Temperature correction is therefore not required, but the temperature

should be measured and recorded to ensure that the test is carried out
within the specified range.

Changes of barometric pressure due to weather are not normally of

significance and can be ignored.

Altitude can, however, have significant effects and the following

correction factors should be applied when appropriate.
The Riken reading multiplied by the stated correction factor gives the true
concentration corrected to Standard Temperature and Pressure (STP).

Altitude Factor Barometric Pressure

(for reference)
600 m (2000 ft) 0.9 910 mb
1200 m (4000 ft) 0.85 850 mb
1800 m (6000 ft) 0.8 813 mb
2400 m (8000 ft) 0.75 745 mb

Method of reading the Riken Analyser

1. Readings may be taken from a tee-piece connected to the
common gas outlet of the anaesthetic machine.
An AGS system must be connected.
2. The sampling tube must be nylon or PTFE (which do not absorb
vapours).
Rubber sleeves may be used to make end connections but there
must be minimal length of rubber exposed to the gases being
sampled.
3. Sample by 2 or 3 squeezes of the hand bulb. Wait for fringe
movement to cease before taking the reading.
4. After each resetting of the vapour control, time must be allowed
for the output to stabilise.
Suggested timescale: at 2 L/min flow - wait 4 minutes
4 L/min flow - wait 2 minutes
8 L/min flow - wait 1 minute

51
CALIBRATION CHECK

5. a) The vaporizer must be half-full, and rigidly supported in its correct

operating position.

b) Temperatures must be stabilised for approximately 4 hours before

checking.

c) The temperature must be in the range 19 to 21oC.

52
CALIBRATION CHECK

12.3 Calibration Check Records

Year One
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
Include a 30 seconds interval between each reading

0.0 0 - 0.1
2.0 1.6 - 2.4
4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

53
CALIBRATION CHECK
Year Two
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
0.0 0 - 0.1
Include a 30 seconds interval between each reading

2.0 1.6 - 2.4

4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

54
CALIBRATION CHECK
Year Three
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
0.0 0 - 0.1
Include a 30 seconds interval between each reading

2.0 1.6 - 2.4

4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

55
CALIBRATION CHECK
Year Four
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
0.0 0 - 0.1
Include a 30 seconds interval between each reading

2.0 1.6 - 2.4

4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

56
CALIBRATION CHECK
Year Five
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
0.0 0 - 0.1
Include a 30 seconds interval between each reading

2.0 1.6 - 2.4

4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

57
CALIBRATION CHECK
Year Six
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
0.0 0 - 0.1
Include a 30 seconds interval between each reading

2.0 1.6 - 2.4

4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

58
CALIBRATION CHECK
Year Seven
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
0.0 0 - 0.1
Include a 30 seconds interval between each reading

2.0 1.6 - 2.4

4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

59
CALIBRATION CHECK
Year Eight
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
0.0 0 - 0.1
Include a 30 seconds interval between each reading

2.0 1.6 - 2.4

4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

60
CALIBRATION CHECK
Year Nine
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
0.0 0 - 0.1
Include a 30 seconds interval between each reading

2.0 1.6 - 2.4

4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

61
CALIBRATION CHECK
Year Ten
Test Period 1 2 3 4

Vaporizer serial number:

Date:
Signature:
Print name:

Carrier Gas
Leak Test
(at 200 mmHg for minimum 60 secs)
Pressure must not drop below 180 mm Hg

Set Tolerance
0.0 0 - 0.1
Include a 30 seconds interval between each reading

2.0 1.6 - 2.4

4.0 3.2 - 4.8
6.0 4.8 - 7.2
8.0 6.4 - 9.6
10.0 8.0 - 12.0
12.0 9.6 - 14.4
15.0 12.0 - 18.0
18.0 14.4 - 20.6
15.0 12.0 - 18.0
12.0 9.6 - 14.4
10.0 8.0 - 12.0
8.0 6.4 - 9.6
6.0 4.8 - 7.2
4.0 3.2 - 4.8
2.0 1.6 - 2.4
0.0 0 - 0.1

Comments:

62
13. SERVICE AND REPAIR RECORDS

Give details of any servicing, component replacements, etc., carried out on

the vaporizer.

Date Comments (including any additional work) Signature

63
SERVICE AND REPAIR RECORDS

Date Comments (including any additional work) Signature

64
Cat No 52898
Doc No A 0208UI
September 2008

Penlon Limited
Abingdon Science Park
Barton Lane
Abingdon
OX14 3PH
UK

Technical Support
Tel: +44 (0) 1235 547076
Fax: +44 (0) 1235 547062
E-mail: [email protected]

International Sales
Tel: +44 1235 547001
Fax: +44 1235 547021
E-mail: [email protected]

UK Sales
Tel: 01235 547036
Fax: 01235 547023
E-mail: [email protected]

Penlon is a member of the

www.penlon.com InterMed Group