Sigma Delta Vaporizer User Manual

ANAESTHESIA SOLUTIONS
 IMPORTANT

Servicing and Repairs For any enquiry regarding the service

To ensure the full operational or repair of this vaporizer, contact the
life of the Sigma Delta vaporizer, nearest accredited Penlon agent, or
periodically check vaporizer output contact the Service Department at Penlon
and carry out a leak check. Limited
Note:
(a) Check the calibration using a UK and International
suitable agent analyser, e.g. a Riken Penlon Limited
refractometer or infrared analyser. Abingdon Science Park
(b) The checks are part of the Barton Lane
recommended pre-use check for Abingdon
your Anaesthesia System. OX14 3NB
Service the vaporizer if the calibration UK
check shows that vaporizer output is www.penlon.com
outside the specified performance
requirement. Technical Support
Output checks and servicing may be Tel: 44 (0) 1235 547060
done on site by: Fax: 44 (0) 1235 547061
E: [email protected]
(a) A Penlon-trained engineer.
(b) An authorised Penlon agent.
(c) A Penlon service engineer. Always give as much of the following
The user should maintain a record of information as possible:
the vaporizer’s performance. 1. Type of equipment
2. Product name
3. Serial number (refer to the I.D.
label)
4. Approximate date of purchase
5. Apparent fault

(i)
FOREWORD

This manual has been produced to

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

(ii)
CONTENTS

Page
USER RESPONSIBILITY 1
1. WARNINGS AND CAUTIONS 2
2. PURPOSE 7

3. DESCRIPTION
3.1 Operating Principles 8
3.2 Controls 8

4. SPECIFICATION
4.1 Physical Dimensions 10
4.2 Weight 10
4.3 Capacity 10
4.4 Filling System 10
4.5 Concentration Control Dial Scale 10
4.6 Environmental 11
4.7 Flow Range 11
4.8 Pressure Range 11
4.9 Device Classification 11

5. FILLING AND DRAINING

5.1 Key Filler System 12
5.2 Screw Cap Filling System (pour fill) 16
5.3 Quik-Fil System 18

6. INSTALLATION
6.1 Gas Port Transit Seals 21
6.2. Installing the Vaporizer on the Anaesthetic Machine 21
6.2.1 All Models 21
6.2.2 Selectatec Compatible Models (with interlock) 22
6.2.3 Cagemount (23 mm) Taper Models 24
6.2.4 Penlon Off-line Mounting System 25
6.2.5 Drager ‘Plug-in’ Compatible (interlock) 26
6.2.6 North American Drager Compatible (interlock) 27
6.2.7 Drager Auto Exclusion Compatible (interlock) 29

(iii)
 CONTENTS

7. PRE-USE CHECKS
7.1 Output check - Commissioning a new vaporizer 30
7.2 Daily Pre-use Check List 31

8. PERFORMANCE CHARACTERISTICS
8.1 Performance Graphs 32
8.1.1 Halothane Models 32
8.1.2 Isoflurane Models 33
8.1.3 Sevoflurane Models 34
8.2 Temperature Compensation 35
8.3 Pressure Effects 35
8.3.1 Ambient Pressure 35
8.3.2 Back Pressure 35
8.4 Summary of Performance Specifications 36
8.4.1 Output Accuracy 36
8.4.2 Resistance to Gas Flow 36
8.5 Effect of IPPV on Output 36
8.6 Effect of Gas Composition on Output 36
8.7 Output when Control is in the ‘Off’ (0) position 37
8.8 Effect of Flush Valve Operation 37
8.9 Effect of Sub-atmospheric Pressure 37

9. USER MAINTENANCE
9.1 Servicing 38
9.2 Cleaning and Sterilisation 39
9.3 Draining - Halothane Models 39
9.4 Training Course 40
9.5 Returning the Vaporizer for Service or Repair 40

10. REFERENCES 41

11. ORDERING INFORMATION 42

12 LABELLING 43

(iv)
USER RESPONSIBILITY

This vaporizer has been built to repair, damage or alteration by

conform with the specification and anyone other than Penlon Limited or
operating procedures stated in its appointed agents.
this manual and/or accompanying
labels and notices when checked, This vaporizer must only be supplied
assembled, operated, maintained to, and used by, suitably qualified
and serviced in accordance with medical practitioners.
these instructions provided.
To ensure the safety of this Statements in this manual preceded
vaporizer it must be checked and by the following words are of special
serviced to at least the minimum significance.
standards laid out in this manual.
A defective or suspected defective, WARNING: indicates a possibility
product must not, under any of personal injury to yourself or
circumstances be used. others.
The user must accept responsibility CAUTION: indicates a possibility of
for any malfunction which results damage to the instrument or other
from non-compliance with the property.
servicing requirements detailed in NOTE: indicates points of particular
section 9.1. interest for more efficient and
convenient operation.
Worn, broken, distorted,
contaminated or missing The reader must take particular
components must be replaced notice of the warnings, cautions,
immediately. Should such a and notes printed throughout the
repair become necessary it is manual.
recommended that a request
for service advice is made to the Territory information
nearest Penlon service centre. USA and Canada
USA and Canadian Federal Law re-
This vaporizer and any of its
stricts the sale and use of this device
constituent parts must be repaired to, or on the order of, a licensed
only in accordance with written practitioner.
instructions issued by Penlon
Limited, and must not be altered Saudi Arabia
or modified in any way without the Any serious incident that has oc-
written approval of Penlon Limited. curred in relation to the device
should be reported to the manufac-
The user of this equipment shall turer and the Saudi Food And Drug
have the responsibility for any Authority.
malfunction which results from
improper use, maintenance,

1
1. WARNINGS AND CAUTIONS

The following Warnings and technician or engineer and

Cautions must be read and by no other person.
understood before using this (see section 9)
vaporizer 5. Vaporizers may malfunction
if exposed to excessively
WARNINGS high temperatures, e.g. by
General Information storage above a radiator.
1. Users must make themselves This may affect calibration.
familiar with the contents of Before use, function test
this manual and the product any vaporizer that has been
before using the vaporizer subjected to temperatures
2. The vaporizer is designed near the upper/lower limits
for use only with the specific given in section 4.6.
anaesthetic agent named on
the filler block (and further Filling and draining the vaporizer
indicated by colour coded 6. Check the drug name on the
labelling). vaporizer and the supply
Misdosage may occur if the bottle before commencing
vaporizer is filled with the the filling process.
wrong drug. Key (agent specific) filler
Agent specific (keyed) models:
filler devices are provided Ensure that the bottle is
on certain models to meet fitted with a keyed collar
national and international 7. The filler system must be
standards. maintained in accordance
(See section 10 for with the instructions given
standards). in the User Maintenance
3. The pharmacopoeia name of section.
the drug is used on the label 8. The vaporizer must be filled
according to BP, USP, or Ph only by suitably skilled and
EUR. trained personnel.
The user is responsible for 9. Anaesthetic drugs are
confirming that any trade poisonous and there is
name of a drug is equivalent evidence that there is a
to the registered name. health hazard to personnel
4 This vaporizer must not be due to prolonged inhalation
modified or disassembled by of trace concentration in
an unauthorised person. It the atmosphere. Care must
should be regularly serviced be taken to avoid spillage
by a Penlon-authorised of anaesthetic drugs when
service agent, trained filling or draining vaporizers.

2
WARNINGS AND CAUTIONS

10. The vaporizer control must 17. Anaesthetic drugs must be

be in the 0 (zero) position treated as a pharmaceutical
during the filling or draining product.
process. Liquid should never be
Overfilling and/or spilling drained from a vaporizer
may occur if the control is into an open container and
not in the 0 (zero) position. then reused. Contamination
Provided the control is in the is likely.
0 (zero) position, gas may Always dispose of such
continue to be delivered from drained liquid as a hazardous
the anaesthetic machine to chemical.
the patient during the filling 18. After filling or draining:
procedure. Pour Fill (Screw cap) filler:
11. The vaporizer must be upright Always refit and retighten
during filling to minimise the the filler cap.
risk of overfilling. Key (agent specific) filler
12. Do not use the anaesthetic models:
agent bottle to fill the Always tighten the filler
vaporizer if the bottle control.
is cracked or the filler In addition, on key filler
connector is loose or broken. systems, always refit the key
This may result in overfilling filler plug and tighten the
or contaminated agent clamp screw before using
entering the vaporizer. the vaporizer. The vaporizer
13. If a new bottle of anaesthetic will leak if this is not done.
agent is to be used, check Quik-Fil models:
that the tamper-evident Remove the bottle and refit
shrink band is undamaged. the filler block cap before
14. Ensure that the drain plug using the vaporizer.
screw, located on the lower Delivered concentrations are
front of the vaporizer, inaccurate while the filler
is correctly tightened to port is open.
prevent loss of liquid agent.
15. Do not tamper with the filling Before using the vaporizer
system valve. This may cause 19. Do not use the vaporizer if
a vapour and fresh gas leak. the agent level is not visible
16. Do not overfill. in the sight glass, or the level
Withdraw the vaporizer from is above the maximum mark
use if it has been overfilled. or below the minimum mark.
Contact Penlon Service
Department for advice.

3
WARNINGS AND CAUTIONS

20. If a vaporizer is transported It is the user’s responsibility to

when filled with liquid drug ensure that the configuration
the control must be in the of the anaesthetic machine
0 (zero) position during allows correct installation of
transport and a period the vaporizer.
of at least ten minutes in There must be sufficient
a secured upright position clearance between the
must elapse before Selectatec manifold and
connection to an anaesthetic the rear frame panelling
breathing system. of the machine to allow the
Movement during transport vaporizer connector block
can result in over-dosage to seal correctly on the
unless time is allowed for manifold.
drainage of liquid to the 24. Before use:
normal position. a) The vaporizer must be
If a vaporizer has been mounted on an anaesthetic
transported with the control workstation or machine that
in the open position it must complies with ISO 80601-2-
be flushed at 5 L/min for ten 13.
minutes before clinical use b) At first installation, carry
on a patient out a vaporizer output check,
21. The vaporizer must not be see section 7.1
tipped over or inverted. c) Test all joints for gas
If the vaporizer has been tightness, and perform
tipped over or inverted it backbar function and leak
must be set to maximum tests as detailed in the user
output and flushed at 5 L/ manual supplied with the
min for ten minutes before anaesthetic machine.
clinical use on a patient. d) Interlock system: check
22. The vaporizer must be that only one vaporizer at a
securely fixed and in an time can be turned on.
upright position before e) Carry out the pre-use
connection to a patient. checks detailed in section
There is a danger of 7.2.
overdosage if sudden
inadvertent movement Using the vaporizer
occurs during use. 25. Do not set the control dial
23. Anaesthetic machine designs between zero (0) and the
are constantly evolving, lowest graduation.
and new models may differ
dimensionally from existing
equipment.

4
WARNINGS AND CAUTIONS

26. Check the liquid level 31. Always use an anaesthetic

frequently when using the gas scavenging (AGS)
vaporizer and maintain the system to extract expired
level between the minimum anaesthetic vapours from
and maximum marks. the operating theatre.
The vaporizer control must The AGS system must comply
be in the zero (0) position with ISO 80601-2-13.
during the filling process 32. Patient monitoring:
(see warning 10). a) Always use an anaesthetic
27. Vaporizer outputs are agent monitor that complies
sensitive to barometric with ISO 80601-2-55.
pressure. b) Always monitor oxygen
A correction factor may be concentrations.
necessary when assessing c) Always check that the
the output using an analyser, monitors are functioning
for example at high altitude. correctly before starting the
Barometric pressure effects clinical procedure.
are not usually of clinical 33. Anaesthesia system
importance. (see section monitors and patient
8.3). monitors are very desirable
28. The vaporizer is a flow aids for the anaesthetist.
direction-sensitive However, they are not true
apparatus and the direction clinical monitors, as the
of gas flow towards the condition of the patient is also
patient must be as indicated dependent on his respiration
by the arrow on the top label. and the functioning of his
Reversal of flow may cause cardiovascular system.
inaccuracies of delivered 34. An alternative means of
concentration. delivering anaesthetic agent
29. The vaporizer must not be must be available whenever
used downstream of the the vaporizer is in use.
common gas outlet.
30. As stated in section 2, the User Maintenance
vaporizer is of relatively 35. Do not pour or spray water,
high resistance and must or any cleaning solutions
not be incorporated within a into the vaporizer.
breathing system. 36. Users must not attempt any
procedures in this manual
that are designated to be
carried out only by trained
technicians or engineers.

5
WARNINGS AND CAUTIONS

CAUTIONS
1. Anaesthetic machine and
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. Penlon Sigma Delta
vaporizers distributed by a
drug company should only
be filled with drug from that
drug company, to ensure
materials compatibility.
3. Users must not attempt to
overcome the seals or safety
devices fitted to the drug
bottles to use a drug from a
different drug company.
4. The user of anaesthetic agent
that is not supplied by Abbvie,
Baxter, or Piramal must
check with the supplying drug
company to ensure materials
compatibility before using
the agent with any vaporizers
supplied by Penlon, its
distributors, or agents.
5. The symbol shown below
denotes:
‘Consult instructions for use’

6
2. PURPOSE

The Sigma Delta Vaporizer is

designed for incorporation in
the fresh gas supply system of
continuous flow anaesthetic
machines, 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 drugs in the fresh gas
supply, in accordance with the
setting of the control dial, when the
fresh gas supply flow is between
0.2 and 15 litres/min.
Refer to section 8 (Performance
Characteristics), which shows
the extent of modifications to the
control calibration.

7
3. DESCRIPTION

3.1 Operating Principles

Each model is uniquely designed
and tested for use only with the
drug specified on the control dial
knob (1). 3
4
1
The vaporizer contains a chamber,
the base of which holds the
anaesthetic agent in liquid form.
A wick ensures that the upper part
of the chamber is filled with the
saturated vapour of the agent.

The concentration of saturated

vapour is many times higher 2
than those used clinically and
the function of the concentration 1. Control dial knob
control is to proportion the flow of
2. Liquid level indicator marks
the carrier gas through a bypass
passage and through the vapour 3. Control dial zero (0) position
chamber so that the desired 4. Interlock bolt
dilution is produced.
In the zero position the bypass
remains open but the vaporizing 3.2 Controls
chamber is shut off completely The vaporizer has a single, forward
from the gas flow to the patient. facing calibrated control to
regulate the vapour concentration
A temperature-compensating delivered.
valve is situated in the bypass, The dial is locked at zero when
arranged to operate so that as not in use. To set a concentration
the vapour pressure varies with level, push the dial assembly in and
temperature, the dilution ratio rotate anti-clockwise.
produced by the control valve is
varied to compensate, and maintain Align the required concentration
a constant output concentration. graduation with the mark at the top
of the bezel.
The vaporizer has a liquid level On returning the dial to zero, the
indicator, with maximum and dial assembly will automatically
minimum level marks. spring outwards into the locked
‘off’ position.

8
DESCRIPTION

Interlock Systems
When the vaporizer is mounted
on the anaesthetic machine
backbar with other interlock
vaporizers, initial operation of the
concentration control dial activates
the interlock system ensuring that
only one of the vaporizers can be in
use at any time.

The interlock deactivates as soon

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

Selectatec Compatible Models

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

Drager Compatible Models

WARNING
Drager compatible models with
interlock must only be used with
other Drager compatible interlock
vaporizers, to maintain the
integrity of the interlock system.
NOTE
The Drager Auto Exclusion
compatible model is not for sale
in the USA.

9
4. SPECIFICATION

4.1 Physical Dimensions

Width Height Depth

Cagemount 133 219 158

Selectatec Compatible with Interlock 120 242 190
Drager Compatible 100 242 190

Dimensions given above are in millimetres

NOTE For depth of Screw Cap Filler models, subtract 11 mm from the
depth dimensions given above.

4.2 Weight
Approximate weight: 4.8 kg.

4.3 Capacity
Volume at MAX mark 250 ml (nominal)
Volume at MIN mark 35 ml (nominal)
NOTE
After draining, approximately 60 ± 10 ml of liquid is retained by the wick.

4.4 Filling System

Key Filler (Agent Specific)
Used with corresponding agent specific filler adaptor, see section 11,
Ordering Information.

Pour Fill (Screw Top)

Quik Fil - Sevoflurane only

Use with corresponding agent specific bottle.

4.5 Concentration Control Dial Scale

The control dial is marked as follows:
From 0 to 2% vol, by intervals of 0.2% vol
From 2 to maximum, by intervals of 0.5% vol
The control dial is marked ‘0’ at zero.

10
SPECIFICATION

4.6 Environmental
Operating conditions
Temperature Range
Sevoflurane models 15 to 40°C (58 to 104°F)
Halothane/Isoflurane models 15 to 35°C (58 to 95°F)
Storage Temperature Range -5 to 40°C (23 to 104°F)
Transport Temperature Range -5 to 40°C (23 to 104°F)
Humidity Range 10% to 95%
Atmospheric pressure range 11.5 to 110 kPa
MRI compatibility The Sigma Delta is not suitable
for use in a MRI environment.
Contact Penlon Ltd Sales
Department for details of the
Sigma Delta MRI model.

4.7 Flow Range

Operating Flow Range 0.2 to 15 litres/min

4.8 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)

4.9 Device Classification

Mode of operation: Continuous
Patient Class All patient types
The device does not contain phthalates.
There are no residual risks from
phthalates that are carcinogenic,
mutagenic, or toxic to reproduction.

11
5. FILLING AND DRAINING

5.1 Key Filler System

WARNINGS
1. The vaporizer must be either
secured to the anaesthetic
machine or free standing on a
level table so that in either case
it is upright during the filling
process. 1
Overfilling may occur if the
vaporizer is tipped during the
filling process.
2. The concentration control (1) must
be in the 0 (zero) position during
the filling process. Provided this
is done, gas may continue to be
delivered from the anaesthetic
machine to a patient during the
filling process.
3. Check that the drug name on the
vaporizer and the supply bottle
are the same before commencing 2
the filling process, and ensure
that the bottle is fitted with a
keyed collar. 3
CAUTIONS
1. Penlon Sigma Delta vaporizers
distributed by a drug company
should only be filled with drug
from that drug company, to ensure
materials compatibility. Filling the Vaporizer
2. Users should not attempt to
This system is manufactured in
overcome the seals or safety compliance with ISO 5360.
devices fitted to the drug bottles
1. Check that the vaporizer
to use a drug from a different drug
concentration control (1) is
company.
in the 0 (zero) position as
3. The user of a vaporizer that is not illustrated.
supplied by a drug company, or
2. Attach the keyed filler
is not labelled as being supplied
adaptor (2) to the bottle (3).
by a drug company, must check
with the drug company to ensure NOTE
materials compatibility before A range of agent specific filler
using any vaporizers supplied by adaptors are available, see section
Penlon, its distributors, or agents. 11.

12
FILLING AND DRAINING

3. Tighten the adaptor to ensure

an airtight joint, which must
be maintained throughout the
filling operation.

WARNING
Failure to observe this instruction may
result in overfilling.

4. Loosen the clamp screw (4).

Remove the plug (5).
4
5. Insert the keyed end of the
bottle adaptor (2) fully into the
vaporizer receiver.
Only the correct keyed-
adaptor can enter the receiver. 5
Tighten the clamp screw (4) to
secure the adaptor.

6. Raise the bottle above the filler

6
(see arrow on the illustration).

7. Open the filler control (6) - lift 7

upwards.
Allow the liquid to flow into
the vaporizer until the upper
mark is reached on the filler
block (7).
2
WARNING - DO NOT OVERFILL.
A vaporizer that has been overfilled
must be withdrawn from use.
If the vaporizer has been inadvertently
overfilled, excess liquid agent will
spill from the drain hole in the keyed
slot in the filler block. DO NOT REUSE
THIS AGENT. Allow all the excess
liquid to drain from the vaporizer
before inserting the plug (5).

13
FILLING AND DRAINING

8. Close the filler control (6).

9. Lower the bottle below the level of 6

the filler and allow the liquid in the
bottle adaptor to flow back into the
bottle.
Loosen the clamp screw (4), 4
remove the bottle adaptor from
the receiver.
NOTE A small amount of liquid is
always likely to spill when the bottle
adaptor is removed from the receiver.

10. Insert the plug (5) and tighten the

clamp screw (4).
WARNING
For the vaporizer to function correctly it
is important to insert the sealing plug (5)
fully, until it stops, before clamping it into
position with the clamp screw (4) after filling 4
is completed.
If this is not done, the possibility exists that
agent may leak from the vaporizer or the
vaporizer may not pressurise properly, giving
reduced concentration output and gas flow to
the patient. 5

14
 FILLING AND DRAINING

Draining the Vaporizer

CAUTION
To reduce atmospheric pollution in the
operating room, it is recommended that
vaporizer drainage should be performed
in a fume cupboard or under an extractor
hood.

WARNING
The vaporizer must be either secured to
the anaesthetic machine or free standing
on a level table so that in either case it is
upright during the draining process.
WARNING
The vaporizer concentration control must
be in the 0 (zero) position during the
draining process

1. Check that the vaporizer

concentration control (1) is in
the 0 (zero) position.
2. Follow steps 2 to 5 of the 1
procedure for filling the
vaporizer (see above), but keep
the bottle below the filler. 2
3. Raise the filler control (2) and
allow the liquid to run into the
bottle until the flow ceases.
4. Close the filler control (2),
loosen the clamp screw (3), and 3
reinsert the plug (4).
Tighten the clamp screw (3).
WARNING
Anaesthetic drugs must be treated as a
pharmaceutical product. 4
Liquid should never be drained from a
vaporizer into an open container and
reused.
Contamination is likely. Always dispose
of such drained liquid as a hazardous
chemical.

15
FILLING AND DRAINING

5.2 Screw Cap Filling

System (Pour Fill)
2
WARNINGS
1. The vaporizer must be either
secured to the anaesthetic machine
or free standing on a level table so
that in either case it is upright 3
during the filling process.
Overfilling may occur if the 4
vaporizer is tipped during the
filling process.
1
2. The vaporizer control must be in the
0 (zero) position during the filling Filling the Vaporizer
process. Provided this is done, gas
may continue to be delivered from If the vaporizer is empty, check that
the anaesthetic machine during the the drain control screw (1) is fully
filling process. tightened before filling.

3. Check the drug name on the 1. The concentration control (2)

vaporizer and the supply bottle must be in the 0 (zero) position,
before filling. as illustrated.
CAUTIONS 2. Unscrew the filler cap (3).
1. To minimise atmospheric pollution
3. Remove the bottle cap. Fill the
in the operating room, fill the
vaporizer in a fume cupboard or vaporizer slowly and carefully,
under an extractor hood. stopping to check the liquid level
2. Penlon Sigma Delta vaporizers occasionally. Stop filling when
distributed by a drug company the upper mark (4) is reached on
should only be filled with drug the filler block.
from that drug company, to ensure WARNING
materials compatibility. DO NOT OVERFILL.
3. Users should not attempt to A vaporizer that has been overfilled
overcome the seals or safety must be withdrawn from use.
devices fitted to the drug bottles 4. Check that the seal in the filler
to use a drug from a different drug cap (3) is clean, and positioned
company. correctly. Replace the filler cap.
4. The user of a vaporizer that is not Tighten finger tight only. DO NOT
supplied by a drug company, or is
use a wrench.
not labelled as being supplied by a WARNING
drug company, must check with the Do not operate the vaporizer if the filler
drug company to ensure materials cap is not secured in position.
compatibility before using any Incorrect concentration may be delivered
vaporizers supplied by Penlon, its to the patient and pollution may result.
distributors, or agents.

16
FILLING AND DRAINING

Draining the Vaporizer

CAUTION
To minimise atmospheric pollution
1
in the operating room, perform
vaporizer drainage in a fume
cupboard or under an extractor
hood. 2
WARNING
The vaporizer must be either
secured to the anaesthetic machine
or free standing on a level table, so
that in either case it is upright during
the draining process. 3
WARNING
The vaporizer concentration control
must be in the 0 (zero) position
during the draining process.
1. Check that the
vaporizer concentration CAUTION
control (1) is in the 0 (zero) Always close the drain screw firmly
position, as illustrated. before replacing the filler cap on the
2. Unscrew the filler cap (2). vaporizer.
3. Place a bottle marked 5. Check that the seal in the
with the drug name on the filler block cap (2) is clean
vaporizer under the drain and positioned correctly.
tube in the base of the filler Refit the cap - do not
block and undo the drain overtighten.
screw (3) at least three full
turns.
WARNING
Anaesthetic drugs must be treated
as a pharmaceutical product.
Liquid should never be drained from
a vaporizer into an open container
and reused.
Contamination is likely. Always
dispose of such drained liquid as a
hazardous chemical.
4. Allow the liquid to run into
the bottle until the flow
ceases
Close the drain screw (3).

17
FILLING AND DRAINING

5.3 Quik-Fil System

WARNINGS
1. Do not use the anaesthetic agent
bottle to fill the vaporizer if the
bottle is cracked or the filler
connector is loose or broken.
This may result in overfilling or
contaminated agent entering the
vaporizer.
2. If a new bottle of anaesthetic
agent is to be used, check that
the tamper-evident shrink band
is undamaged.
3. Firmly secure the vaporizer in a
vertical position before filling.
4. Ensure that the drain plug screw,
located on the lower front of the
vaporizer, is correctly tightened
to prevent loss of liquid agent.
5. Do not tamper with the filling
system valve. This may cause a CAUTIONS
vapour and fresh gas leak. 1. Penlon Sigma Delta vaporizers
6. The filler system must be distributed by a drug company
maintained in accordance with should only be filled with drug
the instructions given in the User from that drug company, to
Maintenance section. ensure materials compatibility.
7. The vaporizer must be filled only 2. Users should not attempt to
by suitably skilled and trained overcome the seals or safety
personnel. devices fitted to the drug bottles
8. After filling, remove the bottle to use a drug from a different
and refit the filler block cap drug company.
before using the vaporizer. 3. The user of a vaporizer that is not
Check that the seal in the cap is supplied by a drug company, or
clean. is not labelled as being supplied
Do not overtighten the cap. by a drug company, must check
9. Do not use the vaporizer if the with the drug company to ensure
agent level is not visible in the materials compatibility before
sight glass or the level is above using any vaporizers supplied
the maximum mark or below the by Penlon, its distributors, or
minimum mark. agents.

18
 FILLING AND DRAINING

Quik-Fil System - Filling the

Vaporizer
1. Check that the vaporizer
concentration control is in the off
(‘0’) position.
2. Remove the yellow protective cap
from the anaesthetic agent bottle
filler, checking that the bottle and
filler mechanism are not damaged.
3. Remove the vaporizer filler block
cap and insert the bottle nozzle into
the filler block, Rotate the bottle to
align the bottle filler keys with the
slots in the filler block.
4. Note the liquid level in the vaporizer
sight glass and press the agent
bottle firmly into the vaporizer filler
against the spring valve assembly.
Allow the liquid to flow into the
vaporizer until the maximum
level mark (1) is reached, paying
continuous attention to the level in
the sight glass and the air return
bubbles flowing into the bottle.
5. Release the bottle when the
vaporizer is full and the continuous
stream of bubbles ceases.
6. Withdraw the bottle from the
vaporizer filler and replace the
yellow cap on the agent bottle.
7. Check that the seal in the vaporizer 1
filler block cap is clean.
Refit the cap - do not overtighten.

WARNING
The filler cap must be refitted before using
the vaporizer.
Do not overtighten.

19
FILLING AND DRAINING

Quik-Fil System - Draining the

Vaporizer
WARNING
To avoid spillage, check that the bottle to be
used for draining has sufficient capacity for
the volume of liquid to be drained.
1. Remove the yellow protective cap
from an empty sevoflurane bottle.
Insert the bottle nozzle into the
drain funnel.
Rotate the bottle to align the bottle
filler keys with the index slots in
the drain funnel, and screw the
drain funnel onto the empty bottle.

2. Remove the vaporizer filler block

cap.
3. Fully insert the drain funnel into
the keyed drain slot, and unscrew
the drain plug. Continue to drain
the vaporizer until empty.
Close the drain plug and tighten,
and withdraw the drain funnel.
4. Unscrew the drain funnel from the
bottle and refit the bottle cap.
5. Check that the seal in the vaporizer
filler block cap is clean.
Refit the cap - do not overtighten.
WARNINGS
1. The filler cap must be refitted before
using the vaporizer.
2. Do not reuse the agent drained from
the vaporizer. Treat as a hazardous
chemical.

20
6. INSTALLATION

6.1 Gas Port Transit Seals

All new vaporizers

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

6.2 Installing the Vaporizer on

the Anaesthetic Machine

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.

6.2.1 All Models

1. Check that the vaporizer concentration
control is in the 0 (zero) position.
2. Follow the instructions in sections 6.2.2
to 6.2.6, depending on the vaporizer
model.
3. New vaporizer at commissioning:
Check the vaporizer output - see
section 7.1.
4. Reinstalling a vaporizer:
Carry out the pre-use checks listed in
section 7.2.

21
INSTALLATION

6.2.2 Selectatec Compatible

Models - with Interlock

These vaporizers are designed for

installation on a Selectatec type
manifold backbar.
1

Three-station backbar manifold

NOTE
2
Non-interlock type manifold
1. When installing two vaporizers
only, the centre station must be 3 2
occupied by one of the vaporizers.
2. If three vaporizers are installed,
and the centre vaporizer is
removed, reposition one of the
remaining vaporizers to the centre
station.
1. Locking Lever
Manifold with interlock system 2. Interlock Bolts
1. Penlon three station backbar 3. Backbar Manifold Locking Shaft
manifolds on anaesthetic machines
built from June 2011 are fitted with
an interlock system.
2. If two vaporizers only are installed
it is not necessary to ensure that
the centre station is occupied.
3. Always check that the backbar
interlock system is functioning
correctly.

22
INSTALLATION

Anaesthetic machine layout the vaporizer are correctly engaged

with the valve capsule before
WARNING tightening the locking lever.
Anaesthetic machine designs are
constantly evolving, and new models
Pre-use Checks
may differ dimensionally from
1. Interlock System - check that
existing equipment
only one vaporizer at a time
can be turned on.
It is the user’s responsibility to
ensure that the configuration of the 2. Observe the WARNINGS below
anaesthetic machine allows correct and carry out pre-use checks:
installation of the vaporizer. (a) Section 7.1 (installing a new
vaporizer)
There must be sufficient clearance (b) Section 7.2 (reinstalling a
between the Selectatec manifold vaporizer).
and the rear panelling/frame of WARNING
the machine to allow the vaporizer 1. Test all joints for gas tightness
connector block to seal correctly on before using the anaesthetic
the manifold. machine.

2. The locking lever MUST be in

Installation the locked position before the
1. Carefully offer the vaporizer vaporizer is operated.
up to the manifold.
2. Align the gas connection Removal
ports with the valve capsule
on the manifold. (The NOTE
capsule is referred to as The concentration control dials of all
the valve ‘cartridge’ in some the vaporizers linked by the interlock
user literature.) system must be turned to zero before
3. Carefully lower the vaporizer removing the vaporizer from the
onto the manifold, and manifold.
recheck that the gas ports
are correctly engaged with To remove the vaporizer, rotate the
the valve capsule on the locking lever 90o anti-clockwise
manifold. and carefully lift the unit vertically
4. Lock into position by pushing until clear of the backbar.
the locking lever downwards
and rotating clockwise
through 90o.
WARNING
To prevent damage to the locking
shaft, recheck that the gas ports on

23
 INSTALLATION

6.2.3 Cagemount (23 mm) Taper 2

Models 4
CAUTION
It is recommended that this type of
vaporizer should only be used on machines
with a single vaporizer mounting station.

Vaporizers fitted with conical tapers

have the male taper (1) (Inlet port) on 5
the left and the female taper (2) on the 3 1
right (viewing the front of the vaporizer).
The conical connectors are designed in
accordance with ISO 5356-1.
Two M6 studs with nuts, 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 claw assembly on a Modura rail
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

backbar 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 (5).

24
INSTALLATION

Installation on Modura Rail

WARNING
The vaporizer must not be tipped or
inverted during installation.
If the vaporizer has been tipped or 3
inverted, it must be set to maximum
and flushed at 5 L/min for ten
minutes. Check for stable output
before clinical use.

1. Remove the M6 nuts and

washers, the clamp plate and 2
the shims from the vaporizer.
2. Fit the Modura claw (1) to the
backplate (2), using the two
M6 screws.
3. Fit the Modura claw backplate
assembly to the studs (3) 1
on the rear of the vaporizer.
Secure with the M6 nuts and
washers.
4. Attach the vaporizer to 6.2.4 Penlon Off-line Mounting
the Modura rail on the System
anaesthetic machine and A vaporizer with cagemount tapers
secure in place by moving may be fitted with a Penlon mounting
the lever into its ‘locked on’ clip, Part No. 58090, in place of the
position. backbar clamp. The vaporizer may
then be fitted to a Penlon off-line
Pre-use Check block, as used on Penlon Anaesthetic
1. Observe the WARNINGS below Machines with Cagemount option.
and carry out pre-use checks: The flexible hoses attached to the
(a) Section 7.1 (installing a new block are connected to the inlet and
vaporizer) outlet of the vaporizer.
(b) Section 7.2 (reinstalling a
vaporizer). It is recommended that detachable
WARNING cagemount connectors are retained
Test the joints for gas tightness with Safety Clip (Part Number 52275),
before using the machine. to prevent inadvertent disconnection.
WARNING
Test the joints for gas tightness before
using the machine.

25
INSTALLATION

6.2.5 Drager ‘Plug-in’

Compatible (interlock)
Installation 1
NOTE
1. Not compatible with the Drager
auto exclusion system.
1. Carefully offer the vaporizer 2
up to the manifold. 3
2. Align the gas connection
ports with the valve capsule
on the manifold. (The capsule
is referred to as the valve 1. Locking lever
‘cartridge’ in some user 2. Interlock bolts
literature). 3. Backbar manifold locking shaft
3. Carefully lower the vaporizer
onto the manifold, and
recheck that the gas ports
are correctly engaged with Pre-use Checks
the valve capsules on the 1. Interlock System - check that
manifold. only one vaporizer at a time
can be turned on.
WARNING
Check that the vaporizer is firmly 2. Observe the WARNINGS below
positioned on the manifold before and carry out pre-use checks:
tightening the locking lever. This (a) Section 7.1 (installing a new
will prevent damage to the locking vaporizer)
shaft (3), and ensure that the gas (b) Section 7.2 (reinstalling a
connection ports are correctly vaporizer).
engaged. WARNING
4. Lock into position by The locking lever MUST be in the
pushing the locking locked position before the vaporizer
lever (1) downwards and is used.
WARNING
rotating clockwise through
Test all joints for gas tightness before
approximately 100°.
using the anaesthetic machine.

Removing the Vaporizer

Rotate the locking lever
anticlockwise and carefully lift the
vaporizer from the manifold.

26
 INSTALLATION

1
6.2.6 North American Drager
Compatible (Interlock)

WARNING
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.

Installation
Installation and adjustment must
be carried out by suitably trained 1
technicians only.

1. Check that each gas port is Pre-use Checks

fitted with the correct O seal 1. Interlock System - check that
(1) (Penlon Part No. 041126). only one vaporizer at a time can
2. Carefully offer the vaporizer be turned on.
up to the manifold. If the vaporizer fails this check,
3. To secure the vaporizer to carry out the adjustment
the manifold, use two M4 x 30 procedure detailed on the next
screws (Penlon Part No. 01267) page.
and fan-type lock washers. 2. Observe the WARNING below
From the rear of the and carry out pre-use checks:
anaesthetic machine fit the (a) Section 7.1 (installing a new
two screws through the holes vaporizer)
(2) in the manifold block, and (b) Section 7.2 (reinstalling a
screw into the threaded holes vaporizer).
in the vaporizer. WARNING
4. Tighten the screws to a torque Test all joints for gas tightness before
of 3.0 Nm. using the anaesthetic machine.

Removing the Vaporizer

1. Support the vaporizer, and
remove the securing screws (2).
2. Detach the vaporizer from the
manifold.
3. Check that the O-seals are
retained in the gas ports (1).
1Anesthesiology, V104, No 4, Apl 2006, p.891.

27
INSTALLATION

Interlock Function Check and

Adjustment
4
3
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 Delta vaporizer, or any

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

28
 INSTALLATION

6.2.7 Drager Auto Exclusion 1

Compatible (Interlock)

Installation
1. Carefully offer the vaporizer
up to the manifold.
2. Align the gas connection
ports with the valve capsule
on the manifold. (The capsule
is referred to as the valve
‘cartridge’ in some user
literature).
3. Carefully lower the vaporizer
onto the manifold, and
recheck that the gas ports
are correctly engaged with
the valve capsules on the
manifold.
WARNING
Check that the vaporizer is firmly
positioned on the manifold before
tightening the locking lever.

4. Secure in position by rotating

the lever (1) clockwise until
locked.
WARNING
Pre-use Checks The locking lever MUST be in the
locked position before the vaporizer
1. Interlock System - check that
is used.
only one vaporizer at a time
WARNING
can be turned on. Test all joints for gas tightness before
2. Observe the WARNINGS below using the anaesthetic machine.
and carry out pre-use checks:
(a) Section 7.1 (installing a new Removing the Vaporizer
vaporizer) Rotate the locking lever
(b) Section 7.2 (reinstalling a anticlockwise, and carefully lift the
vaporizer). vaporizer from the manifold.

29
7. PRE-USE CHECKS

7.1 Output Check - 3. Set the vaporizer concentration

Commissioning a New dial to half scale and set the flow
to minimum.
Vaporizer Connect a 0-400 cmH2O (0-300
mmHg) gauge to the common
Initial checks to be carried out at
gas outlet. Note: If a tee-piece
first installation.
is used to mount the gauge,
To verify the performance of the
occlude the tee outlet.
vaporizer the following checks
4. Carry out a leak test:
should be carried out.
(a) Machines built before the
Note
Output concentration tests should be
introduction of ISO 80601-2-
carried out only by trained persons 13 (includes Prima 101/102,
or a Penlon–trained engineer, using Ecoflow, and Prima SP2):
a suitable purpose-made calibrated With the vaporizer fitted, use the
agent analyser, e.g. a Riken flowmeter to increase system
refractometer. pressure to 200 cmH2O (150
mmHg).
WARNING Check that a flow of less than
The pre-use checks at first installation 200 ml/min is needed to maintain
must be carried out as part of the it. Note: If the anaesthetic
anaesthesia system check.
machine basal flow is greater
Please refer to the anaesthesia system
manufacturer’s user manual, but than 200 ml/min, check that
note that some anaesthesia machine system pressure is maintained
manufacturers may not list specific at the basal flow value.
vaporizer checks.
WARNING (b) Machines built after the
Keep the vaporizer upright at all times; introduction of ISO 80601-2-13.
tilting a vaporizer can result in delivery These machines are fitted with
of dangerously high concentrations of
a safety valve with a maximum
vapour.
pressure of 125 cmH2O
All vaporizers (approximately 92 mmHg).
1. Ensure that the vaporizer has This group of machines includes
been filled and kept at room Prima 400 Series:
temperature (20oC ± 3oC) for Before fitting the vaporizer, use
at least 3 hours. the flowmeter to set a flow of 60
2. Ensure leak tightness of to 80 ml/min, watch the pressure
the anaesthetic machine by gauge rise to a steady state.
performing a backbar manifold The pressure reading must
leak test as detailed in the be greater than or equal to
relevant anaesthetic machine 30 cmH2O (approximately 22
user instruction manual. mmHg).

30
 PRE-USE CHECKS

Repeat this test with the vaporizer 7.2 Daily Pre-use Check List
fitted and locked in place, and WARNING
the concentration dial set to half The daily pre-use checks for the vaporizer
scale. must be carried out as part of the anaesthesia
Compare the pressure gauge system check and must include a backbar
readings from each test to manifold leak test. Refer to the anaesthesia
confirm that they do not vary. system manufacturer’s user manual.
5. Carry out a vaporizer output WARNING
calibration test: Keep the vaporizer upright at all times;
Connect the agent analyser to the tilting a vaporizer can result in delivery of
common gas outlet. dangerously high concentrations of vapour.
Set an Oxygen flow of 4 L/min and
check that the measured output 1. Check that the vaporizer is fitted
concentration is within ±20% for correctly to the anaesthetic machine
set values of 1% and over (at zero and that the backbar locking mechanism
output the concentration should is fully engaged. On Cagemount models
be less than 0.03%). check that the taper connections are
Turn the concentration dial to off secure.
and the flow to minimum. 2. Check that the liquid agent level is
6. Please contact Penlon Technical between the upper and lower marks on
Service or your local Penlon- the agent level sight glass.
trained engineer if you have any 3. Check that the filling port cap is securely
questions or issues regarding the closed. On key fill models, check that
installation and test procedures. the filler plug is fully inserted and that
the clamp screw is fully tightened.
4. Check for correct agent delivery
concentrations – use an agent analyser.

31
 8. PERFORMANCE CHARACTERISTICS

8.1 Performance Graphs

NOTE Variation of concentration output with (a) flow rates and (b) temperature are shown in this
section. The output from individual units may vary slightly from the performance curve shown.

8.1.1 Halothane Models

6 Variation of output with flow rate (Temperature: 20°C)

Set
5 value
5%

4
Output Vol%

4%

2 2%

1 1%
0.6%
0 0.2%

0.2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Flow rate L/min

Variation of output with temperature

5
(Flow rate : 4 L/min)
Set
4 value
5%
Output Vol%

3 4%

2 3%

2%
1
1%
0.6%
0 0.2%
15 2 2 30 35

Temperature °C
32
 PERFORMANCE CHARACTERISTICS

8.1.2 Isoflurane Models

Variation of output with flow rate (Temperature: 20°C)

6 Set
value
5
5%

4 4%

2 2%
Output Vol%

1 1%
0.6%
0 0.2%

0.2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Flow rate L/min

Variation of output with temperature

5 (Flow rate : 4 L/min) Set
value
5%
4
Output Vol%

4%
3
3%
2
2%

1 1%
0.6%
0.2%
0
15 2 2 30 35

Temperature °C

33
 PERFORMANCE CHARACTERISTICS

8.1.3 Sevoflurane Models

Variation of output with flow rate (Temperature: 20°C)
9
8 Set
value
7
8%
6 7%
6%
5
5%
4 4%

3 3%
Output Vol%

2%
2
1 1%
0.6%
0.2%
0
0.2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Flow rate L/min
Set
Variation of output with temperature (Flow rate : 4 L/min) value
8%
8

7 7%

6 6%

5
5%
4
4%
3
3%
2 2%
Output Vol%

1 1%
0.6%
0.2%
0
15 20 25 30 35 40
Temperature °C
34
PERFORMANCE CHARACTERISTICS

8.2 Temperature At any other pressure the true

Compensation output will be modified according
to the equation:
Temperature compensation is
provided by the operation of a C = S% x 101.3
variable resistance valve in the P
bypass passage.
P is absolute pressure in kPa.
The design provides compensation C is delivered concentration vol%,
for the full range of user
temperatures. If the vaporizer is S% is the set value.
used in extreme temperatures,
(outside those shown in section Changes in barometric pressure
4.6) outputs may be lower or higher can be ignored clinically because
than indicated by the concentration they affect the vaporization in the
control. vaporizer and the absorption of
vapour through the lungs in the
NOTE same way. However, they must
The temperature compensator be corrected for when checking
reacts relatively slowly to room outputs with an analyser.
temperature changes.
NOTE
If the temperature around the
Some analysers include automatic
vaporizer is suddenly changed
barometric pressure correction.
(e.g. by wheeling an anaesthetic
Check the instructions provided
machine from a cool store into
with the analyser.
theatre), 1 to 2 hours minimum
should be allowed for it to equalise
with the ambient temperature 8.3.2 Back Pressure
before use.
Back pressures imposed on the
vaporizer by ventilators or other
8.3 Pressure Effects parts of the anaesthetic apparatus
are usually relatively small, but
8.3.1 Ambient Pressure certain ventilators can impose
steady back pressures of 10 to 15
Ambient pressure effects are not kPa (100 to 150 cmH2O) which will
normally of clinical significance, produce a reduction of the output
but the following rules apply: concentration.
The control is graduated in units of
vol% at 101.3 kPa (14.7 psi).

35
PERFORMANCE CHARACTERISTICS

8.4 Summary of 8.5 Effect of IPPV on

Performance Output
Specifications IPPV: Intermittent positive pressure
ventilation.
8.4.1 Output Accuracy When tested in accordance with ISO
80601-2-13*, output will not deviate
Under calibration conditions from the set concentration by more
(temperature at 22°C ±1°C at sea than +30% / -20%.
level to 2440 m (8000 feet), flow rate
of 4 L/min O2) the output will not *Tested at:
deviate from the set concentration
a) 2 kPa IPPV / flow rate of 2 L/min
by more than ±20% of scale
reading, or 5% of maximum setting b) 5 kPa IPPV / flow rate of 8 L/min
(whichever is greater).
8.6 Effect of Gas
8.4.2. Resistance to Gas Composition on Output
Flow
The vaporizer is calibrated with
Resistance measured at: pure oxygen. The scale is therefore
most accurate with this gas.
22oC (72oF)
The effect of other gases normally
101.3 kPa (1013 mbar; 14.7 psi) used in anaesthesia is as follows:
Control position 0 (zero)
Nitrous oxide
Flow rate Resistance Nitrous oxide, added to oxygen, will
using Air (cmH2O) produce a decrease in output below
(L/min) the scale value. At a concentration
of 70% nitrous oxide, output may
1 1.8 decrease by up to 15%.
2 3.4
4 8.0 Carbon dioxide
8 20.3 Carbon dioxide is not usually added
in high concentrations and is usually
Resistance varies from these limited to 5%. At this concentration
nominal values at other control the effect on vaporizer output is
positions, and changes with negligible.
temperature, and for each Air
agent (e.g. the nominal value for Air will reduce the output of the
Sevoflurane at 4 L/min (air) is 12 vaporizer below the scale values by
cmH2O). a maximum of 5%.

36
PERFORMANCE CHARACTERISTICS

8.7 Output when Control is

in the ‘Off’ (0) position
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%.

37
9. USER MAINTENANCE

User maintenance (i) as part of a Penlon Service

Contract (UK only).
User Maintenance by non-technical (ii) by a Penlon-trained
staff is restricted to cleaning the engineer.
external surfaces of the vaporizer (iii) by a suitably qualified
(see section 9.2). hospital technician if agent
All other maintenance and analysis apparatus is
servicing must be carried out only available.
by Penlon-trained engineers. Check the output under
controlled conditions and
CAUTION carry out a leak test.
Do not attempt to dismantle the For further information,
vaporizer or make any adjustment to Penlon-trained engineers
it which is outside the scope of the
should refer to the relevant
following instructions.
section in the vaporizer
service manual.
9.1 Servicing The measured figures must
NOTE be recorded.
A label is fixed across the vaporizer (b) Successive sets of figures
body and top cover, bearing the should be compared to
words: determine if performance
GENUINE PART. is deteriorating. Service the
LABEL TAMPERING vaporizer to restore normal
VOIDS WARRANTY. operation.
(c) A major overhaul must be
When the bottom cover of the performed every ten years
vaporizer is removed this label (Halothane models - 5 years)
will be damaged beyond repair to maintain performance
as permanent evidence of within the specification. This
unauthorised servicing, repair or is a preventive maintenance
modification. requirement.
If this label (or other labels) is (d) The Selectatec compatible
missing, do not use the vaporizer vaporizer locking system
until it has been serviced. should be inspected during
the vaporizer calibration test,
The Sigma Delta must only be and if damage to the locking
serviced at an authorised service shaft is suspected, the device
centre or by Penlon-trained must be referred to a Penlon-
engineers, as follows: trained engineer.
(a) The output of the vaporizer (e) Interlock system vaporizers -
should be checked function test the interlock
periodically, either:

38
USER MAINTENANCE

system during the vaporizer alcohol wipes (e.g. Azowipes).

calibration test. Follow the instructions for use
issued by the manufacturer.
(f) Quik-Fil system - at regular CAUTION
intervals (three-monthly Do not use strong organic acids, or
minimum, six-monthly compounds that release oxygen or
maximum), filling and halogen.
draining must be checked
under controlled conditions 9.2.3 Before clinical use
Check that all cleaning agent
NOTE
residues are fully removed after
The user must accept responsibility
cleaning.
for any malfunction which results
Always allow the vaporizer to dry
from non-compliance with the
off thoroughly before clinical use.
above requirements.

9.2 Cleaning and 9.3 Draining -

Disinfection Halothane Models
Because halothane contains a
WARNING stabilising agent which is only
1. Do not autoclave. slightly volatile (0.1% thymol),
2. Do not immerse in cleaning the vaporizer chamber should
solutions or water.
be drained periodically of all
3. Do not allow liquid to run into
liquid and the liquid disposed
enclosed areas – the filler and
of as a hazardous chemical.
drain ports, the area behind the
concentration control dial, and the If the vaporizer is not drained
fresh gas inlet and outlet ports. periodically, the stabilising agent
4. Do not clean with solvents or will accumulate in the vaporizer
harsh abrasive cleaning agents. and eventually cause low output.

9.2.1 Cleaning external High levels of accumulated thymol

can have clinically undesirable
surfaces effects on the patient. (Ref.
Use a disposable cloth dampened Rosenburg - Alila: Anaesthesia,
with a mild detergent solution. 1984:38:581-583).
Clean all surfaces thoroughly, If the vaporizer is in regular use,
particularly those areas likely to drain weekly.
have been touched during clinical WARNING
procedures. Prolonged exposure of anaesthetic
9.2.2 Disinfection agents to light and gases may lead to
Use proprietary surface a brown or yellow colouration.
disinfectants - isopropyl alcohol or

39
USER MAINTENANCE

Discoloured liquid and/or liquid

drained from a vaporizer must not
be used and should be disposed of
as a hazardous chemical.

9.4 Training Course

A training course is available to
engineers and hospital staff who
wish to service the vaporizer.
The course covers:
- leak testing
- replacement of seals
- internal maintenance
- replacement of major
sub-assemblies
- regulation of output

A service manual describing this

work is available to personnel who
have undergone this course.

9.5 Returning the

Vaporizer for Service
or Repair
Returning the vaporizer to Penlon
Ltd

The vaporizer must be drained and

allowed to dry out before packing.
Always use the original packaging,
to prevent damage during transit.

On key fill (agent specific filler)

vaporizers, loosen the clamp screw
and withdraw the plug (see section
5.1). This will prevent possible
damage to the filler block seal.

40
10. REFERENCES

References

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

(a) General

EN ISO 80601-2-13
Inhalation anaesthesia systems - Part 4: Anaesthetic
vapour delivery devices

ISO 5356-1
Anaesthetic and respiratory equipment - conical
connectors - Part 1: Cones and sockets

(b) Agent Specific (Keyed) Filling System

ISO 5360
Anaesthetic vaporizers - agent specific filling systems

Trademarks
Penlon, InterMed, Delta, and Sigma Delta are trademarks
of Penlon Limited.
Selectatec and Quik-Fil are GE trademarks.
All other trademarks are the property of their respective
owners.

41
11. ORDERING INFORMATION

A wide range of Halothane, lsoflurane and Sevoflurane vaporizers are

available
Various combinations of agent, concentration output, and connector block
type are available with either agent specific filler, screw cap, and Quik-Fil
filler systems

For further information:

Contact your distributor, or Customer Service at Penlon Ltd.

UK:
Tel: 01235 547036
E: [email protected]
International:
Tel: +44 1235 547001
E: [email protected]

Optional Extras and Approved 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)

53450 Agent Specific (Keyed) filler adaptor for halothane bottles

(ICI, May and Baker, and Hoechst)
53453 Agent Specific (Keyed) filler adaptor for isoflurane bottles
53454 Agent Specific (Keyed) filler adaptor for sevoflurane bottles

42
12. LABELLING

Labelling

Operating instructions (this user manual)

Refer to user manual

Do not dispose of in landfill, refer to an

approved recycling facility. Follow your
hospital, local, state, and federal regulations.

1. General Warning (yellow background)

2. Caution (plain background)

Manufacturer

43
REF 52606-en C

Like us at facebook.com/PenlonGlobal Follow us at twitter.com/PenlonGlobal

Part of the InterMed Group © Penlon Ltd, 2021 All rights reserved.
Penlon, InterMed and Sigma Delta are trademarks of Penlon Limited. All other trademarks are the property of their respective owners.

Penlon Limited Technical Support International Sales UK Sales

Abingdon Science Park t +44 (0) 1235 547060 t +44 (0) 1235 547001 t +44 (0) 1235 547036 OBELIS S.A.
Barton Lane, Abingdon f +44 (0) 1235 547061 e [email protected] e [email protected] Bd. Général Wahis, 53
OX14 3NB, UK e [email protected] B-1030 Brussels
Belgium