Penlon Sigma Delta Manuel de l'opérateur

Sigma Delta Vaporizer

User Instruction Manual

Quality and Assurance in Anaesthesia

This manual contains

calibration and service

records for Sigma Delta

Vaporizer, Serial No.

. . . . . . . . . . . . . . . . . . . .

Keep this manual with

the vaporizer at all times

WARNING

Anaesthetic systems have the

capability to deliver mixtures of

gases and vapours to the patient

which could cause injury or

death unless controlled by a

qualified anaesthetist.

There can be considerable

variation in the effect of

anaesthetic drugs on individual

patients so that the setting and

observation of control levels on

the anaesthesia systems does

not in itself ensure total patient

safety.

Anaesthesia system monitors

and patient monitors are very

desirable aids for the

anaesthetist but are not true

clinical monitors as the

condition of the patient is also

dependent on his respiration

and the functioning of his

cardio-vascular system.

IT IS ESSENTIAL THAT THESE

ELEMENTS ARE MONITORED

FREQUENTLY AND REGULARLY

AND THAT ANY OBSERVATIONS

ARE GIVEN PRECEDENCE

OVER MACHINE CONTROL

PARAMETERS IN JUDGING THE

STATE OF A CLINICAL

PROCEDURE.

Servicing and Repairs

In order to ensure the full

operational life of the Sigma Delta

vaporizer, we recommend that a

periodic service check should be

performed by a Penlon trained

engineer. This check comprises a

vaporizer CALIBRATION CHECK

and LEAK CHECK.

Note:

(a) The calibration check must be

performed using a suitable agent

analyser, e.g. a Riken

refractometer or infrared analyser.

(b) The service check is part of the

recommended pre-use check for

your Anaesthesia System.

Should the calibration check show

the unit to be outside the specified

performance requirement (see

section 11) then a service must be

performed.

This may be done on site by:

(a) A trained user.

(b) An authorised Penlon

agent.

A calibration and service record

section is provided to maintain a

record of the vaporizer's

performance.

For any enquiry regarding the

service or repair of this vaporizer,

contact the nearest accredited

Penlon agent* or contact the

Service Department at Penlon

Limited.

*Agent's name and address:

Service and Repair Department

Penlon Ltd

Abingdon

OX14 3PH

Tel: +44 (0) 1235 547063

Fax: +44 (0) 1235 547062

E-mail: [email protected]

Always give as much of the

following information as possible:

1. Type of equipment

2. Product name

3. Serial number

4. Approximate date of

purchase

5. Apparent fault

(i)

IMPORTANT

This manual has been produced to

provide authorised personnel with

information on the function, routine

performance and maintenance

checks, applicable to the Penlon

Sigma Delta vaporizer.

Information contained in the

manual is correct at the date of

publication. The policy of Penlon

Limited is one of continued

improvement to its products.

Because of this policy Penlon

Limited reserves the right to make

any changes, which may affect

instructions in this manual, without

giving prior notice.

Personnel must make themselves

familiar with the contents of this

manual before using the vaporizer.

Terminology

This manual complies with ISO

4135, Anaesthetic Apparatus

Terminology.

The following additional definitions

should be noted:

Vol.% - shortened form of

volumetric 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)

FOREWORD

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 11

4.6 Patents 11

4.7 Temperature Range 11

4.8 Flow Range 11

4.9 Pressure Range 11

5. FILLING AND DRAINING

5.1 Key Filler System 12

5.2 Screw Cap (Pour Fill) System 15

5.3 Quik-Fil Filling System 18

6. INSTALLATION

6.1 Gas Port Transit Seals 21

6.2 Selectatec Compatible Models (with interlock) 21

6.3 Cagemount (23 mm) Taper Models 23

6.4 Penlon Off-line System (Mk.2 and Mk.3) 24

6.5 Drager 'Plug-in' Compatible 25

6.6 North American Drager Compatible 26

6.7 Pre-Use Checklist - All Models 27

7. PERFORMANCE CHARACTERISTICS

7.1 Performance Graphs 28

7.1.1 Halothane Models 29

7.1.2 Enflurane Models 30

7.1.3 Isoflurane Models 31

7.1.4 Sevoflurane Models 32

7.2 Temperature Compensation 33

CONTENTS

(iii)

7.3 Pressure Effects 33

7.3.1 Ambient Pressure 33

7.3.2 Back Pressure 33

7.3.3 Intermittent Back Pressure 33

7.4 Summary of Performance Specifications 34

7.4.1 Factors Affecting Output Accuracy 34

7.4.2 Resistance to Gas Flow 35

7.5 Effect of IPPV on Output 35

7.6 Effect of Gas Composition on Output 35

7.7 Output when Control is at 0 (Zero) 35

7.8 Effect of Flush Valve Operation 36

8. USER MAINTENANCE

8.1 Servicing 37

8.2 Cleaning 38

8.3 Draining - Halothane Models 38

8.4 Checking Vaporizer Output 38

8.5 Training Course 39

8.6 Returning the Vaporizer for Service or Repair 39

9. REFERENCES 40

10. ORDERING INFORMATION 41

11. SERVICE RECORDS

11.1 Service Policy 42

11.2 Calibration Procedure using the Riken Analyser 43

11.3 Servicing and Repair Details 46

11.4 Calibration Check 50

CONTENTS

(iv)

This vaporizer has been built to

conform with the specification and

operating procedures stated in this

manual and/or accompanying

labels and notices when checked.

assembled, operated, maintained

and serviced in accordance with

these instructions provided.

To ensure the safety of this

vaporizer it must be checked and

serviced to at least the minimum

standards laid out in this manual.

A defective or suspected defective,

product must not, under any

circumstances be used.

The user must accept responsibility

for any malfunction which results

from non-compliance with the

servicing requirements detailed in

section 8.1.

Worn, broken, distorted,

contaminated or missing

components must be replaced

immediately. Should such a repair

become necessary it is

recommended that a request for

service advice is made to the

nearest Penlon service centre.

This vaporizer and any of its

constituent parts must be repaired

only in accordance with written

instructions issued by Penlon

Limited, and must not be altered or

modified in any way without the

written approval of Penlon Limited.

The user of this equipment shall

have the responsibility for any

malfunction which results from

improper use, maintenance, repair,

damage or alteration by anyone

other than Penlon Limited or its

appointed agents.

This vaporizer must only be

supplied to, and used by, suitably

qualified medical practitioners.

In the USA and Canada:

Caution: Federal Law restricts this

device to sale by or on the order of

a physician.

Statements in this manual

preceded by the following words

are of special significance.

WARNING - means there is a

possibility of personal injury to

yourself or others.

CAUTION - means there is a

possibility of damage to the

instrument or other property.

NOTE - indicates points of

particular interest for more efficient

and convenient operation.

The reader must take particular

notice of the warnings, cautions.

and notes printed throughout the

manual.

USER RESPONSIBILITY

The following Warnings and

Cautions must be read and

understood before using this

vaporizer

WARNINGS

General Information

1. The user must read and

be familiar with the

contents of this

instruction manual before

using the vaporizer

2. The vaporizer is designed

for use only with the

specific anaesthetic agent

named on the filler block

(and further indicated by

colour coded labelling).

Misdosage may occur if

the vaporizer is filled with

the wrong drug.

Agent specific (keyed)

filler devices are provided

on certain models to meet

national and international

standards.

(See section 9 for

standards).

3. The pharmacopoeia name

of the drug is used on the

label according to BP,

USP, or Ph EUR.

The user is responsible

for confirming that any

trade name of a drug is

equivalent to the

registered name.

4 This vaporizer must not

be modified or

disassembled by an

unauthorised person. It

should be regularly

serviced by a Penlon-

authorised service agent,

trained technician or

engineer and by no other

person.

(see section 8)

5. Vaporizers may

malfunction if exposed to

excessively high

temperatures, e.g. by

storage above a radiator.

This may affect the

calibration.

Maximum storage

temperature: 50oC (122oF)

Minimum storage

temperature: -20oC (-5oF)

Operating temperature

range: 15 to 35oC

(58 to 95oF)

Before use, function test

any vaporizer that has

been subjected to

temperatures near the

upper/lower limits given

above.

1. WARNINGS AND CAUTIONS

Filling and draining the

vaporizer

6. The filler system must be

maintained in accordance

with the instructions

given in the User

Maintenance section.

7. The vaporizer must be

filled only by suitably

skilled and trained

personnel.

8. Anaesthetic drugs are

poisonous and there is

evidence that there is a

health hazard to

personnel due to

prolonged inhalation of

trace concentration in the

atmosphere. Care must

be taken to avoid spillage

of anaesthetic drugs

when filling or draining

vaporizers.

9. The vaporizer control

must be in the 0 (zero)

position during the filling

or draining process.

Overfilling and/or spilling

may occur if the control is

not in the 0 (zero)

position.

Provided the control is in

the 0 (zero) position, gas

may continue to be

delivered from the

anaesthetic machine to

the patient during the

filling procedure.

10. The vaporizer must be

upright during filling to

minimise the risk of

overfilling.

11. 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.

12. If a new bottle of

anaesthetic agent is to be

used, check that the

tamper-evident shrink

band is undamaged.

13. Ensure that the drain plug

screw, located on the

lower front of the

vaporizer, is correctly

tightened to prevent loss

of liquid agent.

14. Do not tamper with the

filling system valve. This

may cause a vapour and

fresh gas leak.

Anaesthesia system

monitors and patient

monitors are very

desirable aids for the

WARNINGS AND CAUTIONS

anaesthetist but are not

true clinical monitors as

the condition of the

patient is also dependent

on his respiration and the

functioning of his

cardiovascular system.

15. Do not overfill.

A vaporizer that has been

overfilled must be

withdrawn from use.

Contact the Service

Department at Penlon for

advice.

16. Anaesthetic drugs must

be treated as a

pharmaceutical product.

Liquid should never be

drained from a vaporizer

into an open container

and then reused.

Contamination is likely.

Always dispose of such

drained liquid as a

hazardous chemical.

17. After filling or draining:

Pour Fill (Screw cap) filler

- always refit and

retighten the filler cap.

Key (agent specific) filler

models - always tighten

the filler control.

In addition, on key filler

systems, always refit the

key filler plug and tighten

the clamp screw before

using the vaporizer. The

vaporizer will leak if this

is not done.

Quik-Fil models - remove

the bottle and refit the

filler block cap before

using the vaporizer.

Delivered concentrations

are inaccurate while the

filler port is open.

Before using the vaporizer

18. Do not use the vaporizer if

the agent level is not

visible in the sight glass

or the level is outside of

the Max - Min indicator.

19. If a vaporizer is

transported when filled

with liquid drug the

control must be in the 0

(zero) position during

transport and a period of

at least ten minutes in a

secured upright position

must elapse before

connection to an

anaesthetic breathing

system.

Movement during

transport can result in

over-dosage unless time

is allowed for drainage of

liquid to the normal

WARNINGS AND CAUTIONS

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