Priorclave Q63 Manuel

Priorclave Manual 27125322-EN Issue 2 06/06/2012

Operation & Maintenance

Manual

Q63 Priorclaves

Electrically Heated

Priorclave Manual 27125322-EN Issue 2 06/06/2012

Introduction

Priorclave autoclaves are a range of general-purpose laboratory autoclaves intended primarily for

media preparation, the making safe of ordinary laboratory and pathological waste and other

apparatus sterilisation purposes. The autoclaves are manufactured to a high standard and feature a

number of patented innovative design features. The sophisticated TACTROL microprocessor control

system provides a very simple method of setting even the most complex cycles. The machines have

been designed from the outset for easy and safe operation and maintenance.

Properly looked after and serviced your autoclave should give years of valuable and trouble free

service.

Priorclave Service

Serial Number:

Date of Manufacture:

Software Version:

Please quote the above when asking for parts or service:

PRIORCLAVE LIMITED

129 -131 Nathan Way

West Thamesmead Business Park

London

SE28 0AB

Telephone: +44 (0)20-8316-6620

Fax: +44 (0)20-8855-0616

E-mail: [email protected]

Website: www.priorclave.co.uk

or your local service agent:

Symbols used in this manual and their meanings

WARNING: Mechanical Hazard

In this manual, warnings draw attention to the potential for Danger to personnel up to and

including risk of severe injury or death. Each Mechanical Hazard Warning is emphasised by the

icon to the left.

WARNING: Electrical Hazard

In this manual, warnings draw attention to the potential for Danger to personnel up to and

including risk of severe injury or death. Each Electrical Hazard Warning is emphasised by the

icon to the left.

WARNING: Bio-hazard

In this manual, warnings draw attention to the potential for Danger to personnel up to and

including risk of severe injury or death. Each Bio-hazard Warning is emphasised by the icon to

the left.

Caution: -Please Note

In this manual, cautions draw attention to the potential for Damage to equipment. Each

caution warning is emphasized by the icon to the left.

Priorclave Manual 27125322-EN Issue 2 06/06/2012

Important Notices and Warnings

Priorclave Pressure Vessels and Autoclaves are manufactured according to BS2646 Part 1

(1993). It is recommended that the user/operator ensures that the autoclave is installed,

operated, maintained and tested according to parts 2,3,4 & 5 of this standard for safe and

effective use and that an adequate logging record of operation and maintenance be

established.

Before despatch from our works all Priorclaves are subjected to rigorous electrical safety tests

to the appropriate standards. Should you or your contractors carry out further insulation and

flash tests as part of your internal procedures please disconnect the switch mode power

supply before testing. Failure to do so will result in a test failure and may lead to corruption of

the microprocessor memory which cannot be covered by our warranty.

Safety

If you are unclear about any aspects of this manual, the use and operation of the autoclave or

your autoclave process please contact Priorclave or your authorised Priorclave dealer before

proceeding.

Always wear gloves a facemask and adequate protective clothing when unloading an

autoclave and ensure that the workload does not exceed safe limits.

Priorclave are pleased provide training for operators in the use of their autoclaves at a small

extra charge.

Thermal Lock

The safety Thermal Lock (80

C door retention device) has been set in accordance with the

load and procedure defined in paras. 3.3.3.2.3 and 3.3.3.3 of BS2646 Part 5:1993.

The relatively light load defined under this procedure may not be appropriate to the load to

be autoclaved in your Priorclave. Therefore, to ensure compliance with Health & Safety

Executive Guidance Note PM73 ‘Safety at Autoclaves’ and to avoid possible injury you are

strongly advised to have your autoclave with its normal working load formally validated, and

the thermal lock set up accordingly by properly trained personnel.

Stainless Steel Pressure Vessels.

Vessels are manufactured from grade 316 stabilised stainless steel, designed built and tested

in accordance with PD5500 category 3 as required by BS2646 Part 1. Grade 316 stainless steel

is employed to reduce the corrosive effects of substances such as hydroxides and chlorine.

However we recommend that the interior of the vessel is kept free of such potentially harmful

substances and is regularly cleaned out with soft water. The use of chlorine based or other

aggressive cleaners is not recommended. Exposure to such chemicals could damage the

surface finish and the integrity of the pressure vessel and door. Care should also be taken not

to routinely introduce such chemicals where they are used to pre-wash items that form part

of the load. In such cases the items should be thoroughly rinsed before autoclaving.

Product Life

Due to fatigue occurring in normal use the life of all pressure vessels is finite regardless of

corrosion, erosion or other damage. Using calculations from PD5500, and assuming working at

the maximum working pressure of 2.4 bar this gives the autoclave vessel a projected fatigue

life of 15,000 operating cycles. The lifespan of the autoclave will obviously depend upon

frequency of use, but for example (based on a 365 day working year) if the autoclave is used

two or four times per day this gives a working life of 20.5 to 10.2 years respectively. Your own

usage of the autoclave should be considered to determine the actual lifespan of the

autoclave.

Cleaning

This equipment contains sensitive electrical equipment. Although designed to withstand

laboratory conditions it is not designed for wet cleaning. Cleaning this equipment by hosing

down may cause damage, invalidating the warranty, and may cause an electrocution hazard.

External cleaning should be carried out with a damp cloth or with proprietary, non-abrasive

cleaners.

Water Supply and Quality

This autoclave has been designed to operate most effectively with a softened water supply.

Connection to a hard water supply can lead to a build up of scale and will damage the heaters

and other parts of the system and could invalidate the warranty.

Equally demineralised, distilled or RO water supplies should not be used with this autoclave as

the controls fitted rely on electrical conductivity to detect water levels.

RO water will damage some elements of the generator system.

Servicing and Maintenance of Priorclave Autoclaves

Priorclave Laboratory Autoclaves are complex pressure systems designed and built to special

regulations and as such should only be serviced or maintained by properly trained personnel.

Priorclave Ltd. cannot be held responsible for hazards or damage resulting from work carried

out on the pressure system including its closure components by untrained or unauthorised

personnel. If in doubt please contact Priorclave Service or your nearest authorised service

agent.

Marking

The mark applied to this autoclave is applied in relation to the EMC (Electromagnetic

Compatibility) directive and the Low Voltage directive of the European Community. This

indicates that this Priorclave autoclave meets the following technical standards:

BSEN61000-6-3:2001

Electromagnetic Compatibility. Generic Emission Standard. Residential, Commercial & Light

Industry.

BSEN61000-6-1:2001

Electromagnetic Compatibility. Generic Immunity Standard. Residential, Commercial &

Light Industry.

BSEN61010-1:2001

Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory

use.

BSEN61010-2-040:2005

Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory

use; Part 2-041, Particular Requirements for Autoclaves using Steam for the treatment of

Medical Materials and for Laboratory Processes.

Pressure vessels

PD5500 2009

Unfired fusion welded pressure vessels

BS2646 1996

Priorclave Manual 27125322-EN Issue 2 06/06/2012

Autoclaves for sterilisation in laboratories

Conformity assessment modules B1 + D of the European Pressure equipment directive have

been applied to ensure compliance with the essential safety requirements.

A “Declaration of Conformity” in accordance with the above standards has been made and is

on file at:

Priorclave Ltd.

129 /131 Nathan Way

West Thamesmead Business Park

London SE28 0AB

Environmental Conditions

This equipment has been designed for safe operation within the following environmental

conditions:

Indoor Use.

Altitude up to 2,000 M. (See Appendix B - Steam Table for special conditions affecting

calibration for operation at elevated altitudes).

Temperatures between 5

C and 27

C. - The cooling performance of Air Cooled autoclaves,

however will be significantly affected at higher temperatures in this range.

Maximum Relative Humidity of 85% at any temperature between 5

C and 40

Mains Supply Voltage Variations not exceeding

10% of that shown on the Serial Plate.

Electromagnetic Interference

This equipment has been designed to comply with the requirements for immunity from

electromagnetic interference under normal conditions of use. Care should be taken when

positioning the equipment however, to avoid interference from potential extreme sources of

interference such as MR scanners or x-ray equipment.

Hazard Statement

Electrical Hazard Stickers

When this sticker has been placed on a removable panel the power must be

switched off before the panel is removed. There may be a number of areas

behind the labelled panel that constitute an electrical shock hazard. All such

panels are service access panels only and should not be removed unless

there is a full understanding of the equipment.

Date of issue: 30/04/2007 Revision No: 2

Place of issue: Manufacturers works Reference: ecdecs\RSC – PED assembly

EU Declaration of Conformity

This is a global declaration relating to the entire pressure equipment of the product range

identified below

Equipment Manufacturer: Priorclave Ltd

129-131 Nathan Way

West Thamesmead Business Park

London, SE28 0AB, UK

Equipment Description:

Priorclave Laboratory autoclaves – Q63 series, with Tactrol microprocessor control system.

Model Numbers:

PS/Q63/EH320. For direct steam heated variants substitute S for E. All models may be suffixed DBL to denote double

entry versions

Conformity Data:

Directive Relevant standards Comments

Low Voltage Directive

72/23/EEC

EN61010-1 2001997

BS EN 61010-2-040:2005

EMC Directive 89/36/EEC as

amended by 93/68/EEC

EN50081-1 EN50082-1

EN61326 1997 (+A1/A2)

Technical construction file ref EMCTCFAU

Competent Body: Inchcape testing Ltd

Manfield Park

Cranleigh

Surrey

Testing conducted in 2004 without certification by a

competent body.

Pressure Equipment

Directive 97/23/EC

Conformity assessment

Modules B1+D

PD5500 2000

BS2646 1993

Notified Body No 0037

Zurich Risk Services

Park House,

Bristol Road South,

Rubery

B45 9AH

Approval references:

Vessel (module B1)

Certificate numbers CEN-

030021/B1

Manufacturing (module

D) certificate number

SS42072280-01

Declaration:

Priorclave Ltd declares that the above products conform with the essential requirements of the above directives.

Where appropriate this has been demonstrated by the application of the relevant standard(s). The CE mark was first

affixed to these products in 1996

Signed for and on behalf of Priorclave Ltd

Terry Ashenden

Technical Director.

Priorclave Manual 27125322-EN Issue 2 06/06/2012

Contents

Introduction .........................................................................................................................................1

Symbols used in this manual and their meanings..................................................................................2

Important Notices and Warnings..........................................................................................................3

EU Declaration of Conformity ...............................................................................................................6

Contents ..............................................................................................................................................7

Layout Diagram ....................................................................................................................................9

Operating Summary ...........................................................................................................................10

Cycle Abort and Thermal Lock Override................................................................................................. 11

Preparing Your Priorclave for Use for the First Time ...........................................................................12

Positioning .............................................................................................................................................. 12

Provision of Space and Access for Accessories....................................................................................... 13

Installation.........................................................................................................................................14

Electrical ................................................................................................................................................. 14

Drainage and Exhaust Gas Ventilation ................................................................................................... 15

General ................................................................................................................................................... 19

Initial Commissioning.............................................................................................................................. 20

Full Commissioning and Performance Qualification .............................................................................. 21

Operation...........................................................................................................................................22

Opening the Door ................................................................................................................................... 22

Automatic Timed Free-Steaming............................................................................................................ 25

Pulsed Free-steaming ............................................................................................................................. 25

Load Sensed Process Timing................................................................................................................... 26

Rapid Cooling.......................................................................................................................................... 26

Media Warming ...................................................................................................................................... 27

Delayed Start Time ................................................................................................................................. 27

Vacuum Options ..................................................................................................................................... 27

Multi Program Memory Options ............................................................................................................ 29

Vent button. ........................................................................................................................................... 30

During the process time. ........................................................................................................................ 30

Cooling .................................................................................................................................................... 31

Thermal lock ........................................................................................................................................... 31

Cycle complete ....................................................................................................................................... 32

Media Warming ...................................................................................................................................... 32

Aborting a Cycle...................................................................................................................................... 32

Changing Date & Time........................................................................................................................33

Operation with Options & Accessories ...............................................................................................34

Setting Lock Keyswitch Option ............................................................................................................... 34

Printer ..................................................................................................................................................... 34

Automatic Waterfill Option .................................................................................................................... 35

Air Intake Filter ....................................................................................................................................... 35

Vent Filter ............................................................................................................................................... 36

Internal Validation System ..................................................................................................................... 36

Heater Over-temperature Protection..................................................................................................... 36

Loading Trolley........................................................................................................................................ 36

Accelerated media cooling ..................................................................................................................... 37

Chart Recorder........................................................................................................................................ 37

Warning Indicators and Fault Codes ...................................................................................................38

Maintenance...................................................................................................................................... 40

Weekly Maintenance .............................................................................................................................. 40

Monthly Maintenance ............................................................................................................................ 42

Quarterly Maintenance .......................................................................................................................... 42

General Maintenance ............................................................................................................................. 44

Specification Table ............................................................................................................................. 47

Spares List.......................................................................................................................................... 48

Notes ................................................................................................................................................. 52

Appendix A - Fault Finding & Rectification Guide................................................................................ 53

Appendix B - Steam Table .................................................................................................................. 55

Appendix C - Wiring Diagrams ............................................................................................................ 57

Output Board Designations .................................................................................................................... 57

Standard Non-Vacuum Models............................................................................................................... 58

Standard Vacuum Models....................................................................................................................... 60

Appendix D - Pipework Schematics .................................................................................................... 63

Non Vacuum Models .............................................................................................................................. 64

Vacuum Models ...................................................................................................................................... 65

Appendix E - Other Options Fitted...................................................................................................... 67