Gima PRESTIGE AUTOCLAVE 12 L, PRESTIGE AUTOCLAVE 9 L User guide

Section 8: Additional Information

Spares

Only those spare parts supplied or specified by Prestige
Medical should be used in the maintenance of the
autoclave. Use of unauthorised parts will invalidate any
warranty given and may adversely affect the
performance and safety of the unit.

Accessories

A range of accessories are available for your autoclave as
described below.

Please contact your supplier for further details.

1. 219500 – Green Silicone Sealing Gasket

2. 219277 – 126oC TST Indicator Strips

3. 259277 – 121oC/134oC TST Indicator Strips

4. 219258 – Cord Set UK

5. 219297 – Cord Set Euro

6. 219294 – Lifting Device

7. 219708 – 9ltr Basket / 219720 – 12ltr Basket

8. 219291 – Cassette Box / 219706 – Cassette Rack

9. 219740 – Cassette Ring

Approvals

Note: Please ask for details of approvals specific to your
model.

• ASME VIII Division 1 – Pressure Vessel

• Medical Devices Directive MDD 93/42/EEC

• Pressure Equipment Directive PED 2014/68/EU

• BS EN 61010-1 Safety standard for electrical equipment

• BS EN 61010-2-040 Safety requirements for electrical

equipment for measurement, control and laboratory use.

• BS EN 61326-1:2013 Electromagnetic compatibility

Cleaning materials

• Mild washing up liquid

• Non-abrasive cream cleaner

• Disinfectant diluted in water - non chlorine base

211830J

Packaging

All packaging materials used are recyclable, please dispose
of accordingly.

Warranty

Prestige Medical shall, in the first 12 months from the date
of purchase, repair or replace free of charge any parts which
prove to be defective in workmanship and/or materials.

Prestige Medical shall not be so liable in the event
that the purchaser has failed to adhere to the
instructions contained herein or if the autoclave has
been abused, interfered with, altered, repaired or
serviced by any unauthorised party this may also
result in the protection provided by the equipment
being impaired.
This warranty excludes the gasket, all internal furniture and

consumables. Consumer’s statutory rights are not affected.

WEEE Statement
(Waste Electrical and Electronic Equipment)

The WEEE directive places an obligation on all EU-based
manufacturers and importers to take back electronic
products at the end of their useful life.
Prestige Medical Limited accepts its responsibility to
finance the cost of treatment of redundant WEEE in
accordance with the specific recycling requirements..

Disposal

The symbol (shown below) is present on all Prestige
Medical Products, which indicates that the product must
NOT be disposed of with other waste. Instead it is the
user’s responsibility to dispose of their waste electrical and
electronic equipment by handing it over to an approved
reprocessor, or by returning it to Prestige Medical for
reprocessing. For more information about where you can
send your waste equipment for recycling, please contact
your local city office or Prestige Medical.

Product decontamination

Should the unit require repair, it must be decontaminated
in accordance with a recognised procedure prior to return
or on-site repair. A statement of equipment contamination
status must be available with the product. (Details of a
suitable procedure are available on request).

Classic User Manual

Page 8

Electromagnetic environment:

The Classic autoclave is conceived for use in the following
environments; laboratory, residential & medical practices.
The device should be located at least 1.5 m away (radius)
from any patient treatment areas.
The classic unit is a class B Group 1, according to CISPR11
standard

Technical Specifications 9 litre

12 litre

Height

335mm

420mm

Width

340mm

340mm

Net Weight

3.6 Kg

4.5 Kg

Capacity

9 Litres

12 Litres

Internal Chamber Dimensions
(d/h)

210/230mm

210/270mm

Max’ Instrument length

228mm

268mm
Max’ Load Weight

3 Kg

4 Kg

Section 7: Technical Specification

Instructions for use

Please read these instructions before using the
autoclave.

Keep these “Instructions for use” in a safe place
close by the unit for future reference.

UK Customer care line: 01254 844 116
e.mail: [e-mail]

The Prestige Medical Customer Service Team is available
to provide advice and assistance during normal office
hours. To avoid delays when making contact, please have
the unit’s Model and Serial Numbers at hand.

For additional information visit
www.prestigemedical.co.uk

Overseas Customers

Contact your local
distributor. In case of
doubt contact Prestige

Medical Ltd

Contents

Section Page

1 Introduction 3
2 Operating symbols, displays 3
& controls
3 Getting Started 4
4 Continued Operation 5
5 Care & Maintenance 6
6 Trouble shooting 6
7 Technical Specification 7
8 Additional Information 8

Model No.

Serial No.

Date of purchase.

Prestige Medical Limited

East House, Duttons Way, Shadsworth Business Park, Blackburn,BB1 2QR

Tel : [phone] - Fax : [phone]

www.prestigemedical.co.uk - [e-mail]

Registered in England

Reg No. 2826793

In the unlikely event that something should go wrong,
we have incorporated a number of safety features to
ensure that your autoclave remains safe at all times.
Safety features

1. Located to the rear of the lid, beneath the cover, is a
spring called the Gasket Offset Device (GOD Spring),
This has been designed to prevent pressure building
up if the lid has been incorrectly fitted.

DO NOT TAMPER WITH THIS SAFETY DEVICE

2. If for any reason, the temperature falls below the
minimum required sterilizing temperature, the Fault
Light (L5) will be illuminated. Switch the unit off and
leave to cool down. Then switch back on. Check
gasket, water level and refill if necessary. Run
another cycle and if the fault persists arrange an
engineer to visit.

3. If there is an electrical or electronic failure resulting
in a build-up of pressure - in excess of normal
operating pressure - one or all of the following safety
features will be activated.

i) Depressurization Valve (A) will loudly and rapidly

“Vent” steam. The overpressure Safety Valve located

underneath the handle (E) will loudly and rapidly vent
steam allowing its exit via the Steam Duct (F)

ii) The gasket will “extrude” through the slot in the
rear of the lid rapidly releasing excess pressure and
steam.

iii) An automatically resetting thermal trip is located in
the base of the unit. This will activate automatically if
a fault was to occur with the unit.

NOTE: Once the machine has cooled down
sufficiently the thermal trip will reset. This will allow
the unit to re-power up. It is advised that you arrange
for an immediate service following this.

Mains plug fuse (User replaceable), F13A to
BS1362 - UK ONLY.

Rating - Models are rated continuously for
intermittent use.

Body - Deep drawn aluminium.
Lid – Stainless Steel
Heater - Externally surface mounted mechanically

fixed electric element.
Temperature cut out - Thermal trip.
Pressure - Calibrated pressure release valve.
Max. Single Fault Temperature – 133.3°C

Over Voltage Category - Group ll

Environment conditions - indoor use - temperature 5°C
to 40°C - altitude up to 2000m - maximum relative
humidity 80% for temperatures up to 31°C decreasing
linearly to 50% relative humidity at 40°C.

-mains supply voltage fluctuations not to exceed +10%
of the nominal voltage input Connections - Mains inlet
socket ‘hot’ format conforming to IEC 302.

Safety shut down - See ‘Temperature Cut Out’.

Packaging - All packaging materials are recyclable

UK Customers

Prestige Medical Limited
East House, Duttons Way,
Shadsworth Business Park,
Blackburn BB1 2QR

Tel : [phone]
Fax : [phone]

www.prestigemedical.co.uk
[e-mail]

Page 2

Page 7

Should any of the devices listed activate, please
observe the following steps:
a) Do not touch the unit.
b) Switch off at the wall socket and un-plug
c) Allow temperature and pressure to drop before
touching the unit or removing your instruments
d) Do not attempt to re-start the unit
e) Arrange for an immediate service.

`

Page 3

Section 1: Introduction

Thank you for choosing the Prestige Medical Classic
Autoclave designed to sterilize solid unwrapped
instruments.

After removing from the box, please check for any
transit damage, if damage to the box is found, please
contact your supplier immediately.

Together with this unit and operating manual, you will
find the following:

• Instrument furniture

• Electrical mains cord

• Spare fuses x2 (230v models only)

• Certificate of Compliance (230V Models Only)

• Performance test certificate

Section 2: Operating Symbols, Displays and Controls

The following descriptions refer to the pictures
of the controls, display lights and operating
symbols opposite.

Controls:
A Depressurization Valve
B Start Cycle Button
C Pressure Rise Indicator
D Display Panel
E Top Handle

Do not touch the top handle immediately after
the cycle has finished as it may be hot.
F Steam Duct - WARNING HOT PART!
Do not cover!

Display lights:

L1 Power “On” light illuminates GREEN
L2 Heating light illuminates ORANGE
L3 Sterilizing light illuminates YELLOW
L4 Sterilizing complete light illuminates

GREEN

L5 Fault light illuminates RED

Warning symbols:

W1 Caution, electric shock hazard
W2 Warning, read manual before using the autoclave
W3 Warning, unit must be earthed/grounded
W4 Warning, heat hazard

WARNING!

Do not touch the body or lid as these parts

become hot when the autoclave is in

operation.

W1

W2

W4

W3

A

D

C

F

E

Section 5:
Daily Care & Maintenance

WARNING!

Disconnect the autoclave from the mains power supply

before cleaning.

Green sealing gasket

• Remove the gasket from inside the lid and clean with
warm, soapy water.

• Rinse thoroughly, shake dry, do not wipe.

• Replace the gasket, carefully placing it under the

location lugs. Please ensure that gasket sits against
the Gasket Offset Device as shown in the image below.
Please note that the gasket may appear slightly
wrinkled until the unit has been used.

• Replace gasket when it begins to show visible signs of
degradation and leakage.

Section 6:
Trouble Shooting

In the event of a fault occurring during any stage of
the units operation, identify the fault by referring to the
descriptions below. The fault can be rectified by
following the Fault Remedy applicable to the problem
encountered.

Fault indication/Description/Remedy
Fault 1: No power to unit

Light: L1 fails to illuminate.
Blown fuse / Defective Socket /
Mains not connected
Ensure mains lead is connected.
Check / replace fuse, check power to socket

Fault 2: Boil dry error.

Light: L5 flashes RED
i) Check water level – allow unit to cool before refilling
to correct water level.
ii) Check & ensure de-pressurization valve is closed.
iii) Clean gasket & vessel rim.
Please arrange for a service engineer visit if the fault
repeats after checking and carrying out the above.

Fault 3: Sterilization failed to be achieved.

Light: L4 fails to illuminate GREEN.
Disconnect from mains then reconnect and repeat
cycle. If the fault repeats arrange for a service
engineer to visit.

Fault 4: Incomplete sterilization cycle

TST strip fails to change / completely change colour.
Check expiry date of TST strips. Disconnect from
mains then reconnect and repeat cycle. If the fault
repeats arrange for a service engineer to visit.

Fault 5: Steam or water leaks from under the lid

i) Worn or dirty gasket.
Wash gasket and sealing surfaces on the body and
lid as described under “Care and Maintenance”. If
the fault persists, replace with a new gasket.
ii) Incorrectly closed lid.
Ensure the unit is fully depressurized by opening
Depressurization Valve (A). Remove lid and re-fit
carefully. Disconnect from mains, reconnect and
repeat cycle.

Fault 6: Excessive steam or water leaking from
depressurization valve (A).

Depressurization valve (A) in “OPEN” position, close
depressurization valve (A).

Fault 7: Settings Issue.

Light L1 flashes continuously, arrange an engineer
visit.

B

Page 6

L2

L4

L3

L5

L1

WARNING!

The mains outlet MUST BE EARTHED

(GROUNDED).

The mains plug should always be easily

accessible as it is to be relied upon as “the

means of disconnection”.

Autoclave

• If a new gasket leaks, or a persistent leak develops,
gently clean the sealing surface of both the lid and
body of the unit with a light nylon pan scourer,
making sure you do not remove any metal. Rinse
both surfaces but do not dry.

• Clean both interior and exterior with warm, soapy
water ensuring the electrical parts are kept dry.

• Monitor the first cycle of the day to check the Air
Bleed Device, which is located inside the lid, audibly
“clicks” shut.

• Lubricate underside of body lugs with “Vaseline” if the
lid becomes stiff.

DO NOT LUBRICATE THE GASKET

IMPORTANT!

Prestige Medical recommends that your unit is

annually serviced & calibrated by a qualified

service technician

G.O.D spring

WARNING!

The manufacturers of instruments should be consulted
about their suitability for autoclaving and the maximum

temperature which the instruments can withstand.

3.5 Starting

Start the sterilizing cycle by pressing button (B).
Lights: L1 illuminates GREEN

L2 illuminates ORANGE

As the temperature rises, air will be displaced by
steam through the Air Bleed Device located in the
lid, until it closes with an audible “click”, sealing
the unit.

The Pressure rise Indicator (C) will rise indicating the
unit is now pressurised.

Sterilizing temperature is reached when:
Lights: L1 illuminates GREEN

L2 flashes ORANGE
L3 illuminates YELLOW

Sterilizing cycle is completed when:

L1 illuminates GREEN
L4 illuminates GREEN

Note: L4 remains GREEN until a new cycle is started
or the unit is disconnected from the mains power.

Section 4: Continued
Operation

To ensure your autoclave gives you the years of service for
which it was designed, it is important to remember a few
“do’s” and “dont’s” with regards to the operation of
the unit and to carry out simple care and maintenance
procedures.

Do ensure that....

1.... You read these instructions and always follow the

operating sequence.

2.... The work surface on which you will place the

autoclave is flat, solid and heat resistant.

3.... The instruments are designed to withstand the

sterilizing temperature, are thoroughly cleaned
and rinsed before sterilizing, and are not any
longer than the maximum length, or exceed the
load weight, specified – see “Technical
Specification” section.

4.... The water level is maintained regularly with clean

distilled or deionised water only.

5.... The unit is in a “draught free” environment and is

positioned not less than 250mm from adjacent
walls.

L2

L4

L3

L5

3.6 Depressurizing

Once the sterilizing cycle has been completed, the unit
needs to be depressurized and allowed to cool down
before the lid and sterilized instruments can be removed.
The time taken to reach the point at which this is safe to do
so can be shortened by manually depressurizing the unit.
Open the Depressurization Valve (A) by turning slowly in
an anti-clockwise direction. The Pressure Rise Indicator
(C) will drop once the steam has been released.

WARNING!

There will be a visual and audible release of steam

from the rear of the Steam Duct.

3.7 Unlocking

Once the pressure has been released the lid may be
unlocked. Ensure the Depressurization Valve (A) is open.
Remove the lid by turning in an anti-clockwise direction

(F1).

3.8 Unloading

Lift off the lid, gently place upside down on a solid work
surface and leave to cool. Ensure the Depressurization
Valve (A) is in the closed position to avoid damaging it.

The unit has completed a successful cycle if the “spot”

on the TST Indicator Strip has completely changed
colour from yellow to purple.

The basket or cassettes containing the sterilized
instruments can now be lifted out of the unit. To avoid
damage, replace the lid as described in step “3.3”.

3.9 Cycle verification

We recommend the use of a 126°C TST strip with
every load to verify the sterilisation cycle. Simply place
the indicator strip in with the load. Prestige Medical can
supply TST strips .

*Please Note: If the “spot” has not completely changed
colour, replace with a new TST strip and start a new
cycle. If the “spot” fails to change colour for a second
time, do not use the unit until it has been checked by a
qualified engineer.

STERILIZATION CYCLE HAS NOT BEEN ACHIEVED

6.... You only use the Prestige Medical green high

pressure sealing gasket and that it is changed at
the end of its life, if visibly damaged, or when
shrinkage has occurred, see “Fault mode - 5”.

7.... The lid is securely closed when the unit is not in

use, to avoid the risk of accidental damage.
Never leave in position as shown in F1. (Page 4)

8.... You quote your model details, serial number and

date of purchase when contacting Prestige
Medical or your supplier.

9…. Change your water on a daily basis

Do not....

1.... Touch the unit whilst in operation - it gets HOT.

2.... Attempt to remove the lid during operation.

3.... Lose this operating instruction manual

4.... Add any chemicals whatsoever to the water.

5.... Attempt to sterilize volatile substances, toxic

materials or inappropriate loads.

6.... Place the unit on heat sensitive surfaces polished

wood or glass.

7.... Open the Depressurization Valve (A) during the

sterilization cycle.

8.... Leave the Depressurization Valve (A) in the

“open” position when placing the lid upside down

on a work surface.

9.... Immerse the unit or electrical cord in water when

cleaning.

10.... Use abrasive materials or lubricants when

cleaning.

11.... Drop or abuse the unit.

12.... Use in areas of risk associated with flammable

materials or gases.

13.... Attempt to change fuses until the unit has been

unplugged from the mains. Only qualified
persons should change fuses.

14.... Reach over the unit when removing the cover, to

do so may cause burns from rising heat and
steam.

15…. Press the start button once the cycle has been

started as this will re-set the cycle timer to zero.

L1

Closed Valve

Open Valve

Page 4

Page 5

A

C

Section 3: Getting Started

Before using the autoclave for the first time please take time
to read the following pages to familiarise yourself with the
operation of the unit.

We strongly recommend that all users of the autoclave are
trained in its operation.

The autoclave is very easy to use. By following this simple
operating sequence in conjunction with the pictures of the
autoclave, its controls, display panel and operating symbols
(page 3), you will be able to ensure your instruments are
correctly sterilized every time.

3.1 Water

Fill the unit to the water level line on the inside of the
chamber with 0.75l of distilled or de-ionised water.

DO NOT USE TAP WATER OR OVERFILL

CHECK WATER LEVEL AFTER EVERY CYCLE

3.2 Loading

Place UNWRAPPED and WASHED instruments ONLY
plus a TST strip into the instrument basket or cassettes,
and place in the unit. TST strips (available as an
accessory) should be placed as near to the centre of the
load as possible.

Please see section 7 – Technical specification for loading
capacities

3.3 Closing

Always place the lid on the autoclave with the
Depressurization Valve (A) open. Align the two black
triangles on the lid and body as shown in (F3) and turn in a
clockwise direction(F1) ensuring the lid is completely closed
(F2). Close the Depressurization Valve (A) so it is aligned
with the top handle on the lid. Never leave the autoclave in
the position as shown in F1.

3.4 Power connection

Attach the cable supplied to the rear of the unit and plug into
an EARTHED mains electrical socket of the CORRECT
voltage. Lights: L1 illuminates GREEN. If this flashes
continuously then there is a fault and you should arrange an
engineer visit.

F1

Close

F2

Open

F3