Prestige medical Advance User manual

304278D
Advance User Manual
Vacuum (B) &
Non-Vacuum (N) Autoclaves

304278D
Please read these instructions before using the
autoclave.
Keep these “Instructions for use” in a safe place
close by the unit for future reference.
Service Helpline: Telephone: [phone]
(UK only - 24hr)
e.mail: [email protected]
Prestige Medical Service staff are available to provide
advice and assistance during normal office hours. To avoid
delays when making contact please have the units Model
and Serial Numbers at hand. These can be found on the
rating plate located at the rear of the unit or on the bezel
inside the door.
For additional information visit
www.prestigemedical.co.uk
UK Customers
Prestige Medical Limited
East House, Duttons Way,
Shadsworth Business Park,
Blackburn BB1 2QR
Tel : [phone]
Fax : [phone]
www.prestigemedical.co.uk
[email protected]
Contents.
Section Page
1 Introduction 3
2 Operating Symbols, Displays
and Controls 4
3 Operation 6
4 Essential Information 9
5 Routine Care and Maintenance 10
6 Trouble Shooting 11
7 Recovery Sequences 12
8 Additional Information 13
9 Warranty 14
10 Printer and data logger Instructions 14
11 Specification 15
12 Cycle Profiles 16
13 Water Quality 19
14 Loading the Autoclave 19
15 Daily Record Sheet 20
Instructions for use
Destination Kit Date of purchase
Vessel rating plate (duplicate)Model no.
Serial no.
Overseas
Customers
Contact your local
distributor. In case of doubt
contact Prestige Medical.
0086
Prestige Medical Limited
East House, Duttons Way,
Shadsworth Business Park,
Blackburn BB1 2QR
Tel : [phone]
Fax : [phone]
www.prestigemedical.co.uk
[email protected]
Registered in England
Reg No. 2826793
BS EN ISO 9001 2000
Cert No FM31988
ISO 13485 2003
Cert No FM79156
2

304278D
Thank you for choosing the Prestige Medical Advance
Autoclave. This machine is fitted with sophisticated control
software and will automatically adjust the cycle time
dependent on the mass of load used. This will ensure the
optimum sterilizing and drying conditions for all loads.
All “Type B” vacuum cycles use the triple pulse
fractionated vacuum system. Non-vacuum cycles use the
thermodynamic air displacement system. Vacuum Drying
cycles employ a “closed door” system. Non-vacuum
machines employ an “open door” system.
An “Auto-cycle start” option is included which allows the
user to programme the time of day at which the selected
cycle should start.
Before unpacking, refer to the “Manual Handling”
section on page 13, section 8.
Whilst unpacking check the unit for transit damage.
If damage is found, please report this to the shipping
agent immediately, in writing, and then notify your dealer.
Product contents comprise of the following: -
•Autoclave with internal furniture.
•Instructions for use.
•Performance Test Certificate and Certificate of
Conformance for pressure vessel (all UK models).
•Installation sheet.
•Written Scheme of Examination (UK models).
•Waste water container.
•Printer or Data Logger (if applicable).
Types of load and loading.
Advance autoclaves are designed to sterilize instruments,
utensils and other items as defined by the European
Standard EN13060.
Only the vacuum models can effectively sterilize wrapped
or pouched instruments and hollow loads.
The autoclaves operate automatically with 134°C and
121°C sterilizing temperatures (with or without drying).
For a full list of sterilizing cycles and times refer to Section
12.
WARNING!
Refer to the instrument manufacturer to ensure the instruments
suitability for autoclaving and the maximum temperature they
can withstand.
A “responsible person” must qualify other loads as
suitable. Refer to “Additional Information” in Section 8.
Refer to “Technical Specifications”, Section 11, for the
maximum instrument load for the autoclave.
All instruments must be cleaned appropriately prior to
sterilizing.
Wrapped or pouched loads should not touch adjacent
loads. Pouches must be used for one item only.
When placing items on a pouch tray, ensure they do not
touch each other and that the load does not touch other
trays or the chamber..
Always use the lifting device when removing pouch trays
from the autoclave as they may be hot.
Long trays should be supported at their rear as they
become free of the tray carrier.
Pouched instruments should be placed on pouch
trays for best drying results
Do not use an unprotected hand to hold hot trays.
Section 1: Introduction
3

304278D
The following descriptions refer to the symbols, controls and displays
used on the ADVANCE range of autoclaves.
Symbols:
S1 Cycle status.
S2 Do not use tap water.
S3 Maximum water fill line.
S4 Fill water tank
General controls / Operations:
Note: The function is selected when the LED
adjacent to the button is illuminated.
AStandby / Ready button.
BCycle start button.
CDoor open button.
DAdjust time/date settings
E1 Adjust date/time settings (hidden)
E2 Accept (hidden)
FSelect vacuum cycles.
GSelect non-vacuum cycles.
HSelect additional drying.
IOn/off switch
JPrinter socket
KMain door.
LFresh water drain.
MWater fill.
NAir filter.
ORating plate.
PPower Inlet.
Section 2: Operating symbols, displays and controls
A
D
F
G
H
L1
L2
L3
B
C
L8
S1
L7L5L4
L6
S2
S4
M
S3
N
O
P
J
IMPORTANT: Read
Operating Instructions
before use.
Hot parts.
Do Not
Touch.
Do not use tap water
(S2 below).
For acceptable water
quality refer to Section 13.
Fill water tank when
LED illuminated
(Maximum fill level is
S3 opposite).
L
K
I
E1
E2
Fill Water Level
4

304278D
Examples below show:-
Press H to select ‘Additional drying’ in 5 minute increments
up to a maximum of 15 minutes.
Additional drying.
AFTER EVERY CYCLE THE UNIT RETURNS TO THE
DEFAULT CYCLE.
Default for vacuum units
Default for Non-Vacuum units
Display Options. (Figures shown are for a vacuum unit)
L1 Display for “Time” “Date”
& “Cycle counter”.
(Vacuum units only) The
normal display mode is
time. The date or cycle
counter can be selected
by pressing the button D
adjacent to the display.
The selection is valid until
a cycle is completed or
until the unit is returned to
standby mode, at which
point the display will revert
to the current time.
L2 Display for “Temperature”
L3 Display for “Pressure”.
The following show the cycle status: (Vacuum unit)
L4 Cycle started.
L5 Heating and air bleed.
L6 Sterilizing.
L7 Depressurisation / drying.
L8 Cycle complete.
Cycle controls vacuum models.
Press F to select the vacuum cycles these are as follows:
134ºC /3½ min. Vacuum cycle for
porous loads, wrapped, pouched, solid
/ hollow instruments with drying.
134ºC /18 min. Vacuum cycle for
porous loads, wrapped, pouched, solid
/ hollow instruments with drying.
134ºC /3½min. Cycle for bagged solid
instruments without drying. Additional
drying should be added.
134ºC /3½min Vacuum cycle for
unwrapped solid or hollow instruments/
Steam penetration test without drying.
Suitable for Bowie Dick Test Pack or
Helix.
Press G to select non-vacuum cycles.
121ºC /15½min. Non-vacuum cycle for
unwrapped solid instruments, without
drying.
134ºC /3½min. Non-vacuum cycle for
unwrapped solid instruments, without
drying.
Cycle controls non-vacuum models.
Non-vacuum cycle for unwrapped
solid instruments, without drying.
Non-vacuum cycle for unwrapped solid
instruments, with drying.
The 121°C or 134°C led will be illuminated to show
which cycle is selected.
134°C. Non-vacuum cycle without drying.
134°C. Non-vacuum cycle with drying.
L1
L2
L3
L4 L7
L6
L5 L8
5

304278D
Please take time to read these instructions before using the autoclave. It is essential that the operator is correctly
trained and a “Responsible Person” has been assigned for the management of the autoclave. By following these
simple step-by-step instructions you can ensure your instruments are correctly sterilized every time.
1. Installation.
Ensure the unit is
placed on a strong,
flat, level & heat
resistant surface
Adjust the feet so
that the unit is level
when viewed from
the front, but angled
backwards when
viewed from the side
(see illustration). To
check that the unit is set up correctly, pour half a cup of
water into the chamber. The water should flow towards
the hole at the rear of the chamber not out of the front. If
this happens, re-adjust the feet.
WARNING!
The autoclave is heavy; at least two people will be needed
to lift it.
2. Connection.
Plug the unit into the mains outlet socket of the correct
type & rating. See rating plate (O). Push the on/off switch
on the front of the unit.
After a few seconds the LED next to button (A) illuminates
and the internal heater operates to control the internal
temperature at a set value.
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”.
3. Single use water system.
This unit has a “single use” water
system designed to prevent the
recycling of any contaminants, which
may be present on the instruments
being sterilized.
Ensure the waste water container is
emptied to the minimum level prior
to filling the fresh water tank to the
maximum level.
Ensure the “waste water container” is checked regularly
to prevent overflowing. The container should be emptied
when the waste water level reaches the “Max” line.
To empty the container, undo the screw cap and carefully
remove the steam condensing coil/cap assembly.
Use the carry handle to support the container when
emptying. Replace the steam-condensing coil and cap;
ensuring it is screwed on securely.
Note: Before using for the first time, and after
emptying, always add cold (tap) water until the level
reaches the minimum level mark.
The waste water container can be located in any
convenient place, although care should be taken that it
cannot be knocked over.
WARNING!
Waste water and steam condensing coil may be hot.
Care should be taken at all times.
4. Setting date and time.
Date and time are set in the following sequence.
Note: This unit uses a 24 hour clock.
Year (tens): Year (hundreds): Month: Day: Minutes: Hours.
•Set the autoclave in “Ready Mode” by pressing ready
button (A). The LED next to button (A) will then go out.
•Press and hold button (D) for 5 seconds.
•Set year (tens) by pressing button (D) up and (E1)
down. Press button (E2) to accept.
•Set year (hundreds); Month; Day; Minutes; hours; by
pressing button (D) up and (E1) down. Press button
(E2) to accept for each.
•The unit returns to “Ready Mode” when the hours are
accepted.
5. Ready.
Press button (A) to set the autoclave into “Ready Mode”.
The LED next to button (A) will go out.
Note: When in “Ready Mode”, the boiler and chamber
are pre-heated.
6. Water fill – DO NOT USE TAP WATER.
Before using the autoclave for the first time fill with water.
Always use de-ionised, distilled or sterile water as
recommended (see page 19).
NEVER USE TAP WATER. THIS WILL INVALIDATE THE
WARRANTY.
Press button (C) to open the door. Pour water into the
fill spout (M) until it reaches the “Maximum line” (S3). Do
not overfill. The water capacity is 3·7 litres. When the low
water indicator illuminates, top up with water.
Section 3: Operation
6

304278D
7. Loading.
Refer to “Loading the Autoclave” at Section 14, page
19 and “Specifications” on page 15 for the maximum
permissible load.
Failure to follow instructions may cause the unit to
malfunction and result in an unsuccessful cycle. Before
loading, ensure instruments are cleaned and rinsed
thoroughly.
Always use the instrument trays or racks, which are
supplied or are available as recommended accessories
through your supplier
Load instruments so that they do not touch each other
and that the load does not touch other trays or the
chamber.
Only one item should be placed in a pouch.
Linen loads should be formed into a rectangular pack of
size 110mm x 110mm x 50mm. (maximum), weighing no
more than 1 kg. Place on a pouch tray in the middle of the
chamber.
Linen loads should not be sterilized in combination with
other loads.
8. Door closing.
Once the trays are in place, close the door by pushing until
a “click” is heard. The LED next to the door open button
(C) will then flash for a period of 20 seconds during which
time entry in to the unit is restricted. This ‘dwell’ period
is used to ensure correct pressure sensing readings are
made prior to a cycle being initiated. Access to the unit
can be made once this period is complete.
9. Cycle options.
After each cycle the unit will return to the default cycle.
On Vacuum units this is the 134ºC /3½min
Vacuum cycle for porous loads, wrapped,
pouched, solid / hollow instruments with
drying (B cycle).
Cycle options available on the vacuum autoclave are:
Press F to select the vacuum cycles these are: -
134ºC /3½min. Vacuum cycle for porous loads,
wrapped, pouched, solid / hollow instruments
with drying.
134ºC /18min. Vacuum cycle for porous loads,
wrapped, pouched, solid / hollow instruments
with drying.
134ºC /3½min. Cycle for bagged solid
instruments, without drying. Additional drying
should be added.
134ºC /3½min. Steam penetration test
without drying. Suitable for Bowie Dick Test
Pack or Helix.
Press G to select non-vacuum cycles.
121ºC /15½min. Non-vacuum cycle for
unwrapped solid instruments, without drying.
134ºC /3½min. Non-vacuum cycle for unwrapped
solid instruments, without drying.
On non-vacuum units pressing G allows you to scroll round
all the 121°C. and 134°C. cycles.
Non-vacuum cycle for unwrapped solid
instruments, with drying. Either 121°C
/15½min. or 134°C/3½min.
Non-vacuum cycle for unwrapped solid
instruments, without drying. Either 121°C
/15½min. or 134°C/3½min.
Press H to select “Additional Drying”.
Additional drying.
This option can be added before or after a cycle.
NB. Additional drying is inactive for the Steam Penetration Test
cycle (TP). Drying on this cycle can only be obtained after the
cycle has ended by selecting additional drying as described
below in (ii).
(i) To select before starting a cycle:
(i) Press button (H) once. L4 illuminates to
indicate 5 additional minutes.
(ii) Press (H) a second time. L4 & L5 illuminate
to indicate 10 additional minutes.
(iii) Press (H) a third time. L4 L5 & L6 illuminate
to indicate 15 additional minutes.
(iv) Press (H) a fourth time. This cancels
additional drying.
(v) Select, then start the required cycle. See “10”.
(ii) To select after a cycle has been completed:
(i) With the door closed press and hold button
(H) for 10seconds. L7 flashes to indicate 5
minute drying in progress.
(ii) Press button (H) once. L4 illuminates to
indicate 5 additional minutes. Now press
and hold button (H) for 10seconds. L4 and
L5 are illuminated. Then L7 flashes to
indicate 10minute drying in progress.
(iii) Press button (H) twice. L4 & L5 illuminated
to indicate 10 additional minutes. Now press
and hold button (H) for 10seconds. L4 L5
and L6 are illuminated. L7 now flashes to
indicate 15minute drying in progress.
3 3✖
7

304278D
10. Start cycle.
Press button (B) to start a fully automatic cycle. A visual
display shows the stages of the cycle:
Stage 1 Cycle started (L4)
Stage 2 Heating and air bleed (L5)
Stage 3 Sterilizing (L6)
Stage 4 Depressurisation / drying (L7)
Stage 5 Cycle completed (L8)
11. Opening door.
At the end of a cycle a buzzer sounds 3 times. Press
button (C) to open the door, allowing access to the load.
Additional operations.
Steam Penetration Test.
On vacuum units the “Steam penetration test” should
be performed on a daily basis to confirm that the unit is
operating correctly.
A Prestige Medical Bowie Dick Test Pack or an Albert
Browne Helix Test MUST be used with this test. The
Pack or Helix should be placed on an instrument tray
in the middle of the chamber towards the front.
Albert Brown Helix Test Bowie Dick Test Pack
Run the cycle for the steam penetration test.
Following this test, the Test Pack or Helix TST should
change to a uniform purple colour. If this is not the case,
clean the gasket and the chamber rim before repeating the
test. If the unit continues to fail, replace the gasket and re-
test before contacting the Prestige Medical customer care
team or dealer.
If the test fails again seek technical assistance.
Vacuum system leak test.
The “vacuum system leak test” checks the integrity of the
vacuum system. NB. A printer or data logger MUST be
fitted.
The test MUST be undertaken when the unit is cold
and dry (before any other cycle has been run).
Set the autoclave in “Standby Mode” by pressing ready
button (A). The LED next to button (A) will illuminate.
Press and hold button (F) for 6 seconds. The display (L1)
will begin to count down. Hold button (F) until the count
down reaches zero. The test will then start.
During the test, the segments of the cycle status graphic
(S1) will flash.
The test will take between 15 to 30 minutes. On
completion the print-out will advise if the unit has passed
or failed the test.
If a failure occurs, clean the gasket and the chamber
rim before repeating the test. If the unit continues to fail,
replace the gasket and re-test before contacting the
Prestige Medical customer care team or dealer.
To return to normal use press button A, then button C.
Auto-cycle start.
The unit can be programmed to enable any cycle to be
started at any time of the day when the unit is unattended.
This option is recommended particularly when the
operator performs “Air leak detection test”.
•Set the autoclave in “Standby Mode” by pressing ready
button (A). The LED next to button (A) will illuminate.
•Press and hold button (D) for 6 seconds and release.
The time display (L1) will flash with the default time of
06.30 being displayed.
•Press (E2) to accept. If another time is required for
the auto-cycle start, change minutes then hours; by
pressing button (D) up and (E1) down. Accept by
pressing button (E2).
•The unit returns to “Ready Mode” and the LED to the
left of the clock symbol continues to flash.
•Select the required sterilizing cycle using buttons (F),
(G) and (H).
•Load the instruments in the chamber and close the
door.
•Press the start button (B). The door LED (C) and the
start LED (B) both flash. The clock symbol LED is still
flashing.
•The selected cycle will start when the programmed
start time is reached. The clock symbol LED flashes
until the cycle is completed.
•To abort a timed cycle (before the cycle starts) press
the “Standby button” (A).
8

304278D
To ensure that the autoclave continues to operate
correctly, it is important to adhere to the following points
and to carry out the necessary care and maintenance
procedures as specified.
This product is not a washing / cleaning machine.
Do ensure that..…
… you read and follow these Instructions for Use.
… the load is suitable for sterilizing and the cycle selected.
… the load can be sterilized at the selected temperature.
… the load has been cleaned.
… the load has been rinsed thoroughly in clean water
prior to sterilization to avoid any chemical residues left
after cleaning contaminating the autoclave.
… when placing instruments on trays, ensure they do not
touch each other and that the load does not touch
other trays or the chamber.
… only distilled, de-ionised or sterile water is used (as
recommended on page 19).
… the autoclave is in a draught free area.
… the autoclave is not installed in an enclosed cupboard
space.
… the door is left ajar when not in use.
… you quote model/serial number (which are located on
the lower left hand side of the front bezel, behind the
door moulding and also on the rear case just above
the mains power cord entry) and date of purchase in all
correspondence.
… only qualified personnel regularly service the autoclave.
… all routine care and maintenance procedures are
followed
It is recommended that a Chemical Indicator strip be
used every cycle to verify that the sterilizing cycle is
effective. If the Chemical Indicator strip fails to change
colour repeat the cycle. If it still fails to change colour
then arrange for a service.
Section 4: Essential information
Disposal
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.
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.
Do not….
… lose this handbook.
… add any chemicals whatsoever to the water.
… attempt to sterilize volatile substances, toxic materials
or other unsuitable loads. (Refer to your “Responsible
Person” for advice)
… place the autoclave in direct sunlight.
… place the autoclave on heat sensitive surfaces.
… use inappropriate cleaning materials.
… drop or abuse the autoclave.
… use in areas of risk associated with flammable materials
or gases.
… remove the casing in an attempt to service or repair the
autoclave.
9

304278D
Section 5: Routine care and maintenance
WARNING!
Disconnect the autoclave from the mains power
supply before cleaning.
DAILY MAINTENANCE
Gasket
THE GASKET MUST BE CLEANED ON A DAILY BASIS,
BEFORE USING THE AUTOCLAVE.
Wipe exposed surface of the gasket with
warm soapy water using a lint-free damp
cloth.
Gently clean the vessel rim sealing surface
with a wet light nylon pan scourer.

Wipe both the gasket and the vessel again with water
using a lint-free damp cloth to remove any residual soap.
MONTHLY MAINTENANCE
Cleaning of the fresh water tank
Fully drain the fresh water tank. Pull the drain button
underneath the door of the autoclave, remove the pipe
from the button and completely drain the water. Refit
the button and refill the water tank with 2 caps of the
autoclave cleaning solution (part no. 279493) and 1 litre
of distilled water. Select and run a sterilization cycle (the
quickest one, for example). At the end of the cycle, drain
the same way, refit the button and fill with fresh water
again. Re-start another quick cycle to remove any residue
of cleaning solution. Drain again. Clean the chamber with
a lint-free cloth to remove water. Refill with fresh distilled
water to use the autoclave.
(Part No. 289138).
WARNING
Failure to perform these procedures may result in the unit showing
UOD1 on the display (UOD1 indicates that the unit may have been
contaminated and could fail to operate correctly).
Exterior surfaces (as required).
Exterior surfaces should be cleaned with warm soapy
water using a damp cloth.
For persistent marks, use a gentle cream cleaner.
Always use de-ionised, distilled or sterile water as
recommended. NEVER USE TAP WATER.
Gasket replacement
Should the gasket develop a persistent leak it should be
removed, cleaned thoroughly in warm soapy water and
shaken dry. Wiping with a lint-free cloth is acceptable
(Other materials may lead to contamination of the gasket
with fibres).
If the leak persists you should obtain and fit a new gasket.
To remove the gasket, undo the two thumb-nuts (309070)
in the centre of the gasket plate.
Remove the plate/gasket assembly and then remove the
gasket from the plate.
CAUTION: Ensure the gasket is located the right way
around on the plate, the lip should face outwards.
During re-assembly, place new black sealing
washers (supplied with the gasket) in the machined
recesses in the door casting.
Re-fit the gasket/plate assembly. Ensure that the entry port
plug aligns with the hole on the right hand side of the door.
Replace the 2 white silicone washers. Prior to tightening
the 2 thumb nuts, ensure that the gasket is correctly
seated on the gasket plate and in the door recess.
DO NOT overtighten the thumb nuts as this may damage
the thread.
Thumb-Nuts
Sealing Lip - ensure
the gasket is
orientated correctly
Entry port plug
This autoclave should be serviced and calibrated annually in accordance with Prestige Medical
procedures by Prestige Medical or authorised service engineer.
10

304278D
If the machine does not complete a sterilizing cycle, a visual and audible indication will be given. The reason can then be
determined by reference to the guide below. The recovery sequence allows access to any instruments within the autoclave
and is the first step when rectifying the condition. In the unlikely event that a cycle fails to complete, instruments
should be reprocessed as they may not be sterile.
User Message Cause Remedy.
UOD1 and UOD2 Unit contamination or gasket
wear.
• Conduct routine maintenance prodcedures & re-run cycle
• Replace gasket if fault persists • If the condition persists, an engineer may be required
Low water LED
Illuminated (S4)
Insufcient water to run a
cycle.
• Press button A twice. Top up with water to mark S3
“Door” illuminates on display
(L2)
Cycle start button pressed
whilst door is open ord door
microswitch requires adjustment.
• If door closed but door LED (C) not illuminated - push on door to see if LED can be
illuminated. • If door open, close door and try again.
• If fault occurs during a cycle – following recovery sequence “i”
01 Power failure during a cycle. • Recovery sequence “i”
• Check power supply – repeat the cycle.
b02 Sterilizing temperature out of
range.
• Recovery sequence “i”
• Conduct routine maintenance prodcedures & re-run cycle
• Replace gasket if fault persists • If the condition persists, an engineer may be required
d02 Probe difference out of range. • Recovery sequence “i”
• Conduct routine maintenance prodcedures & re-run cycle
• Replace gasket if fault persists • If the condition persists, an engineer may be required
t02 Clock error. • Recovery sequence “i”
• Check and reset the clock - repeat the cycle.
• If the condition persists, an engineer is required
p02 Sterilizing pressure out of
range.
• Recovery sequence “i”
• Conduct routine maintenance prodcedures & re-run cycle
• Replace gasket if fault persists • If the condition persists, an engineer may be required
03 Air bleed has not been
successful.
• Recovery sequence “i”
• Conduct routine maintenance prodcedures & re-run cycle
• Replace gasket if fault persists • If the condition persists, an engineer may be required
04 Vacuum failure. • Recovery sequence “i”
•
Conduct routine maintenance prodcedures & re-run cycle • Replace gasket if fault persists
• Check waste water pipe for kinks • If the condition persists, an engineer may be required
07 Sensor fault – boiler
thermistor.
• Recovery sequence “ii” - repeat cycle
• If the condition persists, an engineer is required
08 Sensor fault – pressure
transducer.
• Recovery Sequence “ii” – Repeat cycle.
• If fault persists engineer call-out may be required.
10 Water in the boiler. • Recovery sequence “iii”- repeat cycle running a 134°C non vacuum cycle
• Check whether a previous error code was displayed
• If fault persists, an engineer is required
O0D3 Vacuum failure in drying stage • Recovery sequence “i”
•
Conduct routine maintenance prodcedures & re-run cycle • Replace gasket if fault persists
• Check waste water pipe for kinks • If the condition persists, an engineer may be required
13 Water ll time out. • Recovery sequence “i”
• Drain water out of the fresh water tank and rell with de-ionised, distilled or sterile water.
• Repeat the cycle.
14 Sensor fault – Chamber
probe.
• Recovery sequence “ii” - repeat cycle
• If fault persists, an engineer is required
15 System Leak. • Recovery sequence “ii”
•
Conduct routine maintenance prodcedures & re-run cycle • Replace gasket if fault persists
• If the condition persists, an engineer may be required
Engineer call-outs due to a lack of housekeeping and routine maintenance can be expensive. Please ensure that all consumable items have been
cleaned or replaced as appropriate and that the water quality is as described in Section 13 before contacting Prestige Medical. For engineer assistance,
please contact our Customer Care Team on 01254 844 116 or email: [email protected]
Section 6: Trouble shooting
11

304278D
Recovery Sequence (allows instruments to be removed from the unit).
Recovery Sequence “i” Recovery Sequence “ii” Recovery Sequence “iii”
Press button (A)
Stabilize (no flashing or bleeping)
Service required.
Press button (A) “Recover”
Press button (A)
Stabilize (no flashing or bleeping)
NB: Cannot proceed. Switch off at mains supply.
Service required.
Press button (A)
Stabilize (no flashing or bleeping)
Press button (A) to enter “Ready Mode”
The Recovery sequence (depending on where the fault occurs) will flush the water from the boiler and eventually
complete the cycle with a continuous bleeping to indicate recovery is completed.
Important.
Before restarting a cycle, check that the mains plug is fully inserted into the mains outlet socket and the outlet is of the
earthed/grounded type.
Should all power be lost the door cannot be opened until power is restored and pressure returned to ambient.
Should an internal power failure occur, the door cannot be opened until: -
1. The unit has cooled down to atmospheric pressure. Access can then be made using the supplied tool.
2. A service has been carried out.
In the event of failure of an indication device a service will be required to correct the condition.
Should a safety feature operate, unplug the unit and call for a service – do not attempt to correct the fault.
Primary safety features:
Two primary features have been fitted – a pressure release valve and a boiler over temperature safety cut out.
IMPORTANT NOTE ON EMERGENCY DOOR OPENING PROCEDURES.
If the door interlock lever does not fully release during door opening and the door led has gone out, light pressure on the
door will re-illuminate the door open led. It will then be possible to open the door in the normal manner using the door
open button.
Door opening – Power loss.
If the machine has suffered a loss of power and it is essential to open the machine to remove instruments, the following
procedure should be followed. This should only be performed by the nominated responsible person: -
1. Disconnect the unit from the mains supply.
2. Allow the machine to cool down to room temperature.
3. Remove the protective white protective cap on the top of the machine.
4. Locate the Vessel Pressure Release button on top of the unit and pull button fully
upwards to release the valve and any pressure/vacuum left inside the autoclave.
5. Insert the straight end of the special tool into the interlock lever release guide hole and
push inwards. If the tool starts to buckle at the preformed strain relief repeat from 3
above.
See Photograph opposite.
DO NOT ATTEMPT TO OPEN THE VESSEL IF PRESSURISED.
ONLY USE THE TOOL PROVIDED AND FOLLOW THE INSTRUCTIONS ABOVE
TO GAIN ACCESS TO THE MACHINE.
Section 7: Recovery sequence (allows instruments to be removed from the unit).
Door
release
tool hole
12

304278D
Operator:
The person assigned to use the autoclave.
Responsible person:
The person who is responsible for the management of the
equipment, load assignment, care and maintenance. This
person is also responsible for ensuring that all applicable
Health & Safety Regulations are applied including those
relating to the pressure vessel.
This person must verify that only suitably qualified persons
undertake repair and maintenance work other than that
described under “Routine Care and Maintenance” within
this handbook.
Qualied person:
A person who is qualified by training or experience to a
recognised level in respect of the work to be undertaken.
Service:
Calibration and maintenance as required.
Manual handling:
Due to the weight of the unit two people are required when
unpacking or moving the product.
UNPACKING.
When lifting the unit out of the box ensure there is one
person on either side of the unit. Lift out of the box and
place on the work surface.
POSITIONING.
Start lifting by holding the unit below the front bezel (large
plastic moulding). As clearance is gained, lift at the other
corners. Place in position, and release in the reverse
order to lifting. NOTE Always drain the water tank before
moving. Before moving always allow 30 minutes after use
for the unit to cool down.
Cleaning materials:
Mild washing up liquid. Non-abrasive cream cleaner.
Disinfectant diluted in water. Autoclave Cleaning Kit
279493.
Product decontamination.
Should the unit require to be returned to the factory for
repair, it must be decontaminated in accordance with our
recognised procedures.
Approvals:
Approvals are all model specific. However, the following
standards apply in whole or part:
•Medical Devices Directive MDD 93/42/EEC
•Pressure Equipment Directive PED 97/23/EC
•RoHS2 Directive 2011/65/EU
•Small Steam Sterilizer Standard EN 13060
•Electrical Safety Standard EN 61010
•EMC Standard EN 61326
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 and may adversely affect the performance or
safety of the unit.
Accessories / Consumables
Printer (Part No.) 279519 Europe
279520 UK
279521 Australia
Data Logger 279565
Optional and can be fitted by the user.
Printer roll (Part No.279505): Ten replacement rolls.
Furniture:
22 litre pouch tray (Part No. 309071)
16 litre pouch tray (Part No.309066)
Tray lifter (Part No.279007)
Door tool (Part No.309068)
Door plate thumb screw (Part No.279300)
Set of 4 gaskets (Part number 279571)
“O” Ring door (Part No.279100)
Waste Water Container (Part No.279503)
Container for single use water.
Bowie Dick Test Pack (Part No.309031)
Helix Test Pack (Part No. 329001)
TST strips (Part No. 259277)
Autoclave cleaner (Part No 279493)
For cleaning the autoclave to ensure continued operation.
Air filter (Part No. 273096A screw-in type; Part No.
309077 push-in type).
3 Tray Rack (Part No.289132)
Set of twelve 10 instrument clip trays (Part No. 309082)
Set of two 3 instrument clip trays (Part No.276396A)
Section 8: Additional information
13

304278D
Prestige Medical Ltd will, in the first twelve months from
the date of purchase (or 18 months from the date of
factory despatch – whichever is first), repair or replace free
of charge any parts* inclusive of labour which prove to be
defective in workmanship and / or materials.
Prestige Medical Ltd will not be 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 result
in the protection provided by the equipment being
impaired.
* This warranty excludes the door gasket, all internal
furniture and consumables.
Consumer’s statutory rights are not affected.
The Prestige Medical Ltd policy is one of continuous
development and as such reserves the right to change
the specification of the models and items illustrated and
described herein at any time.
Disposal
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.
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.
Power on procedure
Connect the printer to the power supply and switch on
at the mains. The LED light will illuminate on the printer.
Connect the printer to the autoclave with the cable
supplied. The printer connection at the autoclave is
connector ‘J’ (see page 4).
Replacing paper roll – part no. 279505 (pack of 10)
If the printer roll needs replacing, open the paper cup lid
and remove the remaining paper and bobbin. Reel off a
few centimetres from a new roll, sit the new paper in the
paper cup with the leading edge feeding from the bottom
and close the lid. Press paper feed button to test.
Should the paper become creased or out of line when
feeding in a new roll, cut the end off the paper roll, feed
out the creased paper using the button, and reload
ensuring the paper has a clean straight edge.
Status LED.
The printer incorporates an LED indicator to report its
condition. If there is a fault the LED will flash in sequence.
The fault can be identified by counting the number of
flashes.
LED
Indication.
Condition Solution.
On Printer On -
Off Printer Off or Asleep -
* * * Paper Out Fit new paper
** ** ** Thermal head too hot Allow head to
cool
Place the printer on the worktop at the side of the
autoclave.
Do not place the printer on the top of the autoclave.
Make sure the paper is kept away from hot surfaces
such as the dump pipe etc.
Store the printouts in folders away from direct or
indirect sunlight.
Data logger instructions
Refer to the instructions supplied with the data logger for
setting up and operating the data logger.
Section 9: Warranty
(UK mainland only)
Section 10: Printer instruction
(Optional)
14

304278D
Chamber Capacities 16litre 22litre
Overall product width 480mm. 480mm.
Overall product height 410mm. 410mm.
Overall product length 440mm. 610mm.
Unpacked weight 42Kg. (Max) 43Kg. (Max)
Chamber Diameter 250mm. 250mm.
Chamber length 330mm. 430mm.
Max. Instrument length 290mm. 420mm.
Max. load non-vacuum 6 kg 6 kg
Max. load vacuum
*Pack size
110x110x50mm.
6 kg (un-pouched)
2 kg (pouched)
1 kg (porous)*
6 kg (un-pouched)
2 kg (pouched)
1 kg (porous)*
Sterilizing temp/time. 134ºC/3½mins
134ºC/18mins.
121ºC/15½mins
134ºC/3½mins.
134ºC/18mins.
121ºC/15½mins.
Operating pressure
(Minimum)
2.05bar (gauge). 2.05bar.(gauge)
Voltage/Wattage 230v. /2200W 230v. /2200W
Frequency 50 – 60 Hz. 50 – 60 Hz.
NB. The overall cycle time will increase as the mains supply
voltage decreases.
Chamber component materials.
Vessel: Stainless Steel – 304 –S15
Boiler: Aluminium – LM25
Door: Aluminium – ASME SB26 356.0 T6
Door Plate: Stainless Steel – 304 –S15
Fuses:
Mains plug top fuse (user replaceable)
F13A to BS1362 UK only.
Rating: All products are rated for intermittent use,
continuously.
Heaters: Cast into the boiler.
Internal heater.
Temperature cut out:
Bi-metallic type rated at 180ºC. with automatic reset.
Pressure release valve:
Operates at 2.9bar. Accumulation is <10%.
Maximum single fault temperature:
143ºC determined by the pressure release valve.
Over voltage category: Group II
Pollution degree: Group II
Insulation: Class I.
Environmental conditions:
Indoor use at an altitude of up to 2,000m.
Ambient temperature range +10ºC to +40ºC
Maximum relative humidity 80% for temperatures up to
30ºC, decreasing linearly to 50% at 40ºC.
Mains supply voltage range 207 to 254volts.
Drying performance maybe affected by local environmental
conditions.
Safety shutdown:
The machine is fitted with an automatic thermal reset
mechanism. In the event of the boiler overheating (for
example due to accidental overload), the unit will power
down. After approx. 10 minutes, power will automatically
be restored and the display will show Error 01. The load
will need to be re-processed, ie start the cycle again.
Storage:
When leaving the unit standing idle for any length of time,
switch mains off & drain the water tank especially if there
is a possibility of the room temperature dropping below
freezing point.
Packaging:
Packing materials used have been selected for ease of
recycling. Please ensure you use the correct disposal
system for disposal of packing materials.
Maximum water usage:
Vacuum cycles = 600mls per cycle (typical).
Non-Vacuum cycles = 450mls per cycle (typical).
Maximum power used:
16litre = 1.18kwh
22litre = 1.33kwh.
LEQ sound level = 60db.
Section 11: Specification
15

304278D
The profile for the 134ºC /18min. vacuum cycle differs only in the sterilizing hold time (stage 7 to 8).
The 134ºC /3.5 min. steam penetration test is identical to the above profile but without drying (Stage 9 to 10).
Programme Step Time
min:sec
Temperature
(Measured Value)
Pressure
(Measured Value)
Cycle
identification.
START 00:00
1 00:00 Typical Point 1
1 to 2 02:30 Typical Point 2 300 mbar abs.
2 to 3 06:30 Typical Point 3 2·9 bar abs.
3 to 4 06:00 Typical Point 4 480 mbar abs.
4 to 5 05:00 Typical Point 5 2·90 bar abs.
5 to 6 06:00 Typical Point 6 480 mbar abs.
6 to 7 07:00 Typical Point 7 3.04 bar abs.
7 to 8 03:30 Fixed 134 to 137ºC. 3·04 bar abs. to 3·32 bar abs.
8 to 9 01:30 Typical.
9 to 10 15:00 Fixed.
END 53:00 Typical
Section 12: Cycle profiles
The profile below is for the 134ºC /3½min vacuum cycle.
16

304278D
Programme Step Time
min:sec
Temperature (Measured
Value)
Pressure
(Measured Value)
Cycle Identification.
START 00:00 Point 1
1 TO 2 02:00 Typical Point 2 300 mbar abs.
2 TO 3 09:00 Typical Point 3 2.9bar abs.
3 TO 4 01:30 Typical Point 4 1.5bar abs.
4 TO 5 02:00 Typical Point 5 3.04bar abs.
5 TO 6 03:30 Fixed. 134 to 137ºC. 3·04 bar abs. to 3·32 bar abs.
6 TO 7 02:00 Typical.
7 TO 8 15:00 Fixed ADDED DRYING – NOT SHOWN ABOVE. Could also be 05:00
or 10:00 depending on the amount selected.
END Typical. 35:00
The profile below is for the 134ºC /3½min. cycle for Bagged solid instruments.
NB. Additional Drying must be added to this as detailed on page 7.
17

304278D
Programme
Step
Time
min:sec
Temperature
(Measured Value)
Pressure
(Measured Value)
Cycle Identification.
START 00:00
100:30 & 00:30 Typical Point 2 750-mbar abs.
in both cases.
Figures in bold.
2 to 3 11:00 & 11:00 Typical Point 2
3.04 bar abs. &
2.05 bar abs.
3 to 4 03:30 & 15:30 Fixed 134·0 to 137·0ºC.
121·0 to 124·0ºC.
3·04 bar abs. to
3·32 bar abs.
2.05 bar abs. to 2.25 bar
abs.
Figures in RED.
4 to 5 02:30 & 03:30 Typical
END 17:30 & 27:30 Typical
On non-vacuum machines the vacuum assisted fill is not present.
THE CYCLE PROFILES SHOWN ON THIS AND EARLIER PAGES ARE FOR THE 16 LITRE AUTOCLAVE.
The profile below is for the cycles
(Non-vacuum cycle on a Vacuum Machine) the only difference being in
sterilizing (Stage 3 to 4).
18

304278D
Must be suitable to produce steam in accordance with international standards.
Example specification for clean steam
Determinant Value Recommended test for compliance
Based on sterilized water for Injections BP:
Acid or Alkalinity. NQ BP test. Tests for pH are not an acceptable
substitute.
Ammonium 0.2mg/litre BP test or other suitable method
Oxidisable substances. NQ BP test.
Calcium and Magnesium. NQ BP test. Tests for hardness are not an acceptable
substitute.
Heavy Metals. 0.1mg/litre BP test. Tests for individual elements are not an
acceptable substitute.
Chloride 0.5mg/litre BP test or other suitable method.
Nitrate 0.2mg/litre BP test or other suitable method.
Sulphate NQ BP test.
Residue on evaporation 30mg/litre BP test. Conductivity measurement is not an
acceptable substitute.
Pyrogens 0.25EU/ml BP test.
Based on EN 285:
Phosphate 0.1mg/litre Any suitable method.
Silicate. 0.1mg/litre Any suitable method.
Routine monitoring only:
Electrical Conductivity at 25°C 35μS/cm
NQ = Not Quantied; BP = British Pharmacopeia; EU = Endotoxin unit.
USE OF WATER OUTSIDE THE ABOVE SPECIFICATION MAY INVALIDATE THE MACHINE WARRANTY.
Section 13: Water quality
Section 14: Loading the autoclave
Loading has a significant impact on how the autoclave
performs.
The maximum permissible loads are as follows: -
6 kg for Non Vacuum Cycles
6 kg for Vacuum cycles (un-pouched)
2 kg for Vacuum cycles (pouched)
1 kg for Vacuum cycles (porous load)
Always use the instrument trays or racks, which are
supplied.
Load instruments so that they do not touch other
instruments or the chamber..
Only one item should be placed in a pouch.
Pouches may be placed on the Pouch Trays provided
(additional trays may be purchased as an optional extra).
Pouches should be arranged so that they do not touch or
overlap neighbouring pouches.
If using pouch trays, these should be spaced so that there
is a good airflow between the trays.
When loading the trays into the rack use the top rungs of
the rack first and work down.
Pouches should be placed on pouch trays with the paper
side down as shown below.
NB The use of indicator tape for sealing pouches
is not recommended in this autoclave.
19

304278D
L OAD TYPE.
(See KEY below)
CYCLE
SELECTED.
DATE CYCLE NUMBER PASS OR FAIL * OPERATOR
KEY FOR LOAD
TYPES: -
B= Hollow
Instruments
P= Pouched or bagged Instruments U= Unwrapped
Instruments
M= Mixed
*If a cycle fails record the Error Code in the Pass/Fail column
For engineer assistance, please contact our Customer Care Team on 01254 844 116 or email: customerservice@
prestigemedical.co.uk. Always quote your model details and have your serial number and date of purchase ready when
contacting Prestige Medical or your supplier.
Section 15: Daily record sheet - Advance Autoclave
If printer fitted, staple print outs to the sheet
East House, Duttons Way,
Shadsworth Business Park,
Blackburn BB1 2QR,
England
Registered in England
Reg No. 2826793
Vat No. 633707835
Registered Office:
c/o United Cast Bar (UK) Limited,
Spital Lane, Chesterfield,
Derbyshire, S41 0EX, England
Prestige Medical is a registered trademark
Digital version also available:
http://www.prestigemedical.co.uk/uk/dentistry/downloads
20