LTE TOUCHCLAVE-R User manual

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USER MANUAL
Part 1 – all users
TOUCHCLAVE-R AUTOCLAVES
ADVANCED
STERILIZING
TECHNOLOGY
TCR
-
AUTOCLAVE
PART 1 – ALL USERS
Issue 1
FM 23948
061

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NOTICE
Copyright in this document is the property of LTE Scientific Limited (“LTE”). No part of this
document may be copied, reproduced, or stored in a retrieval system without the prior
written permission of LTE. The design rights in the products described in this document,
including both hardware and software features, are the property of LTE.
Whilst all reasonable precautions have been taken to ensure the accuracy and relevance of
this document, LTE does not accept liability for any errors or omissions, or for any damage or
loss resulting from the use of the information contained herein.
LTE reserves the right to revise or replace any or all of the contents of this document without
notice for any reason. Such reasons may include the need to reflect changes to the products
or any of their features or attributes, or to revise the wording of this document.
Issue Date: 07.03.2012

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CONTENTS
1. GENERAL................................................................................................................7
1.1 Scope of User Manual........................................................................................7
1.2 Classification of User Levels .............................................................................7
1.3 Overview of Touchclave-R autoclaves .............................................................7
1.4 Safety precautions..............................................................................................8
2. MAIN FEATURES AND OPTIONS OF THE TOUCHCLAVE-R RANGE ....9
2.1 Standard features...............................................................................................9
2.2 Optional features................................................................................................9
2.3 Load capacities .................................................................................................10
2.4 The cycle sequence ...........................................................................................10
2.5 Typical cycles....................................................................................................12
3. THE CONTROL SYSTEM – COMMANDS AND SCREEN TYPES .............13
3.1 Commands ........................................................................................................13
3.2 Process screens .................................................................................................13
3.3 Menu screens ....................................................................................................13
3.4 Password and batch code screens...................................................................14
3.5 Parameter screens............................................................................................14
3.6 Warning and confirmation screens ................................................................15
4. THE CONTROL SYSTEM – OPERATING THE DOOR................................16
4.1 Locks .................................................................................................................16
4.2 Restrictions on door operation .......................................................................16
5. THE CONTROL SYSTEM – RUNNING A CYCLE ........................................17
5.1 Starting the cycle..............................................................................................17
5.2 Cycle in progress ..............................................................................................18
5.3 Faults.................................................................................................................18
5.4 Cooling Override..............................................................................................19
5.5 Finishing the cycle............................................................................................19
5.6 Sample cycle printout ......................................................................................20
6. THE CONTROL SYSTEM – RUNNING A CYCLE ........................................21
6.1 Menu access tree for supervisors and operators...........................................21
6.2 Initial Access.....................................................................................................22
6.3 Data Archiving .................................................................................................22
6.4 View/Print Last Cycle......................................................................................23
6.5 Set Time/Date ...................................................................................................23
6.6 Alarms...............................................................................................................23
6.7 Status.................................................................................................................23
6.8 Cycle Setup .......................................................................................................24
6.9 User Setup.........................................................................................................26
6.10 Cooling Override............................................................................................26
7. CARE AND MAINTENANCE.............................................................................28
7.1 Door seal ...........................................................................................................28
7.2 Fitting a replacement seal ...............................................................................29
7.3 Cleaning and draining the chamber...............................................................30
7.4 Printers – instructions for paper installation ................................................30
7.4 Printers – instructions for paper installation ................................................31
7.5 Spare parts – consumable ...............................................................................33
8. AFTER SALES SERVICE………………………………………………………33

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1. GENERAL
1.1 Scope of User Manual
This User Manual provides instructions for the following ‘Touchclave-R’ autoclaves
manufactured by LTE Scientific Ltd (“LTE”):
Model Chamber size Chamber type Siting
TCR/40/H 40 litres Horizontal, front-loading Benchtop
TCR/60/H 60 litres Horizontal, front-loading Floor
TCR/60/V 60 litres Vertical, top-loading Floor
TCR/120/H 120 litres Horizontal, front-loading Floor
TCR/120/V 120 litres Vertical, top-loading Floor
TCR/160/H 160 litres Horizontal, front-loading Floor
TCR/160/V 160 litres Vertical, top-loading Floor
Autoclave users should be given training in the actual application environment. This manual is
not intended as a substitute for such training.
1.2 Classification of User Levels
For safety and security, users of Touchclave-R autoclaves are classified in four User Levels:
•Operator
•Supervisor
•Maintenance Engineer
•Commissioning Engineer
The User Manual consists of two parts. Part 1 is intended for all User Levels. Part 2 is
reserved for use by Maintenance and Commissioning Engineers, who have a higher User
Level allowing them to perform certain functions which cannot be accessed by Operators and
Supervisors.
1.3 Overview of Touchclave-R autoclaves
Autoclaves are steam sterilizers which operate by injecting steam under pressure into the
chamber or vessel where the load to be sterilized has been placed. The Touchclave-R range
has a cylindrical shaped chamber. Steam is generated by water heated within the chamber.
The temperature at which sterilization takes place is pre-programmed, the most common
values being 121
o
C or 134
o
C, depending on the nature of load to be sterilized.
Control of the Touchclave-R autoclave is by means of a touch-screen on the front panel of
the autoclave, using an intuitive hierarchical menu system. Different levels of access are built
into the system by means of passwords indicating the User Level. The menus only display the
options available at the User Level of the current user. Thus a user not trained and
authorised for higher-level access cannot accidentally gain access to the more complex
functions, such as cycle configuration.
During manufacture, the Touchclave-R control system will have been configured to run a
standard range of cycles, which can be modified to suit your needs. Therefore the screen
illustrations shown in this manual may not match exactly those displayed on your autoclave,
although they will be similar.

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1.4 Safety precautions
Whilst the autoclave has built-in safety devices, their operation may be impaired if the
autoclave is not used correctly and in accordance with the instructions. In addition, it is
important to observe the following safety rules at all times:
•wait until the cycle is complete and the machine is cool before attempting to unload
•beware of residual steam in the chamber and hot surfaces when the door is opened
at the end of a cycle
•wear an overall or lab coat, gloves and safety glasses to protect hands, arms and
eyes when loading or unloading the chamber, since the load temperature may be as
high as 100
o
C
•when moving the autoclave, for example during installation, remember that its
weight can make it dangerous if not handled carefully
•ensure that the earth or ground of the power supply cable is connected to a suitable
protective earth supply, and that the supply lines are correctly fused and isolated
•if the plastic bottle for discharge collection has been connected to the autoclave’s
drain system, then in order to avoid being scalded by hot water or steam:
o do not try to empty the bottle while a cycle is in operation
o do not run the autoclave with the drain disconnected from the bottle.

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2. MAIN FEATURES AND OPTIONS OF THE TOUCHCLAVE-R RANGE
2.1 Standard features
All Touchclave autoclaves share the same intuitive and powerful control system, allowing
different levels of access and control, and precise control of the machine. The specification,
configuration and performance vary according to the model purchased and any extra features
which have been fitted.
Touchclave-R models use “in chamber” heaters for steam generation. The base shelf in the
chamber covers a reservoir in which the heaters are located. The functioning of the autoclave
depends on having water in this reservoir. If there is no water, steam generation cannot
occur. Therefore the reservoir needs to be filled with water, either manually or using the
Automatic Water Fill feature, before the cycle can proceed.
2.2 Optional features
The following features are options, which may be fitted to the autoclave to assist the
operator, or to enhance performance by reducing the cycle time and extending its
functionality.
C ndensate Unit: This air-cooled unit ensures that water from the Condensate Discharge or
the Chamber Water Discharge is below 80
o
C. This is important if plastic drains are used to
receive discharges. The Condensate Unit used is a fan-cooled heat exchanger. Cold air is
blown over a radiator, reducing the heat from the air/steam/water running through the coils.
The resulting warm air is blown from the rear of the autoclave.
Aut matic Water Fill: This ensures that the water in the chamber is fully topped up before
commencing the cycle. It saves time for the operator, and reduces problems of spillage which
can occur with manual filling. However it cannot fill the chamber once sterilization is in
progress. The automatic water fill requires a piped water supply to be available in the
building near the autoclave.
Categ ry 3 Effluent Retenti n: This protects the operator by filtering all non-condensable
gases through a 0.2 micron HEPA filter prior to exhaust, whilst returning liquids to the
chamber for sterilization. The filter is fitted inside a stainless steel housing which is accessible
from the rear of the machine. The filter should be checked regularly to ensure that
performance and safety are not impaired.
Aut matic Drain D wn: This enables the Chamber Water Discharge to take place
automatically at the end of each cycle. If this option is fitted, it is necessary also to fit the
Automatic Water Fill, which replenishes the water reservoir before the next cycle, and to
connect the discharge pipe to a floor drain able to withstand temperatures up to 100
o
C.
Vacuum System: This option adds functionality to the start and end of the cycle. It also
increases the range of loads that the machine can deal with. The vacuum system is used to
ensure efficient air removal at the start of the cycle (known as the “pre-vacuum” stage),
when a vacuum is drawn in the chamber to a set pressure. There follows the “negative
pulsing” stage, when the heaters raise the pressure up to a higher set point, before the
vacuum pump takes the pressure back down to the low set point again. This is repeated for a
number of “pulses”, until sufficient air has been removed from the load. After the sterilization
stage, a vacuum can be drawn in the chamber to help dry the load. The vacuum will remove
steam and easily accessible moisture, but it will not draw away pools of water or moisture
tapped in more complex loads.
B sted Heater: This increases the heating power available to your machine, thus speeding
up cycle times and improving the recovery time after negative pulses. Boosted heaters are
recommended if the vacuum system is fitted.

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Keep-warm Facility: Following completion of a cycle, this optional facility allows the
autoclave to keep media warm until removed from the chamber.
Printer: The thermal data printer provides details of each cycle in hard copy form.
Data Archiving: With this option, all cycles are recorded onto an integral flash card system.
The record of each cycle shows the date, time, batch number, operator identification and all
cycle data or failures. The record can be printed via the thermal data printer (if fitted), or
may be viewed on a PC using a serial data cable. The current cycle can also be viewed as a
real-time graph, showing chamber pressure, load temperature and exhaust temperature
using the system software.
Increased Cycle Mem ry: This option allows the number of available operating cycles
stored in the control system to be increased from 8 to 20. This is useful if a wide variety of
loads is to be sterilized by the autoclave.
M dem link: This optional feature allows remote connection to the machine, in order to
interrogate the system control software and make changes if required.
2.3 Load capacities
Load capacity depends on the type of load. In the case of bottles or flasks, the maximum
capacity for each chamber size is as follows:
M del 0.5 litre
b ttles
1 litre
b ttles
2 litre
b ttles
1 litre
flasks
2 litre
flasks
TCR/40/H 14 9 5 6 2
TCR/60/H 21 14 8 8 4
TCR/60/V (+2-tier basket) 12 (18) 8 (14) 4 (6) 4 (8) 2 (1)
TCR/120/H 48 23 13 13 8
TCR/120/V (+2-tier basket) 26 (42) 19 (32) 9 (14) 9 (16) (5)
TCR/160/H 63 30 18 18 10
TCR/160/V (+3-tier basket) 26 (63) 19 (48) 9 (14) 9 (24) (10)
The layouts for each model are illustrated in the Annexe at the end of this document.
2.4 The cycle sequence
The main stages of the sterilizing cycle are as follows.
Water fill
Touchclave-R autoclaves are fitted with water level sensors, which prevent the cycle starting
if there is insufficient water in the reservoir.
If the autoclave does not have the Automatic Water Fill fitted, the water in the chamber must
be filled manually up to the required level. The display on the touchscreen will show “Fill
Water”. When the water has reached the correct level, the display will change to show
“Water Level OK”. When the door has been shut, the display will change again to show the
“Lock” button.
If the autoclave has Automatic Water Fill installed, the display will show “Standby”. When you
close the door, the “Lock” button will be displayed. When you have selected the cycle you
wish to run, the display will show “Water Fill” while water is pumped into the chamber. This
can take up to 5 minutes, depending on the size of the autoclave’s chamber.

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Air rem val
If the autoclave does not have the Vacuum option fitted, the display will show “Steam Purge”,
which is the stage when air is removed from the chamber. The water in the bottom of the
chamber is heated to produce steam, which escapes through a valve at the rear of the
machine, carrying the air in the chamber with it.
For loads that are more likely to trap air, such as plastic discard, a vacuum system is
recommended. The stages displayed in this case are “Pre-Vacuum” and “Negative Pulsing”
(as explained above for the Vacuum System option). The vacuum has superior air removal,
but may increase the overall length of the cycle.
Heating up
The autoclave raises its pressure and temperature to the set sterilizing values specified for
the cycle. The time taken by this stage depends on the level of the set points and the
contents of the load to be sterilized. The load probe should be placed either in the load to be
sterilized or in a simulated load device. The stage will be complete when the sterilizing
temperature has been reached.
Sterilizing
During this stage, the cycle achieves its objective. Whilst the sterilizing temperature can be
set for any given cycle at any value between 105
0
C and 136
0
C, the values most commonly
chosen are 121
0
C or 134
0
C, depending on the nature of load to be sterilized (see below). If
the printer is fitted, its output during this stage will provide proof that the load has been
sterilized. The length of time for sterilization can also be selected by the user, up to a
maximum of 30 minutes.
C ling
The final stage is “Cooling”. The cooling fan blows air over the chamber until the temperature
has been reduced to the desired level (usually 80
o
C). Three types of cooling are available on
Touchclave-R models:
•Normal cooling allows the steam pressure to drop gradually until it reaches
atmospheric pressure, relying on fans to perform the cooling action.
•Dynamic cooling works in a similar manner until the pressure has dropped to
1150mba, when the machine blows air through the chamber, thus speeding up the
cooling action and helping to dry the load.
•Ballast cooling maintains the chamber pressure during cooling by replacing the steam
with air. This method minimises the fluid loss and is recommended for media loads.

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2.5 Typical cycles
The table below shows details of some typical operating cycles, showing set values for
different types of load.
Multi Purp se Machine
OPERATING CYCLE
NAME
CYCLE OR
LOAD TYPE
STERILIZING
TEMPERATURE
STERILIZING
TIME
COOLING
RATE
MEDIA Fluid 121
o
C 15 minutes 40 minutes
to 80
o
C
FLUID DISCARD Fluid 134
o
C 5 minutes 40 minutes
to 80
o
C
PLASTIC DISCARD Plastic
Discard
134
o
C 5 minutes 30 minutes
to 80
o
C
EMPTY GLASSWARE Empty
Glassware
134
o
C 5 minutes 30 minutes
to 80
o
C
MELT/FREE STEAM Melt/
Free Steam
105
o
C 30 minutes 20 minutes
to 80
o
C
INSTRUMENT Instruments 134
o
C 5 minutes 30 minutes
to 80
o
C
P r us L ad Machine – N n Medical Device
OPERATING CYCLE
NAME
CYCLE OR
LOAD TYPE
STERILIZING
TEMPERATURE
STERILIZING
TIME
DRYING
RATE
FABRICS Porous 134 3mins 3mins but
can be
extended
FABRICS Porous 121 15mins 15mins
INSTRUMENT Porous 134
o
C 3 minutes 3mins but
can be
extended
INSTRUMENT Porous 121
o
C 15 minutes 15mins
The following test cycles are also available through the control system. They can only be
carried out when there is no operating cycle in progress.
TEST CYCLE
NAME
TEST PURPOSE
LOCK/UNLOCK Check functioning of door
mechanism
LEAK TEST (vacuum
models only)
Check pressure leak rate
The LEAK TEST on Vacuum/Porous load models has two stages:
•Vac – a vacuum is pulled in the chamber
•Test – the chamber is sealed off.
Each stage is activated alternately by touching the PUMP button on the Leak Test screen of
the control system. The test ends when the FINISH button is touched. The leak test logs
time, pressures and temperature at the start and end of each stage, when requested by the
operator using the PRINT/LOG button.

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3. THE CONTROL SYSTEM – COMMANDS AND SCREEN TYPES
The main command buttons and types of display screen of the touchscreen control system
are described in this section.
3.1 Commands
The basic commands are common to all the screens. They appear on the screens as touch
buttons with the following functions:
 To return to the previous screen – this button appears at top right on the screen.


 

 To move forwards or back to another screen within a set of screens.
  To move between multiple sets of screens.
+/Y -/N To move up or down between multiple-choice options for values on a screen.
  To move up or down through the menu options.


 To select or enter the highlighted option.
3.2 Process screens – Typical
Process Screens show the name of the selected cycle with its temperatures and pressures.
When the autoclave is on standby, a screen such as the one shown below on the left appears
with the door control UNLOCK button. When a cycle is being run, a screen such as the one
shown below on the right appears, showing the cycle status, including the current stage and
the elapsed times.
UNLOCK
Chamber 1013 mBar
Vent 019.6 DegC
Load 023.2 DegC
3.3 Menu screens
Chamber 1013 mBar
Vent 019.6 DegC
Load 023.2 DegC
The various menus which can be accessed through the control system all share a common
format, as in the example below.
Data Archiving
Set Date/Time
Alarms
Status
Cycle Setup
The  and  buttons navigate the menu
options. When the arrow points to the
desired option, touch the 

 select/enter
button. If a menu has more than one page,
the navigation button will move the arrow to
the next page. To move back up the menu or
to return to the process screen, touch the
 return button.

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3.4 Password and batch code screens
A password may be required to gain access to some menus or operations. In such cases, the
screen shown below on the left will appear. The password is entered on the numeric keypad,
followed by touching the 

 enter button. If an invalid password is entered, a warning screen
will appear.
If a cycle is programmed to require a batch code, the screen shown below on the right will
appear when the START button is touched. The batch code can be entered using the
onscreen keypad, and the cycle will start when the 

 enter button is touched.
3.5 Parameter screens
Parameter Screens show the values for each of the parameters (or variables) in the cycle. They
appear in either ‘browse’ or ‘sequential’ mode. The ‘browse’ screen illustrated below on the left
has  and  buttons, so that the user can move back and forth between the different
Parameter Screens. The ‘sequential’ screen illustrated below on the right only has a  button,
so that each Parameter Screen appears in a predetermined sequence, as when a cycle is being
started.
Sterilize Time
0900 Secs
Today
The Parameter Screens may be edited to change the value of a parameter (or variable) on the
screen, either by using the onscreen keypad or, in the case of screens with multiple-choice
options, by selecting a value using the
+
YES and
-
NO buttons. The  return button is
touched to quit a parameter set after editing, or to abort the cycle start sequence.

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3.6 Warning and confirmation screens
Warning Screens appear automatically if a selected action cannot be executed for any reason.
An example is shown below. When the Warning Screen is touched as indicated, the system will
return to the previous screen.
Some actions require confirmation by the operator before being executed, as in the example
below. Touching the N or Yes buttons will confirm or cancel the action.

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4. THE CONTROL SYSTEM – OPERATING THE DOOR
It is only possible to operate the door of the chamber when there is no cycle in progress and no
automatic start has been set.
4.1 Locks
L cking
The door lock is operated by closing the door and touching the LOCK button on the screen.
Unl cking
At the end of a cycle, a screen will appear stating whether the cycle has passed or failed. By
touching the NEXT button, the screen shown below on the left will be displayed, confirming
that the door is locked and that there are no restrictions on unlocking it. The unlocking
sequence can then be started by touching the UNLOCK button. During the unlocking sequence,
a screen such as that illustrated below on the right will appear. The unlocking sequence can be
stopped by touching the ABORT button.
UNLOCK
Chamber 1013 mBar
Vent 019.6 DegC
Load 023.2 DegC
Chamber 1013 mBar
Vent 019.6 DegC
Load 023.2 DegC
4.2 Restrictions on door operation
When certain fault or alarm conditions occur, the control system may restrict the door operation
and show a screen stating the reason for the restriction. For example, the screens for ‘Chamber
Pressure Low’ and ‘Unsafe Chamber Pressure’ show that the door is prevented from being
opened even if the sterilization cycle has been successfully completed, because the chamber
pressure is either lower than the pre-set minimum or higher than the pre-set maximum. The
screen shown below for ‘Unsafe Probe Temperatures’ prevents the door from being opened if
the temperature is higher than the pre-set maximum.

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5. THE CONTROL SYSTEM – RUNNING A CYCLE
5.1 Starting the cycle
After the load has been placed in the chamber, the batch code entered (if required), and the
door closed, the autoclave is ready to start a cycle. By touching the START button on the
standby Process Screen (see section 4.2 above), a sequence of screens is activated to prepare
the autoclave to start a cycle. The operator is first asked to nominate the type of cycle which is
to be run. Some cycles may be set up to require a password to be entered. At the end of the
sequence, a Cycle Start screen similar to the one below appears, allowing the operator to
choose between an immediate start by touching the START button, or a delayed automatic
start by touching the AUTO button.
By selecting ‘automatic start’, the cycle can
be started at a later time. This may be useful
to enable the autoclave to be warmed up
before a sterilization cycle starts, or to allow
a sterilization cycle to be run overnight and
cooled down before unloading in the
morning.
After touching the AUTO button on the Cycle Start screen, the screens below will appear
sequentially, allowing the operator to enter the date and time of the start using the onscreen
keypad.
Today
When the date and time have been entered, a Process Screen will appear such as the one
below.
Chamber 1013 mBar
Vent 019.6 DegC
Load 023.2 DegC
The display shows the countdown time to
the cycle start. The cycle will start
automatically at the set time, provided that
no alarms have been triggered. If there is a
need to stop the automatic cycle before the
cycle starts, the ABORT button may be
touched (subject to a supervisor’s password
being entered).

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5.2 Cycle in progress
During the cycle, a Process Screen will appear at each stage of the cycle, as in the example
below.
Chamber 1013 mBar
Vent 019.6 DegC
Load 023.2 DegC
5.3 Faults
If a fault occurs, an alarm condition is triggered and a fail message will appear on the screen.
To find a description of the problem and to clear the fault, touch the ALARM button. A menu
will then be displayed, as on the screen below, indicating the nature of the fault on the list.
If an alarm condition occurs during a cycle, the system assumes that the integrity of the cycle
has been compromised, and it begins a pre-determined fault sequence of stages in order to
abort the cycle in the safest possible way. All cycles during which an alarm condition has
occurred are marked as ‘failed cycles’.
The LOG button is used to record all the faults which have occurred since the autoclave has
been switched on. This record is deleted when the autoclave is switched off.
When the problem has been resolved, the RESET button will clear the fault from the list.
Resetting can only be done outside the operating cycle, and is normally done by a supervisor
whose password has been entered.
Local Time
Temperatures (
0
C)
Pressure (mBar)
Stage Name
Stage Targets
Elapsed
stage time
Cycle Time
Stage time
remaining
Cycle
Number

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5.4 Cooling Override
It is possible to shorten the overall cycle time by accessing the Cooling Override through the
menu, which can bring the cooling stage to an end after the temperature has reduced to below
100
o
C (rather than the normal 80
o
C). If the Cooling Override is used, care must be taken to
ensure that the temperature inside the chamber is safe for the load when it is suddenly exposed
to ambient air temperature. It is recommended that the user draws up a procedure for use of
the Cooling Override function, and that its availability is limited to supervisors.
5.5 Finishing the cycle
At the end of the cycle, a ‘passed’ or ‘failed’ screen will appear as illustrated below. If the
Cooling Override has been used, a text message indicating this will flash below the result
message.
Chamber 1013 mBar
Vent 019.6 DegC
Load 023.2 DegC
Chamber 1013 mBar
Vent 019.6 DegC
Load 023.2 DegC
The NEXT button is touched to lead directly to door control.

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5.6 Sample cycle printout
The following is a sample of the printout for a sterilizing cycle.