Getinge HS 6613 AR-2 User manual

HS 6613 AR-2
TEHRAN NAFT HOSPITAL
2511022-150-01

TABLE OF CONTENTS
PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Attention symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Reporting an accident or incident . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
HS 66. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Overview of safety devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
THE PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
The steam sterilizing process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Maintenance program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Documentation of the process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
INSTRUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
OPERATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Program start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Error codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
General advice when using the sterilizer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Weekly cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Approved consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
OPERATION INSTRUCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Daily preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
CONTROL UNIT PACS 3500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Operating panel type OP 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Control panel type OP 20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Indicators and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
The operator’s menu tree. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Description of operator menu tree. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Program combination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Program combination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

1
PREFACE
This USER MANUAL, contains all the information you need in order
to safely operate your GETINGE STERILIZATION AB equipment.
Please read and follow the entire manual carefully, and please pay
special attention to the framed warnings and caution remarks. See
“Attention symbols” under Safety.
In the event of an accident or incident you are obliged to report this. See
“Reporting an accident or incident” under Safety.
GETINGE STERILIZATION AB shall not be liable for any damages,
directly or indirectly, due to actions, which are not in accordance with
this manual.
By following this manual you are ensured quality equipment for many
years ahead. Should any unforeseen problems occur, you are of course
welcome to contact our local representative.

2

3
SAFETY
Attention symbols
Some of the warnings, instructions and advice in this manual are so
important that we used the following special symbols to draw attention
to them. The symbols used are as follows:
Warnings
Instructions
Advice
Symbols on the unit
Hot surface This symbol gives warning of a hot surface.
This symbol indicates a warning in the text of the manual.
The nature of what the warning relates to is such that it
may result in more or less severe injury and in certain
cases mortal danger.
The symbol is also used to highlight safety components,
etc. See “Safety devices - an overview” under Introduction
in the USER MANUAL or under Maintenance in the
TECHNICAL MANUAL.
This symbol highlights instructions that are important for
avoiding damage to the unit and/or load, among other
things.
This symbol indicates important advice and hints that
make it easier to work with the unit.
SS
S

4
Reporting an accident or incident
If an accident or an incident associated with the sterilizers occurs, this
must be reported immediately in writing to the address below. The
report must be used to identify the cause of the accident or incident and
to what extent the occurrence was due to the unit
The unit is a product in the GETINGE range.
The unit may also be a sterilizer that is a medical engineering product
and which conforms to the EU medical devices directive, or which is
constructed in a similar way to a medical device. Under the medical
devices directive, the manufacturer must investigate the cause of
accidents/incidents that occur and report them to the authorities
concerned.
The investigation may lead to changes in new or already delivered
devices or in instructions and guidance.
The following circumstances must be reported:
1. Circumstances that caused the death of a patient, user or someone
else, or that caused serious deterioration in the health of a patient,
user or someone else.
2. Circumstances that might have caused, the death of a patient, user
or someone else, or that might have caused serious deterioration in
the health of a patient, user or someone else.
The following information is required:
The manufacturing number of the unit (on a label in the electrical
cabinet), Date/time of event, Description of event, Consequences of
event.
Contact: Name, Phone number, Address:, E-mail:
The information must be sent by letter or fax to:
GETINGE STERILIZATION AB
For the attention of: Quality Manager
Box 69
31044 GETINGE
Sweden
Fax: [phone]
Use this information when reporting incidents and
accidents involving the unit.

5
INTRODUCTION
HS 66 HS 66 is the designation of a series of GETINGE high-pressure
autoclaves with vertically sliding automatic doors, all with the door
opening 660 x 660 mm
There are both stand-alone and built-in versions.
The autoclaves are intended for sterilization of materials in the health
service as well as in industry. They are adapted to their particular
functions by the choice of control equipment. This is built up around a
microprocessor and therefore provides a very large number of process
types, all characterized by exceptional accuracy in controlling the
process parameters. The operator can call up on a display information
on the current process, current process phase and the actual values of the
parameters while the process is in progress.

6
The dominant sterilizing agent is steam at a temperature of 121 -
134 °C. Material that is damaged by this temperature may be sterilized
in some autoclave models in formalin vapour at 55 - 80°C.
Most types of items can be treated in the HS 66-autoclaves, using
adapted programs:
Instruments, machine parts, glass, plastic, leather, textiles, hot or cold
liquids in open or vented containers and small rigid pressure-tight
containers filled with liquids.
European standard EN 285 (Australia/New Zeeland, Standard AS
1410) specifies the use of fixed programs only. However, the control
equipment of HS 66-autoclaves allows the programs to be made
variable during the time testing is in progress.
As not only the processes but door operation too are controlled
automatically, the step to full automation of thehandling of sterileitems
is not a long one. The control unit is therefore prepared for controlling
an autoclave having a GETINGE ASF automatic loading and unloading
unit.
As with other GETINGE double-jacketed autoclaves, the external
surface of the chamber is more than half covered by all-welded U-
sections.. These stiffen the flat walls of the pressure vessel, and at the
same time accommodate the steam which keeps the chamber walls
warm in order to minimize condensation in the chamber. The design
principle makes all welds accessible for visual inspection after the
thermal insulation has been removed.
A vacuum pump of the water-ring type removes air, steam and
condensation from the chamber and door-gasket groove. The sealing
water of the pump is taken from an open tank which in some cases also
supplies the feedwater pump, on autoclaves with a steam generator,
with water.
The condenser between the chamber and vacuum pump converts
waste steam to water. This reduction of the pump handling volume
contributes greatly to improving pump efficiency and protecting the
pump and waste pipes against high temperatures.
A well-damped discharge system after the vacuum pump and well-
dimensioned thermal insulation around the chamber mean that the
autoclave affects the surroundings to an insignificant extent and is
therefore easy to position.