Getinge HS 6613 ER-2 Product information sheet

HS 6613 ER-2
UNITED DOCTORS HOSPITAL
2530290-090-01
Original User Manual

TABLE OF CONTENTS
PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Attention symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Reporting an accident or incident . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
HS 66. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Overview of safety devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Built-in electrical steam generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
THE PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
The steam sterilizing process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Maintenance program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Documentation of the process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Documentation of the process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
INSTRUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
OPERATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Program start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Alarms - Avanti. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Error codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
General advice when using the sterilizer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Weekly cleaning - Avanti. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Approved consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
OPERATION INSTRUCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Daily preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
CONTROL UNIT PACS 3500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Control panel type Avanti . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Operator menu Avanti. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
PROGRAM COMBINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67

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.
Manufacturer address:
Getinge Sterilization AB
Ekebergsvägen 26
305 75 Getinge
Sweden
Fax [phone]

2

SAFETY - 3
SAFETY
Attention symbols
Some of the warnings, instructions and advice in this manual are so
important that we use the following special symbols to draw attention
to them. The designs and symbols used are:
Warnings
Instructions
Advice
This symbol indicates a warning in the text of the manual.
It warns of a hazard that may lead to 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” in the Introduction
chapter in the USER MANUAL or in the Maintenance
chapter 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.

4 - SAFETY
Symbols on the unit
Hot surface
Electrical danger
Other dangers
This symbol warns of a hot surface.
This symbol warns of an electrical danger.
This symbol warns of other dangers.

SAFETY - 5
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 acci-
dents/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 cabi-
net), 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
305 05 GETINGE
Sweden
Fax: [phone]
Use this information when reporting incidents and acci-
dents involving the unit.

6 - SAFETY