Getinge 46 Series User manual

2019-10-31 EN REV.B
User Manual
6002267102
Getinge 46-series
46-4, 46-5

The model name and serial number should always be provided when ordering spare parts or during queries per telephone or written
correspondence:
Serial number of the machine:
……………………………………………………
Machine model:
……………………………………………………
The manual, or parts thereof, are a part of the product. This manual must not be modified, reproduced or copied without Getinge’s written
consent. The content may not be reused by third parties or used for unauthorized purposes. Violators will be prosecuted. Additional
copies of this manual can be obtained from Getinge for a fee.
© Copyright 2013 Getinge. Reprinting prohibited.
Getinge Disinfection AB
Ljungadalsgatan 11
352 46 Växjö
SWEDEN
Internet: www.getinge.com

Contents
PREFACE.......................................................................................................................... 5
1 INTRODUCTION........................................................................................................... 6
1.1 Symbols in this manual....................................................................................... 6
1.2 Intended use statement....................................................................................... 6
1.2.1 Intended application areas.................................................................... 6
1.2.2 Intended user........................................................................................ 7
1.2.3 Intended user environment................................................................... 7
1.3 Potential misuse.................................................................................................. 7
1.4 Product liability.................................................................................................... 7
1.4.1 Declaration of Conformity..................................................................... 7
1.4.2 Disclaimer............................................................................................. 8
1.4.3 Manufacturer......................................................................................... 8
1.4.4 Warranty............................................................................................... 8
1.5 Product label....................................................................................................... 9
2 SAFETY...................................................................................................................... 10
2.1 Important........................................................................................................... 10
2.2 Isolator switch................................................................................................... 10
2.3 In an emergency............................................................................................... 11
2.4 General warnings.............................................................................................. 11
2.5 Safety labels on the machine............................................................................ 11
2.6 Personal protection........................................................................................... 11
3 DESCRIPTION............................................................................................................ 12
3.1 General............................................................................................................. 12
3.2 Configurations................................................................................................... 12
3.3 Components...................................................................................................... 13
3.4 Control panel..................................................................................................... 14
3.5 Control system.................................................................................................. 14
3.6 Door function..................................................................................................... 15
3.7 Dosing system................................................................................................... 16
3.8 Drying................................................................................................................ 16
3.9 Accessories....................................................................................................... 16
3.10 Ambient illumination........................................................................................ 17
3.11 Electromagnetic environment.......................................................................... 17
4 OPERATION............................................................................................................... 18
4.1 Preparations...................................................................................................... 18
4.1.1 Loading the wash cart......................................................................... 18
4.2 Loading the chamber........................................................................................ 19
4.3 Starting program............................................................................................... 20
4.4 During ongoing program................................................................................... 21
4.5 After program completion.................................................................................. 21
4.6 Check cleaning and disinfection results............................................................ 22
4.7 Handling chemical agents................................................................................. 22
4.8 Preparations for downtime................................................................................ 22
4.9 Handling printouts (option)................................................................................ 23
5 DETERGENT.............................................................................................................. 24
Contents
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5.1 Using detergent................................................................................................. 25
5.2 Detergent range................................................................................................ 26
5.3 Positioning......................................................................................................... 26
5.4 Replacing empty containers.............................................................................. 26
6 MAINTENANCE.......................................................................................................... 27
6.1 Daily inspection................................................................................................. 28
6.2 As needed......................................................................................................... 29
6.2.1 Clean the outside................................................................................ 29
6.2.2 Fill up with detergent........................................................................... 30
6.2.3 Maintenance of parts inside the chamber........................................... 32
6.2.4 Descale the washing chamber............................................................ 35
6.2.5 Servicing the printer (option)............................................................... 36
6.2.6 Handling the USB memory stick (option)............................................ 37
6.2.7 Disinfecting chamber.......................................................................... 38
6.3 Preventive maintenance.................................................................................... 38
6.3.1 Periodic maintenance......................................................................... 38
6.3.2 Service table....................................................................................... 39
6.4 Machines that are not in use............................................................................. 39
7 ALARM HANDLING.................................................................................................... 40
7.1 Start condition................................................................................................... 40
7.1.1 Start condition list................................................................................ 41
7.2 Alarm................................................................................................................. 42
7.2.1 Alarm list............................................................................................. 43
7.3 Restart the machine.......................................................................................... 44
8 WATER QUALITY....................................................................................................... 45
9 HANDLING OF WORN-OUT PRODUCTS................................................................. 47
9.1 WEEE directive................................................................................................. 47
9.2 Disposal of detergent or detergent containers.................................................. 47
9.3 Disposal of the machine, accessories or spare parts........................................ 47
9.4 List of materials................................................................................................. 48
10 SERVICE CONTACTS.............................................................................................. 49
Alphabetical index............................................................................................................ 51
Contents
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PREFACE
This manual is intended for users of products from Getinge
Disinfection AB.
The user manual describes the design and operation of the
machine and the maintenance for which the user is responsible.
The installation manual describes the machine's installation. The
technical manual describes necessary information for operators
and maintenance personnel. The information in the manual must
be complied with to ensure safe and error-free operation.
Read the manual before use.
Before using the machine for the first time, users must read this
manual and familiarize themselves with the functioning and
operation of the machine as well as its safety instructions.
Operators and maintenance personnel must complete training
arranged through Getinge's sales organization.
The information in this manual describes the machine as
dispatched from Getinge Disinfection AB. There may be
differences due to customization for customers or countries.
The machine is accompanied by the following documentation:
• User manual
• Installation manual
• Quick guide
• Declaration of conformity
The following documentation is supplied via electronic media:
• User manual
• Installation manual
• Quick guide
• Electrical diagrams
• Program sheets
The following documentation shall be provided by the sales
company to the end user on request:
• Technical manual
• Spare parts list
The accompanying Quick guide must be hung up and clearly
visible in the installation area.
The information in this manual was up-to-date on the date that the
manual was issued.
PREFACE
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1 INTRODUCTION
1.1 Symbols in this manual
In this manual, warnings and information are indicated by the
following symbols.
Indicates a hazardous situation that could result in
death, personal injury or damage to property if it is
not avoided.
Points out important details to consider for trouble-
free and efficient use of the machine.
Information text: Read the manual before use.
1.2 Intended use statement
The intended use of the 46-series washer-disinfector is to clean,
thermally or chemically disinfect, and dry surgical goods.
Typical goods for cleaning and thermal disinfection are:
• Instrument containers
• Anesthesia equipment
• Bowls
• Basins
• OP shoes
• Dental instruments
• Glassware, bottles and beakers
• Invasive surgical instruments, MIS instruments
Typical goods for cleaning and chemical disinfection are:
• OP shoes
1.2.1 Intended application areas
The washer-disinfector performs the following basic functions:
• Cleaning of medical and laboratory equipment.
• Disinfection of medical and laboratory equipment.
• Drying of medical and laboratory equipment.
1 INTRODUCTION
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1.2.2 Intended user
The intended users of the 46-series washer-disinfector are
operators and service personnel.
Operators
Operators are clinical personnel, who use the machine for its
intended use. A typical person in this user group is a nurse or
assisting nurse.
Typical tasks/responsibilities:
• Daily use, loading/unloading items, choosing and starting
processes and cleaning of equipment.
• Daily, weekly and monthly preventive maintenance to be
performed by this type of staff.
Service personnel
A typical person in this user group is a Getinge technician or a
local technician at the facility.
Typical tasks/responsibilities:
• Installation.
• Yearly preventive maintenance.
• Troubleshooting.
• Emergency shut-downs.
• Education.
• End of service life and recycling.
1.2.3 Intended user environment
The 46-series washer-disinfector is a stationary installation used in
facilities such as Central Sterile Supply Departments (CSSD), next
to the Operating Room, in dental clinics or in hospital wards.
1.3 Potential misuse
• The washer-disinfector is not intended for use with household
detergents.
• The washer-disinfector is not intended for cleaning and
disinfection of bedpans or urine bottles (ISO 15883-3).
• The washer-disinfector is not intended for cleaning and
chemical disinfection of thermolabile endoscopes (ISO
15883-4).
1.4 Product liability
1.4.1 Declaration of Conformity
The product compliance is stated in the Declaration of Conformity.
1 INTRODUCTION
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1.4.2 Disclaimer
• The manufacturer cannot guarantee that the product will work
as intended if accessories or spare parts other than those
approved by the manufacturer are used.
• The product liability only applies when the instructions in this
manual have been followed in their entirety.
• The manufacturer accepts no responsibility for personal
injuries when the instructions in this manual have not been
followed in their entirety.
• The manufacturer reserves the right to change the
specification and design of the product without any prior
notice.
1.4.3 Manufacturer
This product was manufactured by:
Getinge Disinfection AB
Ljungadalsgatan 11
352 46 Växjö
SWEDEN
1.4.4 Warranty
The product warranty applies in accordance with the agreement
reached between the Getinge sales company and the customer.
1 INTRODUCTION
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1.5 Product label
The product labels are attached on the inside of the detergent
cabinet. The product model and serial number are important when
communicating with Getinge.
0123
GETINGE DISINFECTION AB
WASHER DISINFECTOR
XXXXXX ETL LISTED
US
CM
C
CONFORMS TO
CERTIFIED TO
Intertek
9700819
CAN/CSA C22.2 No.61010-1,61010-2-040
UL STD 61010-1, 61010-2-040
YYYY-MM-DD
A
CM F
IP 21DMAX
B E
kW
kW
kW Hz
COLD WATER
HOT WATER
STEAM (optional)
TREATED WATER (optional)
100-800 kPa
Pressure Temperature
100-800 kPa
300-500 kPa
100-800 kPa
Max. 20 °C
45-60 °C
Max. 160 °C
Max. 60 °C
WXXXXXXXX
SN
MD
REF
LJUNGADALSGATAN 11, 352 46 VÄXJÖ, SWEDEN
GETINGE DISINFECTION AB
LJUNGADALSGATAN 11, 352 46 VÄXJÖ, SWEDEN
1514
16
2
1
3
6
7
9
4
8
18
17
10
5
11
12
13
005964
1. Designated purpose
2. Serial number
3. Medical device
4. Voltage alternative
5. Frequency
6. Fuse
7. Protection class
8. Manufacturer
9. Total effect
10. Circulation pump effect
11. Heating element effect
12. Date of manufacture
13. Machine model
14. Product listing
15. Recycling symbol
16. CE labeling
17. Media connection
18. Approval marking
1 INTRODUCTION
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2 SAFETY
The machine has a number of built-in safety mechanisms. To avoid
injury, it is highly important not to bypass these safety
mechanisms.
2.1 Important
• Read the manual in its entirety before use.
• The machine must be connected in accordance with the
instructions provided in the installation manual.
• The machine should only be handled by authorized
personnel. Personnel must also receive regular training.
• Exercise caution when using the machine because, it uses
hot water and possibly steam.
• Exercise caution when handling the chemical agent used in
the machine. Follow the instructions on the agent container:
oif the agent is swallowed, comes into contact with the
eyes or skin or if vapors are inhaled.
ofor instructions on dosage amount and washing
temperatures.
ofor instructions regarding storage and sorting/disposal of
packing.
• Make sure that the machine has access to detergent before
the process starts. This is important both for the operation of
the machine and for keeping the washing chamber free off
staining.
• The machine must be kept clean so that it will work properly.
• Do not wash down or hose down the machine with water.
• Installation and service work must be performed by trained
personnel.
• Never bypass the machine's door switch under any
circumstances.
• Leakage in the system, due to a worn door seal, for example,
must be repaired without delay.
• The cover plates, top and plinth may not be removed while
the machine is operating. This overrules safety and the
operation of the machine.
• National and local rules may apply and must always be
followed.
• Spare parts must only be obtained from Getinge's sales
companies.
2.2 Isolator switch
The machine must be preceded by a lockable switch for the
electric power supply. The switch must be easily accessible on a
wall close to the machine. The installation must conform to and be
marked in accordance with local regulations.
2 SAFETY
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2.3 In an emergency
• Switch off the main switch.
• Close shutoff valves in the water and any steam supply lines.
For more information, see section 7.3 Restart the machine.
2.4 General warnings
WARNING!
Risk of burns
Hot steam may escape from the chamber when
the door is opened or during a running process.
- Pay attention when standing next to the
machine.
2.5 Safety labels on the machine
Labels on the machine point out potential hazards.
Symbol Hazard Measure
Warning or
Caution
Pay attention.
Warning about hot
surfaces
Pay attention when in contact
with the washer-disinfector's
surfaces.
Warning about
dangerous voltage
Pay attention when close to
live parts. Do not touch
electrical equipment or
installations.
2.6 Personal protection
Working with the machine includes handling heavy loads and
contact with hot surfaces and chemicals. Use protective gear, for
example, footwear, gloves, clothing, glasses and other equipment
according to local regulations.
2 SAFETY
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3 DESCRIPTION
3.1 General
The customer is responsible for ensuring that an Installation
Qualification, Operating Qualification and Performance
Qualification according to ISO 15883 are carried out before the
product is put into use.
Incorrect use may result in damage to objects and in personal
injury.
The machine has spray arms and dockings as follows:
• 46-4 has two spray arms and two dockings.
• 46-5 has two spray arms and three dockings.
The machine can be equipped with several different accessories
for different cleaning requirements. These accessories are
presented in a special accessories catalog. There are several
possible ways of installing and equipping the machine depending
on its field of application:
• 46-4 and 46-5 have electric or steam heating.
• 46-4 and 46-5 are fitted with a single or double door.
• Connecting treated water.
• Extra dosing pumps that allow, for example, chemical
disinfection of heat-sensitive goods.
• With or without built-in drying system.
• Audible signal with Alarm.
3.2 Configurations
Model Chamber
width
(mm)
Chamber
length
(mm)
Chamber
height
(mm)
Effective
chamber
volume
(L)
Gross
chamber
volume
(L)
46-4 550 620 590 201 280
46-5 550 620 660 225 305
3 DESCRIPTION
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3.3 Components
000821
8
109
7
6
5
4
2
3
1
1. Conductivity (option)
2. Control panel
3. Main switch (option)
4. Wash chamber
5. Bottom strainer with handle
6. Dosing pumps
7. Door
8. Dryer module
9. Suction lance
10. Detergent container
3 DESCRIPTION
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3.4 Control panel
The machine is operated from the control panel above the soiled-
side door. The illustration below shows the locations of buttons and
indicators.
P01 OP-SHORT-D
47.0°C
000822
31 42 5 6 8 97
1. Arrow keys/Menu selection buttons
2. Yellow light: Program running
3. Green light: Program complete
4. Red light: Alarm indication
5. Program number
6. Before starting: Selected program
While running: Program phase (e.g. “Rinsing”)
7. Program selection buttons
8. Alarm reset button
9. Start wash program
3.5 Control system
WARNING!
Programming may only be done by authorized
personnel.
The machine has an electronic controller that contains various
programs. Six of these programs can be selected with the program
selection buttons. The other programs can be selected using the
menu buttons. A number of standard programs in the control
system are provided upon delivery; see separate Program sheets
that are found on the accompanying electronic media.
3 DESCRIPTION
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3.6 Door function
The machine is equipped with either a single door or double
doors.
Machines with double doors have a system of interlocks to ensure
that only one door can be opened at a time. This means that the
clean-side door must be closed and locked before the soiled-side
door can be opened.
Pressing locks the door. When the program is complete, a
green light is lit on both sides (if there are double doors) and the
clean-side door is unlocked. When the door has been opened
manually, the green light turns off. With double doors, the clean-
side door must be closed before the soiled-side door can be
unlocked.
BA
000489
B. Clean side A. Soiled side
3 DESCRIPTION
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3.7 Dosing system
Note!
If the machine is not equipped with flow monitoring, the
dosing must be checked visually.
Note!
When changing the type of detergent, the dosing system
must be recalibrated for the new detergent.
In its standard configuration, the machine has two dosing systems.
Some machines are equipped with a third and fourth dosing
system.
The machine cannot be started until detergent has been added. If
the detergent container is empty, a message that says “DOS 1
LOW LEVEL” appears on the display.
2
000823
1
1. Suction lance
2. Containers for detergent/rinse-aid
3.8 Drying
If the machine does not have a dryer, we recommend that the
goods be dried in a separate drying cabinet.
3.9 Accessories
There are several accessories intended for use with this machine,
such as wash carts. For a complete list, see the Getinge loading
equipment manual.
3 DESCRIPTION
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3.10 Ambient illumination
The ambient illumination must be set according to ISO 12100.
3.11 Electromagnetic environment
The washer-disinfectors in the Getinge 46-series comply with the
EMC standard.
3 DESCRIPTION
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4 OPERATION
4.1 Preparations
4.1.1 Loading the wash cart
WARNING!
A fine filter must be used to clean and disinfect
tubular instruments with a passage of less than 2
mm, to prevent particles from getting stuck in the
instruments. Blocked or reduced water flow may
result in ineffective cleaning and no disinfection.
WARNING!
All containers must be emptied before they are
loaded into the machine.
Load the wash cart and observe the following guidelines:
• Always follow the cleaning instructions from the manufacturer
of goods and instruments.
• Certain types of materials require special handling before,
during and after cleaning in this machine. Instructions for
this are provided by the instrument manufacturer.
• Optics and light guides must be approved by the
manufacturer for thermal disinfection.
• Use inserts and special inserts as intended.
• Only use inserts that are intended for the goods that are to be
washed.
• Place sharp and pointed goods in such a way that they
cannot cause injury when they are loaded and unloaded.
• Ensure that the goods are not placed on top of each other,
which will prevent the water from reaching all surfaces.
• Place containers with openings downwards in the intended
inserts. The water must be able to flow freely through the
vessels.
• Tilt items in such a way that collection of water is prevented.
• Rigid endoscopes must be dismantled in accordance with the
manufacturer’s instructions before cleaning.
• Open all valves and remove covers and seals on items in
such a way that the channels can be thoroughly flushed out.
• Check that the items are retained in their inserts.
• Distribute the load evenly.
• Ensure that the water can flow through perforated
instruments. Special accessories may be needed for cleaning
certain instruments.
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• Ensure that the spray arms can rotate freely without touching
any of the items.
• Ensure that the spray arms reach all surfaces of the items.
• Make sure that the strainers in the machine are clean and
that water can flow through them. It is important to clean and
check the strainers regularly.
For more information about how to load the wash cart, see the
Loading guidebook for common hospital instruments in a Getinge
washer-disinfector manual.
4.2 Loading the chamber
Maximum weight of goods to be washed and wash cart
46-4 50 kg
46-5 60 kg
• Load the goods to be washed onto the appropriate wash
cart. Roll the trolley holding the wash cart up to the
machine. Roll the wash cart into the machine for processing.
• Make sure that the spray arms rotate freely without touching
the goods to be washed.
• Close the door and make sure that the handle is in the locked
position.
000824
4 OPERATION
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4.3 Starting program
WARNING!
Risk of contaminated items
Incorrect selection of a program can affect the
cleaning result.
- Follow operation instructions in User manual.
- Visually inspect the items after unloading.
- Follow manufacturer's reprocessing instructions
for medical items.
WARNING!
If the machine has not been used for more than
72 hours, a wash program with an empty chamber
must be run before using the machine to clean
goods.
WARNING!
A fine filter must be used to clean and disinfect
tubular instruments with a passage of less than 2
mm, to prevent particles from getting stuck in the
instruments. Blocked or reduced water flow may
result in ineffective cleaning and no disinfection.
WARNING!
If the program is aborted before it is completed,
the goods will not be properly washed or
disinfected. The program must then be run again.
4 OPERATION
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