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REFERENCE: .................................
GETINGE 46-SERIES
WASHER DISINFECTOR
CONFIGURATION SHEET
ORDERING INFORMATION
PRODUCT SELECTIONS FOR ORDERING
For ordering tick in your selections.
Standard choice Optional choice
LANGUAGE
Machine displays are available in a selection of languages.
User manuals are available for all EU languages except for
Greek.
Other technical documentation is available in English,
French, German and Swedish.
Please state language choice below:
VOLTAGE SUPPLY
MODEL SELECTION Please refer to technical data table for correct amperage.
Getinge 46-4 All models:
Getinge 46-5 415 V, 3N+PE, 50 Hz
400 V, 3N+PE, 50 Hz
PROGRAM SELECTION 380 V, 3N+PE 50 Hz
As standard all models are equipped with hospital 380 V, 3N+PE 60 Hz
programs adapted for the requirements in each country. 240 V, 3+PE, 60 Hz
All models: 230 V, 3+PE, 50 Hz
220 V-230 V, 3+PE, 60Hz
Hospital program, 90°C 1 min. A0 600
208 V, 3+PE, 60 Hz
Hospital program, 90°C 5 min. A0 3000
200 V, 3+PE, 50 Hz
Laboratory glassware programs (not in combination
200 V, 3+PE, 60 Hz
with dosing 3 or 4)*
* This option requires purified water. HEATING OF WASH, RINSE AND DISINFECTING WATER
As standard, all models are equipped with electrical sump
DOOR SELECTION heating.
Single door, with window and chamber light Electrical heating, coil behind filter
Double door, with window and chamber light Steam heating, coil behind filter
DRYER
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DOSING PUMPS
All models:
As standard two dosing pumps for process chemicals
No dryer
are supplied. As an option a 3rd and a 4th pump can be
Getinge 46-4 single door*:
chosen. When dos. 3 is chosen, the process chemical
Electrical heated dryer with fan and PTC heating
must be indicated below in order to get the adequate
element
machine configuration. All dosing pumps can be equipped
Electrical heated dryer with fan, PTC heating
with flow control. With flow control the dosing is volume
element and HEPA-filter
based.
Getinge 46-4 and 46-5: Dos. 1 and 2
Heat exchanger plus electrical heated dryer with Dos. 3 for instrument lubricant
fan, double PTC heating elements and HEPA-filter Dos. 3 for enzyme wash
with differential pressure monitoring Dos. 4 for chemical disinfection (not for SE, DK,
* Anesthetic equipment must be validated on site. NO, FI, IS)
Drying time might have to be extended to ensure a Liquids with a higher viscosity than 10 cSt can cause a
good drying result. clog of the flow monitoring function.
REV H
CUSTOMER: .................................
REFERENCE: .................................
CONDUCTIVITY MONITORING
No conductivity monitoring
Built-in conductivity control of rinse water with
repeated rinse function
PRINTER
The machine can be equipped with printer as an option.
A printer enables a printout of the process.
Built-in printer, soiled side
Built-in printer, clean side
Printer is required to fulfill EN ISO 15883.
REV H
GETINGE 46-SERIES
WASHER DISINFECTOR
PRODUCT SPECIFICATION
PRODUCT
The Getinge 46-series are fully automatic, microproces-
sor controlled, washer disinfectors. Processing cycles
are factory programmed with recommended treatment
parameters for pre-rinsing, cleaning, post-rinsing, thermal
disinfection, final rinsing and drying. Validated programs
are secured by access codes. Detergents and rinse agents
are automatically dispensed during cycle. The Getinge
46-series includes washer disinfectors with single as well
as double-door option. All models are designed according
to EN ISO 15883.
The Getinge 46-series consist of following models:
yy Getinge 46-4 (maximum 4 levels)
yy Getinge 46-5 (maximum 5 levels)
The capacity is 2 DIN-trays or SPRI II-trays per level.
INTENDED USE
The Getinge 46-Series are washer disinfectors for washing
intermediate level of disinfection and drying of surgical
instruments (rigid and tubular), hollow ware, wash bowls
and baby bottles, containers, laboratory glass and
anesthetic accessories (critical items, such as invasive
surgical instruments and anesthesia devices, must be
further processed by terminal sterilization before use in any
procedure). The receptacles should be loaded in correct
loading equipment recommended by Getinge Disinfection
AB to comply with EN ISO 15883.
The customer is responsible that installation qualification,
operating qualification and performance qualification are
performed according to EN ISO 15883 before product
usage.
KEY FEATURES
yy Rotary spray arms are fixed at the top and bottom of
the chamber
yy Wash carts are equipped with rotary spray arms
between each level to allow water and detergent to yy In Getinge 46-4 and 46-5 the drying air is pre-heated
reach all surfaces to be cleaned in a unique heat exchanger before being heated
yy Injection wash carts automatically connect to water to its optimum drying capacity in the heater box.
and drying air to clean and dry the inside of tubular This energy-saving process means also shorter drying
instruments times. HEPA-filter with differential pressure monitoring
is standard feature when drying system with heat
yy All models are, as standard, equipped with inde-
exchanger is chosen for Getinge 46-4 and 46-5.
pendent temperature monitoring and validation test
port according to EN ISO 15883
yy Data interface RS232 + RS485 for external printer
yy Window in door, chamber light, test port for water
and combined coarse-/fine-meshed strainer are
standard features
QUALITY STATEMENT OPERATOR CONTROL PANEL
Confidence in the Getinge Group is the most important The machine is controlled and operated from the control
quality criterion. It must be the hallmark of all our external panel above the soiled-side door. The panel interface is a
durable LCD display with two rows with 20 character on
and internal commitments, activities and products. Prod-
each row. A screen saver extends the life of the backlit LCD
ucts and service supplied by Getinge must conform to the display. Touching any key illuminates and reactivates the
agreed terms and expectations to ensure recommenda- display.
tions for further business. The achievement of these quality
Following indicators and function keys are located on the
goals is the basis for continued completive and successful display:
enterprise. yy Process running
yy Process complete
STANDARDS AND CODES yy Alarms
The Getinge 46-Series washer disinfectors complies with
the following requirements and standards.
yy Reset alarms
yy Start cycle
yy MDD 93/42/EEC (Medical Device Directive) yy Program selection 1-6
Certificate 41314824 issued by Intertek Semko AB,
The software has a memory for up to 20 programs. Below
Code 0413
the screen there are six programmable buttons for the most
yy ETL/SEMKO (Testing Laboratories Inc.) common programs. The other programs are reachable by
Standard: UL 61010-1, CAN/CSA C22.2#61010.1 entering the menu.
CAN/CSA-C22.2 No. 61010-2-040, IEC 61010-1
IEC 61010-2-40, EN 61010-1, EN 61010-2-040
DOCUMENTATION
yy EMC (Electromagnetic Compatibility) The following documentation will be sent out together with
Product standard: EN 61326-1 the product:
Product Family Standard: EN IEC 60601-1-2:2004
yy Microbiological test yy User manual in local EU language (paper)
SPRI specification 74203 yy Installation manual in English, German, French or
yy EN ISO 15883 CONTROL SYSTEM FEATURES Swedish (paper)
yy Declaration of Conformity (paper)
PACS 350 microcomputer controls yy Goods placement poster/quick start (laminated
The PACS 350 modular PLC control system is dedicated to paper)
the control, operation and maintenance of Getinge steril- yy CD containing all approved language for the user
izers and washer/disinfectors, featuring: manual, installation manual and program sheet
yy CPU processor with battery backup The following documentation is to be provided by the
yy Digital inputs and outputs for machine control sales company to the end customer upon demand:
yy Analog measuring inputs yy Technical manual
yy RS-232 COM port for serial communication yy Parts list
yy RS-232/RS-485 COM port
yy Up to 20 cycle program memory DISCLAIMER
Do not use this product specification for installation of
The PACS 350 controls all system functions, both visually
equipment. Subject to change without notice.
and audibly alerts the operator of cycle malfunction and
on demand, provides visual indication of the chamber
temperature.
OUTER DIMENSIONS
Dimensions in mm
A
Hole min B
Service area
INSTALLATION
Dimensions
50
2”
Steam heated
180 195
7,1” 7,7”
250
9,8”
3,4”
100
50
2”
3,4”
100
4,3” 2,8”
110 70
27,2”
690
17,3”
440
10,8”
11,8”
275
300
50 150
2” 5,9”
235
5,9” 3,4”
150 100
9,3”
420
16,5”
125 250
4,9” 9,8”
250
9,8”
3,4”
100
50
2”
3,4”
100
4,3” 2,8”
110 70
27,2”
690
17,3”
440
11,8”
10,8”
300
275
50 150
5,9” 3,4”
150 100
2” 5,9”
235
9,3”
UTILITY REQUIREMENTS
Utility Unit connection Supply pressure requirements Flow requirement Comments
Cold water (CW) 15 mm (½”) 100 - 800 kPa 20 l/min See notes 1, 6 and 7
Hot water (HW) 15 mm (½”) 100 - 800 kPa 20 l/min See notes 2, 6 and 7
Purified water (DW) 20 mm (¾”) 50 - 800 kPa 20 l/min See notes 3, 6 and 7
Drain (D) 50 mm (2”) N/A 50 l/min See notes 4, 6 and 8
Steam (S) 15 mm (½”) 300 - 500 kPa 0,5 kg/min See notes 5, 6 and 7
Exhaust (EX) Ø 63 mm N/A 125-150 m³/h See note 9
Electrical (E) Pre fuse Max power See notes 10 and 11
* See note 12
Notes:
1) CW recommended quality = drinking water (see installation manual) and temperature 5-25°C (41-77°F).
2) HW recommended quality = drinking water ( see installation manual) and temperature 45-60°C (113-140°F).
3) DW quality = customer selection. Maximum temperature 90°C (194°F). If pressure <100 kPa, a separate pressure
booster pump must be connected.
4) Without drain cooling is the volume > 50 l/minute and temperature up to 90°C (194°F). With drain cooling >90 l/minute
and 60°C (164°F). Recommended drain pipe size is Ø 100 mm (4 inches).
5) Demand is based on 300 kPa pressure and will vary with different loads. Supply pressure shall be dynamic pressure
(pressure at inlet minus condensate back pressure). Max temperature 160° C (320°F).
6) It shall be the users responsibility to insure by use of pressure regulators or other means that maximum specified
pressures are not exceeded.
7) It shall be the users responsibility to eliminate water or steam hammer conditions should they occur in the
service piping.
8) It shall be the customers responsibility to provide a properly sized and located drainage system in accordance with the
national plumbing code. Consider that other equipment is tied to train to eliminate slow drainage or backup.
9) It shall be the customers responsibility to provide a venting system capable of exhausting 150 m³/h measured at
the point of connection to the washer. The venting system shall have an air gap of at least 50 mm direct after the
exhaust. This means that the exhaust air will be mixed with room temperature air. Maximum air temperature from washer
will be 35°C (95°F). The exhaust air humidity will be 100% to start with and then drops to approximately 40% after
2 minutes. The system should be a dedicated, corrosion proof and water tight vent, slope vent back to washer.
10) It shall be the user responsibility to complete all electrical connections using properly sized wiring in accordance with the
national electrical code.
11) It shall be the customers responsibility to proved a fused disconnect switch in all electrical supply lines at the washer
location.
12) LpA levels are measured according to EN ISO 3747:200, 1 meter in front of the washer and 1.5 meter above the floor
level.
COMPLETE SOLUTIONS FOR CONTAMINATION PREVENTION
Getinge is the world’s leading provider of solutions for effective
cleaning, disinfection and sterilization in the healthcare and life
science sectors. We are dedicated to helping our customers
provide maximum productivity in the most cost-efficient way.
We do this by offering well thought through and customized
solutions. This means that we are with our customers all the
way from architectural planning and education to traceability and
support – with complete solutions, long-term commitment and
global presence. Getinge – Always with you.