GETINGE 46-SERIES
Getinge Disinfection AB · Model 46-5
WASHER DISINFECTOR 46-5 D+NO D, D+NO D indicating double door machine without dryer. Cat No was earlier 46-5-401. New Cat No 46-5-501 from March 2019.
Intended use: A mains electricity (AC-powered) unit designed to wash (remove dirt/stains), decontaminate (remove organic debris), and disinfect (destroy microorganisms) reusable surgical instruments, bowls, anaesthesia equipment components, and some surgical footwear. Most instruments, especially those used invasively or in a sterile field will require sterilization after this process. It is typically located in rooms and central supply departments designed to handle soiled instruments/utensils. It typically includes internal baskets/racks in which the utensils are placed to ensure circulation of the heated water/detergents to all surfaces.
Key tips
- ·A failed biological indicator means the entire load is not sterile - no exceptions, regardless of how the cycle printout looks.
- ·Door gasket wear is the most common real cause of a failed vacuum/pressure test - check it before deeper diagnostics.
- ·Water quality directly affects steam-cycle validity - don't ignore scale or mineral buildup.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Will not power on or unexpected shutdown
HighSymptoms: The sterilization is dead, reboots, or shuts down mid-use.
Root cause: Mains lead / fuse, an aged battery, or a power-supply board fault.
Battery will not hold charge
MediumSymptoms: Short run time on battery; low-battery alarm soon after a full charge.
Root cause: Aged rechargeable battery pack or a charger fault.
Display / control-panel fault
MediumSymptoms: Blank, dim or distorted display; unresponsive keys or touchscreen.
Root cause: Display, backlight, or control-board fault.
Fails self-test or calibration
MediumSymptoms: Power-on self-test or the scheduled performance check fails or is out of tolerance.
Root cause: Sensor drift or an internal board fault; recalibration or repair needed.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Rechargeable battery pack
Class Periodic replacementRel. cost $$R&R Fairly easy
Power supply / mains board
Class Major service partRel. cost $$$R&R Difficult
Display / control-panel assembly
Class Major service partRel. cost $$$R&R Moderate
Cooling fan
Class Major service partRel. cost $R&R Moderate
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Rechargeable battery pack | Periodic replacement | $$ | Fairly easy |
| Power supply / mains board | Major service part | $$$ | Difficult |
| Display / control-panel assembly | Major service part | $$$ | Moderate |
| Cooling fan | Major service part | $ | Moderate |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily biological and chemical indicator test loads
- ·Door gasket / seal inspection
- ·Steam trap and drain strainer cleaning
- ·Annual full PM and pressure-vessel certification
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Will not power on
- Confirm the outlet, mains lead and fuse.
- Try on battery, then on mains only, to isolate the supply.
- Look for a power indicator or POST code.
- Replace the fuse / battery / power supply as isolated.
- Run the self-test after any repair.
Symptom: Fails self-test or calibration
- Note the exact failure message / code.
- Power-cycle and repeat the self-test.
- Verify against a reference / simulator where one applies.
- Recalibrate per the service manual.
- Refer the affected board for service if it will not hold calibration.
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Surgical utensil washer/disinfector
- FDA product classification
- Disinfector, Medical Devices
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Central Sterile Supply Department (CSSD)
- OR sterile core
- Satellite reprocessing areas
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
- RECALL
There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.
- RECALL
Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
- RECALL
Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.
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