GETINGE 46-SERIES
Getinge Disinfection AB · Model 46-5
WASHER DISINFECTOR 46-5 S+W D, S+W D indicating single door machine with dryer. Cat no was 46-5-402. From March 2019: 46-5-502.
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
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Door gasket / seal leak
HighSymptoms: Pressure loss, long cycle, steam leak.
Root cause: Aged rubber gasket.
Steam generator / heater fault
HighSymptoms: No steam, low temp, cycle abort.
Root cause: Failed heating element or scale buildup.
Vacuum pump failure
MediumSymptoms: Poor air removal, non-condensable gas fault.
Root cause: Worn vanes/seals.
Water quality / feed fault
LowSymptoms: Scaling, conductivity alarm.
Root cause: RO/DI system failure.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Vacuum pump & seals
Class Periodic replacementRel. cost $$$R&R Difficult
Chamber temperature sensor
Class Periodic replacementRel. cost $$R&R Moderate
RO/DI feed cartridge
Consumable.
Class Frequent wear itemRel. cost $R&R Easy
Door gasket / seal
Most-replaced wear item.
Class Periodic replacementRel. cost $$R&R Fairly easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Vacuum pump & seals | Periodic replacement | $$$ | Difficult |
| Chamber temperature sensor | Periodic replacement | $$ | Moderate |
| RO/DI feed cartridge Consumable. | Frequent wear item | $ | Easy |
| Door gasket / seal Most-replaced wear item. | Periodic replacement | $$ | Fairly easy |
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 structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Door gasket / seal leak
- Confirm the presentation - typically pressure loss, long cycle, steam leak - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: aged rubber gasket.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the door gasket / seal per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Steam generator / heater fault
- Confirm the presentation - typically no steam, low temp, cycle abort - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: failed heating element or scale buildup.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the steam generator heating element per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
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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