- Beckman Coulter Dxh 800 Specifications
- Beckman Coulter Dxh 800 Service Manual
- Beckman Coulter Dxh 800 Operator's Manual
UniCel DxH SLIDEMAKER STAINER Coulter Cellular Analysis System UniCel DxH Slidemaker Stainer Training Modules PN: A96923AA.2 (June 2014) Beckman Coulter Professional Development 1 of 6 COURSE GUIDE This document is not intended to replace the information in your Instrument Instructions for Use Manual (IFU). Product Instructions. Can’t find the manual(s) that came with your Beckman Coulter product? Use our site search or find what you need here. D-link dcs-2120 user manual.
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Beckman Coulter - Unicel Dxi 800
by Beckman Coulter
DESCRIPTION
Beckman Coulter's Unicel Dxi 800 is one of the premier immunology systems.
FORUMSView All
Ask a New QuestionFEATURES
Beckman Coulter Dxh 800 Specifications
Standardized design of reagent packsPolar rs300x heart rate monitor user manual.
- Compatibility across immunoassay systems
- Minimal reagent preparation or reagent management required
- Bar-coded, liquid, ready-to-use reagents
- Onboard capacity of 50 refrigerated reagent packs enhance flexibility — configure the system menu to match testing requirements
- A broad menu across a wide variety of disease states enables your laboratory to consolidate workstations
Simplified operation improves productivity
- Load reagents and all consumables ‘on-the-fly’, without using the console computer or pausing the instrument, minimizing intervention
- Easy-to-follow pictogram and indicator lights show which supplies need replenishment
- Large volume supplies maximize walkaway capacity
Streamlined sample handling
- Load capacity of 120 samples at once; continuous loading capability
- Racks are compatible with SYNCHRON LX systems, decreasing sample handling across multiple systems
- Racks can be loaded directly from the centrifuge, reducing manual processes
- Routine sample loading can be interrupted to load STAT samples quickly
- “Point-in-space” pipetting technology aligned with NCCLS guidelines allows integration with laboratory automation systems
- Releases primary tube in less than five minutes for testing in other areas of the lab
Beckman Coulter Dxh 800 Service Manual
On-board aliquot capability
- Automatically creates aliquots based on the volume of requested tests plus any additional volume that may be required for user-defined reflex or re-run test scenarios
- System stores aliquots for up to three hours in a patented, refrigerated low-evaporation compartment
- Simplifies inventory management — utilize same type of vessel for aliquots and reactions
Proven chemiluminescent detection delivers excellent precision and sensitivity with a broad dynamic range
- System supports multiple assay protocols to ensure peak assay performance
- Magnetic particle separation with chemiluminescent detection delivers exceptional clinical performance
- Rapid assay kinetics improve TAT
Innovative system delivers powerful efficiency
- Intuitive operator interface, with touch screen capability, maximizes efficiency
- Auto-matched pipettors work in parallel to deliver sample and reagent into the reaction vessels – and achieves a peak throughput of 400 tests per hour
SPECIFICATIONS
| Height | 67 in |
| Length | 38 in |
| Weight | 1390 lbs |
| Width | 68 in |
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| 510(k) | | DeNovo | | Registration & Listing | | Adverse Events | | Recalls | | PMA | | HDE | | Classification | | Standards |
| CFR Title 21 | | Radiation-Emitting Products | | X-Ray Assembler | | Medsun Reports | | CLIA | | TPLC |
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| BECKMAN COULTER, INC. UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM HEMATOLOGY ANALYZER | Back to Search Results |
| | Model Number DXH 800 | | Event Date 06/20/2011 | | Event Type Malfunction | | Event Description | A customer contacted beckman coulter inc. (bec) reporting that the unicel dxh 800 coulter cellular analysis system generated a falsely low platelet value for one (1) patient specimen with platelet clumps, in both the complete blood count (cbc) and cbc differential (cd) modes, without instrument generated flags. The erroneous results were not reported out of the laboratory. Per laboratory procedure, a manual smear review was performed because the platelet value was lower than 100. 000 plt/ul. The manual plt estimate indicated a higher platelet value, with platelet clumps observed. In addition, an analysis was performed using a tube not supported by bec (sarstedt thromboexact tube) and 325. 00 plt/ul value was obtained. The same specimen was also rerun on a competitor's instrument (sysmex) and the instrument provided a plt clump flag, consistent with platelet clumps observed by manual review. There was no death, injury, or affect to patient treatment associated with this event. | | Manufacturer Narrative | The specimen was drawn in sarstedt 2. 7 ml monovette edta k2, stored at room temperature, and processed between 30 minutes to 2 hours. The specimen was mixed using a mixer machine low (soft) number of revolution 1-2 minutes. The controls were acceptable for this event. The raw data provided by the customer illustrates that the white blood count (wbc) histogram was moderately high at the front, but the pattern was not the type of typical platelet clump, so the complete blood count (cbc) module did not set a flag. In the nucleated - red blood count (nrbc) module, there were many debris events, but the pattern analysis did not meet the internal criteria required for being classified as a clump. Thus, the cause is that the sample did not meet internal criteria or exhibit typical platelet clump pattern necessary for the algorithm to trigger a platelet clump flag. Service was not dispatched for this event, as this was a sample specific event. Per bec product labeling, giant platelets, platelet clumps, white cell fragments, electronic noise, very small red cells, red cell fragments are interfering substances for plt. Beckman coulter recommends avoiding the use of one type of message or output to summarize results or patient conditions. There may be situations where the presence of a rare event may fail to trigger a suspect message. | | Search Alerts/Recalls |
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Beckman Coulter Dxh 800 Operator's Manual
| Type of Device | HEMATOLOGY ANALYZER |
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| Manufacturer (Section D) | | BECKMAN COULTER, INC. | | 11800 sw 147th avenue | | miami FL 33196 |
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| Manufacturer (Section G) | | BECKMAN COULTER, INC. | | 11800 sw 147th avenue | | miami FL 33196 |
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| Manufacturer Contact | | nora zerounian | | 250 s kraemer boulevard | | brea , CA 92821 | | 7149613634 |
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| MDR Report Key | 2188242 |
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| Report Number | 1061932-2011-01087 |
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| Device Sequence Number | 1 |
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| Product Code | GKZ |
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| Report Source | Manufacturer |
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| Source Type | Foreign,Health Professional,User facility |
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| Reporter Occupation |
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| Type of Report | Initial |
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| Report Date | 07/05/2011 |
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| 1 Device Was Involved in the Event |
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| 0 PatientS WERE Involved in the Event: |
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| Date FDA Received | 08/03/2011 |
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| Is This An Adverse Event Report? | No |
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| Is This A Product Problem Report? | Yes |
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| Device Operator | HEALTH PROFESSIONAL |
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| Device MODEL Number | DXH 800 |
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| Device Catalogue Number | 629029 |
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| Device LOT Number | N/A |
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| OTHER Device ID Number | SW VERSION 1.1.3.1 |
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| Was Device Available For Evaluation? | Yes |
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| Is The Reporter A Health Professional? | No |
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| Date Manufacturer Received | 07/05/2011 |
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| Was Device Evaluated By Manufacturer? | Yes |
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| Date Device Manufactured | 01/01/2011 |
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| Is The Device Single Use? | No |
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| Is this a Reprocessed and Reused Single-Use Device? | No |
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| Type of Device Usage | Invalid Data |
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| Removal/Correction Number | N/A |
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