HemoCue® Glucose 201 Analyzer
Hemocue AB · Model 120706
HemoCue Glucose 201 Analyzer mg/dL plasma.
Intended use: A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Key tips
- ·Run QC controls before trusting any repair - an analyzer that passes self-test can still report clinically wrong results.
- ·Rule out a reagent lot change before opening the instrument - it can look exactly like a hardware fault.
- ·Centrifuge rotors have a hard retirement age/cycle limit regardless of visible condition - don't eyeball it.
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 laboratory & diagnostics 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 QC controls run and reviewed
- ·Calibration verification per assay
- ·Routine cleaning and decontamination
- ·Scheduled reagent-path and pump-tubing maintenance
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
- Storage Environment Temperature
- 0°C to 50°C
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Glucose monitoring system IVD, point-of-care
- FDA product classification
- Glucose Oxidase, Glucose
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Central / core laboratory
- Point-of-care testing stations
- Blood bank
- Microbiology lab
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
- RECALL
HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.
- RECALL
HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches.
- RECALL
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
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