To Next PageTo Next PageWhat to do if EKF Diagnostics DiaSpect Tm Medical Equipment shows unexpectedly high or low result?
If your EKF Diagnostics Medical Equipment displays an unexpectedly high or low result, it might be due to an improper sample. Repeat the sampling, ensuring it is done correctly.
Why is the display blank and measuring not possible on my EKF Diagnostics Medical Equipment?
If the display is blank and measuring is not possible on your EKF Diagnostics Medical Equipment, it's likely the battery is completely discharged. To resolve this, recharge the battery by connecting to a power outlet or computer for a minimum of 4 hours. If recharging fails, contact Technical Support.
How to fix Error E07 on EKF Diagnostics DiaSpect Tm Medical Equipment?
Error E07 on your EKF Diagnostics Medical Equipment indicates that the battery is too low to perform measurements. To fix this, recharge the battery.
What to do if I see Error E02 on my EKF Diagnostics DiaSpect Tm?
If you see Error E02 (Sensor read error) on your EKF Diagnostics Medical Equipment, first, repeat the measurement with the same cuvette. If the error persists, contact Technical Support.
What to do if Error E03 appears on EKF Diagnostics Medical Equipment?
Error E03 on EKF Diagnostics Medical Equipment (Self-check failed) may appear if a filled cuvette is left in the cuvette holder, or was removed too slowly. To reset the self-check function, press down on the empty cuvette holder until the screen displays “---” and a “?”. If the error continues, contact Technical Support.
How to resolve Error E04 (light source too dark) on EKF Diagnostics DiaSpect Tm Medical Equipment?
To resolve Error E04 (light source too dark) on your EKF Diagnostics Medical Equipment, remove the cuvette from the cuvette holder. Press the cuvette holder several times until the screen reads “---” and a “?” appears. If the error persists, contact Technical Support.
How to resolve Error E05 (light source too bright) on EKF Diagnostics DiaSpect Tm?
To resolve Error E05 (light source too bright) on your EKF Diagnostics Medical Equipment, remove the cuvette from the cuvette holder. Press the cuvette holder several times until the screen reads “---” and a “?” appears. If the error persists, contact Technical Support.
Describes the DiaSpect Tm system components and intended use for in vitro quantitative hemoglobin measurement.
Indicates the CLIA complexity for whole blood testing is waived, requiring adherence to manufacturer's instructions.
Explains the photometric principle, multi-chromatic sensor, and absorbance measurement for hemoglobin concentration.
Details the DiaSpect Tm analyzer, including unpacking, storage, and operating temperature requirements.
Describes DiaSpect Tm Cuvettes, their readiness for use, sample volume, and capillary filling mechanism.
Introduces DiaSpect Controls HBT for compliance, available in three concentrations for different hemoglobin levels.
Lists package configurations for DiaSpect Control HBT, including HBT1, HBT2, HBT3, and HBT4 options.
Provides safety guidelines for the analyzer: avoid shocks, liquids, direct sunlight, heat, and wet areas.
Details safety precautions for the power supply: use provided unit, avoid liquids, heat sources, and damaged cables.
Emphasizes handling blood as infectious, using gloves, avoiding contact, and proper disposal of contaminated items.
Explains FCC compliance for Class B digital devices and provides measures to correct radio interference.
States compliance with FCC RF exposure limits for an uncontrolled environment, detailing Bluetooth frequency and power.
Specifies professional use, emphasizes reading the manual, and describes the analyzer being ready for use.
Explains the analyzer's display elements: hemoglobin value, unit of measure, cuvette status, battery, and checkmark.
Details the steps for charging the DiaSpect Tm analyzer's battery using a power supply and USB cable.
Outlines the procedure for charging the analyzer's battery by connecting it to a computer's USB port.
Mentions the analyzer supports USB 2.0 and optional Bluetooth for data transfer, directing users to contact the manufacturer.
Provides step-by-step instructions for cleaning the cuvette holder using a swab, water/detergent, and disinfectant.
Advises against spraying the instrument and recommends using lightly dampened wipes for cleaning and disinfection.
Explains the analyzer performs an automatic self-check after each measurement, indicated by a check-mark or error code.
Instructs on running controls as per section 7.3, ensuring values are within vial label ranges and contacting support if out of range.
Instructs to dispose of used cuvettes in a container for potentially infectious waste, consulting local authorities.
Outlines disposal of the analyzer, battery, and power supply according to regional regulations, or return to manufacturer.
Refers users to the respective instructions for use for the disposal of DiaSpect Control HBT material.
States the analyzer requires no maintenance and lists user-replaceable parts like cuvette holder and cables.
Advises using the Troubleshooting Guide for issues and returning the analyzer to EKF Diagnostics or distributor if unresolved.
Provides contact information for EKF Diagnostics Technical Support, including phone, email, and website.
Details the procedure for capillary blood sampling using gloved hands, finger preparation, and incision technique.
Explains how to fill the cuvette with capillary blood, ensuring sufficient drop size and avoiding air bubbles.
Lists common causes for erroneous results in capillary sampling, such as lancet type, technique, and restricted blood flow.
Describes how to perform confirmatory testing for unexpected results and when to make a new incision for samples.
Details venous sample handling: refrigeration, temperature adjustment, tube mixing, and using K2-EDTA or lithium heparin tubes.
Explains filling the cuvette with venous blood from a transfer pipette or dispenser, ensuring complete fill and no air bubbles.
Describes how to verify the DiaSpect Tm system using DiaSpect Control HBT, including sample preparation and cuvette filling.
Instructs on handling control solution: room temperature, mixing, discarding first drop, and filling cuvette.
Details the steps for inserting the filled cuvette, pressing for measurement, and quickly removing the cuvette after result.
Explains that the result remains on display until the next measurement and how to erase the latest result.
Describes how to handle potential error codes after inactivity by performing a 'blank' measurement.
Troubleshooting for Error E01 (Calibration lost): Contact Technical Support.
Troubleshooting for Error E02 (Sensor read error): Repeat measurement or contact Technical Support.
Troubleshooting for Error E03 (Self-check failed): Reset function or contact Technical Support.
Troubleshooting for Errors E04/E05 (Light source issues): Remove cuvette, reset holder, or contact Technical Support.
Troubleshooting for Error E07/Blank Display (Battery issues): Recharge battery or contact Technical Support.
Lists normal hemoglobin values (g/dL) for different populations: Adult Male, Adult Female, Child/Adolescent, and Infant.
Presents data on within-run and total precision (SD, %CV) for low, medium, and high hemoglobin concentrations.
Summarizes accuracy comparison studies between DiaSpect Tm and a predicate device at point-of-care sites.
Details method comparison results for capillary and venous samples against Hb301 in blood donation centers.
Presents linear and Passing-Bablok regression data comparing DiaSpect Tm with HemoCue Hb 301 for capillary and venous samples.
Calculates bias of DiaSpect Tm at donor eligibility cutoffs for male and female donors using Hb 301 as the reference.
Shows agreement scores and percentages for capillary donors based on DiaSpect Tm and Hb 301 cutoffs.
Presents agreement scores and percentages for venous donors based on DiaSpect Tm and Hb 301 cutoffs.
Shows bias of DiaSpect Tm for capillary samples compared to Sysmex XP-300 at donor eligibility cutoffs.
Presents bias of DiaSpect Tm for venous samples compared to Sysmex XP-300 at donor eligibility cutoffs.
Lists operating temperature, humidity, and storage temperature ranges for the DiaSpect Tm analyzer.
Details sample volume, measurement range, wavelength, and measuring time for the DiaSpect Tm system.
Provides specifications for battery type, instrument input rating, power supply input, and supply current.
States the dimensions and weight of the analyzer and its transport box.
Lists substances and disease states that do not affect test results, along with their test concentrations.
Details potential interferents like Bilirubin, Cholesterol, Creatinine, and their corresponding test concentrations.
Lists references including CLSI documents, ICSH standards, and publications related to hemoglobinometry.
Mentions DiaSpect Tm Cuvettes package insert and DiaSpect Control HBT package Insert as other relevant documentation.
Lists DiaSpect Tm Cuvettes in packs of 100, with their respective REF and Cat. numbers.
Lists DiaSpect Control HBT variants (HBT1-HBT4) with their REF and Cat. numbers for ordering.
Lists spare parts and accessories including Cuvette Holder, USB Cable, and Power supply with US adapter.
Mentions the availability of a carrying case for the DiaSpect Tm analyzer, with its REF number.
Explains IP21 as protection against foreign objects/water and SN as Serial Number.
Defines IVD as In-vitro-Diagnostic Medical Device and REF as Reference Number.
Explains symbols for disposal of electronic equipment and caution notices, as well as manufacturer and direct current.
Describes symbols for Antenna Pole (RF connection) and Temperature limitation.
Provides contact information for EKF Diagnostics, Inc. in the USA, including address, phone, email, and website.
Describes the DiaSpect Tm system components and intended use for in vitro quantitative hemoglobin measurement.
Indicates the CLIA complexity for whole blood testing is waived, requiring adherence to manufacturer's instructions.
Explains the photometric principle, multi-chromatic sensor, and absorbance measurement for hemoglobin concentration.
Details the DiaSpect Tm analyzer, including unpacking, storage, and operating temperature requirements.
Describes DiaSpect Tm Cuvettes, their readiness for use, sample volume, and capillary filling mechanism.
Introduces DiaSpect Controls HBT for compliance, available in three concentrations for different hemoglobin levels.
Lists package configurations for DiaSpect Control HBT, including HBT1, HBT2, HBT3, and HBT4 options.
Provides safety guidelines for the analyzer: avoid shocks, liquids, direct sunlight, heat, and wet areas.
Details safety precautions for the power supply: use provided unit, avoid liquids, heat sources, and damaged cables.
Emphasizes handling blood as infectious, using gloves, avoiding contact, and proper disposal of contaminated items.
Explains FCC compliance for Class B digital devices and provides measures to correct radio interference.
States compliance with FCC RF exposure limits for an uncontrolled environment, detailing Bluetooth frequency and power.
Specifies professional use, emphasizes reading the manual, and describes the analyzer being ready for use.
Explains the analyzer's display elements: hemoglobin value, unit of measure, cuvette status, battery, and checkmark.
Details the steps for charging the DiaSpect Tm analyzer's battery using a power supply and USB cable.
Outlines the procedure for charging the analyzer's battery by connecting it to a computer's USB port.
Mentions the analyzer supports USB 2.0 and optional Bluetooth for data transfer, directing users to contact the manufacturer.
Provides step-by-step instructions for cleaning the cuvette holder using a swab, water/detergent, and disinfectant.
Advises against spraying the instrument and recommends using lightly dampened wipes for cleaning and disinfection.
Explains the analyzer performs an automatic self-check after each measurement, indicated by a check-mark or error code.
Instructs on running controls as per section 7.3, ensuring values are within vial label ranges and contacting support if out of range.
Instructs to dispose of used cuvettes in a container for potentially infectious waste, consulting local authorities.
Outlines disposal of the analyzer, battery, and power supply according to regional regulations, or return to manufacturer.
Refers users to the respective instructions for use for the disposal of DiaSpect Control HBT material.
States the analyzer requires no maintenance and lists user-replaceable parts like cuvette holder and cables.
Advises using the Troubleshooting Guide for issues and returning the analyzer to EKF Diagnostics or distributor if unresolved.
Provides contact information for EKF Diagnostics Technical Support, including phone, email, and website.
Details the procedure for capillary blood sampling using gloved hands, finger preparation, and incision technique.
Explains how to fill the cuvette with capillary blood, ensuring sufficient drop size and avoiding air bubbles.
Lists common causes for erroneous results in capillary sampling, such as lancet type, technique, and restricted blood flow.
Describes how to perform confirmatory testing for unexpected results and when to make a new incision for samples.
Details venous sample handling: refrigeration, temperature adjustment, tube mixing, and using K2-EDTA or lithium heparin tubes.
Explains filling the cuvette with venous blood from a transfer pipette or dispenser, ensuring complete fill and no air bubbles.
Describes how to verify the DiaSpect Tm system using DiaSpect Control HBT, including sample preparation and cuvette filling.
Instructs on handling control solution: room temperature, mixing, discarding first drop, and filling cuvette.
Details the steps for inserting the filled cuvette, pressing for measurement, and quickly removing the cuvette after result.
Explains that the result remains on display until the next measurement and how to erase the latest result.
Describes how to handle potential error codes after inactivity by performing a 'blank' measurement.
Troubleshooting for Error E01 (Calibration lost): Contact Technical Support.
Troubleshooting for Error E02 (Sensor read error): Repeat measurement or contact Technical Support.
Troubleshooting for Error E03 (Self-check failed): Reset function or contact Technical Support.
Troubleshooting for Errors E04/E05 (Light source issues): Remove cuvette, reset holder, or contact Technical Support.
Troubleshooting for Error E07/Blank Display (Battery issues): Recharge battery or contact Technical Support.
Lists normal hemoglobin values (g/dL) for different populations: Adult Male, Adult Female, Child/Adolescent, and Infant.
Presents data on within-run and total precision (SD, %CV) for low, medium, and high hemoglobin concentrations.
Summarizes accuracy comparison studies between DiaSpect Tm and a predicate device at point-of-care sites.
Details method comparison results for capillary and venous samples against Hb301 in blood donation centers.
Presents linear and Passing-Bablok regression data comparing DiaSpect Tm with HemoCue Hb 301 for capillary and venous samples.
Calculates bias of DiaSpect Tm at donor eligibility cutoffs for male and female donors using Hb 301 as the reference.
Shows agreement scores and percentages for capillary donors based on DiaSpect Tm and Hb 301 cutoffs.
Presents agreement scores and percentages for venous donors based on DiaSpect Tm and Hb 301 cutoffs.
Shows bias of DiaSpect Tm for capillary samples compared to Sysmex XP-300 at donor eligibility cutoffs.
Presents bias of DiaSpect Tm for venous samples compared to Sysmex XP-300 at donor eligibility cutoffs.
Lists operating temperature, humidity, and storage temperature ranges for the DiaSpect Tm analyzer.
Details sample volume, measurement range, wavelength, and measuring time for the DiaSpect Tm system.
Provides specifications for battery type, instrument input rating, power supply input, and supply current.
States the dimensions and weight of the analyzer and its transport box.
Lists substances and disease states that do not affect test results, along with their test concentrations.
Details potential interferents like Bilirubin, Cholesterol, Creatinine, and their corresponding test concentrations.
Lists references including CLSI documents, ICSH standards, and publications related to hemoglobinometry.
Mentions DiaSpect Tm Cuvettes package insert and DiaSpect Control HBT package Insert as other relevant documentation.
Lists DiaSpect Tm Cuvettes in packs of 100, with their respective REF and Cat. numbers.
Lists DiaSpect Control HBT variants (HBT1-HBT4) with their REF and Cat. numbers for ordering.
Lists spare parts and accessories including Cuvette Holder, USB Cable, and Power supply with US adapter.
Mentions the availability of a carrying case for the DiaSpect Tm analyzer, with its REF number.
Explains IP21 as protection against foreign objects/water and SN as Serial Number.
Defines IVD as In-vitro-Diagnostic Medical Device and REF as Reference Number.
Explains symbols for disposal of electronic equipment and caution notices, as well as manufacturer and direct current.
Describes symbols for Antenna Pole (RF connection) and Temperature limitation.
Provides contact information for EKF Diagnostics, Inc. in the USA, including address, phone, email, and website.
General| Brand | EKF Diagnostics |
|---|---|
| Model | DiaSpect Tm |
| Category | Medical Equipment |
| Language | English |
