Dolphin Digital Hemoglobinometer
Dolphin HB Microcuvette
Specifications:
Clinical Purpose: Direct hand held battery operated device used for hemoglobin testing inclinical setting population-based screening. The device is intended to be used for quantitative measurement of hemoglobin
Used By: Medical & Nursing Staff/RBSK teams / Laboratory technician/ ANMs/Midlevel health providers at HWCs/ CHO
Working Principle: Absorbance Photometry dual wavelength
Parameter: Blood Haemoglobin Level
Range of HB Estimation: 0-25 gm/dl
On-screen patients result display: LCD Display, unit of measurement is clearly visible
through the display and the display is sunlight readable
Maximum Volume of sample required: Less than 10 y1l(microliter)
Sample Material: Capillary, venous or arterial whole blood
Measuring Time: Less than 5 seconds. The device is always ready for measurement, even in standby mode.
Auto-Calibration: Auto/Self Calibration & code free calibration. The Hb meter is factory calibrated as per the recommendation/guidelines of international council for standardization in Hematology (ICSH)
Accuracy: Sensitivity More than 95 %, Specificity More than 95% & bias less than 0.5 gm/dl
(limit of agreement ) (+1 gm/dl)
Publication: Accuracy parameter /findings are published/ corroborated in two peer reviewed index journals publications.
Memory: 1000 Tests memory along with test date and time stamps
Data Transfer: Provision to capture and transfer data to PC and printer.
Wireless Connectivity: Essential – Comes with USB Cable & In-built Bluetooth for data transfer to printer and PC and mobile-phone.
Auto Disable Lancets: Single use 23G, 1 safety lancet with each cuvette
Dimensions(metries): It is point of care device useful and easily portable in field settings by FLWs
Weight: 375 grams with Battery
Mobility portability: It is easily portable in field setting by FLWs
Power Requirements: 3.7-volt Lithium-ion rechargeable battery. However, it also works on direct connection with electricity source (AC), Whenever required. Supplied with the adapter/ charger and the cable for electricity power connection.
Battery: inbuilt Lithium. ion rechargeable battery(with charging cable) Performs 1000 tests when fully charged. It has visual alarms for low battery and system failure. Printed clear and bold instruction stating “Charge device within 60 days of delivery” on the outer packaging of the device.
Automatic Shut down: On battery power the device will turn off after 5 minutes of no use
Working Temperature: Able to function and capable of being stored in the temperature range of 5-50°C. For Device and cuvette . Also able to perform at extreme of tempertures (5-50 °C )
Working Humidity: Able to function and capable of being stored in the relative humidity of 5-95 %. For device and cuvette, Also be able to perform at high humidity (5-95%)
User’s care /Cleaning: The part of the equipment which comes in contact with blood is easily cleanable. Printed user manual with details of how to clean disinfect and use the device provided along with the device. The factors which affect the hemoglobin estimation (e.g. Haziness of lens) after repeated use are clearly mentioned in the manual. The cleaning material for the lens and cuvette should is provided. The HB meter is provided with sling carrying case, auto-disabled lancet and operational manual.
Cuvette (Working Environment): Disposable and stable at temperature 0° – 50°C, and High humidity 5-90% condition
Cuvette (Storage environment): Stable at temperature of 5 – 50°C and humidity of 5- 95%. Shelf life for storage is 2 years with open vial stability for Cuvettes till expiry date.
Cuvettes Pack: Each cuvette pack contains 50 Cuvettes.
Supplied along with Machine: Carrying case, detailed operational manual (Printed user manual with details of how to clean disinfect and use the device with index of symbol and troubleshooting manual): The HB meter is provided with a compact sling bag/ Carrying case with provision to carry device with all consumables like , cuvette, charger /adapter /cable, operational /user manual ete required to facilitate portability.
Control solution to check quality: Liquid control provided for 3 range —low, normal and high hemoglobin value with device. Controls are thermo stable at room temperature
Certification: CDSCO Manufacturing License, CE, ISO 13485 certification, IEC 60601 for electricity safety, etc.
Training: Free onsite training provided to user such as the medical officers, RBSK teams, CHO, HWC officers, Lab Technician and ANMs ete. Two training (One training at time of installation and another training after six months i.e. refresher training to all the users )
Warranty and on-site AMC : For device -3 years Warranty + 1 year AMC
Safe Disposal of Sharps and Infection Control: Details instruction for safe disposal of all biomedical waste generated (including sharp) during testing is provided.