Calmark - Neo Bilirubin - POC-Analyzer, hand and tests
Calmark Neo bilirubin POC System 1 header
Calmark Neo bilirubin POC System 2 instrument and cassettes
Calmark POC System Neo Bilirubin 4 full system
Calmark Neo bilirubin POC System 3
Calmark Neo bilirubin POC System 4 instrument in use

Calmark Neo-Bilirubin Point-of-Care Diagnostic System

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The Calmark Neo-Bilirubin Point-of-Care Diagnostic System represents a groundbreaking advancement in the field of neonatal care, offering a rapid, portable solution for the measurement of bilirubin levels in newborns’ blood. This innovative system combines the Calmark POC-Analyzer, a portable instrument, with single-use Calmark Neo-Bilirubin Test Cassettes, designed specifically for the efficient detection and management of hyperbilirubinemia and jaundice in infants.
● Minimum Order Quantity (MOQ): 1 device
● Seller Name: Calmark
● Seller Location: Sweden
● Warranty Term: 1 year
● Regulatory Approvals: CE; ISO 13485:2016

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Description

Calmark Neo-Bilirubin Point-of-Care Diagnostic System consist of a portable instrument, the Calmark POC-Analyzer, combined with Calmark Neo-Bilirubin Test Cassettes. The system is used for measuring bilirubin in the blood of newborns, preventing hyperbilirubinemia and jaundice. Only a few drops of whole blood are needed. The analysis can take place wherever the patient is located, eg. return visit at the birth clinic or at the maternity ward. The result is presented on the display after only 2 min, which reduces both costs and time.

High-precision testing with a quantification range of 150-500 µmol/L (9-29 mg/dL). High tolerance for hemolysis and accurate results at up to 60% hematocrit, which can be a problem with traditional test methods. The Neo POC System is optimized for the blood of newborns which also gives shorter time to result, less blood and no manual work for laboratory staff.

The Neo POC System is adapted for hospital environment and is intended for in vitro diagnostics. Calmark Neo-Bilirubin meets the UNICEF characteristics for bilirubinometers in low-income countries and has received a "NEST360 Qualified" approval.

Read our Newborn Jaundice Condition Overview to learn more about newborn jaundice and diagnostic products.

Important Purchasing Information

Unable to ship to: Canada, United States

Unbale to sell to: Egypt, India, Iraq, Jordan, Saudi Arabia, UAE, Bahrain, Cambodia, Laos, Vietnam

3 days

MOQ Shipping Dimensions (Depth), cm = 16
MOQ Shipping Dimensions (Length), cm = 30
MOQ Shipping Dimensions (Width), cm = 21
MOQ Shipping Weight (G.W) (kgs) = 2

Key Features

Usability
Rapid, safe, and easy measurement of bilirubin in blood from newborns. Optimized for accurate analysis with just a few drops of whole blood. Results are presented after 2 minutes as a numeric value on the display of the instrument. Time and cost saving.

Flexible & Portable
Battery indication and capacity of eight working hours, charged with micro-USB connector, charger included. Storage and memory function with 25 results stored locally in the instrument.

Accurate
High-precision testing with a quantification range of 150-500 µmol/L (9-29 mg/dL). High tolerance for hemolysis and accurate results at up to 60% hematocrit, which can be a problem with traditional test methods.

Quality Design
Unique design, easy to handle. The POC-Analyzer is calibrated during manufacturing. Each test cassette contains information needed for automatic calibration of the results; no recalibration needed.

Specifications

Instrument Measurements

  • Dimensions: 120 x 93 x 210 mm (W x H x D)
  • Net weight: 0.9 kg

Test Cassette Measurements

  • Dimensions: 23.2 x 42.1 x 8.7 mm (W x H x D)
  • Net weight: 2.79 g

Performance Neo-Bilirubin Test

  • Detection range: 150-500 µmol/L (9-29 mg/dL)
  • Accuracy <150 µmol/L (<9 mg/dL): 12.9%
  • Accuracy 150-500 µmol/L (9-29 mg/dL): 8.8%
  • Accuracy >500 µmol/L (>29 mg/dL): 4.0%
  • No interference from hemolysis up to 2 g/L
  • Accurate results at up to 60% hematocrite
  • Measurement time: 2 minutes

Power

  • Battery: Powered by a Li-Ion battery
  • Charger: Micro-USB connection (USB-adapter provided) (CE-approved, in 100-240V AC/50-60Hz<500mA, out 5V DC)

Operating Environment

  • Temperature: 18-28°C (64.4-82.4 F)
  • Humidity: 20-80% RH

Transportation and Storage

  • Temperature: 10-40˚C (50-104 F)
  • Humidity 10-90% RH

Standard Accessories

  • Battery charger and adapter (1x)
  • Neo-Bilirubin test cassettes (20x)

Optional Accessories & Add-ons

Product Documents, Manuals & Brochures

calmark poc brochure thumb

Brochure

Regulatory Certificates

ISO 13485 thumb

ISO 13485

calmark neobili freesales thumb

Free Sales Certificate

CE cert thumb

Declaration of Conformity - CE Mark

Videos

FAQ

Where can the tests be performed?
Calmark POC is a point-of-care (POC) system which means that tests can be performed where the baby is. The device can be used at any healthcare unit that needs to check or monitor the bilirubin levels in newborns. The instrument is portable, but should not leave the health care unit, i.e. it is not mobile.
Which unit in a hospital or healthcare facility should use the Calmark POC system?
The end-user can be wherever the baby is during day 2-7 in life, for example: hospital’s delivery and maternity wards, postnatal follow up unit, neonatal care unit, maternity care centres, smaller paediatric or neonatal clinics or offices.
When should the test be performed?
The recommendation for the Neo-Bilirubin test is to measure infants between 2-6 days after birth (full-term pregnancy). At this is the point in time the serum or plasma bilirubin level reaches its peak in most newborns, and the risk of hyperbilirubinemia is greatest. Timely detection, monitoring and treatment started during this time is an effective way to prevent most bilirubin induced morbidity.
Why is it important to use an invasive method for bilirubin diagnostics?
According to the guidelines in most countries, a blood sample should be taken if the bilirubin levels rise above 150 µmol/L (9 mg/dL), 2-3 days after birth. For lower levels of bilirubin, it is enough to use a transcutaneous meter. Approximately 20% of newborns require an additional blood sample to be taken.
What is the advantage of using Calmark POC instead of a traditional laboratory blood test?
The Calmark POC – Neo-Bilirubin system is developed for baby blood and requires only a few drops of whole blood to measure bilirubin levels quickly and with high precision. Laboratory testing requires a larger volume of scarce baby blood that breaks easily (hemolysis) and incurs often higher total costs due to manual handling of baby blood by the laboratory personnel.
What is the qualification range/interval?
In the range 150-500 µmol/L (9-29 mg/dL), the value of bilirubin in the blood is displayed on the screen of the instrument, for example ‘345 µmol/L’ or ‘20.7 mg/dL’ depending on which unit has been set. Values below are shown as ‘<150 µmol/L’ or ‘<9 mg/dL’ and values above as ‘>500 µmol/L’ or ‘>29 mg/dL’.
Does the instrument need to be calibrated?
The POC-Analyzer is calibrated during manufacturing and does not need recalibration. Every test cassette contains information needed for automatic calibration of the results.
How can I clean the instrument?
Follow the hospitals or the clinics provisions for cleaning medical devices. The instrument can be wiped with water and soap and/or 70 % isopropyl alcohol.

Lift the cassette holder to clean the camera window properly. Use only approved cleaning agents and do not use the instrument if there are visible dirt or damage to the glass.

How long can the POC-Analyzer be used without charging the battery?
The instrument should be able to run 40 analyses on full battery. However, the battery gets a little bit drained also when being turned off, so make sure it has been fully charged if you know you won´t be able to connect it to the power for a while.

Studies & Trials

Not available at this time

 

Package Contents

  • 1x POC-Analyzer Neo Main Unit
  • 1x Battery charger
  • 20x Neo-Bilirubin Test Cassettes (1x pack)

Warranty

The POC-Analyzer has 12 months of warranty from delivery of the product. Contact your VIA sales representative if you have any issues with the product.

Testimonials

Not available at this time

 

Egypt, India, Iraq, Jordan, Kenya, Malawi, Nigeria, Saudi Arabia, Cambodia, Laos, Vietnam, Tanzania, UAE, Bahrain
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