CoagMax® PT/INR System:
Making
Coagulation
Monitoring
Simple and
Reliable
Learn more
About
Microvisk
Microvisk Technologies has developed a unique micro-viscometer based on a novel patented Micro Electro Mechanical Sensors (MEMS) technology.
Our main facility is located in Oxford, UK.
Microvisk, an ISO 13485:2016 accredited company originally
funded in 2004, utilises its expertise and knowledge for the
design and development of medical devices for home use and
point of care in vitro diagnostic devices.
Our
Technology
Microvisk technology is based on Micro Electro Mechanical System (MEMS) chip, embeded on a disposable Smart Strip. The MEMS chip incorporates a small and very efficient bimorphcantilever, which pulses in the sample, achieving high sensitivity whilst using very little energy.
CoagMax®
Using laboratory standard methods, CoagMax® is a point-of-care PT/INR monitor designed to make coagulation as simple to perform as blood-glucose testing.
First-in-class Smart Strip technology allows for convenient, safer, accurate, at-home patient testing without the need to visit a specialised clinic for an INR blood test.
Accuracy & Reproducibility
- Limited number of user steps reduces error rates
- Excellent correlation with the laboratory test (98.5%) and a leading INR meter.
Patented MEMS Technology
- Each strip has a memory chip where individual calibration and batch data is stored
- The uploading of strip data is automatic
- No user input of codes or batch information
- Direct clot detection using property MEMS sensor on strip
- Recognitoin of strip expiry date.
Ease of Use
- Ergonomic design, backlit icon screen, clear functionality and low power Bluetooth®
- Meter is designed to be handheld
- Sampling direct from the fingerprick, as with blood glucose testing
- Designed for self-testers and healthcare professionals.
Quality Control (QC)
- Automatic quality control operations
- QC failure is reported before blood is drawn, and the strip is locked
- External QC liquid available
- Compliant with all major laboratory and external quality assurance systems.
Smaller Sample Size
- 5µL blood sample required
- Safety lancets can be used
- Fewer samping errors
- Better user experience and compliance.
Connectivity
- Use the supplied USB cable to simply upload and download information and results.
- Low power BluetoothⓇ wireless technology. CoagMaxⓇ connects all records and data to and from a cloud database.
METER SPECIFICATIONS
- Screen:Backlit with icons
- Wireless technology:Low power BluetoothⓇ
- Temperature:10℃ to 32℃(50℉ to 90℉)
- Humidity:10% RH to 85% RH (without condensation)
- Maximum altitude:3100M
- Measuring range:0.8 to 8.0 INR
- Number of tests stored in memory:750
- Number of tests per battery charge:approx 150
- EU medical IVDD CE marking Safety Class:III
- Automatic power-off:3 minutes
- Weight:128 grams (4.5 oz)
- Power:3.6v Lithium-ion rechargeable
- Dimensions:126mm x 69mm x 25mm (5"H x 2.7"W x 1"D)
- Charging cable:USB 2.0 Charging Cable A to Micro B.
Manuals/Instructions
- coming soon...
Smart
Strip
At the heart of the CoagMax® PT/INR system is the PT/INR Strip. It is designed around our patented MEMS (Micro-Electrical-Mechanical-System) sensor technology. Unlike many other test strips on the market, the CoagMax® PT/INR strip is built around solid state technology.
Microvisk Smart Strip MEMS Technology
Sensor cantilever
Technology widely used in gaming and mobile phone accelerometers has been further refined to add a sensitivity element to the sensor. The sensor cantilever itself is one-six the thickness of a human hair and beats many times per minute in the blood sample, sensing minute changes in the viscosity of the blood as a clot starts to form.
Memory chip
An in-built 'memory chip', individually coded to improve accuracy, stores all the information the system needs to safely run the test in every strip. Other parameters such as calibration data, data about lot numbers/expiry date and even vendor specific information can also be stored.
The Smart Strip can be used to detect a variety of substances by measuring changes in viscosity.
QC sensors
If the strip is out of date or has already been used, the system will reject it before testing is initiated. Two on-board quality control sensors monitor humidity and temperature. If either of these change colour, for example when a strip is left out of its protective wrapper for too long, the meter will again reject the strip.
Composition
The micro capillary and hydrophilic top sheet combine to make this one of the easiest INR testing system on the market. The blood is drawn up the test strip by capillary action requiring only 5µL of blood to successfully run the test. The strips are individually wrapped and available in boxes of 24 and 48.
Smart Strip INR Information
‘Chip on a strip’
Each Smart Strip has an embedded memory microchip which allows it to store calibration data, expiry date and lot number.
On board QC
Each strip has two qualitative controls to monitor the humidity and temperature the strip has been subjected to prior to use. If the strip is compromised, it will be rejected by the CoagMax® monitor.
Low blood volume
The Smart Strip INR uses only 5µL of blood, which enables use of significantly less painful lancets.
Individually wrapped
Each strip is individually wrapped with a smart humidity wafer to keep it in perfect condition prior to use.
Notch design
The test strip has an alignment notch to ensure efficient use requiring only a small blood sample.
PT/INR monitoring
Anticoagulation is the name given to therapy designed to stop people developing potentially fatal blood clots.
It is usually carried out in one of two ways:
- (I) In hospital, where the chosen form of heparin is administered either intravenously or by subcutaneous injection.
- (II) In an outpatient setting, where oral anticoagulants ("blood thinners") are used for long-term clot prevention.
History
To ensure people using these medications stay within the desired therapeutic range, the Prothrombin Time (PT) test was developed. This was further improved in the early 1980s and standardised to PT/INR (International Normalised Ratio). Essentially your INR result indicates how much slower your blood is clotting than normal. For example, an INR result of 2, means your blood is taking twice as long to clot as it usually would if you weren't taking oral anticoagulation therapy.
Whilst taking anticoagulant medication is essential, there is a risk of developing equally dangerous life-threatening bleeds if you take too much of this medication.
To ensure this doesn’t happen, you will be given a target INR range. In healthy people an INR of 1.1 or below is considered normal.
PT/INR testing today
Today PT/INR testing is usually performed in either a hospital-based clinic or in the GP surgery and generally requires a 24-hour wait for your result and any dosage changes. To avoid potentially serious complications such as bleeding or strokes, testing must be performed regularly so dosage adjustments can be made.
Previous
Next
Self testing
Self-monitoring / self-testing is the name given to the methods used by patients to test their own INR.
The technology available for self-testing has improved greatly in recent years and result generally follow those generated by the laboratory. Dosing adjustments are still carried out by a qualified physician, but patients can often avoid unnecessary visits to see the doctor.
CoagMax®
The CoagMax® monitor using Smart Strip technology allows you to self-test in a significantly easier and less painful manner that ever before. Taking our cues from the blood glucose testing industry, we have designed a system with the patient in mind that allows the patient to take the meter to their finger rather than having to manipulate their finger towards the meter.
A paper published in the Lancet in 2011 showed significantly fewer negative outcomes and an improved quality of life in patients and self-testing on oral anticoagulation therapy than those who were tested by conventional laboratory/clinic means:
*Reference: The Lancet Dec 2011 Heneghan. Ward. Perera ‘Self-monitoring of oral anticoagulation: systematic review and meta analysis of individual patient data’.
Benefits to point-of-care testing:
Compliance – Ability to discuss patient’s INR result with them in real time ensures you can positively reinforce any compliance issue face-to-face.
Workflow – A fingerstick test is quick to perform, providing results within 3 minutes.
Flexibility – For patients requiring testing in the community, CoagMax® is a small monitor with its own carrying case that can be taken to the patient. Test results can be easily added to the patient’s record when back at the physician’s office.
Quality control – The CoagMax® Smart Strip has built-in quality checks to ensure the strip is in premium condition for testing. Users can also run external liquid quality control and EQA samples to ensure absolute integrity of the system and results.
Accessibility – Regular Point-of-Care INR testing can improve control, reduce concerns about risk and allow a greater percentage of AF patients to be moved to Oral Anticoagulant Therapy.
Suitability for self-testing
Self-testing can free yourself from regular hospital/laboratory visits and give you control over your anticoagulation regime. Key questions to check suitability to self-test:
•Are you on long-term oral anticoagulation? E.g. Coumadin® (Warfarin)/Marcumar® (Phenprocoumon)
•Are you confident enough to take a greater role in your anticoagulation management?
•Would you prefer to test your own INR using a Fingerstick device or visit a clinic to have a venous blood sample taken?
If you answered yes to the above, ask your doctor about supporting a change in monitoring.
Factors that can affect your INR results
Maintaining a steady and safe INR is reliant on ensuring you take the required dosage of anticoagulant every day, at the same time.
Vitamin K – These drugs work by reducing the amount of Vitamin K your body has to make blood coagulation factors, so anything you eat with large amounts of Vitamin K will influence your anticoagulant need and may require dosage adjustment accordingly. These foods include kiwi, blueberries, broccoli, cabbage, Brussels sprouts, asparagus, cauliflower, peas, lettuce, spinach, parsley, kale, vitamins, soybeans, cashews, beef or pork liver.
Alcohol – Alcohol can affect the performance of anticoagulants. Serious problems can occur with alcohol and Coumadin (warfarin) when you drink more than 2-4 units a day or when you change your usual pattern.
Aspirin – Any product containing aspirin may lessen the ability of your blood to form clots and may harm you when you take Coumadin (Warfarin). If you take any aspirin containing medication, ask your doctor what dose is right for you.
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Contact
Unit 11, Wornal park, Menmarsh Road,
Worminghall, Buckinghamshire, HP18 9PH
Tel: 01483 617548
E-mail: enquiries@microvisk.com
Website: www.mircovisk.com
