calmark COVID19-LDH Point-of-Care Diagnostic System Instruction Manual

calmark COVID19-LDH Point-of-Care Diagnostic System

CALMARK POC – COVID PLATFORM

Thank you for choosing Calmark POC – Covid. The product platform provides a fast and easy way to measure LDH levels in Covid-19 patients. Venous whole blood should be used. The system is adapted to hospital environment and is only intended for in vitro diagnostics.
Read this instruction for use before using the device.

PRODUCT DESCRIPTION

Calmark POC – Covid consists of an instrument and a single-use test for measurement of LDH levels. The test cassette is constituted by four filters with different functions. The first two filters which are in contact with the blood are responsible for the blood filtration. Further the plasma will be separated and migrate through the third filter into the fourth (detection filter) by lateral flow. A color will appear in the detection filter. A camera, inside the instrument, will take photos during the test. The color in the detection filter will be analyzed and converted through a software into the corresponding numeric value of the LDH concentration of the blood sample. The LDH level is sensitive to temperature, hence the measurement should be done in a room temperature between 19-26°C. A thermometer is provided with the instrument as an accessory. When the current temperature has been entered, the LDH level is presented on the screen. All components are developed and manufactured for maximal security. If the system is used in a different way than recommended the safety and performance can be compromised.

MANUFACTURER

Calmark Sweden AB
Sommargatan 101A
656 37 Karlstad
Sweden
For assistance please consult: www.calmark.se
info@calmark.se

COMPONENTS

1. Instrument
2. Test cassette
3.  Inner packaging test cassette
4. Charger
5. Outer packaging for 20 test cassettes
6. Thermometer
7.  Instructions for use (this document)

INSTRUMENT

TEST CASSETTE

SYMBOLS USED

| In vitro diagnostic device
---|---
| CE Marking
| Manufacturer
| On/ Off
| Settings
| Setting date and time
| Setting date
| Return, go back
| Setting time
| Setting units
| Check temperature
| Caution
| Fill cavity completely
| Do not underfill cavity
| Do not overfill cavity
| Apply blood here
| Shows last 25 test results
| Battery indicator
| Battery too low to run a test
| Battery charging
| Battery empty, connect a charger
| Date of manufacture
| Last day for use
| Catalogue number
| Batch number
| Do not use if the package is broken
| Temperature limit
| Humidity limit
| Test is for single use only, do not reuse
| Read the instruction for use
| OK/Confirm
| Erase
| Abort test
| Error, check section 16

UNPACKING POC-ANALYZER

1. Open the box and unpack the parts on a plain surface. Check that the components are complete.
2. Make sure that there are no visible cracks or damages to the instrument.
3. Connect the charger to the instrument and to the wall outlet. Use only the charger provided. Using a different charger might harm the instrument.
4.  Charge the POC-Analyzer Covid for at least 2 hours before it is used on battery power.

START THE SYSTEM

Press the button  while keeping the lid closed and wait until this picture is shown on the screen.

SET THE DATE

Press the symbol on the screen. Then press the symbol followed by . Set the date by pressing the arrows up or down. Finish by pressing the symbol return until you reach the desired menu.

SET TIME

Press the symbol on the screen. Then press the symbol followed by . Set the time by pressing the arrows up or down. Finish by pressing the symbol return until you reach the desired menu.

SET UNIT

Press the symbol . Press . Choose unit U/L or μkat/L. Finish by pressing the symbol return until you reach the menu you wish.

PREPARING A SAMPLE

Correct sampling is a prerequisite for clinically reliable analysis results. As analysis of LDH in plasma is sensitive to hemolysis, it is important that the sampling is done in a safe and correct manner.

PERFORMING A MEASUREMENT

1. Open the lid of the instrument and put the cassette in the holder.

2. Apply a sample of venous whole blood in the intended cavity of the test cassette. Fill the cavity completely with approximately 2- 3 drops (at least 60 μL).

3. Close the lid. The measurement starts automatically, and a bar is shown on the screen.

4. A numeric keypad will appear on the display.

5.  Check the current temperature in the room and type it into the display with one decimal.
   Note! The instrument cannot calculate the LDH value outside of the temperature range 19,0 – 26,0°C.

6. Confirm the entered value for temperature. If correct press the symbol for ‘OK/Confirm’

7.  If a temperature outside the accepted range is entered by mistake, go back and re-enter a correct value, press the symbol for ‘Erase’

8. When a temperature value within the accepted range is confirmed, a numeric value for LDH will be presented on the screen.

Do not open the lid during the measurements, that will cause an abortion of the test. If an error code appears, read section 16 for troubleshooting.

SHOW PREVIOUS TEST RESULT

Press the symbol . The system shows the last 25 test results with the latest on top of the list. When the memory is full the oldest test result will be erased.

BATTERY INDICATOR

Symbol shows the instrument battery level. When the indicator is marked red , the instrument needs to be charged before running a test. If the symbol appears on the display, the instrument needs to be charged. When a lightning is shown over the indicator, the battery is charging . The instrument will turn off after 15 minutes of inactivity.

RESET THE SYSTEM

If the software does not respond to the user, the system can be reset by the reset outlet on the left side of the instrument. Press with a sharp object into the outlet and wait for the instrument to restart.

TROUBLESHOOTING

system off, wait 30 seconds and turn the system on again. If the error code remains, see respective error code.
The instrument does not start| Battery uncharged| Connect the adapter to the instrument and to the wall outlet. If this does not solve the problem, contact Calmark Sweden AB.
R0| Malfunction of the instrument| Contact Calmark Sweden AB.
R1| Instrument glass surface is dirty| Open the lid, remove the test cassette and discard it. Lift up the cassette holder. Take a clean paper with water and soap and/or 70% isopropyl alcohol and clean the glass surface. Repeat test with a new test cassette. Make sure that cassette bottom is clean and detection filter has no visible

defects.

R100| Malfunction of the

instrument

| Contact Calmark Sweden AB.
T1| Invalid test| Open the lid, remove the test cassette and discard it. Redo the test with a new cassette.

Possible issues:

·         detection area not filled properly/completely due to insufficient sample volume

·         sample hemolysis

·         sample level of hematocrit above product specifications

·         slow filling time (above 75 sec)

·         failed blood separation – blood leakage into the detection filter

T8| The entered temperature is outside of the supported range| Open the lid, remove the test cassette and discard it. Redo the test with a new cassette when the room temperature is within the accepted range.
C100| Use of an expired test cassette| Open the lid, remove the test cassette and discard it. Redo the test with a new test cassette from a valid batch.
C101| Use of a used test cassette| Open the lid, remove the test cassette and discard it. Redo the test with a new cassette.

CLEANING

Follow the hospitals provisions for cleaning medical devices. The instrument can be wiped with water and soap and/or 70% isopropyl alcohol. Lift up 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.

PRODUCT SPECIFICATIONS

INTENDED USE

Calmark COVID19-LDH is a diagnostic tool to be used with the point of care (POC) instrument Calmark analyzer. It measures quantitatively LDH levels in whole blood. The device shall be used by medical staff in health care facilities.

DIRECTIVE FOR IN VITRO DIAGNOSTIC

Calmark POC Covid fulfills the directive 98/79/EC for medical technical devices and has a CE-mark.

PRINCIPAL FOR TESTS

LDH is an intracellular enzyme involved in energy production and is found in almost every cell in the body. When body tissue is damaged, due to for example disease or injury, LDH is released from the cells into the blood. Thus, elevated LDH levels can be used as an indicator of tissue damage in pulmonary disorders such as pneumonia. 1-4
It has been shown that patients diagnosed with Covid-19 who has elevated levels of LDH are at >6 fold increased risk to develop severe disease and a

16 fold increased odds of mortality.4
Several published studies show that if elevated LDH levels can be detected at an early stage of Covid-19 infection, there is a greater chance to predict the severity and begin clinical intervention and monitoring. In this way, the prognosis improves and the possibility of recovery increases among the patients.1-4
Thus, LDH is an important biomarker for rapid triage of patients with Covid-19.1-5 In patients with severe pulmonary disease, the increase of LDH is significant and therefore one of the most important biomarkers to prove the prognostic of injury.3

CALIBRATION

The POC-Analyzer Covid is calibrated during manufacturing and does not need recalibration. Every test cassette contains information needed for automatic calibration of the results.

SAFETY PRECAUTIONS

Blood samples shall be handled according to good hospital practice in order to avoid risks for the user, such as infections. If other blood than venous, such as arterial or capillary, is used, it may lead to incorrect results.
Make sure to apply enough volume of blood into the intended cavity of the test cassette. Fill the cavity completely (at least 60 μL, approximately 2-3 drops).
Although the performance of the POC is assured, random variations can lead to a misleading result. Always take into account that the result shall be used together with other indicators and parameters for clinical assessment and decision about treatment.
All blood samples need to be collected in lithium heparin tubes or heparinized syringes. There is not sufficient data to support the collection of samples without anticoagulants. Using any other anticoagulant then Heparin might lead to false results.
Only whole blood shall be applied in the test cassette. If any other solutions are applied the product will not provide correct answers. Please discard the cassette if samples besides whole blood are applied.
The POC-Analyzer Covid is tested and controlled according to IEC 61010-2-101 and fulfils the requirements for IVD Medical Device Directive 98/79/EC. To maintaining safe use, make sure to:

1. Always place the instrument on a stable and flat surface.
2. Never disassemble the instruments’ housing.
3. Use only the supplied battery charger for the instrument.

TRANSPORT, STORAGE AND DISPOSING

Storage and operating conditions
The POC-Analyzer Covid shall be stored at a temperature between 10 and 40°C and a relative humidity between 10 and 90 %.
Tests can be run at a temperature between 19 and 26°C and a relative humidity between 20 and 80%.

Disposing
The test cassette shall be wasted in biological hazard waste. The instrument shall be wasted in electronic waste.

QUALITY CONTROL

The POC-Analyzer has an enclosed quality control system that at every test control that the hardware is functioning correctly. If there are any issues in the system an error code will be displayed at the screen, see chapter 16.

RESULTS AND MEASURING CONCENTRATION RANGES

Measuring concentration range is 180-350 U/L (3-5.8 µkat/L). Values below measuring concentration ranges are displayed as <180 for values <180 U/L LDH and >350 for values over >350 U/L LDH.

LIMITATIONS

Calmark POC-Analyzer Covid can analyze samples with hemolysis up to 0.3 g/L and a level of hematocrit up to 52%. Tests that cannot be analyzed will be displayed as error code T1.

REPEATABILITY

Within-run precision found using 3 different blood samples and 20 replicates according to CLSI EP5-A, using results from the reference method.

Imprecision found over 20 consecutive working days (CV%) for LDH controls according to CLSI EP5-A.

Bias: the mean values have been calculated and grouped into three concentration groups. The difference, in absolute %, is calculated for each sample using results from the reference method. The mean of the differences for each concentration group are calculated.

WARRANT

The POC-Analyzer Covid has 12 months of warrant from delivery of the product. Contact Calmark Sweden AB if you have any issues with the product.

SERVICE

Contact Calmark Sweden AB if you have any issues with the product. The POC- Analyzer Covid shall only be opened by a service technician provided by Calmark Sweden AB.

TECHNICAL SPECIFICATION

| Product name| Calmark POC – Covid
---|---|---
| Product description| Calmark POC – Covid consist of a single-use test cassette combined with a portable instrument. A thermometer is provided with the instrument as an accessory. LDH concentration correlates to the color developed in the filters inside the test cassette. The instrument software correlates the color intensity with the biomarker concentration and the temperature. A quantitative test result is shown on the instrument’s screen within 2.5 min after activation.

The test cassette has a plastic shell, containing four filters. The construction of the cassette determines the blood volume and the initiation of the measurement. Test activation is done automatically by the instrument. The filter combination handles high hematocrit and performs a hemolysis free filtration. The instrument contains a camera,

| **| a light source, software, a test cassette holder and a rechargeable
battery. It is portable and can be used at the patient’s side.
| Test cassette| COVID19-LDH, box with 20 pieces
Article no: 0-82444-CL
| Instrument| POC-Analyzer Covid, boxed
Article no: C-11001
| Sample type and size| Fill the cavity completely with venous whole blood (at least 60 µL)
| Regulatory status| CE marked
| Operating
environment| Temperature: 19-26°C (corresponding to 66.2-78.8 F)
Humidity: 20-80% RH
| Storage environment
instrument**| Temperature: 10-40°C (corresponding to 50-104 F)

Humidity: 10-90 % RH

| Safety classification| According to 61010-2-101
| Electromagnetic compatibility| According to EN61326-2-6
| Line voltage| The instrument has a Li-Ion battery inside and should not be connected to the line voltage directly. The battery is charged through micro-USB connection by using the provided USB-adapter (CE-approved, In 100- 240V AC/50-60Hz <500mA, out 5V DC). The charger voltage is 5V DC and limited to less than 2A by the unit itself.
| Current consumption| Less than 2A at 5V DC when the battery is charging.
| Overvoltage| N/A for the instrument. The adapter has over voltage category II.
| Class of insulation| N/A for the instrument. The adapter should have the requirement to reach double insulation or class II.
| Leak current| N/A (no ground connection to the unit).
| Fuses| None (not needed for this type of battery application since the adapter is approved for overvoltage category II and double insulation).
| Battery capacity| 3600mAh, nominal voltage 3.6V. Battery lasts for eight working hours (five tests/hour).
| Power adapter| DA5-050EU-B
| Single use| The test cassette can be used only once
| Shelf life| The test cassette has a shelf life of 6 months
| Life Cycle| The POC-Analyzer has a life cycle of 4 years
| Cleaning| The instrument can be clean with water and soap and/or 70% isopropyl

alcohol.

Test cassette| Width| 23.2 mm|
Depth| 8.7 mm|
Height| 42.1 mm|
Weight| Approx. 2.79 g|
Instrument| Width| 120 mm|
Depth| 210 mm|
Height| 93 mm|
Weight| Approx. 900 g|

PERFORMANCE SPECIFICATION

g/L
Sample haematocrit| Handles samples with hematocrit up to 52%
Anticoagulants interference| The product can handle up to 18 U/L lithium heparin.
Number of stored results in archive| 25 results stored locally

REFERENCES

1. Poggiali E, Zaino D, Immovilli P, et al. Lactate dehydrogenase and C-reactive protein as predictors of respiratory failure in COVID-19 patients. Clinica Chimica Acta. 2020;509:135-
   138. doi:10.1016/j.cca.2020.06.012

2. Wu M, Yao L, Wang Y, et al. Clinical evaluation of potential usefulness of serum lactate dehydrogenase (LDH) in 2019 novel coronavirus (COVID-19) pneumonia. Respir Res. 2020;21(1):171. doi:10.1186/s12931-020-01427-8

3.  Yan L, Zhang H-T, Goncalves J, et al. An interpretable mortality prediction model for COVID-19 patients. Nat Mach Intell. 2020;2(5):283-288. doi:10.1038/s42256-020-0180-7

4. Henry BM, Aggarwal G, Wong J, et al. Lactate dehydrogenase levels predict coronavirus disease 2019 (COVID-19) severity and mortality: A pooled analysis. The American Journal of Emergency Medicine.2020;38(9):1722-1726. doi:10.1016/j.ajem.2020.05.073

5. Han Y, Zhang H, Mu S, et al. Lactate dehydrogenase, an independent risk factor of severe COVID-19 patients: a retrospective and observational study. Aging. 2020;12(12):11245-11258. doi:10.18632/aging.103372

References

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