HemoCue Hb 201+ Operating Manual

CFR

US Make sure the analyzer is placed horizontally and on a stable surface.

S’assurer de poser l’analyseur horizontalement sur une surface stable.

1a. If AC power is available, plug the supplied power adapter into the power inlet at the back of the analyzer. 1b. If no power is available, insert the 4 type AA batteries, 1.5 V, into the battery compartment. 1c. If a battery symbol appears on the display, the batteries are running low on power. The analyzer will continue to give accurate results, but the batteries should be replaced as soon as possible. 2. Pull the cuvette holder out to the loading position. 3. Press and hold the left button until the display is activated (all symbols appear on the display). 4. The display shows the version number of the program, after which it will show ”6” and ”Hb” and ” ” (audio signal). During this time the analyzer will automatically verify the performance of the optronic unit by performing an automatic SELFTEST. 5. After 10 seconds, the display will show three flashing dashes and the HemoCue symbol. This indicates that the HemoCue Hb 201+ has passed the SELFTEST and is ready for use. If the SELFTEST fails, an error code will be displayed.

1a. Si une alimentation en c.a. est disponible, brancher l’adaptateur fourni dans la prise située à l’arrière de l’analyseur. 1b. S’il n’y a pas de courant, insérer les 4 piles 1,5 V (type AA) dans le compartiment prévu à cet effet. 1c. Un symbole de pile s’affiche à l’écran, dès que les piles sont faibles. L’analyseur continue à donner des résultats précis, mais les piles doivent être remplacées dès que possible. 2. Sortir le support de cuvette dans sa position de charge. 3. Appuyer sur le bouton gauche et le maintenir enfoncé jusqu’à ce que l’écran s’allume (tous les symboles s’affichent). 4. L’écran affiche le numéro de version du programme, puis « 6 », « Hb » et « » (signal audio). Pendant ce temps, l’analyseur effectue un contrôle automatique de l’unité optoélectronique en procédant à un AUTOCONTRÔLE automatique. 5. Au bout de 10 secondes, trois tirets clignotants et le symbole HemoCue apparaissent à l’écran. Ceci indique que l’appareil HemoCue Hb 201+ a réussi l’AUTOCONTRÔLE et qu’il est prêt à l’utilisation. Un code d’erreur s’affiche si l’AUTOCONTRÔLE échoue.

To turn the analyzer off, press and hold the left button until the display reads OFF and then goes blank. Disconnect the equipment from the power source by removing the AC adapter from the outlet.

Pour éteindre l’analyseur, appuyer sur le bouton à gauche et le maintenir enfoncé jusqu’à ce que l’écran indique OFF puis s’éteigne. Débrancher l’équipement de la source d’alimentation en retirant l’adaptateur c.a. de la prise.

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Measuring Capillary blood Mesure Sang capillaire

1

2

3

4

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CFR

US The cuvette holder should be cleaned after each day of use.

Le support de cuvette doit être nettoyé après chaque jours d’utilisation.

1. Pull the cuvette holder out to the loading position. 2. While pressing the catch, carefully rotate the cuvette holder sideways in open position as far as possible to the left. 3. Remove the cuvette holder from the analyzer, it will come off the stainless steel pin it rotates on. 4. Clean the cuvette holder with alcohol (20-70%) or mild detergent

1. Sortir le support de cuvette dans sa position de charge. 2. Tout en abaissant le fermoir, tourner le support de cuvette doucement dans sa position ouverte le plus à gauche que possible. 3. Retirer le support de cuvette de l’analyseur, il se soulèvera du gond en acier inoxydable sur lequel il pivote. 4. Nettoyer le support de cuvette avec de l’alcool (20 à 70 %) ou un détergent doux.

Wait 15 minutes before replacing the cuvette holder and using the analyzer. Make sure the cuvette holder is dry before inserting. The optical parts should be cleaned when directed to do so in the Troubleshooting Guide, see section Maintenance Optical parts.

Attendre 15 minutes avant de remettre le support de cuvette en place et d’utiliser l’analyseur. S’assurer que le support de cuvette est sec avant de l’insérer. Les pièces optiques doivent être nettoyées chaque fois qu’il est indiqué de le faire dans les directives du Guide de recherche de panne, consulter la section Entretien Pièces optiques.

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US

Troubleshooting Guide

If you are unable to resolve the problem by following this Troubleshooting Guide, please contact HemoCue America. The analyzer has no serviceable parts. Note: Do not open the cover of the analyzer. The warranty is voided if the analyzer has been opened.

Symptom

Explanation

Action

The analyzer shows an error code. May be a temporary fault.

Turn off the analyzer and turn it on again after 30 seconds. Take a new microcuvette and repeat the measurement. If the problem continues, see specific error code below.

E00

No stable endpoint is found within the time range. 1. The cuvette is faulty. 2. The circuit board is out of order.

1a. Check the expiration date for the microcuvettes. 1b. Take a new microcuvette and repeat the measurement. 2. The analyzer needs service. Contact HemoCue America.

E01–E05

1. Dirty optronic unit or faulty electronic or optronic unit.

1a. Turn off the analyzer and clean the optronic unit as described in the maintenance section. 1b. The analyzer needs service. Contact HemoCue America.

E06

1. Unstable blank value The analyzer might be cold.

1. Turn off the analyzer and allow it to reach room temperature. If the problem continues, the analyzer needs service. Contact HemoCue America.

E07

1. The battery power is too low.

1a. The batteries need to be replaced. Turn off the analyzer and replace the batteries, 4 type AA. 1b. Use the power adapter.

E08

The absorbance is too high. 1. An item is blocking the light in the cuvette holder.

1a. Check that the analyzer and microcuvettes are being used according to the HemoCue Hb 201+ operating manual and instructions for use. 1b. The analyzer needs service. Contact HemoCue America.

E09–E30

1. Dirty optronic unit or faulty electronic or optronic unit.

1a. Turn off the analyzer and clean the optronic unit as described in the maintenance section. 1b. The analyzer needs service. Contact HemoCue America.

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Symptom

Explanation

HHH

1. Measured value exceeds 25.6 g/dL (256 g/L, 15.9 mmol/L).

No characters on the display

1. The analyzer is not receiving power. 1a. Check that the power adapter is connected to the 2. If on battery power, the batteries need to be replaced. AC power supply. 3. The display is out of order. 1b. Check that the power adapter is securely connected to the analyzer. 1c. Check that the cable is not damaged. 2. Turn off the analyzer and replace the batteries, 4 type AA. 3. The analyzer needs service. Contact HemoCue America.

The display gives erroneous characters.

1. The display is out of order. 2. The microprocessor is out of order.

1. The analyzer needs service. Contact HemoCue America. 2. The analyzer needs service. Contact HemoCue America.

1. The batteries need to be replaced. 2. If on mains power, the mains adapter or the circuit board is out of order.

1. Turn off the analyzer and replace the batteries, 4 type AA. 2a. Check that the power adapter is properly connected and working. 2b. The analyzer needs service. Contact HemoCue America.

1. The magnet in the cuvette holder may be missing. 2. The magnetic sensor is out of order.

1. 2.

The display shows ”

”.

The display does not switch from “” and “Hb” to three flashing dashes and ” ” (ready for measuring).

Action

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The analyzer needs service. Contact HemoCue America. The analyzer needs service. Contact HemoCue America.

Symptom

Explanation

Action

Measurements on control materials are out of range – either too HIGH or too LOW.

1. The microcuvettes are beyond their expiration date, damaged or have been improperly stored. 2. The optical eye of the microcuvette is contaminated. 3. The control has not been mixed properly and/or is not at room temperature. 4. Air bubbles in the microcuvette. 5. The optronic unit is dirty. 6. The control is not suitable for use with the HemoCue Hb 201+ system. 7. The calibration of the analyzer has been changed. 8. The controls are beyond their expiration dates or have been improperly stored.

1. Check the expiration date and the storage conditions of the microcuvettes. 2. Remeasure the sample with a new microcuvette. 3. Make sure that the control is mixed properly and at room temperature. 4. Check the microcuvette for air bubbles. Remeasure the sample with a new microcuvette. 5. Clean the optronic unit as described in the maintenance section. 6. Only use controls intended for the HemoCue Hb 201+ systems. Contact HemoCue for control information. 7. The analyzer needs service. Contact HemoCue America. 8. Check the expiration date and the storage conditions of the control. Take a new microcuvette and repeat the measurement from a new vial/bottle of control.

Measurements on patient samples are higher or lower than anticipated.

1. Improper sampling technique. 2. The microcuvettes are beyond their expiration date, damaged or have been improperly stored. 3. The optical eye of the microcuvette is contaminated. 4. Air bubbles in the microcuvette. 5. The optronic unit is dirty. 6. The calibration of the analyzer has changed.

1. See pages 8–17 in this manual. 2. Check the expiration date and the storage conditions of the microcuvettes. Check the entire system with a commercial control. 3. Remeasure the sample with a new microcuvette. 4. Check the microcuvette for air bubbles. Remeasure the sample with a new microcuvette. 5. Clean the optronic unit as described in the maintenance section. 6. The analyzer needs service. Contact HemoCue America.

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US

Specifications General The HemoCue Hb 201+ is a system used for the determination of the total amount of hemoglobin in whole blood. The system consists of a specially designed analyzer with specially designed microcuvettes containing dried reagents. The microcuvette serves as pipette, reaction vessel and as a measuring microcuvette. No dilution is required. The hemoglobin measurement takes place in the analyzer, which follows the progress of the reaction until the steady state has been reached. The system is factory calibrated against the hemoglobincyanide (HiCN) method, the international reference method for the determination of the hemoglobin concentration in blood, and needs no further calibration.

humidity. Use the HemoCue Hb 201 Microcuvettes prior to their expiration date. The expiry date is printed on each package. Storage of microcuvettes kept in a vial

The microcuvettes are to be stored at room temperature (59–86 °F, 15–30 °C) and in a dry place. The expiry date of the HemoCue Hb Microcuvettes in a sealed vial is printed on the vial. Once the seal is broken, the microcuvettes are stable for three months. Always keep the vial properly closed. Storage of the individually packaged cuvettes

The microcuvettes are to be stored at room temperature (59–86 °F, 15–30 °C) and in a dry place. The individual packaged microcuvettes are stable until the expiry date printed on each package.

Intended Use Quantitative determination of hemoglobin in capillary, venous or arterial blood. The HemoCue Hb 201+ system is used for quantitative determination of hemoglobin in whole blood using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201 Microcuvettes. HemoCue Hb 201 Microcuvettes are for In Vitro Diagnostic use only. The HemoCue Hb 201+ Analyzer is only to be used with HemoCue Hb 201 Microcuvettes.

HemoCue Hb 201+ Analyzer The analyzer can be stored and transported at 32–122 °F (0–50 °C). Operating temperature is 59–86 °F (15–30 °C). Allow the analyzer to reach ambient temperature before use. The analyzer should not be stored at high (i.e. > 90 % non-condensing) humidity. Specimen collection and preparation Capillary, venous or arterial blood may be used. Appropriate anticoagulants (e.g. EDTA or heparin) may be used, preferably in solid form to avoid dilutional effects. Mix all specimen tubes thoroughly on a mechanical mixer for at least 2 minutes or invert the tube 8–10 times by hand. Hemoglobin remains unchanged for days, provided that the blood does not become infected. If the specimen has been stored in a refrigerator, it will be viscid and the blood should be allowed to warm up to room temperature before mixing2. In case of peripheral circulatory failure, hemoglobin measurements from capillary sampling may be misleading. Confirmation of an unacceptable or unexpected laboratory result is considered as a

Theory The reaction in the microcuvette is a modified azidemethemoglobin reaction. The erythrocyte membranes are disintegrated by sodium deoxycholate, releasing the hemoglobin. Sodium nitrite converts the hemoglobin iron from the ferrous to the ferric state to form methemoglobin, which then combines with azide to form azidemethemoglobin. Storage and handling Operating temperature for the system is 59-86 °F (15-30 °C). The system should not be operated at high (i.e >90% non-condensing)

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common, well established routine in the laboratory. Extra cellular fluid present in capillary samples due to individual physiology or the affects of unacceptable capillary sampling technique can cause false hemoglobin results. One of several pre analytical factors associated with technique revolves around the size and action mode of the lancet and how it is used. This and other factors associated with capillary sampling technique can have an impact on the puncture, blood flow and ultimately on the results obtained. Additional factors unrelated to sampling technique, such as an individual’s capillary circulation status, must also be recognized as potential causes of false results. Therefore when testing for hemoglobin using capillary blood as the sample, confirmation of an unacceptable or unexpected result is needed to rule out potential pre analytical factors as the cause. This is particularly helpful when a cut off value is used, i.e. when screening for nutritional status based on hemoglobin. Since the individual performing the test may not always be aware of all the potential pre analytical factors or even those that are directly or indirectly associated with sampling techniques, a second finger stick should be performed when wanting to rule out pre analytical factors as a cause of an unacceptable or unexpected result. Performance of the second finger stick by a different individual may aid in lessening the affect of the factors that could have been technique related. Always handle blood specimens with care, as they might be infectious. Consult local environmental authorities for proper disposal. Always wear protective gloves when handling blood specimens. The microcuvette is for single use only.

• Pipette or other transfer device (for venous, arterial or control material samples) • Lint-free wipe (non-fraying) • Hydrophobic surface (for venous, arterial or control material samples) Quality Control The HemoCue Hb 201+ Analyzer has an internal quality control, the “selftest”. Every time the analyzer is turned on, it will automatically verify the performance of the optronic unit of the analyzer. This test is performed every second hour if the analyzer remains switched on. Upon passing the SELFTEST, the display will show the HemoCue symbol and three flashing dashes, indicating that the analyzer is ready to perform a measurement. An error code will be displayed if the SELFTEST fails. Follow local guidelines regarding quality control procedures. If a quality control test is required by local or other regulations and therefore should be performed, only use controls recommended by HemoCue, see relevant package insert for more information. Expected values2

Adult Males 13.0–17.0 g/dL (130 – 170 g/L, 8.1–10.5 mmol/L) Adult Females 12.0–15.0 g/dL (120–150 g/L, 7.4–9.3 mmol/L) Infants, after neonatal period 11.0–14.0 g/dL (110–140 g/L, 6.8–8.7 mmol/L) Children, two years to teenage: gradual increase to adult normals. Due to a wide range of conditions (dietary, geographical, etc) which affect normal values, it is recommended that each laboratory establish its own normal range.

Materials required • HemoCue Hb 201+ Analyzer • HemoCue Hb 201 Microcuvettes • Lancet (for capillary samples)

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Measuring range 0 – 25.6 g/dL (0 – 256 g/L, 0–15.9 mmol/L). Results above 25.6 g/dL (256 g/L, 15.9 mmol/L) will be displayed as HHH. Values above 23.5 g/dL (235 g/L, 14.6 mmol/L) must be confirmed using a suitable laboratory method.

Signal input and signal output Accessory equipment to the analog and digital interfaces must be certified according to the respective UL standards (i.e. UL 60950-1 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1. Connections of additional equipment to the signal input or signal output connections is deemed to be “configuring a medical system”, and therefore assumes responsibility for the systems compliance within the requirements of IEC 60601-1-1. If in doubt, contact HemoCue AB.

Limitations

HemoCue Hb 201 Microcuvettes are for in vitro diagnostic use only. The HemoCue Hb 201+ Analyzer is only to be used together with HemoCue Hb 201 Microcuvettes. For further limitations of the procedure, see the HemoCue Hb 201 Microcuvettes package insert.

Essential Performance The essential performance is quantitative determination of hemoglobin in capillary, venous or arterial whole blood.

Technical Specifications Dimensions: 3.35 × 6.30 × 1.69 inches (85 × 160 × 43 mm). Weight: 0.77 pounds (350 g) (with batteries installed). 4 batteries type AA. Power adapter: CE marked. Only use adapters recommended by HemoCue in the table, last in Specifications after section Manufacturer. Pollution degree: 2. Overvoltage category: II. Atmospheric pressure: 700 hPa to 1060 hPa. Equipment not suitable for use in the presence of flammable mixtures. The instrument is tested according to IEC 61010-1, Second edition: 2001 and EN 61010-1: 2001, IEC/EN 61010-2-101: 2002, IEC 61326-1: 2005 and EN 61326-1: 2006, IEC 61326-2-6, First edition: 2005 and EN 61326-2-6: 2006, IEC 60601-1-2, Third edition: 2007 and EN 60601-1-2: 2007 and complies with the IVD Medical Device Directive 98/79/EC. The instrument is made for continuos mode.

Warranty The analyzer carries a 24-month warranty from the day of receipt. After the warranty period, service/repair is carried out at fixed prices. Any other use of the system than recommended by the manufacturer will void the warranty. Service and Disposal The analyzer should be cleaned as recommended under Maintenance prior to service or disposal. Consult local environmental authorities for proper disposal. Spare parts – Accessories The following spare parts and accessories are available: Power adaptor Battery Lid HemoCue Cleaners Hard Carrying Case Cuvette holder HemoCue Lancets HemoCue Hb 201+ Control Cuvette

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Recommended separation distance between Portable and mobile RF communications equipment and HemoCue Hb 201+ Analyzer

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequencyrange applies.

The HemoCue systems are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of HemoCue systems can help prevent electromagnetic interference by maintaining a minimum distance between portable and RF communications equipment (transmitters) and HemoCue systems as recommended below, according to the maximum output power of the communications equipment.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Rated maximum output power of transmitter (W)

150 kHz to 80 MHz d=1.2√P

80 MHz to 800 MHz d=1.2√P

800 MHz to 2.5 GHz d=2.3√P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

Separation distance according to frequency of transmitter (m)

For transmitters rated at maximum output power not listed above, the recommended separation distances (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where (P) is the maximum output power rating of the transmitter in watts (W) according to transmitter manufacturer.

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Guidance and manufacturer’s declaration – Electromagnetic immunity The HemoCue systems are intended for use in the electromagnetic environment specified below. The customer or user of the HemoCue systems should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

±2 kV for power supply lines

2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-4

±1 kV for input/output lines

±1 kV for input/ output lines

Surge

±1 kV differential mode

±1 kV differential mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply lines

< 5 %U (> 95 % dip in U) for a 0.5 cycle

< 5 %U (> 95 % dip in U) for a 0.5 cycle

Mains power quality should be that of a typical commercial or hospital environment.

40 %U (60 % dip in U) for 5 cycles

40 %U (60 % dip in U) for 5 cycles

IEC 61000-4-11

70 %U (30 % dip in U) for 25 cycles

70 %U (30 % dip in U) for 25 cycles

< 5 %U (> 95 % dip in U) for 5 seconds

< 5 %U (> 95 % dip in U) for 5 seconds

IEC 61000-4-5

For explanation of U see NOTE 1

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If the user of the HemoCue systems requires continued operation during power mains interruptions, it is recommended that the HemoCue systems be powered from an uninterruptible power supply or a battery.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the HemoCue systems, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

See NOTE 2 and NOTE 3

d=1.2√P d=1.2√P 80 MHz to 800 MHz d=2.3√P 800 MHz to 2.5 GHz Where (P) is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and (d) is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a), should be less than the compliance level in each frequency range (b). Interference may occur in the vicinity of equipment marked with the following symbol.

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NOTE 1

U is the a.c. mains voltage prior to application of the test level.

NOTE 2

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 3

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a)

b)

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HemoCue systems are used exceeds the applicable RF compliance level above, the HemoCue systems should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the systems. Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.

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Technical specifications (EMC-RF)

Use only cables with the following specification: USB shielded maximum 2 m Serial shielded maximum 1.5 m

Guidance and manufacturer´s declaration – electromagnetic emissions The HemoCue systems are intended for use in the electromagnetic environment specified below. The customer or the user of the HemoCue systems should assure that it is used in such an environment. Emission test

Compliance

Electromagnetic environment – guidance

RF emissions

Group 1

The HemoCue systems uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment

RF emissions

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

The HemoCue systems are suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

NOTE 1 NOTE 2

It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility information to the customer or user. It is the user’s responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the device will perform as intended.

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Symbols used

Consult instructions for use

Caution 90

Relative humidity, non-condensing

5

CE mark

References 1. Makarem, A. In clinical Chemistry: Principles and Techniques, 2nd ed., Henry, R.J., Cannon, D.C., and Winkelman, J.W., Harper and Row, Hagerstown, M.D., 1974, pp. 1125–1147. 2. Dacie and Lewis, Practical Haematology Ninth edition. 3. Jacques Wallach, M.D., Interpretation of Diagnostic Tests.

Class II equipment

The Medical Equipment with respect to electrical shock, fire and mechanical hazards only in accordance with UL-2601-1 and related collateral IEC 60601-1 standards for which the products has been found to comply by UL. Only valid within the European Community. Indicates seperate collection for waste of electrical and electronic equipment. Temperature limitation Efficiency Level

Serial port

DC inlet

To maintain safety use only adapter marked HCA01

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Manufacturer HemoCue AB Box 1204 SE - 262 23 Ängelholm, Sweden Phone: +46 77 570 02 10 Fax: +46 77 570 02 12 E-mail: [email protected] www.hemocue.com HemoCue Distributor USA: HemoCue America 250 South Kraemer Boulevard Brea, CA, 92821 Phone (General) 800-881-1611 Orders 800-323-1674 Technical support 800-426-7256 Fax (Cust. Service) 800-333-7043

Adapters to be used: Country USA/Canada World wide

Type Mod nr FE3515060D035 HCA01

Input 120 V~/60 Hz/6.6 VA 100 V~/240 V~/50–60 Hz, < 500 mA

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