Bilimeter II + Prufsonde User and Service Manual Ver 2.0a

Bilimeter II + Prüfsonde User Manual

Version 2.0a

Contents

Chapter - Bilimeter II 1.

Introduction – Bilimeter II

2.

Quality Control Procedure

3.

Technical Information - 3.1 Construction - 3.2 Principle of Measurement - 3.3 Specifications - 3.4 Optimum Measurement Results

4.

Sample Measurement

5.

Optical Warning Indications during Routine Handling

6.

Trouble Shooting

7.

Service- Technical Assistance - 7.1 Lamp Check (Halogen Lamp) - 7.2 Halogen Lamp Replacement (Lamp Justification) - 7.3 Quality control - 7.4 Instrument calibration of the Bilimeter II

8.

Service

9.

Spare Parts List

10.

List of Cables

Chapter - Prüfsonde 11.

Introduction – Prüfsonde

12.

Operation – Prüfsonde

13.

Care and Handling – Prüfsonde

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Bilimeter II + Prüfsonde User Manual

1.

Version 2.0a

Introduction – Bilimeter II The Bilimeter II is a high-precision instrument for the in-vitro measurement of the total bilirubin of new-borns. Measurements can be performed quickly and reliably by both laboratory and ward personnel. The device is delivered already calibrated and is ready for measuring. Please note the guidelines valid for the performance of the quality control in the respective country. Please read the instructions carefully and ensure that they are always available to all persons working with this device. The device is easy to use, however, a maximum precision of measurement can only be guaranteed if it is operated and maintained according to the instructions. Please note that only original accessories and consumables may be used. If you have any questions regarding the operation of the Bilimeter II or if problems should occur don´t hesitate to contact our company. Please have the serial number of the Bilimeter II and an exact description of the error ready to ensure fast assistance.

Contact:

Sartorius Limited Longmead Business Centre Blenheim Road Epsom Surrey KT19 9QQ Tel: (++44) (0) 1372 – 737 102 Fax: (++44) (0) 1372 – 729 927

Serial Number – Bilimeter II

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Bilimeter II + Prüfsonde User Manual

2.

Version 2.0a

Quality Control Procedure In common with all high precision analytical equipment the performance and precision of the Bilimeter II must be monitored regularly. To make this procedure as easy as possible the instrument has been provided with a dedicated control probe or Prüfsonde developed by Pfaff-T&M in cooperation with the Women`s Hospital main laboratory at the University of Tübingen. (European patent pending). Each Prüfsonde is specifically matched to the Bilimeter II with which it is supplied and comes with a certificated value. Instructions on how to use the Prüfsonde are detailed below. In conjunction with the Prüfsonde we strongly advise that the instrument is also regularly checked using a commercially produced serum control. The frequency of this testing should be discussed and agreed with the hospitals Clinical Chemistry Department but it is recommended that this take place at least once a week. Due to the handling and storage requirements of this organic material we recommend that trained laboratory personnel from the hospitals Clinical Chemistry Departments carry out this testing. Measurements made using serum controls are made in exactly the same way as patient samples. Please refer to the appropriate section in this manual for instructions on how to make these measurements. The initial installation and calibration procedure must be carried out using a serum control, after which the Prüfsonde must also be checked and the reading compared to the certificated value. Only when the two measurements are within specification can the instruments be used for patient testing.

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Bilimeter II + Prüfsonde User Manual

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3. Technical Information 3.1 Construction

Capillary Tube Sample Holder

Output Circuits

Lens Blue Filter Input Circuits

Slit Light Source (Halogen Lamp)

Motor 455 nm Filter 575 nm Filter

I/O Circuits

CPU Circuits

Filter Disk

3.2 Principle of Measurement Bilirubin has a maximum absorption wavelength of 455 nm and Haemoglobin one of 575 nm. Light beams with wavelengths of 455 nm and 575 nm pass successively through the serum in the haematocrit capillary tube positioned in the sample holder. Assuming that the respective absorbencies at these two wavelengths are 455 nm and 575 nm, the possible effects of haemoglobin present in sera derived from haemolytic samples can be compensated by deducting the 575 nm. The use of this dual wavelength compensation eliminates the necessity to use a control serum each time a sample is measured. The concentration of total bilirubin shown in the indicator is calculated based on the absorption derived using the following formula :

Total bilirubin = 455 - 575

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Bilimeter II + Prüfsonde User Manual

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3.3 Specifications Measurement Range: Linearity:

0 ~ 999 µmol 0 ~ 500 µmol

Sample Holder:

Capillary tubes for Bilimeter II (article no. / order no. 105000) sealing wax for capillary tubes (article no. / order no. 106000)

Light Source:

Quartz halogen bulb 12 V / 30 W (article no. / order no. 109020)

Measurement Volume:

ca. 4 µl

Filters:

455 nm / 575 nm metal interference filters

Power Supply:

230 V / 90 W / 50 Hz

Fuses:

2 x 1 AT Attention, important note: Before fuse change disconnect from the mains power supply!

Dimensions:

270 x 330 x 142 mm

Weight:

9 kg

3.4 Optimum Measurement Results To optimise the measurement results of the Bilimeter II the following points should always to be kept in mind:  Since both sample and control sera are sensitive to heat and light, careful handling with respect to these factors is essential for good results.  Never use capillaries that are dirty or damaged as this could adversely affect the precision of measurement (through light scatter and absorption).  Depending on the orientation of the capillary tube the measured value can sometimes fluctuate. Therefore turn the capillary tube and use the lowest indicated value as you do so.  During each measurement the slit must be completely covered by the serum fluid column.

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Bilimeter II + Prüfsonde User Manual

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4. Sample Measurement For measuring a patient’s sample the following steps are required:  Turn on the power switch. The value “120” is indicated. The digital value counts from “120” down to “0”.  When the value “0” is indicated, open the cover and take the sample holder out of the slit.  Fill the capillary tube with distilled water, plug one end with sealing putty and insert it into the sample holder ensuring that the slit is completely covered by the fluid column.  Insert the sample holder into the slit and close the cover.  Push the CAL button for calibration. “0.0” is indicated. Now the device is ready for measuring (Please note the respective country guidelines for the performance of a quality control).  Insert the capillary tube with the patient’s centrifuged sample into the sample holder so that the slit is completely covered by the plasma column.  Put the sample holder with the patient’s sample into the instrument, close the cover and push the MEAS button.  The value of the total bilirubin is indicated in digital numbers. IMPORTANT – Please note: Linearity, haemoglobin compensation, accuracy and precision can only be guaranteed by the use of original accessories. Use original capillary tubes only! Incorrect quartz halogen lamps leads to damaged optics and filters and can cause inaccurate results!

5. Optical Warning Indications during Routine Handling

CAL F0.0

LAP

Calibration is required. Keep the Bilimeter II power switch on. The lamp is too weak and should be replaced (see section 5 “Trouble Shooting”). The filters in older devices should be replaced. There is no original capillary tube in the sample holder. There is no distilled water in the capillary tube. The lamp has blown out and must be replaced (see section 6.2 “ Halogen Lamp Replacement”). The capillary holder has not been inserted correctly (see section 5 “Trouble Shooting”).

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Bilimeter II + Prüfsonde User Manual

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6. Trouble Shooting Troubles No indication appears with power switch on.

“LAP” is indicated although the halogen lamp has not blown.

“F0.0” is indicated although the filters are all right.

Measured value is either too high or too low.

Device blushes.

Possible Causes Mains cable has not been correctly plugged in.

Trouble Shooting Plug in the mains cable correctly.

Fuse has blown.

Replace the fuse.

Wall socket has no mains power supply. Sample holder has not been inserted correctly.

Use other wall socket.

Slit is dirty or blocked.

Clean the sample holder.

Halogen lamp has not been vertically inserted into the socket.

Insert lamp correctly.

Sample measure. Sample or control serum is in the capillary tube.

Perform re calibrate 0.0 Fill distilled water into the capillary tube.

Lamp has not been vertically inserted into the socket.

Insert lamp correctly and perform alignment.

Lamp set up.

Perform lamp set up/exchange procedure. Use capillary tube with distilled water and recalibrate 0.0

Sample or control serum is in the capillary tube.

Insert the sample holder correctly.

Slit in the sample holder is not completely covered with fluid. Correct positioning of capillary tube or use less plastic sealing mass. Filters are not in optically correct position. Please call service engineer. The Bilimeter II is happy. Please read the description carefully.

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Bilimeter II + Prüfsonde User Manual

Version 2.0a

7. Service – Technical Assistance 7.1 Lamp Check (Halogen Lamp) Before first using the Bilimeter II, or after replacing the light source (halogen lamp), the lamp alignment must be checked by performing the following halogen lamp replacement procedure.     

Check the sample holder is empty. Insert the sample holder into the device. Keeping the “CAL” button pressed, turn on the power switch. Make sure that the indicated value is › (more than) 300, but ‹ (less than) 350. Turn off the power switch. Perform quality control. Please note your country guidelines for QC.

Note : If the indicated value is ‹ 300 (less than 300), see 7.2 “Halogen Lamp Replacement” (Lamp Justification).

7.2 Halogen Lamp Replacement

Attention, important note! Disconnect from the mains power supply before opening the lid for lamp change!  Switch off the Bilimeter II, disconnect from the mains power supply and allow the lamp time to cool.  Open the lid on the left-hand side of the Bilimeter II. Lift the lamp bow forward and pull the lamp out of the socket.  Insert the new halogen lamp without touching it directly with bare hands. Any dirt on the lamp surface should be wiped off with a clean cloth moistened with alcohol.  Close the lamp bow (lift up). Close the lid on the left-hand side and fix the lid with the screw. Reconnect to the mains power supply.  Keeping the “CAL” button pressed, turn on the Bilimeter II power switch. The indicated value must be › (more than) 300, but ‹ (less than) 350. If the value is ‹ (less than) 300, continue with point 6.  Loosen the large outer fixing screw on the bottom side of the device. Turn the thin inner adjusting screw until the value is indicated as described in point 5. Then tighten the large outer fixing screw.  After lamp replacement a quality control must be performed. Please note the guidelines valid in your country

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Bilimeter II + Prüfsonde User Manual

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7.3 Quality control We recommend using the procedures, recommended by your Clinical Chemistry.

7.4

Instrument calibration of the Bilimeter II We recommend the instrument be serviced every six months, by a certified technician.

8.

Service Servicing, repairs and calibration must only be performed by a fully trained and certified technician.

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Bilimeter II + Prüfsonde User Manual

11.

Version 2.0a

Introduction – Prüfsonde The Prüfsonde is a high precision device for the technical quality control of the Bilimeter II Bilirubinometer from Pfaff-T&M. Using the Prüfsonde the instrument can quickly and reliably be checked by both laboratory and hospital staff. Maximum precision is only guaranteed when these directions are followed exactly and when the device is properly maintained. Please read these instructions carefully and ensure that they are accessible to all personnel working with the Prüfsonde. If you have questions on how to use the Prüfsonde or if a problem should arise please contact your supplier. The serial number of the Prüfsonde and an exact description of the problem should be noted to enable the technical department to assist you.

12.

Operation – Prüfsonde It is very easy to make a reading using the Prüfsonde. The procedure is identical to that used in making a patient reading of performing a serum-based quality control except that the sample holder is removed and the Prüfsonde used instead. We recommend that the Prüfsonde be used to check the instrument every time it is switched on (before any patient samples are tested) and at least once every 24 hours. 10.1 Power switch on*. Indicated figures will count down from 120 to zero. 10.2 When the digital indicator reaches “0”, open the black cover and remove the sample holder from the measuring aperture. Insert a capillary tube filled with distilled water into the sample holder. 10.3 Set the Sample Holder in the measuring aperture and close the cover. 10.4 Push “CAL” button for calibration. “0.0” will be indicated. 10.5 Open the cover and remove the Sample Holder.

10.6 Carefully take the Prüfsonde out of its wooden box and place it in the measuring aperture, coloured spot to coloured spot. 10.7 Please Note! The Prüfsonde must fit in just as easily as the capillary holding device. If this is not the case you must contact your supplier immediately! 10.8 Close the cover and press the “MEAS” button. Page 11

Bilimeter II + Prüfsonde User Manual

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10.10 The indicated value is the measured value of the quality control. 10.11 Note the indicated value.

Minimal fluctuations are acceptable but the measurement should not vary by more than 10%. If greater variations exist recalibrate the Bilimeter and repeat the measurement. If the variation persists please contact your Service agent.

13.

Care and Handling – Prüfsonde 11.1 In order to prevent overheating always remove the Prüfsonde from the Bilimeter after use. 11.2 The Prüfsonde must be stored at room temperature and kept dry. For optimum protection and to keep it free from dust it is recommended to use the wooden box provided. Never store it in the refrigerator. 11.3 The Prüfsonde is not affected by light. 11.4 Dust deposits may be removed with a small soft brush but do not touch the glass insert.

Please note: The accuracy of all measurements, including those of the Prufsonde, will depend on the accuracy of the initial zero calibration. In order to avoid incorrect results please pay great attention to the cleanliness of the measuring slot on the capillaries and of the original lamps. After any repairs the Bilimeter should always be recalibrated before patient samples are measured. This must be done using control serum.

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Bilimeter II + Prüfsonde User Manual

9.

Spare Parts List

No.

Code No. Description

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 41 42 43 44 45 46 47 48 49 50 61 62

403-10-01 403-10-02 403-10-03 403-10-04 403-10-05 403-10-06 403-10-07 403-10-08 403-10-09 403-10-10 403-10-11 403-10-12 403-10-13 403-10-14 403-10-15 403-10-16 403-10-17 403-10-18 403-10-19 403-10-20 403-10-21 403-10-22 403-10-23 403-10-24 403-10-25 403-10-26 403-10-41 403-10-42 403-10-43 403-10-44 403-10-45 403-10-46 403-10-47 403-10-48 403-10-49 403-10-50 403-10-61 403-10-62

Version 2.0a

Quant. Remarks

Power Supply Board CPU Board Input/Output Board Analogue Board Display and Key Board Halogen Lamp JC12V30W 10H/G1 Lamp Socket 601-UL-200 Heat Sink (rectangle) Heat Rays Absorbance Glass HA50 Lens TS-2040S17 Filter Disk Filter Case Interference Filter for 455 nm B-F4550/110, φ 15-5T Interference Filter for 575 nm B-F4550/110, φ 15-5T ND Filter ND0.6 Ball Plunger BSU3 Stepping Motor PX224-03A Pulley (small) P24MKL100 Pulley (large) P36MXL100 Bearing #685 Belt 63T80-6.4 Photosensor EE-SX472 Sensor Disk Transformer Fan MD625B-12 Heat Sink (square) Power Switch JW-M21 AC Inlet ZUG2203-11A Fuse Holder SN2050#3 Fuse 3A Fan Guard FG6B Acrylic Cover Front Operation Panel Lamp Cover Rotary Switch Cover Rubber Leg Sample Holder (with Holding Board) Holding Board

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Bilimeter II + Prüfsonde User Manual

Version 2.0a

10.

List of Cables

No.

Code No. Description

71

403-10-71

Cable for Transformer to Power Supply Board with connector BHR-6N

1

72

403-10-72

Cable for Transformer to Power Supply Board with connector 5051-3

1

73

403-10-73

Cable for Power Supply Board to CPU Board with connector 5051-2 (2 sets)

1

74

403-10-74

Cable for Power Supply Board to Input/Output Board with connector XHP-5, XHP-4

1

75

403-10-75

Cable for Power Supply Board to Analogue Board with connector XHP-3 (2 sets)

1

76

403-10-76

Cable for Power Supply Board to Fan with connector XHP-2

1

77

403-10-77

Cable for Power Supply Board to Lamp with connector BHR-2N

1

78

403-10-78

Cable for CPU Board to Input/Output Board with connector HIF3BA-50D-2.54R (2 sets)

1

79

403-10-79

Cable for Input/Output Board to Motor with connector XHP-6

1

80

403-10-80

Cable for Input/Output Board to Display and Keyboard with connector HIF3BA-30D-2.54R (2 sets)

1

81

403-10-81

Cable for Input/Output Board to Analogue Board with connector XHP-6 (2 sets)

1

82

403-10-82

Cable for Input/Output Board to Photosensor with connector 5051-6

1

Quant. Remarks

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