BLD03/50M

BLD03/50M
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BLD03/50M

Product catalog summary
General Description
The Blood Leak Detector BLD03/50M is a non-invasive optical sensor designed to detect minimal blood presence in clear fluids through transparent tubing. It includes a sensor head and an external electronic board (PCB) with integrated firmware, developed according to IEC 62304:2006 + AMD1:2015, safety class C. It is intended as a built-in component for medical devices.
Scope of Delivery
The delivery includes the sensor head BLD03/50 and the programmed PCB BLD03M, both classified as class C components.
Sensor Head BLD03/50 Specifications
  • Measuring method: Optical transmission with LED
  • Materials: ABS and glass housing, PUR potting
  • Operating temperature: +5 °C to +50 °C
  • Protection: IP67
  • Tube requirements: Optically transparent, 5.5 to 7.0 mm outer diameter, ≤ 1.25 mm wall thickness
Printed Circuit Board BLD03M Specifications
  • Measuring method: Optical transmission
  • Blood sensitivity: Detects ≥ 0.35 ml/min blood leakage at 800 ml/min fluid flow
  • Response time: 280 ms for blood alarm, 550 ms for plausibility test
  • Operating voltage: +3.1 to +5.5 VDC
  • Current consumption: ≤ 40 mA
Electrical Connections
  • J2: Connection to Sensor Head
  • J3: Serial Interface for alternate software
  • J4: Logical Interface for blood alarm and self-test inputs
Standards and Safety
  • Developed in compliance with IEC 60601-2-16:2018 and IEC 60601-1-2:2014 + AMD1:2020
  • Software classified as “C” according to IEC 62304:2006 + AMD1:2015
Manufacturer Information
SONOTEC GmbH, Germany, and SONOTEC US Inc., USA, are the manufacturers and distributors of the Blood Leak Detector BLD03/50M.
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Catalog excerpts

BLD03/50M-1

Technical Data Sheet Blood Leak Detector Original

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BLD03/50M-2

Technical Data Sheet | General Blood Leak Detector BLD03/50M General Description The Blood Leak Detector BLD03/50M is a non-invasive, optical sensor designed to detect smallest amounts of blood in a clear fluid through an optical transparent and flexible tubing. The sensor consists of a sensor head with connection line and an external electronic board (PCB) with integrated firmware. The BLD03/50M meets highest demands on patient safety and reliability: The firmware has been designed according to the requirements of the international standard IEC 62304:2006 + AMD1:2015, safety class C. The sensor...

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BLD03/50M-3

Technical Data Sheet | Sensor Head BLD03/50 Blood Leak Detector BLD03/50M Sensor Head BLD03/50 Technical data Measuring method Optical transmission measurement, LED Specification Sensor head BLD03/50 - channel width 5.0 mm Materials Housing: ABS and glass Measuring channel Width: 5.0 mm; Height: 5.8 mm Mounting Two mounting holes (0 = 3.25 mm) © The sensor must be installed on a plane surface. Working humidity 20 % ... 75 % relative humidity (not condensing) Storage humidity 10 % ... 90 % relative humidity (not condensing) Protection IP67 (Sensor head without connector) © Please provide us with...

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BLD03/50M-4

Technical Data Sheet | Sensor Head BLD03/50 Blood Leak Detector BLD03/50M Special features Tube must be optically transparent within the spectral range of about 415 nm Elasticity Tube must be able to adjust flexibly Liquid requirements Optically transparent liquids Cable Sensocord®-M-UL, 5 x AWG 28, unshielded, black, Length: 500 mm ± 20 mm Connector Molex PicoBlade 51021-0500, Single Row, 5 circuits, 1.25 mm Directives/Standards The sensors were developed to be tested with respect to the following Scope of delivery Sensor Head BLD03/50 (connection cable included) Technical data sheet Labelling...

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BLD03/50M-5

Technical Data Sheet | Printed Circuit Board BLD03M Blood Leak Detector BLD03/50M Printed Circuit Board BLD03MTechnical Data Measuring method Optical transmission measurement Specification Printed Circuit Board BLD03M V1.1, FW V04.05 Blood threshold Light attenuation of 8 % compared to the calibrated light intensity Blood sensitivity Reliable detection of a blood leakage > 0.35 ml/min at a dialysis fluid flow rate of 800 ml/min, haematocrit level of 32 %. © The indication above is a worst case scenario. Depending on tube properties, application and process characteristics the sensor may detect...

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BLD03/50M-6

Technical Data Sheet | Printed Circuit Board BLD03M Blood Leak Detector BLD03/50M Technical Data Safety aspects Self-test - A self-test routine can be triggered via digital input. Working humidity 20 % ... 75% relative humidity (not condensing) Storage humidity 10 % ... 90 % relative humidity (not condensing) Directives/Standards The sensors were developed to be tested with respect to the following • Software is developed acc. to IEC 62304:2006 + AMD1:2015 The embedded software is classified as "C" Technical Data Sheet Operating Manual Labelling Each Printed Circuit Board is labelled with its...

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BLD03/50M-7

Technical Data Sheet | Printed Circuit Board BLD03M Blood Leak Detector BLD03/50M Electrical Connection ATTENTION The board needs to be protected against unintended contact with other conductive parts. J2 – Connection to Sensor Head Connector Board connector header; 5-pin; 1.25 mm Molex: 53261-0571 J3 – Serial Interface Intended for use with another software version. Connector Board connector header; 4-pin; 1.25 mm Molex: 53261-0471 Operating voltage

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BLD03/50M-8

Technical Data Sheet | Printed Circuit Board BLD03M Blood Leak Detector BLD03/50M Connector Board connector header; 6-pin; 1.25 mm Molex: 53261-0671 3 Output "Blood Alarm" 4 Input "External Self-Test" (high active) 6 Input "Calibration" (high active) Signal level Condition High Blood Low No blood (clear liquid) High No plausibility error nor device error Low Plausibility error or device error Signal at input Self-Test S05-007 Signal level Condition High Start self-test High Start calibration

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BLD03/50M-9

Technical Data Sheet | Printed Circuit Board BLD03M Blood Leak Detector BLD03/50M Logical level Parameter Condition Operating Min Typ Max Unit Signal at output Output Voh Ioh = -100 pA 3.1 ... 5.5 V Vcc-0.1 --- --- V Signal at input Input Vih High Voltage

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BLD03/50M-10

Technical Data Sheet | Printed Circuit Board BLD03M Blood Leak Detector BLD03/50M Technical drawing Dimensions in mm Remnants of material up to 0,5mm (due to separation of the PCB production panel) on a sides (bottom side) (due to separation of the PCB production panel) Drawings are not to scale. Dimensions in mm, unless otherwise specified. Information is subject to change without notice. SONOTEC is a registered trademark. Manufacturer Contact USA SONOTEC GmbH Nauendorfer Str. 2 06112 Halle (Saale) Germany Suite 8, 2nd Floor [email protected] Islandia, New York 11749, USA www.sonotecusa.com...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.
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