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Related Manuals for Sonotec SONOCHECK ABD05 Series
Summary of Contents for Sonotec SONOCHECK ABD05 Series
- Page 1 Air Bubble Detector Type SONOCHECK ABD05/xx ® Operating Manual...
- Page 2 © SONOTEC GmbH All rights reserved. Revision: 2.1; Date: 2020-07-22 Information is subject to change without notice!
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Page 3: Table Of Contents
Operating Manual SONOCHECK ® ABD05/xx Contents Notes on operating manual ........................5 General ............................5 Symbols used ..........................5 Safety regulations ..........................6 User qualifications .......................... 6 General safety information ......................6 Sensor description ..........................7 Intended use........................... 7 Construction ........................... 7 Measuring method and functioning .................... - Page 4 SONOCHECK ® ABD05/xx Operating Manual Information for the use in medical devices ..................24 ʻFail-Safe Architectureʼ ......................... 25 ʻInitial Testʼ – enter boot mode ..................... 25 ʻBubble Testʼ..........................25 Response time ..........................26 Indicating the measuring state with the LEDs ................27 Watchdog | Voltage monitor 3.3 V ....................
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Page 5: Notes On Operating Manual
Operating Manual SONOCHECK ® ABD05/xx Notes on operating manual 1.1 General Thank you for choosing the SONOCHECK ABD05. ® This manual forms part of the SONOCHECK ABD05 and must be read carefully, before ® working with the sensor. It contains all the information needed to ensure proper and efficient use, along with all the instructions to ensure safe operation of the SONOCHECK ABD05. -
Page 6: Safety Regulations
SONOCHECK ® ABD05/xx Operating Manual Safety regulations 2.1 User qualifications Risk of death or severe injury. The SONOCHECK ABD05 must only be installed and operated by users ® who have read and understood the entire content of operating manual. Ensure to read all safety regulations below and the special regularities for the use in medical devices (see chapter 6). -
Page 7: Sensor Description
Any misuse (e.g. as hose clamp or butterfly valve) as well as any use other than the designated - is prohibited and can result in death (depending on the application), serious injury or damage to property. The SONOTEC GmbH accepts no liability for damage, including to third parties, caused by improper handling of the sensor. -
Page 8: Measuring Method And Functioning
SONOCHECK ® ABD05/xx Operating Manual 3 Sensor description 3.3 Measuring method and functioning An ultrasound method based on short, high-frequency pulses is used for the measurement. When liquid is in the tube, the ultrasonic signal passes through the tube to the receiver. The intensity of the ultrasound transmitted into the liquid is so low, that no biological effect can occur. -
Page 9: Bubble Sensitivity
Operating Manual SONOCHECK ® ABD05/xx 3 Sensor description 3.4 Bubble sensitivity The bubble sensitivity of the sensor depends on the diameter of the tubing, the mounting position of the sensor and on the correct coupling. Bubbles with a diameter larger than 30 % ... 50 % of the inner diameter of the tubing will be detected. -
Page 10: Sensor Software
SONOCHECK ® ABD05/xx Operating Manual 3 Sensor description 3.5 Sensor software The sensor software is structured into 2 modules. These modules are strictly separated and operate alternately. For more detailed description of modes contact our support. Module Safety Operational Function class. - Page 11 Operating Manual SONOCHECK ® ABD05/xx 3 Sensor description Figure 3 | 4: Settings for sensor SONOCHECK ® ABD05.50 (ABD05.51 … ABD05.57 / ABD05.60 / ABD05.62 are similar) Page 11 of 40 Revision: 2.1; Date: 2020-07-22...
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Page 12: Adaption Of Sensor Parameters: Abd Monitor (Optional Accessories)
SONOCHECK ® ABD05/xx Operating Manual 3 Sensor description 3.7 Adaption of sensor parameters: ABD Monitor (optional accessories) The software ABD Monitor (see screenshots last page) displays measured data in real time, stores the data of a predefined period and allows for a detailed analysis of the sensor performance. -
Page 13: Interfaces And Outputs
Operating Manual SONOCHECK ® ABD05/xx Interfaces and outputs The configuration of the sensor can be adjusted to customer requirements. For example, the output can be configured as switching output or as serial output. Tools for the adjustment of the sensor configuration are available as optional accessories. For the sensor use in medical devices see as well the details in chapter ‘6 Information for the use in medical devices’. -
Page 14: Input Abd-In
SONOCHECK ® ABD05/xx Operating Manual 4 Interfaces and outputs 4.3 Input ABD-IN The sensor provides an input ABD-IN. It is used as serial input to control the sensor (e.g. remote control of LED) and for service (e.g. entering ‘Boot Mode’). This input can be used as digital input to release a ʻBubble Testʼ. -
Page 15: Interface Modes
Operating Manual SONOCHECK ® ABD05/xx Interface Modes The input/output configuration of the sensor depends on operating mode and interface configuration. Parameters can be changed with the help of the ABD Monitor software. For detailed information to serial commands, see the corresponding document: ‘Specification of Serial Interface’... -
Page 16: Interface Mode 0 (Default)
SONOCHECK ® ABD05/xx Operating Manual 5 Interface Modes 5.2 Interface Mode 0 (default) The output is configured as switching output, the input as serial input. ʻSafe Stateʼ of the sensor Output ABD-OUT = H. Default settings of ABD_OUT (can be changed by parameters): Event / Priority Signal on ABD-OUT... -
Page 17: Interface Mode 1 / 2
Operating Manual SONOCHECK ® ABD05/xx 5 Interface Modes 5.3 Interface Mode 1 / 2 The Interface Modes 1 or 2 are used for bubble detection with transmitted information about bubble size. The input/output are connected to UART of sensor. In both modes the output is configured as serial output, the input is configured as serial input. -
Page 18: Interface Mode 3
SONOCHECK ® ABD05/xx Operating Manual 5 Interface Modes To check the sensor functionality, the serial command CmdBubbleTest can be used. Figure 5: Signal on Output in Interface Mode 1 5.4 Interface Mode 3 The ‘Interface Mode 3’ is used for service only (e.g. to read sensor identification). This mode is not suitable for bubble detection in real time. -
Page 19: Interface Mode 4 / 5
Operating Manual SONOCHECK ® ABD05/xx 5 Interface Modes 5.5 Interface Mode 4 / 5 The output is configured as switching output, the input is configured as test input ʻSafe Stateʼ Interface Mode 4: Output ABD-OUT = H (high level) Interface Mode 5: Output ABD-OUT = L (low level) The assignment to events can be configured. - Page 20 SONOCHECK ® ABD05/xx Operating Manual 5 Interface Modes Operating Mode Specification of Input ABD-IN Normal Mode The input is configured as test input to release a ʻBubble Testʼ. Interface Mode 4: L-active pulse Interface Mode 5: H-active pulse For the duration of active pulse the sensor simulates a bubble alarm. The output will react accordingly.
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Page 21: Interface Mode 6 / 7
Operating Manual SONOCHECK ® ABD05/xx 5 Interface Modes 5.6 Interface Mode 6 / 7 The output is configured as PWM output, the input is configured as test input. ʻSafe Stateʼ The ʻSafe Stateʼ is defined as one of the following states: •... - Page 22 SONOCHECK ® ABD05/xx Operating Manual 5 Interface Modes Operating Mode Specification of Input ABD-IN Normal Mode The input is configured as test input to release a ʻBubble Testʼ. Interface Mode 6: L-active pulse Interface Mode 7: H-active pulse For the duration of the active pulse the sensor simulates a bubble alarm.
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Page 23: Interface Mode 8
Operating Manual SONOCHECK ® ABD05/xx 5 Interface Modes 5.7 Interface Mode 8 The output is configured as PWM output, the input is configured as serial input ʻSafe Stateʼ The ʻSafe Stateʼ is defined as one of the following states: • ABD-OUT = static H or static L •... -
Page 24: Information For The Use In Medical Devices
SONOCHECK ® ABD05/xx Operating Manual Information for the use in medical devices For the use in medical devices (MDEV) special regularities apply. The following information and instructions partly refer to the previous chapters. Ensure, that you have read and understood the description of the interface and the interface modes. The sensor offers different features to ensure a high level of patient safety: •... -
Page 25: ʻFail-Safe Architectureʼ
Operating Manual SONOCHECK ® ABD05/xx 6 Information for the use in medical devices 6.1 ʻFail-Safe Architectureʼ The sensor is connected to the controlling and protective unit of the medical device (MDEV). It is classified under the Medical Device Directive 93/42/EEC as a class IIb product. The sensor design includes a ʻFail-Safe-Architectureʼ. -
Page 26: Response Time
SONOCHECK ® ABD05/xx Operating Manual 6 Information for the use in medical devices The output ABD-OUT will act appropriately and the behavior must be verified by the MDEV: Mode 0/ 4: The switching output will be set to H (high) for the period of the assumed bubble Mode 5: The switching output will be set to L (low) for the period of the assumed bubble Mode 1/ 2: The transmitted serial data will indicate the assumed bubble Mode 6/ 7/ 8: The PWM signal will be coded to indicate the assumed bubble... -
Page 27: Indicating The Measuring State With The Leds
Operating Manual SONOCHECK ® ABD05/xx 6 Information for the use in medical devices 6.5 Indicating the measuring state with the LEDs NOTE! There is no optical or acoustical alarm. The sensor provides LEDs to signalize the state of bubble detection only for information. This LED must not be used as a part of an alarm messaging system. -
Page 28: Safety / Directives
0.3 s time frame. The sensor was designed to fulfill the requirements according to IEC 60601-1-2: 2007 (3rd edition). This was verified at SONOTEC by realistic tests. ® The test must be performed by the manufacturer of the medical device in mounted state. -
Page 29: Optimal Mounting Position, Installation And Coupling
Operating Manual SONOCHECK ® ABD05/xx Optimal mounting position, installation and coupling The SONOCHECK ABD05 is designed as a component for the integration into machines and ® equipment, and must be mechanically and electrically incorporated into the controller of the device. No or low bubble sensitivity due to liquid in measuring channel poor coupling of ultrasound and incorrect installation possible. -
Page 30: Defining Correct Installation Position: Sensor Orientation And Bubble Sensitivity
SONOCHECK ® ABD05/xx Operating Manual 7 Optimal mounting position, installation and coupling Tube installation to be avoided: Low bubble sensitivity possible. Bubbles might not pass the sound path (symbolized by the blue wavy lines) because of unfitting tube. Amount of coupled ultrasound is too low: Squeezed: parts of tube outside the channel: Figure 9 | 10: Tube too small / too large [symbolic representation: not in scale, blue wavy lines = ultrasonic path] 7.2 Defining correct installation position: sensor orientation and bubble sensitivity... -
Page 31: Forbidden Liquid In The Sensor Channel: Correct Coupling And Bubble Sensitivity
Operating Manual SONOCHECK ® ABD05/xx 7 Optimal mounting position, installation and coupling 7.3 Forbidden liquid in the sensor channel: correct coupling and bubble sensitivity Coupling medium or liquids (cleaning agents) in sensor channel are strictly prohibited! Ultrasound may be conducted past the tube to the receiver. -
Page 32: Mounting Of The Sensor
SONOCHECK ® ABD05/xx Operating Manual 7 Optimal mounting position, installation and coupling 7.5 Mounting of the sensor The sensor is mounted as follows: Sensor version Mounting Rectangular Recessed M4 threaded holes on the rear of the sensor (see drawing in ‘Technical Data Sheet’) Circular Appropriate clamping fixture (must be provided) to fasten the round sensor base... -
Page 33: Operating The Sensor
(e. g. screw drivers or scissors) to press the tubing into the channel. Incorrect tube insertion can have an impact on sensor performance. • Never stretch or bent the tube before placing it in the channel if not other recommended by SONOTEC . This may alter the coupling ®... -
Page 34: Monitoring Sensor During Operation
SONOCHECK ® ABD05/xx Operating Manual 8 Operating the Sensor Observe the ‘Requirements for tube’ in the ‘Technical Data Sheet’. If no tube is inserted or if the tube is empty, the LED in the channel lights up red. 1. Place the tube in the measuring channel. Press the tube slightly by hand until it meets the bottom of the channel. -
Page 35: Cleaning And Disinfection
Operating Manual SONOCHECK ® ABD05/xx 8 Operating the Sensor 8.4 Cleaning and disinfection Severe measurement error with high risk for patient safety possible. Liquid in the measuring channel may conduct ultrasound. In this case the detection of bubbles, empty tube or missing tube may fail. In the measuring channel must never be any liquid medium. -
Page 36: Maintenance, Service, Troubleshooting And Repairs
Tel.: +49 (0)345 / 133 17- 0 Nauendorfer Str. 2 sonotec@sonotec.de 06112 Halle (Saale), Germany www.sonotec.eu Americas SONOTEC US Inc. 190 Blydenburgh Rd Tel.: +1 631 / 415 4758 Suite 8, 2nd Floor sales@sonotecusa.com Islandia, New York 11749, USA www.sonotecusa.com Keep available: •... -
Page 37: Repairs
Operating Manual SONOCHECK ® ABD05/xx 9 Maintenance, service, troubleshooting and repairs For service and diagnostics the sensors can be connected via USB Data Converter to a computer. Using computer software ABD Monitor you can observe the behavior of sensor and the reaction to bubbles. -
Page 38: Disposal
SONOCHECK ® ABD05/xx Operating Manual 10 Disposal The sensor can be recycled as normal electronic scrap. The sensor does not include any dangerous substances. Electrical and electronic equipment can pose serious health and environmental risks if it is not properly disposed of. For this reason it must not be disposed of in domestic waste according to WEEE directive 2012/19/EU (Waste Electrical and Electronic Equipment Directive) but separately at designated collection points or has to be sent back to the manufacturer. -
Page 39: Personal Notes
Operating Manual SONOCHECK ® ABD05/xx 11 Personal notes Page 39 of 40 Revision: 2.1; Date: 2020-07-22...
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