Sonotec SONOCHECK ABD05 Series Bedienungsanleitung

Air Bubble Detector

Type

SONOCHECK®ABD05/xx

Operating Manual

Revision: 2.1; Date: 2020-07-22

Information is subject to change without notice!

Operating Manual SONOCHECK®ABD05/xx

Page 3 of 40

Revision: 2.1; Date: 2020-07-22

Contents

1Notes on operating manual .................................................................................................................. 5

1.1 General...........................................................................................................................................5

1.2 Symbols used.................................................................................................................................5

2Safety regulations ................................................................................................................................. 6

2.1 User qualifications ..........................................................................................................................6

2.2 General safety information .............................................................................................................6

3Sensor description ................................................................................................................................ 7

3.1 Intended use...................................................................................................................................7

3.2 Construction ...................................................................................................................................7

3.3 Measuring method and functioning ................................................................................................8

3.4 Bubble sensitivity ...........................................................................................................................9

3.5 Sensor software ...........................................................................................................................10

3.6 Settings and default parameters ..................................................................................................10

3.7 Adaption of sensor parameters: ABD Monitor (optional accessories) .........................................12

3.8 Sensor identification.....................................................................................................................12

4Interfaces and outputs........................................................................................................................ 13

4.1 Output ABD-OUT .........................................................................................................................13

4.2 Output specification: default settings and sensor status via LED ................................................13

4.3 Input ABD-IN ................................................................................................................................14

4.4 Serial Interface (UART)................................................................................................................14

5Interface Modes ................................................................................................................................... 15

5.1 Overview interface modes............................................................................................................15

5.2 Interface Mode 0 (default) ............................................................................................................16

5.3 Interface Mode 1 / 2 .....................................................................................................................17

5.4 Interface Mode 3 ..........................................................................................................................18

5.5 Interface Mode 4 / 5 .....................................................................................................................19

5.6 Interface Mode 6 / 7 .....................................................................................................................21

5.7 Interface Mode 8 ..........................................................................................................................23

SONOCHECK®ABD05/xx Operating Manual

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Revision: 2.1; Date: 2020-07-22

6Information for the use in medical devices ...................................................................................... 24

6.1 ʻFail-Safe Architectureʼ .................................................................................................................25

6.2 ʻInitial Testʼ – enter boot mode .....................................................................................................25

6.3 ʻBubble Testʼ.................................................................................................................................25

6.4 Response time .............................................................................................................................26

6.5 Indicating the measuring state with the LEDs..............................................................................27

6.6 Watchdog | Voltage monitor 3.3 V ...............................................................................................27

6.7 Safety / Directives ........................................................................................................................28

7Optimal mounting position, installation and coupling .................................................................... 29

7.1 Selecting the correct sensor version: measuring channel and tubing .........................................29

7.2 Defining correct installation position: sensor orientation and bubble sensitivity ..........................30

7.3 Forbidden liquid in the sensor channel: correct coupling and bubble sensitivity .........................31

7.4 Bends in the tube: turbulences and bubble sensitivity.................................................................31

7.5 Mounting of the sensor.................................................................................................................32

7.6 Connecting the Sensor.................................................................................................................32

8Operating the Sensor .......................................................................................................................... 33

8.1 ʻInitial Testʼ after power on or restart............................................................................................33

8.2 Inserting the tube .........................................................................................................................33

8.3 Monitoring sensor during operation .............................................................................................34

8.4 Cleaning and disinfection .............................................................................................................35

9Maintenance, service, troubleshooting and repairs ........................................................................ 36

9.1 Service and troubleshooting.........................................................................................................36

9.2 Repairs .........................................................................................................................................37

10 Disposal................................................................................................................................................ 38

11 Personal notes..................................................................................................................................... 39

Operating Manual SONOCHECK®ABD05/xx

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Revision: 2.1; Date: 2020-07-22

1 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.

1.2 Symbols used

Hazards or special information is indicated in the following ways:

Warns of imminent threat of danger with very high risk. If not avoided,

it will result in death or serious injury.

Warns of possibly imminent danger with moderate risk. If not avoided,

it could result in death or serious injury.

Warns of danger with low risk. If not avoided, it may result in minor or

moderate injury.

Warns of danger. If not avoided, it may result in material damage.

NOTE!

This paragraph provides information or draws attention to special features.

SONOCHECK®ABD05/xx Operating Manual

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Revision: 2.1; Date: 2020-07-22

2 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).

2.2 General safety information

The SONOCHECK®ABD05 is a state of the art product that complies with all applicable safety

regulations. The sensor is factory tested and is delivered in a safe condition for operation. For

the use in medical devices (MDEV) see the special regularities in chapter 6. The following

general safety instructions apply:

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.

During operation must never be any liquid medium in the sensor

channel. Ensure, that sensor and the measuring channel are always dry and

clean and that the associated tubing stays intact during sensor operation.

Risk of death or severe injury. Incorrect installation and use of the

SONOCHECK®ABD05 sensor and its components can present a hazard

for the user and the patient, if it is integrated in a medical device.

•The integrator is responsible for the legal compliance of the

SONOCHECK®ABD05 installation and its documentation.

•Observe all requirements and conditions specified in the ‘Technical Data

Sheet’. It is forbidden to exceed or fall below the listed limits – even for a

short period.

•The SONOCHECK®ABD05 must never been immersed.

Sensor – especially sensor channel – must be kept dry and clean.

•The SONOCHECK®ABD05 must only be exposed to a minimal risk

of mechanical damage. In other cases, the sensor must be protected

against mechanical influences. Avoid any pulling or torsion movements

on tube during operation.

•If there is malfunction or damage, or if there is a suspicion that the sensor

is no longer functioning properly, take it out of operation immediately.

•The sensor must never be opened. It does not contain any user-

serviceable parts.

•Any kind of sensor modification is prohibited.

Operating Manual SONOCHECK®ABD05/xx

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Revision: 2.1; Date: 2020-07-22

3 Sensor description

3.1 Intended use

The air bubble detector (ABD) SONOCHECK®ABD05 is used to detect air and gas bubbles or foam

in flexible plastic tubes filled with liquids like blood, blood plasma, water or saline solution. In medical

devices the sensor is intended to prevent air infusions which could lead to an endangerment of

patient. The sensor has no contact with the liquid and is suited for disposable tubes.

The SONOCHECK®ABD05 is designed as a component for fixed installation in machines and

equipment e.g. machines for blood treatment, injectors or dialysis machines and is mechanically

and electrically incorporated into the controller.

The sensor can be used in various environments such as blood component collection centers,

catheter laboratory, OR, emergency room, intensive care unit, CT environment as well as for

inter- and intra-hospital transportation. Furthermore, it is possible to use the sensors in

ambulances or for emergency operations outside clinical environments.

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.

3.2 Construction

The sensor consists of the measuring cell and connected circuit boards with the evaluation

electronics. The measuring cell is an integrative part of the housing. The channel width is

adjusted to the type of the tube. The exact sensor design depends on the diameter, the

hardness and, where required, the liquid medium. Two designs are available:

•Rectangular design

•Circular design

Figure 1: Version with rectangular design (view from side and below) and version with circular design (view from side)

For the specifications (different measuring channels) see the ‘Technical Data Sheet’.

In case of very small tubes or tubes with a very low wall thickness (less than 10 % of the outer

diameter) a cover is necessary to press the tube firmly on the right position. A different sensor

series is available for these applications. Contact our service as well for customized adaptations.

SONOCHECK®ABD05/xx Operating Manual

3 Sensor description

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Revision: 2.1; Date: 2020-07-22

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. This was tested and confirmed with different fluids, including human blood.

Figure 2: Sensor design and function [symbolic representation]

The maximum value of the received signal amplitude is recorded in a defined period.

Bubbles in the liquid stream result in a reduction of the signal as the ultrasound is

significantly attenuated by air. So if there is a bubble in the measuring path, the proportion of

ultrasound that reaches the receiver is considerably lower – how much depends on the bubble

size as well.

The integrated electronics of the sensor evaluates the amplitude of the received signal and

sets the output accordingly.

The sensor includes 3 LEDs in colors red, green, and blue at the bottom of channel to

indicate the state of measuring. These LEDs are freely configurable. For default settings see

chapter 4.2 Output specification: default settings and sensor status via LED.

Sensor housing with integrated electronics

3x LED in the measuring

channel

Ceramics (Sender

)

Detected air bubble

Tube filled with liquid

Ultrasonic signal

[symbolized by the blue wavy lines]

passing the measuring channel

Ceramics (Receiver)

Operating Manual SONOCHECK®ABD05/xx

3 Sensor description

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Revision: 2.1; Date: 2020-07-22

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.

Observe chapter 7 Optimal mounting position, installation for correct installation.

When the sensor is installed as recommended, bubbles with the following size can be detected:

Sensor type Tubing Bubble Detection: Ø and Volume

SONOCHECK®

Material Outer Ø Inner Ø

ABD05.50 /

ABD05.51 PVC 4.0 mm 1.6 mm

mostly > 1.5 mm 2 µl

reliably > 2.0 mm 4 µl

ABD05.52 /

ABD05.53 PVC 6.8 mm 4.3 mm

mostly > 2.0 mm 4 µl

reliably > 3.5 mm 20 µl

ABD05.54 /

ABD05.55

PVC

Silicone

2.8 mm

3.0 mm

2.0 mm

1.0 mm

mostly > 1.2 mm 1.0 µl

reliably > 1.5 mm 1.5 µl

ABD05.56 PVC 2.4 mm 0.8 mm reliably > 1.0 mm 0.5 µl

ABD05.57 PVC 5.5 mm 3.5 mm

mostly > 2.0 mm 4 µl

reliably > 2.9 mm 10 µl

Table 1: Bubble sensitivity depending on sensor type

SONOCHECK®ABD05/xx Operating Manual

3 Sensor description

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Revision: 2.1; Date: 2020-07-22

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

class.

Operational

mode

Function

Main C Start mode After power on or on restart the ‘Init Interval’ is

started. In this period the sensors acts to

commands of serial interface (see notes to input

ABD-IN).

After ‘Init Interval’ the ‘Initial Test’ will be

performed.

Both, ‘Init Interval’ and ‘Initial Test’, take approx.

1.5 s. Afterwards ‘Normal Mode’ will be started.

Normal mode Measuring and detection of bubbles

Cyclical Self-Test

Output of result

Boot A Boot mode Service

Adjusting settings

Updating of software

Table 2: Modules in Software

3.6 Settings and default parameters

Default settings are archived in files. The settings as shown in the figures on the following

page (screenshots of ABD Monitor, optional accessories) are similar for the entire family

ABD05.xx, V1.43.

Deviating from this are the parameters for adjusting the gate (ABD Monitor settings: tab ‘Page 1’)

and the CRC (tab ‘Page 2’). Please find the default parameters in table.

Sensor Gate begin Gate width CRC

ABD05.50 | ABD05.51 | ABD05.52 | ABD05.53

3.0 µs

6.0 µs $4C37

ABD05.54 | ABD05.55 | ABD05.56 1.0 µs $C735

ABD05.57 | ABD05.60 | ABD05.62 6.0 µs $4C37

Table 3: Default Settings

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