Real-time tomographic images for organ function monitoring and diagnosis

electricalimpedancetomography

S w i S S t o m B B 2 P R o d u c t I n f o R m at I o n

Watch the lungs breathe!Eit real-time monitoring

Swisstom BB2

2St100-112, Rev. 002 © Swisstom aG 2015 Patents pending

S w i S S t o m B B 2 P R o d u c t I n f o R m at I o n

> Real-time> Continuous > Single cable> Intuitive touch screen> Perfect usability> Highest design quality> ScoutView> VentView> LuFuView

Real-time tomographic images for organ function monitoring and diagnosis

electricalimpedancetomography

Swisstom BB2 is based on the principles of electrical impedance tomography (EIT), whe-re weak alternating currents are applied to the body and travel along the paths of least resistance thereby creating electric potentials at the body surface. these potentials are being measured continuously by electrodes and turned into tomographic images of lung function – 24 hours a day, 7 days a week.

for intensive care doctors, pulmonologists and physiotherapists EIt is an imaging method that provides real-time information about regional ventilation. as opposed to conventional methods, EIt does not require the patient to breathe through a sensor, does not apply ionizing x-rays and can be used for extended periods, say 24 hours or even lon-ger. therefore, EIt can be used continuously and is suited for monitoring treatment effects in real-time directly at the patient´s bedside.

EIt was first used to monitor respiratory function in 1983 and remains the only bed-side method that allows continuous, nonin-vasive measurements of regional changes in lung volumes. Instead of plotting dynamic images, characteristic features can be ext-racted from these images and displayed as numbers or indices on a breath wise basis.

Since contour, composition and content of the thoracic cavity contribute as much to the measured potentials as the ventilation process itself, robust EIt imaging of regional ventilation requires both, knowledge about shape and location of the thorax and its organs and continuous measurement of the electrical contact between electrodes and skin. Swisstom BB2 is the world´s only system that fulfills these essential requirements.For details visit: www.swisstom.com

Pioneering work for monitoring mechanical ventilation

2St100-112, Rev. 002 © Swisstom aG 2015 Patents pending

S w i S S t o m B B 2 P R o d u c t I n f o R m at I o n

Real-time monitoring – easy and skin friendlySwisstom BB2 was especially developed to continuously monitor lung function of Icu patients undergoing mechanical ventilation. to do this, a belt-like disposable textile patient interface, the SensorBelt, is fastened to the patient‘s thorax. Its integrated sensors measure the respiration in different lung regions, constantly con-verting the generated data into images. the SensorBelt´s core contains 32 miniaturized active electrodes, the EIt-chips, which all report to and are controlled by the SensorBeltConnector located on the patient´s sternum.

the reusable SensorBeltConnector is much more than just a simple connector. It acts as Swisstom BB2´s brain using cutting-edge electronics and sensors inside. among these sensors is also a 3d accelerometer which tracks the patient´s body position. Information about this position and the measurement quality of each electrode are sent together with the EIt signals directly to the Tomographic- ImageCreation module within the bedside monitor. there the images are created and displayed in real-time on the graphical user interface.

Swisstom´s disposable single-patient-use SensorBelt respects the essential needs of patients and caregivers alike.

Single cable with easy-to-use SensorBeltConnector

Comfortable SensorBelt fits like a second skin

Breathable soft textile packaging of highly integrated electronics

Custom-made high-tech fabric lets the skin breathe

A nurse‘s perspective

des need to be placed on the patient, instead they are all integrated within the SensorBelt´s soft structure. While the textile silver sensors face the patient´s skin, the 3d spacer cushion underneath them allows the skin to breathe even under maximal compression and yet its adaptive nature ensures electrode coupling also in anatomically problematic areas.

the unique ingredients of the foamy Contact-Agent not only ensure an optimal electrical connection between SensorBelt and patient skin, it also protects it. this allows the belt to be worn for up to 72 hours. the ergonomic design of the matchbox-sized non-disposable SensorBeltConnector with just a single cable running to the monitor eliminates many potential sources of handling errors or accidents.

the appealing green vest carrying the SensorBelt was designed together with nursing specialists such that it can be applied comfortably to a lying passive patient by one caregiver alone. due to its highly flexible materials the application procedure, which takes less than one minute, closely resembles that of changing linen. the stretchable mini-malistic vest feels like a second skin carrying all marker lines needed for its placement. the skin friendly vest holds the electrical interface in place even when patients are turned, moved or regain activity.

the oblique design makes the SensorBelt fol-low the movement of the ribs and thus does not restrict breathing as this would be highlyundesirable in patients already suffering from respiratory insufficiency. no individual electro-

> Easy to apply> Skin friendly> Breathable> Stretchable vest> Flexible materials> Ergonomic design> Single cable> Infection control> Single use> Skin care

Highly integrated electronics: 32 active electrodes within each SensorBelt for the best EIT images

Monitoring the lungs´ function right at the bedsideComfortable electrode belt made of textile – skin friendly and easy to applyInfection control due to single-use sensor belt

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Why BB2 makes me take better care of my patients ...» «

S w i S S t o m B B 2 P R o d u c t I n f o R m at I o n

Why I need BB2 to improve mechanical ventilation ...

A doctor‘s perspective

VentView

time (s) 010

LuFuView

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relative stretch

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trenddetails

ScoutViewcurrent time signal quality SensorBelt time leftfailing electrode patient position

12 h14:15 R

LuFuView stretch

VentView minimum maximum

time (s) 010

current time signal quality failing electrode patient position SensorBelt time left

12 h14:15 RScoutView

The VentView lets the users watch the lungs breathe

The LuFuView visualizes both, parameter values in individual lung regions as well as their relative frequencies

Seeing where the lungs breathe – continuously and in real-time

Finding the best PEEP to reduce ventilator-induced lung injury

Intuitive presentation of clinically relevant information for timely and effective decision making

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the touch user interface combines perfect usability with highest design quality. Its interaction is intuitive. the user friendly way clinically relevant information is presented facilitates decision making.

the interface is divided into three main sections which overlap on the screen. the selected view displays detailed information on a large area. at the same time, the other two sections are shown in a compact view. they display any relevant data in reduced form so that it is still possible to keep an overview of the entire situation. a new view can be selected by simply tapping it: the area expands, moving the previous view to the background. this clear structure allows for a fast operation of Swisstom BB2 even within the stressful intensive care environment. the unambiguous interface structure ensures a maximum of usability.

ScoutView (topographic view)the ScoutView provides the user with an overview of the patient‘s general data and indicators of monitoring quality and body position. once a belt of appropriate size for an individual patient has been determined,

Perfect usability at highest qualityall the user has to do is enter height, weight and gender using the number picker of the ScoutView. from these inputs Swisstom BB2 automatically selects reference contours of thorax, lungs and heart that best match the individual patient. the EIt system then transmits the breathing lungs directly into these contours on the screen.

VentView (ventilation view)the VentView displays continuously and in real-time the amount of ventilation within the lungs during breathing. taking the lungs´ contours into account the user can immedia-tely recognize lung zones in which ventilation is reduced or even absent.

LuFuView (lung function view)the parameters shown in the LuFuView are calculated and updated with each new breath. the unique way lung function indices are calculated and displayed allows the user to visually identify patterns of health or disease. next to their spatial distribution, the frequency of each parameter expression is made available as an intuitive histogram. Swisstom BB2‘s inter-action and design concept provides the user with a clear picture of complex information.

LuFuView stretch

VentView

time (s) 010

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ScoutView

patient data

531/2 chest circumference

cm

182height

cm

89weight

kg

gender

050V5020130416-0008

SensorBelt data

100recommended SensorBelt size

SensorBelt size on patient

serial number

reset to default

current time signal quality failing electrode patient position

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SensorBelt time left

12 h

LuFuView stretch

VentView minimum maximum

time (s) 010

current time signal quality failing electrode patient position SensorBelt time left

12 h14:15 RScoutView

The ScoutView contains graphics that show the patient‘s body position and indicate whether the electrodes of the belt are in sufficient electrical contact with the patient´s skin

> Real-time> Continuous > Compact> 32 active electrodes> Intuitive touch screen> Perfect usability> Highest design quality> ScoutView> VentView> LuFuView

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Innovative and cost-effective technology

S w i S S t o m B B 2 P R o d u c t I n f o R m at I o n

> Attractive design> Cost-effective> Fewer ventilator days> Increased patient throughput> Reliable> Robust> Swiss Quality> Clear functionalities> Friendly appeal> Supporting communication

Swisstom´s BB2 sets a new benchmark for usability and design

Regional lung function measurement by EIt clearly holds the poten-tial to improve mechanical ventilation in general. Particularly, lung overdistention and lung collapse can be monitored [1] and used to eventually optimize PEEP [2]. EIt-guided ventilation results in improved respiratory mechanics, improved gas exchange, and reduced histolo-gic evidence of ventilator-induced lung injury in an animal model [3]. thus, EIt can be expected to reduce ventilator-induced lung injury in patients and to save ventilator days. this will result in an expected payback for a Swisstom BB2 of less than one year.

for nurses and physicians alike clinical usability is of the essence [4]. this is especially true for the patient interface as well as for the graphical user interface. next to the unique SensorBelt, Swisstom BB2´s novel approach to presenting EIt information facilitates its interpretation. Pulmonary function indices are shown in the clinical context of the patient´s position and the contours of thorax, lungs and heart.

A hospital administrator‘s perspective

Disposable: The easy-to-apply SensorBelt with 32 active electrodes inside

[1] Gómez-Laberge et al. A unified approach for EIT imaging of regional overdistension and atelectasis in acute lung injury. IEEE Trans Med Imaging. 2012 Mar;31(3):834-42.

[2] Luecke et al. Lung imaging for titration of mechanical ventilation. Curr Opin Anaesthesiol. 2012 Apr;25(2):131-40.

[3] Wolf et al. Mechanical ventilation guided by electrical impedance tomography in experimental acute lung injury. Crit Care Med. 2013 May;41(5):1296-304.

[4] Adler et al. Whither lung EIT: where are we, where do we want to go and what do we need to get there? Adler et al. Physiol Meas. 2012 May;33(5):679-94.

the touch user interface stands out from comparable medical interfaces, making its operation both, joyful and efficient. that way, caregivers can take timely and targeted actions to address changing lung conditions.

despite its clarity, the interface has a friendly and positive appeal, supporting communi-cation between doctors, caregivers, patients and their families.

Pertinent information at a glance: The LuFuView supports desicion making in a unique way

Reusable: The SensorBeltConnector with just one cable but plenty of cutting-edge electronics inside

Innovative tool that supports decision making where it is needed the most – right at the bedside

Cost-effective new technology that improves patient care and increases patient throughput

Device that fosters communication between caregivers, patients and their families

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Why BB2 helps me solve patient flow challenges ...» «

technical specifications of Swisstom BB2

All specifications are preliminary and subject to change.

Ambient conditions during operation

•Temperature(device):10to40°C

•Temperature(electrodebeltandcables):10to40°C

•Atmosphericpressure:660to1060hPa(9.57to15.37psi)

•Relativehumidity:10to85%,withoutcondensation

Ambient conditions during transportation

•Temperature:-20to65°C

•Atmosphericpressure:660to1060hPa(9.57to15.37psi)

•Relativehumidity:5to95%,withoutcondensation

Ambient conditions during storage

•Temperature:5to40°C

•Atmosphericpressure:660to1060hPa(9.57to15.37psi)

•Relativehumidity:5to85%,withoutcondensation

•SpecialconditionsforContactAgent:shelflife3yearsat25°C

User settings

•Patientheight:150to210cm

•Patientweight:40to150kg

•Patientage:minimum16years

•Patientgender:femaleandmale

Performance characteristics

•Numberofelectrodes:32electrodes,reference

electrode integrated

•Imagerate:upto50imagespersecond

•Feedcurrentamplitude:10-50%ofmaximumpatient

auxiliarycurrentconformingtoIEC60601-1(3rdedition)

•Feedcurrentfrequency:150kHz

•EITsignalqualityindicator:qualitative

•SensorBeltangleinspace:elevationofupperbody

+/-90 degrees, rotation +/-180 degrees

•Sensorusagetimeleft:inhoursandminutes,accurate

to 5 minutes

operating data

•Mainssupplynominalvoltageandfrequencyrange:

100Vto240V,50/60Hz

•Currentconsumptionat230V:max.0.6A

•Currentconsumptionat100V:max.1A

•Maximumpowerconsumptionduringoperation:60W

•Powerconsumptioninstandby:0.5W

•Soundpressurelevel(forfree-fieldmeasurementovera

reflectingsurface):notmeasurable

•WeightSensorBeltConnector:<200g

•WeightofBB2:<13kg

Classification

•Appliedparts:SensorBeltwithintegratedreference electrode.

•Modeofoperation:continuous

•Protectionagainstelectricshockregardingexternal

power supply

•Appliedpart:typeBFconformingtoIEC60601-1

•Protectionagainstharmfulingressofwater:IP54conforming

toIEC60529(SensorBeltConnector)

•Microenvironmentsofpollutionlevel2conformingto

IEC60601-1

•Electromagneticcompatibility(EMC):conformingto

European directive 93/42/EEc in accordance with

IEC60601-1-2(3rdedition)

•Biocompatibilityofappliedpartstestedinaccordance

with ISo 10993 for intact, compromised or breached skin

andanapplicationdurationof<30days

Communication interfaces

•USBport

•ETHERNETsocket

mounting options

•Trolley

•Vesa100/75

S w i S S t o m B B 2 P R o d u c t I n f o R m at I o n

2St100-112, Rev. 002 © Swisstom aG 2015 Patents pending

Real-time tomographic images for organ function monitoring and diagnosis

electricalimpedancetomography

> Easy to apply> Skin friendly> Breathable> Stretchable vest> Flexible materials> Ergonomic design> 32 active electrodes> Single cable> Infection control> Single use> Skin care

electricalimpedancetomography

Real-time tomographic images for organ function monitoring and diagnosis

Contact us!

call:+41(0)813300972 mail: info@swisstom.comvisit: www.swisstom.com

Swisstom aGSchulstrasse1,CH-7302 Landquart, Switzerland

S w i S S t o m B B 2 P R o d u c t I n f o R m at I o n

Swisstom AGSwisstom aG, located in Landquart, Switzerland, develops and manufactures innovative medical devices. our new lung function monitor enables life-saving treatments for patients in intensive care and during general anesthesia.

unlike traditional tomography, Swisstom´s bedside imaging is based on non-radiating principles: Electrical ImpedanceTomography(EIT).Todate,nocomparabledevices can show such regional organ function continuously and in real-time at the patient’s bedside.

Swisstom creates its competitive edge by passionate leadership in non-invasive tomography with the goal to improve individual lives and therapies.

Made in Switzerland

Swisstom BB2

Now available!

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2St100-112, Rev. 002 © Swisstom aG 2015 Patents pending