SOMNOmedics GmbH – Am Sonnenstuhl 63 – D-97236 Randersacker Phone: (+49) 931 / 35 90 94-0 – Fax: (+49) 931 / 35 90 94-49

E-Mail: info@somnomedics.de – Internet: www.somnomedics.eu

I NSTRUCTION MANUAL

SOMNOtouchTM RESP

ECG

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SOMNOmedics GmbH – Am Sonnenstuhl 63-65 – D-97236 Randersacker Phone: (+49) 931 / 35 90 94 - 0 – Fax: (+49) 931 / 35 90 94 - 49 E-Mail: info@somnomedics.de - Internet: www.somnomedics.eu

Rev. 3 08.06.2016

All proper names marked with TM are copyright protected by SOMNOmedics.

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Content

1 Introduction ................................................................................................................ - 4 -

2 Initialisation ................................................................................................................ - 5 -

3 Applying the sensors .................................................................................................. - 7 -

4 Blood pressure ........................................................................................................... - 9 -

5 Analysis – Global Settings DOMINO light ................................................................. - 12 -

5.1 Heart Rate Analysis........................................................................................... - 13 -

5.2 Pleth Analysis.................................................................................................... - 15 -

5.3 PTT Analysis (PTT: Pluse Transit Time) ............................................................ - 15 -

6 Report ...................................................................................................................... - 18 -

6.1 ECG .................................................................................................................. - 18 -

6.2 Blood pressure .................................................................................................. - 20 -

7 Technical Specifications ........................................................................................... - 26 -

8 Cleaning / Disinfection .............................................................................................. - 26 -

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1 Introduction

The following ECG sensors are available:

1-channel-ECG

3-channel-ECG

The ECG-Sensors expand the possibilities of your SOMNOtouchTM RESP to record ECG and/or blood

pressure.

This instruction manual provides you with information about the application and the sensor specific

settings. Please note the main instruction manual of the SOMNOtouchTM RESP.

Please refer to the safety notes in the main manual of the SOMNOtouchTM RESP.

Device and sensors may not be used in live sustaining or life supervising

measures.

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2 Initialisation

Having entered the patient data (see chapter 6.1 of the main manual), select the Easy Start tab

“ECG/BP” or go to the tab “Montage” of the advanced mode and select the montage “SOT

RESP+ECG1” or “SOT RESP+ECG3”. Then proceed with the initialisation as usual.

a) 1-channel-ECG

Figure 1. Montage adjustment - 1.

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b) 3-channel-ECG

Figure 2. Montage adjustment - 2.

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3 Applying the sensors

Patients with a pacemaker should consult a physician before applying the device.

Clean the bone-covering parts of the skin where you want to fix the ECG-electrodes with alcohol-pads.

First, connect one ECG-electrode (e.g. SEN004) with each ECG-sensor. Apply one ECG-sensor with

electrode below each collarbone and one ECG-sensor with electrode above the fifth intercostal space

of the left side of the body as shown in the figures below. Due to the automatic recognition of the

sensor-ID you can plug the ECG-sensor arbitrarily in one of the two sockets. The second, free AUX

socket of the SOMNOtouchTM RESP may be used for optional sensor applications.

a) 1-channel-ECG

Figure 3. Applying the sensors - 1-channel-ECG.

or

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b) 3-channel-ECG

Proceed as described in 3 a) and add a further ECG-sensor electrode on the right side of the body,

above the fifth intercostal space.

Figure 4. Applying the sensors - 3-channel-ECG.

or

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4 Blood pressure

>>> The following instruction requires the optional extra “Blood pressure”.

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Manual calibration:

First, the signal quality for the calculation of the PTT will be checked. If the PTT could be calculated

successfully, the display will switch to the following screen:

Figure 6. Blood pressure calibration - 2.

Take a blood pressure measurement and press the patient marker of the SOMNOtouch™ once

(follow the instructions on the display). This patient marker sets the time of the manual blood pressure

measurement. Enter the measured blood pressure values in the corresponding fields.

Figure 7. Blood pressure calibration - 3.

Now the current blood pressure, the heart rate and the oxygen saturation will be shown during the

measurement.

Figure 8. Blood pressure calibration - 4.

If you can’t calibrate at the chosen point (error in PTT) or the calibration was aborted via , you can

repeat the calibration measurement or abort it and proceed without a calibration.

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[10 h]

HR

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Skip / Abort:

After aborting the calibration, only the PTT will be shown during the recording:

Figure 9. Blood pressure calibration - 5.

If you didn’t take a blood pressure measurement at the beginning of the recording, you can perform it

later and mark it by setting a patient marker . In this case note the time and values. The calibration

has then to be carried out later in the analysis after the transfer (see “Calibration after transfer”).

If you programmed an automatic start of the recording, the SOMNOtouchTM will enter the waiting mode

after the initialisation. The waiting-display can be accessed by pressing the On/Off button. If ECG and

SpO2 are connected, the blood pressure can be calibrated up to 10 min before the recording starts by

pressing “BP calibration” and following the steps of “Manual calibration”. Else, the PTT-values will

be displayed during the recording and the calibration has to be carried out in the analysis after the

data transfer. In any case, a manual measurement of the patient’s blood pressure will be necessary.

To mark the time of the measurement, press the patient marker.

Figure 10. Blood pressure calibration - 6.

Calibration after transfer:

Right click on the raw data next to the patient marker set during the manual Blood Pressure

Measurement and select “BP calibration”. Enter the Blood Pressure values, and confirm with . The

Systolic and Diastolic Blood Pressure will be calculated and displayed in the Analysis Window.

[15 h]

Record starting in:

BP calibration .

[10 h]

HR

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5 Analysis – Global Settings DOMINO light

In all analysis settings you can change the settings of the parameters of the analysis, the colour

display of the analysis curves and the colour classification of the events (click on the colour field; red

frames in the figures). The analysis source is shown down right (blue frames in the figures).

Select the analysis template “Respiratory”:

Figure 11. Analysis settings.

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5.1 Heart Rate Analysis

Figure 12. Heart Rate Analysis settings.

1) Artefact variation [bpm]

Artefact variation represents the maximum difference of consecutive heart frequencies. If the change

of heart rate exceeds the previous value, an artefact will be recognised.

2) Body artefact [s]

An artefact will be indicated if there is a body position change during a given duration. Therefore, no

HR-event will be determined in this area (for this, ‘Artefact Source’ must be activated).

3) HRV Averaging

The averaging factor can be determined for the HRV-curve in the analysis

4) Asystole [ms]

An asystole is determined by the distance between two consecutive R waves. If this distance is longer

than the given value, an asystole will be recognised.

5) Tachycardia [bpm]

If the measured heart rate exceeds a previously entered value, the heart rate curve will be marked in

colour as a tachycardia. In addition, the criterion ‘Min. Duration’ must be fulfilled.

6) Bradycardia [bpm]

If the measured heart rate falls behind a previously entered value, the heart rate curve will be marked

in colour as a bradycardia. In addition, the criterion ‘Min. Duration’ must be fulfilled.

7) Min. Duration (s)

Minimal duration of a continuous increase or decrease of the heart rate.

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Tachycardia with wide and narrow QRS complexes

1) Tachycardia [bpm]

If the measured heart rate exceeds a previously entered value, the heart rate curve will be marked as

tachycardia. In addition, the criterion ‘Min heartbeat number’ must be fulfilled.

2) Min. beats count

A tachycardia will be determined according to the criteria if the registered number in heartbeats

reaches at least the entered value.

3) Wide complex QRS min. [ms]

If the duration of the QRS-complexes exceeds the registered value, a tachycardia with wide QRS

complexes will be recognised in the raw data channel and analysis channel ‘Cardio Complex’.

4) Narrow complex QRS max. [ms]

If the duration of the QRS complexes is smaller than the registered value, a tachycardia with narrow

QRS complexes will be recognised in the raw data channel.

Acceleration/Deceleration

1) Arrhythmia Variation [%]

If the beat-to-beat variation (distance of two succeeding R-waves) exceeds a previously entered value,

an arrhythmia will be detected.

2) Min. duration [s]

Minimum duration of a continuous increase or decrease of the heart rate.

3) Min. change [1/ min]

Minimum size of the continuous increase/decrease of the heart rate for classifying as an

acceleration/deceleration.

4) Max. duration [s]

Maximum duration of a continuous increase or decrease of the heart rate.

5) Tachycardia Limit

In this field the limits for tachycardia at night or day can be chosen.

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5.2 Pleth Analysis

Figure 13. Pleth Analysis settings.

This parameter is used to determine the PTT. As it is used only for calculation, it is not displayed in the

Analysis window. If Artefact Source is active, you can select the raw data channel SpO2 or Pulse. If

an artefact is detected on the selected channel, the Pleth Analysis will detect an artefact, too.

Furthermore, this analysis is used to detect autonomic arousal.

FFT-Average

This option enables a powerful tool for the significant reduction of fluctuations during blood pressure

measurements via a patented algorithm. Due to the high demand of computational power, this option

should only be activated if major beat-to-beat deviations in blood pressure need to be avoided.

In addition, this analysis enables the detection of autonomous arousals.

5.3 PTT Analysis (PTT: Pulse Transit Time)

The pulse transit time is calculated from the ECG signals and the plethysmographic wave form. As

shown below, the PTT is the time it takes for the arterial pulse to travel from the heart to the Pulse

Oximeter Site (finger or toe).

Figure 14. Calculation of the PTT.

SOMNOmedics has developed an algorithm to calculate the blood pressure based on the PTT. For

this, it is necessary to perform a one point calibration during the measurement with an external blood

pressure meter.

ECG

R-Zacke

PTT

Maximum Rise

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Figure 15. PTT Analysis settings.

1) Averaging

This value is used for the smoothing of the PTT curve. A value of 5 means that 5 values are averaged

and displayed as one value in the PTT curve.

2) Min./Max. PTT [ms]

If the PTT curve exceeds the maximum or falls below minimum level, an artefact will be detected.

Adjust both values to each individual patient (child, adult) and to the measurement site (finger, toe).

Figure 16. PTT diagram.

3) Min. Change [mmHg]

Change of the Systolic Blood Pressure required for the detection of an event.

4) Min. Duration [s]

Minimum duration of an increase in PTT.

5) Max. Duration [s]

Maximum duration of an increase in PTT.

min. PTT

max. PTT

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Figure 17. Duration of a BP increase.

6) PTT [ms] PTT value at the time of the blood pressure calibration. 7) BP [mmHg] Manually measured blood pressure values. 8) Max. Blood press. [mmHg] Blood Pressure values above this threshold will be detected as artefact. 9) Reference press. [mmHg]

This value is used to calculate the nocturnal Blood Pressure lowering in the report. If no value is set,

the software will calculate the average Blood Pressure during the first three minutes of Time-In-Bed.

10) Min. Change [mmHg]

Minimum change of the blood pressure required to detect an event.

11) Report step

The mean value of the chosen time interval is displayed in the report in the figure of the blood

pressure course.

12) Limit hypertension

Here, the limits can be set for the systolic and diastolic blood pressure at night and during the day as

well as those for the mean arterial pressure and pulse pressure. These values will be considered in

the report, but they do not have any influence on the analysis data.

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6 Report

6.1 ECG

Select the following report sections:

Figure 18. Selection window for Report settings.

Click “Preview” to display the report.

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Figure 19. Heart Rate report (left side) and percentage distribution of the Heart Rate in relation to the total recording time (right side).

Definitions:

Acceleration (Index) Number of Increases in the Heart Rate during TST (index: per hour of sleep).

Deceleration (Index) Number of Decreases in the Heart Rate during TST.

Arrhythmia (Index) Number of Arrhythmias occurring during TST.

Maximum HR (bpm) Maximum Heart Rate (beats per minute) during TST with an indication of the

time point of the event.

Minimum HR (bpm) Minimum Heart Rate during TST with an indication of the time point of the

event.

Average HR (bpm) Average value of all Heart Rates during TST.

Figure 20. RR-Interval report.

Definitions:

Average (ms) Average duration of RR-Intervals in milliseconds

RR SD (ms) Standard deviation of the RR-interval

Max/Min RR Max/Min. value of the RR-interval

SD1 (ms) Standard deviation of the orthogonal interval of the RRi/RRi+1 –dots to the cross

diameter of the ellipse

SD2 (ms) Standard deviation of the orthogonal interval of the RRi/RRi+1 –dots to the longitudinal

diameter of the ellipse

SD1/SD2 Standard deviation of the difference between adjacent RR-intervals

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6.2 Blood pressure

Choose the following settings:

Figure 21. BP report settings.

Note: Only events during TIB will be evaluated in the report.

Figure 22. Pulse Transit Time report.

Figure 23. PTT sleep disturbance diagram.

The bars show the percentage of Sleep that was disturbed by two PTT events within an interval of e.g.

0-1 min.

Definitions:

Dec. (Index) Number of PTT Decreases – according to the criteria of PTT – during TST

(index: per hour of sleep).

Maximum Dec. (ms) Maximum Decrease of PTT in milliseconds and indication of time point.

Maximum PTT (ms) Maximum value of PTT and indication of time point.

Minimum PTT (ms) Minimum value of PTT and indication of time point.

Average PTT (ms) Average value of all PTT values.

Artefact (min) Duration of Artefact during TST.

The diagram indicates the sleep fragmentation of a patient’s

sleep caused by PTT changes. It shows the patient

Disturbed and Undisturbed sleep.

Disturbed: Sleep fragmentation mainly in the intervals

0-1 min and 1-5 min

Undisturbed: sleep fragmentation mainly in the intervals

10-30 min, >30 min

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Figure 24. BP report (left side) and BP diagram (right side).

Definitions:

Inc. (Index) Number of all Increases of the Systolic Blood Pressure during TST

(index: per hour of sleep).

Maximum Increase (mm

Hg)

Maximum Increase of the Systolic Blood Pressure (mm Hg) and

indication of the time point.

Average Increase (mm Hg) Average value of all Increases of the Systolic Blood Pressure.

Max. Systol. (mm Hg) Maximum value of the Systolic Blood Pressure and indication of the

time point.

Min. Systol. (mm Hg) Minimum value of the Systolic Blood Pressure and indication of the time

point.

Average Systol. (mm Hg) Average value of all Systolic Blood Pressure values.

Artefact (min) Duration of Artefact during TST.

Figure 25. BP Day/Night report.

The reference Blood Pressure is calculated during the first 3 minutes after the Lights Off marker. The

Blood Pressure Decrease is calculated to this reference.

BP-decrease

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Advanced Blood Pressure Report

In order to correlate the Blood Pressure Report to conventional 24-hour Blood Pressure Recording

devices, the report “Blood Pressure Day/Night (advanced)” can be used (see figure 26).

The advanced blood pressure report day/night displays all relevant blood pressure parameters of the

whole recording. If you defined the TIB (time in bed) of the recording with the lights off/ lights on

markers an additional analysis of the blood pressure parameters for daytime and night-time can be

carried out (day report and night report). In the Day/Night report the dipping of the blood pressure

parameters during the night (as percentage of daytime value = Dipping) is calculated.

Figure 26. Advanced BP report.

Definitions:

Syst [mmHg] Systolic blood pressure

Diast [mmHg] Diastolic blood pressure

HR [bpm] Heart rate

MAP [mmHg] Mean arterial pressure

PP [mmHg] Pulse power

Ø Min. Minimum blood pressure value computed as mean from 8 values

Aver. Average blood pressure

Ø Max. Maximum blood pressure value computed as mean from 8 values

SD Standard deviation

> Limit % of blood pressure values above the limit

No. BP

Values

Number of BP values measured (e.g., 31282 BP values, corresponding to 92% of the

total rec time (TRT), giving 8% of artefacts)

Day/Night

Dipping

Classification based on nocturnal BP decrease (Reverse Dipper: ≤ 0%; Non-Dipper:

0%-10%; Dipper: 10%-20%; Extreme Dipper: ≥ 20%)

Classification

of BP Values

(in mmHg)

optimal: syst. ≤ 120 mmHg; normal: 120-129 mmHg; high normal: 130-139 mmHg;

Grade 1 HT: 140-159 mmHg; Grade 2 HT: 160-179 mmHg; Grade 3 HT ≥ 180 mmHg

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Supplemental to the tables of the blood pressure values, a graphic of the chronological progress of the

systolic and diastolic blood pressures, mean arterial pressure (MAP), pulse and pulse power (PP) will

be displayed. The Time In Bed is highlighted in grey.

Figure 27. BP report graphic.

Within the advanced blood pressure report, the percentage of recording time in which the Blood

Pressure, MAP or Pulse exceeds a defined value is displayed in the column “> Limit” (red boxes in

picture below).

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Figure 28. Advanced BP report day/night - Limits.

In order to make this report most flexible, the limits for the Blood Pressure report can be defined by the

user. Limits for calculation of Systolic, Diastolic Blood Pressure, Mean Arterial Pressure (MAP) and

Pulse Power (PP) can be set in the settings of the PTT analysis.

Go to the “Analysis” tab in the Global Preferences and select “PTT Analysis”. Here the button “Limit

Hypertension” is available. Clicking on it will open a window where limits for the parameters blood

pressure systolic, blood pressure diastolic, MAD and PP can be set independently for both Day and

Night sections of the recording.

Figure 29. PTT analysis settings.

To edit the limits for the calculation of the Pulse, select “Heart Rate Analysis” or “Heart Rate Analysis

AASM” from the “Analysis” tab of the “Global Preferences”. Select the button “Limit Tachycardia” to

open the window for editing the Pulse Rate limits.

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Figure 30. Heart Rate Analysis settings

To get an overview of the respective limits set by the user, the defined values will be displayed in the

footer of the Blood pressure Day/Night (advanced) report.

The limits of the blood pressure-report can also be defined within the local “Preferences” of the

respective measurement.

Conventional BP recording

Additionally available is the report ’Conventional BP recording’.

The data is listed as in conventional blood pressure reports. During the day (6am – 10pm) the blood

pressure and heart frequency value are listed for every 15 minutes, during the night for every 30

minutes. For comparison the mean value of the continuous blood pressure measurement for the

respective time interval is shown. Furthermore, the mean activity is listed.

Position Blood Pressure

Figure 31. Position BP report.

Indication of the mean blood pressure values in each body position.

MAP = Mean Arterial Pressure

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7 Technical Specifications

Name Measuring range Frequency range

ECG1 ± 6mV ± 5% 0.3 – 150Hz Hz ± 20%

ECG3 ± 6mV ± 5% 0.03 – 150Hz ± 20%

8 Cleaning / Disinfection

Clean the sensors according to the directions of the SOMNOtouchTM RESP main manual.