SOMNOmedics SOMNO HD Eco User manual

SOMNO HD Eco

I

nstruction Manual

SOMNOmedics GmbH – Am Sonnenstuhl 63 – D-97236 Randersacker

Tel. (+49) 931 / 35 90 94-0 – Fax (+49) 931 / 35 90 94-49

ha

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

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SOMNOmedics GmbH – Am Sonnenstuhl 63 – D-97236 Randersacker

Tel.: (+49) 931 / 35 90 94 - 0 – Fax: (+49) 931 / 35 90 94 - 49

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

Rev. 1

28.10.2019

SOMNO HD eco is a trade mark of the

SOMNOmedics company.

 

Inhalt 
 Getting started – Quick Guide ......................................................................................... 5 
 Introduction ..................................................................................................................... 7 
1 Intended use ............................................................................................................ 7 
2 Patients ................................................................................................................... 7 
3 Essential performance features of the device .......................................................... 7 
4 Safety instructions. .................................................................................................. 8 
5 System components & accessories ....................................................................... 10 
6 Labels/Symbols ..................................................................................................... 11 
Preparing the patient: applying main device, sensors and electrodes ........................... 12 
1 Connecting the sensor plug to the main device ...................................................... 13 
2 Sensors for Polysomnography ............................................................................... 14 
2.1 Attaching the effort belts ................................................................................. 14 
2.2 Nasal Cannula ................................................................................................ 15 
2.3 SpO2 sensor................................................................................................... 16 
2.4 Leg EMG sensor ............................................................................................. 16 
2.5 Mikrophone ..................................................................................................... 17 
2.6 Flow sensor (Thermistor) ................................................................................ 18 
2.7 ECG ............................................................................................................... 18 
3 EEG/ EOG ............................................................................................................. 19 
3.1 Attaching the PSG headbox according to AASM Guidelines ........................... 19 
3.2 Application for 32-channel headbox according to 10-20 System ..................... 20 
4 CPAP sensor and CPAP device ............................................................................ 20 
Operating the main device ............................................................................................ 21 
1 Control Elements ................................................................................................... 21 
1.1 Switch-on /-off of the device ............................................................................ 22 
1.2 Patient markers/event markers ....................................................................... 23 
2 Initialisation of a recording ..................................................................................... 23 
2.1 Initialisation via DOMINO Software ................................................................. 24 
2.2 Direct initialisation of the device ...................................................................... 26 
3 Functionality of the LEDs/buttons during the recording .......................................... 27 
4 Signal view via tablet ............................................................................................. 27 
5 Impedance check and biocalibration ...................................................................... 28 
6 Blood pressure calibration ..................................................................................... 28 
7 The docking station ................................................................................................ 28 
7.1 Data transfer via docking station ..................................................................... 29 
7.2 Recharging of the battery ............................................................................... 29 

 

7.3 Firmware Update ............................................................................................ 29 
Troubleshooting ............................................................................................................ 29 
Cleaning and maintenance ........................................................................................... 31 
1 Cleaning and disinfection ....................................................................................... 31 
2 Maintenance interval .............................................................................................. 33 
3 Usage and maintenance of the rechargeable battery ............................................. 33 
Technical Data .............................................................................................................. 34 
Service .......................................................................................................................... 41 
1 Interference ........................................................................................................... 41 
2 Product life cycle .................................................................................................... 41 
3 Storage and transport ............................................................................................ 41 
4 Storage and usage conditions ................................................................................ 41 
5 Warrenty ................................................................................................................ 41 
6 Accessories and replacement parts ....................................................................... 42 
7 Disposal of application parts and batteries and/or the device ................................. 42 
8 EMV declaration .................................................................................................... 42 
9 Service hotline and contact .................................................................................... 46 
 
   

5

Getting started – Quick Guide

Control and display elements of the main device

Control elements which are active and selectable are backlit.

1 Power button: with this button the device can be turned on and off. The button is

illuminated continuously red if the device is on. The button is flashing red if the device

is recording and green if in wait mode.

2 Button for starting a recording. Until serial number 76 the button is not illuminated. From

serial number 77 onwards the button is backlight with a green and a red LED. The

button is illuminated in green if a recording with manual recording start is initialised or

the device is ready to start the recording. If the button is illuminated in red this is a

warning for the user that there is an untransferred recording on the device. The

recording can be started anyway.

3 Marker button for indicating events. Backlit with a red LED. If connection between

device and PC is active the LED is flashing red quickly.

4 Light sensor: detects ambient light

5 Battery status:

• yellow → battery is being charged

• green → battery is fully charged, docking station is connected to the power supply

• switched off → docking station is not connected to the power supply

6 Bluetooth: blue light indicates connection with the paired receiver

7 LEDs for sensor ports: either green or red. LEDs are indicating missing/connected

sensor during start of the recording and during the recording. When switching on the

device all LEDs light up shortly and indicate the operational state and battery capacity

of the device. Afterwards, the LEDs turn red and show which sensors are needed for

the next recording. All LEDs turn off after 5 minutes after the recording has started. If a

sensor is accidentally removed during the recording the LED next to the port turns red

and stays red until the sensor is re-connected again. LEDs for flow (9) and abdomen

(10) are green all the time (as soon as they are part of the montage).

8 LED for headbox connector. Functionality identical to 7.

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Introduction

Thank you for purchasing the SOMNO HDTM eco from SOMNOmedics. Please read the

following instruction manual carefully before installing and using the device. We gratefully

accept any feedback and helpful suggestions to improve our product or instruction manual.

Please find the safety instructions and important information in the chapter “Safety

instructions”, as well as in the individual chapters where they are labelled as follows:

Note: This is an example.

2.1 Intended use

The SOMNO HDTM eco is a mobile device for recording, displaying and saving biophysical

parameters. The device is used as polysomnography system (PSG) for assisting in the

diagnosis of sleep related disorders. The device is used in hospitals, medical offices, sleep

centres, clinics or other research facilities where adults and/or infants are observed. The

system may also be used in ambulatory settings.

The software DOMINO is part of the system and offers the opportunity to record video signals

or signals of external devices. Those signals are displayed synchronously with the SOMNO

HDTM eco signals.

DOMINO is not providing full, automatic diagnosis. The software is supposed to be used by

trained medical experts. DOMINO generates reports of the recorded and manually scored data

(number, index, average values, maximum and minimum, ranges). All values displayed within

the software and on the device itself must be checked and evaluated by trained medical stuff.

Diagnosis must be given after visual evaluation of all recorded data.

This device is not intended to be used as a life support system or together with other

systems in life support applications. The device does not provide an alarm. The device

is not designed to be used as an automatic apnoea monitor. The device is not designed

for use with HF surgical equipment.

2.2 Patients

The SOMNO HDTM eco and its components may only be used as follows:

- At patients as of the first month of life, no premature infants

2.3 Essential performance features of the device

According to DIN EN 60601-1:2013-12 (Edition 3.1) SOMNO HDTM does not have any

essential performance features if used as polysomnography device. The basic safety of the

device must be ensured without the presence of essential features.

For extension of the intended use of the device to neurological applications then the DIN EN

60601-2-26 is applicable. The following essential performance features are defined:

- Accuracy of signal reproduction 201.12.1.101.1

- Input dynamic range and differential offset voltage 201.12.1.101.2

- Input fault 201.12.1.101.3

- Frequency response 201.12.1.101.4

- common mode rejection 201.12.1.101.5

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Electromagnetic influences, caused by other devices or device with radio equipment, may

affect the essential performance feature or could lead to a loss of the essential performance

features. The waveforms of EEG signal can be affected by an increased noise level, peaks,

offset or other noise.

2.4 Safety instructions.

Evaluation and functional diagnosis of the recorded data is intended to be done by trained

medical experts. For evaluation of the data it is necessary to consider all data together. Signal

quality, interfering signals, dropouts and impedance must be checked previously to the final

diagnosis by the user.

Applications with children must be performed under continuous control.

The SOMNO HDTM eco system may not be used in the course of life support monitoring.

In order to guarantee the correct interpretation of the recorded data the operator should hold

suitable qualifications recognised in their local country.

We recommend that patients with a cardiac pacemaker should wear the main device on the

abdomen rather than on the thorax. We recommend placing the main device at least 16 cm

away from the pacemaker. When following these instructions, no signs of interference of the

cardiac pacemaker with the main device are expected. Additionally, a safe distance needs to

be maintained between the Bluetooth data receiver and patients with cardiac pacemakers or

other implanted stimulation devices.

It is important to deactivate Continuous Impedance Measurement for all EXG channels in

patients that have a cardiac pacemaker or other implanted stimulation devices. Please find a

detailed description regarding this topic in the instruction manual of the DOMINO software, in

the section called “Continuous impedance measurement”.

If a sensor cable or the device housing itself is damaged do not use it any longer. A risk of

injury due to electrical voltage or thermal energy may occur. The device housing, all wires,

sensor cables and plug connections must be checked for damage before every use. Damaged

parts should not be used and must be repaired or replaced by trained experts or by persons

authorized by SOMNOmedics.

Warning: Avoid using the device in close proximity to other equipment or in stacked

combination with other equipment. This could lead to improper operation. However, if

necessary, in the manner described above, this device and the other devices should be

observed to verify that they are working properly.

When using the 4-channel analogue optocoupler to record signals from several external

devices, medical devices and non-medical devices should not be connected at the same time

as there is no galvanic separation between the 4 signal inputs.

The main device is not designed to be used in a potentially explosive or combustible

environment.

The main device is not designed for outdoor use and thus must be protected against

temperatures below 0°C and above 50°C. Ingression of dust, dirt and water may damage the

device.

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Regarding ingression of humidity and water, the main device complies with protection class IP

22. Consequently, the device must be protected against humidity and water.

Should any liquids enter the device, the device must be cleaned immediately by

SOMNOmedics customer service personnel. Following this, the device will undergo a safety-

related examination. Do not switch on the device if any liquids have entered.

Cleaning should only be conducted with a lint-free and damp cloth. Don’t use steam autoclave.

Please refer to the information about disinfection (see chapter 6.1 Cleaning and disinfection).

Adhere to the indicated dosages as well as to the application time. Use disposable protective

gloves when using aggressive disinfectants.

Chemicals required for maintenance have to be stored, prepared and kept ready in appropriate

containers to avoid confusion.

When stored for a longer period, the main device should be kept in a closed room to avoid

water condensation caused by temperature fluctuations at high humidity.

Do not use Radio Transmitters and Receivers, High Frequency Devices, CB-Radio Systems,

Cellular Phones, Microwave Ovens, etc. within a distance of 30 cm (in accordance with IEC

60601-1-2) to SOMNO HD™.

If a battery change is required, only batteries specified by SOMNOmedics may be used.

SOMNOmedics cannot guarantee error-free operation if different batteries are used.

Refrain from removing the battery while the device is running as this can result in data loss

and damage of the storage media.

Insert the battery always with the imprinted arrow pointing up and to the back.

Do not put any labels or stickers onto the battery. This could lead to a malfunction of the battery.

Do not put any kind of lable on the battery. Sticking a lable on the battery could lead to a

malefunction of the battery.

Check on the battery regularly. Do NOT use batteries that appear severely swollen.

Please note that the internal time and date will not be saved when storing the device without

a battery. If the device is stored without a battery, it must be initialized before use via the

DOMINO software in order to synchronize time and date.

Repairs, modifications and opening of the main device must be carried out in the

factory. Otherwise, this will lead to immediate loss of warranty.

Any damage of the warranty seal “Warranty void, if seal is broken”, located on the back of the

device case, will lead to immediate loss of warranty.

The main device should only be used with micro SD cards specified by SOMNOmedics.

SOMNOmedics cannot guarantee error-free operation if third-party memory cards are used.

The memory card must not be removed during recording as this may lead to data loss.

Since 1st October 1998, batteries may not be disposed of in household waste. The consumer

is obliged to hand used batteries to the manufacturer, authorized dealers or to local collection

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points. The foundation Das Gemeinsame Rücknahmesystem (GRS) which was founded in

Hamburg organises safe disposal.

When recharging a partly-charged Li-Ion battery, this counts as one whole recharging cycle

and shortens the durability of the battery.

Always recharge the battery with the SOMNOmedics docking station NGA102 as the battery

can otherwise be damaged.

SOMNO HDTM eco should only ever be used with sensors and electrodes specified and

approved for usage with this device by SOMNOmedics.

The docking station of the main device should only be used with the supplied power supply,

XP-Power VEP15US12.

Connect the docking station to a freely accessible socket. In case of a fault it should be

possible to unplug it easily.

When using SOMNOmedics equipment with an external plug-in power supply unit, the

power supply unit should not be placed in direct proximity to the patient.

2.5 System components & accessories

Main Device

Internal channels: body position, movement, flow/snore, CPAP-pressure, RIP effort

abdomen, ambient light, patient marker, battery status

Additional Sensors

PSG Headbox

EEG32 Headbox

RIP effort sensor thorax

SpO2 sensor (SpO2, pulse, pleth)

Limb EMG sensors left and/or right (for paediatric applications and adults)

Microphone

Thermistor

Pneumotachograph

Dual pressure sensor

Accessories

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Nasal cannula

RIP effort belt abdomen

RIP effort belt thorax

--- Check the current price list for all available options ---

Cable length

Item

Article number

Cable length

USB cable for docking

station (1-port)

NGA102

180cm

USB cable for docking

station (3-port)

NGA103

180cm

Network cable for Bluetooth

receiver

Komp90

200cm

Network cable for Camera

Komp90

200cm

Electrode cable Gold cup

SEN710

75 cm

Electrode cable snap

fastener

SEN018

80 cm

2.6 Labels/Symbols

Information, Symbols, Icons and Classifications on the Type Label of SOMNO HDTM eco

and its accessories:

HF-Transmitter with integrated Bluetooth Protocol.

Read the instruction manual very carefully before you start working with the

SOMNO HD™ eco.

Protection Class: BF

The CE icon shows that the SOMNO HD™ eco complies with the

applicable regulations of the EU and that the conformity was declared by

the manufacturer.

IP22

This device complies with the IP-Protection-Class 22.

Regulatory Compliance Mark (Australia)

Do not dispose electronic devices in the domestic waste.

The power supply meets the requirements of protection class II and does

not need any additional protective conductor connection.

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The power supply is intended for indoor use only.

3 Preparing the patient: applying

main device, sensors and

electrodes

Note: The main device should be placed on top of

light clothes (nightshirt, pyjamas) and should not

be in direct contact with the skin.

Note: If applying the main device and the sensor in a

different way then shown in the figure this could lead

to wrong results.

Note: Attach the belts and sensor/electrode wires

securely to the patient to avoid strangulation. Fix

the sensor cable with adhesive tape if needed.

Recordings with children may only be performed

while under continuous observation.

We recommend placing the main device in the

abdominal region of the patient. Alternatively, you

can place the device in the thoracic region.

Please take note of the following images in order

to place the main device and the sensors correctly

on the patient’s body. If the main device and the

sensors are placed differently to that shown in

the images, invalid data may be generated.

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Main device and sensors on the patient’s body

3.1 Connecting the sensor plug to the main device

Please insert the sensor plugs into the main device as shown in the following image:

Inserting a sensor plug into the main device

The device automatically recognises the connected sensors.

The Luer-lock plug of the nasal cannula is screwed directly into the sensor port:

Connecting the luer-lock plug to the main device

Insert the headbox plug into the designated port and position. Turn the safety screw as

indicated by the arrows in the image and indicated on the plug/device.

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Connecting the headbox plug to the main device

Insert the SpO2 plug into the bottom as shown in the image.

Connecting the SpO2 plug to the main device

Note: In order to prevent damage of the sensor, patient should take off SpO2 sensor while

washing hands or splashing water.

3.2 Sensors for Polysomnography

3.2.1 Attaching the effort belts

Insert the thin end of the effort belt into the slot on the left side of the main device (seen from

the front). Follow the steps shown in the following image:

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Connecting the effort belt to the main device using the thin end

Wrap the belt around the patient. Insert the wider side of the effort belt to the right side following

the guiding rail.

Connecting the effort belt with the main device using the wider end

Thread the belt into the sensor.

Attaching the effort belts to the patient

3.2.2 Nasal Cannula

Attach the nasal cannula to the patient’s nose. Make sure that the

holes of the sensor elements (highlighted red in the following image) are placed directly below

the nostrils.

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Note: Nasal cannulas are single-use items.

Attaching the nasal cannula

3.2.3 SpO2 sensor

The finger sensor should be attached to the most suitable finger. The upper side of the sensor

is marked by the embossing of a finger as shown in the following image. You can use adhesive

tape to secure the cable.

Attaching the finger sensor

3.2.4 Leg EMG sensor

The active electrodes (EMG) should be attached to the skin in the area of the anterior tibialis

muscle of each leg between the knee and ankle (see the following image). Use two adhesive

disposable snap electrodes to place it in the correct position. Connect the electrodes with the

sensor before attaching it to the patient. Use adhesive tape to secure the cable to ensure an

accurate measurement and for strain-relief.

The sensors are labelled L and R and should only be applied to the corresponding leg.

Adjust fixing sleeve

in order to secure the

sensor’s position.

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Attaching the PLM electrodes to the legs

Note: Do not use dried-out adhesive snap electrodes. Only use electrodes provided by

SOMNOmedics to ensure the best signal quality.

Note: When using the leg EMG sensors, always use a ground lead electrode to ensure optimal

signal quality. You can use the following sensors: PSG-headbox, ECG sensor, combi electrode

EEG/EOG.

3.2.5 Mikrophone

Attach the microphone between the larynx and carotid artery to record the snoring sounds.

(DO NOT place the sensor directly on the larynx and not too close to the carotid artery). Ensure

that the cable does not restrict the patient’s breathing or endanger the patient in any way.

Attach the sensor with the flat side of the microphone towards the skin. The patient’s head

should be as straight as possible (looking straight ahead) when attaching the microphone to

prevent discomfort. Check to make sure the patient can turn their head to the left and right

before applying the securing tape.

Attaching the microphone Fixation of the microphone

Strain relief

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3.2.6 Flow sensor (Thermistor)

The thermistor measures the air flow via temperature changes and can be worn like a nasal

cannula. See the following image to fit the sensor to the patient’s face. Make sure that both

upper sensor elements (highlighted red in the following image) are located directly below the

nostrils and that the lower element is located directly in front of the mouth. Adjust fixing sleeve

(small rubber sleeve) along the tube in order to ensure the sensor’s position during the whole

measurement. The sensor can be adjusted to the contour of the patient’s face by bending it

gently. When using the nasal cannula and the thermistor simultaneously, they can be

connected by using the nasal cannula adapter. Use adhesive tape to attach the cable to the

cheeks for an optimal fit.

Attaching of the thermistors Adapter for thermistor and nasal cannula

3.2.7 ECG

Note: Use disposable snap electrodes only. Clean the skin before attaching the ECG

electrodes.

Note: The main device must not be placed directly on the skin. The cables of the ECG

electrodes should run under the pyjamas/nightshirt. The connecting cable of the corresponding

ECG sensor should run on top of the pyjamas/nightshirt to the main device.

The ECG is applied using the PSG or EEG32 channel headbox.

Please use two snap electrode cables similar to the following figure. Insert the two ECG cables

into the ports labelled “ECG” on the digital headbox.

Attaching the ECG cables to the headbox (similar for EEG32 channel headbox)

Adjust fixing jacket in

order to secure the

sensor’s position.

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3.3 EEG/ EOG

Previous to the application clean all skin areas with Nuprep abrasive gel.

Connect the EEG electrodes in accordance to the labelling and colour-coding to the headbox.

Make sure you are using the same type of electrodes for all derivations (e.g. only Ag/AgCl or

only gold cup).

3.3.1 Attaching the PSG headbox according to AASM Guidelines

Position der Elektroden (PSG nach AASM)

GND: Centre of forehead

REF: Applied to Cz, see 10/20 system

EOG l: 1cm above outer canthus of left eye

EOG r: 1cm below outer canthus of right eye

F3/4: See 10/20-System

C3/4: See 10/20-System

O1/2: See 10/20-System

M1/2: Behind left/right ear (mastoid; select boniest area)

EMGref: centred 1 cm above the inferior edge of the mandible

EMG1/2: 2 cm below the inferior edge of the mandible and 2 cm to the left/right of the center.

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3.3.2 Application for 32-channel headbox according to 10-20 System

Electrode positions (10-20)

Use the cable link between the reference electrode and the second free EMG port for

application of EMG electrodes according to AASM rules

3.4 CPAP sensor and CPAP device

The PAP device is connected via the dual pressure sensor. Therefore, you need the following

items: dual pressure sensor, pneumotachograph (blue) and connecting tube. The

pneumotachograph is connected directly to the dual pressure sensor. Make sure that the white

Luer-Lock of the pneumotachograph is connected in the direction of the end of the CPAP tube

and the also connected with the positive pole of the dual pressure sensor. Use the small

connecting tube to connect the pneumotachograph to the dual pressure to the PAP device. To

the other end of the pneumotachograph connect the end of the masks’ tube. Afterward,

connect the cable of the dual pressure sensor with the main device.

Cable link

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SOMNOmedics SOMNO HD Eco User manual

SOMNOmedics SOMNO HD Eco User manual

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