SOMNOmedics SOMNOscreen HD User manual

SOMNOscreen™HD
Instruction Manual
Revision 0
November 14th, 2016
Caution: Federal law restricts this device to sale by or on the order of a physician.

All proper names marked with TM are copyright protected by SOMNOmedics.
Manufacturer:
SOMNOmedics GmbH
Am Sonnenstuhl 63 –97236 Randersacker –Germany
Phone: (+49) 931 / 35 90 94 - 0 –Fax: (+49) 931 / 35 90 94 - 49

Content
Getting started –Quick Guide.........................................................................................5
Introduction.....................................................................................................................7
Intended use/Indication of Use.................................................................................7
Patients ...................................................................................................................8
About this instruction manual...................................................................................8
Explanations of Symbols used in this Manual..........................................................8
Safety instructions ...................................................................................................8
System components & accessories.......................................................................12
Label / symbols......................................................................................................13
Preparing the patient: applying main device, sensors and electrodes........................... 15
Connecting the sensor plug to the main device......................................................17
Attaching the effort belts........................................................................................19
Nasal cannula........................................................................................................20
SpO2 sensor..........................................................................................................21
Leg EMG sensor....................................................................................................21
Microphone............................................................................................................22
Flow sensor (thermistor)........................................................................................22
CPAP sensor and CPAP device ............................................................................23
ECG ......................................................................................................................24
EEG/EOG..............................................................................................................25
Operating the main device............................................................................................27
The control and display elements ..........................................................................27
Switch-on /-off of the device............................................................................28
Navigation in the menu...................................................................................29
Using the touch display: Interactive buttons and their meaning..............................29
Bluetooth on/off ..............................................................................................31
Sound on / off.................................................................................................31
Patient markers/event markers.......................................................................31
Initialization of a measurement ..............................................................................32
Initialization via DOMINO software .................................................................32
Initialization via the device..............................................................................34
Signal view on the display......................................................................................35
Numerical display of parameters.....................................................................35
Raw data view –channel selection.................................................................35
Scrolling channels ..........................................................................................36
See individual channels..................................................................................36

Reviewing the raw data...................................................................................36
Zoom..............................................................................................................36
Impedance display..........................................................................................36
Warnings on the display.....................................................................................3637
The docking station................................................................................................38
Data transfer via docking station.....................................................................38
Recharging the battery....................................................................................38
Firmware Update............................................................................................38
Troubleshooting............................................................................................................39
Cleaning and maintenance ...........................................................................................40
Cleaning and disinfection.......................................................................................40
Maintenance interval..............................................................................................41
Usage and maintenance of the rechargeable battery.............................................41
Technical data ..............................................................................................................42
Service..........................................................................................................................44
Interference ...........................................................................................................44
Product life cycle/lifetime .......................................................................................44
Storage and transport............................................................................................44
Conditions of storage and usage ...........................................................................44
Warranty................................................................................................................45
Accessories and replacement parts.......................................................................45
Disposal of application parts and batteries and/or the device.................................45
EMC declaration....................................................................................................45
Accessories...........................................................................................................49
Service hotline und contact....................................................................................50

5
Getting started –Quick Guide
Control and display elements of the main device
Control functions
Control functions which are active and selectable are backlit.
1Power button: when touching the power button (1) the device can be switched on and
off respectively, or, during the measurement, the display can be switched on. The
button flashes red when recording or green when the device is in waiting mode.
2Return button: bypressing the return button, the previous display in the menu is shown.
3Confirm: to confirm and to move forwards in the menu
4Light sensor: detects ambient light
Display functions
5Battery 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
6Bluetooth: blue light indicates connection with the paired receiver
7Screen: the screen is an interactive touch and signal display
1
2
3
4
5
7
6

6
2Wait for the unlock screen to
appear then move the slider
form left to right

7
Introduction
The SOMNOmedics team would like to thank youfor purchasing thisproduct.We are confident
that you will enjoy using the SOMNOscreen™ HD for many years. The SOMNOscreen™ HD
has been developed by SOMNOmedics to meet the highest quality control standards available.
Caution: Federal law restricts this device to sale by or on the order of a physician.
In order to obtain the best results from your system, we recommend that you carefully read
this instruction manual before connecting the SOMNOscreen™ HD to a patient.
Advice and suggestions to improve the functionality of the device and this manual we will be
gratefully accepted.
Warning: Take care in arranging patient and sensor cables to avoid risk of patient
entanglement or strangulation. To minimize the risk of patient strangulation, the sensor and
electrode cables must be carefully placed and secured. Medical tape can be used to
additionally secure the sensors in place if necessary.
Technical Specifications are subject to change without notice.
The Initialisation of the System and Analysis of the Data must be performed by Trained
Operators. Measurements can be performed in professional healthcare facilities or at the
Patients’ home. When used at the Patients’ home, the Patient should be carefully instructed
on how to use and care for the system.
Please also hand out to the patient a copy of the enclosed Patient Instruction Manual. The
initialized device will automatically start recording the measurement at the pre-set time. The
data transfer and the analysis must be performed by the doctor or qualified physiologist.
The device should be programmed by the physician/medical staff to start recording
automatically at a pre-set time. Therefore, there is no need for the patient to start the device
manually. Once the patient returns the device, the data transfer and analysis must be
performed by the doctor or a qualified physiologist.
The SOMNOscreen™ HD may not be worn during swimming and showering.
Please refer to the safety instructions in chapter 2.5.
Intended use/Indication of Use
The SOMNOscreen™HD system is a polysomnography (PSG) system which records and
displays physiological data for the usage by clinical or medical experts. The recorded data is
displayed graphically on a computer monitor and can be diagnostically evaluated by trained
experts. The device is used in hospitals, medical offices, neurological sleep centers, clinics or
other research facilities where adults’sleep-related, neurological, respiratory or other
physiological diseases are monitored. The system may also be used in ambulatory settings.
The device is intended to be prescribed for use by a physician in the office, sleep laboratory or
patient’s home.

8
This device does not provide an alarm system and must not be used in life support
applications. The device is not designed to be used as an automatic apnea monitor.
Patients
The SOMNOscreen™HD and its components may only be used as follows:
- The AASM rules indicate that the respiratory screening setting for adults can be used for
patients >18years, but an individual sleep specialist can choose to use adult setting and
scoring for children ≥13years.
- Excluded are monitored and intensive care patients
About this instruction manual
It is essential that you read each paragraph carefully when you see this icon on the left
of that paragraph. This instruction manual is a part of the device and it must be available
at all times.
Explanations of Symbols used in this Manual
Indicates a hint or tip. This Symbol provides assistance with possible
problems when working with the SOMNOscreen™ HD.
This Warning Symbol indicates potential danger to Patients, Property
or Data Loss.
Safety instructions
This instruction manual is regarded as part of the instrument and should always be kept on
hand.
The SOMNOscreen™HD system may not be used in the course of life support
monitoring, surgical rooms, intensive care units, or in emergency vehicles.
The SOMNOscreen™ HD must be applied only under instruction of a physician. Cleaning and
disinfection also has to be done by a physician or medical professional with recommended
chemicals and not by the patient.
Check all cables and connections for damage before using this device.
Damaged parts must be replaced immediately. Please contact SOMNOmedics or your
SOMNOmedics Distributor. If the device is damaged (e.g. broken case) it has to be taken out
of service. If any sensor cable or the device housing itself is damaged, a low risk of injury to
the patient may occur through a direct connection to the ground lead. The maximum voltage
generated by the device is 3.3 V. Please check the device housing, all wires, sensor cables
and plug connections 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.
In order to guarantee the correct interpretation of the recorded data the operator should hold
suitable qualifications recognised in their local country.

9
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”.
Do not use Radio Transmitters and Receivers, High Frequency Devices, CB-Radio
Systems, Cellular Phones, Microwave Ovens, etc. where the electrical field strength
exceeds 3 V/m (in accordance with IEC 60601-1-2) close to SOMNOscreen™ HD.
All sensors are provided unsterile and should never be sterilized.
This device is not to be used on broken skin. If this device comes in contact with broken
skin/blood, do not reuse this device and discard.
Only accessories/sensors designed or recommended by SOMNOmedics are allowed to
be connected to or used with the SOMNOscreen™ HD.
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.
This device is not designed for use in an MRI (Magnetic Resonance Imaging)
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.
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. Small amounts
of water are tolerated by the device. Do not expose the device to huge amounts of water. Do
not wear the device during showering or bathing. Prevent the device of rain.
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. Do not use a 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.

10
Chemicals requiredfor maintenance have to bestored, prepared andkept 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.
Avoid using the main device in close proximity to radio devices, e. g. high frequency operation
devices, wireless (mobile) phones, CB radio devices, microwave ovens etc. where the
electrical field may exceed 10 V/m (according to norm IEC 60601-1-2).
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 front.
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 side 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.
Note: Since 1st October 1998 portable batteries must no longer be disposed of in household
waste after use. Consumers are obliged to hand over used batteries to the manufacturer,
authorized dealers or to the local collection point.
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 as the battery can
otherwise be damaged. The docking station of the main device should only be used with the
supplied power supply.
SOMNOscreen™HD should only ever be used with sensors and electrodes specified and
approved for usage with this device by SOMNOmedics.
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.

11
There was no testing conducted to demonstrate the moisture retention filter for nasal cannula
used is effective in preventing cross-contamination.
Opening the case, repairing or modifying the SOMNOscreen™ HD in any way will void
the guarantee and might affect the safety of the device. Only SOMNOmedics and its
authorised distributors may repair the unit.
The body strap is made of material commonly used in clothing and non-medical watchbands,
however if redness or swelling of the skin occurs where the band is in contact, please
discontinue use immediately and consult your physician.
Pulse Oximeter and sensor related Warnings and Cautions:
The SOMNOscreen™ HD has no audible alarms for monitoring Pulse and SpO2.
The SOMNOscreen™HD must be able to measure the pulse properly to obtain accurate SpO2
measurement. Verify that nothing is hindering the pulse measurement before relying on the
SpO2measurement.
Fingernail polish may reduce light transmission and thereby affect SpO2accuracy.
Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor
alignment and skin integrity. Patient sensitivity to sensors may vary due to medical status or
skin condition. Avoid excessive damage to the skin beneath the sensor.
Do not use damaged SpO2 sensors. If the sensor is damaged in any way, discontinue use
immediately and replace the sensor.
Misuse of the pulse oximeter sensor with an increased pressure over a prolonged period can
lead to a barotrauma.
Follow local governing ordinances and recycling instructions regarding disposal or recycling of
the sensor and any components.
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or probe.
Factors that may degrade pulse oximeter performance include:
Excessive motion and low perfusion may affect the accuracy of the SpO2 measurement.
Cardiogreen and other intravascular dyes, depending on the concentration, may affect the
accuracy of the SpO2measurement.
Excessive ambient light, artificial nails, excessive motion, Incorrect sensor type, poor
pulse quality, electrosurgical interference, Venous pulsations, cardiovascular dyes, sensor not
at heart level, Dysfunctional haemoglobin, fingernailpolish, moisture in the sensor, Improper
applied sensor, carboxyhemoglobin, methemoglobin, Residue (e.g. dried blood, dirt, grease,
oil) in the light path, Anemia or low haemoglobin concentrations , Aterial catheters, blood
pressure cuffs on same arm, infusion lines, etc.
The pulse oximetry device integrated in SOMNOscreen™ HD is calibrated to determine the
percentage of arterial oxygen saturation of functional haemoglobin. Significant levels of
dysfunctional haemoglobin such as carboxyhemoglobin or methemoglobin may affect the
accuracy of the measurement.

12
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
EEG/EOG combi electrode
1-Channel ECG
RIP effort sensor thorax
Multiplex-RIP effort sensor (for paediatric use)
SpO2 sensor (SpO2, pulse, pleth), paediatric or adult
Limb EMG sensors left and/or right
Microphone
Thermistor
Pneumotachograph
1-channel analogue optical coupler to record external analogue signals
Digital optocoupler to connect the LoFlo Capnometer
Accessories
Nasal cannula
RIP effort belt abdomen
RIP effort belt thorax
--- Check the current price list for all available options ---

13
Label / symbols
Information, Symbols, Icons and Classifications on the Type Label
Manufacturer information / address
Direct Current
Read the instruction manual very carefully before you start working with the
SOMNOscreen™HD.
Protection Class: BF
The CE icon shows that the SOMNOscreen™HD 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.
Electronic waste –no domestic garbage
Device Type
Serial number
Non-ionizing electromagnetic radiation. Equipment includes an RF
transmitter: interference may occur in the vicinity of equipment marked with
this symbol
Bluetooth®wireless technology
This device contains
FCC ID: PVH0946
IC: 5325A-0946
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions;
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may
cause undesired operation.

14
Symbols on the Docking Station
IP20
This device complies with the IP-Protection-Class “20”.
Electronic waste –no domestic garbage
USB Interface
Device Type
Manufacturer information / address
The CE icon shows that the SOMNOscreen™HD complies with the applicable
regulations of the EU and that the conformity was declared by the
manufacturer.
Read the instruction manual very carefully before you start working with the
SOMNOscreen™HD.
Symbols on the power supply label
Protection Class II
Electronic waste –no domestic garbage
The CE icon shows that the SOMNOscreen™HD complies with the applicable
regulations of the EU and that the conformity was declared by the
manufacturer.
REF

15
Preparing the patient: applying main device, sensors and
electrodes
Note: The main device should be placed ontop of light clothes(nightshirt, pyjamas) and should
not be in direct contact with the skin.
Note: Attachthe belts and sensor/electrode wires securely tothe 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.
Main device and sensors on the patient’s body

16
For home sleep tests it is highly recommended that the physician/medical professional either
attach the device and the accessories before the patient leaves the office or the physician
explain and demonstrate the attachment and use of the device and sensors face-to-face.
The physician/medical professional should go through the following points with the patient:
1. Attaching device and sensors.
2. Testing of correct sensor connections.
3. Patient marker on the device and status indications.
It is important to remind the patient to follow the instructions given, prior to the recording. A
detailed instruction sheet for attaching the device and sensors is available and can be sent
home with the patient to remind them how to properly attach the device and sensors.
The decision asto whether an examination at home is possible must be made by the physician
on a case by case basis.
When making this decision the physician should take the following items into consideration:
Physical size, mobility, coordination, flexibility, strength and stamina
Range of vision and hearing abilities and tactile sensitivities.
The abilities to process information and literacy levels, as well as some type of
cognitive impairment (feedback about e.g. comfort; follow instructions and tolerating
the attached sensors must be given by the patient).
The emotional state of the user.
After evaluating the characteristics of the patient, the physician should determining that a home
sleep test is appropriate, the physician should then choose and provide the appropriate
informational material and individual training.
All cables should be routed and fixed carefully as described in the attachment information to
reduce the possibility of entanglement or strangulation.
The size of the sensors has to be chosen according to the individual patient to ensure acorrect
fit. If the sensors do not fit correctly the measurement should not be performed.

17
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 recognizes the connected sensors.
Main device with plugged-in sensors; signals are shown on the display
The luer-lock plug of the nasal cannula is screwed directly into the sensor port. In case you
are using the moisture retention filters the filter is screwed directly to the nasal cannula and
then to the luer-lock plug. We recommend using the moisture retention filters but the device is
working without as well.
Connecting the luer-lock plug to the main device

18
Connecting the luer-lock plug to the moisture retention filter and then 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.
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

19
Note: In order to prevent damage of the sensor, patient should take off SpO2 sensor while
washing hands or splashing water.
Attaching the effort belts
The effort belts are provided in different size. Measure the patients circumference for selecting
the correct size. 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:
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. Adjust the fitting by use of the xxx. The belt should
Connecting the effort belt with the main device using the wider end
>>Click<<
>>Click<<

20
Attaching the effort belts to the patient
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.
Note: Nasal cannulas are single-use items.
Attaching the nasal cannula
Adjust fixing sleeve
in order to secure the
sensor’s position.