SOMNOmedics SOMNOscreen plus User manual

I

nstruction Manual

SOMNOscreen™ plus

Caution: Federal law restricts this device to sale by or on the order of a physician.

USA

SOMNOmedics America Inc. – 815 Ponce de Leon Blvd., Suite

P-209 – Coral Gables, FL 33134

Toll free: 866 361 9937

info@somnomedics-diagnostics.com

www.somnomedics-diagnostics.com

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SOMNOscreen™ is a registered trademark of the

SOMNOmedics Company.

Rev. 6

30.10.2019

 
  - 3 - 
Table of contents 
Introduction .................................................................................................................................... 5 
1  About this instruction manual ................................................................................................... 6 
2  Explanation of Symbols used in this Manual ........................................................................... 6 
3  SOMNOscreen™ plus Menu Structure .................................................................................... 7 
About the SOMNOscreen™ plus .................................................................................................. 8 
1  Indication for Use ..................................................................................................................... 8 
2  Intended Use ............................................................................................................................ 8 
3  Device Description ................................................................................................................... 8 
4  Model and Device Number ...................................................................................................... 9 
5  Interactive display and keyboard ........................................................................................... 10 
6  Configurations ........................................................................................................................ 11 
Safety instructions ....................................................................................................................... 12 
Operating Instructions ................................................................................................................. 14 
1  How to switch the SOMNOscreen™ plus On and Off ........................................................... 14 
2  Recording Measurements ...................................................................................................... 14 
2.1  Safety Instructions ............................................................................................................. 14 
2.2  Initializing the Compact Flash Card ................................................................................... 15 
2.3  Manual Start ...................................................................................................................... 18 
2.4  Programmed Start without signal check on Display .......................................................... 18 
2.5  Auto Start with Prior Signal Check .................................................................................... 19 
2.6  Manual cancellation of recording ....................................................................................... 20 
2.7  Manuel cancellation of the waiting mode .......................................................................... 20 
2.8  Saving Recording .............................................................................................................. 20 
2.9  Relevant information for Performing Measurements ......................................................... 21 
3  Menu System (Battery check/ Time Set / Firmware update / Reading Error log) .............. - 23 - 
Attach the Sensors to the Patient ........................................................................................... - 24 - 
1  SOMNOscreen™ plus
 
and Shoulder Belt .......................................................................... - 25 - 
2  Effort Sensor ...................................................................................................................... - 26 - 
3  PLM Sensors ...................................................................................................................... - 28 - 
4  Activity Sensor (wrist) ......................................................................................................... - 29 - 
5  SPO2 Sensor ..................................................................................................................... - 30 - 
6  Microphone ........................................................................................................................ - 31 - 
7  Flow Sensor (Thermistor)................................................................................................... - 32 - 
8  CPAP Sensor with Nasal Cannula ..................................................................................... - 33 - 
9  CPAP Pressure Sensor with CPAP Device ....................................................................... - 34 - 
10  ECG.................................................................................................................................... - 36 - 
11  EEG- / EOG electrodes ...................................................................................................... - 38 - 

 
  - 4 - 
Troubleshooting ....................................................................................................................... - 40 - 
1  Overview ............................................................................................................................ - 40 - 
  Description of Errors in the Logbook .................................................................................. - 45 - 
2  - 45 - 
Maintenance .............................................................................................................................. - 46 - 
1  Maintenance rate ............................................................................................................... - 46 - 
2  Cleaning and disinfection ................................................................................................... - 46 - 
3  Use and Maintenance of the Rechargeable Battery .......................................................... - 50 - 
Service ....................................................................................................................................... - 51 - 
1  Biological Calibration and Measuring the Electrode Impedance ....................................... - 51 - 
2  Technical Specification .......................................................................................................... 52 
3  Malfunctions ........................................................................................................................... 55 
4  Warranty ................................................................................................................................. 55 
5  Accessories and Spare Parts ................................................................................................. 55 
6  Disposal of Parts, Batteries or the SOMNOscreen™ plus Device ........................................ 55 
7  Contact ................................................................................................................................... 56 
Notes ............................................................................................................................................. 57

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1 Introduction

SOMNOmedics thanks you for purchasing this product. Please read the following instruction manual

carefully before you turn on the device. We are thankful for any feedback and helpful suggestions you

can make, in order to improve our product or our instruction manual.

If due to some possible technical difficulties our staff cannot answer, you will be redirected to our mail

box. If that is the case, please leave your name and telephone number so that we can call you back as

soon as possible.

In case accessories are used which do not come from SOMNOmedics, a bill

will be issued for any repairs.

The device is not guaranteed if opened. Repairing or modifying the

SOMNOscreen™ plus in any way will void the guarantee.

*

Our Service-Hotline is available 24 hours a day at:

866 361 9937 (toll free)*

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1.1 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 icon indicates potential danger to Patients, Property, Data Loss

or in connection with external devices. This icon also appears on the label on the

bottom of the SOMNOscreen™ plus. This instruction manual is a part of the device and

it has to be kept available at all times.

1.2 Explanation of Symbols used in this Manual

Indicates a hint or tip. This Symbol provides assistance with possible problems

when working with the SOMNOscreen™ plus.

This Warning Symbol indicates potential danger to Patients, Property or Data

Loss.

Screen Views similar to this show the current Menu, Text or Information on the

SOMNOscreen™ plus display.

7

1.3 SOMNOscreen™ plus Menu Structure

weiß

Capacity OK:

Start Recording

Capacity Low:

Recording Will Be

Started With Shorter

Recording Period

Capacity Empty:

Recording Will Not Be Started -

Battery Has To Be

Charged

System Check:

Check Battery And

Storage Capacity

Start Recording

Selected Montage

Device ID

Record

Check Signals

weiß

Logbook

weiß

Software-Update

Time / Date

Device ID

Battery Capacity

System

Exit

Main Menue Structure

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SOMNOscreen™ plus has not been designed for outdoor use. It is very important to

protect the SOMNOscreen™ plus from temperatures below 0°C and above 50°C. Also,

protect the SOMNOscreen™ plus from coming into contact with water, dust and dirt.

Please refer to the safety instructions in chapter 3.

2 About the SOMNOscreen™ plus

Display

Li ION Battery

Status LED

Control Keys

and Marker

Light Sensor

External Sensors

Body Position

Internal Effort

Flashcard

Pulse Oximeter

Eject Mechanism

EXG 1-24

Fig. 2-1: SOMNOscreen™ plus

2.1 Indication for Use

The SOMNOscreen™ plus is a non-life-supporting portable physiological signal recording device

intended to be used for testing adult patients suspected of having sleep-related breathing disorders.

2.2 Intended Use

The SOMNOscreen™ plus is indicated for use in the recording, displaying, monitoring, printing, and

storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and

Sleep Disorders.

2.3 Device Description

The SOMNOscreen™ plus is a portable physiological signal recording system intended to be used to

record, display, monitor, print and store biophysical events to aid in the diagnosis of neurologic and

sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep

laboratory or patient’s home.

This device is NOT designed to be used in a Life Support situation.

This device is not designed for use on patients with cardiac pacemakers.

Caution: Federal law restricts this device to sale by or on the order of a physician.

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.

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2.4 Model and Device Number

When unpacking the SOMNOscreen™ plus, check to make sure that all items are in good condition

and that all accessories correspond to the delivery note. Also compare the Model on the delivery note

with the label on the bottom of the SOMNOscreen™ plus.

Fig. 2-2: SOMNOscreen™ plus label

Information, Symbols, Icons and Classifications on the Type Label

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

SOMNOscreen™ plus.

Protection Class: BF

The CE icon and the correlating number show that the SOMNOscreen™ plus

complies with the regulations for Medical Products.

This device complies with the IP-Protection-Class "20". This Classification

states that the SOMNOscreen™ plus is NOT Waterproof.

This device works with a nominal 3.7 volts DC.

HF-transmitter with integrated Bluetooth-protocol.

FCC ID: PVH0925

Additional in

devices with

integrated

bluetooth-

module:

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2.5 Interactive display and keyboard

The Display is divided into 2 lines of 16 characters per line and 2 columns giving 4 fields. The blinking

cursor indicates the active field. The display shows the complete Menu, Selected Signals and Current

Status including warning notes, error codes and hints.

Fig. 2-3: Display

The interactive display and the keyboard provide some useful features and functions including,

controlling the signals, biological calibration, a marker button, battery capacity, firmware update, etc.

These are integrated into a simple menu structure.

Fig. 2-4: Keyboard

Explanation of the keyboard elements

Picture

Description

Function

S1

Moves the cursor up and down.

S2

Moves the cursor left and right.

S3

This button activates/confirms the selected display item (see the

blinking cursor).

Also, the patient uses the S3 button as a Marker during the

measurement. To place a marker for denoting an event (going to bed,

getting up, taking medication, etc.), the patient must push this button

for at least one second.

S4

Power ON. This button is placed underneath the second "O" of the

word SOMNOscreen™ plus. Push this button for at least one second

to switch the SOMNOscreen™ plus on.

LED

The status LED shows the current status of the SOMNOscreen™ plus.

Off = Recording Mode or SOMNOscreen™ plus is switched off.

LED blinking green = Waiting Mode

Models with integrated BT-module for telemetric data transfer:

LED blinking blue: SOMNOscreen™ plus is connected to the BT-

receiver.

Cursor

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2.6 Configurations

The SOMNOscreen™ plus is available in 4 different configurations. All configurations include a

Compact Flash Card, Compact Flash Card Reader (USB or adapter for PCMCIA-slot), 2 x Li ION

Batteries (2550mAh) with 1 x Battery Charger, a Carry Bag for housing the SOMNOscreen™ plus and

Sensors, Instruction Manuals and the DOMINO software for Initialisation, Data Transfer and Analysis.

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3 Safety instructions

This instruction manual is regarded to be a part of the instrument and should always be kept

on hand.

This device is NOT designed to be used in a Life Support situation, surgical rooms, intensive

care units, or in emergency vehicles.

This device is not designed for use on patients with cardiac pacemakers.

The SOMNOscreen™ plus has to be applied only under instruction of a physician.

The SOMNOscreen™ plus and the effort belts must be worn over light clothing such as

pyjamas.

Because the SOMNOscreen™ plus has no audible alarms for monitoring pulse and SpO2,

international labelling requirements dictate it to be labelled “Not for continuous monitoring”.

The SOMNOscreen™ plus 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

SpO2 measurement.

Fingernail polish may reduce light transmission and thereby affect SpO2 accuracy.

The pulse oximetry device integrated in SOMNOscreen™ plus is calibrated to determine the

percentage of arterial oxygen saturation of functional haemoglobin. Significant levels of

dysfunctional haemoglobin such as carboxyhaemoglobin or methaemoglobin may affect the

accuracy of the measurement.

Cardiogreen and other intravascular dyes, depending on the concentration, may affect the

accuracy of the SpO2 measurement.

Only sensors and accessories recommended by SOMNOmedics are allowed to be connected to

the SOMNOscreen™ plus.

A minimal risk of injury through electric shock (limited to 3.3 volts and 180µA) may occur due

to the use of Defective cables when a ground lead is contacted to 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.

This device is not designed for usage in Explosive Environmental Conditions.

This device was not designed for outdoor use. It is necessary to protect this device from

temperatures below 0°C and above 50°C. Also, keep the device away from water, dust and dirt.

Avoid the use of Radio Transmitters and Receivers, High Frequency Devices, CB-Radio

Systems, Cellular Phones, Microwave Ovens, etc. where the electrical field strength exceeds 10

V/m (correlating to IEC 60601-1-2).

This device complies with IP protection class “20”. This means that this device is NOT

waterproof.

If liquids do enter the system, DO NOT switch it on. Please send the device to SOMNOmedics

Customer Services immediately.

Do not use an autoclave for cleaning the SOMNOscreen™ plus or any of its accessories,

cables and sensors.

Follow the manufactures instructions when using disinfectants. Keep to the prescribed dose

and contact time.

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Use protective gloves when using aggressive disinfectant agents.

Chemicals which are used for cleaning the unit should be stored, prepared and kept ready in

their own marked containers to avoid confusions.

All sensors are not provided sterile nor are they intended to be sterilized.

Long-term storage of this device should only be in a closed and dry room to avoid

condensation caused by thermal fluctuations.

Avoid the use of Radio Transmitters and Receivers, High Frequency Devices, CB-Radio

Systems, Cellular Phones, Microwave Ovens, etc. where the electrical field strength exceeds 10

V/m (correlating to IEC 60601-1-2).

When replacing the battery, only use batteries supplied by SOMNOmedics. Alternative

batteries must not be used.

Removal of the battery while recording a measurement will cause the data to be corrupted.

The removal of the main battery for extended periods will shorten the life of the integrated

clock battery. Always store the SOMNOscreen™ plus with a battery installed.

Always use the battery charger supplied by SOMNOmedics!

Do not dispose of Li ION batteries in domestic waste. It is strictly forbidden to put hazardous

substances in domestic waste. Please return used batteries to your distributor or hand them in

at your local municipal collecting point.

Opening the case, repairing or modifying the SOMNOscreen™ plus in any way will void the

guarantee. Only SOMNOmedics and its authorised distributors may repair the unit.

Damaging the Guarantee Seal “Warranty void, if seal is broken” will immediately void the

guarantee of this SOMNOmedics product.

Use only Compact Flash Cards, which are supplied by SOMNOmedics. The use of any other

Compact Flash Card could cause data to be corrupted. SOMNOmedics cannot guarantee error

free operation where incorrect Compact Flash Cards are used.

Removing the Compact Flash Card during recording will delete all data. If this occurs, the

Compact Flash Card must be formatted and then initialized (using the DOMINO software)

before inserting it into the SOMNOscreen™ plus device.

We recommended that the Automatic MS Windows Time Change Feature (Summer/ Winter

time) of your PC be disabled if you have a SOMNOscreen™ plus Tele device.

We also recommended that recording a measurement during the change of year (31.12. to

01.01.) be avoided.

Do not dispose of Li ION batteries in domestic waste. It is strictly forbidden to put hazardous

substances in domestic waste. Please return used batteries to your distributor or hand them in

at your local municipal collecting point.

Every charging cycle, even when the battery is almost full, will be counted as a complete

charge. It is therefore recommended to only charge the battery when the display status

indicates that the battery is low or the power drops below 3.7 volts.

Only sensors designed and supplied by SOMNOmedics may be used with this unit.

Do not add or remove sensors while the SOMNOscreen™ plus is switched on. Sensors should

only be connected while the device is switched off.

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SOMNOmedics only guarantees for the safety, reliability and function of the instrument if

▪ Installation, extension, modifications and repairs are exclusively carried out by personnel

authorized for these tasks by SOMNOmedics.

▪ The room in which the equipment is operated complies with the instruction

▪ The ambient conditions at the place of installation are suitable for the unit.

▪ The unit is used according to the training and instruction manual.

4 Operating Instructions

4.1 How to switch the SOMNOscreen™ plus On and Off

The SOMNOscreen™ plus can be switched on by pushing the button S4

O

for at least one second.

To switch the SOMNOscreen™ plus off, use the EXIT item on the displayed Menu.

The SOMNOscreen™ plus should not be switched off while still recording. If the

recording needs to be cancelled, follow the instruction described in chapter 4.2.6

to avoid any data loss. The SOMNOscreen™ plus will switch itself off

automatically after 8 minutes if none of the keys are pressed or no data is stored.

4.2 Recording Measurements

4.2.1 Safety Instructions

Before starting to Record a Measurement, Format the Compact Flash Card. Use

only the FAT or FAT16 File System. Follow instructions shown in chapter 4.2.2.

It is very important that the SOMNOscreen™ plus time correlates to the Computer

time. See chapter 4.3.

Use only Compact Flash Cards, which are supplied by SOMNOmedics. The use of

any other Compact Flash Card could cause data to be corrupted. SOMNOmedics

cannot guarantee error free operation where incorrect Compact Flash Cards are

used.

Removing the battery, the Sensors or the Compact Flash Card during recording

will delete all data.

We recommended that the Automatic MS Windows Time Change Feature (Summer/

Winter time) of your PC be disabled if you have a SOMNOscreen™ plus Tele

device.

We also recommended that recording a measurement during the change of year

(31.12. to 01.01.) be avoided.

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4.2.2 Initializing the Compact Flash Card

Fig. 4-1: DOMINO Panel

Fig. 4-2: Patient Data Input

You can add more details to the patient in the database (see Fig. 4-3).

Fig. 4-3: Patient Data Input DB

Patient Data Input:

After having formatted the Card, enter the

data into the corresponding fields (see

Fig. 4-2). Type carefully as this information

will be saved for later use. It is important to

enter a Patient ID number. This number is

used to store the Patient Data in the

optional Patient Database.

It is also possible to use an existing

Patients’ Data from the Database using the

button DB. Select the Patient from the

selection window and confirm with the

button OK. To speed up the database

search, it is possible to sort the columns

patient ID’s, first/ last names and date of

birth by clicking on the column heading.

If you click on Add to DB, the patient data

will be stored in the Patient database

(*optional, only when you buy the Patient

Database).

Patient Data: Here you can edit the patient data.

Questionnaire: Here you can add a questionnaire for

the daytime sleepiness (ESS) or the

Restless Legs Syndrome (RLS)

Notes: Add special information to the patient with

date and time.

- 16 -

Now, click on the Next button or on the tab sheet Date.

Select one of the following start options. These options can be set either on the Date or Montage tab

sheet. Below you will find a description of all start options.

Fig. 4-4: Menu - Montage

- Auto Start with Signal Check on LCD Display: (3/4)

This option is used where the operator is able to check the signals prior to an automatic recording

starting. Once selected, it is necessary to manually confirm the signals on the SOMNOscreen™

plus display when the unit is switched on. All signals are shown either as bar graphs or as

numeric data.

- Signal control: (2)

As soon as you turn on the SOMNOscreen™ plus a prerecording will start. This can last about 30

minutes. The patient should be wired up before starting the SOMNOscreen™ plus. The signal

control can be used for starting the recordings. During the signal control the blood pressure can

be measured manually. A digital optocoppler can optionally be connected to the PC.

The battery power output (5) defines the maximal duration of the recordings. The battery power output

is written on the label of your battery.

The programmable period is between 00:00 and 23:59 o’clock. If the recording should

start at 24:00 o’clock, please type in the date of the following day at Recording Start

and set the start time to 00:00 o’clock!

The different start options are:

- Manual start without timer: (1)

Measurement is started manually. This option

is used for attended recordings. The operator

starts the recording prior to the patient going

to sleep.

- Auto Start without Signal Check on LCD

Display: (3/4)

This option is used when the patient uses the

SOMNOscreen™ plus unattended. The

operator switches the unit ON. The unit

initializes itself and switches to the Standby

Mode (Green light flashes) until the

programmed time is reached. Recording will

start automatically at this pre-programmed

Date and Time and record the data for the

Duration programmed (3).

1

4

3

2

5

- 17 -

Press on Next, and choose a montage.

Fig. 4-5: Selecting a Montage

Remove the card from the Card Reader and insert it to the SOMNOscreen™ plus. Connect the

sensors to the patient and switch on the SOMNOscreen™ plus.

Select the predefined Montage you

require. Please ensure that the displayed

Hardware ID is identical to that on the

SOMNOscreen™ plus label. Selecting the

Online Mode (4) activates data transfer via

telemetry or cable.

Lastly, click on the button Initialize Flash

Card.

We recommend selecting Format

Flashcard to delete old data during

initialization. After a few seconds, a

message Initialization Successful

will appear. All the data which was on

the card has now been deleted.

Click OK.

4

- 18 -

4.2.3 Manual Start

Connect the sensors to the patient and switch on the SOMNOscreen™ plus.

Please Note:

The SOMNOscreen™ plus should only be turned on after the patient has been fully set up. The

on button is found on the second “O” of the word SOMNOscreen™ plus.

Press the red arrow 4 times in order to manually start the recording.

Fig. 4-6: Manual Start

→ A successful Start will be indicated by “01. Recording…” on the display!

After the recording the device turns itself off automatically.

4.2.4 Programmed Start without signal check on Display

Connect the sensors to the Patient and Switch on the SOMNOscreen™ plus.

Please Note:

The SOMNOscreen™ plus should only be turned on after the patient has been fully set up. The

on button is found on the second “O” of the word SOMNOscreen™ plus.

If using the Auto Start Without Signal Check on Display, the SOMNOscreen™ plus automatically

changes to waiting mode after being switched on.

...when the start

time is reached...

The device carries out a system check and checks all settings. In the event that

there is insufficient battery capacity or storage space on the Compact Flash

Card see chapter 4.2.9.

The waiting mode is activated automatically (the status LED blinks) until the

pre-programmed start time is reached.

It is possible to interrupt the waiting mode by pushing S4 button

O

for at least 5

seconds to cancel the recording.

When the Start Time is reached, the recording will start automatically.

→ Successful start will be shown on the display as “01. Recording…”!

The device switches off automatically after the recording is completed.

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4.2.5 Auto Start with Prior Signal Check

Connect the sensors to the patient and switch on the SOMNOscreen™ plus.

Please Note:

The SOMNOscreen™ plus should only be turned on after the patient has been fully set up. The

on button is found on the second “O” of the word SOMNOscreen™ plus.

The ID (last name of patient) will be shown on the display.

To check the signals, select the Menu button on the display and confirm using

S3 .

Select the Signals menu and confirm using S3 .

The display will show the number of channels as set in the Montage as well as

the required storage capacity per hour. To check the signals, select Display.

On the top left of the display the name of the first signal appears. To view the

detailed signal on the screen select Display with key S3 . You may close

and exit the Signal Display Mode at any time using the Back button.

You will be returned to the Main Menu and can now start the recording by

selecting Record and confirming it with S3 .

Select OK and confirm with S3 .

Select START and confirm with S3 .

The device will execute a System and parameter check.

when start time is

reached..

The waiting mode is activated and the status LED blinks until the pre-

programmed start time is reached.

It is possible to interrupt the waiting mode by pushing S4 button

O

for at least 5

seconds to cancel the recording.

When the Start Time is reached, the recording will start automatically.

→ Successful start will be shown on the display as “01. Recording…”!

The device switches off automatically after the recording is completed.

- 20 -

4.2.6 Manual cancellation of recording

You can abort the recording process at any time. The following instructions explain how to cancel a

recording while the system is still running:

Display

Function

Simultaneously press S1 , S2 and S3 for at least 1 second.

Select CANCEL with S2 and confirm with S3 .

Now select SURE with S2 and confirm with S3 .

The SOMNOscreen™ plus stops recording. The system will save the data to

the Compact Flash Card and switch itself off. The display goes blank.

4.2.7 Manuel cancellation of the waiting mode

During the waiting mode you have the possibility to cancel it. Follow the instructions:

Display

What to do?

Press on S4 for at least a second.

Select in the main menu CANCEL with S2 and confirm with S3 .

Select YES with S2 and confirm with S3 .

The device Stops the waiting mode and brings you back to the main menu.

4.2.8 Saving Recording

A Compact Flash Card Reader and the DOMINO software are supplied with the SOMNOscreen™

plus. One or more successfully completed recordings on the Compact Flash Card can be transferred

to the computer using the Reader and Software.

Never remove the Compact Flash Card from the SOMNOscreen™ plus while it is still

recording. Only remove the Card from the SOMNOscreen™ plus when the display

indicates it is safe to do it!

This process reduces the pre-programmed recording duration. Aborting a recording

creates an “Error Code E08” in the Error Logbook!

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SOMNOmedics SOMNOscreen plus User manual

SOMNOmedics SOMNOscreen plus User manual

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