SOMNOmedics SOMNOscreen plus User manual

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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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Rev. 6
30.10.2019
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Table of contents
1 Introduction .................................................................................................................................... 5
1.1 About this instruction manual ................................................................................................... 6
1.2 Explanation of Symbols used in this Manual ........................................................................... 6
1.3 SOMNOscreen™ plus Menu Structure .................................................................................... 7
2 About the SOMNOscreen™ plus .................................................................................................. 8
2.1 Indication for Use ..................................................................................................................... 8
2.2 Intended Use ............................................................................................................................ 8
2.3 Device Description ................................................................................................................... 8
2.4 Model and Device Number ...................................................................................................... 9
2.5 Interactive display and keyboard ........................................................................................... 10
2.6 Configurations ........................................................................................................................ 11
3 Safety instructions ....................................................................................................................... 12
4 Operating Instructions ................................................................................................................. 14
4.1 How to switch the SOMNOscreen™ plus On and Off ........................................................... 14
4.2 Recording Measurements ...................................................................................................... 14
4.2.1 Safety Instructions ............................................................................................................. 14
4.2.2 Initializing the Compact Flash Card ................................................................................... 15
4.2.3 Manual Start ...................................................................................................................... 18
4.2.4 Programmed Start without signal check on Display .......................................................... 18
4.2.5 Auto Start with Prior Signal Check .................................................................................... 19
4.2.6 Manual cancellation of recording ....................................................................................... 20
4.2.7 Manuel cancellation of the waiting mode .......................................................................... 20
4.2.8 Saving Recording .............................................................................................................. 20
4.2.9 Relevant information for Performing Measurements ......................................................... 21
4.3 Menu System (Battery check/ Time Set / Firmware update / Reading Error log) .............. - 23 -
5 Attach the Sensors to the Patient ........................................................................................... - 24 -
5.1 SOMNOscreen™ plus
and Shoulder Belt .......................................................................... - 25 -
5.2 Effort Sensor ...................................................................................................................... - 26 -
5.3 PLM Sensors ...................................................................................................................... - 28 -
5.4 Activity Sensor (wrist) ......................................................................................................... - 29 -
5.5 SPO2 Sensor ..................................................................................................................... - 30 -
5.6 Microphone ........................................................................................................................ - 31 -
5.7 Flow Sensor (Thermistor)................................................................................................... - 32 -
5.8 CPAP Sensor with Nasal Cannula ..................................................................................... - 33 -
5.9 CPAP Pressure Sensor with CPAP Device ....................................................................... - 34 -
5.10 ECG.................................................................................................................................... - 36 -
5.11 EEG- / EOG electrodes ...................................................................................................... - 38 -
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6 Troubleshooting ....................................................................................................................... - 40 -
6.1 Overview ............................................................................................................................ - 40 -
Description of Errors in the Logbook .................................................................................. - 45 -
6.2 - 45 -
7 Maintenance .............................................................................................................................. - 46 -
7.1 Maintenance rate ............................................................................................................... - 46 -
7.2 Cleaning and disinfection ................................................................................................... - 46 -
7.3 Use and Maintenance of the Rechargeable Battery .......................................................... - 50 -
8 Service ....................................................................................................................................... - 51 -
8.1 Biological Calibration and Measuring the Electrode Impedance ....................................... - 51 -
8.2 Technical Specification .......................................................................................................... 52
8.3 Malfunctions ........................................................................................................................... 55
8.4 Warranty ................................................................................................................................. 55
8.5 Accessories and Spare Parts ................................................................................................. 55
8.6 Disposal of Parts, Batteries or the SOMNOscreen™ plus Device ........................................ 55
8.7 Contact ................................................................................................................................... 56
9 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 SOMNOscreenplus 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 SOMNOscreenplus 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.
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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
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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
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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 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.
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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!
/