SOMNOscreen plus Ver 2.2.0 Instruction Manual

Medic al Devic es for Sleep Diagnostic s and Thera py

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

Rev. 1 12.10.2009

SOMNOscreen™ plusTM is a registered trademark of the SOMNOmedics Company.

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Table of contents 1

2

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

About the SOMNOscreen™ plus ... 8 2.1

Fields of use... 8

2.2

Model and Device Number... 8

2.3

Interactive display and keyboard ... 9

2.4

Configurations ... 10

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 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 4.2.8 4.2.9 4.3 5

Safety Instructions ... 14 Initializing the Compact Flash Card... 15 Manual Start... 19 Programmed Start without signal check on Display ... 20 Auto Start with Prior Signal Check... 21 Manual cancellation of recording ... 22 Manuel cancellation of the waiting mode... 22 Saving Recording ... 23 Relevant information for Performing Measurements ... 24 Menu System (Battery check/ Time Set / Firmware update / Reading Error log)... 26

Attach the Sensors to the Patient... 27 5.1

SOMNOscreen™ plus and Shoulder Belt ... 28

5.2

External Effort Belt ... 29

5.3

PLM Sensors... 30

5.4

Activity Sensor (Wrist)... 32

5.5

SPO2 Sensor ... 33

5.6

Microphone ... 34

5.7

Flow Sensor (Thermistor)... 35

5.8

CPAP Sensor with Nasal Cannula... 36

5.9

CPAP Pressure Sensor with CPAP Device ... 37

5.10

ECG... 39

5.11

EEG- / EOG electrodes... 42 -3-

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6

7

8

9

Troubleshooting ... 44 6.1

Review... 44

6.2

Description of Errors in the Logbook... 51

Maintenance... 52 7.1

Maintenance rate ... 52

7.2

Cleaning and disinfection ... 52

7.3

Use and Maintenance of the Rechargeable Battery ... 56

Service... 57 8.1

Biological Calibration and Measuring the Electrode Impedance ... 57

8.2

Technical Specification ... 58

8.3

Malfunctions ... 60

8.4

Warranty... 60

8.5

Accessories and Spare Parts... 60

8.6

Disposal of Parts, Batteries or the SOMNOscreen™ plus Device... 60

8.7

Contact ... 61

Certificate... 62

10 Notes ... 65

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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.

Our Telephone-Hotline offers competent help and advice.at:

9:00 – 17:00

+49 (0) 9 31 / 35 90 94 0

Our Mobile-Hotline offers competent Help and Advice in case of emergency and technical problem at*:

7:00 – 9:00 17:00 – 24:00

+49 (0) 1 72 / 6 75 69 90 +49 (0) 1 72 / 6 75 69 90

* 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 we can.

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.

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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.

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1.3

SOMNOscreen™ plus Menu Structure

Main Menue Structure Record

weiß Capacity OK: Start Recording

Check Signals

System

Device ID

Battery Capacity

Selected Montage

Device ID

Start Recording

Time / Date

System Check: Check Battery And Storage Capacity

weiß Software-Update

Capacity Low: Recording Will Be Started With Shorter Recording Period

Capacity Empty: Recording Will Not Be Started Battery Has To Be Charged

weiß Logbook

Exit

Medic al Devic es for Sleep Diagnostic s and Thera py

2 About the SOMNOscreen™ plus Display Status LED

Li ION Battery

Control Keys and Marker

EXG 1-24

Light Sensor External Sensors

Body Position Internal Effort

Flashcard

Pulse Oximeter Eject Mechanism

Fig. 2-1: SOMNOscreen™ plus

2.1

Fields of use

The SOMNOscreen™ plus is available in several configurations allowing it to be used for Basic Respiratory Screening through to a full On-line Acquisition Polysomnography System. The Initialisation of the System and Analysis of the Data must be performed by Trained Operators. Measurements can be performed in a Sleep Laboratory 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. It may also be useful to give the patient a copy of the enclosed Patient Instruction Manual. The initialised device will automatically start recording the Measurement at the preset time. . 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.

2.2

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 SOMNOscreen™ plus.

Fig. 2-2: SOMNOscreen™ plus label

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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.

2.3

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).

Cursor

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.

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Explanation of the keyboard elements Picture Description

S1 S2 S3

O

S4 Status LED

2.4

Function Moves the cursor up and down. Moves the cursor left and right. 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. 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. The status LED shows the current status of the SOMNOscreen™ plus. Blinking = Waiting Mode Off = Recording Mode or SOMNOscreen™ plus is switched off.

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 (2000mAh) 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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SOMNOscreen™ plus Signal und Sensors

RC easy

NEURO

PSG

Puls oximeter (SpO2, Pulse, Plethysmographie) Patienten marker Ambient light Body position Movement (Magnitude) Effort (Thorax) Effort (Abdomen) Pneumatic Efforts RIP-Efforts Obstruktions grad* Syst./Diast. Blutdruck* Respiration Flow (Thermis) Snoring (Microphone) PLM (left and right) PT Flow (by ACT) Mot. Activity (by ACT) Respiration, Snore, CPAP/BiPAP Pressure (Pressure sensor, Cannula) 10 x EEG / EOG + REF 20 x EEG / EOG + REF 2 x EMG 1-ACG Channel 3-ACG Channel (by EXG) EEG/EOG Combi-Electrode OnlineData transfer Signal-Check via Cable Synchronisation, digitales IR Video ECG, PH, CO2, EDA, Temp, pOesoph (individually by AUX) NPT (with PLM L and R) Ext. 8 Channels PSG Kit for EEG 10-20 Legend: Standard

Option

*Patent Pending

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EEG 10-20

Medic al Devic es for Sleep Diagnostic s and Thera py

3 Safety instructions This device is NOT designed to be used in a Life Support situation. For patients with pacemakers we recommend placing the SOMNOscreen™ plus and the radio transmitter on the abdominal region rather than the thoracic region. We recommend placing both modules at least 6 inch away from the pacemaker. Following these placement guidelines, there is no indication for complications in patients with a pacemaker. On patients with cardiac pacemakers, the active impedance analysis of all EXG channels may be affected and MUST be turned off in the Montage Editor Settings of the Domino software. Please see the instruction manual for the Domino software for details. 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. 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. 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. 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, CBRadio Systems, Cellular Phones, Microwave Ovens, etc. where the electrical field strength exceeds 10 V/m (correlating to IEC 601-1-2). When replacing the battery, only use batteries supplied by SOMNOmedics. If alternative batteries are used, SOMNOmedics cannot guarantee error free operation. 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. - 12 -

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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. Always use the battery charger supplied by SOMNOmedics! 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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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 2 minutes if none of the keys are pressed or no data is stored. For further information see chapter 4.2.6.

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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Medic al Devic es for Sleep Diagnostic s and Thera py

4.2.2

Initializing the Compact Flash Card

Fig. 4-1: DOMINO panel

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).

Fig. 4-2: Patient Data Input.

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

Fig. 4-3: Patient Data Input

Patient Data: Here you can edit the patient data. Questionnaire: Here you can add a questionnaire for the daytime sleepiness (ESS) or Notes: Add special information to the patient with date and time.

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

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Now, select one of the following start options. These options can be set either on the Date or Montage tab sheet. In the following you will find a description of all start options.

The different start options are: 1 2 3

4

5

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Fig. 4-4: Menu - Montage

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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: (4) This option is used when the patient uses the SOMNOscreen™ plus unattended. The operator Switches the unit ON. The unit initialises itself and switches to the Standby Mode (Green light flashes) until the programmed time is reached. Recording will start automatically at this preprogrammed Date and Time and record the data for the Duration programmed. Auto Start with Signal Check on LCD Display: (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 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 cabled 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 also be connected to the PC optionally.

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 up the start time to 00:00 o’clock!

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Press on Next, and choose a montage.

Select the predefined Montage you require and select the On-line Mode as described above (4). Lastly, click on the button Initialise Flash Card.

4 Fig. 4-5: Selecting Montage.

After a few seconds, a message Initialization Successful will appear. All the data which was on the card is now deleted. Click on „OK“.

Remove the card from the Card Reader and insert it in the SOMNOscreen™ plus. Connect the sensors to the Patient and Switch on the SOMNOscreen™ plus.

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

Fig. 4-6: Manual Start

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

After the recording the device turns itself off automatically.

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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. 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. ...when the start time is reached...

Æ 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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