SOMNO lab

Transcription

SOMNO lab

Device Description
and User’s Manual
SOMNOlab
Polysomnography System
Overview
Headbox
1 Socket for
headbox/
transferbox
connection cable
2 Sockets for
electrode
connection
3 LEDs for sensor test
and impedance
measurement
4 Socket for bodybox connection
Bodybox
front
Bodybox
rear
5 Plug to
headbox
6 Socket to
pulsoximetry
clip sensor
connection
7 Pressure
connection
with sealing
cap
8 Key to
trigger sensor
test and
impedance
measurement
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9 Connection
to effort
sensor with
black plug
10 Connection
for connecting
piece
2
Overview
Transferbox, front
11 Electrical connection
12 Fiber optic cable connection,
blue
13 Fiber optic cable connection,
black
18 Direct-voltage
symbol
14 Light sensor
17 LED direct-voltage
symbol
16 LED standby key
15 Standby key
Transferbox rear
19 Buddy loks
to fasten the
transferbox to
SOMNObutler
Power Supply Unit
22 Power
supply unit
21 Sockets to
cable
connection
for headbox/ 3
transferbox
2
1
20 Sockets for
connections to
external devices
23 Plug to
transferbox
SOMNObutler
24 Tray
25 Protective cover
28 Holder for
device cases
27 Holder for
cables /sensors
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26 Buddy loks to
fasten transferbox
3
Overview
SOMNOlab Headbox holster
29 Fastening belt
30 Colored Velcro closing
31 Headbox holster
32 Black Velcro closing
33 Effort sensor DUO with blue plug
34 Fastening tab
35 Gray Velcro closing
SOMNOlab Bodybox holster
36 Effort sensor DUO with black plug
37 Connection piece
38 Abdominal belt
39 Eyelet
40 Bodybox holster
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Overview
Effort Sensor DUO with
black plug
Effort Sensor DUO with
blue plug
43 blue
41 black
42 Eyelets
Connecting piece
45 blue
44 Eyelets
46 Eyelets
Headbox-Transferbox
connection cable
47 Gray plug
Fiber optic cable
48 blue
49 black
57 Respiratory Flow/
Snore Sensor
52 Sensor nodules 53 Sleeve
55 Microphone
50 blue
51 black
54 Plug
56 Carrying plate
Sensors
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Overview
75 Individual parts
76 SOMNObutler
77 Application
78
79
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Contents
1. Description ..........................................................9
1.1 Purpose of Use ................................................ 9
1.2 Functional Description .................................... 13
1.2.1 SOMNOlab Application Parts ............... 13
1.2.2 SOMNOlab Software ......................... 14
1.2.3 Sensors ............................................. 15
1.2.4 Audio-Video System ............................... 18
1.2.5 SOMNOsupport and SOMNOadjust
Modules (optional) ................................ 18
1.3 Symbols on Device ....................................... 19
1.4 Signals and Messages from SOMNOlab Devices .. 20
1.5 Measurement Conditions ................................ 20
2. Safety Precautions .............................................24
2.1 SOMNOlab Devices .................................... 24
2.2 SOMNOlab Software ................................... 27
3. Therapy System Combinations ...........................28
3.1 Tested Devices ............................................. 28
3.2 Masks ........................................................ 28
4. Installation ........................................................29
4.1 System Requirements ..................................... 29
4.2 Hardware Installation .................................... 29
4.3 SOMNObutler Installation .............................. 32
4.4 Audio-Video System Installation ........................ 32
4.5 Software Installation ...................................... 32
4.6 Preparation for connection to SOMNOlab Devices 33
4.7 Connection of External Devices to Free
Channels on Transferbox ............................... 33
5. SOMNOlab Operation .......................................34
5.1 SOMNOlab‚ Software ................................... 34
5.2 Applying SOMNOlab System........................ 35
5.2.1 Applying SOMNOlab Components ......... 35
5.2.2 Putting on the Headbox .......................... 38
5.2.3 Putting on the Bodybox........................... 42
5.2.4 Measurement Preparation ............................ 45
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6. Important Instructions for You and Your Patients .48
7. Cleaning and Disinfecting ..................................50
7.1 Before Each Use ........................................... 50
7.1.1 Respiratory Flow/Snore Sensor ................ 50
7.1.2 Thorax and Abdomen Sensor .................. 50
7.1.3 Pulsoximetry Sensor ............................... 50
7.1.4 Pressure Measurement Hose .................... 50
7.2 After Each Use ............................................. 51
7.2.1 Gold-plated Cup Electrodes .................... 51
7.2.2 Suction Electrodes ................................. 51
7.3 At Change of Patient ..................................... 51
7.3.1 Headbox, Bodybox and Transferbox......... 51
7.3.2 Cases and Belts .................................... 52
7.4 PC, Audio-Video System................................. 52
8. Functional Check ...............................................53
9. Failures and Remedies .......................................54
9.1 Bodybox ..................................................... 54
9.2 Headbox .................................................... 54
9.3 Transferbox .................................................. 55
9.4 SOMNOlab Software ................................... 55
9.5 Power Loss .................................................. 56
9.6 Video camera .............................................. 56
10. Maintenance, Service.......................................57
11. Disposal ..........................................................57
12. SOMNOlab System Components .......................58
13. Technical Data .................................................63
13.1 Technical Data – Application Parts ................. 63
13.2 Technical Data for PC, Audio-Video System...... 65
14. Warranty ........................................................66
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1. Description
1.1 Purpose of Use
SOMNOlab is a polysomnography system to support
the diagnosis, therapy settings and monitoring of sleep
disorders. The system serves to measure, store and depict
physiological data recorded during sleep. The system is
intended for use on persons weighing at least 45 kg to
whom appropriate sensors are applied. The primary area
of use is in sleep laboratories for clinical examination of
sleep disorders. The system records all parameters required
for the classification of sleep.
SOMNOlab is made up of the following components:
• Application parts are composed of: bodybox, headbox,
transferbox, sensors, secondary power supply unit and
secondary free analog ports
• SOMNOlab software under the operating system
MS Windows 2000.
• SOMNObutler for the recording and storage of application parts
• Non-medical electrical devices: EDP system (PC, mouse,
etc.), video system, room microphone, connection cables
to video or PC.
SOMNOlab components are to be used as directed to
record the following sleep-related parameters:
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Headbox
• EEG 1: C3 / A2
• EEG 2: C4 / A1
• EOG1: left eye / A1
• EOG 2: right eye / A2
• EMG Chin
• ECG
• EMG tibialis
• Two freely configurable electrophysiological channels
that can be set (optionally) for parameters EMG, EOG,
EEG and ECG
Bodybox
• Movements in thorax and abdomen
• Oxygen saturation (SpO2; pulsoximetric)
• Pulse rate (pulsoximetric)
• Respiratory flow (via thermistors or pressure sensor)
• Snoring sounds (via microphone or pressure sensor)
• CPAP, BiLevel or APAP pressure
• Patient’s position
• Quality signal of oxygen saturation
Transferbox
• Three analog ports ± 1V
• Brightness of the room
• Connection of fiber optic cable to PC
• Power supply connection
The free analog ports serve to connect to external devices
that are medically-approved and allowed by Weinmann.
The analog port voltage must correspond to specifications
laid down by Weinmann.
All measured signals are decoupled in blocks through a
fiber optic cable and transmitted to a PC.
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SOMNOlab Software
SOMNOlab software records, stores, processes, visualizes, analyzes, documents and archives patient-related
bio-signals to support diagnostis and therapy monitoring of
sleep disorders.
SOMNObutler
SOMNObutler holds and stores SOMNOlab application
parts and helps to maintain an overview of the entire system. The transferbox is permanently installed in SOMNObutler. When not in use (e.g., bodybox in MSLT), the
headbox and bodybox should be hung up in SOMNObutler. It’s also possible to store electrodes, sensors and
application material in SOMNObutler.
Non-medical electrical devices:
Video system:
Audio system:
PC system:
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Recording of patient while he sleeps.
Recording of room noises
Data recording, storage, archiving
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General Information about the entire SOMNOlab system
• SOMNOlab generates information signals that are
graphically visualized and stored by a PC system. These
signals check for the presence of signals to be recorded
and check the functioning of the devices. The information
signals also serve to reduce the number of recordings
that cannot be analyzed, thus eliminating the need for
costly repetitions of nocturnal measurements.
• Alarms are not produced by the system.
• Automatic analyses (sleep stage, PLM, arousal, snore
and cardiorespiratory analysis) take place offline using
the signals stored on the PC and support the analyst in
the diagnosis of sleep disorders.
• With reference to electrical safety, the PC system is not
considered to be a piece of the SOMNOlab application part since there is a decoupling between the application part and the PC system. The PC system fulfills the
guidelines of EN-60950.
• The PC software serves to visualize, analyze, document
and archive patient-related data from long-term examinations for the diagnosis of sleep disorders. The system is
configured for this purpose and the transmitted data are
automatically analyzed offline.
• The system is intended for use with Weinmann-specified
sensors on persons weighing at least 45 kg.
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1.2 Functional Description
The SOMNOlab system consists of:
• Headbox
• Bodybox
• Transferbox
• Sensors
• PC system
• Visualization and Analysis software
• SOMNOadjust module for remote setting of Weinmann
therapy devices
• Optional audio-video system
• Optional SOMNOsupport for therapy monitoring
1.2.1 SOMNOlab Application Parts
1.2.1.1. Headbox Function
The headbox records eletrophysiological parameters
and processes and transmits all measured signals to the
transferbox.
With the help of light-emitting diodes (LEDs) 3, a sensor test
/ impedance check can determine which electrodes are
correctly or incorrectly applied.
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1.2.1.2. Bodybox Function
The body box records respiratory parameters,
processes and transmits all measured signals to the head
box, which then directs them to the transferbox. The user
can trigger a sensor test / impedance check with a double-click on the Test button 8 on the bodybox.
8
17 16 15 12
14
20
1.2.1.3. Transferbox Function
The transferbox records the brightness of the room 14
and analog signals from external devices 20 (e.g.,
CAPNOsleep‚).
The analog ports 20 are decoupled so that there is no
electrical connection to the attached devices.
The transfer box transmits measured data via a fiber optic
cable 12 to the PC system and supplies electrical power to
the headbox and bodybox.
An LED 17 shows whether the power supply unit is plugged
in and a second LED 16 shows that the transfer box has
been turned on. You can turn on the transferbox by pressing
the standby key 15 or by connecting the headbox. You
can also let the PC turn on the transfer box automatically.
1.2.2. SOMNOlab Software
The data transmitted during measurement are stored and
visualized. The stored data can be automatically analyzed
according to time and value criteria. SOMNOlab software
can execute the following automatic analyses:
• Sleep stage analysis
• Arousal analysis
• PLM analysis
• Snore analysis
• Cardiorespiratory analysis
On the basis of the analysis results and the depicted
signals, you can evaluate the results according to your own
criteria.
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1.2.3. Sensors
52
55
52
1.2.3.1. Respiratory flow / Snore Sensor 57
With the respiratory flow /snore sensor, you can record the
nasal and oral air flow and the snoring noises of your patient.
• The sensor nodules 52 consist of thermistors. They record
the respiratory flow by measuring the temperature of the
exhaled and inhaled air.
• The microphone 55 registers the snoring noises made by
the patient.
1.2.3.2. Respiratory flow/Snore Nasal Cannula 58
In conjunction with the pressure sensor integrated in the
bodybox, the respiratory flow/snore nasal cannula records
respiratory flow and snoring noises. Inspiration is registered
by means of the negative pressure created and expiration
is registered via positive pressure. Snoring produces pressure fluctuations in the nostrils, which are likewise registered. Pressure measurement reacts more sensitively than
thermal measurement to slight flow limitations when the
mouth is closed. However, the signals are impaired when
the patient breathes through his mouth. Pressure measurement, which is unaffected by ambient temperature, permits
a visual evaluation of the flow curve over time.
• The signal depiction and the automatic analyses have been
coordinated with the original Weinmann nasal cannula.
1.2.3.3. Pressure Measurement Hose 64
Use the pressure measurement hose together with a nasal
cannula to monitor therapy. The hose measures your
patient’s respiratory flow and snoring during therapy along
with the therapy pressure in the mask.
• Pressure fluctuations in inspiration and expiration are
directed from the mask over the pressure measurement
hose to the bodybox. The exhalation of air creates a
slight positive pressure in the hose while the inhalation
of air correspondingly produces negative pressure. It is
possible to identify individual breaths on the basis of the
pressure differences.
• Snoring noises are measured by means of rapid pressure
changes.
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• Therapy pressure is derived from the statistical components of the pressure signal.
1.2.3.4. Pulsoximetry Sensor 70
The pulsoximetry signals, oxygen saturation of the blood
and the patient’s pulse rate are measured by the pulsoximetry sensor.
• The main components of the sensor are two light-emitting
diodes (LEDs) and a receiver diode.
• Several SpO2 values are determined for each pulse
wave (Split Pulse Wave Algorithm).
NOTE:
Pulse rate is derived from arterial pulse at the point the sensor is applied and is given in beats per minute. Pulse rate
corresponds to heart rate as long as arterial blood flow
is not restricted or defective and no extrasystoles occur. In
contrast to heart rate, pulse rate is shown averaged over
several heartbeats.
For each registered saturation value, SOMNOlab calculates a quality value that indicates how good or accurate
the measured SpO2 value is. If the signal is impaired
by movements, the number of values is low. Unimpaired
signals provide a greater number of values. Consequently,
an impaired signal produces a low quality level while
an unimpaired signal produces a high quality value. The
quality signal has a value in a range from 0 to 100%. The
quality signal can be helpful in evaluating SpO2 long-term
measurement since it eliminates artefacts that occur during
measurement.
Instead of using the standard sensor WM 94034, you can
use the vario-adapter 63 WM 94036 together with the
pulsoximetry sensor 74 WM 94037 (finger clip sensor with
short cable) or WM 90326 (flexible disposable sensor).
1.2.3.5. Thorax Sensor and Abdomen Sensor
The thorax and abdomen sensors register thoracic and
abdominal respiratory effort.
• The measurement of respiratory movement takes
place with the help of thorax and abdomen sensors.
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Respiratory movements cause changing tensile stress
on the measurement recorder in the fastening belts. The
measurement recorder converts the piezoelectric effect
resulting from movement into electrical signals.
1.2.3.6. Eletrophysiological Signals
Electrophysiological signals are measured by means of
electrodes and the headbox. For this purpose, gold-plated
cup or disposable electrodes can be used.
1.2.3.6.1. Electroencephalogram (EEG)
The EEG registers brain waves, or more specifically, the
cortical electrical activity that results from a summation of
postsynaptic potential.
1.2.3.6.2. Electro-oculogram (EOG)
The EOG registers eye movements. Registration is made
of the electric potential caused by eye movement and
produced as electric dipole in the adjacent electrodes.
1.2.3.6.3. Electromyogram (EMG)
The EMG registers muscle activity on the chin and legs. It
serves to record the physiological and pathological movement activity in the body or extremities.
NOTE: The EMG is required to distinguish among various
sleep stages. The EMG of the legs is especially for the
diagnosis of Restless Legs Syndrome (RLS) and Periodic Leg
Movement Syndrome (PLMS).
1.2.3.6.4. Electrocardiogram (ECG)
The ECG registers the electrical potential that occurs
between certain points on the skin as a result of cardiac
stimulation. SOMNOlab can recognize changes or disruptions in cardiac rhythm.
NOTE: SOMNOlab records a one-channel ECG for the
recognition of changes in cardiac rhythm. SOMNOlab
cannot accurately record disruptions in stimulus conduction
or involutional disturbances, both of which require more
ECG channels. Therefore, SOMNOlab cannot be used for
cardiological diagnostics or monitoring.
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1.2.3.7. Function of the Light Sensor in the transferbox
The light sensor 14 in the transferbox records the brightness
in the room. With the help of this sensor, you can determine sleep parameters such as TIB (Time In Bed). It registers
when the light in the room is turned on or off.
1.2.4 Audio-Video System
Video monitoring is used to observe and monitor the patient who spends the night in a room separated from night
shift staff. The system assists in the reliable recognition of
artefacts and documentation of nighttime behavior. In addition, analysis of video material also provides important differential diagnostic information regarding sleep disorders.
The audio system registers room noises such as snoring.
1.2.5 SOMNOsupport and SOMNOadjust Modules (optional)
1.2.5.1. Purpose of Use
SOMNOsupport is the supplementary PC software for
therapy devices SOMNOtron 4, SOMNOcomfort, SOMNOsmart, SOMNOvent S and SOMNOvent ST. It permits
therapy monitoring data to be read and depicted and allows remote setting of all the above-named therapy devices
via SOMNOlab software as well as PC-supported analysis
of titration data from SOMNOsmart.
You can make settings to Weinmann therapy devices by
using the SOMNOlab software. It is not necessary to start
SOMNOsupport for this purpose. Reading of stored data
into therapy devices takes place via SOMNOsupport
software.
NOTE: Please follow the detailed instructions in the User’s
Manual WM96275 for SOMNOsupport.
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1.3. Symbols on Device
The symbols on the devices have the following
meanings:
Date of manufacture
Signal outlet
Signal input
Power supply / Direct Current
On / Off
Observe User’s Manual
Application part of Type BF
CE Label
Single use only
Connection to PC (optical waveguide)
Connection of patient-applied parts
to transferbox
IPX3
Protection against water penetration
IPX0
Not protected from water penetration
SN xxxx
Serial number
LOT xxxx
Lot number
REF xxxx
Order number
IIa
E..G1
Classification in accordance with EG Directive 93/42/EWG
Free electrophysiological port
Protective Class II
Si 1,0 Atr.
Fuse 1.0 A , surge-proof
Thermal fuse
Use only in closed rooms
Isolating transformer
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1.4 Signals and Messages from SOMNOlab Devices
So that you can always be sure your measurements proceed without error, SOMNOlab provides visual signals.
They are depicted by light-emitting diodes (LEDs) on the
headbox and transferbox.
Direct current symbol
1.4.1. Green LEDs on transferbox:
LED direct
current
symbol
LED
Stand-by
botton
Stand-by
button
• LED direct current symbol shows that the power supply
unit has been plugged in (light stays on).
• LED Stand-by button shows that the system has been
turned on.
1.4.2. Green LEDs on headbox:
• The LED of the corresponding signal no longer flashes at
the end of the impedance test: impedance of electrode
< 5 k , which means it is all right or a sensor signal is
available.
• The LED of the corresponding signal flashes slowly at the
end of the impedance test: impedance of the electrode
is < 10 k , which means the signal is not of optimal
quality, but is acceptable.
• The LED of the corresponding signal flashes quickly at the
end of the impedance test: impedance of the electrode
> 10 k or no sensor signal (check the electrode or
sensor; unacceptable signal quality).
• Refer to SOMNOlab Online Help for more information.
1.5 Measurement Conditions
• Please observe the usage instructions for application of
the sensors and electrodes.
• If the sensors become soiled, for example, by secretions, build-up of electrode gel or dampness, false
measurements can result.
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1.5.1. Pulsoximetry Sensor 70, 74
• Make sure the LEDs and the receiver in the sensor are
not soiled or damp.
• Using a reference value based on fractional saturation
measurement, the pulsoximetry sensor is calibrated on
pulsoximetric hemoglobin-oxygen saturation with dyshemoglobin-free blood. If the portion of dysfunctional hemoglobin (e.g., carboxyhemoglobin or methemoglobin)
is high, the measurement will not be accurate. Likewise,
intravascular dyes or colored nail polish can reduce the
accuracy of the measurement.
1.5.2. Respiratory flow / Snore sensor 57
• The measurement of the respiratory flow curve is based
on the measurement of a temperature difference between the inhaled and exhaled air stream. Therefore,
an insufficient signal is recorded when the ambient
temperature is between 33° C and 38° C.
NOTE:
If the sensor is covered by a blanket, the ambient temperature rises to body temperature, which can cause an
incorrect measurement.
• The sensor nodules 52 have to be placed exactly in the
nasal and oral respiratory flow.
• The sensor nodules cannot be used if soiled. If they are
covered by secretions, for example, a false measurement can result.
• The membrane over the microphone has to be in good
condition.
• The microphone 55 of the respiratory flow/snore sensor registers the snoring noises made by the patient as
well as ambient noises of similar frequency. Make sure
that the volume of ambient noises is much lower than
the volume caused by snoring noises.
• Do not use the respiratory flow /snore sensor
simultaneously with the pressure measurement hose 64
WM 94040 for CPAP pressure measurement.
• The sensor can be reused only after it has dried
completely.
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1.5.3. Respiratory flow / Snore Nasal Cannula 58
• The respiratory flow / snore nasal cannula can be used
as an alternative to the thermistor with microphone (air
flow/snore sensor) but not at the same time.
NOTE:
In order to use the respiratory flow/snore nasal cannula,
you will have to define it as a converter for the flow in the
device configuration.
• The respiratory flow / snore nasal cannula is used for
diagnostic measurement, but cannot be used simultaneously with the pressure measurement hose for CPAP or
BiPAP therapy monitoring.
• The difference between nasal pressure and ambient pressure is recorded. Therefore, changes in ambient pressure
during measurement are irrelevant.
• Large amounts of secretions (mucous) or blood (nose
bleeds) can impair the measurement of respiratory flow
and snoring.
• Noises from outside (e.g., sounds of traffic) can impair
snore measurements.
• The respiratory flow / snore nasal cannula must be
directly connected to the pressure measurement port on
the bodybox.
• Please do not use damaged nasal cannula.
• The hose should not be allowed to tangle during measurement.
• The respiratory flow / snore nasal cannula is a disposable article.
• Make sure that you have deactivated the visualization
filter for the flow signal before you use the respiratory
flow / snore nasal cannula.
1.5.4. Position Sensor in Bodybox
• The position sensor integrated in the device works as it
should when the bodybox, holster 40 and belt 38 are
applied according to the instructions in this User’s Manual. Otherwise, incorrect measurements can result.
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1.5.5. Thorax and Abdomen Sensors
• Make sure that the belts 29, 38 fit tightly enough when
you apply the sensors. A lack of sufficient tension can
lead to the loss of signal amplitude or to a complete loss
of signal.
1.5.6. Pressure Measurement Hose 64
The pressure measurement hose
• must be clean and dry.
• cannot have kinks or tangles.
• is attached securely and tightly to the mask.
1.5.7. Headbox Electrodes
Electrodes measure electrical potential, specifically the
difference in the potential between two points on the body.
Because the measurement is non-invasive, the measurable
differences are very small. In the EEG, EOG and EMG,
they are in the range of Volt and in the ECG in the range
of mV. Critical for the quality of the measurement is the
resistance between skin, electrode and the gap between
them. The resistance of the electrode is negligibly low. The
skin’s resistance is strongly dependent upon the thickness of
the keratin layer, which can vary greatly. Resistance in the
skin can be decreased with thorough cleansing, application of lotion and slight roughing up of the skin. The greatest
resistance, which is found in the gap between skin and
electrode, can be reduced with the use of electrode gel.
Always essential in the derivation is the reference electrode (Z electrode), which guarantees a common reference
potential of the electronics.
1.5.8. Transferbox Light Sensor
The light sensor 14 located in the transferbox measures the
brightness of the room (light on / off). For the light sensor
to be able to function correctly, it should never be covered.
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2. Safety Precautions
For your patients’ and your own safety and in accordance
with the requirements of the Medical Device Directive
(MDD), please observe the following:
2.1 SOMNOlab Devices
• When articles from other suppliers are used, this can
lead to malfunctions and problems with biocompatibility.
Please note that in such cases, all guarantee and liability
claims are invalid, if neither the accessories recommended in the user manual nor the original replacement
parts are used.
• Every operation of the device requires thorough knowledge and observance of this User’s Manual. The device
is intended only for the purpose described. Please read
this User’s Manual carefully. It is considered a part of the
device and therefore must be available at all times.
• The system is not to be used to monitor a patient’s vital
signs.
• The system produces information signals which serve
to monitor the presence of signals to be recorded and
to check the functioning of the device. Alarms are not
produced.
• The personal computer on which the data are stored and
visualized as well as the PC’s peripheral components
(e.g., printer) and non-medical devices cannot be in the
immediate area of the patient (within 4.5 feet).
• Additional equipment attached to the device’s analog
and digital interfaces must verifiably satisfy relevant EN
specifications (e.g., EN60950 for data processing
devices and EN 60601 for electrical medical devices).
Furthermore, all configurations must satisfy the currently
valid version of system norms EN 60601-1-1. Whoever
connects additional devices to the signal inlet or output
part is considered to be responsible for the system
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•
•
•
•
•
•
•
•
•
•
•
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configuration and for making sure that the valid version
of system norm EN 60601-1-1 is used. For questions
about this matter, please contact your local authorized
dealer or Weinmann Customer Service.
SOMNOlab can be combined with other devices only
when the safety of the patient is not endangered.
Before a defibrillator can be used, all system parts that
have been applied to the patient must be removed.
Observe the User’s Manual for all the optional SOMNOlab system components (e.g., for allergies to electrode
gels).
SOMNOlab can be used only by trained experts with
sufficient knowledge of the subject matter.
SOMNOlab components cannot be submerged in
liquids. If dampness permeates the device while in operation or storage, the function and safety of the device
may be reduced.
SOMNOlab cannot be operated in an atmosphere
where there is a risk of explosion.
Replace all parts that are damaged, worn or contaminated before using the device.
Observe the recommended maintenance schedule.
Allow only authorized experts to maintain the device.
Servicing, inspecting and opening of the device can
be done only by the manufacturer or expert personnel.
Unauthorized opening of the device invalidates claims
for warranty.
Weinmann is not liable for the function and safety of the
device if the owner or operator of the device improperly
maintains the device or if the owner or operator operates
the device in a way that does not correspond to the
intended use described in this User’s Manual.
Operate this device only in conjunction with the original
Weinmann power supply unit.
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• Do not operate any devices that produce electromagnetic fields near SOMNOlab. Interference or measurement
errors can be caused by the following devices:
- Interference with electrosurgery unit
- X-ray radiation
- Nuclear magnetic resonance imaging (NMRI)
- Radio signals (cordless phones, cellphones. . . )
- Hi-intensity electric wires
- Electro-stimulation devices
• Do not operate SOMNOlab with devices that feed
electrical energy into the body, such as electro-stimulation
devices.
• The device can be operated and stored only according
to the environmental conditions described in the technical
data.
• Observe the cleansing and disinfecting regulations outlined in this User’s Manual.
• Dispose of accessories in accordance with valid regulations in your field of medicine.
• Before you clean SOMNOlab, unplug the power plug
and all other plugs connected to the device.
• Place all the sensor connectors in the prescribed connector holders.
• Observe proper application of sensors and sensor
cables. Incorrectly applied sensor cables can result in
injury.
• Never operate SOMNOlab during a thunderstorm. In
case of a thunderstorm, remove all power plugs from the
outlets. Otherwise, lightning can destroy the insulated
segment of the components.
• The device can provide incorrect measurements if the
patient ingests something that changes the color of his
blood or alters the measured physiological parameters.
• Do not touch the patient when you are holding the connecting plug of the power supply unit in your hand and
the unit is plugged into the wall outlet.
• While the device is operating, do not touch the heat sink
(dissipator) of the infrared radiator since it can become
very hot. In a darkened room and in direct view of the
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•
•
•
•
•
infrared spotlight, you should keep more than one meter
away from the spotlight. Observe the User’s Manual for
the infrared radiator.
If a multiple outlet strip is used, only SOMNOlab system
devices can be plugged into it.
Do not place portable multiple outlets on the floor.
Do not use any extension cords to connect SOMNOlab
to the main power supply.
The electrodes applied to the patient have electrical
contact to other conductive portions of the application
parts. The electrodes should not be allowed to come into
contact with other conductive parts that are not part of
SOMNOlab.
Leakage current can increase when external devices are
connected.
2.2 SOMNOlab Software
• Please consider that the software provides a proposed
analysis for the determination of sleep-related respiratory
disorders. The doctor is responsible for the evaluation of
an automatically created analysis.
• Do not place the CD in bright sunlight, which can result
in the loss of data.
• Do not bend the CD.
• Protect the CD from scratches, which could make data
impossible to read.
• Follow the online help contained in the software. No
other software besides SOMNOlab – unless it has been
approved by Weinmann – is permitted to be installed or
operated on the SOMNOlab computer.
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3. Therapy System Combinations
3.1 Tested Devices
Note:
You can combine the bodybox with standard CPAP,
BiLevel and APAP therapy systems to construct a monitoring
system. The coupling of both systems can be made quickly
and simply by means of the pressure measurement hose 64
which connects the mask 79 to the bodybox.
A list of the supported therapy devices can be found in the
online help of SOMNOadjust.
3.2 Masks
Important!
Observe the User’s Manual for the mask.
The SOMNOlab bodybox can be combined with standard
masks that are suitable for use in the treatment of sleep
apnea.
If you would like to connect a mask to the SOMNOlab
body box, select one of the three possible set-ups described in Section 5.2.3.4, depending on the mask type
used.
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4. Installation
4.1 System Requirements
SOMNOlab is delivered with a PC system that corresponds to all requirements for reliable visualisation,
recording and analysis. Before the installation, check all
components for possible damage.
Make sure that the PC and its components are installed on
a firm base and cannot tip or fall over.
Do not use any other PC system to connect to SOMNOlab
devices.
4.2 Hardware Installation
The SOMNOlab hardware will be installed by a Weinmann employee or by authorized partner.
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Instructions for the user:
• Insert the ST plug on the fiber optic cables 48 – 51 into
the color-coded socket 12/13 of the transfer box.
• Make sure when you push in the plug that it is placed
exactly in the slit of the socket. By lightly pushing and turning, you can secure the plug in the bayonet catch. The
catch is likewise directed through pins, which guarantees
a secure plug connection.
• Insert the ST plug on the fiber optic cable into the colorcoded socket of the PC system. The PC should be turned
on when you do this. Make sure that the fiber optic
cable is not tangled or otherwise damaged and that
the bending radius is not smaller than 5 cm. Otherwise,
data transfer is not possible.
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• Insert the power plug 23 into the socket 11 on the
transferbox.
• Plug the power supply unit 22 into an electrical outlet.
• The microphone’s amplifier has to be correctly set up in
order to receive a good audio signal. Make sure that
the microphone is not covered and that it can record the
noises made by the patient. Follow the instructions for
the microphone or microphone amplifier in the relevant
User’s Manual.
Tip: After you have put the microphone into use for the
first time, leave the settings where they are, if possible.
Then use only the POWER button or a switch on the
electrical outlet itself to turn the microphone on and off.
• To make the settings for the video camera, call up the
video window in the SOMNOlab software either by
clicking the video icon or by selecting View and then
Video in the menu. Click the registration tab Record and
then Settings. The pan-and-tilt head of the camera is
operated with the lever on the control panel, moving the
camera horizontally and vertically. The two ZOOM keys
allow you to enlarge or reduce the image. The two FOCUS keys permit you to set the sharpness of the image.
• The infrared radiator has to be turned on for nighttime recordings. The radiator should be set up so that its smooth
side – the side opposite its cooling ribs – is directed
toward the patient. Observe the User’s Manual for the
video components.
• If you use an uninterruptible power supply (UPS), you
should regularly check its ability to function. Do not
attach a printer to the port on the UPS since the UPS cannot guarantee a power supply to the printer. The typical
service life of the rechargeable battery it contains is 3 - 6
years (depending on the number of discharge cycles and
on ambient temperature). Refer to the UPS User’s Manual
for more information.
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4.3 SOMNObutler Installation
• The SOMNObutler should be installed on the wall near
the patient. Installation requires four 5 x 40 mm screws.
Note:
Make sure that no electrical, water or gas lines are in the
area to be drilled.
4.4 Audio-Video System Installation
• The audio-video system should be installed on the wall,
far from the patient. The location should be chosen so
that a complete view of the bed is recorded.
Note:
The infrared radiator should be set up so that it provides
optimum lighting of the picture detail. There should be no
direct illumination of the light sensor on the transferbox. A
distance of two meters is required. Make sure that no electrical, water or gas lines are in the area to be drilled.
4.5 Software Installation
The SOMNOlab software is already installed on your PC
and ready to be started. A SOMNOlab installation CD is
included in the standard supply schedule. If you want to
uninstall or reinstall SOMNOlab software, please contact
your SOMNOlab specialist beforehand. Installations and
de-installations may only be carried out by trained experts.
Note: Do not install any other software or hardware components on your PC. Otherwise, a reliable recording can
no longer be guaranteed.
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4.6 Preparation for Connection to SOMNOlab Devices
• Connect the bodybox to the headbox 75.
• Connect the headbox to the transferbox 75.
• The system is now ready to be used.
• Turn on the transferbox.
Check to see that the system is transferring data to the PC.
How to apply the sensors and start a recording with the
SOMNOlab system is described in Section 5.2.
Important:
When the headbox and the transferbox are connected or
when the SOMNOlab software establishes communication
with the headbox (e.g., at the start of a new recording),
the transferbox turns on automatically. Make sure that the
headbox, bodybox and transferbox are all connected
to each other. Communication without connection is not
possible.
4.7 Connection of External Devices to Free Channels on Transferbox
External devices can be attached to the free channels on
the transferbox 20 by means of a Western plug (RJ 1 1 or
RJ 12). The channels are numbered from 1 to 3 and can
be correspondingly assigned in the software on the PC.
The maximum analyzable signal is ± 1V. The plan for the
transferbox sockets shows the following pin configuration
(shown from left to right):
Pin
Pin
Pin
Pin
Pin
Pin
1
2
3
4
5
6
=
=
=
=
=
=
not configured
not configured
negative pole of signal port
positive pole of signal port
not configured
not configured
Note:
Before you connect external devices to the transferbox,
make sure that the devices function properly. The maximum
allowable voltage for the free channel ports on the transferbox is ± 1V. Higher voltages can destroy the device.
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5. SOMNOlab Operation
In this section you will find all the information you need
for starting the SOMNOlab system. All the applications
and explanations can be found in the online help in the
SOMNOlab software, which also contains a printable
software manual.
5.1 SOMNOlab Software
Starting SOMNOlab
In order to start SOMNOlab, you first have to start the PC
system and sign on as a local user under MS Windows 2000™.
Login:
Password:
Domain:
Illustration 5.1.1.1
Start with the
SOMNOlab icon.
User
********
–
• The system is configured to display the SOMNOlab icon
on the screen (Illustration 5.1.1.1). Open the program
with a double-click on the icon.
• You can also start SOMNOlab by using the menu selections Start, Programs, SOMNOlab.
Click on the submenu SOMNOlab to start the program
(Illustration 5.1.1.2).
Illustration 5.1.1.2 Start with menu selections.
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5.2 Applying the SOMNOlab System
Note:
Leave the SOMNOlab software in the configuration as it is
described in the following sections. This guarantees that the
system can be quickly and correctly applied at any time.
5.2.1 Applying SOMNOlab Components:
Using the two holsters, a three-point fastening belt and a
two-point fastening belt, attach the headbox and bodybox
to your patient’s body.
The supply schedule for SOMNOlab contains the following
components required for application:
• SOMNOlab Headbox DUO case
• SOMNOlab Bodybox DUO case
• Three-point fastening belt (two sizes)
• Two-point fastening belt (two sizes)
• Connection piece thorax sensor / bodybox
• Connection tab head box / bodybox
• Thorax sensor DUO (with blue plug)
• Abdomen sensor DUO (with black plug)
Note:
Please be sure that all belts, sensors and cables that are
applied to the patient cannot cut off his air or restrict his
breathing. Your patient has to be able to breathe freely.
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5.2.1.1 SOMNOlab Headbox DUO case 31 &
SOMNOlab Bodybox DUO case 40
Along with the fastening belt, the holsters serve to apply the
headbox and bodybox to the patient’s body.
• Place the headbox and body box in the holsters so that
you can see the control panels.
• Attach the holsters securely but comfortably to your
patient. Only under these conditions, the integrated
position sensor can function reliably. Otherwise, incorrect
measurements can result.
• The holsters are made of Cambrelle+.
5.2.1.2
Three-point fastening belt 29 / Two-point fastening belt 38
The fastening belts are used to hold the holsters on your
patient’s body.
• Various belts are included in the standard supply schedule. The belt marked with yellow is the standard size; the
belt marked with green is extra large. Choose the belt
that fits your patient.
• The belt is an elastic strap with a skin-friendly covering.
• Make sure that the colored end of the belt is on the righthand side of the patient’s body.
5.2.1.3 Connection Tabs for Headbox / Bodybox 34
Use the headbox / bodybox connection piece to connect
the headbox to the bodybox. This piece guarantees that
the correct spacing between the two boxes is maintained
while they are on your patient’s body.
• Make sure that the spacing is set up in the best way
possible.
• The belt is an elastic strap with a skin-friendly covering.
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5.2.1.4 Thorax Sensor DUO / Bodybox Connection Piece
The connection piece is used in combination with the
SOMNOlab Bodybox DUO case and the 2-point fastening belt. The connection piece transmits the measurement
values of the thorax sensor to the bodybox.
The connection piece is made of an elastic skin-friendly
material.
• Make sure that the connection piece is shortened to the
extent possible.
• Make sure that the connections (push buttons) for fastening the thorax sensor are turned toward the outside.
• Make sure that the cable port is set up facing the holster.
5.2.1.5 Thorax Sensor DUO
Use the thorax sensor (effort sensor DUO with blue plug)
together with the SOMNOlab headbox DUO holster and
the T-fastening belt.
The thorax sensor records thoracic respiratory effort.
The T-fastening belt is used to keep the thorax sensor and
the head box on your patient’s body.
• The yellow T-fastening belt is a standard size; the green
belt is extra large. Choose the belt that fits your patient.
• Make sure that the belt is taut across your patient’s body;
otherwise, respiratory movements cannot be recorded.
• The belt should not be so tight that it cuts off air to your
patient. Your patient must be able to breathe freely at all
times. The belt is made of a skin-friendly elastic material.
5.2.1.6 Abdomen Sensor DUO
The abdomen sensor (effort sensor DUO with black plug) is
used with the abdominal belt to record abdominal respiratory movements.
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5.2.2 Putting on the Headbox
5.2.2.1 Putting on the Headbox
Note:
Be sure that the colored end of the belt is on the patient’s
right-hand side. Ensure that the belt is taut across your
patient’s body, but not so tight that it cuts off his air. Your
patient must be able to breathe freely at all times.
• Place the headbox in SOMNOlab Headbox DUO case
31 so that you can see the control panel through the
window.
• All belt ends have Velcro closures 30, 32. By adjusting
the Velcro‚ closures, you can fit the belt to your patient.
It should sit securely but comfortably on your patient’s
body.
• Make sure that the device is positioned correctly. It
should be in the middle of the chest (sternum).
• Open the push buttons on the case. Place the thorax
sensor DUO in both sides of the case. The cable must
face down and each of the cable bushings on the sensor
must be on the side of the case. Fix the sensor in position
by closing the push buttons.
• Place the holster with the chest belt on your patient.
• Pull the black end of the belt 32 through the side eyelets
of the sensor.
• Hang the long end of the belt over your patient’s
shoulder.
• Thread the colored end of the belt 30 that’s hanging over
your patient’s shoulder through the upper eyelets of the
headbox and secure the belt.
• Make sure that the system is secure, but not too tight.
• Now pull the third colored end 30 of the belt through the
still open eyelet on the sensor and fasten the belt.
• Now you can attach the electrodes.
5.2.2.2 Position and Attach Electrodes
EEG, EOG and mental or submental EMG are essential
parameters for polysomnography. The positioning of the
electrodes for all three measurements are laid down in the
manual by RECHTSCHAFFEN and KALES (1968).
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5.2.2.2.1
Attaching gold-cup electrodes (EEG, EMG, EOG)
Part the hair at the previously determined indicated point
(see Section ”Positioning EEG Electrodes”).
Cleanse the selected spot on the skin with a physiologic saline solution (NaCL 0.9%) or alcohol. You can use a cotton
swab or a gauze pad. Roughen up the skin with the paste
delivered with your system. With your finger, rub the paste
(adhesive + electrolytes) onto the scalp. This promotes
conductivity and offers a good surface on which to attach
the electrode. Fill the electrode cup with a pea-sized bit of
paste and press the electrode firmly on the scalp so that the
paste squeezes out from under the edge. Place a gauze
pad over the electrode and excess paste and press again.
Make sure that the edge of the electrode is firmly attached
to the scalp and that the conducting surface is closed off.
This prevents the drying out of the electrode, which would
lead to a loss of conductivity. Fix the electrode cable in
place with an adhesive strip. This reduces the pulling and
guarantees secure conductance overnight. It is also recommended that you arrange the cables across the patient’s
forehead and over the center of his head so that they can
be directed, bundled together and without kinks, to the
headbox.
You can also use disposable adhesive electrodes for
EMGs. Cleanse the skin just as you would for gold-plated
cup electrodes and fix the electrodes in place with adhesive strips.
Make sure that the adhesive strip does not twist out of
place. To do this, you can place the strips diagonally
across each other.
Note:
• Apply the electrodes very carefully. The quality of the
measurement depends on how good the adhesive spot
is since the transition between scalp and electrode is
subject to interference. Poorly secured electrodes result in
increases in artefacts, which can make evaluation of the
recordings difficult. Clean the electrodes with alcohol or
saline solution before every measurement.
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• Observe the instructions for adhesive electrodes, gels
and pastes, paying close attention to skin compatibility and
allergic reactions to the materials used.
• Check the expiry date on gels, pastes and electrodes.
5.2.2.2.2 Positioning the EEG Electrodes
In order to carry out a proper sleep derivation according
to Rechschaffen and Kales, the EEG electrodes should
be attached in accordance with the Ten Twenty Electrode
System. For the registration of EEGs during sleep, you need
the derivations C3 and/or C4. Use the opposite ear or
mastoid electrode as reference electrode, which will give
you the derivations C3 – A2 /M2 and/or C4 – A1/M1.
In addition to the EEG electrodes, you’ll also have to attach
a grounded electrode as electrical reference (Cz or FPz).
Tip:
Use the mastoid electrodes (M1/M2) as reference. They
are easier to attach and are not as interference-prone as
the ear electrodes (A1/A2).
5.2.2.2.3 Positioning the EOG Electrodes
SOMNOlab has two channels for the derivation of eye
movements. Place one electrode about one centimeter
(1 cm) above and slightly lateral to the outer canthus of
the right eye. The reference electrode is the homolateral
ear lobe or mastoid electrode, as in the EEG. Attach the
second electrode about one centimeter (1 cm) below and
slightly lateral to theouter canthus of the left eye. The reference is the contralateral ear or mastoid electrode.
With this wiring, the EOG signals during REM sleep and
in a waking condition are recorded out-of-phase. Artefacts and EEG signals are represented in-phase when this
circuitry is used.
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5.2.2.2.4 Positioning the Chin EMG Electrodes
Place the EMG electrodes to the left and right in the middle
of each muscle area on the chin. Attach the electrodes
about three to four centimeters ( 3 – 4 cm) apart. The EMG
is derived from two poles (bipolar). That is, the signals do
not refer to the reference on the ear or mastoid; the signals
are measured against each other.
Note:
Because the EMG signal is the most sensitive electrophysiological signal, the electrodes should be attached very
carefully.
5.2.2.2.5 Positioning the Leg EMG Electrodes
Bipolar derivation is used in the leg EMG as in the chin
EMG. That means that the signals do not refer to the
reference on the ear or mastoid, but rather the signals are
measured against each other.
The first conductive point is about one hand span below
the top of the kneecap ligaments and one finger-width
lateral to the front edge of the shin bone. The second point
is about five cm distal from there.
You can also use disposable adhesive electrodes for the
leg EMG. Cleanse the skin as you would for gold-plated
cup electrodes. Attach the electrode cable with several
strips of adhesive tape all the way from the attachment
point to the headbox. This prevents the cable from falling
off when the patient moves.
5.2.2.2.6 Positioning the ECG Electrodes
As is the case with EMGs, the ECG is also bipolar. The
polysomnographic derivation of SOMNOlab follows the
Einhoven derviation. For this purpose, firmly attach the
negative (red) electrode to the sternal end of the second
rib on the right and the positive (yellow or green) electrode
over the apex of the heart. In SOMNOlab the reference
electrode is the grounded electrode on Cz or on the forehead (Fz). Use the enclosed disposable adhesive electrodes for the ECG. Cleanse the skin as for the other electrophysiological signals. Attach the electrode cable with
adhesive strips in order to prevent the cable from falling off
when the patient moves.
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Note:
• Always conduct an impedance measurement of the
electrodes before a recording.
• Do not connect electrodes to another system parallel to
their use with SOMNOlab. In this situation, the function
of SOMNOlab cannot be guaranteed.
• Make sure that you have correctly connected the
electrodes to the headbox. If the connection is not right,
you will receive false analysis results and false signal
depiction.
• Do not attach any third-party devices with a 1-5 mm plug
to the headbox.
5.2.3 Putting on the Bodybox
2.
1.
3.
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5.2.3.1 Putting on the Bodybox
• Open the push buttons on the case. Place the thorax
sensor DUO in both sides of the case. The cable must
face down and each of the cable bushings on the sensor
must be on the side of the case. Fix the sensor in position
by closing the push buttons.
• Insert the abdomen sensor plug into 2. the device.
Secure the connection piece 37 on the abdomen sensor
eyelet. The hook-ups of the connection piece should be
pointed toward the control panel.
• Now join the plug on the connection piece 1. to the
basic device. Close the tabs 3. on the holster. Put the
holster on your patient with the abdominal belt.
• Pull the black end of the abdominal belt 38 through the
eyelet on the sensor and place the belt around your
patient’s abdomen.
• Pull the free colored end of the belt through the other
eyelet and secure the belt.
• Thread the connection belt 34 between the headbox and
bodybox through the lower eyelet 39 on the headbox
and the upper eyelet on the bodybox holster and secure
the belt with the Velcro pieces.
• The belt should not be so tight that it cuts off air to your
patient. Your patient must be able to breathe freely at all
times.
42
• Connect the blue plug on the thorax sensor to 43 the
connection piece and close the blue tab on the connection piece over the plug.
5.2.3.2 Putting on the Air flow / Snore Sensor
Important:
Do not use the respiratory flow / snore sensor simultaneously with the pressure measurement hose for CPAP pressure measurement or with the nasal cannula.
• Unwind the sensor 57 from the carrying plate 56.
Place the sensor on your patient‘s upper lip. Make sure
that the microphone 55 is turned to face away from the
patient‘s skin, that is, it should remain visible.
• Pull the cable over the patient‘s ears and fit it snugly by
sliding the sleeve 53 upwards.
• If the connection has not already been made, place the
round plug 54 of the respiratory flow/snore sensor into
the round socket on the finger sensor.
• To prevent the sensor from kinking, place it on the carrying plate after the measurement has been made and
wind the cable around the sensor and the plate.
• Place the combo-plug 72 of the pulsoximetry sensor in
the socket 6 on the bodybox.
Make sure the plug is secure. The two side clamps
should click into place.
• Close the CPAP connection 7 with the enclosed sealing
cap.
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Warning!
Do not use the nasal cannula
and the respiratory flow/
snore sensor at the same
time.
5.2.3.3 Putting on the respiratory flow / snore nasal
cannula
• Remove the protective cap from the pressure connection
7 on the bodybox and screw the hose on the nasal
cannula 62 into place (one-half turn).
• Move the double hose to the left and right so that the
cannulas point upwards.
• Now place the cannulas 60 in the nostrils and direct the
hoses along the chin and behind the ears. Adjust the
sleeve 59 on the fork in the hose so that the hose lies
loosely but does not slip out of place.
5.2.3.4. Putting on the Pressure Measurement Hose
Tip:
Ask your patient to bring a mask with him. If you would
like to carry out a therapy check on your patient, please
put on the pressure measurement hose 64 as follows:
• Turn the threads 68 on the pressure connection 7 on
the bodybox. A one-half turn is enough!
• Secure the other end of the pressure measurement hose
to the mask.
(1) For masks with protruding outlets: push the connection
hose suitable for an outside diameter of four to six mm
onto the white connection piece 65 and onto an outlet
on the mask.
(2) For masks with recessed outlets: place the white
connection piece 65 of the pressure measurement hose
into one of the outlets.
• The pressure measurement hose for therapy pressure
measurement is a disposable article.
• Do not use the pressure measurement hose simultaneously with the respiratory flow / snore sensor
WM 94010.
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5.2.3.5 Putting on the Pulsoximetry Sensor
• Use the pulsoximetry sensor only in connection with the
bodybox.
• If you monitor your patient’s blood pressure with a
blood pressure cuff at the same time, do not attach the
pulsoximetry sensor to the same arm as the cuff.
(1) Fasten the pulsoximetry sensor 73 to your patient’s index
finger. Make sure that the finger marking is pointed
upwards. The sensor should sit firmly but comfortably
and should not squeeze the finger.
(2) If necessary, fix the sensor to the finger with an adhesive strip. Note: Adhesive strips should not touch the
sensor casing.
(3) Place the plug 72 in the socket of the bodybox.
Make sure that the plug is secure. The two side clamps
should click into place.
(4) If you want to use the respiratory flow / snore sensor
for your measurement, connect the round sensor socket
71 on the pulsoximetry sensor to the sensor plug 54 on
the respiratory flow / snore sensor.
• When you use the pulsoximetry vario-adapter 63, you
can also use the disposable finger sensor from the
Weinmann product line. Observe the accompanying
instructions for use.
5.2.3.6 Connection the headbox and bodybox
Now you can connect the headbox and bodybox. To do
so, place the plug of the bodybox 5 in the lower socket 4
of the headbox.
5.2.4 Measurement Preparation
5.2.4.1 Hook-up to PC System
Note:
Do not cover the light sensor 14 on the transferbox since
SOMNOlab would then be unable to measure brightness.
As described in the section on installation, the transferbox
has to be connected to the PC and to the SOMNOlab
power supply unit. Check the connection.
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• Connect the headbox with the transferbox. Lay the cable
between the headbox and transfer in such a way that
you do not cut off the patient’s air supply.
• Turn on SOMNOlab via the transferbox.
• The system is now ready to measure.
5.2.4.2 Carrying Out a Sensor Test
So that you and your patient can be certain that all the
sensors are connected properly, carry out a test after you
have applied the sensors and devices.
8
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5.2.4.3 Impedance Measurement and Sensor Test
• Start the sensor test or impedance measurement with a
double click on the test key 8 on the bodybox or by calling up the impedance measurement program on the PC.
• During the test, the LED on the headbox flashes quickly
(4Hz) for the electrode currently being tested.
• Results are depicted on the headbox as follows:
➔ > 10 kΩ: (improvement urgently required)
LED flashes quickly (1 Hz)
➔ 5 – 10 kΩ: (acceptable, should be corrected)
LED flashes slowly (0.5 Hz)
➔ < 5 kΩ: (no action required)
LED is off.
After the successful placement of all configured electrodes/
sensors, no LED is illuminated on the headbox. There is
then no other change in the LED on the headbox when the
sensor test is ended with the closing of the impedance window in the software. In a sensor test, all channels, all effort
and pulsoximetry sensors, thermistors and nasal cannula
will be checked for availability of signals. If the LED is off,
it means:
”Sensor is connected and transmits a (physiological)
signal”. An impedance test always runs through all the
configured channels once and then displays the result until
the window is closed or a new test is started.
46
Note:
A correct derivation and implementation of the automatic
analysis is possible only with a low impedance value. For
optimum signal quality, we recommend that the LED for all
channels be out.
Important:
SOMNOlab has to be hooked up to the PC. The SOMNOlab software has to be started so that the impedance
values can be transmitted.
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6. Important Instructions for You and Your
Patients
You and your patient can prevent the inconvenience of
incorrect measurements by following these instructions:
• Sensors 94070 and 94080 are only to be used
in combination with 94052 Bodybox and 98022
SOMNOlab Headbox cases.
• DUO sensors 98032 and 98025 are only to be used in
combination with 98031 Bodybox DUO and 98024
SOMNOlab Headbox DUO cases.
• Never open the device.
• Don’t kink or twist the fiber optic cable.
• The SOMNOlab devices have to be securely but comfortably attached to the body so that the body position
can be correctly recorded.
• The effort sensors always have to be taut so that all
respiratory movements can be recorded.
• The cable on the pulsoximetry sensor should be secured
on the patient’s finger or hand with an adhesive strip.
This keeps the cable from disturbing the patient and
holds the sensor in place.
• The patient should sleep with the windows closed in
order to keep street noises from interfering with measurements results.
• The sensors should be clean and dry. If the patient sneezes, secretions should be carefully wiped away.
Note: You can pull the cable of the pulsoximetry sensor
through the sleeve of your patient’s pyjamas before you
place the sensor on his finger.
• The patient should avoid pulling the blanket or pillow
over his head. The ambient temperature would increase
so quickly that the respiratory flow / snore sensor would
deliver incorrect measurement data.
• Nail polish should not be used on the fingernail of the
index finger to which the pulsoximetry sensor is attached.
WM 96227 f / BD114f – 08.08
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• Please check the position and fit of the sensors and
electrodes before you begin a measurement. Too much
contact resistance between the electrode and skin (for
example, with a poorly attached electrode) delivers unsatisfactory derivation. Make sure that the electrodes are
securely attached and check their electrical properties.
You can check the quality of the electrode application
with an impedance measurement.
• If SOMNOlab devices are replaced during a recording,
SOMNOlab software has to be restarted.
• Back up your patient data on a CD after each recording.
WM 96227 f / BD114f – 08.08
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7. Cleaning and Disinfecting
7.1 Before Each Use
7.1.1 Respiratory flow / Snore sensor
The respiratory flow / snore sensor has a silicone
covering. Please clean it with a mild detergent. For disinfecting, we recommend a Terralin or a spray disinfection
with Incidin liquid spray. Make sure than no liquid enters
the plugs. Let the sensors dry completely before you use
them again.
7.1.2 Thorax and Abdomen sensors
Clean the sensors with a disinfectant (as described above
for the respiratory flow / snore sensor) or wipe them with
a damp cloth. Let the sensors dry completely. The sensors
cannot be submerged in liquids or put into an autoclave.
7.1.3 Pulsoximetry Sensor
Clean the pulsoximetry sensor with a disinfectant like
Terralin.
7.1.4 Pressure Measurement Hose
The pressure measurement hose is disposable.
WM 96227 f / BD114f – 08.08
50
7.2 After Each Use
7.2.1 Gold-plated Cup Electrodes
Clean the gold-plated cup electrodes by immersing them
for five to 10 minutes in water or in suds. Rinse carefully.
Clean the electrode cable with a disinfectant like
Terralin.
Please observe the cleaning instructions in the accompanying User’s Manuals for the individual components.
Note:
Soiled or damp electrodes deliver false measurement results
or can lead to reduced signal quality.
7.2.2 Suction Electrodes
Clean the electrode cable with a disinfectant like
Terralin.
7.3 At Change of Patient
7.3.1 Headbox, Bodybox and Transferbox
Important! Do not allow any liquids to penetrate the headbox, bodybox, transferbox or plug connections. Before
cleaning, be sure to close the pressure port on the bodybox with the sealing cap!
Clean the surface of the components with a dry or slightly
damp cloth. If the components are heavily soiled, you can
use weak suds or a disinfectant containing alcohol, such
as Terralin. However, don’t allow any fluids to get into the
device. Observe the disinfectant’s instructions for use.
WM 96227 f / BD114f – 08.08
51
7.3.2 Case, holsters belts
The carrying case, holsters and belts can be cleaned in the
washing machine at 40°C. Please let the cases and belts
air-dry. Important! Do not use a clothes dryer!
7.4 PC, Audio and Video Systems
WM 96227 f / BD114f – 08.08
52
8. Functional Check
Before each use, please carry out the following functional
check or measures:
• Make sure that all utilized devices and sensors are free
of damage and are fully functional.
• Make the electrical connections from the bodybox to the
headbox and from the headbox to the transferbox.
• Check the communication between SOMNOlab components with the PC system by triggering the sensor test and
impedance measurement.
• Check the function of the video system by opening the
video window and selecting the tab card Camera.
The video picture should appear.
Note: Make sure that the room has been darkened and
the light has been turned off.
• Check the function of the audio system by listening to the
room noises in the patient room.
• Make sure that the transferbox is not covered and that it
can record the room brightness. The transferbox contains
an integrated sensor for brightness detection.
• Check that all the belts, sensors and cables have been
properly applied to your patient and cannot cut off or
restrict your patient’s breathing.
WM 96227 f / BD114f – 08.08
53
9. Failures and Remedies
9.1 Bodybox
Failure
Failure Cause
No signal in flow, snore and/or
pulsoximetry channel
The respiratory flow / snore sen- Place the sensors on your patient.
sor 57 and/or the pulsoximetry
sensor 70 have not been applied.
A signal curve indicates a nonphysiological course.
An effort sensor 33/36 delivers
no signal.
Remedy
The plug connections 72 have
not been made correctly.
Connect the plugs tightly.
The sensors are soiled, damp or
defective.
Clean the sensors and wipe them
dry.
The plug connections were not
correct.
Connect the plugs tightly.
During the measurement, the
sensors were dirty or they slipped
out of place.
Repeat the measurement with
clean or replacement sensors.
The belt is too loose.
Pull the belt a little tighter.
Failure Cause
Remedy
9.2. Headbox
Failure
The plug connections have not been Connect the plugs tightly
made in the head box correctly.
(head-box).
The channels were not configuRepeat the measurement with
red.
correct configurations.
A signal curve doesn’t look as if it The electrodes are dirty or wet.
Clean the electrodes and wipe
is of physiological origin
them dry.
SOMNOlab shows no signal.
The plug connections weren't
correctly connected thogether.
Carry out a sensor test before or
during measurement. Check the
plug connections.
The electrodes are defective or
slipped during measurement.
Repeat the measurement with new
electrodes or readjust them.
The thorax sensor delivers no
signal.
The belt is too loose.
Pull the belt a little tighter.
The electrophysiological signals
contain noise.
The cables receive interference
from the surroundings or interfere
with each other.
Apply the electrode cables again.
WM 96227 f / BD114f – 08.08
54
9.3. Transferbox
Failure
Failure Cause
Remedy
No light signal appears.
The light sensor is covered.
Remove the covering.
Free channels can no longer be
transmitted.
The PIN configuration of the port
is wrong.
Correct the PIN configuration.
The free channels are incorrectly
configured.
Check the configuration.
The input signals do not correspond to the required ±1V.
Check the outlet voltage on your
device.
The connection to SOMNOlab
cannot be made.
Plug the patient cable into the
The cable connection between
headbox and bodybox is broken. headbox or the transferbox.
The power supply light on the
transferbox is not illuminated.
The optical waveguide connection between transferbox and PC
is broken.
Check the optical waveguide.
The power supply is not plugged
into the outlet.
Plug the power supply pack into
the electrical outlet.
The transferbox is turned off.
Turn on the transferbox.
9.4. SOMNOlab Software
Failure
Failure Cause
Remedy
The program cannot make a
connection to SOMNOlab.
The cable connection between
headbox and transferbox is
broken.
Plug the patient cable into the
headbox or the transferbox.
The PC transmission cable is not Make the connection between the
connected to the optical wavegui- optical waveguide cable and the
PC board.
de board in your PC.
WM 96227 f / BD114f – 08.08
55
9.5. Power Loss
Error
Error Cause
Error Correction
Turn off the PC completely and
remove it from the network. Restart
the PC and all the software. Use
an uninterruptible power supply.
The PC does not start after a loss
of power.
9.6. Video camera
Failure
Failure Cause
Remedy
Your overlay displays a blue
picture.
The wrong video input was
chosen.
Connect the video to the correct
input port.
Your overlay displays a black
picture.
The infrared radiator is not
turned on.
Check the functioning of the infrared radiator. Turn the camera
off and then on.
Note: If the infrared radiator is
on an automatic timer, make
sure that the timer is active.
The video recording freezes
after less than one second.
Problems with the video driver.
Turn off the PC completely. Then
restart the PC and the software.
LanVideo camera only: software unable to control the pan-andtilt head of the camera.
Internal camera fault.
Perform a hardware reset of the
camera by briefly interrupting
the power supply to the camera.
WM 96227 f / BD114f – 08.08
56
10. Maintenance, Service
SOMNOlab must be serviced by the manufacturer every
two years in order to guarantee its functioning capability.
The following work will be carried out:
A functional check is made of the bodybox. The pressure
sensor for CPAP pressure measurement is checked and recalibrated if necessary. As soon as a pressure calibration is
required, this information will be stored in the SOMNOlab
software under Remarks.
A functional check is made of the headbox. The amplifiers
are checked for measurement accuracy and re-calibrated if
necessary.
A functional check is made of the transferbox. The free
amplifiers are checked for measurement accuracy and recalibrated if necessary.
The functioning of all the plugs on the headbox, bodybox and transferbox is checked. Defective parts will be
replaced.
11. Disposal
Please consult a registered and certified electrical scrap
reclamation service for proper disposal of your device.
Addresses can be obtained from your environmental officer
or your city government.
The bodybox contains small amounts of mercury in the
position sensor. These are gas-tight and encapsulated to
prevent leakage and pose no danger to your patient. For
the protection of the environment, they must be disposed
of as described above. Information to this effect is clearly
indicated on the inside of the device cover.
WM 96227 f / BD114f – 08.08
57
12. SOMNOlab System Components
98005 SOMNOlab Standard Set „Application Parts”
consists of:
98010
98011
98020
98021
98024
98023
98030
98031
94053
94054
98032
98025
94081
94082
94083
94040
SOMNOlab Transfer Box
SOMNOlab European Power Supply Pack
230V with 9-pin Lemo plug
SOMNOlab Headbox
Connection cable Headbox –
Transfer Box 3 m with 2 Lemo plugs
SOMNOlab Headbox Duo holster
Connection Tab for Headbox holster
SOMNOlab Bodybox
SOMNOlab Bodybox Duo holster
Fastening belt, 1.10 m, yellow tab
Fastening belt, 1.50 m, green tab
Effort sensor Duo with black plug
Effort sensor Duo with blue plug
Connection piece for effort sensor with blue
plug
Abdominal belt, 1.50 m, green tab
Abdominal belt, 1.10 m, yellow tab
Pressure Measurement Hose
SOMNOlab Variable Application Parts
94034
Pulsoximeter Clip Sensor Envitec with connection to respiratory flow / snore sensor
90326
Disposable sensor for adults, package of 10
94036
Pulsoximeter vario-adapter
94037
Pulsoximeter clip sensor Envitec with 40 cm
cable 1)
94042
Sealing cap for pressure measurement
connection
94010
Respiratory flow/snore sensor for adults, large
94044
Package of 10 respiratory flow/snore nasal
cannula
WM 96227 f / BD114f – 08.08
58
SOMNOlab System Components
98075
SOMNObutler
98510
Remote service software (host + remote)
94091
SOMNOcheck Software
23975
SOMNOsupport including converter box
98040
Starter package of electrodes
96225
SOMNOlab user’s manual, german
96226
SOMNOlab abridged user’s manual, german
96227
SOMNOlab user’s manual, english
96228
SOMNOlab abridged user’s manual, english
96229
SOMNOlab user’s manual, italian
96230
SOMNOlab abridged user’s manual, italian
96231
SOMNOlab abridged user’s manual, french
96232
SOMNOlab user’s manual, french
98500
SOMNOlab Software
SOMNOlab Video Components
98610
Black and white Camera
98611
Black and white/color infrared camera,
automatic switch 1/3” 24 VAC 12 VDC
98612
Black and white infrared camera,
high resolution 1/3” 24 VAC 12 VDC
98613
LanVideo camera
98622
Variable focus lens, manual setting
98630
Infrared lamp 15W PSG with power supply
230V/12/2,5A
98643
Wall-ceiling mounting arm, for camera without
pan-and-tilt head
98615
Camera power supply pack,
230 VAC 12 VDC/24 VAC
98620
Motorized zoom lens
98662
LanVideo microphone
98663
Extension cable 3.5 mm cinch plug
98641
Video pan-and-tilt head
98642
Remote control for video pan-and-tilt head
98813
Pre-assembly pan-and-tilt head
98814
Central socket pan-and-tilt head desk
98810
Cable set – video/pan-and-tilt control, 50 m
98811
Cable for video control, piece goods
WM 96227 f / BD114f – 08.08
59
98812
98850
98851
98815
98817
98818
98853
98816
98852
98644
Plug with mount for cable video control
(1 piece/side)
Video control – D-SUB plug
Video control – D-SUB socket
Video cable set BNC/cinch 50 m
BNC plug with mount for video cable
(first side)
Cinch plug with mount for video cable
(second side)
Video cinch plug
Cable for video signal, piece goods
Video BNC plug
Wall arm with spherical head for infrared
radiator
SOMNOlab Audio Components
98660
Microphone
98661
Microphone with feed adapter
98670
Microphone amplifier with power supply pack
98675
Power supply pack microphone amplifier
98825
Audio cable for PC In 1.5 m
98826
Audio cable 1.5 m with 2x3.5 mm stereo
jack plug
98820
Audio cable set for PC In (50 m)
98821
Audio cable for PC, piece goods
98823
Audio plug set XLR socket/Mini XLR plug
98824
Cable adapter (10 cm) Mini XLR socket / XLR plug
98854
Audio XLR plug, large
98855
Audio XLR socket, large
SOMNOlab PC Components
98100
Tower PC, without operating system and
keyboard
98105
19" PC, without operating system and
keyboard
98110
Language package German (OEM only
possible in connection with a new PC/server)
98115
Language package English (OEM only
possible in connection with a new PC/server)
WM 96227 f / BD114f – 08.08
60
98300
98305
98220
98221
98230
98240
98250
98260
98330
98340
98350
98360
98370
98380
98395
98396
98420
98430
98431
98432
98433
98434
98490
98440
98450
98470
98441
98442
98472
98481
80095
98482
98510
WM 96227 f / BD114f – 08.08
Tower server, without operating system and
keyboard
19" server, without operating system and
keyboard
CD writer
CD-ROM drive
MPEG encoder board
RS 232 fibre optic cable insert card for PC
Serial interface board PCI
ISDN board, PCI
5 Port Gigabit switch
ISDN Internet Access Router
19‘‘ cabinet
UPS for 19‘‘ cabinet
Patch cable 10 m CAT 6
Patch cable 5 m CAT 6
USB housing for external burner
19 inch monitor
21 inch monitor
17 inch LCD monitor
19 inch LCD monitor
20 inch LCD monitor
External stereo speakers
Laser printer, black and white, A4
LWL TCP / IP Kit
USB extension 5 m active
Color ink-jet printer, A4
Color laser printer, A4
Documentation, manuals for utilized
components (if not enclosed) for monitor,
printer, etc.
UPS back-up, active
Servicing the UPS incl. changing the
rechargeable battery
Shockproof plug adapter for low-power device
Tele-maintenance software (Host + Remote)
61
SOMNOlab fibre optic cable PMMA for distances up to
50 m, consisting of:
98830
Fiber optic cable 3 m PMMA ST-ST,
blue and black
98831
blue and black
98832
blue and black
98838
Fiber optic cable, PMMA piece goods
98839
Plug construction for PMMA fibre optic cable
ST-ST, blue and black
SOMNOlab fibre optic cable HCS for distance of more
than 50 m, consisting of:
98833
Fiber optic cable 3 m HCS ST-ST,
blue and black
98834
blue and black
98835
blue and black
98840
Fiber optic cable, HCS piece goods
98841
Plug construction for HCS fiber optic cable
ST-ST, blue and black
SOMNOlab Assembly Accessories for Fiber optic cable
98836
Fiber optic cable coupler socket for cable
duct
98837
Fiber optic cable coupler / pair
WM 96227 f / BD114f – 08.08
62
13. Technical Data
13.1. Technical Data – Application Parts
Product class as per 93/42/EEC
II a
Dimensions (W x H x D)
- Bodybox
- Headbox
- Transferbox
65 x 130 x 30 mm
66 x 107 x 31 mm
95 x 155 x 47 mm
Type of protection from penetration of water
Bodybox
Headbox
Transferbox
IPX 3
IPX 3
IPX 0
SOMNOlab weight without PC
approx. 500 g
Distribution voltage, basic device
7 – 15 V
Electrical connection, power supply pack
230 V / 50 Hz
Network fuse DIN EN 60127-2
medium power requirement
approx. 7 V
Classification according to EN 60601-1
Protection against electric shock
Degree of protection against electric shock
Electromagnetic compatibility (EMC)
Protection class II
Type BF
EN 60601-1-2
Interference suppression
EN 55011
Immunity to interference
IEC 1000-4, Parts 2-6, 11
Operational temperature range
+ 5°C to + 45°C
qualified for respiratory flow/
snore sensor
Storage temperature range
-10°C to +60°C
Relative humidity – operating and storage
0 to 95% not condensed
Air pressure – operating and storage
900 to 1100 hPa
BODYBOX
Pulsoximeter
SpO2 measurement range
SpO2 accuracy
at SpO2 above 85%
at SpO2 between 75% and 85%
at SpO2 between 50% and 75%
Pulse rate measurement range
Pulse accuracy
WM 96227 f / BD114f – 08.08
50% – 99%
± 1.5% points
± 2.0% points
± 3.0% points
30 – 250 bpm
(beats per minute)
± 1%
63
Respiratory flow
Respiratory flow / snore sensor
3 thermistors as cumulative
signal, no measurement function at
ambient temperatures between 33
and 38° C
Respiratory flow /
snore nasal cannula
inspiratory / expiratory
pressure fluctuations
Snore
Respiratory flow / snore sensor
integrated microphone
Respiratory flow / snore nasal cannula
pressure sensor
Methods
logical average value of acoustic
sound pressure signal (microphone)
or pressure fluctuations (pressure sensor)
Position
Position sensor integrated in device
Value range
right, left, front, back, upright
Position accuracy
approx. 45° - 15°
CPAP/BiPAP and SmartPAP pressure
Measurement range
0 – 20 mbar
Accuracy
± 0.2 mbar
Effort Sensors (Thorax, Abdomen)
Methods
piezoelectric measurement
HEADBOX
Electrophysiological signals
Channel
EKG
EEG
EMG
Volume range
(physical range)
± 5mV
±500 µV
±250µV
±500µV
Resolution
12 Bit
12 Bit
12 Bit
12 Bit
0.53 Hz
3.1 Hz
0.53 Hz
Upper cut-off frequency 90 Hz
70 Hz
500 Hz
70 Hz
Amplification
approx.
approx.
approx.
approx.
400
4000
8000
4000
Lower cut-off frequency 0.16 Hz
WM 96227 f / BD114f – 08.08
EOG
64
2 open configurable electrophysiological ports
Can be set
EMG, EOG, EEG, ECG
Specification
as with EMG, EOG, EEG, ECG
Electrodes
Protected plug connection in
accordance with DIN 42802
1.5 mm
TRANSFERBOX
3 free analog ports
Port voltage range (analyzable)
± 1V
Amplification factor
1
Accuracy
± 4%
Insulation voltage of analog ports
1500 V ~
Data transmission baud rate
230400 baud
Data output
fiber optic cable to PC
Brightness sensor
photoelectric cell
Output
LED 1 green constant
stand by
LED 2 green constant
device on
Data output
fiber optic cable to PC
13.2 Technical Data for PC, Video, Audio Systems
Please observe the user’s manuals for the individual components that are part of the delivery made to you.
WM 96227 f / BD114f – 08.08
65
14. Warranty
If you need support, please
contact your local Weinmann
distributor.
• Weinmann guarantees that the product, when used in
accordance with requirements, will remain free from
defects for a period of two years from date of purchase.
For products whose durability is clearly indicated as less
than two years, the warranty runs out on the expiration
date indicated on the packaging or in the user’s manual.
• Claims against the warranty can be made only when
accompanied by the sales receipt, which must show
salesperson and date of purchase.
• We offer no warranty in the case of:
– Disregard of usage instructions
– Operating errors
– Improper use or handling
– Third-party intervention by non-authorized persons for
the purpose of device repair
– Acts of God, e.g., lightning strikes
– Transport damage as a result of improper packaging
of returned items
– Lack of maintenance
– Operational and normal wear and tear, which
includes, for example, the following components:
– Respiratory flow / snore sensor
– Failure to use original spare parts
• Weinmann is not liable for consequential harm caused
by a defect if it is based on intention or gross negligence.
Weinmann is also not liable for minor physical injury to
life or limb resulting from negligence.
• Weinmann reserves the right to decide whether to eliminate defects, to deliver a defect-free item or to reduce the
purchase price by a reasonable amount.
• If Weinmann rejects a claim against the warranty, it
assumes no expense for transport between customer and
manufacturer.
Implied warranty claims remain unaffected by these
changes.
Send devices to be repaired complete with all accessories to:
MCC-Technischer Service, Südendstraße 42, D-76135 Karlsruhe.
WM 96227 f / BD114f – 08.08
66
WM 96227 f / BD114f – 08.08
67
For decades Weinmann has been
developing, producing and marketing
medical devices for markets around
the world. In cooperation with our
partners we design economic health
systems for diagnosis and therapy in
Sleep Medicine, Oxygen Medicine
Technical Service:
MCC – Technischer Service
Südendstraße 42
D – 76135 Karlsruhe
Weinmann
Geräte für Medizin GmbH+Co. KG
P.O. Box 54 02 68 · D -22502 Hamburg
Phone +49/40/5 47 02-0
Fax
+49/40/5 47 02-461
e-mail int.sales@weinmann.de
Internet www.weinmann.de
WM 96227 f/ BD114 f – 08.08
and Emergency Medicine.

SOMNO lab

Transcription

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