Lowenstein Medical SOMNOcheck micro CARDIO User manual

SOMNOcheck micro
SOMNOcheck micro CARDIO
Sleep apnea diagnosis set
EN Instructions for Use

2Contents
EN
Contents
1. Overview . . . . . . . . . . . . . . . . . . . 3
1.1 Device . . . . . . . . . . . . . . . . . . . . . . 3
1.2 Components . . . . . . . . . . . . . . . . . 5
1.3 Menu structure for signal control
mode/recording mode . . . . . . . . . . 6
1.4 Menu structure for results display. . 7
1.5 Symbols in the display . . . . . . . . . . 9
1.6 Symbols for risk for sleep
disturbances . . . . . . . . . . . . . . . . 14
1.7 Display of cardiovascular risk . . . . 15
1.8 Display of charging state . . . . . . . 16
1.9 Markings on the device . . . . . . . 17
1.10 Markings on the packaging . . . . . 18
1.11 Safety instructions . . . . . . . . . . . . 19
2. Description of device . . . . . . . . 20
2.1 Intended use . . . . . . . . . . . . . . . . 20
2.2 Description of function. . . . . . . . . 21
2.3 Measuring conditions . . . . . . . . . . 25
3. Safety instructions . . . . . . . . . . 27
4. Commissioning . . . . . . . . . . . . . . 31
4.1 Put on device . . . . . . . . . . . . . . . . 31
4.2 Put on diagnostic nasal cannula . . 31
4.3 Attach pulsoximetry sensor. . . . . . 33
4.4 Make a connection to the PC . . . . 34
5. Operation . . . . . . . . . . . . . . . . . . 35
5.1 Prepare a recording . . . . . . . . . . . 35
5.2 Give patient instructions. . . . . . . . 35
5.3 Perform a recording . . . . . . . . . . . 36
5.4 Cancel recording . . . . . . . . . . . . . 38
5.5 After the recording. . . . . . . . . . . . 39
5.6 Read out results . . . . . . . . . . . . . . 40
5.7 Insert batteries . . . . . . . . . . . . . . . 45
5.8 Use rechargeable batteries . . . . . . 46
5.9 Transport device. . . . . . . . . . . . . . 48
6. Hygiene treatment . . . . . . . . . . 49
6.1 Intervals . . . . . . . . . . . . . . . . . . . . 49
6.2 Clean . . . . . . . . . . . . . . . . . . . . . . 50
6.3 Disinfect. . . . . . . . . . . . . . . . . . . . 50
6.4 Sterilization . . . . . . . . . . . . . . . . . 51
6.5 Change of patient . . . . . . . . . . . . 51
7. Function check . . . . . . . . . . . . . . 52
7.1 Intervals. . . . . . . . . . . . . . . . . . . . 52
7.2 Perform a visual inspection. . . . . . 52
7.3 Perform function check . . . . . . . . 52
8. Troubleshooting . . . . . . . . . . . . . 54
8.1 Faults in the device . . . . . . . . . . . 54
8.2 Error messages in the display . . . . 55
9. Servicing . . . . . . . . . . . . . . . . . . . 56
9.1 Storage . . . . . . . . . . . . . . . . . . . . 56
9.2 Disposal. . . . . . . . . . . . . . . . . . . . 56
10. Scope of supply . . . . . . . . . . . . . 58
10.1 Standard scope of supply. . . . . . . 58
10.2 Accessories . . . . . . . . . . . . . . . . . 59
10.3 Replacement parts . . . . . . . . . . . . 60
11. Technical data . . . . . . . . . . . . . . 61
11.1 Specifications. . . . . . . . . . . . . . . . 61
11.2 Pulsoximetry sensor . . . . . . . . . . . 62
11.3 Safety distances . . . . . . . . . . . . . . 63
12. Warranty . . . . . . . . . . . . . . . . . . . 64
13. Declaration of conformity . . . . 64

Overview 3
EN
1. Overview
1.1 Device
2Button
3Connection for pulsoximetry
sensor/CARDIO-Sensor
1Connection for diagnostic nasal cannula
5Display
4Attachment for wristband
6Wristband
7USB port
8Rubber cover
9Battery
compartment

4Overview
EN
Key
1 Connection for diagnostic nasal
cannula
This is where the diagnostic nasal cannula is
connected to the device. Using the Luer lock
sealing cap supplied, you can seal the connection
for the diagnostic nasal cannula during the
hygiene treatment.
2 Button
You can use this button to switch on the device,
navigate through the menu and start a
measurement.
3 Connection for pulsoximetry sensor/
CARDIO-Sensor
This is where the pulsoximetry sensor is
connected.
4 Attachment for wristband
You can attach the pulsoximetry sensor or the
CARDIO-Sensor here.
5 Display
The display shows you the results of the recording
and current measured values.
6 Wristband
You can use the wristband to attach the device to
your patient’s forearm.
7 USB port
The USB port is for connecting the device to a PC.
8 Rubber cover
The rubber cover protects the USB port from
splashes.
9 Battery compartment
This is where batteries/rechargeable batteries are
inserted.

Overview 5
EN
1.2 Components
Key
1 Pulsoximetry sensor / CARDIO-Sensor
(optional)
The pulsoximetry sensor is used to measure your
patient’s oxygen saturation, pulse frequency and
pulse wave. A CARDIO-Sensor is used as an option
on the SOMNOcheck micro CARDIO. The term
"pulsoximetry sensor" is used for both variants in
the text which follows.
2 Luer lock adapter
The Luer lock adapter is used to connect the
diagnostic nasal cannula to the device.
3 Diagnostic nasal cannula
You can use the diagnostic nasal cannula to
detect your patient’s respiratory flow and snoring.
4 Carrying bag
You can give the patient the device and its
components to take away in the carrying bag.
5 CD-ROM
The CD-ROM enables you to install the PC
software on your PC.
6 USB cable
The USB cable connects the device to your PC.
2Luer lock adapter
3Diagnostic nasal cannula
1Pulsoximetry sensor /
CARDIO-Sensor (optional)
4Carrying bag
5CD-ROM 6USB cable

6Overview
EN
1.3 Menu structure for signal control mode/
recording mode
Signalkontrollmodus
Aufzeichnungsmodus
Signal control mode
Recording mode

Overview 7
EN
1.4 Menu structure for results display
SOMNOcheck micro

8Overview
EN
SOMNOcheck micro CARDIO

Overview 9
EN
1.5 Symbols in the display
Display Symbol* Meaning
Signal control mode
(if at least one sensor is connected)
Respiratory flow display: moves when there are signals
SpO2 Oxygen saturation
Pulse frequency display: symbol flashes at pulse
frequency if there are signals
Signal test* Signal test in progress
Recording mode
Respiratory flow display: moves when there are signals
SpO2 Oxygen saturation
Pulse frequency display: symbol flashes at pulse
frequency if there are signals
Floppy disk symbol with arrow: indicates that a
recording is in progress
Results display (if no sensor is connected)
Name / Name*
Name of patient. Page is not shown if neither the
name nor the recording time have been programmed
using the PC software (from SOMNOlab Version 2.11).
If the programmed name cannot be shown, a "smiley"
is shown instead.
Start of
Recording*
Start time for recording. Page is not shown if neither
the name nor the recording time have been
programmed using the PC software.
Cardiovascular
Risk*
Cardiovascular risk. Page shown only if recording
performed using a CARDIO-Sensor.
Name
Doe, John
2011-06-30 22:00
Start of recording
MODERATE
Cardiovascular
Risk
CRI 0.5

10 Overview
EN
Check for
Arrythmia
(AFib)*
Check for arrhythmia (AFib): page shown only in the
event of positive findings.
Risk for sleep
disturbance*
Risk for sleep disturbances (see “1.6 Symbols for risk
for sleep disturbances” on page 14)
Analysis time
insufficient*
Duration of recording inadequate. If the sensors were
connected to the device for less than 2 hours during a
recording, the recording time is not adequate for
reliable results. A message appears in the display to
indicate that the recording time was insufficient.
Respiratory
events* Respiratory events
AHI
Apnea/Hypopnea Index: number of apneas and
hypopneas per hour within the artifact-free evaluation
time of the flow signal
OAHI
Obstructive Apnea/Hypopnea Index: number of
obstructive apneas and hypopneas per hour within the
artifact-free evaluation time of the flow signal. The
sum of OAHI and CAHI may be less than AHI, especially
if there has been no differentiation between central
and obstructive apneas due to arrhythmias.
CAHI
Central Apnea/Hypopnea Index: number of central
apneas and hypopneas per hour within the artifact-free
evaluation time of the flow signal. The sum of OAHI
and CAHI may be less than AHI, especially if there has
been no differentiation between central and
obstructive apneas due to arrhythmias.
Check for
arrhythmia
(Afib)