Lowenstein Medical MiniScreen plus User manual

Table of Contents
1. Introduction.........................................................2
1.1. Assigned Purpose:............................................2
1.2. Contraindications..............................................2
1.3. Accessories.......................................................2
2. Information..........................................................3
2.1. Safety-related informations...............................3
2.2. General information..........................................4
2.3. Tec nical inspection..........................................4
2.4. Liability for functioning or damage....................4
3. Recording measurement data using the
MiniScreen unit........................................................4
3.1. Sensors.............................................................4
3.1.1. Sensors for flow and snoring noises.....................4
3.1.2. T ermistor sensor for breat ing............................5
3.1.3. Sensor for PAP (pressure)....................................5
3.1.4. Sensor for oxygen saturation and pulse frequency
.........................................................................................5
3.1.5. Sensor for t orax and abdominal movement........5
3.1.6. Sensor for body position.......................................6
3.1.7. Sensor for leg movement......................................6
3.1.8. Sensor for ECG.....................................................6
3.1.9. Sensor for Neuroport............................................6
3.2. Preparing for measurement (ambulatory).........6
3.3. Operating elements of t e device.....................6
3.4. Attac ing t e MiniScreen unit and starting t e
measurement............................................................7
4. Service and Maintaining the device..................7
4.1. C arging t e battery.........................................7
4.2. Cleaning instructions........................................7
4.3. Maintenance.....................................................8
4.4. Transport and storage conditions.....................8
. Evaluation software for PC................................8
5.1. Installing t e software.......................................8
5.2. Selecting a printer.............................................9
5.3. Viewer Software "Sleep Xpert App"..................9
6. Troubleshooting..................................................9
7. Ordering informations......................................10
8. Technical specifications...................................11
9. Used Symbols...................................................12
10. EMC Information.............................................13
11. Index.................................................................16
REV 2018-11-09
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1. Introduction
1.1. Assigned Purpose:
T e MiniScreen plus and MiniScreen premium Sleep
Diagnosis Systems are recording systems for use in
professional ealt care environment. T ey serve as
a differentiated pre-diagnosis for t e sleep apnea
syndrome and enable continuous recording of up to
40 c annels for at least 15 ours wit out loss of data.
T e recording of data on battery power is also
permitted in ome care environment.
T ey record signals for t e following p ysiological
variables:
• Flow
• Oxygen saturation SpO 2
• Pulse frequency
• Pulse wave
• Body position
• Respiratory and snoring sounds
• PAP (Positive Airway Pressure)
• Ambient Lig t
• T orax effort
• Abdomen effort
• Breat ing frequency
• P ase s ift T orax Abdomen
optional:
• T ermistor
• ECG
• Central eart Frequency
• PTT (Pulse Transit Time)
• Systolic Blood Pressure (Trend)
• Leg movement (LEG)
• EEG (Neuroport, only MiniScreen plus)
• 8 x Analogue c annel
• 13 x c annels of prismaLINE
1.2. Contraindications
T ere are no absolute or relative contraindications to
using t e device. In t e following cases, t e device
must be used under t e supervision of qualified
medical personnel:
• in patients wit acute life-t reatening illnesses.
• in patients wit acute, serious infections.
• in mentally confused patients.
• in infants and c ildren
1.3. Accessories
T e MiniScreen system as a w ole (ME system)
contains t ree components:
• T e microprocessor controlled MiniScreen
recording device
• PC software for measurement data presentation
and PC analysis
• Optional: Analogue box for 8 analogue inputs
incl. connection cable
It is also equipped wit t e following applied parts:
• SpO 2 finger sensor wit cable for obtaining
pulse frequency and oxygen saturation values
• Velcro strap for securing t e finger sensor to t e
wrist
• Flow prongs for obtaining t e respiratory signal.
• Adapter ose for measurement during PAP
T erapy
• Differential pressure adapter for measurement
under PAP ventilation
• Flexible carry belt wit integrated pressure
transducers (t orax effort) to fasten t e Mini-
Screen unit to t e patient
• Flexible belt wit integrated pressure transducer
to record abdominal effort
• S oulder bag for storing t e MiniScreen
Ot er accessories:
• USB Interface cable for data transfer between
t e MiniScreen and PC
• Battery rec arger
• Transport case
Optional applied parts:
• LEG sensor for detecting leg movements
• ECG electrode for recording ECG signals
• Neuroport electrode cable
• T ermistor for additional breat ing detection
Ot er optional accessories:
• Splitter box for connection t e Leg and ECG
sensors
• USB isolator for online measurement
• Viewer "Sleep Xpert App" for tablet.
T e data can be displayed and analysed on a
standard commercial PC. T e measurement curves
and t e analysis results can be printed on all
commonly available printers, including dot-matrix,
laser or ink jet printers.
T e MSV (MiniScreen Viewer) analysis program as
t e following minimum configuration requirements:
• PC wit Windows operating system
• Microsoft Windows 7 or ig er
• 512 MB of RAM (2 GB recommended)
• 1 GB of disk space on t e ard drive
• CD-Rom drive for installation
• Mouse
• 128 MByte VGA grap ics card wit a resolution
of at least 1024 x 768 (512 MB, 1280 x 1024 /
True Colour recommended)
• Free USB port
• Printer wit Windows driver
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2. Information
2.1. Safety-related informations
Observe t e instruction manual:
Every use of t e device requires exact knowledge
and observance of t is instruction manual. T e
device is only intended for t e use described erein.
No alarm function available!
T e device is not suitable for continuous monitoring
of vital or p ysiological functions (for example,
intensive monitoring, monitoring operation) since
t ere is no SpO2 alarm. No direct data analysis takes
place in t e device.
No SIDS Monitoring:
T e device is not suitable for use as a SIDS monitor
(SIDS: Sudden Infants Deat Syndrome, sudden
c ild deat ).
Patient instruction:
Patient instruction must be provided by a ealt care
professional trained in t e device. An attac ed s ort
manual does not replace t e manual instructions or
t e warning of possible azards.
Separation from t e supply network::
To isolate t e device from t e supply network, t e
plug of t e power supply must be disconnected.
Do not open the device!
Warning:
Additional devices t at are connected to medical
electrical (ME) devices must be able to meet t eir
IEC or ISO standards. Anyone connecting additional
devices to ME devices is a system configurator and
is responsible for t e ME system being in compliance
wit t e normative requirements (for example, IEC
60601-1).
Warning:
For online measuring you must use an electrical or
optical isolator for connection of t e device to t e PC
(available from your ome care provider). A connec-
tion of t e device to t e PC wit out electrical or
optical isolator is only allowed if all patient connec-
tions ave been removed first. Only P ysicians or
trained staff is allowed to perform online measure-
ments.
Warning:
Magnetic and electrical fields can impact on t e func-
tioning of t e device. Use of t is equipment adjacent
to or stacked wit ot er equipment s ould be
avoided because it could result in improper ope-
ration. If suc use is necessary, t is equipment and
t e ot er equipment s ould be observed to verify t at
t ey are operating normally. W en operating t e
device, ensure t at all t ird-party devices being
operated in t e vicinity are meeting t eir relevant
EMC requirements. X-Ray equipment, HF surgical
devices, tomograp y devices etc. can interfere wit
ot er devices as t ey may emit ig er levels of
electromagnetic interference.
Warnung:
T e device as no defibrillator protected application
parts! Disconnect t e device before defibrillation! A
direct application of t e device to t e eart (esp.
ECG!) is not allowed!
W ile t e device is being worn, no invasive or
intracorporal measurements and interventions (e.g.,
electro- or HF-surgical devices) may take place.
Warning:
Using multiple devices for patient screening could re-
sult in excessive leakage current above t e allowed
value!
Warning:
W en using t e device on patients wit active
implants, suc as Cardiac pacemakers, perip eral
nerve stimulation devices, tongue pacemaker etc.,
medical professionals s ould be alert to possible
interference wit t e device or t e implant.
Warning:
Applying t e device to more t an one patient at any
one time is not allowed.
Warning:
T e device must not be operated in ve icles and
aircraft.
Warning:
W en applying sensors to t e patient, please ensure
t at no electrical line of t e device is in contact wit
any ot er electrical conductive parts including
ground.
Warning:
Avoid placing t is instrument in direct sunlig t or in
close proximity to intense eat. Prevent also t e
contact wit dust, lint, dirt, moisture and liquids.
Warning:
C ildren or incompetent persons s ould not use t is
device unattended wit out first aving obtained ins-
tructions for t e safe use of t e device. Ensure t at
infants, c ildren and animals cannot touc t e device
unattended
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