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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2.2. General information
T is instruction manual s ould be regarded as a
component of t e device. It s ould be kept on and
somew ere near t e device at all times. Reading and
understanding t e instruction manual is a prerequi-
site for proper use and correct andling of t e device
in order to maintain t e safety of t e patient and
operator.
T e guarantee is valid for a period of 24 mont s for
t e device and 6 mont s for t e equipment from t e
date of sale.
Only accessories w ic are listed in t is instruction
manual s ould be used wit t e device. We cannot
guarantee t e safe operation and function of t e
device if unknown proprietary accessories / consum-
ables are used t at ave not been tested. (E.g.
Patient leads, Sensors, Consumables, Memory
cards etc.)
Damages resulting from the use of third-party
accessories or consumables shall render this
warranty void.
T e manufacturer will only assume responsibility for
t e device in terms of safety, reliability and function
if:
1. assembly, add-ons, reinstallation, changes
and repairs are carried out by the manufac-
turer or a qualified agent authorized by the
manufacturer to do so;
2. The device is used in accordance with the
instruction manual.
All printed material relates to t e model of t e device
and t e safety regulations at t e time of printing. All
devices, switc es, processors, software programs
and names contained erein are subject to copyrig t
law.
LM s all only be liable for t e malfunction of t e
device and its software if used in t e normal
operating conditions in accordance to t is manual.
If a PC is included in delivery t ird party software is
not allowed to be installed on t is PC.
Medical devices must only be operated by a qualified
experienced person(s) to ensure correct andling of
suc devices.
T e operator must read and understand t e user
manual to operate t e device correctly.
T e operator must c eck t e functionality of t e
device before eac use to ensure it is in sound
condition and in good working order.
Functional testing of t e device must be carried out
at regular intervals. It is recommended t at t is is
conducted once a mont .
Upon reac ing t e end of its service life, t e device
and its accessories s ould be disposed of in
accordance wit t e WEEE Directives or relevant
Electronic Disposal protocol.
For furt er details please contact LM.
2.3. Technical inspection
Only devices t at are regularly c ecked and main-
tained are deemed safe to use. It is recommended
t at units are subject to a test protocol and t e
battery is replaced every 24 mont s.
For more details on servicing and service contracts,
please contact t e LM Customer Service Department
or your service provider. A functional tester can not
be used to assess t e accuracy of t e finger sensor
or pulse oximeter of t e device.
T e following tests need to be carried out by t e
operator before eac measurement:
• Visual inspection of t e device and accessories
for obvious damage w ic could result in
mec anical failure.
• Testing all ose connections are air tig t.
• Testing t e t orax and abdominal sensors for
leaks.
• C ecking t e display LEDs.
• Testing t e pulse and SpO2 finger sensors and
carrying out a plausibility test (timed pulse test
using).
• Testing t e battery capacity.
2. . Liability for functioning or damage
In t e event of improper use or repair by t e owner or
operator, t e liability for t e device will be transferred
to t ose parties. LM s all not be liable for damages
arising from non-observance of t is instruction
manual. T e actual guarantee and warranty condi-
tions in t e LM terms of sale/delivery are not exten-
dable.
3. Recording measurement data using the
MiniScreen unit
3.1. Sensors
3.1.1. Sensors for flow and snoring noises
T e detection of patient flow is determined by t e
use of a nasal flow prong t at transmits t e pressure
signal to an internal pressure transducer of t e
device. T e flow prong can be easily applied by t e
user and will ave no adverse affect on t e quality of
sleep. T e use of a flow prong also eradicates t e
problem w ere ad esive sensors cannot be used.
(i.e.: patients wit beards). In addition t e flow prong
is an economical c oice of sensor as it is commonly
available.
No additional sensor is required for respiratory and
snoring detection. Respiratory sounds are trans-
mitted to t e MiniScreen unit via t e flow prong. T e
built in microp one detects t e sounds w ic are
t en electronically analysed. T erefore additional
microp ones are not required.
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Due to t e ig sensitivity of t e internal pressure
transducer, t e MiniScreen device is capable of
measuring and recording ultra fine pressure diffe-
rences associated wit patients w o mout breat e.
In order to connect t e flow prong, ensure t e blue
connector of t e prong attac es into t e blue
connector of t e device.
T e flow prong s ould be used in accordance wit
t e manufacturer’s instructions.
Warning:
T e flow prong is intended for single patient use. No
attempt s ould be made to clean or use t e flow
prong t e more t an once. Multiple use can result in
cross infection!
3.1.2. Thermistor sensor for breathing
Additional to t e flow prong a T ermistor can be
used to measure t e breat ing. Please also observe
t e instructions accompanying t e sensor.
T e brown connector of t e T ermistor needs to be
attac ed to t e brown connector on t e MiniScreen.
3.1.3. Sensor for PAP (pressure)
a.) MiniScreen plus
W en performing measurements on a patient under-
going PAP t erapy, a T-Adapter is used instead of t e
flow prong. T is is to be placed between t e
respiratory mask and t e t erapy tube at t e patient
and is connected to t e top of t e MiniScreen plus
wit t e blue marked LuerLock connection.
a.) MiniScreen premium
W en performing measurements on a patient under-
going PAP t erapy, a pressure diff adapter is used
instead of t e flow prong. T is is to be placed
between t e respiratory mask and t e t erapy tube
at t e patient. It as two pressure measuring oses
wit one blue and one yellow connection.
T e near-patient red marked tube as a blue con-
nection and is connected to t e top of t e MiniScreen
premium wit t e blue marked LuerLock connection.
T e patient-far colorless tube as a yellow connec-
tion and is connected to t e top of t e MiniScreen
premium wit t e yellow marked LuerLock
3.1.4. Sensor for oxygen saturation and pulse
frequency
A pulse oximeter as been integrated into t e device
for t e purpose of measuring oxygen saturation and
pulse frequency. A failure of t e finger sensor or a
missing data update by t e pulse oximeter is
indicated to t e user by t e red LED on t e device. At
t e same time t e values for SpO2 and pulse are fed
to 0.
Please ensure t at blood circulation at t e point of
measurement is not affected by t e manner in w ic
t e sensor as been secured. Excessive pressure
s ould not be exerted on t e finger, especially if t e
temperature exceeds 41 ° C.
W en using a finger sensor, please use t e Velcro
wrist/armband to secure t e sensor and cable. All
nail polis (coloured or clear) must be removed from
t e measuring finger to obtain usable data.
To minimize interference (e.g., motion artifacts), t e
pulse oximetry values are filtered by digital data
processing. As a result of data averaging and signal
processing, slig t delays in t e display of t e pulse
oximetric values occur. T e internal pulse oximeter
works wit a time orizon of 4 seconds. By additio-
nally considering t e c ange tendency, t e minimum
value of saturation at t e end of an apnea is correctly
reproduced. T e data is updated at every beat, so
t ere are no measurable delays due to data refres
and transmission. Please read and understand t e
instructions accompanying t e finger sensor.
3.1. . Sensor for thorax and abdominal
movement
T e sensors used for recording t orax and abdomi-
nal movement consists of small rubber pressure
pads t at are connected to t e MiniScreen device via
measuring oses. T e sensor for recording t orax
movement comprises of two pressure pads w ereas
t e sensor for abdominal movement contains only
one. T e sensors are inserted into t e pockets of t e
elasticated effort belts. T e t orax belt is applied at
t e eig t of t e sternum, t e abdominal belt in t e
stomac region.
For ygiene reasons and to avoid allergic reactions
t e belts s ould be worn over clothes.
T e red connector of t e t orax sensor needs to be
attac ed to t e red connector and t e black
connector of t e abdominal sensor needs to be
attac ed to t e black connector of t e device.
T e effort belts are adjustable in size due to t e
Velcro fasteners, and s ould be suitable for most
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patients. T ese belts are owever also available in
special sizes.
Note:
Overstretc ing of t e belts may result in poor signals
and possible loss of data.
3.1.6. Sensor for body position
T e position sensor integrated in t e MiniScreen unit
displays information related to t e patient’s body
position during t e study.
For accurate determination of body position, ensure
t e MiniScreen is applied to t e patient correctly. T e
body positions detected are: Supine, Prone, Left
side, Rig t side, Uprig t.
3.1.7. Sensor for leg movement
To diagnose restless or periodic leg movements
(restless leg), t e MiniScreen can be equipped wit a
leg sensor and internal recording software (optional).
T e device t en enables continuous recording of leg
movements and associated analysis results in t e
report.
Attac ing t e leg sensor:
T e RLS sensor is attac ed to t e leg using t e
Velcro wrist band. T e sensor s ould be positioned
approximately 10 cm below t e knee joint, lateral to
t e s in bone.
Since t e leg sensor detects muscle movements,
ensure t at t e sensor is placed on t e muscle and
not t e s in bone!
T e red and black safety plugs of t e sensor ave to
be plugged into t e red and black sockets of t e
splitter box.
3.1.8. Sensor for ECG
T e supplied ECG cable (optional) is compatible wit
all commonly available ad esive electrodes and can
be used as consumables.
Attac ing t e ECG electrodes:
T e yellow, green and w ite safety plugs ave to be
plugged into t e yellow, green and w ite socket of
t e splitter box.
Important:T e ECG is not suitable for a differential
cardiac diagnosis!
3.1.9. Sensor for Neuroport
T e Neuroport signal is obtained via t e supplied
EEG cable (optional, MiniScreen plus only). We
recommend special 3-part EEG electrode strips as
consumables.
T e 3 part EEG electrode strip needs to be applied to
t e fore ead. Before applying t e electrode t e
fore ead must be cleaned wit a sterile solution. A
eadband around t e fore ead will eliminate
movement of t e electrode during t e study.
T e blue marked connecting plug of t e EEG
electrode cable needs to be plugged into t e blue
socket on t e MiniScreen plus unit.
3.2. Preparing for measurement (ambulatory)
In preparation of an ambulatory study w ere t e
patient will use t e device at ome, please ensure
t e following:
1. C arge t e battery: see Page 7.
2. Start t e MiniScreen software on t e PC.
3. Fill out t e fields relating to personal data of t e
patient in t e menu item ”Record / Initialize
device (Offline)“ and start t e transfer.
4. Connect t e MiniScreen wit t e USB interface
cable. For testing purposes, bot LEDs will lig t
up initially. T e red LED will t en go off. T e
green LED on t e MiniScreen unit will remain lit
for t e duration of t e initialization process.
5. A dialogue window will be displayed in order for
t e operator to determine t e start time for
recording. Once confirmed t e unit can t en be
disconnected from t e PC. Note: (remove cable
by pulling on t e plug - not on t e cable).
6. T e MiniScreen unit is now ready for use. T e
unit will now rest in stand-by mode until t e
selected Start Time of t e recording. T e unit
will t en automatically switc on and start
recording data.
3.3. Operating elements of the device
T e MiniScreen device will automatically switc on /
off w en connected / disconnected to a PC. T e
device as an internal clock for timer recording. If t e
timer as been programmed, recording will start
automatically at t e predetermined time. Up to eig t
recordings can be programmed.
Note: If necessary t e MiniScreen can be switc ed
on by t e patient before t e selected Start Time by
pressing and olding t e Start button for one second.
By pressing t e start button (longer t an 7 seconds),
t e device can be switc ed off by t e patient.
T e c arging condition of t e units battery can be
displayed by pressing t e "Akku" button on top of t e
device.
Attention: T is function will only work w en t e
device is switc ed off and disconnected from t e PC.
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3. . Attaching the MiniScreen unit and starting
the measurement
W en apply t e sensors, make sure t at t ey are
applied in suc a way t at strangulation is not
possible due to t eir lengt (for example flow prongs,
finger sensor). In order to ensure reliable recording
of data, you need to observe t e following points
w en attac ing t e MiniScreen unit and sensors.
T ese steps s ould be demonstrated and practised
wit t e patient before and in t e clinic:
1. If applicable, attac t e ECG electrodes.
2. Secure t e MiniScreen unit to t e t orax using
t e elasticated t orax belt (wit t e two built in
pockets). Apply t e belt w ilst in t e standing
position and ex ale. A correctly fitted belt s ould
not slip up or down once fastened. To record
abdominal breat ing, attac t e abdominal belt
(wit t e single built-in pocket) around t e
stomac in t e same way. Always ensure t e
belts are fitted over t e nig t clot es and not
directly onto bare skin.
3. C eck t e position of t e pressure transducers
(black rubber pads). T e sensors s ould be fully
inserted into t e built-in pockets sewn onto t e
belt. Never pull on the tubing connected to
the pressure pads.
4. Apply t e flow prong and/or respiratory t er-
mistor to t e nose or fix t e adapter ose to t e
oxygen mask.
5. If applicable, attac t e leg sensor and EEG
electrodes.
6. Apply t e finger sensor (SpO2) to a finger and
secure t e cable to t e wrist using t e Velcro
wrist band. W ilst doing so, ensure t at you do
not apply pressure to t e finger t ereby
disturbing t e blood flow.
7. T e MiniScreen will automatically switc itself
on at t e predetermined time. Bot LEDs lig t
up briefly for testing purposes.
If all sensors ave been connected correctly, t e
red LED will go out. T e green LED blinks at
regular 4 second intervals.
T e red LED signals a faulty pulse signal. C eck
t e finger sensor and cable.
Once t e patient as been educated on fitting t e
device, t e device can t en be packed into its ard
carry case for t e patient to take ome. T e patient
can refer to t e quick reference guide w en fitting t e
device at ome.
When going to bed the patient needs to:
• Attac t e MiniScreen using t e elasticated
t orax belt.
• Attac t e flow prong and finger sensor.
• If applicable, attac t e abdominal belt, leg
sensor, ECG and EEG electrodes.
• C eck t at t e sensors and t eir connectors are
positioned correctly.
The next morning :
• T e patient as to detac t e MiniScreen unit
and sensors and return all parts to t e case.
Cleaning of t e sensors will be carried out by
t e tec nical staff at t e clinic or ospital.
• Bring t e case back to t e clinic or ospital.
• For automatic evaluation t e measurement can
be transferred to t e PC using t e device
software. Select t e "Record" tab followed by
"Read measurement from device".
4. Service and Maintaining the device
.1. Charging the battery
T e MiniScreen unit is equipped wit a special fast-
c arge Li-Ion battery. T e battery c arging adaptor
included wit your device is specially designed for
t is type of battery and s ould only be used wit your
MiniScreen unit. It is recommended to c arge t e
battery completely after eac measurement.
Caution: It is not allowed to use a different
battery charger than the one provided!
Battery c arging procedure :
• Connect t e battery c arger adaptor to t e
MiniScreen device
• Plug t e c arger into a power outlet
• T e integrated LED's in t e top cover of t e
MiniScreen displays t e c arging status of t e
batteries. T e device can remain connected to
t e c arger adaptor for a long period of time
wit out suffering any damage.
.2. Cleaning instructions
General
As wit any medical device, w en using t e Mini-
Screen plus / premium polygrap ic systems, certain
ygienic procedures are required for safe reuse on
t e patient. Reusable products must ave safe
disinfectability to exclude any risk of infection from
subsequent users / patients. T e regulations of t e
Medical Devices Act stipulate t at for suc medical
devices disinfection activities wit procedures accor-
ding to t e RKI guideline are to be carried out in
analogy to t e met ods of surface or instrument dis-
infection. It is recommended to create a ygiene plan
for t e MiniScreen plus / premium product. Sterili-
zation of t e products listed below is not necessary.
T e MiniScreen plus / premium polygrap ic systems
are medical devices t at are in t e patient's environ-
ment w en used as intended, wit direct contact wit
t e ands of t e staff and t e patient. T ese
products are t erefore classified as so-called "non-
critical medical products" in accordance wit t e
guidelines for ospital ygiene and infection
prevention.
- 7 -

T e recommendations are based on t e following
provisions:
Lists of tested and approved disinfectants and
procedures by VAH, IHO, DGHM, RKI
As a disinfectant of t e applied parts a product
s ould be selected for rapid disinfection wit s ort
exposure times on an alco ol-free basis, w ic is
listed in VAH, IHO or DGHM (for example Mikrozid®
sensitive). T e information given by t e manufacturer
regarding dosage and time of use s ould be
considered.
Periods
Applied part Cycle Clea-
ning
Disin-
fection
After eac use
After patient c ange
By and
Was ing mac ine Spray disinfection
Wipe disinfection
Immersion disinfection
Basic device MiniScreen plus /
premium
● ● ●
Carrying case, outside ● ● ●
Carrying case, inside ● ● ●
S oulder bag clot bag wit
s oulder strap
● ● ●
SpO2 finger sensor ● ● ●
Velcro wrist strap for finger sensor ● ● ●
T orax- /Abdomen sensor ● ● ●
T orax- /Abdomen strap ● ● ●
Pressure Diff Adapter ● ● ●
T ermistor ● ● ●
EEG electrode cable (Neuroport) ● ● ●
LEG sensor ● ● ●
ECG electrode cable ● ● ●
Splitter box for LEG-Sensor and
ECG electrode cable
● ● ●
Flow prong Disposables (Single use)
CPAP Adapter Disposables (Single use)
Tubes for Pressure Diff Disposables (Single use)
Cleaning
It is recommended t at all components of t e
MiniScreen plus / premium be cleaned prior to
disinfection to remove coarse dirt, ad esive residue,
odours and t e like. All components can be wiped
wit a slig tly damp clot and a lig t detergent. Allow
all components to air dry completely before
reinstalling.
Warning:
No liquid s ould enter t e MiniScreen plus / premium
or plug connections. T e sensors must not be
immersed in liquid. Before cleaning, close t e
pressure connections of t e device wit caps!
Disconnect t e c arging and data cable from t e
device before eac cleaning.
In the washing machine
T e t orax and abdominal straps can be was ed in
t e was ing mac ine at 60° C (use a laundry net!).
Let t e straps dry in t e air.
Attention:
• Do not use a dryer
• Remove t oracic and abdominal sensor
before and
Disinfection
It is recommended to subject all components to a
disinfection procedure. T e periods can be found in
t e table. In general, a product s ould be used for
rapid disinfection wit s ort exposure times on an
alco ol-free basis. Observe t e instructions for use
of t e disinfectant used.
• Wipe and spray disinfection wit Mikrozid®
sensitive liquid
• Dive disinfection wit gigasept® FF (new)
Disposables
Disposables must not be used multiple times or on
different patients. Follow t e guidelines for waste
disposal in ospitals.
.3. Maintenance
We recommend t e device including all accessories
is serviced every two years. T e servicing s ould
only be carried out by t e manufacturer or by an
aut orised agent. Calibration of t e pressure c annel
s ould be carried out once at t e first time w en t e
device is used. In order to maintain basic safety and
essential performance, no special measures need to
be taken wit regard to EMC.
. . Transport and storage conditions
T e ambient temperatures for transport and storage
lie between:
• -25 ° C and + 5 ° C,
• + 5 ° C to + 35 ° C wit a relative umidity of
up to 90%, wit out condensation,
• > 35 ° C to 70 ° C at a water vapor pressure
of up to 50 Pa.
Condensation must always be avoided.
. Evaluation software for PC
5.1. Installing the software
To install t e MiniScreen software place t e CD
supplied wit your device into t e CD-ROM drive of
your computer. T e program will automatically run. If
t e program does not run automatically open t e
Explorer option on your operating system and select
t e CD-ROM drive. Once selected double click t e
Setup.exe file from t e software.
You can c eck your computer and network (if
applicable) for MiniScreen software versions t at
may ave been previously installed. To ensure t e
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correct up to date version is selected, open t e
software installed and click t e Searc button. T e
program will t en automatically find and use t e
latest version installed.
After selecting t e target drive t e installation pro-
gram will now automatically create t e necessary
directories and copy all t e required files to t e ard
drive. T e installation will automatically insert a new
group containing an entry for t e new software in t e
Programs folder of t e Start Menu. In addition a
s ortcut on your Windows desktop will be created.
After successful installation, remove t e CD and
store it in a safe place.
5.2. Selecting a printer
T e measurement curves and reports can be printed
on any commonly available type of printer (ink jet,
dot-matrix or laser printer) t at is already installed on
your Windows system. T e correct printer driver can
be selected using t e Windows Control Panel
application.
5.3. Viewer Software "Sleep Xpert App"
During an online measurement, t e measurement
curves can be displayed on a tablet (Windows or
IOS) optionally wit t e elp of t e software "Sleep
Xpert App". T e tablet only serves to visualize t e
measured curves. T ere are no data stored and no
findings or evaluation can be made.
6. Troubleshooting
Channels (e.g. pressure) are missing in the
display.
The channels are deactivated and therefore do not
appear during ”Test” and ”Record”.
C eck w ic c annels are active for recording using
t e menu item Options / Edit Channel sets.
Channels are missing after loading a measure-
ment.
T ey were not recorded or ave been idden for
measurement data display.
Flow signal is missing during recording or
follows the edge of the range.
The flow signal follows a straight flat line in the
middle of the channel.
C eck t e flow prong on t e patient and t e connec-
tion on t e MiniScreen unit. W en measuring during
PAP t erapy, c eck t e connection of t e PAP
adapter ose on t e oxygen mask and on t e
MiniScreen unit.
Signal amplitudes are very small or do not
appear.
C eck t e corresponding sensors on t e patient and
t eir connections to t e MiniScreen unit. W ilst doing
so, c eck t at t e tube oses and t e black pressure
pads of t e t orax sensors are intact. A leaking sen-
sor can cause inaccurate readings in t e t orax
c annel. T e pressure pads s ould be attac ed to
t e patient securely wit out over tig tening t e belt
and t e tube oses s ould be routed in suc a way
t at t ey cannot kink.
C eck all cables and connectors on t e MiniScreen
unit and t e PC.
Pulse oximeters not responding.
The channels for oxygen saturation and pulse
frequency are registering 0% and 30 P/min respec-
tively despite the patient being connected.
First c eck t at t e finger sensor is seated correctly
on t e patient and remove any nail polis t at may
be present. A small red lig t s ould be present in t e
sensor w en t e finger is inserted. If t e lig t doesn't
switc on w en t e sensor is applied to t e finger,
t en you need to c eck t e connection at t e
MiniScreen unit and any intermediate extensions.
Printout not working.
The printer prints characters on the page but in no
apparent format.
T e wrong printer or printer driver as been installed.
The printer is not responding to the print command.
C eck t e printer cable and t e connections to t e
printer and PC. T e printer s ould be switc ed on
and operational, i.e. t e control LED’s on t e printer
s ould be lit.
Cannot establish connection to the MiniScreen
unit.
The USB cable is not connected correctly.
C eck t e connection of t e USB cable to t e
MiniScreen unit and t e PC.
USB interface was deactivated
T e USB interface can be activated in t e
MiniScreen device software. Select t e "Options" tab
followed by menu "Device Settings".
Battery is discharged.
C arge t e battery correctly.
For clarification and in case of problems during
the installation, maintenance or use, please refer
to your local distribution partner, or directly to
the manufacturer.
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7. Ordering informations
Art.-No.
Spare parts / consumer material / Accessories
200-0310 Finger sensor SpO2 soft finger cuff, latex free
200-0311 Velcro wrist strap
to fix finger sensor cable to t e wrist
200-0312/10 Flow prong nose spectacles for flow and snoring
measurement
200-0861 Thermistor for MiniScreen, wit connection for
flow prong and Lemo plug, reusable
200-0313/01 Adapter tube, 20cm, Luerlock
200-0155/22 PAP adapter hose, wit 150cm tube
LM95066 Pressure Diff Adapter for MiniSreen premium
200-0316 Thorax sensor, complete
2 pressure pads, flexible connection tubes
200-0617 Thorax strap, Size S, blue, 98cm
200-0618 Thorax strap, Size M, black, 122cm
200-0619 Thorax strap, Size L, red, 142cm
200-0320 Abdomen sensor, complete 1 pressure pad,
connection ose
200-0321 Abdomen strap for MiniScreen, flexible, blue,
Size S, 98cm
200-0322 Abdomen strap for MiniScreen, flexible, black,
Size M, 122cm
200-0323 Abdomen strap for MiniScreen, flexible, red,
Size L, 142cm
200-0858 Splitter box with cable for connection of leg
sensor & ECG cable to MiniScreen
200-0850 ECG electrode cable to record t e ECG signal
200-0951 EEG electrode cable for Neuroport module (only
MiniScreen plus)
200-0653/01 LEG sensor for detection of leg movements
(restless legs)
200-0936 USB cable for data transmission between
MiniScreen and PC
100-0815/03 Electrical isolator USB for galvanic separation
between MiniScreen device and PC during online
measurement
200-0910 Power adapter Friwo for MiniScreen wit Lemo
connector, medical approval
200-0812 Shoulder bag clot bag wit s oulder strap for
carrying MiniScreen plus, blue
200-0872 Shoulder bag clot bag wit s oulder strap for
carrying MiniScreen premium, grey
200-0813 Carrying case grey plastic case for unit and
accessories
Art.-No.
Spare Parts / Accessories for use with children
200-0312/31 Flow prong for children, 50cm, Luerlock
200-0368/05 Flow prong for infants, 50cm, open end
200-0364 Thorax sensor, complete, 2 pressure pads wit
flexible connection tubes (red marked) and
lengt ened tube for positioning MiniScreen near
c ild
200-0965/03 Thorax strap, XS, black, 79cm
200-0965/04 Thorax strap, XXS, black, 65cm
200.0965/05 Thorax strap, XXXS, black, 40cm
200-0366 Abdomen sensor, complete, 1 pressure pad wit
flexible connection tube (black marked) and
lengt ened tube
200-0967 Abdomen strap, XS, black, 79cm
200-0967/01 Abdomen strap, XXS, black, 65cm
200-0967/02 Abdomen strap, XXXS, black, 40cm
300-0201/02 Infant sensor SpO2 (in combination wit 200-
0370), neonatal, 90cm
300-0201/01 Soft clip sensor SpO2 (in combination wit 200-
0370), 15-50kg, 45cm
200-0370 SpO2 connection cable
- 10 -

8. Technical specifications
Dimensions : 30,5mm x 62,7mm x 140mm (H x W x L, wit out bag)
Weig t : 160 g including storage battery, wit out bag
Housing : metallized plastic (ABS, UL 94HB)
Temperature range : +5°C...+40°C
Moisture : 10% - 95%
Atmosp eric pressure : 70kPa - 106kPa
Storage media : Internal flas memory
Storage capacity : mind. 48 ours
Registered parameters:
Respiratory activity : Differential pressure measurement via flow prong (wit adaptor also during PAP
t erapy), alternative or additional measurement by means of t ermistor possible (option)
T oracic effort : Differential pressure measurement by means of rubber cuffs built into c est strap
Abdominal effort : Differential pressure measurement by means of rubber cuffs built into abdomen strap
Breat ing sounds : P onometric transducer via flow prong
SpO
2
/Pulse : Built-in pulsoximeter, calibrated for functional oxygen saturation
SpO
2
measurement range: 80%-100%  2% SpO
2
60%-79%  4% SpO
2
Pulse measurement range: 50 1/min - 150 1/min  2%
(Reference: electrical pulse simulator)
Finger sensor: special rubber-coated t imble finger sensor
Pulse wave : Plet ysmogramm display; measurement via finger sensor
Position : Acceleration sensor for position recording (5 positions)
Ambient Lig t : P otometric measurement and lig t-Intensity display
PAP : Differential pressure measurement directly on oxygen mask
Measurement range: 0cmH
2
O - 45cmH
2
O  5%
Neuroport : Special electrode for frontal lead (option, MiniScreen plus only)
Leg movement : Piezo pressure sensor (option)
ECG : One c annel lead via ad esive electrodes (option), suitable for patients <10kg
Central eart frequ.: Measurement range: 30 1/min - 200 1/min  2% (option)
PTT : Measurement range: 100 ms – 355 ms  4% (option)
Syst. blood pressure : Trend (option)
External c annels : External box wit voltage input (RJ11; 0..2.5 V) for up to 8 external c annels wit
galvanic separation and RJ11-jack
Fault indicator : 2 LEDs on front of t e device
Power supply : Rec argeable Li-Ion storage battery 3.6 V wit built-in Semiconductor safety
C arger : Plug-in power supply wit medical approval
Output : USB interface wit cable for data transmission
Power consumption : Approx. 70mA
Online operations : In online operation wit a patient, an optical wave guide to t e PC is
indispensable (option)
- 11 -

9. Used Symbols
- 12 -

10. EMC Information
Medical electrical devices subjected to special preventive measures regarding to electromagnetic compatibility (EMC).
T ey must be put in operation and installed according to t e EMC information in t is manual. Portable and mobile RF
communications equipment (e.g. mobile p ones) can influence medical electrical devices. Portable RF communications
equipment (including perip erals suc as antenna cables and external antennas) s ould be used no closer t an 30 cm
(12 inc es) to any part of t e MiniScreen, including cables specified by t e manufacturer. Ot erwise, degradation of t e
performance of t is equipment could result. For an intended use of t e MiniScreen, t e specified equipment in t is
manual must be used. T e application of ot er equipment can led to a ig er emission and a reduction of t e immunity.
Guidelines and Manufacturer‘s Declaration – Electromagnetic Emissions
T e MiniScreen is intended for use in an electromagnetic environment as specified below. T e customer or user of t e
MiniScreen s ould ensure t at it is used in suc an environment.
Emission Test Compliance Electromagnetic Environment - Guidelines
RF – Emission according to CISPR 11 Group 1
T e MiniScreen uses RF energy only for it‘s internal
function. So it‘s RF emission is very low and it‘s
implausible t at it cause any interferences to surroun-
ding electronic devices.
RF – Emission according to CISPR 11 Class B T e MiniScreen is suitable for t e use in all establis -
ments, including domestic establis ments and t ose,
w ic are connected to t e public power supply, w ic
powers buildings for residential purposes.
Harmonic Emissions according to
IEC 61000-3-2 Not applicable
Voltage Fluctuations / Flicker Emissions
according to IEC 61000-3-3 Not applicable
Table 1: Table 201 EN 60601-1-2, Electromagnetic Emissions
Guidelines and Manufacturer‘s Declaration – Electromagnetic Immunity
T e MiniScreen is intended for t e electromagnetic environment as specified below. T e customer and user of t e
MiniScreen s ould ensure t at it is used in suc an environment.
Immunity Test Test Specification Electromagnetic Environment - Guidance
Electrostatic Disc arge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
Floors s ould consists of wood, concrete or
s ould be covered wit ceramic titles. If t e floor
is covered wit synt etic material, t e relative
umidity must be at least 30 %.
Electrical fast Transient / Burst
IEC 61000-4-4
± 2 kV for AC power line
± 1kV for input and output line
100 kHz
Surges
IEC 610004-5
± 1 kV differential mode
± 2kV common mode
Voltage dips
IEC 61000-4-11
0% U
T
for ½ cycle (1 p ase)
0% U
T
for 1 cycle
70% U
T
for 25/30 cycles
a
s ort interruptions and voltage
variations on power supply input
lines
IEC 61000-4-11
0% U
T
for 250/300 cycles
a
Power Frequency
(50/60 Hz) Magnetic Field
IEC 61000-4-8
30 A/m
Note
a
U
T
is t e a.c. mains voltage prior to application of t e test level.
25/250 cycles at 50 Hz or 30/300 cycles at 60 Hz
Table 2: Table 4, , 7, 8 EN 60601-1-2, Electromagnetic Immunity
- 13 -

Guidelines and Manufacturer‘s Declaration – Electromagnetic Immunity
T e MiniScreen is intended for an electromagnetic environment as specified below. T e user of t e MiniScreen s ould
make sure t at is used in suc an environment.
Immunity test Test Specification Electromagnetic Environment - Guidance
Conducted RF disturbance
IEC 61000-4-6 3 V
eff
150kHz - 80MHz
6 V
eff
ISM/Amateur bands
80 % AM / 1 kHz
Radiated RF disturbance
IEC 61000-4-3
Proximity fields from RF wireless
communications equipment
IEC 61000-4-3
10 V/m
80MHz - 2,7 GHz
80 % AM / 1 kHz
380 - 390 MHz
27 V/m; PM 50%; 18 Hz
430 - 470 MHz
28 V/m; (FM ±5 kHz, 1 kHz sine)
PM; 18 Hz
704 - 787 MHz
9 V/m; PM 50%; 217 Hz
800 - 960 MHz
28 V/m; PM 50%; 18 Hz
1700 - 1990 MHz
28 V/m; PM 50%; 217 Hz
2400 - 2570 MHz
28 V/m; PM 50%; 217 Hz
5100 - 5800 MHz
9 V/m; PM 50%; 217 Hz
Interferences may occur in t e environment
of devices, w ic are marked wit t e
following symbol:
Table 3: Table 4, , 7, 8 EN 60601-1-2, Electromagnetic Immunity
- 14 -

Guidelines and Manufacturer‘s Declaration – Electromagnetic Immunity
Test
frequency
MHz
Frequency
band
a
MHz
Radio
service
a
Modulation
b
Max. Perfor-
mance
W
Distance
m
Immunity test level
V/m
385 380 - 390 TETRA 400 Pulse Modulation
b
18 Hz 1,8 0,3 27
450 430 - 470 GMRS 460,
FRS 460
FM
c
± 5 kHz Hub
1 kHz Sinus
2 0,3 28
710
704 - 787 LTE Band 13,
17
Pulse Modulation
b
27 Hz 0,2 0,3 9745
780
810
800 - 960
GSM 800/900
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse Modulation
b
18 Hz 2 0,3 28
870
930
1 720
1 700 - 1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25;
UMTS
Pulse Modulation
b
217 Hz 2 0,3 28
1 845
1 970
2 450 2 400 - 2 570 Bluetoot ,
WLAN 802.11
b/g/n,
RFID 2450,
LTE Band 7
Pulse Modulation
b
217 Hz 2 0,3 28
5 240
5 100 - 5 800 WLAN 802.11
a/n
Pulse Modulation
b
217 Hz 0,2 0,3 95 500
5 785
NOTE: If necessary, to ac ieve immunity test levels, t e distance between t e transmit antenna and t e MiniScreen can
be reduced to 1 m. T e 1 m test distance is permitted according to IEC 61000-4-3.
a For some radio services, only t e frequency for t e radio link from t e mobile communication device to t e base
station (en: uplink) as been included in t e table. T e carrier must be modulated wit a square wave signal wit
50% duty cycle.
b T e carrier must be modulated wit a square wave signal wit 50% duty cycle.
c As an alternative to Frequency Modulation (FM), pulse modulation at 50% duty cycle at 18 Hz may be used, as
t is, if not t e actual modulation, would be t e worst case scenario
Table 4: Table 9 EN 60601-1-2, Test specifications for the immunity of enclosures to high-frequency wireless
communication devices
- 15 -

11. Index
Abdominal sensor...................................................5
Accessories........................................................2, 4
Assigned Purpose...................................................2
Attac ing t e MiniScreen........................................7
Attac ing t e sensors.............................................6
Battery c arging......................................................6
C arging t e battery...............................................7
Cleaning instructions..............................................7
Disposal..................................................................4
Equipment...............................................................2
Finger sensor..........................................................5
Flow prong..............................................................4
Flow sensor............................................................4
Functional testing....................................................4
Information..............................................................3
Installing t e software.............................................8
Leg movement........................................................6
Maintenance...........................................................8
Neuroport................................................................6
Operating elements................................................6
Optical isolator........................................................3
Ordering informations...........................................10
PAP.........................................................................2
PAP sensor.............................................................5
Position sensor.......................................................6
Preparing for measurement....................................6
Pressure pads.........................................................5
RLS sensor.............................................................6
Safety-related informations.....................................3
Selecting a printer...................................................9
Sensors...................................................................4
Sleep Xpert App......................................................9
Starting t e measurement......................................7
Symbols................................................................12
System requirements..............................................2
Tec nical inspection................................................4
Tec nical specifications........................................11
T ermistor...............................................................5
T ird-party accessories..........................................4
T ird-party software................................................4
T orax sensor.........................................................5
Transport and storage conditions...........................8
Troubles ooting......................................................9
Warranty.................................................................4
W ole system.........................................................2
- 16 -

- 18 -