Path medical QSCREEN User manual

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User Manual
Q SCREEN

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Manufacturer
PATH MEDICAL GmbH
Landsberger Straße 65
82110 Germer ng
Germany
Ema l  [e-mail]
Telephone [phone]
Fax [phone]
Manual Information
Art cle number: 101203-EN
Release date: 2021-09
Rev s on: 1610_MA_QScreen_Manual_EN_02
Val d from: F rmware Rev. 2.0, PC Software Rev. 1.0
Dev ce: Q SCREEN (PM1610)
All ment oned tems, products, brands and trademarks are reg stered or owned by the ment oned
compan es.
All nformat on, llustrat ons, and spec f cat ons prov ded w th n th s manual are based on the latest
product nformat on ava lable at the t me of publ cat on. PATH MEDICAL reserves the r ght to make
changes at any t me w thout not ce.
The latest rev s on of the user manual s ava lable onl ne at www.pathme.de/downloads.
Errors and om ss ons excepted.
Copyright Notice
No part of th s manual may be reproduced, translated, stored, or transm tted, n any form or by any
means, electron c, mechan cal, photocopy ng, record ng, or otherw se, w thout the pr or wr tten
consent of PATH MEDICAL GmbH.
Copyr ght © 2021 PATH MEDICAL GmbH

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Table of Contents
1 Overv ew .......................................................................................................................................... 5
1.1 Introduct on ............................................................................................................................. 5
1.2 Dev ce Overv ew ...................................................................................................................... 6
1.3 Intended Use ........................................................................................................................... 6
1.4 Performance Character st cs ................................................................................................... 7
2 Explanat on of Symbols ................................................................................................................... 7
3 Operat ng Instruct ons ..................................................................................................................... 9
3.1 Screen Layout .......................................................................................................................... 9
3.2 Onl ne Help .............................................................................................................................. 9
3.3 Screen ng Result Icons ........................................................................................................... 10
3.4 Dev ce Hardware ................................................................................................................... 11
3.4.1 Turn ng On/Off the dev ce ............................................................................................. 11
3.4.2 Dev ce Reset .................................................................................................................. 11
3.4.3 Dev ce and Dock ng Stat on Sockets .............................................................................. 11
3.4.4 Dev ce Charg ng ............................................................................................................. 13
3.5 Dev ce Funct ons ................................................................................................................... 14
3.5.1 User Management ......................................................................................................... 14
3.5.2 Home Screen ................................................................................................................. 15
3.5.3 Pat ent Data Handl ng.................................................................................................... 16
3.5.4 Dev ce Sett ngs .............................................................................................................. 18
3.5.5 Hardware and Qual ty Tests .......................................................................................... 19
3.5.6 Pr nt ng .......................................................................................................................... 23
3.5.7 Barcode .......................................................................................................................... 26
3.5.8 L cense Management .................................................................................................... 26
3.5.9 System Informat on ....................................................................................................... 27
3.5.10 W reless Modem Data Transm ss on (l cense requ red)................................................ 27
3.6 Prepar ng for test ng .............................................................................................................. 28
3.6.1 Prepar ng Q SCREEN ......................................................................................................... 28
3.6.2 Prepar ng the OAE probe ............................................................................................... 28
3.6.3 Connect ng the OAE probe ............................................................................................ 28
3.6.4 Connect ng the electrode cable for ABR test ng ........................................................... 29
3.6.5 Connect ng the ear coupler cable for ABR test ng ........................................................ 29
3.7 Prepar ng the test env ronment ............................................................................................ 30

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3.8 Prepar ng the Pat ent ............................................................................................................ 31
3.8.1 Prepar ng the Pat ent for f tt ng the ear probe ............................................................. 31
3.8.2 F tt ng the eart p on the probe ...................................................................................... 31
3.8.3 Insert ng the probe nto the pat ent’s ear canal ........................................................... 32
3.8.4 Plac ng the electrodes for ABR test ng .......................................................................... 32
3.8.5 F tt ng the ear couplers ................................................................................................. 33
3.8.6 Start a Test ..................................................................................................................... 35
3.8.7 Aud tory Bra nstem Response (ABR) ............................................................................. 35
3.8.8 Otoacoust c Em ss ons (OAE) ......................................................................................... 38
3.8.9 Adapt ve No se Cancell ng ............................................................................................. 42
3.8.10 Add ng comments to a test or pat ent .......................................................................... 42
3.9 Q
LINK PC Software .................................................................................................................. 43
3.10 PATH Serv ce Tool .................................................................................................................. 43
3.11 Troubleshoot ng .................................................................................................................... 43
4 Serv ce and Ma ntenance .............................................................................................................. 44
4.1 General Serv ce Informat on ................................................................................................. 44
4.2 Rout ne Ma ntenance and Cal brat on .................................................................................. 44
4.3 Repa r .................................................................................................................................... 45
5 Clean ng ......................................................................................................................................... 46
5.1 Clean ng and ma ntenance of EP-DP/LT probes .................................................................... 46
5.2 Clean ng the ear coupler cable .............................................................................................. 47
5.3 Clean ng the electrode cable ................................................................................................. 47
6 Accessor es .................................................................................................................................... 48
7 Warranty........................................................................................................................................ 49
8 Notes on Safety ............................................................................................................................. 50
8.1 General Usage ....................................................................................................................... 50
8.2 Handl ng, Transport, and Storage.......................................................................................... 51
8.3 Electr cal Safety ..................................................................................................................... 51
8.4 Electromagnet c Compat b l ty .............................................................................................. 52
8.5 Accessor es ............................................................................................................................ 52
8.6 Waste D sposal ...................................................................................................................... 53
9 Techn cal Spec f cat ons ................................................................................................................. 54
9.1 General Dev ce Informat on .................................................................................................. 54
9.2 Dev ce Character st cs ........................................................................................................... 54
9.3 Power Supply ......................................................................................................................... 55

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9.4 Storage, Transport, and Operat ng Cond t ons ..................................................................... 55
9.5 Test module parameters ....................................................................................................... 56
9.5.1 TEOAE ............................................................................................................................ 56
9.5.2 DPOAE ............................................................................................................................ 56
9.5.3 ABR ................................................................................................................................ 57
10 Electromagnet c Compat b l ty Informat on .............................................................................. 58
1Overview
1.1 Introduction
Thank you for purchas ng the Q SCREEN . Th s manual s your gu de for safely operat ng and ma nta n ng
your dev ce.
Please read th s manual carefully before us ng Q SCREEN for the f rst t me. We recommend tak ng
part cular note of the safety (see sect on 8: Notes on Safety), ntended use (see sect on 1.3: Intended
Use), clean ng (see sect on 5: Cleaning) and ma ntenance (see sect on 4: Service and Maintenance)
nstruct ons.
Q SCREEN s a rel able, easy-to-use, and mob le med cal dev ce, wh ch prov des easy nav gat on v a touch-
screen and s ntended for hear ng exam nat ons (see sect on 1.3: Intended Use).
Some of the ment oned f rmware modules n th s manual may not be ncluded w th your l cense. Please
contact your d str butor f you would l ke to upgrade your l cense to nclude more modules.

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1.2 evice Overview
Your Q SCREEN dev ce s del vered w th a dock ng stat on for w reless charg ng of the handheld dev ce
and for data transm ss on to the PC v a USB. The handheld dev ce and the dock ng stat on are able to
exchange data v a Bluetooth.
Figure 1: SCREEN (left) and Docking Station (right)
1.3 Intended Use
The Q SCREEN dev ce s a hand-held, portable hear ng screener ntended for record ng and
automated evaluat on of Otoacoust c Em ss ons (OAE) and Aud tory Bra nstem Responses
(ABR). D stort on Product Otoacoust c Em ss on (DPOAE) and Trans ent Evoked Otoacoust c Em ss on
(TEOAE) tests are appl cable to obta n object ve ev dence of per pheral aud tory funct on. ABR tests
are appl cable to obta n object ve ev dence of per pheral and retro-cochlear aud tory funct on
nclud ng the aud tory nerve and the bra nstem. Q SCREEN s ntended to be used n subjects of all ages.
It s espec ally nd cated for use n test ng nd v duals for whom behav oral aud ometr c results are
deemed unrel able.
Q SCREEN s to be used by aud olog sts, ear-nose-throat (ENT) doctors, and other hear ng
health care profess onals, nurses and aud olog cally tra ned personnel. It s not ntended to
be operated by lay users. Please cons der local regulat ons regard ng the qual f cat on requ rements
for perform ng measurements w th Q SCREEN ’s test modules.
Q SCREEN s not ntended for operat onal use by the general publ c. All test procedures must be
superv sed or conducted by qual f ed personnel. In the Un ted States of Amer ca, Federal law restr cts
th s dev ce to sale by or on the order of a l censed phys c an.
Q SCREEN s ntended for ndoor-use only and must be operated at def ned env ronmental
cond t ons. See also operat ng cond t ons n sect on 9: Technical Specifications and
nformat on about env ronmental cond t ons regard ng electromagnet c d sturbances n sect on
10: Electromagnetic Compatibility Information. Q SCREEN s not ntended for use n oxygen-r ch
env ronments.

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CONTRAINDICATIONS:
Q
SCREEN must not be used n cases of external ot t s (outer ear canal nfect on) or n any case
wh ch y elds to pa n when nsert ng an ear probe or apply ng any other transducer.
SIDE EFFECTS:
There are no known undes rable s de effects for Q SCREEN .
See also sect on 8: Notes on Safety.
1.4 Performance Characteristics
Q SCREEN s capable of produc ng acoust c s gnals wh ch are transm tted to the pat ent v a an a r
conduct on transducer, record ng acoust c s gnals from the pat ent v a an ear probe, and record ng b o-
potent al s gnals from the pat ent us ng electrodes. Test result data s shown on the dev ce d splay. In
order to preserve dev ce funct onal ty, rout ne ma ntenance s requ red (see sect on 4.2: Routine
Maintenance and Calibration).
Q SCREEN has no essent al performance as related to DIN EN / IEC 60601-1.
2Explanation of Symbols
Th s sect on expla ns all symbols used w th n th s manual and on the dev ce label.
Symbols w th n th s manual:
Symbol Explanation
Important not ce: please read for mportant nformat on.
Warn ng: please read for safety-relevant nformat on, wh ch may cause r sk of
danger to persons and/or dev ce f not followed.
Symbols on the dev ce and/or dock ng stat on label:
Symbol Explanation
Read ng nstruct ons for use s mandatory. Follow nstruct ons n th s manual.
Consult nstruct on for use, .e. th s manual.
Ser al number
Art cle number

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Med cal dev ce
Manufacturer name and address, product on date
Compl ance w th appl ed part type BF (body float ng) requ rements
accord ng to DIN EN 60601-1
Dev ce w th safety class II accord ng to DIN EN 60601-1
D rect current nput
The dev ce s electron c equ pment covered by the d rect ve 2012/19/EC on waste
electr cal and electron c equ pment (WEEE). When d scarded, the tem must be
sent to separate collect on fac l t es for recovery and recycl ng.
CE mark to declare conform ty w th med cal dev ce d rect ve 93/42/EEC. The
number below the CE mark refers to the dent f er of the not f ed body.
2D code, Un que Dev ce Ident f er (UDI). Informat on next to the UDI represents:
(01) dent f er, (11) manufactur ng date, (21) ser al number; add t onal codes on
other labels: (17) exp rat on date
PATH MEDICAL company logo
For further symbols, e.g. on accessory labels, please refer to the respect ve manual or data sheet of
the accessory. Important symbols may nclude:
Symbol Explanation
S ngle use only. Do not reuse the respect ve tem.
Exp rat on date. Do not use the respect ve tem after the spec f ed date.

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3Operating Instructions
After sw tch ng on Q SCREEN (see sect on: 3.4.1: Turning On/Off the device), the dev ce can be operated
v a a touch-sens t ve d splay. In the follow ng sect ons the most mportant dev ce funct ons and screen
elements are expla ned.
3.1 Screen Layout
The screen s part t oned nto the follow ng sect ons:
Figure 2: Device screen layout (example)
① Header, nclud ng the follow ng elements:
-Dev ce t me (e.g. 12:00)
-Screen name
-Bluetooth connect on status: Bluetooth connect on
establ shed
-Battery status: charg ng; status nd cator from
empty to full
② Patient header, nclud ng pat ent last name, name and
ID on the left and ed t opt on on the r ght
③ Main screen, nclud ng screen-related elements (e.g. test
module l st, pat ent l st, test data result v ew)
④ F nction Footer, nclud ng funct on elements (e.g.
add comment, browse measurements, pr nt data)
⑤ Navigation Footer, nclud ng control elements (e.g.
or for brows ng to d fferent screens) and onl ne help
(see sect on 3.2: Online Help)
For explanat on of symbols please refer to the dev ce onl ne help (see sect on 3.2: Online Help) and for
explanat on of other screens see sect on 3.5: Device Functions.
3.2 Online Help
Context-sens t ve help screens allow an ntu t ve handl ng of the dev ce. Automat cally generated
message boxes may add t onally present context-sens t ve warn ngs or nformat on.
The context-sens t ve help screens are ava lable v a the nformat on con , wh ch s d splayed n the
nav gat on footer. The help screens expla n the currently ava lable symbols and the r funct ons.
1
2
3
4
5

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3.3 Screening Result Icons
Test results are shown w th an overall test result status con. The cons correspond to the follow ng
def n t ons:
Test res lt PASS
Screen ng passed successfully; no further test ng necessary
Test res lt Incomplete
Screen ng ncomplete (e.g. test could not be f n shed, test aborted by user), screen ng
should be repeated
Test res lt REFER
Screen ng referred. Please consult your local fac l ty protocol for next steps w th
rescreen ng or aud olog cal referral.
The screen ng result cons are ntended as a rough hear ng status est mator. A screen ng
result s not to be nterpreted as a b nd ng aud olog cal d agnos s. A green status con s not
necessar ly an nd cat on of full aud tory funct on. A complete aud olog cal evaluat on should be
adm n stered f concerns about hear ng sens t v ty pers st. A red status con should not be assumed to
be an nd cator of a lack of aud tory funct on or the presence of pathology. However, t should be
followed w th full aud olog cal d agnost c test ng as appropr ate. In all cases, the exam ner needs to
check and nterpret result data w th n the context of the pat ent’s case h story, cons der ng results
from other measurements and add t onal nfluenc ng factors as appropr ate (e.g. env ronmental
cond t ons dur ng the test, pat ent cooperat veness).

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3.4 evice Hardware
3.4.1 Turning On/Off the device
The on/off sw tch s located at the top s de of the dev ce hous ng (see Figure 3). For turn ng on the
dev ce, press the on/off sw tch br efly. The boot screen appears. For turn ng off the dev ce, e ther press
the Power button on the bottom left corner of the screen or hold down the on/off sw tch for
approx. 5 seconds.
Figure 3: On/off switch (left: device on/off switch, right: screen Power button)
3.4.2 evice Reset
If the dev ce s unrespons ve ( .e., no react on when press ng the touch screen), the dev ce can be reset
by hold ng down the on/off sw tch (see Figure 3) for approx. 5 seconds. Restart the dev ce afterwards.
The reset does not change any dev ce or test module sett ngs or affect any other saved data on the
dev ce.
3.4.3 evice and ocking Station Sockets
Mult ple accessor es can be connected to the Q SCREEN dev ce. Th s ncludes transducers (e.g. nsert
earphones, ear coupler cable, ear probe) and an electrode cable.
Mult ple accessor es can be connected to the dock ng stat on. Th s ncludes USB-Pr nters, PC
commun cat on cable (USB-C), and power supply un t.

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Figure 4:
SCREEN device sockets (top), docking station sockets (bottom)
For further nformat on see sect on 6: Accessories.
The accessor es descr bed n Table 1 can be connected to the Q SCREEN dev ce sockets (see Figure 4).
Socket Connectable accessory
Blue Insert earphones, ear coupler cable, ear probe
Black Electrode cable
Table 1: SCREEN device socket overview
The accessor es descr bed n Table 2 can be connected to the dock ng stat on sockets (see Figure 4).
Socket Connectable accessory
USB-C socket (1) USB PC Commun cat on Cable
USB-A sockets (2) USB Pr nter, Modem
Texas socket (3) Power Supply Un t
Ethernet socket LAN Cable (future use, not ava lable yet)
Table 2: Docking station socket overview
1
2
3

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3.4.4 evice Charging
3.4.4.1 Battery
The nstrument s powered by a rechargeable s ngle cell L th um-Ion (L -Ion) battery. The battery s
charged by plac ng the nstrument on the dock ng stat on. The battery s replaceable by author zed
serv ce personnel.
•Do not damage the battery or use a damaged battery
•Do not touch or short c rcu t the battery contacts
•Keep the battery away from f re and water
•The battery must be replaced by an author zed serv ce partner only
3.4.4.2 Charging
Connect the power supply un t to the dock ng stat on (see sect on 3.4.3: Device and Docking Station
Sockets). Make sure to connect the power plug to a ma ns socket w th appropr ate output voltage and
frequency. The nd cator l ght defaults to wh te nd cat ng the dock ng stat on s powered on and the
charger s n standby mode (see Figure 5).
Figure 5: Docking station charging indicator light
For w reless charg ng of the Q SCREEN dev ce, place the dev ce on the dock ng stat on. Please
make sure that the dev ce s well located on the dock ng stat on and the nd cator l ght starts
flash ng. When charg ng s complete the nd cator l ght shows a sol d green colour. If the nd cator l ght
s not flash ng or shows a sol d red colour, the Q SCREEN dev ce may be ncorrectly pos t oned on the
dock ng stat on and w reless charg ng s not n progress. Wh lst the Q
SCREEN s connected to the dock ng
stat on test ng s d sabled.

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The charg ng process starts automat cally and s f n shed w th n approx mately 8 hours from 0% to 90%
capac ty. When fully charged, the battery w ll last for a full day of test ng under normal test cond t ons
when the default power save and power off s enabled. The battery status can be der ved from the
battery status con symbol: fully charged; charg ng; status nd cator from empty to full.
•Ensure that no metal objects or metall c mater al nterferes w th w reless
charg ng, .e. do not place any conduct ve objects between Q
SCREEN and the
dock ng stat on when charg ng
•Do not place any other object between Q SCREEN and the dock ng stat on when
charg ng
•Do not use w th any other w reless charg ng enabled dev ce: charger may
overheat
•Use only the charger prov ded w th Q SCREEN
3.5 evice Functions
3.5.1 User Management
The Q SCREEN can be conf gured to requ re user log n on the dev ce v a Q LINK (see Q LINK onl ne help for
more nformat on). When user log n s enabled the User L st screen s d splayed after sw tch ng on the
dev ce. You w ll be asked to select your name and to enter your password. Please follow the on-screen
nstruct ons. If you would l ke to change a user you need to restart the dev ce. If the user management
s act ve, you are only enabled to change module parameters when logged n as adm n strator.
Please make sure that local data protect on requ rements are met. When deact vat ng users
on Q SCREEN , the dev ce does not prov de any nherent access protect on ( .e. no log n w th
password).
When start ng the dev ce the l st of ava lable users appears. Select
the correct user name. You can scroll through the user l st by
sw p ng the screen from top or bottom.
You can also search for your user name by press ng the con n the
bottom toolbar.

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After select ng the correct user name, the password entry screen
appears. Enter the correct password n the text box (1) and press OK
afterwards.
3.5.2 Home Screen
Select any of the follow ng start screen opt ons (
from
left to r ght, from top to bottom):
-
Test
:
-New Pat ent:
-Search Pat ent:
-Test V ew:
-Pr nt:
-Barcode:
-Qual ty Tests:
-Sett ngs:
-W reless
Start t
est
Add pat ent
Search and select pat ent
Show pat ent test data
Pr nt pat ent test data
Reads 1D barcodes and QR-codes where
pat ent demograph cs, test data and
further nformat on s stored
Dev ce funct onal checks
Dev ce sett ngs
W reless data transm ss on v a modem
(l cense requ red)
Footer opt on:
-Power off:
-Quest on mark:
Power down dev ce
Onl ne help
1
2

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3.5.3 Patient ata Handling
You can enter pat ent data manually, upload pat ent data from Q LINK (see the Q LINK User Manual for
nstruct ons) or mport data from pathTrack.
3.5.3.1 Adding a new patient
To add a new pat ent
,
manual
ly press the
New Patient
button.
A
pat ent can be added n Home menu, dur ng or after the
measurements n open sess on mode.
①
②
③
The New Patient screen shows a l st of entr es you can f ll out for
enter ng pat ent data. To v ew more f elds sw pe up from the bottom.
There are two types of f elds for data entry: Mandatory f elds ② and
Opt onal f elds ①
In mandatory f elds the text “Press to ed t” str ng s shown n red. You
must always enter a value n the mandatory f eld.
Press a f eld to enter pat ent data. When you have entered all the
data, press the OK button to save the data and then proceed to the
Test Men or press the Add Patient button to store n the pat ent l st
and proceed to Home Men .
To s mpl fy pat ent data entry you can scan the pat ent’s barcode to
read n pat ent data ③. Proceed as follows:
-Press the Barcode button to turn on the camera.
- Place a Barcode or QR code in front of the camera, so it is
centered in the box displayed on the screen .
-Once the barcode has been read, the pat ent f elds are f lled
out automat cally.
-Check the pat ent data after scann ng
-Add to pat ent l st or proceed to Test Menu

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3.5.3.2 Select a patient
To select a pat ent
stored on the dev ce
press the
Select
Patient
button. A pat ent can be selected n Home menu, dur ng or after the
measurements n open sess on mode.
①
③
②
④ ⑤
Each entry of the pat ent l st ncludes several entr es:
-f rst and last name
-The Dot ① nd cates that pat ent doesn’t have any tests and
comments (new pat ent).
-Button to add a comment (speech bubble ③)
-Number nd cat ng the number of tests ②
The l st s sorted by date ⑤ when called from Select Patient
button n Home menu. It guarantees that new pat ents are on top of
the l st.
The l st s sorted by name, when called to pr nt data ( ) or to
rev ew data n arch ve ( )
The sort sequence (e.g. A-Z or Z-A) can be changed by press ng the
button.
You can f nd the des red pat ent by press ng the Find Patient
button ④ or by sw p ng up from the bottom of the screen.
For further nformat on about pat ent management please see dev ce onl ne help (see sect on 3.2:
Online Help).

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3.5.4 evice Settings
There are mult ple opt ons to conf gure the dev ce to your needs.
The dev ce sett ngs can be reached w th the Settings button from
the Home menu. The follow ng dev ce sett ngs are ava lable:
-Date and t me, date and t me format
-Language
-Sound (key cl ck, result sound) ,
-D splay (br ghtness, power t meout)
-Keyboard
-Delete Data
-System nfo:
oF rmware vers on,
oSer al number,
oNext serv ce date,
oTransducer status
oMemory usage
oL cense Management
For further nformat on about dev ce sett ngs please see dev ce onl ne
help (see sect on 3.2: Online Help).

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3.5.5 Hardware and Quality Tests
The ma n dev ce funct ons can be tested w th the “Dev ce tests” opt on.
The dev ce
tests
menu
can be reached w th the
Device Test
button
from the Home menu.
The follow ng dev ce sett ngs are ava lable:
-Dev ce Test: The test ncludes check ng the Camera, SD
card and the aud o funct onal ty.
-Probe Test: exam nes ear probe funct onal ty
-Battery State: d splays current status of battery voltage,
rema n ng capac ty, temperature and health.
-Electrode cable test: allows test ng of the AEP cable for
damage. Can detect broken cables and neffect ve cable
sh eld ng.
-EEG/Aud o spectrum v ewer: can be used for d agnost cs
test ng, acoust c and EMI env ronments.
3.5.5.1 Device Test
The Device Test exam nes several dev ce propert es
-Power supply
-Aud o funct on
-SD Card
-Camera
An error message s shown f the dev ce s not properly
work ng. Please contact your d str butor for further
ass stance.

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3.5.5.2 Pro e Integrity Test
To run the probe test, nsert the probe w thout eart p nto e ther the blue test cav ty for test ng the
small probe t p (PT-S, PT-LT) or the red test cav ty for test ng the large probe t p (PT-A). Do not use
other comb nat ons.
Select “Probe test” from the “Dev ce tests” menu. The probe test
w ll automat cally start. If the probe funct ons correctly the
message “Probe OK” appears
If the probe does not funct on correctly the message “Probe fa led”
appears
For further nformat on on poss ble error messages please refer to
Table 3 as below.
If the probe test fa ls mult ple t mes, please do not
cont nue to test on pat ents. Contact your local
d str butor for ass stance.