Maico ERO SCAN User manual

Operation Manual
ERO•SCAN
®
Screening and Diagnostic Version

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
1 11/15
Table of Contents
Trademark No ice
Trademark No iceTrademark No ice
Trademark No ice ................................
................................................................
................................................................
................................................................
......................................................
............................................
...................... 4
44
4
1
11
1 S andards Compliance
S andards ComplianceS andards Compliance
S andards Compliance ................................
................................................................
................................................................
................................................................
..........................................
....................
.......... 5
55
5
2
22
2 Warran y
Warran yWarran y
Warran y ................................
................................................................
................................................................
................................................................
.............................................................
..........................................................
............................. 6
66
6
2.1 In ended Use ............................................................................... 6
2.2 Indica ions for Use ....................................................................... 6
3
33
3 Warnings, Cau ions and Errors
Warnings, Cau ions and ErrorsWarnings, Cau ions and Errors
Warnings, Cau ions and Errors ................................
................................................................
..............................................................
............................................................
.............................. 7
77
7
3.1 S a us/Error Messages .................................................................. 9
4
44
4 Cus omer Responsibili y
Cus omer Responsibili yCus omer Responsibili y
Cus omer Responsibili y................................
................................................................
................................................................
................................................................
......................................
............
...... 11
1111
11
5
55
5 Safe y Precau ions
Safe y Precau ionsSafe y Precau ions
Safe y Precau ions ................................
................................................................
................................................................
................................................................
..............................................
............................
.............. 12
1212
12
5.1 Cau ions - General ..................................................................... 12
5.2 Warning - Elec ric Shock Hazards................................................ 13
5.3 Warning - In Case of Emergency ................................................ 13
5.4 Warning - Explosion ................................................................... 13
5.5 Warning - Ba ery Safe y ............................................................ 13
5.6 Warning - General ..................................................................... 13
6
66
6 Recycling/Disposal
Recycling/DisposalRecycling/Disposal
Recycling/Disposal ................................
................................................................
................................................................
................................................................
..............................................
............................
.............. 14
1414
14
7
77
7 Regula ory Symbols
Regula ory SymbolsRegula ory Symbols
Regula ory Symbols ................................
................................................................
................................................................
................................................................
............................................
........................
............ 15
1515
15
8
88
8 In rod
In rodIn rod
In roduc ion
uc ionuc ion
uc ion................................
................................................................
................................................................
................................................................
.......................................................
..............................................
....................... 17
1717
17
8.1 How Does he ERO•SCAN
®
Device Work? .................................. 17
8.2 How are he Resul s S ored and Repor ed? ................................. 18
8.3 Sensi ivi y and Specifici y ............................................................ 18
9
99
9 Se up
Se upSe up
Se up ................................
................................................................
................................................................
................................................................
................................................................
................................................................
................................ 19
1919
19
9.1 Unpacking he Sys em ................................................................ 19
9.2 Ba ery Charging ........................................................................ 19
9.3 Ins alling he Micro-Probe........................................................... 20
9.4 A aching Ear ips ....................................................................... 21
9.5 Removing Ear ips ....................................................................... 21
10
1010
10 Opera ing Ins ruc ions
Opera ing Ins ruc ionsOpera ing Ins ruc ions
Opera ing Ins ruc ions ................................
................................................................
................................................................
................................................................
........................................
................
........ 22
2222
22
10.1 Preparing he Pa ien for Tes ing ................................................ 22
10.2 Turning On he Ins rumen ......................................................... 22
10.3 Con rol Panel ............................................................................. 22
10.4 Main Menu ................................................................................ 23
10.5 Selec ing he Tes Pro ocol ......................................................... 23

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
2 11/15
10.6 Probe Check (Beginning a Tes ) .................................................. 24
10.7 Calibra ion and Tes ................................................................... 25
10.8 Viewing Resul s .......................................................................... 25
10.9 Tes Technique ........................................................................... 26
10.10 Noise Sources ............................................................................ 26
10.11 TEOAE and Pause Func ion ......................................................... 27
10.12 Turning Off he Ins rumen ......................................................... 27
11
1111
11 Managing Resul s
Managing Resul sManaging Resul s
Managing Resul s ................................
................................................................
................................................................
................................................................
..............................................
............................
.............. 28
2828
28
11.1 Saving Resul s ............................................................................ 28
11.2 Dele ing Resul s ......................................................................... 29
11.3 Prin ing o a Thermal Prin er ....................................................... 29
11.4 Connec ing o he PC Da abase Sof ware ................................... 30
11.5 Connec ing o he Direc - o-Prin Sof ware ................................. 30
12
1212
12 MPT
MPTMPT
MPT-
--
-II SANIBEL Mobile hermal mini prin er
II SANIBEL Mobile hermal mini prin erII SANIBEL Mobile hermal mini prin er
II SANIBEL Mobile hermal mini prin er ................................
................................................................
.........................................
..................
......... 32
3232
32
12.1 Opera ion .................................................................................. 33
13
1313
13 In erpre in
In erpre inIn erpre in
In erpre ing Resul s
g Resul sg Resul s
g Resul s ................................
................................................................
................................................................
................................................................
............................................
........................
............ 36
3636
36
13.1 Unders anding he Display.......................................................... 36
13.2 SNR Graph View ........................................................................ 37
13.3 Value Graph View ...................................................................... 37
14
1414
14 In
InIn
In erpre ing Prin ed Resul s
erpre ing Prin ed Resul serpre ing Prin ed Resul s
erpre ing Prin ed Resul s ................................
................................................................
................................................................
................................................................
.................................
..
. 38
3838
38
14.1 Unders anding he DPOAE Prin ou ............................................ 38
14.2 Unders anding he TEOAE Prin ou ............................................. 39
15
1515
15 Rounding Resul s
Rounding Resul sRounding Resul s
Rounding Resul s ................................
................................................................
................................................................
................................................................
...............................................
..............................
............... 40
4040
40
16
1616
16 Clock and Da e Se ings
Clock and Da e Se ingsClock and Da e Se ings
Clock and Da e Se ings ................................
................................................................
................................................................
................................................................
.....................................
..........
..... 41
4141
41
16.1 Accessing he Clock Menu ......................................................... 41
16.2 Changing he Da e/Time ............................................................ 41
17
1717
17 Ins rumen Se ings
Ins rumen Se ingsIns rumen Se ings
Ins rumen Se ings ................................
................................................................
................................................................
................................................................
............................................
........................
............ 42
4242
42
17.1 Wireless Device Pairing – Thermal Prin er .................................... 42
17.2 Clearing Tes Resul s .................................................................. 43
17.3 Au o Shu down Time ................................................................. 43
17.4 Save Mode/S oring Tes Resul s .................................................. 44
17.5 Minimum Ampli ude .................................................................. 45
17.6 Clock Mode ............................................................................... 45
17.7 Graph S yle ................................................................................ 45
17.8 Boys Town Norms ...................................................................... 46
17.9 Language .................................................................................. 46

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
3 11/15
17.10 Rese o Defaul ......................................................................... 47
18
1818
18 Advanced Op ions for DPOAE Tes ing
Advanced Op ions for DPOAE Tes ingAdvanced Op ions for DPOAE Tes ing
Advanced Op ions for DPOAE Tes ing ................................
................................................................
.................................................
..................................
................. 48
4848
48
18.1 Ins ruc ions for Cus omizing a Tes Pro ocol ................................ 48
18.2 Selec ing he Level of Primary Tones ........................................... 49
18.3 Se ing he Averaging Time ........................................................ 49
18.4 Se ing he PASS SNR Level ......................................................... 49
18.5 Se ing he Number of Frequencies for PASS ............................... 50
18.6 Rese Pro ocol ............................................................................ 50
18.7 Save Pro ocol ........................................................................... 50
19
1919
19 Advanced Op ions for TEOAE Tes ing
Advanced Op ions for TEOAE Tes ingAdvanced Op ions for TEOAE Tes ing
Advanced Op ions for TEOAE Tes ing ................................
................................................................
..................................................
....................................
.................. 51
5151
51
19.1 Ins ruc ions for Cus omizing a Tes Pro ocol ................................ 51
19.2 Selec ing he Averaging Time ..................................................... 52
19.3 Se ing he PASS SNR Level ......................................................... 52
19.4 Se ing he Number of Frequencies for PASS ............................... 53
19.5 Rese Pro ocol ............................................................................ 53
19.6 Save Pro ocol ............................................................................. 53
20
2020
20 Cleaning and Main enance
Cleaning and Main enanceCleaning and Main enance
Cleaning and Main enance ................................
................................................................
................................................................
................................................................
.................................
..
. 54
5454
54
20.1 Cleaning and Disinfec ion .......................................................... 54
20.2 Main enance .............................................................................. 55
20.3 Probe Tube Replacemen ............................................................ 55
21
2121
21 Troubleshoo ing
Troubleshoo ingTroubleshoo ing
Troubleshoo ing ................................
................................................................
................................................................
................................................................
.................................................
..................................
................. 56
5656
56
22
2222
22 Specifi
SpecifiSpecifi
Specifica ions
ca ionsca ions
ca ions ................................
................................................................
................................................................
................................................................
.....................................................
..........................................
..................... 59
5959
59
Appendix A: Flowchar s
Appendix A: Flowchar sAppendix A: Flowchar s
Appendix A: Flowchar s ................................
................................................................
................................................................
................................................................
...........................................
......................
........... 61
6161
61
A.1 Tes Opera ion Flowchar ................................................................ 61
A.2 Se up Menu Flowchar ................................................................... 62
Appe
AppeAppe
Appendix B: Tes Sequence
ndix B: Tes Sequencendix B: Tes Sequence
ndix B: Tes Sequence ................................
................................................................
................................................................
................................................................
......................................
............
...... 63
6363
63
Appendix C: Pass/Refer Cri eria
Appendix C: Pass/Refer Cri eriaAppendix C: Pass/Refer Cri eria
Appendix C: Pass/Refer Cri eria ................................
................................................................
................................................................
................................................................
................................ 65
6565
65
Appendix D: Configura ions and Tes Pro ocols
Appendix D: Configura ions and Tes Pro ocolsAppendix D: Configura ions and Tes Pro ocols
Appendix D: Configura ions and Tes Pro ocols ................................
................................................................
.........................................
..................
......... 68
6868
68
Appendix E: EMC
Appendix E: EMC Appendix E: EMC
Appendix E: EMC Compa ibili y
Compa ibili yCompa ibili y
Compa ibili y ................................
................................................................
................................................................
................................................................
................................ 69
6969
69

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
4 11/15
Ti le: ERO•SCAN
®
Screening and Diagnos ic Version – Opera ion Manual
MAICO Diagnos ics
10393 Wes 70
h
S ree
Eden Prairie, MN 55344
Tel.: [phone]
Fax: [phone]
E-mail: info@maico-diagnos ics.com
In erne : www.maico-diagnos ics.com
Copyrigh © 201
Copyrigh © 201Copyrigh © 201
Copyrigh © 2015
55
5 MAICO Diagnos ic
MAICO Diagnos icMAICO Diagnos ic
MAICO Diagnos ics
ss
s
All righ s reserved. No par of his publica ion may be reproduced or ransmi ed in any form
or by any means wi hou he prior wri en permission of MAICO. The informa ion in his
publica ion is proprie ary o MAICO.
Compliance
Compliance Compliance
Compliance
MAICO Diagnos ics is an ISO 13485 cer ified corpora ion.
Trademark Notice
ERO•SCAN
®
is a U.S. regis ered rademark of E ymo ic Research, Inc.

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
5 11/15
1Standards Compliance
S andard
S andardS andard
S andard
Issue
Issue Issue
Issue
Da e
Da eDa e
Da e Ti le
Ti leTi le
Ti le
ANSI/ASA 3.6
2010
Specifica ion for Audiome ers
ANSI/AAMI
60601-1
2005 Medical Elec rical Equipmen – General Requiremen s for
Basic Safe y and Essen ial Performance, Ed. 3
IEC 60645-1 2004 Elec roacous ics - Audiological equipmen -- Par 1: Pure-
one audiome ers
IEC 60645-3 2007 Elec roacous ics - Audiome ric equipmen -- Par 3: Tes
signals of shor dura ion
IEC 60645-6 2010 Elec roacous ics – Audiome ric Equipmen – Par 6:
Ins rumen s for he measuremen of o oacous ic emissions
ISO 14971
2007
Applica ion of Risk Managemen o Medical Devices
ISO 10993 2009 Biological Evalua ion of Medical Devices
EN 60601-1-2 2007 Medical elec rical equipmen -- Par 1-2: General
requiremen s for basic safe y and essen ial performance -
Colla eral s andard: Elec romagne ic compa ibili y -
Requiremen s and Tes s.
FCC Par 15 FCC 47CFR, Par 15.
..
.247 & 15.249
IEC 60601-1 2005 Clause 8.9.1.8; Pollu ion Degree Classifica ion: 2

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
6 11/15
2Warranty
MAICO Diagnos ics warran s ha his produc is free from defec s in ma erial and
workmanship and, when properly used, will perform in accordance wi h applicable
specifica ions. If his ins rumen does no mee hese cri eria wi hin one year of original
shipmen , i will be repaired, or a our op ion, replaced a no charge when re urned o our
service facili y.
NOTE:
NOTE:NOTE:
NOTE: Changes in he produc no approved by MAICO Diagnos ics shall void his warran y.
MAICO Diagnos ics shall no be liable for any indirec , special or consequen ial damages,
even if no ice has been given of he possibili y of such damages.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
For assis ance wi h his ERO•SCAN
®
O oacous ic Emission Tes Sys em con ac your Special
Equipmen Dis ribu or or con ac MAICO Diagnos ics by phone a 888.941.4201 or by fax
a 952.903.4100.
2.1
2.12.1
2.1 In ended Use
In ended UseIn ended Use
In ended Use
The ERO•SCAN
®
is a es ins rumen ha measures o oacous ic emissions in infan s,
children, and adul s.
2.2
2.22.2
2.2 Indica ions for Use
Indica ions for UseIndica ions for Use
Indica ions for Use
The ERO•SCAN
®
is indica ed for es ing of cochlear func ion in infan s, children and adul s
by measuring o oacous ic emissions (OAEs). The OAEs are genera ed by a series of clicks
ha are direc ed in o he ear canal.
O oacous ic emissions are low level audio-frequency sounds ha are produced by he
cochlea as par of he normal-hearing process. Available evidence sugges s ha o oacous ic
emissions are genera ed by he cochlea’s ou er hair cells and ha he presence of OAEs is
an indica ion ha he ou er hair cells are viable. Clinical evidence indica es ha hese
emissions normally occur wi h normal hearing, or a mos , mild hearing loss (usually 30-40
dB HL). The majori y of hearing-impaired individuals will be iden ified by a simple OAE es .

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
7 11/15
3Warnings, Cautions and Errors
In his manual he following wo labels iden ify po en ially dangerous or des ruc ive
condi ions and procedures.
The WARNING label iden ifies condi ions or prac ices ha may
presen danger o he pa ien and/or user.
The CAUTION label iden ifies condi ions or prac ices ha could
resul in damage o he equipmen
NOTE:
NOTE: NOTE:
NOTE: No es help you iden ify areas of possible confusion and avoid po en ial problems
during sys em opera ion.
The ERO•SCAN
®
O oacous ic Emission Tes Sys em should be
charged using only he provided power supply. Injury o personnel
or damage o equipmen can resul when a hree-prong o wo-
prong adap or is connec ed be ween he ERO•SCAN
®
power supply
and an AC ou le .
No modifica ions of he equipmen are allowed by anyone o her
han a qualified MAICO represen a ive. Modifica ion of he
equipmen could be hazardous.
The ERO•SCAN
®
produc has been verified by an independen
labora ory o conform o in erna ional s andards for EMC
(elec romagne ic emissions and immuni y). The user is advised o
avoid ins alla ion and use of his ins rumen in proximi y wi h o her
devices or equipmen ha may emi or be suscep ible o
elec romagne ic in erference, including mobile phones. If he
ins rumen is used adjacen o o her devices or equipmen , he user
is ins ruc ed o verify ha no dis urbance is found in he opera ion
of his or o her equipmen in proximi y.
This icon indica es ha pa ien applied par s of he ins rumen
conform o IEC 60601-1:2005, Type B requiremen s.
US federal law res ric s his device o sale by or on he order of a
physician or licensed hearing care professional.
WARNING
CAUTION
WARNING
CAUTION

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
8 11/15
Ins rumen s which bear he Underwri ers Labora ories, Inc. label
should be in erconnec ed wi h accessories ha have he proper
elec rical compa ibili y and are lis ed as mee ing he requiremen s of
he UL Medical and Den al Equipmen S andard. Connec ion of
accessories no mee ing hese requiremen s may resul in elec rical
leakage curren s in excess of hose allowed by he s andard and
presen a po en ial elec rical shock hazard o he person being
es ed.
Any program aimed a ob aining reliable measuremen s of
o oacous ic emissions should be s affed and supervised by
appropria ely- rained individuals.
This device complies wi h par 15 of he FCC Rules. Opera ion is
subjec o he condi ion ha his device does no cause harmful
in erference.

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
9 11/15
3.1
3.13.1
3.1 S a us/Error Messages
S a us/Error Messages S a us/Error Messages
S a us/Error Messages
Display Messages:
A ach Probe
No probe is de ec ed a he s ar of a es .
BT Device No
Found
The paired wireless device canno be de ec ed. The device may be urned off
or oo far away.
BT Error #xxx
There is an error condi ion wi h he wireless device. Check he s a us.
BT No
Configured
The ERO•SCAN
®
ins rumen is no paired wi h any wireless device.
Device no
Responding
The prin er is no responding o queries from he ins rumen .
Due For Service
Indica es calibra ion of ins rumen is recommended. Message will appear
upon he calibra ion due da e se in he device. Message appears during
device s ar up once per day.
Fi Error
Canno Ob ain L
For a DP es , he desired level (L1 or L2) canno be ob ained wi hin
allowable limi s. User should refi he probe and re ry he es .
Fi Error
Too High
For a DP es , he level of he calibra ion one is oo high. User should refi
he probe and re ry he es .
Fi Error
Too Low
For a DP es , he level of he calibra ion one is oo low. User should refi he
probe and re ry he es .
Limi Error
Overflow error during he calcula ion of he DFTs for a DP es . User should
repea he es .
Memory Almos
Full
Saved es s are wi hin 5 es s of he maximum limi .
Memory Full!
The maximum saved es limi is reached. The user will need o clear he
memory before any addi ional es s can be performed.
Power Low!
The ba ery charge level is oo low for opera ion. The user mus charge he
ba ery before addi ional es s can be performed.
Prin er Error
Indica es a problem wi h he prin er. Check he prin er s a us.
Prin er Paper
Ou !
Indica es ha prin er paper has run ou .
Time/Da e Error
The clock is checked during power on o ensure i has no los ime and been
rese . In he case of clock rese , his message is shown. The user should se
he correc da e/ ime.

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
10 11/15
Indica or LEDs (ligh s):
NOISE /
Orange
The indica or labeled ‘NOISE’ provides a visual indica ion (AMBER) ha he
noise level measured during he es exceeds a nominal hreshold.
Also used o indica e some error condi ions and when he ou come of es is
REFER, NOISY, or NO SEAL.
TES
T / Yellow
The indica or labeled ‘TEST’ provides a visual indica ion (YELLOW) ha he
selec ed es is being performed. This indica or will remain on s eady s a e
during he es func ion.
READY / Green
The indica or labeled ‘READY’ le s he user know ha he ins rumen is no
curren ly performing a es func ion and ha i is available o perform a es
func ion.
CHARGE / Blue
The indica or labeled ‘CHARGE’ provides a visual indica ion (BLUE) of he
ba ery recharging func ion and ba ery s a us. The ra e of illumina ion of he
indica or provides a means of iden ifying he s a us of he charging func ion.

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
11 11/15
4Customer esponsibility
This produc and i s componen s will perform reliably only when
opera ed and main ained in accordance wi h he ins ruc ions
con ained in his manual, accompanying labels, and/or inser s. A
defec ive produc should no be used. Make sure all connec ions o
ex ernal accessories are snug and secured properly. Par s which may
be broken or missing or are visibly worn, dis or ed, or con amina ed
should be replaced immedia ely wi h clean, genuine replacemen
par s manufac ured by or available from MAICO.
This produc should no be used in he presence of fluid ha can
come in o con ac wi h any of he elec ronic componen s or wiring.
Should he user suspec fluids have con ac ed he sys em
componen s or accessories, he uni should no be used un il
deemed safe by a MAICO cer ified service echnician.
Do NOT use in he presence of flammable gaseous mix ures. Users
should consider he possibili y of explosions or fire when using his
device in close proximi y o flammable anes he ic gases.
Do NOT use he ERO•SCAN
®
in a highly oxygen-enriched environ-
men , such as a hyperbaric chamber, oxygen en , e c.
Equipmen is no user repairable. Repairs and ba ery replacemen
mus be performed by a qualified service represen a ive only.
This equipmen /sys em may cause radio in erference or may disrup
he opera ion of nearby equipmen . I may be necessary o ake
mi iga ion measures, such as reorien ing or reloca ing he
ERO•SCAN
®
or shielding he loca ion.
Use and s ore he ins rumen indoors only. I is recommended ha
he ins rumen be opera ed wi hin an ambien empera ure range
of 15 °C o 35 °C / 59 °F o 95 °F and in rela ive humidi y be ween
30 % and 90 % (non-condensing).
Transpor and s ore he ins rumen in empera ure be ween 5 °C o
40 °C / 41 °F o 104 °F.
Annual calibra ion recommended. Have an au horized service
echnician perform elec rical safe y checks on he uni in order o
main ain con inued compliance o IEC and UL 60601-1.
WARNING
CAUTION

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
12 11/15
5Safety Precautions
The following safe y precau ions mus be observed a all imes. General safe y precau ions
mus be followed when opera ing elec rical equipmen . Failure o observe hese precau ions
could resul in damage o he equipmen and injury o he opera or or pa ien .
The employer should ins ruc each employee in he recogni ion and avoidance of unsafe
condi ions and he regula ions applicable o his or her work environmen o con rol or
elimina e any hazards or o her exposure o illness or injury.
I is unders ood ha safe y rules wi hin individual organiza ions vary. If a conflic exis s
be ween he ma erial con ained in his manual and he rules of he organiza ion using his
ins rumen , he more s ringen rules should ake precedence.
The ERO•SCAN
®
is in ended o be used by hearing heal hcare professionals (i.e. ENT doc ors,
audiologis s) and/or echnicians, neona al nurses and school nurses who have been rained
by a hearing heal hcare professional.
5.1
5.15.1
5.1 Cau ions
Cau ions Cau ions
Cau ions -
--
- General
General General
General
I
f he sys em is no func ioning properly, do no opera e i un il all
necessary repairs are made and he uni is es ed and calibra ed for
proper func ioning in accordance wi h MAICO published
specifica ions.
Use only he disposable ear ips designed for use wi h his
ins rumen .
Never inser he probe ube in o he ear canal wi hou affixing an
ear ip.
The ear ips are disposable and for single pa ien use only. Do no
clean or reuse ear ips.
Probe ubes are disposable and should be replaced when clogged.
If a probe ube is reused af er removal from he probe head, i will
no si as igh as before.
Do no a emp o clean probe ubes. This may cause damage o
he probe.
Do no drop or o herwise cause undue impac o his device. If he
ins rumen is dropped or o herwise damaged, re urn i o he
manufac urer for repair and/or calibra ion. Do no use he
ins rumen if any damage is suspec ed.
CAUTION

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
13 11/15
5.2
5.25.2
5.2 Warning
Warning Warning
Warning -
--
- Elec ric Shock Hazards
Elec ric Shock Hazards Elec ric Shock Hazards
Elec ric Shock Hazards
Do no open he case of he ERO•SCAN
®
Ins rumen . Refer servicing
o qualified personnel.
Do no ouch he con ac s on he bo om of he ins rumen and he
pa ien a he same ime.
Do no connec he ins rumen o he pa ien and he PC a he same
ime.
5.3
5.35.3
5.3 Warning
Warning Warning
Warning -
--
- In Case of
In Case of In Case of
In Case of Emergency
EmergencyEmergency
Emergency
In case of emergency, disconnec he ins rumen from he supply mains
by removing he micro-USB cable from he connec or as shown in Figure
2 on page 20.
5.4
5.45.4
5.4 Warning
Warning Warning
Warning -
--
- Explosion
Explosion Explosion
Explosion
This sys em is no explosion proof. Do no use in he presence of
flammable anes he ics or o her gases.
5.5
5.55.5
5.5 W
WW
Warning
arning arning
arning -
--
- Ba ery Safe y
Ba ery Safe y Ba ery Safe y
Ba ery Safe y
This ins rumen con ains a rechargeable li hium-ion ba ery. The ba ery
is no user replaceable and mus be re urned o an au horized MAICO
service loca ion for repair.
5.6
5.65.6
5.6 Warning
Warning Warning
Warning -
--
- General
General General
General
Proper use of his device depends on careful reading of all ins ruc ions.
WARNING
WARNING
WARNING

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
14 11/15
6ecycling/Disposal
Many local laws and regula ions require special procedures o recycle or dispose of
elec rical equipmen -rela ed was e including ba eries, prin ed circui boards,
elec ronic componen s, wiring and o her elemen s of elec ronic devices. Follow all
your respec ive local laws and regula ions for he proper disposal of ba eries and
any o her par s of his sys em.
Below is he con ac address for proper re urn or disposal of elec ronic was es rela ing o
MAICO produc s in Nor h and Sou h America.
MAICO Diagnos ics
10393 Wes 70
h
S ree
Eden Prairie, MN 55344
Tel.: [phone]
Fax: [phone]
E-mail: info@maico-diagnos ics.com
In erne : www.maico-diagnos ics.com
Ba eries may explode or cause burns, if disassembled, crushed or
exposed o fire or high empera ures.
WARNING

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
15 11/15
7egulatory Symbols
Symbol
SymbolSymbol
Symbol
IEC Pub.
IEC Pub.IEC Pub.
IEC Pub.
Descrip ion
Descrip ionDescrip ion
Descrip ion
980 & 60601-1 Serial Number
980 & 60601-1 Da e of Manufac ure
980 & 60601-1 Manufac urer
980 & 60601-1 Cau ion, Consul Accompanying
Documen s
980 & 60601-1 Re urn o Au horized Represen a ive,
Special Disposal Required
980 & 60601-1 Reference Number
60601-1 B Pa ien Applied Par According o
IEC60601-1
980 & 60601-1 Consul Opera ing Ins ruc ions
60601-1 Keep Dry
60601-1 Transpor and S orage Tempera ure range
Logo
980 & 60601-1
EU Au horized Represen a ive
980 & 60601-1
Conforms o European Medical Device
Direc ive 93/42/EEC
REF
REFREF
REF

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
16 11/15

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
17 11/15
8Introduction
The purpose of he ERO•SCAN
®
es sys em is o provide a rapid measuremen and
documen a ion of Dis or ion Produc O oacous ic Emissions (DPOAEs) or Transien Evoked
O oacous ic Emissions (TEOAEs) a several frequencies.
The ERO•SCAN
®
is available as a Screening or Diagnos ic version. Please see chap er 18 and
19 for fur her informa ion.
8.1
8.18.1
8.1 How Does he ERO•SCAN
How Does he ERO•SCANHow Does he ERO•SCAN
How Does he ERO•SCAN
®
®®
®
Device Work?
Device Work?Device Work?
Device Work?
The sys em consis s of he ins rumen ,
Micro-Probe, single-use ear ips,
replaceable probe ubes, and o her
accessories. The ERO•SCAN
®
ins rumen
con ains he hardware and sof ware for
genera ing he es s imuli, measuring and
displaying he OAEs, and s oring he resul s
un il hey are prin ed. The plas ic housing
con ains circui boards ha provide he
signal processing and display he es
resul s. The ins rumen also con ains a
rechargeable li hium-ion ba ery o power
he device. The ins rumen uses an organic
ligh -emi ing diode (OLED) display screen
and hree ligh -emi ing diodes (LEDs) o
provide a visual display of es s a us o he
opera or. Four membrane- ype push
bu ons loca ed on he keypad of he
device allow he user o con rol es ing and
prin ing, and o rese es pro ocols.
The Micro-Probe houses speaker and
microphone which produce es s imuli
and measure he sound pressure level (SPL)
presen in he sealed ear canal. In erface of
he ins rumen o he ear canal is
accomplished hrough disposable ear ips,
which fi on o he probe ube. The
disposable ear ips are color coded o
facili a e easy selec ion by size.
User
In erface
Bu ons
Probe Connec or
Micro
-
USB
Connec or
Figure
Figure Figure
Figure 1
11
1
Charge S a us
Indica or
Display
Tes S a us
Indica ors

Operation Manual ERO•SCAN
®
8106286-3_EROSCAN_US_15i.docx
18 11/15
8.2
8.28.2
8.2 How are he Resul s S ored and Repor ed?
How are he Resul s S ored and Repor ed?How are he Resul s S ored and Repor ed?
How are he Resul s S ored and Repor ed?
When he ERO•SCAN
®
is se in i s defaul se ings, he ins rumen will s ore he resul s from
one pa ien (lef and righ ear) in i s non-vola ile memory for subsequen prin ing. However,
he ERO•SCAN
®
ins rumen is capable of s oring up o 250 es resul s. The resul s are
displayed via he OLED on he fron of he device and are s ored in he device’s in ernal
memory. Af er es ing is comple ed, resul s can be prin ed using he prin er and/or expor ed
o a compu er. Tes resul s are s ored in he non-vola ile memory so he opera or can delay
prin ing un il a la er ime if desired.
8.3
8.38.3
8.3 Sensi ivi y and
Sensi ivi y and Sensi ivi y and
Sensi ivi y and S
SS
Specifici y
pecifici ypecifici y
pecifici y
Sensi ivi y and specifici y of his ype of device are based on he es charac eris ics defined
by he user, and may vary depending on environmen al and opera ing condi ions. The
presence of o oacous ic emissions sugges s normal ou er hair cell func ion, which in urn
correla es o normal hearing. However, a passing resul using his ins rumen is no an
indica ion ha he full audi ory sys em is normal. Thus, a PASS resul should no be allowed
o override o her indica ions ha hearing is no normal. A full audiologic evalua ion should
be adminis ered if concerns abou hearing sensi ivi y persis . A REFER es resul should no
be assumed o be an indica or of a lack of audi ory func ion, however, i should be followed
wi h full audiologic diagnos ic es ing.