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
®
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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

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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
®
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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
®
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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
®
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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
®
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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
®
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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.