Interacoustics Sera, Instructions For Use Manual

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Table of contents
1 Introduction ...............................................................................................................................1
1.1 About this manual................................................................................................................. 1
1.2 Intended use ........................................................................................................................ 1
1.3 Contraindications.................................................................................................................. 1
1.4 Product description ............................................................................................................... 2
1.5 Clinical benefit...................................................................................................................... 3
1.6 Warnings ............................................................................................................................. 4
1.7 Malfunction .......................................................................................................................... 4
2 Safety precautions .....................................................................................................................5
2.1 General................................................................................................................................ 5
2.2 Cautions - general ................................................................................................................ 5
2.3 Environmental factors ........................................................................................................... 6
2.4 Electrical and electrostatic safety ........................................................................................... 6
2.5 Electromagnetic compatibility (EMC)...................................................................................... 6
2.6 Explosion hazards ................................................................................................................ 6
2.7 Use in home healthcare environment ..................................................................................... 7
2.8 Measuring security and clinical benefit ................................................................................... 7
2.9 Miscellaneous ...................................................................................................................... 7
2.10 Use of equipment after transport and storage ......................................................................... 7
3 Unpacking and installation ........................................................................................................9
3.1 Unpacking and inspection ..................................................................................................... 9
3.2 Markings ............................................................................................................................ 10
3.3 Installing the cradle............................................................................................................. 11
3.4 Installing the HM-E200 label printer (optional) ...................................................................... 12
3.4.1 Battery charging........................................................................................................ 13
3.4.2 Installing label paper in the printer .............................................................................. 13
3.4.3 Turning the printer on and off ..................................................................................... 13
3.4.4 Connecting the wireless printer to the Sera
TM
.............................................................. 13
3.4.5 Printer offline ............................................................................................................ 14
3.5 The Sera TM hardware.......................................................................................................... 15
3.6 Connecting the probe cable to the Sera TM ............................................................................ 16
3.7 Connecting transducers to the preamplifier........................................................................... 16
3.8 Connecting the electrode cables to the preamplifier .............................................................. 16
3.9 Use of the IP30 transducer with ear tips or EarCups (ABRIS only) ......................................... 17
3.10 Connecting to the optional pass-checker .............................................................................. 17
3.11 Transducers and calibration ................................................................................................ 18
3.12 Charging and powering Sera TM ............................................................................................ 19
3.12.1 The battery ............................................................................................................... 19
3.13 Battery lifetime and charging time ........................................................................................ 19
3.13.1 Indication lights on Sera
TM
......................................................................................... 20
3.14 HearSIM
TM
software bundle................................................................................................. 21
3.15 Licenses ............................................................................................................................ 21
3.15.1 Adding a new license to Sera TM .................................................................................. 21
3.16 Updating the firmware ......................................................................................................... 21
4 Operating instructions ............................................................................................................. 23
4.1 General precautions ........................................................................................................... 23
4.2 Switching the Sera TM on and off........................................................................................... 24
4.3 Testing during charging....................................................................................................... 24
4.4 Battery charge status indicator ............................................................................................ 24
4.5 Sera TM operation and button overview.................................................................................. 25
4.5.1 The Sera
TM
screen format.......................................................................................... 25