GM INSTRUMENTS Osicus User manual

Osicus User Guide V8 09/09/2021 Page 1of 46
Osicus
Audiometer
User Guide
Version 8

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Contents
1. Osicus Audiometer Important Safety Information......................................................5
2. Technical Specification ..............................................................................................8
3. Table of symbols used .............................................................................................10
4. Introduction............................................................................................................12
5. Installation..............................................................................................................13
5.1 Osicus Program Installation.............................................................................................................13
5.2 Osicus Driver Installation.................................................................................................................18
5.3 Installing the Hardware ...................................................................................................................20
5.4 Check Installation ............................................................................................................................21
6. Preparing the System ..............................................................................................22
6.1 Starting the program .......................................................................................................................22
6.2 Introducing the Home Screen ..........................................................................................................22
6.3 Perform Machine Checks.................................................................................................................23
6.4 Select Audiometer...........................................................................................................................23
6.5 Settings ...........................................................................................................................................24
6.6 Tester Information ..........................................................................................................................25
7. Subject Details ........................................................................................................25
7.1 New Subject ....................................................................................................................................25
7.2 Find Subject.....................................................................................................................................26
7.3 Comparison of Audiograms .............................................................................................................28
7.4 Predictive Analysis...........................................................................................................................28
8. Running Hearing Tests.............................................................................................30
8.1 Calibration check.............................................................................................................................30
8.2 Patient Preparation .........................................................................................................................30
8.3 Automatic Operation.......................................................................................................................31
8.4 The Testing Screen...........................................................................................................................31
8.5 Manual Operation ...........................................................................................................................32
8.6 Audiograms and HSE Categories......................................................................................................32
8.7 Comparison of Audiograms .............................................................................................................33
8.8 Printing Audiograms........................................................................................................................33
9. Categorisation of Results –H&SE Categories............................................................34
10. Troubleshooting and Error Messages .....................................................................36
11. Factors which affect absolute accuracy ..................................................................37
12. Maintenance / Technical Information ....................................................................37
13. Calibration ............................................................................................................37
14. Cleaning ...............................................................................................................38
14.1 Instrument Enclosure ....................................................................................................................38
14.2 Patient Contact Parts.....................................................................................................................38
15. Supplied Parts .......................................................................................................39
16. Spare Parts and Consumables................................................................................39
Appendix 1: Guidance on the Electromagnetic environment in which to operate the
instrument..................................................................................................................40
Appendix 2: Technical Information (relative to EN 60601-1:2006+A12:2014)................44

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Osicus Audiometer User Manual
© 2019 GM Instruments Limited
Reproduction, transfer, distribution or storage of part or all of the contents in this
document in any form without the prior written permission of GM Instruments Limited is
prohibited.
Osicus is a trademark of GM Instruments Limited. Other product and company names
mentioned herein may be trademarks or trade names of their respective owners.
GM Instruments Limited reserves the right to make changes and improvements to any
products described in this document without prior written notice.
Under no circumstance shall GM Instruments be responsible for the loss of any data or
income or any special, incidental, consequential, or indirect damages howsoever caused.
The contents of this document are provided ‘as is’. Except as required by applicable law,
no warranties of any kind, either expressed or implied, including but not limited to, the
implied warranties of merchantability and fitness for a particular purpose, are made in
relation to the accuracy, reliability, or contents of this document. GM Instruments Limited
reserves the right to revise this document or withdraw it at any time without prior notice.

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Warranty
This warranty is extended to the original purchaser of the audiometer by GM Instruments
Ltd, through approved Distributors or through GM Instruments Ltd, and covers defects in
materials of workmanship for a period of 1 year from the date of delivery to the original
purchaser.
Defects will be corrected at no cost to the purchaser within the first year, except for
shipping charges to and from the point of service. This warranty does not apply to those
parts that are subject to normal wear and tear, such as cords, ear cushions and
headbands. Replaceable parts which may deteriorate with use will be supplied at a
reasonable cost.
The manufacturer’s warranty is void if the audiometer is repaired by persons other than
GM Instruments Ltd or an approved Distributor.
The terms of this warranty do not affect your statutory rights.

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1. Osicus Audiometer Important Safety Information
Read this Operating Manual before attempting to use the
Instrument.
Warnings
This Instrument is for indoor use only and it should only be used as described in this
manual.
The system must not be used in the presence of flammable gases or in an environment,
which is susceptible to explosions. (Beware of oxygen, dust and anaesthetic gases)
This unit is powered by the USB from a PC or laptop. It is advisable not to touch the
patient while using the equipment.
The equipment should be positioned in such a way that it can be easily disconnected from
the mains supply. The operation of the system can be safely terminated by switching off
or removing the mains plug.
If your desktop PC or printer does not have a power supply approved for a patient
environment, then an isolation transformer, which is in compliance with BS EN 60601,
should be used to power the PC, printer and the Osicus. You must use the isolation
transformer to ensure that the Osicus is in compliance with BS EN 60601.
Applied Parts. The Applied Parts are the headset and the response button.
Connect only items that have been specified as part of, or specified as being compatible
with the Osicus Audiometer. Supplied and compatible spare parts and accessories are
listed in Section 15 & 16 of this manual.
“WARNING The use of PC and Printer in the Patient Environment is defined below and
must be followed to ensure safety compliance of the instrument.”

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Option 1: Patient Environment for Non –Medically approved PC & Printer
If the PC and/or printer are not medically approved then NV2 should be positioned as
shown below, outwith the patient environment. The PC and/or printer must be compliant
to EN60950-1.
Figure 1: Patient Environment for Non-Medically approved PC & Printer
Option 2: Patient Environment for Medically approved PC & Printer
If the PC and/or printer is compliant to BS EN 60601-1 and medically approved, then the
Printer and PC can be positioned within the patient environment as shown below.
Figure 2: Patient Environment for Medically approved PC & Printer
In circumstances where the PC and /or printer are not medically approved but are to be
used within the patient environment then an isolation transformer, which is in
compliance to BS EN 60601-1 MUST be used to ensure safety compliance, or run the PC
on battery power without mains connection.
Osicus
Audiometer
Patient Environment (2 metres)
Headset and
Response Button
(2 metre)
USB cable
(2 metre max)
Osicus
Audiometer
USB cable
(2 metre max.)
Headset and
Response Button
(2 metre)
Patient Environment (4 metres)

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CAUTIONS
Federal (USA) law restricts this device to sale by or on the order of a physician.
The use of the Osicus near to sources of electromagnetic radiation, such as mobile
phones, radio transmitters, x-ray equipment etc, may prevent it from functioning
correctly. Appendix 1 provides guidance on the Electromagnetic environment in which to
operate the instrument.
This is a medical instrument, which has an electrical classification of Class 1 Type B and a
Medical Device Directive classification of Class IIa.
A Class 1 Type B device categorisation is used to describe an instrument which:-
a) Does not rely on basic insulation only to provide protection against electrical shock but
is constructed in such a way that accessible metal parts cannot become live in the event
of failure of the basic insulation and
b) Applied parts offer protection to the subject against electrical shock and in the event of
a single fault condition arising, leakage current will be limited to less than 0.5 mA.
Any incident, which results in actual or potential injury or death to a subject while using
the Osicus should be immediately communicated to GM Instruments at the address
below.
The Osicus should only be connected to other mains powered devices such as computers
and printers, which comply with EN 60950-1 and we also advise the use of a separating
transformer. Unless computers and printers built to EN 60950 are used, patient safety
might be compromised.
Non-medical equipment such as computers and printers should be kept out of reach of
subjects being tested as such equipment does not comply with medical safety standards.
Refer to clause 16 of EN 60601-1:2006 to ensure compliance.
If the PC is allowed to go in to sleep mode, the USB interface is powered down. When
brought out of sleep mode, the PC does not re initialise the USB interface, and therefore it is
effectively not present. A solution is to remove the USB connection at the PC or instrument
side then re connect. That may be sufficient, but if not, save any results, then close down the
instrument software and restart it
Servicing can only be carried out by GMI approved and
authorised personnel. No modifications are allowed.

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2. Technical Specification
No modification of this equipment is allowed. Factory-trained personnel or engineers
familiar with the standard EN 60601 can only undertake servicing of the Osicus
Audiometer. Circuit diagrams will be made available to competent persons on request.
Medical CE
Mark
The CE mark indicates that the device meets the requirement of Annex V & VII
of the Medical Device Directive 94/42/EEC. Approval of the Quality System is
made by LRQA whose notified body number is 0088
Standards
Safety
BS EN 60601-1 Class 1 Type B applied parts
EMC
BS EN 60601-1-2
Audiometer
BS EN 60645 -1, Type 4
Categorisation
UK & Ireland H&SE
Operation
Environment
Temperature
15°C to 35°C
Relative Humidity
30% to 90%
Ambient Pressure
98kPa to 104kPa
Warm up time
5 Minutes
Transport &
Storage
Storage
&Transport
Temperature
-40°C to +60°C
Relative Humidity
30% to 90%
Supply Power
Voltage
+5V DC from USB
Current
0.2 A
Tone Type
Tone switching
-Tone Presentation
-Tone Interruption
-Pulsed
-
Automatic Mode
Tone Switching
-Pulsed
Manual Mode
Response
Required during TONE or as set by the user from the
Options menu
Frequency
Range
Discrete
Frequencies and
Maximum
Outputs
250Hz (90dB),500Hz (90dB) ,1KHz(90dB),
2KHz(90dB),3KHz(90dB), 4kHz(90dB),
6KHz(90db), 8KHz(90dB)
Accuracy
≤0.2%
Total
Harmonic
Distortio
n
≤1%
Test Type
Auto
Threshold
Determin
ation
Hughson Westlake
Intensity
Range
-10 dB to +90dB
Accuracy
≤1%
Rate of Change
40 ms
Duty Cycle
Continuous
Intensity Limit
The tones are limited to 90dB HL
Headset
Earphones,
Cushions &
Audio cups
TDH39P / DD45 (10 ohm impedance) with MX41/AR
Cushions and AO22Audio cups.
Mechanical
Dimensions
13x 8 x 4 cm
Weight
0.2 Kg

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Calibration
Frequency
Annual calibration required by Manufacturer or Manufacturer
approved provider
Method
ISO 8253-1:Calibration undertaken using Referenced
Transducers and Acoustic Coupler –see calibration
certificate supplied
EMC
Effects
Please refer to page 7 and Appendix 1 of this manual
Service Life
Safety and
Performance
The service life of the Osicus has been evaluated to be 10
years from the date of manufacture.
* Additional Technical Information (relative to BS EN 60601-1) is also provided in
Appendix 2

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3. Table of symbols used
The following symbols appear on the Osicus or the mains adaptor
Symbol
Meaning
Socket Type
Location
Connected
Part
Refer to
Instruction Manual
ISO 7010-M002
USB Type B
Instrument Back
Panel
Computer
(Via USB Port)
Type B
Applied Parts
IEC 60417- 5840
Jack Plug
Instrument Back
Panel
Right and Left
Input Socket
Response
Button *
Direct Current
IEC 60417 - 5931
_
Instrument Label
Computer (Via
USB Port)
For connected parts marked * only connect the accessories supplied with
the instrument. These parts have been tested for use with the
instrument for compliance to standards IEC 60601-1 and IEC 60601-1-2.
Symbols used on labelling and packaging
Symbol
Meaning
Location
Manufacturer
BS EN ISO 15223-1
Instrument Label
Serial Number
BS EN ISO 15223-1
Instrument Label
Consult Instructions for Use
BS EN ISO 15223-1
Instrument Label
0000
Council Decision 93/465/EC. Annex B(d)
Instrument Label