GSi TYMPSTAR PRO User manual

RELIABLE
CLINICAL
TYMPANOMETER
TYMPSTAR PRO
USER MANUAL

Title: GSI TympStar Pro ™ Clinical Middle Ear Analyzer User Manual
Manufacturer
Grason-Stadler
10395 West 70
th
Street
Eden Prairie, MN 55344
USA
Copyright © 2022 Grason-Stadler. All rights reserved . No part of this publication may
be reproduced or transmitted in any form or by any means without the prior written
permission of Grason-Stadler
. The information in this publication is proprietary to
Grason-Stadler.
This product incorporates software developed by others and redistributed according to
license agreements. Copyright notices and licenses for these external libraries are provided
in a supplementary document that is included with the other software applications
distributed with this product.
Compliance
The CE 0123 mark identifies compliance with the Medical Device Directive 93/42/EEC.
Grason-Stadler is an ISO 13485 certified corporation.
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark
0123
Caution: US Federal law restricts this device to sale by or on the order of a physician or
licensed hearing care professional.

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TABLE OF CONTENTS
Table of Contents .......................................................................................................................... 1
Preface.......................................................................................................................................... 12
Manual Conventions ................................................................................................................ 12
Regulatory and Device Symbols.............................................................................................. 13
Warnings and Cautions............................................................................................................... 16
Important Safety Instructions ................................................................................................. 16
Safety Precautions.................................................................................................................... 16
Fluids ................................................................................................................................................... 17
Damage ...............................................................................................................................................17
Electrical Warnings..............................................................................................................................17
Line Voltage Brownout and Interruptions .......................................................................................... 18
Connections ........................................................................................................................................ 18
Connecting Additional Equipment ......................................................................................................18
Battery Safety......................................................................................................................................19
Explosion.............................................................................................................................................19
ENVIRONMENTAL FACTORS .................................................................................................... 19
ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS ........................................... 19
Introduction ................................................................................................................................. 20
Indications for Use ................................................................................................................... 20
Intended Use ............................................................................................................................ 20
Contraindications..................................................................................................................... 20
Essential Performance............................................................................................................. 20
Description and Operating Principles..................................................................................... 21
Installation.................................................................................................................................... 23
Unpacking the system.............................................................................................................. 23
Standard Components............................................................................................................. 24
Optional Accessories........................................................................................................................... 24
System Assembly...................................................................................................................... 25
Base Unit Rear Panel................................................................................................................ 25

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Connections ........................................................................................................................................ 25
Right Side Panel........................................................................................................................ 28
USB Ports.............................................................................................................................................28
USB A/B Cable .....................................................................................................................................29
Left Side Panel .......................................................................................................................... 29
Monitor ..................................................................................................................................... 30
Operating the TympStar Pro....................................................................................................... 31
Preliminary Checks................................................................................................................... 31
Prepare to Test ......................................................................................................................... 31
Helpful hints ............................................................................................................................. 31
Data Collection ......................................................................................................................... 32
Instructing the Patient ........................................................................................................................32
Positioning the Probe Box................................................................................................................... 33
Probe Insertion ...................................................................................................................................33
Front Panel Controls.................................................................................................................... 34
Power ........................................................................................................................................ 34
Examiner ................................................................................................................................... 34
Patient ....................................................................................................................................... 34
Data Erase................................................................................................................................. 35
Test Type Buttons..................................................................................................................... 35
Screener .................................................................................................................................... 35
Tymp.......................................................................................................................................... 35
Reflex......................................................................................................................................... 35
ETF ............................................................................................................................................. 35
More .......................................................................................................................................... 35
Tympanometry Controls.......................................................................................................... 36
Manual ...................................................................................................................................... 36
Hold ........................................................................................................................................... 36
Stop ........................................................................................................................................... 36
Start ........................................................................................................................................... 36
Pressure Control ...................................................................................................................... 36

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Reflex Stimulus Controls.......................................................................................................... 37
Stimulus .................................................................................................................................... 37
Level .......................................................................................................................................... 37
Present ...................................................................................................................................... 37
Print ........................................................................................................................................... 37
Instrument Operation While Printing ................................................................................................. 37
Print Messages.................................................................................................................................... 37
Printout ...............................................................................................................................................38
Data Transfer............................................................................................................................ 38
Configure .................................................................................................................................. 39
Print Settings Menu ............................................................................................................................40
Test Type Displays ....................................................................................................................... 41
Title Bar ...............................................................................................................................................41
Test Type Information......................................................................................................................... 42
Test Tabs ............................................................................................................................................. 42
Test Menu ........................................................................................................................................... 42
Time and Date..................................................................................................................................... 42
Common Icons ....................................................................................................................................43
Settings Icon........................................................................................................................................ 43
Comments Icon................................................................................................................................. 43
Screener Tests .......................................................................................................................... 44
Probe Status Indicator ........................................................................................................................ 45
Admittance and Pressure Meters ....................................................................................................... 45
Tympanometry Test Results ...............................................................................................................45
Set Type...............................................................................................................................................46
Reflex Parameter Buttons...................................................................................................................46
Reflex Result........................................................................................................................................ 47
Screener Test Menu............................................................................................................................ 47
Zoom ................................................................................................................................................... 48
Settings................................................................................................................................................49
Comments...........................................................................................................................................49

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Tympanometry ......................................................................................................................... 50
Probe Status Indicator ........................................................................................................................ 51
Admittance and Pressure Meters .......................................................................................................51
Manual ................................................................................................................................................ 51
Tympanometry Test Results ...............................................................................................................52
Set Type...............................................................................................................................................52
Tympanometry Test Menu ................................................................................................................. 53
Reflex Test................................................................................................................................. 58
Probe Status Indicator ........................................................................................................................ 59
Admittance and Pressure Meters ....................................................................................................... 59
Reflex Stimulus Information ............................................................................................................... 60
Reflex Test Menu ................................................................................................................................ 60
Auto Zero ............................................................................................................................................ 60
Probe................................................................................................................................................... 60
Stimulus Ear ........................................................................................................................................60
Threshold Seek....................................................................................................................................60
NR Store ..............................................................................................................................................61
Store.................................................................................................................................................... 61
Zoom ................................................................................................................................................... 61
Settings................................................................................................................................................62
Threshold Seek....................................................................................................................................62
Non-Threshold Seek............................................................................................................................ 63
Timing.................................................................................................................................................. 64
Stimulus...............................................................................................................................................64
Scaling .................................................................................................................................................64
Immittance.......................................................................................................................................... 65
Comments...........................................................................................................................................65
Reflex Decay ............................................................................................................................. 66
Probe Status Indicator ........................................................................................................................ 67
Admittance and Pressure Meters ....................................................................................................... 67
Reflex Stimulus Information ............................................................................................................... 67

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Stored Reflex Decay Information........................................................................................................ 68
Reflex Decay Test Menu......................................................................................................................68
Auto Zero ............................................................................................................................................ 68
Probe................................................................................................................................................... 68
Stimulus Ear ........................................................................................................................................68
Zoom ................................................................................................................................................... 69
Store.................................................................................................................................................... 69
Settings................................................................................................................................................69
Level ....................................................................................................................................................70
Timing.................................................................................................................................................. 70
Scaling .................................................................................................................................................70
Immittance Component......................................................................................................................70
Comments...........................................................................................................................................70
Acoustic Reflex Latency Test (ARLT) [Licensed Option]......................................................... 71
Probe Status Indicator ........................................................................................................................ 72
Admittance and Pressure Meters .......................................................................................................72
Reflex Stimulus Information ............................................................................................................... 72
Stored Reflex Latency Information .....................................................................................................73
Reflex Latency Test Menu................................................................................................................... 73
Auto Zero ............................................................................................................................................ 73
Probe................................................................................................................................................... 73
Stimulus Ear ........................................................................................................................................73
Store.................................................................................................................................................... 73
Zoom ................................................................................................................................................... 74
Settings................................................................................................................................................75
Level ....................................................................................................................................................75
Measurement......................................................................................................................................75
Timing.................................................................................................................................................. 76
Averages..............................................................................................................................................76
Scaling .................................................................................................................................................76
Immittance.......................................................................................................................................... 76
Comments...........................................................................................................................................77

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Eustachian Tube Function (ETF) - Intact ................................................................................. 78
Probe Status Indicator ........................................................................................................................ 78
Admittance and Pressure Meters ....................................................................................................... 79
Instructions box .................................................................................................................................. 79
ETF Intact Test Results ........................................................................................................................79
ETF Intact Test Menu ..........................................................................................................................80
Continue.............................................................................................................................................. 80
Probe................................................................................................................................................... 80
Immittance.......................................................................................................................................... 80
Baseline............................................................................................................................................... 80
Sweep Rate .........................................................................................................................................80
Mark Test ............................................................................................................................................80
Zoom ................................................................................................................................................... 81
Settings................................................................................................................................................81
Test Options........................................................................................................................................ 82
Display Options ...................................................................................................................................83
Comments...........................................................................................................................................83
Eustachian Tube Function (ETF) - Perforated......................................................................... 84
Probe Status Indicator ........................................................................................................................ 85
Pressure Meter ...................................................................................................................................85
Notifications box .................................................................................................................................85
ETF Perforated Test Results ................................................................................................................86
Max Pressure.......................................................................................................................................86
Time .................................................................................................................................................... 86
Mark Test ............................................................................................................................................86
Comments...........................................................................................................................................86
Patulous Eustachian Tube Test (ETF)...................................................................................... 87
Probe Status Indicator ........................................................................................................................ 88
Admittance and Pressure Meters ....................................................................................................... 88
Test Condition..................................................................................................................................... 88
Patulous ETF Test Results....................................................................................................................88

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Patulous ETF Test Menu......................................................................................................................89
Auto Zero ............................................................................................................................................ 89
Probe................................................................................................................................................... 89
Store.................................................................................................................................................... 89
Zoom ................................................................................................................................................... 89
Settings................................................................................................................................................90
Scaling .................................................................................................................................................91
Immittance.......................................................................................................................................... 91
Comments...........................................................................................................................................91
Multiple Frequency Tympanometry Test (Multi Hz) [Licensed Option] .................................... 92
Probe Status Indicator ........................................................................................................................ 93
Admittance and Pressure Meters ....................................................................................................... 93
Multi-Hz Test Results ..........................................................................................................................94
Multi-Hz Test Menu ............................................................................................................................ 96
Auto Start............................................................................................................................................ 96
Immittance.......................................................................................................................................... 97
Baseline............................................................................................................................................... 97
Sweep Rate .........................................................................................................................................97
Age ......................................................................................................................................................97
Zoom - Tymp ....................................................................................................................................... 97
Zoom-Delta Peak-Start........................................................................................................................98
Settings................................................................................................................................................99
Test Options...................................................................................................................................... 100
Display Options .................................................................................................................................100
Comments.........................................................................................................................................101
Wideband Tympanometry Test (WBT) [Licensed Option]...................................................... 102
WideBand Tympanometry Test Menu..............................................................................................103
Probe Status Indicator ...................................................................................................................... 107
Admittance and Pressure Meters ..................................................................................................... 107
WideBand Test Results .....................................................................................................................107
Typical Evaluations .................................................................................................................... 115

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Test Type Buttons...................................................................................................................115
Tympanometry .......................................................................................................................115
Acoustic Reflex........................................................................................................................ 116
Application Software & Integration.......................................................................................... 118
TympStar Pro Config App ...................................................................................................... 118
Installing the Configuration Software............................................................................................... 118
Customizing the Configuration ......................................................................................................... 118
Menu................................................................................................................................................. 118
Instrument ........................................................................................................................................ 119
Diagnostic Protocols ......................................................................................................................... 120
Screener Protocols............................................................................................................................ 121
Auto Sequence Protocols.................................................................................................................. 121
GSI Instrument Service ..........................................................................................................121
Description........................................................................................................................................ 121
Operation ..........................................................................................................................................121
Public Interface (Direct) .................................................................................................................... 121
Data Port (Direct) ..............................................................................................................................122
GSI Suite ..................................................................................................................................122
OtoAccess™.............................................................................................................................122
Noah 4..................................................................................................................................... 122
AudBase ..................................................................................................................................122
Routine Maintenance ................................................................................................................123
Pretest Tympanometry Checks............................................................................................. 123
Test Cavity......................................................................................................................................... 123
Calibration Quick Check for Probe........................................................................................ 123
226 Hz ...............................................................................................................................................123
678 Hz and 1000 Hz...........................................................................................................................124
Biological Calibration Check .................................................................................................. 125
Preventive Maintenance........................................................................................................ 125
Cleaning the System...............................................................................................................125
LCD Touch Screen.............................................................................................................................. 125

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Cleaning and Disinfecting Agents ......................................................................................... 126
LCD Touch Screen..............................................................................................................................127
Cleaning patient contact devices .......................................................................................... 127
Probe care............................................................................................................................... 127
Use of the cleaning tool......................................................................................................... 129
Error Messages ..........................................................................................................................131
Error - Invalid Start Direction ................................................................................................ 131
Error – No Data to Print .........................................................................................................131
XXX is not available................................................................................................................. 131
Printer communication error ................................................................................................ 131
Calibration Error..................................................................................................................... 131
WideBand Calibration Error .................................................................................................. 131
Altitude Change Error ............................................................................................................131
Error ........................................................................................................................................132
Appendix A: System Defaults.................................................................................................... 133
Instrument Settings................................................................................................................ 133
Screener Settings ...................................................................................................................134
Tympanometry Settings.........................................................................................................135
Reflex Settings ........................................................................................................................136
ETF Settings.............................................................................................................................137
Multi-Hz Settings .................................................................................................................... 138
WideBand Settings .................................................................................................................139
Auto Sequence Settings.........................................................................................................140
Factory [System] ............................................................................................................................... 140
Auto Sequence 1: T+RT-I/C+RD-C [I/C+RD]................................................................................140
Appendix B – Technical Data .................................................................................................... 141
Measuring System..................................................................................................................143
Probe Signals..................................................................................................................................... 143
Probe Signal Level ............................................................................................................................. 143
Measurement Range......................................................................................................................... 144
Accuracy of Measurement................................................................................................................ 144

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Temporal Characteristics ..................................................................................................................144
Pneumatic System..................................................................................................................144
Acoustic Reflex Activating Stimulus System......................................................................... 145
Pure Tone Stimulus Signals ...............................................................................................................145
Pure Tone Harmonic Distortion ........................................................................................................ 146
Broad Band Noise Stimulus Signals...................................................................................................146
Noise Bandwidths .............................................................................................................................146
Click Stimulus Signals ........................................................................................................................147
Stimulus Interval and Minimum Range............................................................................................. 147
Stimulus Level Control Accuracy.......................................................................................................147
Multi-Frequency, WideBand Tympanometry WideBand Click Signal...............................................147
Stimulus Presentation Control On-Off and Signal-to-Noise Ratios................................................... 147
Pulsed Stimulus Signal....................................................................................................................... 147
External Stimulus Signals ..................................................................................................................148
External Stimulus Signals Calibration................................................................................................ 148
Appendix C – Specification of Input/output Connections ...................................................... 149
Mains Cable ............................................................................................................................149
USB Computer Connection ................................................................................................... 149
LAN Connection...................................................................................................................... 149
USB Connectors...................................................................................................................... 150
Patient Response Input..........................................................................................................150
Headphones (2 connectors, R, L) .......................................................................................... 150
DC output (only for use with the 4” Sanibel printer)........................................................... 150
External Monitor Output ....................................................................................................... 151
External Input .........................................................................................................................152
Probe box................................................................................................................................ 152
Appendix D - Safety, EMC, and Associated Standards............................................................ 153
Cautions regarding EMC ........................................................................................................ 153
Electromagnetic Compatibility .............................................................................................. 154
Guidance and Manufacturer’s Declaration Electromagnetic Emissions............................ 155

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Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and the TympStar Pro ........................................................................................ 156
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity .......................... 157
Appendix E - Warranty and Repair........................................................................................... 160
Warranty ................................................................................................................................. 160
Repair ...................................................................................................................................... 161
Appendix F – Recycling and Disposal....................................................................................... 162

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PREFACE
This user manual provides information about the GSI TympStar Pro. This manual is
intended for technically qualified personnel. This manual contains information pertinent to
the use of the TympStar Pro system including safety information as well as maintenance
and cleaning recommendations. Proper use of this device depends on careful reading of all
instructions and labeling. Also be sure to follow all safety standards set by your facility.
Please note: This Instructions for Use is not intended as a training manual. The reader
should consult standard audiology texts for the theory and application of the tests
provided by this instrument.
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!
MANUAL CONVENTIONS
Throughout this manual, the following meaning of warnings, cautions and notices are used.
WARNING
The WARNING symbol identifies conditions or practices that may present
danger to the patient and/or user.
CAUTION
The CAUTION Symbol identifies conditions or practices that could result in
damage to the equipment
NOTE: Notes help you identify areas of possible confusion and avoid potential problems
during system operation.

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REGULATORY AND DEVICE SYMBOLS
Symbol
Description
Conforms to European Medical Device
Directive 93/42/EEC.
Indicates that the device is a Medical Device
Symbol for "SERIAL NUMBER."
GSI Part Number.
Return to Authorized Representative, Special
disposal required.
Medical Equipment Classified by Intertek
Testing Services NA Inc. with respect to
electric shock, fire, and mechanical hazards
only, in accordance with UL 60601-1.
Classified under the Medical Device Directive
(93/42/EEC) as a Class IIa device.
China RoHS symbol for product compliance
Symbol for “European Representative.”
Symbol for “Manufacturer.”
Symbol for “Date of Manufacture.”

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Symbol
Description
On/Off
Keep Dry
This side up.
Class II medical equipment
Consult the operating instructions/directions
for use. A copy of the operating manual is
available on this website: www.grason-
stadler.com
A printed copy of the operating instructions
can be ordered from Grason-Stadler for
shipment within 7 days; or you can contact
your local representative.

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Symbol
Description
WARNING: To avoid the risk of electric shock,
this equipment must only be connected to
supply mains with protective earth
USB
Connection for USB Cable – used for both
type A and type B cable connections
LAN Connection – not used or supported
Monitor
Patient response switch
DC connection 2.1 mm – only for use with the
4” Sanibel printer MPT-III, 12 VDC, 0.5A
Connection for headphones. The red
marking around the connector indicates the
right and is used for the optional Contra
headset. The blue marking indicates the left
connector and not supported.
On/Off - Next to power switch.
The following symbol appears on the instrument.
Definition: Type B applied part – IEC 60601-1 uses the term applied part to
refer to the part of the medical device which comes into physical contact with
the patient for the device to carry out its intended function. This icon
indicates that the GSI TympStar Pro is Type B, Class 1 according to the
international standard IEC 60601-1. The applied parts are the probe assembly, probe clip,
wrist strap, shoulder strap, contralateral insert earphone or headphone, and the ear tips.

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WARNINGS AND CAUTIONS
IMPORTANT SAFETY INSTRUCTIONS
The following safety precautions must always be observed. General safety
precautions must be followed when operating electrical equipment. Failure to
observe these precautions could result in damage to the equipment and injury
to the operator or patient.
The instrument must only be used by hearing health care professionals qualified to
perform tympanometry and auditory tests such as an audiologist, otolaryngologist,
researcher, or a technician under direct supervision by the specialist. Users should use
their professional skills when interpreting the results and this should be done in
conjunction with other testing as deemed appropriate given their professional skills.
Incorrect use could lead to wrong results.
The employer should instruct each employee in the recognition and avoidance of unsafe
conditions and the regulations applicable to his or her work environment to control or
eliminate any hazards or other exposure to illness or injury. It is understood that safety
rules within individual organizations vary. If a conflict exists between the material
contained in this manual and the rules of the organization using this instrument, the more
stringent rules should take precedence.
SAFETY PRECAUTIONS
This product and its components will perform reliably only when operated and
maintained in accordance with the instructions contained in this manual,
accompanying labels, and/or inserts. A defective product should not be used.
Make sure all connections to external accessories are snug and secured
properly. Parts which may be broken or missing or are visibly worn, distorted, or
contaminated should be replaced immediately with clean, genuine replacement parts
manufactured by or available from GSI.
This instrument is suitable in hospital environments except for near active high frequency
(HF) surgical equipment and radio frequency (RF) shielded rooms of systems for magnetic
resonance imaging, where the intensity of electromagnetic disturbance is high.
In case of emergency, disconnect the instrument from the supply mains by pulling the plug
out of the power socket.
Before the first use of the instrument each day, or if suspect or inconsistent results are
apparent, the checks specified in the Routine Maintenance section should be carried out. If
the system is not functioning properly, do not operate it until all necessary repairs are

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made and the unit is tested and calibrated for proper functioning in accordance with
Grason-Stadler published specifications.
No parts of the equipment can be serviced or maintained while in use with the patient.
Latex is not used anywhere in the manufacturing process. The base material for the
earphone cushions is made from natural and synthetic rubber.
Fluids
The device is not intended to be used in environments exposed to fluid spills.
No means is specified for fluid protection (not IP classed). Do not use the
device in the presence of fluid that can contact any of the electronic
components or wiring. Should the user suspect fluids have contacted the
system components or accessories, the unit should not be used until deemed safe by an
authorized service technician. Do not immerse the unit in any fluids. See the Routine
Maintenance Section of this manual for the proper cleaning procedure for the instrument
and its accessories and the function of single-use parts.
Damage
Do not drop or otherwise impact this instrument. If the instrument is dropped
or damaged, return it to the manufacturer for repair and/or calibration. Do
not use the instrument if any damage is suspected.
Do not attempt to open, modify, or service the instrument. Return the instrument to the
manufacturer or distributor for all repair and servicing requirements. Opening the
instrument will void the warranty. See Warranty and Repair in the Appendix.
Electrical Warnings
The TympStar Pro is designed to be used with a hospital grade outlet. To avoid
the risk of electric shock, this equipment must only be connected to supply
mains with protective earth. Ensure that the earth connection at the mains
electrical power outlet is properly grounded. This device uses a three-wire power cord with
a hospital grade plug (for international applications, IEC 60601-1 approved plug). Injury to
personnel or damage to equipment can result when a three-prong to two-prong adaptor is
connected between the TympStar Pro power plug and an AC outlet or extension cord. For
grounding reliability, connect the device to a hospital grade or hospital only receptacle (for
non-US applications, IEC 60601-1 approved receptacle). Inspect the power cord often for
fraying or other damage. Do not operate the apparatus with a damaged power cord or
plug. Improper grounding is a safety hazard. Periodically check the system ground integrity.
Do not use extension cords for the instrument or isolation transformer. Extension cords
can cause ground integrity and impedance problems. In addition to electrical safety
considerations, poorly earthed mains power outlets could cause inaccurate test results due

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to the introduction of electrical interference from the mains. Only use power cords with
insulation rated for the voltages and currents being carried and provided/approved by GSI.
The third conductor in the power supply cord is only a functional earth. The power supply
in the device provides protection against short-circuit, overload and over voltage. The
device will not operate outside the specified voltage rating.
Line Voltage Brownout and Interruptions
There are four (4) UV detectors in the digital domain, two (2) over current
detectors in the analog domain, one for USB and four (4) OV/UV detectors on
the main supply lines. If just ONE fails, all output to the transducers will be
muted.
Connections
Make sure all connections to external accessories are snug and secured
properly. Parts which may be broken or missing or are visibly worn, distorted,
or contaminated should be replaced immediately with clean, genuine
replacement parts manufactured by or available from GSI. Do not switch on any system
power until all cables have been properly connected and verified. See this manual, which
accompanies all deliveries of the system, for setup instructions. Switch off the system
power before connecting or disconnecting any system component(s) or accessories.
Connecting Additional Equipment
This equipment is intended to be connected to other equipment thus forming
a Medical Electrical System. External equipment intended for connection to
signal input, signal output or other connectors shall comply with the relevant
product standard e.g., IEC 60950-1 for IT equipment and the IEC 60601-series
for medical electrical equipment. In addition, all such combinations – Medical Electrical
Systems – shall comply with the safety requirements stated in the general standard IEC
60601-1, edition 3, clause 16. Any equipment not complying with the leakage current
requirements in IEC 60601-1 shall be kept outside the patient environment i.e., at least 1.5
m from the patient support or shall be supplied via a separation transformer to reduce the
leakage currents.
Any person who connects external equipment to signal input, signal output or other
connectors has formed a Medical Electrical System and is therefore responsible for the
system to comply with the requirements. If in doubt, contact a qualified medical technician
or your local representative. If the instrument is connected to a PC (IT equipment forming
a system) ensure not to touch the patient while operating the PC. If the instrument is
connected to a PC (IT equipment forming a system) assembly and modifications shall be
evaluated by qualified medical technician according to safety regulations in IEC 60601.