Grason-Stadler gsi 39 User manual

GSI 39™
USER MANUAL
Part Number D-0121780 Rev .C
Setting The Clinical Standard www.grason-stadler.com
Grason-Stadler, 10395 West 70th Street, Eden Prairie, MN, USA55344
800-700-2282 • 952-278-4402 • fax [phone] • e-mail [email protected]

Title: GSI 39 Auto Tymp User Manual
Manufacturer
Grason-Stadler, Inc.
10395 West 70
th
Street
Eden Prairie, MN 55344
USA
Copyright © 2019 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.
Compliance
The CE 0123 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-
Stadler is an ISO 13485 certified corporation.
European Authority Representative
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.

TABLE OF CONTENTS
TABLE OF CONTENTS...............................................................................................................................3
Preface ....................................................................................................................................................9
Safety Summary..................................................................................................................................9
Warning...........................................................................................................................................9
Caution............................................................................................................................................9
Notes...............................................................................................................................................9
Safety Notes........................................................................................................................................9
Warning: Service Symbol ..................................................................................................................10
Customer Responsibility ...................................................................................................................10
Regulatory Symbols ..........................................................................................................................12
Device Symbols .................................................................................................................................14
Safety Precautions ................................................................................................................................15
Cautions - General.........................................................................................................................15
Cautions –Warm Elements...........................................................................................................16
Warning –Connection Additional Equipment ..............................................................................16
Warning –Electric Shock Hazards.................................................................................................16
Warning –Explosion .....................................................................................................................16
Warning –Connections.................................................................................................................16
Warning –General ........................................................................................................................16
Warning –Voltage / Current Detectors........................................................................................17
Recycling / Disposal ..........................................................................................................................17
Warranty and Repair.............................................................................................................................18
Indications for Use................................................................................................................................19
Introduction ......................................................................................................................................19
Tympanometry and Gradient ..........................................................................................................21
Gradient ............................................................................................................................................22
Screening Acoustic Reflex .................................................................................................................22
Screening Audiometry ......................................................................................................................24
Unpacking and Inspection.....................................................................................................................25
Standard Components - General ......................................................................................................25
Combo Probe -related Components.................................................................................................26
Optional Accessories.........................................................................................................................26
GSI 39 Initial Set Up...............................................................................................................................27

Components......................................................................................................................................28
Display and Printer........................................................................................................................28
Probe (226 Hz)...............................................................................................................................28
Combo Probe (226Hz and 1kHz) ...................................................................................................28
Rear Panel Labels and Connectors................................................................................................29
Bottom Panel ................................................................................................................................29
Loading the Paper .............................................................................................................................30
Paper Storage................................................................................................................................30
Operation..............................................................................................................................................31
226 Hz Probe Indicators....................................................................................................................31
Combo Probe Indicators (226 Hz and 1000 Hz Probe Tone) ............................................................32
Preparing the Probe Assembly......................................................................................................32
Front Panel Controls and Indicators .................................................................................................34
Individual display Formats ............................................................................................................37
226 Hz Tympanometry Screen..................................................................................................37
226 Hz Tympanometry/Reflex Screen ......................................................................................37
1000 Hz Tympanometry Screen................................................................................................38
1000 Hz Tympanometry/Reflex Screen ....................................................................................38
Audiometry Screen ...................................................................................................................39
Tympanometry Testing Information.................................................................................................40
Obtaining a Seal ................................................................................................................................40
Combo Probe Insertion.....................................................................................................................42
Audiometry Testing (Version 3 and Version 4).................................................................................43
Instructing the Patient ..................................................................................................................43
Placement of Earphones...............................................................................................................43
Placement of Insert Phones..........................................................................................................44
Response Handswitch (Optional Accessory).................................................................................44
Tympanometry/Reflex Test Sequence..............................................................................................45
Tympanometry Only Mode...........................................................................................................45
Tympanometry and Ipsilateral Reflex...........................................................................................47
Temporary Programming of Ipsilateral acoustic Reflex Test Frequencies ...................................48
Tympanometry and Contralateral Reflex (Version 2 and Version 3)............................................49
Tympanometry and Ipsilateral/Contralateral Reflexes (Version 2 and Version 3).......................51
Ipsilateral and Contralateral Acoustic Reflex testing ...............................................................51
Exit tympanometry/reflex.........................................................................................................52

Audiometry Sequence (Version 3 and Version 4).............................................................................53
To enter the Audiometry mode....................................................................................................53
Transducer Selection.....................................................................................................................53
To change the frequency ..........................................................................................................53
To change the intensity level of the test tone ..........................................................................54
Screening audiometry...............................................................................................................55
Audiometric Threshold .................................................................................................................55
Manual Threshold Audiometry.................................................................................................55
Automatic Hearing Level...............................................................................................................56
Theory of Operation..................................................................................................................56
Performing the Auto HL Procedure ..........................................................................................57
Exit audiometry.........................................................................................................................57
Tests in memory............................................................................................................................57
Page mode ................................................................................................................................58
Memory erase...........................................................................................................................58
Printing test results...................................................................................................................58
Program Mode......................................................................................................................................59
Program Mode .................................................................................................................................59
Program Mode Menu Items .........................................................................................................59
Program Menu Page 1 Option Descriptions .....................................................................................60
PROBE HZ . . . ................................................................................................................................60
TYMP OPTIONS . . .........................................................................................................................60
NORMAL BOX ASHA/NORMAL BOX OFF...................................................................................60
NEWBORN NRM ON 1k / NEWBORN NRM OFF 1k...................................................................61
50th PERCNT ON 1k / 5OthPERCNT OFF 1k ..............................................................................61
BASELINE ON 1k / BASELINE OFF 1k .........................................................................................61
AUTOSTART ON 1k / AUTOSTART OFF 1k.................................................................................61
Reflex Display....................................................................................................................................62
Reflex dB HL plus curve.................................................................................................................62
Reflex dB HL only ..........................................................................................................................62
Reflex yes/no.................................................................................................................................63
226 Hz Reflex.................................................................................................................................63
1000 Hz Reflex...............................................................................................................................63
Auto HL Setup ..............................................................................................................................64

Programming the Auto HL Procedure ......................................................................................64
Test Frequencies (Hz)................................................................................................................64
Intensity Range (dB Hz).............................................................................................................64
Start Test Ear.............................................................................................................................65
Scoring Rule...............................................................................................................................65
Tone Format..............................................................................................................................65
Language .......................................................................................................................................66
Aud Range Normal/Aud Range Narrow........................................................................................66
Print - Audiogram/Print –Aud Table ................................................................................................67
DEF XDUCER DD45 / DEF XDUCER INSERT ....................................................................................67
Program Menu Page 2 option descriptions ......................................................................................68
Data Xfer Config ............................................................................................................................68
Power Up Settings.........................................................................................................................68
PRN Header GSI/PRN Header Off/PRN Header Custom ...................................................................69
Internal Printer / External Printer.................................................................................................69
RESET TO DEFAULTS .........................................................................................................................70
Exiting the program mode........................................................................................................70
Routine Maintenance ...........................................................................................................................71
Pretest Tymp Checks.........................................................................................................................71
Calibration Quick Check for 226 Hz...............................................................................................72
Calibration Quick Check for Combo Probe ...................................................................................73
Altitude Adjustment..........................................................................................................................74
Pre-Test Audiometric Checks (Version 3 and 4 only)........................................................................76
Noise recovery period...................................................................................................................76
Elimination of ambient noise ......................................................................................................76
Biological Check ................................................................................................................................77
Preventive Maintenance...................................................................................................................78
Cleaning the system......................................................................................................................78
Cleaning and Disinfecting Agents..............................................................................................78
Cleaning patient contact reusable devices...................................................................................79
Probe Care –226 Hz Probe ...............................................................................................................80
Probe nose cone cleaning.............................................................................................................80
The O-Ring.................................................................................................................................81
The probe wire..........................................................................................................................81
Probe reassembly......................................................................................................................82

Probe Care - Combo Probe Tip ........................................................................................................83
Earphone Care (Versions 3 and 4 only) ...........................................................................................85
Paper supply .....................................................................................................................................86
Test Results ...........................................................................................................................................87
Ear canal Volume –226 Hz Probe Tone............................................................................................87
Normal ..........................................................................................................................................87
Abnormal ......................................................................................................................................87
Compliance Peak...............................................................................................................................88
Normal ..........................................................................................................................................88
Abnormal ......................................................................................................................................88
Pressure Peak....................................................................................................................................89
Normal ..........................................................................................................................................89
Abnormal ......................................................................................................................................89
Gradient ............................................................................................................................................89
Normal ..........................................................................................................................................89
Abnormal ......................................................................................................................................89
Acoustic reflex...................................................................................................................................90
Normal ..........................................................................................................................................90
Abnormal ......................................................................................................................................90
Audiometry .......................................................................................................................................90
Normal ..........................................................................................................................................90
Abnormal ......................................................................................................................................90
Special Messages and Error Codes ...................................................................................................91
Sample Test Results ..........................................................................................................................92
Computer Interface...............................................................................................................................95
Introduction ......................................................................................................................................95
Operation..........................................................................................................................................95
Transferring during normal operation..........................................................................................95
Transferring from memory pages .................................................................................................95
Other LCD screen messages..........................................................................................................95
INVALID SELECTION...................................................................................................................95
NO DATA AVAILABLE.................................................................................................................96
NOT AVAILABLE.........................................................................................................................96
Data Transfer Program Mode ...........................................................................................................96
Computer Interface...........................................................................................................................97

Interface configuration ................................................................................................................97
Cable connections ........................................................................................................................97
GSI Suite ............................................................................................................................................97
GSI Suite Interface configuration ................................................................................................97
Uploading data from the GSI 39 to GSI Suite................................................................................98
Appendix A - Technical Data .................................................................................................................99
Standards ..........................................................................................................................................99
Protective Classification....................................................................................................................99
Appendix B: Secifications....................................................................................................................100
Tympanometry Modes....................................................................................................................100
Pneumatic System ..........................................................................................................................100
Acoustic Reflex Stimuli....................................................................................................................101
Probe LED Indicators.......................................................................................................................102
Audiometry mode (Versions 3 and 4 only) .....................................................................................102
Transducers.................................................................................................................................102
Intensity Levels ...........................................................................................................................103
Tone Format................................................................................................................................103
Printer .............................................................................................................................................103
Power..............................................................................................................................................104
Environmental.................................................................................................................................104
Mechanical - Instrument.................................................................................................................104
Appendix C: Glossary of Terms ...........................................................................................................105
Appendix D: Bibliography....................................................................................................................106
Appendix E: Electromagnetic Compatibility (EMC).............................................................................107
Cautions regarding EMC .................................................................................................................107
Guidance and manufacturer’s declaration Electromagnetic emissions .........................................108
Recommended separation distances between portable and mobile RF communications equipment
........................................................................................................................................................109
Guidance and Manufacturer’s Declaration Electromagnetic Immunity.........................................110

Page 9 of 112
PREFACE
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!
Safety Summary
In this manual, two symbols identify potentially dangerous or destructive conditions and procedures.
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.
NOTES
NOTE: Notes help you identify areas of possible confusion and avoid potential problems during
system operation
Safety Notes
WARNING The GSI 39 is designed for compliance to IEC and UL 60601-1 when
used in the patient vicinity. To achieve this compliance, the GSI 39 is equipped with a specific power
transformer (ref: 8511988), which should not be interchanged with any other transformer or supply.
Any program aimed at obtaining reliable records of hearing thresholds should be staffed and
supervised by appropriately-trained individuals.
Latex is not used anywhere in the manufacturing process.
The base material for the earphone cushions is made from natural and synthetic rubber.
The material used to manufacture GSI’s eartips is Krayton Thermoplastic Rubber.

Page 10 of 112
Warning: Service Symbol
WARNING
The indicates the location of a service adjustment part and is intended for service
personnel only. The GSI 39 is a specifically calibrated audiometer and Tympanometer,
and the periodic service and adjustments for the instrument that may be required should be done
only by an authorized GSI service technician.
Please read the entire manual prior to using the GSI 39 to become familiar with the test functions and
proper accessory connections.
Accessory equipment connected to the analog and digital interfaces must be certified to the
respective IEC standards (IEC950 for data processing or IEC 60601-1 for medical equipment).
Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Everyone who
connects additional equipment to the signal input or signal output port configures a medical system
and is therefore responsible that the system complies with the requirements of the system standard
IEC60601-1-1. If in doubt, consult the technical service department or a local GSI representative.
Customer Responsibility
WARNING
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. Parts
which may be broken or missing or are plainly worn, distorted or contaminated should be replaced
immediately with clean, genuine replacement parts manufactured by or available from GSI.
The responsibility of GSI for a malfunction product is limited by the warranty set forth in this manual.
Should repair or replacement of this product become necessary after the warranty period, the
customer should seek advice from GSI Technical Support prior to such repair or replacement. If this
product is in need of repair, it should not be used until all repairs have been made and the unit is
functioning properly and ready for use. The owner of this product has sole responsibility for any
malfunction resulting from improper use or maintenance, or repair by anyone other than GSI, and
from any malfunction caused by parts that are damaged or modified by anyone other than GSI.
This product should not be used in the presence of fluid that can come into contact with 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 a GSI certified service
technician.
Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of
explosions or fire when using this device in close proximity to flammable anesthetic gases.

Page 11 of 112
Periodically, have a service technician perform electrical safety checks on the unit in order to show
continued compliance to IEC and UL 60601-1.

Page 12 of 112
Regulatory Symbols
Symbol
Description
Conforms to European Medical Device Directive 93/42/EEC.
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.
Symbol for “European Representative.”
Symbol for “Manufacturer.”
Symbol for “Date of Manufacture.”
China RoHS symbol for products with a 50 year life cycle.
Type B 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.

Page 13 of 112
Symbol
Description
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.

Page 14 of 112
Device Symbols
The following symbols appear on the instrument
Symbol
Description
Type B Equipment
Attention, Consult Accompanying Documents
Stand-By Switch
DC Power
Patient Response Handswitch
Left Ear
Right Ear
Printer Connector
Computer Connector
USB Type Connectors
Power Supply Part Number
 
    


Page 15 of 112
SAFETY PRECAUTIONS
WARNING
The following safety precautions must be observed at all times. 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 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.
This device should only be used by hearing health care professionals such as an audiologist,
otolaryngologist, researcher or a technician under the direct supervision by the fore mentioned
specialist. User 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.
The maximum sound levels that can be generated by the system can cause serious injury to the ear.
Before attaching the earphones to the patient, ensure that:
a. The system is running.
b. The hearing levels in the test set to be used are appropriate.
c. A biologic check of the stimulus has been performed by the operator.
The customer is responsible for maintaining all system software in a safe, secure location.
ANY EQUIPMENT CONNECTED TO THE GSI INSTRUMENT AND USED IN THE PATIENT VICINITY MUST
BE POWERED BY AN ISOLATED POWER SOURCE TO MAINTAIN THE ELECTRICAL SAFETY OF THE
OVERALL SYSTEM. The isolated power source can be purchased directly from GSI, or elsewhere when
approved for use by GSI.
CAUTIONS - GENERAL
If the system is not functioning properly, do not operate it until all necessary repairs are made and the
unit is test and calibrated for proper functioning in accordance with Grason-Stadler published
specifications. Equipment is not user repairable. Repairs and battery replacement must be performed
by a qualified service representative only.

Page 16 of 112
CAUTIONS –WARM ELEMENTS
In conditions at the high limit of the operating temperature (40 degrees), certain parts of the probe,
and the event switch may reach a temperature of 46 degrees Celsius. Incidental contact of these parts
with the patient should be avoided and must be limited in duration to less than 10 minutes.
WARNING –CONNECTION ADDITIONAL EQUIPMENT
Accessory equipment connected to the analog and digital interfaces must be certified to the
respective IEC standards (IEC 950 for data processing or IEC 60601-1 for medical equipment and/or
appropriate European Directives). Furthermore, all configurations shall comply with the system
standard IEC 60601-1-1. Everyone who connects additional equipment to the signal input or signal
output port configures a medical system, and is therefore responsible for the system compliance with
the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service
department or your local representative. Connect all nonmedical equipment to the GSI Isolated Power
Supply.
The AC power outlets on the isolation transformer/power box are intended for use with GSI approved
components only. Use of any other equipment may result in damage to the power unit. Follow all
safety standards set by each place of employment.
NOTE: If the Instrument is connected to a PC, power to the monitor and computer must be
controlled by the isolation transformer. Always leave the monitor and computer power switches in
the ON position and control power from the isolation transformer. Always turn OFF system power
before connecting or disconnecting system components to help guard against personal injury.
WARNING –ELECTRIC SHOCK HAZARDS
Do not open the case of the GSI instrument. Do not remove any GSI instrument covers. Refer servicing
to qualified personnel.
WARNING –EXPLOSION
This system is not explosion proof. Do not use in the presence of flammable anesthetics or other gases.
WARNING –CONNECTIONS
Do not switch on any system power until all cables have been properly connected and verified. See
this manual for setup instructions, which accompanies all deliveries of the system. Switch off the
system power before connecting or disconnecting any system component(s) or accessories. This may
damage the device(s).
WARNING –GENERAL
Proper use of this device depends on careful reading of all instructions and labels. Follow all safety
standards set by each place of employment.

Page 17 of 112
WARNING –VOLTAGE / CURRENT DETECTORS
If voltage or current detectors are tripped the outputs will be muted.
Recycling / Disposal
Many local laws and regulations require special procedures to recycle or dispose of
electrical equipment and related waste including batteries, printed circuit boards,
electronic components, wiring and other elements of electronic devices. Follow all local
laws and regulations for the proper disposal of batteries and any other parts of this
system.
Below is the contact address for proper return or disposal of electronic wastes relating to Grason-
Stadler products in Europe and other localities. The contact information for the WEEE in Europe:
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark

Page 18 of 112
WARRANTY AND REPAIR
We, Grason-Stadler, warrant that this product is free from defects in material and workmanship and,
when properly installed and used, will perform in accordance with applicable specifications. This
warranty is extended to the original purchaser of the instrument by GSI through the distributor from
whom it was purchased and covers defects in material and workmanship for a period of one year
from date of delivery of the instrument to the original purchaser. If within one year after original
shipment, it is found not to meet this standard; it will be repaired, or at our option, replaced at no
charge except for transportation costs, when returned to an authorized Grason-Stadler facility. If
field service is requested, there will be no charge for labor or material; however, there will be a
charge for travel expense at the service center’s current rate.
NOTE: Opening the instrument case or changes to the product not approved in writing by
Grason-Stadler shall void this warranty. Grason-Stadler shall not be responsible for any indirect,
special or consequential damages, even if notice has been given in advance of the possibility of
such damages. The transducers may go out of calibration due to rough handling or impact
(dropping). The lifetime of probe, probe seals and eartips is dependent upon conditions of use.
These parts are only guaranteed against faulty materials or manufacture.
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.
We advise you against attempting to rectify any faults by yourself or commissioning non-experts to
do so. Equipment is not user repairable. Repairs must be performed by an authorized service
representative only.
WARNING
No modifications of the equipment are allowed by anyone other than a qualified GSI
representative. Modification of the equipment could be hazardous. If this equipment
is modified, appropriate inspection and testing must be conducted to ensure
continued safe use of the equipment.
In order to ensure that your instrument works properly, the GSI GSI 39 should be checked and
calibrated at least once per year. This check must be carried out by your dealer or authorized GSI
service facility.
When returning the instrument for repairs or calibration it is essential to send the acoustic
transducers with the device. Send the device to an authorized service center only. Please include a
detailed description of faults. In order to prevent damage in transit, please use the original packing
if possible when returning the instrument.

Page 19 of 112
INDICATIONS FOR USE
The GSI 39 is an audiometric screening product that offers basic pure tone audiometry and
tympanometry with reflex. The GSI 39 is available with both 226Hz and 1Khz probe tones to
accommodate testing for patients between the ages of birth through geriatric. The instrument is to
be used by trained personnel only, such as audiologists, ENT surgeons, physicians, hearing healthcare
professionals or personnel with a similar level of education. This device should not be used without
necessary knowledge and training to understand its use and how results should be interpreted.
Introduction
The GSI 39 Auto Tymp (hereafter referred to as ‘instrument’ in this guide unless otherwise noted for
clarity) is a versatile combination instrument that provides testing capability for tympanometry alone,
tympanometry combined with screening acoustic reflex measurements, and screening audiometry.
Five different versions are available to meet individual testing needs.
•Version 1 - tympanometry alone and tympanometry plus screening ipsilateral acoustic reflex
testing.
•Version 2 - tympanometry alone and tympanometry plus ipsilateral and contralateral
screening acoustic reflex measurements.
•Version 3 - tympanometry alone, tympanometry plus ipsilateral and contralateral screening
acoustic reflex measurements, and screening audiometry, both manual and automated.
•Version 4 - tympanometry alone, tympanometry plus ipsilateral acoustic reflex screening
testing, and screening audiometry, both manual and automated.
•Version 5 - tympanometry only.
It is possible to upgrade versions 1, 2, 4 and 5 with the full functionality provided with version 3 after
the time of original purchase.
Each version can be ordered with the Combo Probe that allows for both 226 Hz and 1000 Hz probe
tone. 1000 Hz probe tone is recommended for testing on infants 0 - 6 months of age.
An optional soft-sided carrying case is available for portability. Also, a patient handswitch, patch cords,
and earphone sound enclosures may be purchased as optional accessories.
WARNING
The GSI 39 is designed to be used with a hospital grade outlet. Injury to personnel or
damage to equipment can result when a three-prong to two-prong adapter to is
connected between the GSI 39 power plug and an AC outlet or extension cord.
Additionally, the GSI 39 is equipped with a specific power transformer (8511988), which should not
be interchanged with any other transformer or supply. The GSI 39 is a specifically calibrated device
and the periodic service and adjustments, which the instrument may require, should be done only by

Page 20 of 112
an authorized GSI service technician.
CAUTION
The GSI 39 is designed to comply with the EMC requirements according to IEC 60601 1-
2 Radio transmitting equipment, cellular phones, etc. should not be used in the close
proximity of the device since this could influence the performance of the device.
Particular caution must be considered during use of strong emission sources such as high frequency
surgical equipment and similar devices. If in doubt, contact a qualified technician or a local GSI
representative.