Maico easyTone User manual

Operation Manual
easyTone

Operation Manual easyTone
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1Introduction.................................................................................................................. 3
1.1 Intended Use Statement ........................................................................................ 3
1.2 Indications for Use Statement................................................................................ 3
1.3 Contraindications of Use........................................................................................ 3
1.4 Features and Benefits of easyTone........................................................................ 3
1.5 Description............................................................................................................. 4
2For Your Safety............................................................................................................. 5
2.1 How to Read this Operation Manual....................................................................... 5
2.2 Customer Responsibility ........................................................................................ 6
2.3 Manufacturer’s Liability .......................................................................................... 6
2.4 Regulatory Symbols............................................................................................... 7
2.5 General Precautions .............................................................................................. 8
2.6 Electrical and Electrostatic Safety.......................................................................... 8
2.7 Electromagnetic Compatibility (EMC)....................................................................10
2.8 Cyber Security and Data Protection......................................................................11
2.9 Device Control ......................................................................................................12
3Warranty, Maintenance and After-Sales Service.......................................................13
3.1 Warranty...............................................................................................................13
3.2 End User License Agreement (Tablet)..................................................................15
3.3 Maintenance.........................................................................................................15
3.4 Cleaning and Disinfection Recommendations.......................................................16
3.5 Accessories and Replacement Parts.....................................................................16
3.6 Recycling and Disposal.........................................................................................17
4Unpacking and Hardware Orientation........................................................................18
4.1 Unpacking the System..........................................................................................18
4.2 Hardware Orientation............................................................................................20
4.3 Establishing a PC Connection...............................................................................21
4.4 Powering...............................................................................................................22
4.5 Storage.................................................................................................................22
5Operating the Device...................................................................................................23
5.1 Getting started with the easyTone.........................................................................23
5.2 Switching On.........................................................................................................23
5.3 Switching Off.........................................................................................................23
5.4 AndroidTM Navigation ...........................................................................................24
5.5 Managing Protocols ..............................................................................................24
5.6 Testing..................................................................................................................28
5.7 Test Result –Screen Layout.................................................................................34
5.8 Add Notes.............................................................................................................35
5.9 easyTone Companion Software............................................................................35
5.10 Managing Test Results .........................................................................................45
5.11 Settings.................................................................................................................47
5.12 Device Information................................................................................................50
5.13 About....................................................................................................................51
5.14 Updating the easyTone App..................................................................................52
5.15 Calibration Reminder ............................................................................................53
5.16 Troubleshooting....................................................................................................53
6Technical Data.............................................................................................................54
6.1 easyTone Hardware and Software........................................................................54
6.2 Connection and Pin Assignment...........................................................................57
6.3 Calibration Values and Maximum Levels...............................................................57
6.4 Electromagnetic Compatibility (EMC)....................................................................58
6.5 Electrical Safety, EMC and Associated Standards................................................61
6.6 Checklist for Subjective Audiometer Testing.........................................................62

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Title: easyTone –Operation Manual
Date of issue/last revision: 10/05/2022
All available operation manuals can be found in
the download center on the MAICO homepage:
MAICO Diagnostics GmbH
Sickingenstr. 70-71
10553 Berlin
Germany
Tel.: + 49.30.70 71 46-50
Fax: + 49.30.70 71 46-99
E-mail: [email protected]
Internet: www.maico.biz
Germany:
International:
Copyright © 2022 –MAICO Diagnostics.
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 MAICO. The information
in this publication is proprietary to MAICO.
Compliance
MAICO Diagnostics is an ISO 13485 certified corporation.
Caution for USA: Federal Law restricts this device to sale by or on the order of a
licensed medical professional.
Trademark Notice
Android is a trademark of Google LLC.
Windows is a registered trademark of Microsoft Corp.
Mac and macOS are trademarks of Apple Inc., registered in the U.S. and other
countries and regions.

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1 Introduction
This section offers you important information about:
▪the intended use of the device
▪indications and contraindications of use
▪features and benefits
▪a description of the device
1.1 Intended Use Statement
The easyTone is a screening audiometer designed to perform a hearing screening.
The instrument is intended for all patient populations over 3 years of age and able to
respond to a test signal in a rational way.
1.2 Indications for Use Statement
The easyTone is a portable or standalone audiometer intended to be used for the
identification of hearing loss and the factors that contribute to the occurrence of the
hearing loss in the age range of children to adults. It is used as part of a total test
battery to determine hearing acuity by audiologists, ENTs, hearing healthcare
professionals, or other trained technicians under the supervision of a professional such
as an audiologist, doctor or nurse in a hospital, clinic, healthcare facility or other
suitable quiet environment as defined in ISO 8253-1 or ANSI S3.1 or equivalent.
1.3 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.
1.4 Features and Benefits of easyTone
1.4.1 General information about the easyTone
The easyTone gives you the benefit of:
•Portable headphone audiometer with tablet
•Air Conduction screening audiometry
•Site specific screening protocol creation
•Pass or Refer result with report
•Guided workflow
•Start screen adaptability
•Import / export screening lists
•Quick reporting (e-mail, printer, drive)
•Noise monitoring
1.4.2 easyTone Companion Software
The easyTone Companion Software allows you to:
•Import screening list to easyTone app
•Download subject results for easy result management

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1.5 Description
The easyTone audiometer is designed to be a device for screening for hearing loss.
Output and specificity of this type of device are based on the test characteristics
defined by the user and may vary depending on environmental and operating
conditions. The screening for hearing loss using this kind of audiometer depends on
the interaction with the patient. As with any type of hearing screening, a “pass” result
should not overrule any additional concerns regarding hearing ability. A full audiologic
evaluation should be administered if concerns about hearing sensitivity persist.

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2 For Your Safety
This section offers you important information about:
▪how to read the operation manual
▪where to spend special attention
▪the customer responsibility
▪the explanation of all regulatory symbols used
▪important cautions and warnings that have to be considered during the
whole time handling and operating your device
2.1 How to Read this Operation Manual
This Operation Manual contains information pertinent to the use of the MAICO device
system including safety information as well as maintenance and cleaning
recommendations.
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS
SYSTEM!
Use this device only as described in this manual.
All images and screenshots are only examples and may differ in
appearance from the actual device settings.
In this manual, the following two labels identify potentially dangerous or destructive
conditions and procedures:
The WARNING label identifies conditions or practices that may
present danger to the patient and/or user.
The CAUTION label identifies conditions or practices that could
result in damage to the equipment.
The information sign displays alternative documents or sections
in this operation manual that provide more detailed information.
NOTE: Notes help you identify areas of possible confusion and avoid potential
problems during system operation.
WARNING
CAUTION

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2.2 Customer Responsibility
All safety precautions given in this operation manual must be observed at all times.
Failure to observe these precautions could result in damage to the equipment and
injury to the operator or subject.
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 device, the more stringent rules should take precedence.
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 MAICO.
Customer responsibility includes proper maintenance and cleaning of the device.
Section 3.3
Maintenance
Section 3.4
Cleaning and Disinfection Recommendations
Breach of the customer responsibility can lead to limitations of Manufacturer’s
Liability and Warranty.
Section 2.3
Manufacturer’s Liability
Section 3.1
Warranty
NOTE: In the unlikely case of a serious incident, inform MAICO as well as the
competent authority in the country where the user is established.
2.3 Manufacturer’s Liability
Usage of the device in a way deviant from the intended use leads to a limitation or
termination of the manufacturer’s liability in case of damage. Improper use includes
disregarding the operation manual, the operation of the device by underqualified
personnel as well as making unauthorized alterations on the device.
WARNING

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2.4 Regulatory Symbols
Serial number
Date of manufacture
Manufacturer
Caution, consult accompanying documents
Warning, consult accompanying documents
Information sign (reference for more detailed information)
Return to authorized representative, special disposal required
Reference number
Medical Device
UDI information: (01) GTIN (Global Trade Item Number), (11)
Date, (21) Serial number
Patient applied part type B according to IEC 60601-1
Refer to operation manual (mandatory)
Keep away from rain
Transport and storage temperature range
Transport and storage humidity limitations
Transport and storage atmospheric pressure limitations
CE label with notified body ID
Non-ionizing electromagnetic radiation
Direct Current (DC)
ETL listed mark
Logo
REF

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2.5 General Precautions
Before starting a measurement make sure, that the device
works properly.
Use and store the device indoors only. For operation, storage
and transport conditions see Table in Section 6 Technical Data.
For operation in certain places, a recalibration may be
necessary.
No modification of this equipment is allowed.
No part of the equipment can be serviced ormaintained while
in use with the patient.
Do not drop or otherwise cause undue impact to this device.
If the device is dropped or otherwise damaged, return it to the
manufacturer for repair and/or calibration. Do not use the
device if any damage is suspected.
Uncalibrated devices may lead to faulty measurements and
may cause the examinee to be exposed to loud sounds.
Ensure that the device does not come into contact with
liquids. Should the user suspect fluids have contacted the
system components or accessories, the unit should not be
used until deemed safe by a MAICO certified service
technician.
2.6 Electrical and Electrostatic Safety
This icon indicates that patient applied parts of the device
conform to IEC 60601-1 Type B requirements.
In Case of Emergency
In case of emergency, disconnect the audiometer
headphone from the tablet.
In case of emergency, disconnect the tablet from the
computer.
In Case of Emergency
In case of emergency, disconnect the device from power
supply.
Position the device in such a way that it can be easily
disconnected from the power supply at any time.
Do not use the device if the power supply unit and/or the
plug is damaged.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

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DatatransfertothePCcanbedoneviaWiFiorUSBconnection.
To learn how to safely establish a PC connection with a power
suppliedPCorlaptopviaUSBconnection(medicaldevice/non-
medical device) or to a battery-driven laptop see:
Section 4.3
Establishing a PC Connection
Thisequipmentisintendedtobeconnectedtootherequipment
thus forming a Medical Electrical System. External equipment
intended for connection to signal input, signal output or other
connectorsshallcomply withthe relevantproductstandarde.g.
IEC 60950-1 for IT equipment and the IEC 60601-series for
medical electricalequipment.Inaddition,allsuchcombinations
–Medical Electrical Systems –shall comply with the safety
requirements stated 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
equipmenttosignalinput,signaloutputorotherconnectorshas
formed a Medical Electrical System and is therefore
responsible for the system to comply with the requirements. If
in doubt, contact qualified medical technician or your local
representative.
A Separation Device (isolation device) is needed to isolate
the equipment located outside the patient environment from
the equipment located inside the patient environment. In
particular such a Separation Device is required when a
network connection is made. The requirement for the
Separation Device is defined in IEC 60601-1 clause 16.
If the device 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-series.
Do not touch the contacts of the device/tablet and the
patient at the same time.
If the tablet is connected to a PC (IT equipment forming a
system) do not touch the patient and the IT equipment at
the same time.
The consequence of not following this warning could be a
too high leakage current to the patient.
WARNING
WARNING
WARNING
WARNING
WARNING

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The device is not intended for operation in areas with an
explosion hazard. Do NOT use the device in a highly
oxygen-enriched environment, such as a hyperbaric
chamber, oxygen tent, etc. If the device is not used switch it
off and disconnect it from the power supply.
Never short-circuit the terminals.
To avoid the risk of electric shock, this equipment must only
be connected to the medical power supply originally
delivered by MAICO. Using another power supply can also
lead to electrical damage on the device.
Prevent cable breakage: cables must not be bent or
buckled.
2.7 Electromagnetic Compatibility (EMC)
This device is suitable in hospital environments except for
near active HF surgical equipment and RF shielded rooms of
systems for magnetic resonance imaging, where the intensity
of electromagnetic disturbance is high.
The device fulfills the relevant EMC requirements.
Avoid unnecessary exposure to electromagnetic fields, e.g.,
from mobile phones etc.
Use of this device adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this device and
the other equipment should be observed to verify that they
are operating normally.
Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
The list of accessories, transducers and cables can be found in:
Section 6.1
easyTone Hardware
Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part
of the easyTone, including cables specified by the
manufacturer. Otherwise, degradation of the performance of
this equipment could result in improper operation.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

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2.8 Cyber Security and Data Protection
To ensure data protection it is essential to follow common practice in terms of cyber
security. This involves:
1. Ensure operating systems are security patched
2. Keep your software up to date.
3. Install only apps and software from trusted sources.
4. Install an antivirus protection and anti-malware software and a firewall from a
trusted vendor and keep them up to date.
5. Utilize the tablet/PC password settings and use safe passcodes.
6. Ensure secure physical and network access to computers with local data
storage.
7. Implement an appropriate backup policy.
8. Do not use public WiFi.
9. Learn about phishing scams: Be very suspicious of emails and calls.

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Permanent Deletion of Test Data
NOTE: We recommend permanently deleting the test data before selling the easyTone
system to protect personal data to protect personal data from misuse.
To permanently delete test data, proceed as follows:
Figure 1
Press the easyTone app icon until the info selection dialog box
opens (Figure 1). Open the App info and press Storage &
cache (Figure 2).
Figure 2
Press CLEAR STORAGE and CLEAR CACHE to
permanently delete all test data (Figure 3).
Figure 3
2.9 Device Control
The user of the device should perform a subjective device check once a week
according to ISO 8253-1.
For a checklist see:
Section 6.6
Checklist for Subjective Audiometer Testing
For annual calibration please see sections:
Section 2.5
General Precautions
Section 3.3
Maintenance

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3 Warranty, Maintenance and After-Sales Service
This section offers you important information about:
▪warranty conditions
▪maintenance
▪cleaning and disinfection recommendations
▪accessory and replacement parts
▪recycling and disposal of the device
3.1 Warranty
3.1.1 General
The MAICO device is guaranteed for at least 1 year. Ask your authorized local
distributor for more information.
This warranty is extended to the original purchaser of the device by MAICO through
the distributor from whom it was purchased and covers defects in material and
workmanship for a period of at least one year from date of delivery to the original
purchaser.
The device shall only be repaired and serviced by your distributor or by an authorized
service center. Opening the device case will void the warranty.
In the event of repair during the guarantee period, please enclose evidence of
purchase with the device.
3.1.2 Ownership, Warranty and Disclaimer (Software)
Ownership
The easyTone Software (hereinafter the “SOFTWARE”) is solely owned by MAICO
Diagnostics GmbH, Sickingenstr. 70-71, D-10553 Berlin, Germany. By purchasing the
SOFTWARE the buyer is entitled the right of usage, but not ownership of the
SOFTWARE. The SOFTWARE is to be used in accordance to the agreed terms of
usage provisioned by MAICO.
Copyrights
MAICO’s ownership of the SOFTWARE covers worldwide and is therefore, protected
against any unauthorized copying of the SOFTWARE. Non conformity of use of the
SOFTWARE is strictly prohibited.
Restrictions
You may not:
Reverse engineer or attempt in any manner to discover the source code of the
SOFTWARE.
Attempt to defeat any mechanisms in the SOFTWARE, including those mechanisms
responsible for password protection of data and limiting the number of concurrent
users.

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Rent, lease, sublicense or in any manner, copy or transfer (except as permitted above)
the SOFTWARE.
Obscure or obliterate any MAICO copyright or trademark notices which appear on the
SOFTWARE, the documentation, the screen-display, or otherwise in connection with
the SOFTWARE.
MAICO specifically calls your attention to the fact that, any violation or infringement of
above restrictions will result in legal action.
The SOFTWARE can be used by any number of users, on any number of computers,
and in any place, provided but not on more than one display screen at the same time.
Limited Warranty
MAICO warrants that any physical media and physical documentation provided by
MAICO are free of defects in materials and workmanship. This limited warranty is
effective for a period of ninety (90) days from the original purchase date.
If MAICO receives notification within the warranty period of defects in materials or
workmanship and determines that such notifications are correct, MAICO will replace
defective media or documentation.
Do not return any product until you have obtained authorization to do so from your
supplier. The entire and exclusive liability and remedy for breach of this limited
warranty shall be limited to replacement of defective media or documentation supplied
by MAICO, and shall not include or extend to any claim for or right to recover any other
damages, including but not limited to, loss of profit, data, or use of the SOFTWARE, or
special, incidental or consequential damages, or other similar claims, even if MAICO
has been specifically advised of possibility of such damages. In no event will MAICO’s
liability for any damages to you or any other person ever exceed the lowest list price
or the actual price paid for the license to use the SOFTWARE, regardless of the form
of the claim.
Disclaimer
MAICO covers; including but not limited to; all warranties, representations and terms
and conditions, either expressed or implied; under specified terms of use and
application of the SOFTWARE for its specific purpose. All other terms and conditions
shall not apply.
Furthermore, MAICO does not guarantee that the SOFTWARE or Documentation is
free of bugs, or fulfill the relevant standards, requirement or needs of a user. In this
case, all the warranties, guarantees and terms and conditions on all MAICO delivered
physical disk and documentation shall be limited to the 90 days warranty period.
MAICO is not liable for any third party’s product, disks, SOFTWARE or documentation
that is used in conjunction with MAICO’s SOFTWARE or programs, but is not directly
manufactured or supplied by MAICO.
NOTE: A list of applied third party’s software can be found in the About screen.
Section 5.13
About

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General Terms and Conditions
Any change made to this Agreement shall be notified in writing, agreed and signed
between both parties, namely the purchaser of the SOFTWARE and a representative
of MAICO.
In the event that the essential purpose of the above remedy (limited warranty) is not
fulfilled, all other limited liability including the liability limits and exclusions of damage
claims shall continue to apply.
This SOFTWARE License Agreement shall be interpreted and construed according to,
and governed by, the laws of Jurisdiction of Federal Republic of Germany.
In the event that any legal or commercial dispute or controversy arising out of, or
relating to this agreement; provided MAICO is in all case violated of the rights, to the
SOFTWARE or other intellectual property protection right related to the SOFTWARE;
shall be presented under the Jurisdiction of Federal Republic of Germany in the court
of Berlin.
The SOFTWARE is protected under both Copyright Law and the International
Copyright Treaties. Copying of the SOFTWARE is strictly prohibited except for copies
made of the SOFTWARE for backup purposes to protect data loss.
3.2 End User License Agreement (Tablet)
By using the device, you agree to the End User License Agreement from AndroidTM
and Lenovo.
3.3 Maintenance
In order to ensure that the device works properly, it has to be checked and calibrated
at least once every 12 months.
The service and calibration must be performed by your dealer or by a service center
authorized by MAICO.
When returning the device for repairs or calibration it is essential to send the
audiometer headphones and tablet. Please include a detailed description of faults. In
order to prevent damage in transit, please use the original packing when returning the
device.

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3.4 Cleaning and Disinfection Recommendations
It is recommended that parts (device and accessories like headphones, ear cushions)
which come in direct contact with the patient be subjected to standard cleaning and
disinfecting procedure between patients.
Recommendations for cleaning and disinfection of MAICO device presented in this
document are not intended to replace or contradict policies in effect or procedures
required for infection control at the facility.
If there is not a high infection potential, MAICO recommends:
•Before cleaning always switch off the tablet and disconnect the headphones
from the tablet.
•For cleaning the headphones use a lightly dampened cloth with soap water
solution. For cleaning the tablet follow the instructions of the manufacturer of the
tablet.
•Disinfect the plastic housing of the easyTone and its accessories by wiping the
surfaces with wet disinfectant wipes. Follow the instructions on the specific
disinfection product.
oWipe before and after each patient
oAfter contamination
oAfter infectious diseases
•Disinfect tablet, computer, keyboard, etc. with wet disinfection wipes:
oonce a week
oafter contamination
owhen polluted
To avoid damage of the device and its accessories, please
mind the following:
Do not autoclave or sterilize.
Do not use the device 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 MAICO certified service technician.
Do not use hard or pointed objects on the device or its
accessories.
3.5 Accessories and Replacement Parts
Some reusable components are subject to wear with use over time. MAICO
recommends that you keep these replacement parts available (as appropriate for your
easyTone device configuration). Ask your authorized local distributor when
accessories need to be replaced.
CAUTION

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3.6 Recycling and Disposal
Within the European Union it is illegal to dispose of electric and
electronic waste as unsorted municipal waste. According to
this, all MAICO products sold after August 13, 2005, are
marked with a crossed-out wheeled bin. Within the limits of
Article (9) of DIRECTIVE 2002/96/EC on waste electrical and
electronic equipment (WEEE), MAICO has changed their sales
policy. To avoid additional distribution costs we assign the
responsibility for the proper collection and treatment according
to legal regulations to our customers.
Non-European
countries
Outside the European Union, local regulations should be
followed when disposing of the product after its useful life.

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4 Unpacking and Hardware Orientation
This section provides information on:
▪unpacking the device
▪becoming familiar with the hardware including connections
▪system assembly
▪how to power the device
▪how to store the device
4.1 Unpacking the System
Check Box and Contents for Damage
•It is recommended that you unpack your easyTone and the tablet carefully
making sure that all components are removed from the packing materials.
•Verify that all components are included as shown on the packing slip included
with your shipment.
•If any component is missing, contact your distributor immediately to report the
shortage.
•If any component appears to be damaged in shipment, contact your distributor
immediately to report it. Do not attempt to use any component or device that
appears to be damaged.
Reporting Imperfections
Notify the carrier immediately if any mechanical damage is noted. This will ensure that
a proper claim is made. Save all packaging material so the claim adjuster can inspect
it as well.
Report Immediately any Faults
Any missing part or malfunction should be reported immediately to the supplier of the
device together with the invoice, serial number, and a detailed report of the problem.
Keep Packaging for Future Shipment
Save all the original packing material and the shipping container so the device can be
properly packed if it needs to be returned for service or calibration.