Carestream DENTAL CS 8 200 3D User manual

CS 8200 3D
English
Safety, Regulatory and Technical Specications User Guide

2CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
Notice
The Regulatory Information and Technical Specifications User Guide for CS 8200 3D includes
information on the safety instructions, regulatory information and the technical specifications of the
devices. We recommend that you thoroughly familiarize yourself with this guide to make the most
effective use of your system.
The CS 8200 3D comprises the panoramic modality and the dental volumetric reconstruction modality
(3D focused teeth acquisition and the 3D full upper and lower jaw acquisition).
The CS 8200 3D can be upgraded to cephalometric modality with the Scan Ceph module option.
This document refers to all models as CS 8200 3D unless otherwise specified.
The information contained in this guide may be subject to modification without notice, justification
or notification to the persons concerned.
No part of this guide may be reproduced without the express permission of CarestreamDental LLC.
U.S. Federal law restricts this device to sale by or on the order of a dentist or physician.
This document is originally written in English.
Manual Name: CS 8200 3D Safety, Regulatory and Technical Specifications User Guide
Part Number: SMA67
Revision Number: 02
Print date: 2022-01
The CS 8200 3D complies with Medical Device Directive 93/42/EEC until September 14th, 2022.
After this date, the product will be certified according to Medical Device Regulation (EU) 2017/745
and UK Medical Devices Regulations 2002 (SI 618) as subsequently amended by the EU Exit
Regulations of 2019 (SI 791) and 2020 (SI 1478).

CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02 3
Contents
1Safety Information ...................................................................- 4 -
Indications for Use.......................................................................................................- 4 -
Clinicl benefits and performance characteristics.....................................................- 5 -
Conventions in this Guide...........................................................................................- 5 -
Note to the User............................................................................................................- 6 -
Warning and Safety Instructions ................................................................................- 6 -
Precaution before use..................................................................................................- 8 -
Cleaning and Disinfection ...........................................................................................- 8 -
Marking and Labeling Symbols ................................................................................- 13 -
Label Locations..........................................................................................................- 14 -
CS 8200 3D Labels.........................................................................................- 14 -
2Regulatory Information .........................................................- 16 -
General Regulatory Information ...............................................................................- 16 -
Compliance with International Regulations.............................................................- 20 -
3Technical Specifications.......................................................- 21 -
Model ...........................................................................................................................- 21 -
CS 8200 3D Technical Specifications.......................................................................- 21 -
Minimum Computer System Requirement...............................................................- 24 -
X-ray Dose Emission Information.............................................................................- 25 -
Panoramic mode for CS 8200 3D.................................................................- 27 -
3D mode for CS 8200 3D...............................................................................- 29 -
Cephalometric mode for CS 8200 3D with Scan Ceph configuration......- 31 -
User Dose information...............................................................................................- 33 -
Stray radiation in Panoramic Mode.............................................................- 33 -
Stray radiation in 3D Mode...........................................................................- 34 -
Stray radiation in cephalometric mode.......................................................- 35 -
Imaging performance information............................................................................- 36 -
Panoramic and Cephalometric.....................................................................- 36 -
3D....................................................................................................................- 36 -
Controlling the Image Quality ...................................................................................- 36 -
CS 8200 3D Environmental Requirements...............................................................- 37 -
CS 8200 3D Electrical Specifications .......................................................................- 38 -
X-ray Tube Assembly Technical Specifications......................................................- 40 -
4 Contact Information ...............................................................- 48 -
Manufacturer’s Address ............................................................................................- 48 -
Factory.........................................................................................................................- 48 -
Authorized Representatives......................................................................................- 48 -
List of Importers for European Union according MDR 2017/745...........................- 48 -
List of Importers for Switzerland ..............................................................................- 49 -

4CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
1 Safety Information
Indications for Use
The CS 8200 3D is intended to produce complete or segmented tomographic digital panoramic
images and three-dimensional digital X-ray images of the dento-maxillofacial area to be used at
the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
In addition, the CS 8200 3D can be upgraded to produce cephalometric digital X-ray images. This
includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
The CS 8200 3D can be upgraded to cephalometric modality with the Scan Ceph module option.
The following chart illustrates the different product configurations of the CS 8200 3D:
This document refers to all models as CS 8200 3D unless otherwise specified.

CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02 5
WARNING: Do not use cone beam imaging for routine or screening
examinations. Consider using other diagnostic tools. You must
justify that the imaging method that you use to examine each patient
demonstrates that the benefit outweighs the risks.
Clinicl benefits and performance characteristics
CS 8200 3D benefits healthcare professionals by allowing them to acquire digital X-ray images
(two-dimensional and three-dimensional) of the dento-maxillofacial regions as diagnostic support
for pediatric and adult patients.
CS 8200 3D essential performance concerns accuracy of loading factors and the reproducibility
of the radiation output
Conventions in this Guide
The following special messages emphasize information or indicate potential risk to personnel or
equipment:
WARNING: Warns you to avoid injury to yourself or others by
following the safety instructions precisely.
CAUTION: Alerts you to a condition that might cause serious damage.
Important: Alerts you to a condition that might cause problems.
Note: Emphasizes important information.
Tip: Provides extra information and hints.

6CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
Note to the User
WARNING: X-rays can be harmful and dangerous if not used
properly. The instructions and warnings contained in this guide
must be followed carefully.
As a manufacturer of radiology units that conform to stringent radiological protection standards in
force throughout the world, we guarantee as low as reasonably achievable degree of protection
against radiation hazards. Nonetheless, you are handling a radiology unit specially designed to
emit X-ray doses in order to carry out a medical diagnosis.
The room in which your radiology unit is to be installed must comply with all official regulations
applicable to protection against radiation. You must install your radiology unit in a room protected
against X-ray emission.
Your local representative will assist you in the initial use of your radiology unit and will supply any
relevant information you may require.
To use and operate the unit you must follow the instructions contained in this guide.
Warning and Safety Instructions
When operating CS 8200 3D, observe the following warning and safety instructions:
Important: All known residual risks, contra-indications or undesirable side-
effects are listed in this guide. If any serious incident occurs in relation to
the device, you must report it to Carestream Dental and to the competent
authority in your country.
DANGER OF ELECTRIC SHOCK
This is an electrical unit. Do NOT expose it to water spray. Such action
may cause an electric shock or a malfunction of the unit.

CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02 7
WARNINGS
Unit
Read and understand this Safety Information before using the unit.
You are responsible for the operation and maintenance of this unit. Only
legally qualified persons can operate this unit. They MUST have training to
use the radiological equipment. Do NOT open the cover of the unit. When
necessary, have a trained authorized service technician carry out inspection
and maintenance operations.
Install this unit in an X-ray room that complies with current installation
standards. From this location, you must be able to maintain visual or audio
communication with the patient and be able to access the Acquisition
interface module during exposure.
This unit must be permanently connected to the ground with a fixed power
supply cable. To avoid the risk of electric shock, this equipment must ONLY
be connected to a mains supply with protective earth.
Do NOT operate the unit if there is the threat of an earthquake. Following an
earthquake, ensure that the unit is operating satisfactorily before using it
again. Failure to observe this precaution may expose patients to hazards.
X-ray equipment is hazardous to patients and the operator if you do not
observe the exposure safety factors and operating instructions.
Considering radiation safety of pediatric population, protocol for Acquisition
on Pediatric patients must be followed. For more information on imaging
pediatric patients more safely and effectively, refer to FDA Pediatric X-ray
Imaging webpage:
http://www.fda.gov/radiation-
emittingproducts/radiationemittingproductsandprocedures/medicalimaging
/ucm298899.htm
Do NOT place objects within the field of operation of the unit.
The patient should wear a protective lead-lined shoulder apron with a thyroid
collar, unless other Radiation Protection Protocols apply locally.
While adjusting the height of the unit, ensure that the patient is kept clear of
the mechanism.
When the unit is not in use, ensure that the ON/OFF switch is set to OFF (O).
If the unit develops a fault, switch it to off (O), display an “Unserviceable”
notice and contact a service technician.
Ask the patient to refrain from moving during the entire period of exposure.
Ask the patient to remain still until the unit arm has stopped moving and the
RESET movement has completed.
Do NOT use this unit in conjunction with oxygen-rich environments. This
unit is not intended for use with flammable anesthetics or flammable agents.
Do NOT hang from the cephalostat
It is not recommended to use accessories other than those specified in this
document and sold by Carestream Dental.
The Technician who installs the unit has the responsibility to warn
Carestream Dental if the post installation produces a failed error message
which, if ignored, can result in the improper installation of the unit.

8CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
Computer
Do NOT place the computer and the peripheral equipment connected to
it in the immediate vicinity of the patient in the unit. Leave at least 1.83m
distance between the patient and the unit. The computer and the
peripheral equipment must conform to the IEC 60950-1 or IEC 62368-1
standard.
See your computer installation guide for details of the data processing
system and screen. Leave a sufficient amount of clear space around the
CPU to ensure that it is properly ventilated.
To obtain maximum image quality and visual comfort, position the screen
to avoid direct light reflections from internal or external lighting.
Always use Microsoft Windows Update to make sure that the latest
security patches are correctly installed.
Disposal:
This equipment contains certain materials and chemical compounds inci-
dental to the manufacture of electrical and electronic equipment, and im-
proper “end-of-life” disposal of such equipment can result in environmental
contamination. Therefore, this equipment should not be disposed of as or-
dinary household waste but should instead be delivered
to a designated
electrical and electronic waste disposal or recycling center. For further in-
formation on disposing of electrical and electronic waste, contact the cogni-
zant authority within the local jurisdiction.
To dispose of the unit or its components, contact a service technician.
Precaution before use
Perform the following Cleaning and Disinfection activities on your product and accessories before
use.
Cleaning and Disinfection
Cleaning the unit
To clean the unit, follow these steps:
1. Switch off the unit.
2. Remove all visible soil, if any, with disposable cloth or paper wipe.
Note: No disassembly shall be performed on the unit
3. Dampen (not soak) a lint-free cloth with soap and running water.
4. Thoroughly clean manually all accessible parts of the unit, including the temporal head
clamps, with the dampened lint-free cloth.
5. Dry the unit with hygienic disposable cloth.

CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02 9
6. Dampen (not soak) a lint-free cloth with a low-level disinfectant that is U.S. Environ-
mental Protection Agency (EPA)-registered or low-level disinfectant that is recognized by
your Local Authority (for example, quaternary ammonium compounds and some phenol-
ics). An EPA-registered hospital disinfectant or any other low-level disinfectant must have
clear label claims for intended use.
7. Wipe thoroughly on all accessible parts of the unit with the dampened lint-free cloth.
You must follow the disinfectant’s manufacturer instructions for use, especially
with respect to contact time.
8. Allow to dry in the open air for a minimum of 5 minutes.
9. Visually inspect the unit for signs of deterioration. If any damage is noted, do not use
the unit and contact a service technician.
CAUTION
Avoid applying any cleaning liquid to the inside parts of the unit.
Cleaning and disinfecting the Accessories
Cleaning and disinfecting the accessories that have contact with the mucous mem-
branes
CAUTION
You MUST cover the standard bite block and the bite block for eden-
tulous patients with FDA-cleared or CE mark protective sheaths that
are available from distributors to use them between each patient.
We recommend that you cover the TMJ nose rest and the 3D bite
blocks with FDA-cleared or CE Mark protective sheaths that are avail-
able from distributors to use them between each patient.
The following accessories must first be cleaned and then steam-sterilized between each
patient use:
•TMJ nose rest
•Standard bite block
•Frankfort guide bite block for panoramic
•Bite block for edentulous patient
•3D bite blocks
Note: It is recommended that the accessory be reprocessed as soon
as reasonably practical following use.
Cleaning

10 CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
To clean the accessories that have contact with the mucous membranes, follow these
steps:
1. Remove and discard the protective sheath from the accessory.
2. Remove all visible soil by with disposable cloth or paper wipe.
3. Rinse at least 1 minute under running water to thoroughly clean the accessory from
any excess soil.
4. Using a soft brush, apply medical enzyme detergent solutions (basically with a multi-
enzymatic formula) to all surfaces of the accessory. Detergent manufacturer’s direc-
tions must be strictly adhered to.
5. Rinse thoroughly under running water for at least 1 minute to remove detergent residue.
6. Dry the accessory with compressed air or hygiene disposable cloth.
7. Visually inspect the accessory for residual soil. If soil is visible, either repeat steps 2 to
5, or safely dispose of the accessory.
Disinfecting with Steam Autoclave
To steam autoclave the accessory, once cleaning is complete, follow these steps:
CAUTION
You must use a medical autoclaving equipment cleared by the FDA
in the USA or that is recognized by your Local Authority.
You must always follow the operating parameters recommended by
the manufacturer of the autoclaving equipment.
Use FDA cleared or CE mark standard packaging material.
1. Wrap the cleaned accessory using a standard packaging material for autoclaving.
2. Steam autoclave at 132°C (270°F) for 4 minutes in the USA or depending on your local
regulation you can steam autoclave at 134°C (273°F) for 18 minutes.
3. Visually inspect the accessory for signs of deterioration. If any damage is noted, do not
use the accessory and contact your representative.
4. Once disinfected, the accessory can be used immediately or stored dry and dust-free
in its sterilization wrapping under temperature specified in section “CS 8200 3D Envi-
ronmental Requirements” of the present guide.
Cleaning and disinfecting Ear cones of Scan ceph module (optional)

CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02 11
CAUTION
Ear cones must be covered with a use FDA-cleared or CE mark pro-
tective sheaths that are available from distributors to use them be-
tween each patient. After use, remove and discard the protective
sheath.
You must clean and disinfect the ear cones between each patient use
with an EPA-registered, or CE mark, intermediate-level disinfectant
with label claims of tuberculocidal activity.
Cleaning
To clean the ear cones, follow these steps:
1. Remove and discard the protective sheath from the accessory.
2. Remove all visible soil with disposable cloth or paper wipe.
3. Dampen (not soak) a lint-free cloth with soap and running water.
4. Thoroughly clean manually the ear cones with the dampened lint-free cloth.
5. Rinse thoroughly with lint-free cloth with running water.
6. Dry the accessory with hygienic disposable cloth.
7. Visually inspect the accessory for residual soil. If soil is visible, either repeat steps 2 to
6, or safely dispose of the accessory.
Disinfecting
1. Use an intermediate-level disinfectant with tuberculocidal activity as identified above
and as recommended by the manufacturer of the disinfectant.
2. Allow to dry in open air.
Cleaning and disinfecting the accessories and the components that have skin
contact
The following accessories must first be cleaned and then disinfected between each patient
use:
•Panoramic chin rest
•Sinus chin rest
•Temple support cone
The following component and accessory of the Scan Ceph module (optional) must first be
cleaned and then disinfected between each patient use:
•Nasion support
•Frankfort tool
•Carpus support (available only with Carpus exam option)
Note: It is recommended that the accessory be reprocessed as soon
as reasonably practical following use.
Cleaning

12 CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
To manually clean the accessories that have skin contact, follow these steps:
1. Remove all visible soil by with disposable cloth or paper wipe.
2. Rinse at least 1 minute under running water to thoroughly clean the accessory from
any excess soil.
3. Using a soft brush, apply medical enzyme detergent solutions (basically with a multi-
enzymatic formula) to all surfaces of the accessory. Detergent manufacturer’s direc-
tions must be strictly adhered to.
4. Rinse thoroughly under running water for at least 1 minute to remove detergent residue.
5. Dry the accessory with compressed air or hygiene disposable cloth.
6. Visually inspect the accessory for residual soil. If soil is visible, either repeat steps 1 to
4, or safely dispose of the accessory.
Disinfecting
To disinfect the accessory, once the cleaning is complete, follow these steps:
1. Disinfect the accessory by using an EPA-registered hospital disinfectant for low-level
activity or low-level disinfectant that is recognized by your Local Authority (for example,
quaternary ammonium compounds and some phenolics). You must follow the disin-
fectant’s manufacturer instructions for use, especially with respect to contact
time.
CAUTION
If there is a visible contamination with blood, you must clean the ac-
cessory with an EPA-registered hospital disinfectant for intermediate-
level disinfectant or intermediate-level disinfectant that is recognized
by your Local Authority that has claim for activity against hepatitis B
after cleaning. The disinfectant’s manufacturer instructions for use
must always be followed, especially with respect to contact time.

CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02 13
Marking and Labeling Symbols
Type B device symbol complying with the IEC 60601-1
standard.
In the European Union, this symbol indicates: Do NOT
discard this product in a trash
receptacle; use an
appropriate recovery and recycling facility.
Contact your local sales representative for additional
information on the collection and recovery programs
available for this product.
WARNING
Attention, consult Accompanying document
IONIZING RADIATION symbol warn you about
radiation dangers.
The ON/OFF button.
Refer to instruction manual/booklet
Manufactured Date.
Manufacturer’s address.
Earth protection (ground).
Medical Device
Name of the European Authorized Representative and
address of the registered place of business
Name of the Responsible Person in the United King-
dom and address of the registered place of business

14 CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
Label Locations
CS 8200 3D Labels
The following figures are used only to illustrate the label locations, the labels contents may be
different.
Figure 1 CS 8200 3D Label Locations
Important:
* Only for USA: This warning appears in the Parameter pane of the Acquisition interface.
** Canada specific labels.
*** X-ray tube can be Toshiba/Canon D-067 or CEI OPX110.
**** Product label can be CS 8200 3D.

CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02 15
Figure 2 CS 8200 3D Label Locations (with Scan Ceph configuration)
Important:
* Only for USA: This warning appears in the Parameter pane of the Acquisition interface.
** Canada specific labels.
*** X-ray tube can be Toshiba/Canon D-067 or CEI OPX110.
**** Product label can be CS 8200 3D.
Table 1 Label Definition
Label Definition
Defines the unit’s model
Defines the date that the unit was installed
This product is in conformity with performance
standards for diagnostic X-
ray systems and their
major components under 21 CFR 1020.30, and for
computed tomography equipment under 21 CFR
1020.33, except with respect to those
characteristics authorized by Va
riance Number
FDA-2020-V-1568.
Defines the unit’s compliance with theUS FDA
radiation standards

16 CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
2 Regulatory Information
General Regulatory Information
Compliance with European and International Standards
EN/IEC 60601-1
Medical Electrical Equipment - Part 1: General Requirements
For Basic Safety and essential performance.
EN/IEC 60601-1-2
Medical Electrical Equipment, Part 1-2: General requirements
for basic Safety and essential performance -
Collateral
Standard: Electromagnetic Disturbances -
Requirements and
tests.
EN/IEC 60601-1-3
Medical Electrical Equipment, Part 1-3: General requirements
for basic Safety and essential performance -
Collateral
Standard: Radiation protection in diagnostic X-ray equipment.
EN/IEC 60601-1-6
Medical Electrical Equipment, Part 1-6: General requirements
for basic Safety and essential performance -
Collateral
Standard: Usability.
EN/IEC 62366-1
Medical devices – Part 1: Application of usability engineering
to medical device.
EN/IEC 60601-2-63
Medical Electrical Equipment - Part 2-63: Particular
requirements for the basic safety and essential performance
of dental extra-oral X-ray equipment.
EN/IEC 62304 Medical device software – Software life cycle processes.
EN ISO 15223-1
Medical devices - Symbols to be used with medical device
labels, labeling and information to be supplied -
Part 1:
General requirements.
EN 1041 Information supplied by the manufacturer of medical devices.
ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation
and testing.
ISO 14971
Medical devices - Application of risk management to medical
devices.
CAN/CSA C22.2 N°60601-1
Medical Electrical Equipment - Part 1: General Requirements
For basic safety and essential performance.
ANSI/AAMI ES60601-1
Medical Electrical Equipment - Part 1: General Requirements
For basic safety and essential performance.

CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02 17
Classification in Accordance with EN/IEC 60601-1
Type of protection against electric shock
Class 1 equipment
Degree of protection against electric shock
Type B
Protection against harmful ingress of water
Ordinary equipment
Operation mode
Continuous operation with intermittent loading
Flammable anesthetics
Not suitable for use in presence of flammable
anesthetics or a mixture of flammable anesthetics
with air or oxygen or nitrous oxide
Conformity with EN/IEC 60601-1-2
Group I, class B
CS 8200 3D is intended to be used in a professional healthcare facility environment.
Conformity with EN/IEC 60601-1-2
Electromagnetic Compatibility Precautions
•Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC).
•CS 8200 3D must be installed and put into service according to the EMC
information provided in this document.
•CS 8200 3D may interfere with other equipment even if that other equipment
complies with CISPR emission requirements.
•Portable and Mobile RF communications equipment can affect medical
electrical equipment.
CS 8200 3D System Components
Compliance to CS 8200 3D was achieved using the following cables:
1 main power supply cable (maximum length of 3 m)
1 Ethernet cable (maximum length of 10 m)

1 X-ray switch cable (maximum length of 10 m)

18 CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
WARNINGS
•Use limitation: the use of accessories, cables, or transducers other than
those specified in the user’s guide with the exception of cables,
accessories or transducers sold by Carestream Dental LLC as
replacement parts of internal components may result in increased
emissions or decreased immunity of the CS 8200 3D.
•Use limitation: the use of CS 8200 3D adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, the CS 8200 3D equipment and the
other equipment should be observed to verify that they are operating
normally.
•Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 1
m (39 in) to any part of the CS 8200 3D including cables specified by
Carestream. Otherwise, it could result in degradation of the
performance of the CS 8200 3D equipment.
WARNING: The room in which your radiology unit is to be installed
must comply with all official regulations applicable to protection
against radiation.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2)
The CS 8200 3D is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS 8200 3D should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11 Group 1
The CS 8200 3D uses RF energy only for its
internal function. Therefore, its
RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11 Class B
The CS 8200 3D is
suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-
voltagepowersupply networkthat
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3 Complies

CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02 19
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The CS 8200 3D is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS 8200 3D should assure that it is used in such an environment.
The essential performance concerns accuracy of loading factors (mA, kV), if the essential
performance is lost or degraded due to EM DISTURBANCES, the system stops the examination
and the user is notified of the error.
Immunity Test IEC 60601 Test Level
Electromagnetic Environment -
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5 ±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be that of
a typical commercial or
hospital
environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0 % UT for 0.5 cycle at 8 angles
At 0°, 0 % UT for 1 cycle and 70 % UT
for 25 cycles
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the CS
8200
3D requires continued operation
during power mains interruptions, it is
recommended that the CS 8200
3D
be powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial
or hospital environment
NOTE: UT is the a.c. mains voltage prior to application of the test level.

20 CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2)
The CS 8200 3D is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS 8200 3D should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level
Electromagnetic Environment -
Guidance
Conducted RF
IEC 61000-4-6
3 V
150 kHz to 80 MHz and 6V at ISM
Frequencies
Environment of a care facility professional
health.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
Test levels and frequencies
according to table 9 from IEC
60601-1-2: 2014
WARNING: Portable RF communications
equipment (including peripherals such as
antenna cables and external antennas)
should be used no closer than 1 m (39
inches) to any part of the CS 8200 3D in-
cluding cables specified by the manufac-
turer. Otherwise, degradation of the per-
formance of this equipment could result
NOTE:
These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
tel
ephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be cons
idered. If the measured
field strength in the location in which CS 8200 3D is
used exceeds the applicable RF compliance
level above, the CS 8200 3D
should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-ori
enting or
relocating the CS 8200 3D.
Compliance with International Regulations
Medical Device Directives 93/42/EEC until September 14th, 2022, then
Medical Device Regulation (EU) 2017/745, Class IIb.
Directive 2011/65/EU on the Restriction Of the use of certain Hazardous
Substances in electrical and electronic equipment (RoHS), as amended by
Directive (EU) 2015/863.
UK Medical Devices Regulations 2002 (SI 618) as subsequently amended by
the EU Exit Regulations of 2019 (SI 791) and 2020 (SI 1478), Class IIb.
FDA Center for Devices & Radiological Health: This product is in conformity
with performance standards for diagnostic X-ray systems and their major
components under 21 CFR 1020.30, and for computed tomography
equipment under 21 CFR 1020.33, except with respect to those
characteristics authorized by Variance Number FDA-2020-V-1568 (USA).
Radiation Emitting Devices Act - C34 (Canada).
Medical Devices Regulations (Canada).