Carestream CS 8100 3D User manual

CS 8100 3D Family CS 8100 3D, CS 8100 3D Access, CS 8100SC 3D and CS 8100SC 3D Access
Safety, Regulatory and Technical Specications User Guide
English

2CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
Notice
The Regulatory Information and Technical Specifications User Guide for CS 8100 3D Family
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 8100 3D Family comprises:
CS 8100 3D: panoramic modality and dental volumetric reconstruction modality (3D
focused teeth acquisition and 3D full upper and lower jaw acquisition).
CS 8100 3D Access: panoramic modality and dental volumetric reconstruction
modality (limited to 3D focused teeth acquisition). The system has the capability to
expand the field of view to the 3D full upper and lower jaw acquisition with license
upgrade.
CS 8100SC 3D: panoramic modality, dental volumetric reconstruction modality (3D
focused teeth acquisition and 3D full upper and lower jaw acquisition) and
cephalometric modality.
CS 8100SC 3D Access: panoramic modality, dental volumetric reconstruction mo-
dality (limited to 3D focused teeth application) and cephalometric modality (without
the 26x24 Field of View (FoV)). The system has the capability to expand the field of
view to the 3D full upper and lower jaw acquisition and to the cephalometric 26x24
FoV with licence upgrade.
The CS 8100 3D and CS 8100 3D Access can be upgraded to Cephalometric modality, when the
Scan Ceph module is provided as an upgrade kit.
This document refers to all models as CS 8100 3D Family 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 Carestream Health,
Inc.
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 8100 3D Family Safety, Regulatory and Technical Specifications User Guide
Part Number: SM844
Revision Number: 10
Print date: 2017-05
CS 8100 3D Family comply with Directive 93/42/EEC relating to medical devices.
0086

CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10 3
Contents
1Safety Information..................................................................- 4 -
Indications for Use .......................................................................................................- 4 -
Conventions in this Guide...........................................................................................- 5 -
Note to the User............................................................................................................- 6 -
Warning and Safety Instructions................................................................................- 6 -
Hygiene and Disinfection.............................................................................................- 8 -
Marking and Labeling Symbols ................................................................................- 13 -
Label Locations ..........................................................................................................- 14 -
2Regulatory Information ........................................................- 17 -
General Regulatory Information ...............................................................................- 17 -
Compliance with International Regulations.............................................................- 23 -
3Technical Specifications......................................................- 24 -
Factory.........................................................................................................................- 24 -
Manufacturer...............................................................................................................- 24 -
Model ...........................................................................................................................- 24 -
CS 8100 3D Family Technical Specifications ..........................................................- 24 -
Minimum Computer System Requirement...............................................................- 27 -
X-ray Dose Emission Information.............................................................................- 28 -
Panoramic mode for CS 8100 3D and CS 8100 3D Access.......................- 28 -
3D mode for CS 8100 3D and CS 8100 3D Access.....................................- 32 -
Panoramic mode for CS 8100SC 3D and CS 8100SC 3D Access.............- 32 -
3D mode for CS 8100SC 3D and CS 8100SC 3D Access...........................- 32 -
Cephalometric mode for CS 8100SC 3D and CS 8100SC 3D Access ......- 32 -
User Dose information...............................................................................................- 36 -
Stray radiation in Panoramic Mode.............................................................- 36 -
Stray radiation in 3D Mode...........................................................................- 38 -
Imaging performance information............................................................................- 39 -
Panoramic and Cephalometric.....................................................................- 39 -
3D....................................................................................................................- 39 -
Controlling the Image Quality ...................................................................................- 39 -
CS 8100 3D Family Environmental Requirements ..................................................- 40 -
CS 8100 3D Family Electrical Specifications...........................................................- 41 -
X-ray Tube Assembly Technical Specifications......................................................- 43 -
4 Contact Information ...............................................................- 51 -
Manufacturer’s Address ............................................................................................- 51 -
Factory.........................................................................................................................- 51 -
Authorized Representatives......................................................................................- 51 -

4CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
1 Safety Information
Indications for Use
The CS 8100 3D Family 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 diag-
nostic support for pediatric and adult patients.
In addition, the CS 8100SC 3D and CS 8100SC 3D Access are also intended to produce
cephalometric images. This includes imaging the hand and wrist to obtain carpus image
for growth and maturity assessment.
The CS 8100 3D Family comprises:
CS 8100 3D: panoramic modality and dental volumetric reconstruction mo-
dality (3D focused teeth acquisition and 3D full upper and lower jaw acquisi-
tion).
CS 8100 3D Access: panoramic modality and dental volumetric reconstruc-
tion modality (limited to 3D focused teeth acquisition). The system has the
capability to expand the field of view to the 3D full upper and lower jaw ac-
quisition with license upgrade.
CS 8100SC 3D: panoramic modality, dental volumetric reconstruction mo-
dality (3D focused teeth acquisition and 3D full upper and lower jaw acquisi-
tion) and cephalometric modality.
CS 8100SC 3D Access: panoramic modality, dental volumetric reconstruc-
tion modality (limited to 3D focused teeth application) and cephalometric
modality (without the 26x24 Field of View (FoV)). The system has the capa-
bility to expand the field of view to the 3D full upper and lower jaw acquisition
and to the cephalometric 26x24 FoV with license upgrade.
The CS 8100 3D and CS 8100 3D Access can be upgraded to Cephalometric Modality, when the
Scan Ceph module is provided as an upgrade kit.
This document refers to all models as CS 8100 3D Family unless otherwise specified.
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.

CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10 5
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 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
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 8100 3D Family, observe the following warning and safety instructions:
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 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10 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/radiationemittingproduct
sandprocedures/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.
To dispose of the unit or its components, 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 Health.

8CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
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 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.
Hygiene 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.
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
phenolics). 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. Visuallyinspect the unit for signs of deterioration. If anydamage is noted,donot usethe
unit and contact a service technician.
CAUTION
Avoid applying any cleaning liquid to the inside parts of the unit.

CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10 9
Cleaning and disinfecting the Accessories
Cleaning and disinfecting the accessories that have contact with the mucous
membranes
CAUTION
You MUST cover the standard bite block and the bite block for
edentulous 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
available 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
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 mul-
ti-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.

10 CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
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 8100 3D Family En-
vironmental Requirements’’ of the present guide.
Cleaning and disinfecting Ear cones of CS 8100SC 3D and CS 8100SC 3D Access
CAUTION
Ear cones must be covered with a use FDA-cleared or CE mark protec-
tive sheaths that are available from distributors to use them between
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.

CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10 11
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 CS 8100SC 3D and CS 8100SC 3D Access
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
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 mul-
ti-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.

12 CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
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 accessory
with an EPA-registered hospital disinfectant for intermediate-level disin-
fectant 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 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10 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).

14 CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
Label Locations
CS 8100 3D and CS 8100 3D Access Labels
The following figure illustrates the label locations of the CS 8100 3D and CS 8100 3D Access.
Figure 1 CS 8100 3D and CS 8100 3D Access 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 CEI OPX110
**** Product label can be CS 8100 3D or CS 8100 3D Access

CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10 15
CS 8100SC 3D and CS 8100SC 3D Access Labels
The following figure illustrates the label locations of the CS 8100SC 3D and CS 8100SC 3D
Access.
Figure 2 CS 8100SC 3D and CS 8100SC 3D Access Label Locations
Important:
* Only for USA: This warning appears in the Parameter pane of the
Acquisition interface.
** X-ray tube can be CEI OPX110
*** Canada specific labels
**** Product label can be CS 8100SC 3D or CS 8100SC 3D Access

16 CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
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 Variance Number
FDA-2014-V-0657 effective 2014-07-15.
Defines the unit’s compliance with the US
FDA radiation standards
Only applicable for CS 8100 3D
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-2015-V-0980 effective 2015-05-28.
Defines the unit’s compliance with the US
FDA radiation standards
Only applicable for CS 8100 3D Access
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-2016-V-4097 effective December 23, 2016.
Defines the unit’s compliance with the US
FDA radiation standards
Only applicable for CS 8100SC 3D and
CS 8100SC 3D Access

CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10 17
2 Regulatory Information
General Regulatory Information
Compliance with European and International Standards
EN/IEC 60601-1
Medical Electrical Equipment - Part 1: General Requirements
For 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
Medical devices - Application of usability engineering to
medical device.
EN/IEC 62304 Medical device software – Software life cycle processes.
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 980 Symbols for use in the labeling of medical devices.
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 Safety and essential performance.
ANSI/AAMI ES60601-1
Medical Electrical Equipment - Part 1: General Requirements
For Safety and essential performance.

18 CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
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 8100 3D Family 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 8100 3D Family must be installed and put into service according to the
EMC information provided in this document.
•CS 8100 3D Family 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 8100 3D Family System Components
Compliance to CS 8100 3D Family 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)
WARNINGS

CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10 19
•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 Health, Inc. as
replacement parts of internal components may result in increased
emissions or decreased immunity of the CS 8100 3D Family.
•Use limitation: the use of CS 8100 3D Family adjacent to or stacked
with other equipment should be avoided because it could result in
improper operation. If such use is necessary, the CS 8100 3D Family
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 8100 3D Family including cables
specified by Carestream. Otherwise, it could result in degradation of
the performance of the CS 8100 3D Family 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 8100 3D Family is intended for use in the electromagnetic environment specified below.
The customer or the user of the CS 8100 3D Family should assure that it is used in such an
environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions
CISPR 11 Group 1
The CS 8100 3D Family 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 8100 3D Family is
suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3 Complies

20 CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The CS 8100 3D Family is intended for use in the electromagnetic environment specified below.
The customer or the user of the CS 8100 3D Family should assure that it is used in such an
environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Electromagnetic Environment -
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±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
±
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
±
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
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
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
8100 3D Family requires continued
operation during power mains
interruptions, it is recommended that
the CS 8100 3D Family be powered
from an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 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.