Carestream DENTAL CS 8100 Series User manual

Safety, Regulatory and Technical Specications User Guide
CS 8100 Family CS 8100, CS 8100 Access, CS 8100SC and CS 8100SC Access
ENGLISH

2 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
Notice
The Regulatory Information and Technical Specifications User Guide for CS 8100 Family includes
information on the safety instructions, regulatory information and the technical specification 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 Family includes:
CS 8100: the complete panoramic modality.
CS 8100 Access: the panoramic modality without the 2D+ radiological exam.
CS 8100SC: the complete panoramic and cephalometric modality.
CS 8100SC Access: the panoramic modality (without the 2D+ radiological exam feature) and the
cephalometric modality (without the 26x24 FoV (Field of View)).
In this guide, the generic name CS 8100 Family is used when the information refer to all models. If
not the specific name of each model is used.
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 Dental 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 8100 Family Safety, Regulatory and Technical Specification User Guide
Part Number: SM785
Revision Number: 13
Print date: 2019-04
The CS 8100 Family complies with Directive 93/42/EEC relating to medical devices.

CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13 3
Contents
1Safety Information ...................................................................- 4 -
Indications for Use.....................................................................................................- 4 -
Conventions in this Guide.........................................................................................- 4 -
Note to the User .........................................................................................................- 5 -
Warning and Safety Instructions ..............................................................................- 5 -
Hygiene and Disinfection ..........................................................................................- 7 -
Marking and Labeling Symbols...............................................................................- 12 -
Label Locations........................................................................................................- 13 -
2Regulatory Information .........................................................- 15 -
General Regulatory Information..............................................................................- 15 -
Compliance with International Regulations...........................................................- 20 -
3Technical Specification.........................................................- 21 -
Factory......................................................................................................................- 21 -
Manufacturer ............................................................................................................- 21 -
Model.........................................................................................................................- 21 -
CS 8100 Family Technical Specification ................................................................- 21 -
Minimum Computer System Requirement.............................................................- 24 -
X-Ray Dose Emission Information..........................................................................- 25 -
Imaging performance information..........................................................................- 32 -
Controlling the Image Quality .................................................................................- 32 -
CS 8100 Family Environmental Requirements.......................................................- 33 -
CS 8100 Family Electrical Specifications...............................................................- 34 -
X-ray Tube Assembly Technical Specifications ....................................................- 36 -
4 Contact Information ................................................................- 44 -
Manufacturer’s Address..........................................................................................- 44 -
Authorized Representatives....................................................................................- 44 -

4 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
1 Safety Information
Indications for Use
The CS 8100 Family are intended to produce complete or segmented tomographic digital panoramic
X-ray images to be used at the direction of health care professionals of the dento-maxillofacial
region of the human anatomy as diagnostic support for pediatric and adult patient. In addition, the
CS 8100SC and CS 8100SC 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 Family includes:
CS 8100: the complete panoramic modality.
CS 8100 Access: the panoramic modality without the 2D+ radiological exam.
CS 8100SC: the complete panoramic and cephalometric modality.
CS 8100SC Access: the panoramic modality (without the 2D+ radiological exam feature)
and the cephalometric modality (without the 26x24 FoV (Field of View)).
The CS 8100 and CS 8100 Access can be upgraded to Cephalometric modality, when the Scan Ceph
module is provided as an upgrade kit.
This guide uses the generic name of CS 8100 Family when making reference to all models. If not, it
uses the specific name of the concerned model.
CAUTION
Do NOT use on patients who are about 5 years old and below and who are less
than about 21 kg (46 lb) in weight and 113 cm (44.5 in) in height.
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.

CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13 5
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 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.

6 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
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/ucm2
98899.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 Dental.
If the installation of the Product is not carried out by qualified personnel or if the
Product is installed incorrectly and as a result is not operating correctly or is
damaged, it is the responsibility of the Distributor. The above will lead to an
expiration of the warranty and the liability of Carestream Dental; Carestream Dental
accepts no responsibility for failures caused by sub-standard or incorrect
installations.
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.

CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13 7
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 1.83 m 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. Environmental
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-regis-
tered 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 con-
tact 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.

8 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
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 pa-
tients 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 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
Note: It is recommended that the accessory be reprocessed as soon as rea-
sonably 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 multi-enzymatic
formula) to all surfaces of the accessory. Detergent manufacturer’s directions 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.

CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13 9
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 reg-
ulation 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 Family Environmental
Requirements’’ of the present guide.
Cleaning and disinfecting Ear cones of CS 8100SC and CS 8100SC Access
CAUTION
Ear cones must be covered with a use FDA-cleared or CE mark protective
sheaths that are available from distributors to use them between each pa-
tient. After use, remove and discard the protective sheath. You must clean
and disinfect the ear cones between each patient use with an EPA-regis-
tered, or CE mark, intermediate-level disinfectant with label claims of tuber-
culocidal 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.

10 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
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 component and accessories that have skin contact
The following accessories must first be cleaned and then disinfected between each patient use:
Frontal head rest
Panoramic / Sinus chin rest
The following component and accessory of the CS 8100SC and CS 8100SC 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 rea-
sonably practical following use.
Cleaning
To manually clean the component and 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 component and 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 component or accessory. Detergent manufacturer’s directions
must be strictly adhered to.
4. Rinse thoroughly under running water for at least 1 minute to remove detergent residue.
5. Dry the component and accessory with compressed air or hygiene disposable cloth.
6. Visually inspect the component and accessory for residual soil. If soil is visible, either repeat
steps 1 to 4, or safely dispose of the accessory.

CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13 11
Disinfecting
To disinfect the component and accessory, once the cleaning is complete, follow these steps:
1. Disinfect the component and accessory by using an EPA-registered hospital disinfectant for
low-level activity or low-level disinfectant that is recognized by your Local Authority (for exam-
ple, quaternary ammonium compounds and some phenolics). You must follow the disinfect-
ant’s manufacturer instructions for use, especially with respect to contact time.
CAUTION
If there is a visible contamination with blood, you must clean the component
and accessory 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, es-
pecially with respect to contact time.

12 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
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 DOCUMENTS
IONIZING RADIATION symbols warn you about radiation
dangers
The ON/OFF button
Refer to instruction manual/booklet
Manufactured Date
Manufacturer’s address
Earth protection (ground)

CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13 13
Label Locations
CS 8100 Labels
The following figure illustrates the label locations of the CS 8100 and CS 8100 Access. This figure
illustrates only the CS 8100 model but it also applies to the CS 8100 Access model.
Figure 1 CS 8100 Label Locations
Important:
* Only for USA: This warning appears in the Parameter pane of the Acquisition
interface.
** X-ray tube can be Canon D-054 or CEI OPX105 or Siemens SR 90/15 FN
Table 1 Label Definition
Label Definition
Defines the unit’s model
Defines the date that the unit was installed
Conforms to all applicable standards under 21
CFR chapter 1 subchapter J
Defines the unit’s compliance with the US
FDA radiation standards

14 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
CS 8100SC Labels
The following figure illustrates the label locations of the CS 8100SC and CS 8100SC Access. This
figure illustrates only the CS 8100SC model but it also applies to the CS 8100SC Access model.
Figure 2 CS 8100SC Label Locations
Important:
* Only for USA: This warning appears in the Parameter pane of the Acquisition interface.
** X-ray tube can be Canon D-054 or CEI OPX105 or Siemens SR 90/15 FN
Table 2 Label Definition
Label Definition
Defines the unit’s model
Defines the date that the unit was installed
Conforms to all applicable standards under 21
CFR chapter 1 subchapter J
Defines the unit’s compliance with the US
FDA radiation standards

CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13 15
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 Medical devices - 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.
EN ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and
testing.
EN 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.

16 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
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 Family is intended to be used in a professional healthcare facility environment.
Compliance of the CS 8100 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)
Conformity with EN/IEC 60601-1-2
Electromagnetic Compatibility Precautions
Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC).
CS 8100 Family must be installed and put into service according to the EMC
information provided in this document.
CS 8100 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 Components
CS 8100

CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13 17
CS 8100 Access Components
CS 8100 Access
CS 8100SC Components
CS 8100SC
CS 8100SC Access Components
CS 8100SC Access
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 CS 8100 Family.
CS 8100 Family should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the CS 8100 Family
should be observed to verify normal operation in the configuration in
which it will be used.
WARNING: The room in which your radiology unit is to be installed must comply
with all official regulations applicable to protection against radiation.

18 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2)
CS 8100 Family is intended for use in the electromagnetic environment specified below. The
customer or the user of CS 8100 Family should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11 Group 1
CS 8100 Family uses RF energy only for their
internal function. Therefore, their RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11 Class B
CS 8100 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

CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13 19
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
CS 8100 Family is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS 8100 Family 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 Compliance 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 8100 Family system
requires continued operation during power
mains interruptions, it is recommended that
the CS 8100 Family systems 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 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2)
CS 8100 Family is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS 8100 Family should assure that it is used in such an environment.
Immunity Test Compliance Level Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
and 6V at ISM
Frequencies and
amateur radio
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 ca-
bles and external antennas) should be used no closer
than 30 cm (12 inches) to any part of the CS 8100 in-
cluding cables specified by the manufacturer. Other-
wise, degradation of the performance 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)
telephones 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 considered. If the measured field
strength in the location in which the CS 8100 Family is used exceeds the applicable RF compliance
level above, the CS 8100 Family should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the CS 8100 Family.
Compliance with International Regulations
Medical Device Directives 93/42/ European Economic Community (EEC), Class
IIb as amended by 2007/47/EEC
Directive 2011/65/EU on the Restriction Of the use of certain Hazardous
Substances in electrical and electronic equipment (ROHS).
FDA Center for Devices & Radiological Health (CDRH-CFR title 21 chapter 1
subchapter J) (USA)
Radiation Emitting Devices Act - C34 (Canada).
Medical Devices Regulations (Canada).