Carestream HEALTH CS 9000 User manual

CS 9000 Family: CS 9000, CS 9000 3D, CS 9000C,
CS 9000C 3D
Safety, Regulatory & Technical Specification
User Guide

2CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
Notice
The Regulatory Information & Technical Specification User Guide for the CS 9000 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 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 9000 Family Safety, Regulatory & Technical Specification User Guide
Part Number: SM766
Revision Number: 04
Print date: 2014-10
CS 9000 Family complies with Directive 93/42/EEC relating to medical devices.
0086

CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04 3
Contents
1Safety Information ...................................................................- 4 -
Indications for Use.....................................................................................................- 4 -
Conventions in this Guide.........................................................................................- 4 -
Note to the User .........................................................................................................- 5 -
Warning and Safety Instructions ..............................................................................- 5 -
Warning and Safety Instructions ..............................................................................- 6 -
Hygiene and Disinfection ..........................................................................................- 7 -
Marking and Labeling Symbols...............................................................................- 12 -
Label Locations........................................................................................................- 13 -
2Regulatory Information .........................................................- 15 -
General Regulatory Information..............................................................................- 15 -
Compliance with International Regulations...........................................................- 21 -
3Technical Specification.........................................................- 22 -
Factory......................................................................................................................- 22 -
Model.........................................................................................................................- 22 -
CS 9000 Family Technical Specification ................................................................- 22 -
Minimum Computer System Requirement ............................................................. - 25 -
X-Ray Dose Emission Information..........................................................................- 26 -
Imaging Performance Information..........................................................................- 31 -
Controlling the Image Quality .................................................................................- 31 -
CS 9000 Family Environmental Requirements.......................................................- 32 -
CS 9000 Family Electrical Specifications...............................................................- 33 -
X-Ray Tube Assembly Technical Specifications...................................................- 35 -
4 Contact Information ................................................................- 45 -
Manufacturer’s Address..........................................................................................- 45 -
Authorized Representatives....................................................................................- 45 -

4CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
1 Safety Information
Indications for Use
The CS 9000 Family is intended to produce digital X-ray images and to be used at the
direction of health care professionals of extra-oral dento-maxillofacial region of the human
anatomy.
The CS 9000 Family includes:
• CS 9000: panoramic modality
• CS 9000 3D: panoramic and dental volumetric reconstruction modality
• CS 9000C: panoramic and cephalometric modality
• CS 9000C 3D: panoramic, cephalometric and dental volumetric reconstruction
modality
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 light cause problems.
Note: Emphasizes important information.
Tip: Provides extra information and hints.

CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04 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. This room must reduce to at least 12dB the
frequency interferences of the 30 MHz to 1 GHz band.
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 your radiology unit and your digital imaging software you must follow
the instructions contained in this guide.
Warning and Safety Instructions
When operating CS 9000 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.
LASER WARNING
For maximum safety, advise the patient not to
look at the beam. Before turning on the
beams, lower the Frankfurt plane beam to the
lowest level. While making adjustments,
ensure that the beam is not directed into the
eyes of the patient.
CAUTION
Use of controls, adjustments or performance
of procedures other than those specified
herein may result in hazardous radiation
exposure.

6CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
Warning and Safety Instructions
WARNINGS
Unit
Read and understand this Safety Information before using the the CS
9000 Family.
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.
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.

CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04 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 IEC60950 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
Daily
Cleaning the CS 9000 Family units
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 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-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.

8CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
Cleaning and disinfecting the accessories
CAUTION
You MUST cover the panoramic bite blocks and the bite block for eden-
tulous patients with FDA-cleared or CE marking 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 block
with FDA-cleared or CE marking protective sheaths that are available
from distributors to use them between each patient. After you remove
and discard the protective sheath, each accessory must be cleaned and
disinfected between each patient use.
Cleaning and disinfecting the accessories that have contact with the mucous
membranes
The accessories are delivered unsterilized. To ensure maximum hygienic safety for the
patient, follow the following instructions carefully to prepare them for use:
The following accessories must first be cleaned then steam-sterilized between each
patient use:
• TMJx4 nose rest
• Panoramic standard bite block
• Bite block for edentulous patient
• 3D bite block
Note: It is recommended that the accessory be reprocessed as soon as rea-
sonably practical following use.
Cleaning
To clean and disinfect the accessories that have contact with 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 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.

CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04 9
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
To disinfect with heat, you must use a medical autoclaving equipment
cleared by the FDA in the USA or that is recognized by your Local Au-
thority.
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 sterilized, the accessory can be used immediately or stored dry and dust-free in its
sterilization wrapping under temperature specified in section ‘‘CS 9000 Family Environmental
Requirements’’ of the present guide.
Cleaning and disinfecting the ear cones
CAUTION
Ear cones must be covered with a FDA-cleared or CE marking pro-
tective sheath which is available from distributors.
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 marking, intermediate-level hospital disin-
fectant with label claims of tuberculocidal activity (for example: a
chlorine containing product, a quaternary ammonium compound
with alcohol, a phenolics, an iodophors, an EPA-registered chlo-
rine-base product).
Cleaning
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 directions
must be strictly adhered to.

10 CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
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
1. Use an intermediate-level disinfectant with tuberculocidal activity as identified above
and as recommended by the manufacturer of the disinfectant.
WARNING
Do not rinse the ear cones.
2. Allow to dry in open air.
Cleaning and disinfecting the components and accessories that have skin contact
You must disinfect all components and the following accessories with a low-level
disinfectant between each patient use:
• Panoramic/ TMJx2/ Sinus chin rest
• 3D bite block support
• 3D head rest
• Nasion support
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 directions
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.

CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04 11
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 activ-
ity or low-level disinfectant that is recognized by your Local Authority (for example, quater-
nary ammonium compounds and some phenolics). You must follow the disinfectant’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
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.

12 CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
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
ATTENTON: consult ACCOMPANYING DOCUMENTS
IONIZING RADIATION symbols warn you about radiation dangers
LASER WARNING
Laser radiation. Do NOT stare into the beam.
Class 2 laser product.
Maximum output power: 1 mW, 650 nm, IEC 60825-1 Ed.2 (2007)
This unit emits laser radiation.
The ON/OFF button
Refer to instruction manual/booklet
Non-ionizing radiation
Manufactured Date
Manufacturer’s address

CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04 13
Label Locations
CS 9000 and CS 9000 3D Labels
The following figure illustrates the label locations on CS 9000 and CS 9000 3D.
Figure 1 CS 9000 and CS 9000 3D Unit Label Locations
** Only for USA. This warning also appears in the Parameter Pane of the Acquisition
interface.
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 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
CS 9000C and CS 9000C 3D Labels
The following figure illustrates the label locations of the CS 9000C and CS 9000C 3D.
Figure 2 CS 9000C and CS 9000C 3D Units Label Locations
** Only for USA. This warning also appears in the Parameter Pane of the Acquisition
interface.
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 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04 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 Safety
EN /IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General requirements for Safety -
Collateral Standard: Electromagnetic Compatibility
EN /IEC 60601-1-3 Medical Electrical Equipment, Part 1-3: General requirements for safety -
Collateral Standard: Radiation protection in diagnostic X-ray equipment
EN /IEC 60601-1-4 Medical Electrical Equipment, Part 1-4: General requirements for
collateral standard: Programmable Electrical Medical Systems
EN /IEC 60601-1-6 Medical Electrical Equipment, Part 1-6: General requirements for safety -
Collateral Standard: Usability
EN /IEC 60601-2-7 Medical Electrical Equipment - Part 2-7: Particular Requirements for the
Safety of high voltage generators of diagnostic X-ray generators
EN /IEC 60601-2-28
Medical Electrical Equipment - Part 2-28: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for medical
diagnosis
EN /IEC 60825-1 Safety of laser products - Part 1: Equipment classification and
requirements
EN /IEC 62304 Medical device software - Software life cycle processes
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
CSA 22.2 N°601-1 Medical Electrical Equipment - Part 1: General Requirements For Safety
UL 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Safety
EN/IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Safety
and essential performance.

16 CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
EN/IEC 60601-1-2
Medical Electrical Equipment, Part 1-2: General requirements for basic
Safety and essential performance - Collateral Standard: Electromagnetic
Compatibility
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 60601-2-28
Medical Electrical Equipment - Part 2-28: Particular requirements for the
basic safety and essential performance of X-ray source assemblies and
X-ray tube assemblies for medical diagnosis.
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 equip-
ment
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 +12 dB
Conformity with EN/IEC 60601-1-2
Electromagnetic Compatibility Precautions
•Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC).
•The CS 9000 Family must be installed and put into service according to the
EMC information provided in this document.

CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04 17
•The CS 9000 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 9000 Components
CS 9000
CS 9000 3D Components
CS 9000 3D
CS 9000C Components
CS 9000C
CS 9000C 3D Components
CS 9000C 3D
•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 9000 Family.
•The CS 9000 Family should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the CS 9000 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. You must
install your radiology unit in a room protected against X-ray emissions. This
room must reduce to at least 12 dB the frequency interferences of the 30
MHz to 1 GHz band (CISPR 11: 2003 + A1 2004).

18 CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2)
The CS 9000 Family is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS 9000 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 9000 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 + 12 dB
The CS 9000 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 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04 19
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The CS 9000 Family is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS 9000 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
±6 kV contact
±8 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)
Not applicable
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
<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
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the CS
9000 Family system requires
continued operation during power
mains interruptions, it is
recommended that the CS 9000
Family systems be powered from an
uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 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 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2)
The CS 9000 Family is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS 9000 Family should assure that it is used in such an environment.
Immunity Test IEC 60601
Test Level Compliance Level Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
[V1]= 3 V
[E1]= 3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the CS 9000 Family systems,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
aField 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 9000 Family is used exceeds the
applicable RF compliance level above, the CS 9000 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 9000 Family.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.