Regulatory Information

General Regulatory Information

Compliance with European and International Standards
EN/IEC 60601-1	Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance.
EN/IEC 60601-1-2	Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbances – Requirements and tests.
EN/IEC 60601-1-3	Medical Electrical Equipment, Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
EN/IEC 60601-1-6	Medical Electrical Equipment, Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability.
EN/IEC 62366-1	Medical devices - 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 ISO 15223-1	Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements.
EN ISO 20417	Medical devices - Information to be supplied by the manufacturer.
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.

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 9600 is intended to be used in a professional healthcare facility environment.

Compliance of the CS 9600 has been achieved using the following cables:

One main supply cable (maximum length 3 m)
One Ethernet cable (maximum length 10 m)
One X-ray switch cable (maximum length 10 m)

Conformity with EN/IEC 60601-1-2

Warning!

Electromagnetic Compatibility Precautions

Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC).
The CS 9600 must be installed and put into service according to the EMC information provided in this document.
The CS 9600 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 9600 Components

CS 9600

Warning!

Use limitation: the use of accessories, cables, or transducers other than those specified in the user’s guide with the exception of cables, accessories or transducers sold by Carestream Dental LLC, as replacement parts of internal components may result in increased emissions or decreased immunity of the CS 9600 system.
The CS 9600 system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the CS 9600 system should be observed to verify normal operation in the configuration in which it will be used.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the CS 9600 including cables specified by Carestream. Otherwise, it could result in degradation of the performance of the CS 9600 equipment.

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 emission.

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2)
The CS 9600 system is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 9600 system should assure that it is used in such an environment.
Emissions Test	Compliance	Electromagnetic Environment - Guidance
RF emissions CISPR 11	Group 1	The CS 9600 system 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	The CS 9600 system 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

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The CS 9600 system is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 9600 system should assure that it is used in such an environment. The essential performance concerns accuracy of loading factors (mA, kV), if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES, the system stops the examination and the user is notified of the error.
Immunity Test	IEC 60601 Test Level	Electromagnetic Environment - Guidance
Electrostatic discharge (ESD) IEC 61000-4-2	±8 kV contact ±15 kV air	Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/burst IEC 61000-4-4	±2 kV for power supply lines ±1 kV for input/output lines	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5	±1 kV line(s) to line(s) ±2 kV line(s) to earth	Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11	0 % UT for 0.5 cycle at 8 angles At 0°, 0 % UT for 1 cycle and 70 % UT for 25 cycles	Mains power quality should be that of a typical commercial or hospital environment. If the user of the CS 9600 system requires continued operation during power mains interruptions, it is recommended that the CS 9600 system 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.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2)
The CS 9600 system is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 9600 system should assure that it is used in such an environment.
Immunity Test	IEC 60601 Test Level	Electromagnetic Environment - Guidance
Conducted RF IEC 61000-4-6	3 Vrms 150 kHz to 80 MHz and 6V at ISM Frequencies	Environment of a care facility professional health
Radiated RF IEC 61000-4-3	3 V/m 80 MHz to 2.7 GHz Test levels and frequencies according to table 9 from IEC 60601-1-2: 2014	Warning! Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the CS 9600 including cables specified by the manufacturer. Otherwise, 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 9600 system is used exceeds the applicable RF compliance level above, the CS 9600 system 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 9600.