MTR 221 ACS - MTR 221 ACS DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
I
NTRODUCTION
2
Model R 221 ACS - R 221 ACS DHHS
MT
R
2
21
ACS
-
MTR
2
21
AC
S DHH
S - In
trod
uction
21 CFR subchapter J (FDA)
8750 01 & 8750 81 (CSA)
CE
*Ralco can provide documentation regarding its adherence to any of the above standards.
EN 60601-1 par. 5
Protection against electric hazards: "Class I" equipment.
Protection against direct and indirect contacts: Type B equipment with applied parts.
Protection against water see page: "Common equipment".
Safety of operation in the presence of inflammable anaesthetics with air or oxygen or nitrous oxide: Equipment not suited
to application in the presence of inflammable anaesthetic mixtures containing air or oxygen or nitrous oxide.
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Operation conditions: Equipment for continuous operation at intermittent loads - See Chapter Operation Instructions.
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Should label data on the collimator not correspond to the specifications herein, inform Ralco of the non conformity.
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Verifications of the specifications are to be performed according to the indicated equipment standards.
Inherent Danger of X-Rays
The collimator has been constructed to current standards to meet the safety requisites of Directive 2007/47/CE and all
other applicable standards. However, due to Radiology being an inherent dangerous activity which cannot be completely
safe guarded against, it is crucial that all safety procedures are followed. The installer and operator must follow ALL
established procedures (including those mentioned in this manual) to reduce the inherent danger of X-Rays.
The inherent risk of using collimators in Radiological systems is deemed reasonable as determined by applicable
standards. The use of collimators for Radiological systems is strictly regulated. Ralco follows all applicable standards. It
is up to the installer and operator to ensure that all possible steps are followed to ensure the health and safety of the
patient and operator.
The contact with the moving parts can be considered impossible and may occur only during installation or maintenance
(low hazard). The internal parts are protected by a mechanical safeguard in the form of a metal or plastic sheath which
impedes access. Also motor units are not accessible as knobs are fixed using the Allen screws and can be removed only
by using a tool, in accordance with paragraph 5.92.3 of EN 60601-1 and EN 60601-2-54 par. 201.9.2.2.5. In addition the
collimator has been tested in accordance with EN 60601-1, paragraph 4.8.2
Read all information in this chapter carefully.
You are responsible to take safety precautions and to follow the safety instructions. Thus, you can prevent harm
form yourself and other persons.
TECHNICALLY QUALIFIED PERSONNEL ONLY!
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Only technically qualified Field Service Engineers (FSEs) must do the service work. The FSEs must be appropriately
and successfully trained and instructed.
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Perform all service tasks such as installation, maintenance, or repair in strict compliance with the provided safety
instructions!
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Perform all action as for example unpacking, installation, setting to work, testing and replacement according to the
sequence stated in this manual.
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Perform all service tasks in strict compliance with the local regulations concerning safety, health, accident preven-
tion, and medical X-ray devices!
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Never change any system parameters or components that reduce the mechanical safety, electrical safety, radiation
protection properties of the product!
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Do not modify this equipment without authorization of Ralco.
Any unauthorized modification can cause malfunction or deterioration of performance and quality and can therefore
lead to personal injury, clinical misdiagnosis or clinical mistreatment.
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Never leave problems unsolved that may affect the safety of the product!
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Order spare parts via Ralco distribution channel.
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Always perform all relevant safety checks before handing the product over to the customer!
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Keep in mind that certain details or procedures change since you previously installed or serviced a similar product!
If you do not obey these instructions, there is a risk of death or serious injury.
A temperature of the collimator cover, under normal operating conditions and at the maximum ambient operating
temperature (40°C), could exceed 41°C. According to the Table 24 of the General IEC 60601-1 standard, contact with the
collimator cover must be less than 1 minute, both for the operator and for the patient. During the diagnostic test the
operator must pay attention that the patient does not come into contact with the collimator surface for more than 1 minute.
If you do not obey these instructions, there is a risk of serious injury.
