Hans Pausch CS 2000 User manual

Operating Instructions CS 2000

English Edition

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CONTENTS Page

Important Note 3

Safety-technical Remarks

- Regulations 3

Product Safety 4

- Electrical Safety 4

- Mechanical Safety 4

- Crush Zones 4

- Radiation Safety 5

- Explosion Protection 6

- Electromagnetic Interference, EMI 6

- Classification per IEC 601-1-1 6

- EC Conformity 6

- Environmental Conditions for Operation 6

- Disposal 6

Design Features

- Design 7

General

- Brief Description 8

- Area of Applicability 9

- Important Note 9

Setup

- Space Requirement 10

- Room Height 10

- Connection 10

- Line Power 10

- Al Equivalency Value 10

Control Elements

- Location 11

- Explanation of Symbols/Function 12

- Setting the Exposure Position/Exposure 14

- Accessories 16

Maintenance

- Important Note 18

- Testing by the Operator 18

- Testing by Customer Service 18

- Cleaning 18

- Disinfection 19

- EEC Guideline 93/42 Regarding Medical Products 19

Placement of Model Labels

- Labeling 20

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IMPORTANT NOTE

Proper use of this product by operating personnel requires knowledge of these OPERATING INSTRUCTIONS; these must be studied prior to starting up the equipment.

This radiographic equipment may be operated only by personnel who possess the required specialized knowledge of radiation safety or who are familiar with radiation safety and who have been instructed in the operation of the radiographic equipment.

The operator is always responsible for maintaining the regulations that apply for operation of the radiographic equipment.

SAFETY-TECHNICAL REMARKS

Regulations

If there are legally specified regulations regarding the operation of radiographic equipment, it is the responsibility of the operator to observe them.

In the interest of safety for patient, operating personnel as well as for third parties, tests which assure the operating reliability and functionality of the product must be performed in accordance with the Maintenance Instructions in intervals of 12 months. We request that you contact your customer service department regarding performance of these tests.

If tests are required in shorter intervals in order to comply with national specifications or regulations, it is absolutely necessary to observe them.

Modifications and additions made to the product must be in accordance with legal regulations as well as with generally accepted rules of the technology.

As the manufacturer of the radiographic equipment, we can assume responsibility for the safety-technical features of the product only if: any maintenance, repair and modification on it is carried out only by us or by facilities that have been authorized by us for this purpose, and if there is a failure of parts which affect the safety of the product, such parts are replaced with original spare parts.

When performing this work, we recommend that written confirmation regarding the nature and extent of work be requested from the person performing the work, and if applicable, include any changes made in nominal values or to the operating range. In addition, the company performing the work, the date and a signature should be included.

Prior to daily use, the user must assure himself that all devices provided for safety are functional and that the product is operational.

If the operator of the radiographic equipment wishes to combine it with other products, components or assemblies, and this capability is not clear from the technical data, he must assure that the safety of patients as well as of operating personnel is not adversely affected by the intended combination by contacting us as the manufacturer of the equipment or by contacting someone who has specialized knowledge of the equipment.

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PRODUCT SAFETY

Electrical Safety

Only specially trained maintenance personnel may remove the covers and panels on the radiographic equipment.

This radiographic product may be operated only in medical rooms that meet the requirements of VDE 0107. It is designed for a permanent connection with universal isolation from the power source (IEC 601, Chap. 57.1).

Mechanical Safety

Please make sure that neither the patient nor you can reach into the movement path of the radiographic equipment or that parts of clothing can be caught by it.

Make sure that all objects within the movement range of the radiographic equipment have been removed.

Crush Zones

The highlighted locations in the following sketch represent the danger zones in which the patient or operator can be injured by crushing or striking.

See following page

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Radiation Safety

The equipment does not have any control elements with which radiation can be triggered. Triggering of exposure is made from the generator radiation-protected location. The general regulations regarding radiation safety must be observed.

We also recommend:

1. Keep the tube current as low as possible.

2. Keep the radiation field as small as possible.

3. Maintain the max. possible distance.

4. Do not forget to provide radiation protection for the patient.

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Explosion Protection

This product is not intended for use in areas where there is a risk of explosion. Only those household cleaning products whose gas-air mixture is inflammable may be used.

Electromagnetic Interference (EMI)

The product meets EMI specifications as defined in EEC Guideline 89/336. The limit values for measurement of interference per EN 55011, Group 1, Class B and the requirements for immunity to interference per EN 50082-1, Degrees 2 and 5 are maintained.

Classification per IEC 601-1-1

Depending on the type of protection against electrical shock, the equipment corresponds to Safety Class 1 and, depending on the degree of protection, Type B.

EC Conformity

This radiographic equipment meets the basic requirements as defined by EEC Guideline 93/42 of the Committee for Medical Products, per Article 11, Paragr. 3 and the procedure listed in Appendix II.

The CE symbol is valid only for the product without the radiographic components.

Further information can be obtained upon request from: Hans Pausch

Röntgengerätebau Qualitätssicherung

Postfach 28 60 D-91016 Erlangen

Fax: ..49 9131 99 24 22

Environmental Conditions for Operation

Ambient temperature range 10° C to 40° C Relative humidity in the range 20% to 80% Ambient pressure in the range 700 hPa to 1100 hPa

Disposal

Legal disposal regulations may exist for this product. To avoid environmental and human damage, we request that you contact your customer service department before the product is taken permanently out of operation.

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