Hans Pausch ELEVATOR-2 User manual

OPERATING INSTRUCTIONS ELEVATOR-2

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CONTENTS Page

Technical Safety Procedures

- Regulations 3

Product Safety

- Electrical safety 4

- Mechanical safety 4

- Danger of Injury 4

- X-Ray Protection. 5

- Explosion protection 6

- Interference suppression 6

- Classification of product 6

- EC Conformity 6

- Environment condition 6

- Disposal of equipment 6

Design Features

- Conception 7

General

- Brief Description 8

- Range of Application 8

Installation

- Floor Space Required 9

- Room Height 9

- Power 9

- Mains 9

Operating Elements

- Arrangement 10

- Meaning of Symbols/Function 10

- Adjustement of the exposure position/exposure 12

- Optional accessories 14

Maintenance

- Important note 16

- Operator`s service and maintenance 16

- Periodic maintenance 16

- Cleaning 16

- Disinfection 17

- The Council Directive 93/42EEC on Medical Devices 17 Location of Name Plate

- Labeling 18

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Important Note:

To ensure proper operation of this product it is essential that the service personnel is familiar with the "Operating Instructions" which should be studied carefully before use.

Special attention is to be given to the chapter "Safety Notes"

The equipment must be used in accordance with the safety procedures described below, and must not be used for purposes other than those for which it was designed. The equipment may only be used by persons having recognized qualification, including adequate training in radiation protection, authorizing them to perform the examination or treatment carried out.

It is the responsibility of the user to ensure that the government regulations are observed in the installation and operation of the equipment.

Technical safety note:

Regulations

If legal regulations govern the operation of the above equipment, it is the responsibility of the operator to observe them.

For the safety of patients, operators and others, as well as the efficient functioning of the equipment it is necessary to have periodic service inspections at 12month intervals according to the maintenance schedule. Please apply to your service organisation for inspection and maintenance.

Inspections intervals must by all means meet the requirements of the respective legislation or government regulations.

Changes and additions to the product must comply with the relevant legislation as well as with the accepted standards of good manufacturing practice.

As manufacturer of electromedical systems, we assume responsibility for the safety of the equipment only if maintenance, repairs and changes are carried out exclusively by us or third parties expressly authorised by us to do so, and if defective parts relating to the safety of the equipment are replaced by genuine spare parts.

We recommend that the service personnel is being asked to issue a certificate specifying the kind and extend of things or work ranges. Also the certificate should show the date of repair, the name of the service company and the signature of the technician.

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Before operating the equipment, the operator must check all devices concerning the safe and efficient functioning.

If the user of this equipment likes to combine the unit with other units, components or assemblies and this can not be made clear from the technical data, he must question us as manufacturer or another expert to make sure that the safety of the patients and operator is given by the planned combination.

Product Safety

Electrical safety

Only trained service personnel are permitted to remove covers and panels from the x-ray equipment .

In the Federal Republic of Germany, the electrical installation of rooms used for medical purposes must conform to the provisions of the VDE Standard 0107. In all other countries, the provisions of the applicable local laws and regulations have priority. The unit is only prepared for solid installation with an all poled separation from the power (ICE 601, Kap. 57.1).

Mechanical safety

It is the responsibility of the operator to ensure safety of patient while the unit is in operation by visual check, proper patient positioning, and use of devices that are provided.

Danger of injury

The solid black arrows and dotted lines in the illustration show areas which present potential Danger of Injury to operating personnal and patient from the equipment motion.

See next page.

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X-Ray Protection.

The unit has no controls with which radiation could be triggerd. Exposure is triggerd only from the radiation-protected location of the generator. The general radiation-protection measures must be observed.

In addition, we recommend the following: 1 Set the tube current as low as possible .

2 Limit the radiation field to the maximum possible extent. 3 Keep as fare away as possible. 4 Provide radiation protection for the patient.

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Explosion Protection

This equipment is not designed for use in areas where explosion hazard can take

place. Only skin cleansing agents may be used which form non-explosive mixtures with air.

Interference Suppression

The equipment complies with the EMC-requirements of the guideline 89/336 EWG of

* Special board International Electronic Commission (IEC). This unit complies to

EN 55011 and the reference value is according EN 55011 Group 1 Class B the in-

ternational electrotechnical committee (IEC).

Classification of product

The equipment complies to the protection degree of Class 1 and

for protection against electric shock Type B.

EC Conformity

The ELEVATOR-2 to which this declaration relates fulfills the essential requirements for safety of medical electrical equipment and follows the provisions of Medical Device Directive 93/42 EEC part 11 para. 5 according the procedure in

annex VII. The CE-Mark is only applicable for the product without X-ray components and Bucky.

The declaration of EC-conformity can be sent to you by request: Write to: Hans Pausch Röntgengerätebau c/o Quality Assurance Sys. Mgr. Postfach 28 60 D-91016 Erlangen Fax #: ..49 9131 99 24 22

Environment Condition Surrounding temperature range 10° C to 40° C Humidity 20% to 80% Atmospheric pressure 700 hPa to 1100 hPa

Disposal of equipment

Legal waste disposal regulations may apply to the disposal of this product. To avoid causing damage to the environment and personal injury, we recommend that you contact your Customer Services representative before permanently removing this product from service.

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