Hans Pausch CS 2000 TOMO User manual

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OPERATING INSTRUCTIONS CS 2000 TOMO

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English Edition 07/98 -1 of 24- 0125 7322

CONTENTS Page

Technical Safety Procedures

- Regulations 3

Product Safety

- Electrical safety 4

- Mechanical safety 4

- Rest risk 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 9

Installation

- Floor Space Required 10

- Room Height 10

- Power 10

- Mains 10

- AL weakening equivalent 10

Operating Elements

- Arrangement 11

- Meaning of Symbols/Function 12

- Procedures before exposure 16

- Accessories 19

Maintenance

- Important note 21

- Operator’s service and maintenance 21

- Periodic maintenance 21

- Cleaning 21

- Disinfection 22

- The Council Directive 93/42EEC on Medical Devices 22 Location of Name Plate

- Labeling 23

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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 the efficient functioning of the equipment it is necessary to have periodic service inspections at 12-month intervals according to the maintenance schedule. Please apply to your service organization 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 authorized 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. The certificate should also show the date of repair, the name of the service company and the signature of the technician.

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

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Please see: Daily check in chapter Maintenance.

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.

Rest risk: During proper operation and in case that a first mistake may occur there will be no

damage to patient and/or environment.

Danger of injury

The solid black arrows and dotted lines in the illustration show areas which present potential Danger of Injury to operating personal 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 triggered. Exposure is triggered 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 far 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 CS 2000 TOMO 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. 3 according the procedure in

annex II. 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

Enviroment 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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Design Features

Constructional Conception

A Table top, floating, manually movable, scratch-proof B Profile rail with trim cover, smooth, accepts accessories C Upper table frame D Bucky unit, movable E Table base, solid, vibration-free F Guide rails for tube stand G Foot treadle H Vertical carriage with X-ray tube support arm I Column, rotatable K X-ray tube L Control handle M Protractor N Control-panel for Tomo

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General

Short description

The equipment consists of a patient table with coordinate table top and diaphragm carriage, and of a column with X-ray tube, collimator and control arm.

The solid, vibration-free table base and the rail stand with column form one unit. The large and 2.20 m long, floating table top is manually movable and locks electromagnetically. The table top is provided for a maximum patient weight of 136 kg. It allows spacious lateral travel (60 cms to the left, 50 cm to the right and ± 12 cms transversely). For fast and easy positioning of the patient.

Especially for patient comfort and easy cleaning, the table top offers a scratch-proof surface (Resopal) and trim-covered, smooth profile rails on both sides, which can accept accessories.

The Bucky carriage accepts cassette trays from all renowned manufacturer. In longitudinal direction, it is manually moved and electromagnetically locked. The shortest possible OFD of 70 mm guarantees images of superior geometrical proportion. Low radiation absorption by the table top reduces the X-ray amount. The brake of the Bucky is released by a pushbutton on the operating handle.

As accessory is a automatic mechanical coupler available for automatic connection from the Bucky and tube stand.

The foot treadle along the table base allows the release of the electromagnetic table top brakes.

The tube stand for the X-ray tube support arm and tube is moved on the rail stand parallel to the longitudinal table axis.

The X-ray tube with collimator and control arm for the tube stand is supported by a lateral arm fixed to the vertical carriage. Vertical movement and rotation of the tube around the longitudinal axis of the lateral arm permit vertical, horizontal or oblique beam projections. Each position is electromagnetically locked.

The X-ray tube with column stand rotates around the vertical column axis and catches mechanically at angles of 0° (basic position), ± 90° (for lateral exposures).

The standard tube support is intended for DIN 6836 flanged plate C. The max. weight of the X-ray tube and collimator must not exceed 40 kg.

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For operating there are 3 operating methods from the control panel while pushing the key available:

Table mode - the automatic tube stand - Bucky linkage will adjust automatically the Bucky in their travel range to the middle of the column. Exactly positioning of the tube at 0° and ± 90°.

Wall mode - while pushing the key two (adjustable while mounting) SIDs will be motorised positioned while the tube rotates in direction of wall stand. By manual movement of the column is an automatically stop at the SID`s.

Tomo mode - while pushing the Prep-key the column and the Bucky drive into central position. After adjusting the tomography a test run or a linear blurring movement is possible. Tomography starts from direction of wall stand.

The totally integrated, microprocessor controlled tomography allows linear blurring movement in Tomo mode.

The tomography exposure can be made with 8°, 20°, 30° and 40° tomo angles from 0-24 cm tomography layer height. There are 2 exposure times for each tomo angle available. These tomo times can be programmed in correspondence with the Generator while installing.

The operator will be guided through the programme from the display of the control panel.

Range of use

The equipment is an universal X-ray examination system for doctors practices as well as for hospitals. It provides high-quality gridded exposures and linear blurring movement on lying patients. Large travel of the table top and uncomplicated functioning facilitate operation and increase patient comfort. A special cassette holder is available for lateral exposures. With a Bucky wall stand or a cassette stand, exposures can also be made with patients standing or sitting. Without requiring wall and ceiling fixtures, the equipment easily adjust to change in location.

Prerequisition

For safe and efficient operation of this product the personnel must be familiar with the operating instructions. The chapter on „Safety procedures“ deserves special attention.

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Installation Requirements

Floor space

The system is designed for stationary operation. The approximate floor space required measures 330 cm x 152 cm. An additional 20 cm minimum distance must be kept between tube stand and wall.

Height of room

The tube stand height is 234 cm. Installation requires a minimum room height of 245 cm. The table top of the equipment has a working height of 75 cm above floor.

Power

The system is equipped for single-phase alternating current with fixed installation. Two versions are available, depending on order. The unit is only prepared for solid installation with an all poled separation from the power (ICE 601, Kap. 57.1). Without transformer, the system corresponds to nominal ratings as follows:

Nominal voltage: 115/230 V AC Nominal current: 3/3 A Rated frequency: 50/60 Hz Nominal capacity: 690 VA

Mains

The mains connection requires a 30 mA circuit breaker to be installed by the customer. The electrical installation must meet the relevant legislation, e.g. VDE 0107, IEC/SC 62A.

AL-equivalent

The weakening equivalent of the table top (patient pos. table top) is £ 0,7 mm. According to: DIN EN 60601-1-3 with 100 kV and HWS 3,7 mm AL

and FDA 21 CFR § 1020.30 (n) with 100 kV and HWS 2,7 mm AL.

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Arrangement

1 Green LED lights when the Bucky is contered to the column

2 Green LED lights when the x-ray tube assembly rotation is catched

3 Green LED lights when the preferd SID is reached.

4 Switch for horizontal movement of the column

5 Switch for vertical movement of the x-ray tube ass.

6 Switch for tube rotation

7 Switch for release of all column brakes

8 Control handle with handgrips

9 Protractor

10 Rotation of tube stand by abrupt movement in appropriate

direction on control handle

11 Push button for Bucky

12 Hand grip for cassette tray

13 Foot treadle for table top break

16 Emergency stop switch

17 Switch for table mode

18 Switch for wall mode

19 Switch for small SID in wall mode

20 Switch for large SID in wall mode

21 Switch for tomo mode

22 Prep-switch for driving in central position

23 Switch for test run

24 Switch for selection of exposure angles

25 Switch for reducing the tomo height

26 Switch for increasing the tomo depth

27 Switch for selection of exposure time

28 Control panel display

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Meaning of Symbols/Function

Foot Treadle 13

unlocks the brakes for the floating table top. By fully pressing down and staying on the foot treadle, the table top can be moved manually in longitudinal and in transverse directions. Release of the foot treadle locks the table top in its changed working position.

Push button 6

unlocks the tube rotation brake. Release of the switch locks the tube in position.

Push button 4

unlocks the tube stand brake for horizontal movement. Release of the switch locks the tube in position.

Push button 5

unlocks the tube stand brake for vertical movement. Release of the switch locks the tube in position.

Push button 7

unlocks all column brakes. Release of the switch locks all movements in position.

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Indicator lamp green 1

lights up to indicate that the tube stand with tube is

coupled in the traveling area of the Bucky. The control

lamp goes out when leaving the traveling area.

(not in tomo - mode)

Turn of X-ray tube 10

The column stand with X-ray tube can be turned round

its longitudinal axle to the left or right side by 90 ° with

a strong start on both hand grips of the control arm. It

catchs at 0° , + 90° each.

Emergency Stop switch 16

The Emergency Stop switch has to be pressed inridi-

ately if there is any risk of injury for the patient, opera-

tor or the unit.

Resetting the stop switch by turning the button to the

right is only allowed when the risk of injury is surely

eliminated.

Table mode switch 17

for selection of table mode. As soon as the table mode

is activated, the SID lights up. While travelling the tube

stand, the Bucky in the table range and the X-ray tube

will follow and centered automatically. Both SIDs 1 and

2 light up when the centering has taken place.

Control panel display 28

The indication in the display will guide the operator

through the programme respectively shows the opera-

tor the working steps.

Errors in Tomo mode will be shown with error message EXX.

Switch - off unit as soon as error lights - up and switch

- on again after approx. 3 minutes. If the error still lights

- up please contact your service support.

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Switch 18 for selection of wall mode. As soon as the wall mode is activated,

the LED lights up.

Switch 19 for motorised start of the adjusted small SID.

Attention: The motorised start is only possible when the X-ray tube is on the vertical prefered SID and the green LED3 lights up. The tube stand drives on the SID and the X-ray tube rotates in direction of wall stand as long as the switch 19 is pressed. When the SID is reached, the LED at the switch lights up.

Switch 20 for motorised start of the adjusted large SID.

Attention: The motorised start is only possible when the X-ray tube is on the vertical preferred SID and the green LED 3 lights up. The tube stand drives on the SID and the X-ray tube rotates in direction of wall stand as long as the switch 20 is pressed. When the SID is reached, the LED at the switch lights up.

Switch 21 for selection of tomo mode.

The LED lights up as soon as the tomo mode is activated. Attention: The motorised movement are only possible, if the ta-

ble is at the exposure height, the preferred vertical SID is adjusted and the column is locked at the 0° position.

Prep-switch 22 for drive of column, Bucky and for rotation of the X-ray tube in

central starting position. Attention: Only in this central position, the tomo parameters can

be selected. The Prep-switch always has to be pressed after switching on the unit (when it`s not at the central position) and after selection of omo mode.

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Switch 23

for performance of a test run respectively for drive in ex-

posure position after selection of tomo parameters.

Attention: The tube stand will stay in exposure starting

position for approx. 1 sec. during test run. The test run

starts and ends in central position.

Switch 24

for selection of tomo angles.

Attention: Only possible in central position.

Switch 25

for increasing the tomography layer height in mm steps.

Attention: Only possible in central position.

Switch 26

for reducing of the tomography layer height in mm steps.

Attention: Only possible in central position.

Switch 27

for selection of the tomography exposure time.

Attention: Only possible in central position.

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Procedures before Exposure

Positioning of Patient / Centering of Bucky, Exposure Object, and Tube

Position the patient on the table top.

Note

To prevent injury from the patient sitting down or being positioned, move the tube stand and tube out of the critical range before positioning the patient.

Centering of the Bucky

Push switch 17 on control panel, the green LED lights up. Push switch 7 on control arm and drive the X-ray tube to the preferred SID (green LED 3 lights up) and the tube stand with tube to the middle of the table. The centering respectively adjustment of the Bucky will go automatically, when the column will be moved the X-ray tube is in 0° position and the column is in travel range of Bucky. The LED 1 lights up, when tube and Bucky are centered.

Centering of the object

Move the object into the central beam by adjusting the table top. For this purpose, press the foot treadle 13 fully down. The brakes of the floating table top are now unlocked. Adjust the table top. Release the foot treadle. The table top is locked in position.

Centering of the radiation field

Use the cassette size sensing for optimal localization of the radiation field of the collimator (operating instruction of the collimator).

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Exposure preparation

Insert cassette. Choose SID (FFD). Set expo-

sure dates on control desk. Control readiness

for exposure. Command patient to „hold your

breath“.

Note

Do not forget radiation protection devices for

the patient (lead rubber apron, gonad protec-

tion, etc.)

Oblique Exposure

Move column to the needed position. Adjust Bucky while pressing push button 11 under ex posure object. Rotate X-ray tube and center with switched-on optical pointer of the collimator to middle of Bucky.

Exposure with Bucky Wall Stand

Move the table top in the direction away from

the wall stand. Slide the tube stand towards the

wall stand. Rotate the tube to a 90° angle

(indication of angle!), switch on the indicator

light, then center the tube and adjust the wall

stand Bucky to the patient by vertical move-

ment.

Lateral Exposure

For lateral exposures with the cassette holder

lateral (cf. page with accessories), rotate the

tube stand to a 90° angle. Then rotate the tube

to a 90° angle (indication of angle!). Proceed as

described above.

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Adjustment of tomography (in tomo mode)

Position patient on table. Remark: Before positioning of patient move tube stand with Xray tube so that patient cannot be hurt while getting up or laying down !

Drive X-ray tube to the preferred SID while pressing switch on the control arm, the LED lights up.

Choose with switch 21 the tomo mode. Press prep-switch 22 and keep depressed until the column,

stops in central position and the tomo parameters are shown on the display. Remark: Column, Bucky and tube cannot be moved manually in tomo mode. Choose tomo parameters (tomo angle, exposure time, and tomography layer height). Press test switch 23 for performance of a test run. Fade-in light field of collimator to film size and switch-on.

Adjust exposure object to the light field. Put cassette in Bucky. Drive column in exposure start position with switch 23 or start test run.

Exposure preparation

The exposure can only be triggered at the generator. Set exposure dates on control desk. Control readiness for exposure. Command patient to „hold your breath“. Press the generator’s exposure switch until the exposure is finished.

Note:

Do not forget radiation protection devices for the patient (lead rubber apron, gonad protection, etc.)

Attention: If the exposure is interrupted or another exposure shall be made, the tube

stand has to be moved to the central position by pressing the prep-switch. After selection of the tomo parameters the unit is ready for a new exposure. It`s possible to drive to the start position with the first step of the generator`s exposure switch.

Attention: The operator has to observe the patient and the motion of the unit during

test run and exposure and has to stop immediately if there is any danger.

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Accessories

Compression Belt / Head Supports / Hip Clamps / Table Mattres

Compression Belt

Fastening and application: Slide support frame B into profile rail at wall side or

into Bucky profile rail. Turn knob screw to clamp in position.

Slide tightener A into front profile rail ( operator side ). Turn hand screw C to clamp in working position opposite of B

Press ratchet mechanism F. Unroll belt and stretch across patient.

Guide belt through complementary frame and once around frame bar. Fix belt bracket D into slot of shaft

G. Turn ratchet mechanism E to tighten belt.

Untightening:

Press locking lever F

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Lateral cassette holder

The lateral cassette holder permits lateral exposures if the tube unit is mounted to a tube swivelling device. The lateral cassette holder is slipped in one of the profile rails.

Grip screw (A): secures the holder at the table top Grip screw (B): locks the holder setting Grip screw (C): fixes the lateral position of the cassette clamps.

Head Supports

The head supports slide into profile rails of the

table or Bucky. The supports can be clamped in any position desired. The patient’s head is fixed to the appropriate exposure position by cushioned plates on adjustable bars.

Hand screw A: Clamping head supports to table top or Bucky.

Hand screw B: Clamping of head holder

Hand grips

The hand grips are slipped in the profile rails of the table. They may be fixed at any position and offer a reliable hold for the patient.

Grip screw (A): secures the grip in place

Important note:

The positioned patient may only hold on to the hand grips. In no case may he put his hands around the edge of the table top.

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Maintenance:

Important note:

Like all technical equipment, this unit requires also a regular maintenance service

to increase the safety of the equipment.

Operator´s service and maintenance

The operator has to check the x-ray equipment for defects as listed below:

Daily routine checks

Before operating check all functions of the indicator lamp, the operating elements,

the brakes and movements. Please check existence and legibility of the inscription

and warning signs.

In case of functional defects or other deviations from the normal operation the

equipment has to be switched off at once and the service company has to be

informed.

The equipment can not be used before all defects have been eliminated.

Weekly checks

Check all cables and their connections for treaces of wear.

Periodic maintenance

For trouble-free operation of the CS 2000 TOMO as well as safety for patient and

user it is necessary to carry out a technical maintenance from the service company

every 12 months.

Please see „technical maintenance“ of the mounting instruction.

The steel rope of the column has to be replaced every three years.

Attention:

In case of failure from components, which can limit the safety of the equipment,

original spare parts have to be used.

We recommend that the service personnel is being asked to issue a certificate

specifying the kind and extend of work that was done. Also the certificate should

show the date of repair, the name of the service company and the signature of the

technician.

Cleaning:

The equipment must be switched off before cleaning. Plastic surface should only

be cleaned with mild soap. Do not use strong cleaners or solvents as they will

damage the finish or blur the lettering.

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At least once a month external parts and exposed tracks on which rollers move

should be wiped to remove foreign material that may have accumulated.

DO NOT USE A DAMP CLOTH.

Wipe the tracks with a cloth lightly soaked with light machine oil or WD-40.

To protect the finish, polish the equipment with PURE liquid paste wax. Do not use

wax containing a cleaning substance. Polish all enameled metal surfaces.

Disinfection:

The equipment has to be switched off before disinfection. Only disinfection meth-

ods can be used that correspond to the relevant regulations and rules as well as

the protection for explosion.

Spray disinfection is not recommended because it can get in the inside of the x-ray

equipment.

The Council Directive 93/42/EEC on Medical Devices Article 12

This document is revised at the moment by the council.

However the Article 12 must be followed by the company or the legal person who put this X-ray unit into work.

The user is responsible for compliance and implementation of national deviations in the EC.

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Name Plate Location:

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Notes:

Specifications are subject to change without notice. TV/Ru 0125 7322 - 24 of 24- 07/98

Hans Pausch CS 2000 TOMO User manual

Specifications and Main Features

Frequently Asked Questions

User Manual