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Combi Elevator Tomo-2 Operating Instructions - ST

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0% found this document useful (0 votes)
101 views25 pages

Combi Elevator Tomo-2 Operating Instructions - ST

Uploaded by

ignashew
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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OPERATING INSTRUCTIONS

Combi Elevator Tomo-2

1 1275
English Edition

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Rev. 03 © 2005 Pausch technologies Graf-Zeppelin-Str. D-91056 Erlangen ALL RIGHTS RESERVED Ru
OPERATING INSTRUCTIONS Combi Elevator Tomo-2 .....................................1
1 Technical safety note:........................................................................................3
2 Product Safety ....................................................................................................3
2.1 Electrical safety........................................................................................................... 3
2.2 Mechanical safety ....................................................................................................... 4
2.3 Danger of injury........................................................................................................... 4
2.4 X-Ray Protection. ........................................................................................................ 4
2.5 Explosion Protection ................................................................................................... 5
2.6 Interference Suppression ............................................................................................ 5
2.7 Classification of product.............................................................................................. 5
2.8 EC Conformity............................................................................................................. 5
2.9 Enviroment Condition.................................................................................................. 5
2.10 Disposal of equipment .............................................................................................. 5
3 Design Features .................................................................................................6
4 General ................................................................................................................7
4.1 Short description ......................................................................................................... 7
4.2 Range of use .............................................................................................................. 7
4.3 Prerequisition .............................................................................................................. 8
5 Installation Requirements..................................................................................8
5.1 Floor space ................................................................................................................. 8
5.2 Height of room ............................................................................................................ 8
5.3 Power.......................................................................................................................... 8
5.4 Mains .......................................................................................................................... 8
5.5 AL-equivalent .............................................................................................................. 8
6 Arrangement .......................................................................................................9
7 Meaning of Symbols/Function ........................................................................10
8 SETTING EXPOSURE POSITION/EXPOSURE ................................................16
9 Accessories ......................................................................................................21
10 Maintenance: ..................................................................................................23
10.1 Important note:........................................................................................................ 23
10.2 Operator´s service and maintenance ...................................................................... 23
10.3 Weekly checks ........................................................................................................ 23
10.4 Periodic maintenance.............................................................................................. 23
10.5 Cleaning:................................................................................................................. 24
10.6 Disinfection: ............................................................................................................ 24
10.7 The Council Directive 93/42/EEC on Medical Devices ............................................ 24
11 Name Plate Location:.................................................................................... 25

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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.

1 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
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 ac-
cepted standards of good manufacturing practice. As manufacturer of electromedical sys-
tems, 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. 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 con-
cerning the safe and efficient functioning. 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.

2 Product Safety

2.1 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 (IEC 601,
Kap. 57.1).

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2.2 Mechanical safety
It is the responsibility of the operator to ensure safety of patient while the unit is in opera-
tion 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 accur there will be no damage
to patient and/or environment.

2.3 Danger of injury


The arrows in the illustration show areas which present potential Danger of Injury to operat-
ing personnal and patient from the equipment motion.

2.4 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 far away as possible.

4 Provide radiation protection for the patient.

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2.5 Explosion Protection
This equipment is not designed for use in areas where explosion hazard can take place.
Only skin cleaning agents may be used which form non-explosive mixtures with air.

2.6 Interference Suppression


The equipment complies with the EMC-requirements of the guideline 89/336 EWG. 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 international electrotech-
nical committee (IEC).

2.7 Classification of product


The equipment complies to the protection degree of Class 1 and for protection against
electric shock Type B.

2.8 EC Conformity
The Combi Elevator Tomo-2 to which this declaration relates fulfills the essential require-
ments for safety of medical electrical equipment and follows the provisions of Medical De-
vice 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:
Pausch technologies
Hotline
Postfach 28 60
D-91016 Erlangen
Fax: +49 9131 99 24 69

2.9 Enviroment Condition


Surrounding temperatur range 10° C to 40° C

Humidity 20% to 80%

Atmospheric pressure 700 hPa to 1100 hPa

2.10 Disposal of equipment


Legal waste disposal regulations may apply to the disposal of this product. To avoid caus-
ing 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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3 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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4 General

4.1 Short description


The equipment consists of a motor-driven elevating Bucky table with coordinatus table top
and Bucky carriage as well as a floor mounted column stand for X-ray tube unit, collimator
and control arm including a totally integrated tomography device for linear blurring move-
ment without mechanical coupling. 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 mov-
able and locks electromagnetically. The table top is provided for a maximum patient weight
of 136 kg. For fast and easy positioning of the patient, it allows spacious lateral travel: 60
cm to the left, 50 cm to the right and ± 12 cm transversely. 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 takes
up cassette trays as supplied by any reknowned 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 push-button on the
operating handle. The foot treadle along the table base allows the release of the elctro-
magnetic 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 handle for the tube stand is supported by a lateral arm fixed to the vertical car-
riage. 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 electromagneti-
cally 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. For operating there are 3 operating meth-
ods 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. Exact positioning of the tube at 0° and ± 90°. Wall mode - while pushing the
key two (adjustable while mounting) SIDs will be motorized positioned while the tube rotates
in direction of wall stand. By manual movement of the column is an automaticly 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 con-
trolled tomography allows linear blurring movement in Tomo mode. The tomography expo-
sure 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 correspondance with the Generator while installing. The operator will be
guided through the programme from the display of the control panel.

4.2 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 opera-
tion and increase patient comfort. A special cassette holder is available for lateral expo-
sures. With a Bucky wall stand or a cassette stand, exposures can also be made with pa-
tients standing or sitting. Without requiring wall and ceiling fixtures, the equipment easily
adjust to change in location.

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

5 Installation Requirements

5.1 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.

5.2 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.

5.3 Power
The system is equipped for single-phase alternating current with fixed installation. Two ver-
sions are available, depending on order. The unit is only prepared for solid installation with
an all poled separation from the power (IEC 601, Kap. 57.1).

Without transformer, the system corresponds to nominal ratings as follows:

Nominal voltage: 230 V AC 115 V AC

Nominal current: 6A 12 A

Rated frequency: 50/60 Hz 50/60 Hz

Nominal capacity: 1380 VA 1380 VA

5.4 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.

5.5 AL-equivalent
The weakening equivalent of the table top (patient pos. table top) is ≤ 0,7 mm.

According to:

DIN EN 60601-1-3 mit 100 kV und HWS 3,7 mm AL and FDA 21 CFR § 1020.30 (n) mit
100 kV und HWS 2,7 mm AL.

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6 Arrangement

1) Green LED lights when the Bucky is centered to the column


2) Green LED lights when the x-ray tube assembly rotation is catched
2a)Green LED lights when the table exposure height
3) Green LED lights when the preferred SID is reached.
4) Switch for horizontal movement of the colum
5) Switch for vertical movement of the x-ray tube ass
6) Switch for tube rotation
6a)Safety switch
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
14) Foot treadle for motorized lowering of the table top
15) Foot treadle for motorized raising of the table top
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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7 Meaning of Symbols/Function
Foot switch 14 and security switch 6a for motorised lower-
ing of the table top. The table is moving down as long as
the switches are pressed. The lowering speed with soft
start and break is constant. Automatic shutdown of the
down motion in end position and in exposure height. Con-
tinue of movement after interruption in exposure height.
Release foot switch/security switch. Push again.

Foot switch 15 and security 6a for motorised raising of the


table top. The table raises as long as the switches are
pressed. The raising speed with soft start and break is
constant. Automatic shutdown of the up motion in end po-
sition and exposure height. Release foot switch/security
switch. Push again.

Foot switch 13 to release the brakes of the floating table


top. The table top can be manually shifted longitudinally
and transversely as long as the switch is depressed. The
table top locks in place when the switch is released.

Security switch 6a for motorised raise respectively lowering


of the table top.

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Switch 6

to release the brakes for the rotation movement of the X-


ray tube. Release of the switch locks the tube in position.
By turning the x-ray tube close to the 0° and 90° position,
the LED blinks. Release of the switch causes a exactly
motorized positioning of the x-ray tube.

Switch 4

unlocks the column brake for longitudinal movement. Re-


lease of the switch locks the column in place.

Switch 5

unlocks the vertical carriage. Release the switch and the


vertical carriage will be locked in place again. The motion
stops automatically at the preferred vertical SID and can
be continued by pressing the switch agin. The motion
stops automatically at the preferred vertical SID and can
be continued by pressing the switch again.

Switch 7

unlocks the column brakes. Release of the switch locks all


movements in place

Protractor 9

indicates the angle of the tube vs. Exposure object.

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Indicator LED (green) 1

lights up to indicate that the Bucky is centered to the col-


umn

Indicator LED (green) 2a

lights when the table top is in exposure height.

Indicator LED (green) 2

indicates an exactly 0° or 90° positioned x-ray tube

(not in Tomo mode)

Indicator LED (green) 3

indicates the adjusted vertical SID

Rotation of column 10

The column can be turned about his vertical axis by abrupt


movement on the control handle. It is locked at 0° and 90°
left and right.

Emergency Stop switch 16

The Emergency Stop switch has to be pressed immedi-


ately if there is any risk of injury for the patient, operator 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.

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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 table range and the X-ray tube will fol-
low and centered automatically. Both SIDs 1 and 2 light up
when the centering has been taken place.

Control panel display 28

The indication in the display will guide the operator through


the programme respectively shows the operator the work-
ing 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.

Switch 18

for selection of wall mode. As soon as the wall mode is


activated, the LED lights up.

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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 preferred SID and the green LED3 lights up.
The tube stand drives on the SID and the X-ray tube ro-
tates 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 ro-
tates 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 motorized mou-
vements are only possible, if the table is at the exposure
height, the preferred vertical SID is adjusted and the col-
unm 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 cen-
tral 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 se-
lection of tomo mode.

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Rev. 03 © 2005 Pausch technologies Graf-Zeppelin-Str. 1 D-91056 Erlangen ALL RIGHTS RESERVED Ru
Switch 23

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


sure 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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8 SETTING EXPOSURE POSITION/EXPOSURE
Patient Positioning/ Centering of Bucky, Object and Tube Unit.

Patient Positioning

Press the foot switch 13 to unlock the table top brakes. Move the table top manually float-
ing to the rear stop. Release the foot switch. Press the foot switch 14 and the safety switch
6a simultaneously. The table top is lowered by the motor in a telescopic way. Release the
switch when comfortable working height for patient access or transfer is reached.

Note

When reaching the preset exposure position of the table top, the downward movement is
interrupted automatically. To continue movement, release the foot switch. Press again.

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Exposure

Press the foot switch 15 and the safety switch 6a. The table top is lifted up by the motor to
exposure position. Release the switch after the automatic stop.

Exposure in table mode

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 col-
umn is in travel range of Bucky. The LED 1 lights up, when tube and Bucky are centered.

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Centering of patient and beam field

Collimate the x-ray beam to film size (field light, manual of collimator) Move the table top
with the patient after actuating foot switch 13 under the light field. Releasing the foot switch
13 locks the table top.

Adjustment of angular exposure

Move column to the needed position. Adjust Bucky while press-


ing push button 11 under exposure 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 table top in the opposite direction of Bucky wall stand.


Push with switch 18 in wall mode, the LED lights up. Press 20
or 21 (depending on SID) and keep depressed, the X-ray tube
rotates automatically in direction of wall stand and column
stand to the required SID. The tube stand can be moved
manually too. Then it stops automaticlly at the SID. Drive Bucky
of the wallstand in the vertical corresponding to exposure ob-
ject. Switch on light and adjust X-ray tube for centering while
pressing switch 5.

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Lateral exposure

Rotate tube stand and X-ray tube by 90° (protractor) when lat-
eral exposure with side cassette holder (see also accessories)
is required.

Exposure preparation

Insert cassette. Choose SID (FFD). Set exposure dates on con-


trol 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 protection, etc.)

Adjustment of tomography (in tomo mode)

Position patient on table. Remark: Before positioning of patient


move tube stand with X-ray tube so that patient cannot be hurt
while getting up or laying down ! Drive table to the exposure
height 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 to-
mography 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.

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Exposure preparation

The exposure can only be triggered at the generator. Set expo-


sure 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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9 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 ac-


cross 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 pro-
file 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 ta-
ble. They may be fixed at any position and offer a reli-
able 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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10 Maintenance:

10.1 Important note:


Like all technical equipment, this unit requires also a regular maintenance service to in-
crease the safety of the equipment.

10.2 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 equip-
ment 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.

10.3 Weekly checks


Check all cables and their connections for treaces of wear.

10.4 Periodic maintenance


For trouble-free operation of the COMBI ELEVATOR TOMO-2 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.

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10.5 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 fin-
ish or blur the lettering. 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 enamelled metal surfaces.

10.6 Disinfection:
The equipment has to be switched off before disinfection. Only disinfection methods can be
used that correspond to the relevant regulations and rules as well as the protection for ex-
plosion. Spray disinfection is not recommended because it can get in the inside of the x-ray
equipment.

10.7 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 EU.

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Rev. 03 © 2005 Pausch technologies Graf-Zeppelin-Str. 1 D-91056 Erlangen ALL RIGHTS RESERVED Ru
11 Name Plate Location:
Labeling:

Specifications are subject to change without notice. TV/Ru

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Rev. 03 © 2005 Pausch technologies Graf-Zeppelin-Str. D-91056 Erlangen ALL RIGHTS RESERVED Ru

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