Combi Elevator Tomo-2 Operating Instructions - ST
Combi Elevator Tomo-2 Operating Instructions - ST
1 1275
English Edition
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.
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
Rest risk:
During proper operation and in case that a first mistake may accur there will be no damage
to patient and/or environment.
2.8 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.
Write to:
Pausch technologies
Hotline
Postfach 28 60
D-91016 Erlangen
Fax: +49 9131 99 24 69
5 Installation Requirements
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).
Nominal current: 6A 12 A
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.
Switch 4
Switch 5
Switch 7
Protractor 9
Rotation of column 10
Switch 18
Switch 20
Switch 21
Prep-switch 22
Switch 24
Switch 25
Switch 26
Switch 27
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.
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.
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.
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.
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
Note
Note:
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.
Compression Belt
Untightening:
Head Supports
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:
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.
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.
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.
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.