Famed SU-02 User manual

USER MANUAL
Operating table
SU-02
Factory no.: .............................................
Version 12.00
Żywiecka Fabryka Sprzętu Szpitalnego
FAMED S.A.
Appendixes: 2, 3, A List of Spare Parts.

Operatin Manual for Operatin Table SU-02.0
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As provided in the Directive on Medical Equip ent 93/42/EEC of 14 June 1993
this is first risk class product.
The producer declares that the product eets basic require ents of the
directive contained in Appendix 1.
The co pliance procedure was carried out in accordance with appendix VII of
the directive.
Manufacturer:
ywiec Hospital Equipment Company FAMED S.A.
Fabryczna 1
34-300 ywiec
Phone numbers:
Infoline ([phone] (24-hours a day)
Head office ([phone]
Marketing Department ([phone] ...02
Export Department ([phone] ... 52
Service ([phone]
Fax [phone]
Medical device was registered at Registration Office of Healing Products, Medical Products
and Bio fight Products under no: PL/ DR 00 05 28
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Operatin Manual for Operatin Table SU-02.0
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Dear Clients,
Congratulations on choosing the right product, we wish you would find a
lot of satisfaction while operating it.
Please read this manual very carefully as it includes all the vital
information and notes from the producer concerning proper installation
and maintenance of the product as well as its service.
ywiecka Fabryka Sprzętu Szpitalnego
FAMED S.A.
General notes
•The use, aintenance as well as servicing of this product perfor ed in other
ways than those, which have been stated in this anual is forbidden and ay
result in da ages, which will encu ber the user and which will not be a atter of
producer’s responsibility.
•When the operation and para eters of the product do not atch the description in
ite ‘Operation’ in this anual, the use of the product is not allowed and any
defects have to be reported to the producer or the supplier.
•Every repair of the product ust be done by a factory or an authorized service
and recorded on the list of repairs, which is supplied with the guarantee certificate.
Disregarding this require ent will cause the guarantee for the product to be
invalid.
Notes concerned with safety
The sign shown below says: ‘Caution – pay special attention to the Operating Manual’.
A label showing this sign is placed on any parts or echanis s, which ay
prove to be har ful to the patient or the personnel if their operation does not
co ply with the descriptions found in this Operating Manual.
•Throughout surgical procedures table wheels should be blocked.
•When using the table close to edical equip ent working on high frequencies and
defibrillators one should closely follow operating instruction for that equip ent.
I proper operation ay beco e a source of dangerous accidents. There is a
danger of serious burning of the patient through the contact with etal parts of
the table or its equip ent.
•Throughout surgical procedures the table ust be connected to the installation of
potential equalization in the operations roo .
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Operatin Manual for Operatin Table SU-02.0
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•When perfor ing longitudinal (Trendelenburg or reverse Trendelenburg) and
lateral tilting, patient should be secured against uncontrolled sliding down fro
the operating table. Use shoulder supports, supporting rollers, side supports,
belts and grips as securing ele ents.
Notes concerning: start-up, operation and use
•When anti-trendelenburg function is perfor ed, footrests ay collide with the
basis
•The floor under the table should be free fro any obstacles
•When rolling the table avoid collisions
•Do not roll the table over electric cables
•If it is necessary to replace oil (dangerous waste), one should follow existing
environ ental protection regulations
Notes concerning cleaning and disinfecting
•The product ust not be disinfected in disinfecting cha bers!
•No disinfecting agents containing alcohol are allowed for cleaning of polyurethane
ele ents ( attresses).
•No bleaching agents (containing active chlorine or oxygen), caustic or corrosive
che icals are allowed!
•No agents destroying the structure of plastic (organic solvents) can be applied to
the plastic ele ents!
Disregarding the above require ents concerning cleaning and disinfecting shall
result in losing the guarantee for the product!
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Operatin Manual for Operatin Table SU-02.0
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CONTENTS
1. PROPER USE AND APPLICATION ..............................................................................................................6
1.1. APPLICATION......................................................................................................................................................6
1.2. GENERAL REQUIREMENTS.....................................................................................................................................6
1.3. DUTIES OF THE USER ..........................................................................................................................................6
1.4 DESCRIPTION OF THE PRODUCT...............................................................................................................................6
1.5 DESCRIPTION OF ELEMENTS....................................................................................................................................7
1.6 TECHNICAL SPECIFICATIONS...................................................................................................................................9
1.7 USE PARAMETERS..............................................................................................................................................10
1.8 SAFETY............................................................................................................................................................11
1.9 CRITICAL PARAMETERS.......................................................................................................................................11
2 TRANSPORT AND FIRST USE......................................................................................................................12
2.1 TRANSPORT.......................................................................................................................................................12
2.2 UNPAC ING AND FIRST USE..................................................................................................................................12
3 OPERATION AND USE...................................................................................................................................13
3.1 RAISING AND LEVELLING OF TABLE TOP.................................................................................................................13
3.2 LONGITUDINAL TILT OF THE TABLE-TOP.................................................................................................................13
3.3 TABLE TOP SIDE INCLINATION...............................................................................................................................14
3.4 CHANGE OF ANGULAR POSITION OF THE BAC REST SEGMENT.....................................................................................14
3.5 CHANGE OF ANGULAR POSITION OF IDNEY BENCH .................................................................................................14
3.6 CHANGE OF ANGULAR POSITION OF THE FOOTRESTS.................................................................................................14
3.7 CHANGE OF ANGULAR POSITION OF DIVIDED FOOTRESTS ...........................................................................................15
3.8 ROTATION OF THE FOOTREST................................................................................................................................15
3.9 INSTALLATION AND REMOVAL OF THE FOOTREST......................................................................................................15
3.10 INSTALLATION AND OPERATION OF THE HEADREST.................................................................................................15
3.11 INSTALLATION AND DISMOUNTING OF MATTRESSES.................................................................................................16
3.12 TABLE MOBILITY..............................................................................................................................................16
3.13 ANTISTATIC PROPERTIES....................................................................................................................................16
3.14 POTENTIAL EQUALISING CLAMP ..........................................................................................................................16
3.15 COLLISIONS.....................................................................................................................................................17
4 INSTALLATION AND OPERATION OF ACCESSORIES.........................................................................18
5 CRITERIA ON WHOSE BASIS IT IS ASSESSED WHETHER PRODUCT OPERATION IS
CORRECT OR NOT............................................................................................................................................19
6 TABLE MAINTENANCE.................................................................................................................................19
6.1 STORAGE .........................................................................................................................................................19
6.2. CLEANING AND DISINFECTING ...........................................................................................................................20
6.3. DAMAGES AND DEFECTS.....................................................................................................................................20
6.4. REPAIRS AND INSPECTIONS..................................................................................................................................20
CONTROL OF TECHNICAL CONDITION...........................................................................................................................21
6.5. CONTROL OF TECHNICAL CONDITION.....................................................................................................................21
6.6. LOCATION OF DEFECTS AND THEIR REMOVAL.........................................................................................................21
6.7 PRODUCT LIQUIDATION.......................................................................................................................................22
7. TABLE IDENTIFICATION............................................................................................................................22
7.1. NAMEPLATE.....................................................................................................................................................22
7.2 LABELS...........................................................................................................................................................23
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Operatin Manual for Operatin Table SU-02.0
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1. Proper use and application
1.1. Application
Operatin table SU-02 is desi ned for supportin the patient durin carryin out treatments and
operations. The table with proper accompanyin equipment can be used for procedures of eneral
sur ery, vascular sur ery, cardiosur ery, neurosur ery, urolo y, ynecolo y, proctolo y, ENT,
endoscopy, laparoscopy, ophthalmolo y, trauma sur ery, oncolo y sur ery, dental sur ery, plastic
sur ery and others. Se ments of the table-top are radiotransparent.
1.2. General require ents
The product is intended to be used indoors. Required climatic conditions: temperature from +10 to
+40ºC, acceptable chan e of surroundin temperature durin 8 hours should not exceed 20°C,
relative humidity of the air should ran e from 30 to 80%, atmospheric pressure from 700 to 1060 hPa.
The product should be used, maintained and serviced accordin to the instructions contained in this
manual.
Caution!
Using, maintaining and servicing the product in other way than indicated in this
manual is not permitted and may lead to damages for which the user is to blame
and for which the producer is not responsible.
Installation of other accessories than those offered by the producer for the
product is allowed only on the basis of a written acceptance of the producer.
1.3. Duties of the user
User: any individual or corporate body who uses the product as its owner, lessee, pled ee or who
has a different ri ht to the product as well as an entity who uses the product on its own or on whose
behalf it is used.
The user must ensure that the product shall be used exclusively in conformity with its destination and
that it is used in appropriate conditions and in consistence with this manual. The user is also obli ed to
take all necessary precautions in order to prevent all life and health hazards concernin the user,
patients and any third party. Only authorised persons who underwent special trainin and are
acquainted with this manual may operate the product. The user must also ensure that all persons who
operate the product have read, understood and apply instructions contained in this manual.
1.4Description of the product
The table consist of table base and table top.
The table has a mobile base (standard or Supermobile – with lar e wheel), equipped with central
blockade, which is released with a foot lever. The top of the operation table is permanently attached to
the base. The table-top consists of se ments, and their number and confi uration is deliver accordin
to a customer order. The table top is X-ray permeable. The table top is provided with polyurethane
mattresses. On both sides of the table top there are side strips which allow to install accessories.
Adjustments of the position of individual se ments, as well as column movements are performed by
mechanical systems.
Thanks to the wide ran e of offered accessories the table can be used for different types of operations
accordin to client wish. List of accessories can be found in Para raph 4 - Installation and operation of
accessories.
The producer reserves the right to introduce in the product structural modifications resulting
from technical progress which are not covered in this user manual.
The producer reserve that all parameters and accessories can be modified or change
especially construction, technology and materials, not lowering accepted parameter
technically-user and safeties of products.
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Operatin Manual for Operatin Table SU-02.0
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1.5Description of ele ents
drawin 1 Operatin table SU-02 (standard version)
drawin 2 Operatin table SU-02 (Supermobile version)
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Operatin Manual for Operatin Table SU-02.0
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drawin 2 Operatin table SU-02 (version with steerin panel on the head side)
item
on drawin
1-3
Description
1 Headrest
2 Backrest se ment
3 Kidney bench
4 Seat se ment
5 Footrest se ment
6 Base
7 Column
8 Side strips
9 Potential equalisin clamp
10 Hydraulic pump pedal (adjustment of table-top hei ht)
11 Headrest an le chan e lever
12 Bolster blockade knob
13 Lon itudinal tilt handle
14 Handle
15 Handle turn block
16 Backrest se ment an le chan e lever
17 Blockade of lever of back support an le adjustment
18
18.1
18.2
18.3
Kidney bench crank
-stora e position
- adjustment position of kidney support
- adjustment position of lateral tilt
19 Crank sleeve of kidney support
20 Screw of kidney support mechanism
21 Footrest restorin knob
22 Footrest blockade lever
23 Footrest an le chan e lever
24
24.1
24.2
24.3
Pedal of central wheel blockade / feet ejection
- wheel unblocked position / feet elevated
- wheel blocked position / feet lowered
- direction blockade position
25 Feet
26 Wheels
27
2 .1
2 .2
Crank for side inclination an ular chan e
– rest position
– work position
28 Blockade of lateral tilt an le knob
29 Shaft of lateral tilt device
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Operatin Manual for Operatin Table SU-02.0
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1.6Technical specifications
•Total len th of table top (4 and 5 sectional table top) 2025mm ± 15 mm
•Total len th of table top (6 sectional table top) 2160mm ± 15 mm
•Total table-top width (with slats) 550 mm ± 5 mm
•Width of mattress 500 mm ± 5 mm
•Minimum hei ht of the top from the floor 750 mm ± 15 mm
•Maximum hei ht of the top from the floor 1000 mm ± 15 mm
•Backrest raise an le 70°
•Backrest lowerin an le 40°
•Kidney bench raise an le 110°
•Footrest raise an le (4 and 5 sectional table top) 15°
•Footrest raise an le ( 6 sectional table top) 45° (+45°)
•Footrest lowerin an le 90°
•Footrests widenin an le 180°
•An le of side inclination ± 25°
•Headrest raise an le 50°
•Headrest lowerin an le 20°
•trendelenbur 30°
•anti-trendelenbur 25°
•Table wei ht about 195 k
•Nominal workin load 150 k
•Usa e time 10 years
For the special client request it’s possibly to produce the product with change parameters, not
lowering it’s safety.
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Operatin Manual for Operatin Table SU-02.0
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1.7Use para eters
The fi ure below indicates the most important functional parameters of the table.
drawin 4
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