Famed SU-14 User Manual

Download

Page 1

USER MANUAL

Operating table

SU-14

Factory number: ........................................

…. ....................................

Edition 10.00

Issuance date:

March 2017

FAMED ŻYWIEC Spółka z o.o.

Appendixes: 2, 3, List of Spare Parts.

Page 2

User manual for Operating table SU-14

As provided in the Directive on Medical Equipment 93/42/EEC of 14 June 1993 this is first risk class product. The producer declares that the product meets basic requirements of the directive contained in Appendix 1. The compliance procedure was carried out in accordance with appendix VII of the directive.

Manufacturer:

Famed Żywiec Sp. z o.o.

Fabryczna 1 34-300 Żywiec POLAND

Phone numbers:

Info line (+48 33) 866 63 75 (24-hours a day)

Head office (+48 33) 866 62 00 Marketing Department (+48 33) 866 63 00 ...02 Export Department (+48 33) 866 62 50 ... 52 Service (+48 33) 866 63 25 Fax : (+48 33) 475 58 90

Page

Page 3

User manual for Operating table SU-14

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.

FAMED ŻYWIEC Spółka z o.o.

General notes

• The use, maintenance as well as servicing of this product performed in other ways

than those, which have been stated in this manual is forbidden and may result in damages, which will encumber the user and which will not be a matter of producer’s responsibility.

• When the operation and parameters of the product do not match the description in

item ‘Operation’ in this manual, 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 must 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 requirement will cause the guarantee for the product to be invalid.

• Before starting any repairs the table must be disconnected from mains.

• Operation table has been designed for a patient of 200kg of weight.

Notes concerned with safety

The sign shown below says: : "Warning! - Follow the instructions for safe use ".

• Do not move the table when it is connected to the main power supply. Before

moving the table, remove the power cord from the mains.

• The table should not be in the place which obstructs its disconnection from the

mains!

• Throughout surgical procedures table wheels should be blocked.

• Do not lay patient's torso on the footrest segment.

• During carrying out angle adjustments or lowering operation table's height,

anyobstacles must be removed from below the table's surface.

• During changing the position of the table top segment should not extend

belowor between elements of tabletop.

• Do not shift operation table's position with installed orthopedic

attachment,proctology attachment, installed gynecological segment or installed shoulder operation attachment due to danger of capsizing the table.

Page

Page 4

User manual for Operating table SU-14

• Lock operation table in given position before transporting a patient.

• When using the table close to medical equipment working on high frequencies

and defibrillators one should closely follow operating instruction for that equipment. Improper operation may become a source of dangerous accidents. There is a danger of serious burning of the patient through the contact with metal parts of the table or its equipment.

• Throughout surgical procedures the table must be connected to the installation

of potential equalization in the operations room.

• You must make sure, that accessories are properly fixed to the tabletop.

• When changing operation table's position you must avoid any collisions

between the table and accessories.

• Not original accessories may be applied only after consulting with Famed

Żywiec company about their use.

• Operation table's electrical conductivity must be checked once a year. The

check should be carried out by trained service personnel.

• Avoid endangering patient's respiratory system, neural pathways and

circulatory system by ensuring the patient is in proper position and by observing his/her condition.

• When performing longitudinal (Trendelenburg or reverse Trendelenburg) and

lateral tilt, patient should be secured against uncontrolled sliding down from the operating table. Use shoulder supports, supporting rollers, side supports, belts and grips as securing elements.

Notes concerning: start-up, operation and use

• The table, during use, should not be in the place which obstructs its

disconnection from the mains!

• When performing longitudinal (Trendelenburg or reverse Trendelenburg),

backrest should be in zero position or above the horizontal level.

• When anti-trendelenburg function is performed, footrests may collide with the

basis.

• When performing Trendelenburg function or functions downward movement

may take place collision with the base of the backrest ( backrest tilted down).

• Adjusting angle position of a back rest requires manual operation.

• The table should be moved by 2 people at least.

• Do not move table with workload (patient).

• The table should be moved in minimal height.

• The floor under the table should be free from any obstacles.

• When rolling the table avoid collisions.

• Do not roll the table over electric cables.

• The table has to be connected to mains in consistence with its name plate.

• Do not use the cable when it is damaged or its insulation is worn out.

• Do not connect the table to mains in places where there is a danger of an

explosion.

• Do not store a table with flat batteries (a red diode is illuminated on a controlling

device during any movement).

Page

Page 5

User manual for Operating table SU-14

• When batteries need to be exchanged, do always exchange a set of two

batteries, exchange of a single battery causes limitation to operating time of a table and quick wear of a new battery.

• Hand support should be fixed on table strip with a multi-position grip which

makes angular movement of the support possible.

• If it is necessary to replace oil or a battery (dangerous waste), one should follow

existing environmental protection regulations.

• Hand controller is the obligatory accessories for surgical tables.

• Hand controller must be within reach of the medical staff.

Notes concerning disinfecting

• The product must not be disinfected in disinfecting chambers!

• No bleaching agents (containing active chlorine or oxygen), caustic or corrosive

chemicals are allowed!

• No agents destroying the structure of plastic (organic solvents) can be applied

to the plastic elements!

• No disinfecting agents containing alcohol are allowed for cleaning of

polyurethane elements (mattresses).

• Before disinfecting disconnect the table from mains pulling out the cable!

Disregarding the above requirements concerning cleaning and disinfecting shall result in losing the guarantee for the product!

Page

Page 6

User manual for Operating table SU-14

Contents

1 PROPER USE AND APPLICATION ......................................................................................................... 7

1.1 USE ......................................................................................................................................................... 7

1.2 GENERAL REQUIREMENTS ............................................................................................................... 7

1.3 DUTIES OF THE USER .......................................................................................................................... 7

1.4 DESCRIPTION OF PRODUCT ............................................................................................................... 7

1.5 COMPONENTS AND FUNCTIONS DESCRIPTION .......................................................................... 8

1.6 TECHNICAL DATA ............................................................................................................................. 9

1.7 USE PARAMETER.……………………………………………………………………………………. 10

1.8 SAFETY .............................................................................................................................................. 11

1.9 CRITICAL PARAMETERS…………………………………………………………………………....11

1.10 ELEKTROMAGNETIC COMPATIBILITY…………………………………………………………...11

2 TRANSPORT AND FIRST USE ................................................................................................................ 13

2.1 T

RANSPORT

.......................................................................................................................................... 13

2.2 UNPACKING AND FIRST USE …………………………………………………………………… ..13

3 OPERATION AND USE ............................................................................................................................ 15

3.1 CONTROLLING ELEMENTS ............................................................................................................. 15

3.2 RAISIING AND LEVELING OF TABLE TOP .................................................................................. 16

3.3 TABLE TOP LONGITUDINAL INCLINATION ............................................................................... 16

3.4 TABLE TOP SIDE INCLINATION .................................................................................................... 16

3.5 MEMORY OF TABLE TOP POSITION ( ZERO POSITION) .............................................................. 16

3.6 CHANGE OF THE ANGULAR POSITION OF THE BACKRES SEGMENT .................................. 16

3.7 CHANGE OF ANGULAR POSITION OF THE FOOTRESTS ................................................................ 17

3.8

INSERT AND TAKE OUT OF FOOTREST

........................................................................................................ 17

3.9 INSERTING AND REMOVING FOOTREST………………………………………………………….18

3.10 INSTALLATION AND REMOVAL OF THE HEADREST .................................................................... 18

3.11 INSTALLATION AND DISASSEMBLY OF MATRESSES ............................................................. 18

3.12 T ABLE MOBILITY ............................................................................................................................ 18

3.13 ANTISTATIC PROPERTIES ................................................................................................................. 19

3.14 POTENTIAL EQUALIZING CLAMPS ................................................................................................ 19

3.15 COLISION ............................................................................................................................................ 19

3.16 BATTERY CHARGINGS ................................................................................................................... 19

4 INSTALLATION AND OPERATION OF ACCESSORIES ................................................................. 20

5 CRITERIA FOR ASSESSING THE ACCURACY OF OPERATION...................................................21

6.1 STORING ............................................................................................................................................. 22

6.2 CLEANNING AND DISINFECTION .................................................................................................. 22

6.3 DAMAGES AND DEFECTS .............................................................................................................. 22

6.4 REPAIRS AND CONSERVATION .................................................................................................... 22

6.5 CONTROL OF TECHNICAL INSPECTION ....................................................................................... 23

6.6 LOCATION OF DEFECTS AND THEIR REMOVAL ......................................................................... 24

6.7 PRODUCT LIQUIDATION ................................................................................................................. 24

7 CHARAKTERISTIC OF ELECTROMAGNETIC ENVIRONMENT .................................................. 25

8 TABLE IDENTIFICATION ...................................................................................................................... 27

8.1 NAME PLATE ..................................................................................................................................... 27

8.2

LABELS ................................................................................................................................................ 28

Page

Page 7

User manual for Operating table SU-14

Using, maintaining and servicing the product in other way than indicated in this

1. Proper use and application

1.1 Use

Operating table SU-14 is designed for supporting the patient during carrying out treatments and operations. The table with the proper accessories can be used for treatments and operations in the range of general surgery, vascular surgery, cardio surgery, neurosurgery, urology, proctology, gynecology, laryngological, ophthalmology, endoscopies, laparoscopy, traumatic, oncology, dental, plastic surgery and others. Table top segments are X-ray permeable.

1.2 General requirements

The product is intended to be used indoors. Required climatic conditions: temperature from +10 to +45ºC, acceptable change of surrounding temperature during 8 hours should not exceed 20°C, relative humidity of the air should range from 30 to 80%, atmospheric pressure from 700 to 1060 hPa. The product should be used, maintained and serviced according to the instructions contained in this manual.

manual is not permitted and may lead to damages for which the user is to blame and for which the producer is not responsible.

Caution!

1.3 Duties of the user

User: any individual or corporate body who uses the product as its owner, lessee, pledge or who has a different right 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 obliged to take all necessary precautions in order to prevent all life and health hazards concerning the user, patients and any third party. Only authorised persons who underwent special training 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.

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.

1.4 Description of product

The operating table consist of table base and table top that are permanently connection. In standard version the table has a mobile base , equipped with central blockade, which is released with a foot lever. The table-top consists of segments, which number and configuration has constants number and configuration (according to a customer special order this number will be change). Segments of table top are X-ray permeable. The table top is provided with polyurethane mattresses. On both sides of the top there are side strips which allow installing accessories. Change of the angle of table top segments as well as movement of the column are adjusted by mechanic electro-mechanics systems. In standard version the electric and electromagnetic movements of table can be controlled by wire-connected controller. Thanks to the wide range of offered accessories the table can be used for different types of operations according to client wish. List of accessories you can find in Paragraph 4 - Installation and operation of accessories. The main power outlet is connected to the table by the power cord. In order to disconnect, the user must unplug the power cord from the main power outlet.

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 reserves 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.

Page

Page 8

User manual for Operating table SU-14

1.5 Components and Functions description

Fig.1 Operating table SU-14

Page

Page 9

User manual for Operating table SU-14

17 central switch(off) table supplying

18 wire-connected controller

26 Power socket

Nr on fig.1

1 headrest 2 backrest segment 3 seat segment 4 footrest segment 5 basis 6 headrest angle change lever 7 table top handle 8 blocking control of headrest

9 backrest position angle change lever 10 footrest blockade control 11 footrest angle change lever 12 side stripes 13 wheels 14 bottle assembling belts (option) 15 wheels central blockade lever 16 Potential equalizing clamps

19 basket for accessories (option) 20 Blockades of lowering of backrest lever

21 Footrest segment two-piece (option) 22 Footrest angle change lever 23 Footrest abduction bolt 24 Footrest blockade lever 25 Alimentation cable holder

Description

27 Power cable

1.6 Technical data

• total table top length 2030mm ± 15 mm

• mattress width 605 mm ± 5 mm

• total width of the table top ( with terminal ) 650 mm ± 5 mm

• min table top height from floor (the table stands on wheels) 750 mm ± 15 mm

• max table top height from floor (the table stands on wheels) 1050mm ± 15 mm

• lifting angle of seat segment 85°

• lowering angle of seat segment 40°

• lifting angle of leg segment 20°(25)*

• lowering angle of foot-support 90°

• Footrests widening angle 180° (for two-piece footrests)

• angle of lateral tilt ± 20°

• head section lifting angle up 35°

• head section lifting angle down 65°

• Trendelenburg 20°

• Anti-Trendelenburg 20°

• table mass 160 kg

• maximum workload 200 kg

• power supply 24V –

• work time without external alimentation ok. 10 operations

• power supply from main charge the batterie ~230 V 50/60 Hz

• integrated driver with charger and batteries

• Power consumption 240VA

• Class of protection before electric paralysis I

• Type of the part application B

• Degree of protection before influence of environment IP-X4

• type of work missing 2 / 18 min

• usage time 10 years

For special requests of the client it is possible to make a product of changed technical parameters, not lowering its safety.

Page

Page 10

User manual for Operating table SU-14

1.7 Use parameters

The drawing below presents the main use parameter

fig.2

Page

Page 11

User manual for Operating table SU-14

1.8 Safety

The structure of the table assures its safe operation and use if the rules provided in this manual are followed.

The sign shown below says: "Warning! - Follow the instructions for safe use ".

A label showing this sign is placed on any parts or mechanisms, which may prove to be harmful to the patient or the personnel if their operation does not comply with the descriptions found in this Operating Manual. When operating the table one should pay attention to elements and mechanisms with this label.

• Throughout surgical procedures table wheels should be blocked.

• When using the table close to medical equipment working on high frequencies and

defibrillators one should closely follow operating instruction for that equipment. Improper operation may become a source of dangerous accidents. There is a danger of serious burning of the patient through the contact with metal parts of the table or its equipment.

• Throughout surgical procedures the table must be connected to the installation of

potential equalization in the operations room.

• When performing longitudinal (Trendelenburg or reverse Trendelenburg) and lateral

tilting, patient should be secured against uncontrolled sliding down from the operating table. Use shoulder supports, supporting rollers, side supports, belts and grips as securing elements.

• Pay special attention when performing sliding down from the operating table

,Trandelenburg or anti- Trandelenburg while the backrest or fotrest are inclination to the bottom.

1.9 Critical parameters

Maximum work load - 200 kg Maximum authorized segment load:

- head rest 15 kg

- backrest segment 75 kg

- seat segment 70 kg

- footrest (single) 20 kg

- footrests (simultaneusly loaded) 40 kg

Fig. 3

1.10 Electromagnetic compatibility

Medical device the operating table SU-14 is an electric appliance. Electric appliances are a source of electromagnetic radiation and themselves are under its influence Therefore, use of an electric appliance requires some safety precautions connected with electromagnetic compatibility.

Page

Page 12

User manual for Operating table SU-14

In tables: item 7 Characteristics of electromagnetic environment – electromagnetic environment in which medical device the table SU-14 should be used. Recommendations and warnings which should be followed by the users were also presented.

Use of different accessories, additional equipment, cables, spare parts than those offered and/ or recommended by the producer may cause an increase of emission and/ or decrease of bed’s resistance to all electromagnetic phenomena.

Caution!

Recommended distances between portable radio-transmitters and the product

Rated maximum output power of

transmitter

0.01 0.1 0.1 0.2

0.1 0.4 0.4 0.7 1 1.2 1.2 2.3

10 4 4 7

100 12 12 23

For transmitters, the maximum output power of which is not specified above, the separation distance should be calculated according to the formulas provided. P is a power in watts (W) according to the declaration of the transmitter manufacturer.

NOTE The above guidelines may not be applicable to all cases. Propagated electromagnetic waves are absorbed and reflected from buildings, objects and people.

150 kHz to 80 MHz

distance in meters

Pd 2,1=

150 kHz to 800 MHz

Pd 2,1=

distance in meters

800 MHz to 2.5 GHz

Pd 3,2=

distance in meters

Page

Page 13

User manual for Operating table SU-14

2. Transport and first use

2.1 Transport

There is a possibility to transport the product by any covered transport means. The transport conditions are as follows:

- temperature: from –10OC to 60OC,

- relative humidity: from 25% to 75%.

Operating table must be set in transportation position during carrying table by locomotion means without using table movable system (truck, trolley). Table base and tabletop should be transported in separate package. Transportation position means that table base is on minimum height and tabletop in horizontal position with leg segments and head rest. Transportation position is shown on the label situated on table base and table top. Product should be secured against humidity and stable. In case of lack of original packaging, the product should be properly secured in order to prevent its damage, preferably by experienced transport company.

While product transporting, storage and unpacking, the temperature gradient should be less than 10OC per hour. It is strongly recommended to unpack the product after reaching room temperature.

After transporting a product into a building where it is to be installed, a product should be left for at least 12 hours. Only after this time you can set a product in operation.

Laminar storage is permissible in accordance with the packaging marking. In the absence of the marking, storied storage is prohibited.

In case of the specific transport conditions (particularly: low temperature transport), it is necessary to negotiate the way of transport and product packaging with the product manufacturer in order to ensure safe transport.

A label which indicates product position during transport

A label for the Polish market. A label for foreign countries

Fig. 3 Label “Transport position”

2.2 Unpacking and first use

If the Product is installed by service point of FAMED ŻYWIEC company, User is released from the responsibility to carry out procedures described in this section.

Caution!

The table is shipped by the producer in an assembled form in a wooden, open-work chest or in a cardboard box with the following dimensions L: 1340 x W:700 x H:890 mm and weight 160 kg. The table should be unpacked indoors in order to be protected from damages.

To prepare the table for operation after its transport or delivery one should:

- read product operating manual carefully

- take off the fastening tapes

- remove the package

- remove the materials protecting the table during its transportation

Page

Page 14

User manual for Operating table SU-14

If the product is not fully functional, i.e. the output parameters diffe

r from the

Caution!

- take out accessories

- remove elements which block the table base

- place the footrests horizontally (items 3.7 Change of angular position of the footrests and 3.11

Change of angular position of separated footrests)

- release the central blockade (item 3.12 Table mobility)

- with a help of another person carefully take the table from the palette and stop it

- add the headrest (item 3.10 Installation and operation of the headrest)

- place the product in its destination which meets the requirements described in this manual (item

1.2 General requirements),

Package may be marked with following signs:

- multiuse package

- package for recycling

- low-density polyethylene packaging

LDPE

Packaging waste disposal should be carried out in accordance to environmental regulations, that are in force where the packaging containing the Product was delivered. Packaging waste are the materials subject to recycling, they should be properly segregated and passed to selective waste collection point in accordance with local law regulations. Returnable packaging must be returned the medical product's supplier.

- Connect the table to the mains voltage of 230V, 50/60 Hz, by connecting the power cord (fig. 1, Item 27) into the power socket at the base of the table, and then to a wall outlet

- Fig. 4 Power cord – european version

- connect to the electric mains by connecting of the wire to the socket and charge the batteries,

- on the basis of information given in item 3 Operation check whether the table works as described

in item 5 Criteria on whose basis it is assessed whether product operation is correct or not.

description contained in this manual, the bed must not be used. This situation should be reported to the producer or supplier. The use of an improperly

Caution!

functioning product may result in damages, which will encumber the user and which will not be a matter of producer’s responsibility.

Page

Page 15

User manual for Operating table SU-14

The wi

re-connected controller is obligatory accessories for surgical tables.

3 Operation and use

3.1 Controlling elements

3.1.1 Wire- connected control

1,2 – Height adjusting 3,4 – 5,6 –

Fig.5 wire-connected control

The wire-connected control is permanently connected to the controlling box at the table basis. The table is switch on through place the switching in “I „position (Fig. 1, pos. 17). At this moment the table is activated and carrying out the movements through pushing the functioning control button is possible. The buttons [1] to [7] are functioning buttons. When the functioning button is pressed, the movement represented by button’ symbol is operated so long as the button is pressed.

The wire-connected controller must be on the hand of operating personnel. To recommended use the operating table connected to net.

Caution!

Longitudinal movement Side inclination

7 – Memory buttons 8 – Record for memory button

Page

Page 16

User manual for Operating table SU-14

3.2 Raising and levering of table top

The height of table top is changed within the range defined in technical data by pressing the button [1] or [2] of controller (wire-connected controller, wireless controller or side control panel). When the extreme position is reached, table top stops automatically.

3.3 Table top longitudinal inclination

In order to change longitudinal inclination of table top (trendelenburg and anti-trendelenburg) within the range indicated in technical data, one should press button [5] or [6] of controller (wire-connected controller, wireless controller or side control panel). The movement lasts as long as the button is being pressed. When an extreme position is reached, table top stops automatically.

Angular couch position can be changed only by medical personnel. The Trendelenburg position is a rescue position.

When performing longitudinal and side tilting functions, patient should be

Caution!

secured against uncontrolled sliding down from the operating table. Use shoulder supports, supporting rollers, side supports, belts and grips as securing elements.

When trendelenburg function is performed, the backrest should be in zero position or above the horizontal level so that no collisions take place!

3.4 Table top side inclination

In order to change side inclination of table top within the range indicated in technical data, one should press button [5] or [6] of controller (wire-connected controller, wireless controller or side control panel). The movement lasts as long as the button is being pressed. When an extreme position is reached, table top stops automatically.

When performing longitudinal and side tilting functions, patient should be secured against uncontrolled sliding down from the operating table. Use shoulder supports, supporting rollers, side supports, belts and grips as securing

Caution!

elements.

3.5 Memory of table top position (zero position)

The table controller enable writing 3 any table top position in this memory. Every table top position may have free height, longitudinal and side inclination. One of this changed position can be the zero position of table top.

In order to write the position in memory, first should place the required position by means of function buttons 1-6 on the controller (fig. 4). Press (just a while) the 8 function button of controller (fig. 4). Next press one of the changed memory buttons-7 (fig. 4), which writes the preset table top position. The proper writing of position is signalizing by meant of sound signal.

In order to receive the preset position should press one of the function buttons of controller- 7and keep until receiving the changed position, which is until moment when the table op has been stopped.

In the case of finding the discrepancy between preset and receive position, one should again carry out the position preset procedure.

Caution!

3.6 Change of angular position of the backrest segment

The angle of the backrest segment (fig. 1, item 2) is changed by the use of the force of muscles with support of gas spring. In order to adjust a segment position, press blockade (fig.1, pos.20), deviate the lever (fig. 1, pos.9) to up and then place a segment in a desired position and release a lever (fig.1, item 9). After releasing a lever, a backrest segment mechanism is blocked and further movement is prevented. Remember to hold a segment with both hands while adjusting position. Thanks to the

Page

Page 17

User manual for Operating table SU-14

If a patient is very heavy, over 90 kg, the angl

e of backrest segment should be

central position of the lever the backrest segment can be operated from the right, from the left and from behind the backrest segment.

changed with particular care; one should be prepared that it would be necessary to use considerable force to move it up and to cushion lowering at the moment of

Caution!

lever release (drawing 1 and 2, item 9).

3.7 Change of angular position of the footrests

Angular position of the footrest inclination is changed within the range defined in technical data by rising of the lever (drawing 1, item 11) or pressing the lever (fig.1, item 22) (on the side removable footrests) or rising or lowering of the footrest segment to the required level. When the pressure is removed from the lever, the mechanism is locked and the position of the footrest determined.

Change of the angle between the divided footrests, in the range included in technical data, is obtained by turning of footrest abduction bolt 3-4 turns (fig.1, item.23) and turning the footrest of the desired angle to the side.

When the function is performed, the footrests may collide with the base!

Check the proper clamp of the handle that locked the footrest turning.

Caution!

3.8 Insert and take out of footrest

Footrest plate (fig. 5, item 1) is fixed by wedges ( fig. 1, item 10) placed on the bottom of the seat segment by the blockages placed on both sides of the footrest (fig.5, item 2). Before assembling the footrest to the seat segment it is necessary to pull out and turn both blockades of the footrest about 90º. After that put on wedge sockets of the footrest on wedge plugs of the seat segment and establish its position by turning blockades of the footrest up back to the starting position. Disassembly of the footrest relies on pulling out and turning both blockades of the footrest about 90º and pulling out the footrests of the wedge plugs of the seat segment. Footrest angle change is obtained by a lever (fig.5, item 3) activating the gas spring mechanism. Pressing of the lever makes possible the change of angular position of the footrest. Releasing of the lever provokes blocking of the footrest in chosen position.

Make sure that the footrest is correctly fixed!

Caution!

Fig. 6

Page

Page 18

User manual for Operating table SU-14

3.9 Inserting and Removing Footrest

Footrest segments (Fig. 1, Pos. 4) can be attached and removed from the seat segment thanks to the mechanism activated by the lever (Fig. 1, Pos. 24). In order to remove the footrest segment, it should be grasped from underneath, the lever (Fig.1, Pos. 10) should be pulled till its level, and the footrest segment should be lifted till it comes off the wedge pin located on the seat segment (Fig. 1, Pos.2 4). Attaching footrest segment consists of raising the lever to its horizontal position (Fig. 1, Pos. 10) and mounting wedge socket of the footrest on the wedge pin of the seat segment till their levels are even. After mounting the segment the lever must be lowered (Fig. 1, Pos. 24) back to the starting position and pressed down

Caution!

Make sure that the footrest is correctly fixed!

3.10 Installation and operation of the headrest

The headrest is fastened on installation wedges which are situated at the end of the backrest segment using a knob. When the headrest is put on the stripe, one should determine its position by screwing down the screw (fig.1, item 8). The headrest is dismounted by unscrewing of the screw and removal of the headrest from the stripe. The angle of the headrest is changed similarly to the backrest segment, that is, by the handle which moves the mechanism of the gas spring. When the lever is pressed (fig.1, item 6), the required angle of the headrest may be chosen. Its release locks the headrest in the chosen position.

Make sure that the headrest is correctly locked!

Caution!

3.11 Installation and disassembly of mattresses

All mattresses can be removed without any tools. They are fixed on fixing pegs

3.12 Table mobility

Wheels installed in the base of table make it possible to move it in every direction. The table is equipped with movement lock used during operations and treatments performed on the table.

The table is equiped with central blockades of wheels. The central blocking pedal has three position:

- Upper - direction blockade (fig.7, pos.3),

- Middle (horizontal) - blockade released (fig. 7, pos.1),

- Lower - all castors blocked (fig.7, pos.2).

Fig.7

The direction blockade is used during the table movement on long, straight sections and makes it easy

Page

Page 19

User manual for Operating table SU-14

If after 12 hours of charging and after disconnecting a power supply cord, it is

The table may not be stored with batteries low.

to turn the table. All castors brake causes a total bed immobilization.

Throughout surgical procedures table wheels should be blocked. Table should be move by 2 people at least. Do not move table with workload (patient) through inclines and outside of

Caution!

buildings). Table should be move in minimal height. The floor under the table must be free from any obstacles! When rolling the table avoid collisions! Do not roll the table over electric cables!

3.13 Antistatic properties

A table structure allows for drainage of electrostatic charge through the following channels:

– By antistatic wheels to conducting floor, – By potential equalisation clamp.

Operating table SU-14 should be used on antistatic floor. In case of lack of such floor, an electrostatic charge is drained through a potential equalization line. The potential equalising conductor is a standard table accessory. Antistatic properties of the table shall be maintained if mattresses produced by FAMED Sp. z o.o. are used.

3.14 Potential equalising clamp

Operating table have inside system of potential equalization leading to the clamp (fig. 1, item pos. 16) marked by symbol .

Throughout surgical procedures the table must be connected to the installation of potential equalization in the operations room.

Caution!

The cable is provided in standard table accessories

3.15 Collisions

In some extreme positions of the table, in particular, when accessories installed on side stripes are used, mechanical collisions may take place. Because of that, one should protect the table and accessories from damages.

3.16 Battery charging

A charger built-in in the table makes it possible to charge the batteries in the table. In order to charge batteries, connect a power supply cord to a socket in a table and set a switch (fig.1,

item 17) in position „I”. The batteries are charge automatically.

impossible to activate any electrical movements, this means that the table is damaged. This fact should be notified to an authorized service centre.

Caution!

Table work time is about 10 surgeries from full batteries. It is required to charge batteries when there is a lack of possibility of carrying out movements or in the case of noticeable slowdawn of movements. Battery life time is 3 years.

If batteries need to be exchanged, do always exchange a set of two batteries. Exchanging a single battery limits an operating time of a table and causes quick

Caution!

wear of a new battery.

Page

Page 20

User manual for Operating table SU-14

33 lithotomic stirrups

WS-

64.5 25 kg

4 Installation and operation of accessories

The following extra accessories may be provided with the operating table SU-14:

Elements of accessories Symbol

1 Screen frame WS-01.5 14 kg 2 Screen frame with width regulation WS-01.6 14 kg 3 Hand grip WS-02.5 17 kg 4 Thigh grip WS-03.5 23 kg 5 Shank grip WS-04.5 23 kg 6 Knee support WS-05.5 17 kg 7 Left and right arm support WS-06.5 14 kg 8 Hand angular support WS-07.5 14 kg 9 Big supporting bolster WS-08.5 50 kg

10 Trolley for accessories WS-13.5 50 kg 11 Grip for anaesthesiologist pipes WS-14.5 14 kg 12 Table for tools WS-15.5 14 kg 13 Single position stripe WS-16.5 100Nm 14 Multi position clamp mechanism WS-17.6 100Nm 15 Multi position clamp mechanism WS-17.7 100Nm 16 Hand support WS-22.5 20 kg 17 Complete handrails WS-32.5 23 kg 18 Side x-ray handle WS-33.0 14 kg 19 Wrist grip WS-34.5 14 kg 20 Attachment do arthroscopy WS-39.5 17 kg 21 Attachment for meniscus operation WS-40.5 17 kg 22 Belly belts WS-41.0 125 kg 23 Footrest belts WS-42.0 23 kg 24 Hand belt WS-43.0 17 kg 25 Thigh belt WS-44.0 23 kg 26 Support for hand surgery WS-48.5 17 kg 27 Womb support WS-49.5 40 kg 28 Side support WS-50.5 40 kg 29 Side rest with lever WS-50.6 40 kg 30 Chest rest WS-52.5 40 kg 31 Partial denture of sides shelves WS-53.0 14 kg 32 Shoulder-sides rest WS-59.5 14 kg

34 Mattress for spine WS-65.0 80 kg 35 collar WS-66.0 20 kg 36 Collar under neck WS-68.0 10 kg 37 headrest WS-69.0 10 kg 38 Support for shoulder surgery WS-87.5 14 kg 39 hand rest PR-01.5 20 kg 40 Drip hander WK-01.5 10 kg

When ordering table accessories, please give table’s name and symbol.

The producer reserves the right to modify accessories according to client requirements and produce new accessories complains with norm of safety.

Page

Page 21

User manual for Operating table SU-14

If the product is not fully functional, i.e. the output parameters differ from the

5 Criteria on whose basis it is assessed whether product

operation is correct or not

Correctness of table operation shall be checked every day before the beginning of its operation.

Caution!

The method of checking whether operation of the table is correct:

1. Check stability of the table when its feet are down by trying to move the table manually ( when the wheels are blocking): pushing of the table in any direction should not cause tilting or moving.

2. Check mechanisms of adjustment of positions of the segments controlled by gas springs by a change of position and locking (see item 3 Operation). The mechanism should work without jamming, after locking the segment should not change its position (check by manual pressing of the segment).

3. Check if there are no mechanical plays by manually moving the top of the table.

4. Check the work of the electro-mechanics system by performance of all movements controlled by wire-connected control.

If the table underwent the above described tests with positive results and there were no disturbing sounds (squeaks and grinds), the table can be used safety. Otherwise see item 6.6 ‘Location and removal of defects’.

Caution!

description contained in this manual, the bed must not be used. This situation should be reported to the producer or supplier (dealer). The use of an improperly functioning product may result in damages, which will encumber the user and which will not be a matter of producer’s responsibility.

Page

Page 22

User manual for Operating table SU-14

6 Technical operations

6.1 Storing

If the product is not to be used for a longer period of time, it should be stored in the below mentioned climatic conditions:

• temperature: 25º ±10ºC,

• relative humidity: 50% ± 25%.

During storing, the operating table must be turned off. The switch (position 17, figure 1) must be in the “0” position.

If the table is stored for a longer period of time, it must be connected to the power

Caution!

supply for 24 hours each 6 months to charge the batteries. The table may not be stored with batteries low

6.2 Cleaning and disinfecting

For cleaning and disinfecting use cleaners, disinfectants recommended by Famed Żywiec Sp. z o.o. in Annex 2 to this manual (allowed to turnover and use on the territory of the country, where they are used). After disinfection the Product should be washed with water to eliminate any stains. After disinfecting dry thoroughly. Dry with hot air (maximal temperature 60°C) or by wiping with a soft sterile cloth.

Before disinfecting disconnect the product from mains! The product/ table must not be disinfected in disinfecting chambers. Bleaching (containing active chlorine or oxygen), caustic and corrosive agents

Caution!

must not be used. No disinfecting agents containing alcohol may be applied to elements made of

polyurethane (mattresses)! No agents destroying the structure of plastic (organic solvents) may be applied to

the plastic elements. Disregarding the above requirements concerning cleaning and disinfecting shall

result in losing the guarantee for the product

6.3 Damages and defects

Damages and defects found in the product or product accessories should be reported immediately to a person in charge of such issues. The bed which can not be safely operated (e.g. damaged electric or mechanical elements ) must not be used till it is repaired.

6.4 Repairs and conservation

Repairs are done by the producer. The user can not carry out any repairs on his own unless he has undergone special training or has been authorised to do that. When the producer has given his written permission for repair of the product by client’s technical staff, the producer shall provide the client with necessary charts, lists of spare parts, descriptions and information on repairs. The producer allows only using original spare parts. In order to provide safe and reliable operation of the product one should use only spare parts provided by the producer. Worn out parts shall be removed as provided in environmental protection regulations

The product contains products which may be dangerous to the environment:

- a battery integrated with controller – type BA 1812V 1,2Ah (2pieces). The rules of proceeding with used products which may be dangerous to the

Caution!

environment are defined in environmental regulations. If there is a need to replace the batteries, used batteries are collected by the medical device's producer or an authorised service point indicated by the producer.

Used batteries receives a medical device manufacturer or indicated by the authorized repairer or Third Party having required by environmental law decisions to conduct.

Page

Page 23

User manual for Operating table SU-14 Repairs and maintenance must be performed only by qualified personnel. If a product is operated outside Poland, one should inform about a necessity of a repair a producer or the dealer from whom the product was purchased.

Every repair of the product should be recorded on the list of repairs enclosed to the guarantee card on pain guarantee loss!

6.5 Control of technical condition

To ensure safety and proper technical condition of the product, User is required to have it undergone periodic technical inspections. These inspections are carried out at the user's expense, by the Producer or customer's qualified technical staff.

Periodic inspections of the table must be recorded in the Device Passport or the product’s warranty card.

Caution!

• IEC 62353 (Table 1) compliance check

• General technical condition check (Table 2)

• Checking safety and functions

– check of functioning of remote operated functionalities – check of reset function — calibration of inclinometers – checking collision limits

– checking antistatic parameters of mattresses. Resistance value shall be within the range from 104 to 106Q

– Check of electric connections.

– Check of base and column condition.

– Check of mechanical connections.

– Check of longitudinal movement function.

– Check of battery capacity.

– Check of play on the column.

Visual inspection

Measurements

Functional test

Technical inspections of the product must be recorded on the list of repairs enclosed with the guarantee certificate.

After the product's period of use expires, permission for further use is granted after positive result from technical inspection carried out in authorised service

point. Each time a permission is granted for 12 months.

Subject of inspection frequency

Every 12 months

Scope of inspection in line with IEC 62353

• Checking all fuses accessible from the outside, and their conformity with documentation (fuse capacity, characteristics),

• Checking if all markings and labels are in place and legible,

• Checking if all mechanical parts are in place,

• Checking for damages and checking the cleanliness of the device,

• Checking accessories,

• Checking product documentation and documentation of previous

inspections.

• Measurement of protective earthing resistance,

• Measurement of leakage currents,

• Measurement of patient’s leakage current,

• Measurement of insulation resistance.

• The functional test must be carried out by a suitably experienced person

and trained in operation of the device.

• The functional test and the results of specific tests and measurements should be documented

Page

Page 24

User manual for Operating table SU-14

When to do the inspection:

– the device has been repaired; – periodically (every 12 months) during technical inspection.

To ensure safe and correct operation of the device during the service life, the user must perform technical checks listed below every 6 months.

Scope of technical condition check

- Check of all mechanical functions by executing all movements in line with the technical specification parameters: – Checking the table movement capabilities. – Checking central wheel lock. – Checking the removal and installation of removable segments. – Checking the load bearing plates under mattresses.

– Check all visible bolted connections without removing housing. – Check for mechanical play and if all locks work. – Check the condition of the power supply cable. – Check the insulation of wired controller cable. – Check the condition of columns cover. – Check condition of mattresses.

– Check efficiency of the central wheel lock.

An inspection should involve a visual inspection and the noticed malfunctions should be handled as provided in item 6.6 Location of defects and their removal.

6.6 Location of defects and their removal

damage Possible cause removal

The table cannot be moved locked wheels Unlock blockade pedal

Batteries discharged Charge the batteries Control plug incorrectly

Plays in screw joints Lack of possibility of using

the preset position

plugged to the socket in the table Damaged pilot Contact your service

Blockage of the driver Plays appeared during

product operation Change of position setting Insertion again the position to memory

Plug in the plug correctly

Disconnect the table of the alimentation, wait few seconds and reconnect. Screw down with generally available wrenches

according to point 3.5

If a fault can't be eliminated, abstain from using the product and report the matter in the Service Department, or service of FAMED ŻYWIEC company.

6.7 Product liquidation

If the customer resigns from further product exploitation, he is obliged to product liquidation according to rules of environment protection; detailed information is situated in annex no. 3.

Page

Page 25

User manual for Operating table SU-14

Medical device

operating table

SU-14 is to be used in electromagne

tic environment

Type of emission

Classification

Explanations and instructions

Medical device operating

table SU

14 produces energy

with radio frequency only for its internal function.

Therefore, its RF emission are very low and are not

likely to cause any interference in nearby electronic

Medical device operating t

able SU

14 is suitable for use

in all establishments, including domestic establishments

voltage

power supply network that supplies buildings used for

Voltage fluctuation,

IEC 61000

-3-3

7 Characteristics of electromagnetic environment

Electromagnetic emissions

specified below. The customer or the user of medical device the SU-14 should assure that it is used in such an environment

Emission RF CISPR 11

Group 1

equipment..

emission RF CISPR

Harmonic emission

IEC 61000-3-2

flickering

Class B

Class A

Complies

and those directly connected to the public lowdomestic purposes.

Electromagnetic immunity

Medical device operating table SU-14 is to be used in electromagnetic environment specified below. The customer or the users of medical device the SU-14 should assure that it is used in such an environment.

Immunity test

Electrostatic discharge (ESD) IEC 61000-4-2

Surge IEC 61000-4-5

Series of quick transitory stages IEC 61000-4-4

Voltage dips, short interruption and voltage variations on power supply input lines IEC 61000-4-11

NOTE UT is the a.c. mains voltage prior to application of the test level

IEC 60601-1-2

Test level

± 6 kV contact ± 8 kV air

1 kV differential

mode ± 2 kV common

mode

2 kV for power

supply lines ± 1 kV for input/

output lines < 5% UT (>95% dip UT) for 0.5 cycle

40% UT (60% dip UT) for 5 cycles

70% UT (30% dip UT) for 25 cycles

< 5% UT (>95% dip UT) for 5 seconds

Compliance level Electromagnetic environment – guidance

± 6 kV contact ± 8 kV air

1 kV differential

mode ± 2 kV common

mode

2 kV for power

supply lines ± 1 kV for input/

output lines < 5% UT (>95% dip UT) for 0.5 cycle

40% UT (60% dip UT) for 5 cycles

70% UT (30% dip UT) for 25 cycles

< 5% UT (>95% dip UT) for 5 seconds

In the location of SU-14 use the floor should be wooden, concrete or covered with ceramic tiles. If the floor is covered with a synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment

Mains power quality should be that of a typical commercial or hospital environment.

In normal use operating table SU-14 is battery operated.

Connect to mains network only for battery charging.

Page

Page 26

User manual for Operating table SU-14

Electromagnetic immunity

Medical device operating table SU-14 is to be used in electromagnetic environment specified below. The

customer or the user of medical device the SU-14 should assure that it is used in such an environment.

Immunity test

Transmitted disturbances induced by fields with radio frequencies IEC 61000-4-6

Electromagnetic field with radio frequency IEC 61000-4-3

a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which medical device the operating table SU-12 is used exceeds the applicable RF compliance level above, the operating table SU-12 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating medical device the operating table SU-12.

b Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m. NOTES These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

IEC 60601-1-2

Test level

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Compliance level Electromagnetic environment – guidance

3 Vrms

3 V/m

Portable and mobile RF communications equipment should not be used closer to any part of the operating tables SU-12, including cables, than the srecommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separating distance:

Pd 2,1=

80 MHz to 800 MHz

Pd 2,1=

800 MHz to 2.5 GHz

Pd 3,2=

Where P is the maximal output power of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance in each frequency range

Interference may occur in the vicinity of equipment marked with following symbol:

Page

Page 27

User manual for Operating table SU-14

8 Table identification

When sending/ asking any questions concerning the table and when ordering spare parts, please give the serial number of the table placed on the nameplate and the guarantee certificate.

8.1 Nameplate

Description of meanings of particular boxes of a name plate

1 – Name, logo and address of the Manufacturer, 2 – Product symbol, 3 – General markers,

CE mark,

"Warning! - Follow the instructions for safe use ".

Caution! – During disposal of the product, one should act according to the Act concerning

electrical and electronic equipment waste

4 – Product trade number with untypical order number (if applicable) 5 – Index of the product, 6 – Class of duty, 7 – Power supply specification 8 – Additional markings

IP-X4

Degree of protection

Application part B

Page

Page 28

User manual for Operating table SU-14

8.2 Labels

Page

Page 29

1 Watch point 8.1 Name plate

Transport position of the table (see point (see point 2.1)

The method of battery charging

Warning! - Follow the instructions for safe use.

For clearing and disinfection you should not use agents containing active oxygen and chlorine

Maximal workload 200 kg

Central wheels blockade

Back rest adjustment

Page 30

Operating manual for Operating Table SU-12

Head rest adjustment

Foot rest adjustment

Hook for alimentation cable

Follow the instructions

Power socket

Notice! The producer reserves the right to introduce in the product structural modifications resulting from technical progress which are not covered in this operating manual.

Page 30

Page 31

Operating manual for Operating Table SU-12

Item:

SU-14

Edition:

Spare Parts List

Basic spare parts

No. Name Qt. Code number Category

Column

Control box

Brake lever

Caster

Pilot sleeve I

Sliding sleeve

Pin I

Pin II Motive system of head rest

section

Driving unit of backrest

Head rest matress

Earthing screw

Base cover

Lock pedal left

Lock pedal right

Back rest mattress

Servo-motor for Trendelenburg

Servo-motor of heel side

Backrest rail

Seat mattress

Seat pin

Manual control device ( pilot)

Side strip

Mattress of footrest

Driving unit of foot stool L+P

Handwheel

Stopper

1 1 1 1 1 2 2 C073600000014/-01/ 2 Famed Żywiec Sp. z o.o. 4 3 1

1 2

1 1 1 2 2 1 1 1 2 1 2 1 2 1 2 2 2

August 2014

S09164004010310 S09164004020710

C043306000501/-02/

S06549041501031 S06549041501030 S06549041502014

S30250100000200

C183600000005 C183600000006

C183701020000 C183702050000 C183701000005

C028001010088000

C183600000016 S06549065006020 S06549065006021

C183702000003 S09164004005711 S09164004003111

C183702000004

C183703000003

C183703000004 S09164004025510

C047311000019

C183704030005

C183704080000 S13622900000867 S13622900010250

3 Famed Żywiec Sp. z o.o. 1 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 3 Famed Żywiec Sp. z o.o. 3 Famed Żywiec Sp. z o.o. 3 Famed Żywiec Sp. z o.o.

2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o.

2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o.

2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o. 1 Famed Żywiec Sp. z o.o. 1 Famed Żywiec Sp. z o.o. 1 Famed Żywiec Sp. z o.o. 1 Famed Żywiec Sp. z o.o. 3 Famed Żywiec Sp. z o.o. 3 Famed Żywiec Sp. z o.o. 3 Famed Żywiec Sp. z o.o. 2 Famed Żywiec Sp. z o.o.

SJW-4-01-02

Remarks

Repair kit

No.

1 2

Name Qt. Code number Remarks

Page 31

Page 32

Legend:

Markers in column „Category”

1 - The elements endanger fast wear out 2 - The elements not endanger fast wear out 3 - The elements wear out depended of condition of exploitation

Operating manual for Operating Table SU-12

Page 32