SCANDIA RC Operating Instructions (E)

2 SCANDIA RC Operating Instructions (E)

CONTENS PAGE

1. Introduction 3

2. Routine checks following delivery 4

3. Removal of the table from the pallet 4

4. First usage 4

5. Important notes for safe usage 4 - 5

6. Operating the SCANDIA RC 5 - 10 6.1 Description 5 6.2 Control unit 6 6.3 Description of the operating elements and symbols 6 - 7 6.4 Battery charging 7 - 8 6.5 Overload protection and emergency stop 8 6.6 Locking of the wheels 8 6.7 Emergency mode 9 6.8 Adjustment head section 9 6.9 X ray cassette 9 6.10 Remove or assemble from sections 10

7. Maintenance 11 7.1 Daily maintenance 11 7.2 Monthly service 11 7.3 Six-monthly service 11

8. Notes on product responsibility 11

9. Technical description 12

9.1 Technical data 12 9.2 Certification 13

3 SCANDIA RC Operating Instructions (E)

1. INTRODUCTION

The wide range of surgical operations accordingly requires many different ways of positioning the patient on the

operating table. Not only is it necessary to ensure the maximum ease of access to the operating area for the sur-geon, but constant anaesthesia monitoring must also be possible, as well as the administration of drugs and infu-sions and the use of image amplifiers and C-arcs. In addition, in order to avoid disturbances of the blood supply, the patient needs to be placed in a position that is carefully adapted to the body shape. The SCANDIA RC is a mobile operation table. Its advantage is that it can be moved freely in the operating theatre or operating department. Electrical installation is not required as special chargeable batteries provide the electrical energy needed for 10 normal operations to be carried out with this table. The SCANDIA RC consists of a mobile table support with a fixed central section and several movable sections. The individual sections can be adapted to the various surgical disciplines, as required, and the sections can be ar-ranged independently from another as required. The operation table upholstery plates are designed with large soft radii in order to avoid pressure points. The up-holstery is radiolucent, so that it is also suitable for X-raying or intra-operative radioscopy. They are antistatic ac-cording to ICE 601-1. Control of the electro-hydraulic adjustment possibilities of the table support and respective table surfaces is carried out with a control unit connected to the table via a control cable. These SCANDIA RC serve for positioning and transporting the patient for general surgical and/or medical opera-tions. The table is designed for use under ambient conditions in accordance with EN 60601 Paragraph 10.2.1 in rooms intended for medical use, which are installed in accordance with the regulations of VDE 0100 Part 710.

4 SCANDIA RC Operating Instructions (E)

2. ROUTINE CHECKS FOLLOWING DELIVERY

The operating table and accessories should be inspected for possible transport damage or other defects imme-

diately on arrival. Reclamation regarding damage or defects can only be entertained by the selling organisation (BERCHTOLD GmbH & Co.) or the delivering agency when they are immediately reported. In case of complaint, the forward-ing agent or the Berchtold sub-agency must immediately be informed, prior to the submission of a damage / deficiency report to the BERCHTOLD main offices in Germany for further processing by our insurance agents. When returning a unit or one of its components to BERCHTOLD or to a BERCHTOLD service centre, every effort should be made to use the original packaging material. The following information/documentation must also accompany the returned items: Name and address of the owners, product identification number (See plate affixed to unit), Detailed description of the defect.

Check that all the wheels can move freely and turn through 360.

Connect the control unit and check all the functions.

Connect the accompanying battery charging cable and check that the battery charging procedure functions perfectly.

3. REMOVAL OF THE TABLE FROM THE PALLET

Never use sharp tools to open the packaging as the contents could be damaged!

The operation table should be taken off the pallet as follows, to avoid damage to the plunger cylinder:

remove the transport protection;

remove the battery charging cable;

release the locks on all three wheels;

Hold the operation table on the side with one wheel and move it horizontally until both of the other wheels are on the edge of the pallet;

carefully place the single wheel on the floor and lock it;

hold the operation table on the side with two wheels, lift, remove the pallet and also place this side on the floor.

4. FIRST USAGE

Before the OP table is first used surgically, the manufacturer or their official agent shall:

a) have fully tested the OP table in the position in which it is to be used;

b) have given full operational instructions for the unit to a responsible person.

5 SCANDIA RC Operating Instructions (E)

5. IMPORTANT NOTES FOR SAFE USAGE

Wrong operation and a disregard of these operating instructions can lead to serious injury!

Take care to study these operating instructions supplied with your SCANDIA RC.

In order to avoid functional faults, no objects should come into the movement area of the operation table.

Care must be taken that feet and cables are not trapped when the table support moves to the lowest position against the base.

The foot section must be in a horizontal position before the SCANDIA RC is lowered to its lowest position.

Do not move the SCANDIA RC if the battery charging cable is still attached.

The SCANDIA RC must never be exposed to electromagnetic fields from high frequency equipment, which are above normal levels, e.g. electro-surgical equipment, defibrillators, defibrillator monitors.

The SCANDIA RC must not be used in a manner other than shown in the illustrations in the product documen-tation.

Antistatic coverings must be used to conduct electrical charges to antistatic floors.

6. OPERATING THE SCANDIA RC

6.1 Description

1 Head section 2 Section 40 cm 3 Section 25 cm 4 Control unit 5 Lock of the wheel 6 Locking handle for adjustment head section 7 Catch 8 Cover for socket for battery loading cable 9 Emergency Trendelenburg 10 Grounding plug 11 Foot for operation position (park position)

6 SCANDIA RC Operating Instructions (E)

6.2 Control unit

1 - 10 Table position adjustment: Push the button for the required adjustment and hold it down

until the required position is reached. 1 Height adjustment downwards 2 Height adjustment upwards 3 Lateral tilt right 4 Lateral tilt left 5 Trendelenburg 6 Anti-Trendelenburg 7 Back section inclination downwards 8 Back section inclination upwards 9 Leg section inclination downwards

10 Leg section inclination upwards

11 Neutral position: Press the button and hold it down, until the table automatically stops in the horizontal position.

12 - 14 Battery indicators: 12 Red signal lamp blinks: Charge the batteries after the operation. 13 Yellow signal lamp illuminates: Charging. Supply cable con-

nected.

14 Green signal lamp illuminates: Batteries are charged. Note: If the batteries are nearly fully charged and are connected via the battery charging cable, it is possible that

that the yellow and green signal lamps light up alternately. This indicates the process of the service charging. Attention! The red signal lamp indicates that the batteries are nearly flat. With regular charging this signal lamp should not light up. If the batteries are not charged, in spite of the red signal lamp lighting up repeatedly, short intermittent faults occur.

6.3 Description of the operating elements and symbols

Symbol indicates On pressing this button the table moves down.

Symbol indicates On pressing this button the table moves up .

Symbol indicates On pressing this button the table inclines to the right, as long as the button is held down.

Symbol indicates On pressing this button the table inclines to the left, as long as the button is held down.

7 SCANDIA RC Operating Instructions (E)

Symbol indicates On pressing this button the whole table at the head end inclines downwards, as long as the button is held down (Trendelenburg).

Symbol indicates On pressing this button the whole table at the head end inclines upwards, as long as the button is held down (Anti-Trendelenburg).

Symbol indicates On pressing this button the table on the back section in-clines downwards, as long as the button is pressed.

Symbol indicates On pressing this button the table on the back section in-clines upwards, as long as the button is pressed.

Symbol indicates On pressing this button the table on the leg section inclines downwards, as long as the button is pressed.

Symbol indicates On pressing this button the table on the leg section inclines upwards, as long as the button is pressed.

Symbol indicates On pressing this button and holding it down the table is automatically set to the horizontal position.

Symbol indicates Charge the batteries at the end of the operation, red signal lamp blinks.

Symbol indicates Charging. Battery charging cable connected, yellow signal lamp illuminate.

Symbol indicates Batteries charged, yellow signal lamp illuminate.

6.4 Battery charging The SCANDIA RC is equipped with an integrated charger. Electrical connection of the operation table to charge

the batteries can only take place in medical rooms equipped according to VDE 0107 or IEC 60364-710. The con-nection must be made using the accompanying battery charging cable to a shockproof socket. For safety reasons flexible distribution boxes or extension cable must not be used. The power supply socket must be at least pro-tected with a 10 A fuse. The primary voltage of the operation table is shown on the type plate. The connection for the battery charging cable is under a protective cap.

8 SCANDIA RC Operating Instructions (E)

Charging the batteries should take place outside of the oper-ating theatre without a patient on the operation table. Charging:

1. Immobilize the operation table by operating the lock (5).

2. Open the safety cover (8).

3. Connect the battery loading cable (12) and ensure, that the yellow pilot light illuminated on the control unit.

The various phases of charging are indicated at the control unit. Changing the position of the table is not possible

during charging. Regular charging ensure high operational reliability and long battery life. Attention! The batteries are special waste. The official environment instructions have to be carried out exactly.

6.5 Overload protection and emergency stop

To protect the components and increase operational safety, the control circuit contains an automatic circuit breaker, which at the same time, functions as the main and emergency Off switch. Switch (14) upwards, automatic fuse activated. If the automatic circuit breaker is actuated, wait for several seconds and then tip the switch upwards. If the automatic circuit breaker triggers again, inform the service technician.

If the SCANDIA RC is not used for a long time, first charge the batteries and then switch off the automatic cir-

cuit breaker The circuit breaker is switched off on delivery to the site. Emergency stop: Move the switch (13) downwards.

6.6 Locking of the wheels

All of the wheel pairs are locked against turning and rolling. A battery charging cable, possibly still connected, must be removed before the wheels are unlocked again.

Locking: Operate the front part (A) of the pedal. Unlocking: Operate the back part (E) of the pedal.

On locking the single wheel of the operation table the foot (11) unfolds downwards for stability (park position).

9 SCANDIA RC Operating Instructions (E)

6.7 Emergency mode

The Trendelenburg-movement has an additional manual safety switch for emergencies.

1 Grasp the table top with both hands.

2 Depress pedal (P) with the foot and set the table top to the desired inclination Trendelenburg or Anti-Tren-delenburg.

3 Release pedal (P).

An external battery package can be connected if the inte-grated battery is discharged. Descriptions see Service Manual. Should only be carried out by medical technical device staff.

6.8 Adjustment head section

Adjustment of the angle of inclination: 1 Push the shackle (A) upwards.

2 Set the head section to the desired inclination.

3 Release the shackle (A).

Adjustment of the height: 1 Turn the lever (B)anti-clockwise.

2 Angle the head plate upwards and lock lever (B).

3 Set the head plate parallel with the back section, as de-scribed in Adjustment of the angle of inclination.

6.9 X-ray Cassette

The SCANDIA RC is equipped with guide rails (Illustration C chapter 6.7) to accept 43 x 43 cm X-ray cassettes. To introduce the cassette on the head side the head section must be set as high as possible using the shackle (Illus-tration A chapter 6.7).

10 SCANDIA RC Operating Instructions (E)

6.10 Assemble or remove from sections The sections are connected with each other with a locking system. The locking mechanism must only be operated

if the sections are to be separated from one another. A little force as possible should be used when introducing or removing a section. Care must be taken not to inter-change the sides.

Assemble: 1 Slide in the pins (B), until the whole fitting piece is in

the receptacle (still approx. 5 mm left).

2 Slide in further and take care that the pins are slipped in at the same time.

Attention! As soon as all the sections are put together, snap in the locks. Care must be taken to ensure that the locks snap in properly. With locks, which have not been snapped in properly, the sections are not properly connected to each other and can come loose if pulled.

Remove: 1 Unfold the locks (A) on both sides as far as possible.

2 Hold the section to be removed firmly with both hands and pull evenly, lengthwise along the table. Slight lifting of the section at the same time makes removal easier.

Attention! The lower the force used and the more evenly one pulls, the easier it is to remove the section.

11 SCANDIA RC Operating Instructions (E)

7. MAINTENANCE

7.1 Daily maintenance

The daily maintenance is to be carried out by the ward staff.

Ensure that the pads are protected from contact with oil or grease. Pads with antistatic surface must be cleaned

with a warm soap solution. Allow the pads to dry separately before stacking them or placing them on the table.

The operating table should be wiped down with a warm soap solution and desinfected with approx. 70 % alco-hol. The amount of cleaning fluid used should not be so great that the fluid penetrates into the table or control box.

7.2 Monthly service

The monthly service is to be carried out by the ward staff.

Remove all sections. Clean all pins, locating dowels, latches and locating holes and lubricate with machine oil or

instrument oil.

Lubricate the hinges of the leg and back sections with thin machine oil or instrument oil.

Check that the wheels run freely, and are unlocked when the table is parked.

Check all movements of the table top by setting one movement at a time in its end positions and check that they can locked in all positions in between. The speed can be reset if necessary, see the Service Manual.

7.3 Six-monthly service

The six-monthly service is to be carried out by the technical staff.

Carry out all checks specified under Monthly service. Raise the table to its highest position and lift up and

secure the cover of the base.

Check for free play in the table top and adjust, if necessary, as described in the Service Manual. Lubricate the guides with Molycote or equivalent.

Check all of the hydraulic connections for leaks and tighten if necessary.

Check the piston rods seals for leaks. Oil residues, after some length of time, are normal. Wipe off the oil and push the rods in and out a few times, then check if oil comes out again. Repair or replace parts if necessary.

Check the oil level in the tank according to the Service Manual.

Check the pressure in the hydraulic accumulator according to the Service Manual.

Check that cables and plugs are intact and that the connections are correct.

12 SCANDIA RC Operating Instructions (E)

8. NOTES ON PRODUCT RESPONSIBILITY

The BERCHTOLD company can only consider themselves responsible for the safety, reliability and function of

the product under the following conditions: a) installation, modifications or repairs have been performed only by BERCHTOLD or by an agent expressly au-thorized by BERCHTOLD to do so, b) the electrical installation of the room complies with regulations IEC 60364-7-10, c) the product is used in accordance with the operating instructions.

9. TECHNICAL DESCRIPTION

9.1 Technical data Charging Voltage 230 V AC 50 Hz

Power consumption maximum: 30 VA

Battery Voltage 18 V

Enclosure: IP 24

Safety type: B

Safety class: I

Operating mode: intermittent

Test load: 135 kg (EN 50115)

Overall length: 2000 mm

Overall width: 550 mm

Height adjustment: 650 1010 mm

Trendelenburg position 25

Reserve Trendelenburg position 25

Lateral tilt: 20

Back section: + 70, - 25

Leg section: + 70, - 90

Head section: 35, can be raised 110 mm

Patient weight limit: 190 kg 9.2 Certification

conform with 93/42/EEC

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14 SCANDIA RC Operating Instructions (E)

56 789/M-S/B/05.2002 BERCHTOLD GmbH & Co. KG Reproduction, including excerpts, prohibited. Alteration in technology and designed reserved.

BERCHTOLD GmbH & Co. KG Ludwigstaler Strae 25 Postfach 4052 D-78505 Tuttlingen Internet: www.Berchtold.de e-mail: Info@Berchtold.de

Tel. (+49) 7461 / 181-0 Fax (+49) 7461 / 181-200 Service department: Tel. (+49) 7461 / 181-217 Fax (+49) 7461 / 181-311