Operating Instructions
44 Pages
Preview
Page 1
ALPHAMAXX
Universal operating table
Englisch
Operating instructions
1133.02BX/FX
GA113302GB11
1133.02BX
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Overview 1 2 3 4
Potential equalization 17 Socket for mains cable 15 Mains cable 16
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Head rest (e.g. 1130.64) Fastening screws for head rest Locking lever for upper back plate Back plate, removable 1133.31X0 Back plate for general surgery Connection point for removable back plates Lower back plate Bellows Leg plates Locking lever for leg plate abduction Unlocking of leg plates Seat plate Infrared receiver and transmitter Override system with status indicators for operating table Sockets for cable-connected hand control and foot switch Socket for mains cable Mains cable Potential equalization Cable-connected hand control (optional) IR remote control (optional) Interface for servicing
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Contents I. II.
Important safety instructions ... 4 Important information ... 6 1. Important notes on these operating instructions ... 6 2. Using the operating table in accordance with the intended purpose ... 6 3. Intended purpose ... 6 4. Fundamental safety aspects ... 6 III. General description ... 7 1. General features ... 7 2. Control of functions ... 8 2.1. Cable-connected hand control – functions ... 9 2.2. Override system = emergency operation ... 10 2.3 IR remote control (optional) ... 12 2.3.1 IR system code ... 13 2.3.2 IR charging station ... 14 2.4 IR wall control panel ... 14 2.5 Control via foot switch ... 14 2.6 Special functions ... 14 3. Table top ... 15 3.1 General features ... 15 3.2 Table top components ... 16 3.3 Attaching the back plate modules ... 17 3.4 Removing the back plate modules ... 18 3.5 Leg plates ... 18 3.6 Table top padding ... 19 3.7 Accessories ... 19 4. Motor drive for the base ... 20 IV. Use of the operating table ... 21 1. General ... 21 2. Operation on battery power ... 21 3. Operation on mains power ... 22 4. HF surgery / Use of defibrillators ... 22 V. Patient positioning ... 23 1. General ... 23 2. Positioning a patient weighing up to 135 kg (300 lb.) ... 25 3. Positioning a patient weighing from 135 kg up to 225 kg (300 lb. up to 500 lb.) ... 28 4. Positioning a patient weighing from 225 kg up to 450 kg (500 lb. up to 1000 lb.) ... 31 VI. Care and maintenance ... 32 1. Cleaning ... 32 2. Disinfection ... 32 3. Maintenance ... 33 4. Malfunctions ... 33 5. Environmental protection ... 34 VII. Technical data ... 35 1. Operating table adjustments ... 35 2. Electrical data ... 35 VIII. List of accessories ... 36 1. Accessories for the head rest interface ... 38 2. Accessories for the back plate interface ... 40 3. Accessories for the legplate interface ... 40 4. Accessories for attachment to the side rails ... 41 5. Special accessories ... 41 6. Control modules ... 42 IX. Spare parts list ... 42
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I. Important safety instructions
1133.02BX
I. Important safety instructions Mount only the accessories listed in Chapter VIII. Make sure that the operating table is set up horizontally and is stable! Lock the operating table in position prior to use! Press the LOCK key! Lock the operating table in position prior to transferring the patient! Press the LOCK key! The patient may only be transferred from the side of the operating table. It is not allowed to transfer the patient from the head or foot end onto the table. Danger of tipping over! Danger of injury! If the patient is not secured during transport, adjustments of the operating table or positioning (especially in Trendelenburg positions), he/she may slip off the operating table. Always secure and observe the patient. Danger of burns to the patient! When using HF surgical equipment, defibrillators and defibrillation monitors, make sure to avoid that the patient comes into contact with the metal parts of the operating table, the table tops or the accessories. Also make sure to avoid that the patient is lying on moist underlays or sheets on the conductive pads. Be absolutely sure to comply with the manufacturer’s operating instructions. Danger of damage! Take care to avoid collisions between accessories and the operating table during adjustment procedures. Consult MAQUET prior to using accessories produced by other manufacturers if they affect the longitudinal geometry of the table top. There is no explosion protection while recharging the batteries or the operating table is on mains power. When connecting and removing the mains cable, observe the correct order of the procedure! (see page 22) The patient has to be positioned and observed so as to avoid hazards to respiration, the nervous system and the circulatory system. The operating table’s electrical conductivity has to be checked once a year by trained service personnel! Unplug the operating table before opening! Electrical devices (such as cellphones, radios, magnetic resonance tomographs) can interfere with the functioning of the operating table when used near the operating table. Please observe the Technical Description for the operating table. It contains information on electromagnetic compatibility (EMC) for the operating table (both radiation and resistance to interference). Adhere to those specifications when using electrical equipment and respond properly in the event of effects on the operating table.
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I. Important safety instructions
Danger of injury! Before aligning the leg plates horizontally, check the patient’s position carefully, particularly when using knee crutches. Danger of crushing! Do not touch the side rails in the area of the joints when adjusting the operating table top! Danger of pinching! Do not reach under the table top or between the table top components during adjustment procedures. Danger of crushing! When locking the operating table (LOCK), the operator’s feet may be crushed or shorn. When setting the operating table, keep enough distance from the table base. Danger of pinching! Danger of damage! Do not place any objects on the base of the operating table! Danger of damage! Do not press or pull on the covers of the joints.
Danger of collision!
Danger of damage! Make sure the cable of the hand control does not get jammed when adjusting the operating table.
Î Î
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II. Important information
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II. Important information Your hospital has opted for the 1133.02 operating table. Thank you for the confidence you have demonstrated in doing so. 1. Important notes on these operating instructions: • • • •
Please read these operating instructions thoroughly and carefully. They were written to make you familiar with the features of the operating table. Please observe these instructions at all times. Please keep these instructions close to the equipment for ease of reference. In these operating instructions we have used the following symbols: This symbol indicates safety instructions in accordance with the prevailing international standard for medical equipment. Î Note This symbol is placed before all instructions that ensure the trouble-free operation of the unit. (X) An „X“ in the order number (e.g. 1133.53XX) stands in place of the different versions.
2. Using the operating table in accordance with the intended purpose The operating tables distributed by MAQUET are to be used exclusively in the field of human medicine. The user must have been instructed in the proper operation of the table before using it. This familiarization session is confirmed in an acceptance log. The location selected for the table must satisfy the requirements set down in applicable standards and guidelines. Mandatory for utilization is the proper assembly and maintenance of the unit. 3. Intended purpose The 1133.02 operating table serves to support and position patients for surgical treatment • immediately before, during and after the operative phase • in rooms designated for medical use and which provide the following required features: – equipment to protect against electric shocks – additional potential equalization – electrically conductive floor (corresponding to Group 1 or 2 as per VDE 0100 part 710); • under medical supervision. • Considering patient positioning a max. 450 kg (1000 lb.) patient weight is permissible. Avoid excentric patient positions, i.e. the patient’s centre of gravity (near the navel) must be as close as possible to the centre of the column.
Due to the design of the table top, the operating table is suitable for all surgical disciplines. The patient positioning options are listed in these Operating instructions. The operating table adjustments are made electrohydraulically using a cable-connected hand control, an IR remote control, an IR wall control panel or a foot switch. Side rails serve to attach accessory components in accordance with the manufacturer’s specifications. The radiotranslucent operating table top allows for intraoperative use of X-ray equipment. Î Note Make sure to comply with the generally applicable provisions relating to hygienics, and to cover the table top of the operating table with sheets before positioning the patient. 4. Basic safety aspects „CLASSIFIED BY UNDERWRITERS LABORATORIES INC: WITH RESPECT TO ELECTRIC SHOCK; FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1“ This operating table meets the requirements set forth in the IEC 601-1 international standard, which is equivalent to EN 60601-1. The operating table is classified as Class I equipment of the Medical Device Directive. Whenever maintenance work is required, remember that the MAQUET service is the right address in terms of quality and maintaining guarantee protection. You will certainly understand that MAQUET can be held responsible for the safety technology features of the product only if assembly, enhancements, readjustment, modifications and repairs are made exclusively by our service department or by an authorized agent and if the unit is used in full compliance with the Operating Instructions.
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III. General description
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III. General description 1. General features In principle, the ALPHAMAXX 1133.02 operating table is suitable for the following surgical procedures: 〈 in the thorax and abdominal areas 〈 in the head area 〈 in gynaecology 〈 in urology 〈 in orthopaedics If required, separate accessories can be attached to the operating table. The table top is subdivided into 6 sections: 〈 Head rest (removable) 〈 Upper back plate (removable) 〈 Lower back plate 〈 Seat plate 〈 Split leg plates
Fig. 1: Permissible patient orientation
The lower back, seat and leg plates are adjusted under motor power. The head rest and the upper back plate are adjusted manually. X-ray cassettes can be inserted underneath the back plate. The side rails are used to fix the accessories. For patients weighing up to 135 kg (300 lb), place the operating table only on its castors (UNLOCK) up to the maximum table top height of 940 mm (37 in)! The warning sign is not seen! For patients weighing from 135 kg up to 225 kg (300 - 500 lb), place the operating table only on its castors (UNLOCK) when the table top is in its lowest position! Using the UNLOCK function for patient weights exceeding 225 kg (500 lb) is not permissible! 2. Versions
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Various versions of the 1133.02 operating table are available: 1133.02B1 Operating table incl. SFC pads and standard side rails 1133.02B3 Operating table incl. SFC pads, standard side rails and motor drive for the base 1133.02F1 Operating table incl. SFC pads and US side rails 1133.02F3 Operating table incl. SFC pads and US side rails and motor drive for the base The cable-connected hand control, the IR transmitter and charging station for the IR transmitter as well as the head rests, upper back plates and leg plates are to be ordered separately. The order numbers are listed in Chapters VIII and IX.
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III. General description
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2. Control of functions The electrohydraulic functions of the operating table can be operated using the following control elements: • Cable-connected hand control (see 2.1)
•
Override system = emergency operation (see 2.2) or optionally: • IR remote control (see 2.3)
• •
Wall control panel
(see 2.4)
Foot switch 1009.79F0 (see 2.5) The cable-connected hand control and the IR remote control have almost the same function keys. The override system is only used for emergency operation of the operating table. The foot switch functions are: table height, Trendelenburg/reverse Trendelenburg position and another function (lateral tilt, longitudinal shift for the back plate or leg plate adjustment). Î Note: For safety reasons only the TRENDELENBURG/ REVERSE TRENDELENBURG functions can be used when the UNLOCK function is activated. The sockets 14 for the cable-connected hand control and the foot switch are located on the override control panel. Î Note: If the functions are controlled simultaneously by more than one operating element, each movement of the operating table is stopped immediately. Danger of operating table tipping over! Make sure to remove any potential hindrances before adjusting the operating table! Danger of damage during adjustments! Do not place any objects on the base of the operating table! Danger of pinching! Do not reach under the table top or between the table top components during adjustment procedures. Danger of injury! If the patient is not secured during transport, adjustments of the operating table or positioning (especially in Trendelenburg positions), he/she may slip off the operating table. Always secure and observe the patient. Danger of damage! When not in use, hang up the cable-connected hand control at the side rail of the operating table. Make sure the cable of the hand control does not get jammed when adjusting the operating table.
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III. General description 2.1 Cable-connected hand control The cable-connected hand control is connected to the operating table at one of the two sockets 14 at the override control panel (for simultaneous connection of cable-connected hand control and foot switch). The electric motor-powered adjustments of the operating table can be made immediately by pressing completely the corresponding function keys.
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Lower table top Raise table top Tilt to the left (view from head end) Tilt to the right (view from head end) Trendelenburg position Reverse Trendelenburg position Flex position operates the reverse Trendelenburg and lower back plate functions until a flex position is achieved to force the surgical field upward Beach chair raises the back plate, moves the entire table top into Trendelenburg position and lowers the leg plates. The patient is moved into a seated position. Slope (both) leg plates downward Slope (both) leg plates upward Slope (lower) back plate downward Slope (lower) back plate upward Shift the table top toward the foot end Shift the table top toward the head end Adjust the left leg plate individually The left leg plate can be controlled individually only together with the appropriate function key for the desired movement – downward (r+j) or upward (r+k), under two-button control Adjust the right leg plate individually Similar to the individual plate, by pressing the two keys for downward movement (s+j) or for upward movement (s+k) (two-button control) Lock Press the LOCK key for at least 1 second; the table will be locked automatically. Unlock To unlock the operating table, press the UNLOCK key for at least 1 second, then the castors will be extended automatically and the table can be displaced. Motor drive for the base for 1133.02B2 (optional) Displace the operating table backward (toward the head end). Displace the operating table forward (toward the foot end). When displacing the operating table under motor power, it must be guided with a hand.
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III. General description
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z) 0-position Resets the lateral tilt, Trendelenburg/reverse Trendelenburg, back plate and leg plate adjustments to the horizontal position. If the function key z is pressed, the operating table top will first reset the adjustments in the following order – lateral tilt, Trendelenburg/reverse Trendelenburg, back plate. An acoustic signal will indicate that these adjustments have been reset. Release the function key z and press once again to reset the back plates to the horizontal position; if the leg plates have been adjusted individually, they will be positioned parallel to one another. Î Notes: Manual adjustment functions such as those for the upper back plate, head rest and leg plate abduction will not be affected by the IR remote control (and as a consequence neither by the automatic 0-position function). Î The transmission power of the IR hand control is sufficient to be able to adjust the operating table even from a greater distance. If the operating table does not respond to the command even though the function key is completely depressed, either reaim the hand control or move to a slightly different transmission position. In such cases the receiver at the column is probably being blocked by a person’s body. 2.2. Override system = emergency operation 2.2.1 Override control panel In case of a malfunction or a defective hand control, you can control the operating table functions via the control panel 13 on the upper column casing = emergency operation.
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Î Note: Always press the ON key together with the desired function key. Î Note: If the operating table batteries are discharged, the override system only works if the operating table is connected to the mains. Î Note: When using the override control panel, the anticollision feature is not activated. Avoid extreme adjustments – the combination of maximum Trendelenburg/reverse Trendelenburg position and maximum lateral tilt.
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III. General description
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The functions of the override control panel are shown in the following: A) LED status indicators of operating table Î Note: The status indicators are only active when the cable-connected hand control or IR remote control is switched on. Description of the symbols from left to right: z Mains connection: the green LED lights up when the operating table is connected to the mains. z Battery charge level: the red LED flashes when the operating table batteries have to be recharged as soon as possible. z Lock operating table: the green LED lights up when the operating table is locked, i.e. LOCK activated. z Extend operating table castors: the red LED lights up when the operating table is on its castors and can be displaced, e.g. UNLOCK activated. A
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B)
ON switches the motor ON and must be pressed in addition to each function key
C)
TREND Moves table top into Trendelenburg position
D)
REV. Moves table top into reverse Trendelenburg position
E)
UP Move table top up
F)
DOWN Move table top down
G)
TILT Lateral tilt to the left
H)
TILT Lateral tilt to the right
I)
UP Slope back plate upward
K)
DOWN Slope back plate downward
L)
UP Slope leg plate upward
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III. General description
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DOWN Slope leg plate downward
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LOCK Operating table locked
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UNLOCK Operating table on castors, movable
2.3. IR remote control (optional)
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The operating table can be equipped with an IR remote control, as desired. The required charging station for the IR remote control is not included with the order no. 1133.91A0. The layout of the function keys for the operating table adjustments is the same on the cable-connected hand control and IR remote control apart from the following exceptions: There are no function keys for the motor drive for the base. For safety reasons, you can only activate this function via the cable-connected hand control. Î Note: When switching on the IR remote control, the LED status indicators on the control panel on the operating table column are active (see chapter on “Override system”). Î Note: When using the IR remote control or the cable-connected hand control, the electronics generally avoid collisions with the floor or parts of the operating table.
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III. General description
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2.3.1 IR system code An IR remote control is clearly assigned to each operating table through a code. The operating table has the same system code as the associated IR remote control. You can see from the label at the operating table column whether the IR reception has been activated for this operating table. If the system code is crossed out, then the IR reception has been locked for this operating table. The operating table and the IR remote control are activated / locked for IR reception by authorized personnel. The operating table and the associated IR remote control are marked by adhesive labels bearing the set system code: • The adhesive labels are affixed to the operating table column next to the IR receiver. • The adhesive labels are affixed to the back of the IR remote control. The two dot-shaped adhesive labels bear a number from 0 to 9 or a letter from A to F: • left: 0, 1, 2 ...A, B, ... F • right: 0, 1, 2 ...A, B, ... F Examples of preset IR system code markings: 1 5 3 A C 2 D A Î Note: The order of the identification letters/numbers is significant, i.e. the IR system code 4 B does not equal B 4. Î Note: Always leave the IR remote control in the immediate vicinity of the operating table to which it is assigned, since the operating table can only be moved via this IR remote control. Of course, the operating table can be adjusted via a cable-connected hand control or the override system at any time, regardless of the IR remote control.
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Î Note: The transmission power of the IR hand control is sufficient to be able to adjust the operating table even from a greater distance. If the operating table does not respond to the command even though the function key is completely depressed, either reaim the hand control or move to a slightly different transmission position. In such cases the IR sensor at the column is being blocked by a person’s body.
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III. General description
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2.3.2 Charging station Recharging the IR remote control: •
Connect the charging station to the mains.
The green LED in the charging station indicates whether the required supply voltage is available or not. •
Place the IR remote control in the charging station as follows: – Keypad visible, in the position for normal use, i.e. the 0-position key x is located at the bottom right – The base of the hand control is in contact with the lower limit stop of the holder.
Î Note: The rechargeable battery of the IR remote control has enough capacity to ensure several day’s use of the operating table. Nevertheless, we recommend that you insert the hand control into the holder of the charging station so that the battery is recharged overnight.
2.4 Control via IR wall panel The desired adjustment functions for the operating table can be controlled by means of the function keys (1) at the wall control panel or the separate IR hand control (2). Î Note: The IR wall control panel can be mounted to the wall at a later date. For further information, please refer to the operating instructions GA115095GBxx.
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1133.02BX 2.5 Control via foot switch 1009.81DX (optional) 14 14
Connect the foot switch to one of the two sockets (14) at the column head. Three functions can be activated using the following foot switch versions: 1009.81D0 1009.81D1 1009.81D2 1009.81D3
Foot switch for height, Trendelenburg/rev., back plate Foot switch for height, Trendelenburg/rev., lateral tilt Foot switch for height, Trendelenburg/rev., leg plates Foot switch for height, Trendelenburg/rev., longit. shift
Î Note Be sure to observe the Operating instructions for the foot switch.
2.6 Special functions If requested, the MAQUET service personnel can set the NEUROLOCK function at the operating table. This function avoids adjustments of the table position due unintentional actuation of the keys at the hand control.
a+b) The ”Neurolock” function can be unlocked by pressing simultaneously the ”table top down” key a and the ”table top up” key b on the control module. The operating table can now be adjusted. If no further keys on the control module are actuated for approx. 8 sec., then the operating table is locked again. Adjusting the operating table again is only possible after actuating the ”table top down” a and ”table top up” b function keys simultaneously. Î Note: The ”table top up” and ”table top down” functions cannot be actuated simultaneously using the foot switch 1009.81X0. Use a second control module to unlock the Neurolock function.
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III. General description
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3. Table top 3.1 General features The 1133.02 has been designed to meet the requirements of various surgical disciplines. Selecting from a variety of modules lets you adapt the geometry of the table top to accommodate individual patient height. The table top is divided into a maximum of 6 sections, depending on the type of leg plate and upper back plate module selected: • head rest • upper back plate (extension plate) • lower back plate • seat plate • leg plate(s) The table top is equipped with a motor-powered longitudinal shift feature through 215 mm (9 inches) and motor-powered adjustment functions for the back plate and leg plates. Furthermore, the mounting sockets for the leg plates automatically detect whether one-piece components have been installed, thus increasing reliability and safety in use. Depending on the application, the adjustment ranges for the accessories mounted at the leg plate connection point may be restricted. Please refer to the Operating instructions for the accessory in question. Mounting various back plate modules at the upper/lower back plate connection point allow for positions matching the patient perfectly and create a favourable working environment for the surgical team and for the intervention. Guide rails used to insert X-ray film cassettes are located below the back plate. The side rails are intended for the attachment of accessories. Various head positioning accessories, used instead of a head rest, can be attached at the head end of the back plate modules (see Section V. Patient positioning). Î Note: According to the internationally valid standard IEC 60601-1, the operating table is designed for safe handling of a patient weight of 450 kg (1000 lb.). When using accessories, the maximum load may be restricted. Please observe the Section VIII. List of accessories.
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III. General description
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3.3 Attaching the back plate modules
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First remove the pad
2) •
Loosen the eccentric safety levers at the right and left (3); press the safety push buttons x (fig.1) to do so. If a back plate is already installed, hold it with one hand.
3) •
Insert the back plate into the bars from above, holding it almost vertically and set it to the requested position (fig. 2)
4) •
When making the adjustment, hold the back plate with one hand and re-tighten the eccentric levers (3) (fig. 3).
5) •
Re-place the pad in the correct position.
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x fig. 1
fig. 2
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3.4 Removing the back plate modules •
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To remove the back plate modules, refer to section 3.3 ”Attaching the back plate modules” and proceed in reverse order.
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III. General description
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3.5 Leg plates 1133.53 • To mount the split leg plates, press the push button 10 and insert the leg plate pins into the mounting holes up to the stop (Fig. 5).
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They are locked in position automatically as soon as the button 10 is released (Fig. 5a).
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The slope of the back plate is adjusted electro-hydraulically by means of the hand control.
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To abduct the leg plates, open the eccentric lever 9 and set to the desired abduction angle.
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Re-tighten the eccentric lever after making the adjustment.
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A dual-pivot joint is used for abduction of the 1133.53 leg plates so that on the one hand the surgeon has access to the patient’s body from the foot end while at the same time the patient’s legs are given sufficient support.
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To remove the leg plate, press the push button 10 and pull the leg plate out of the mounting holes.
fig.5
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fig.5a
Take care that the leg plates are not crossed / on top of each other before aligning the leg plates for the horizontal position. Danger of collision! Danger of injury!
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III. General description
1133.02BX 1133.58BC Single-section leg plate
3.6 Table top padding
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To attach or remove the single-section leg plate, actuate the release lever a and insert the leg plate in the bore holes up to the stop or remove it.
The table top will be supplied with table top plates and SFC padding secured with Velcro straps.
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The single-section leg plate is suitable for surgical procedures in orthopaedics and vascular surgery where the patient’s legs are to be X-rayed. It is sloped electrohydraulically by means of the control module.
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1133.55BC Seat plate extension •
To attach or remove the seat plate extension, actuate the release lever a and insert the seat plate extension in the bore holes up to the stop or remove it.
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The seat plate extension is suitable for surgical procedures in gynaecology and urology.
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The downward movement for the seat plate extension is locked for safety reasons.
3.7 Accessories Mount only the accessories listed in Chapter VIII. Use accessory parts from other manufacturers, which can affect the table top geometry, only after consultation with MAQUET! Accessories which are mounted on the side rails of the operating table provided for this purpose should also been drawn exclusively from the MAQUET line of accessories. MAQUET attaches great importance to careful harmonization with the operating tables in our range. This results in maximum safety for the patient and the surgical staff when used in accordance with the instructions. Accessories (to be mounted on the side rails) which are made by other manufacturers must be particularly carefully examined to ensure that they do not represent a hazard to the patient and staff or to the operating table (due to possible collisions). Particularly accessory units with high weights or long lever arms (such as hand operating tables, retractor systems, etc.) must be expressly permitted by MAQUET.
a Danger of injury! Do not use worn out or damaged accessories!
Danger of injury! Make sure to fasten the table top accessories properly!
Danger of damage! While making adjustments, avoid collisions between the operating table and its accessories! GA113302GB11
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III. General description
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4. Motor drive for the base The table top versions 1133.02B2/F3 are equipped with a motor drive for the base. A table equipped with a motor drive for the base starts moving slowly and slows down softly after releasing the function key (i or k). i)
BACKW. Move table backwards in the longitudinal direction
k)
FORW. Move table forwards in the longitudinal direction
To move the operating table, proceed as follows: • Remove the mains cable from the operating table • Extend the operating table castors fully (press UNLOCK key) • Guide the operating table with at least one hand • Press the function key (v or w) and the operating table will move in the selected direction. • Release the function key (v or w) and the operating table will gently brake until it stops. Î Note If the LEDs of the LOCK and UNLOCK functions are flashing, press the UNLOCK key. Guide the operating table with at least one hand during displacement. Î Note When moving the operating table, do not press the override system keys, since this will cause several functions to be activated simultaneously and involves the risk of injuries or collisions with potential hindrances.
Î Note The operating table can only be moved laterally if you have not activated the BACKW. or FORW. function.
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