Operating Instruction
24 Pages
Preview
Page 1
Betaclassic
1118.01 A0/B0/C0/E0/F0/G0/J0/K0
Operating Instructions
Mobile Operating Table
Englisch
for general surgery
GA111801GB08
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Overview 1
Head rest 1130.64C0/D0
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Back plate
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Seat plate
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Leg plates 1118.50A0/B0
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Lever (leg plate up/down)
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Locking lever (leg plate)
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Grip screw (abduct leg plates)
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Castors
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Bellows
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Column casing
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Base cover
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Pump pedal
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Locking pedal (table locking)
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Lowering pedal (lower table top)
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Foot selector
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Locking screw (head rest)
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Operating bar (back plate)
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Connecting pin for equipotential bonding
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(located below table top) 20
Operating lever for head rest
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Release handle for longitudinal shift
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Hand crank for body elevator
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List of contents Overview ... 2 I. Important safety instructions ... 4 II. Important information ... 6 1. Important information on the Directions for Use ... 6 2. Use in the manner intended ... 6 3. Purpose ... 6 4. Basic safety aspects ... 6 III. General description ... 7 1. General description ... 7 2. Moving/locking the operating table ... 7 3. Activating the functions ... 8 3.1 Functions ... 8 3.2 Function of foot selector ... 8 3.3 Pump pedal function ... 9 3.4 Lowering pedal function (lower table top) ... 9 3.5 Locking pedal function ... 9 3.6 Table top functions ... 10 3.7. Body elevator (Version G) ... 11 3.8. Longitudinal shift (Versions J and K) ... 11 IV. Operating the operating table ... 12 1. Equipotential bonding ... 12 2. Explosion protection regulations ... 12 3. Table top components ... 13 3.1 Head rest ... 13 3.2 Adjusting the head rest ... 13 3.3 Leg plates ... 13 3.4 Table top covering ... 14 3.5 Back plate adjustment ... 14 V. Positionings ... 15 1. General ... 15 2. Lithotomy position ... 15 3. Thyroid ... 16 4. Maxillo-facial surgery ... 16 5. Lateral positioning ... 17 6. Neurosurgical procedures ... 17 7. Orthpedic extension ... 18 8. Gall bladder ... 18 VI. Maintenance and servicing ... 19 1. Cleaning ... 19 2. Disinfection ... 19 3. Disinfecting the castors ... 19 4. Maintenance ... 20 5. Malfunctions ... 20 6. Nature and scope of maintenance work ... 20 7. Environmental protection ... 20 VII. Specifications ... 21 VIII. List of accessories ... 22 IX. Replacement parts list ... 23
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I.Important safety instructions The operating table is designed for a patient weight limit of 135 kg (300 lb), surgical interventions may only be performed using defined patient positions. Make sure that the patient lies in the specified position. Never place the patient’s torso on the leg plates. Danger of operating table tipping over. Do not move an operating table with an add-on extension or rectal unit attached when a patient is lying on the table. Danger of operating table tipping over. The table top may not be shifted longitudinally when the extension plate or the rectal positioning unit is mounted. Hazard of collision! Make sure that the operating table is positioned horizontally and is stable. Secure the operating table before use. Secure the operating table in position before transferring the patient. Secure the patient before re-adjusting the operating table When using high-frequency equipment, defibrillators and defibrillator monitors, avoid contact between the patient and metal parts of the operating table, the table tops and accessories, and do not position patients on wet or damp surfaces or electrically conductive pads. This may result in the patient sustaining burns. It is absolutely essential to comply with the manufacturer’s Directions for Use. Make sure that table top accessories are fixed properly. When adjusting the operating table, take care to avoid collisions between accessories and the operating table. Do not use worn or damaged accessories. This may result in injury to the patient. Non-original accessories which affect the longitudinal geometry of the table top may only be used after consultation with MAQUET. Avoid endangering the patient’s respiratory system, nerve pathways and circulatory system by ensuring the patient’s proper positioning and observing the patient’s condition. Check the electrical conductivity of the operating table once a year. This check should be performed by trained servicing personnel only. Actuating the longitudinal shift feature is only permissible when the table top is in the 0-position.
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Remove possible obstacles before lowering or tilting the operating table. Danger of operating table tipping over.
Do not reach below the table top or between the components of the table top when making adjustments. Pinching hazard.
When adjusting the table top (e.g. Trendelenburg/ reverse Trendelenburg position, height down, leg plate down), avoid collisions between table top components and the operating table base!
Do not move an operating table with an add-on extension attached when a patient is lying on the table. Danger of operating table tipping over.
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Do not move an operating table with an rectal unit attached when a patient is lying on the table. Danger of operating table tipping over.
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II.Important information First of all, we should like to thank your clinic for choosing our mobile operating table 1118. 1.Important information on these Directions for Use: l Please read these Directions for Use carefully. We have prepared them for you so that you can familiarize yourself with the system’s characteristics. l Always follow the instructions contained here. l Keep these Directions for Use near by the equipment at all times. l In these Directions for Use, we have used the following symbols:
è Note This symbol is displayed with all notes which help you to avoid equipment malfunctions.
This symbol indicates safety instructions in accordance with the prevailing international standard for medical equipment.
2.Use of an operating table in the manner intended The operating tables which MAQUET sells are intended for human medicine purposes only. Prior to use, the user must be given instructions for operation of the equipment in the manner intended. The provision of instruction must be verified in the form of a hand-over report. The chosen place of use for the equipment must conform to the applicable standards and guidelines. A compulsory requirement for use is proper installation and maintenance of the equipment. 3.Purpose: The purpose of the operating table is to position patients for surgery l directly before, during and after the operative phase l in rooms which are used for medical purposes and fulfil the following conditions: - they are equipped with electric shock protection devices - additional equipotential bonding - electrically conductive floor covering (as per Groups 1 or 2 according to VDE 0107) l under medical surveillance Due to the design of the table top, the operating table is suitable for all surgical disciplines. The range of possible positionings is listed in the Directions for Use. Movements are initiated manually; they are executed electrohydraulically by means of pedals and handles, otherwise they are executed hydraulically. Side rails are provided for securing accessories in accordance with the manufacturer’s specifications. The translucent table top of the operating table permits intraoperative use of X-ray equipment. 4.Basic safety aspects This operating table meets the provisions of the international IEC 601-1 standard and IEC 60601-2-46. The operating table is classified as Class I equipment under the Medical Products Act. You should include it in your inventory. For your maintenance work, please remember that the MAQUET Customer Service is the right address as far as quality of work and warranty are concerned. We are sure you will appreciate that MAQUET can only accept responsibility for the safety of your equipment if installation, extension work, adjustments, modifications and repairs to your equipment have been carried out exclusively by our Customer Service or by technical experts authorised by us and also if the equipment has been operated strictly in accordance with our Directions for Use.
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III.General description 1.General description The 1118. is a mobile operating table for general surgery. Depending on the leg plate type selected, the operating table top can have up to 5 subdivisions: Located beneath the table top are guide rails for inserting X-ray cassettes at the head end. X-ray cassettes can be inserted below the table top in the head, back and seat areas. The lateral side rails are for fixing accessories to the operating table. Versions of the operating table: 1118.01A0 Operating table with PUR pads, European side rails 1118.01B0 Operating table with SFC pads, European side rails 1118.01C0 Multi-coloured operating table with black SFC pads, European side rails 1118.01E0 Operating table with SFC pads, U.S. side rails 1118.01F0 Multi-coloured operating table with black SFC pads, U.S. side rails 1118.01G0 Operating table with SFC padding, European side rails and body elevator 1118.01J0 Operating table with PUR padding, European side rails, longitudinal shift 1118.01K0 Operating table with SFC padding, European side rails, longitudinal shift The operating table can be enabled by releasing or fixing a foot lever. è The operating table is designed to handle safety patients weighing up to 135 kg as per IEC 601-1 standard. The operating table may only be equipped with original MAQUET accessories (observe the Operation Instructions.). Non-original accessories may only be used with the manufacturer’s express prior approval and must be examined carefully prior to use to make absolutely sure that they do not represent a hazard to patients or personnel and cannot damage the operating table. è Note: On the immobilised operating table, all surgical procedures may be performed on patients weighing up to 135 kg (300 lb.).
2.Moving/locking the operating table: è Before starting patient positioning and during the operation, the operating table must always be immobilised by operating the locking lever (14). To move the operating table in a longitudinal direction, l move the locking pedal (14) up.
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To immobilise the operating table, l move the locking pedal (14) down.
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1118.01 3.Activating the functions 3.1.Functions The hydraulic functions of the operating table: l height function l inclination function l lateral tilt function are foot-activated via the following operating elements.
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q Foot selector (16) q Pump pedal (12) q Lowering pedal (15)
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3.2 Functions of foot selector The desired function is activated by pressing the selector as shown.
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Table top up Trendelenburg position Reverse Trendelenburg position Lateral tilt right Lateral tilt left
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Pressing foot selector in the middle = height function
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Tilting the foot selector in the direction of the t arrow = Trendelenburg position
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Tilting the foot selector in the direction of the s arrow = reverse Trendelenburg position
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Tilting the foot selector in the direction of the arrow = lateral tilt right
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Tilting the foot selector in the direction of the arrow = lateral tilt left
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1118.01 3.3 Pump pedal function The functions adjusted under 3.2 are executed with the pump pedal (12).
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3.4 Lowering pedal function The sole purpose of the lowering pedal (15) is to reduce the height of the table top. The position of the dome-shaped selector switch has no relevance to this function. 15
3.5 Locking pedal function When the Locking pedal (14) is pressed, the two castors are locked. Operations and patient positioning shall only be performed when the operating table is locked.
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1118.01 3.6 Table top functions The manual functions are activated via the controls on the table top.
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Operating bar for back plate (18).
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Operating lever for head rest (20)
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Locking screw for head rest (17)
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Lever for leg plate (5)
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Locking lever for leg plate (6)
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Grip screw (abduct leg plate) (7)
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Release handle for longitudinal shift (21)
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Hand crank for body elevator (22)
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Remove any possible obstacles before lowering or tilting the operating table. Danger of operating table tipping over.
Do not reach below the table top or between the components of the table top when making adjustments. Pinching hazard.
If table tops are adjusted downwards, avoid collisions with the base of the operating table when making adjustments.
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3.7 Body elevator (Version G) The hand crank (22) and its mount (22a) used to actuate the body elevator are located at the back section of the table top. In the top position the two hard paper plates of the back section are set to the body elevator position.
22 The hand crank should always be engaged in the clips when not in use. Be careful when inserting the hand crank in the mount at the back plate supporting bar or engaging it in the clips, in order to prevent injury caused by the crank. Ensure that the patient’s nerve pathways and circulation are not compromized by the body elevator adjustment. Do not reach between the moving parts of the body elevator during adjustment procedures. Moreover, ensure that the patient’s limbs do not come between the moving parts of the body elevator.
3.8 Longitudinal shift (Versions J and K) The release handle (21) for the longitudinal shift is located at the head end on the table top. When pulled towards the head end, this handle releases the locking mechanism for the longitudinal shift; the table top can be shifted manually to the desired position. When shifting the table top, hold it with both hands at the head end. When the handle (21) is released, the table top is locked automatically (9 positions, spacing 36.5 mm)
Actuating the longitudinal shift feature is only permissible when the table top is in the 0-position.
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Check to ensure that the table top is properly locked before displacing the table in the longitudinal direction or before actuating the Trendelenburg adjustment feature.
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IV. Operating the operating table 1.Equipotential bonding: Connect the equipotential bonding pin (19) and the equalisation wire to an equipotential bonding system in the operating room. è
Note In countries where potential equalization is required, the operating table has to be connected to the potential equalization system of the operating room. For this purpose, connect the potential equalization pin of the operating table to one connector of the potential equalization pin of the operating table to one connector of the potential equalization pin of the operating room. In countries where potential equalization is not used, it is not required to connect the operating table to the potential equalization system. If no potential equalization cable (5 m long) with connectors at both ends is included in the scope of supply of your operating table and you are required to use PE cable during surgery please order p/n 0200 403 4 at your local MAQUET representative.
2. Explosion protection regulations: The blue 1118.11A0 pads are not electrically conductive. These pads must not be employed when using inflammable detergents and disinfectants – there is no explosion protection! You can find details of the classification of areas subject to explosion hazards into zones in Information Leaflet M 639, which is issued by the Professional Association for Health and Welfare (BGW). To obtain a copy, contact: Berufsgenossenschaft fuer Gesundheitsdienst und Wohlfahrtspflege Schaeferkampsallee 24 20357 Hamburg Germany
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1118.01 3.Table top components 3.1 Head rest 1130.64A0/B0/C0 To fix the head rest (1), insert the two pins into the locating holes until they fully engage. Then tighten the two fastening screws (17).
Check to see if the head rest is attached securely by pulling it.
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3.2 Adjusting the head rest The head rest can be inclined upwards by pulling the end of the plate up. The head rest engages automatically step by step. To incline the head rest downwards, pull the operating lever (20) towards the padding. The head rest is automatically located in the next ratchet after you release the operating lever (20). è Make sure you comply with the Operating instructions for the head rest.
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3.3 Leg plates 1118.50X0 l To attach the leg plate 1118.50X0, insert the pin into the locating hole up to the stop. Pull the locking lever (6) towards the foot end up to the stop. Insert the pin fully into the locating hole, with the locking lever still pulled. Release the locking lever so that it returns to its original position. l The leg plate can be folded down and into the horizontal position by pressing down lever (5) at the foot end of the operating table. l The leg plates can be abducted by slackening the grip screw (7). To secure the leg plate in a detent position, re-tighten the grip screw (7). l To remove the leg plate, pull the locking lever (6) towards the foot end of the operating table and pull the leg plate out from the locating holes.
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1118.01 3.4 Table top covering The SFC table top padding is affixed to the paper base laminate plates by Velcro fasteners. The PUR pads are also attached to the frame by means of bolts.
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3.5 Back plate adjustment: The table top is equipped with a manually adjustable back section with gas-filled spring support and is activated by means of the bar (18). When a patient of normal weight is lying on the table top, the motion of the back plate is normally compensated. When the back plate is not bearing any load, it moves up after you release the bar. The back plate is automatically immobilised after you release the bar.
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V. Positionings 1. General l The operating table must be integrated in the equipotential bonding system of the operating room. For this purpose, connect the equipotential bonding pin and the equalisation wire to an equipotential bonding of the operating room near the patient. An equalisation cable (5 m long) with connectors at either end is supplied with the operating table. l After positioning the patient, check to see if all the excentric levers are closed and if all clamping screws on the operating table as well as the accessories are fastened tightly. è Note According to generally recognized hygiene regulations, the table top must be draped prior to use. HF surgery Use of defibrillators and defibrillator monitors When using HF equipment, defibrillators and defibrillator monitors, it is imperative that you observe the equipment manufacturer’s Directions for Use, since ignoring the prescribed safety precautions can result in serious damage to equipment or personal injury. Contact between the patient and metal parts of the operating table or operating table accessories can cause burns. There is also a risk of burning if the patient is placed on damp or wet surfaces or drapes on the electrically conductive padding of the operating table.
2. Lithotomy position l Immobilize the operating table. l Attach the leg supports to the side rails near the leg plate mounts using the radial setting clamp. l Position the patient’s legs and remove the leg plates. l Move the back plate upwards with the bar (18). l Tilt the table top slightly into the Trendelenburg position; set the foot selector (16) to b. Adjust the inclination by pressing pedal (12). l Move the leg supports into position.
Recommended equipment 1001.65A0 Goepel knee crutch (2 pcs.) 1003.23C0 Radial setting clamp (3 pcs.) 1002.57A0 Anaesthesia screen 1001.44D0 Arm posturing device 1002.24C0 Wristlet 1002.59A0 Elongation tubes for anaesthesia screen Alternative: 1002.2300 Leg holder with straps
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1118.01 3. Thyroid l Immobilize the operating table l Tilt the table top into the Trendelenburg position l Move the back plate upwards l Align the leg plate l Adapt the head rest
Recommended equipment 1132.64X0 Head rest 1002.57A0 Anaesthesia screen 1003.23C0 Radial setting clamp 1001.44D0 Arm posturing device 1002.24C0 Wristlet 1001.56A0 Body strap 1002.59A0 Elongation tubes for anaesthesia screen è Note: Be sure to comply with the Directions for Use for all accessories used.
4. Maxillo-facial surgery l Immobilize the operating table l Attach the required head positioning accessories to the table top using the connecting bracket 1130.54B0 l Tilt the table top into the Trendelenburg position l Move the back plate upwards l Align the leg plate l Adapt the head positioning accessories
Recommended equipment 1130.54B0 Connecting bracket 1002.64A0 Connecting fixture 1002.7000 Horseshoe-shaped head rest, split 1002.57A0 Anaesthesia screen 1003.23C0 Radial setting clamp 1001.44D0 Arm posturing device 1002.24C0 Wristlet 1002.59A0 Elongation tubes for anaesthesia screen è Note: Be sure to comply with the Directions for Use for all accessories used.
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1118.01 5. Lateral positioning (e.g. kidney, thorax) l Immobilize the operating table l Tilt the table top into the reverse Trendelenburg position l Move the back plate downwards l Adapt the head rest Recommended equipment 1130.53B0 Double articulation head rest 1002.57A0 Anaesthesia screen 1003.23C0 Radial setting clamp 1001.44D0 Arm posturing device 1001.56A0 Body strap 1001.4600 Arm restraint cuff 1002.21C0 Lateral support 1002.19C0 Fixture for body supports 1002.11A0 Back-buttocks support 1002.59A0 Elongation tubes for anaesthesia screen è Note: Be sure to comply with the Directions for Use for all accessories used.
6. Neurosurgical procedures (patient in prone or supine position) l Immobilize the operating table l Now attach the neurosurgical head positioning accessories using the connecting bracket 1130.54B0 l Lay the patient in the prone or supine position l Set the head positioning accessories
Recommended equipment 1130.54B0 Connecting bracket 1005.2900 Basic unit 1005.3400 Clamp adapter 1005.3500 Mayfield skull clamp 1002.57A0 Anaesthesia screen 1003.23C0 Radial setting clamp 1101.44D0 Arm posturing device 1002.59A0 Elongation tubes for anaesthesia screen è Note: Be sure to comply with the Directions for Use for all accessories used.
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1118.01 7. Orthopedic extension l Immobilize the operating table l Attach extension unit 1419 and secure the supports l Remove the head rest l Place patient on table and position legs
Recommended basic equipment 1419.01X0 Extension unit 1003.23C0 Radial setting clamp (3 pcs.) 1002.57A0 Anaesthesia screen 1001.44D0 Arm posturing device 1002.59A0 Elongation tubes for anaesthesia screen
8. Gall bladder l Immobilize the operating table l Tilt the table top into the reverse Trendelenburg position l Move the back plate downwards l Adapt the head rest
Recommended equipment 1130.64C0 Head rest 1002.57A0 Anaesthesia screen 1003.23C0 Radial setting clamp 1001.44D0 Arm posturing device 1002.24C0 Wristlet 1001.5500 Body strap 1002.59A0 Elongation tubes for anaesthesia screen
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VI. Maintenance and servicing We recommend you cover the operating table with drapes when it is not in use. 1. Cleaning Avoid excessive use of water on the surfaces of the mobile operating table. Also avoid spraying joints with spray cleaning or disinfection equipment. Pressurized jets of water or detergent can result in liquid entering the gaps between joints and causing corrosion. To clean the operating table and accessories, we recommend you use a weak alkaline detergent (soap solution) containing tensides and phosphates as active agents. To clean the table, align the operating table horizontally and move it to its highest position. If surfaces are heavily soiled, use the detergent in concentrated form. Afterwards, wipe the surfaces with clean water and remove any excess water with a dry cloth.
2. Disinfecting To disinfect the operating table, we recommend you use commercially available surface disinfectants on an aldehyde base in aqueous solution. Make sure you use an agent that appears in the DGHM* list. Here, you can find additional information on the individual constituents in the disinfectants. è Note: The disinfectant should not contain the following components: l Chlorine or chlorine-splitting compounds l These agents attack the metallic surface. Alcohol or compounds of alcohol. Hand disinfectants contain alcohol. l These agents attack plastic parts, e.g. operating table padding, operating levers. l These agents form flammable mixtures. 3. Disinfecting the castors Turn the castors outwards. Wipe the castors with surface disinfectants.
* Deutsche Gesellschaft für Hygiene und Mikrobiologie DGHM c/o Institut für Hygiene und Mikrobiologie Universität Würzburg Josef-Schneider-Str. 2 97080 Würzburg http://www.dghm.org
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1118.01 4. Maintenance
The operating table will have to be serviced once a year by the MAQUET factory service department or by service technicians authorized by MAQUET to do so. Please adhere to prescribed maintenance intervals as otherwise guarantee coverage will lapse. In so doing you also make a contribution to patient and staff safety and extend the useful life of your costly equipment. We recommend concluding a maintenance contract with MAQUET. Outside Germany please contact your local representative in all matters relating to service. 5. Troubleshooting If you are having trouble with your equipment, please contact your local MAQUET representative or our factory. Please give us detailed information regarding the symptoms of the trouble and state the serial number of the equipment. This will enable us to remedy your problem more quickly. 6. Nature and scope of maintenance work Inspect components and joints critical to the functioning of your equipment for wear and corrosion. Pay special attention to the following parts: - Connecting bolts of the table top - Fastening bolts of the column guide - Pump and pump pedal suspension For your patients’ safety, you are strongly advised to comply with the yearly maintenance intervals. è Note: Non-observance of the prescribed maintenance intervals will render the warranty on the equipment null and void. Special tools are required to perform maintenance work on the equipment. However, servicing and repair work should always be referred to the trained technicians of MAQUET’s Customer Service. è Note: Do not attempt to perform any repairs if the equipment malfunctions, and never use force. 7. Protection of the environment Please note the following: Ÿ Packaging materials: The materials used for packaging MAQUET products are environmentally friendly. They are made of untreated wood, cardboard, recyclable plastics or other reusable materials.
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MAQUET-Products: MAQUET takes used and not recyclable Products back. All parts will be deposited environmentally. Please call your MAQUET-Service to get more information.
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Plastic components: Large plastic components have a symbol to indicate what type of plastic they are made of in order to make recycling easier. Padding can be disposed of through the hospital waste system.
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