Opmaster Model 505, 508 and 506P Manual Issue 6

Introduction The Lab-Med Ltd Opmaster 506P is particularly suited to ophthalmology and endoscopic sinus surgery. It has been designed to provide a theatre quality table that meets the extensive demands of the busiest Day Surgery Units. The Opmaster 506P offers excellent access for the surgeon, powered table movements, an exceptional height range and a choice of mattresses; provide excellent patient comfort and ease of use for nursing staff.

Specifications Overall

Weight Length Overall Width Mattress Width Height Range Capacity

160 kg 1990 mm 750 mm 600 mm 578 - 978 mm (top of mattress) 225 kg (patient prone)

Movements

Trendelenberg Reverse Trendelenberg Back section Head section Foot section

0° to - 20° 0° to + 15° 0° to + 60° - 36° to + 36° 0° to - 87°

Power Supply

Battery: 24v DC 4.5AH capacity Control Voltage: 24vDC Mains: 230v 50/60Hz single phase (For charging batteries either in-situ or via charging station) Inlet Fuses: T x 2A 250v x 2 (UK & EU) T x 2A 250v x 2 (AM) Battery Discharge: Typically 12 duty cycles Battery Recharge: Typically 8hrs

Features

Drop down removable cot side rails Euro size side bars to trunk and back sections Pressure-relief mattresses IV pole sockets Four castor braking with selectable steer.

Classification

The 506P is a Class 1 medical device and is designed to meet ISO 60601- 2 - 46:1998 and carries the CE mark.

506P General Overall Dimensions Opmaster 506P Manual Issue 6

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Markings and Meanings Opmaster 506P Manual Issue 6

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Markings applied to the Opmaster 506P have the following meanings:-

Attention, consult accompanying documentation

Alternating Current

Power ON/OFF (connection/disconnection from the mains)

Protective Earth (ground)

Earth (ground)

Precautions The antistatic pathway is dependent on the mattresses as originally supplied with the table and should always be replaced with genuine Lab-Med Opmaster mattresses. If an anti-static pathway is required the table should be used on an anti-static floor. Use of a defibrillator should be in accordance with the manufacturer’s instructions and contact with the table during defibrillation MUST be avoided.

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The Opmaster 506P is packed according to destination, United Kingdom Whenever possible, Lab-Med Ltd will deliver throughout the UK using its own transport. Any specified accessories will be packed independently. Please inspect the table, reporting any obvious signs of damage or missing parts to the supplier/dealer and/or carrier as appropriate. Overseas: Depending upon contractor/order conditions, the tables will normally be delivered in a stout case which incorporates a timber pallet base with tri-wall cover and strapping. Any specified accessories will normally be inter-packed with the table and these should be carefully removed before lifting the table from the pallet. To remove the table from the pallet base, first carefully release the coach bolts retaining the timber bracing. Please note that these tables are heavy pieces of capital equipment and care should be taken when lifting. Along with the Opmaster 506P there will be a Power Cord and User Manual. The battery pack will normally be pre-installed and fully charges at the factory prior to delivery. The battery is located on the right hand underside of the back section. Please see page 10 of the manual for further details. Note:

If the table is to be unused or stored for more than 21 days we recommend the battery pack is un-installed.

Please inspect the table, reporting any obvious signs of damage or missing parts to the Lab-Med Ltd immediately. We try to provide a power cord-set of the correct pattern found in your market area. If the plug is not compatible with the socket outlet it will be necessary to obtain an alternative cord set.

Caution:

Before use please clean the table and any accessories supplied in accordance with hospital practise / regulations. Avoid the use of abrasive or corrosive cleaning agents.

Note:

Before use, ensure the battery pack is installed and fully charged.

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Instructions for Use The controls used on the 506P have been designed with simplicity, safety and ease of use in mind. The table top functions are operated from the Handset Controller (with the exception of the foot section). Please familiarise yourself with these controls prior to use. Braking & Steering The braking and steering functions can be actuated from either side of the table via the foot pedals located at the foot end of the table. The steering/brake foot pedal has three functions. Position 1: Position 2: Position 3:

In the ‘horizontal’ position all of the castors are free to swivel and roll. Pushing fully down on the ‘Green’ end of the pedal, directionally locks the castors at the foot end of the table thus increasing control when manoeuvring the table. Pushing fully down on the ‘Red’ end of the pedal all castors locked and braked, preventing swivel and roll.

Pushing and Manoeuvring Pushing the table with or without a patient on it is best done from the head end and with the brake pedal in Position 2 as described above. When the back section is up, there are two convenient grab handles for pushing and manoeuvring, with the table flat, pushing is best achieved with one hand on the cot side rails and the other on the head section. Adjusting the table height to suit will assist with pushing and steering. Caution:

For patient safety, Cot Side Rails should be up when manoeuvring the table.

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Hand Controller Functions Caution:

For patient safety all positional controls should be operated with care and proper patient restraint methods should be employed.

The following functions are controlled via the Hand Control Unit:-

Raise Column

Lower Column

Reverse Trendelenberg

Trendelenberg

Raise Back

Lower Back

Raise Head

Lower Head

SEWARD THACKRAY TM

Innovators in Surgery

Whilst two functions can be operated at once, it is recommended that only one function is operated at a time when a patient is on the table. Pressing and holding the desired function button operates that function continuously until the button is released. Pressing and releasing the function button repeatedly will allow for fine adjustment

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Hand Controller Functions (cont) There is a LED indicator on the top left hand side of the hand controller which indicates the condition of the battery when a function button is pressed, the LED lights up as follows; ‘Lights Green’

Battery charge level full

‘Flashes Green’

Battery charging.

‘Lights Orange’

Battery charge level is getting low. Completion of full movement of actuator possible

‘Flashes Orange’

Battery charge is very weak, recharge required.

When the LED lights or flashes ‘Orange’ an acoustic signal also sounds. Safety Note:

In the event of a table malfunction emergency the table can be stopped by disengaging the battery.

Safety Note:

In the event of a battery failure emergency the table can be operated from the mains supply. Care should be taken however to avoid the trailing cord set

Head Section The Head Section has an additional levelling / articulation feature giving greater scope for patient position, stability and comfort. This feature is controlled manually by releasing the Clamping Lever whilst holding the head section and adjusting to suit before re-tightening. Note: Once clamped, the handle of the Clamping Lever can be repositioned without loosening by pulling out and rotating

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Trendelenberg There is a simple “table level” indicator situated on the right hand side of the table to indicate when the Trendelenberg position is set level. Caution:

Do not operate the Trendelenberg with the table at its lowest height setting and with Gas Bottle in –situ.

Foot Section The foot section is manually adjusted. Adjusting the foot section is best done whilst standing at the foot end of the table. Actuate the control lever situated under the foot section using both hands from either side of the table by holding the foot section and squeezing the control lever towards it allows actuation and adjustment in one motion. Releasing the lever locks the foot section in the desired position.

The Foot Section is detachable from the table. This is achieved by pulling out and turning the spring-loaded knobs located on either side of the table adjacent to the Foot Section pivot, then pulling the Foot Section away from the table. Re-instatement is the reverse procedure. Caution:

Ensure that the spring-loaded knobs are re-engaged before using the table

Cot Side Rails The 506P table is equipped with detachable Cot Sides for patient safety. To gain patient access slide the ‘Cot Side Latch Knob’ towards the head end of the table which releases the Cot Side allowing it to swing outward and down. Lifting the Cot Side upward and pushing it upright should automatically re-engage the latch. Please ensure it has done so before letting go of the Cot Side To remove the Cot Side pinch together the two ‘Release Pins’ using thumb and fore finger whilst holding the Cot Side with your other hand. Replace the Cot Side by again pinching the ‘Release Pins’ together and aligning the Cot Side with the support brackets and release the ‘Release Pins’ ensuring that the pivot shafts engage into the support brackets before letting go of the Cot Side.

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Caution:

For patient safety Cot Sides must be in the up position when raising or lowering the table.

Battery Installation and Charging Before using the table the battery unit will need to be installed, if not already done so. The battery docking station is located under the back section of the table. Holding the battery unit with the locking lugs facing upwards, locate them into the docking station and push the battery unit toward the foot end of the table. There will be resistance and a “positive” feel when engaged correctly. Removal is the reverse procedure. The battery is supplied fully charged. Caution:

Before connecting the table or charging unit to a power supply check that the voltage and frequency details shown on the device are compatible with your mains supply. The table should only be connected to protectively earthed mains. In the event of uncertainty a qualified electrician should be consulted.

To charge the battery in-situ, fit the cord-set between the table appliance inlet situated on the left hand side of the back section and the mains socket, and ensure the mains socket is switched on. Operate the power switch which should illuminate indicating that the charger is now in use, charge overnight for at least eight hours to fully recharge. The LED indicator on the top left hand side of the hand controller will indicate the status of battery charging, there is a delay of approximately 5 minutes before the LED lights up as follows; ‘Flashes Green’

Battery charging.

‘Lights Green’

Battery charged.

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To charge the battery using the wall mounted charging unit. Remove the battery from the table and install into the charging unit by locating the locking lugs into the docking station and push the battery unit down. There will be resistance and a “positive” feel when engaged correctly. Removal is the reverse procedure. Note: A wall-mounted charging unit, accessory part no. TA63/000, allows for additional battery units to be re-charged and on stand-by. Routine Cleaning The 506P table should be cleaned regularly in accordance with normal hospital practice, usually after each operating session. It is recommended that the mattresses are removed from the table and cleaned separately, whilst checking for signs of damage or splits. Damaged mattresses should be replaced as soon as possible. The mattresses are retained by Velcro. Cleaning the table may be easier with the back section elevated and the table at its maximum height. Avoid the use of abrasive or corrosive cleaning agents which may damage the surface finish of the table. Warning:

Do NOT hose or pressure wash the 506P Opmaster.

Routine Maintenance We recommend that the table is inspected monthly as a preventive procedure inspecting for signs of damage, wear, malfunction and the security of all fastenings and any required attention or replacement of component parts is carried out at the earliest possible opportunity to reduce the risk of damage or failure. Particularly attention should be paid to the hand controller, checking for signs of damage to the keypad cause by long finger nails or damage caused by being dropped. The keypad buttons should be checked for their ‘tactile’ feel, they should offer some resistance with a ‘clicking’ feel when depressed. If there are any signs of softness in the buttons it would indicate the need to replace the hand controller. Warranty Policy The Opmaster 506P table is protected by a 12 month warranty (extended warranties are available) covering faulty workmanship and materials. In the event of a fault developing within this period, contact Lab-Med Ltd, Unit 4 Brunel Business Court, Brunel Way, Thetford, Norfolk, IP24 1HP Tel. 01842 762513, Fax. 01842 753927, Email. [email protected] Providing the warranty claim is valid, replacement parts will be issued or repairs carried out free of charge. At Lab-Med Ltd’s discretion, we may forward replacement parts without charge prior to receipt of warranted material providing such parts are fitted by trained, competent technicians or other authorised personnel. The defective items must, in this instance, be returned.

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LAB-MED LTD IS UNABLE TO ACCEPT ANY LIABILITY IMPLIED OR OTHERWISE FOR THE INCORRECT FITMENT OF SUCH PARTS OR COSTS INCURRED IN THE FITMENT OF ANY REPLACEMENT PARTS FITTED BY THIRD PARTIES. It is important that the routine checks above are carried out at regular intervals and the necessary corrective action taken to rectify any malfunction. The warranty is rendered invalid if this is not adhered to. Servicing Service and maintenance should only be carried out by suitably qualified, competent and authorised personnel who are fully conversant with this type of equipment. Prior to commencing work it is recommended that this manual is studied completely. LAB-MED LTD ACCEPT NO RESPONSIBILITY IMPLIED OR OTHERWISE FOR ANY DAMAGE, LOSS OR INJURY AS THE RESULT OF INCORRECT USE, MAINTENANCE OR INTERPRETATION OF THESE INSTRUCTIONS. Servicing Procedures The following procedures are intended for guidance only and are dependent upon tools and facilities available. Variations and alternative methods are equally valid provided they follow good engineering practice. Structural parts and fabricated assemblies, in our experience, very rarely require servicing and therefore have not been included in these procedures. Castor Removal and Replacement Ensure the foot pedal is in the neutral position. Support the table appropriately so that the castors are a minimum of 125 mm above ground level to allow the castor stem to be fully extracted. The brake pedals are usually at the head end of the table. The pedal adjacent to the castor to be change should be removed. Glass reinforced plastic pedals are removed by undoing the securing bolt clamping the pedal to the shaft and the metal pedals by using a suitable pin punch to drive the securing pin out. The pedal can then be pulled off of the hexagonal shaft. (Where the brake pedal is one piece cross bar it is necessary to release both brake levers and retaining collars from both sides of the base.) Carefully remove the black plastic inserts from the end of the base frame which allows access to the link lever and loosen the retaining grub screws. From the side of the table use a suitable drift to tap the hexagonal bar inwards until it is free from the castor stem. Take care not to disengage the link lever. Undo the two screws above the castor and gently slide it from the frame. Replacement is the reverse procedure however, care should be taken to ensure that the hexagonal link bar and the castor being fitted are both in the correct orientation in relation to the other castors and the steering/brake foot pedals. Also ensure new securing pins are used when reassembling.

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Actuator Removal and Replacement Ensure that the table is disconnected the mains power supply. Remove the back cover to gain access to the control box. Un-plug the appropriate cable from its port (a special tool may be required) and pull the cable clear. Support the table section from which the actuator is to be removed. Undo the shoulder bolt or remove the circlip and pin at either of the actuator end using a suitable drift. (plugged access holes provided were necessary to allow access). Telescopic Column Removal and Replacement Three people are required to perform this task safely. Ensure that the table is disconnected the mains power supply. Remove the back cover to gain access to the control box. Disconnect the cables from Ports 1 & 2(a special tool may be required) pull these cables clear so that table top can be removed when ready. Remove the trunk section mattress and trunk section plate. With two people holding the table top, undo the four screws securing the main pivot frame to the telescopic column. Lift the table top clear ensuring the leads previously disconnected are feed through the main frame. Store the table top safely. Support the table base on suitable blocks to give access underneath the frame. Undo the four screws and lift the telescopic column clear. Replacement is the reverse procedure. Ensure that the cables to Ports 1 & 2 are properly reconnected before replacing the back cover. Caution:

The table top is heavy and will require at least two people to lift it.

Foot Section Gas Spring Removal and Replacement To remove a gas spring, slacken the lock nut at the clevis end, remove the shoulder screw or pivot pin at the trunnion end and then unscrew the gas spring from the clevis mounting. To replace, fit the rubber damper on to the new gas spring and fit the lock nut. Screw the gas spring into the clevis until there is 0.5mm - 1.0mm of float on the control lever, i.e. the lever moves slightly with no effect. Tighten the locknut to retain the adjustment. The gas spring can now be rotated to enable the shoulder screw to be fitted at the trunnion end. Note: Lab-Med Ltd recommends that gas springs are always replaced as a matching pair.

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Control Unit / Battery Station Removal and Replacement The control unit / battery station is a non-serviceable item and will need replacing in the event of a fault as follows. Ensure that the table is disconnected the mains power supply. Raise the back section under battery power; remove the battery and the back cover to gain access. Noting the plug /port positions as necessary, disconnect all cables from all ports (a special tool may be required). Remove the back section mattress and undo the screws holding the control unit or battery station in place. Replacement is the reverse procedure; ensure all connections are sound before refitting the back cover. Primary Fuses The primary fuses can only be replaced with the aid of a screw driver, as they are not considered replaceable by the operator. In the event of a fuse failure it is recommend that the equipment and mains supply is checked by a qualified electrician. Warning:

Ensure that fuses are replaced with fuses of the same rating and specification.

Wiring Diagram

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Common Replacement Parts The list below is restricted to the items that may possibly require replacement within the table’s operation lifetime. However a comprehensive parts list is available upon request from Lab-Med Ltd Technical Service Department. Item 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

Part No. B-M001307 B-M001299 B-M001300 B-M001301 B-M001304 B-E001303 B-E001305 C/3/1988 C/2/1989 C/2/1990 C/2/1991 C/1/1605 C/1/1605/A B-M000336 B-M000335 B-M000336 B-M000345 B-M001277 B-E000040

Description Hand Controller Lift Column Trendelenberg Actuator Back Actuator Head Actuator Control Unit Battery Mattress Rubens Head Mattress Back Mattress Trunk Mattress Foot Cot Side Rail (RH) Cot Side Rail (LH) Castor (Directional Lock) Castor (Free Swivel) Castor (Directional Lock) Brake Pedal (Double Lever) Gas Spring (Foot Section) Primary Fuses.

Maintenance Service Contract Options Lab-Med Ltd can provide maintenance services for your Opmaster table(s) and offer three service options   

Annual service contract – One scheduled visit Annual service contract – Two scheduled visits Annual service contract – Fully comprehensive

Standard Contracts are for a period of 12 months. Longer Contracts are available for periods of 24, 36, 48 & 60 months and these do provide financial savings over standard 12 month contracts. Long term contracts can be charged in full or annually in advance. If you would like a Maintenance Service Contract quotation or require any further information please do not hesitate to contact us at; Lab-Med Ltd, Unit 4 Brunel Business Court, Brunel Way, Thetford, Norfolk, IP24 1HP Tel. 01842 762513, Fax. 01842 753927, Email. [email protected]

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Accessories Compatible Accessories for the Opmaster 506P. TA02/000 TA03/000 TA04/000 TA05/000 TA06/000 TA06/001 TA07/000 TA13/000 TA15/000 TA17/000 TA17/001 TA23/000 TA24/000 TA45/000 TA46/000 TA56/000 TA57/000 TA61/000 TA62/000

Anaesthetic Screen Support Arm Table Standard Arm Table Square Arm Table Multi-position Rotary Clamp UK Rotary Clamp EU Standard Clamp UK/EU I/V Pole Knee Crutch Lithotomy Set Lithotomy Pole Set 16mm Dia Lithotomy Pole Set 19mm Dia Shoulder Rest Set 508 Vein Board Perspex Arm Restraint ‘L’ Shape 8” c/w Gel Pad (Pair) Perspex Arm Restraint ‘J’ Shape 8” c/w Gel Pad (Pair) Standard Head Attachment Oxygen Delivery System Cot Side Covers (Pair) Neck/Back Mattress Wedge

Accessory Safety      

As with all accessories, please ensure correct fitment and, where necessary, that all fixings are properly located and securely tightened. Ensure that all side bar clamps are correctly located onto table side bars and that accessory poles are correctly positioned with a minimum of 1/2” (12mm) protruding from the bottom of the clamp. Check that clamps are securely tightened before use. Please be aware that it is possible to adjust handles with coloured buttons to achieve optimum position once tightened. Ensure that all spring-plungers and pins are fully located prior to accessory use. If mattresses have been removed for cleaning, check that they have been replaced correctly onto the Velcro fixing pads. When using the Opmaster Oxygen Cylinder Mounting System (suitable for cylinder sizes PD, SD, AD6, D and E), ensure that locking screws are sufficiently tightened to prevent bracket movement (see below).

Note: Lab-Med Ltd accepts no responsibly for personal injury or damage to equipment caused by the incorrect use of accessory equipment.

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Certificate of Origin and Declaration of Conformity According to Medical Device Directive 93/42/EEC BS EN ISO 9001 2000 ISO 13485 2003 Equipment Type

505, 508 and 506P Opmaster operating table

Brand names or trademarks

Lab-Med Ltd OPMASTER®

Designation/ Model

0505/***, 0508/*** AND 506P/***

Manufacturers contact details Registered Office; Lab-Med Ltd Unit 4 Brunel Business Court Brunel Way Thetford Norfolk IP24 1HP Tel ++44 (0)1842 762 513 Fax ++44 (0)1842 753 927 E- Mail [email protected] Certificate of Origin The equipment is manufactured by Lab-Med Ltd in the EU from materials produced to the required specification for use in surgical equipment. Conformity Documentation With the Directives/Standards above relates to the following reference documents; Product Classification Class 1 medical device As the manufacturer established in the EEC we declare under our sole responsibility that the equipment follows the provisions of the Directives as Stated above and therefore carries the CE mark. Authorised person

Date: 8th August 2005

Signature: Name: Position:

Keith Garner. Company Director

‘OPMASTER’ is a registered name and trademark of Lab-Med Ltd

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