autotilt delta Operating and Maintenance Manual Rev8 (109-004 Iss 6)

Contents Introduction ... 6 Explanation of symbols and abbreviations ... 6 Health and Safety Information ... 7 Electrical Risk ... 7 Contamination Risk ... 7 Explosion Risk ... 7 Weight Limit ... 7 Injury Risk ... 7 Electromagnetic Interference ... 7 Accessories... 7 Purpose and Planning Information ... 8 Operating Information ... 8 General Operating Information ... 8 Operating Instructions ... 9 Treatment of Malfunctions... 10 Specification Autotilt Delta and Delta Plus ... 11 Specification Autotilt XTRA ... 11 Handling, Installation, Storage and Transit Information ... 12 Unpacking and Storage ... 12 Transit ... 12 Installation ... 12 Maintenance Instructions and Schedules ... 13 Maintenance Schedule... 13 Maintenance Instructions ... 13 Cleaning and Decontamination... 14 Cleaning ... 14 Decontamination ... 14 Resistance to stains and chemicals ... 14 Parts Lists ... 15 Modification Instructions ... 15 Disposal Instructions ... 15 Advice and Assistance ... 16

Introduction Explanation of symbols and abbreviations Symbols found on the equipment Caution – Consult accompanying documents

Electrical equipment EN 60601-1 Classification class 2 Type B

This device conforms to the requirements of the European Medical Device Directive 93/42/EEC and has been classified by the manufacturer as a Class 1 device.

IP54

IEC 60529 - Degree of protection of enclosures against dust and water: Protected against dust (limited ingress – no harmful deposit). Protected against water sprayed from all directions (limited ingress permitted). Maximum load evenly distributed.

Symbols used in this Manual Note

Inspection

Warning, Prohibition

Maintenance Action Assistance

Risk of Electrocution

Health and Safety Information Electrical Risk This equipment is supplied with mains voltage. Electrical components are double insulated and no earth connection is made to the metalwork. Do not attempt to open any electrical component. If any damage to cables or connections is discovered, disconnect from mains power at the wall socket. DO NOT continue to use the equipment. Maintenance operations must be carried out by a suitably trained and qualified technician. The electrical plug acts as a disconnect device.

Contamination Risk These instruments are used in a medical environment. In use they may come into contact with chemicals or body fluids. After use ensure that any contamination is removed in accordance with local rules and the section in this manual on decontamination. Always check for contamination before carrying out any maintenance, transporting the equipment to another location or disposing of it.

Explosion Risk Do not use electric couches in the presence of flammable gasses.

Weight Limit Maximum load refer to Specification, distributed evenly. Do not concentrate weight on either side of the couch. Do not allow any person to sit on the footrest. This will cause damage and is not covered by the warranty.

Injury Risk Do not allow any part of the body near moving parts under the top of the couch. Do not allow children to play with the couch at any time. Especially do not allow children anywhere near the couch while it is in motion. Ensure adequate supervision of children in the vicinity of the couch at all times.

Electromagnetic Interference This device may emit or be affected by electromagnetic interference. Do not keep or use close to pacemakers or other sensitive electronic medical equipment. These devices conform to the requirements of Electromagnetic Compatibility standard EN ISO 60601-1-2.

Accessories Use only accessories that have been designed or approved for use with this couch.

Purpose and Planning Information The AUTOTILT range of ultrasound couches is intended for use whilst performing ultrasound examinations on patients. A range of movement is provided to facilitate positioning the patient optimally for the examination being undertaken. These couches are for use ONLY by suitably trained and qualified persons in accordance with any local rules in place.

Operating Information General Operating Information This manual should be read in its entirety before attempting to use the equipment. Particular attention should be paid to the Operating Instructions described in the next section. Ensure that all the instructions in the Installation section of this manual have been carried out prior to using the equipment.

Controls There is a hand control switch to allow the couch to be positioned as required.

Connections There is a mains cable to provide power to the equipment. The mains cable includes a quick-release plug and socket to protect the cable. The hand control is connected to a low voltage electrical control unit.

Operating Instructions Before Use  

Ensure that Installation has been completed in accordance with the instructions contained within this manual. Ensure that all the risks in the Health and Safety Information section of this manual have been considered and accounted for.

Operation Height Adjustment Use this switch to adjust the height

Ensure that the mains lead and hand-switch cable are not tangled around the frame of the couch and fit the mains plug into a suitable mains supply socket. The couch can be raised and lowered to the required height by simply pushing the appropriate buttons on the hand-switch.

Please Note: The controller has a thermal fuse to prevent overheating. Overuse of the height operation will cause the fuse to operate.

Please Note: The mains cable has a quick-release plug and socket. Always ensure that the two-pin plug is firmly inserted into the socket and that the cable is free of obstructions.

WARNING: Do not operate more than one motor at a time. Adjust height, back rest, trendelenburg and foot rest one at a time.

Back Rest, Trendelenburg and Foot Rest Adjustment

Back Rest The back rest is adjusted by using the appropriate switch on the hand control unit. Trendelenburg Tilting The Ultrasound couch can be tilted to a maximum of 20 degrees by using the appropriate switch on the hand control unit. Foot Rest The foot rest is adjusted by using the appropriate switch on the hand control unit.

It is important that the operator keeps a close check on the patient at all times, particularly when any tilting angles are used. DO NOT allow anyone to sit on the foot rest.

Split Backrest (Factory Option) A split backrest is available as a factory option. It provides the facility to raise the head and neck. Always support the head section when adjusting. To lower the head section, support and slightly lift the end, then rotate a locking knob in the direction shown. To raise the head section, lift the end; it will lock in place when released. It may be necessary to rotate a locking knob in the opposite direction to release the head section from the horizontal position.

Treatment of Malfunctions Malfunctions If any malfunction occurs DO NOT continue to use the equipment. Disconnect the couch from the mains supply by removing the plug at the wall socket. Refer to the maintenance section of this manual.

Specification Autotilt Delta and Delta Plus Maximum load Auotilt Delta Autotilt Delta Plus EN 60601-1Classification

Supply Voltage / Frequency Mains Plug Fuse rating Max. Power IEC 60529 protection Hand-switch Actuators: Main Lift Autotilt Delta Main Lift Autotilt Delta Plus Tilt Back rest Foot rest Approx. Dimensions: Back rest Seat section Footsection Narrow Footsection Overall Length Height range Approx. weight:

180 kg / 390 lbs / 28 Stone - evenly distributed 225 kg / 490 lbs / 35 Stone - evenly distributed Class 2 Type B

230 -240V / 50Hz 5A 500W IP54 (Dust and sprayed water protected) Low voltage control 311810+1020014E 343100+3020004A 311710+1005014C 311710+1020014C 311710+1015014C Length Width 90cm 70cm 52cm 70cm 38cm 70cm 38cm 53cm (for use with leg support kit) 184cm 49cm – 96cm 100kg

Specification Autotilt XTRA Maximum load EN 60601-1Classification

250 kg / 551 lbs / 39 Stone - evenly distributed Class 2 Type B

Supply Voltage / Frequency Mains Plug Fuse rating Max. Power IEC 60529 protection Hand-switch Actuators: Main Lift Tilt Back rest Foot rest Approx. Dimensions: Back rest Seat section Footsection Narrow Footsection Overall Length Height range Approx. weight:

230 -240V / 50Hz 5A 750W IP54 (Dust and sprayed water protected) Low voltage control 343100+3020004U 311710+1005014P 311710+1020014P 311710+1015014P Length Width 90cm 90cm 52cm 90cm 40cm 90cm 40cm 70cm (for use with leg support kit) 184cm 52cm – 99cm 130kg

Handling, Installation, Storage and Transit Information Unpacking and Storage Care should be taken when unpacking the couch. DO NOT use scissors or knives, as these could easily tear or split open the upholstery. The operating instructions should be read before moving the equipment to its area of use. Great care must be taken when moving the couch through double doors etc to avoid damaging the upholstered top. Transport, store and use between 10C and 40C and between 30% and 75% relative humidity. For use in normal atmospheric pressures (700 hPa to 1060 hPa).

Transit To move the couch the wheel levers at both ends of the couch must be firmly depressed by foot, which will raise the couch slightly and engage the wheel system (this can be done from either side of the couch). To disengage the wheel system, place foot beneath wheel levers and flick upwards, which will lower the couch onto its four legs. CAUTION: ENSURE THAT THE WHEEL SYSTEM IS DISENGAGED BEFORE USE. The wheel system must NOT be used with a patient on the couch.

Installation Having unpacked the couch and moved it to its area of use, the wheel system should be disengaged so that the couch sits level and firm on the floor. It is at this stage that the adjustable leg must be set for maximum stability. This is done by means of rotating the leg on its screw thread. Once the couch is level and stable, the locking nut should be tightened to lock the leg in position.

Disengage wheels

Adjustable leg

The mains cable includes a quick-release connection to protect the cable. Please ensure that the two-pin plug is firmly inserted in its socket as shown. Ensure that the cable is free and not wrapped around other objects.

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Maintenance Instructions and Schedules Maintenance Schedule It is recommended that the couch is inspected and serviced annually by a suitably qualified person. This service can be provided by the supplier. WARNING: The device contains sealed electrical units and no parts can be repaired or require maintenance (other than normal cleaning etc.) by the user. DO NOT ATTEMPT TO OPEN. Opening will void any guarantee offered by the manufacturer.

Maintenance Instructions Framework

The frame is of steel construction with epoxy powder coating to give a hardwearing and durable finish. Inspection must be carried out to identify any signs of stress, cracks, metal fatigue or other form of impending failure.

Wheels

Clear fluff, dust etc from the axle area and apply a light oil.

Pivot Points

Pivot points can be lubricated if required with a light oil. All nuts and bolts should be checked for security, but care should be taken not to over tighten as this will cause binding. Nyloc nuts are used on all pivot points for added safety.

Upholstery

All upholstered sections are secured to the frame by crosshead wood screws. These should be checked for tightness. The upholstery itself is made of fire retardant vinyl covering high density foam. The vinyl can be cleaned using soap and warm water. Do NOT use alcohol wipes. Care should be taken to protect the vinyl from oil based products (including body oils) as continued contact will cause the vinyl to harden and crack - for further instructions see the section on cleaning and decontamination.

Back/Foot rest

Hinge pins should be checked for security and the ratchet bars should be kept clean and secure.

Electrical Safety

The couch must be PAT tested according to the requirements for class 2 devices. Visual inspection should include the mains cable and hand-switch cable and the mains plug should be opened and connections inspected. Any part showing signs of damage or wear must be replaced.

Cleaning and Decontamination WARNING:  

  

Do not use Alkalis or other Organic Solvents for routine cleaning. Do not use Chemical bleaching materials, abrasive cleaners, and wax polish or aerosol spray polishes. The use of these substances is likely to be harmful to PVC coated fabrics and repeated use can result in the removal of plasticiser from the PVC compound, which will result in hardening and subsequent cracking of the material’s surface. Replace torn or damaged vinyl immediately. If contamination is known or suspected always decontaminate before use. Always cover vinyl with fresh paper or sheet between patients.

Cleaning The frequency of routine cleaning will depend on application and use. Always wear suitable protective clothing. Disconnect mains supply. Locate the couch in a suitable cleaning area with castors disengaged or wheels locked. 1. Using a clean damp cloth, warm water and soap carefully wipe couch from top to bottom, taking care around electrical components. 2. Wipe couch carefully from top to bottom using a clean damp cloth and clean water. 3. Wipe couch dry with clean paper towels. 4. Pay special attention to any areas that may come into contact with a patient. 5. If disposable wipes are used, they should be water based only. Alcohol will damage the upholstery.

Decontamination Be sure to follow any local rules regarding decontamination 1. Repeat steps 1 to 3 above using a dilute Hypochlorite / warm water mixture (10,000ppm) instead of warm water and soap. 2. Safely discard cleaning / decontamination materials. 3. Wash hands thoroughly. 4. Put couch back into service.

Resistance to stains and chemicals The fabrics are resistant to most mild acids, alkalis and household stains. Some substances such as ball point pen, lipstick, newsprint and food colourings may be absorbed by the vinyl and cause permanent staining. This can be minimised by immediate cleaning with a damp soapy cloth wiped dry with a paper towel.

Parts Lists There are no user serviceable parts and it is recommended that users contact the manufacturer in the event of any difficulty. Please refer to the Advice and Assistance section of this manual.

Modification Instructions Modifications to this manual should be recorded on page 3. Modifications to the equipment are not permitted.

Disposal Instructions When disposing of equipment do so in accordance with any relevant legislation in force at the time. Ensure that there is no contamination present.

A D V I C E A N D A S S I S TA N C E For advice, assistance, maintenance or any other enquiries please contact our office on +44 (0)114 267 0482

Paradigm House, 3 Melbourne Avenue, Broomhill, Sheffield, England, S10 2QJ, U.K. Tel: +44 (0)114 267 0482, Fax: +44 (0)114 266 3944 E-mail: [email protected], Web: www.knightimaging.co.uk A

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