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Installation Manual OKS 1000 Model Number: 0301 0001 Article Number: 0301 7201-E_R00 GENERAL INFORMATION 0301 7201-E_R00 Published by: Integral Medical GmbH Friedrich-Ebert-Straße 10a 32339 Espelkamp Germany Internet: E-Mail: [email protected] The present manual contains information protected by copyright laws and is intended exclusively for customers of Integral Medical GmbH or operators of the equipment described herein. No part of this publication may be reproduced, reprinted or disclosed to third parties without prior permission of Integral Medical GmbH. The original edition of this Installation Manual is the German edition. © 2019 Integral Medical GmbH, Espelkamp II Installation Manual 0301 7201-E_R00 Installation Manual GENERAL INFORMATION III GENERAL INFORMATION 0301 7201-E_R00 INSTALLATION MANUAL OKS 1000 IV Installation Manual 0301 7201-E_R00 GENERAL INFORMATION Table of Contents 1 General information .................................................................................................................... 1 1.1 Used terms .............................................................................................................................. 1 1.2 Regarding the safety instructions............................................................................................ 2 1.2.1 Installation Manual.......................................................................................................... 2 1.2.2 Symbols ........................................................................................................................... 3 1.3 Customer and service support ................................................................................................ 4 1.4 Information Installation Manual ............................................................................................. 4 1.5 Declaration of conformity ....................................................................................................... 4 2 General safety provisions ............................................................................................................ 5 2.1 Principe .................................................................................................................................... 5 2.2 Room installation .................................................................................................................... 5 2.2.1 Explosion protection........................................................................................................ 5 2.2.2 Emergency Stop switch ................................................................................................... 5 2.2.3 Compatibility with other equipment ............................................................................... 5 2.2.4 Complying with statutory national regulations ............................................................... 6 2.3 Responsibilities of the operating agency ................................................................................ 6 2.3.1 Training of personnel ...................................................................................................... 6 2.3.2 Operation ........................................................................................................................ 6 2.3.3 Add-on parts and spare parts .......................................................................................... 6 2.4 Danger due to electrical current ............................................................................................. 7 2.5 Protection of components endangered by electrostatic discharge ........................................ 7 2.6 Limits ....................................................................................................................................... 7 3 Employed staff............................................................................................................................. 8 3.1 Qualifications........................................................................................................................... 8 3.1.1 Authorised operating personnel ..................................................................................... 8 3.1.2 Authorised maintenance personnel ................................................................................ 8 4 Product safety ............................................................................................................................. 9 4.1 Electromagnetic compatibility ................................................................................................ 9 4.2 Classification in accordance with EN 60601-1......................................................................... 9 4.3 EG conformity .......................................................................................................................... 9 5 Technical data............................................................................................................................ 10 5.1 Electrical specifications ......................................................................................................... 10 5.2 Weight ................................................................................................................................... 10 5.3 Environmental conditions ..................................................................................................... 10 5.4 Packing and transport routes ................................................................................................ 10 6 Space planning........................................................................................................................... 11 6.1 Dimensional drawing ............................................................................................................. 11 Installation Manual I GENERAL INFORMATION 6.2 7 0301 7201-E_R00 Floor anchoring (Left-handed version) .................................................................................. 12 Installation ................................................................................................................................. 13 7.1 Equipment construction ........................................................................................................ 13 7.2 Product description ............................................................................................................... 14 7.3 On-site operations ................................................................................................................. 14 7.3.1 Measuring instruments required .................................................................................. 15 7.3.2 Special tools required .................................................................................................... 15 7.4 Unpacking the equipment ..................................................................................................... 15 7.4.1 Installing the table ......................................................................................................... 15 7.4.2 Mount the running rail .................................................................................................. 16 7.4.3 Fastening the table ........................................................................................................ 17 7.4.4 Remove the transport locks .......................................................................................... 19 7.5 7.5.1 7.6 7.6.1 7.7 Installing the Bucky unit (or a detector) ................................................................................ 20 Bucky unit P ................................................................................................................... 20 Installing the tabletop ........................................................................................................... 21 Installation of the tabletop in small rooms ................................................................... 22 Installing the column ............................................................................................................. 23 7.7.1 Put up ............................................................................................................................ 23 7.7.2 Mounting ....................................................................................................................... 24 7.8 7.8.1 Installing the X-ray tube assembly and collimator ................................................................ 27 Standard control arm mount ......................................................................................... 27 7.9 Mains supply.......................................................................................................................... 28 7.10 Weight compensation of the tube support arm ................................................................... 28 7.11 Cables and cladding ............................................................................................................... 28 7.12 Installing the SID scale display............................................................................................... 29 8 Adjustment ................................................................................................................................ 30 8.1 Aligning the column............................................................................................................... 30 8.2 Bracket adjustment of the tube support arm ....................................................................... 31 8.3 Other adjustment options of the tube support arm ............................................................. 32 8.4 Adjusting the vertical SID switch ........................................................................................... 33 8.5 Centring the Bucky unit in the direction transverse to the table .......................................... 33 9 Function testing ......................................................................................................................... 34 9.1 Tools required ....................................................................................................................... 34 9.2 Controls ................................................................................................................................. 34 9.3 Vertical movement and counterbalance adjustment of the tube support arm ................... 34 9.4 Tabletop................................................................................................................................. 34 9.5 SID latch ................................................................................................................................. 34 9.6 Tube support arm .................................................................................................................. 35 9.7 Bucky unit .............................................................................................................................. 35 II Installation Manual 0301 7201-E_R00 GENERAL INFORMATION 9.8 Bucky unit coupling ............................................................................................................... 35 9.9 Rotating the tube .................................................................................................................. 35 9.10 Report of funktional testing .................................................................................................. 36 10 Circuits diagrams ....................................................................................................................... 37 10.1 Circuit diagram of the table................................................................................................... 37 10.2 Circuits diagram of the column ............................................................................................. 38 10.3 Component designation for the circuit diagrams ................................................................. 39 11 Maintenance.............................................................................................................................. 41 11.1 Preliminary work ................................................................................................................... 41 11.1.1 Resources / Tools.......................................................................................................... 41 11.1.2 Preparation .................................................................................................................... 41 11.2 Table ...................................................................................................................................... 42 11.2.1 Floor anchor .................................................................................................................. 42 11.2.2 Bucky unit ...................................................................................................................... 42 11.2.3 Table frame.................................................................................................................... 43 11.2.4 Tabletop......................................................................................................................... 43 11.2.5 Foot switch .................................................................................................................... 44 11.3 Column .................................................................................................................................. 44 11.3.1 Vertical carriage............................................................................................................. 44 11.3.2 Supproting ropes ........................................................................................................... 45 11.3.3 Replacing the supporting ropes..................................................................................... 45 11.3.4 Vertical brake ................................................................................................................ 48 11.3.5 Column carriage ............................................................................................................ 49 11.3.6 Carriage at the table ...................................................................................................... 50 11.3.7 Horizontal brake ............................................................................................................ 50 11.3.8 Rail system ..................................................................................................................... 50 11.3.9 Cleaning ......................................................................................................................... 51 11.3.10 Completing maintenance .............................................................................................. 51 11.4 12 Maintenance certificate ........................................................................................................ 52 Spare parts................................................................................................................................. 53 12.1 Table ...................................................................................................................................... 53 12.2 Column .................................................................................................................................. 57 12.3 Tube support arm .................................................................................................................. 59 13 Disposal ..................................................................................................................................... 61 14 Labelling equipment identification ........................................................................................... 62 Appendix................................................................................................................................................ 63 Appendix A – Directive 93/42 / EEC regarding medical device Article 12 ................................... 63 Appendix B – Technical Description .................................................................................................... 64 Installation Manual III GENERAL INFORMATION 0301 7201-E_R00 Appendix C – Tighten torques for screw connections ........................................................................ 65 IV Installation Manual 0301 7201-E_R00 GENERAL INFORMATION 1 GENERAL INFORMATION 1.1 USED TERMS The terms used in this Installation Manual have the following meanings: O PERATING A GENCY Operating agency means any natural or legal person who uses the system or on whose behalf the system is used. The operator is responsible for proper installation, particularly the instruction of expert and assembly staff based on this manual, in order to avoid injuries of persons or damages to property during the assembly and operation of the device. O PERATOR Operator are persons who, because of their training, experience and position as well as their knowledge, are able to use the OKS 1000 and have been instructed in its handling. Furthermore, the operator can assess the clinical condition of the patient and recognize and avoid possible dangers. P ATIENT Patients are referred in this manual as persons, on whose duly for justified medical reasons a radiological diagnosis is used. T ECHNICAL S TAFF Technical Staff are employees of the manufacturer who, due to their training or instruction, are entitled to deliver, assemble, transport and dismantle the device. S ERVICE P ARTNER Service partners are companies that have been authorized by the manufacturer Integral Medical GmbH to sell devices and perform their services. Installation Manual 1 GENERAL INFORMATION 0301 7201-E_R00 1.2 REGARDING THE SAFETY INSTRUCTIONS 1.2.1 INSTALLATION MANUAL The following graphic symbols are used in this manual: D ANGER ! Type and source of danger! Texts with this symbol draw attention to a serious accident, injury or life hazard. ⋙ The following text explains the actions you can take to protect yourself from the danger. W ARNING ! Type and source of danger! Texts with this symbol draw attention to an increased risk of accidents or injury. ⋙ The following text explains the actions you can take to protect yourself from the danger. A TTENTION ! Type and source of danger! Texts with this symbol draw attention to the risk of damage to the device, a possible inability to function or functional limitation. ⋙ The following text explains the actions you can take to protect yourself from the danger. ⋙ A CTION S TEP This symbol indicates operational instructions. I NFORMATION Information on best, efficient and disturbance-free operation of the unit. ▪ 2 B ULLET This symbol follows a list. Installation Manual 0301 7201-E_R00 1.2.2 GENERAL INFORMATION SYMBOLS The following symbols are used in the present manual and on the OKS 1000 unit itself: D O NOT PUT LOADS ! This icon indicates parts or areas that should not be subjected to loads. O PERATOR M ANUAL Follow the operator manual! TYPE B APPLIED PART Mark of an applied part Typ B in accordance with IEC 60601-1. CE-M ARKING OF CONFORMITY The described product fulfils the requirements of the European Medical Device Directive 93/42/EEC of June 14, 1993 under annex VII. D ATE OF MANUFACTURE M ANUFACTURER G ROUND TERMINAL Installation Manual 3 GENERAL INFORMATION 0301 7201-E_R00 1.3 CUSTOMER AND SERVICE SUPPORT The products of the Integral Medical GmbH are distributed only throught an authorized dealer network. For questions regrading maintenance and repair, please always contact your authorized dealer first. For add-on components, such as the collimator, Bucky etc. contact the appropriate dealer or your authorized dealer. The OKS 1000 is part of an X-ray system that may only be operated and maintained by persons with the necessary professional qualifications. The operator is responsible for compliance with the regulations that apply to the installation and operation of an X-ray system. This device is a class I medical product according to Council Directive 93/42/EEC of June 14, 1993 ("Medical Device Directive"), annex IX. 1.4 INFORMATION INSTALLATION MANUAL This document describes the safe and efficient use of the application device. If X-ray components are fitted (collimator, etc.), follow the instructions of the respective manufacturer. The graphic representations in this manual are intended to provide a basic understanding and may differ from the actual design. In this manual always the left-hand version of the device is displayed! This documentation is part of the device. Keep the manual always at the place of use. For safe and proper use, read the operator manual and other product-accompanying documents carefully and completely. This can prevent damage to persons or the device due to incorrect operation. Be sure to follow safety instructions and act with care to avoid personal injury and property damage. 1.5 DECLARATION OF CONFORMITY This product fulfills the requirements of Directive 93/42/EWG from 14. June 1993. The respective declaration of conformity is available on request. 4 Installation Manual 0301 7201-E_R00 GENERAL SAFETY PROVISIONS 2 GENERAL SAFETY PROVISIONS 2.1 PRINCIPE No work may be performed on live parts (over 42V). This prohibition is not applicable to measurement and adjustment work. However, special caution needs to be exercised when carrying out such work. If voltage must be switched on for equipment movements according to the installation manual, the system must be de-energised immediately thereafter. For adjustments and checks or tests that need to be carried out with X-ray beams, the radiological protection regulations must be observed and followed, and radiation protection clothing must be worn. The tightening torques for screws connections that are described in Appendix C must be observed and complied with. 2.2 ROOM INSTALLATION The electrical installation of medical rooms in the Federal Republic of Germany must comply with the VDE provision 0107. In all other countries, the national provisions must be followed. The operating agency is obliged to ensure that the equipment is operated only in permissible ambient conditions. ⋙ see Chap. 5.3 Environmental conditions ⋙ see Chap. 6 Space planning 2.2.1 EXPLOSION PROTECTION D ANGER ! Operation in explosion-prone areas! Hazard to life and helth caused by risk of explosion. ⋙ Use only those cleaning agents that do not form flammable gas/air mixtures. ⋙ This equipment is not meant for operation in explosion-prone areas! 2.2.2 EMERGENCY STOP SWITCH The operating agency is obliged to install / mount an Emergency Stop switch and to instruct the personnel in the use of the same. The operation of the device must be disabled with this Emergency Stop switch in the event of hazard. The operating agency must ensure that the Emergency Stop switch is always freely accessible. 2.2.3 COMPATIBILITY WITH OTHER EQUIPMENT If the operating agency wishes to connect the X-ray equipment with other devices, components or assemblies and cannot find information about this in the technical specifications, it must ensure by consulting us as the manufacturer or an expert that the safety of patients and operating personnel is not adversely affected by the intended combination. Installation Manual 5 GENERAL SAFETY PROVISIONS 2.2.4 0301 7201-E_R00 COMPLYING WITH STATUTORY NATIONAL REGULATIONS The operating agency is obliged to comply with all statutory national regulations in the respective country. In Germany, according to the Radiation Protection Act, the following must be available before commissioning: ▪ ▪ ▪ Acceptance test Expert inspection Constancy test (in according with the prescribed intervals of time) Also observe the local occupational safety and accident prevention regulations. 2.3 RESPONSIBILITIES OF THE OPERATING AGENCY 2.3.1 TRAINING OF PERSONNEL In order to use this product properly, the operating and maintenance personnel must be familiar with the Operator Manual, which must be studied prior to commissioning. 2.3.2 OPERATION The operating agency is obliged to keep the equipment in a fault-free and safe condition. This includes: ▪ ▪ Adherence to inspection and maintenance intervals Taking the equipment out of service if it is not in a safe condition. D ANGER ! Operation in an unsafe condition! Risk of radiological exposure and injury to the patient and / or operating personnel. ⋙ Operate the equipment only when it is in a safe and functional condition. 2.3.3 ADD-ON PARTS AND SPARE PARTS The operating agency is obliged to operate the device only with approved attachments. It is strongly recommended to expand or supplement the device only with the components provided for it. In particular, attention must be paid to compliance with the permissible weight and height. ⋙ The maximum weight of the X-ray tube assembly with collimator may be 40 kg. ⋙ The maximum permissible structural height of the Bucky unit is 71mm. D ANGER ! Incorrect or defective spare parts may impair the safety and also lead to damages, malfunctions or total failure. ⋙ Only use original spare parts provided by the manufacturer! 6 Installation Manual 0301 7201-E_R00 GENERAL SAFETY PROVISIONS 2.4 DANGER DUE TO ELECTRICAL CURRENT The X-ray equipment may be operated only in medical facilities that meet the requirements of VDE 0107. Only competent maintenance personnel may remove the covers and claddings of the X-ray equipment. W ARNING ! Electric shock! In order to prevent the RISK of an electric shock, this equipment may only be connected to a POWER SUPPLY SYSTEM with a permanently wired protective earth conductor. W ARNING ! Electric shock! This device does not have any mains switch for switching the unit on and off. ⋙ Only connect the system with the power supply when all covers and claddings are installed. This equipment is operated with electrical power; hence, there is a risk of electrical shock. 2.5 PROTECTION OF COMPONENTS ENDANGERED BY ELECTROSTATIC DISCHARGE The integrated circuits and boards used that are populated with electrical components require particularly careful handling on account of the structures that are highly sensitive to electrostatic discharge and owing to the extremely high input resistance. The means of protection prescribed must be used. ESD – C OMPONENT ENDANGERED BY ELECTROSTATIC DISCHARGE Boards, pins and connectors that are marked with this label should not be touched with the hands or there should be no connection between these connectors without adopting suitable and relevant protective measured with respect to ESD. 2.6 LIMITS ▪ Maximum patient load 320 kg ▪ Maximum weight of the tubes with collimator 40 kg ▪ Structural height of the Bucky unit 71 mm Installation Manual 7 EMPLOYED STAFF 0301 7201-E_R00 3 EMPLOYED STAFF In order to use this product properly and as intended, the operating and maintenance personnel must be familiar with the Operator Manual, which must be studied prior to commissioning. 3.1 QUALIFICATIONS 3.1.1 AUTHORISED OPERATING PERSONNEL The equipment may be used only by those who have the following qualifications: ▪ Specialist medical and radiological knowledge in accordance with the country-specific legislation. For exampel, radiology technicians or personnel with specific additional training have this specialist kowledge. ▪ Induction of authorised personnel for performing examinations with this equipment. This equipment may be cleaned only by those who have the following qualifications: ▪ 3.1.2 Specialist knowledge can, for example, be imparted by induction of authorised personnel into the cleaning of the equipment. AUTHORISED MAINTENANCE PERSONNEL The equipment may be repaired and maintained only by those who have the following qualifications: ▪ ▪ ▪ ▪ 8 Technical knowledge about radiological protection Specialised knowledge in handling electrical systems (For example, electrical technicians or personnel with specific additional training have this specialised knowledge.) Introductory training in the operation, maintenance and repair of the systems by the distributer or the manufacturer Authorisation of the distributer or manufacturer of this equipment to repair or maintain the same Installation Manual 0301 7201-E_R00 PRODUCT SAFETY 4 PRODUCT SAFETY See also in the Operator Manual! 4.1 ELECTROMAGNETIC COMPATIBILITY The unit meets the EMV provision of EN 60601-1-2. A TTENTION ! Medical electrical equipment is subject to special precautionary measures with respect to EMC and must be installed and put into operation in accordance with the EMC instructions given in the documents supplied with the equipment. W ARNING ! Portable and mobile HF communication devices may affect medical electrical equipment. 4.2 CLASSIFICATION IN ACCORDANCE WITH EN 60601-1 The equipment has the protection class 1 for the type of protection against an electric shock and type B for the level of protection. 4.3 EG CONFORMITY This Device meets the basic requirements in accordance with the provision of the Directive 93/42 EEC of the Council for medical products according to Article 11, paragraph 3 and the procedure given in Apendix II. The CE mark is applicable only to the product without the X-ray components. The description includes the final purpose in order to faciliate understanding by the user. Installation Manual 9 TECHNICAL DATA 0301 7201-E_R00 5 TECHNICAL DATA 5.1 ELECTRICAL SPECIFICATIONS Mains connection: Frequency: Rated current: Rated connectd load: 115 / 230 V 50 / 60 Hz 2/1A 230 VA 5.2 WEIGHT Patient positioning unit Stand column Fixed tube support arm Swivel tube support arm Swivel tube support arm with telescopic feature 187 kg 120 kg 20 kg 25 kg 25 kg 5.3 ENVIRONMENTAL CONDITIONS max. working altitude Permissable ambient temperature Permissable relative atmospheric humidity Atmospheric pressure range Operation 2000 m +10°C to +40°C Transport Storage ---20°C to +60°C ---20°C to +60°C 20% to 70% 10% to 90% 10% to 90% 700 hPa to 1060 hPa 500 hPa to 1060 hPa 500 hPa to 1060 hPa Lenght 1,60 m 2,10 m Width 0,75 m 0,91 m Weight 217 kg 2,30 m 0,91 m 2,41 m 0,76 m 5.4 PACKING AND TRANSPORT ROUTES Table pallet Short tabletop cardboard box Long tabletop cardboard box Column pallet Heaviest individual part Minimum door width 10 163 kg 187 kg 0,90 m Installation Manual 0301 7201-E_R00 SPACE PLANNING 6 SPACE PLANNING 6.1 DIMENSIONAL DRAWING Installation Manual 11 SPACE PLANNING 0301 7201-E_R00 6.2 FLOOR ANCHORING (LEFT-HANDED VERSION) 12 Installation Manual 0301 7201-E_R00 INSTALLATION 7 INSTALLATION 7.1 EQUIPMENT CONSTRUCTION (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) Installation Manual Vertical carriage X-ray tube assembly support arm, swivel-type, movable Column stand Rail system for stand column X-ray tube assembly Control arm with protractor Tabletop, floating, manually positionable, scratch-proof Profile rails for holding accessories Table upper frame Bucky unit, movable Table base Foot switch 13 INSTALLATION 0301 7201-E_R00 7.2 PRODUCT DESCRIPTION The OKS 1000 is an application unit for X-ray diagnostics from the head to the foot. For this purpose, it needs to be fitted with the radiation components (tube assembly, collimator, Bucky unit, generator, etc.). Thereafter, images can be captured of the cranium, thorax, pelvis, skeleton and extremities of a patient in the lying or sitting position and in combination with a wall stand on a patient in the standing position. There are basically two variants of the OKS 1000 application unit: ▪ ▪ The left-hand version (standard version, the figures always illustrates in this version) The right-hand version (special version) Both versions consist of a patient table with a floating tabletop, as well as a guided column stand for X-ray tube assemblies or a collimator and a control arm. The left-hand version (standard version) of the OKS 1000 can be recognized by the guide rail projection towards left from the column stand on the rear. ⋙ See also chapter 6.1 Product description in the Operator Manual. 7.3 ON-SITE OPERATIONS The OKS 1000 is supplied as specified in the order either as a left-hand version or a right-hand version. A TTENTION ! The conversion from the right-handed version to the left-handed one may only be carried out only by employees or by persons who have been authorised for this in purpose by the manufacturer. The electrical connection data must match that of the equipment supply voltage. For this device a supply voltage of 115/230 V AC and an appropriate earth connection wire are necessary. Each of the anchor points must be able to withstand a tensile force of 2500 N (concrete quality C20/25 DIN EN 206-1/DIN 1045-2 when using the anchoring material supplied along with the equipment). The anchoring boreholes must be made in the floor at the site in accordance with the dimensional drawing in Chap. 6.2. A TTENTION ! The specified minimun clearance are to be kept in order safeguard all movement possibilities of the system. With PVC or carpeted floors, cut out the flooring around the anchor points of the table base. Place flat shims (installation material / accessories) corresponding to the height of the flooring material at the anchor points of the table base. The connection cable for the Bucky unit and the measuring chamber, must be laid depending on the version at the site according to the installation plan right up to the connection box in the table base or up to the Bucky unit. Check the completeness of the delivery using the accompanying packing list. Check the delivered parts for damage. Store cardboard found on the pallets in a safe place until they are needed for equipment installation. Properly dispose of packaging materials (see also chapter 13). 14 Installation Manual 0301 7201-E_R00 7.3.1 INSTALLATION MEASURING INSTRUMENTS REQUIRED Machine spirit level 7.3.2 SPECIAL TOOLS REQUIRED Hammer drill Masonry drill bit ø12 mm for 120 mm drilling depth 7.4 UNPACKING THE EQUIPMENT The following procedure is recommended for installing this device: Remove the packaging from the table frame, column and tabletop. Dispose it properly! 7.4.1 INSTALLING THE TABLE Loosen both fixing screws of the front cladding (do not remove them). Press the front cladding up and towards the front from inside and remove it by moving it upwards. A TTENTION ! The contacts for the LED lighting are provided with arrows. When connecting, make sure that these arrows are opposite ( ). Loosen all four fastening screws from the table frame on the pallet and drive them out from below. Installation Manual 15 INSTALLATION 7.4.2 0301 7201-E_R00 MOUNT THE RUNNING RAIL The running rail is fixed on a pallet together with the stand column. Remove the packaging of the column pallet. Remove all transport locks and the cardboard box containing the accessories. Remove and unpack the running rail for installation. Let the column stand remain on the pallet until it is to be installed. Mount the running rail at the rear of the table frame. The standard version is illustrated in the figure. For the right-hand version, the rail needs to be placed with an offset to the other side. (1) To simplify the installation of the rail between the tables and pallet, slide equalising sheets (1) (from the cardboard box for accessories, the equalising sheets are somewhat longer on one side.), (raise the table slightly from behind). Mount the rail for the standard version as shown. While doing so, ensure that the angled side of the rail is at the top. Mount the rail using two threaded strips and four fixing screws to the table frame. ATTENTION: For the right-hand version it is necessary to exchange the long stop collar on the right side of the rail with the short one on left side. In addition, reposition the bracket that is pre-mounted on the rail in such a manner that it is located at the centre of the table. Appropriate boreholes are provided for this purpose. 16 Installation Manual 0301 7201-E_R00 7.4.3 INSTALLATION FASTENING THE TABLE Push the table frame from the rear of the pallet, tilt it backwards, pull out the pallet from the front and place the table carefully on the ground. Bring the table frame to the place of installation, push it over the fixing screws (for this purpose, see chapter 6.2 Floor anchoring) or align the equipment at the installation site. Prepare heavy-duty anchors and insert them in the anchor points. The floor anchor holes are the same for the left-handed and right-handed versions. Check the evenness of the table frame in the longitudinal and transverse directions using a spirit level at the locations marked with arrows. Check the evenness of the running rail. If uneven, proceed as follows: Installation Manual 17 INSTALLATION 0301 7201-E_R00 C B A C If the surfaces are not even, bring the table with the running rail to an even position with the help of the levelling screws. Compensate the unevenness of the floor. To do this, push flat shims below the locations at the table and the running rail illustrated with A, B, C and D. The illustrated items have the following numbers: ▪ ▪ ▪ ▪ 0301 5812, ……13, …….14_plate_small 0301 5809, ……10, …….11_plate_medium 0301 5808_L-corner as a shelf for 0301 5801, ……02, …….03_compensating plate 0301 5804, …...05, …….06_plate_big (A) (B) (C) (D) Place the shims on the metallic bracket and push them below the running rail at the locations marked with C. Tighten all screws for the floor anchoring (50Nm). B A C D A TTENTION ! The table frame must not be twisted in any direction. The running rail must not swing. 18 Installation Manual 0301 7201-E_R00 7.4.4 INSTALLATION REMOVE THE TRANSPORT LOCKS Loosen the fastening screws and remove the cladding panel at the rear. Loosen the fastening screws of the transport locks from the Bucky unit and carriages and remove the transport locks. Remove the transport locks from the upper frame. Remove the transport lock of the brake magnets at the upper frame. Installation Manual 19 INSTALLATION 0301 7201-E_R00 7.5 INSTALLING THE BUCKY UNIT (OR A DETECTOR) Bucky units from diffrent manufacturers may be installed. The equipment is prepared according to the order and the required fastener materials are supplied with it. The following procedure is recommended: Insert the Bucky unit (with the cartrige opening towards the front) in the Bucky carriage. (1) 7.5.1 Connect the connection cable and the measuring chamber cable according to the information given by the manufacturer. BUCKY UNIT P Fixture with 2 screws each (1) on the left and right side. 20 Installation Manual 0301 7201-E_R00 INSTALLATION 7.6 INSTALLING THE TABLETOP Follow the procedure below to install the table top and dispose it properly: ⋙ Take the tabletop out of the packaging. ⋙ Detach the end stops on the front side. ⋙ Push the tabletop onto the transverse carriage. (1) When the tabletop is inserted, the brake magents (1) need to be pressed downwards! ⋙ Reinstall the end stops. Take the corrugated cardboard supplied in the packaging for the protection of the tabletop and place it on the tabletop until the installation has been completed! A TTENTION ! Mount the tabletop only after complete adjustment according to this instruction. Installation Manual 21 INSTALLATION 7.6.1 0301 7201-E_R00 INSTALLATION OF THE TABLETOP IN SMALL ROOMS Detach the end stops on both front sides. Detach the two ball bearings located at the front (1). (1) Place the tabletop on the table frame, raise the table tabletop on the operating side by approx. 45° and while doing this, place the rear tabletop profile over the polyamide roll and the ball bearings. Carefully place the tabletop back down. Move the tabletop lengthwise and reinstall the detached ball bearings. Readjust the setting of the eccentric. Reinstall the end stops. Take the corrugated cardboard supplied in the packaging for the protection of the tabletop and place it on the tabletop until the installation has been completed! A TTENTION ! Mount the tabletop only after complete adjustment according to this instruction. 22 Installation Manual 0301 7201-E_R00 INSTALLATION 7.7 INSTALLING THE COLUMN 7.7.1 PUT UP Remove the transport locks (parts are red) from the pallet. Unscrew the X-ray tube assembly support arm from the mounting bracket. It is helpful to position the pallet relative to the table in such a way that it can then be moved directly in the running rail. Place the X-ray tube assembly support arm vertically (only with the swivel-type / transversal support arm). Firmly secure the control arm to the tube bracket with cable ties. Push the column a few centimetres in front of the pallet. Installation Manual 23 INSTALLATION 0301 7201-E_R00 Aligning the column! Use the transport panel at the front end of the column as a point of approach. At least two persons are needed for the installation! 7.7.2 MOUNTING Remove the stopper: (5) (1) (2) (3) ⋙ Remove the stopper (1) ⋙ Remove the sheet metal (2) and the distance bolt (3) ⋙ Remove trip-safety (4) ⋙ Remove cover (5) (4) Now the column can be moved into the running rail. Bring the column into position relative to the table. (In the right-handed version, the column must be placed accordingly on the right side of the table!) (1) Guide the column carefully into the rail at the table. Reposition the column fixture (1) for the righthanded version on the left side. Remount the stopper. The column must be safeguarded against falling down until it has been fixed to the carriage using screw. 24 Installation Manual 0301 7201-E_R00 INSTALLATION Remove the cladding (1) of the column fixture. (1) (2) (4) (3) Remove the fastening screws (2). Turn the centring screw (3) backwards until the end of the screw no longer projects over the flange plate. Move the carriage to the right (to the left for the right-handed version) and bring it in position with the column. Push the installation aid plate (4) under the bearing of the carriage. Turn the centring screw again inwards, and it must move into the centring borehole of the carriage. Fasten the fixing arm of the column at the carriage by tightening the two fastening screws and washer. Installation Manual 25 INSTALLATION 0301 7201-E_R00 Join the connection cable of the table and column according to the circuit diagrams (connector). Screw on the cable holder and clamp the cable so that it is not under tension. Screw the cladding of the fixing arm and while doing so lay out the cable accordingly. Dismount all installations aids (three rollers) and the transport locks. Remove both transport lock brackets, at the front (visible) and at the rear. Remove the two transport lock screws. These two screws are used to secure the X-ray tube assembly support arm. They must be removed prior to installing the X-ray tube assembly and collimator. 26 Installation Manual 0301 7201-E_R00 INSTALLATION 7.8 INSTALLING THE X-RAY TUBE ASSEMBLY AND COLLIMATOR 7.8.1 STANDARD CONTROL ARM MOUNT (1) Fix the control arm mount (1) between the tube and collimator. A TTENTION ! Note the defined distance between the focus and the collimator. This distance can be found in the documentation of the collimator. This distance can be adjusted as needed by using spacer plates. Installation Manual 27 INSTALLATION 0301 7201-E_R00 7.9 MAINS SUPPLY Make the mains connection on the terminal strip at the base of the equipment with on-site cable duct according to the circuit diagram (see chapter 10 Circuit diagrams). See also chapter 6.2. A TTENTION ! The equipment is ready for use as soon as it is connected to the mains supply! 7.10 WEIGHT COMPENSATION OF THE TUBE SUPPORT ARM Place the weights supplied equally at the front and rear. The weight calibration is produced if the force for upward and downward movement of the tube support arm is roughly equal. A TTENTION ! If the counterbalance adjustment is not proper, the tube support arm may move upwards or downwards on its own. This may cause personal injury or damage to property. 7.11 CABLES AND CLADDING Screw on the upper cable holder and clamp the cable so that it is not under tension. The three other boreholes are meant for laying the HV cables. Fix all other cladding panels of the column using the screws provided. 28 Installation Manual 0301 7201-E_R00 INSTALLATION Screw all panels of the column in the following order: ▪ The lower short centre cladding ▪ The upper short centre cladding ▪ Headpiece Fix the cladding panel of the table at the rear using the screws provided. 7.12 INSTALLING THE SID SCALE DISPLAY ▪ Adjust the SID clearance by moving the vertical carriage (measure the distance between the tube focus and the cartridge or the detector). ▪ Fix the scale on the column using adhesive. The lower edge of the vertical housing must match the scale value of the distance measured. Do not fix the scale with adhesive to the centre cladding. Installation Manual 29 ADJUSTMENT 0301 7201-E_R00 8 ADJUSTMENT 8.1 ALIGNING THE COLUMN Align the column in both vertical directions using the spirit level. (1) If needed, loosen the four fixing screws (1) on the arm and retighten them. With the eccentrics in the column carriage, the alignment of the column can be readjusted. 30 Installation Manual 0301 7201-E_R00 ADJUSTMENT 8.2 BRACKET ADJUSTMENT OF THE TUBE SUPPORT ARM Remove the tabletop (see also chapter 11.1.2). Loosen the mounting screws of the cable holder and remove the cable holder. Loosen the mounting screws of both half-shells of the arm cladding and remove the half-shell. Loosen the screw fastening of the side cover, and take off the cover. Bring it to the right SID distance. Carefully adjust the eccentric screw with an open-end spanner (1) and align it with respect to the centre of the carriage panel. Retighten the mounting screw of the eccentric and install the cladding panels in reverse sequence. 1 Installation Manual Retract the tabletop again (see chapter 7.6). 31 ADJUSTMENT 0301 7201-E_R00 Using a ball head pin wrench loosen the fastening screws 2 slightly. 2 1 Adjust the tilt of the tube support arm using the adjusting screws 1. To check the setting, move the tube vertically. Turn and retighten the fastening screws 2. 1 2 8.3 OTHER ADJUSTMENT OPTIONS OF THE TUBE SUPPORT ARM Adjust the support arm in the transverse direction with the 4 screws (1) (two each opposite one another) so that the cartridge is illuminated properly at the SID height. Move the support arm vertically again and check whether the light field remains aligned on the cartridge and readjust it, if necessary. (1) Remove claddings of the vertical carriage. Using the 4 threaded pins (1) on both sides of the flange plate the light field can be readjusted to a wall stand. 32 Installation Manual 0301 7201-E_R00 ADJUSTMENT 8.4 ADJUSTING THE VERTICAL SID SWITCH For easier detection or recognition of the SID, a micro-switch is optionally installed or may be retrofitted. If the micro-switch reaches the switch cam during the vertical movement of the tube support arm, the lamp in the collimator lights up. This means the SID has been achieved. If the lamp in the collimator goes off, the SID is no longer satisfied. On retrofitting (or upgrading) Unscrew the cladding panels of the column (headpiece, long and short cladding panels) and of the tube support arm. Screw on the switch cam and the micro-switch. Connect the contacts of the micro-switch with pre-wired plug of the tube support arm. To adjust the SID, the micro-switch as well as the switch cam can be adjusted within their slots. After checking the SID, screw all claddings panels back on. 8.5 CENTRING THE BUCKY UNIT IN THE DIRECTION TRANSVERSE TO THE TABLE The Bucky unit can be centred in the transverse direction of the table: Loosen the top screws on the fastening clips. Move the Bucky unit in the required offset direction. Installation Manual 33 FUNCTION TESTING 0301 7201-E_R00 9 FUNCTION TESTING Perform a functional check before commisioning and after maintenance work. We recommend that a report of the function testing be compiled. Use the table given at the end of the chapter as a template for the report. 9.1 TOOLS REQUIRED ▪ ▪ ▪ Spring balance Spring balance Tape measure 1N – 100N 100N – 300N 9.2 CONTROLS Testing all buttons on the control arm and foot switch at the table. See chapter “Control Elements” in the Operator Manual. All buttons must work as described in the manual. 9.3 VERTICAL MOVEMENT AND COUNTERBALANCE ADJUSTMENT OF THE TUBE SUPPORT ARM Release the brake and move the tube support arm across the entire range of movement. For this purpose, move the column completely to the left or to the right in case of the right-handed version. It should be possible to move the vertical carriage across the entire range of movement with uniform and equal force. It should essentially be the same in both directions and be less than 30 N for both directions. With the brake released, the counterbalance of the tube support arm must be adjusted. Fix the brake and then obtain the retaining or holding force of the brake. This must be greater than 150 N. W ARNING ! Difficult move and scraping or grinding noices! The equipment must be put out of service immediatelly! There may be a rope break. ⋙ Notify your service department. ⋙ Try to avoid all kinds of severe impact and vibrations. 9.4 TABLETOP Test the movement of the floating tabletop: Release the brake. It must be possible to position the tabletop as desired comfortably and easily. Fix the brake. Now, it should be possible to move the tabletop only with great exertion of force. Reference value: >300N ± 50N 9.5 SID LATCH Move the vertical carriage over the latching cam of the SID switch. The switch must get operated properly at a height of 115 cm above the film. 34 Installation Manual 0301 7201-E_R00 FUNCTION TESTING 9.6 TUBE SUPPORT ARM Unlock the latching lever and rotate the arm by +90° und -90° respectively. The latch must engage every 90° on its own automatically. Release the brake for the transverse movement of the support arm. The latch for the transverse movement should be adjusted in such a manner that 70N - 80N are required to release the latch. Transverse movement beyond the latch should be smooth and easy (10N – 15N). 9.7 BUCKY UNIT Move the Bucky unit over the entire range of its movement. Check for easy of movement and smooth running. Check the brakes. 9.8 BUCKY UNIT COUPLING Move the column over the entire range of movements. The Bucky unit should be moved automatically in the region between the bolts and should get decoupled at each of the bolts. 9.9 ROTATING THE TUBE Does the tube get latched easily and comfortably every 45°? Check whether the unlocking or unlatching force is reasonable (without braking ≥40N). The tube should remain latched even if the brake is released. Installation Manual 35 FUNCTION TESTING 0301 7201-E_R00 9.10 REPORT OF FUNKTIONAL TESTING Controls Column brake button Vertical movement button Button for horizontal and vertical movement Is working properly? yes [ ] / no [ ] Button for rotating the tube Is working properly? yes [ ] / no [ ] Button for transverse movement of the tube Foot switch Vertical movement of the Brake released column Brake active Horizontal movement of Brake released the column Floating tabletop Brake active Brake released Brake active SID latching Switch contact Bucky unit SID Moving distance Brakes active Tube support arm Swivel movement Transverse movement Bucky unit coupling Rotating the tube Is working properly? yes [ ] / no [ ] Is working properly? yes [ ] / no [ ] Brake released Is working properly? yes [ ] / no [ ] Is working properly? yes [ ] / no [ ] Is the force required for movement uniform? yes [ ] / no [ ] Upward movement: Downward movement: N N Holding force of the brake: N Is the force required for movement uniform? yes [ ] / no [ ] Force required for movement: Holding force of the brake: Can it be positioned easily? yes [ ] / no [ ] Tabletop arrested? yes [ ] / no [ ] Is the switch operated? yes [ ] / no [ ] Fokus-Film-Abstand: cm N N Is the force required for movement uniform? yes [ ] / no [ ] Holding force of the brake yes [ ] / no [ ] Is it latching properly? yes [ ] / no [ ] Transverse latching Force required for latching: Transverse movement: Force required for moving: Is working properly? yes [ ] / no [ ] Is it latching properly? yes [ ] / no [ ] Latching moment: N N Nm Serial number: Function testing carried out by: _____________________ from the company: ___________ 36 Installation Manual 0301 7201-E_R00 CIRCUITS DIAGRAMS 10 CIRCUITS DIAGRAMS 10.1 CIRCUIT DIAGRAM OF THE TABLE Installation Manual 37 CIRCUITS DIAGRAMS 0301 7201-E_R00 10.2 CIRCUITS DIAGRAM OF THE COLUMN 38 Installation Manual 0301 7201-E_R00 CIRCUITS DIAGRAMS 10.3 COMPONENT DESIGNATION FOR THE CIRCUIT DIAGRAMS Unit part =AA function comment Fixed Bucky-Table =AA =AA =AA =AA -F1 -F2 -F3 -F4 fuse fuse fuse fuse =AA -PE1 main ground-stud table =AA =AA =AA -S1 -S2 -S3 footpedal to release tabletop brake footpedal for collimator light switch release bucky-brake =AA =AA =AA -N1 -N2 LED1 power adapter I power adapter II RF Controller LED-light =AA -X1 terminal-block =AA =AA =AA =AA =AA =AA -X3 -X4 -X5 -X6 -X7 -X8 connector tabletop-brake connector foot-pedal connector column connector connector bucky-brake terminal-block table brake =AA =AA =AA =AA =AA =AA -Y1 -Y2 -Y3 -Y4 -Y5 -D1 D3 D5 brake tabletop longitudinal brake tabletop longitudinal brake tabletop transversal brake tabletop transversal brake bucky diode brake Installation Manual T1,6 A ~ 230 V / T3,2 A ~ 115 V T3,15 A T3,15 A T3,15 A actuated in neutral position actuated in neutral position (for collimator) UMNL 09 pole UMNL 06 pole UMNL 12 pole UMNL 09 pole UMNL 12 pole 39 CIRCUITS DIAGRAMS unit part 0301 7201-E_R00 function =AB column =AB control handle =AB -S1 switch SID vertical =AB =AB =AB =AB =AB =AB =AB -S3 -S4 -S5 -S6 -S7 -S8 -S9 switch Bucky unit coupled switch release tube-rotation brake switch release horizontal brake switch release horizontal and vertical switch release horizontal and vertical switch release vertical brake switch release transversal brake (optional) =AB =AB =AB -X1 -X2 -X3 terminal-block control handle terminal-block brake vertical terminal-block tube-rotation =AB =AB =AB =AB -X5 -X6 -X7 -X8 terminal-block horizontal brake connector column - table connector horizontal brake terminal-block control box =AB =AB =AB =AB -Y1 -Y2 -Y3 -Y4 brake vertical brake horizontal brake rotation brake transversal =AB =AB =AB =AB -D1 -D2 -D3 -D4 diode brake diode brake diode brake diode brake 40 comment 1-2 connection Collimator 3-4,5 power supply 6-11 brakes 12 reserve Installation Manual 0301 7201-E_R00 MAINTENANCE 11 MAINTENANCE Maintenance described below is to be performed after every 12 months. If functions are to be checked with the power on during maintenance, the equipment should be disconnected from the mains supply again immediately after the particular work step is finished. Failed components may only be replaced by original parts that are listed in the spare parts list enclosed. Only acid-free greases may be used for maintenance, and do not grease or oil ball bearings with sealing shim. 11.1 PRELIMINARY WORK ▪ ▪ ▪ ▪ ▪ Check the equipment for damage and missing parts. Check ensure all cables are in proper condition and not damaged, especially at the anchor points; replace them if necessary or, if possible, repair them after consulting with the customer. Check to ensure that cable loops are of sufficient lenght. Check the all claddings and covers. ⋙ If necessary, replace damage parts or arrange for their replacement. Check the travel range of the equipment movements for objects that may be in the way. If there is a risk of collison, point out the danger to the operator. 11.1.1 RESOURCES / TOOLS Customary installation tools: ▪ ▪ ▪ ▪ ▪ ▪ ▪ Ladder Torque wrench Spirit level Spring scale (100 N und 300 N) Thickness gauge Cleaning agents Lubricants 11.1.2 PREPARATION ▪ ▪ Switch off the system. Dismount the tabletop. ⋙ Dismantle the end stop and end piece at one of the front ends of the tabletop from the side guide rails. ⋙ Remove the tabletop. Place it carefully and safety. Installation Manual 41 MAINTENANCE 0301 7201-E_R00 11.2 TABLE Loosen both fixing screws of the front cladding (do not remove them). Press the front cladding up and towards the front from inside and remove it by moving it upwards. A TTENTION ! The contacts for the LED lighting are provided with arrows. When connecting, make sure that these arrows are opposite ( ). 11.2.1 FLOOR ANCHOR Check the anchor bolts are fitted tightly, and tighten them if necessary (Torque 50 Nm). 11.2.2 BUCKY UNIT Check the easy of movement over the entire range of travel. If you hear some running noise replace any item that is damaged. Clean running rails and ball bearings and grease the running rails lightly. Check the play. Reposition eccentric bearings (1) as needed. Correct setting: The ball bearings can just be turned by hand. (1) Check end stop (2) for tight fit and integrity. Switch on the system and check if it is necessary to adjust the brakes. Switch off the equipment. (2) 42 Installation Manual 0301 7201-E_R00 MAINTENANCE 11.2.3 TABLE FRAME (1) Clean the guide shaft on the left and right sides (1) and grease it slightly. (2) Switch on the system. Check the function of the transverse brakes (2) (retaining or holding force at least 250N). Adjust as needed. (4) (3) (5) To do this, loosen the locknut (4) and adjust the braking force at the threaded pin (5). Check that the end stops are unscathed on both sides (3) and are fitted firmly. Reinstall the left and right cover on both sides. 11.2.4 TABLETOP Check the plastic castors (1) for wear and replace them if necessary. (1) (1) Clean all ball bearings and check that they move easily and are unscathed. If required, replace them and grease the running surface of the rails slightly. Clean the guide profiles of the tabletop. Push the tabletop inside. (2) Switch on the system and check the longitudinal brake (2) Replace the brake magnet if necessary. Switch off the equipment. (1) (2) Loosen Allen setscrew (1) and adjust the braking force with the help of the hex screw (2) at the bottom side of the brake magnet (it can be reached through the borehole at the bottom of the frame). Lock it with the Allen setscrew (1). Repeat the adjustment at the second brake magnet. Installation Manual 43 MAINTENANCE 0301 7201-E_R00 (1) Move the tabletop over the entire range of its travel. Running noise? Easy of movement? Readjust the eccentric bearing if necessary. Reinstall the end stop and the end piece at one side of the tabletop in the side guide rails (see chapter 7.6). 11.2.5 FOOT SWITCH Check the easy movement and the switching point. If required, adjust the switch. Check the cable connections of the switches. 11.3 COLUMN 11.3.1 VERTICAL CARRIAGE Remove the cladding panels of the column and the vertical carriage. Clean the guide rails of the column and the casters of the vertical carriage, and check that they are unscathed and grease them slightly. Check the entire range of travel for easy of movement. Running noise? Identify and, if necessary, replace any defective bearings. 44 Installation Manual 0301 7201-E_R00 MAINTENANCE 11.3.2 SUPPROTING ROPES ▪ ▪ ▪ The steel ropes must be inspected at least once each year by the service team. To do this, move the vertical carriage al the way down and remove the centre caldding. Clean both steel ropes (do no use any grease-dissolving agents) and check to ensure they are unscathed. To do this, run through the entire range of travel and wipe off the steel rope with a wool cloth or swab. A defective rope can thus easily be detected if deposits of the woll cloth or wadding get stuck on the cable. A TTENTION ! The ropes must be replaced: ▪ after 3 years of operating time, ▪ if 12 or more broken individual strands of the rope are found over a 100mm lenght, ▪ if 3 or more broken individual strands of the rope are found over a 10mm lenght. 11.3.3 REPLACING THE SUPPORTING ROPES ▪ Move the column all the way to the left (to the right with the right-handed version) over the table. ▪ Rotate the tuby by 90° (so that the table is passed over) and move the tube support arm all the way down. ▪ Loosen the mounting screws of the head cap and remove the head cap, loosening any cable strands from the cap in the process. ▪ Loosen the mounting screws of the left and right cover of the tubes support arm and remove the covers. ▪ Remove the base cladding. Installation Manual 45 MAINTENANCE 0301 7201-E_R00 ▪ Loosen the mounting screws of the lower centre cladding on the column, and pull the cladding upwards to remove it. 1 2 The figure shows the column with the covers removed. ▪ Remove the sealing plugs (1) on the backside of the column. ▪ Push the rod (2) (included in the delivery) through the holes in the column. The rod has approximately the same length protrude from the holes of the column. ▪ Move the tube support arm up until the counterweight comes to rest on the rod. 46 Installation Manual 0301 7201-E_R00 MAINTENANCE ▪ Raise the tube carrier and support it with a piece of wood 80x60x360mm on the vertical carriage so that the support ropes are unloaded. In the process, make sure that the support occurs directly on the vertical carriage and not on the cover bracket. ▪ Remove the headpiece. ▪ Knock out the dowel pins and unscrew the upper rope`s locking straps. ▪ Remove the locking ring on the retaining pin and remove the rope from the retaining pin. ▪ Replace the ropes and reinstall in the reverse sequence. Installation Manual 47 MAINTENANCE 0301 7201-E_R00 ▪ During installation of the dowel pins, make sure that their open side points outwards so that the rope cannot get damaged. A TTENTION ! Before you reinstall the headpiece, check the newly installed ropes again for correct fixture. Inter alia: ▪ dowel pin ▪ upper locking straps on the headpiece ▪ retaining pin ▪ locking ring 11.3.4 VERTICAL BRAKE Check the braking force with the spring scale over the entire range of travel. Target value at least 150N. 48 Installation Manual 0301 7201-E_R00 MAINTENANCE 11.3.5 COLUMN CARRIAGE Check the castors of the column carriage and make sure that it is unscathed. Check the ease of movement over the entire range of travel. Running noise? Identify and, if necessary, replace any defective bearings. Check the bearing play in the castors; if necessary, adjust at the eccentrics of the roller shaft. It must be possible to just turn the thrust bearing by hand over the entire range of travel. Installation Manual 49 MAINTENANCE 0301 7201-E_R00 11.3.6 CARRIAGE AT THE TABLE Check the bearing play in the upper and lower castors, and, if necessary, adjust at the eccentrics of the roller shafts. It must be possible to just turn the thrust bearing by hand over the entire range of travel. 11.3.7 HORIZONTAL BRAKE Switch on the system and check the brake for function and readjust it if necessary. 11.3.8 RAIL SYSTEM Clean the guide rail, check to see that it is in proper condition and grease it lightly. Check that end stops are unscathed and fitted tightly. Check the column with the spirit level placed on it over the entire range of travel. Correct any deviations as required. 50 Installation Manual 0301 7201-E_R00 MAINTENANCE 11.3.9 CLEANING Dirt that is not accessible to the customer´s cleaning personnel must be removed during maintenance work. Soften the contrast agent with water and remove it. See also chapter on „Cleaning and Disinfection“ in the Operator Manual. 11.3.10 COMPLETING MAINTENANCE After completion of the maintenance work, screw all cladding panels back on. Perform functional check according to chapter 9. Installation Manual 51 MAINTENANCE 0301 7201-E_R00 11.4 MAINTENANCE CERTIFICATE Maintenance was carried out according to the maintenance instructions enclosed. Where necessary, parts have been replaced only by original spare parts according to the list. Work performed: Date: Company: Signature: Company: Signature: Company: Signature: Company: Signature: Company: Signature: Company: Signature: Company: Signature: Work performed: Date: Work performed: Date: Work performed: Date: Work performed: Date: Work performed: Date: Work performed: Date: 52 Installation Manual 0301 7201-E_R00 SPARE PARTS 12 SPARE PARTS Components that fail may be replaced only with the original parts specified. When procuring spare parts, always indicate the type number and the serial no. of equipment, the name and the Integral Medical order number of the part completely. The replacement of components or assemblies may be carried out only by us directly or by agencies that have been expressly authorised by us for this purpose. 12.1 TABLE Installation Manual 53 SPARE PARTS No.: Designation Table with rail system 1 front cladding 2 foot pedal 3 pedal holder 4 compressing spring 5 micro-switch 6 7 flat brake magnet 8 stopper-V2 9 rubber-metal buffer_M4 10 stopper-V1 11 guide roller, small 12 guide roller, large 13 leaf spring 14 bearing with bush 15 eccentric axis, complete 16 bearing with bearing bush 17 guide shaft 18 linear ball bearing 19 rubber-metal buffer_M6 20 pushbutton 21 running roller, centre 22 running roller, eccentric 54 0301 7201-E_R00 Order-No.: 0301 1401 0301 1630 0301 1601 2510 1845 on request 3221 0001 0301 1204 2999 0108 0301 1203 0301 1116 0301 1117 0301 0401 0301 1171 2400 0924 0301 1160 0301 1112 2401 2045 2999 0104 on request 0301 1360 0301 1350 Installation Manual 0301 7201-E_R00 Installation Manual SPARE PARTS 55 SPARE PARTS No.: Designation Table with rail system 7 flat brake magnet 13 leaf spring 28 guide rail, welded 29 rubber-metal buffer_M4 30 rear cladding 31 guide rail, front 32 guide rail, rear 33 rear wall 34 castor, comlete 35 magnet holder 36 castor, mountes 37 driver 38 spring 39 latching lever 40 latching lever 41 eccentric castor 42 micro switch 43 additional actuator 44 running rail 56 0301 7201-E_R00 Order-No.: 3221 0001 0301 0401 0301 1920 2999 0103 0301 1402 0301 1005 0301 1004 0301 2004 0301 1390 0301 2008 0301 2030 0301 2007 0301 1372 0301 1370 0301 1380 0301 1390 on request on request 0301 2003 Installation Manual 0301 7201-E_R00 SPARE PARTS 12.2 COLUMN Installation Manual 57 SPARE PARTS No.: Designation Column, complete 7 flat brake magnet 13 leaf spring 45 cable arch, welded, painted 46 head cap, welded, painted 47 scale 48 magnetic rail 49 centre cladding, top 50 centre cladding, bottom 51 cover 52 column base cladding, welded, painted 53 eccentric with bearing 54 bearing pin with bearing 55 guide pin 56 rope roll, complete 57 rope 58 cover 59 cover, welded, painted 60 cable clamp upper part, painted 61 cable clamp lower part 62 slide runner_D9 63 slide runner_D4 64 slide runner_D5 65 additional (add-on) weight 66 base weight 67 grinding jack 68 parabolic spring_M8 69 running roller, eccentric 70 running roller, centre 71 running roller pair 58 0301 7201-E_R00 Order-No.: 3221 0001 0301 0401 0301 0660 0301 0650 0301 0211 0301 0207 0301 0630 0301 0640 0301 0206 0301 0601 0301 0205 (2400 1228) 0301 0230 0301 0240 0201 0260 0301 0311 0301 0602 0301 0270 0301 0209 0301 0208 0301 0305 0301 0306 0301 0304 0301 0301 0301 0302 0301 0309 2999 0101 0301 0440 0301 0460 0301 0450 Installation Manual 0301 7201-E_R00 SPARE PARTS 12.3 TUBE SUPPORT ARM Installation Manual 59 SPARE PARTS No.: Designation Tube support arm 72 cladding, left 73 cladding, right 74 magnete brake, complete, painted 75 spring washer, complete 76 arm cladding, right 77 arm cladding, left 78 cover, welded 79 catch 80 spring 81 arresting piece 82 83 84 60 Control arm handle, painted pushbutton front foil 0301 7201-E_R00 Order-No.: 0301 0490 0301 0480 0301 1720 0301 1725 0301 0740 0301 0730 0301 0720 0301 0706 2510 0901 0301 0790 0301 0907 3348 0001 0301 0902 Installation Manual 0301 7201-E_R00 DISPOSAL 13 DISPOSAL WARNING ! H AZARD CAUSED BY IMPROPER DISPOSAL ! Personal injury and damage to the environment ⋙ Do not dispose the equipment independently. ⋙ The manufacturer or distributer is responsible for the disposal of the equipment. ⋙ There may be statutory disposal regulations that are specific to a given country. Before final decommissioning and disposal of the equipment, contact the customer service! A TTENTION ! Seperate disposal of electrical and electronic components. The RoHS and REACH guidelines applicate at the time of equipment delivery have been taken into consideration at the time of construction the equipment. For more information regarding this, please contact the manufacturer. Installation Manual 61 LABELLING EQUIPMENT IDENTIFICATION 0301 7201-E_R00 14 LABELLING EQUIPMENT IDENTIFICATION Name plate Protection class type B Danger of tripping 62 Do not put loads Danger of crushing Installation Manual 0301 7201-E_R00 APPENDIX APPENDIX APPENDIX A – DIRECTIVE 93/42 / EEC REGARDING MEDICAL DEVICE ARTICLE 12 Special procedure for systems and treatment units (1) Notwithstanding article 11, this article applies to systems and treatment units. (2) Any natural or legal person who combines products that bear the CE mark, in accordance with their intended purpose and withhin the limitation of use provided by the manufacturer, in order to distribute them in the form of a system or a handling unit, must submit a declaration of the contents, stating that: a) he has checked the mutual compatibility of the product corrsponding to the instructions of the manufacturer and has performed the work steps corresponding to the instructions; b) he has packed the system or the treatment unit and has provided the relevant user information including the relevant manufacturer instructions; c) all of the activity was internally monitored and checked in a suitable manner. If the conditions according to paragraph 2 are not statisfied, as is the case if the system or the treatment unit contains products that do not bear a CE- mark or if the selected combination of products is not compatible with their original intended purpose, the system or treatment unit is treated as an independent product and, as such, is subject to the relevant procedure of Article 11. The operator is responsible for complying with and carrying out the national variations in the EU countries! Installation Manual 63 APPENDIX 0301 7201-E_R00 APPENDIX B – TECHNICAL DESCRIPTION Installation together with other equipment A TTENTION ! This system may be placed or installed and operated in the immediate vicinity of and together with other electronic equipment. Nonetheless, should this be necessary, the equipment must be checked for its intended and proper operation. Use of other accessories A TTENTION ! The use of accessories, boards and cables other than those specified, with the exception of those boards and cables that the manufacturer of the OKS 1000 supplies as spare parts for internal components, may lead to increase emmisions or reduces interference immunity of this system. General safety specifications according to EN 60601-1-2 Guidelines and manufacturer`s declaration – Electromagnetic Emissions This device is intended for operation in an environment as specified below. The customer of the user of the OKS 1000 should ensure that it is used in such an environment. Emission Measurements Compliance HF – emissions according to CISPR 11 Class B Harmonics according to IEC 61000-3-2 Class A Voltage fluctuations / Flickers according to IEC 61000-3-3 statisfied 64 Electromagnetic Environment - Guidelines This device is also meant for use in premises other than residential ones and similar, which are directly connected to a public low-voltage mains supply that is also used to supply residential buildings. Installation Manual 0301 7201-E_R00 APPENDIX APPENDIX C – TIGHTEN TORQUES FOR SCREW CONNECTIONS Thread diameter M2 M2,5 M3 M4 M5 M6 M8 M10 M12 0,18 0,23 0,36 0,51 0,61 0,31 0,18 0,17 -- 0,37 0,46 0,74 1 1,2 0,63 0,53 0,34 -- 0,67 0,83 1,3 1,9 2,2 1,1 0,82 0,62 0,1 1,5 1,9 3 4,2 5,1 2,6 2 1,4 0,2 3 3,7 6 8,4 10 5,1 3,7 2,8 0,5 5,1 6,4 10 14,4 17,3 8 6,5 4,8 1 12,6 15,8 25 36 43 20 16 11,9 2 25 31 50 70 84 39 30 23,3 3 44 55 88 123 148 69 -41,1 4 Strenght class 4.8 5.8 8.8 10.9 12.9 A2, A4 45H CU2 (brass) Polyamide All tightening torques in Nm, permissible variance ±10%. With screws of different strength classes (bolt and nut), the torque of the smaller strength class always applies! Installation Manual 65