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5100054

BND01O03.docx

8.

Product Specification

8.1.

Specified Use

The system is a rotating and swiveling carrier system. Its purpose is carrying and
positioning the CT Exprès® injector in climate-controlled rooms in medical facilities.
Furthermore, it can be used to route power and data cables.

It is the responsibility of the operator to ensure the device is safe for use and to provide
the user with the instructions for use and information about the intended purpose.

8.2.

Component Description

Figure 1

System with its component names

Axis B

Axis A

Axis C

Connection Plate

Canopy

Ceiling Column

Extension Arm

Spring Arm

Injector Holder

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Summary of Contents for CT Expres

Page 1: ...Bracco Injector Holder CT Exprès CARRIER SYSTEM Service Manual Page 1 of 54 BND01O03 docx ...

Page 2: ...tion purposes only The products described are subject to change without notice in the course of continuous development MAVIG only assumes warranty for this manual and the products within the scope of the manufacturer s liability Amendments MAVIG products are subject to continuous development MAVIG reserves the right to make changes to the manual packaging equipment or technical specifications with...

Page 3: ...Standards 10 7 Initial Commissioning 10 8 Product Specification 11 8 1 Specified Use 11 8 2 Component Description 11 8 2 1 Canopy 12 8 2 2 Ceiling Column 12 8 2 3 Extension Arm 12 8 2 4 Spring Arm 12 8 2 5 Injector Column 12 8 2 6 Connection Plate 12 8 2 7 Cables 12 8 3 Service Life 13 8 4 Information on the Identification Label 13 8 5 Manufacturer and Contact Information 16 8 6 Customer Care and ...

Page 4: ...5 Adjusting the Friction Brakes 33 10 15 1 Adjusting the Brakes for the Extension Arm 33 10 15 2 Adjusting the Brakes for the Spring Arm 33 10 15 3 Adjusting the Brakes for the Injector Column 33 10 16 Installation Disassembly of Extension Arm Covers 34 10 17 Installation Disassembly of Socket Covers 35 10 18 Installation Disassembly of Spring Arm Covers 35 10 18 1 Front Spring Arm Cover Panels 35...

Page 5: ... Spare Parts 49 15 Spare Part Replacement 52 15 1 Extension Arm 52 15 2 Injector Holder 52 15 3 Spring Arm 52 15 4 Canopy 52 15 5 Connection Plate 52 15 6 Spring Arm Side Panels 52 15 7 Spring Arm Rear and Front Covers 52 15 8 Cover Plates 52 15 9 Lubricant Microgleit GP 360 53 15 10 Extension Arm Socket Covers 53 15 11 Extension Arm Covers for Axis A 53 15 12 Securing Element for Axis C 53 15 13 ...

Page 6: ...em device is used solely for its intended purpose and its operation complies with the information provided in this Installation Service Manual BND01Oxx xx are placeholders for the last revision and the Instructions for Use BND01Gxx xx are placeholders for the last revision Only original authorized replacement parts or accessories as specified and approved by MAVIG are to be used The use of unautho...

Page 7: ...t can hold COLLISION WARNING Collisions with other equipment can cause structural failure of the suspension arm resulting in operator or patient injury If collision occurs immediately have the arm inspected by a qualified service technician CE SYMBOL With this symbol MAVIG declares that the products comply with the relevant regulations set forth in the applicable European Directives RECOGNIZED UL ...

Page 8: ...NING Electric shock Every effort must be made to ensure that the electricity power supply to the entire system is disconnected when assembling and installing the system and or its associated components Danger of death NOTE The IEC 60601 1 2005 AMD1 2012 certification applies to the non electrified system The system must therefore be re certified by an appropriately trained technician after the ins...

Page 9: ...lled in an end product consideration must be given to the following Humidity preconditioning treatment shall be considered during end product evaluation clause 5 7 The power input measurements must be conducted during the end product evaluation with all loads supplied and operated in the least favorable condition Applicable leakage current tests shall be conducted during the end product evaluation...

Page 10: ...rectives The CE symbol on the label indicates conformity The products fulfill as partly completed machinery all relevant provisions of the EU Directive 2006 42 EC on machinery MAVIG is EN ISO 13485 2016 certified 7 Initial Commissioning Once the system has been successfully installed in accordance with this manual the following must be considered during use Avoid collisions with other devices the ...

Page 11: ... in medical facilities Furthermore it can be used to route power and data cables It is the responsibility of the operator to ensure the device is safe for use and to provide the user with the instructions for use and information about the intended purpose 8 2 Component Description Figure 1 System with its component names Axis B Axis A Axis C Connection Plate Canopy Ceiling Column Extension Arm Spr...

Page 12: ...ween 45 and 70 The height end stop can be adjusted continuously between 0 and 45 Section 10 13 page 31 The spring force is balancing out the weight of the injector and is preset to 18 5 kg If the payload varies from that amount the force needs to be adjusted A friction brake prevents an upward movement of the spring arm when the injection liquid is depleted The friction brake exerts a force of 1 5...

Page 13: ...em inspected according to the then valid MAVIG checklist by an experienced technician at minimum on a yearly basis If the product exceeds some wear limits during such inspection it will need to be dismounted and replaced Failing to proceed so means user takes all responsibilities in case of failure incident related to the MAVIG Product 8 4 Information on the Identification Label There are sales ar...

Page 14: ...cx Figure 2 Position of the Type Label for the Ceiling Column Figure 3 Position of the Type Labels for the Injector Holder Figure 4 Position of the Type Label for the Extension Arm Figure 5 Position of the Type Label for the Spring Arm ...

Page 15: ... two digits of the serial number Warning Symbol General advice to handle the product carefully Observe the Instructions for Use Read the Instructions for Use carefully before using the product for the first time CE Symbol The products fulfill as partly completed machinery all relevant provisions of the EU Directive 2006 42 EC on machinery UR Symbol UL APPROVED COMPONENTS These components have been...

Page 16: ... technical knowledge for the servicing maintenance and repair of the product Your first point of contact should therefore be your Bracco affiliate or legal agent depending on your country 9 Packaging Packages Dimensions LxWxH Package Weight Ceiling Column 200 mm 380x380x400 mm 5 5 kg Ceiling Column 400 mm 380x380x600 mm 7 5 kg Ceiling Column 800 mm 380x380x1000 mm 11 5 kg Extension Arm Cables 1190...

Page 17: ...tform e g ladder according to the local occupational safety regulations Level or Digital Protractor Cable routing aid ideally 400 mm cable tie type Colson Testing weight of 3 0 kg e g a weighed canister of water Standard tool set including Torx T10 screwdriver Medium sized slotted flat headed screwdriver 24 mm open ended wrench 24 mm socket for torque wrench Allen keys sizes 2 5 5 8 Torque wrenche...

Page 18: ...can be found in installation instructions DBF02Oxx Figure 9 Installation of the Ceiling Column to the Substructure 10 3 Installation of Ceiling Column Prior to installation the ceiling must be checked by a structural engineer and the installation must occur under the guidance of the respective construction supervision The determination of the individual fastening elements and their respective tigh...

Page 19: ...Page 19 of 54 5100054 BND01O03 docx Figure 10 Graphical display of the system in maximum dimensions configuration considering maximum load to be attached to the injector column ...

Page 20: ...eiling Column 815 mm 10 5 kg 0 mm Canopy 0 7 kg 0 mm Extension Arm 9 5 kg 403 5 mm Spring Arm 13 0 kg 1474 2 mm Injector Holder 4 5 kg 1845 6 mm CT Exprès Injector CM Saline Cables Handle 19 0 kg 1977 0 mm Table 1 Weights and Center of Gravity for System Components The Ceiling Column flange plate dimensions are shown in Figure 11 Figure 11 Ceiling Column Flange Plate Dimensions ...

Page 21: ... Column tube and secure it with the Securing Element 4 Rotate the Extension Arm until the threaded hole in the spindle is in alignment with the hole in the Ceiling Column tube for the screw Tighten the Extension Arm brake screws if the spindle is not rotating See Section 10 15 1 5 Screw in the Allen cylinder screw ISO 4762 M6x10 and tighten it to a torque of 10 Nm Allen Key Size 5 6 Move the Decor...

Page 22: ...bles can be twisted off without a mounted end stop 1 Pull both latch pins upward and both securing elements out of the extension arm until the latch pins snap into the securing elements 2 Insert the spring arm spindle into the extension arm up to the end stop without tilting 3 Push both securing elements into the extension arm until they snap into place Both securing elements must protrude into th...

Page 23: ... in the component grounding screw with the spring washer and the flat washer and tighten in to a torque of 2 Nm Figure 15 Assembly of the Injector Holder 4 Install the Holding Plate to the Injector Column with 4x countersunk screws Allen Key Size 3 5 Tighten the screws to a torque of 5 Nm 6 Screw in the component grounding screw with the spring washer and the flat washer and tighten in to a torque...

Page 24: ...the right as depicted in Figure 16 5 Insert the injector column spindle into the spring arm up to the end stop Avoid tilting it 6 Push both securing elements into the spring arm 7 Rotate the securing sleeve upwards and turn it approximately 90 degrees to the left The cutout in the securing sleeve must protrude over the brake screw not depicted 8 Adjust the brake screws See Section 10 15 3 9 Before...

Page 25: ...ring Figure 17 Placing the Handle on the Injector Holder 1 Place the CT Exprès Handle on the Injector Holder taking care to align the positioning holes together Figure 18 Attaching the Injector to the Injector Holder 2 Use the provided Allen Key and screw in the four M4x20 screws delivered with the CT Exprès Handle WARNING Using other screws can impact the correct power supply function of the CT E...

Page 26: ...llation of the extension arm according to Section 10 4 WARNING Electric Shock Damaged cables can energize the carrier system The cables must lay next to each other without crossing themselves The cables must not be twisted The cable insulations must be undamaged 1 Route the cables at the front through the cable aperture downward to the spring arm Start with the cable with the largest cable plug 2 ...

Page 27: ...e 21 Make sure you position the cable with the largest cross section centrally 5 Click the three cable clips back onto the parallel guide at their previous position 6 Check the clearance of the cables The cables must be laid to the front and rear joint of the spring arm with a slight strain free curvature Check that the external cables are not exposed to tensile stress in any possible position and...

Page 28: ...n cable at position Blue cable at position N 5 Route the power cable provided by the hospital through the opposite cable tie 6 Attach the wires accordingly at the positions and 7 Tighten the cable ties to provide a stress relief Fixating the Connection Plate in place The connection plate has to be fixed in place to avoid movement and damage to the cables As every installation site is different it ...

Page 29: ...position next to the PE Symbol The grounding cable provides grounding for every component of the carrier system Figure 26 Attaching the grounding cables to the connection plate 2 Attach both grounding cables to the grounding point at the connection plate in the depicted order Serrated Washer Ceiling Column Grounding Cable Hospital Grounding Cable Washer Cylinder Screw M5x14 3 Tighten the screw to ...

Page 30: ...ight of 3 kg to the injector with the two plastic covers for the bottles Follow the following instructions to change the spring force if the spring arm is moving up or down at any point Figure 27 Adjusting the Spring Force The spring force has to be adjusted if the spring arm moves up or down unsolicited 1 Disengage the rear bottom cover plate according to Section 10 18 4 page 36 2 Carefully route...

Page 31: ...arm cover according to Section 10 18 1 page 35 2 Insert a size 5 Allen key into the adjustment hole 3 Slightly pull down the spring arm in order to relieve the adjustment screw in the spring arm 4 To reduce the swivel range Turn the Allen key anti clockwise To extend the swivel range Turn the Allen key clockwise 4 Perform a function test 5 Install the front spring arm cover and the cover plates ac...

Page 32: ...nsert the grove of the end stop ring into the two fit in keys and lower the end stop ring Rotate the Extension Arm clockwise to check the end stop position Push the end stop ring out of the two fit in keys towards the top and rotate it such that it is positioned on top of the fit in keys Rotate the Extension Arm into the second end stop position desired Lift the end stop ring and rotate it in a wa...

Page 33: ...ews are tightened equally 10 15 2 Adjusting the Brakes for the Spring Arm Figure 31 Brakes for Spring Arm The extension arm 6 brake screws at axis B provide friction brakes for the spring arm They are positioned as shown in Figure 31 To increase the brake force Turn the brake screw with an Allen key size 5 clockwise To reduce the brake force Turn the brake screw with an Allen key size 5 counter cl...

Page 34: ...des of the extension arm cover Torx T10 2 Disengage the snap lock of the covers by gently pushing a suitable slotted screwdriver into the slot on top of the covers 3 Carefully disengage the latches and remove the left cover half Figure 34 Removing the right cover half Right Cover Halve Installation Follow the disassembly instructions in reverse order Disassembly 1 Unscrew the two PT screws 3x12 mm...

Page 35: ...s sit tightly in place and there are no gaps between the covers Disassembly To disassemble the covers follow the instructions in reverse order 10 18 Installation Disassembly of Spring Arm Covers 10 18 1 Front Spring Arm Cover Panels Figure 37 Front Spring Arm Cover Panels Installation 1 Place both front cover panels at the spring arm and carefully engage the latches 2 Secure each front cover panel...

Page 36: ...y disengage the latches of both rear cover panels and remove the cover panels 10 18 4 Cover Plates See Figure 38 Installation of Lower Cover Plates 1 Insert the lower cover plate into the side panels up to the latches The latches must point outwards of the spring arm 2 Push the cover plate forwards and manually insert the two latches into the two cover panels Make sure that the cover plate runs in...

Page 37: ...both side panels 2 Carefully engage the latches on the side panels 3 Check that the side panels are securely in place The side panels must sit against each other without gaps Disassembly 1 Gently disengage the latches on the side panels 2 Take off both side panels Figure 38 Spring Arm Covers ...

Page 38: ...s around the ceiling tube and press them tightly together Apply pressure at the bottom part and focus on one side first if the snap in hooks are not engaging properly 2 Screw the canopy halves together with 4 PT screws 3x6 mm 3 Push the canopy upwards to the false ceiling 4 Tighten the four preinstalled setscrews DIN 916 M6x10 to 0 2 Nm Philips screwdriver 5 Check that the canopy is securely in pl...

Page 39: ...ly to the entire system is disconnected when conducting any maintenance work Danger of death A qualified service technician must carry out the following checks every 2 years After 8 years the checks have to be done annually 11 1 Maintenance Check List Visual Inspection The ceiling column flange plate is flush with the raw ceiling respectively the substructure is correctly in place The ceiling colu...

Page 40: ...on 11 4 Check the securing sleeve on the front spring arm joint for damage All end stop components are undamaged The carrier system parts are free of deformation The system is free of paint damage All plastic parts are available in position and free of cracks All cables are free of pressure chafe marks and there is no abrasion visible ...

Page 41: ...k it for abrasion and damage Mount it again before checking the second securing element see Section 11 2 o Both securing elements are on the front extension arm in their correct position Check the securing elements between the spring arm and the injector column and lubricate them with Microgleit GP 360 o Remove the first securing element and check it for abrasion and damage Mount it again before c...

Page 42: ...e spring arm to the opposite side of the securing element 3 Check if the securing element is at least 2 1 mm tick and 24 5 mm long 4 Replace the securing element in case the minimally required dimensions are not met 5 Lubricate the securing element and the matching counterpart at the spring arm spindle through the fitting aperture with Microgleit GP 360 6 Position the securing element in a way tha...

Page 43: ...nd in order to prevent it from dropping out of the spring arm To relief stress from the securing element lift the injector up or try moving the injector to the opposite side of the securing element 4 Route the securing sleeve back upwards 5 Check whether the securing element achieves a minimum thickness of 1 8 mm and a minimum length of 8 3 mm Use a caliper gauge for measurement Replace the securi...

Page 44: ...he height stop point back to its original position according to Section 10 13 page 31 11 4 Checking the Securing Ring at Axis A Figure 42 Checking the Securing Ring 1 Disassemble the covers according to Section 10 16 page 34 2 Remove the bottom cover panel Unscrew the three cross recessed head screws M4x10 with a Torx T10 screwdriver Carefully remove the bottom cover panel 3 Check the securing rin...

Page 45: ...s 6 Disassemble the covers according to Section 10 17 page 35 7 Unscrew the brake screws as described in Section 10 15 2 page 33 8 Lubricate the brake screws with Microgleit GP360 and screw them back into place 9 Adjust the brake screws according to Section 10 15 2 page 33 10 Install the covers according to Section 10 17 page 35 11 5 3 Lubricating the brake screws for the Injector Column Figure 45...

Page 46: ...iderable risk of injury The system device must be disposed of in accordance with the nationally applicable provisions at an appropriate recycling facility for electrical and electronic equipment If you have any questions please do not hesitate to contact either your Bracco affiliate or legal agent depending on your country or MAVIG at on e Mail info mavig com or Phone 49 0 89 420 96 0 ...

Page 47: ...h headroom 1 The bottom end of the ceiling column must be located at 2200 2600 mm above the floor 2 If a substructure is used it must not protrude out of the false ceiling 3 Choose either a ceiling column with an appropriate length or a combination of a substructure with a ceiling column Components Length Ceiling Column 200 mm 230 mm Ceiling Column 400 mm 430 mm Ceiling Column 800 mm 830 mm Substr...

Page 48: ...nopy 0 7 kg Extension Arm 9 5 kg Spring Arm 7 8 kg Injector Holder 4 5 kg Connection Plate 0 3 kg 13 3 Dimensions Figure 47 System Dimensions Figure 47 shows the system dimensions for a 400 mm ceiling column Please note that all ceiling columns are 30 mm longer than their nominal value measured from the top of the flange plate to the bottom end of the tube ...

Page 49: ... GD40030 BO INJ Injector Holder IF50 ML19 incl Mounting Material Holding Plates 3 E 7110618 Spring Arm 920 FK18 26 RB incl Cover and Mounting Material 4 E GD40030 BO BAL Canopy DA360 DI66 for GD40030 BO 5 E GD40030 BO WAGO Connection Plate GD40030 BO assembled 6 E GD40030 BO SET1 Kit Side Panels Spring Arm 920 FK18 26 RB for GD40030 BO Spring Arm Side Panel both sides Decorative Spring Arm Cover b...

Page 50: ...4x 9 E 7110141 5 ml Microgleit GP 360 Lubricant 10 E GD40030 BO SET3 Kit Joint Covers Axis B for Extension Arm 1050S IF50 Socket Covers both sides Screws M4x10 4x Decorative Covers 2x 11 E GD40030 BO SET4 Kit Joint Covers Axis A for Extension Arm 1050S IF50 Extension Arm Cover Halves Rear left and right 2x screw 3x12 2x screw T10 KN1041 2x ...

Page 51: ...ring Element Axis C 13 E 7110134 Brake Screws Axis B C M10 10x 14 E 7110129 Brake Screws Axis A M10 10x 15 E 7110130 Securing Elements Axis B 10x 16 E 7110124 Securing Element Axis A 10x 17 E TS152X Installation Kit TS152X 4x Screw M10x35 DIN 912 type 10 9 4x Washers M10 DIN 125 A 4x Snap Ring M10 DIN 127 1x Loctite 270 10 ml ...

Page 52: ...andle and injector according to the specified sections Route the cables back through the injector holder 15 3 Spring Arm 1 Route all cables back to the extension arm according to Section 10 9 2 Uninstall the injector and the handle according to Section 10 8 3 Uninstall the injector holder according to Section 10 7 4 Replace the spring arm with the spare part according to Section 10 5 5 Install the...

Page 53: ...15 Securing Elements for Axis B Replace the securing elements for axis B according to Section 11 2 15 16 Securing Element for Axis A 1 Route both the cables from the injector side and the ceiling side back to the extension arm according to Section 10 9 2 Uninstall the injector and the handle according to Section 10 8 3 Uninstall the injector holder according to Section 10 7 4 Uninstall the spring ...

Page 54: ... Copyright 2021 5100054 BND01O03 docx MAVIG GmbH Munich Germany Technical amendments reserved ...

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