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6.6 Responsibility of the Device Owner

The Device Owner is the person who operates the device for commer-
cial or business purposes himself or entrusts operation/use to a third party,
and who bears the legal product responsibility to protect the user, per-
sonnel, or third parties during operation of the unit.

The device is used in the medical field. The device owner has certain le-
gal obligations, including with respect to occupational and patient safe-
ty.

NOTICE

1. The device owner is also obligated to know and comply

with all relevant, locally applicable laws and related
standards and guidelines at the time the device is in use.

¡

The device owner must obtain information on the applicable acci-
dent-prevention and hygiene regulations and also conduct a risk as-
sessment to identify hazards that arise from the particular working
conditions at the place where the device is used. Such risks must be
presented in the form of operating instructions.

¡

Throughout the period the device is used, the device owner must
check whether the operating instructions created correspond to the
latest edition of the standard regulations and make adjustments as
required.

¡

The device owner must clearly regulate and establish the responsibili-
ties for installation, operation, troubleshooting, maintenance, and
cleaning.

¡

The device owner must ensure that all employees working with the
device have read and understood this operating manual. Further-
more, the operator must periodically train personnel and review the
dangers.

¡

The device owner must ensure that the maintenance intervals and
safety inspections specified in this operating manual are observed.

¡

The device owner must ensure that only accessories exclusively ap-
proved and released by BERCHTOLD are used in conjunction with the
device.

Device Owner

Responsibilities of the
Device Owner

Risk assessment

Responsibilities of
personnel

Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Safety

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Содержание Operon D760

Страница 1: ...OPERON Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Read the instructions before beginning any work ...

Страница 2: ...BERCHTOLD GmbH Co KG Ludwigstaler Straße 25 78532 Tuttlingen Germany Distributed by BERCHTOLD Corporation 1950 Hanahan Road Charleston SC 29406 www BERCHTOLD biz Phone 843 569 6100 Phone 800 243 5135 Fax 843 569 6133 2 ...

Страница 3: ... Connecting the potential equalization 23 3 7 Checks before initial start up 24 4 Operation 25 4 1 Safety instructions for operation 25 4 2 Patient positioning 26 4 3 Software controlled limits of the OR table 26 4 4 Switching the hand pendant on and off 29 4 5 Checking the battery charge 31 4 6 Locking and unlocking the OR table 32 4 7 Setting reverse orientation 33 4 8 Movement of the OR Table o...

Страница 4: ...ids 75 5 11 Product Label 75 6 Safety 77 6 1 Intended use 77 6 2 Fundamental dangers 78 6 3 General risks at the workplace 78 6 4 Danger due to mechanical parts 79 6 5 Note on X ray exposure 79 6 6 Responsibility of the Device Owner 80 6 7 Personnel requirements 82 6 7 1 Qualifications 82 6 7 2 Unauthorized persons 83 6 7 3 Instruction 84 6 7 4 Personal protective equipment 84 6 7 5 Environmental ...

Страница 5: ...D 850 100 9 4 2 Auxiliary hand pendant D 820 D 760 100 10 Disassembly and disposal 102 10 1 Safety instructions for disassembly and disposal 102 10 2 Disassembly 102 10 3 Disposal 103 11 Appendix 104 11 1 Information on electromagnetic compatibility EMC 104 11 2 Guidelines and manufacturer s declaration Electromag netic emissions 104 11 3 Guidelines and manufacturer s declaration Electromag netic ...

Страница 6: ...o scale and may deviate slightly from the actual version of the device The user should be aware of the difference between table operation for tables with software versions prior to 8 040 All D860 D830 and D770 ta bles and D850 D820 and D760 tables starting with the following S Ns contain software 8 040 D850 S N 35 XXXXX V 10841 D820 S N 34 XXXXX V 10355 D760 S N 33 XXXXX V10254 Older tables that h...

Страница 7: ...on that if not avoided will result in death or serious bodily injury WARNING Indicates a possibly dangerous situation that if not avoided can result in death or serious bodily injury CAUTION Indicates a possibly dangerous situation that if not avoided can result in moderate or minor injuries CAUTION Indicates a possibly dangerous situation that if not avoided can result in damage to property Warni...

Страница 8: ... performed exclusively by skilled electri cians To draw attention to operating instructions results listings references and other elements the following marks are used in this manual Mark Description 1 2 3 Step by step instructions Results of steps performed References to sections and related documents List without defined sequence Button Controls e g button switch Display element e g signal light...

Страница 9: ...al terms and conditions the manufactur er s delivery terms and any regulations legally valid at the time the con tract is concluded apply We reserve the right to make technical modifi cations to improve and further develop the product 1 4 Copyright protection Treat this manual as confidential It is exclusively for the use of persons handling the device This manual may not be transferred to third p...

Страница 10: ...RCHTOLD via web visti http www berchtoldusa com contact us Mailing Address BERCHTOLD 1950 Hanahan Road Charleston SC 29406 Phone 843 569 6100 Phone 800 243 5135 Fax 843 569 6133 E Mail Info berchtold biz We are also always interested in feedback to improve our products 1 7 UL Listing This device is safety listed to ANSI AAMI 60601 1 IEC 60601 2 46 and UL file E347014 Operator Manual Surgical Mobil...

Страница 11: ...2 Design and function 2 1 Overview 1 Head rest 5 Column Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Design and function 11 ...

Страница 12: ...via InstaDrive optional The OR ta ble is locked using 4 base control cylinders The various sections of the OR table can be adjusted using the hand pendant and be individually con figured by the user 2 3 Controls NOTICE Functional descriptions of the controls and indicator lights are found in the Operation chapter 2 4 Points with increased pinching hazard NOTICE The following list of pinch points i...

Страница 13: ...tional back section 8 Base 4 Head rest at back section 9 Foot pump handle floor 5 Back and leg plate connection split leg section frame 10 Split leg section Leg sections telescope cover 2 5 Scope of delivery Contents of the small carton Hand pendant OPERON MOT OR Table Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Design and function 13 ...

Страница 14: ...ccessories have not been tested with the OPERON Surgical Mobile Operat ing Table and can induce unsafe conditions NOTICE Damage resulting from accessory use ü Attaching accessories changes the geometry of the ta ble and increases the risk of collision because crash pre vention no longer operates to its fullest extent 1 Only use accessories approved by the manufacturer NOTICE For a full list of ava...

Страница 15: ...al installation do the following 6 Ensure that all installation work was performed accord ing to the information and instructions in this operating manual and is complete 7 Ensure that no one is in the hazard zone 3 1 Prerequisites at the installation site When setting up the OR table ensure the following The installation site is level Ensure the OR table will stand securely Use the OR table only ...

Страница 16: ...not exposed to vibration oscillation The flooring is resistant to solvents impervious to liquids antistatic and easy to clean There are no machines nearby that would cause electrical or electro magnetic interference See section 11 3 3 2 Unpacking and installing Protective equipment Protective clothing Protective gloves Safety boots Special tools Spirit level Protractor Measuring tape Wrench 11 mm ...

Страница 17: ... for the address 1 Cut through the straps 2 on the transport container 3 and remove the top covers 1 2 Remove the ramp wood cover from the transport container 3 Carefully cut and remove all straps and the upper cross bracing 4 Carefully remove the plastic wrapping from the OR table 5 Check the contents of the carton for completeness 6 Loosen and remove the wing nuts 4 7 Loosen and remove transport...

Страница 18: ...le and carefully roll it down the ramp WARNING 1 Risk of pinching or crushing from OR table over balanc ing CAUTION Risk of pinching on section frame Attach ramp Roll the OR table down the ramp Attach module Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Installation and initial start up 18 ...

Страница 19: ... marking on the module frame is not visible then the module is not completely locked in place CAUTION Risk of section detachment and patient user injury is possible if the section is not securely locked If the green markings on both sides of the section frame are not visible the section is NOT com pletely locked into place Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820...

Страница 20: ...2 The pads should be initially installed only by the manu facturer s technicians 1 To attach the pads align them flush with the edge of the table 2 Press the pads down The pads are held in place with Velcro strips NOTICE Sample design Pad shapes and variants can differ depending on the scope of delivery NOTICE Removing pads To remove pads slide your hand between the pad and base sec tion and unhoo...

Страница 21: ...ns and push into the lock 3 5 Connecting the foot control optional 1 Attach the foot control optional to the control sleeve by connect ing the cable and the jack Open protective cap and align the red dots on the plug connections See Section 3 4 on connecting the hand pendant Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Installation and initial start up 21 ...

Страница 22: ...ect the power supply by pulling out the plug never pull on the cord 6 Route the cord so that it cannot be bent clamped or run over 7 Make sure no one can trip over the cable 8 Do not use an extension cord or multi outlet power strip 9 Keep an eye on the power cord when table is moving 10 Never bypass or deactivate fuses Make sure the amper age is correct when changing fuses ð Keep conductive parts...

Страница 23: ...sing other devices with requirements to do so connect the potential equalization cable to the potential equalization pin of the mobile OR table Connect the other end of the potential equalization cable to the potential equalization pin of the operating room NOTICE An authorized service technician must check the electrical con ductivity of the product annually Overview of IEC connectors Establish p...

Страница 24: ...packing materials have been removed 3 Ensure that the supply voltage is 110 120 V AC 60 Hz or 230 V AC 50 Hz 4 Check all motion limits Motion range limits section and all func tions Operation section of the OR table 5 Check the function of the auxiliary hand pendant Auxiliary hand pendant section and the foot pump Operating the foot pump section 6 Visually check for leaking hydraulic fluid especia...

Страница 25: ...etween persons and pinch points when the table is being moved 3 Do not reach into or handle moving parts during use CAUTION Material damage from objects on the base cover of the OR table Objects lying on the base cover can end up against the telescop ing column shields when the OR table is being repositioned and cause damage to the covers and brackets inside the covers 1 Never place objects on the...

Страница 26: ...rg angle greater than 15 the maxi mum patient weight is 617 lb 280 kg and 500 lb 227 kg reverse orientation This ensures that the longitudinal slide will work correctly 1 Position the patient on the OR table according to the technical data Patient positioning section 4 3 Software controlled limits of the OR table CAUTION Risk of pinching or crushing when operating the leg section LEG 1 There is a ...

Страница 27: ...ady reached the activated function s limit NOTICE If this yields no results level the OR table to its starting position or slide SLIDE function D820 D850 only it to center the BERCH TOLD lettering on the side skirts is in the middle above the lifting column section 11 The following table lists the software controlled motion limits Function Description Trendelenburg TREND The TREND function stops i...

Страница 28: ...e floor base or col umn Longitudinal slide D820 D850 only SLIDE The SLIDE function stops if any table section nears the floor base or col umn CHAIR FLEX and LEVEL preset posi tions The automatic functions stop any function that could come into con tact with the floor base or column The LEVEL function activates other functions to prevent collisions and finish leveling the tabletop NOTICE Material d...

Страница 29: ...Trendelenburg Reverse Trendelenburg Tilt Back section Leg section Split leg section Kidney elevator optional Flex Chair Level The following are manually adjustable Headrest Split leg section spread Indicator lights on the primary hand pendant Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 29 ...

Страница 30: ...ed movement has reached a software controlled limit to avoid damaging table components NOTICE To activate functions using the main hand pendant the main switch on the base and the pendant must both be ON and the feet must be locked If feet are not locked when a function button is pressed the table will automati cally lock the feet before the user is allowed to proceed with the function movement An...

Страница 31: ... connected to the power supply via the power cord and the indicator light charge display is lit the hand pend ant remains active until it is turned off Press POWER The backlighting of the hand pendant and the indicator light POWER ON goes out The hand pendant is switched off 4 5 Checking the battery charge The following prerequisites must be met The OR table is turned on 1 Charge display 2 Battery...

Страница 32: ...s turned on Sufficient charge on batteries if unplugged Locking the OR table Press FLOOR LOCK NOTICE 1 Unlocking with two presses of the button is required for all D860 D830 and D770 tables D850 D820 and D760 tables with serial numbers prior to those specified below require only one press of the button to unlock 35 XXXXX T 10431 34 XXXXX T 10167 33 XXXXX T 10120 Additional ly all D850 tables start...

Страница 33: ...e orientation reverses some control functions The opera tor must be aware of these functions and the ori entation of the OR table Failure to do this can result in movement of the wrong section and serious injury See NOTICE on page 33 1 Do not lean on the different sections or use them for sup port 2 Comply with specifications provided in the technical da ta on patient weight size and positioning P...

Страница 34: ...everse during reverse orientation 1 LEG 2 Back section BACK 3 Trendelenburg TREND 4 Lateral tilt TILT 5 Flex 6 InstaDrive Hold down the corresponding button on the hand pendant until the desired position is reached see Changing patient position chap ter Press REV POSITION 1 The REV POSITION indicator light goes out when reverse orientation is turned off CAUTION Always make sure that the OR table i...

Страница 35: ...a lateral force in the direction of motion do not lift up on a section or push down on a section 8 Immediately lock the table when the new location is reached The InstaDrive option is available on the OPERON Mobile tables The in tended use of the function is to aid in the transport or movement of OR table from room to room The OR table with or without the InstaDrive option is not approved for pati...

Страница 36: ...nd place it on the castors see section 4 7 Reposition the table The people at each end must use a lateral force in the direction of movement Do not lift up or push down on a table section Immediately re lock the table once it has reached its new position CAUTION If repositioning the OR Table in an OR with the patient on it be certain that the patient is securely positioned on the table and fol low...

Страница 37: ...son steers the table at the leg sec tion As an alternative the InstaDrive arc which docks onto the ta ble s side rails can be used to have both hands on the table to oper ate the InstaDrive while steering When InstaDrive is active the forward guide rollers are blocked especially to prevent the table from drifting sideways during transport over longer distances 4 Release FWD The OR table stops movi...

Страница 38: ...s 5 Release REV The OR table stops moving The traction drive roller then stays in passive mode for approx 2 seconds to prevent longitu dinal and traverse movement and ensures an additional electromoti ve braking function The rollers are blocked during these 2 seconds During this time avoid moving the table at all especially pulling or pushing it sideways suddenly 4 9 Attaching the InstaDrive Arc D...

Страница 39: ... fully fastened NOTICE Check that both levers on the InstaDrive Arc Docking System are in the locked position then slightly pull on the arc to ensure that it is secured to the side rails Insert the and pendant through the top of the docking station on the arc as seen in Section 4 9 4 To remove the hand pendant pull it upwards and out Do not use force when returning the hand pendant to its dock To ...

Страница 40: ...the OR table ü Unintended movements of the OR table can result in pa tient injuries 1 Carefully monitor all OPERON Table movement and stop immediately when in doubt Button Result Button Result BACK BACK UP BACK DOWN TABLE LEG Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 40 ...

Страница 41: ...OPERON table may cause injury Unintended movements of the OPERON table can result in pa tient injuries 1 Carefully monitor all OPERON Table movement and stop immediately when in doubt The following prerequisites must be met The OR table is turned on The hand pendant is turned on The OR table is locked Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 4...

Страница 42: ...tilt TILT TILT LEFT TILT RIGHT Kidney elevator KIDNEY KIDNEY UP KIDNEY DOWN NOTICE Hold down the corresponding button until the desired position is reached 4 12 Leveling the OR table Button Result LEVEL Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 42 ...

Страница 43: ...eturned to their zero positions in preset 10 increments Fi nally the slide is centered over the table s column NOTICE BEFORE leveling the OPERON Table ensure that there is suffi cient clearing at the head and foot sections allowing it to return to its center point Pay special attention to wires or tubes connected to the patient as well as any other surgical equipment located in close proximity to ...

Страница 44: ... re verse trend 3 Tables with software versions prior to 8 040 do not slide the table to the head when Flex is pressed see page 6 4 Pressing FLEX from the flex position will continue to posi tion the OPERON Table to its full flex limit if the table is at or past the centered position toward the head side 5 Ensure that there is sufficient clearing at the head and foot sections allowing OPERON Table...

Страница 45: ...h a patient on the OPERON Table 1 Trendelenburg Reverse Trendelenburg 2 Left right lateral tilt 3 Height up and down 4 15 Adjusting the head rest CAUTION The instability of the patient s head can cause injury 1 Do not use the headrest to support anything except the pa tient s head 2 Do not use the headrest as a support for an infant The head rest has a maximum weight capacity of XX pounds Operator...

Страница 46: ... this model can also be adjusted horizontally 1 Loosen the star knob 2 and move the support surface into the de sired position by lifting or lowering it 2 Then lock the headrest into position using the star knob CAUTION High risk of detachment and injury if the section is not securely locked Pinch risk on the section frame To avoid pinching ensure that all objects are clear of the section frame an...

Страница 47: ...ector system with coding that allows the OR table control to know where the various sections are attached at all times 1 To release the section locks press and hold the locks 1 located on both sides under each section Head rest 2 piece back plate Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 47 ...

Страница 48: ... the green marking on the section frame is not visible on both sides then the section is not correctly locked in place 2 Pinch risk on the section frame To avoid pinching en sure that all objects are clear of the section frame and support surface Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 48 ...

Страница 49: ... 1 located on the side of the split leg sections 2 Press and hold the lock 2 The snap in mechanism releases Split leg plates Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 49 ...

Страница 50: ...he section locks press and hold the locks 1 located on both sides under the rails 2 Carefully pull out the module and keep it from falling 1 pc leg section 1 pc back section Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 50 ...

Страница 51: ...and make sure the OR table is free of voltage 2 Never use steam or water hotter than 150 F 66 C for cleaning 3 Never use a high pressure cleaner or similar equipment for cleaning 4 Keep the OR table out of high humidity environments to prevent condensation 5 Never clean the OR table in an automatic trolley wash ing system or steam sterilizer Cleaning the OR table Operator Manual Surgical Mobile Op...

Страница 52: ...ulations during clean ing procedures NOTICE The operator must observe the facility s infection control program requirements The product warranty applies to undamaged surfa ces only Non compliance with cleaning instructions terminates any claims under warranty Materials Use only mild non chlorinated and non corrosive cleaning agents 1 Apply a mild cleaning solution to a lint free cloth 2 Wipe the s...

Страница 53: ...CE Material damage from disinfectants such as lodophor Using disinfectants such as lodophor causes spotting on the OR table 1 Use only quaternary ammonium compounds for disinfec tion NOTICE Material damage from sodium hydroxide and sodium hypochlor ite The use of sodium hydroxide lye and sodium hypochlorite bleach on coated aluminum parts can lead to surface changes and affect the service life of ...

Страница 54: ...ogen releasing compounds strong organic acids oxygen releasing compounds solvents gasoline and similar products can cause material damage 1 Never use solutions containing halogen releasing com pounds strong organic acids oxygen releasing com pounds solvents gasoline or similar products Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 54 ...

Страница 55: ...d damaging the stainless steel parts 4 Avoid contact with aldehyde and amine base prod ucts Perform a preliminary cleaning before first use of al dehyde disinfectants especially if an amine containing product was previously used Non compliance can re sult in residues that are impossible to remove 5 Immediately rinse and dry all surfaces that come into contact with quaternary cleaning agents Table ...

Страница 56: ...h as lodophor causes spotting on pads and reduces their service life 1 Use only quaternary ammonium compounds or phenol containing disinfectants for cleaning NOTICE Material damage from incorrect cleaning agents Using the wrong cleaning agents can damage the pads 1 Do not use any solvents such as thinners or acetone to clean pads 2 Do not treat pads in sterilizers 3 Do not use any sharp pointed or...

Страница 57: ...n liquids Submerging the pad in liquid can damage it 1 Only wipe the pad 2 Never submerge pads in liquids 3 Never place pads and straps on a damp tabletop NOTICE Removing pads To remove pads slide your hand between the pad and base sec tion and unhook the Velcro fastener NOTICE Pads and other accessories must be clean to maintain proper grounding Operator Manual Surgical Mobile Operating Table Mod...

Страница 58: ...r care cleaning and disinfection of BERCHTOLD OPERON D Series Surgical Table Hand Pendant 1 If dropped inspect immediately for damage otherwise remove from service until a thorough inspection for cracks and dam aged seals can be performed 2 When the hand control is not actively being used ensure it is hung from the medical rail on the head section 3 Prevent hand control from being exposed to gross...

Страница 59: ...mediately Contact BERCHTOLD technical service for evalua tion assistance 13 Do not use abrasive cleaners solutions with pumice scotch bright pads etc when cleaning and disinfecting hand controls 14 Before each use users should inspect the hand control for signs of damage or abuse e g frayed cable cracked housing missing fas teners lack of glue beak on face etc 15 If damage is suspected remove from...

Страница 60: ...ealing bead that is starting to wear Figure 5 illustrates a case that is sealed with signs that it is starting to sepa rate These are acceptable but should be close ly monitored If ques tionable contact BERCHTOLD Service Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 60 ...

Страница 61: ...gure 9 illustrates pooling of fluids Materials Mild spray disinfectant NOTICE Material damage from cleaning with cloths Cloths leave fibers cleaning with cloths Cleaning Velcro fasteners Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Operation 61 ...

Страница 62: ...t 2 Alcohol containing disinfectants should be allowed to sit for a short time only Materials Detergent 1 Close the restraint straps 2 Wash at a max temperature of 140 F 60 C do not spin do not dry clean NOTICE Closing the restraint straps protects both the straps and other items from damage during the laundering process Washing the restraint straps Operator Manual Surgical Mobile Operating Table ...

Страница 63: ... section up down 30 90 3 Headrest up down 45 90 Kidney elevator optional Lift to 3 75 mm3 Flex 225 Tabletop width including side rails 21 in 534 mm 23 1 in 587 mm with rails Image width 18 3 in 465 mm X ray cassette channel continuous Manual backup system integrated Collision protection integrated Serial interface integrated Battery capacity 5 8 days Tabletop segments up to 8 Tabletop material Car...

Страница 64: ...n 0 see section 4 12 2 With kidney elevator 4 Varies depending on config uration 5 1 Dimension sheets NOTICE The numbers in square brackets are the dimensions in inches the other numbers represent mm Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Technical Data 64 ...

Страница 65: ...s displayed based on D850 one piece long leg plate kidney elevator and one piece back plate max slide at foot end Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Technical Data 65 ...

Страница 66: ...Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Technical Data 66 ...

Страница 67: ...s displayed based on D850 one piece long leg plate kidney elevator and one piece back plate max slide at head end Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Technical Data 67 ...

Страница 68: ...p tions 1 Maximum load capacity in normal orientation 1000 lb 454 kg 2 Maximum load capacity in reverse orientation 500 lb 227 kg 3 Reverse orientation with split leg sections optional is not possible 5 3 Motion range limits NOTICE The add ons and accessories can further restrict the motion rang es NOTICE 1 If the Trendelenburg or reverse Trendelenburg angle is larger than 15 the maximum load for ...

Страница 69: ...Trendelenburg TREND Lateral tilt TILT Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Technical Data 69 ...

Страница 70: ...Longitudinal slide SLIDE Slide center Slide max head Slide max leg Leg section headrest LEG HEAD Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Technical Data 70 ...

Страница 71: ...Leg back section LEG BACK Flex BEACH CHAIR Trendelenburg lateral tilt TREND TILT Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Technical Data 71 ...

Страница 72: ...ith side rails 23 23 1 in 583 587 mm and 23 78 in 604 mm with rails Width without side rails 21 in 534 mm Height range 22 64 46 46 in 575 1180 mm Specification Value Length 14 17 14 49 in 360 368 mm Width 21 in 534 mm Specification Value Length 21 69 in 551 mm Width 21 in 534 mm Specification Value Length 21 06 in 535 mm Width 21 in 534 mm Head rest Back section long Split back section both segmen...

Страница 73: ...fication Value Unit Voltage 10 at 50 60 Hz 120 V Voltage 10 at 50 60 Hz 100 V Voltage 10 at 50 60 Hz 230 V Current consumption at 120 V maximum 3 0 A Current consumption at 230 V maximum 2 0 A Fuse protection at 120 V 1 6 A Fuse protection at 230 V 3 15 A Protection class 24 IP Center section with kidney elevator optional Center section without kidney elevator Leg section short optional Leg sectio...

Страница 74: ...e 10on 20off 5 8 Load capacity Specification Value Normal orientation all movements 1000 lb 454 kg Reverse orientation all movements 500 lb 227 kg Lift only Capacity only valid for D 850 D 860 1250 lb 567 kg 5 9 Operating conditions Specification Value Temperature range 50 100 4 F 10 38 C Relative humidity maximum 10 95 Barometric pressure 700 1060 hPa UL Classification to 60601 1 Lift and movemen...

Страница 75: ...43 5135 Option 2 4 l 5 11 Product Label The product label is located at the head end above the holder for the auxiliary hand pendant and contains the following information NOTICE Example depicted the end user configuration and type may differ depending on the model ordered 1 Serial number 2 Manufacturer 3 Model 4 Safety class 5 Current consumption 6 Health Industry Bar Code 7 CE mark 8 Note on ope...

Страница 76: ...12 Operating duration Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Technical Data 76 ...

Страница 77: ...s compliance with all instructions provided in this operating manual Any use for purposes beyond or other than those intended is considered misuse The OPERON OR table is used for bearing and positioning patients for surgical treatment before during and after the surgical phase The de sign of the tabletop of the OR table makes it suitable for all surgical disci plines The OPERON OR table may not be...

Страница 78: ...lifting device for equipment 6 2 Fundamental dangers The following section describes residual risks that can arise even from proper use of the product To reduce risk of injuries and material damage and prevent dangerous situations observe the safety instructions provid ed here and those in other sections of this operating manual 6 3 General risks at the workplace WARNING Risk of infection due to i...

Страница 79: ...ator can sustain a pinching or crushing injury at a pinch point 1 Point out pinch points to OR personnel and instruct them accordingly 2 Ensure there is enough distance between persons and pinch points when the table is being moved 3 Do not reach into or handle moving parts during use 6 5 Note on X ray exposure NOTICE Damage to the upper or lower side of section surfaces from nicks and scratches d...

Страница 80: ...uch risks must be presented in the form of operating instructions Throughout the period the device is used the device owner must check whether the operating instructions created correspond to the latest edition of the standard regulations and make adjustments as required The device owner must clearly regulate and establish the responsibili ties for installation operation troubleshooting maintenanc...

Страница 81: ...safety inspections are not or dered and carried out by the due date Functional failures and problems with the device that have resulted in personal injury must be immediately reported to the responsible au thorities and the manufacturer The safety evaluation must include the following information What was the cause of the event Was the device in proper condition Was the risk eliminated after the d...

Страница 82: ...ious tasks BERCHTOLD authorized company Certain tasks may be performed only by BERCHTOLD technicians or per sonnel authorized by BERCHTOLD Other personnel are not permitted to perform these tasks Contact our customer service to perform tasks needed Engineer or Biomedical Engineer A facilities Engineer or Biomedical Engineer on the basis of his or her train ing skills and experience and well as kno...

Страница 83: ...dical specialists have the required technical knowledge for properly using the device in the given area of application and comply especially conscientiously with all hygiene regulations for rooms used for medical purposes and for the use of medical devices 6 7 2 Unauthorized persons WARNING Risk of death to unauthorized persons from hazards in danger and work zones ü Unauthorized persons who do no...

Страница 84: ...e equipment specified in each of the individ ual sections of this operating manual or as specified by local policies and procedures Individuals must put on the required personal protective equipment specified in the various sections of this manual prior to beginning any work Follow the information on the personal protection equipment posted in the work area Protective clothing Protective clothing ...

Страница 85: ... measures immediately should hazard ous substances accidentally be released into the envi ronment In case of doubt notify the responsible local authorities regarding the damage and ask for measures to be taken The following environmentally hazardous substances are used Hydraulic fluid should not be released into the environment Hydraulic flu id causes long term harm to bodies of water Disposal mus...

Страница 86: ...e signage Over time labels may become soiled or illegible obscuring hazard warnings and preventing required instructions from being fol lowed Risk of injury may result if labels cannot be read 1 Always keep all safety warning and instruction signs in legible condition 2 Immediately replace damaged signs and labels 6 7 7 Warnings on the device TIPPING PATIENT SAFEGUARDS This warning is located to t...

Страница 87: ... of the OR table NOTICE The OR table cannot detect objects placed on the base cover Placing objects accessories on the OR table base can cause damage to the table and or accessories if the table surface is low ered or a collision occurs Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Safety 87 ...

Страница 88: ... dealers or directly from the manu facturer 6 7 9 Securing device during maintenance WARNING Risk of death through unauthorized or accidental power up ü Unauthorized or accidental power up of the device can cause serious injury and even death during mainte nance 1 Before turning the device back on make sure that all covers are installed and functional and that there are no hazards present 2 Always...

Страница 89: ... it on The sign must display the following information Turned off on Turned off at Turned off by Note Do not turn on Note Turn on only after it is certain that there is no longer a hazard Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Safety 89 ...

Страница 90: ...or to as sembly 7 2 Transport inspection Check the delivery immediately for completeness and any damage dur ing transport For obvious transport damage do the following Do not accept the delivery or accept it only conditionally Note the extent of the damage on the shipping documents or on the transporter s delivery note File a complaint by calling BERCHTOLD Technical Services at 800 243 5135 Option...

Страница 91: ...following conditions The construction of the forklift truck must be appropriate for the weight of the units under transport The item must be firmly secured to the pallet 1 Drive the forklift truck forward positioning the forks between or be neath the pallet rails 2 Drive forward until the forks protrude from the opposite side 3 If the center of gravity is off center make sure the pallet cannot ove...

Страница 92: ...Pa When storing for 3 months or longer periodically check the general condition of all components and the packaging Refresh or renew anti corrosion protection if applicable NOTICE Certain boxes may be labeled with storage instructions that are more extensive than the requirements cited here Follow them ac cordingly Storing packages Operator Manual Surgical Mobile Operating Table Models D860 D850 D...

Страница 93: ...e that all maintenance work has been performed and completed in accordance with the specifications and instructions in this operating manual 6 Ensure that no one is in the hazard zone 7 Ensure that all covers and safety equipment are installed and working properly 8 2 Maintenance schedule The following sections describe the maintenance work required for opti mal and trouble free operation of the d...

Страница 94: ...ectrical safety visual Monthly Operation of hydraulic system Every 6 months Ground continuity leakage current Every 6 months Flexible hydraulic lines Annually Condition of hydraulic fluid Annually or if a leak is suspected or if hydraulic components were re placed Fasteners and restraining clamps Annually Clamps and accessories Monthly accessories can be changed often Screws on the longitudinal sl...

Страница 95: ... covers that were removed have been reinstalled properly 3 Ensure that all tools materials and other equipment used have been removed from the work area 4 Clean up the work area including any materials that leaked out or dropped e g fluids processing materials and the like 5 Make sure all the safety equipment on the device is functioning prop erly Operator Manual Surgical Mobile Operating Table Mo...

Страница 96: ...icator light does not illu minate even though supply voltage is present at the wall Defective supply voltage fuse or short break in electrical cord Replace fuse or replace cord Contact BERCHTOLD Technical Services at 800 243 5135 Option 2 The hand pend ant will not turn on The OR table is off or the hand pendant is not connected prop erly Turn on the OR table Hand pendant does not work even throug...

Страница 97: ...unc tion using the Auxiliary hand pend ant and use the foot pump to pro vide hydraulic power Contact BERCHTOLD Technical Services at 800 243 5135 Option 2 Pump or control ler problem Contact BERCHTOLD authorized company Pump motor works but mod ules do not move Controller mal function Contact BERCHTOLD authorized company Emergency hand pendant does not work Emergency hand pendant defec tive or pro...

Страница 98: ...ounterclockwise 3 Pull out the foot pump pedal to the second end stop Foot pump is now activated and the main hand pendant id de acti vated 1 Push the pedal back into the table until the end reaches the base cover 2 Push the pedal further into the table until it snaps into position The foot pump is deactivated and the hand pendant is activated Activating the foot pump Deactivating the foot pump Em...

Страница 99: ...tored 1 Keeping it straight pull out the foot pump pedal to the first end stop 2 Turn pedal counterclockwise 3 Pull out the foot pump pedal to the second end stop Fig 4 Emergency release 4 Stick your finger into the opening where the pedal is stored and press the emergency release button The power supply on the magnetic valve is activated which releases the OR table and allows it to be moved as lo...

Страница 100: ...X PENDANT light on the Auxiliary hand pendant goes out 5 Return the Auxiliary hand pendant to its storage box 2 after use NOTICE The following functions will not work with the Auxiliary Hand Pendent Slide Level Chair and Flex 9 4 2 Auxiliary hand pendant D 820 D 760 The following prerequisites must be met The foot pump is activated The Auxiliary hand pendant is activated 1 To tilt the table press ...

Страница 101: ...ction 9 4 1 However it is perma nently attached to the column and does not have any indicator lights NOTICE The following functions will not work with the Auxiliary Hand Pendant Slide Level Chair and Flex Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Malfunctions 101 ...

Страница 102: ...mponents and tools lying around loose or atop one another are accidents waiting to happen 4 Disassemble components properly Components are heavy be careful Use hoists if necessary 5 Secure components from falling or over balancing 6 Always contact the manufacturer with any doubts or concerns 10 2 Disassembly Before you begin disassembly Switch off the device and secure it against switching back on...

Страница 103: ...ling of waste electronic and electrical equipment must be observed The packaging is made of environmentally sound materials NOTICE Danger to the environment due to improper disposal ü Improper disposal poses dangers to the environment 1 Lead batteries contain toxic substances and are subject to special waste handling Remove lead batteries after use and dispose of them as hazardous waste 2 Electron...

Страница 104: ...pes of monitors refer to the equipment manu facturers instructions to ensure compatibility issues are considered 2 When using the table in the vicinity of neurodiagnostic monitoring equipment interference may appear on the monitoring device To eliminate this if interference is present set the BACKLIGHT TIMER to 1 sec using the serv ice software 11 2 Guidelines and manufacturer s declaration Electr...

Страница 105: ...quality should corre spond to that of a typi cal commercial or hos pital environment Surges per IEC 61000 4 5 2 kV Countervoltage The supply voltage quality should corre spond to that of a typi cal commercial or hos pital environment 1 kV Asymmetrical volt age Voltage drops short interruptions and fluctuations in the power supply volt age per IEC 61000 4 11 VT AC line power voltage prior to use of...

Страница 106: ...ce im munity checks IEC 60601 test compliance level Electromagnetic envi ronment guidelines 5 VT t 5000 ms 95 dip Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Appendix 106 ...

Страница 107: ...tal protection 85 Exchanging sections 47 F Foot control optional 45 H Hydraulic fluid 85 I Installation conditions 16 Installation site 15 installing 16 Intended use 77 L Lead batteries 85 Leveling 42 Liability 9 Load capacity 74 Locking the OR table 32 M Maintenance 93 Malfunctions 96 Medical devices book 81 Misuse 77 O Operating conditions 74 Operating Manual 6 Operator 80 P Personnel requiremen...

Страница 108: ...t off 30 Switching the hand pendant on 30 Symbols in the instructions 7 T Transport 91 Troubleshooting tasks 97 U Unlocking the OR table 32 W Warranty 10 Operator Manual Surgical Mobile Operating Table Models D860 D850 D 830 D820 D770 D760 Index 108 ...

Страница 109: ...www BERCHTOLD biz Phone 843 569 6100 Phone 800 243 5135 Fax 843 569 6133 Manufactured by BERCHTOLD GmbH Co KG Ludwigstaler Straße 25 78532 Tuttlingen Germany Reprints even of excerpts prohibited We reserve the right to make changes in technology and design 57445 F S A 09 2014 ...

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