Installation Instructions for the Manufacturer of the End Product

Installation Instructions for the Manufacturer of the End Product DUOMAT 7 Drive System CARE L - HOSP L Issue 11/2008 11/2008 ID No. 43698 DUOMAT 7 CARE L/HOSP L Contents General Information........................................................................................................ Designated use............................................................................................................... Prerequisites................................................................................................................... Getting to know the system............................................................................................ Fitting.............................................................................................................................. Operation........................................................................................................................ Maintenance and Repairs............................................................................................... Type Plate and Seal........................................................................................................ Design of the DUOMAT 7 Drive System......................................................................... Trouble-shooter’s Guide................................................................................................. Cleaning and care........................................................................................................... Manufacturer’s Declaration, Declarations of Conformity, Additional Information............ General Information These instructions are intended for the manufacturer of the end product and are not designed for passing on to operator of the end product. With regard to the specialist information contained herein, these instructions can serve well as a basis for drawing up the instructions for the end products. It is essential to note the information contained in these instructions! In doing so, you can prevent mistakes being made in installing or connecting the system which could result in... page 2 3 3 5 7 10 15 17 18 19 20 21 Ÿ injury and accidents as well as Ÿ Damage to the drive system or the end product. DEWERT accepts no liability for damage caused as a result of … Ÿ non-observance of these instructions, Ÿ alterations to the product not approved by DEWERT or ... Ÿ the use of spare parts not manufactured or approved by DEWERT - these may not ensure adequate safety! Due to the policy of ongoing product improvement, DEWERT reserves the right to carry out technical changes at any time without prior notification! 2 11/2008 ID No. 43698 1. Designated Use Ÿ for the disabled (CARE L version), Ÿ for the hospital sector (HOSP L version), Ÿ for the motorized adjustment of moveable bed parts using original DEWERT fittings and accessories. The DUOMAT 7 drive system is designed for installation in beds … The DUOMAT 7 drive system is not intended for use ... Ÿ in the proximity high-frequency surgical equipment and defibrillators, Ÿ in an environment where inflammable or explosive gases or vapours (e.g. Ÿ anaesthetics) are likely to occur, in a damp environment, i.e. outdoors nor in beds intended for cleaning in wash tunnels Caution! In the case of the CARE und HOSP versions only the standards expressly listed in the Additional Information (Page 23/24) have been correspondingly applied. In as far as standards/requirements to the end product must take additional measures to ensure that these are met. 2. Prerequisites The installation steps described in these instructions must be performed by a fully trained electrical engineer. Ÿ This being the case, you should never carry out this work yourself unless you are a qualified electrical engineer or Ÿ you should entrust this work to suitably qualified persons only. Conformity according to EC Directives The drive system is supplied ex factory as a machine not ready for use in accordance with the EC "Machines" Directive. In other words, you may not put the drive system into operation until you have met the safety objectives of the "Machines" Directive and issued a corresponding Declaration of Conformity! The drive system meets the safety objectives of the EC Directives concerning "Low voltage" and "Electromagnetic Compatibility (EMV)". 11/2008 ID No. 43698 3 DUOMAT 7 CARE L/HOSP L The drive system is not a medical product - for installing into same, manufacture in conformity with the EC Directive for "Medical Products" or other regulations is the responsibility of the manufacturer of the end product. For this purpose, in the case of the HOSP L and CARE L drive systems, DEWERT has additionally applied, fully or partially, a number of standards from the medical products sector, in order to facilitate use in medical products, e.g. EN 60601-1 EN 60601-1-2 EN 60601-2-38 EN 1970 Safety of Electromedical Equipment Electronicmagnetic Compatibility of Electromedical Equipment Safety of Hospital Beds (HOSP L version only) Adjustable Beds for the Disabled (CARE L version only) Caution! For your own safety! The CARE L/HOSP L versions with the handset type: IPROXX are "first error secure" without the blocking device (e.g. locking device, supervisor or IPROXX®SE). The CARE L/HOSP L versions with the handset type: MEDIX are also "first error secure" – and only then provided the functions to be safeguarded are blocked on the locking device/ supervisor. Please bear this in mind ® Ÿ on designing the construction of beds for areas where the Occurrence of unintentional movements must not prove harmful or hazardous Nonetheless, according to the specifications of the European Standards EN 60601-2-38, a blocking device is required for the "Hospital" sector. Shutdown in an emergency is achieved by pulling out the mains plug! The mains plug must therefore be accessible at all times when the system is in operation to ensure it can be quickly pulled out of the wall socket in an emergency. Ÿ If, despite pulling out the mains plug, movement continues due to the optional Ÿ battery backup system, this can be stopped in the CARE L/HOSP L versions by blocking all the functions on the locking device! If necessary, the plug can be pulled out of the battery unit, see page 8. Avoid subjecting the mains connection lead to mechanical loads. Regular visual checks of the mains connection lead should be carried out at short-term intervals and in particular each time it has been subjected to a mechanical load. If the mains connection lead of the DUOMAT 7 drive system gets damaged, it must be replaced in order to prevent hazards. Work to and replacement of the mains connection lead may only be carried out by specialist personnel holding the qualifications described on page 3 or by persons who have taken part and successfully completed the corresponding training programmes offered by DEWERT. In the Operating Instructions to be drawn up by yourselves, it is essential that you draw the operator’s attention to the points mentioned here. 4 11/2008 ID No. 43698 3. Getting to Know the System The DUOMAT 7 drive system is intended for the German market and complies with the Law applicable in Germany in implementation of relevant EC Directives. a) Product versions The drive system is supplied ex factory for the power-adjustment of the head and foot ends of a bed (DUOMAT 7). This version is also available with just one motor (MONOMAT 7). Slaves drives can be connected as optional extras, e.g. in order to allow power-adjustment of further bed elements. With a connectable slave drive and further connectable slave drives, the product is called TRIO/QUAD 7. All the information contained in these Installation Instructions apply to this product accordingly. Version Slave drives CARE MEGAMAT MEGAMAT P MULTIMAT B23 MEDIX CARE MEDIX CARE SB/SK IPROXX® IPROXX® SE1) Optional HOSP MEGAMAT MEGAMAT P Handsets MEDIX HOSP ® IPROXX ® IPROXX SE1) Blocking devices Locking device HOSP Supervisor HOSP IPROXX® SE1) First error security Function-LED Trendelenburg Anti-Trendelenburg (only with the optional battery backup system) Function First error security Function-LED 1) integral locking device 11/2008 ID No. 43698 5 DUOMAT 7 CARE L/HOSP L b) Technical data Power supply............................................... : Power consumption with rated load............ : Permissible compressive force....................: Permissible compressive force per side......: Fuse............................................................ : Operating mode at max. rated load.............: classification................................................: Noise level...................................................: Current input of all slave drives .................: Drive type.................................................... : Drive options............................................... : Stroke (other strokes on request)............. : Adjustment speed .....................................: Protection category......................................: Colours........................................................: Dimensions and weights Length x width of the drive.......................... : Axle base.....................................................: Weight......................................................... : Technical data of battery backup system Voltage........................................................ : Capacity.......................................................: Fuse............................................................ : Battery type................................................. : Ambient and storage conditions Room temperature...................................... : Rel. humidity................................................: Barometric pressure....................................: 2 x 12 VDC 1.2 Ah (with new batteries)) T 15 A Lead battery from +10° to +40° C from 30% to 75% from 700 hPa to 1060 hPa 750 x 175 mm 750 x 190 mm with "Emergency Release" 581 mm approx. 6.3 kg (without battery backup system) 4) 3) 2 100 / 110 / 115 / 120 / 230 / 240 VAC 50-60 Hz 0.63 A AC - 3.15 A AC (depending on mains voltage and load) max. 7000 N (double-sided) max. 3500 N T 0.63 A – T 3.15 A (depending on mains voltage) intermittent duty AB 2 min./18 min. Protection I or II 65 dB(A) max. 7.5 ADC dual drive MONOMAT / DUOMAT / TRIOMAT / TRIO/QUAD / QUADROMAT 87 – 69 (standard) / 87 – 87 / 69 – 69 mm from 3 to 5.5 mm/s IP44 see sales brochure 1) Operating mode = intermittent duty AB 2 min./18 min., i.e. run for 2 min. max. under rated load, then a rest period of 18 min. must be observed, otherwise operational failure could occur! According to regulations, no more than two drives may be run simultaneously at the rated load! Stroke = maximum distance that the push block travels from the starting position in the retracted state to the end position in the extended state. Adjustment speed = speed at which the push block travels without load (speed varies according to the load) 2) 3) 4) 6 11/2008 ID No. 43698 4. Fitting Caution! Only ever connect or disconnect electrical components when they are voltage-free. Included in the supply package is the drive and depending on the order a handset, a locking device or a supervisor and one or two slave drives. The components are prewired and receive plugs/ready to plug in. If the optional battery back up system is part of the order, it is already attached and connected to the drive at the factory. When unpacking, take care not to damage the cable of the battery backup system. Caution the battery backup system contains a residual charge! During installation take care not to activate a function on the handset inadvertently the residual charge could otherwise cause the drive to operate! a) Installation Applying slight force, pull out engaged closer (1) until receivers (2) for the linkage levers are exposed. (2) (1) (2) (1) DUOMAT 7 Push the DUOMAT 7 with the receivers (2) onto the mounting (3). Note: this is only possible, however provided the application has travelled to the starting (home) position. (3) (3) Application (2) (2) DUOMAT 7 Slide the closer (1) back again until they engage. (1) (1) DUOMAT 7 11/2008 ID No. 43698 7 DUOMAT 7 CARE L/HOSP L b) Electrical connection In the Operating Instructions to be issued by you, point out to the operator that if leads, in particular the mains connection lead, are driven over they could sustain damage. Mechanical loads should also be avoided. When routing the cables make sure that they Ÿ cannot get entangled or trapped, Ÿ are not subjected to mechanical loads (i.e. do not pull, apply pressure or bend), Ÿ cannot get damaged in any other way. Make sure that the cables, in particular the mains connection lead, are fastened to the bed with adequate strain relief and kink protection and that suitable constructional measures prevent the mains connection lead from trailing on the floor when the bed is being moved. First connect the slave drives and controls, as shown (see page 18). Make sure that any sockets not being used are sealed off with blind plugs (protection against spray water IP44). If you intend connecting an external battery (e.g. for emergency lowering), engage the battery in the holder provided (see page 18, pos. 5) If necessary, remove the cap and blind plug from the socket designated for the battery backup system and connect the lead for the battery backup system there. Then fasten the cap over the plug using the enclosed screws (2). 3 1 2 In order to properly fit cap (1) on the DUOMAT 7 (3), slot on cap (1) as shown and fasten in place using the two enclosed screws (2). In order to shut down the drive in an emergency, remove screws (2), pull off cap (1) and pull out the plug from plug-in station no. 5 (see page 18). 8 11/2008 ID No. 43698 c) Dismantling Loosen the screws, remove the cap and then the leads from the respective plug sockets. Drive the application in basic position, support the drive before opening the closer - once these are open, the drive is released immediately! Make sure that the closer re-engage so that they cannot get lost. Caution! For your own safety! For drive systems incorporating a built-in battery backup system it is not simply sufficient to pull out the mains plug! Due to residual charge in the battery, the drive can still start up even if the mains plug has been pulled out! Therefore, in addition to pulling out the mains plug, also pull out the plug for the battery backup system, as described on page 8. Removing the mechanical connections between the mounting and drive system before the bed has been allowed to travel back to the horizontal starting position, presents a trap risk and hence a potential injury hazard. Before opening the closer, it is therefore essential to allow the bed to first travel back to the horizontal starting position! 11/2008 ID No. 43698 9 DUOMAT 7 CARE L/HOSP L 5. Operation For drawing up the Operating Instructions for the end product, you can use the specialist information described herein. Please bear in mind that these instructions are intended for you as a specialist and not for the possibly nonprofessional operator of the end product. a) Prerequisites The functions of adjustment keys are only available provided these are not blocked on ® the locking device, the supervisor or the IPROXX SE. In certain circumstances it may be advisable to block functions in order to prevent specific movements being carried out. Only in the CARE L and HOSP L versions... Ÿ does the function LED indicate that a key has been pressed ... An error (first error) has occurred if Ÿ the LED does not light up when a key is pressed, Ÿ the LED glows permanently The drive system must then be replaced immediately! b) Accumulator (optional) If you have acquired the DUOMAT 7 drive system with a battery backup system for emergency lowering, please note following: Ÿ Charge the battery (mains plug in the wall socket ) for at least 10 hours before first time use. Not until then is the emergency lowering facility fully functional. Ÿ Should the battery backup system have been used for emergency lowering, it must then be charged until the signal is given that it is again ready for operation. Futher informations see installation instructions of lead accumulator AG 7 / AG 300. 10 11/2008 ID No. 43698 c) Emergency Release “ER” (optional) If you have acquired the DUOMAT 7 with Emergency Release, please note the following: Ÿ Aided by the “Emergency Release” you can mechanically lower the backrest / Ÿ Ÿ legrest in an emergency. You must first relieve the backrest / legrest, e.g. by lifting the correctly lever. With the backrest / legrest in the no-load state, operate the “Emergency Release” lever, hold lever in this position (fig. below) and lower the backrest / legrest. Caution: Depending on backrest / legrest version, it is possible that the backrest / legrest could lower itself under its own weight. If backrest / legrest is not possible to sink down with own weight, you must press down the right side of application. Ÿ After activating the “Emergency Release” and re-operating the drive system, the release coupling automatically engages. The drive system is then operational again. Attention! In conjunction with the release (“ER“ version), it is absolutely imperative that mechanical limit stops are installed in your end product at the bottom end-of-travel position, in order to prevent mechanical damage to the drive system. Emergency Release “backrest” Direction of pressure 11/2008 ID No. 43698 11 DUOMAT 7 CARE L/HOSP L d) Handset (example) The IPROXX® handset is also offered with an integral blocking device via a magnetic lock ® and is then called IPROXX SE. This can be equipped with up to 10 adjustment keys. The keys are explained as follows: Function LED Backrest up down Foot rest up down Reset back + foot Stroke adjustment up down up down LED mode magnetic lock Example: IPROXX SE ® There is a fault/first error in the integral blocking device, Ÿ if the mode LED glows in the blocked state Ÿ if the mode LED does not glow in the released state Ÿ if on pressing an adjustment key in the blocked state (mode LED) a change in the light intensity (mode LED) is visible The function corresponds to the arrows underneath the pictograph: UP or DOWN. The handset also features a function LED. This lights up when a function is being carried out. If the function LED does not light up when a key is pressed or it glows constantly, without a key having been pressed, this indicates an error. The drive system must then be replaced immediately. Passing the enclosed magnet over the lock symbol´s magnet, blocks or releases the adjustment keys. The released state is indicated by the mode LED glowing. Check the blocked adjustment keys (mode LED does not glow) by pressing the corresponding adjustment key on the handset. The drive should be immobilized. Note: keep the handset away from magnetic objects and strong magnetic fields (>= 1 mT). The integral blocking device can be activated or deactivated. Further information on trouble-shooting can be found on page 20. 12 11/2008 ID No. 43698 f) Locking device (Example) Blocking switch blocked released Backrest blocked Foot rest blocked Stroke motors blocked Example of a control box with 3 blocking switches and 2 adjustment keys Adjustment keys for the TrendelenburgFunction Only permissible for DUOMAT 7 HOSP L To guarantee first error security, you can block the drive movements via the locking device: Ÿ Turn the blocking switch to the "blocked" position. Ÿ Check that the function is blocked by pressing the corresponding adjustment key Ÿ on the handset. The drive should be immobilized. If movement is carried out, the drive system must be replaced immediately. The locking device features the same pictographs as on the handset, i.e. the depicted function is blocked by the blocking switch. Blocking is symbolized by a closed shackle lock. Furthermore, the locking device in the CARE L and HOSP L versions features up to 3 adjustment keys which by way of example (depending on the version) can initiate Trendelenburg or other functions. Blocking the other functions is possible by blocking the backrest, foot rest and/or the stroke motors (height adjustment). 11/2008 ID No. 43698 13 DUOMAT 7 CARE L/HOSP L f) Supervisor (Example) Blocking switch Adjustment keys Release key Example of a Supervisor with 3 blocking buttons and 3 adjustment functions Trendelenburg The supervisor control system gives the hospital/care staff over the DUOMAT 7 drive system in the CARE L and HOSP L versions. To ensure first error security, proceed as follows: Ÿ Turn the blocking switch to the "blocked" position. Ÿ Check that the function is blocking by pressing the corresponding adjustment key Ÿ on the handset. The drive should be immobilized. If movement is carried out, the drive system must be replaced. The supervisor allows the bed to be adjusted as well as the adjustment functions to be blocked. The supervisor has been designed as a two-hand control, thereby making it impossible to actuate adjustment inadvertently. It is only possible to initiate adjustment via key provided one of the two release keys, represented by the symbol on the left, has been pressed. 14 11/2008 ID No. 43698 g) Maintenance and Repairs At regular intervals carry out the inspections in accordance with the BGV A3. The inspections must be performed by an electrical specialist. The recommended inspection period is: 6 months In addition to the above, the following checks should be carried out at shorter intervals: Ÿ Regular visual checks for damage of all kinds Check the housing for cracks and fractures and the mains connection lead for signs of pinching and shearing-off. Also check the strain relief with kink protection, in particular after each case of mechanical loading. Ÿ Regular checks of the protective conductor resistance and leakage currents (by a specialist) Ÿ Regular functional checks of the auto diagnostic system Operate the drive to travel to the end-of-travel positions, in doing so check whether the function LED on the handset lights up. Check the function of the blocking device as described on pages 12 to14. Ÿ Regular checks of the battery backup system to ensure its readiness for operation (in as far as battery backup system included). With the drive system disconnected from the mains, but with batteries fully charged, operate the drive to travel to the bottom end-of-travel position. If it is not possible to do this, the batteries must be replaced. Ÿ The battery backup system must be checked once a month to ensure its readiness for operation! (in as far as battery backup system included) Ÿ Regular functional testing of the “Emergency Release” by actuating the release lever, as described on page 11. 11/2008 ID No. 43698 15 DUOMAT 7 CARE L/HOSP L Changing the mains connection lead and/or primary fuse Work to mains connection lead and replacement of same may only be carried out by specialist personnel holding the qualifications described on page 3 or by persons who have taken part and successfully completed the corresponding training programs offered by DEWERT. After correctly changing the mains connection lead, check for safety and proper function. Ÿ Disconnect the drive from the mains (pull out the mains plug). Ÿ Loosen the fastening screws on the mains connection cap (see bottom of page 16). Ÿ Carefully pull the mains connection cap out of housing (take care with flat gasket!). Ÿ Using a suitable tool, pull the flat plug of the mains connection lead from the fuse cartridge. Ÿ Change the mains connection cap with the mains connection lead or fuse(s) Ÿ Slot the flat plug of the mains connection lead back on again. Ÿ Slot the mains connection cap, correctly positioned with the flat gasket, back on again Ÿ Retighten the fastening screws on the mains connection cap. Fastening screws 16 11/2008 ID No. 43698 6. Type Plate and Seal Each drive component carries a type plate giving the exact designation, item number and technical specifications (for explanation see following figure as an example). Application Range Type designation Primary voltage max. primary current TRIO/QUAD 7 CARE L 38916 Item number Intermittent duty 2 minutes/ 18 minutes 230V 50Hz max. 1,0A AB (Intermit.Operation) 2min / 18min max. Druckkraft (Force): 7000N (je Seite max. (max. Per side) 3500N) Baujahr (Prod.Date): 05/07 Seriennr. (Serial-No.): D123456 0001 IP44 Hub (stroke): KOPFTEIL (Head) 87 FUSSTEIL (Feet) 69 A Phoenix Mecano Company DEWERT DEWERT logo Stroke specification for head and foot ends Graphical Symbols Conformity marks Protection classification II Application part of Type B In order to guarantee the safety of DEWERT products, a seal is attached to all DEWERT products. Opening the product damages the seal, thereby indicating that the drive has been altered or tampered with. The drive may only be opened by specialist personnel holding the qualifications as described on page 3. IP44 Protection category Do not dispose of with the normal household waste! Dual system Use in dry rooms only 11/2008 ID No. 43698 17 DUOMAT 7 CARE L/HOSP L 7. Design of the DUOMAT 7 CARE L/HOSP L Drive System (Example) (Figure: DUOMAT 7 as QUADROMAT 7 with 2 slave drives) 6 1 5 2 3 4 7 Only connect the components as shown! This can otherwise result in demage to the drive control unit! Pos. 1 Part designation DEWERT short circuit plug (option: only with the CARE version) Locking device only with the HOSP version DEWERT slave drive DEWERT handset DEWERT slave drive DEWERT battery backup unit DUOMAT 7 dual drive Emergency Release Description Required if neither locking device nor supervisor are connected Blocking function e.g. MEGAMAT ... Version depends on application ® range (e.g.: IPROXX ) e.g. MEGAMAT ... AG 7 attachable, optional QUADROMAT version mech. emergency lowering On the optional earthing bolt (protection classification I) you can connect your bed to the mains protective conductor. This is marked by an earthing symbol. The connection lead is not included in the supply pack. 2 3 4 5 6 7 18 11/2008 ID No. 43698 8. Trouble-shooter’s Guide to Detect and Eliminate Faults/Errors The following table has been developed to help you detect and eliminate common faults and errors. If you come across a fault/error that is not listed here, please contact your supplier. All of these faults/errors may only be inspected and rectified by specialists holding the qualifications as described on page 3. Problem Handset or drive system without function Drives suddenly no longer respond, no movement takes place Possible Cause - Handset or drive system defective - No supply voltage - Thermoswitch on transformeror in the control unit has been triggered Remedy - Contact your supplier/dealer - Leave the drive system in rest. position for approx. 20-30 minutes - Contact your supplier/dealer - Temperature fuse in transformer defective - Miniature fuse defective - Feeder cable (mains and/or handset/ - Check the feeder cable, if necessary restoring contact slave drives) interrupted Permanent or longer- - Control unit is defective sounding waring signal (CARE/HOSP only) Functions LED in the - Fault in the control system handset does not light - End-of-travel position reached up when keys pressed or glows constantly - Blocking switch on locking device/ (CARE/HOSP only) Supervisor or IPROXX® SE set at "blocked” - Fault in the handset IPROXX® SE: Mode LED lights up in the blocked state Mode LED does not light up in the released state No movements can be carried out - Handset is blocked. (after a power failure, the IPROXX® SE handset automatically switches to the blocked state) - Contact your supplier/dealer - Contact your supplier/dealer - Operate drive to move from the end-of-travel position - Release the blocking switch - Contact your supplier/dealer - Use the magnet to release The handset 11/2008 ID No. 43698 19 DUOMAT 7 CARE L/HOSP L 9. Cleaning The DUOMAT 7 drive system has been designed to facilitate cleaning for the user, and this has been made even easier thanks to the large number of flat surfaces. The DUOMAT 7 drive system should be cleaned with a proprietary cleaning agent suitable for polyamid 6 using a damp cloth. Always note the instructions provided by the manufacturer of the respective cleaning agent used. Before cleaning, always pull out the mains plug! Never clean the drive system in a wash tunnel or with a high-pressure cleaner nor spray liquids onto it. You risk damaging the equipment! When cleaning take care not to damage the drive system’s mains connection lead! The drive system only offers protection against spray water (classification IP44). Do not use any solvents such as benzene, alcohol or similar substances. 10. Disposal The DUOMAT 7 drive system contains electronic components, cables, metal, plastic etc. The DUOMAT 7 drive system should be disposed of in accordance with the environmental regulations applicable in the respective country. Information on this subject can also be obtained from: Federal Association for Disposal Management BDE Behrenstraße 29 D-10117 Berlin Germany Phone: +49 (0) 30-59 00 33 5-0 www.bde-berlin.de Notes on environmental directives and legislation Ÿ The product complies with the European Directive 2002 / 95 / EC (RoHS as of 01.07.2006). Ÿ The product is not subject to the European Directive 2002 / 96 / EC (WEEE) and its amendment EU Directive 2003 / 108 / EC. In as far as this product includes batteries, this complies with Ÿ the Battery Ordinance of 27th March 1998 (BGBI. I S.658) Accumulators are to be disposed of in line with the AltBattVO. Drive systems and accumulators may not be disposed of with the normal household waste! (Ordinance on Disposal of Old Batteries). 20 11/2008 ID No. 43698 EC Manufacturer’s Declaration According to Appendix II B of the EC Machines Directive (98/37/EEC) The Manufacturer: DEWERT Antriebs- und Systemtechnik GmbH Weststr. 1 32278 Kirchlengern Germany hereby declares that the drive system described below DUOMAT 7 CARE L/HOSP L is not a ready-to-use machine in keeping with the EC Machines Directive and, therefore, does not fully comply with the requirements of the Directive! This machine may not be put into operation until conformity with the above Directive of the entire machine, into which it is to be installed, has been declared! Partially applied harmonized standards: EN 292-1 Safety of Machines, Basic Terminology, Methods EN 292-2 Safety of Machines, Guiding Technical Principles Kirchlengern, 25th November 2008 Andreas Roither Managing Director R&D and Engineering 11/2008 ID No. 43698 21 DUOMAT 7 CARE L/HOSP L EC Declarations EC Declaration of Conformity according to appendix IV of the EC Directive on Electromagnetic Compatibility 2004/108/EEC, according to appendix III of EC Low-Voltage Directive 2006/95/EEC The Manufacturer: DEWERT Antriebs- und Systemtechnik GmbH Weststr. 1 32278 Kirchlengern Germany hereby declares that the drive system described below DUOMAT 7 meets the following EC Directives: Directive on Electromagnetic Compatibility 2004/108/EEC Low-Voltage Directive 2006/95/EEC Applied Standards: EN 60335-1 EN 55014-1 EN 55014-2 EN 61000-3-2 EN 61000-3-3 EN 50366 (measurement distance: 5cm) Constructional changes which affect the technical data stated in the Installation Instructions as well as the designated use, in other words which change the drive system in a considerable way, make this Declaration of Conformity null and void! CARE L/HOSP L Kirchlengern, 25th November 2008 Andreas Roither Managing Director R&D and Engineering 22 11/2008 ID No. 43698 Additional Information DUOMAT 7 drive system (see system overview) For the CARE L und HOSP L versions the following standards were applied Based on EN 60601-1:1990 +A1:1993 +A2:1995, Electromedical Equipment EN60601-1, main section 2 EN60601-1, main section 3 EN60601-1, section 21 EN60601-1, main section 7 EN60601-1, main section 9 EN60601-1, main section 10 EN60601-1, section 56.8 Environmental Conditions Protection against Electrical Shock Hazard Mechanical Strength Protection against excessive temperatures Operation outside the requirements and faults cases Constructional requirements Power supply indicator not available For the CARE version the following standards were applied Based on EN1970:2000 Beds for Disabled EN1970, in part section 4 - Unintentional movement: Prevention via blocking device (e.g. Locking device or MEDIX SK CARE or MEDIX SB CARE) or ® IPROXX - Lowering of the backrest using a battery backup system or lowering of the back rest using a mechanical release - Operator’s control with keypad Dimensions of control unit Operating forces of electrical functions Function speeds (head/foot end adjustment) Electrotechnical requirements Protection category IPX4 Electromagnetic compatibility EN1970, section 5.5.8 EN1970, section 5.6 EN1970, section 5.7 En1970, section 5.11 EN1970, section 5.12 11/2008 ID No. 43698 23 DUOMAT 7 CARE L/HOSP L Additional Information Duomat 7 drive system (cont.) For the HOSP L version the following Standards were applied Based on EN60601-2-38:1996 +A1:2000, Power-operatedHospital Beds EN60601-2-38, section 5.2 EN60601-2-38, section 5.3 EN60601-2-38, section 22.2.102 EN60601-2-38, section 22.4.101 EN60601-2-38, section 36 EN60601-2-38, section 52.4 EN60601-2-38, section 52.5 Classification of application part Protection category of the system: >= IPX4 Blocking device: Control box, Supervisor or IPROXX SE Control unit with keypad Electromagnetic compatibility Unintentional movement First error (electrical): Prevention via blocking device or ® IPROXX Failure of subassemblies: prevention via blocking device Failure of electrical components Tilting of the backrest and Trendelenburg in the event of a power failure: Use of a battery backrest system or use of a mechanical release Lighting (not required) Mains connection lead Mains plug ® EN60601-2-38, section 52.5.9 EN60601-2-38, section 52.5.101 EN60601-2-38, section 52.5.102 EN60601-2-38, section 56.8 EN60601-2-38, section 57.3a) EN60601-2-38, section 57.3.101 24 11/2008 ID No. 43698 Notes 11/2008 ID No. 43698 25 DUOMAT 7 CARE L/HOSP L Notes 26 11/2008 ID No. 43698 Notes 11/2008 ID No. 43698 27 DEWERT Antriebs- und Systemtechnik GmbH Weststraße 1 32278 Kirchlengern Germany Phone:+49(0)5223/979-0 Fax: +49(0)5223/75182 http://www.dewert.de Info@dewert.de 11/2008 ID No. 43698