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Declaration of conformity

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Содержание Majestic II

Страница 1: ...REV 09 2018 USER S MANUAL AND TECHNICAL DESCRIPTION MAJESTIC II BED...

Страница 2: ...y and precise work of our employees our products and services are focused on ensuring the requirements of our customers and achieve their full satisfaction by providing safe reliable and consistent fu...

Страница 3: ...tic auto regression backrest system 29 11 Leg rest 29 12 Headboard and footboard 29 13 Side rails 30 a Split side rails adjustment 31 14 Central brake 32 15 Bed extension 33 16 Accessories 34 a IV pol...

Страница 4: ...9 Feet section adjustment 29 Figure N 10 Unblocking lever for headboard and footboard 30 Figure N 11 Insert spikes into structures 30 Figure N 12 Headboard footboard fixing 30 Figure N 13 Split foldin...

Страница 5: ...munity 1 14 Table N 6 Guide and manufacturer declaration electromagnetic immunity 2 15 Table N 7 Recommended separation distances between portable and mobile RF communications equipment 16 Table N 8 B...

Страница 6: ...rding to ISO 9001 2008 EN ISO 13485 2012 e ISO 14001 2004 According the requirements of rule EN 60601 2 38 an electric hospital bed must allow achieving Trendelemburg position even without power suppl...

Страница 7: ...original or not approved by the manufacturer accessories since they can affect the electromagnetic performance During maintenance or cleaning in the space between base and mattress adjustment controls...

Страница 8: ...r supply cable must be hold in a plastic hook placed in one of the bed ends or in other safe place to avoid cable entrapments that could damage it Do not push the bed over more than 2 cm height obstac...

Страница 9: ...used in application environments 1 and 2 When used in an application environment 3 the values are 20 kg for the mattress and 15 kg for accessories as well as the weight carried by the accessories Tab...

Страница 10: ...on Height with the mattress in his lowest and highest Maximum measures when packaged 220 108 Packaged Height 73 cm Without accessories Volume 2 40 m 3 NOTE Packaging measures can vary depending on acc...

Страница 11: ...llowing security systems EOP safety system electrical protection against overloads protects the actuator against overloads by disconnecting the current in case of overload during operation EAS safety...

Страница 12: ...id unsafe product situations the IEC60601 1 2 standard has been implemented This standard defines the levels of immunity to electromagnetic interference as well as the maximum levels of electromagneti...

Страница 13: ...MAJESTIC II uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Clas...

Страница 14: ...00 4 5 1 kV line to line 2 kV line to line 1 kV l nea a l nea 2 kV l nea a tierra The quality of the power network should be that of a typical commercial environment or that of a hospital Voltage drop...

Страница 15: ...ths from the fixed RF transmitter as determined by an electromagnetic study of the site should be less than the compliance level in each frequency range Interference can occur in the vicinity of the e...

Страница 16: ...2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For assigned transmitters with a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation appl...

Страница 17: ...itions o ABS side rails o Patient handset except with ABS side rails with embedded controls o Nurse panel o Safety GO button o Auto contour 11cm backrest 7 cm pelvis o Rechargeable long life battery o...

Страница 18: ...detachable C 3 Base 4 Four 150 mm wheels Central brake and steer 5 Accessories sockets for IV pole lifting pole Balkan beam etc 6 Easily detachable ABS footboard 7 Set of split side rails 4 units wit...

Страница 19: ...ect the bed to the power supply until at least 24 hours have elapsed to adapt it to indoor temperature conditions 7 Attach the accessories 6 To install both the lifting pole and the I V pole Place the...

Страница 20: ...on supply Otherwise the functions would be disabled b Equipotential connection Since it is possible to place the instruments connected to the patient intravascularly or intra cardiac the bed has a con...

Страница 21: ...e of the battery Battery should be charged approximately during 12 hours if it is completely run out Check the charging process on nurse panel If the bed is going to be unplugged during a long period...

Страница 22: ...is a risk of entrapment crushing cutting and or shearing of the user between the raised railings and the footboard While making these procedures check that there are no objects above or under the mat...

Страница 23: ...backrest and upper leg section auto contour Upper leg section and backrest can be adjusted synchronize both sections move at the same time up to Fowler position that it is achieved when both sections...

Страница 24: ...is pressed sections and height achieve their horizontal position and the bed goes down to its lowest position This function cannot be blocked The bed includes a system that allows lowering the backre...

Страница 25: ...caution to avoid damages while the bed is being adjusted Also be aware of the space around IV pole lifting pole and other accessories placed above mattress which will move when height is adjusted Whi...

Страница 26: ...Nurse panel 1 2 Backrest adjustment 3 4 Leg rest section adjustment 5 6 Height adjustment 7 8 Synchronized adjustment for back and leg sections auto contour 9 Trendelemburg 10 Reverse Trendelemburg 1...

Страница 27: ...o adjust any position Procedure to do it is the same as nurse panel 1 Check that the led on handset is on in Green colour This indicates that the handset is working 2 Press the selected key and mainta...

Страница 28: ...do not use it leave the bed without using and contact technical department Before CPR manoeuvre place the side rails in their lowest position Do not place hand between side rails and backrest while ho...

Страница 29: ...ich the rastomat will move freely Afterwards lower the section carefully until the restomat is locked on again Figure N 9 Footrest adjustment 12 Headboard and footboard MAJESTIC II bed is equipped wit...

Страница 30: ...structure until they Excel under the structure 4 Then fix the headboard footboard turning the red pieces towards the bed until they are completely placed under the structure and inserting the slots of...

Страница 31: ...amages There are available covers for side rails as optional accessory These provide additional protection against contact injuries with the handrails The use of these protective covers is recommended...

Страница 32: ...closer to the back section remains fixed in the longitudinal direction of the bed for an easier transfer of the same by pushing it from the foot end The steering feature is activated B Neutral positi...

Страница 33: ...accessories The length extension of the upper frame can be adjusted by means of telescopic guides and fixing points at both sides of the frame Both for extending and retracting this part manually rele...

Страница 34: ...9 Accesories list Model Dimensions Density Medicare 10 195x85x13 cm 25 kg m3 Medicare 20 195x85x14 cm 30 kg m3 Medicare 30 195x85x13 cm 50 kg m3 Medicare 40 190x85x15 cm 60 kg m3 Table N 10 Recommend...

Страница 35: ...ious risk of tipping the bed over That s why the lifting pole has only two correct positions defined by the socket Manufacturing date is placed in the triangle of the lifting pole It is convenient to...

Страница 36: ...keep the bed functioning correctly it must be cleaned disinfected and tested as soon as possible after each use so that it can be used immediately afterwards without risk Incorrect cleaning disinfecti...

Страница 37: ...s Disinfectant Company BACOBAN DESINFECTANTE BACOBAN WB DESINFECTANTE AGENOR EQUIPAMIENTO BACCLINIC DESINFECTANTE BACCLINIC TOWELBAC DESINFECTANTE PHARMABAC DESINFECTANTE SALLO KYRA S L F 66 SR DESINF...

Страница 38: ...infection All bed components set out in paragraphs 1 and 2 plus All internal components of the structure accessible Bottom of the bed 19 Maintenance All persons involved in maintenance or service must...

Страница 39: ...sure that there is no contact with the power supply during at least 20 minutes After power supply and battery disconnection This is to allow progressive self discharge of the condenser that could pos...

Страница 40: ...qualified jobs should be carried out by a professional service organization The user can request Medisa s Technical Service to perform a preventive check of the bed every twelve months Medisa will iss...

Страница 41: ...out using a cone defined in DIN EN 60601 2 52 The force used for the measurement of A must be at least 250 N Figure N 21 Functional check of side rails Table N 14 Dimensions Letra Descripci n Dimensi...

Страница 42: ...excessively tight or twisted The mains connection plug That the cable hooks are not damaged VI Cable Check The cable guides and that the connectors are correctly placed and do not present any damage...

Страница 43: ...Equipotential connection diagram 20 PROBLEMS AND SOLUTIONS The following table informs of the possible functional problems that users can solve by themselves Any maintenance responsible person should...

Страница 44: ...ke Brake system is worn Change wheels call Technical service Wheels don t turn correctly Dirty wheels Clean wheels Do not try to repair the electric motors during malfunction Do not open the motor pro...

Страница 45: ...al protected areas of buildings All the resulting residual packaging once the bed has been put into operation are marked according to the Packaging Law Order this waste according to the graphic symbol...

Страница 46: ...e manufacturer or the authorized service grants a guarantee which covers all their products for a period of two 2 years from the date of purchase During said guarantee period any defect affecting the...

Страница 47: ...ly authorised by this company proven miss use bumps drops exposure to degradable environments smoke fire neglect improper maintenance and in general any external cause to the product itself This guara...

Страница 48: ...maintenance staff and sanitary staff have been trained to use the bed Warranty period Date Customer sign and stam Supplier sign and stamp Ground terminal The product must be disposed according to dire...

Страница 49: ...cations MODEL Model of the bed in the example Galaxy 2 VOLT Tension and frequency in the example 230 110 V 50 60 Hz DESCRIP Description of the device In the example Electric hospital bed LOT Lot and s...

Страница 50: ...Page 50 28 Declaration of conformity...

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