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Medifa 5000, User Manual

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Medifa 5000 User Manual Download Page 15

15

User manual for medifa 5000 operating table Version 2.1

Symbols used

8.2 

Symbols on the transport packaging

On the transport packaging, there are various symbols related to handling.

Element / symbol

Description

 Temperature range for storage and transport -20 °C to 50 °C. 

 Relative humidity for storage and transport 10% to 95%.

 Air pressure for storage and transport 70 kPa to 106 kPa.

Protect transport packaging from moisture.

Read the user manual.

Protect against sunlight.

Manufacturer information.

Observe instructions for disposal.

Data matrix code (UDI carrier).

Medical product.

Production period.

Article number.

Serial number.

The device is declared compliant according to 2017/745 ordinance.

+50°C

10%

-20°C

70 kPa

106 kPa

95%

Summary of Contents for 5000

Page 1: ...medifa 5000 Mobile operating tables User manual for the 501130 501135 models Version 2 1 EN ...

Page 2: ......

Page 3: ...ls 9 5 Safety instructions and user obligations 10 5 1 General safety instructions 10 5 2 Measures to be taken prior to each use 10 5 3 Infection prevention 10 5 4 High frequency HF surgical devices and defibrillators 11 5 5 Maintenance and repair 11 5 6 Service life 11 6 Intended use 12 6 1 Intended users 12 7 Type label 13 8 Used icons 14 8 1 Symbols on medifa 5000 14 8 2 Symbols on the transpor...

Page 4: ...ng the split leg plates 22 12 5 Removing split leg plates 23 12 6 Connection of the potential equalisation cable 23 12 7 501135 24 13 Positioning of patient 25 13 1 Preparing medifa 5000 for patient positioning 25 13 2 Positioning the patients 25 13 3 Height adjustment 26 13 4 Trendelenburg Anti Trendelenburg 27 13 5 Lateral adjustment 28 13 6 Backrest adjustment 29 13 7 Triggering the driveabilit...

Page 5: ...re Code 34 17 Technical data 36 17 1 Dimensions weights and load limits 36 17 2 Adjustment range 36 17 3 Classification 36 17 4 Environmental conditions for operation storage and transport 37 18 Delivery unpacking and installation 38 18 1 Delivery 38 18 2 Unpacking and installation 38 19 Accessory list 39 20 Disposal 40 Table of contents ...

Page 6: ...7 0 Service hotline 49 2721 7177 410 Fax 49 2721 7177 255 info medifa com www medifa com 1 5 Copyright statement This user manual including all figures is subject to copyright The transmission and reproduction of this docu ment as well as the exploitation and communication of its contents are unless expressly permitted prohibited Contraventions shall impose an obligation to compensation for damage...

Page 7: ...ment design and production at medifa have been certified according to DIN EN ISO 9001 and DIN EN ISO 13485 The products comply with the requirements of the EU Medical Device Regulations MDR and bear the CE label The operating table consists exclusively of high quality materials with a long service life medifa offers a wide range of accessories to meet your requirements Periodic maintenance by our ...

Page 8: ... taking into account the professional qualifications The user manual must be strictly observed and must be available at the place of use ATTENTION Using the operating table is safe Remaining residual hazards are indicated at the relevant points in the user manual Please observe these instructions 3 1 List of abbreviations Abbreviation Description CE European Community derived from the French Commu...

Page 9: ...ed will result in death or serious injury WARNING WARNING indicates a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION CAUTION indicates a potentially hazardous situation which if not avoided could result in minor or moderate injury ATTENTION Indication of harmful situation with the possible consequences the device or something in its vicinity co...

Page 10: ...under Intended use When operating medifa 5000 the factors specified under Technical Data must be observed For the intended and safe use of additional equipment the corresponding user manual for this additional equipment must be followed Instructions to users and or patients All serious incidents relating to the device must be notified to the manufacturer and the competent authority of the Member S...

Page 11: ... that the patient does not come into contact with wet cloths or underlays Use only dry materials 5 5 Maintenance and repair To avoid failure faults and to ensure operational safety annual maintenance must be carried out so that the functioning is fully maintained It is recommended to hire a medifa certified service technician for this mainte nance procedure Repairs Repairs may only be carried out ...

Page 12: ...he manufacturer or by other persons authorised by the manufacturer This user manual must be followed for the intended use of the medifa 5000 Any other use of medifa 5000 shall be deemed to be not in compliance with the intended purpose The supplier manufacturer shall not be liable for personal injury or damage to property as a result of improper operation or use Only accessories from the Accessori...

Page 13: ...Type label The type label is located at the foot of the frame above the column Element symbol Description Manufacturer details and contact information Production period Article number Serial number Data matrix code UDI carrier Details of unladen weight and maximum additional load Degree of protection against electric shock application part type B Observe the safety instructions in the accompanying...

Page 14: ...removed or covered by other objects Damaged or detached warning symbols must be replaced according to the specifications 8 Used icons Used icons Symbol Description Danger of crushing Do not sit Risk of injury due to tilting of the medifa 5000 medifa 5000 may only be operated on surfaces with an inclination of max 5 Connection for potential equalisation Adhere to the user manual Fig 2 Warning stick...

Page 15: ...20 C to 50 C Relative humidity for storage and transport 10 to 95 Air pressure for storage and transport 70 kPa to 106 kPa Protect transport packaging from moisture Read the user manual Protect against sunlight Manufacturer information Observe instructions for disposal Data matrix code UDI carrier Medical product Production period Article number Serial number The device is declared compliant accor...

Page 16: ... the medifa 5000 are aligned Do not insert any sharp edged objects into the padding or place them on the padding Do not attach adhesive foils The paddings are available in SF or PUR version The padding is attached to the padded plate with stud mount ing holes 9 Padding 9 1 SF padding The padding is made of 80 mm thick viscoelastic foam with a 3 fold sandwich construction and a non remova ble elect...

Page 17: ...the padding upwards 9 3 Attaching the padding Padding 1 Place the padding on the padded plate press the bushings in the padding onto the stud mounting holes 1 on the padded plate 2 Check if the padding is securely held on the oper ating table The padding must be fixed exactly on the padded plate 9 4 Removing the padding ...

Page 18: ...an slip away which poses the risk of inserted cannulas being pulled out m1 M M L L1 1 L L2 2 m2 M MQ Q Figure 3 Torque on standard rail The maximum permissible torque on a standard rail of the medifa 5000 is 70 Nm around the longitudinal axis and 100 Nm around the transverse axis The torque is applied as soon as an accessory is coupled to the standard rails The dead weight of an accessory used can...

Page 19: ... mm Choice of SF padding H 80 mm or PUR padding H 60 mm electrically conductive removable radiolucent Four Ø 125 mm twin castors with central braking system electrically conductive two castors with directionally stable locking Floor space L x W 920 mm x 520 mm Article no 501135 has a longitudinal shift of up to 310 mm 11 Features and functions Figure 4 Model 501130 No Name 1 4 twin castors lockabl...

Page 20: ... Features and functions Figure 5 Model 501135 11 3 Model 501135 No Name 1 Release button for triggering the relocating capability Model 501135 has the same functions as model 501130 see Fig 4 plus an additional longitudinal shift of the table top by up to 310 mm ...

Page 21: ... 1 Insert the two square bolts of the head plate into the square openings on the table 2 Hold the head plate and tighten the black star knob screws 1 on both spars of the table 1 Hold the head plate and pull the release lever 2 at the head end upwards 2 Hold the head plate and move it to the desired position 3 Release the release lever 2 The head plate is locked in the end position 1 Hold the head...

Page 22: ...cking lever 1 upwards 2 Hold the leg plate and tighten the release lever 1 on the table downward to secure the leg plate to the table 1 Hold the leg plate and pull the release lever up under the foot end of the leg plate 2 Hold the leg plate and move it to the desired position with the release lever 2 tightened 3 Release the release lever 2 The leg plate is locked in the end position 1 Loosen the ...

Page 23: ...qualisation line to the potential equalisation of the operating room This must be done according to VDE 0107 or the corresponding national regulations Figure 6 Potential equalisation pin 12 6 Connection of the potential equalisation cable Initial commissioning 12 5 Removing split leg plates 1 Hold the leg plate and turn the release lever on the table upward 2 Pull the leg plate out of the square o...

Page 24: ... if Trendelenburg is horizontal and the leg plate s is are not in the negative range The position of the backrest can be disregarded here The table top may only be relocated in direction B if Trendelenburg is horizontal and the backrest is not in the negative range The position of the leg plate s can be disregarded here The 61125 and 63000_1 accessories may only be used if the operating table is n...

Page 25: ...ck fastening elements for secure fit CAUTION Patient hazard monitor patient position To avoid injuries the position of the patient on the medifa 5000 must be monitored permanently Incorrect loading can cause plate segments to break off the medifa 5000 or the medifa 5000 can tip over The ascending or descending may only be carried out in the area of the lifting column via the seat plate Do not step...

Page 26: ...on it Adjustment range 750 mm to 1000 mm CAUTION Patient hazard The ascending or descending may only be carried out in the area of the lifting column via the seat plate Do not step over the plate segments when on or off the medifa 5000 CAUTION Patient hazard When the table top is lowered it may collide with the bogie the floor or other objects which are located under the table top and which are po...

Page 27: ... s body weight CAUTION Patient hazard due to danger of collision When the table top is tilted Trendelenburg Anti Trendelenburg position it may collide with the lifting col umn the floor or other objects which are located under the table top and which are possibly covered by cloths or documents To avoid the risk of all movements monitor the table top continuously Clear the area under the table top ...

Page 28: ...he basin section The movement of the lying surface is performed by turning the crank Adjustment range 20 to 20 CAUTION Hazard Operation with both hands is absolutely necessary for safety reasons since the operator must exert his her own body strength for adjustment depending on the patient s body weight WARNING Risk of personal injury due to tilting of the medifa 5000 medifa 5000 may only be opera...

Page 29: ...eased and by slightly lifting or lowering the back plate at the head rest section end the adjustments are made Releasing the lever locks the backrest position Adjustment range 40 to 70 CAUTION Risk of injury Operation with both hands is absolutely necessary for safety reasons since the operator must exert his her own body strength for adjustment depending on the patient s body weight Positioning o...

Page 30: ...iveability The driving situation is controlled via the operation shackle 1 Upper position operating table is di rectionally stable because the foot side castors are directed straight ahead Middle position operating table can be moved in all directions as all castors are freely movable Lower position brake is put on the operating table ...

Page 31: ...ld the accessories on the medifa 5000 or remove them from the medifa 5000 3 Always move the table top to the lowest position 4 Disconnect the potential equalisation line ATTENTION Damage to the cables Before moving the medifa 5000 disconnect the potential equalisation line from the medifa 5000 Do not roll over or crush the potential equalisation line when moving the medifa 5000 1 Release the parki...

Page 32: ...gulations for the medical sector and or be included in the list of the German Society for Hygiene and Microbiology Verbund für Angewandte Hygiene e V Association for Applied Hygiene Clean contaminated products immediately Cleaning disinfection is limited to regular wiping not immersing with suitable agents 15 1 Cleaning For cleaning stainless steel and plastic parts use a pH neutral or slightly al...

Page 33: ...alin protect 2 Schülke Mayr GmbH Incidin Pro Ecolab GmbH Incidin Plus Ecolab GmbH Incidin Active 3 Ecolab GmbH Incidin OxyWipe S Ecolab GmbH Hexaquart lemon fresh 2 B Braun Melsungen AG Meliseptol foam pure undiluted B Braun Melsungen AG Meliseptol rapid undiluted B Braun Melsungen AG FD 300 1 Dürr Dental AG FD 366 undiluted Dürr Dental AG Biguacid S 2 Antiseptica Dr H J Molitor GmbH Descogen Liqu...

Page 34: ...an use the QR code to access the product documents e g user manual and to send service queries directly to medifa If your mobile phone language is not yet available in the we care Code system the English variant will be shown to you Tap on EN or DE to set the language to English or German 1 Scan the QR code Your product will be shown on the home page Scroll down to get more information about your ...

Page 35: ...ets for this product provided you have already created tickets will be shown In order to create a new ticket tap on the in the green circle on the plus symbol After sending the ticket you can optionally specify your email address to get updates regarding the created ticket via email 4 Alternatively you must again scan the QR code later 5 Tap on CREATE TICKET to view a feedback for the ticket creat...

Page 36: ... SF 80 mm Own weight 501130 145 kg 501135 160 kg Maximum table load 200 kg Standard rail load Longitudinal axis 70 Nm each Transverse axis 100 Nm each Height adjustment 250 mm Longitudinal shift 310 mm only for 501135 Trendelenburg 30 to 30 Lateral 20 to 20 Back adjustment 40 to 70 Headrest adjustment 45 to 45 Leg plate adjustment 90 to 30 Medical product class I Technical data 17 1 Dimensions wei...

Page 37: ...a Temperature 20 C to 50 C storage transport 10 C to 40 C operation Relative humidity 10 to 95 storage transport 20 to 80 operation Air pressure 70 kPa to 106 kPa storage transport 80 kPa to 106 kPa operation 17 4 Environmental conditions for operation storage and transport ...

Page 38: ... contents 7 Remove the tensioning straps and securing members 8 Release the central brake of the medifa 5000 via the brake pedal 9 Push the medifa 5000 off the transport pallet 10 Brake medifa 5000 11 Dispose of the pallet and packaging material in an environmentally friendly manner 18 Delivery unpacking and installation The medifa 5000 is delivered on a pallet in a carton Ordered parts accessorie...

Page 39: ...6 80 Pelvic girdle extension 61125 10 80 Single leg plate 61625 16 80 Split leg plates 61615 20 for every 40 Double split leg plate 61660 20 for every 40 Carbon bearing plate 61690 8 50 Transfer leg plate 61635 2 5 20 Paediatric surgery plate 61633 12 80 Distribution segments 61355 2 5 10 Fifth wheel 50645 Connecting cross member 61670 Cassette slider 61640 3 Rinsing set 61120 0 3 Padding support ...

Page 40: ...ied out in an environmentally friendly manner i e in accord ance with the valid legal regulations For proper disposal of old devices please contact medifa s Technical customer service department your local dealer or the appropriate national authority The medifa company takes back old devices defective or no longer used products For detailed information please contact medifa s technical customer se...

Page 41: ......

Page 42: ...medifa GmbH Co KG Industriestraße 5 57413 Finnentrop Germany Telephone 49 2721 7177 0 Fax 49 2721 7177 255 info medifa com www medifa com ...

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