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Medifa 6000 User Manual

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User manual
medifa 6000
REF: 601820, 601700
Made in Germany
Version: 3.1 EN
www.medifa.com

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  • Page 1 User manual medifa 6000 REF: 601820, 601700 Made in Germany Version: 3.1 EN www.medifa.com...

  • Page 2: Table Of Contents

    Warning stickers on medifa 6000........
  • Page 3 10. Apply the brake / release the brake on medifa 6000 ......
  • Page 4 12. Configure medifa 6000 prior to surgery ........

  • Page 5: Important Information

    All rights according to the copyright law are expressly reserved by medifa. medifa shall only be responsible for the safety-related properties of this device within the framework of the legal regulations if maintenance, ser- vicing, and changes to this device are carried out by medifa itself or a representative in accordance with instruc- tions.

  • Page 6: Foreword

    Foreword 2. Foreword We at medifa would like to thank you for purchasing the medifa 6000. By choosing the medifa 6000, you have opted for a product that combines design, functionality and comfort in the highest possible ‘Made in Germany’...

  • Page 7: Understand The User Manual

    This user manual must be read and understood in full by the operating personnel before commissioning medifa 6000; this applies in particular to the chapter on safety instructions and user obligations. If necessary, verified mediation by means of in-house training is also possible, taking into account the professional qualifi- cations.

  • Page 8: List Of Abbreviations

    Attach and remove accessories and pads prior to surgery Preparing medifa 6000 after use Cleaning and maintenance measures after use: Technical data Properties of the medifa 6000 and conditions of use Information on the installation, decommissioning and disposal of the medifa 6000 Appendix Accessories Safety instructions in the chapters and steps Information on residual dangers and hazardous situations.

  • Page 9: Symbols Used

    Cross-references in the text are shown in a different text colour and are distinguished by a symbol: Work instructions and procedural steps are presented in chronological order in numbered steps. Standard accessories This user manual contains only the basic components of medifa 6000. You can find a complete list of accessories in the accessories list. Options These instructions for use also contain descriptions of permanently installed options with figures, which do not correspond to your configuration.

  • Page 10: Safety Instructions And User Obligations

    • The medifa 6000 may only be used with the specified products and for the purposes indicated under Intended use. When operating the medifa 6000, the values given under  Technical Data...

  • Page 11: Measures To Be Taken Prior To Each Use

    The use of defective or damaged products is prohibited. Risk of explosion There is a risk of explosion if the user operates the medifa 6000 under one or more of the following conditions: • Operating with mains supply in a room enriched with oxygen and anaesthetics.

  • Page 12: Service Life

    Service life The medifa 6000 has a lifespan of 10 years if the specified inspections are carried out by medifa Service. This does not include any parts subject to wear, such as drives, controls, cushions and buttons on the operating units on the device or separately, such as infrared manual switches, control consoles, foot-operated switches and joysticks.

  • Page 13: Medifa 6000

    This user manual must be followed for the intended use of the medifa 6000. Any other use of medifa 6000 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.

  • Page 14: Warning Stickers On Medifa 6000

    Warning stickers on medifa 6000 Observe the danger points and hazards marked by warning symbols (stickers) on the medifa 6000. All warning symbols on the product must be complete and legible. They must not be moved, altered, removed, or covered by other objects.

  • Page 15: Medifa 6000 And Components

    6000 and components The medifa 6000 in the 601820 and 601700 versions has a two-part table top (without head, leg and upper back plates), with two hydraulically adjustable joint pairs (back and kidney joints) and a rigid coupling point for the head and leg plates.

  • Page 16: Lifting Column

    The lifting column contains: • Column keypad • Connection for the manual switch • Infrared receiver of the infrared manual switch (optional) • Manual safety system (optional) Fig. 4: Connection for the manual switch User manual of medifa 6000 601700_601820 Version 3.1...
  • Page 17 6000 Fig. 5: Infrared receiver on the lifting column (optional) Fig. 6: Lifting column with safety system (optional) User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 18: Socket

    • battery fuse and mains fuses • fifth wheel under the socket and foot pedal • foot pedals of the manual safety system (optional) Fig. 8: Fifth wheel centred under the socket User manual of medifa 6000 601700_601820 Version 3.1...
  • Page 19 Fig. 9: Trolley, foot pedal for 5th wheel (left), optional foot pedal safety system (centre, right) 5.6.1 Stability cylinder (optional) The stability cylinders ensure increased stability of the medifa 6000. Fig. 10: Socket with stability cylinder User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 20: Trolley

    The medifa 6000 has a trolley. The handling behaviour of the medifa 6000 is regulated by 4 freely swivelling double castors. So as to prevent collisions, the user must control the medifa 6000 manually. In order to do this, the medifa 6000 is attached to the side standard rails 5.7.1 Fifth wheel...

  • Page 21: Connections And Symbols

    Place Description Socket Connection for the foot-operated switch Lifting column Connection for the manual switch Socket Connection for potential equalisation Socket Connection for the mains cable Socket Information on mains fuse User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 22: Type Label

    Adhere to the user manual. (next to the type label) Type label The type label is located on the base frame above the lifting column of the medifa 6000.  See chapter ‘Connections and symbols’ Fig. 14: Type label Element / symbol...
  • Page 23 Continuous operation with intermittent load (DBAB) 1 min ON, 9 min OFF AC 100 - 240 V Input voltage 24 VDC Battery voltage 300 VA Power consumption 50-60 Hz Frequency of input voltage Class AP device User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 24: Symbols On The Transport Packaging

    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 User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 25: Padding

    Do not use if the padding surface is damaged. Operating the medifa 6000 with non-approved padding is prohibited and will result in loss of CE conformity. They are fastened to medifa 6000 by means of stud-mounting holes. The padding is disinfectable and washable as well as radiotransparent.

  • Page 26: Square Receptacles For Table Segments

    Thus, additional table top elements such as leg or head plates can be attached quickly, easily and securely without tools. Fig. 16: Square receptacles for table segments (example) User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 27: Standard Rails

    Irrespective of the permissible load on the individual standard rails, a one-sided total moment of 100 Nm over the longitudinal axis and 150 Nm over the transverse axis of the medifa 6000 must not be exceeded when used as intended! 5.14...

  • Page 28: Internal And External Power Supply

    External power supply The external power supply of medifa 6000 is provided via the power supply of a room (not the surgical room). medifa 6000 requires approx. 9 hours to fully charge. The charging current is reduced to a trickle charging current once the charging process is complete.

  • Page 29: Standard Accessories

    See chapter ‘Attaching the split leg plates’ • See chapter ‘Removing the split leg plates’ Head plate • See chapter ‘Attaching the head plate’ • See chapter ‘Removing the head plate’ User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 30: Controls

    The direction of movement of the individual functions refers to the figure shown. All functions of medifa 6000 can be fully operated via the manual switch (wired or infrared) and are shown simultaneously by a visual display on the manual switch display.
  • Page 31 Operation and function of the buttons Hold button Function on Release button Function stops and interrupts the process immediately medifa 6000 TILT LEFT TILT RIGHT HEIGHT TREND REV.TREND FLEX REFLEX SLIDE LEVEL Fig. 19: Manual switch User manual of medifa 6000 601700 601820 Version 3.1...
  • Page 32 Only use the original battery charger, which generally ensures that the battery is not damaged during charging. • The battery may only be replaced by personnel trained by medifa. The following instructions must be observed to ensure that the infrared manual switch functions safely and continuously: •...
  • Page 33 6000 Fig. 21: Charging station with mains plug for the infrared manual switch • Notify medifa customer service if the battery of the infrared manual switch is defective. User manual of medifa 6000 601700 601820 Version 3.1...
  • Page 34 79 – 20% capacity – Working mode. Batteries are ready normal - yellow to use. Battery status 100 – 80% capacity – batteries are full. medifa 6000 can full - green be disconnected from the mains and put into the surgical theatre.
  • Page 35 601700. SLIDE Longitudinal shift of the table top towards the head. SLIDE This function is not available on the model 601700. FLEX FLEX Position Table top moves to the FLEX position. User manual of medifa 6000 601700 601820 Version 3.1...
  • Page 36 All electrically driven table segments move LEVEL Zero position into the horizontal position. Turning the manual switch on and off. All functions On/off switch Manual switch can be selected after switching on. User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 37: Column Keypad

    Column keypad The column keypad of the medifa 6000 is a permanently integrated control unit on the metal cladding of the lifting column. The column keypad is backlit. The medifa 6000 is displayed in a graphically simplified way on the column keypad.
  • Page 38 79 – 20% capacity – Working mode. Batteries are ready status - yellow LED to use. 100 – 80% capacity – batteries are full. medifa 6000 can Battery status full - be disconnected from the mains and put into the surgical green LED theatre.
  • Page 39 BACK UP The back plate is tilted upwards. Back upwards BACK DN BACK DN The back plate is tilted downwards. Back downwards REFLEX Position Table top moves to the REFLEX position. User manual of medifa 6000 601700 601820 Version 3.1...
  • Page 40 TILT RIGHT Tilt the table top over the longitudinal axis to the right. Lateral to the right LEVEL LEVEL All electrically driven table segments move into the horizon- Zero position tal position. User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 41: Foot-Operated Switch (Optional)

    The right pedal is used to select and connect through the basic functions from left to right. Each time the pedal is pressed, one function is switched further. The respective LED lights up blue. Right side Height adjustment Trendelenburg Lateral adjustment User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 42: Manual Safety System (Optional)

    Manual safety system (optional) The optional manual safety system on the lifting column to the right of the column keypad of the medifa 6000 ensures that the surgical table can be operated in the event of a failure of all electrical functions due to an electronic defect.
  • Page 43 Controls Fig. 24: Safety system with left and right function selector switch Fig. 25: Foot lever manual safety system User manual of medifa 6000 601700 601820 Version 3.1...
  • Page 44 Controls 6.4.1 Operation and function of the safety system If all electrical functions fail, the medifa 6000 can be used with the manual safety system. ATTENTION Use only if electronic functions fail The safety system should only be used in the event of a power failure (acute need).
  • Page 45 Kidney – upper back section up Kidney – top back part down Back – lower back section up Back - lower back down Brake – brake fixed Brake – release brake User manual of medifa 6000 601700 601820 Version 3.1...
  • Page 46 Stability cylinders are retracted Lateral – to the right as seen by the patient Lateral – to the left as seen by the patient Trendelenburg Anti-Trendelenburg Height – upwards Height – downwards User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 47: Switch On And Switch Off Medifa 6000

    • Operate medifa 6000 only with a connected potential equalisation cable on an electrically conductive floor. • The connection point for the potential equalisation cable on medifa 6000 complies with IEC 60601-1.

  • Page 48: Establish Potential Equalisation

    Risk of personal injury due to electric shock The risk of a possible patient leakage current is reduced and potential equalisation to all connected medical devices is ensured if medifa 6000 is connected to the potential equalisation in the room. Connect the potential equalisation cable to...

  • Page 49: Witch On Medifa 6000

    The light on the manual control unit and the column keypad goes out. Switch off the main switch. Situations in which the main switch of medifa 6000 must be switched off: • after delivery and charging of the batteries, if a longer period of inactivity follows.

  • Page 50: Charge Medifa 6000

    Only use the power cable supplied! • Charge medifa 6000 immediately after being used in the surgical theatre so that it is always ready for use. The medifa 6000 must be fully charged before first use.
  • Page 51 Now unplug the plug of the power cable from the connection jack on the socket. WARNING Danger of personal injury. Do not make any electromotive adjustments to medifa 6000 while it is disconnected from the power supply! User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 52: Recognising The Battery Charging Mode And State Of Charge

    Otherwise, the patient shall be at risk due to batteries that are not ready for use or are no longer functional. The medifa 6000 may be connected to the power supply in order to bring the patient into a safe position on a one-off basis.

  • Page 53: Possible Faults And Causes

    (2x 4 AT) defective. red. medifa 6000 cannot be charged, Power input on medifa 6000 Notify technical customer service. charging mode indicator is not lit. defective. User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 54: Patient Transport

    Do not jam your feet in the trolley section when turning or moving the medifa 6000. CAUTION Danger of collision! Take special care when transporting with the medifa 6000. Exclude collisions with persons in the area or the furniture and impact effects! •...

  • Page 55: Patient Transport With Mechanical 5Th Wheel

    Patient transport without 5th wheel Release the brakes of the medifa 6000 using the BRAKE button on the manual switch or on the column keypad. Keep the BRAKE button pressed until the function switches off after approx. 5-10 seconds.

  • Page 56: Stability Cylinders (Optional)

    Patient transport On the column keypad, the LED next to the BRAKE button lights up red. Drive the medifa 6000 manually with two people. The direction, speed and stopping are determined by you. Stability cylinders (optional) The stability cylinders ensure increased stability of the medifa 6000.

  • Page 57: Apply The Brake / Release The Brake On Medifa 6000

    CAUTION Patient hazard! applying the brakes on the medifa 6000 while it is running is prohibited! First stop the medifa 6000. Bring the medifa 6000 to a stop. When the brake is released, the brake symbol on the manual switch lights up red.

  • Page 58: Releasing The Brake

    The optional manual safety system on the lifting column to the right of the column keypad of the medifa 6000 ensures that the surgical table can be operated in the event of a failure of all electrical functions due to an electronic defect.

  • Page 59: Positioning Of Patient

    If the electrical functions fail, it is only possible to change the position of the patient by using suitable aids (e.g. padding placed underneath) or by recovering the patient from medifa 6000. If the medifa 6000 is equipped with a manual safety system, use the safety system to secure the patient positioning.

  • Page 60: Preparing Medifa 6000 For Patient Positioning

    WARNING Danger to the patient due to improper fastening! • Check that the plate segments and accessories are securely attached to medifa 6000 before each use! Detached elements may move independently or slip out of place. • Loosen the controls only for adjustment, then tighten them again immediately! •...

  • Page 61: Positioning The Patients

    Danger of personal injury. Extremities must not overhang in the longitudinal direction! Due to incorrect loading, parts of the medifa 6000 can break off, or the medifa 6000 can tip over. The ascending or descending may only be carried out in the area of the lifting column via the seat plate! Sequence for setting a desired patient position: Please decide whether the patient should assume the normal position or the reverse position.

  • Page 62: Reverse Position

    No reverse position possible with a total weight > 250 kg The reverse position may only be used up to a total load of 250 kg on the medifa 6000. Do not use the reverse position if the total load on the medifa 6000 is over 250 kg.

  • Page 63: Height (Height)

    With various functions such as Trendelenburg and Lateral, height adjustment is always the first function used to set the desired table top height. For each patient ascent and descent, the medifa 6000 is moved to the lowest position and then moved to the working height with the patient lying on it...
  • Page 64 Height adjustment from Adjusting the height with the safety system Function switch Function switch Foot lever Foot lever Description on the left on the right DOWN Height – upwards Height – downwards User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 65: Trendelenburg/Anti-Trendelenburg (Trend/Rev.trend)

    Trendelenburg/Anti-Trendelenburg position. This function carries a risk of clamping and injury if the Trendelenburg function is approached at the lowest table height. Then the table segments of the upper back section collide with the socket of the medifa 6000. 30°...
  • Page 66 Tilting of the table top over the transverse axis in the foot-down position. Adjusting Trendelenburg/Anti-Trendelenburg with the safety system Function switch Function switch Foot lever Foot lever Description on the left on the right DOWN Trendelenburg Anti-Trendelenburg User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 67: Lateral Position

    In the lateral function, the table top is tilted to the left or right around its longitudinal axis. Lateral adjustment is not permitted in moving mode! WARNING Risk of personal injury due to tilting of the medifa 6000! No lateral adjustment may be made at maximum table load! 20°...
  • Page 68 Foot lever Foot lever Description on the left on the right DOWN Lateral – to the right as seen by the patient Lateral – to the left as seen by the patient User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 69: Longitudinal Shift (Slide)

    When the table is in the reverse position, the table must not be pushed towards the head with the longitudinal shift. The head plate collides with the upper frame of the table. Fig. 32: Longitudinal shift of the table top with standard accessories User manual of medifa 6000 601700 601820 Version 3.1...
  • Page 70 Positioning of patient Column keypad Symbol of manual switch Description Longitudinal shift of the table top towards the head or foot. SLIDE Pressing the corresponding arrow button determines the direction. User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 71: Back Plate (Back Up/Back Dn)

    BACK UP BACK UP Back plate with any head plate accessories is tilted upwards. Back plate downwards BACK DN BACK DN Back plate with any head plate accessories is tilted downwards. User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 72: Flex And Reflex

    When using the FLEX and REFLEX functions, two functions are performed simultaneously to create a kink between the pelvis and back plate of the table top. 210° 15° 15° Fig. 34: Flex position: Anti-Trendelenburg and back plate down User manual of medifa 6000 601700_601820 Version 3.1...
  • Page 73 25° Fig. 35: Reflex position: Trendelenburg and back plate up. Column keypad Manual switch Description FLEX FLEX FLEX Anti-Trendelenburg and back plate down function REFLEX Trendelenburg and back plate up function User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 74: Upper Back Plate (Kidney Up/Kidney Dn)

    Fig. 36: Adjusting the upper back plate Symbol of column Symbol of manual switch Description keypad The upper back plate is tilted upwards. KIDNEY UP KIDNEY UP Upper back plate is tilted downwards. KIDNEY DN KIDNEY DN User manual of medifa 6000 601700_601820 Version 3.1...
  • Page 75 11.11.1 Renal bridge (KIDNEY UP/KIDNEY DN A renal bridge can be set by combining the back plate positions ‘upper back plate down’ and ‘lower back plate up’. 650 mm Fig. 37: Renal bridge User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 76: Zero Position (Level)

    Positioning of patient 11.12 Zero position (LEVEL) The zero position means that the medifa 6000 can be moved independently to a horizontal position. The movement takes place in a fixed sequence: Combined movement in which the motorised joints of the table top, the Anti-Trendelenburg or Trendelenburg...

  • Page 77: Configure Medifa 6000 Prior To Surgery

    Owing to the heavy weight when lifting and carrying the plate segments and accessory parts, as well as when making manual adjustments to the medifa 6000 with or without the patient lying on it, you must ensure that your back is not injured.
  • Page 78 Hold the leg plate and move it to the desired upwards under the foot end of the leg plate. position with the release lever [2] tightened. Release the release lever [2]. The leg plate is locked in the end position. User manual of medifa 6000 601700_601820 Version 3.1...
  • Page 79 12.2.4 Removing split leg plates Hold the leg plate and turn the release lever [1] Pull the leg plate out of the square opening on the table upwards. on the table. User manual of medifa 6000 601700 601820 Version 3.1...
  • Page 80 12.2.6 Removing the head plate Hold the head plate and loosen the black star Pull the head plate out of the square knob screws [4] on both spars of the table. opening on the table. User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 81: Padding

    The padding is made of 60 mm thick PUR padding or 80 mm thick SFC padding. They are fastened to medifa 6000 by means of stud-mounting holes. The padding is disinfectable and washable as well as radiotransparent. Furthermore, the padding is latex-free and breathable.
  • Page 82 The padding must be fixed exactly on holes [1] on the padded plate. the padded plate. 12.3.2 Removing the padding Reach under an edge on the side of the padding and pull the padding upwards. User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 83: Load Limits

    No reverse position possible with a total weight > 250 kg The reverse position may only be used up to a total load of 250 kg on the medifa 6000. Do not use the reverse position if the total load on the medifa 6000 is over 250 kg.

  • Page 84: Preparing Medifa 6000 After Use

    • Protective gloves / protective clothing • Eye protection / face protection 14.1.2 Cleaning und disinfecting HAZARD Risk of explosion! Do not use any alcohol-based agents when using HF surgical devices. User manual of medifa 6000 601700_601820 Version 3.1...
  • Page 85 After cleaning and disinfecting, remove any excess moisture build-up, for example drops on the bottom edge of the standard rail of the table top, with a dry cloth. 14.1.4 Disposal Dispose of all cleaning and disinfectant residues or remnants in a harmless and environmentally friendly manner. User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 86: Technical Data

    100 V - 240 V / 50 Hz - 60 Hz Power consumption max. 300 VA Power plug Country-specific, connection cable 3m Mains fuse 2 x 4 AT Battery fuse type ASO 15 A User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 87: Adjustment Ranges

    -30° to +30° (tolerance ± 2°) Lateral -20° to +20° (Tolerance ± 2°) Flex 210° Reflex 120° Backrest adjustment -40° to +70° (Tolerance ± 5°) (lower segment) Backrest adjustment -35° to +50° (upper segment) User manual of medifa 6000 601700 601820 Version 3.1...

  • Page 88: Classification

    Portable HF communication devices (radios) (including their accessories such as antenna cables and external antennas) should not be used at a distance less than 30 cm (or 12 inches) from the medifa 6000. User manual of medifa 6000 601700_601820 Version 3.1...

  • Page 89: Appendix

    16. Appendix 16.1 Delivery, unpacking and installation 16.1.1 Delivery The medifa 6000 is delivered on a pallet in a carton. Ordered parts/accessories are individually packaged on the pallet or are attached to medifa 6000. Dimensions of the packaging Length 1200 mm...
  • Page 90 After medifa 6000 is delivered and before it is switched on or connected to an external power source, it is necessary to wait a certain amount of time (at least 12 hours is recommended). Place medifa 6000 in an environment, which has the same ambient temperature and relative humidity as the room in which it is used.

  • Page 91: If The Product Is Not In Use For A Long Period Of Time

    When not in use, medifa 6000 should be turned off via the main switch. If medifa 6000 is not used for a longer period of time, the batteries may no longer be fully charged. To prevent a defect or failure of the batteries, the batteries must be charged every month, even if medifa 6000 is not used for a longer period of time.

  • Page 92: Accessories

    Infusion pole 61800 1.5 kg per hook Pivotable infusion pole 61805 1.5 kg per hook Instrument table 61410 Guiding profile extension 61560 Manual push handles 61571 Side holder 61341 Shoulder rest 61351 User manual of medifa 6000 601700_601820 Version 3.1...
  • Page 93 Leg holders according to Goepel Comfort 81705 15 per leg holder Elbow braces 61780 10 per leg holder Lower leg clamp 61760 Thigh clamp 61770 Rectal positioning unit 61632 Colonoscopy thread 61315 User manual of medifa 6000 601700 601820 Version 3.1...
  • Page 94 Upper arm support 61226 Arm and hand surgery table 61231 Arm and hand surgery table 61232 Meniscus roller 61330 Arthroscopy leg holder system 61328 Knee support unit 61327 Intervertebral discs surgical cushions 61900 User manual of medifa 6000 601700_601820 Version 3.1...
  • Page 96 Made in Germany medifa GmbH Industriestraße 5 57413 Finnentrop Germany Phone no. +49 2721 7177-0 fax +49 2721 7177-255 info@medifa.com www.medifa.com...

This manual is also suitable for:

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