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GA Medifa 6000 601700 V3.0 03.23 EN Web
GA Medifa 6000 601700 V3.0 03.23 EN Web
GA Medifa 6000 601700 V3.0 03.23 EN Web
medifa 6000
REF: 601700
Made in Germany
Version: 3.0 EN
www.medifa.com
Table of contents
Table of contents
1 Important information.............................................................................. 7
1.1 Revision history ........................................................................................................... 7
1.2 CE marking .................................................................................................................. 7
1.3 Conformity .................................................................................................................. 7
1.4 Manufacturer and distributor ...................................................................................... 7
1.5 Copyright notice .......................................................................................................... 8
2 Foreword.................................................................................................. 9
3 Understanding these operating instructions ............................................. 10
3.1 Where can I find certain information? ......................................................................... 10
3.2 List of abbreviations .................................................................................................... 11
3.3 Symbols in use............................................................................................................. 12
3.4 Standard accessories ................................................................................................... 13
3.5 Options ....................................................................................................................... 13
5 medifa 6000.............................................................................................. 17
5.1 Proper and intended usage.......................................................................................... 17
5.2 Intended users............................................................................................................. 18
5.3 Warning stickers on the medifa 6000........................................................................... 18
5.4 medifa 6000 and components...................................................................................... 20
5.5 Lifting column.............................................................................................................. 21
medifa 6000 v
Table of contents
17 Appendix .................................................................................................. 91
17.1 Delivery, unpacking and setting up .............................................................................. 91
17.1.1 Delivery ............................................................................................................... 91
17.1.2 Unpacking and setting up.................................................................................... 91
17.1.3 Symbols on the transport packaging................................................................... 93
17.2 When the device has not been used for a long time..................................................... 94
17.3 Disposal....................................................................................................................... 94
17.4 Accessories.................................................................................................................. 94
1 Important information
1.2 CE marking
This product is a Class 1 medical device as defined by European regulation (EU) 2017/745 concerning
medical devices. It complies with the version of this regulation in force at the time that this product is
placed on the market.
1.3 Conformity
The manufacturer declares that this product conforms with the essential safety and performance
requirements according to MDR Annex I. The manufacturer also declares that the technical
documentation has been implemented according to MDR Annex II. The manufacturer declares conformity
by means of an EU Declaration of Conformity according to MDR Annex IV.
medifa 6000 7
Important information
2 Foreword
The company medifa thanks you for purchasing the medifa 6000. The medifa 6000 is a product that
combines design, functionality and comfort with the highest quality associated with German
manufacturing.
The medifa products are manufactured to have a long and trouble-free lifespan. The development, design
and production at medifa have been certified to comply with DIN EN ISO 9001 and DIN EN ISO 13485.
These products comply with the requirements of the EU Medical Device Regulation (MDR) and bear the
CE mark.
The demanding requirements of the OP(surgical) sector can only be met by high-quality long-life
materials, comprehensive functionality and ease of use.
We at medifa offer a wide selection of permanently installed and versatile accessories to meet all your
requirements. The periodic maintenance carried out by our trained service technicians ensures that your
table is always in perfect working order during routine operations.
We are always available to help if you have any questions.
medifa 6000 9
Understanding these operating instructions
ATTENTION
Please read and observe these operating instructions.
These operating instructions must be read and fully understood by the operating personnel before the
initial commissioning of the medifa 6000. This applies in particular to the 4 Safety instructions and user
obligations, Page 14 chapter. If necessary, in-house training for technical qualifications may be carried
out by a qualified person.
The operating instructions must be closely followed and available at the place of use.
ATTENTION
This operating table is safe to use!
Any remaining residual hazards are indicated at the affected locations in the operating instructions.
Follow these instructions!
4 Safety instructions and user ● Basic safety instructions for the operation and use of the
obligations medifa 6000
7 Switching the medifa 6000 ● Switching the power supply on/off; switching the control unit
on and off on/off
8 Charging the medifa 6000 ● Charging the lead-gel batteries for battery-run operations
10 Braking and releasing the ● Braking the medifa 6000 or releasing the brakes for driving
brakes on the medifa 6000
11 Positioning the patient ● Description of all functions for patient positioning and position
adjustment
13 Load limits ● Adjusting the medifa 6000 depending on the total weight
Notices about residual hazards and dangerous situations. Please pay particular attention to these notices.
EN European Standard
HF High Frequency
IP Ingress Protection
medifa 6000 11
Understanding these operating instructions
Abbreviation Description
OP Operations (surgery)
Safety instructions
DANGER
DANGER indicates a hazardous situation which, if not avoided, will result in death or serious injury.
WARNING
WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION
CAUTION indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
ATTENTION
Notice about a harmful situation; possible consequences: the device itself or surrounding objects could
be damaged.
Notices
Cross-references
Cross-references in the text are displayed in a different text colour and offset by a symbol: 4 Positioning
the patient, Page 61
Work instructions
1. Work instructions and steps are chronologically displayed using numbered steps.
3.5 Options
These operating instructions also describe the built-in options. Some illustrations or figures depict options
that do not match your configuration. The infra-red handset, the foot switch or other options may not be
available.
medifa 6000 13
Safety instructions and user obligations
WARNING
Danger for the patient!
Do not change this medical product! The manufacturer assumes no liability resulting from changes made
to the OP table.
WARNING
Danger for the patient!
We cannot completely rule out the possibility of a malfunction of the medifa 6000 according to current
state of the art technology. In this rare case, the motor-driven functions would no longer be available
during the surgery.
If there is an electrical malfunction, it is possible to change the patient's position using suitable aids (e.g.
by placing cushions under the patient) or by extricating the patient from the medifa 6000.
● All work with or on the medifa 6000 (installation, commissioning, operation, maintenance,
decommissioning, transport or disposal) may only be carried out by trained medical or nursing staff.
● The medifa 6000 may only be used with the specified products for the purposes specified in the
4 Proper and intended usage, Page 17 section. The values specified in 4 Technical
specifications, Page 88 must be complied with whenever the medifa 6000 is being used.
● In order to use additional equipment properly and safely, the operating instructions for such
equipment must be observed.
DANGER
Danger of explosion!
The OP table is not suitable for use in hazardous areas.
The OP table may not be used in rooms or areas where flammable mixtures of anaesthetics with air,
oxygen or N20 (nitrous oxide) are used.
Technical specifications and further information on explosion protection can be found under
4 Classification, Page 89.
4.4 Electricity
The electrical safety of the medifa 6000 and your power supply should be checked before first usage and
regularly thereafter by a qualified electrician. We recommend that a general safety inspection be carried
out yearly by medifa's technical support.
● Do not crush or run over mains power cables or equipotential bonding cables. Do not use cables which
have been damaged.
● Remove the cables before changing the location of the table.
● Electrical discharges to the patient or operator may occur if there is no earthing/grounding present.
If you have any doubts about the safety of the mains power cables or equipotential bonding cables,
Use only the internal power supply until the problematic cable has been replaced.
● Only use the medifa 6000 on an electrically conductive floor and with an equipotential bonding cable
connected.
medifa 6000 15
Safety instructions and user obligations
DANGER
Danger of patients being burned
The use of HF surgery equipment, defibrillators, and defibrillator monitors may pose a risk of the patient
being burned if no safety precautions are taken. Take the following security precautions:
– Position the patient on the medifa 6000 so that they are isolated from (not touching) the metal parts
(medifa 6000 or accessories), conductive cushions or hoses.
– Do not touch the patient with moistened wipes or other moist materials. Use only dry materials!
WARNING
Danger for the patient!
The electro-motor functions of the medifa 6000 may be interrupted while high-frequency surgery
devices are being used.
Repairs
Repairs may only be carried out by the medifa technical support or by personnel who have been
authorized, trained and certified by medifa. The company medifa is not liable for any damages due to
neglected inspections, inadequate repair, improper maintenance or changes made to the product!
For servicing work, please contact the medifa technical support department.
Telephone number of the medifa service hotline: +49 2721 7177 410
5 medifa 6000
The model 601700 is described in these operating instructions.
medifa 6000 17
medifa 6000
Symbol Description
Do not sit!
Read the operating instructions before use (found on the sticker on the mains socket on
the recessed socket).
medifa 6000 19
medifa 6000
① ② ③ ④ ⑤
⑥
⑧
⑦
Features
medifa 6000 21
medifa 6000
5.6 Base
medifa 6000 23
medifa 6000
Figure 9: Chassis, foot pedal of fifth wheel (left), foot pedals for the safety system (middle, right)
medifa 6000 25
medifa 6000
Base (the sticker on the Read the operating instructions before use
mains socket on the
recessed socket).
medifa 6000
(01) 04250411XXXXXX
601700 (21) XXXXX
xxxxx 01/2020
Date of manufacture
Article number
Serial number
Medical device
24 V DC Battery voltage
Max. load Maximum weight, including the accessories and the patient
medifa 6000 27
medifa 6000
5.9 Chassis
The medifa 6000 has a chassis. The handling of the medifa 6000 is regulated by 4 swivelling double
castors. To prevent collisions, the user must steer the medifa 6000 manually. The medifa 6000 should be
held on the side rails in order to steer it.
The fifth wheel helps to stabilize and maintain the direction. Therefore, we recommend
using the fifth wheel. The fifth wheel can only move straight. It must be retracted while the
table is being moved sideways.
For the model 601700, the fifth wheel can be retracted or extended using the foot pedal.
5.10 Cushioning
The cushions are made of 60 mm thick PUR padding or 80 mm thick SFC padding (optional).
ATTENTION
Do not use this product if the surface of the cushions is damaged.
It is forbidden to use the medifa 6000 with unauthorized cushions; such usage would result in the loss of
CE conformity.
Peg holders are used to attach the cushions to the medifa 6000. The cushioning can be disinfected and
washed. It is also transparent for X-rays. The cushioning is also latex-free and breathable.
The cushion prevents the patient from getting pressure sores. In order to eliminate any residual risk,
medically trained personnel must implement an active decubitus prophylaxis method during the
positioning of the patient. The cushioning is anti-static and, when properly attached, complies with the
relevant normative regulations.
4 Attaching and removing the cushions, Page 81
medifa 6000 29
medifa 6000
L2
ML
m1
m2
L1
MQ
The torque acting on the standard rails can be approximately calculated using the following rule of thumb.
M(L or Q) = m x L x 10
Torque [Nm] = mass [kg] x length [m] x 10 [m/s2]
The weight of the patient's body part that will be resting on the accessory should be specified for mass (m).
WARNING
Danger: risk of personal injury when the medifa 6000 is tilted!
Regardless of the permissible load on the individual rails, a total torque of 100 Nm on the lengthwise axis
and 150 Nm on the transverse axis of the medifa 6000 must not be exceeded during normal use!
medifa 6000 31
medifa 6000
The external power supply for the medifa 6000 uses the mains power from a room (but not the surgery/
operating room). The medifa 6000 takes about 9 hours to fully charge. The charging current is reduced to
a trickle charge current after the charging process is completed. The trickle charge current is harmless to
the lead-gel batteries. 4 Electricity, Page 15
Lead-gel batteries
The internal power supply is provided by the two lead-gel batteries. Refer to the technical data for more
information. 4 Electrical connection data, Page 88
ATTENTION
Defective lead-gel batteries
Contact customer service if you experience a battery malfunction.
medifa 6000 33
User controls
6 User controls
CAUTION
Risk of injury!
Become familiar with the keypad symbols and their functions. This helps you to avoid misinterpreting the
function or incorrectly positioning the patient.
The medifa 6000 can be operated and controlled by the following components:
● Column keypad
● Handset (wired)
● Optional infra-red handset
● Optional foot switch
● Optional manual safety system
1. press the STOP key on the handset or on the column keypad. The ongoing
electrical adjustment of the medifa 6000 will be stopped immediately.
STOP
6.2 Handset
As on the column keypad, the handsets show simplified schematics of the medifa 6000. These diagram
shows the functions of the lifting column, the brake mechanism, as well as the Trendelenburg, lateral and
height adjustments. Underneath this are the functions for the table plate segments (viewed from the
head end). The keys for the adjustment functions are marked by arrows. They are assigned to the
corresponding table plate segments.
The direction of movement of the individual functions is shown by the key illustrations.
All functions of the medifa 6000 are fully available via the handset (wired or infra-red). The functions are
shown simultaneously on the handset's display.
WARNING
Explosion and fire hazard; danger of release of pollutants
– Use only the original charger. It ensures that the battery will not be damaged during charging.
– Only personnel that have been trained by medifa may replace the battery.
The following instructions must be observed to ensure that the infra-red handset functions safely and
properly:
● The infra-red sensor on the lifting column must not be obstructed by obstacles (cloths, sheets, etc.).
● The signal path between the transmitter (handset) and the receiver (infra-red sensor on the lifting
column) must always be unobstructed. The signal range is 3 m.
● The battery of the infra-red handset may only be charged with the corresponding mains charger.
Figure 20: Charging station and power plug for the infra-red handset
medifa 6000 35
User controls
Release the key Function is deactivated (thus immediately interrupting the procedure)
medifa 6000
FLEX REFLEX
BACK DN BACK UP
KIDNEY DN KIDNEY UP
LEVEL
STOP
No display BRAKE If the red brake icon appears on the display, the
Brake engaged brake has been engaged.
The medifa 6000 is braked. All functions are
unlocked.
4 Braking the medifa 6000 and releasing the
brake, Page 59
medifa 6000 37
User controls
HEIGHT
Upwards height 4 HEIGHT, Page 65
adjustment
TILT LEFT Tilt the table top (at the lengthwise axis) to the
Lateral left left.
4 Lateral position (TILT RIGHT / TILT LEFT), Page
69
TILT RIGHT Tilt the table top (at the lengthwise axis) to the
Lateral right right.
4 Lateral position (TILT RIGHT / TILT LEFT), Page
69
TREND Tilt the table top (at the transverse axis) into a
Trendelenburg lowered-head position.
4 Trendelenburg/reverse Trendelenburg (TREND/
REV.TREND), Page 67
REV.TREND Tilt the table top (at the transverse axis) into a
Reverse Trendelenburg lowered-feet position.
4 Trendelenburg/reverse Trendelenburg (TREND/
REV.TREND), Page 67
On/off switch for Switches the handset on and off. Any function can
handset be selected after the table has been switched on.
The medifa 6000 is in standby mode after it is
switched on.
STOP / Emergency Stop This key can be pressed when a function does not
stop or if the medifa 6000 moves unintentionally
STOP
and independently.
Action: Press STOP. Immediately stops the
problematic function.
To restore functionality, the main power switch
must be switched off and on again.
4 Interrupting adjustments to the medifa
6000, Page 34
medifa 6000 39
User controls
Release the key Function is deactivated (thus immediately interrupting the procedure)
STOP / Emergency Stop This key can be pressed when a function does not stop or if the
medifa 6000 moves unintentionally and independently.
STOP
Action: Press STOP. Immediately stops the problematic function.
The STOP key is enabled even when the column keypad is locked!
To restore functionality, the main power switch must be switched
off and on again.
4 Interrupting adjustments to the medifa 6000, Page 34
Key lock on The controls of the column keypad are locked. This prevents a
LED off function from being accidentally carried out.
Key lock off The keys are unlocked and enabled. The keypad will lock
LED green automatically 10 seconds after the last key press on the column
keypad.
Battery status: normal 79 – 20% capacity: working mode. The batteries are ready for use.
Batteries are okay
LED yellow
Battery status: full 100 – 80% capacity: batteries are full. The medifa 6000 can be
Battery full unplugged from the mains power supply and used in surgery.
LED green
LOAD Power cord is connected. The medifa 6000 is charging. The medifa
Battery is charging 6000 may not be used in surgery while charging.
Red LED 4 Charging the medifa 6000, Page 52
BRAKE The BRAKE key must be pressed for 5 to 10 seconds before this
Brake engaged braking function is enabled. The medifa 6000 is braked when this
LED is off. All functions are unlocked.
LED off
4 Releasing the brake, Page 60
BRAKE The BRAKE key must be pressed for 5 to 10 seconds before this
Brake released braking function is enabled.
Red LED A red LED indicates that the medifa 6000 is not braked, the brake
system is not fully extended, or the medifa 6000 is not completely
chocked. All functions except the Trendelenburg are locked.
4 Braking the medifa 6000, Page 59
medifa 6000 41
User controls
Normal position disabled The normal position is disabled. The LED is off. The reverse position
LED off has been selected.
Normal position enabled The normal head position: The patient's head is on the head end of
LED blue the table plate.
4 Normal position, Page 63
Reverse position disabled The reverse position is disabled. The LED is off. The normal position
LED off has been selected.
Reverse position enabled Foot position: The patient's head is at the foot end of the table
LED blue plate.
4 Reverse position, Page 64
KIDNEY UP KIDNEY UP The upper back plate (optionally with attached head plate
Kidney bridge upwards accessory) is tilted upwards.
4 Kidney bridge (KIDNEY UP / KIDNEY DN), Page 75
KIDNEY DN KIDNEY DN The upper back plate (optionally with attached head plate
Kidney bridge downwards accessory) is tilted downwards.
4 Kidney bridge (KIDNEY UP / KIDNEY DN), Page 75
BACK UP BACK UP The back plate (optionally with attached head plate accessory) is
Back upwards tilted upwards.
4 Back plate (BACK UP/BACK DN), Page 71
BACK DN BACK DN The back plate (optionally with attached head plate accessory) is
Back downwards tilted downwards.
4 Back plate (BACK UP/BACK DN), Page 71
HEIGHT
Upwards height 4 HEIGHT, Page 65
adjustment
TREND Tilt the table top (at the transverse axis) into a lowered-head
Trendelenburg position.
4 Trendelenburg/reverse Trendelenburg (TREND/REV.TREND), Page
67
REV.TREND Tilt the table top (at the transverse axis) into a lowered-feet
Reverse Trendelenburg position.
4 Trendelenburg/reverse Trendelenburg (TREND/REV.TREND), Page
67
TILT LEFT Tilt the table top (at the lengthwise axis) to the left.
Lateral left 4 Lateral position (TILT RIGHT / TILT LEFT), Page 69
TILT RIGHT Tilt the table top (at the lengthwise axis) to the right.
Lateral right 4 Lateral position (TILT RIGHT / TILT LEFT), Page 69
medifa 6000 43
User controls
CAUTION
Tripping hazard
The foot switch should be positioned so that you cannot trip over the foot switch or its cables.
Right The basic functions can be selected from left to right and switched
using the right pedal. Each pedal press advances one function further.
The corresponding LED lights up blue.
Height adjustment
Trendelenburg
Lateral adjustment
Reverse Trendelenburg
The medifa 6000 moves to the reverse
Trendelenburg position and the function LED lights
up.
Lateral left
The medifa 6000 tilts laterally to the left and the
function LED lights up.
Trendelenburg
The medifa 6000 moves to the Trendelenburg
position and the function LED lights up.
Lateral right
The medifa 6000 tilts laterally to the right and the
function LED lights up.
medifa 6000 45
User controls
Figure 24: Safety system with left and right function selector switch
ATTENTION
Use this only when the electronic functions are not functioning.
The safety system should only be used if there is a power outage (only when absolutely necessary).
ATTENTION
Danger of malfunction
After the functionality is restored,
the function selector switches at the control panel may be set incorrectly. This can cause a malfunction if
the handset is used.
– Switch off the medifa 6000 at the main switch.
– Switch the main switch back on.
9 The selector switches at the control panel are then automatically set to their zero positions.
ATTENTION
Limited function:
The lengthwise shift (SLIDE) cannot be adjusted using the safety system.
medifa 6000 47
User controls
The control panel shows six different patient positions for the table. The selector switches must be set for
the corresponding patient positioning. The foot pedals are used here.
Trendelenburg – 0 2 x
upwards
Trendelenburg – 0 2 x
downwards
Height – upwards 0 3 x
Height – downwards 0 3 x
WARNING
Risk of injury
– Do not crush or run over mains power cables or equipotential bonding cables. Do not use cables
which have been damaged.
– Remove the cables before changing the location of the table. If there are any concerns about the
safety of the mains or equipotential bonding cables, only use the internal power supply until the
problematic cable is replaced.
– Only use the medifa 6000 on an electrically conductive floor and with an equipotential bonding cable
connected!
– The connection point for the equipotential bonding cable at the medifa 6000 complies with IEC
60601-1.
Figure 27: Main switch and connection for the equipotential bonding
medifa 6000 49
Switching the medifa 6000 on and off
CAUTION
Risk of personal injury due to electric shock
When the medifa 6000 is connected to the equipotential bonding in the room, the risk of patient-related
leakage currents is reduced. This also ensures equipotential bonding with all other connected medical
devices.
1. Connecting the equipotential bonding cable 2. Connect with the equipotential bonding in
at the equipotential connection (male port) the room.
at the base of the medifa 6000.
After it is switched on, the red brake symbol appears in the handset display.
3. Hold down the BRAKE key on the handset until the function switches off after
approx. 5 to 10 seconds. The table can now be moved.
4 Braking the medifa 6000 and releasing the brake, Page 59
The battery and charging indicators on the handset and on the column keypad show when the power cord
is plugged into the medifa 6000 and the current charging state of the lead-gel batteries.
There are certain situations where the medifa 6000 should be switched off using the main switch:
● After the batteries have been delivered and charged, if a long downtime follows. 4 When the device
has not been used for a long time, Page 94
medifa 6000 51
Charging the medifa 6000
DANGER
Danger of electrocution and loss of life
– The medifa 6000 should be set up and positioned so that all plugs and device functions are easy to
reach.
– The medifa 6000 may only be connected to a power supply network that uses a cable with a
protective earth conductor. This eliminates the risk of electric shock.
Cables that are pinched or have insulation damage may no longer be used. Such cables must be
replaced immediately.
– Cables should be replaced if there are any concerns that they are not in perfect condition. Use only
the internal power supply until the problematic cable has been replaced.
WARNING
Danger of explosion when using combustible mixtures of anaesthetics and air!
The medifa 6000 is not intended for use in an oxygen-enriched environment while it is being charged
from the mains power supply. Usage in such environments is only permitted when running on battery
power.
DANGER
Danger of explosion!
Detergents, alcohol-based disinfectants or flammable anaesthetic mixtures, when mixed with air,
oxygen-enriched air or nitrous oxide, may cause an explosion.
CAUTION
Danger of personal injury posed by stumbling hazard.
Do not roll or squeeze the power cord! Route the cable so that nobody can trip or fall over it!
ATTENTION
Observe the mains voltage!
– The medifa 6000 must only be connected to the voltage specified on the ratings plate!
– Do not extend the mains cable. Do not use an extension cable! The permissible value of the patient
leakage current will be exceeded if you use an extension! Only use the original power cord!
– Charge the medifa 6000 immediately after surgery, so that it is always ready for use.
The medifa 6000 must be fully charged before its initial use.
3. Turn on the main switch at the base of the medifa 6000. Look at the column
keypad to check if the medifa 6000 is charging.
Approximately 9 seconds later, the LED on the column keypad next to the battery
symbol lights up green.
After 2 hours of charging time, an approximate 30% charge will be reached: after
5 hours 80%, and after 9 hours 100% charging capacity.
During this entire charging process, the handset will display the green charging
symbol. There is no charging progress bar.
4. Disconnect the medifa 6000 from the power supply by pulling the power cable
socket from the room's power outlet.
5. The LED on the column keypad next to LOAD goes out after changing to battery
operated mode.
6. Pull the plug of the power cable out of the socket at the bottom of the table's
base.
WARNING
Risk of personal injury!
Do not make electric motor-drive adjustments of the medifa 6000 while disconnecting the power supply!
medifa 6000 53
Charging the medifa 6000
20 – 79 % of charge capacity
0 – 20 % of charge capacity
Charge the medifa 6000 immediately!
CAUTION
Danger for the patient
If the battery status changes to red (under 20 % charge), the medifa 6000 must be taken immediately out
of the surgery room and charged.
There would otherwise be a risk to the patient due to batteries that are not ready for use or that are no
longer functional.
The medifa 6000 may be connected to the power supply so that the patient can be brought to a safe
position once.
– First, connect the power cable to the medifa 6000 and then to the power supply.
– Move the patient into a safe position.
– Move the medifa 6000 immediately out of the surgery room and recharge it in a separate room.
The medifa 6000 cannot be The lead-gel batteries of the Connect the medifa 6000 to the
switched on. medifa 6000 are completely power supply.
discharged.
The medifa 6000 cannot be The controller electronics, mains Notify the Technical Support
charged. The battery status cable or input fuses (two 4 AT) department.
indicator remains red. are defective.
The medifa 6000 cannot be The power input on the medifa Notify the Technical Support
charged. The charge mode 6000 is defective. department.
indicator does not light up.
medifa 6000 55
Transporting patients
9 Transporting patients
CAUTION
There is a risk of personal injury when the medifa 6000 is tilted.
The OP table could tip over when it crosses a threshold.
The medifa 6000 may only be moved or driven using two persons and when it is at its lowest height!
CAUTION
There is a risk of personal injury from being crushed!
Be careful not to get your feet caught under the chassis when turning or moving the medifa 6000.
CAUTION
Danger of collision!
Be very careful when transporting the medifa 6000. Make sure that there are no collisions with
bystanders or furniture!
– Make yourself familiar with the drive characteristics and handling of the table before you transport a
patient for the first time.
1. Move the medifa 6000 to its home position by pressing the LEVEL key.
LEVEL
2. Adjust the spreadable leg plates by hand so that they are parallel to the
lengthwise direction of the medifa 6000.
4. Move the tabletop to the lowest position by pressing the HEIGHT key.
HEIGHT
5. Disconnect the mains power plug and the equipotential bonding cable
ATTENTION
Damage to the cables
Before driving the medifa 6000, make sure you disconnect the equipotential bonding from the medifa
6000. When driving the medifa 6000, do not roll over or pinch the connecting/equipotential bonding
cables!
CAUTION
Danger for the patient
Monitor and carefully check the movement of the medifa 6000! A defect or a fault in the electronics can
cause the brake assist function to fail.
If the optional manual safety system is available, the brake can be operated using that system.
1. Move the foot pedal to its uppermost 2. Press the fifth wheel pedal down.
position as far as it will go. The fifth wheel is retracted.
The fifth wheel is extended.
2. Wait until the red brake symbol appears in the handset's display. The brake is
released.
medifa 6000 57
Transporting patients
3. The LED next to the BRAKE key lights up red on the column keypad.
4. Push/pull the medifa 6000 manually with two persons. You control the direction,
speed and stopping.
2. Press the BRAKE key on the handset or the column keypad until the stability
cylinders are fully extended.
1. Press the BRAKE key on the handset or the column keypad until the brake icon on
the handset display disappears.
2. The table can now be moved.
Brake key
The medifa 6000 is currently braked or the brake is being
released. Press the key for at least 5 to 10 seconds until the
function is triggered.
Brake engaged
The medifa 6000 is braked. All functions are unlocked.
Nothing is displayed on the handset.
CAUTION
Danger for the patient
Do not use the brake while you are driving the medifa 6000! Stop the medifa 6000 first.
4. Hold down the BRAKE key on the handset or the column keypad until the function
switches off after approx. 5 to 10 seconds.
5. The red LED goes out on the column keypad.
6. The medifa 6000 is now braked. All adjustment functions are now enabled.
medifa 6000 59
Braking the medifa 6000 and releasing the brake
The LED next to the BRAKE key does not light up on the column keypad.
1. To release the brake using the column keypad, press the BRAKE key until the LED
lights red.
2. To release the brake using the handset, press the BRAKE key.
When the brake is released, a red display symbol appears on the handset. Only
the Trendelenburg adjustment is possible.
3. The brake is now released. The medifa 6000 can now be moved. Check this before
you start driving the table.
The optional manual safety system on the lifting column (to the right of the column keypad of the medifa
6000) secures the functionality of the OP table in the event of the failure of all electrical functions due to
an electronic outage.
Description Selector switch on Selector switch on Foot pedal UP Foot pedal DOWN
the left the right
WARNING
Patients are at risk if there is a malfunction!
The electrical functions must not be carried out continuously. One minute of electrical operation must be
followed by 9 minutes of no electrical operations. Otherwise, an overload can occur and functions may
fail.
The load limits must be strictly observed!
WARNING
Danger for the patient!
We cannot completely rule out the possibility of a malfunction of the medifa 6000 according to current
state of the art technology. In this rare case, the motor-driven functions would no longer be available
during the surgery.
If there is an electrical malfunction, it is possible to change the patient's position using suitable aids (e.g.
by placing cushions under the patient) or by extricating the patient from the medifa 6000.
If the medifa 6000 is equipped with a manual safety system, use this safety system to secure the patient
in the proper position.
CAUTION
Danger of being crushed
There is a danger of being crushed by moving parts. Familiarize yourself with how the table works before
using it. Danger of injury due to protruding parts.
CAUTION
Danger for the patient: monitor the patient's situation!
Monitor the patient's position on the medifa 6000 continuously to prevent any injuries.
medifa 6000 61
Positioning the patient
5. Check the handset to verify that the charge status indicator is green or yellow.
7. Prepare the medifa 6000 (along with the accessories and controls). 4 Configuring
the medifa 6000 before surgery, Page 77
8. Unlock the key lock on the column keypad (by pressing the ACTIVATE
MOVEMENTS key) before using it. The LED above the lock key will turn green to
indicate that the keypad is unlocked. You should immediately perform the desired
adjustments, since the keypad will automatically lock after ten seconds.
WARNING
Any improper attachments pose a danger to the patient!
– Check all table segments and accessories to make sure that they are safely attached before using the
medifa 6000! It is possible for loose components to slip out of position.
– Controls should only be loosened while they are being adjusted; they should then be re-tightened
immediately!
– Check to make sure that all fasteners are secure!
CAUTION
Danger for the patient!
Risk of personal injury! Patient extremities must not protrude over the ends of the table!
Components which are under improper loads can break off from the medifa 6000 or cause the medifa
6000 to tilt. The patient may only get on or off in the area of the lifting column over the seat plate!
Normal position
The normal head position: The patient's head is on the
head end of the table plate. The position of the
patient's head must always match the position shown
on the displays of the handset and column keypad!
medifa 6000 63
Positioning the patient
ATTENTION
No reverse position is possible when the total weight is greater than 250 kg.
The reverse position may only used with a total load on the medifa 6000 that is not greater than 250 kg.
Do not use the reverse position with a total load of over 250 kg on the medifa 6000.
1. Press the REVERSE key on the column keypad or on the handset. The figure of the small red man
appears in the handset display. The blue LED lights up on the column keypad next to the patient
symbol.
Reverse position
Foot position: The patient's head is at the
foot end of the table plate.
11.5 HEIGHT
The height adjustment moves the entire table plate up or down.
For certain functions (such as the Trendelenburg and lateral), the height adjustment is always the first
function used to set the desired table plate height.
Each time the patient is raised or lowered, the medifa 6000 is brought to its lowest position and then
moved to the working height with the patient lying down.
CAUTION
Danger for the patient!
The patient may only get on or off in the area of the lifting column over the seat plate!
4 Warning stickers on the medifa 6000, Page 18
CAUTION
Danger for the patient!
Lowering the table plate may result in a collision with the chassis, floor or other objects that are under
the table plate (which may be obscured by cloths or pads).
Pay attention to the downwards adjusted table segments! Clear the area under the table plate or move
the corresponding table segments (leg / back plate joints) upwards. Then move the table plate
downwards.
1050 mm
690 mm
medifa 6000 65
Positioning the patient
Height adjustment up
Description Selector switch on Selector switch on Foot pedal UP Foot pedal DOWN
the left the right
Height – upwards 0 3 x
Height – downwards 0 3 x
CAUTION
Danger to patients due to collision hazard!
When tilting the table plate (Trendelenburg/reverse Trendelenburg), collisions can occur with the lifting
column, floor or other objects that are located under the table plate and may be covered by cloths or
pads.
Always monitor all movements of the table plate to minimize this risk. Clear the area under the table
plate, adjust the table plate to a higher position or move the corresponding table segments further
upwards. Then adjust the table to the desired Trendelenburg or reverse Trendelenburg position.
There is a danger of jamming and injury when this Trendelenburg function is adjusted at the lowest table
height. The table segments of the upper back part would then collide with the base of the medifa 6000.
30° 30°
medifa 6000 67
Positioning the patient
Trendelenburg
Table plate tilted (at the transverse axis) into a
lowered-head position.
Reverse Trendelenburg
Table plate tilted (at the transverse axis) into a
lowered-feet position.
Adjusting the Trendelenburg and reverse Trendelenburg using the safety system
Description Selector switch on Selector switch on Foot pedal UP Foot pedal DOWN
the left the right
Trendelenburg – upwards 0 2 x
Trendelenburg – downwards 0 2 x
WARNING
There is a risk of personal injury when the medifa 6000 is tilted.
No lateral adjustments may be made when the table is under its maximum load!
20° 20°
medifa 6000 69
Positioning the patient
Lateral left
Lateral right
Description Selector switch on Selector switch on Foot pedal UP Foot pedal DOWN
the left the right
70°
40°
medifa 6000 71
Positioning the patient
Description Selector switch on Selector switch on Foot pedal UP Foot pedal DOWN
the left the right
210°
15° 15°
Figure 33: Flex position: Reverse Trendelenburg and back plate downwards
120°
35° 25°
medifa 6000 73
Positioning the patient
REFLEX
Trendelenburg function and back plate up
CAUTION
Danger to patients: danger of clamping and collision
Watch out for motor movements! When the leg plate joints are lowered, there is a risk of collision with
the lifting column or the chassis, especially during the Trendelenburg or reverse Trendelenburg and
lateral adjustments!
45°
30°
45°
- 90°
Figure 35: Leg plates and head plate, maximum range of motion
The head plate and the leg plates are adjusted manually.
650 mm
127 mm
medifa 6000 75
Positioning the patient
Description Selector switch on Selector switch on Foot pedal UP Foot pedal DOWN
the left the right
CAUTION
Risk of injury when attaching heavy accessories
There is a risk that personnel can be injured whenever the health and safety regulations are not
followed.
Make sure that you do not injure your back while moving the heavy plate segments and accessories and
while making manual adjustments to the medifa 6000 (with or without a patient).
Work with an additional person when necessary. Never connect or disconnect multiple plate segments
or heavy, bulky accessories at the same time. Hold the equipment and parts securely and do not drop
them.
CAUTION
Danger for the patient!
The coupling points must be checked that they are securely fastened before the patient gets on the
table! Pay attention to the safety and release levers.
CAUTION
Danger for the patient!
The square couplings must be checked to make sure they are securely fastened before the patient gets
on the table!
Pay attention to the safety levers.
medifa 6000 77
Configuring the medifa 6000 before surgery
CAUTION
Risk of injury!
Always use both hands when working with the table! This is necessary for safety reasons, since the
operator has to apply his own physical strength for the adjustment depending on the body weight of the
patient.
1. Insert the two square bolts of the leg plate 2. Hold the leg plate and tighten the locking
into the square openings on the table. The lever [1] on the table down to secure the leg
locking lever [1] must be turned upwards. plate to the table.
3. Hold the leg plate and pull up the release 4. Hold the leg plate and bring it into the
lever [2] under the foot end of the leg plate. desired position with the release lever [2]
pulled out.
5. Release the release lever [2]. The leg plate is
now locked into its end position.
1. Loosen the black star knob screw [1] on the 2. Swing the leg plate into the desired position.
hinge of the leg plate. 3. Tighten the black star knob screw [1] on the
hinge of the leg plate.
1. Hold the leg plate and turn up the release 2. Pull the leg plate out of the square openings
lever [1] on the table to tighten it. on the table.
CAUTION
Risk of injury!
Always use both hands when working with the table! This is necessary for safety reasons, since the
operator has to apply his own physical strength for the adjustment depending on the body weight of the
patient.
medifa 6000 79
Configuring the medifa 6000 before surgery
1. Insert the two square bolts of the head plate 2. Hold the head plate and tighten the black star
into the square openings on the table. knob screws [1] on both sides of the table.
3. Hold the head plate and pull up the release 4. Hold the head plate and move it to the
lever [1] at the head end. desired position.
5. Release the release lever [2]. The head plate
is now locked into its end position.
1. Hold the head plate and loosen the black star 2. Pull the head plate out of the square
knob screws on both sides of the table. openings on the table.
ATTENTION
Safety instructions
– Only use original cushions from medifa!
– The patient should not be on the medifa 6000 when the cushions are not in place.
– If the table components are fastened correctly, the cushion edges should align flush with the medifa
6000.
– Do not place sharp objects in or on the cushions.
– Do not attach adhesive tape.
● The cushion is attached to the cushion plate using the peg holders.
1. Place the cushion on the cushion plate. Press 2. Check that the cushion is firmly attached to
the sockets in the cushion on the peg holders the OP table. The cushion must be secured
of the cushion plate. precisely on the cushion pad.
medifa 6000 81
Load limits
13 Load limits
The load limits described below are calculated using the following formula:
Total weight (safe work load) = patient weight + accessory weight
The centre of gravity of the safe work load must be positioned centrally above the lifting column.
ATTENTION
No reverse position is possible when the total weight is greater than 250 kg.
The reverse position may only used with a total load on the medifa 6000 that is not greater than 250 kg.
Do not use the reverse position with a total load of over 250 kg on the medifa 6000.
CAUTION
Risk of personal injury!
– Only cleaned and disinfected equipment and devices should be handed over to service technicians for
maintenance and repair work!
– Replace any cushioning that no longer complies with the relevant hygiene and infection
requirements!
– Always disconnect the external power supply before starting any maintenance or cleaning on the
medifa 6000.
– Turn off the main switch!
– Make sure that no motor movements can occur!
ATTENTION
Danger: incorrect maintenance may damage property!
The medifa 6000 is not suitable for an automated cleaning process!
Do not use a high-pressure cleaner! Due to the high pressure of the water jet, liquid could penetrate
through gaps or joints and damage the device (through corrosion).
Improper cleaning products can damage the surface!
When cleaning the device, do not use scouring cleansers or detergents and disinfectants containing
halide or peracetic acid.
For the plastic parts and cushions, do not use alcoholic or solvent-based (flammable) cleaning/
disinfecting agents!
The cleaning products for the cleaning and disinfection must comply with the applicable national
regulations for the medical sector and/or be listed by the German Society for Hygiene and Microbiology /
Association for Applied Hygiene.
Follow the hospital's hygiene regulations!
medifa 6000 83
Preparing the medifa 6000 after it has been used
Clean contaminated products immediately! The cleaning/disinfection is limited to a regular wiping (not
dipping!) using the appropriate substance.
CAUTION
Risk of personal injury!
If incorrect cleaning products are used, the anti-static properties of the cushion (according to IEC
60601-1: DIN EN 60601-1) will be lost. Only use the specified cleaning agents and disinfectants!
14.1.1 Cleaning
ü For cleaning stainless steel and plastic parts, use a pH-neutral or slightly alkaline all-purpose
cleaner with surfactants for cleaning-active components.
ü If parts are heavily contaminated, use concentrated cleaner and then wipe with clear water.
1. For the cleaning, move the medifa 6000 to its highest table position and wipe with a damp cloth.
2. In this position, the panels of the lifting column can be pulled apart so they are easy to clean.
Remove the cushions in order to clean the bottom of the cushions and the table top!
14.1.2 Disinfecting
Recommended disinfectants
Disinfectant Manufacturer
Disinfectant Manufacturer
The composition of these disinfectants was up to date on March 2019. Medifa GmbH & Co. KG does not
accept any liability for any changes to the formulation of the disinfectants by the manufacturers.
14.1.3 Drying
After cleaning and disinfecting, remove any excess moisture (for example, drops on the bottom edge of
the table top) using a dry cloth.
14.1.4 Disposal
Dispose of all cleaning and disinfectant residues in a proper and environmentally friendly manner!
medifa 6000 85
Troubleshooting and service – the we care.Code
1. Scan in the QR code. Your 2. Tap on "Troubleshooting". 3. Select the subject for which
product will be displayed you require assistance.
on the start page. You can
scroll down to view more
information about your
product and to download
supporting documents.
After you have selected the problem related to your product, you will receive step-by-step instructions on
how to fix it yourself.
You may submit a service request directly to medifa if you cannot solve the problem by yourself.
1. Tap on the < symbol in the 2. From the Home screen, tap 3. A window will open
header bar. on "CREATE TICKET". showing your existing
tickets (if any) for this
product. To create a new
ticket, tap on the plus
symbol (+) in the green
circle. After submitting the
ticket, you may optionally
enter your e-mail address
so that you can be
informed about updates to
the ticket.
4. Otherwise, you will need to 5. Tap on "CREATE TICKET" to 6. A window will open
re-scan the QR Code at a view the feedback on the showing your existing
later date. ticket you created. tickets for this product.
medifa 6000 87
Technical specifications
16 Technical specifications
Mass 190 kg
Maximum table load 454 kg (depending on the accessories used and the patient
positioning)
Power 9.5 W
Frequency 50 – 60 Hz
Flex 210°
Reflex 120°
16.5 Classification
Protection class 1
medifa 6000 89
Technical specifications
WARNING
Impairments caused by electromagnetic radiation
– This medical device must not be used directly next to other devices. If necessary, the device should
be observed to verify its proper operation in the particular arrangement.
– The use of accessories, transformers, and cables other than those specified by medifa for this device
may result in increased electromagnetic emissions or reduced electromagnetic immunity of the
device. This can result in improper operation.
– Portable RF communications equipment (radios, including their accessories such as antenna cables
and external antennas) should not be used closer than 30 cm (12 inches) from the medifa 6000.
17 Appendix
17.1.1 Delivery
The medifa 6000 is delivered on a pallet in a box. The ordered plate segments and accessories are
individually packed on the pallet or are already attached to the medifa 6000.
Length 1200 mm
Width 800 mm
Height 1050 mm
Mass 190 kg
Packaging 30 kg
ATTENTION
Danger of property damage!
The packaging is not weatherproof! Observe the instructions for storage. 4 Technical
specifications, Page 88
CAUTION
Danger: risk of personal injury when the medifa 6000 is tilted!
– Do not move or push the medifa 6000 over the edge of the pallet!
– Use at least two people to carefully move the medifa 6000 from the pallet onto a flat place!
ATTENTION
Danger of damage to the electronics due to condensation!
During transport, there is a risk of condensation which could damage electronic components. After
receipt of the medifa 6000, you must wait a certain amount of time (we recommend at least 12 hours)
before switching it on or connecting it to an external power source. The medifa 6000 should be set up in
an environment that has the same ambient temperature and relative humidity as the room in which it
will be used.
medifa 6000 91
Appendix
The following sequence must be followed for unpacking and setting up:
1. Unpack the medifa 6000 in a room with a level floor and sufficient free space for
unrolling from the pallet.
8. Keep the medifa 6000 switched off and disconnected from the power supply for
at least 12 hours. This allows any condensate that has formed during transport to
evaporate completely.
11. Release the brake on the medifa 6000. The brake is completely released when the
red LED next to the brake symbol lights up and the brake symbol on the handset
lights up red.
13. Use the column keypad or handset to brake the medifa 6000. The medifa 6000 is
braked when the brake symbol at the handset and the red LED on the brake
symbol at the column keypad are no longer illuminated.
Symbol Description
+50 °C
Temperature range for storage and transport: -20 °C to 50 °C.
-20 °C
95 %
Relative humidity for storage and transport: 10% to 95%.
10 %
106 kPa
Air pressure for storage and transport: 70 kPa to 106 kPa.
70 kPa
Date of manufacture
Medical device
Date of manufacture
Article number
Serial number
medifa 6000 93
Appendix
17.2 When the device has not been used for a long time
When not in use, switch off the medifa 6000 at the main switch.
If the medifa 6000 has not been used for a long time, the batteries may not be fully charged. To prevent a
battery malfunction or outage, the batteries must be charged each month during periods when the
medifa 6000 is not being used.
Clean and disinfect the medifa 6000 before a period of long disuse.
Cover the cushions or cover the entire medifa 6000 in a foil (the cover material must be permeable to air).
The medifa 6000 must be stored in a dry place.
17.3 Disposal
The medifa 6000, accessories and packaging must be recycled in an environmentally friendly manner. The
disposal of individual parts must also be carried out in an environmentally friendly manner (i.e. according
to the relevant legal regulations)!
For more information about the proper disposal of used devices, please contact medifa Technical Support,
your local dealer or the appropriate national authority.
The company medifa will take back old devices, defective devices, or products no longer in use. Contact
medifa Technical Support for more details.
If the medifa 6000 will be taken out of service (decommissioned), the lead-gel batteries must be removed
from the device by a medifa service technician or by a person authorized by medifa medifa 6000.
Send any removed unusable batteries, in suitable packaging, to medifa Technical Support.
Attention: the return package must be declared as dangerous goods according to Class 9/UN3480!
The company medifa will then ensure that the batteries are disposed of in an environmentally manner.
17.4 Accessories
Product name Article number Weight (kg) Permissible load (kg)
medifa 6000 95
Made in Germany
medifa GmbH
Industriestraße 5
57413 Finnentrop
Germany
fon +49 2721 7177-0
fax +49 2721 7177-255
info@medifa.com
www.medifa.com