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MAT5000 III

Surgery Table
User manual
501130 503220 504220 504320 505220 505320
Technical description
501135 503225 504225 504325 505225 505325

Contents:
I. General security information ......................... 2-3 IV. First usage ......................................................... 24
4.1 Charging the batteries ................................. 24
II. Additional information .................................... 4 4.2 Potential equalization .................................. 24
2.1 About this manual ..................................... 4 4.3 Explosion-secure-advisory ......................... 24
2.2 Operation fields of medifa products ........ 4 4.4 Additional accessories for body storage .. 24
2.3 Basic security advice ................................ 4 4.4.1 Head rest............................................. 24
4.4.2 Leg plate/s .......................................... 25
III. General description of medical device ......... 5 4.5 Cushions ...................................................... 25
3.1 Basics of the tables .................................. 5
3.1.1 Field of operation ............................ 5 V. Care instructions ...................................................... 26
3.2 Variations of the tables ............................. 5-6 5.1 Cleaning and disinfection advisory ........... 26
3.3 Measurements and functions................... 7 5.2 Disinfection of the castors 26
English Issue: 31.12.2011

3.3.1 Type 501130 ..................................... 7-8 5.3 Maintenance (general information) ............ 26
3.3.2 Type 501135 ..................................... 8 5.3.1 Maintenance ....................................... 26
3.3.3 Type 503220 ..................................... 9-10 5.4 Malfunctions................................................. 27
3.3.4 Type 503225 ..................................... 11 5.5 Environmental protection ........................... 27
3.3.5 Type 504220 ..................................... 12-13 5.5.1 Packing materials .............................. 27
3.3.6 Type 504225 ..................................... 14 5.5.2 Defective parts and others. ............... 27
3.3.7 Type 504320 ..................................... 15-16
3.3.8 Type 504325 ..................................... 17 VI. Technical information ....................................... 28-29
3.3.9 Type 505220 ..................................... 18-19
3.3.10 Type 505225 ................................... 20 VII. Accessory list .................................................... 30-31
3.3.11 Type 505320 ................................... 21-22
3.3.12 Type 505325 ................................... 23 VIII. Spare part list ..................................................... 31

IX. Declaration of conformity .................................. 32-33


MAT5000 III surgery tables

I. General security information

The surgery table is made for a maximum patients weight of 150/ 200 kg.
Surgical interferences may be accomplished only at patients with permissible weight!

Take care of the defined lying direction of the patient. Even do not store the patient with his upper body on
the leg plate, because otherwise the complete table might fell off!

For avoiding the risk of overbalancing the whole table, take care of an stable and secure placement of the
table itself!

Before usage of the table make sure the brake is activated!

Make sure the brake of the table is activated before transferring the patient to a bed!

Take care of the patients security before doing any adjustment with the table!

For back rest adjustment and (Anti-) Trendelenburg position take care of the placement of the patient!
A two hand adjustment is absolutely necessary because of safety reasons. The users own body strength
might be needed for adjustment, depending on the patients weight!

By use of high frequency surgery devices, defibrillators as well as their monitors take care of the patient does
not affect any metal parts of the surgery table. Furthermore the patient must not lie on a wet surface or elec-
trical conductive cushions!
Otherwise the patient could get burned!

The electrical conductivity of the cushions should be inspected annually by appropriate service-personnel !

Take care of correct adaption of additional body storage accessories!

Strictly avoid the usage of damaged or worn out accessory parts!


A risk of injury is given!

Beware of collisions between the table and accessory parts!

By use of accessories from competitors read the instruction manual carefully!

By use of accessories from competitors which influence the static of the table, keep in touch with medifa Ser-
vice-Team before!

Only usage of accessories listed in accessory list is allowed!

Avoid endangerments for respiration, nerve courses as well as blood cycle by right positioning and observa-
tion of the patient!

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For back rest adjustment and (Anti-) Trendelenburg position take


care of the placement of the patient!
A two hand adjustment is absolutely necessary because of safety
reasons. The users own body strength might be needed for adjust-
ment, depending on the patients weight!

Keep the area directly around the table free from other things
before doing an down-movement!
Otherwise there is a risk of overbalancing the whole table!

Keep your extremities away from spaces between body stor-


age parts!
There is a risk of squeezing!

Beware of collisions between the lying surface and the base of


the table by doing the following adjustments:
Height adjustment (downwards)
(anti-) Trendelenburg position
Leg plate adjustment (downwards)

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MAT5000 III surgery tables

II. Additional information

You have decided to buy one of the excellent medifa products.


Therefore and for the confidence you spend us we would like to say Thank You!!

2.1 About this manual


Read this manual carefully.
It is written to beware you to do mistakes and to introduce you into the easy handling of our products!
To ensure your own and even security of your patients it is absolutely necessary that you follow the herein
written instructions and advise.
Store this manual in direct near to the corresponding device to ensure quick access.

Sign explanation:

This symbol signs chapters, which describe abatement measures for injuries at patient
or yourself!

This symbol signs chapters, which warn for wrong handling that could cause damages
or injuries.

This symbol signs chapters, which advice for being carefully to beware of injuries or
wrong handling!

2.2 Operation fields of medifa products


All medifa products are made for human medicine.
The devices have to be used only by authorised personal and in special equipped rooms according to the
current applicable regulations.
Authorised persons are only people who have got a product introduction by special trained personal.
The product introduction has to be signed and confirmed on an instruction protocol!

Use only devices which are good in order and condition, which have been maintained regularly!

2.3 Basic security advice


Because of compliment to the requirements according to the international technical standards IEC 601-1
and IEC 60601-2-46 this is a medical device of class I regarding to the Medical Device Directive (MDD).

It has to be included into the medical inventory listings! Even every maintenance work on medical products,
installations of new medical devices as well as calibrations and assemblies at older ones have to be
reported there.
Take care of doing the above mentioned work only by service technicians of medifa to ensure safety related
proper function of the products.
This should also be done according to the warranty conditions!

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III. General description of medical device

3.1.1 Basics of the tables


All surgery tables of the MAT5000 III series are mobile surgery tables and depending on the number of leg
plates and accessory equipment f. special disciplines divided into 4-8 sections.
Below the lying surface there is a x-ray cassette tunnel for x-ray cassette insert.
This x-ray cassettes can be put below the head rest, back rest, pelvis part as well as below the leg plates.

Depending on the equipped leg plate/s they need to be adjusted to the same height level for inserting.
Spreading of the plates is not possible then.
Furthermore the tables are equipped with lateral side rails (25x10mm) for accessory attachment!

3.1.1 Field of operation


The surgery tables of the MAT5000 III series are made for short storages of patients during examination or
surgery process.
Given by the possible adjustments of the table the patient can be stored in lying or seating position. De-
pending on the equipped accessories it is also possible to store the patient in lithotomic position and others
also.
The patients entrance or the patients positioning has to be done from beside at the middle of the table.

The electric functions are made by hand switch or operating panel at the column.

The manual adjustable parts are used by hands or feet.

3.2 Types of MAT 5000 tables

501130 > Mobile universal surgery table including central brake. Height ad-
justment is made manually by hydraulic foot pump system,
Trendelenburg positioning as well as back rest adjustment is made
by gas spring system, lateral tilt is made by hand crank gear.
The upholsteries are detachable foamed PUR cushions.

501135 > Same as 501130, however with an additionally sliding table top in
longitudinal direction. Sliding table top is made manually by hand
grips.

503220 > Mobile universal surgery table including central brake. The table is
equipped with a hydraulic foot pump system for height adjustment,
Trendelenburg positioning, lateral tilt, as well as back rest adjust-
ment. The table is made for hand-free adjustment.
The upholsteries are detachable foamed PUR cushions.
503225 > Same as 503220, however with an additionally sliding table top in
longitudinal direction. Sliding table top is made manually by hand
grips.

504220 > Mobile universal surgery table including central brake. The table is
equipped with three electric engines for height adjustment,
Trendelenburg positioning and lateral tilt. Only the back rest is ad-
justed manually by gas spring system. All electric functions are
controlled by hand switch or an additional operating panel at the
column of the table.
The upholsteries are detachable foamed PUR cushions.

504225 > Same as 504220, however with an additionally sliding table top in
longitudinal direction. Sliding table top is made electrically by hand
switch or operating panel.

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MAT5000 III surgery tables

504320 > Mobile universal surgery table including central brake. The table is
equipped with four electric engines for height adjustment,
Trendelenburg positioning, lateral tilt as well as back rest adjust-
ment. All electric functions are controlled by hand switch or an ad-
ditional operating panel at the column of the table.
The upholsteries are detachable foamed PUR cushions.

504325 > Same as 504320, however with an additionally sliding table top in
longitudinal direction. Sliding table top is made electrically by hand
switch or operating panel.

505220 > Same as 504220, however with another range for height adjust-
ment, because of the lower base of the table.
Herewith the table can reach a very low entrance and of course a
lower working position.

505225 > Same as 504225, however with another range for height adjust-
ment, because of the lower base of the table.
Herewith the table can reach a very low entrance and of course a
lower working position.

505320 > Same as 504320, however with another range for height adjust-
ment, because of the lower base of the table.
Herewith the table can reach a very low entrance and of course a
lower working position.

505325 > Same as 504325, however with another range for height adjust-
ment, because of the lower base of the table.
Herewith the table can reach a very low entrance and of course a
lower working position.

It is only allowed to adapt medifa accessories to the tables!


Usage of accessories from foreign manufacturers is only allowed after consultation and explicit acceptance
of medifa.
For issuing an explicit acceptance for a foreign accessory part an accurate inspection for trapping hazards
at users and patients, as well as for possible damages at the table itself is absolutely necessary.

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3.3.1 Type 501130


a) 4 double swivelling castors, 125mms, lockable
h f b) Hydraulic foot pump for height adjustment
i
c) Starting component for (anti-) Trendelenburg positioning
d) Hand crank insert for lateral tilt
e) Starting component for back rest adjustment
f) Cushions acc. to DIN 53596 made of PUR-foam, detachable
e g) Side rails (25x10mm) at whole length of lying surface
g h) Insert for accessories at head end of the table
d
i) Insert for accessories at foot end of the table
c j j) Pedal for activation of central brake

Length of lying surface 2160 mm


(incl. head and leg plate/s)

Width of lying surface 540 mm


a
b Weight (incl. head and leg plate/s) ca. 150 kg

Height adjustment:
Pressing foot pump pedal (b) = Table raises up.
For lowering the table lift up the pedal (b).

b Range: 750 to 1000 mm

Back rest adjustment:


e By pulling lever (e) into direction of the head end the gas springs for back rest ad-
justment will be released. Now the back rest can be adjusted by lifting or lowering
into wanted position.
By releasing the lever (e) the back rest will be fixed in current position.

Two hand adjustment is absolutely necessary because of safety reasons. The


users own body strength might be needed for adjustment, depending on the pa-
tients weight!

Range: (-) 40 to (+) 70

(Anti-) Trendelenburg adjustment:


By pressing both levers (c) below the back
rest the gas springs for Trendelenburg
adjustment are released. Now Trendelen-
burg position can be adjusted by lowering
or raising the lying surface. By releasing
c both levers the lying surface will be fixed
in current position.
Two hand adjustment is absolutely necessary
because of safety reasons. The users own
body strength might be needed for adjustment,
depending on the patients weight!

Range: (-) 30 to (+) 30

Lateral tilt:
d Lateral tilt is adjusted by use of a hand crank (d). It can be inserted below the seat
part from both sides.

Range: (-) 20 to (+) 20

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MAT5000 III surgery tables

Activation of the central brake:

j Upper position5th castor is activated (optional accessory)

Middle positionall castors are free wheeling

Lower positionall castors locked

The pedal (j) is for activation of the central brake. If the pedal is in upper position the table is moveable. Additionally a fifth castor
(optional accessory) is activated centrally in the base of the table for more easy manoeuvrability.
If the pedal is in the middle position all castors are free wheeling, 5th castor (optional accessory) is not activated.
If the pedal is in lowest position all castors are locked. The table is fixed on current position.

3.3.2 Type 501135


Type 501135 has the same basic features like type 501130 (page 7ff.), but additionally there is also the
function of a manually adjustable longitudinal sliding table top.

Sliding table top adjustment:


155 mm (A) (310 mm)
General information:
155 mm (B)
The possible longitudinal slide of the table top is
about 300 mm. It can be fixed every 30 mm.

Functionality:
For a sliding table top just press sliding lever and
move the table top into wanted position.
Release the sliding lever and move table top until it
is fixed at the current position.
If you slide the table top you will hear a scratch by
sliding over middle position and you can feel a little
resistance.
Sliding lever This Position is called 0-position.

A slide of the table top into direction A is only allowed, if the table top is horizontally and the leg plate/s is/ are
not angled negatively.
You do not need to pay attention to the position of the back rest.

A slide of the table top into direction B is only allowed, if the table top is horizontally and the back rest is not
angled negatively.
You do not need to pay to the position of the leg plate/s.

If the table top itself is angled roughly into (anti-) Trendelenburg position the sliding function need not be
used, because the patient might fell off!
Please make yourself conversant with the tables attitude when a patient lies on it before usage!

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3.3.3 Type 503220

d
a) 4 double swivelling castors, 125mms, lockable
b) Pedal for activation of central brake
c) Insert for accessories at head end of the table
k c d) Cushions acc. to DIN 53596 made of PUR-foam, detachable
b e) Side rails (25x10mm) at whole length of lying surface
f) Insert for accessories at foot end of the table
h Foot pump pedal lifting
f g)
g h) Foot pump pedal lowering
i) Pre selection lever for hydraulic functions
j j) Lever for leg plate adjustment
e k) Lever for head rest adjustment

i a
Length of lying surface 2160 mm
(incl. head and leg plate/s)

Width of lying surface 540 mm

Weight (incl. head and leg plate/s) ca. 160 kg

Height adjustment:
Set pre selection lever (i) on position of height adjustment (Pic. 1)
For doing an adjustment just use pedal (g) for raising, and pedal (h) for lowering (for lowering just keep the pedal under pressure)

Pic. 1
h

Range: 750 to 1000 mm

Back rest adjustment:


Set the pre selection lever (i) on position of back rest adjustment (Pic. 2)
For doing an adjustment just use pedal (g) for raising, and pedal (h) for lowering

Pic. 2

Range: (-) 40 to (+) 70

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MAT5000 III surgery tables

(Anti-) Trendelenburg adjustment:


Set the pre selection lever (i) on position of (anti-) Trendelenburg adjustment (Pic. 3)
For doing an adjustment just use pedal (g) for raising, and pedal (h) for lowering

Pic. 3

Range: (-) 30 to (+) 30

Lateral tilt:
Set the pre selection lever (i) on position of lateral tilt einstellen (Pic. 4)
For doing an adjustment just use pedal (g) for raising, and pedal (h) for lowering

Pic. 4

Range: (-) 20 to (+) 20

Activation of the central brake:

b Upper position5th castor is activated (optional accessory)

Middle positionall castors are free wheeling

Lower positionall castors locked

The pedal (b) is for activation of the central brake. If the pedal is in upper position the table is moveable. Additionally a fifth castor
(optional accessory) is activated centrally in the base of the table for more easy manoeuvrability.
If the pedal is in the middle position all castors are free wheeling, 5th castor (optional accessory) is not activated.
If the pedal is in lowest position all castors are locked. The table is fixed on current position.

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3.3.4 Type 503225


Type 503225 has the same basic features like type 503220 (page 9ff.), but additionally there is also the
function of a manually adjustable longitudinal sliding table top.

Sliding table top adjustment:

155 mm (A) (310 mm)

155 mm (B)

General information:
The possible longitudinal slide of the table top is
about 310 mm. It can be fixed every 30 mm.

Functionality:
For a sliding table top just press sliding lever and
move the table top into wanted position.
Release the sliding lever and move table top until it
is fixed at the current position.
If you slide the table top you will hear a scratch by
Sliding lever sliding over middle position and you can feel a little
resistance.
This Position is called 0-position.

A slide of the table top into direction A is only allowed, if the table top is horizontally and the leg plate/s is/
are not angled negatively.
You do not need to pay attention to the position of the back rest.

A slide of the table top into direction B is only allowed, if the table top is horizontally and the back rest is not
angled negatively.
You do not need to pay attention to the position of the leg plate/s.

If the table top itself is angled roughly into (anti-) Trendelenburg position the sliding function need not be
used, because the patient might fell off!
Please make yourself conversant with the tables attitude when a patient lies on it before usage!

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MAT5000 III surgery tables

3.3.5 Type 504220


d f

a) 4 double swivelling castors, 125mms, lockable


b) Pedal for activation of central brake
c) Insert for accessories at head end of the table
k d) Cushions acc. to DIN 53596 made of PUR-foam, detachable
c i e) Side rails (25x10mm) at whole length of lying surface
h f) Insert for accessories at foot end of the table
g
e g) Remote control for electric functions
b h) Lever for leg plate adjustment
i) Lever for back rest adjustment
j) Operation panel for electric functions
k) Lever for head rest adjustment
j
Length of lying surface 2160 mm
(incl. head and leg plate/s)
a
Width of lying surface 540 mm

Weight (incl. head and leg plate/s) ca. 170 kg

Display

Height adjustment
(Anti-) Trendelenburg position
Lateral tilt

0-Position

On-/Off switch

Appliance
1. The tables system will be activated by pressing the On/Off switch at remote control or at operating panel at the column. If no ad-
justment is done after 60 minutes the system will be deactivated automatically.
2. For doing any adjustment the corresponding button at remote control or operating panel at the column has to be pressed and held.
For stopping just release the button and the table stops moving immediately. This is because of safety reasons.
It is only possible to make one adjustment after the next, not at the same time.
3. The display at remote control or operating panel at the column shows current movement of the table. The display at operating panel
at the column shows furthermore the current charging status of the tables batteries.
4. By pressing the 0-Position button on the hand switch or operating panel the table will drive into its starting position (zero-position).
By pressing and holding the button every engine will drive back into its starting position.

Height adjustment:
For adjustment of the tables height just press and hold the corresponding button
at remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: 790 to 1090 mm

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Back rest adjustment:


By pulling lever (i) into direction of the head end the gas springs for back rest ad-
i justment will be released. Now the back rest can be adjusted by lifting or lowering
into wanted position.
By releasing of the lever (i) the back rest will be fixed in current position.

Two hand adjustment is absolutely necessary because of safety reasons. The


users own body strength might be needed for adjustment, depending on the pa-
tients weight!
Range: (-) 40 to (+) 70

(Anti-) Trendelenburg position:


To adjust the table into (anti-) Trendelen-
burg position just press and hold corre-
sponding button at remote control or
even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 30 to (+) 30

Lateral tilt:
To adjust the lateral tilt of the table just press and hold corresponding button at
remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 20 to (+) 20

Activation of the central brake:

b Upper position5th castor is activated (optional accessory)

Middle positionall castors are free wheeling

Lower positionall castors locked

The pedal (b) is for activation of the central brake. If the pedal is in upper position the table is moveable. Additionally a fifth castor is acti-
vated centrally in the base of the table for more easy manoeuvrability.
If the pedal is in the middle position all castors are free wheeling, 5th castor is not activated.
If the pedal is in lowest position all castors are locked.
The table is fixed on current position.

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MAT5000 III surgery tables

3.3.6 Type 504225


Type 504225 has the same basic features like type 504220 (page 12ff.), but additionally there is also the
function of an electrically adjustable longitudinal sliding table top.

Sliding table top adjustment:

155 mm (A) (310 mm)


155 mm (B)
General information:
The possible longitudinal slide of the table top is
about 310 mm. It can be fixed in each position.

Functionality:
For a sliding table top just press the corresponding
button on the hand switch or the operating panel at
the column of the table.
The button is signed as follows:

If the table top is shifted, the following functions are


blocked because of safety reasons:
(Anti)-Trendelenburg positioning (> 10)
Lateral tilt

For unblocking these functions it is necessary to get


the table top into its starting position (zero position/
0-position). Therefore you have to press the corre-
sponding button on the hand switch or the operating
panel at the column of the table.

Sliding the table top into direction A is only possible, if Trendelenburg angle and lateral position is horizon-
tally. Otherwise the sliding function is blocked. The leg plate/s must not be in negative position. The position
of the back rest is irrelevant.

Sliding the table top into direction B is only possible, if Trendelenburg angle and lateral position is horizon-
tally. Otherwise the sliding function is blocked. The back rest must not be in negative position. The position
of the leg plate/s is/are irrelevant.

If the table top itself is angled into (anti-) Trendelenburg position or lateral tilt the sliding function cannot be
used, because the patient might fell off (fall hazard)! Therefore the function is blocked.
Please make yourself conversant with the tables attitude when a patient lies on it before usage!

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3.3.7 Type 504320


d f

a) 4 double swivelling castors, 125mms, lockable


b) Pedal for activation of central brake
c) Insert for accessories at head end of the table
j d) Cushions acc. to DIN 53596 made of PUR-foam, detachable
c e) Side rails (25x10mm) at whole length of lying surface
h f) Insert for accessories at foot end of the table
g
e g) Remote control for electric functions
b h) Lever for leg plate adjustment
i) Operation panel for electric functions
j) Lever for head rest adjustment

Length of lying surface 2160 mm


i
(incl. head and leg plate/s)
a Width of lying surface 540 mm

Weight (incl. head and leg plate/s) ca. 170 kg

Display

Height adjustment
(Anti-) Trendelenburg position
Lateral tilt
Back rest adjustment

0-Position

On-/Off switch

Bedienung
1. The tables system will be activated by pressing the On/Off switch at remote control or at operating panel at the column. If no ad-
justment is done after 60 minutes the system will be deactivated automatically.
2. For doing any adjustment the corresponding button at remote control or operating panel at the column has to be pressed and held.
For stopping just release the button and the table stops moving immediately. This is because of safety reasons.
It is only possible to make one adjustment after the next, not at the same time.
3. The display at remote control or operating panel at the column shows current movement of the table. The display at operating panel
at the column shows furthermore the current charging status of the tables batteries.
4. By pressing the 0-Position button on the hand switch or operating panel the table will drive into its starting position (zero-position).
By pressing and holding the button every engine will drive back into its starting position.

Height adjustment:
For adjustment of the tables height just press and hold the corresponding button
at remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: 790 to 1090 mm

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MAT5000 III surgery tables

Back rest adjustment:


For adjustment of the tables back rest just press and hold the corresponding but-
i ton at remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 40 to (+) 70

(Anti-) Trendelenburg position:


To adjust the table into (anti-) Trendelen-
burg position just press and hold corre-
sponding button at remote control or
even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 30 to (+) 30

Lateral tilt:
To adjust the lateral tilt of the table just press and hold corresponding button at
remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 20 to (+) 20

Activation of the central brake:

b Upper position5th castor is activated (optional accessory)

Middle positionall castors are free wheeling

Lower positionall castors locked

The pedal (b) is for activation of the central brake. If the pedal is in upper position the table is moveable. Additionally a fifth castor is acti-
vated centrally in the base of the table for more easy manoeuvrability.
If the pedal is in the middle position all castors are free wheeling, 5th castor is not activated.
If the pedal is in lowest position all castors are locked.
The table is fixed on current position.

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3.3.8 Type 504325


Type 504325 has the same basic features like type 504320 (page 15ff.), but additionally there is also the
function of an electrically adjustable longitudinal sliding table top.

Sliding table top adjustment:

155 mm (A) (310 mm)


155 mm (B)
General information:
The possible longitudinal slide of the table top is
about 310 mm. It can be fixed in each position.

Functionality:
For a sliding table top just press the corresponding
button on the hand switch or the operating panel at
the column of the table.
The button is signed as follows:

If the table top is shifted, the following functions are


blocked because of safety reasons:
(Anti)-Trendelenburg positioning (> 10)
Lateral tilt

For unblocking these functions it is necessary to get


the table top into its starting position (zero position/
0-position). Therefore you have to press the corre-
sponding button on the hand switch or the operating
panel at the column of the table.

Sliding the table top into direction A is only possible, if Trendelenburg angle and lateral position is hori-
zontally. Otherwise the sliding function is blocked. The leg plate/s must not be in negative position. The
position of the back rest is irrelevant.

Sliding the table top into direction B is only possible, if Trendelenburg angle and lateral position is hori-
zontally. Otherwise the sliding function is blocked. The back rest must not be in negative position. The
position of the leg plate/s is/are irrelevant.

If the table top itself is angled into (anti-) Trendelenburg position or lateral tilt the sliding function cannot be
used, because the patient might fell off (fall hazard)! Therefore the function is blocked.
Please make yourself conversant with the tables attitude when a patient lies on it before usage!

medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop English 17


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MAT5000 III surgery tables

3.3.9 Model 505220


d f

a) 2 double swivelling castors, 125mms, lockable (head end),


2 fixed casotrs, directional (foot end)
b) Pedal for activation of central brake
k c) Insert for accessories at head end of the table
c i d) Cushions acc. to DIN 53596 made of PUR-foam, detachable
g e) Side rails (25x10mm) at whole length of lying surface
e h f) Insert for accessories at foot end of the table
b g) Remote control for electric functions
h) Lever for leg plate adjustment
i) Lever for back rest adjustment
j) Operation panel for electric functions
k) Lever for head rest adjustment
j
Length of lying surface 2160 mm
a (incl. head and leg plate/s)

Width of lying surface 540 mm

Weight (incl. head and leg plate/s) ca. 170 kg

Display

Height adjustment
(Anti-) Trendelenburg position
Lateral tilt

0-Position

On-/Off switch

Appliance
1. The tables system will be activated by pressing the On/Off switch at remote control or at operating panel at the column. If no ad-
justment is done after 60 minutes the system will be deactivated automatically.
2. For doing any adjustment the corresponding button at remote control or operating panel at the column has to be pressed and held.
For stopping just release the button and the table stops moving immediately. This is because of safety reasons.
It is only possible to make one adjustment after the next, not at the same time.
3. The display at remote control or operating panel at the column shows current movement of the table. The display at operating panel
at the column shows furthermore the current charging status of the tables batteries.
4. By pressing the 0-Position button on the hand switch or operating panel the table will drive into its starting position (zero-position).
By pressing and holding the button every engine will drive back into its starting position.

Height adjustment:
For adjustment of the tables height just press and hold the corresponding button
at remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: 600 to 950 mm

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medifa

Back rest adjustment:


By pulling lever (i) into direction of the head end the gas springs for back rest ad-
i justment will be released. Now the back rest can be adjusted by lifting or lowering
into wanted position.
By releasing of the lever (i) the back rest will be fixed in current position.

Two hand adjustment is absolutely necessary because of safety reasons. The


users own body strength might be needed for adjustment, depending on the pa-
tients weight!
Range: (-) 40 to (+) 70

(Anti-) Trendelenburg position:


To adjust the table into (anti-) Trendelen-
burg position just press and hold corre-
sponding button at remote control or
even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 30 to (+) 25

Lateral tilt:
To adjust the lateral tilt of the table just press and hold corresponding button at
remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 20 to (+) 20

Activation of the central brake:

Upper position - Head end castors are locked (brake activated)


b

Lower position - Head end castors are unlocked (brake deactivated)

The pedal (b) is for activation of the central brake. If the pedal is in upper position the table is moveable!
Please make yourself sure that the foot end castors just drive straight forward.
The tables brake is activated when the foot pedal is in lower position.

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MAT5000 III surgery tables

3.3.10 Type 505225


Type 505225 has the same basic features like type 505220 (page 18ff.), but additionally there is also the
function of an electrically adjustable longitudinal sliding table top.

Sliding table top adjustment:

155 mm (A) (310 mm)

155 mm (B) General information:


The possible longitudinal slide of the table top is
about 310 mm. It can be fixed in each position.

Functionality:
For a sliding table top just press the corresponding
button on the hand switch or the operating panel at
the column of the table.
The button is signed as follows:

If the table top is shifted, the following functions are


blocked because of safety reasons:
(Anti)-Trendelenburg positioning (> 10)
Lateral tilt

For unblocking these functions it is necessary to get


the table top into its starting position (zero position/
0-position). Therefore you have to press the corre-
sponding button on the hand switch or the operating
panel at the column of the table.

Sliding the table top into direction A is only possible, if Trendelenburg angle and lateral position is horizon-
tally. Otherwise the sliding function is blocked. The leg plate/s must not be in negative position. The position
of the back rest is irrelevant.

Sliding the table top into direction B is only possible, if Trendelenburg angle and lateral position is horizon-
tally. Otherwise the sliding function is blocked. The back rest must not be in negative position. The position
of the leg plate/s is/are irrelevant.

If the table top itself is angled into (anti-) Trendelenburg position or lateral tilt the sliding function cannot be
used, because the patient might fell off (fall hazard)! Therefore the function is blocked.
Please make yourself conversant with the tables attitude when a patient lies on it before usage!

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medifa

3.3.11 Type 505320


d f

a) 2 double swivelling castors, 125mms, lockable (head end),


2 fixed casotrs, directional (foot end)
b) Pedal for activation of central brake
j c) Insert for accessories at head end of the table
c d) Cushions acc. to DIN 53596 made of PUR-foam, detachable
g e) Side rails (25x10mm) at whole length of lying surface
e h f) Insert for accessories at foot end of the table
b g) Remote control for electric functions
h) Lever for leg plate adjustment
i) Operation panel for electric functions
j) Lever for head rest adjustment
i Length of lying surface 2160 mm
(incl. head and leg plate/s)
a
Width of lying surface 540 mm

Weight (incl. head and leg plate/s) ca. 170 kg

Display

Height adjustment
(Anti-) Trendelenburg position
Lateral tilt
Back rest adjustment

0-Position

On-/Off switch

Appliance
1. The tables system will be activated by pressing the On/Off switch at remote control or at operating panel at the column. If no ad-
justment is done after 60 minutes the system will be deactivated automatically.
2. For doing any adjustment the corresponding button at remote control or operating panel at the column has to be pressed and held.
For stopping just release the button and the table stops moving immediately. This is because of safety reasons.
It is only possible to make one adjustment after the next, not at the same time.
3. The display at remote control or operating panel at the column shows current movement of the table. The display at operating panel
at the column shows furthermore the current charging status of the tables batteries.
4. By pressing the 0-Position button on the hand switch or operating panel the table will drive into its starting position (zero-position).
By pressing and holding the button every engine will drive back into its starting position.

Height adjustment:
For adjustment of the tables height just press and hold the corresponding button
at remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: 600 to 950 mm

medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop English 21


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MAT5000 III surgery tables

Back rest adjustment:


For adjustment of the tables back rest just press and hold the corresponding but-
ton at remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 40 to (+) 70

(Anti-) Trendelenburg position:


To adjust the table into (anti-) Trendelen-
burg position just press and hold corre-
sponding button at remote control or
even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 30 to (+) 25

Lateral tilt:
To adjust the lateral tilt of the table just press and hold corresponding button at
remote control or even at operating panel at the column.
The button itself is signed as follows:

Range: (-) 20 to (+) 20

Activation of the central brake:

Upper position - Head end castors are locked (brake activated)


b

Lower position - Head end castors are unlocked (brake deactivated)

The pedal (b) is for activation of the central brake. If the pedal is in upper position the table is moveable!
Please make yourself sure that the foot end castors just drive straight forward.
The tables brake is activated when the foot pedal is in lower position.

22 English medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop


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medifa

3.3.12 Type 505325


Type 505325 has the same basic features like type 505320 (page 21ff.), but additionally there is also the
function of an electrically adjustable longitudinal sliding table top.

Sliding table top adjustment:

155 mm (A) (310 mm)

155 mm (B) General information:


The possible longitudinal slide of the table top is
about 310 mm. It can be fixed in each position.

Functionality:
For a sliding table top just press the corresponding
button on the hand switch or the operating panel at
the column of the table.
The button is signed as follows:

If the table top is shifted, the following functions are


blocked because of safety reasons:
(Anti)-Trendelenburg positioning (> 10)
Lateral tilt

For unblocking these functions it is necessary to get


the table top into its starting position (zero position/
0-position). Therefore you have to press the corre-
sponding button on the hand switch or the operating
panel at the column of the table.

Sliding the table top into direction A is only possible, if Trendelenburg angle and lateral position is horizon-
tally. Otherwise the sliding function is blocked. The leg plate/s must not be in negative position. The position
of the back rest is irrelevant.

Sliding the table top into direction B is only possible, if Trendelenburg angle and lateral position is horizon-
tally. Otherwise the sliding function is blocked. The back rest must not be in negative position. The position
of the leg plate/s is/are irrelevant.

If the table top itself is angled into (anti-) Trendelenburg position or lateral tilt the sliding function cannot be
used, because the patient might fell off (fall hazard)! Therefore the function is blocked.
Please make yourself conversant with the tables attitude when a patient lies on it before usage!

medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop English 23


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MAT5000 III surgery tables

IV. First usage


4.1 Charging the batteries
n For all electric types we recommend to charge the batteries before
first usage.
The plug (k) is for power supply of the tables (110-230V) and also
for charging the batteries.
To connect the table with the mains use the power supply cable.

How to connect the table to the mains and charge the batteries:
k 1. Make yourself sure, the power connection is in compliance
to the power connection named on identification label of the
table.
2. Put the cable into the corresponding plug (k) at the base of
the surgery table.
3. Put the other end into a socket (power supply)
4. Switch the battery switch (n) on (red mark visible)

Attention:
Whenever the table is unused, it should be connected to the mains in order to charge the batteries. Further-
more the table has to be activated by hand switch additionally.
This is to ensure a continuous and durable functionality of the table.

4.2 Potential equalization connection

We recommend to connect the table to a potential equalization


pole by a corresponding cable before every usage. Connect the
potential equalization jack (l) with an potential equalization cable
to the potential equalization of the operating theatre (Connection
acc. to VDE-0107 or even other national directives). The jack itself
is below the base cover of the table at head end.
l

4.3 Explosion-secure-advisory
It is only allowed to use the table in battery mode in highly combustible ranges (AP). You can get the in-
struction card M 639 the BGW for the allocation of the highly combustible ranges in zones by following insti-
tution:
Berufsgenossenschaft
fr Gesundheit und Wohlfahrtspflege
Schferkampsallee 24
D-20357 Hamburg

4.4 Additional accessories for body storage


4.4.1 Head rests

Adaption of a head rest:


For head rest adaption just put the two slide ins of the head rest
completely into the corresponding inserts for accessories at head
end of the table.
Then fix them with the two yellow marked screws (2) below the
back rest.
Check if the screws are tight then.

1 Adjustment of head rest (up/down movement):


2 Just pull the yellow marked lever (1) upwards to adjust the head
plate. After release of the lever it will be fixed in current position
immediately.
Two hand adjustment is absolutely necessary because of safety reasons. The users own body strength might
be needed for adjustment, depending on the patients weight!

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medifa

4.4.2 Leg plate/s


Adaption of leg plates
For adaption of a leg plate to a surgery table just turn the two yel-
low marked levers (1) beside the pelvis part upwards. Now put the
slide in of the leg plate into corresponding insert at foot end of the
table. Afterwards you have to turn back the yellow marked
levers (1) again to lock the leg plate. You should check the proper
fit of the plate before usage by pulling.

Inclination of leg plates


1 2 3 For inclination of leg plates just open the toothing elements of the
leg plates by the yellow marked screw (2) below the leg plates.
Now the leg plates can be stilted up to 90. If you have reached
wanted position just fix it with the yellow marked screw (2) again.

Leg plate adjustment (up/ down movement)


Just pull the yellow marked lever (3) upwards to adjust the leg
plate. After release of the lever it will be fixed in current position
immediately.

Two hand adjustment is absolutely necessary because of safety


reasons. The users own body strength might be needed for ad-
justment, depending on the patients weight!

4.5 Cushions
The cushion are made of PUR foamed onto a synthetic board. The pads provide a maximum of comfort to
patients and protect against decubitus. The main features of their design are the ergonomic shape and
rounded edges which also support their functionality. They are radio translucent, electrically conductive and
comply to DIN 53596.
Pads are removable for easy cleaning and disinfection (except types with sliding table top).
The adaption to the table occurs by easy hoisting the holes below the cushions onto pins of the upper frame.

Attention:
You have to make sure that no sharp things interfere the cushions.
You should even avoid hard compressions like fingernails on one
point of the cushion.

Otherwise the cushions, especially the lacquer will be damaged


and an adequate hygienic protection can not be granted.
Even the electrical conductivity will be influenced then.
We recommend to exchange the cushions annually.

medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop English 25


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MAT5000 III surgery tables

V. Care instructions
5.1 Cleaning and disinfection
Make sure the table is always covered with sterile cloth by non usage.
Avoid using of too much water by cleaning the tables surfaces.
Furthermore spraying of spray-cleaners as well as disinfection devices directly into splices or technical nec-
essary cleaving should be avoided, too! Otherwise an ingress of fluid into the inside of the table might effect
corrosion damages!
For cleaning of the table just use normal universal-cleaners on alkalescent basis where tensides as well as
phosphates are included as cleaning-active elements, also!
Do not use cleaning powder or scrubbing agents!

For cleaning procedure itself the table has to be adjusted into a flat, as well as into highest position.

In hard cases of dirt contamination the cleaners can be used in concentrated form.
After this the tables treated segments should be cleaned with clear water and dried immediately.

For disinfection all normal large-surface disinfectants can be used (except those, separating chlorine or
those including alcohol or acetic acids)
Make yourself sure, the corresponding disinfectant is listed at DGHM*. There Deutsche Gesellschaft fr Hygiene
und Mikrobiologie DGHM
you can also get additional information concerning consistence of listed disin- c/o Institut fr Hygiene und Mikrobiologie
fectants. Universitt Wrzburg
Josef-Schneider-Str. 2
The quantity of disinfection as well as the one which is used have to comply to 97080 Wrzburg
http://www.dghm.org
the rules of manufacturer as well as the agenda of the user.
If the chair will be stored over a period of time, it should be covered and every
function should be driven from lowest to end position regularly (once weekly).

5.2 Disinfection of the castors


For disinfection of the castors you should drive the table a little bit. Depending on direction of movement two
of the castors turn outwards. Then you can get better access to them.
Disinfect the castors with a corresponding surface disinfectant.
Then repeat this process on the other side of the table .

5.3 Maintenance (general information)


All medifa products are made on basis of latest production engineering and standards.
They underlie a heavy-handed quality assurance to ensure a long usage without malfunctions!
An assumption for this is, of course, the correct usage and care of the product.
To ensure an equal proper functionality we recommend an regular maintenance (once annually).
Get a maintenance agreement with medifa and we will arrange everything for you!
In foreign countries please ask our authorised retailers!

5.3.1 Maintenance
Nearly all necessary parts of the table will be checked concerning function and corrosion damages. A check
of wear for these parts is also included in maintenance procedure.
Content of maintenance:

a) check on corrosion damages, tight compression couplings etc.


b) functional check of mechanic, electric and the engines
c) calibration (correct adjustment ranges etc.)
d) product introduction

We recommend strongly to follow the maintenance rules and their intervals, because otherwise no warranty
claims can be given to medifa!
Furthermore by doing the maintenance as recommended the patients security is always ensured and the liv-
ing time of your product will be enlarged, too!

26 English medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop


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medifa

5.4 Malfunctions
In cases of signals for malfunctioning as well as complete breakdown of any function please contact the
medifa service-team immediately. In foreign countries get into contact with medifas authorised representa-
tive.
For a quick processing please have the following information ready if you will be asked for:
Product type
Serial number
Exact description of the problem (symptoms etc.)

Our qualified staff will find a quick and competent solution for your problem.

5.5 Environmental protection


5.5.1 Packing materials
The packing material of medifa products consist of recyclable materials.
The packing consist of pallets made of untreated wood, paperboard containers as well as foam films.
All these materials can be disposed in normal household garbage.
The materials can even be returned to our works by our drivers on request

5.5.2 Defective parts and others


After doing maintenance or reparation work we ask you for a secure and environmentally friendly disposal of
exchanged parts, older parts as well as additives and consumables. These can be given to our assemblers if
there is something unclear concerning disposal!

Please note, that you are not allowed to dispose the build in batteries of our tables in
standard consumer waste. Please dispose the batteries according to the regional regula-
tory!
Alternatively you are allowed to give them to our assemblers!

The signs on the batteries have the following meaning:


The sign of a crossed waste container means, that batteries must not be disposed to the
standard consumer waste.
Pb = Batterie consists of more than 0,004 % plumb
Cd = Batterie consists of more than 0,002 % cadmium
Hg = Batterie consists of more than 0,0005 % quicksilver

medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop English 27


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28
VI.
Range 501130 501135 503220 503225 504220 504225 504320 504325 505220 505225 505320 505325

English
Height adjustment 750-1000 mm

Height adjustment 750-1050 mm


MAT5000 III surgery tables

Height adjustment 600-950 mm

Trendelenburg positioning -30 / +30


Technical information

Trendelenburg positioning -30 / +25

Lateral tilt -20 / +20

Back rest adjustment -40 / +70

Central brake

Sliding table top um 300 mm

Safety load 150 kg 150 kg 200 kg 200 kg 150 kg 150 kg 200 kg 200 kg 150 kg 150 kg 200 kg 200 kg

Explanations: manual adjustment (manually by hand or feet)


electric adjustment (Hand switch or operation panel)

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medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop
medifa

Measurements:
Length of lying surface 2160 mm
(incl. head and leg plate/s)

Width of lying surface 540 mm


Width of lying surface incl. side rails 605 mm

Weights:
1. Tables weight: Get information concerning the weight of each
type in chapter 3.3 Measurements and func-
tions

2. Safety load: Get information concerning the safety load of


each table in chapter VI. Technical
information

Power connection:
To connect the table to the mains a power connection of 110V/230V is required.
The surgery device does not need to be used in non-stop operation. After one minute full-load operation we
recommend 6 minutes off-time (INT 1min/6 min)

Applied directives:
Applied directives of the operation tables are mentioned at the declaration of conformity in chapter IX. Dec-
laration of conformity.

Other Information:

classification
Medicine product class
Active medical device of class I
acc. to MDD as well as rule 93/42/EWG
Protection class I
Type B
Application part The leakage current of the casing complies to the requirements of IEC 601-1 for
the leakage current of the patient acc. to CF
Protection against ingress of fluids IPX4
AP with battery usage
Protection against flammable substances Not certified usage in highly combustible environment of zone M, if connected
to the mains (AP-M).
EMC Surgery table is in accordance to the directive EN ISO 60601-1-2.

medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop English 29


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MAT5000 III surgery tables

VII. Accessory list

Take care of correct adaption of additional accessories for body storage!

Strictly avoid the usage of damaged or used up accessory-parts!


Otherwise risk of injury is given!

Beware of collisions between the table and accessory parts!

By use of accessories from competitors read the instruction manual carefully!

By use of accessories from competitors which influence the static of the table, keep in touch with medifa Ser-
vice-Team before!

Only usage of below listed accessories is allowed!

In following there are all allowed accessories for MAT 5000 III surgery tables out of medifas range of prod-
ucts listed. We structured the list as follows:
1. Accessories inserted at head end of the table
2. Accessories inserted at foot end of the table
3. Accessories for adaption at the side rails of the table
4. Other accessories
1. Accessories inserted at head end of the table
61110 - Head calotte
61112 - Head calotte
61143 - Small head rest
61144 - Big head rest
61146 - Big head rest with double joint
2. Accessories inserted at foot end of the table
61150 - knee rest
61385 - 3-parted back plate for shoulder operations
61615 - Divided leg plate
61625 - One parted leg plate
61635 - Transfer leg plate
61660 - Divided leg plate with possibility of knee bend down
61125 - Pelvis part extension
3. Accessories for adaption at the side rails of the table
61210 - Arm rest, adjustable, integral foam electrically conductive, incl. clamp, L=300mm
61215 - Arm rest, adjustable, integral foam electrically conductive, incl. clamp, L=400mm
61220 - Arm rest, swingable, electrically conductive, incl. fastening means, l=600 mms
61230 - Arm-, hand surgical table, height adjustable with guide rails, l/w 650/250 mms
61300 - Shoulder and side support (piece), incl. bracket, l=145 mms, w=120 mms
61315 - Rectoscope roll, height adjustable, with bracket, integral foam upholstery
61330 - Meniscotomy roll, height adjustable, with bracket, integral foam upholstery
61341 - Side support, pair, including fixation
61351 - Shoulder support, pair, including fixation
61355 - Pads to extent the width of operating table (pair), incl. fixation
61360 - Supporting roll with bracket, integral foam upholstery electrically conductive
61361 - Holder for supoorting cusions 61361_1, 61361_2, 61361_3
61400 - Hand cuff (pair) with fastening
61405 - Body and leg strap with bracket
61410 - Instrument serving table, incl. clamp
61510 - Clamp (piece), rotatable, made of s/s steel
61550 - Clamp (piece), rigid, made of s/s steel
61560 - Side rail extension (25x10mm), L= 200mms
61630 - Knee rest
61700 - Leg rest acc. to Goepel (piece), integral foam pads, electrically conductive
61720 - Leg holders, pair, gas-spring assisted with padded interior and EU-clamps
61750 - Narcosis bow, height adjustable, telescopic to both sides, including bracket
61760 - Fixation for lower leg (piece), including bracket

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medifa

61770 - Fixation for femur (piece), including bracket


61780 - Elbow supports (pair), incl. clamps
61800 - Infusion rod with clamp, made of s/s, height adjustable
61805 - Infusion rod with rotatable clamp, made of s/s, height adjustable

4. Other accessories
61115 - Head ring
61120 - TUR-flushing device
61147 - Head support cushion
61640 - Cassette insert for X-ray cassettes
61655 - Kidney bridge
61670 - Stabilisation bar, radio translucent
61900 - Cushion for operation of intervertebral disc, electr. conductive
91605/OP - Stainless steel dish with draining outlet and tube
91608 - Bucket made of 18/8 s/s steel, volume 12 litres, incl. lid with tube-inlet
91610 - Stainless steel dish

VIII. Spare part list


Spare cushions
1. Cushions for surgery table
B601000M1 - Cushion for pelvis part
B601000M2 - Cushion for back rest

2. Cushions for additional standard accessories


B601000M12 - Cushion for small head plate (61143)
B601000M6 - Cushion for big head plate (61144)
B601000M6 - Cushion for head plate with double joint (61146)
B601000M2 - Cushion for one parted leg plate (61625)
B601000M5 - Cushion for divided leg plate (61615) left & right
B601000M7 - Cushion for divided leg plate w. knee bend down (61660) short cushion, left & right
B601000M8 - Cushion for divided leg plate w. knee bend down (61660) large cushion, left & right
B601000M13 - Cushion for arm board (61220)
PU-A-300-S - Cushion for Arm rest, adjustable, L=300mm (61210)
PU-A-400-S - Cushion for Arm rest, adjustable, L=400mm (61215)

Caution!
Be sure to use only spare parts of medifa, or spare parts approved by medfia!

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MAT5000 III surgery tables

IX. Declaration of conformity

Declaration of conformity
We

medifa-hesse GmbH & Co. KG,


Industriestr. 5,
D-57413 Finnentrop,
Germany

hereby declare that the below listed product, to which this declaration refers,
is in compliance with the legal requirements
as well as the regulations of directives

93/42/EC directive for medicine products,


2007/47/EC directive for medicine products,
2006/42/EC directive for machines,
2004/108/EC directive for electromagnetic compatibility

Classification and conformity appraisal procedure:


This product is

an active medicine product of class I


acc. to directives 93/42/EC and 2007/47/EC, appendix IX, rule 12

The conformity appraisal procedure is in compliance with directive


93/42/EC and 2007/47/EC, appendix VII

Applied standards and regulations:

EN 60601-1 Medical devices part 1: General definition of security including capability charac-
teristics
EN 60601-1-2 Medical devices part 1-2: Auxiliary standard to the electromagnetic compatibility
requirements and examinations
EN 14971:2007 Application of the risk management to medicine products
DIN 53596 Regulation for the measurement of the electrical resistance of the pads

Designation: Surgery tables of MAT5000 III series, incl. accessories Types: 501130, 501135,
503220, 503225

........................................
Gerhard Hesse
General Manager 01.09.2011

32 English medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop


Tel.: +49 (0) 2721-7177-0 Fax: +49 (0) 2721-7177-77
medifa

Declaration of conformity
We

medifa-hesse GmbH & Co. KG,


Industriestr. 5,
D-57413 Finnentrop,
Germany

hereby declare that the below listed product, to which this declaration refers,
is in compliance with the legal requirements
as well as the regulations of directives

93/42/EC directive for medicine products,


2007/47/EC directive for medicine products,
2006/42/EC directive for machines,
2006/95/EC low-voltage guideline,
2004/108/EC directive for electromagnetic compatibility

Classification and conformity appraisal procedure:


This product is
an active medicine product of class I
acc. to directives 93/42/EC and 2007/47/EC, appendix IX, rule 12

The conformity appraisal procedure is in compliance with directive


93/42/EC and 2007/47/EC, appendix VII

Applied standards and regulations:


EN 60601-1 Medical electrical devices part 1: General definition of security including ca-
pability characteristics
EN 60601-1-2 Medical electrical devices part 1-2: Auxiliary standard to the electromagnetic
compatibility requirements and examinations
EN 60601-2-46 Medical electrical devices part 2-46: Special definition for the security of sur-
gery tables
EN 14971:2007 Application of the risk management to medicine products
DIN 53596 Regulation for the measurement of the electrical resistance of the pads

Designation: Surgery tables of MAT5000 III series, incl. accessories Types: 504220, 504225,
504320, 504325,
505220, 505225,
505320, 505325
........................................
Gerhard Hesse
General Manager 01.09.2011

medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop English 33


Tel.: +49 (0) 2721-7177-0 Fax: +49 (0) 2721-7177-77
medifa-hesse GmbH & Co. KG Industriestrae 5 D-57413 Finnentrop
Tel.: +49 (0) 2721-7177-0 Fax: +49 (0) 2721-7177-77

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