Mercado Medic REAL 8200 PLUS EL 24V SCREENING User manual

Translation of manual
Document No.: 21-08996-UK
Revision: 00
Valid from: 2021-05-26
Amended: -
INSTRUCTIONS FOR USE
for REAL 8200 PLUS Mammography
Medical Clinic Chairs
Instructions for use and care
UK

[Space for device label with
serial number]

Table of contents
User information
1. Introduction ....................4
1.1. Contact details ....................5
1.2. Warranty ..........................5
2. Getting started ..................6
2.1. Before use ........................6
2.2. How to use the device’s functions ....9
2.3. Charging ..........................9
3. Caring for the device ........... 10
3.1. Padded parts .................... 10
3.2. Castors and brake feet ............ 10
3.3. Other parts ...................... 10
3.4. Transport and storage ............ 11
Device information
4. intended use .................. 12
4.1. Operating environment ........... 12
5. Configurations and settings ..... 13
5.1. Required level of competence
forsetting and adjusting........... 13
5.2. Basic design..................... 14
5.3. Electrical functions ............... 15
5.4. Seat ............................ 16
5.5. Backrest ........................ 16
5.6. Backrest mechanism ............. 17
5.7. Armrest panel ................... 17
5.8. Armrest mechanism .............. 18
5.9. Neck support .................... 19
5.10. Base .......................... 20
5.11. Manual brake................... 20
5.12. Individual adaptation ............ 22
6. Important safety information.... 23
6.1. Standards met and classification ... 23
6.2. Warnings........................ 24
6.3. Expected service life.............. 25
6.4. Reporting of adverse events
andincidents .................... 26
Service manual
7. Technical information .......... 27
7.1. Symbols ........................ 29
8. Servicing & reconditioning ...... 31
8.1. Troubleshooting guide ............ 32
8.2. Battery replacement.............. 34
8.3. Reconditioning and periodic
maintenance .................... 35
9. Instructions for destruction ..... 41
9.1. Recycling ....................... 41
Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs
21-08996-UK-00

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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Introduction
21-08996-UK-00
1. Introduction
Thank you for choosing Mercado Medic as the supplier of this device. By choosing
a REAL chair, you get to learn about a 50-year history of developing medical
devices with high function, safety, quality and flexibility. We manufacture all our
different medical chairs under our own management in Sweden.
Mercado Medic is certified to ISO 13485, ISO 9001 and ISO 14001, and complies with
applicable labour and environmental legislation.
We reserve the right to make changes to this manual and its contents.
Sufficient competence in the safe use of this device is achieved by carefully reading through
these instructions for use before using the device for the first time.
PDF versions of our instructions for use with zoom options are always
available in their most current version on our website www.mercado.se.

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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Introduction
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1.2. Warranty
All components of Mercado Medic's devices
are covered by warranty, under the time
periods and general terms and conditions
set out below, unless other specific periods
and conditions are agreed in writing between
Mercado Medic and the contracting customer
in connection with major procurements.
As the operator, you must contact your
distributor if you experience problems
with the device. Distributors in turn should
contact Mercado Medic using the contact
details available under Section 1.1. Contact
details.
Warranty periods
• Metal structures: 3 years.
• Electric lifting mechanism: 2 years.
• Other components (e.g. wheels, batteries,
padded parts): 1 year.
General terms and conditions
The warranty does not cover:
• Damage or condition considered to be
normal wear and tear.
• Damage caused by negligence or misuse.
• Spare parts, components or accessories
not sold by Mercado Medic.
• Adjustments to the device made by
unauthorised service technicians.
• Components previously fitted to devices
other than the item in question.
• Bleaching or natural variations in the
colours of faux leather.
1.1. Contact details
Manufacturer
Street address: Mercado Medic AB,
Tryffelslingan 14, SE-181 57 Lidingö, Sweden
Postal address: Mercado Medic AB,
Box 1074, SE-181 22 Lidingö, Sweden
Telephone: [phone]
Email: [e-mail]
Website: www.mercado.se
Servicing and technical support
Telephone: [phone]
Email: [e-mail]
To report warranty claims, adverse events
and incidents or other feedback please use
the form at www.mercado.se/en/support.
Distributor
Responsible person: Henrik Sellberg
Mercado UK Ltd
Repton House, Bretby Business Park,
AshbyRoad
DE15 0YZ Burton on Trent
United kingdom
[phone]
[email protected].uk
www.mercado-medic.co.uk
Space for additional distributor contact
details:

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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Getting started
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2. Getting started
As the operator of the device, this section is primarily aimed at you. It describes how to
prepare the device for use, how to use its functions, and how to charge it. For care instructions,
see 3. Caring for the device.
If you have any questions about the device or if something unexpected has happened, please
contact your distributor first. You can find up-to-date contact details in Section 1.1. Contact
details. You are also welcome to contact us at Mercado Medic.
2.1. Before use
All devices come with a seat, back rest,
armrests, a brake and electric height
adjustment. When delivered from Mercado
Medic, the back rest and brake lever may not
yet be fitted. These should always be fitted
before the device is first used.
Backrest mechanism
For models with back rest, insert the back
rest pole into the back rest mechanism (B)
and adjust to the desired height, see Figure
2.1. Tighten all levers (A).
Brake lever
We recommend that the brake lever not be
mounted if you intend to use the foot brake.
If you intend to use the handbrake function,
mount the brake lever as follows: Insert the
brake lever into the brake lever bracket (A),
see Figure 2.1. The brake lever can be placed
on the right or left side.
Armrests
Loosen the armrest controls (C) and set the
desired height and width levels, see Figure
2.1. Tighten all controls (C).
Neck support
If the device is supplied with a neck support,
insert the neck support mechanism into the
backrest bracket (D) and set the desired
height level, see Figure 2.1. Tighten all
controls (D).
Battery
Before initial use, activate and charge the
battery. This is done by connecting the
battery charger to the device's charging
socket and to a wall outlet (E), see Figure
2.1. The charging socket can be placed in
different places on the device. The device is
usually delivered with the charging socket
mounted at the rear edge under the seat.
Wait until the battery is fully charged before
using the device. This normally takes 2 to 5
hours. When the battery is fully charged, the
LED on the charger lights up green. For other
charging instructions, see 2.3. Charging.

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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Getting started
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Figure 2.1. Preparations before the device is put into use.
Armrests
Neck support Battery
Brake lever
Backrest mechanism
B
A
C
DE
Consider the following before and during
use of the device
• Tighten all setting controls before putting
the device into service.
• The device must not be used without
fitting the backrest.
• The device must not be used without
fitting the armrests.
• The brake on the device must always be
applied when the patient gets in and out
of the chair.
• The braking capacity of the device may be
impaired on heavily sloping floors.
• The braking capacity of the device may be
impaired on uneven floors.
• The device must be operated with care.
• The foot ring is designed to rest your feet
on, not to stand on.
• Charge the device according to these
instructions for use, see Charging.
• The electrical functions cannot be used
when the device is charging.
• If the device is equipped with leg
supports, the patient’s feet must always
be in contact with the foot plate when the
electrical functions are used.
• Never set the seat to a height that makes
it is unsafe for the patient to get out of the
device.

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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Getting started
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• The device must not be moved when the
seat is in the raised position.
• Remote control emergency stop: If,
for whatever reason, the system does
not interrupt a movement after the
corresponding control button has
been released, the movement can be
interrupted by pressing any of the other
buttons on the hand-held controller.
• Button lock on remote control: To enable
or disable the button lock for a function,
press and hold both of the directional
buttons of the relevant function for at
least three seconds. The button lock locks
only the current function. To lock multiple
functions, each function must be locked
separately.
Warning! As a user, you should
contact your distributor if device
performance deteriorates or
changes. A device showing a loss
of or change in performance must
immediately be taken out of use
in order to avoid an accident. The
device must not be used again
until an authorised technician has
examined the device.
Warning! You are not permitted to
modify the device yourself. Please
contact your distributor if you would
prefer individual customisation.
If the device is modified, the CE
marking no longer applies and
Mercado Medic may no longer have
full device liability. Modifications
may affect the safety of the device
and lead to accidents.
Warning! The device may be
equipped with long cables or
wires that cannot be secured in
order for the device to function
properly. Cables and wires can pose
strangulation risks to small children,
for example. Do not leave the device
unattended with small children
nearby.
Warning! The device is equipped
with small parts such as screws
that can come loose. Small parts
that have come loose can pose
a potential choking hazard for
children.
Warning! Metal surfaces may
become very hot if they are exposed
to direct sunlight. Skin contact with
hot surfaces can lead to burns. Avoid
exposing metal surfaces to direct
sunlight.
Warning! Always make sure that
the device’s brake is applied when
the patient sits down and gets up.
If the device’s brake is not applied,
there is a risk that the device will roll
away when the patient stands up
or sits down, which could cause fall
injuries.

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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Getting started
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2.2. How to use the device’s functions
The device has remote-controlled electric
height adjustment, see Figure 2.2. The device
is also equipped with manual foot brake
and hand brake. The manual foot brake is
activated and deactivated via a pedal and the
manual hand brake is activated by pushing
the brake lever forwards and deactivated
by pulling the brake lever backwards, see
Figure 2.2. We recommend not mounting
the brake lever if you intend to use the foot
brake. Depending on the model, the device
may be equipped with an electric seat tilt
and an electric back rest mechanism. These
are remote-controlled, see Figure 2.2. See
5. Configurations and settings for detailed
information about all the features and
controls of the device.
2.3. Charging
The battery should be charged once every 24
hours. Fully charging the battery on a daily
basis will take 2 to 5 hours. It is important that
the battery is never completely discharged,
as this helps to prolong the life of the battery.
Daily battery charging is especially important
for configurations with an electric brake and
seat tilt. The device emits a low battery level
warning sound, for both low and critical. Low
battery is indicated by a short signal. Critical
battery level is indicated by a short signal
that ends with a loud beep.
The device must be charged in a safe
manner. The electrical functions cannot be
used when the device is charging. For this
reason, choose an easily accessible wall
socket to plug the charger into. The charger
cable to the wall socket is 1 metre long and
must not be extended. In case of emergency,
disconnect the device from the mains by
unplugging the charger from the wall socket.
How to charge the device
1. Inset the plug into the charging socket
(see Figure 2.3). The charging socket is
usually located at the rear edge under
theseat.
2. Connect the charger plug into the wall
socket. The LED on the charger will
indicate that charging is underway.
3. The battery is fully charged when the LED
on the charger changes colour from red
to green. This is shown by the three green
battery LEDs on the remote control’s
battery indicator flashing in sync.
If the electrical functions have not been
used for 7 days, the battery switches off
automatically. To reconnect the battery,
connect the battery charger to the charging
socket and the wall outlet and wait at least
5 seconds before unplugging the charger. It
is recommended to charge the battery fully
after the battery has been disconnected.
If no electrical functions are working, try
charging the battery. Contact your distributor
if electrical functions still do not work, see1.1.
Contact details.
Figure 2.2. Controls on the electric model.
Figure 2.3. Plug connection to the charging
socket under the seat.

3. Caring for the device
Clean the device according to the instructions in this section to maintain its functions and
service life. If needs arise that cannot resolved with the resources available, please contact
your distributor for reconditioning.
PLEASE NOTE! Do not wash the device with water or other liquids and chemicals.
3.1. Padded parts
To prevent contamination, device upholstery
must be cleaned after each period of use.
Synthetic leather padded parts
Use soap and water or surface disinfectant
to clean synthetic leather padded parts.
Start by removing any loose debris. Then
use a cloth to clean the upholstery with soap
and water or surface disinfectant. If the
upholstery is cleaned using soap and water,
finish by wiping with a clean, damp cloth.
3.2. Castors and brake feet
Regular cleaning of castors and brake feet
is required to maintain the operation of the
device. Wipe castors and brake feet with
a damp cloth. Remove any hair from the
castors using a thin crochet needle or similar
implement.
3.3. Other parts
Do not clean the device’s lifting mechanism
and other actuators, see Figure 3.1 (can
be located in the electric seat tilt, back
rest mechanism and leg supports). This
is because there is a risk that the grease
required for these mechanisms to function as
intended might be removed during cleaning.
If necessary, a dry cloth can be used to
remove dust from any electronic parts of
the device. Clean the other non-electronic
parts of the device once a week or when
necessary. Use a clean, damp cloth with mild
detergent (pH 7-12), surface disinfectant or
use a steam cleaner (max. 8 bar).
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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Caring for the device
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Figure 3.1. device’s lifting mechanism and other actuators.

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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Caring for the device
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3.4. Transport and storage
When transporting and storing the device,
keep the following in mind:
• The device moves by rolling on a flat
surface.
• The device should be lifted by two people.
Suitable grip points are at the front,
rear, right and left sides of the seat, see
Figure3.2.
• The device is intended to be transported
and stored at between -25°C to +60°C
and up to 90% non-condensing relative
humidity.
• The device must be transported in the
intended cardboard box on a pallet.
If the device is transported by car, it
must be strapped in place using straps
over both the base and the seat, and it
should be set to the lowest possible seat
height. To reduce the size of the device
during transport, the backrest can be
removed and the armrests lowered. Be
sure to select the settings so that they
can be easily reset. Tape or similar easily
removable marking is recommended.
• The device must not be used as a seat
when transported in a car or aircraft, for
example.
• In the case of air transport, the device
must be stored in the hold. Original
Mercado Medic batteries are approved for
air transport. For information on battery
type, see 7. Technical information.
Figure 3.2. Suitable grips when lifting.

The REAL 8000 product range consists
of modular patient seats designed to be
used in combination with primary clinical
examination equipment, such as X-ray
machines. The device is intended to be used
in conjunction with other medical devices in
environments and situations that may require
customised seat positions for different
patients in order to be able carry out the
examination efficiently and with satisfactory
results. Applicable situations include, but
are not limited to, mammography and other
radiological examinations, as well as various
kinds of ophthalmological examinations.
REAL 8000 is designed to be used wherever
a good seat position is required, such as in
the following situations:
• the patient has to be able to cope with a
complete examination.
• the patient needs support to remain
still enough in order for the examination
method to give satisfactory results:
• for example, the patient needs support to
remain still enough during a biopsy.
• being able to carry out more efficient
examinations in situations where there is
a need to reduce the time the patient has
to endure an emotional strain (such as
during a mammogram).
The REAL 8000 product range is designed to
be operated by a professional who ensures
an appropriate adjustment in relation to both
the patient and the primary examination
equipment.
Contraindications
There are no known contraindications for
using the REAL 8000 product range.
4.1. Operating environment
• The device is intended for indoor use only
and must not be used outdoors.
• The device is intended to be used at
between -5°C to +40°C and 15-90%
non-condensing relative humidity. If
the device is stored in an environment
outside these limits, the device must be
acclimatised for up to 4 hours to achieve
an approved temperature before use.
• The device must not be used at altitudes
greater than 2000 m above sea level.
• The device must not be exposed to
extreme cold or heat, prolonged sunlight
or other radiation.
• The device must not be exposed to water,
liquids or chemicals to any extent other
than that specified in the care information
in Section 3. Caring for the device.
4. intended use
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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs intended use
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5. Configurations and settings
It describes the device's models, options when configuring the device, and information about
setting and adjusting the device's functions. For dimensions and performance, see 7. Technical
information.
The device is available in two fixed models. The basic design of each model is described below,
see 5.2. Basic design. The configuration of the models can be adapted to the needs of different
clinicians; for more information please contact Mercado Medic, see 1.1. Contact details.
Data sheets and order forms are found at www.mercado.se. There are also instructions for use
and device information for all Mercado Medic devices.
5.1. Required level of competence for setting and adjusting
The device should be configured for each individual patient in order to acquire the correct
position for accurate X-ray images. Only the operator may makes settings and adjustments.
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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Configurations and settings
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5.2. Basic design
The Device is always supplied with a seat, back rest, armrests, a base with four castors
(100mm as standard), a push bar and foot and hand brake. The device is available in two
models, Screening Mammography and Clinical Mammography.
PLEASE NOTE! The basic model of the device may vary depending on the agreement between
Mercado Medic and the customer.
REAL 8200 PLUS EL 24V
Screening Mammography
REAL 8200 PLUS EL 24V
Clinical Mammography
Height adjustment Electric height adjustment with
wireless remote control
Electric height adjustment with
wireless remote control
Seat height 440–720 mm 440–720 mm
Seat ErgoMedic 440 x 430 mm
(asstandard)
ErgoMedic 440 x 430 mm
(asstandard)
Seat tilt No Electric
Seat tilt range10° -15°/+15°
Folding foot ring Yes Yes
Brake Manual foot and hand brake Manual foot and hand brake
Castors 100 mm 100 mm
Backrest ErgoMedic 400 x 340 mm ErgoMedic 420 x 430 cm
Back recliner Fixed Electric
Back rest mechanism
interval1
0° -23°/+28°
Push bar Yes Yes
Armrests ErgoMedic 250 mm (as standard) ErgoMedic 250 mm (as standard)
Neck support No ErgoMedic Plus 230 x 80 mm
Fabrics Faux leather (For available
colour, see www.mercado.se)
Faux leather (For available
colour, see www.mercado.se)
1 Negative angle (-) refers to forward tilt and positive angle (+) refers to backward tilt.
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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Configurations and settings
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5.3. Electrical functions
The product is equipped with electric height adjustment. The REAL 8200 PLUS EL 24V
Clinical Mammography model is also equipped with an electric seat tilt and electric back rest
mechanism. Electrical functions are adjusted via wireless remote control.
Remote control
The remote control comes in models with 1 or 4 functions. The 1-function is intended to only
control raising and lowering. The 4-function model can control multiple functions. The remote
control also has a button lock function (see Figure 5.4).
Seat height
Buttons on the top left-hand keypad (see Figure 5.1).
Adjustment:
1. Press up for upward movement.
2. Press down for downward movement. Figure 5.1. Button for adjusting seat height.
Seat tilt
Buttons on the upper right-hand keypad, see Figure 5.2.
Adjustment:
1. Press up for forward seat tilt.
2. Press down for backward seat tilt. Figure 5.2. Button for adjusting seat tilt.
Back recliner
Buttons on the lower keypad in the middle, see Figure 5.3.
Adjustment:
1. Press up to move the back recliner forwards.
2. Press down to move the back recliner backwards. Figure 5.3. Button for adjusting back recliner.
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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Configurations and settings
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Button lock
Activating and deactivating the button lock:
1. To activate the button lock, press and hold both of the
directional buttons of the relevant function for at least
three seconds.
2. To deactivate the button lock, press and hold both of
the directional buttons of the relevant function again
for at least three seconds.
PLEASE NOTE! The button lock only locks and unlocks
the function that has locked buttons. To lock multiple
functions, each function must be locked separately. Figure 5.4. Button for activation and
deactivation of button lock.
5.4. Seat
Seats are available in the ErgoMedic model.
The fabric for seats is in faux leather. Further details about fabrics and available colours, please
visit our website www.mercado.se.
ErgoMedic
ErgoMedic is a flat seat with seat indentation and
additional support under the thighs (see Figure 5.5).
Figure 5.5. ErgoMedic seat.
5.5. Backrest
Back rests are available in the ErgoMedic model.
The fabric for back rests is in faux leather. Further details about fabrics and available colours,
please visit our website www.mercado.se.
ErgoMedic
ErgoMedic is a lightly cupped back rest, see Figure 5.6.
The back rest is available in size 400 x 340 mm for the
REAL 8200 PLUS EL 24V Screening Mammography model
and 420 x 430 mm for the REAL 8200 PLUS EL 24V
Clinical Mammography model.
Figure 5.6. ErgoMedic backrest.
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Instructions for use for REAL 8200 PLUS Mammography Medical Clinic Chairs Configurations and settings
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40 cm
34 cm
33 cm
36 cm
38 cm
26 cm
33 cm
26 cm
42 cm
43 cm
46 cm
43 cm
46 cm
43 cm
3s

5.6. Backrest mechanism
The REAL 8200 PLUS EL 24V Screening Mammography model is equipped with fixed back
mechanism with a push bar. For the REAL 8200 PLUS EL 24V Clinical Mammography model,
adjustment of the back rest mechanism is available as an electrical function, see 5.3. Electrical
functions.
Fixed back mechanism with high back with push bar
The back rest can be adjusted at an angle with the
back mechanism, see Figure 5.7. The back rest
mechanism has a fixed angle.
Setting the angle of the backrest:
1. Loosen the handle and adjust to the desired angle.
2. Tighten the handle.
Figure 5.7. Fixed back rest mechanism with high
back with push bar.
5.7. Armrest panel
Armrest panels are available in the ErgoMedic model.
Armrest panel fabric is available in faux leather. Further details about fabrics and available
colours, please visit our website www.mercado.se.
ErgoMedic
The ErgoMedic armrest panel is curved at the back to keep
the elbow stable. The front of the armrest panel is shaped
to provide a good grip when standing up and transferring,
see Figure 5.8. The armrest panel is available in a length
of 250 mm.
Figure 5.8. ErgoMedic armrest panel.
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5.8. Armrest mechanism
Armrest mechanism is available in the PLUS armrest model.
On the REAL 8200 PLUS EL 24V Clinical Mammography model, the armrests are mounted to so
that they follow the seat when it is tilted, see Figure 5.37.
PLUS armrest
The height (A) and the width (B) of the PLUS armrest are
adjustable, see Figure 5.9.
Height setting:
1. Height adjustment. Loosen the knob and adjust to the
desired height.
2. Tighten the knob.
PLEASE NOTE! Tighten the knob fully on the PLUS
armrest.
Depth setting:
1. Loosen the knob and adjust to the desired width.
2. Tighten the knob securely. Figure 5.9. PLUS armrest.
A
B
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5.9. Neck support
The REAL 8200 PLUS EL 24V Clinical Mammography model is equipped with an ErgoMedic Plus
head rest.
ErgoMedic Plus
ErgoMedic Plus has a bowled shape and is available in size
230 x 80 mm.
The head rest is adjustable in height (A), depth (B) and
angle (C), see Figure 5.10.
Height setting:
1. Loosen the wheels and adjust to the desired height.
2. Tighten the wheels.
Depth setting:
1. Loosen the knobs and adjust to the desired depth.
2. Tighten the knobs.
Adjusting the angle:
1. Loosen the handle and adjust to the desired angle.
2. Tighten the handle. Figure 5.10. Neck support
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AA
B
C

5.10. Base
The device is equipped with a Base 8000 Plus Clinic 48 White. The base is equipped with a
foldable foot ring 1/4.
8000 Base PLUS Clinic 48 White
The base has two brake legs, and it is reverse braked,
see Figure 5.11.
Figure 5.11. Base 8000 Plus Clinic 48 White.
Folding foot ring 1/4
Foldable foot ring 1/4 is located at the front edge of the
base and folds up into one piece, see Figure 5.12.
Figure 5.12. Foot ring 1/4.
5.11. Manual brake
Two versions of manual braking are available: a foot brake and a brake lever.
Foot brake
The foot brake is located on the base brake axel,
see Figure 5.13.
Activation and deactivation:
1. Push down to the locking position to brake.
2. Press upwards on the underside of the pedal to
disengage the brake.
PLEASE NOTE! The brake must be in locked mode
whenever the patient is sitting down on or getting out
ofthe chair. Figure 5.13. Foot brake.
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