Mobile Surgical Chair

SC 5010 SEK

User Manual
276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 1 of 22
INDEX

1 General 4

1.1 Copyright 4

1.2 Disclaimer 4

1.3 Applicable rules and regulations 4

1.4 Warning and cautioning signs 4

1.5 User instructions for safe operation 5

2 Useful life and warranty conditions 6

3 Scope of delivery 6

4 Intended use 6

5 Mounting and commissioning 7

6 Electrical connections 7

7 Product description and controls 7

7.1 Battery 7

7.2 Battery re charger unit 7

7.3 Battery holder on the SC 5010 SEK chair 8

7.4 Electric actuators and control unit 9

7.5 Handheld control panel 9

7.6 Control lever for heavy duty castors 10

8 Operation of chair 10

8.1 Duty cycle (continuous operation) of electrical motors 10

8.1.1 Battery charge status 10

8.2 Electric controls 11

8.2.1 Adjustment of chair height 11
8.2.2 Adjustment of seat cushion tilt 11
8.2.3 Adjustment of back rest 12

8.3 Removable backrest segments 12

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 2 of 22

8.4 Adjustment of head rests 13
8.4.1 Standard head rest 13
8.4.2 Adjustment of padded head support 13
8.4.3 Adjustment of multi articulated head rest 14
8.4.4 Adjustment DCHR head stabilizer 15

8.5 Adjustment of leg supports 16

8.6 Trendelenburg 16

9 Accessories 17

10 Cleaning and contamination protection 19

11 Maintenance 19

12 Product safety inspection 19

13 Disposal of device 19

14 Technical data 20

15 Environmental conditions 21

16 Trouble shooting 21

17 CE conformity 21

18 Manufacturer 21

19 Wiring diagram 22

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 3 of 22

1 General
To safely operate and control the SC 5010 SEK please carefully read this user manual be-
fore operating. Please pay attention to all cautionary statements pertaining to the safe opera-
tion of the SC 5010 SEK. Please keep the manual on file at all times while the product is in
service.
The manufacturer reserves the right to make technical changes or modifications in accord-
ance with advanced technical developments. This manual is not subject to an updating ser-
vice.
1.1 Copyright
© Distributing, copying or any commercial use of this manual is strictly prohibited unless ex-
pressly permitted in writing by the manufacturer. The manufacturer is entitled to compensa-
tion for any violation of this right.

The manufacturer claims any and all rights in case a patent is granted or the design is regis-
tered.
1.2 Disclaimer
Manufacturer excludes any and all liabilities in case of improper or not authorized operation
or maintenance or servicing of the product.
1.3 Applicable rules and regulations
The device complies with the following Regulations for medical devices.

o MDD 93/42 EEC

o DIN / ISO 60601-1
o DIN / ISO 60601-1-2 EMC
o UMDNS No 13-961
o Medical Device Class I

The device meets the requirements of MDD 93/42/EEC and the corresponding national re-
quirements of the Medical Devices Act MDA (Medizinprodukte Gesetz MPG).

User must observe the national legal requirements governing the prevention of accidents.

1.4 Warning and cautioning signs

Warning Indicates a hazardous situation which may result in fatal or serious

bodily injury if the appropriate safety precautions are not heeded.

Caution Indicates a hazardous situation which may result in minor injury if

the appropriate safety precautions are not heeded.

This pictograph on the label indicates:

Equipment Category B according to EN 60601-1

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 4 of 22

1.5 User instructions for safe operation
Before using this medical device, please carefully read and observe the safety in-
structions and recommendations listed in this manual

Caution The device may only be installed, operated, used and main-
Risk of oper- tained by persons who have been properly trained or who
ating errors have the required knowledge and experience to do so. Please
also adhere to the national qualification guidelines applicable
in your country.

o To safely use and operate the medical device, use only as directed.
o Operation of the
o medical device only in accordance with the intended use.
o Do not operate the medical device in explosive or hazardous environments. The med-
ical device must not be operated, with the exception of very minute quantities, in the
presence of combustible anesthetics, or volatile solvents like alcohol, benzene or the
like.
o Do not set up the medical device in humid or damp rooms. Never expose the product
to sprinkling, dripping or splashing water.
o Modifications, authorized by manufacturer, may only be performed by staff authorized
by manufacturer. Any modification non authorized or instructed by manufacturer may
cause malfunctions or hazards to persons.
o Maintenance or repair work on this product may only be performed by staff authorized
by manufacturer.
o Pay special attention to any emphasized safety instruction or information in this user
manual.
o Only trained and authorized staff may operate the medical device.
o Only trained service staff authorized by manufacturer may open the medical device.
o No water or other liquids may enter the electric connector housing during mainte-
nance or cleaning procedures. Please refer to section “Cleaning and routine care”.

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 5 of 22

2 Useful life and warranty conditions

The useful product life is expected to be 8 years. Both, the useful life time and the warranty
offered by manufacturer are conditional upon the adherence to the conditions outlined below.

Caution The device may only be installed, operated, used and main-
Risk of oper- tained by persons who have been properly trained or who
ating errors have the required knowledge and experience to do so. Please
also adhere to the national qualification guidelines applicable
in your country.

Caution The development, production and maintenance of these medi-

General cal devices, together with associated risks, are based on an
Hazards expected service life of eight years, provided the device is ser-
viced at the specified intervals.
Modifications to the product or failure to follow the manufac-
turer’s instructions may substantially reduce the expected ser-
vice life and significantly increase the risks associated with the
use of this device.
It is the responsibility of the institution operating this product to
follow the manufacturer’s instructions and to decide on the
risk/benefit ratio upon expiration of the expected service life or
maintenance and inspection intervals specified by the manu-
facturer.

Caution The product is only operated in compliance with the provisions

General of the intended use and the environmental conditions set forth
Hazards in the chapter “Ambient conditions”

3 Scope of delivery
The SC 5010 SEK scope of delivery comprises
Position Qty
SC 5010 SEK examination chair 1
Re charger unit incl. power cord 1
Battery 1
Quality- test report 1
User Manual 1
Options according to order
4 Intended use
The medical device is intended for use as a surgical chair. Any other use of the product is not
permitted.
o The medical device is designed for a maximum patient weight of 135 kg (297 lbs) (EN
60601-2-46 particular requirements for safety of operating tables). A 200 kg (440 lbs)
version is available upon request.
o The headrest is designed for a maximum load of 20 kg (44 lbs).
o The chair is suitable to be employed in the immediate proximity of patients.

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 6 of 22

5 Mounting and commissioning
The medical device is delivered completely assembled. If optional parts or accessories are
part of the delivery, please refer to the respective section in this user manual for mounting or
connecting instructions.

No additional assembly or calibration work is required to operate the medical device.

6 Electrical connections

Warning The medical device is only de-energized when the mains plug has
Electrical been pulled.
shock

Find the location of the power input on the device or the battery charger unit in the respective
section of this user manual. To connect the device to the power supply use only the power
cable delivered with the devices or as specified by the manufacturer.

7 Product description and controls

7.1 Battery
Electrical power is provided by a re chargeable battery. Battery capacity will last for approxi-
mately 40 examination procedures under typical load requirements. Please also refer to
chapter “Disposal of device”.
7.2 Battery re charger unit
Attach the re charger unit permanently to the wall using two screws or set up at a suitable
place. Make sure the unit is oriented vertical to assure the gravity-assisted contact of the
electrical metal contacts.
The re charger unit is equipped with a voltage detecting power unit approved for 110V to 230
V line voltage. Battery Ready mode is indicated by a green LED.
The re charging process is indicated by a yellow LED and may take up to 4 hours. Upon
completion the yellow LED extinguishes.

Re charger unit with

power cord

Control light
ON

Control light
CHARGE Vertical orientation of re
charger unit

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 7 of 22

7.3 Battery holder on the SC 5010 SEK chair
The battery holder is located under the lower frame and easily accessible. Gently pull at the
handle at the head end of the battery to unlock and remove battery from holder. To insert
battery in holder, slide battery in position applying a gentle push on battery and wait for the
audible click.

Position of battery holder

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 8 of 22

7.4 Electric actuators and control unit
The SC 5010 SEK is powered by low voltage actuators. The electronic control unit is located
in the lower frame section under the cover.
7.5 Handheld control panel
The hand held control panel is connected with a helix cable to the control unit under the cov-
er on the lower frame. To hook up the panel at any desired position use the hook on the
backside. Make sure however that the helix cord is not exposed to squashing or pinching by
any moving parts of the chair.

Back Rest Up - Down

Chair Up - Down

Seat tilt 0° - 29°

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 9 of 22

7.6 Control lever for heavy duty castors

The chair features 4 heavy-duty

castors and two foot levers on ei-
ther side of the lower frame.

The three settings below are available

- All wheels locked (kick on black arm)
- All wheels unlocked and swiveling (set arms horizontal)
- All wheel unlocked, one wheel set for steering (kick on green arm)

Foot operated control lever in different settings

all wheels locked all wheels unlocked one wheel locked for di-
rectional control

8 Operation of chair
8.1 Duty cycle (continuous operation) of electrical motors
The electrical motors are designed for a duty cycle of approximately 6 minutes at full load.
Continuous operations exceeding that time period may cause overheat conditions and per-
manent damage to the transformer.
8.1.1 Battery charge status
After discharging the battery down to approximately 20% of total capacity, the control unit will
sound a beep, indicating that the battery is due for recharging. A total discharge may cause
damage to the battery.. A total discharge may cause damage to the battery.

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 10 of 22

8.2 Electric controls
To adjust chair height, back rest or seat cushion tilt push the corresponding button on the
control panel or foot control switches.

8.2.1 Adjustment of chair height

The chair travels from a minimum height of 68 cm to a maximum height of 97 cm. Patients
can be accommodated seated up or horizontal.

8.2.2 Adjustment of seat cushion tilt

The product features an electrically actuated seat section tilt. By pushing the respective but-
ton on the handheld control panel the seat cushion can be moved to the desired position.

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 11 of 22

8.2.3 Adjustment of back rest
To change the back rest tilt, just push the corresponding buttons on the controls.

8.3 Removable backrest segments

The back rest features two removable segments, allowing access to the shoulder area or to
position patients in a lateral orientation (park bench).

To remove a segment from backrest, unfasten the lock bolt (arrow) and pull segment out of
position.

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 12 of 22

8.4 Adjustment of head rests
Various different head rests and head supports are available for the SC 5010 SEK. All head
rests can be mounted or changed, without the need for any tools, within seconds.
8.4.1 Standard head rest

One central lock bolt con-

trols both, the length ex-
tension as well as the self
leveling tilt.

8.4.2 Adjustment of padded head support

The padded head support is vertically ad-

justable by a toggle screw. This will assist
patients comfort in prone, lateral or supine
positions..

Slide head rest sideways to enhance pa-

tients comfort in different positions.

Caution
Over winding the full stop IN –OUT posi-
tion by applying too much force on the
knob may cause damage to the adjust-
ment mechanism

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 13 of 22

8.4.3 Adjustment of multi articulated head rest

The two cushioned bars headrest assures an

optimal head support at all times. The dis-
tance between the visco- elastic foam bars is
individually adjustable by a clamp lock and
perfectly supports any head size.

By briefly opening the lock bolt, the head of

the patient will automatically move the self
leveling cushioned bars into a very comfort-
able position to the patient.

The head rest is designed to support pa-

tients head in a sideways orientation without
changing any attachments.

Two locking bolts are located underneath the headrest controlling

- Length Extension of headrest
- Tilt of headrest and width of cushioned support bars
To adjust the locking force, tighten or loosen lock nut on threaded bolt.

Tilt angle – 20°

Headrest fully retracted

Tilt angle +20°

Headrest maximum extended

8.4.3.1 Articulated arm for additional head rest tilt

Some procedures do require additional ventral or dorsal tilt. The articulated arm features an
additional clamp joint, which is located underneath the head rest.

Tilt angle +40°

Lock bolt for tilt

mechanism
Tilt angle -50°

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 14 of 22

8.4.4 Adjustment DCHR head stabilizer
The DCHR head stabilizer assists to stabilize and hold in place the head and upper body of
patients under general anesthesia during seated or partly reclined procedures. After unlock-
ing the lock bolts the upper and lower head rest can be shifted and tilted in any direction.

Place head gently and com-

fortably on the lower head
rest Unlock the central lock
bolt and place upper head
rest on patients head, exer-
cising gentle pressure.
Tighten lock bolt. Head and
upper body are now securely
stabilized.

For any procedure in the

shoulder area place the
patient near to the chair
edge to assist comforta-
ble access to the sur-
geon. To place the head
stabilizer into its proper
position, use the vertical
and sideways move-
ments.

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 15 of 22

8.5 Adjustment of leg supports
The chair features two individually adjustable and detachable leg supports.

Clamps and a notched bar allow to individually set up the leg supports to any desired posi-
tion or detach them completely.
8.6 Trendelenburg
To drive the chair into the Trendelenburg position, tilt the seat cushion and back rest electri-
cally and move the leg supports manually to their horizontal position.

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 16 of 22

9 Accessories

The SC 5010 features stainless steel side

rails alongside the backrest and the seat
cushion to attach certain accessories.
Make sure to secure blocks properly when
attaching any equipment to the side rails.
Arm rest Multi articulated

Make sure, the tips of the armrests will not

collide with the side rails when moving the
backrest to a fully vertical position.

Drape support flexible, incl. oxygen tube

stainless steel side rails

IV pole

Drape support, solid stainless steel bar.

Instrument tray

Morbus Bechterew extension

Safety reeling

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 17 of 22

Back or chest support for lateral patient
orientation (park bench position)

Knee clamp, electrically adjustable

Multi articulated Goepel supports, adjusta-

ble to any position..
Multi articulated arm rest

Knee clamp, manually adjustable

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 18 of 22

10 Cleaning and contamination protection
o Contamination protection
In order to protect the product against contamination by liquids, body liquids or other
unwanted substances it is recommended to, while in use, cover the product with a
non sterile disposable impermeable cover sheet.
o Surfaces are resistant to all commonly used disinfectants as listed in the
D G H M (Deutsche Gesellschaft fuer Hygiene und Mikrobiologie) list.
http://www.gesundheitsamt.de/alle/technik/download/seuche/bakt/list/dghm.pdf. Any
apprpropriate desinfectant must not exceed the concentrations given for the following
ingredients. Propanol=35% // Ethanol=25%.
o Do not attempt to sterilize the SC 5010 SEK
o Clean only the external surfaces of the equipment using a damp cloth. In case of
heavy stains do not use abrasive or aggressive materials other than common cleans-
ers or detergents. Do not use ether, acetone or concentrated acids.
o No water or cleaning detergents may enter the inside of the equipment.
o To clean soiled upholstery surfaces, use a damp cloth and/or commonly used uphol-
stery spray.
o Before resuming operation, allow sufficient time to dry.
11 Maintenance
The chair is maintenance-free to users and operators.

Product is subject to the regular service intervals. Refer to the current issue of local (national)
“Minimum requirements for medical products class I”.
12 Product safety inspection
A product safety inspection is not required by manufacturer however, operator must adhere
to any current national regulations governing the requirements for medical products class I”.

13 Disposal of device
The battery and all electrical components must be disposed off in accordance with national
applicable laws and regulations.

All other components are household waste.

276g001e_SC5010_SEK_3rd ed.docx 18. feb 2014 Page 19 of 22