RADIUS Operating Instructions GA 1557.05 Dec 2007

1557.05XX

Page Contents 3 3 4 5 6 7 8 9 10 10 11 11 12 13 14 14 15 16

17 18 19 20

Pictorial guide – Model 1557.05AX Pictorial guide – Model 1557.05BX For your safety, Use in accordance with the intended purpose Standards and laws, Intended purpose General safety notes Preoperational instructions, Installation Foot-operated switch for model 1557.05XX Function of the hand control Using the paper roll holder Using the foot rests Using the rinsing bowl Using the leg plate which can be attached Displacing the chair for cleaning purposes Cleaning, disposal Disinfection Maintenance and repairs Cleaning agents and disinfectants Technical description - Description of functions - Explanation of symobls on the type plate - Transport and storage - Maintenance work Functions of the software Elimination of malfunctions Technical specifications Accessories Adresses, Service hotline

Brief description Model 1557.05XX (3 motors): Electrically adjustable gynaecological examination chair with low mounting position, Radius foot plates (version AX) or Goepel knee crutches (version BX) and detachable Composé pads. With height adjustment, motor-driven table top slope, seat and back rest are linked electronically (Synchromatic), seat can be adjusted separately, Memory function, castors.

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Pictorial guide – Model 1557.05AX

Model 1557.05AX

2 4 5 3 6 9

7

13

1 8

12

11

1

Levelling feet

2

Head cushion (accessory no. 1557.720X)

3

Paper roll holder

4

Back plate pad, detachable

5

Paper slot

6

Seat pad, detachable

7

Foot plate pad, detachable

8

Secretions basin, swivelling

9

Radius foot plates with arches

11

Foot-operated switch, removable

12

Brake for foot plate joint

13

Type plate

Model 1557.05BX

Model 1557.05FX: The Radius foot plates (items 7 and 9) are replaced by gas-strut assisted foot rests (see page 9, Fig.3).

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For your safety Please read these operating instructions carefully and completely. They were provided to familiarize you with the correct use and features of your examination chair. Be sure to always follow the instructions given here and use the examination chair only in accordance with these instructions. Always store these operating instructions near the equipment. We have marked important notes in these operating instructions with these symbols:

This symbol identifies information which is critical for safety! Non-observance can result in injury to persons or damage to the device.

Î This symbol precedes all notes which will help to avoid operational difficulties.

Use in accordance with the intended purpose This device is intended to be used exclusively in human medicine. The examination chair may be used only in rooms where the electrical equipment complies with the requirements of the DIN VDE 0107 standard or an equivalent national standard. According to the requirements of the Medical Products Act, the examination chair may be operated only by persons who have been instructed in its proper use. Before using the equipment, you must be absolutely certain that it is properly installed and maintained.

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Standards and laws This product meets the requirements of the valid standards EN 60 601-1 and EN 60 601-1-2. EN 60 601-1-4 According to the classification regulations in Appendix IX of the Medical Device Directive 93/42/EEC, the examination table is a Class 1 medical device. It has been evaluated with regard to fulfilling the fundamental requirements mentioned in Annex I of Directive 93/42/EEC and as a sign of its conformity with the legal requirements has been identified with the CE symbol.

Intended purpose The examination chair is used to position patients for a short time (max. 2 hours) for gynaecological examinations and treatment in rooms of application group 1 as per VDE 0107 used for medical purposes under the supervision of medical personnel (doctor’s receptionist, doctor). The ergonomic design of the examination chair and the available accessories allow modern examination positions which are the accepted practice to be set up from a medical point of view, some of them powered by an electric motor. Î The pads are to be covered with clean sheets or paper towels before use. According to the results of the risk analysis, this examination chair may not be used for the following purposes or under the following conditions: • In the presence of explosive gas-air mixtures. • In conjunction with electrical appliances which do not comply with IEC 601-1. • For long-term positioning of patients. • For positioning unconscious patients or those of unsound mind. • As an operating table. • With accessories not approved by MAQUET.

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General safety notes Before using the mains cable check to ensure that it is in perfect condition, i.e. that there are no mechanical damages. Never unplug the chair by pulling on the mains cable; always pull out the plug! Before connecting the chair to the power supply, check to ensure that the mains voltage corresponds to the specifications found on the type plate of the examination chair (see Fig. (1). Connection to multiple sockets or extension cords is not permitted as the limiting values for the leakage current would be exceeded. Electric cables from other equipment must not be led across the examination chair or the patient. There must be no equipment which does not meet the requirements of IEC 601-1 at a distance of 1.50 m or less from the patient. The equipment may be installed only on a horizontal, even and sufficiently solid ground. Never reach beneath moving parts of the examination chair. Always ensure that no part of the body or objects are pinched or crushed when making motor-driven adjustments. When adjusting the height of the examination chair, please ensure that the knee crutches, the Radius foot plates or the gas-strut assisted foot rests do not collide with anything. Failure to do so could result in major damages.

WARNING! Injury hazard! Electrical devices (e.g. cellphones, radios, magnetic resonance tomographs) can interfere with the functioning of the product when used near the product. Electrical devices which can interfere with the functioning of the product must not be used near the product. Please observe the information in the Technical Specifications concerning electromagnetic compatibility (EMC) (emission and resistance to interference). Adhere to these specifications when using electrical devices and respond properly in the event of effects on the device or the product.

6

Î Do not use the Radius foot plates and the gas-strut assisted foot rests as seats! The maximum permissible load at the external end of the Radius foot plates is 20 kg! Î Adhere to the on / off times specified on the type plate (2) in order to avoid overloading the power supply.

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Preoperational instructions, Installation Choose a place of installation for the examination chair where all four levelling feet (1) are in contact with the floor. Even out uneven floors by turning the levelling feet. To do so, use the handle screws (2) to screw the levelling feet underneath in or to unscrew them until the examination chair is stable and level. Unscrew the levelling feet as little as possible so that the base cover is as close as possible to the floor.

1

Î If the base needs to be adjusted to an uneven floor at the front as well, these levelling feet can be adjusted from underneath after tipping up the chair.

Î When installing the chair, make sure that no cables are caught under the base.

2

Î When putting the chair into operation for the first time, or after an interruption to the power supply, test all the functions, one by one, in the order seat, back rest and height adjustment, up to the final positions. This will reinitialize the controls and automatically adjust the parallel motion and the safety program.

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Foot-operated switch for Model 1557.05XX: Model 1557.05XX:

The convenient menu controls on the foot-operated switch can be used to control both the memory function and the motors for the height, seat and back rest adjustment with only four push-buttons. Push-button (1) retrieves the fixed mounting position M1 and the stored, user-specified examination position M2 alternately. The menu select button (2) is used to select which part of the chair is to be adjusted next under motor power. When it is used, the LED display changes colour, moving from symbol (5) to symbol (6) and symbol (7) thus indicating which section is being moved, the section is always displayed in darker colours. Î

Symbol (5) = Back rest adjustment (yellow) Symbol (6) = Seat adjustment (green) Symbol (7) = Height adjustment (blue)

The push-buttons (3) and (4) are marked with the symbols × for upward and Ø for downward These push-buttons are used to move the section of the chair selected via the menu select button (2) in the desired direction.

The examination position M2 and the treatment position M3 can be stored by means of the hand control. The menu select button (2) can be used to stop any motor-powered movement. Î Standard operating sequence: When the examination chair is in the mounting position, you can move it to the examination position 2 just by touching the push-button (1). If required, you can correct the position of the back rest, the seat and/or the height adjustment by selecting from the menu as appropriate. After the examination press push-button (1) = mounting position until the examination chair has reached its final position. If another button is pressed at the same time, any motor-driven adjustment will be stopped. This is also the emergency stop function in the event of malfunctions.

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Function of the hand control, Memory function The push-buttons on the electric hand control are equipped with the symbols × for upward and Ø for downward and the symbols for the section of the chair which is moving (darker colour). a / b = Back rest adjustment c / d = seat slope e / f = Height adjustment Model 1557.05XX:

Push-button (1) is used to move the examination chair to the mounting or dismounting position. Hold the pushbutton until the final position is reached. a

b

c

d

e

f

4

Push-button (2) is used to move the examination chair to the stored examination position M2. Just touch this push-button once. When pressing another push-button, the movement will be stopped! Push-button (3) is used to retrieve the stored treatment position M3.

1

2

3

s

The stored position of push-button (1) cannot be changed. Storing positions M2 and M3: To store the memory positions, use the push-buttons (a) to (f) to move the chair into the desired position. Then press the push-button (S) once (no longer than 2 seconds) and then the push-button (2) or (3). An acoustic signal will indicate that the position has been stored. For safety reasons the maximum back rest position stored on M2 is approx. 30°! Any position can be stored for M3. The „stop“ push-button (4) will stop any movement. Î When operating the chair, be sure to observe that the cable of the hand control is neither pinched nor damaged. Î Other functions of the hand control used to eliminate errors in the operational sequence are described on page 18.

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Using the paper roll holder To change or insert the paper roll, slightly pull on the handle (1) of the paper roll holder on the rear of the examination chair in order to open the snap of the cover. Remove the paper roll axle (2) and slide it through the new paper roll. Place the paper roll in the cover, turning the side to which the roll is to be uncoiled to the top. Guide the paper from behind the back rest (3) through the paper slot (4).

3

Place the paper roll axle into the recesses provided for this purpose (5) in the rear casing and close the cover of the paper roll holder.

2

1

5

4

Using the gas-strut assisted foot rests (only for model 1557.05FX) The foot rests are equipped with gas struts to support their adjustment, thus enabling one-hand operation. Grasp around the padded arch of the foot rest with one hand and pull the handle (6) against the arch to adjust the foot rest vertically. The foot rest can be swivelled vertically. Let go of the handle to fix the foot rest in position.

6

Open the tommy screws (7) of the brake under the seat to adjust the foot rest horizontally.

7

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Using the secretions and drainage basin Once the chair is in the examination position, swing the basin outward from underneath the seat. It is fixed to the holder by means of a handle screw (2). Loosen the handle screw (2) to remove the basin from its holder to clean it.

Accessories (only for models 1557.05BX 1557.05FX): using the leg plate 1557.560X

and

The leg plate which can be attached is used for supine positioning of the patient, e.g. positioning for ultrasonic examinations. Use both hands to hold the leg plate from above, Fig. (a). Insert the locking plates (3) above the side rails (4) at the seat (see Fig. (b).

Fig. (a)

The side rails for the seat 1557.3100 are accessories as well.

Tacke care that the locking plates (3) are lying flat on the side rails (4) and the hook of the locking plate is attached under the side rail fixture. see Fig. (c).

Do not use the leg plate as a seat! The maximum load for the leg plate is 65kg.

3

4

Fig. (b) The leg plate is fitted with a gas strut to prevent overloading and to prevent the leg plate from acting as a lever which would result in the chair’s tipping over. If a person sits down on the outer edge of the leg plate, the leg plate will give way.

3

4

Fig. (c) GA155705EN09

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Displacing the chair for cleaning purposes: For cleaning purposes the examination chair can be displaced to the side using fixed castors. This function may never be used to move a patient with the examination chair!

1 Use the hand control to raise the lifting column for approx. 5 cm in order to activate this function. Press the lever (1) fully in (Fig. (a) and (b)) while at the same time actuating the „height down“ function on the hand control until the lifting column is fully retracted. The chair will lift off for approx. 2.5 mm around a central axis. Detach the plug from the socket at the power point, roll up the cable and place it on the base cover in the rear area of the chair. Coil the cable of the foot switch round the foot switch and place it also on the base cover (Fig. (c)).

Fig. (a)

1 Fig. (b)

Hold the chair from the front at the foot plates or the Goepel knee crutches and pull it to the desired location (Fig. (d)). Plug in the mains cable in order to return the chair to a stable position. Actuate the „height up“ function on the hand control. The chair will be lowered until it stands on its feet again.

When using this adjustment function, be absolutely sure to observe that there is no cable or any other object being pinched or crushed under the base cover!

Fig. (c)

Fig. (d)

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Care and maintenance Cleaning Î Note Be absolutely sure to follow the instructions for use provided by the manufacturer of the cleaning agent.

Cleaning / Wipe disinfection of stainless steel surfaces Î Note Do not use: • Water containing particles of iron. • Any implements containing iron, such as wire brushes or steel wool. • Products containing hydrochloric acid.

Caution! Improper cleaning can cause property damage! Avoid using excessive quantities of cleaning agent • or cleaning liquid and remove excess cleaning agent and cleaning liquid by wiping with a dry cloth. • • • Caution! Improper cleaning can cause property damage! • Never use a high-pressure cleaning unit! • Clean the product only by wiping down. Normal cleaning operations: • Use only all-purpose cleaners which are slightly alkaline (soap solution) and which contain tensides or phosphates as the active cleaning ingredients. • Do not use scouring agents, as they would damage the surfaces.

Never use disinfectant agents which contain either chlorides or compounds which could liberate chlorine. Use a lint-free cloth to wipe the surfaces dry. Do not scour. Keep any excess cleaning agent from drying on the surface. Remove lime deposits and scale immediately. Should surface rust appear in spite of regular cleaning, then use special cleaning agents such as Perr aktiv or Helotil to clean the surfaces.

In the event of heavily soiled surfaces: • Use the cleaning agent in concentrated form. • Rinse with clear water. • Use a dry cloth to remove any water which has collected.

Cleaning and manual disinfection of the padding Caution! Improper cleaning can cause property damage! Moisture can penetrate damaged padding. Hygiene requirements are then no longer satisfied. Replace damaged padding immediately. • • •

Use a cloth moistened with an approved cleaning or disinfectant agent to wipe down the padding. After cleaning wipe the padding with a wet cloth. To clean heavy soiling and stubborn stains, rub a soft bristle brush in circular motion over the affected areas.

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1557.05XX Disinfection Î Note Be absolutely sure to follow the instructions for use provided by the manufacturer of the disinfectant. Caution! Property damage! Do not use any mechanical cleaning or disinfection processes.

Warning! Explosion hazard! Agents containing alcohol can form explosive vapour mixtures and ignite where high-frequency equipment is being used. Do not use agents containing alcohol where highfrequency equipment is being used.

Aldehydes, quaternary compounds and guanidine derivatives will not attack surfaces and will pass recurring hygiene inspections. Thanks to the markedly longer evaporation period and extended residence of the disinfectant agent on the surface, germicidal effect beyond 95 % is achieved within a few minutes, provided that coarse soiling is removed beforehand. Information on the active ingredients is provided in the following table.

Caution! Property damage! If used over an extended period of time, alcoholbased disinfectants can damage surfaces and accessories. Disinfectant agents which have been approved for use: Use only surface disinfectants with the following combinations of active ingredients: • Aldehydes • Quaternary compounds or • Guanidine derivatives. Disinfectants which are not approved for use: • Hand disinfectants as these usually contain alcohol or alcohol-containing compounds, • Disinfectants containing alcohol since alcohol applied in excess (i.e. accumulations of liquids containing alcohol remaining on the surface for more than about 5 minutes) can damage the surface.

Group of active substances

Active substances

2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal, o-phthalic aldehyde, succinaldehyde Alkyl didecyl polyoxethyl ammoniumpropionate, alkyl dimethyl alkyl benzyl ammonium chloride, alky dimethyl ethyl ammonium chloride, alkyl dimethyl ethylbenzyl ammonium chloride, benzalkonium propionate, benzalkonium chloride (alkyl dimethyl benzyl ammonium chloride, cocos dimethyl benzyl ammonium chloride, lauryl dimethyl benzyl ammonium chloride, myristyldimethyl Quaternary compounds benzyl ammonium chloride), benzethonium chloride, benzyl dihydroxy ethyl cocosalkyl ammonium chloride, dialkyl dimethyl ammonium chloride (didecyl dimethyl ammonium chloride), didecyl methyloxyethyl ammoniumpropionate, mecetronium ethyl sulphat, methylbenzethonium chloride, n-octyl-dimethyl benzyl ammonium chloride Alkylbiguanid, chlorhexidin digluconat, cocospropylendiaminguanidiniumGuanidinderivates diacetate, oligomere biguanide, polyhexamethylene biguanide hydrochloride (oligodiimino-imidocarbonyl-iminohexamethylene, polyhexanide) Aldehydes

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Recommendation: Cleaning agents and disinfectants for leatherette upholstery for MAQUET examination chairs / delivery beds / examination tables / stools in accordance with the colour schemes F960-4, F960-5

Disinfectant

Manufacturer

Concentration of the solution

Descocid

yes

Antiseptica

2%

Kohrsolin FF

yes

Bode Chemie

0.50%

Mikrobac forte

yes

Bode Chemie

0.50%

yes

Bode Chemie

2.0%

yes

Bode Chemie

0.50%

yes

Bode Chemie

2.5%

Hexaquart Plus

yes

B. Braun Medical AG

1.5%

Melsitt

yes

B. Braun Medical AG

3%

Quatohex

yes

B. Braun Medical AG

5%

Eskaphor HD6

no

Haug Chemie

50%

Tege-Planenreiniger

no

Heine / Weizen

pure

Incidin Extra N

yes

Henkel

5%

Incidin Plus

yes

Henkel

1%

Incidur

yes

Henkel

3%

Köhler Sprühdesinfektion

yes

Köhler / Neckarsulm

pure

TASKI Frost, Selfon Frost

no

Lever Sutter

pure

TASKI Mela

no

Lever Sutter

5%

TASKI R50 Concentrated

no

Lever Sutter

0.25%

Medichem Flächenwischdesinfektion

yes

Medichem

0.50%

Dodenal neu

yes

Merck Wien

0.50%

Quartamon Med

yes

Schülke&Mayr

7.5%

Sagroplus Forte

yes

Schülke&Mayr

0.5%

Terralin

yes

Schülke&Mayr

0.50%

TPH 5225

yes

Schülke&Mayr

0.50%

Steinet 670

no

Steinfels Cleaning Sys.

pure

Membranreiniger A+B

?

Wesoko AG

pure

Product

Mikrobac extra

REMARK: The different products were tested and declared to be suitable by the leatherette manufacturer, the STAMOID company. The agents were tested with the highest recommended concentration. The operating instructions for the cleaning agent or disinfectant have to be strictly followed in any case. After every cleaning and disinfection procedure it is necessary to wipe down the upholstery with clear water in oder to avoid concentrations and aftereffects of the chemicals. MAQUET accepts no responsibility for damages to the upholstery (e.g. embrittlement, colour detaching itself etc.) which are caused by improper use of the cleaning agents and disifectants. Right to claim under guarantee will expire.

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Maintenance We recommend servicing the product once a year to ensure operational safety, availability of all functions and an extended service life of the product. Therefore MAQUET offers maintenance works comprising different services. After each maintenance a safety inspection will be performed according to EN62353. Maintenance may be carried out only by the MAQUET service department or by service technicians authorized by MAQUET. These authorized service engineers may order descriptions, wiring diagrams, spare parts lists and adjustment instructions from MAQUET. Service hotline for Germany: 0 180 32 12 144 Service hotline for all other countries: +49 / 72 22 / 932 – 745

Disposal Within the European Trade Area This product is governed by the 2002/96/EEC Directive (Directive on Waste Electrical and Electronic Equipment). This product has not been registered for use in private households; disposal using municipal collection points for used electrical equipment is not authorized. Please contact your MAQUET factory representative for more detailed information on correct and legal disposal. Outside the European Trade Area When disposing of this product, be sure to comply with the applicable national regulations on the handling and disposal of used equipment.

Labelling as per 2002/96/EEC Directive (Directive on Waste Electrical and Electronic Equipment). Symbol for „Do not dispose of at municipal collection points for used electrical equipment“.

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Technical description: Description of functions The examination chair is equipped with three 24V DC linear drives to power movements of the back rest, seat and height adjustment. They are maintenance-free. These drives are controlled and monitored by an electronic control unit.

Explanation of symobls on the type plate Follow the operating instructions!

IP X5 CE

Type B device hoseproof symbol of conformity

Transport and storage The packaged examination chair can be subject to the following environmental conditions for up to 15 weeks: - Ambient temperature -20°C to +50°C - Relative humidity of 10% to 95% - Atmospheric pressure between 500 hPa to 1060 hPa

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1557.05XX Functions of the software The integrated software enables storing two different userspecified examination positions. Memory 1: Mounting or dismounting position is stored and cannot be changed. Memory 2: User-specified standard examination position can be stored. As Memory 2 is an automatic function which is activated by touching the appropriate pushbutton on the foot switch or the hand control, the position of the back rest cannot be stored at an angle less than 30° from the horizontal for reasons of safety. Memory 3 can be used to store another frequently used treatment position. It can, for example, be very practical to store the horizontal position here. Retreiving Memory 3 is ony possible using the hand control.

Elimination of malfunctions Î The adjustments drives are equipped with a safety nut for pressure load. It is activated if the main nut fails. Then it will only be possible to move the adjustment drive downward. The adjustment drive will no longer work properly and will have to be replaced.

When the adjustment drives are replaced or when the position indicator gives frequent error messages, there can be what is known as position loss in the control unit. In this case an acoustic signal will sound when pressing a button on the operating elements. To eliminate the malfunction, press push-button (1) on the hand control or or use the individual function buttons ( b, d and f) to move the chair mounting position as far as it will go. As soon as the adjustment drives have reached their final position, the control unit will work properly again.

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Technical specifications Nominal voltage: Nominal frequency: Power consumption: Operating mode:

Back rest adjustment

Seat adjustment

Mounting height

Equipment fuse:

230 VAC 50 Hz 290 VA Short-time operation 6 min/h 2 min. on /18 min. off 1.25 AT

Class: Degree of protection: Type of protection:

I IPX5 Type B ( )

Lifting capacity: Patient weight limit: Noise level:

approx. 2000 N 180 kg < 52 dB (A)

Length (supine position): Length (supine position) with foot plate: Width of foot plates:

1700 mm 1830 mm 790 / 1300 mm

max. height at the front edge of the seat (Trendelenburg position): 1557.05XX: 1050 mm

Length of back rest:

Weight: 1557.05XX:

AX 118 kg

Length of back rest: Width of padding: Length of seat:

BX FX 121 kg 121 kg 920 mm 630 mm 300 / 190 mm

Padding width

Mounting height / height adjustment: 1557.05XX: 560 mm / 285 mm

Foot plate abduction

Seat adjustment: 1557.05XX:

+20° / 0°

Back rest adjustment: 1557.0XXX:

+51° / -11°

Ambient conditions in operation:

+4°C -+40°C

Classification as per MPG (MDD) (or Directive 93/42/EEC):

Class I

Overall length (supine position)

Length of seat

Colour:

RAL 9002

Upholstery colours:

Colour Scheme 960-4/5

Subject to modifications due to technical development! Height adjustment

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RADIUS - Model 1557.

05AX

05BX

05FX

Order No. 1557.3000

Colposcope holder

9

9

9

1557.3100

Accessory rails, pair mounted at the seat

9

9

9

Accessory rails, pair mounted at the back rest

9

9

9

Instrument tray suitable for standardized trays

9

9

9

Instrument tray suitable for standardized trays with swivel mount

9

9

9

1557.4200

Secretions basin – spare part

9

9

9

1557.4600

Instrument tray with mount

9

9

External paper roll holder for paper rolls 600 mm wide

9

9

9

1557.720X

Head cushion

9

9

9

1557.500X

Supine position cushion two-section

9

Supine position cushion one-section

9 9

9

1557.3200 1557.4000 1557.4100

1557.6300

1557.540X 1557.560X 1557.60AX 1557.60BX 1557.7600 1557.7700 1557.9400 1557.9500 1557.9900 1557.900X

Single-section leg plate for supine position Elbow rests for RADIUS foot plates

9

Elbow rests for Goepel knee crutches, pair

9

PVC protective covers, pair for RADIUS foot plates AX

x9

PVC protective covers, pair for seat

9

9

PVC protective covers, pair for foot rests FX

9 x9

PVC protective covers, pair for foot-operated switch

9

9

9

PVC protective covers for Head cushion 1557.720X

9

9

9

Terry fitted sheet for seat and back rest

9

9

9

x

standard

9

available

MAQUET cannot assume liability whatsoever for injuries to persons or property damage caused by using other accessories which are not included in this list.

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