Dewert Dx1 series User manual

Dewert User Manual DX1 Series–Updated 05.2021/1 MDR Page 1 of 16

User Manual

DX1 series model

Dear customer,

Congratulations on purchasing a product of outstanding quality. Use of the best materials from renowned

suppliers guarantees years of trouble-free operation, provided the device is handled correctly and as intended

in accordance with the conditions described in the user manual.

In the unlikely event you need to make a claim, please contact us.

We welcome suggestions from the users of our products.

K.H. DEWERT GmbH

Vollmestr. 7

33649 Bielefeld

Germany

Tel. +49 / 521 400 27-0

Fax +49 / 521 400 27-27

[email protected]

www.khdewert.de

Dewert User Manual DX1 Series–Updated 05.2021/1 MDR Page 2 of 16 
Contents 
Safety information.......................................................................................................................................3 
1 Applied symbols.................................................................................................................................... 3 
2 Applied standards.................................................................................................................................3 
3 Safety regulations.................................................................................................................................3 
4 Intended purpose..................................................................................................................................3 
5 Information on setup and use...............................................................................................................4 
6 Commissioning..................................................................................................................................... 4 
7 Safety instructions ................................................................................................................................ 4 
8 Model designation and type labelling ...................................................................................................5 
9 Meaning of the serial number............................................................................................................... 5 
Operating manual........................................................................................................................................6 
1 Table design.........................................................................................................................................6 
2 Height adjustment.................................................................................................................................6 
3 Upholstery adjustment..........................................................................................................................6 
4 Movability (model dependent or optional):............................................................................................7 
5 Additional equipment............................................................................................................................7 
Additional accessories (for user-specific table configuration, model dependent)....................................... 8 
Technical data............................................................................................................................................. 9 
1 DX1 series............................................................................................................................................9 
2 Technical data for electric motor ........................................................................................................10 
3 Technical data for hydraulic system...................................................................................................10 
Cleaning instructions................................................................................................................................. 10 
Maintenance and technical inspection......................................................................................................11 
Safety devices...........................................................................................................................................12 
Reporting obligation..................................................................................................................................13 
Disposal ....................................................................................................................................................13 
Declaration of Conformity .......................................................................................................................14 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. Safety information

1.1 Applied symbols

Safety instructions and key sections in these operating instructions are marked with the exclamation mark

symbol on the left. Please pay particular attention to these instructions and sections.

Other symbols possibly used on the device:

Observe instructions for use:

Risk of pinching when adjusting:

Risk of hazard zone:

1.2 Applied standards

This device has been designed and manufactured in accordance with national and international

regulations. This ensures a very high level of equipment safety.

The models described here comply with the following regulations and directives:

Regulation (EU) 2017/745

DIN EN IEC 60601-1

DIN EN ISO 14971

DIN EN 60601-2-52 partly based on

DIN EN IEC 62353

DIN EN ISO 10993-5/-10

DGUV Regulation 3

This device is a Class 1 medical device according to Regulation (EU) 2017/745 (MDR).

1.3 Safety regulations

This section contains a summary of the most important safety information.

Correct operation of the device is essential for safe operation. Therefore, please familiarise yourself with the

contents of these instructions for use before using the device. We recommend that you keep these

instructions for use near the device for future reference. The device may only be used by authorised,

instructed and competent persons who are sufficiently familiar with its adjustment mechanism or have read

and understood the operating manual fully. The manufacturer cannot be held responsible for damage caused

by or involving unauthorised persons.

The user must ensure that the device is not accessible to unauthorised persons or cannot be operated by

unauthorised persons even when left unattended. When leaving the device, it should be secured in such a

way that unauthorised adjustment is impossible.

Keep a sufficient safety distance to the device during all adjustment procedures. Special attention

must be paid to the arms, hands, legs and feet of the user and the patient - RISK OF CRUSHING!

Make sure that there are no objects located directly around or underneath the device!

1.4 Intended purpose

The table is used for the ideal positioning of patients for the purpose of curative and disease treatment,

examination, massage and health therapy.

Table operation and patient positioning on the table may only be performed by professionally trained persons

who have been instructed in its use or who, through experience with other similar medical devices, have

knowledge of its proper use, taking into account possible hazards.

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Equipped with the options of movability (not wheel-lifting/fixing mechanism), side guards and push handle, the

intended purpose of the table is extended and also provides for the ideal positioning of patients for the

purpose of transport to pre-treatment or post-treatment locations. Patient positioning during the recovery

phase after a medical procedure is also permitted under supervision.

Otherwise, the device must only be moved within the room for cleaning or patient access.

This device has been developed exclusively for use indoors and in normal ambient conditions and can be

used in the following areas: laboratories, medical practices, examination and treatment rooms, hospitals,

clinics, physiotherapy practices, occupational therapy centres and doctors’ surgeries. This table is not classed

as surgical furniture and must, therefore, not be used for surgical purposes. The expected service life is 10

years or 100,000 drive cycles (double stroke = 1x up and down).

1.5 Information on setup and use

When packed, the device may be exposed to the following environmental conditions for approx. 3 months:

Transport and storage temperature: -20° to + 50°

Operating temperature: +10° to +40°

Relative humidity: 30% to 75%

Air pressure: 800hPa to 1060hPa

When transporting the device in a vehicle, it must be secured properly against moving. To do so, lock the

castors (optional equipment) and ensure further safety measures.

When transporting the table, take hold of the underframe, NOT the upper frame.

When setting up the device, do not lift it at the head part, as this may damage the head part and/or the

release mechanism. Hold and lift the table on the left and right-hand side of the frame.

The table must stand securely on its feet or castors on a level, flat and solid surface. Before use, activate the

brakes on the castors and make sure they are working properly.

1.6 Commissioning

The device is ready for use upon delivery.

Remove the power cable from the film packaging on the underframe of the table and connect it properly to a

permanently installed mains socket. When routing the power cable, make sure the cable cannot be crushed,

rolled over or otherwise damaged.

Lock the castors (optional) or the wheel system (optional).

As the operator, carry out a thorough and precise function check once the device has been set up. Prior to

commissioning, clean the device and remove any contamination from transport. Make sure that no connecting

cables from the hand or foot switch to the motor are trapped in the mechanism and thus damaged. Operation

in potentially explosive atmospheres is not permitted.

1.7 Safety instructions

This table may only be used for its intended purpose. Any other use is strictly prohibited and possibly

dangerous. The manufacturer cannot be held responsible for damage caused by improper use. Patients may

only be positioned in preparation for treatment/examination by professionally trained persons.

Please note: This table is not classed as surgical furniture.

Prior to and when adjusting the height of the table, make sure that no persons or objects are located in the

adjustment range of the table and that nobody has their hands on the underframe.

The following basically applies: Never reach into or under the frame of the table when adjusting the height.

Height adjustment can result in injury if the user does not pay due care and attention. Therefore, take great

care when performing this procedure.

When adjusting the upholstery parts, make sure that no persons or objects are in the adjustment range. Make

sure that no persons reach under the upholstery part or lean on the underframe.

Important for the user: When adjusting the upholstery parts, do not reach under the spacers located beneath

the upholstery parts.

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Always use both hands when adjusting the lying surface elements: Use one hand to operate the adjustment

mechanism and the other hand for the lying surface adjustment.

The lying surfaces and the underframe are not anti-static as standard. Our products are not intended for use

in wet rooms and must under no circumstances be cleaned using so-called bed washers. This would

irreparably destroy the product.

The head part and armrests are only intended to support the patient and must not be used for sitting.

If the underframe is designed with movability (optional), all the castors must always be locked before using

the table.

Do not put a damaged device into operation.

Disconnect the device from the mains (power supply) in the event of a fault or during

maintenance work. To disconnect, be sure to grasp the plug, not the power cable.

This device must not be modified without the express permission of the manufacturer.

When transporting the table, only take hold of the underframe, NOT the upper frame.

1.8 Model designation and type labelling

The exact model designation depends on the choice of frame colour:

-00 white powder coated (RAL 9010);

-03 white aluminium powder coated (RAL 9006);

-04 grey aluminium powder coated (RAL 9007)

and the type of selected height adjustment:

E = electromotive;

/H = hydraulic

The type plate is attached to the underframe on one long side of the table. It provides information about key

table data.

The following symbols are listed there (by way of example), their meanings are:

Read the operating

manual

Serial no.

Applied part Type B

Caution, potential

hazard

Max. load

capacity

CE mark

Date of manufacture

Product may only

be used in dry

rooms

Do not dispose of with

household waste

Address of

manufacturer

Protective

insulation,

protection class II

1.9 Meaning of the serial number

The serial no. is located on the type plate or shown separately next to the type plate of the table. This number

is unique and firmly linked to this specific individual product. It enables us to identify this table model and

trace back assemblies/safety-relevant components at any time. Please always state this serial number when

enquiring about spare parts.

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2. Operating manual

2.1 Table design

When designing the table frames, special emphasis was placed on functional and operational safety. The

number of possible pinching points has thus been minimised, while remaining ones have been covered or

protected with spacers to prevent injury, thus ensuring safe and yet simple operation. Nevertheless,

necessary caution must always be exercised when using the table.

The table consists of the following assemblies: - underframe, - scissor section, - upper frame, - upholstery.

Depending on the respective version, these assemblies can feature further attachment parts. The surfaces of

the welded design are plastic coated.

The height adjustment unit is located between the scissor section and the underframe, which guarantees very

high power transmission even in the lowest adjustment range (min. height). By extending or retracting the

lifting tube, the scissors are pushed apart or together, thus enabling adjustment of the lying surface.

The electrical adjustment system does not pose a hazard to the health and safety of the user or the patient

when used as intended. The lifting motor is activated by a low control voltage.

2.2 Height adjustment

Height adjustment (all models with electromotive height adjustment)

To adjust the height, the enclosed foot switch (optionally also hand switch) is operated according to the

marking.

Beforehand, brief activation (double tap) must take place via the foot switch (or the hand switch). Please refer

to section 7. The table is lifted or lowered.

Height adjustment using foot switch rails (optional)

The electric motor for height adjustment is operated by a switch rail attached to the long side of the table,

which can be operated with your foot.

Press the switch rail down = the table is lifted.

Lift the switch rail up = the table is lowered.

Here, too, brief activation (double tap) must take place beforehand (see section 7).

Alternatively, the switch rails can also be led out to the short side of the table. This facilitates

height adjustment from the short sides of the table. The lifting motor is equipped with a freewheeling clutch as

standard. This ensures automatic declutching if an obstacle is encountered when lowering. In other words,

the active tractive force of the motor no longer acts; instead, simply the weight of the upper part of the table is

applied. In the event of unforeseen entrapment, the risk of injury is significantly reduced.

Note on operation

The electric motor is to be operated in intermittent duty mode. This means that a maximum duty cycle

of 25 s must not be exceeded. Before switching the motor back on, an interruption time of at least 400

s must be observed. If the maximum duty cycle is exceeded, an internal thermal switch (protective

temperature limiter) in the motor interrupts the power supply to the actuator. After the electric motor

has cooled down, the thermal switch automatically reconnects the power supply to the actuator.

Height adjustment (with hydraulic height adjustment)

At tables equipped with hydraulic height adjustment, the height is adjusted by repeatedly depressing

(pumping) the foot lever on one side of the table.

To lower the table, the foot lever is simply lifted with your foot.

If the table is only lifted slightly each time the foot lever is depressed after transport or a longer period of non-

use, air bubbles have formed in the hydraulic system. To remove the air bubbles, pump the table upwards

under load and perform an additional 20 - 30 strokes of the pump when the table is in the uppermost position.

This will force air out of the system.

2.3 Upholstery adjustment

Despite the very robust and strong design of the gas spring, the head part must not be used for

sitting!

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Adjustment of the head part (and foot part for models 1050E, 1050/H and 1095/H)

The head part is adjusted using a gas spring. To operate, press the release lever, which is located at the end

of the head part underneath the upholstery part, in the direction of the upholstered surface. The head part is

lifted slowly to the positive end position. To lower, press down the head part and operate the release lever at

the same time. Once the desired position has been reached, let go of the release lever.

3-sectioned head part (optional)

The 3-sectioned head part consists of an adjustable head part as described under 2.3 and additional

armrests, which can be lowered and removed steplessly, to the right and left of the head part. The clamping is

released by loosening the knurled screw located underneath each armrest. The armrest can now be pulled

down through a range of approx. 180 mm. Re-clamping takes place by subsequently tightening the knurled

screw. To remove the armrests, loosen the knurled screw located directly underneath the head part. The

complete armrest can then be pulled off the head part from the side. The armrests must not be used for

sitting. They only serve to support the patient’s arms.

2.4 Movability (model dependent or optional):

Individually lockable castors

The castors can be locked using the foot-operated brake on the castor housings. In this case, the castors can

neither be moved nor rotated. To release, operate the brake on each castor again.

Please note:

Standard castors are not electrically conductive = optional equipment.

You can recognise conductive castors via the respective marking = yellow dot on the side of the running

surface or a yellow ring.

With this movability option, access to the patient is improved during examination and treatment thanks to easy

positioning within the room. Transporting patients is not considered as intended use.

Central movability

By operating a lever (on the outside of the table feet), all four castors are activated simultaneously. The

following moving options exist:

Stage 1: The castors of the table are locked and can neither be moved nor rotated.

Stage 2: = centre position: The castors are released and can be moved and rotated, the table can be moved

in all directions.

Stage 3: Three castors are released (= can be moved and rotated). The fourth castor is locked and cannot be

rotated (directionally locked castor), i.e. the wheel rolls in a fixed position and helps to steer the table in the

intended direction.

Please note: Rotational movement is only prevented when the castor is swivelled parallel to the lying surface.

This then allows the table to be moved in a straight line without pulling off to the side.

Wheel-lifting/fixing mechanism

The wheel-lifting/fixing mechanism allows a combination between fixed and movable table. There are two twin

castors on each short side of the underframe and foot levers at each corner. The foot levers consist of two

ergonomically arranged counter holders.

This way, the table can be lifted and lowered quietly with your foot. The wheel-lifting/fixing mechanism is not

controlled centrally; a foot lever must be operated on each short side of the table in order to lower the table

onto its feet or to place it on the castors. This option ensures the device can be simply relocated; however,

the device is not intended for transporting patients (ground clearance (distance foot - ground) when moving

the table is approx. 14 mm).

2.5 Additional equipment

Nose opening

If a nose opening is upholstered in the head part as an optional equipment feature, the opening can be closed

with a cushion (optional). To open up the nose opening, reach under the head part when the table is standing

still and press the cushion out from the bottom upwards (a slight amount of pressure is required). To close it,

simply insert the cushion into the opening (a slight amount of pressure is required).

Paper roll holder (optional equipment)

The paper roll holder consists of a holding bar and angle mount brackets or retaining brackets. In addition to the

stainless steel bar, the paper roll holding bar consists of a spring-loaded stainless steel sleeve featuring a round

Dewert User Manual DX1 Series–Updated 05.2021/1 MDR Page 8 of 16

steel gripping disc at the end. To insert the holding bar, feed the guide cotter pin of the stainless steel bar into the

rear hole of the angle mount bracket/retaining bracket. Then push the sleeve with the gripping disc against the

spring force and feed the front guide cotter pin into the second hole. Then relieve the spring tension on the sleeve.

To release the paper roll holder, proceed in the same way.

Side guard (optional):

Laterally lowerable side guard (standard equipment for models 1090/H, 1093/H and 1095/H)

Operating the side guard:

Hold the centre of the rail of the side guard with one hand and release it by moving it minimally sideways

(either towards the head or foot part). At the same time, use your other hand to pull out and turn the locking

pin (red knob) located in the centre of the side guard underneath the upholstery frame. Press down or pull up

the side guard using the rail until the locking pin engages audibly. After the locking pin has engaged, the side

guard is secured in place. To check whether the side guard has engaged properly, move it sideways on the

rail (either towards the head or foot part). Only limited movement should then be noticeable.

Always operate the side guard with the necessary caution. Never operate the side guard if the hands,

fingers, etc. of another person are located between the bars or on the mechanism of the side guard.

Risk of being crushed/pinched!!!

The laterally lowerable side guard is completely screwed in place. If the side guard becomes too loose or has

excessive lateral play over time due to use, it can be readjusted by tightening the screws. The moving parts of

the side guard should be re-lubricated slightly at regular intervals (spray oil, e.g. Ballistol).

Side guard, lowerable, for side rail

This side guard can be placed and fixed on any side rail using a clamp. By loosening the toggle screw of the

clamp, the position and height of the inserted side guard can be shifted and adjusted respectively.

Complete lowering below the upholstery level can only be achieved if the guide points in the direction of the

upholstery when the side guard is inserted into the clamp.

Please note: Never use the side guard as a push handle. It has not been designed for this purpose.

3. Additional accessories (for user-specific table configuration, model dependent)

•Upholstery width 800 mm

•Twin castors ∅ 100 mm, centrally lockable, non-conductive

•Twin castors ∅ 100 mm, individually lockable

•Wheel-lifting/fixing mechanism

•3-sectioned head part

•Side guard

•Paper roll holder

•Additional foot switch or hand switch

•Foot switch fixation on the underframe

•Foot switch rails, for operating the height, laterally or surround

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4. Technical data

4.1 DX1 series

Model

1000E

1000/H

1030E

1030/H

Max. length (mm)

1950

Width (mm)

700

Head part length (mm)

550

750

Middle part length (mm)

Foot part length (mm)

1400

1200

Weight (approx., depending on

equipment) kg

Min. –max. height (mm)

480 to 920 *

470 to 920 *

520 to 960 *

510 to 960 *

Adjustment time (motor) (s)

Head part adjustment range

+40° / -35°

0° / +75°

Foot part adjustment range

3-sectioned head part adjustment

range

+45° / -25°

Max. patient weight (kg)

225

Model

1050E

1050/H

Max. length (mm)

1950

Width (mm)

700

Head part length (mm)

550

Middle part length (mm)

480

Foot part length (mm)

920

Weight (approx., depending on equipment) kg

Min. –max. height (mm)

500 to 940 *

490 to 940 *

Adjustment time (motor) (s)

Head part adjustment range

+40° / -30°

Foot part adjustment range

0° / + 50°

3-sectioned head part adjustment range

45° / -25°

+45° / -25°

Max. patient weight (kg)

225

Model

1090/H

1093/H

1095/H

Length (mm)

1950

Width (mm)

700

Head part length (mm)

550

750

550

Middle part length (mm)

480

Foot part length (mm)

1400

1200

920

Overall length (mm)

2060

Overall width (mm)

780

Weight (approx., depending on equipment) kg

100

105

110

Min. –max. height (mm)

500 to 950

540 to 990

520 to 970

Head part adjustment range

0° / + 65°

0° / +75°

0° / + 65°

Foot part adjustment range

0° / + 50°

Max. patient weight (kg)

225

Technical data subject to change

*for movability art. no.046: Height plus 20 mm

for movability art. no. 040N: Height minus 10 mm

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The motor is equipped with a thermal protective switch as standard. This causes the motor to cut out if the weight

load is too extreme or the motor’s duty cycle (DC: 25 s/400 s) is exceeded. The table should be ready for use again

after a 15-minute rest period. There is, therefore, no risk of overloading the motor.

The mechanics of the tables have been designed with extensive safety margins in mind.

The max. patient weight is provided with a 4-fold static safety factor, i.e. the design has been fully tested for a 4-

fold load.

4.2 Technical data for electric motor

Manufacturer: Hanning Elektro-Werke GmbH & Co, D-33813 Oerlinghausen

Type of motor: SL 95

Type of actuator: Brushless asynchronous industrial motor

Mode of operation: Electromechanical linear motor with maintenance-free lifetime lubrication

Intermittent duty –installed thermal switch

Electronic activation with internal supply for the control element

Duty cycle (DC): 25 s / 400 s

i.e. move the table for max. 25 seconds under nominal load, then observe

a break of at least 400 seconds.

Nominal voltage: 220 –240 V, 1-50/60 Hz

Nominal consumption: 850 W

Current consumption: 3.7 A

Protection class: II (protective insulation), connecting cable without protective conductor

Protection rating: IPX4 –resistant to water splashes,

Degree of protection: B

The motor is maintenance free.

When operated with sinusoidal alternating voltage, the motors used do not cause field or line-borne interference

within the meaning of EN 50081, Part 1 and 2, nor can their function be impaired by electromagnetic influences

within the meaning of EN 50082, Part 1 and 2.

4.3 Technical data for hydraulic system

Manufacturer: Power-Packer Europa B.V., NL-7575 AT Oldenzaal

Type: Compact MK5 long

Mode of operation: Hydraulic cylinder with pump

The hydraulic unit is maintenance free.

5. Cleaning instructions

Upholstery covering

There are two different collections of upholstery covering to choose from:

•Skai Pandoria Plus (manufactured by Hornschuch/Continental in Germany)

•Skai Toronto EN (manufactured by Hornschuch/Continental in Germany)

•

For cleaning and disinfection, a selection of agents from various manufacturers has been tested for

compatibility. Please refer to the separate enclosed sheet.

The table is equipped as standard with the Dewert hygiene standards, which enable optimal cleaning and

disinfection:

•Hinge lids are made of the identical upholstery covering

•All undersides of the upholstery parts are coated with an upholstery covering and can thus be cleaned

and disinfected

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•Vent holes underneath the upholstery:

For the homogeneous foam to recover quickly, a rapid exchange of air is necessary. To ensure this, there

are individual vent points on the underside of the upholstery, which are hygienically sealed with special air

compensation caps that assume a valve function.

•Easy hygiene due to an open design

•Optional: Upholstery covering Skai Toronto EN with staynu

Table frame

The plastic-coated table frame can be cleaned with mild household cleaners, if necessary. Do not use

aggressive, abrasive or corrosive agents. After cleaning, dry the frame with a soft dry cloth.

Seal deep scratches and worn areas with suitable repair agents to prevent moisture penetration.

Important:

At tables with hydraulic height adjustment as well as for the gas springs, wipe the piston rod with a soft cloth

at regular intervals. This prevents dust from entering through the dust lip and preserves the service life of the

unit.

Please note:

When cleaning, secure the table against unintentional lowering of the lying surface.

To do so, set all the adjustable sections to the horizontal position.

At tables with electromotive height adjustment, disconnect the power plug from the mains socket

beforehand.

At tables with hydraulic height adjustment, block the foot levers.

The power plug must not come into contact with water or cleaning agents.

The electrical components must not display any external damage through which liquid could enter. Do not

clean the table with water jets, a high-pressure cleaner or with a so-called bed washer. Only use moist cloths.

6. Maintenance and technical inspection

The device has been designed and manufactured in such a way that it will operate safely over a very long

period of time if used as intended and in a correct manner. Depending on the conditions of use, place of use

and care, the expected operating service life is 10 years or 100,000 drive cycles (double stroke = 1x up and

down).

Regular maintenance procedures are required to ensure patient, user and product safety. They must be

carried out every two years at the latest.

The maintenance procedures can be carried out by qualified personnel/instructed personnel. The scope of

maintenance includes, for example:

•Thorough visual inspection of all components, especially motor and switch with mains supply line or

hydraulic system

•Function check

•Check all swivel joints for completeness.

•Check proper fit of the screw connections.

•Lubricate the swivel joints and operating levers slightly with low viscosity spray oil, if necessary.

•Lubricate the roller guides with a little bearing grease or similar using a brush, if necessary.

Insufficient lubrication is noticeable through noise development.

A checklist for maintenance/technical inspection can be found in the appendix.

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In addition to maintenance in accordance with the legal requirements of DGUV Regulation 3 / IEC

62353, a technical inspection must be carried out every two years at the latest on tables with

electromotive adjustment.

This technical inspection may only be carried out by authorised and trained specialists.

A checklist for maintenance/technical inspection can be found in the appendix.

Despite regular maintenance/technical inspection, the user is also responsible for patient safety and proper

and reliable functioning.

As the user, make sure that the table is in good working order prior to each use (visual inspection). In the

event of any abnormalities, take the table out of service immediately and inform the operator.

Replace damaged or worn components immediately and do not use the table until it has been repaired.

The table complies with the safety regulations prescribed at the time it was placed on the market. Improper

repairs and structural modifications (disassembly of original parts, installation of third-party parts, etc.) may

result in hazards for patients and users. In the event of uncoordinated modifications to the table, the

Declaration of Conformity loses its validity and the warranty shall become null and void.

We cannot be held liable for damages resulting from uncoordinated modifications.

Only original Dewert spare parts may be used.

Risk of electrocution!

Work on the electrical system may only be carried out by qualified and authorised personnel in

compliance with all relevant provisions and safety regulations!

Foot and hand switches for adjusting the electric motor as well as gas springs are wearing parts whose

function may be impaired over the years depending on the frequency of use.

Both can be replaced without too much effort. Please request the corresponding installation diagram, if

required.

Replacement parts can be obtained directly from Dewert.

7. Safety devices

Tables with electromotive adjustment must have an automatic device to deactivate the control elements when

moving the table. Reactivation of the control elements must be designed in such a way that they cannot be

triggered accidentally by patients, users or third parties.

The actuator of this table is equipped with an integrated safety device to protect against

unauthorised/unintentional operation. This device goes into “sleep mode” 3 seconds after the last operation

and can only be reactivated with a defined switching sequence, the so-called double tap. To “wake up” the

actuator or the control unit, first press the desired direction of travel for approx. 1 second on the control

element. After a short waiting time (1-2 seconds), press the desired direction of travel again and the actuator

can be moved for a maximum of 30 seconds in this direction of travel. If the switching cycle of the double-tap

function is not observed, the actuator cannot be operated. After 30 seconds of operation in one direction of

travel, the actuator switches off and goes into sleep mode. The actuator can still be operated for up to 3

seconds after the last operation to ensure fine adjustment. Within this time window, it is possible to move in

each direction of travel again for a maximum of 30 seconds. The actuator always goes into “sleep mode”

automatically 3 seconds after the last operation.

The motor is equipped with a safety freewheeling clutch as standard:

When lowering, the motor declutches automatically if an obstacle is encountered, and automatic declutching

is interrupted. In other words, the active tractive force of the motor no longer acts; instead, simply the weight

of the upper part of the table is applied. In the event of unforeseen entrapment, the risk of injury is significantly

limited.

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8. Reporting obligation

All serious incidents occurring in connection with the product shall be reported to the manufacturer (K.H.

Dewert GmbH) and to the competent authority of the Member State in which the user and/or the patient

resides.

Member State

Competent authority

Web

Estonia

Health Board

Terviseamet

https://www.terviseamet.ee/en

Finland

Fimea

https://www.fimea.fi/web/en

Iceland

Iceland Medicines

Agency

https://www.ima.is/

Luxembourg

CNS

https://cns.public.lu/en

Malta

MCCAA

https://mccaa.org.mt/

Switzerland

Swiss medic

https://www.swissmedic.ch/swissmedic/de/home.html

A serious incident is an incident that directly or indirectly had, could have had, or may have had any of the

following consequences:

•death of a patient, user or other person,

•temporary or permanent serious deterioration of the state of health of a patient, user or other person,

•serious threat to public health.

9. Disposal

•Packaging

Safety notice: Pay attention to sharp edges and pointed objects during disposal!

The packaging materials produced are mainly:

oCardboard/Paper

oPlastic

oWood (when delivered on a pallet)

Please observe the local regulations for waste disposal and preferably recycle the materials.

As a manufacturer, we are licensed as a participant in the Dual System in accordance with the German

Packaging Act (VerpackG) and therefore bear the disposal costs, meaning you can dispose of the packaging

free of charge.

•Product

Safety notices:

oPay attention to sharp edges and pointed objects!

oWhen transporting the table, only take hold of the underframe, NOT the upper frame.

oIn order to prevent accidents later on, the no longer used product must be rendered unusable

immediately, e.g. by disconnecting the power cable.

Please observe the local regulations for waste disposal and preferably recycle the materials.

Tables with electromotive height adjustment are subject to WEEE Directive 2012/19/EU. These old devices

must be collected, recycled and disposed of in an environmentally sound manner. Use the return and

collection systems available to you for this purpose.

Dewert User Manual DX1 Series–Updated 05.2021/1 MDR Page 14 of 16

10. Declaration of Conformity

EU Declaration of Conformity for medical devices

Manufacturer: K.H. DEWERT GmbH

Vollmestr. 7

D-33649 Bielefeld

The product: Height adjustable table

Model designation: DX1 series –models:

1000E; 1000/H

1030E; 1030/H

1050E; 1050/H

1090/H; 1093/H; 1095/H

The numerical codes -00, -03, -04 appended to the individual model designation only indicate the colour of the frame

(-00 = white frame, -03= white aluminium frame, -04= grey aluminium frame).

Basic UDI-DI: 4063907KHDewertLiegenP2

SRN: DE-MF-000005967

Intended purpose: