Eleva

Technical manual
Eleva
ACTIVATION: SUMMARY
Version : I 09/02/2023
IMPORTANT: RETAIN FOR FUTURE REFERENCE: READ CAREFULLY
PREFACE
Dear user,
Haelvoet would like to thank you for the confidence you have put in our company by opting for a
Haelvoet product. You have chosen a high-end product resulting from our inexhaustible experience in
the development and production of care furniture. Our continuous pursuit of improvement and
optimisation aims at increasing our customer satisfaction even more. All our products are fully
checked before they leave our company. If you face a problem, however, please do not hesitate to
contact us.
This manual has been written to make you familiar with the installation, the electric and mechanical
aspects, and the maintenance of this Haelvoet product. Therefore, we strongly advise you to go
through this document before using or servicing the product. Please do not hesitate to ask for extra
manuals at Haelvoet NV in case this may seem necessary. We kindly request you to make sure that
all users and maintenance technicians have the necessary information at their disposal and have
access to it at all times.
The purpose of this manual is to offer you a clear and transparent overview of the functional and
technological aspects of the examination table. Consequently, Haelvoet NV cannot be held liable for
any damage or injuries that result from incorrect product usage, incorrect interventions or any possible
unclear descriptions in this document. Since Haelvoet NV continually aims at making technological
progress, Haelvoet reserves the right to modify the product as well as this manual, and all this without
prior notice.
Nothing from this edition may be multiplied and/or made public in any form or manner, either
mechanically or electronically, without prior written consent of Haelvoet NV
Eleva TECHNICAL MANUAL

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TABLE OF CONTENTS
ACTIVATION: SUMMARY ...................................................................................................................... 1
PREFACE................................................................................................................................................ 2
TABLE OF CONTENTS .......................................................................................................................... 3
LIST OF FIGURES .................................................................................................................................. 5
I. SAFETY INSTRUCTIONS ................................................................................................................... 6
1.1 General instructions ........................................................................................................................... 6
1.2 Moving parts ...................................................................................................................................... 8
1.3 Sideguards ........................................................................................................................................ 8
1.4 Preventive maintenance and Safety responsibility ............................................................................ 9
1.5 Mains cable ....................................................................................................................................... 9
1.6 Battery ............................................................................................................................................. 10
1.7 Spareparts and options ................................................................................................................... 10
1.8 Alarm signals ................................................................................................................................... 10
II. GENERAL TECHNICAL DESCRIPTION ......................................................................................... 11
III. ELECTRIC TECHNICAL DATA ....................................................................................................... 14
3.1 Control box ...................................................................................................................................... 14
3.2 Foot pedal ........................................................................................................................................ 14
3.3 Hand switch (option) ........................................................................................................................ 14
3.4 Lock box (option) ............................................................................................................................. 14
3.5 Battery BA21 (option) ...................................................................................................................... 15
3.7 Gas spring backrest......................................................................................................................... 16
3.8 Backrest Actuator (option) ............................................................................................................... 16
3.9 High-low actuator............................................................................................................................. 16
3.10 Gas spring headrest ...................................................................................................................... 16
3.11 Specifications of the CO61 control box ......................................................................................... 17
3.12 Ambient conditions for the actuators ............................................................................................. 18
3.13 Precautions for cable connections ................................................................................................ 18
IV. MECHANICAL TECHNICAL DATA ................................................................................................ 21
V. TECHNICAL DATA CASTORS ........................................................................................................ 21

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VI. STORAGE OF THE EXAMINATION TABLE .................................................................................. 22
VII. PREVENTIVE AND CURATIVE MAINTENANCE ......................................................................... 23
7.1 Safety responsibility ......................................................................................................................... 23
7.2 Spare parts ...................................................................................................................................... 24
7.3 Used fastening methods .................................................................................................................. 24
7.4 Replacement of a high/low actuator ................................................................................................ 25
7.5 Replacement of a mattress platform actuator (option) .................................................................... 25
7.6 How to replace a gas spring ............................................................................................................ 26
7.8 Battery BA21(option) ....................................................................................................................... 28
7.9 Replacement of the mains cable ..................................................................................................... 30
7.10 Replacement of a control box ........................................................................................................ 31
VIII. POSSIBLE PROBLEMS................................................................................................................ 32
IX. ACCESSORIES ............................................................................................................................... 33
X. GUARANTEE ................................................................................................................................... 33
XI. RESIDUAL WASTE AND THE ENVIRONMENT ............................................................................ 34
XII. SYMBOLS ...................................................................................................................................... 36
XIII. CONFORMITY AND IDENTIFICATION ........................................................................................ 37
13.1 UDI-DI (GTIN) ................................................................................................................................ 37
13.2 Explanation CE-label and Identification-label ................................................................................ 37
13.3 Used symbols ................................................................................................................................ 38
APPENDIX 1: EC-DECLARATION ELEVA ......................................................................................... 39
APPENDIX 2: EC-DECLARATION ELEVA FIXED HEIGHT ............................................................... 40
APPENDIX 3: CHECKLIST MAINTENANCE....................................................................................... 41
APPENDIX 4: EMC TABLES................................................................................................................ 43
APPENDIX 5: TRAINING CERTIFICATE ............................................................................................. 47

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LIST OF FIGURES
Figure 2.1: Dimensions Examination table Eleva .................................................................................................. 13

Figure 2.2: Most important manipulation data of the Eleva .................................................................................... 13
Figure 3.1: How to open the cover of the control box ............................................................................................ 17
Figure 3.2: Led indication for the control box CO061 ............................................................................................ 18
Figure 3.3: Circuit diagram of the control box Eleva high/low with long back ........................................................ 19
Figure 3.4: Circuit diagram of the control box Eleva high/low with short back ....................................................... 19
Figure 3.5: Circuit diagram of the control box Eleva fixed height with long back ................................................... 20
Figure 3.6: Circuit diagram of the control box Eleva fixed height with short back .................................................. 20
Figure 7.1: Axle and axle retaining ring ................................................................................................................. 24
Figure 7.2: Cable clamp ........................................................................................................................................ 25
Figure 7.3: Led-indication on a BA19 battery......................................................................................................... 27
Figure 7.4: Led-indication on a BA21 battery......................................................................................................... 28
Figure 7.5: Release of the strain relief ................................................................................................................... 30
Figure 7.6: Replacement of a mains cable in the control box ................................................................................ 30
Figure 7.7: Fixing of the strain relief ...................................................................................................................... 31
Figure 7.8: Replacement of the control box ........................................................................................................... 31

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I. SAFETY INSTRUCTIONS
1.1 General instructions
We strongly advise you again to read the entire manual, so that the instructions for an optimal use as
well as those for a preventive and curative examination table maintenance are carefully followed. The
examination table should be installed, maintained and used in accordance with this manual. Please
inform all readers about the possible risks that can be run when not reading or following this manual.
The manufacturer, installer, importer or distributor of this product can only be held liable and stand surety
for the basic safety, reliability and required qualities of the product if:
▪ decently trained technicians perform assembly tasks (e.g. assembly of accessories),

adjustments, modifications, repairs and/or maintenance work.
▪ the examination table is connected to electric installations that meet the requirements of the
examination table.
▪ the examination table is used and maintained in accordance with the instructions in this
manual and in a way that is considered a normal use of an examination table.
▪ the user, patient and technician have become acquainted with this manual and/or have
received a good training of a qualified person.
By doing so, the risks for both the nursing staff and the patient are reduced considerably, whereas the
product life of the examination table is increased. At all times, the reader of this manual should be aware
of the fact that this is an electric examination table, and that the nursing staff and patient should be
informed of the risks involved. Furthermore, all examination table functions should be checked annually.
Haelvoet NV even recommends that the examination table is checked every six months, so that the
safety of the patient is guaranteed even more.
A patient should always be supervised by a doctor or nurse. If this is not the case, we recommend that
you turn off the electrical functions using the lock function (option). Be especially careful when children
are present in the vicinity of the examination table.
The examination table is intended and made for the examination and treatment of injuries or handicaps.
The maximum safe working load of the examination table is 200 kg. The maximum safe patient weight
is 180 kg.
Please inform every user about the possible risks when the examination table is used incorrectly,
especially when the actuators and the sideguards (option) have to be used.
Before you start using the examination table, please make sure that the examination table functions
properly. That is why you have to check the following elements before you use it:
• Remove all packing material and recycle it environment-friendly.

• Please check if the examination table and all its parts have been delivered in accordance with
the delivery note.
• Please check if the examination table has not been damaged during transport and delivery.
• In case huge temperature differences have to be overcome: let the examination table adapt
itself to the room temperature for 24 hours before using it and connecting it to the net.
• Make sure that the brakes of the examination table have been activated.
• Read the entire manual.

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• Clean the examination table like described in chapter IV of this manual.
• Please check if the power cable and the examination table are compatible with the mains current
of the room.
• Please check if the power cable, actuator cables and foot switch cable have not been damaged.
Make sure that they have been installed in such a way that they cannot be damaged.
• Make sure that no obstacles hinder the free movement of the examination table.
• Place, when required, a mattress cover or towels, etc. ... but make sure it will not hinder the
operation of the control levers and the sideguards (optional).
• Check the examination table functionality by means of the check list. (see appendix)
• Connect the examination table only to a correctly installed socket in the vicinity of the
examination table.
Only use electric appliances that function perfectly in the vicinity of the examination
table. Make sure that these appliances are never connected by means of a multi-
socket under the examination table (risk of electrocution and fire because of the
fluids). You should avoid using extension cords and multi-sockets.
This examination table complies with the regulation medical devices EU 2017/745 and is categorized
as a class I product.. Keep in mind that every technical product, whether it is mechanical or electric, can
be dangerous when it is used incorrectly. You should give priority to the interest and safety of the patient,
visitor and manipulator at all times. Make sure that all users have access to this manual.
It is the responsibility of the distributor to inform the customer about the examination table’s functionality,
maintenance and disinfection. The customer has to contact the distributor in case of uncertainties or
insufficient user information. He also has to address himself to the distributor if he wants additional
training.
Persons (playing children in particular) or obstacles may never be under the examination table. Please
make sure that all other equipment is put in safe conditions, before the examination table is lowered,
raised or removed. Take also care of the patient’s safety during any examination table manipulation. No
table function may be activated if there are obstacles of any kind in the vicinity of the examination table.
Sitting on the examination table is not allowed for persons other than the patient.
Please make sure that the patient is put on the examination table in the correct position. His head should
be placed at the head end, whereas his feet should be at the examination table’s foot end.
Load the examination table and its actuators only to the extent as described in the technical file. Always
contact the technical service when the examination table makes strange noises or movements.
Activate the brakes when the examination table does not have to be moved. Please ascertain yourself
of this by trying to move the examination table afterwards. By doing so, you minimize the risk of having
unwanted accidents when the patient tries to leave the table. Make also sure that the examination table
has been put in its lowest position before you leave the patient alone. Furthermore, the examination
table has to be put on a flat, horizontal surface.
Never remove the examination table when the castors are braked. You should also make sure that
certain table accessories (IV rod…) do not hinder a safe and fluent passage through doors and the like.
Please be careful when moving the examination table and avoid collisions, especially with other persons.
When you use additional or peripheral equipment, you have to make sure that everything has been
installed correctly and that everything functions properly. Please avoid using loose cables or wires and
do not use multi-sockets. Contact your supplier or Haelvoet NV if you have any questions about
peripheral equipment.

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Devices that create strong electromagnetic fields and that may possibly influence the control of the
examination table are not permitted in the direct vicinity of the examination table. Take also into account
that the examination table creates electromagnetic fields and may possibly influence the (measure)
equipment used near the table. However the examination table is approved according to EN 60601-1-
2, residual risks are possible.
The examination table may not be used when there is a risk of explosion, or in the vicinity of inflammable,
volatile anaesthetic gases.
When you think that there is some damage or that the examination table does not function properly, you
have to disconnect the table immediately. You also have to indicate clearly on the examination table
that it is OUT OF USE. Contact the person who is in charge of examination tables as soon as possible.
The examination table may only be used when the following ambient conditions are present:
▪ Temperature between 5°C and 40°C.

▪ Humidity of 20% to 90% at 30°C without condensation.
▪ Atmospheric pressure between 700 and 1060 hPa.
1.2 Moving parts

Make sure that you can’t get stuck between or in the moving sections, even if these sections are not
activated.
All sections should be able to move freely (do not install the examination table near a windowsill or other
obstacles).
Make sure that the mains cables of peripheral equipment (patient lift, compressors, reading lamp,…)
can never get stuck or damaged during a table manipulation.
1.3 Sideguards
If the examination table is moved with the patient still in it (only with a version with Linea castors
Ø125 mm), the sideguards must always be put in their highest position. The same instruction
applies when the patient is sleeping, or for all other circumstances, during which the nursing
staff deems this necessary. Always check if the sideguards are locked properly.
Always put the different mattress platform sections and mattress platform inclination in the
lowest horizontal position. Of course, this can only be done when the medical condition of the
patient is not jeopardized. The aim of this action is to prevent that the patient gets stuck or can
fall out of the examination table. After all, this table position guarantees the best patient
protection.
It should, however, be stressed that the sideguards do not constitute an obstacle to stop people
that wish to leave the examination table wilfully. If the medical staff thinks this will happen, they
should take the necessary precautions.
Never remove the examination table by pulling at the sideguards. Only use undamaged, and technically
perfect sideguards, of which the distances between the siderails comply with the statutory standards.

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Only use original Haelvoet sideguards, since these have been tested in accordance with the official
standards. Regularly check if the sideguards still function properly.
Only use fitting, fire-retardant mattresses that have the correct dimensions and a sufficient hardness.
Never use mattresses that are too thick. In order to protect the patient sufficiently, there always has to
be a distance of 22 cm between the non-compressed mattress and the upper side of the sideguards.
Mattresses that are too thick cause an efficiency loss of the sideguards. If the required distance is not
obtained, you have to opt for another mattress or extra aids, so that this safe height is always
guaranteed.
Always check if the sideguards and the distances between the siderails guarantee enough protection
for the patient. Do not forget to keep the patient’s figure in mind. It may be necessary to use additional
protection equipment – such as a protective cover – for thinner and more fragile patients. Such
accessories can be the only alternative to reduce the patient’s risk from falling through the sideguards
or getting stuck. Always pay attention to the physical and mental state of the patient and always take
the necessary precautions.
If you don’t keep the above-mentioned guidelines in mind, a patient can run the risk of getting
stuck between the siderails. If the distances between the siderails are too big, the patient can
also fall out of the examination table. These distances can be caused by damage, incorrect usage
or faulty sideguards. It is also possible that this has happened because the sideguards have
been locked incorrectly.
1.4 Preventive maintenance and Safety responsibility

All examination table functions should be checked at least annually. For this purpose we refer to chapter
X of this manual.
The examination table may only be repaired by a qualified technician in case of a malfunction or defect.
Disconnect the examination table immediately and clearly indicate on the examination table that it is
“OUT OF USE”. Contact the person who is in charge of the examination table as soon as possible.
Repairs by unqualified persons may cause severe damage or injuries.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user is established.
1.5 Mains cable

When installing or removing the examination table, please ascertain yourself of the fact that the
examination table does not stand on the connecting cable or that the cable is not jammed between the
moving sections. Never ride with the examination table over the connecting cable or pull at it.
Please check the mains cable at regular times. Pay attention to any damage (e.g. compressed, a kink,
open wires, etc.). Make sure that the cable is not jammed, and never ride with the examination table
over the mains cable. Never remove the examination table without first disconnecting the mains cable.
Also ascertain yourself of the fact that the strain relief sufficiently clamps the mains cable.
Pull the plug out of the socket when you want to clean the examination table or perform an intervention
on it.

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1.6 Battery
Never try to bore the battery. Never throw it in a fire. Please return the replaced batteries to the
manufacturer or dealer for recycling.
If an examination table or control box with internal batteries (option) has not been used and/or connected
to the net for a long period, it is recommended to remove the batteries. By doing so, you avoid problems
with leaking batteries.
We refer you to Chapter X of this manual for the annual maintenance of the battery.
The examination table Eleva is equipped with an alarm signal that warns the user for a potential risk
situation. If the capacity of the battery is going below a safe level to guarantee the electric functions of
the bed, a warning signal will sound at the moment when one of these functions is activated. Connect
the bed to the net as soon as this warning signal sounds.
1.7 Spareparts and options

Only use spare parts or options that have been approved by Haelvoet NV.
Haelvoet NV cannot be held liable for any damage or injuries resulting from modifications to the
examination table, and/or the use of non-original spare parts or options without the knowledge and
written consent of the manufacturer.
1.8 Alarm signals

The examination table Eleva is equipped with an alarm signal that warns the user for a potential risk
situation.

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II. GENERAL TECHNICAL DESCRIPTION
The design of this examination table is the answer to the demand of the hospital and health care sector
for an examination table providing optimal qualities in the fields of functionality, aesthetics and
maintenance. The Eleva examination table is a multifunctional, height-adjustable table that maximizes
both the comfort of the patient and the user-friendliness.
All steel elements are protected by an epoxy coating or a chromium-plated layer, whereas the hinge
points have self-lubricating synthetic bearings (= maintenance-free). Rough surfaces, sharp corners and
edges which may cause injuries or damage have been avoided or covered.
A well and preventively maintained table that is used in accordance with the specifications of this manual
can be used for 10 to 25 years (or at least 10,000 cycles per table function) without any problems. An
incorrect or very intensive use of the examination table affects its lifespan very negatively. The same
goes for bad preventive or curative maintenance. While maintaining the examination table curatively or
preventively, the technician always has to check if the examination table still guarantees the basic safety
of the patient or its user. If this is not the case anymore, the examination table has to be put out of use.
Do not modify the examination table without the explicit permission of Haelvoet NV. After a permitted
modification, the examination table always has to be inspected correctly. Furthermore, the examination
table has to be submitted to a thorough test to make sure that the examination table still functions safely.
The examination table consists of 3 major parts:
▪ undercarriage
▪ examination table frame
▪ mattress platform
H in mm X in mm
Hidden castors Ø 50mm braked per 2 500 – 1050 mm 75 mm
Integral S castors Ø 100mm braked per 2 560 – 1110 mm 135 mm
▪ Accessibility of the undercarriage
▪ 1-section examination table

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▪ 2-section examination table with adjustable headrest
▪ 2-section examination table with long back
▪ 2-section examination table with short back
▪ 3-section examination table with long back

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▪ 3-section examination table with short back
Figure 2.1: Dimensions Examination table Eleva
Figure 2.2: Most important manipulation data of the Eleva

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III. ELECTRIC TECHNICAL DATA
3.1 Control box

Type CO 61
Manufacturer LINAK
Country of production Denmark
Degree of protection IPX6
Primary power supply/ Max. current intensity 100-240 VAC / 3,9 A
Frequency 50 Hz
Secondary power supply 24 VDC
Duty cycle Max. 10 % of 2 min/18 min
Mains cable length 3m
Plug type Moulded three-pin Euro plug
The control box generates a direct current of 24V by means of a transformer. This direct current of 24
V drives the actuators and is not dangerous for the patient and its user.
The control box may only be connected to the mains, as mentioned on the control box label.
3.2 Foot pedal

Type FS3
Manufacturer LINAK
Max. current intensity 30 mA
3.3 Hand switch (option)

Type HB 8X
Manufacturer LINAK
3.4 Lock box (option)

Type ACL
Manufacturer LINAK

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3.5 Battery BA21 (option)
Type BA21 Li-Ion battery
Manufacturer Linak
Input/output voltage 24 VDC
Minimum charge duration (empty) About 10 hours
Capacity 1,8 Ah
Max. storage duration (not connected to the 12 months without recharging
control box)
Duty cycle Max 5%, of 1min/19 min
Max. connection duration (to the control box Advisable to connect the battery to the net at all
without recharging) times.

Type BA19 Closed lead-acid battery
Manufacturer Linak
Input/output voltage 24 VDC
Minimum charge duration (empty) About 6 hours
Capacity 1,2 Ah
Max. storage duration (not connected to the 6 months without recharging
control box)
Duty cycle Max 10%, of 2min/18 min
Max. connection duration (to the control box Advisable to connect the battery to the net at all
without recharging) times.
Battery operation:
▪ If the battery voltage is at ‘low level’, a battery alarm beeps constantly when an electrical function
is activated (Low level means that battery charging is necessary to maintain the best possible
lifetime. The low level battery limit corresponds to approx. 19 V (+/- 5%).
▪ If the battery voltage is at ‘critical level’, the battery alarm function immediately shuts down all
operation. (If trying to operate the system anyway, the battery could start leaking or the actuator
system could get damaged).
▪ The CB16 with battery back-up only commences battery charging when it is connected to the
mains.
▪ A battery stored at 25° C has to be recharged every 3 months.
▪ Prior to the first use of the battery, please make sure that the battery has been charged for at
least 12 hours. By doing so, you also prolong the lifetime of the battery.
▪ The longest lifetime is obtained when the battery has always been fully charged.

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3.7 Gas spring backrest
Manufacturer Bloc-o-lift
Country of production Stabilus
Degree of protection Germany
Built-in length (including operation) 381mm
Stroke 200 mm
Extension force 330 N
3.8 Backrest Actuator (option)
Type LA 40
Manufacturer LINAK
Input voltage 24 VDC
Length of stroke 200 mm
Speed 7 - 11 mm/s
Sound level Max. 45 dB(A) DS/EN ISO 3746
Thrust 4000 N
Including Clamp safety
3.9 High-low actuator

Type LA 40
Manufacturer LINAK
Input voltage 24 VDC
Length of stroke 250 mm
Speed 3.6 – 6 mm/sec
Sound level Max. 45 dB(A) DS/EN ISO 3746
Thrust 8.000 N
Including Clamp safety
3.10 Gas spring headrest

Manufacturer Bloc-o-lift
Country of production Stabilus
Degree of protection Germany
Built-in length (including operation) 230 mm
Stroke 100 mm
Extension force 200 N

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3.11 Specifications of the CO61 control box
a. Short circuit check
The CO61 control box is equipped with a safety device that indicates the ‘first error’. This ‘first error’ is
checked by the hardware of the control box.
When functioning properly (no error has been detected), the power LED turns yellow when a control
button is activated.
If the power LED turns yellow without having activated a control button, this means that an error has
occurred. (1st error)
The control box can function without any problem, even when the power LED is yellow before a control
button is activated. However, the ‘1st error’ still is present and has to be removed to prevent that this
causes a dangerous situation.
b. Energy-saving standby mode
A few seconds after a manipulation, the control box is set in an energy-saving standby mode. As soon
as a function has been manipulated, the control box is activated automatically. The energy consumption
of the standby mode is 0.3W.
c. Internal protection of the control box
The control box is internally protected by a safety fuse.
The CO61 is thermally protected. If the permitted duty cycle limit is continually exceeded, or the control
box is exposed to other kind of thermal stress, the CO61 will protect itself by shutting down. Once the
thermal condition is normalized, the CO61 will recover and allow further operation.
At the customer’s request, the examination table can be delivered with the corresponding electric
parameters that are statutory in the respective country (Voltage, mains cable plug).
To open the control box CO61, you have to use an appropriated Tool (ref 15249).
Figure 3.1: How to open the cover of the control box

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Figure 3.2: Led indication for the control box CO061
3.12 Ambient conditions for the actuators

Temperature: 5°C to 40°C
Relative humidity: 20 % to 90 % at 30°C without condensation (for IP X4)
Atmospheric pressure: 700 to 1060 hPa
3.13 Precautions for cable connections

Never install/remove a cable or actuator when the control box is connected to the
net and/or a table function has been activated !
The following procedure has to be followed when replacing a cable or an actuator:
1. disconnect the examination table from the net and wait for 5 seconds.
2. open the cover of the control box. (see fig. 6.1)
3. remove/install the necessary cables and/or actuator.
4. check if all cable fittings have been equipped with a rubber O-ring. Install the cables and fasten
them by means of the appropriate lock mechanism.
5. connect the examination table with the net and test its functionality.
Ignoring this procedure can result in a damaged control box.
Connections that are not used have to be closed with the correct cover to guarantee the mentioned IP
degree.

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Figure 3.3: Circuit diagram of the control box Eleva high/low with long back
Figure 3.4: Circuit diagram of the control box Eleva high/low with short back

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Figure 3.5: Circuit diagram of the control box Eleva fixed height with long back
Figure 3.6: Circuit diagram of the control box Eleva fixed height with short back

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IV. MECHANICAL TECHNICAL DATA
Type examination table Eleva

Weight empty without options 74 kg
Degree of protection IP X4
Safe working load 200 kg
Maximum load on the backrest 80 kg
Max. sound level during a manipulation max 50dB(A)
V. TECHNICAL DATA CASTORS
Type Hidden twin castors Integral S castors Linea twin castors

Ø 50mm Ø 100mm Ø 100mm
Braked per 2 Braked per 2 Individual braked
(only for Eleva fixed
height)
Manufacturer Steinco Tente Tente
Country of production Germany Germany Germany
Castor diameter 50 mm 100 mm 100 mm
Castor width 2 x 19.5mm 62 mm 46 mm
Bearing Precision ball bearings Precision ball bearings Precision ball bearings
Dynamic load capacity 100 kg 100 kg 100 kg
Static load capacity 200 kg 200 kg 200 kg
Load 500 N 1000 N 1000 N 1000 N
Swivelling resistance 34 N 72 N 50 N 200 N
Rolling resistance 11 N 23 N 11 N 14 N
Tread Polyurethane Polyurethane Polyurethane
Operating angle of the 30° 35°
central brake

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VI. STORAGE OF THE EXAMINATION TABLE
Before storing the examination table, you have to make sure that:
▪ the examination table and the mattress platform sections have been put in their lowest
position.
▪ the central brake has been activated.
▪ all electric functions have been switched off.
▪ all accessories have been removed.
▪ the internal battery has to be charged every week, in case the examination table is
stored for more than one week.
▪ the examination table has been covered.
▪ the storage space is dry and dust-proof (relative humidity of 20 to 90% without condensation).
▪ the temperature remains relatively constant and lies between -10 and +50°.
▪ the atmospheric pressure lies between 700 hPa and 1060 hPa
You have to check all functions before you want to use the examination table again
(see checklist in appendix).

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VII. PREVENTIVE AND CURATIVE MAINTENANCE
7.1 Safety responsibility

It is the responsibility of the institute to make sure that the examination table guarantees the patient’s
safety during its entire life span. For this reason, the safety of the examination table has to be checked
regularly. Moreover, the examination table has to be maintained preventively. The examination table
has been developed in such a way that it can be used safely for many years, on the condition that it is
manipulated correctly and checked regularly. It also has to get at least one preventive maintenance a
year.
It is the nurses’ task to perform a routine check at regular times, especially when a new patient has to
be put in the examination table.
The maintenance of the examination table may only be carried out by qualified and
technically trained personnel. The guarantee is nullified, if the maintenance of the
examination table has been carried out unprofessionally and causes damage to the
examination table functions.
All repairs to actuators, control boxes and actuator accessories have to be carried out
by an authorised Linak service shop or by a technician that has been acknowledged by
Linak. All guarantee conditions are nullified, if Linak parts have been opened. An
acknowledged Linak technician can always obtain further information about Linak parts
from Haelvoet or Linak.
Never perform maintenance work or repairs while the patient is still in the examination
table.
In order to optimize the life span of the examination table and to avoid accidents, the
European regulation obliges an annual preventive and registrated maintenance. Use the
checklist in appendix during this annual preventive maintenance. If necessary, consult
this manual as well.
The standard IEC EN 62353 - Medical electrical equipment - Recurrent test and test after repair of
medical electrical equipment - can be used as a guide for a good maintenance procedure.
In addition to the annual registered preventive maintenance, we strongly recommend you to check the
following items regularly:
• All electric functions.
• All mechanical functions (sideguards, castors,…).
• All cables and especially the mains cable.
• The hand switch and the connection cables
• Always check the mains cable when the examination table has been moved and
before connecting it to the net again.
When you think that there is some damage or that the examination table does not function properly, you
have to stop using the examination table immediately. You also have to indicate clearly on the
examination table that it is OUT OF USE. Contact the person who is in charge of the examination tables
as soon as possible. The checklist in appendix 3 can serve as a guideline during controls.

page 23 of 48
7.2 Spare parts
Haelvoet NV can provide all necessary spare parts. All you have to do, is to specify the article number,
the sales order number and the serial number of the respective product. This information can be read
on the identification label. This label is to be found on the side beam of the examination table frame at
the head end.
Article number
UDI-PI
Serial number
In order to keep the right of the guarantee, you are only allowed to use original Haelvoet NV spare parts.
This instruction also applies to further maintain the safety of the examination table. Do not hesitate to
contact Haelvoet NV if you have specific questions or if you want to order spare parts:
Haelvoet nv
Leon Bekaertstraat 8
8870 Ingelmunster
Belgium
Tel: +32 (0) 51 48 66 95
Fax: +32 (0) 51 48 73 19
Email: [email protected]
www.haelvoet.com
7.3 Used fastening methods

▪ axle retaining ring: This ring is used to fasten the control box, the mattress platform actuators and
the metal parts. It can be easily removed by just pulling the clip. The axle can be locked again by
pushing the retaining ring back in the groove.
Figure 7.1: Axle and axle retaining ring

page 24 of 48
▪ cable clamp: All cables are fastened by means of clamps that can be removed and locked without
needing any tools.
Figure 7.2: Cable clamp
7.4 Replacement of a high/low actuator

1. Put the examination table in a position as high as possible.
2. Support the mattress platform at the head and foot end of the examination table so that it cannot fall
suddenly.
3. Disconnect the actuator cable from the actuator. It is advisable to check if the actuator you have to
replace is really damaged. This is possible by plugging a new actuator in the control box without
actually building it in, and checking its functions.
4. First remove the axle at the side of the HL arm. Do not forget to support the actuator so that it cannot
swivel downwards. After this, the second axle near the suspension point can be removed, making
it possible to remove the actuator from the examination table.
The opposite working method has to be followed to install an actuator in the examination table.
7.5 Replacement of a mattress platform actuator (option)

1. Disconnect the examination table from the net.
2. Remove the load (e.g. accesoiries) from the mattress platform that exerts pressure on the actuator.
3. Disconnect the actuator from the control box. It is advisable to check whether the actuator is really
damaged. This is possible by plugging a new actuator in the control box without actually building it
in, and checking its functions.
4. First, you have to get the bar that activates the mechanical quick release (CPR) out of the quick
release, before you remove the backrest actuator. This can be done by removing the cover of this
mechanism.
5. Open all cable clamps and remove the axle retaining ring from both axles.
6. First remove the axle on the side of the moving mattress platform section, but make sure that the
moving mattress platform section and/or the actuator cannot come loose and/or fall. Afterwards, the
second axle can also be removed, making it possible to take the actuator out of the examination
table.
The opposite working method has to be followed to install an actuator into the examination table.
When you want to put back a removed actuator cable in the actuator or the control box,
you always have to make sure that this happens correctly. Always plug in the cable as deep

page 25 of 48
as possible and fasten the protective cap again. This is necessary to guarantee a reliable
sealing and functioning. Always make sure that the cables are fastened in such a way that
they cannot be damaged (no loops, kinks or incisions).
Only persons that have been acknowledged by Linak are allowed to open and repair an
actuator. Always replace the entire electric part without opening it. Only a qualified
technician is allowed to replace an actuator.
7.6 How to replace a gas spring

1. Remove the load (e.g. accessories) from the mattress platform section that exerts pressure on the
gas spring.
2. Before removing the gas spring, you first have to remove the bar that activates the gas spring from
the release lever. To do so, remove the lock ring first.
3. Then remove the lock ring on both sides of the fastening axles.
4. Now remove the axle on the side of the moving mattress platform section. Block the gas spring
and/or the moving mattress platform section. By doing so, you prevent that the gas spring and
mattress platform section fall. Then the second axle can be removed, making it possible to take the
gas spring out of the examination table.
The opposite method has to be followed to install a gas spring in the examination table.

Technical specifications:
Type: closed lead-acid battery with a capacity of 1,2 Ah
Average life span at correct use according the technical manual: minimum 4 years. The way of use can
shorten this life span considerably.
Operating time: depending on the kind of movement (backrest, high-Low adjustment) and load. A height
variation requires the largest amount of current. 6 to 10 complete high/low cycles can be carried out
when there is a load of 130 kg. Obviously, a lot more manipulations are possible for a backrest
adjustment. An alarm signal warns you during an electric manipulation, in case the capacity of the
battery does not suffice anymore to manipulate the bed. Immediately connect the bed to the net as soon
as this alarm signal is audible.
Charge the battery completely before you start using the bed (at least 6 hours). Multiple high discharges
have a harmful effect on the life span of the battery.

page 26 of 48
Figure 7.3: Led-indication on a BA19 battery
Description:
Linak uses closed lead-acid batteries. Given its long-time experience in using this type of battery, Linak
considers the closed lead-acid battery as the safest battery available at the moment. To prevent potential
problems, we strongly recommend you to follow the maintenance advice as described hereunder:
▪ The battery sets have an minimal life span of minimum 4 years. Frequent discharges have a
harmful effect on the life span of the battery. It is recommended to connect the control box as
much as possible to the net, so that a long life span of the battery is guaranteed. It is also
necessary to charge a battery that is not built-in, and not used, at least every 6 months. In this
way, you prevent a self-discharge of the battery.
▪ The sintered plug in the ventilation hole of the battery that is connected to the CB06 control box
has to be replaced or pricked once a year to prevent it from being blocked with dirt, lime or other
substances. This plug can be removed very easily by using a screwdriver. Furthermore, the
ventilation hole can be cleared with a spill Ø 1 mm.
▪ Irrespective of its use, the battery must be replaced every 5 years. If you use the battery for a
longer period, it can damage the controlbox and/or the battery.
▪ Replaced batteries go via Linak or Haelvoet to the recycling cycle, or may be recycled in the
same way as car batteries.
Control of the functioning of the battery + eventual replacement:
Make sure that the battery is completely charged before it is tested. Disconnect the bed from the net
and put a weight of about 75 kg on the mattress platform. The battery should be able to carry out at
least one or two complete high/low cycles without any problems. If this is not the case, it is advised to
replace the battery immediately.
The ventilation opening always has to be released by replacement of the battery.
Always replace a battery that is older than 5 years or of which the capacity is too low.
Faulty or old batteries increase the risk of explosion.
Defective or damaged batteries may leak acid and adequate precautions must be taken
during handling and transportation.
Do not open the battery case as damage to the cell or circuitry may develop excessive
heat.

page 27 of 48
Do not exceed the storage temperature (-5°C to +40°C) as it will shorten the product life
and reduce performance. The batteries must be stored in an applicable storage room
to avoid direct sunlight.
If disposed to fire, the battery may explode.
7.8 Battery BA21(option)

Technical specifications:
Type: Li-Ion battery with a capacity of 1,8 Ah
Li-Ion batteries are moving in the direction of minimising the physical size and at the same time,
increasing the capacity of the battery. This gives a very size effective battery but with a high
concentration of energy within a small physical size. It also increases the risk of thermal runaway
(Thermal runaway is overheating of a cell and it could lead to a small fire and smoke from the cell) due
to internal short circuits. The size of that risk could be as little as 1PPM or even less.
A BA21 Li-Ion battery contains several mechanisms to protect itself from being damaged due to
excessive use:
▪ In case of overheating, the device will activate a thermal protection. No power output will be
available until the temperature is back again within normal operating range. (Extensive use at
high temperatures or when exceeding the 1/19 duty cycle may lead to overheating)
Life span at correct use according the technical manual: at least 6 to 9 years for a Li-Ion battery. The
way of use can shorten this life span considerably.
Operating time: depending on the kind of movement (backrest, height adjustment) and load. 19 to 23
complete high/low cycles can be carried out when there is a load of 130 kg. Obviously, a lot more
manipulations are possible for a backrest adjustment. An alarm signal warns you during an electric
manipulation, in case the capacity of the battery does not suffice anymore to further manipulate the bed.
Immediately connect the bed to the net as soon as this alarm signal is audible.
Charge the battery completely before you start using the bed (at least 10 hours). Multiple high
discharges have a harmful effect on the life span of the battery. A complete discharge of the battery is
therefore not recommended.
Figure 7.4: Led-indication on a BA21 battery

page 28 of 48
Description:
The Ba21 Li-Ion battery has a deep discharge protection to protect the battery life. The deep discharge
protection is activated when the battery is discharged. The battery has to be discharged to exit the deep
discharge mode. To prevent potential problems, we strongly recommend you to follow the advice as
described hereunder:
▪ The battery sets have an average life span of 7 years at correct use. Frequent and/or huge
discharges have a harmful effect on the life span of the battery. It is recommended to connect the
control box to the net as much as possible, so that a long life span of the battery is guaranteed. It is
also necessary to charge a battery that is not built-in, and not used, at least every 3 months. In this
way, you prevent a self-discharge of the battery.
▪ The battery has to be replaced every 9 years, irrespective of the operating conditions. Using the
battery longer can damage the control box and/or battery.
▪ Replaced batteries go via Linak or Haelvoet to the recycling cycle, or may be recycled in the same
way as car batteries.
Annual preventive battery check:

Make sure that the battery is completely charged before it is tested. Disconnect the bed from the net
and put an adult person on the mattress platform. The battery should be able to carry out at least two
complete relax cycles without any problems. If this is not the case, it is advised to replace the battery
immediately.
If the control box is damaged because of a shock (e.g. because it has fallen on the
floor), it is important that the external battery is disconnected from the control box and
is replaced by a new external battery.
Always replace a Li-Ion battery that is older than 9 years or of which the capacity is too
low. Faulty or old batteries increase the risk of explosion.
Transportation: The Li-Ion batteries must be packed and transported according to

applicable regulations. Always ask your local transportation provider how to handle the
transportation of Li-Ion batteries. Defective or damaged Li-Ion batteries or Li-Ion
batteries that may produce excessive heat or fire are not allowed for aircraft
transportation.
Do not open the battery case as damage to the cell or circuitry may develop excessive
heat.
Do not exceed the storage temperature (-5°C to + 40°C) as it will shorten the product
life and performance. The batteries must be stored in an applicable storage room
avoiding direct sunlight. The batteries are best stored close to an exit, and in a zone
where fire spread is small.

page 29 of 48
7.9 Replacement of the mains cable
If the mains cable is damaged, you have to replace it immediately. You have to follow the instructions
described hereunder to replace the mains cable correctly:
1. Disconnect the plug from the net.
2. Release the strain relief. The strain relief is situated at the head end, underneath the backrest. .
Strain relief
Unscrew both screws from the synthetic strain relief and loosen the upper part. The mains cable
can be removed now.
Figure 7.5: Release of the strain relief
3. Disconnect the mains cable from the control box. To do this, you have to push in two red pins, while
pulling the plug out of the control box. A flat screwdriver is the best tool to push in these red pins.
To install the mains cable, you have to push in both pins while you plug in to the control box. Make
sure that both pins are anchored properly in the control box. You can check this pulling the plug.
Figure 7.6: Replacement of a mains cable in the control box
4. Install the strain relief again. Make sure that the strain relief is fixed properly and not damaged. The
strain relief has an extremely important function: it avoids traction on the control box in case the
mains cable is used incorrectly.

page 30 of 48
Figure 7.7: Fixing of the strain relief
7.10 Replacement of a control box

Disconnect the control box from the net. Lift the backrest and remove the cover of the control box holder
(1). Unplug the control box (2) and replace he control box.
Figure 7.8: Replacement of the control box

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VIII. POSSIBLE PROBLEMS
Problem 1: The examination table is acting slower than normal.

Is the examination table connected to the (electricity) net?
▪ No -> The examination table is functioning on its battery, which is slowing down the functions.
▪ Yes -> Please check if the examination table is not too much charged/loaded (too much weight
on the examination table)?
Is overload the cause of reducing the speed of the operations ?
▪ Yes -> Please lower the charge/ the load of the examination table and don’t use the
examination table for a couple of hours.
▪ No -> Please check the voltage of the net.
Problem 2: Not all functions of the examination table are working.

Are some functions on the nurse box not blocked?
▪ Yes-> Please unlock the blocked functions on the nurse box.
Are the lights on the nurse box not flashing ?
▪ Yes-> Please implement the reset procedure. (please ask for reset procedure document)
▪ No-> Please check if all cables are well plugged in, as well as please check the condition of the cable
of the actuator that is not functioning. In the worst case a new cable have to be installed.
Is the problem solved?
▪ No-> Please connect a new actuator onto the control box and check it’s functioning with the hand
control.
Is the problem solved?
▪ Yes-> Install the new actuator on the examination table.
▪ No-> Replace the hand control or the nurse box.
Problem 3: One of the hand control units are not working.
Please check if the hand controls are well plugged in as well as check the condition/ the functioning of
their cables. Move the cable when activating a function of the hand control. If needed replace the hand
control unit.
Problem 4: no functions are working at all.

Is the examination table connected to the net?
▪ No-> The battery is completely empty. Please connect the examination table to the net
Is the green light of the control box lighting up?

▪ Yes-> Please check if the functions are not blocked on the nursing box (ACO box) or check the hand
control.
▪ No Check the condition of the feeding cable (in between net & control box) as well as check the
voltage of the net.

page 32 of 48
IX. ACCESSORIES
Only the following accessories that have been acknowledged by Haelvoet can be used for the
examination table. If you use other accessories, Haelvoet NV cannot be held liable for any possible
accident, malfunction or damage.
Accessories
IDnr Description IDnr Description
11230 Paper roll holder 12133 Lumbar support cushion
12130 Handles 12134 Neck cushion
12132 Removable tray 12618 Kneerest
12196 Din rail (head- and/or footside) 12619 Legrest
15465 Din rail (full length) 12620 Armrest
12149 Din rail connector d13 mm 13008 Medical lamp
12150 Din rail connector d16 mm Armrest fixed under small headrest
12466 IV rod 15671 Neck cushion for small headrest
Removable headrest fixed on backrest (only for mattress platform 3-section with short backrest)
When using the high/low function or the backrest, you have to make sure that the patient
does not get stuck because of accessories. If this cannot be guaranteed, then the nurse
has to prevent that the patient can use the high/low function or backrest.
This can be done by blocking these functions placing the hand switch outside the reach of
the patient (e.g. at the foot end of the examination table), or by blocking these functions (by
means of the lock box)
X. GUARANTEE
The contractual guarantee is nullified, if spare parts are used that are not permitted, or if non-authorized
interventions or actions are performed, such as:
• Opening an actuator, control box, hand switch, battery or any other electric or electronic part.
• Cleaning of an IPx4 examination table in a wash tunnel or cleaning with unauthorized products.
• Incorrect use or incorrect assembly.
• Activations that conflict with the instructions in this manual.
• Activations that exceed the expectations of a standard examination table.
The stipulated guarantee period in the contract is only valid if a “registered” preventive check is
performed annually. Spare parts that are covered by the guarantee will not be invoiced when the
faulty parts are returned.

page 33 of 48
XI. RESIDUAL WASTE AND THE ENVIRONMENT
Please sort the residual waste in accordance with the regulatory environmental requirements. Replaced
electric parts such as actuators, control boxes and hand switches have to be processed as electronic
waste. If you decide not to use the examination table any longer and to destroy it, then the examination
table has to be disassembled and recycled in accordance with the environmental legislation.
This product contains recyclable aluminium, steel, synthetic material and electronic components. In
order to recycle optimally at the end of the examination table’s life span, all parts have to be separated
in such a way that the basic materials of this product can be used again.
Haelvoet NV is fully aware of the fact that the environment has to be protected for the next generations.
That is why we pay extra attention to development, innovation, production and the use of environment-
friendly technologies and materials.
This logo wants to point This symbol – known as the Recyclable synthetic material.
out to the consumer möbius loop – can mean two A number refers to the sort of
that waste belongs in a things: “Recyclable” product plastic that is used to make the
dustbin and not in or “This product contains product. For the moment, only
natural areas or on the recycled material”. plastic types 1, 2 and 3 can be
public highway. If the latter is the case, then recycled.
the word ‘recycled’ has to be
mentioned. Plastic types:
1 = PET
2 = HDPE
3 = PVC
4 = LDPE
5 = PP
6 = PS
7 = other types
This product is made of environment-friendly materials! It does not contain any dangerous substances
such as cadmium, mercury, asbestos, PCBs or CFCs. The sound level of the examination table complies
with the regulatory demands to protect the public health against unwanted noise and vibrations in a
protective interior area.
This product has a lead-acid battery (option). When the life span of the battery has come to an end,
hand in this battery to a person or institute that is authorized for battery collection.

page 34 of 48
Information for the users of electric and electronic equipment.
This symbol on the product or supplied documentation means that the used electric or
electronic components (waste of electric and electronic equipment = OEEZ/WEEE) may
not be given or destroyed with domestic waste. Only specialised firms are authorized to
process this waste. These firms will accept your waste without charge.
By removing and recycling these components properly, you protect valuable natural resources. You also
prevent possible negative effects on public health. Further information can be obtained from the
governmental agencies that are officially acknowledged for the protection of the environment, or from
the nearest assembly point for the collection of separated waste.
If you don’t follow the correct procedures for waste disposal, the national legislation
can seriously fine you!
Information about the disposal of electric and electronic equipment for users in countries
outside the European Union:
The symbol as showed above only applies for countries of the European Union. Please consult your
local authorities or distributor for more information about the correct disposal of OEEZ/WEEE (waste of
electric and electronic equipment) and lead-acid batteries.
Protect your health and the environment.

Protecting the environment is protecting the future. Thank you.

page 35 of 48
XII. SYMBOLS
Backrest adjustment High/Low adjustment
Examination position Underbedlight Equipotential connection
Warning Not following this instruction

Not following this instruction can lead to material damage
can lead to accidents with to the examination table
serious injuries. and/or surroundings. Forbidden
Direction of the head, Consult the manual when It is forbidden to transport

obliged reading of the using the examination table patients with backrest upwards
manual before using the
examination table

page 36 of 48
XIII. CONFORMITY AND IDENTIFICATION
The Eleva examination table is produced in accordance with ISO 9001:2015 and ISO 13485:2016 and
complies with the regulation medical devices EU 2017/745 and all applicable European harmonized
norms:
EN 60601-1 Medical electrical equipment. Part 1: General requirements for basic safety and
essential performance.
EN 60601-1-2 Medical electrical equipment. Part 1-2: General requirements for safety and essential
performance – Secondary norm: Electromagnetic compatibility – Requirements and
tests.
EN ISO 14971 Application of risk management to medical devices.
13.1 UDI-DI (GTIN)
Eleva High/Low Eleva Fixed height
13.2 Explanation CE-label and Identification-label

page 37 of 48
1 Medical Device 12 Input current
2 Class II equipment 13 Input voltage
3 Conformity mark in accordance with the 14 UDI-DI
regulation medical devices EU 2017/745 15 Name article
4 Safe working load 16 Article number
5 Safe patient load 17 Date of manufacture
6 Attention! Electronic waste 18 Software number
7 Type B equipment according to EN 60601-1 19 Address manufacturer
8 To be used indoors 20 Website manufacturer
9 Protection against splashing water coming 21 Manufacturer
from all directions 22 UDI-PI / Series number
10 Brut weight 23 Name Article
11 Move for a maximum of 2 minutes, then 18 24 Article number
minutes pause
13.3 Used symbols
Safe working load Safe patient weight Medical device
IP X4
Protection against splashing

Type B equipment according water coming from all
Serial number to EN 60601-1 directions
Thermal switch off in the

Electrical Class II equipment To be used indoors transformer
Conformity mark in The used electric or electronic

accordance with the components may not be given
Double insulated regulation medical devices or destroyed with domestic
transformer EU 2017/745 waste
.

page 38 of 48
APPENDIX 1: EC-DECLARATION ELEVA
EC- DECLARATION OF CONFORMITY

Following the EC Regulation concerning medical devices MDR EU 2017/745, annex IV.
I, the undersigned, agent of the following manufacturer:

Haelvoet nv Tel.: +32 (0) 51 48 66 95
Leon Bekaertstraat 8 Fax: +32 (0) 51 48 73 19
8770 Ingelmunster Email: [email protected]
Belgium Single Registration NR.: BE-MF-000000056
Declare hereby under sole responsibility that the following product:
Eleva examination table

No.: 12154
Basic UDI-DI.: 5430002080ElevaYQ
Medical device class I (non-invasive device), according MDR annex VIII, rule 1 & 13, intended
and made to treat, guard, alleviate or compensate diseases, injuries or handicaps of an adult,
when installed, maintained and used in accordance with the manual, the rules of good craftsmanship,
and the intended purpose complies with all necessary safety requirements and other relevant provisions
of annex I of:
Medical Devices Regulation EU 2017/745

The following norms have been applied to indicate the conformity:
EN 60601-1 Medical electrical equipment. Part 1: General requirements for basic safety and essential
performance.
tests.
The above-mentioned product has been designed, produced and checked in accordance with the
quality management system of ISO 9001:2015 and ISO 13485:2016.
Ingelmunster, 26/05/2020 Signature:
Haelvoet Vincent
Managing director
Eleva APPENDIX
page 39 of 48
APPENDIX 2: EC-DECLARATION ELEVA FIXED HEIGHT
EC- DECLARATION OF CONFORMITY

Following the EC Regulation concerning medical devices MDR EU 2017/745, annex IV.
I, the undersigned, agent of the following manufacturer:

Haelvoet nv Tel.: +32 (0) 51 48 66 95
Leon Bekaertstraat 8 Fax: +32 (0) 51 48 73 19
8770 Ingelmunster Email: [email protected]
Belgium Single Registration NR.: BE-MF-000000056
Declare hereby under sole responsibility that the following product:
Eleva examination table fixed height

No.: 12456
Basic UDI-DI.: 5430002080ElevaYQ
Medical device class I (non-invasive device), according MDR annex VIII, rule 1 & 13, intended
and made to treat, guard, alleviate or compensate diseases, injuries or handicaps of an adult,
when installed, maintained and used in accordance with the manual, the rules of good craftsmanship,
and the intended purpose complies with all necessary safety requirements and other relevant provisions
of annex I of:
Medical Devices Regulation EU 2017/745

The following norms have been applied to indicate the conformity:
EN 60601-1 Medical electrical equipment. Part 1: General requirements for basic safety and essential
performance.
tests.
The above-mentioned product has been designed, produced and checked in accordance with the
quality management system of ISO 9001:2015 and ISO 13485:2016.
Ingelmunster, 26/05/2020 Signature:
Haelvoet Vincent
Managing director
Eleva APPENDIX
page 40 of 48
APPENDIX 3: CHECKLIST MAINTENANCE
Customer:
Address:
Performed:  check on delivery  periodical check

 other  check after repair or maintenance
Table type:  Eleva high/low  Eleva fixed  Protection class: II
height
Model: ELEVA Id nr.:
Installation:
Manufacturer: Haelvoet nv
Class: Class I Medical Device
I. Visual check Good Not good Malfunction description

Visual check of the electric parts
Stickers and identification plates Present
Housing of the control box Correct position, damage
Housing of the actuators Correct position, damage
Battery Age
Fixation of the actuator shafts All fastening clips are
present
Foot pedal / Hand switch Damage
Actuator, foot pedal supply Damage, because the cable
cables is jammed or cut/incised.
Check the cable route and
fixation
All plug connections with the Plugged in correctly,
control box bayonet lock is present +
installed correctly
Strain relief of the supply cable Supply cable is fastened
properly
Equipotential connections Damage, fastened properly
(optional)
Visual check of the mechanical parts
Stickers and identification plates Present
Carriage Damage, deformation
Castors Damage
Mattress platform sections Damage, deformation
Welded joints Broken joint
Sideguards Damage, deformation,
compliance with the
statutory norm
Wear-sensitive parts, such as Wear, breakage
hinge points
All nuts/bolts
Dinrail Fixing
II. Electric measurement in accordance with EN 62353 Good Not good Malfunction description
Eleva APPENDIX
page 41 of 48
III. Performance check Good Not good Malfunction description
Performance check of the electric parts
Performance of all actuators Test as instructed by the
and control box manual
Sound of all actuators and
control box
Battery Performance
Foot pedal / Hand switch Functioning, sound
Lock box, locking mechanism Test as instructed by the
manual
Limit switch on the actuators Automatic
Control Examination table Reset
Performance check of the mechanical parts
Complete table functionality
Hinges and virtual pivot points Smooth, fluent movement
Lubrication with vaseline
Castors Brakes, unblocking
Sideguards Functioning, blocking
Backrest adjustment Fluent functioning
Seatrest Fluent functioning of the
telescopic adjust
Headrest Fluent functioning
Lock box Functioning of the slide
Length of the cable
Check results
All check results are within  yes  no Next date of inspection:
the permitted limits
Successful check  yes  no
Unsuccessful check  Malfunction, do not use the examination table! repair
 Malfunction, do not use the examination table!  put the examination table OUT OF
USE
 Examination table does not comply with the safety norm
Test sticker is present  yes  no
Other remarks
Comments
Datum of inspection: Inspector: Signature:
Eleva APPENDIX
page 42 of 48
APPENDIX 4: EMC TABLES
Guidance and manufacturer´s declaration – electromagnetic

emission
The Eleva examination table is intended for use in the electromagnetic environment specified below. The customer or
the user of the Eleva examination table should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
Group 1
CISPR 11 The Eleva examination table uses RF energy only for its internal
RF emissions function. Therefore, its RF emissions are very low and are not likely to
Class B
CISPR 11 cause any interference in nearby electronic equipment. The Eleva
Harmonic emissions examination table is suitable for use in all establishments, including
Class A domestic establishments and those directly connected to the public
IEC 61000-3-2 low-voltage power supply network that supplies buildings used for
Voltage fluctuations /
flicker emissions domestic purposes.
Complies
IEC 61000-3-3
Eleva APPENDIX
page 43 of 48
immunity
The Eleva examination table is intended for use in the electromagnetic environment specified below. The customer or the
user of the Eleva examination table should assure that it is used in such an environment.
IEC 60601 Electromagnetic environment -
Immunity test Compliance level
test level guidance
Electrostatic Floors should be wood, concrete or
± 6 kV contact ± 6 kV contact
discharge (ESD) ceramic tile. If floors are covered
with synthetic material, the relative
± 8 kV air ± 8 kV air
IEC 61000-4-2 humidity should be at least 30 %.
± 2 kV for power ± 2 kV for power
Electrostatic
supply lines supply lines Mains power quality should be that
transient / burst
of a typical commercial or hospital
± 1 kV for input/output ± 1 kV for input/output environment.
IEC 61000-4-4
lines lines
± 1 kV differential ± 1 kV differential
Surge Mains power quality should be that
mode mode
of a typical commercial or hospital
IEC 61000-4-5 environment.
± 2 kV common mode ± 2 kV common mode
< 5 % UT < 5 % UT
(>95 % dip in UT ) (>95 % dip in UT )
for 0,5 cycle for 0,5 cycle
Mains power quality should be that
Voltage dips, of a typical commercial or hospital
40 % UT 40 % UT
short environment. If the user of the Eleva
(60 % dip in UT ) (60 % dip in UT )
interruptions and examination table requires
for 5 cycles for 5 cycles
voltage variations continued operation during power
on power supply mains interruptions, it is
70 % UT 70 % UT
input lines recommended that the Eleva
(30 % dip in UT ) (30 % dip in UT )
examination table be powered from
for 25 cycles for 25 cycles
IEC 61000-4-11 an uninterruptible power supply or a
battery.
< 5 % UT < 5 % UT
(>95 % dip in UT ) (>95 % dip in UT )
for 5 sec for 5 sec
Power frequency
Power frequency magnetic fields
(50/60 Hz)
should be at levels characteristic of
magnetic field 3 A/m 3 A/m
a typical location in a typical
commercial or hospital environment.
IEC 61000-4-8
NOTE UT is the a. c. mains voltage prior to application of the test level.
Eleva APPENDIX
page 44 of 48
immunity
The Eleva examination table is intended for use in the electromagnetic environment specified below. The customer or the user
of the Eleva examination table should assure that it is used in such an environment.
Immunity test IEC 60601 test Compliance level Electromagnetic environment - guidance
level
Portable and mobile RF communications equipment
should be used no closer to any part of the Eleva
examination table, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
3V 3V Recommended separation distance

3,5
d =[ ] P
V1
Conducted RF
IEC 61000-4-6
3 V/m
3,5
80 MHz to 2,5 GHz 3 V/m d =[ ] P 80 MHz to 800 MHz
E1
7
d =[ ] P 800 MHz to 2,5 GHz
Radiated RF E1
where p is the maximum output power rating of the
IEC 61000-4-3 transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).b
Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment

marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the Eleva examination table is used exceeds the applicable RF
compliance level above, the Eleva examination table should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the Eleva examination
table.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Eleva APPENDIX
page 45 of 48
Recommended separation distances between
portable and mobile RF communications equipment and the Eleva
examination table
The Eleva examination table is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Eleva examination table can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Eleva
examination table as recommended below, according to the maximum output power of the communications equipment
Separation distance according to frequency of transmitter

m
Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
output of 3,5 3,5 7
transmitter d =[ ] P d =[ ] P d =[ ] P
V1 E1 E1
W
0,01 0,12 0,12 0,23
0,1 0,37 0,37 0,74
1 1,17 1,17 2,33
10 3,69 3,69 7,38
100 11,67 11,67 23,33

For transmitters rated at a maximum output power not listed above the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Eleva APPENDIX
page 46 of 48
APPENDIX 5: TRAINING CERTIFICATE
Eleva APPENDIX
page 47 of 48
Manufacturer:
Haelvoet NV
Leon Bekaertstraat 8
8770 Ingelmunster
Belgium
Tel. +32 51 48 66 95
Fax. +32 51 48 73 19
[email protected]
www.haelvoet.com
Authorised Representative (Regulatory Affairs) Switzerland:

Obelis Swiss GmbH
Ruessenstrasse 12,
6340 Baar/ZG
Switzerland
Tel. +41 41 544 15 26
[email protected]
Authorised Representative (Regulatory Affairs) UK:

UK RepMed Limited
Unit D, Crondall Place. Coxbridge Business Park
Alton Road,
Famham, GU10 5EH
UK
Tel. +44 1252 912933
[email protected]
All Written by:

Haelvoet NV
All rights reserved. Nothing from these operating instructions and this technical manual may be
reproduced without the prior written consent of Haelvoet NV.
Eleva
page 48 of 48

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Technical manual

Eleva TECHNICAL MANUAL

ACTIVATION: SUMMARY ...................................................................................................................... 1

TABLE OF CONTENTS .......................................................................................................................... 3

LIST OF FIGURES .................................................................................................................................. 5

I. SAFETY INSTRUCTIONS ................................................................................................................... 6

1.1 General instructions ........................................................................................................................... 6

1.2 Moving parts ...................................................................................................................................... 8

1.3 Sideguards ........................................................................................................................................ 8

1.4 Preventive maintenance and Safety responsibility ............................................................................ 9

1.5 Mains cable ....................................................................................................................................... 9

1.6 Battery ............................................................................................................................................. 10

1.7 Spareparts and options ................................................................................................................... 10

1.8 Alarm signals ................................................................................................................................... 10

II. GENERAL TECHNICAL DESCRIPTION ......................................................................................... 11

III. ELECTRIC TECHNICAL DATA ....................................................................................................... 14

3.1 Control box ...................................................................................................................................... 14

3.2 Foot pedal ........................................................................................................................................ 14

3.3 Hand switch (option) ........................................................................................................................ 14

3.4 Lock box (option) ............................................................................................................................. 14

3.5 Battery BA21 (option) ...................................................................................................................... 15

3.6 Battery BA19 (option) ...................................................................................................................... 15

3.7 Gas spring backrest......................................................................................................................... 16

3.8 Backrest Actuator (option) ............................................................................................................... 16

3.9 High-low actuator............................................................................................................................. 16

3.10 Gas spring headrest ...................................................................................................................... 16

3.11 Specifications of the CO61 control box ......................................................................................... 17

3.12 Ambient conditions for the actuators ............................................................................................. 18

3.13 Precautions for cable connections ................................................................................................ 18

IV. MECHANICAL TECHNICAL DATA ................................................................................................ 21

V. TECHNICAL DATA CASTORS ........................................................................................................ 21

Eleva TECHNICAL MANUAL

VII. PREVENTIVE AND CURATIVE MAINTENANCE ......................................................................... 23

7.1 Safety responsibility ......................................................................................................................... 23

7.2 Spare parts ...................................................................................................................................... 24

7.3 Used fastening methods .................................................................................................................. 24

7.4 Replacement of a high/low actuator ................................................................................................ 25

7.5 Replacement of a mattress platform actuator (option) .................................................................... 25

7.6 How to replace a gas spring ............................................................................................................ 26

7.7 Battery BA19 (option) ...................................................................................................................... 26

7.8 Battery BA21(option) ....................................................................................................................... 28

7.9 Replacement of the mains cable ..................................................................................................... 30

7.10 Replacement of a control box ........................................................................................................ 31

VIII. POSSIBLE PROBLEMS................................................................................................................ 32

IX. ACCESSORIES ............................................................................................................................... 33

XI. RESIDUAL WASTE AND THE ENVIRONMENT ............................................................................ 34

XII. SYMBOLS ...................................................................................................................................... 36

XIII. CONFORMITY AND IDENTIFICATION ........................................................................................ 37

13.1 UDI-DI (GTIN) ................................................................................................................................ 37

13.2 Explanation CE-label and Identification-label ................................................................................ 37

13.3 Used symbols ................................................................................................................................ 38

APPENDIX 1: EC-DECLARATION ELEVA ......................................................................................... 39

APPENDIX 2: EC-DECLARATION ELEVA FIXED HEIGHT ............................................................... 40

APPENDIX 3: CHECKLIST MAINTENANCE....................................................................................... 41

APPENDIX 4: EMC TABLES................................................................................................................ 43

APPENDIX 5: TRAINING CERTIFICATE ............................................................................................. 47

Eleva TECHNICAL MANUAL

Figure 2.1: Dimensions Examination table Eleva .................................................................................................. 13

Eleva TECHNICAL MANUAL

1.1 General instructions