The warranty covers faults or defects in the material of our products within a period of
3 years from date of invoice. Products subject to minor technical modifications and design
deviations E. & O.E.
de
Die Garantie gilt für drei Jahre ab Rechnungsdatum für Material- und Herstellungsfehler. Druckfehler, technische Änderungen und Modellabweichungen vorbehalten.
fr
La garantie couvre les vices de fabrication et de matériaux pour une durée de 3 ans à partirde la date de facturation. Sous réserve de modifications techniques et d’erreurs d’impression.
nl
De garantie is tot 3 jaar na factuurdatum geldig voor materiaal- en fabricagefouten. Onder voorbehoud van drukfouten, technische wijzigingen en modelafwijkingen.
sv
Garantin gäller i 3 år från fakturadatum för material- och fabrikationsfel. Med reservation för tryckfel, tekniska ändringar och modellavvikelser.
no
Garantien gjelder i 3 år fra fakturadato for material- og fabrikasjonsfeil. Med forbehold for trykkfeil, tekniske endringer og modellforskjeller.
es
La garantía cubre fallos de material o fabricación durante los 3 años posteriores a partir de la fecha de factura. Mantenemos reservas en caso de problemas de presión, modificacio-nes técnicas y variaciones de modelo.
it
La garanzia copre i difetti di materiale o di fabbricazione per un periodo di 3 anni. I prodotti sono soggetti a piccole modifiche tecniche e a variazioni nel design.
Takuu kattaa tuotteidemme materiaaliviat tai -puutteet 3 vuoden sisällä laskun päiväyk-sestä. Tuotteisiin voi kohdistua pieniä teknisiä muutoksia ja suunnittelupoikkeamia (vikoja ja puutteita lukuun ottamatta).
Trzyletnia gwarancja obejmuje usterki oraz wady produkcyjne i materiałowe. Produkty mogą ulec
pl
nieznacznym zmianom technicznym i projektowym. Zastrzegamy sobie prawo do błędów i pominięć.
Disposal and recycling ................................................27
Original instructions
8
Page 9
Symbols used in this manual
The following symbols are used in this manual as well as the associated
documentation supplied with the product.
!
WARNING
WARNING indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
!
CAUTION
CAUTION indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury. It may also be used to alert against
unsafe practices.
IMPORTANT
IMPORTANT indicates important information about handling and use of
the product.
NOTICE
NOTICE is used to address practices not related to personal safety.
Head injury warningHand injury warning
Genitialia injury warningFeet injury warning
en
9
Page 10
en
+
+
Do not leave the user unattended.
Compatible productsSpare parts
REF
Max. user weightArticle number/ versions
Product weightElectrical data
10
Page 11
General safety
!
WARNING
• Read and understand the manual completely before use. Keep the
manual close to the unit.
• Comply with this manual to avoid accidents involving serious personal
injury.
• Never use or handle this product in other ways than specified in this
manual, as this can put your safety at risk and cause damage to the
product.
• Make sure that everyone who is to install or use the product and its
systems has the necessary information and access to this manual.
!
CAUTION
• Please comply with these instructions to avoid the product becoming
damaged or destroyed.
• Do not perform repairs, disassembly, or assembly operations,
extensions, re-adjustments or modifications to this product. These
must be carried out by Pressalit or by persons authorized by Pressalit
only.
en
• Never allow children to operate this product unless under supervision.
The product is not intended for play.
• Never use the product if it is defective or damaged. Do not use a
defective product before it has been repaired.
NOTICE
• The information in this manual is based on correct fitting of the
product in accordance with our mounting instruction.
• Pressalit cannot be held liable if the product is used in any way which
differs from that described in the guide.
• We reserve the right to amend this manual without prior notice.
11
Page 12
Safety distances
Make sure that the unit is at safe distance from surrounding objects. Check
the distances before any use.
en
ISO 17966:2016
Max 120/60 mm
Max 4.72/2.36”
Max 8/4 mm
Max 0.31/0.16”
Max 8 mm
Max 0.31”
Max 35/25 mm
Max 1.38/0.98”
!
WARNING
/
Min 25 mm
Min 0.98"
Min 75 mm
Min 2.95"
Min 120 mm
Min 4.72"
Min 300 mm
Min 11.81"
If the unit moves within the safety distances, you must keep a close eye on
especially surrounding people and objects to avoid crushing hazards.
12
Page 13
Intended use
This product is intended for changing a person who is unable to stand or sit.
The person is lying horizontally on the change trolley.
Intended operator profile
Only personnel who are trained in healthcare and/or in changing someone
under their care should use this product.
Intended user profile
The product can be used by all – adults, children, young, old, whose weight
does not exceed the maximum load of 200 kg / 440 lbs.
Operating environment
The change trolley is intended to be used at room temperature in public
changing places, schools, private homes, day/residential/nursing facilities
and hospitals under normal working conditions.
The change trolley may be used in dry rooms and not as a shower table in
showers. If the relative humidity is above 70%, the expected life of the unit will
be significantly reduced. The change trolley must not be exposed to chlorinecontaining fumes.
en
!
CAUTION
The product surface may become hot or cold if exposed to external sources
of heat or cold, such as sunlight or frost.
NOTICE
Any serious incident that has occurred in relation to the product should be
reported to the manufacturer and the health authorities.
A serious incident is defined as an incident that leads to the death of a
patient, user, or any other person, or causes a temporary or permanent
deterioration in the person’s health. Any incident that has resulted in or has
the potential to result in a serious incident must be reported.
13
Page 14
Contraindications for use
If the product is being used for users with damaged skin, wounds, or other
similar conditions, it is recommended to use a towel as a barrier to prevent
open wounds from coming into direct contact with the substrate.
Biocompatibility
The biocompatibility of the materials that come in contact with the user’s
skin during the intended use has been evaluated according to the procedures
outlined in DS/EN ISO 10993-1:2020, which involves assessing the materials
for harmful substances. Based on this evaluation, the materials are considered
suitable for their intended use.
Flammability
The product materials have undergone flammability testing in accordance
with ISO 8191-1:1987 and ISO 8191-2:1988.
en
14
Page 15
Operating instructions
Safety brakes
The change trolley has brakes on all four wheels to prevent it from moving
accidentally.
en
To lock the brakes: Step on the
lock pedal on all four wheels to
engage the brakes.
Always use your foot to lock or unlock the
wheels. Wear closed-toe shoes and never use
your hand to lock or unlock the wheels.
!
WARNING
Always ensure that the locks on
all four wheels are securely locked
before transferring a user to or
from the trolley.
To unlock the brakes: Step on the
release button on all four wheels to
release the brakes.
Do not leave the
user unattended.
15
Page 16
Safety rails
The safety rails can be folded up and down individually for easy transfer of the
user.
en
To fold down: Lift the safety rail
upwards to unlock it, and swing it
down.
When locking the safety rails , be careful not
to pinch the user's hand or genitals.
!
WARNING
Always keep all safety rails upright and locked in place when using the
trolley to prevent the user from falling out.
16
To fold up: Swing the safety rail up
and push it down to lock it in place.
Page 17
Height adjustment
+
+
200 kg / 440 lbs
The change trolley can be adjusted 500 mm / 19.69" up and down. The
maximum height is 950 mm / 37.4". The height adjustment is controlled by
the wired remote control unit.
Press and hold the up button to raise the unit.
When the button is released, the motion stops.
Press and hold the down button to lower the unit.
When the button is released, the motion stops.
Do not put your foot on the bearing frame
and be especially cautious of the risk for
pinching of feet, hands, children, or objects
when adjusting the height of the unit.
Never let children be close to the unit when it is height adjusted.
Be aware that the cord of the hand control
does not wrap around the user's neck and
pose a suffocation risk. The corded hand
control must be placed on the safety rail
when it is not in use.
!
WARNING
en
17
Page 18
Moving
To move the trolley, unlock all four wheels as described. Grab hold onto the
lying surface itself, not the safety rails when moving the unit. Be careful when
you move the unit.
!
WARNING
Make sure that the power cord is not wrapped around the user’s feet or
en
positioned in a way that could lead to suffocation. When the unit is in use,
the power cord should be placed on the floor, and when it is not in use, it
should be placed at the side of the unit.
!
CAUTION
Be aware of the power cord and make sure not to trip over it while it is on
the floor.
Please note that although the product can be moved, it is connected to an
outlet with a power cord. So be cautious when moving the product so as
not to damage the electrical installation or the product.
Before plugging it in, always inspect both the cord and the plug for any
signs of damage. If any damage is detected, replace the cord to avoid the
risk of electrical shock.
18
Page 19
Accessories
Mattress
You can add a mattress to the
change trolley for increased comfort.
The mattress is reversible and can be
used on both sides.
1
To mount the mattress, unscrew the
locking screw ① by about 1 cm (0.5").
en
Pull the mattress flap down over
the screw. Do the same with all four
flaps.
The product is to be cleaned with hot
water or a mild soapy cleaning agent.
A list of suitable cleaning agents/
disinfectants tested by Pressalit canbe found on pressalit.com.
A mounting instruction
is included with the
mattress.
be downloaded from pressalit.com.
EN
Mounting instructionNLMontage-voorschrift
DK
MonteringsvejledningSVMonteringsanvisning
DE
MontageanleitungNOMonteringsveiledning
FR
Notice de montageESInstrucciones de montaje
PL
Instrukcja montażuFIAsennusohje
Subject to alteration without further notice. Ret til ændringer forbeholdes.· Recht auf Änderungen sind
vorbehalten. ·Nous nous réservons le droit d’apporter toutes modifications sans préavis. · Wijzigingen
voorbehouden. ·Rätten till ändringar förbehålles.· Vi forbeholder oss rett til endringer. · Salvo variaciones.
Podlega zmianom bez wcześniejszego powiadomienia. · Pidätämme oikeuden muutoksiin.
Pressalit
Pressalitvej 1
DK 8680 Ry
Danmark
Page 1/4
20XX-01-01
+45 87 88 87 88
Telephone:
+45 87 88 87 89
Telefax:
pressalit@pressalit.com
E-mail:
pressalit.com
Web:
19
Page 20
IMPORTANT
To maintain hygiene, it is recommended to check for any visible damages
or signs of wear and tear on the mattress regularly. If any damages are
found, the mattress should be replaced immediately to prevent any risk of
contamination or infection.
Cleaning
To clean the product, use a damp cloth that has been wrung out in a mild
soap mixture, such as universal cleaning solution.
After cleaning, it is essential to wipe the product with a dry, soft cloth. This
step is crucial to prevent the materials from discoloration. Additionally, it
helps prevent any potential degradation of the surface paint.
!
CAUTION
Always read the supplied instructions of the cleaning agent and comply
with these instructions for safe use, dilution, rinsing, drying, handling and
en
storage of the agent.
IMPORTANT
• Do not rinse or spray water directly on the product.
• Do not use an autoclave or other type of steam cleaner.
• Avoid aggressive cleaning agents containing acid or base.
• Avoid using abrasive, caustic or chlorine-based cleaning agents
!
CAUTION
Do not perform any type of cleaning or disinfection of the change trolley
while the user is lying on it.
20
Page 21
Maintenance
It is recommended that a maintenance inspection be carried out once a year.
Maintenance inspection
Lubricate the sliding rails at
least every six months. Use a
food grade grease.
en
Check whether all nuts, screws and
hinges have become loose. Tighten if
necessary.
Check the wheels for corrosion.
Replace them if necessary.
21
Page 22
Electromagnetic compatibility
!
WARNING
• Use of accessories, transducers and cables other than those specified or
provided by the manufacturer could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment
and result in improper function.
• Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the unit, including its cables, to avoid
any degradation of the performance of this unit.
• Use of this equipment adjacent to or stacked with other equipment
should be voided because it could result in improper operation. If such
use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
Electromagnetic immunity / emission
Electrostatic discharge
en
Test standardImmunity test level
EN 61000-4-2+/- 8 kV contact, +/- 2, 4, 8, 15 kV air
Radiated RF electromagnetic field
Test standardImmunity test level
EN 61000-4-315 V/m 80 MHz to 1 GHz, 15 V/m 1,01 GHz to 6 GHz
80 % AM 1 kHz
Electrical fast transient/burst
Test standardImmunity test level
EN 61000-4-4+/- 1 kV , +/- 2 kV, 100 kHz repetition frequency
Surge immunity
Test standardImmunity test level
EN 61000-4-5Line-to-line: +/- 0.5 kV, +/-1 kV
Line-to-ground: +/- 0.5 kV, +/-1 kV, +/- 2 kV
Immunity to conducted disturbances induced by RF fields
Test standardImmunity test level
EN 61000-4-63 V (6 V in ISM bands and amateur radio bands)
0,15 to 80 MHz , 80 % AM at 1 kHz
22
Page 23
Immunity to proximity fields from RF wireless communication
equipment
Test standardImmunity test level
EN 61000-4-3385 MHz, 27 V/m, 18 Hz PM (50 % duty cycle square wave)
Test standardImmunity test level
EN 61000-4-110 % U_T; 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°, 0 % U_T; 1 cycle at 0°, 70 % U_T; 25 cycles at 0°
Single phase at 0°
Voltage interruptions
Test standardImmunity test level
EN 61000-4-110 % U_T; 300 cycle
Conducted / Radiated RF emission
Test standardEmission test class and group
EN 55011Class B, group 1
Harmonic current emissions
Test standardEmission test class and group
IEC 61000-3-2Class A
Voltage changes, voltage fluctuations and flicker
Test standardEmission test class and group
EN 61000-3-3Tested according to the standard.
en
23
Page 24
(01)0XXXXXXXXXXXXX(10)YYMMDD
2 min
REF
+
+
Product label
en
RZZZZYYYXXX-X
YYYY-MM-DD
xxx kg
xxx lbs
xxx kg
xxx lbs
Pressalit A/S, Pressalitvej 1, DK-8680 Ry
Consult manual for use
Medical device
Maximum user weight
XX-XX HzIPXX
U:XXXV
+
+
18 min
xxx kg
xxx lbs
YY-MM-DD
P:X WI:XXA
XXXXX
Production date
Article number
Max load
Mains voltage
Frequency
24
Maximum power consumption
Page 25
IP class
Electric Current
GS1-128 barcode
Product weight
Batch code
UK Conformity Assessed
These products are CE-marked in accordance with relevant
requirements in:
• Regulation (EU) 2017/745 (5 April 2017) on medical devices.
• Council Directive 2006/42/EC (of 17 May 2006) on machinery.
• Council Directive 2011/65/EC (of 8 June 2011) on RoHS.
A declaration of conformity can be found at pressalit.com
This product does not contain any of the hazardous substances
mentioned in the Council Directive 2011/65/EC on RoHS.
Product name (if any)
Do not dispose as unsorted municipal waste. The product should
be collected separately and returned to the designated recycling
service.
Type BF applied part Part of the product in normal use necessarily
comes into physical contact with the patient to perform its function
The product complies with requirements of IEC 60601-1 to provide
protection against electric shock
Duty cycle
Consult the manual for important cautionary information such as
warnings and precautions
Consult manual for use
Name and address of manufacturer
Class II Product, double insulated
en
25
Page 26
Storage and transportation
• The temperature for transportation and storage of the unit must be
between -10 and 50 degrees Celsius (14 and 122 degrees Fahrenheit). Keep
humidity below 70%.
• The unit must always be transported in its original packaging.
• Avoid subjecting the packaging to shocks and impacts.
• Do not use the product if the packaging is broken or damaged.
Troubleshooting
SymptomCauseAction
No power.The power plug
has been pulled
out.
Plug the power plug back into
the socket.
The trolley has
difficulty moving
up and/or down,
and the lifting
mechanism emits
a clicking sound.
en
The lifting unit
lacks lubrication.
The lifting unit
may be stuck.
Lubricate the lifting unit.
See Maintenance.
See Resetting.
Contact Pressalit A/S or your local dealer if the problem cannot be remedied.
Do not attempt to repair the product yourself, as this will invalidate the
warranty. Expected service life of the change trolley is 10 years.
Resetting
①
②
③
Click
Click
④
3 sec
If the unit is stuck and will not go down, press the up button for 3 seconds
and then the down button.
26
Page 27
Contact Pressalit for a list of available spare parts.
Power cordRemote control
EU/worldLB0696
UK/IRLV6336
AUS/NZT4285
US/CANLB0688
T4361
Disposal and recycling
The unit contains reusable materials. There are no known hazards or risks
associated with disposal of the product. All components can be discarded
after having been cleaned and disinfected. When disposing of the product,
we recommend that it be disassembled and broken down into different waste
groups for recycling or combustion. The following table provides information
on the recycling and handling of the product.
Recyclable
components
SteelSteel can be recycled by being melted down and included
as a secondary material in the production of new steel.
PlasticsUse plastic sorting and recycling systems where they
are locally available. If such systems are not available,
incineration of plastic waste can be an alternative,
as it can generate energy that can be used for power
production.
ElectronicsThe electronic components should be collected
separately and returned to the designated recycling
service.
Material
en
27
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