Levabo TURN ALL User manual

Turn All userguide 3C EN 2021.05.21 Rev.4
Automated lateral turning system 3C
EN
medical cushions
®
Patent pending

2Turn All userguide 3C EN 2021.05.21 Rev.4
1 piece. Turn All®Pump System
1 piece. power cord to the pump
system
1 piece. Turn All®lift mattress
1 piece. Turn All®Cover
The lift mattress is supplied
pre-assembled inside the cover
1 piece. user manual.
About using and installing
the system
This operator’s manual provides some
important information about working
with the Turn All®system.
Please read the instructions before
attempting to use this device.
These operating instructions are part of
the product and must be kept close to
the system so that it can be consulted
at any time by personnel and operators.
If the system is transferred to a third
party, the instructions must
accompany it.
The illustrations in these instructions
are intended to provide a clear
demonstration of the current situation
and are therefore not necessarily to the
correct scale, they may vary slightly
from the actual design of the device.
All information and advice in this manual
has been prepared in accordance with
the applicable standards.
Contents of the Turn All®
system

3Turn All userguide 3C EN 2021.05.21 Rev.4
Table of contents
Contents of the Turn All®system.......................................................................................2
About using and installing the system ...............................................................................2
About positioning patients and the Turn All®system .........................................................4
Turn All®system function ..................................................................................................5
Installation of the Turn All®system ....................................................................................6
Getting the Turn All®system on a bed...............................................................................6
Important information! Regarding the hose connection .....................................................7
Starting and adjusting the Turn All®system.......................................................................8
Using the Turn All®system for static lifting.........................................................................9
Indications and contraindications....................................................................................10
Allowed uses / locations .................................................................................................11
Safety.............................................................................................................................12
Warranty and liability provisions ......................................................................................13
Cleaning and disinfection................................................................................................14
Notication of accidental events......................................................................................16
Technical data ................................................................................................................16
Approvals, standards and regulations .............................................................................17
Turn All®product range...................................................................................................18
Explanation of symbols on the packaging .......................................................................18
Declaration of Conformity (CE)........................................................................................19

4Turn All userguide 3C EN 2021.05.21 Rev.4
Benets of the Turn All®system
• Comprehensive pressure relief
• Prevention of pressure injuries / ulcers
• Treatment of existing injuries / ulcers
• Comfortable and doesn’t interrupt
normal sleep
• Quiet when used
• Bariatric/heavy patients can be
carefully and easily turned thereby
protecting the health and wellbeing of
staff working with them
• Full overview as the patient is always
lying on their back on the mattress
• Gentle positioning even for patients
in pain
• Slight lifting of the mattress, on the
reverse side of the primary lift side,
provides support and reassurance as
well as decreases the risk of shear,
see figure. page 5
• Time saving results in more care time
available for the patient
• Improved microclimate and blood
circulation
• Robust, durable and reliable
• Can be integrated into any bed
with removable mattres.
About positioning patients
and the Turn All®system
Pressure ulcers are areas of the skin
where the skin or underlying tissue is
damaged.
In the case of immobility and risk of
skin damage, pressure ulcers can
occur within 10 - 15 minutes, which is
why a quick and preventative effort is
important. Most pressure ulcers can be
prevented!
Pressure ulcers can occur anywhere on
the body, but particularly vulnerable are
those places on the body where bone
protrusions increase pressure against
the substrate. It is therefore important to
focus on relieving these vulnerable areas
in the prevention of pressure ulcers.
Older people and bedbound patients
are at particular risk of developing
pressure ulcers.
Paralysis, poor nutritional status
and diseases such as Diabetes and
Atherosclerosis also increase the risk of
pressure ulcers. At high risk are those
who are unable to change or ask for a
change of position for themselves.
It is therefore important in the prevention
of pressure ulcers that relatives or staff
frequently turn and relieve patients in the
supine and sitting position. At the same
time, it is important to avoid friction
against the substrate which may result
in shear (loosened skin). The need for
relief and reversal is individual, but the
most frequent interval for reversal is
1½ - 2 hours.
The Turn All®system that can
automatically turn the patient is a big
help.
The system frees up caregiver
resources thereby helping both staff
and patients.

Turn All userguide 3C EN 2021.05.21 Rev.4
Static side position, like a cushion.
30, 60 or 90 minutes
lateral side position
15 minutes supine position
15 minutes supine
position. Then the
sequence is repeated .
The illustration below shows the
sequence of the automatic positioning
in the Turn All®system.
30, 60 or 90 minutes
lateral side position
5
Turn All®system function
Dynamic mode - Automatic
The Turn All®system is an automatic side
positioning system, for the patient in need of
pressure ulcer prevention or treatment.
Positioning is carried out easily and quietly.
The system takes approx. 7-14 minutes for
a change of position. Due to this very slow
and even change of position, the system is
perceived as very comfortable by the
patient.
The system is based on an air chamber
system that lifts the patient lying on it
alternately on the right and left sides.
The system thereby places the patient in a
30° side position, alternately right and
left side.
Static mode - Manual adjustment
In Static mode, the system is used as an
inclined cushion (without automation), where
the slope is manually controlled 0-30°.
The slope is determined by how much air is
pumped into the system.

6Turn All userguide 3C EN 2021.05.21 Rev.4
Getting the Turn All®system
on a bed
Remove the mattress from the bed
(Figure 1).
Place the Turn All®system (A) on the
bed base, orienting the system so that
the hose connection (B) is at the foot
end of the bed (Figure 1.2).
Attach the Turn All®system to the bed
base using the straps (H) on the cover
(Figure 1.2).
Put the mattress back onto the bed on
top of the Turn All®system (Figure 1.3).
The Turn All®pump (C) is placed on
the bed end using the two braces on
the back of the pump (Figure 1) (Figure
1.3).
Insert the hose connection (B) into the
pump (C) (Figure 2) and (Figure 3)
page 7.
Installation of the Turn All®
system
Figure 1
A
BH
C
Turn All®
Turn All®
Bed
Bed
Bed
Mattress
Mattress
Figure 1.3
Figure 1.2

7Turn All userguide 3C EN 2021.05.21 Rev.4
Lift right side Lift left sideFigure 2 Figure 3
B B
Important information! Regarding
the hose connection
The orientation of the hose connection
(B) determines which side of the
mattress is lifted rst.
This is important if the system is to be
used for static lifting of the patient on
one side, such as a sloped cushion.
See section “Using the Turn All®System
for Static Lifting” on page 9.
The hose connection (B) is marked with
the letters “R” on the right
and ”L” for the left.
B
B
If the lift must start on the right side of
the bed, seen from the foot end, the
hose connection with the letter “R” is
turned towards the text “Start side” on
the pump, as shown in (Figure 2).
If the lift must start on the left side of
the bed, seen from the foot end, the
hose connection with the letter “L” is
turned towards the text “Start side” on
the pump, as shown in (Figure 3).
C C

8Turn All userguide 3C EN 2021.05.21 Rev.4
Connect the power cord to the
pump (Figure 7)
Connect the power cord to the mains.
Turn on the pump on the “POWER”
button (D) (Figure 4).
Set the timer “G” with the “+” and “-”
buttons.
The number in the timer “G” indicates
how many hours the system should run
automatically.
The Turn All®system now runs
automatically. One side of the mattress
is now lifted for 30/60/90 minutes, then
lying at for 15 minutes, then the other
side is lifted for 30/60/90 minutes, then
lying at for 15 minutes.
This sequence is repeated for the
number of hours set in the timer
”G”, then returned to lying at. See
illustration on page 5.
IMPORTANT. When not in use after
automatic operation, the system is
turned off by the POWER button (D),
and then by the mains socket.
Disconnect hose connection (B) from
the pump (C).
DO NOT install the cover (E) on hose
connection (B).
Starting and adjusting the
Turn All®system
Figure 4
D
GTimer window, shows
the number of hours
the system runs
automatically.
LED lights when
the system is on.
Select turning cycle
30, 60 or 90 minutes.
See page 5.
The “+” and “-”buttons
are used to set how
many hours the system
should run automatically.
POWER
Turns the system
on / off.
+ -

9Turn All userguide 3C EN 2021.05.21 Rev.4
Using the Turn All®system
for static lifting
If the Turn All®system is to be used for
a static lift as an inclined cushion, the
hose connection is reversed according
to the side that is to be lifted.
See section “Important! About the hose
connection ”page 7.
The pump is started and pumped until
the desired lift height is reached.
Then disconnect the hose connection
(B) from the pump (C) (Figure 5).
The hose connection (B) is now closed
with the cover (E) (Figure 6).
When the cover (E) is mounted on the
hose connection (B), the pump (C) is
turned off by the “POWER” button (D).
The Turn All®system will now remain
in this position until the cover (E) is
removed again and the air is thereby
eliminated from the system.
Make sure the air chambers are com-
pletely emptied before re-attaching the
hose connection (B) to the pump (C).
Figure 5
Figure 6
Figure 7
B
B
C
E

10 Turn All userguide 3C EN 2021.05.21 Rev.4
Indications and
contraindications
Indications / Purpose
Pressure ulcer prevention and
treatment.
Existing pressure ulcers and risk of
development of pressure ulcers.
Risk of pressure ulcer.
The Turn All®system can be used
in beds with or without adjustable
surfaces.
When using the Turn All®system in
beds with adjustable surfaces, be sure
to follow guidelines to avoid shear.
The Turn All system is suitable for the
prevention of pressure ulcers including
all levels of skin damage risk.
The product can be used with all
grades of pressure ulcer.
However, it is important that the person
responsible for treatment is consulted
and their recommendation/s followed.
The system is designed for patients
with a body weight of up to 317 kg.
The Turn All®system is suitable and
recommended:
•For people with moderate to high risk
of pressure ulcers, according to the
Braden scale
•For persons whose disability or
sickness means they must spend
long periods lying down
•For people who cannot change their
position when lying down
•For people who have suffered from
one stroke with partial paralysis
•For people with spinal cord injury,
who want to change their position
when lying down, using theirs arms.

11Turn All userguide 3C EN 2021.05.21 Rev.4 Turn All userguide 3C EN 2021.05.21 Rev.4
Contraindications / Risks of use /
The product cannot be used
The Turn All®system cannot be used in
patients with:
•Unstable fractures
•Severe burn injuries.
•Equilibrium Disorders
•Underlying neurological diseases that
lead to anxiety behaviour in patients.
Allowed uses / locations
The Turn All®system can be used in all
beds with removable mattress.
The Turn All®system can be used
for the same patient for an extended
period of time.
The Turn All®system is an aid for the
prevention of pressure injuries and an
auxiliary therapy for the treatment of
pressure injuries.
Even with the use of the Turn All®
system, the skin should be examined
regularly by caregivers and / or qualied
medical personnel with knowledge of
pressure injuries
Note! Claims of any kind for damages
resulting from improper or inappropriate
use are excluded.
It is the operator who is solely
responsible for all damages in the event
of incorrect or inappropriate use.

12 Turn All userguide 3C EN 2021.05.21 Rev.4
Safety
This section provides an overview
of the important safety aspects, for
optimum protection of patients and
caregivers, as well as safe and trouble-
free use of the system.
If the Turn All®System is used in a bed
with bed rails, the bed rail must be 220
mm higher than the mattress when
lying at.
The Turn All®system is an aid for
pressure injury prevention and auxiliary
therapy for the treatment of pressure
injuries.
Even with the use of the Turn All®
system, the skin should be examined
regularly by caregivers and / or qualied
medical personnel with knowledge of
pressure injuries.
Note! The operator alone is
responsible for all damages in the event
of incorrect or inappropriate use.
Warning Notice
If the pump is to be disconnected from
the mains during operation or if there
is a power failure, an acoustic warning
signal will sound for approx. 5 minutes.
The warning signal can be closed by
pressing the “POWER” key (D) (Figure
4) page 8.
Then restart the system.
The location of the pump and the
location of the mains cable must
be chosen so that unintentional
disconnection from the supply network
is excluded. The power cord must be
routed in such a way that it cannot be
pinched or crushed. It must also be
guided in such a way that it does not
pose a risk of stumbling.
CPR function
If a medical emergency should occur,
rapid deation may be necessary.
To do this, pull the red strip marked
CPR to open for venting the hose
connections to the mattress.
See illustration below.
By disconnecting this connection, the
air chambers will be quickly emptied
and the bed will return to a horizontal
position.
This process can be further accelerated
by pressing the mattress.
Make sure the air chambers are
completely emptied before re-attaching
the CPR connection again.
Then restart the system.

13Turn All userguide 3C EN 2021.05.21 Rev.4 Turn All userguide 3C EN 2021.05.21 Rev.4
Elevation of the care bed
The system supports the elevated
position of the healthcare bed in the
head and foot parts. However, attention
must be paid here to the correct
position and pose of the patient in
care. This will depend on body shape
and clinical picture. In case of doubts
or questions, please ask the treating
doctor or the specialist care provider.
With the head end of the bed elevated,
it is important to make sure that
the patient is prevented from falling
forward.
Depending on the body shape, a
head cushion should only be used
appropriately.
The maximum elevation of the head
end of the bed should 20º, but if
necessary the head of bed can be
higher for short/long periods for
situation when eating and drinking.
20º
Warranty and liability
provisions
When used correctly, Levabo ApS gives
a 24-month guarantee from the invoice
date.
During this period, defective parts will
be repaired or replaced free of charge
due to manufacturing defects.
Levabo ApS assumes no liability for
damages due to:
1. Not follow the operating instructions
2. Non-compliant use with the
instructions
3. Unauthorised changes
4. Technical changes
5. Use of unauthorised spare parts.
The warranty is based on legal
provisions and directives.
If the system is intervened without
the prior approval of Levabo ApS, the
warranty lapses.
If the warranty is claimed and if, after
verication, it should prove that these
are based on signs of wear and tear or
other types of damage not covered by
the warranty, Levabo Aps is entitled to
transfer the expenses incurred (test ,
transportation costs, and the like) to the
client.

14 Turn All userguide 3C EN 2021.05.21 Rev.4
Cleaning the Turn All®system
Turn All®Cover (the blue outer cover)
The internal lifting mattress must be
removed from the Turn All®Cover
before washing the cover. see page 15.
Turn All®Cover can be washed in
washing machine v. 90° C. and tumble
drier on low setting.
Turn All®Cover can be cleaned in
autoclave v. Max. 121° C.
The Turn All®system must be
disconnected from the mains socket
before cleaning.
Cleaning and disinfection
If the Turn All®system has been
contaminated by body uids, it can be
cleaned.
The Turn All®Multi Patient inner mattress
can be cleaned with warm water and
soap. Disinfection can be done with a
1% chlorine based appropriate solution.
The Turn All®Control Box can be
sprayed with a suitable disinfectant or
with alcohol / propyl alcohol on a damp
cloth for wiping.
Note! Do not use caustic or abrasive
cleaners or sharp objects to clean the
Turn All®system.

15
Turn All userguide 3C EN 2021.05.21 Rev.4
Turn All userguide 3C EN 2021.05.21 Rev.4
Figure 1
Figure 2
Figure 3
Figure 4
J
L
B
B
K
H
H
If the Turn All®system needs to be cleaned
you can take out the inner mattress (H)
gure 1, open the zipper in the cover (J)
gure 1 and remove the upper part.
Open the zipper (L) gure 1 and pull the
connection tubes (B) Figure 1-2)
through the opening into the lower part
of the cover.
Losen the 6 kamsnaps (K) Figure 3.
The inner mattress (H) Figure 4, can
now be removed. The cleaned
mattress is mounted as shown in
reverse order.

16 Turn All userguide 3C EN 2021.05.21 Rev.4Turn All userguide 3C EN 2021.05.21 Rev.4
Notification of
accidental events
Technical data
Malfunctions or malfunctions in the
appliance that have caused personal
injury must be notied immediately
to the competent authority and the
company Levabo ApS.
Note! The competent authority may
require that the operator be notied of
the incident by an expert at his own
expense and submit the assessment
in writing. The expert shall be selected
in agreement with the competent
authority.
The technical safety assessment
includes the following elements:
•What the event can be attributed to
•Whether the product was in good
condition
•If there is any further danger after
repair of malfunction
•Whether new knowledge has been
obtained, which require others or
further precautions.
Dimensions (L x B x H)
Cover: ...................... 200 x 85 x 15 cm
Lifting mattress: ................ 200 x 85 cm
Pump: ....................... 8 x 27 x 13,5 cm
Veight
Pump: ....................................... 1.5 Kg
Mattress with cover: ..................... 4 Kg
Lifting angle
Dynamic (automatic): ....................... 30
Static (manual):.......................... 0- 30
Electrical data
Mains voltage: ..............................240V
Frequency: ....................... 50Hz / 60Hz
Power consumption: ...........Max. 12 W
Classication: ..........................Klasse II
Fuse: ........................... T500mA L250V
Storage
-10 to 50 Celcius.
Relative humidity 0% to 95% without
condensation.
Conditions of use
Designed for continuous operation.
Application temperature:
0 ° to 40 ° Celcius.
Relative humidity 20% to 95% without
condensation.
Standards
See approvals on page 16.

Turn All userguide 3C EN 2021.05.21 Rev.4
Approvals, standards and
regulations
17
Cover upper part
Medical BI ELASTIC PES PU
Antibacterial and Antifungal:
ISO 22196:2011 - PASS
Flammability BS 7175 ignition source 5
Pre-treatment: None
Method of Test: BS 7175: 1989 (2013)
Section 3 - PASS
Flammability BS 7177: 2008 + A1:
2011 Low Hazard
Method of Test: BS EN 597-1: 1995 &
BS EN 597-2: 1995 - PASS
EN 1021-1-2: - PASS
Cover bottom part TPU
Fire retardant black
600D TPU coating dacron fabric.
Antibacterial and Antifungal:
ISO 22196:2011 - PASS
Flammability BS 7175 ignition source 5
Pre-treatment: None
Method of Test: BS 7175: 1989 (2013)
Section 3 - PASS
Flammability BS 7177: 2008 + A1:
2011 Low Hazard
Method of Test: BS EN 597-1: 1995 &
BS EN 597-2: 1995 - PASS
EN 1021-1-2: - PASS
Cover bottom part PVC
Black 600D PVC-coating dacron fabric.
Pump
Tested and approved in accordance to:
IEC 60601-1: 2006 +A1: 2013:
General Requirements for Basic Safety
and Essential Performance.
Tested and approved in accordance to:
EN60601-1-2: 2007
General Requirements for Basic
Safety and Essential Performance,
Collateral Standard: Electromagnetic
Compatibility.
Tested and approved in accordance to:
IEC 60601-1-11: 2015 (2. Edition) for
use in conjunction with IEC 60601-
1:2012 (3. Edition) + A1: 2012
General Requirements for Basic Safety
and Essential Performance,
Collateral Standard: Requirements
for medical electrical equipment and
medical electrical systems used in the
home healtcare environment.

Turn All userguide 3C EN 2021.05.21 Rev.4Turn All userguide 3C EN 2021.05.21 Rev.4
Turn All®product range
Explanation of symbols on the packaging
Explanation of symbols on the packaging
Read the user guide Expiration date Conformité Européenne
Production number Single-patient device Material in the packaging
Manufacturer Date of manufacture Product number
Product name Size in cm Max weight in Kg Product no. Application
Turn All multi-patient
incl cover w/ PVC lower part 85 x 200 150 70100
System containing Turn All®lifting
mattress, 1 Turn All®cover w/ PVC
lower part, and 1 pump
Turn All multi-patient
incl cover w/ TPU lower part 85 x 200 150 70112
System containing Turn All®lifting
mattress, 1 Turn All®cover w/ TPU
lower part, and 1 pump
Turn All inner lifting mattress
multi-patient 85 x 200 150 70113
The inner lifting mattress in nylon
for the Turn All®system
multi-patient
Turn All Cover
w/ PVC lower part 85 x 200 NA 70083
Cover for the
Turn All®lifting mattress
w/ PVC lower part.
Turn All Cover
w/ TPU lower part 85 x 200 NA 70114
Cover for the
Turn All®lifting mattress
w/ TPU lower part.
Turn All Pump 1C 27 x 13 x 10 NA 76057 Pump for the
Turn All®1 cycle system
Turn All Pump 3C 27 x 13 x 10 NA 76117 Pump for the
Turn All®3 cycle system
18

19Turn All userguide 3C EN 2021.05.21 Rev.4
Notes
Declaration of Conformity (CE)
The company Levabo ApS,
Sverigesvej 20A, 8660 Skanderborg,
declares that the products are designed
and manufactured in accordance with
the technical documentation and legal
requirements.
Product
Turn All®is an active medical product
in accordance with:
EU Regulatory MDR (EU) 2017/745,
Medical Devices - Class 1.
Production
EN ISO 9001: 2015 QMC
EN ISO 13 485: 2016 MD-QMC

Levabo ApS
Sverigesvej 20
8660 Skanderborg DK
medical cushions
®
Turn All userguide 3C EN 2021.05.21 Rev.4
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