Arjo Alpha Active 5 User manual

INSTRUCTIONS FOR US
E
Alpha Active 5
6
48931EN_02 • 06
/
202
2

Desi
g
n Polic
y
and
C
op
y
ri
g
h
t
®
and ™ are trademarks belon
g
in
g
to the Ar
j
o
g
roup o
f
companies.
©
Ar
j
o 2022.
As our polic
y
is one o
f
continuous improvement, we reserve the ri
g
ht to modi
fy
desi
g
ns without prior notice. The
c
ontent o
f
this publication ma
y
not be copied either whole or in part without the consent o
f
Ar
j
o.
WARNING
To avoid injury, always read this Instructions For Use and accompanied documents before using the
product.
Mandatory to read the Instructions For Use.

3
Foreword
...................................................................................
.
4
Intended use for Alpha Active
5
................................................................
.
6
Safet
y
instructions
..........................................................................
.
7
Home car
e
..................................................................................
.
9
P
re
p
arations
...............................................................................
.
1
0
P
arts desi
g
nation - Alpha Active
5
p
u
mp
.......................................................
.
1
1
P
arts desi
g
nation -
Alpha Active 5
mattress
5
....................................................
.
12
P
roduct descri
p
tion - Alpha Active
5
p
u
mp
.....................................................
.
1
3
P
roduct descri
p
tion - Alpha Active
5
m
attress
..................................................
.
15
&35UD
S
LGGHÀDWLRQ
.........................................................................
.
17
Installin
g
Alpha Active 5 s
y
ste
m
..............................................................
.
1
8
M
attress and
p
um
p
o
p
eration
................................................................
.
19
Initial setup o
f
Alpha Active
Sy
stem
............................................................
1
9
S
upport settin
g
procedure.
...................................................................
1
9
Active
(
Alternatin
g)
mod
e
....................................................................
2
1
R
eactive
C
onstant Low Pressure
(S
tatic
)
mod
e
...................................................
2
1
M
anual-onl
y
mod
e
..........................................................................
2
1
C
han
g
e in patient positio
n
....................................................................
2
2
P
o
w
e
r
fa
il
u
r
e
..............................................................................
2
2
T
o
d
i
sco
nn
ec
t th
e
t
ubeset
....................................................................
2
2
Transpor t mod
e
............................................................................
2
2
D
econtamination
...........................................................................
.
2
3
Routine Maintenanc
e
........................................................................
.
2
4
Alpha Active
5
System
5
......................................................................
24
Alpha Active 5
Pump
5
.......................................................................
24
Alpha Active 5
Mattress Replacement
5
.........................................................
24
'
HÀDWHDQGVWRUH Alpha Active
5
m
attress
......................................................
.
2
5
T
roubleshootin
g
and alarm conditions
.........................................................
.
26
T
echnical descri
p
tion
.......................................................................
.
2
7
L
abels
....................................................................................
.
3
0
E
lectroma
g
netic compatibilit
y
(
EMC
)
data shee
t
.................................................
.
3
2
Contents

F
O
R
EW
O
R
D
4
Foreword
Customer contact information
For questions re
g
ardin
g
this product, supplies, maintenance, or additional in
f
ormation about Ar
j
o products and
s
ervice, please contact Ar
j
o or an Ar
j
o authorized representative, or visit www.ar
j
o.com.
Please read and fully understand the Instructions for Use (IFU) before using
Alpha Active 5TM
In
f
ormation in this IFU is necessar
y
to per
f
orm the proper operation and maintenance o
f
the equipment. It will
h
elp to protect
y
our product and make sure that the equipment per
f
orms to
y
our satis
f
action. The in
f
ormation
in this IFU is important
f
or
y
our sa
f
et
y
and must be read and understood to help prevent possible in
j
ur
y
.
8
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p
roducts. Routine maintenance must be per
f
ormed on the Alpha Active
5
system before every use or every
5
week
(
i
f
f
or lon
g
term use
)
to maintain sa
f
et
y
and reliabilit
y
o
f
the equipment, see
“
Rou
tin
e
M
a
int
e
n
a
n
ce
”
o
n
p
age
2
4.
Support
I
f
y
ou require
f
urther support, please contact Ar
j
o
f
or comprehensive support and maintenance to maximize the
l
on
g
-term sa
f
et
y
, reliabilit
y
and value o
f
the product.
C
ontact
y
our local Ar
j
o representative
f
or spare parts. The
telephone numbers appear on the last pa
g
e o
f
this IFU.
Serious incident
,
I
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p
atient should report the serious incident to the medical device manu
f
acturer or the distributor. In the European
U
nion, the user should also report the serious incident to the
C
ompetent Authorit
y
in the member state where
the
y
are located.
Expected service life
The Alpha Active® pump has an expected service life of seven
y
ears. To maintain the condition of the pump,
h
ave the pump serviced re
g
ularl
y
accordin
g
to the schedule recommended b
y
Ar
j
o. D
o
N
O
T use unapproved
accessories or attempt to modi
fy
, disassemble or otherwise misuse the Alpha Active s
y
stem. Failure to observe
this caution could result in in
j
ur
y
, or in extreme cases, death.
Environmental protection
Incorrect disposal o
f
this equipment and its component parts, particularl
y
batteries or other electrical
c
omponents, ma
y
produce substances that are hazardous to the environment. To minimise these hazards,
c
ontact Ar
j
o
f
or in
f
ormation on correct disposal.

F
O
R
EW
O
R
D5
Warnin
g
means:
S
a
f
et
y
warnin
g
. Failure to
u
nderstand and obe
y
this warnin
g
ma
y
result in in
j
ur
y
to
y
ou or to others.
C
aution means: Failure to
f
ollow these instructions
ma
y
cause dama
g
e to all or parts o
f
the s
y
stem or
e
quipment.
Note means: This is important in
f
ormation
f
or the
c
orrect use o
f
this s
y
stem or equipment.
WARNING
CAUTION
NOTE
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INTE
N
D
E
D
USE
F
O
R
ALP
H
A A
C
TI
V
E
5
6
Intended use for Alpha Active 5
Alpha Active 5 is a pump and mattress s
y
stem intended
f
or use b
y
care
g
ivers
1
in acute care, lon
g
-term care
and home care
f
acilities, includin
g
private homes,
f
or the prevention and
/
or mana
g
ement o
f
pressure in
j
uries
(
pressure ulcers
)
.
The Alpha Active 5 s
y
stem is
f
or patient’s wei
g
ht
f
rom 40 k
g
(
88 lb
)
to 200 k
g
(
441 lb
)
.
The Alpha Active 5 s
y
stem is indicated
f
or the prevention and
/
or mana
g
ement o
f
all patient risk levels when
c
ombined with an individualised, comprehensive pressure in
j
ur
y
protocol:
f
or example, repositionin
g
, nutritional
s
upport, skin care.
S
election should be based upon a holistic assessment o
f
the individuals care needs.
These s
y
stems represent one aspect o
f
a pressure in
j
uries
(
pressure ulcers
)
mana
g
ement protocol; all other
aspects o
f
care should be considered b
y
the prescribin
g
clinician. I
f
existin
g
wounds do not improve or the
p
atient
’
s condition chan
g
es the overall therap
y
re
g
imen should be considered b
y
the prescribin
g
clinician.
The above are
g
uidelines onl
y
and should not replace clinical
j
ud
g
ement.
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other use is prohibited.
Contraindication
Do not use Alpha Active 5 s
y
stem
f
or patients with unstable spinal
f
ractures.
P
atient
/
Resident assessmen
t
We recommend that
f
acilities establish re
g
ular assessment routines.
C
are
g
ivers should assess each patient
accordin
g
to the
f
ollowin
g
criteria prior to use:
• The Alpha Active 5 system has been designed for use with patients ranging from 40 kg (88 lb) to 200 kg
(441 lb) for the Alpha Active 5 mattresses.
I
f
the patient does not meet these criteria an alternative equipment
/
s
y
stem shall be used.
Cautions
I
f
patients have other unstable
f
ractures, or conditions which ma
y
be complicated b
y
a so
f
t or movin
g
sur
f
ace,
advice should be sou
g
ht
f
rom an appropriate clinician be
f
ore use. While the Alpha Active 5 s
y
stem has been
desi
g
ned to mana
g
e patients up to the wei
g
ht limits indicated above, those approachin
g
this upper limit are
l
ikel
y
to have additional care and mobilit
y
needs and ma
y
be better suited to a s
y
stem with a hi
g
her wei
g
ht limit.
1
.
C
aregiver ma
y
be a healthcare pro
f
essional or la
y
person who operates this medical device.

S
AFE
T
Y IN
S
TR
UC
TI
O
N
S
7
Safety instructions
Be
f
ore
y
ou connect the s
y
stem pump to a mains socket, read care
f
ull
y
all the installation instructions contained
within thi
s
m
a
n
ua
l.
The s
y
stem has been desi
g
ned to compl
y
with re
g
ulator
y
sa
f
et
y
standards includin
g:
• EN60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012
• EN60601-1-11:2015; IEC 60601-1-11:2015 and IEC60601-1-8/A1:2012
• ANSI/AAMI ES 60601-1(2005)+AMD(2012) and CAN/CSA C22.2 No.60601-1(2008)+(2014).
WARNING
Make sure that the mains power cable and
tubeset or air hoses are positioned to avoid
causing a trip or other hazard, and are
clear of moving bed mechanisms or other
possible entrapment areas. Where cable
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sides of the mattress, these should be used
to cover the mains power cable.
WARNING
To avoid serious injury or death, the CPR
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accessible at all times.
WARNING
Whilst the patient is unattended, safety
sides should be used based on clinical
assessment and in line with local policy.
WARNING
It is the responsibility of the care giver to
ensure that the user can use this product
safely.
WARNING
The cover of this product is vapour
permeable but not air permeable and may
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WARNING
Do not use the pump in the presence of
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WARNING
Alignment of the bed frame, safety sides
and the mattress should leave no gap wide
enough to entrap a patient’s head or body,
or to allow egress to occur in a hazardous
manner where entanglement with the mains
power cable and tubeset or air hoses may
result. Care should be exercised to prevent
occurrence of gaps by compression
or movement of the mattress. Death or
serious injury may occur.
WARNING
The mains power socket/plug must be
accessible at all times. To disconnect
the pump completely from the electricity
supply, remove the plug from the mains
power socket.
WARNING
Disconnect the pump from the mains power
socket before cleaning and inspecting.
WARNING
Keep the pump away from sources of
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S
AFE
T
Y IN
S
TR
UC
TI
O
N
S
8
WARNING
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misused. There are no user-serviceable
parts inside the pump. The pump’s case
must only be removed by authorised
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CAUTION
Pets and children must be supervised in
the vicinity of the system.
CAUTION
Do not expose the system, especially
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cigarettes, etc.
CAUTION
Never use sharp objects or electrically
heated under blankets on or under the
system.
CAUTION
Do not store the system in direct sunlight.
WARNING
Only the pump and mattress combination
as indicated by Arjo should be used. The
correct function of the product cannot be
guaranteed if incorrect pump and mattress
combinations are used.
CAUTION
Do not use phenol-based solutions to clean
the system.
CAUTION
Placing extra layers between the patient
and the mattress potentially reduces the
EHQH¿WVSURYLGHGE\WKHPDWWUHVVDQG
should be avoided or kept to a minimum.
As part of sensible pressure area care, it is
advisable to avoid wearing clothing which
may cause areas of localised high pressure
due to creases, seams, etc. Placing objects
in pockets should be avoided for the same
reason.
CAUTION
Make sure the system is clean and dry prior
to use or storage.
CAUTION
Store the pump and mattress in the
protective bags supplied.
CAUTION
When the pump is in use the operator
should remain in area in case the system
alarms.
CAUTION
To avoid damage to the cover ensure only
the recommended cleaning method is used.
CAUTION
To avoid entrapment risks ensure the
mattress and bed are the correct sizes.
Incompatible support surfaces can create a
patient safety hazard.

H
O
ME
C
AR
E
9
WARNING
To avoid injury to the patient when operating the Alpha Active 5 system as a caregiver and as a
lay person:
M
ake sure the s
y
stem is operatin
g
accordin
g
tosection “Mattress and pump operation” on pa
g
e
19
.
If the s
y
stem is not operatin
g
correctl
y
, see section “Troubleshootin
g
and Alarm Conditions” on
p
a
g
e 25
.
If the s
y
stem is still not operatin
g
correctl
y
, or if
y
ou have concerns, contact the patient’s doctor
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Home care
Use the Alpha Active 5 system
Be
f
ore usin
g
the
Alpha Active 5
system in a home environment make sure that all caregivers, including
5
r
elatives, have read and understood the instructions in this
I
F
U
.
Wh
e
n th
e
Alpha Active 5
system is in use, make sure:
5
• The Alpha Active 5 system is kept away from sources of heat and moisture, and protected from dust, lint and
dirt.
• The Alpha Active 5 system is not covered.
•7KHRSHUDWLRQDOHQYLURQPHQWIXO¿OVWKHUHTXLUHPHQWVVSHFL¿HGLQ
“
Pump environmental in
f
ormation” on page
2
7.
• Routine maintenance must be performed on the Alpha Active 5 system before every use or every week (if
for long term use) to maintain safety and reliability of the equipment.
S
ee
“
Routine Maintenance” on page
2
4.
Wh
e
n th
e
Alpha Active 5
system is not in use, make sure:
5
• No children can access the Alpha Active
5
system.
• No pets can come in contact with the Alpha Active
5
system.
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³
'H
À
DWHDQGVWRUH$OSKD$FWLYH


m
attress” on page
2
5.
CAUTION
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Active 5 system.

P
R
EPARATI
O
N
S
10
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1.
C
heck the packa
g
e
f
or dama
g
e. I
f
the product looks dama
g
ed durin
g
transport, contact the transport
agency
.
D
o
N
O
T use the product.
2.
C
heck that the items are complete
:
• Alpha Active 5 pump with power cable and hanging brackets.
•
Alpha Active 5
mattress replacement integrated tube-sets.
5
•
C
over.
3
.
R
ec
y
cle the packa
g
in
g
accordin
g
to local re
g
ulations.
4.
Read
thi
s
I
F
U
.
5
.
S
tore the
IFU
in a designated area, where it is easily accessible at all times.
U
Actions before every use (2 steps)
1. Inspect the
Alpha Active 5
system, according to section
5
“
Routine Maintenance” on page 24.
2. I
f
an
y
item is dama
g
ed - do
N
O
T use the product.
After each patient
C
lean and disin
f
ect the product a
f
ter each patient accordin
g
to section
“
Decontamination” on page 23.
The position of the caregiver
The care
g
iver should be positioned in
f
ront o
f
the pump durin
g
operation.
Preparations