Page 1
Grade
* This ‘Grade’ is a guide only. Each individual must be assessed
by a tissue viability specialist, the correct product chosen and set
to operate according to the patient’s needs. Regular repositioning
schedules need to be in place as this product does not replace
good nursing care.
MANUAL
DX550
Alternating Air-Pressure Mattress
Replacement Syste
m (Digital)
Digital Auto Sensor
Alternating Air- Pressure
Mattress System
USER MANUAL
SERIES
5
DX550
Grade* 4
Page 2
Contents Page
1
1. The Purpose of this Manual
1. The
Purposeofthis
Manual
2.
Important
Safeguards
3.
Quick Start-up guide
Arrival of
Product
Preparation of area
Inflationofmattress
Mattress
CPR
check
Mattress
comfort
check
Hand check
4.
Emergency Air
Release – CPR valve function
Alarm
Function
Deactivation of
Alarm
5.
Product
Description
Intended
Use
Features of Master
Control
Unit/pump
Features of Mattress
6.
Instructions for Proper
use
7.
Maintenance
Troubleshooting
8.
Cleaning&Disinfection
Protocol
Cleaning
of
Mattress
Cover
CleaningofMattress
Cells
Cleaning
of Master
Control
Unit
Cleaning of Air
Filter
9. How to Replace
Air
Filter
page
1
page
2
page
3
page
3
page
4
page
5
page
5
page
5
page
6
page
6
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6
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7-8
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7
page
7
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8
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8
page
9
page
10-11
page
10
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10
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11
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11
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11
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12
page
13
page
14-17
page
18
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18
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18
page
19
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19
page
20-22
page
20
page
21
page
22
10.
11.
12.
13.
14.
15.
16.
17.
18.
Storage & Care
Specification/Technical
Data
EMC
(Electro Magnetic Compatibility)
Guide
Waste Disposal
Symbols
Used
Expected
Service Life
Warranty
Legal Disclaimer
Service
Guidelines
& Equipment
Notes
Steiss
Service Record
Contents Page
1. The
Purposeofthis
Manual
2.
Important
Safeguards
3.
Quick Start-up guide
Arrival of
Product
Preparation of area
Inflationofmattress
Mattress
CPR
check
Mattress
comfort
check
Hand check
4.
Emergency Air
Release – CPR valve function
Alarm
Function
Deactivation of
Alarm
5.
Product
Description
Intended
Use
Features of Master
Control
Unit/pump
Features of Mattress
6.
Instructions for Proper
use
7.
Maintenance
Troubleshooting
8.
Cleaning&Disinfection
Protocol
Cleaning
of
Mattress
Cover
CleaningofMattress
Cells
Cleaning
of Master
Control
Unit
Cleaning of Air
Filter
9. How to Replace
Air
Filter
page
1
page
2
page
3
page
3
page
4
page
5
page
5
page
5
page
6
page
6
page
6
page
7-8
page
7
page
7
page
8
page
8
page
9
page
10-11
page
10
page
10
page
11
page
11
page
11
page
12
page
13
page
14-17
page
18
page
18
page
18
page
19
page
19
page
20-22
page
20
page
21
page
22
10.
11.
12.
13.
14.
15.
16.
17.
18.
Storage & Care
Specification/Technical
Data
EMC
(Electro Magnetic Compatibility)
Guide
Waste Disposal
Symbols
Used
Expected
Service Life
Warranty
Legal Disclaimer
Service
Guidelines
& Equipment
Notes
Steiss
Service Record
This
operation
manual is
mainly focused
on the
setup, cleaning
and
routine maintenance
of the Steiss
DX550
Alternating Air-Pressure Mattress Replacement
System.
The Steiss DX550 i s a
high-specification alternating air-pressure mattress replacement system designed
to
prevent
and treat
pressure ulcers
up to grade
IV.
We
recommend
you
keeping this
manual
handy
to answer
most
of the
questions related
to the system.
NOTE: This manual is just a guide and we advise all Nurses & Cares to take responsibility for the
care of their mattress.
1. The Purpose of this Manual
Contents Page
Page 3
2
•
•
•
PLEASE READ ALL INSTRUCTIONS BEFORE USING THIS ELECTRICAL APPLIANCE
Warning & Cautions
Only
connect
the Steiss 5
pump
to a Steiss M 5 0 mattress.
Only connect the master control unit of the DX550 mattress to a 220-240V power source
Place
power
cable and
pump
away
from
head end to
reduce riskofstrangulationorentanglement with
any
cord,
cable or pipe.
Keep the
tubes
free of kinks.
Disconnect
the
control unit power plug
before
moving
the bed.
Do
not unplug
the
control unitbypulling
the cord.
Only use the DX550
products
indoors.
Only use
this product
if it has an
un-damaged cord
or plug.
Keep the
cord
away
from
heated surfaces.
Do
not
use
this product,
if it has been
dropped
or damaged, or it has been
submerged into
water.
(Do
return
the
product
to a
service
centre to be
examined
and/or repaired).
Do
not
expose the
control unittohumidityordirect
moisture.
Operation Temp: 15 to 35 degree, 30% to 75% non-condensing
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Never
block
the air
openingsorinsert
any
object into
them.
Never place
mattress
on a
couch
or sofa where the air
openings could
be blocked. Do
not spray
any
aerosols onto
the mattress.
Note
cleaning/washing instructions
later in manual. This
deviceisnot
registered
as AP/APG protected.
Do
contact your service
centre if
this productisnot working
properly.
Use
only manufacturer-approved parts
when
maintainingorrepairing
the Steiss DX550
Use
only manufacturer-approved accessories with this
device.
All parts and accessories supplied are specifically designed for use with the Steiss DX550
control
unit.
Use of
other parts
and
accessoriesinconjunction with this deviceisnot
recommended.
The
control unit
can
onlyberepaired
by an
authorized
technician.
Re-positioning
of the
patientisalways recommended
when
usinganalternating pressure
air mattress.
It is
advisabletomonitor product
when used by, on or near
children
and
physically/mentally
challenged
individuals
If any pain,
redness, irritation, numbnessorswelling occurs while using cushion,
please
inform
healthcare
professional for
them to
assess
and evaluate the situation.
Should
the carer
decidetoinsert
extra foam or place
this mattressontopofanother mattress,
it is at all
times
the
carer’s responsibilitytoensure
that there is
adequate/legal clearance from topofthis mattress
to
the
top
of the siderails.
•
•
•
•
•
•
•
In the event of an
extended power failure,
it is
advisabletodisconnect
the air hose
from
the
pump
and
attach
the
transport
clip.
Do
remembertoreconnect
the
mattress
to the
pump
once the
power
has been re-established.
•
2.
Important
Safeguards
2. Important Safeguards
Page 4
3. Quick Start-up guide of Steiss DX550
3
ARRIVAL OF PRODUCT
BOX 1:
Air-Alternating mattress,
pump,
carry
bag, manual
PREPARATION OF AREA
1. Unpack
products
2. Place the Steiss DX550
Alternating Pressure Mattress directlyontop
of the bed frame and
ensure
that the air hose is at the
foot
of the bed.
CAUTION: When securing the mattress to the bed, please ensure that you are securing onto
the
movable parts of the bed and NOT the actual bed frame, as this will obstruct the
mechanical
movement and could cause damage to both mattress and bed. The warranty for both
the
mattress and the bed may well be invalidated if damage is caused by this
means.
NOTE: When the mattress is opened for the first time, please write today’s date (with a
non-
Phenol based pen) in the top white box on the PU cover and add in the ‘same date’ for
the
following three years in the bottom white box. This will remind the care team when the
annual
service is
due.
3. Hang the Steiss DX550
pump
at the
foot
of the bed.
Connect
the
push-fit
hose
connector from
the
4. Plug the
pump power
cable
into
the
mains outlet. Ensure
that
electrical cables
are safe and
tidy,
are not
caught
in the bed frame and are free
from obstruction.
Turn the
power
on at the
mains outlet
and
turn
the
power switch
on the
pump
to the ‘ON’ position.
CAUTION: It is important to routinely inspect power cables to ensure they are not obstructed
or
causing a tripping hazard. Check the power cable is not under strain or is
damaged.
3. Quick Start-up guide of DX550
Page 5
4
INFLATION OF MATTRESS
1.
Ensure
that the
Cardio Pulmonary Resuscitation
(CPR) valve of side
mattress
is closed.
CAUTION: It is important to ensure that no person/object is lying/sitting on the mattress when
it
is initially
being
2.
maximum
pressure.
NOTE: ‘MAX’ and ‘STATIC’
modes
are
designedtoreturnto‘dynamic mode’
after 30
minutes
activation.
3.
4. When the mattress is fully inflated, the mattress is now ready to be used and patient can be placed
on to the air mattress. The pump is designed automatically default to Alternate mode with Automatic
Weight Detection enable. The system will automatically set to an optimum pressure for a patient’s
weight from 30 to 160Kg.
5. The
pump
and
mattress will
then run
continuouslyin‘dynamic
mode’.
2
Page 6
5
MATTRESS CPR VALVE CHECK
After approximately
30-40
minutes
the
mattress shouldbefully inflated.
If the
mattress
is NOT
fully
inflated,
check
that the CPR valve is in the
closed position
and that the
pumpisconnected
to the
mattress
correctly.
"
"
"
"
CAUTION: Please ensure that the PU mattress cover is fully zipped and CPR connection
is
closed properly after
inspection.
CAUTION: During a power cut, pump will stop functioning and the ‘power failure LED’ indicator
may be flashing, and the power failure alarm may be triggered if equipped; this is normal. The
pump will return to its normal operation when power is resumed.
"
MATTRESS COMFORT CHECK
•
•
Re-check the
comfort control setting
on the
pump
unit.
If
required, adjust
the
control settingtoincrease
or decrease the
required firmness
of the
mattress,
using
the
patient’s weight
as an
initial
guideline.
If the
patient
back rest
moves greater
than 30 degrees,
increase
the
pressure
in the
mattress
to
accommodate
the extra load on the
sacral
cells.
•
HAND CHECK
•
To
check whether
the
patientisbeing properly supported, slide
one hand in between the air
mattress
and
the base to
ensure
that they are
not ‘bottoming
out’.
A gap of 2-4 cm /1-2
inches
between the
patient’s bottom
and the bed base is an
acceptable
gap and is an
indication
of the
correct pressure setting.Ifthisisnot
the case, the
pressure
can be
adjusted
accordingly,
using
the
comfort control
dial.
•
Page 7
4. Emergency Air Release – CPR Valve Function
6
This
mattress featuresaCardio Pulmonary Resuscitation
(CPR) valve at the head-end side of the mattress.
In the event of a
cardiac
arrest,
twist
the CPR valve to the
‘open’ position
and
unplug
the air hose
from
the
IMPORTANT:
ALARM FUNCTION
The DX550
Alternating Air -Mattress Replacement
System is
equipped with visual
and
audible alarms
in the
event of low pressure.
.
When the
patient’s position changes,
the
mattress pressure will drop from
the set
pressure
and the audible
DEACTIVATION OF AUDIBLE ALARM:
Press the 'Mute' button to switch off the audible alarm.
4.
Emergency Air
Release - CPR
Valve
Function
Page 8
5. Product Description
7
INTENDED USE
The Steiss™ DXR500DX550 is an
advanced digital
cell and
foam Alternating Air-Pressure Mattress
Replacement
The
system
uses the
latest technologyinalternating mattress therapytoprovide accurate pressure settings
for
individual
patients’
needs. The 18
cells
of the
mattress
are
arranged
in a
transverse
manner to
provide
extra
protection
and
comfort for
the patient.
Through
the use of
alternating therapy
Steiss™ DXR500 D X550
system works
on the
principleofactively
cycles.
This
results
in the
reductionofsurface pressures helpingtoprevent tissue breakdown
and encourage
healing.
The ten thoracic/sacral cells feature therapeutic micro air loss holes maximizing the air circulation inside the
body of the mattress, providing additional comfort.
For added
durability,
and
longer working
life,
your
Steiss™ DXR500 DX550
mattress
has been
constructed
using
high
strength components
and
premium
grade materials. The
mattress features
a heavy
duty
base layer
and
a
100%
waterproof, multi-stretch vapor permeablePUcovertoreduce risksoffriction
and shear.
FEATURES OF MASTER CONTROL UNIT/PUMP
•
•
•
•
•
•
•
•
•
•
•
Clear,
quiet
and
intuitive digital adjustment for comfort
controls
1:2
alternation providing
a very low
interface pressure
at 12
minute
cycles
Static
and
alternating
modes
Static
mode
with 30minute auto-return for
safer
patient transfers
and
nursing
tasks
Intuitive
LED
indicator for function
status
6
adjustable comfort
settings
Acoustic &optical
low
pressure/power-failure alarms for
added safety
NOTE: The audio alarm will resume normal operation after the initial 45 minutes
of
Auto lock-out feature prevents unauthorized
change to settings
Transport security
device
Allows
you to
select
the Alternate
or
static
mode
Allows
you to mute the alarm while
actionisbeing
taken to
determine
the
cause of the alarm
5.
Product
Description
DX550
DX550
DX550
advanced digital
cell and
foam Alternating Air-Pressure Mattress
to
provide accurate pressure settings
for
in a
transverse
manner to
provide
extra
system works
on the
principleofactively
for
manner to
provide
extra
on the
principleofactively
and encourage
mattress
has been
constructed
Page 9
8
6. Instructions for Proper Use
FEATURES-MATTRESS
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Advanced Digital Full Mattress Replacement
System,
suitable for hospital,
home and care units
Grade IV
risk
/ management
1:2
alternation therapy for pressure
care
18
full depth alternating cells for pressure
care management
3
static
head cell
section for greater patient
comfort
Multi stretch, highly vapour-permeable PUtop cover providing
low sh ear,
friction
and
moisture
protection
Therapeutic Micro Air Loss feature assisting with moisture
and temperature
Static
mode
with 30minute auto-return for
safer
patient transfers
and
nursing
tasks
External
CPR
design for
fast
emergency
deflation
Anti-kink tubing for
added
safety
and reliability
Premium quality
all
round
zip
with
large
waterfall cover
for
improved infection
control
Modularized design allowing for
easy
cleaning
and
replacement
of air cells
Strong base-mount straps holding
the
mattress
when
insitu
and when in the
rolled-form during
storage
Transport Facility, with stopper ensuring mattress remains inflated
even
though disconnected from
pump
Recommended minimum
safe
working capacity
of 30kg/4.1stone
Recommended maximum
safe
working capacity
of 160Kg/25.2 stone
It is
important
to read
this information
before
using
the Steiss
DX550
Alternating Pressure Mattress
System. Please
follow
the
guidelines below for your safety
and to
maintain
the
system’s
performance.
•
•
•
•
•
Minimum patient weight 30kg/4.1stone.Maximum
patient weight:
160kg / 25.2 stone.
Avoid exposing
the
pump
to liquids.
Use a Steiss 5
pump with
a Steiss M50
mattress
only.
When
cleaningdonot
use
Phenol
based
substances.
Steiss offer Multi-surface disinfection wipes
which are ideal for cleaning both pump housing and mattress.
6. Instructions for Proper Use
FEATURES-MATTRESS
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Advanced Digital Full Mattress Replacement
System,
suitable for hospital,
home and care units
Grade IV
risk
/ management
1:2
alternation therapy for pressure
care
18
full depth alternating cells for pressure
care management
3
static
head cell
section for greater patient
comfort
Multi stretch, highly vapour-permeable PUtop cover providing
low sh ear,
friction
and
moisture
protection
Therapeutic Micro Air Loss feature assisting with moisture
and temperature
Static
mode
with 30minute auto-return for
safer
patient transfers
and
nursing
tasks
External
CPR
design for
fast
emergency
deflation
Anti-kink tubing for
added
safety
and reliability
Premium quality
all
round
zip
with
large
waterfall cover
for
improved infection
control
Modularized design allowing for
easy
cleaning
and
replacement
of air cells
Strong base-mount straps holding
the
mattress
when
insitu
and when in the
rolled-form during
storage
Transport Facility, with stopper ensuring mattress remains inflated
even
though disconnected from
pump
Recommended minimum
safe
working capacity
of 30kg/4.1stone
Recommended maximum
safe
working capacity
of 160Kg/25.2 stone
Page 10
7. Maintenance & Troubleshooting
9
If
issue not resolved,
please
contact your
Steiss Supplier.
Fault/problem Description
Troubleshooting
Solution
No
indication
that the
pump
is on Check
pump unitisconnected
to the
mains power
supply.
Check the
pumpisswitched
on.
Ensure mains plug
is connected
and on.
Check the
pumpisswitched
on.
Check
mains plug
fuse. Replace fuse if blown.
Check if
mains socket
is faulty. Try
another socket.Ifstill not
working;
consult
the
Steiss
technician.
The
pump
is noisy. Make sure the
pumpishanging
freely Check there is
nothing rubbing
against
the pump.
Reposition.Ifstill
noisy;
consult
the
Steiss
technician
Low
Pressure
in mattress/mattress
not
inflating.
Check the
pump unitisconnected
to
the
mains power
supply.
Check the
pumpisswitched
on and
fuse in
plug
is ok.
Check
pump/mattress
air
connections
are
fitted
securely.
Ensure
air is
coming from
pump.
Ensure connectors
are fastened
securely
and
reconnect pump
air
hoses
if loose.
Check CPR is
connected correctly
and is
not
leaking.
Reconnect
CPR if
not
secure.
Check the
connector tubes for
kinks,
obstructions
or damage.
Untwist
any
kinks,
or move any
obstructions.
Check the
setting
on the
comfort
control pressure
range dial.
Turn up dial to
increase pressure,
wait
for pressuretostabilize
(a few
minutes
before
making another
adjustment.
Remove
filter
on back of the
pump
to
check
if it is dirty.
Replace
with
new filter.
Pump
controls
‘freeze’ Turn off and
unplug
the pump. Wait a few
seconds,
then
plug
the
pump
back in. Turn on the pump.
Low
pressure lightisconstantly
illuminated
or
mattress
does
not inflate
when
pump
is operating.
Check
for loose
hose
connections.
Check the CPR valve.
Check air
cells for holes/tears
(other
than where part of the design)
Make sure
connectors
are secured.
Make sure CPR valve is closed.
Replace any damaged air cells.
Consultaqualified service technician
if the
problem
persists.
7. Maintenance & Troubleshooting
Page 11
8. Cleaning & Disinfection Protocol of all parts
10
CLEANING OF THE MATTRESS COVER
The
mattress should
be cleaned on the bed
weekly using
a damp,
soft cloth
and
mild
detergent.
NOTE: Do not use a phenol-based cleaning solution as this may reduce the life of the
mattress.
Steiss
has
developedadedicated
wipe to ease the
process for their
clients.
If the
topPUcover becomes dirty, unzip top cover from bottom section
and wash.
If the PU
cover
on the
base-foam becomes dirty, unzip top cover from bottom section
and wash.
If the
top cover
or base
cover becomes excessively soiled, putonprotective
wear and remove the
covers
from
the air
cells
and
tubing.
Place the
soiled covers
in an
appropriate plastic
bag and
consult your supplier
for
advice onspecialist cleaning.
Then replace
with
clean covers.
If the
covers
are
minimally soiled,
then these can be washed and
thermally disinfected
in a
washing
machine
by
following
the
procedures
below:
Industrial
Break wash
Main wash
Main wash
Extraction
Cold Rinse
Extraction
Cold
60°C
(140°F)
70°C
(158°F)
10
minutes
6
minutes
10
minutes
2minutes
5 minutes
Domestic
Pre-wash
Main
wash
Extraction
Cold
rinse
Extraction
Cold
70°C
(158°F)
10
minutes
2minutes
5 minutes
Note: Tumble Drying or Tunnel Drying is not
recommended.
CLEANING OF THE MATTRESS CELLS
Mattress cells
can be
wiped down withasolutionofsodium hypochlorite
1,000ppm or any
other
non-phenol-
based
germicidal cleaning
solution.
Steiss
have
developedadedicated
wipe to ease the
cleaning process for their
clients.
Please ask
your mattress supplier for
Multi-surface disinfection wipes.
Page 12
11
9. How to replace the Air Filter
CLEANING OF THE MASTER CONTROL UNIT
Caution: Always
switch
the electrical supply to the pump and disconnect the power cord from
the
main supply before cleaning or
inspection.
The
pump unit should
be cleaned
weekly using
a damp,
soft cloth
and a
mild
detergent.
If the
casingisespecially dirty,
the
pump
can be
wiped down withasodium hypochlorite solution
to a
dilution
of
1,000ppm, or any
EPA-approved hospital-grade
disinfectant.
The
pump casingismanufactured from
ABS
plastic
- therefore:
NOTE: Do not use a phenol-based cleaning solution. Steiss has designed cleaning wipes called Multi-
surface disinfection wipes. Please contact your supplier for this
product.
CLEANING OF THE AIR FILTER
9. How to
replace the Air
Filter
CLEANING OF THE MASTER CONTROL UNIT
Caution: Always
switch
the electrical supply to the pump and disconnect the power cord from
the
main supply before cleaning or
inspection.
The
pump unit should
be cleaned
weekly using
a damp,
soft cloth
and a
mild
detergent.
If the
casingisespecially dirty,
the
pump
can be
wiped down withasodium hypochlorite solution
to a
dilution
of
1,000ppm, or any
EPA-approved hospital-grade
disinfectant.
The
pump casingismanufactured from
ABS
plastic
- therefore:
NOTE: Do not use a phenol-based cleaning solution. Steiss has designed cleaning wipes called Multi-
surface disinfection wipes. Please contact your supplier for this
product.
CLEANING OF THE AIR FILTER
Page 13
10. Storage and Care of all parts
12
MATTRESS
•
•
Check the air
manifold for kinksorbreaks
and replace it if necessary.
Turn the CPR valve to the
“OPEN” position
and
disconnect
the air
tubes from
the
control unittoallow
the
mattresstodeflate
quickly.
Starting
at the head of the
mattress, roll
the
unit
up and use the base
mount strapstosecure
it.
Place the
mattressincarry
bag
provided for this
purpose.
•
•
MASTER CONTROL UNIT/PUMP
•
•
•
Check the
power cord
and
plug for abrasionsorexcessive
wear.
Plug in the
control unit
and
verify
air
flow from
the hose
connection
ports.
Place the
control unit
in a
plastic
bag to
store
it.
Note: Please follow the recommended guidelines when
storing.
It is
recommended
the
following guidelines
are used
whenever this systemisbeing storedortransported
to
another
location:
Temperature limitations:
Relative Humidity:
5°C (41°F) ~ 60°C
(140°F)
30% to
90%
10. Storage and Care of all parts
Page 14
11. Specication/Technical Data
13
Steiss 5 Master Control Unit /
Model Name
Size
L x W x
H
W
eight
Cycle
Time
Min
Operating
pressure
Max
Operating
pressure
Max
Flow Rate
Rated Voltage
Max
Current
Fuse
rating
Mode of Operation
Environment
(temperature)
Environment (humidity)
Test Standard:
Safety Standard:
Steiss DX550 Mattress
Model Name
Size L x W x H (mattress)
Weight
Cells Number
Cell Height
Cells Material
Cover Material
Base Material
Insert
Underlay
Transport
Facility
Maximum
Weight Capacity
Steiss 5 Master
Control
Unit
34.5 x 14.5 x 21cm (13.58 x 5.71 x 8.26 inches)
3.2kg (7.05lbs)
10 minutes
14 +/- 6mmHg
60 +/- 6mmHg
5 L/min
AC
220-240V/50Hz
0.1Amp
T1AH
250V
Class II Type BF (Not AP/APG type) /
Ingress
of Water
Protection
IP21
Continuous
Operation:
15°Cto 35°C(59°F to
95°F)
Storage:
5°Cto 60°C(41°F to
140°F)
Operation:
30% to 75% non-condensing
Storage:
30% to 90% non-condensing
IEC60601-1 & IEC60601-1-2 &
IEC60601-1-11
CE
Steiss DX550
Alternating Air-Pressure
Mattress
200.66 x 90.17 x 20.32cm (79” x 35.5” x 8”)
10.5kg (23.15lbs)
18
cells(2types.
5 are
vented
and 13 are
not
vented)
20.32cm (8 inches) PU
coated
nylon
PU
laminated nylon coverw/premium quality all-round
zip
PVC
laminated
polyester
PU
covered
Foam
Yes & secure
160kg /25.2 stone
Page 15
12. EMC-Related Notications
14
Warning: Medical electrical equipment needs special precautions regarding EMC and needs to
be
installed according to the EMC (Electro Magnetic Compatibility) information provided.
Careful
consideration of this information is essential when stacking or collocating equipment and when
routing
cables and
accessories.
Warning: RF mobile communications equipment
can effect medical electrical equipment
Caution: During power outage, pump will stop functioning, the POWER LED indicator may be flashing,
and the power failure alarm may be triggered if equipped; this is normal. The pump will return to its
normal operation when power is resumed.
Recommended separation distances between portable and mobile RF communications equipment and
the
Steiss
DX550
The Steiss
DX550isintended for
use in an
electromagnetic environmentinwhich radiated
RF disturbances are
controlled. The
customer
or the user of the Steiss
DX550
can help
prevent electromagnetic
interference by
maintainingaminimum distance
between
portable
and
mobileRFcommunications equipment (transmitters)
and the
Steiss
DX550asrecommended below, according
to the
maximum output power
of the communications
equipment.
Rated Maximum
output
power of transmitter
W
Separation distance according to frequency of
transmitter
(metres)
150 kHz to 80
MHz
d =
1,2
80 MHz to 800
MHz
d =
1,2
800 MHz to 2.5
GHz
d =
2,3
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
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
transmitterinwatts
(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:
ppp
Page 16
15
Guidance and manufacturer’s declaration – electromagnetic
emissions
The Steiss DX550 is intended for use in the electromagnetic environment specified below
the customer or the user of the Steiss DX550 should ensure that it is used in such an environment.
Emissions
Test Compliance
Electromagnetic environment –
guidance
RF
Emissions
CISPR
11
Group
1
The Steiss DX550 uses RF
energy only for its internal
function.
Therefore, itsRFemissions
are very low and are
not likely
to
cause any
interferenceinnearby electronic
equipment.
RF
Emissions
CISPR
11
Class B
The Steiss DX550 is
suitable for
use in all establishments,
including
domestic establishments
and
those directly connected
to the
public
low-voltage power supply network
that
supplies buildings
used
for
domestic
purposes.
Harmonic Emissions
IEC
61000-3-2
Class
A
Voltage Fluctuations
IEC
61000-3-3
complies
Page 17
16
Guidance and manufacturer’s declaration – electromagnetic
immunity
The Steiss DX550 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Steiss DX550 should ensure that it is used in such an environment.
Immunity
test
IEC
60601
test
level
Compliance
level Electromagnectic
environment -
guidance
Electrostatic
discharge
(ESD)
IEC
61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors shouldbewood, concrete,
or
ceramic
tile.
material,
the
relative humidity
should
be at least 30
%.
Electrical
fast
transient/burst
IEC
61000-4-4
±2 kV
for
power
supply
lines
±1 kV
for input/output
lines
±2 kV
for
power
supply
lines
±1 kV
for input/output
lines
Mains
power quality should
be that of
a
typical commercial
or hospital
environment.
Surge
IEC
61000-4-5
±1 kV
line(s)
to line(s)
±2 kV
line(s)
to earth
±1 kV
line(s)
to line(s)
±2 kV
line(s)
to earth
Mains
power quality should
be that of
a
typical commercial
or hospital
environment.
Interruptions
and
voltage variations
on
power
supply
lines
IEC
61000-4-11
*<5 %
UT
(>95 % dip in
UT)
for
0,5 cycle
*40 %
UT
(60 % dip in
UT)
for
5 cycles
*70 %
UT
(30 % dip in
UT)
for
25 c ycles
*<5 %
UT
(>95 % dip in
UT)
for
5 sec
<5 %
UT
(>95 % dip in
UT)
for
0,5 cycle
40 %
UT
(60 % dip in
UT)
for
5 cycles
70 %
UT
(30 % dip in
UT)
for
25 c ycles
<5 %
UT
(>95 % dip in
UT)
for
5 sec
Mains
power quality should
be that
of a
typical commercial
or hospital
environment. If it is essential that
the user of the Steiss
DX550 requires
continued
operation during
mains power
interruptions,
it is
recommended that the product
isss
powered
by an
uninterruptible
power
supply, such
as a
generator
or
a
battery.
Power frequency
(50/60
Hz)
IEC
61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should
be at
levels characteristicofa
typical location
in a
typical commercial
or
hospital
environment.
*NOTE: UT is the AC
mains voltage priortoapplication
of the test level.
Page 18
17
Guidance and manufacturer’s declaration – electromagnetic
immunity
Immunity
test
IEC
60601
test
level
Compliance
level
Electromagnectic
environment -
guidance
Conducted
RF
IEC
61000-4-6
Radiated
RF
IEC
61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
3 Vrms
3 V/m
Portable
and
mobile
RF communications
equipment should
be used no
closer
to any
part of the Steiss DX550, including
cables,
than the
recommended
separation
distance calculated from
the equation
applicable
to the
frequency
of the
transmitter
.
Recommended separation
distance
d =
1,2
d = 1,2 80 MHz to 800
MHz
d = 2,3 800 MHz to 2,5
GHz
Where P is the
maximum output power
rating
of the
transmitterinwatts
(W)
according
to
the
transmitter manufacturer
and d is the
recommended separation distance
in
metres
(m).
determined
by an
electromagnetic
site survey,
should
be less than the
compliance
level in
each
frequency
range.
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.
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 cannotbepredicted 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
Steiss DX550
is used exceeds
the
applicableRFcompliance
level above, the Steiss DX550
shouldbeobservedtoverify normal
operation. If
abnormal performanceisobserved, additional measures
may be
necessary, suchasreorienting
or
relocating
the
product.
b.
Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
ppp
The Steiss DX550 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Steiss DX550 should ensure that it is used in such an environment.
Page 19
13. Waste Disposal
18
14. Symbols Used
15. Expected Service Life
This
product
has been
supplied
by an
environmentally
aware
manufacturer
that
complies with
the
WEEE (Waste
Electrical&Electronic Equipment)
directive.
This
product
may
contain substances which couldbeharmful
to the
environmentifdisposed
of in
Please be
environmentally responsible
and
recycle this product
via
your recycling facility
at the end
of
its product
life.
The Steiss DX550
pump
has an
expected minimum service life
of three years.
To
maintain
the
condition
of the pump, do
ensure
that the
pumpisserviced according
to the schedule
recommendedbySteiss
.
Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse
the
Steiss DX550
system.
15.
Expected Service
Life
Type BF Protection
Against Electronic
Shock
Class II Equipment
Operating Instructions
Waste Disposal
Caution, consult
accompanying documents
Alternating Current
Manufacturer
Interference
14.
Symbols
Used
13. Waste Disposal
This
product
has been
supplied
by an
environmentally
aware
manufacturer
that
complies with
the
WEEE (Waste
Electrical&Electronic Equipment)
directive.
This
product
may
contain substances which couldbeharmful
to the
environmentifdisposed
of in
Please be
environmentally responsible
and
recycle this product
via
your recycling facility
at the end
of
its product
life.
Type BF Protection
Against Electronic
Shock
Class II Equipment
Operating Instructions Waste Disposal
Caution, consult
accompanying documents
Alternating Current
Manufacturer Interference
14.
Symbols
Used
13. Waste Disposal
This
product
has been
supplied
by an
environmentally
aware
manufacturer
that
complies with
the
WEEE (Waste
Electrical&Electronic Equipment)
directive.
This
product
may
contain substances which couldbeharmful
to the
environmentifdisposed
of in
Please be
environmentally responsible
and
recycle this product
via
your recycling facility
at the end
of
its product
life.
13. Waste Disposal
Page 20
16. Warranty
19
17. Legal Disclaimer
•
Steiss guarantees this equipment
to be free
from defectsinmaterial
and
workmanship for
up to 36
months
from
the date of
deliverytoyour
unit.
At the
manufacturer’s discretion,
we agree to
service, repair
or replace any
equipment
or part
found
to be
defective,
at no charge.
This
warranty excludes equipment
that has been damaged
during shipping,orthrough
tampering,
improper maintenance, carelessness,anaccident, negligence,ormisuse,
as well as
equipment
that has
been altered,
repairedordismantled other
than
with
the
manufacturer’s written authorization
and by
a
properly qualified technicians following approved
procedures.
In no event
shall Steissbeliable for
any
direct, indirectorconsequential
damage or loss
resulting from
the use of
this
equipment.
The
warranty
is non-transferable.
•
•
•
•
A. Terms
suchas‘Medium Risk’, ‘High Risk’
and ‘Very High
Risk’
are
descriptions
of an
individual’s risk
level of
developingapressure
sore.
(Descriptive
Risk
Levels).
These
risk levels
are
assessedbynurses
and as there
may be some
variability
between
nurse measurements/observations, descriptive risk levels should only
be used
as a guideline.
B.
Steiss
uses these
Descriptive
Risk
Levels
based on
existing market research
and
internal
study to
show
the
suitability
and
effectiveness
of the
pressure
care s
ystems provided. Internal
and
external
research is and
will
always
be
ongoing.
These
Descriptive
Risk
Levels should not
be taken as
prescriptive
criteria.
C. Steiss
mattresses/cushions should
be seen as an aid to care and DO NOT replace the need
for
good
nursing
care and
intervention. All
Steiss
products must
be used as part of an
individualised
care plan which
includes proper nursing practices
i.e.
turning/repositioning,
and
regular patient skin
assessments.
D.
Pressure-relieving equipment
alone
will not prevent pressure ulcers. Pressure ulcers
are
multi factorial
and
both external
and
internal factors
may cause them to
develop.
It is up to the
professional judgementofa
nurse
to
assess
the
risk
and
develop
a care plan
which prescribes suitable pressure reducing equipment
and
appropriate nursing
care. Some
pressure sores
are
inevitable
due to
falls
and
longer periods
of immobility.
Some
sores
can
developing below
the
surface
of the
skin.
It may
notbevisible
to the naked eye and may
therefore not
become
obvious for hours
or days after a
fallorlonger periodsofimmobilityorinjury.
For this
reason Steiss cannot guarantee
that the use of the
equipment
alone
will prevent pressure
ulcer formation.
E. The care
giver, operatinginaccordance with
the
guide for
best
clinical practice, willbeadvising
suitable
treatment
and
just using this mattress
manual as a
guide
only.
17. Legal Disclaimer
16. Warranty
•
Steiss guarantees this equipment
to be free
from defectsinmaterial
and
workmanship for
up to 36
months
from
the date of
deliverytoyour
unit.
At the
manufacturer’s discretion,
we agree to
service, repair
or replace any
equipment
or part
found
to be
defective,
at no charge.
This
warranty excludes equipment
that has been damaged
during shipping,orthrough
tampering,
improper maintenance, carelessness,anaccident, negligence,ormisuse,
as well as
equipment
that has
been altered,
repairedordismantled other
than
with
the
manufacturer’s written authorization
and by
a
properly qualified technicians following approved
procedures.
In no event
shall Steissbeliable for
any
direct, indirectorconsequential
damage or loss
resulting from
the use of
this
equipment.
The
warranty
is non-transferable.
•
•
•
•
16. Warranty
Page 21
18. Service
20
-
Report
and replace and
defective
items
SERVICE
GUIDELINES
General Condition - check these
areas:
Details:
PU Cover, Cover Welds, Screen
Print
and Base Substrate
Look for signs
of damage
Mainslea
d
Signs
of wear and tear
Pump Case &
HangingMechanis
m
Check that they are
working
properly
Check
labelling, Decal
membrane, buttons Check
for excessive
wear
fluid penetrati
on
and that there is a
good button
functionality
CPR Mechanism Check it is in
good working
order
Internal Mattress condition - check these
areas:
all T and L connectors
Check
for
wear,
strain
or damage
internal assembly
tubing
Check
for
wear,
strain
or damage
connecting
tube Check
for
wear,
strain
or damage
cells condition, including
welds Check
for
wear,
strain
or damage
Pump Function - Functional
calibration
Functional calibration check
of Pump /
Mattress
system This is a
physical
test
changing modes
and
checking
cells.
Ensure Dynamic
mode and
static
mode are
working
in the pressure
range
This is a
physical
test
changing modes
and
checking
cells.
Ensure power failure
alarm and
high
and low
pressure alarms
are
working
if fitted
Turn
power
o. and
disconnect
hose
separately
Check cell
therapeutic
pressure Use Manometer (Low mm/hg-
high
mm/Hg)
on alternation
SERVICE
EQUIPMENT
Flow gauge
Manometer
Detailsofmattress
and
pump audit
procedure
RECORD PRODUCT
DETAILS
Serial Number
Model Number
Ward or Care Establishment
Deployment
date /
first opening
date
18. Service
Page 22
21
NOTE: This is only a physical check of the mattress / pump system and by no way meant to
replace
anything
that is recommended by the MHRA EPUAP or similar professional body
.
W
e recommend you check your relevant Healthcare Body website for any further information that
may
need
to be incorporated into your checks. These may be some country specific legislation re
audit
procedures
for this kind of equipment. You may need to change and adapt this procedure to suit
your
particular
market
SERVICE NOTES
Page 23
Service Record
22
First service
due:
Steiss Authorised Service
Centre:
8
All applicable service actions
checked:
Open service actions
completed:
Date:
Genuine Steiss** parts
used:
First service
due:
Steiss Authorised Service
Centre:
7
All applicable service actions
checked:
Open service actions
completed:
Date:
Genuine Steiss** parts
used:
First service
due:
Steiss Authorised Service
Centre:
6
All applicable service actions
checked:
Open service actions
completed:
Date:
Genuine Steiss** parts
used:
First service
due:
Steiss Authorised Service
Centre:
5
All applicable service actions
checked:
Open service actions
completed:
Date:
Genuine Steiss** parts
used:
First service
due:
Steiss Authorised Service
Centre:
4
All applicable service actions
checked:
Open service actions
completed:
Date:
Genuine Steiss** parts
used:
First service
due:
Steiss Authorised Service
Centre:
3
All applicable service actions
checked:
Open service actions
completed:
Date:
Genuine Steiss** parts
used:
First service
due:
Steiss Authorised Service
Centre:
2
All applicable service actions
checked:
Open service actions
completed:
Date:
Genuine Steiss** parts
used:
First service
due:
Steiss Authorised Service
Centre:
1
All applicable service actions
checked:
Open service actions
completed:
Date:
Genuine Steiss** parts
used:
Service Record
Page 24
Last Edited June 2018
Supplier Contact Details
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