Select Medical OLA 8 User manual

User Manual
Dynamic Pressure Redistribution Mattress
& Mattress Overlay

USER MANUAL - OLA 8 & 4
TABLE OF CONTENTS
Statements and Symbols.......................................
Important Noce...................................................
Introducon...........................................................
Contact Informaon..............................................
Product Overview..................................................
Safety.....................................................................
Symbols & Denions............................................
Control Unit & Maress Parts................................
Installaon.............................................................
Operaon...............................................................
Cleaning & Decontaminaon................................
Storage..................................................................
Troubleshoong.....................................................
Maintenance..........................................................
Specicaons.........................................................
Electromagnec Compability..............................
Warranty and Service............................................
2
2
2
2
3
4
6
8
10
12
16
18
20
21
23
24
29
1

Thank you for choosing the OLA 8 or OLA 4 pressure redistribuon
system. This manual should be read carefully before using the maress
as it contains important safety and maintenance informaon to ensure
long lasng and reliable service.
INTRODUCTION
IMPORTANT NOTICE
STATEMENTS AND SYMBOLS
Before operang this medical equipment, it is important to read this
manual and understand the operang instrucons and safety
precauons. If you have any quesons regarding the use of this
equipment please contact your supplier.
Refer to manual
NB: Tips or informaon users should be aware of
Warning to highlight potenal hazards that, if disregarded, could lead to
injury or death.
CONTACT INFORMATION
For any service, warranty, sales or customer service informaon on this
product please contact your supplier or if in doubt contact Select Medical Ltd.
at the following address:
Select Medical Ltd, Unit 10 Philips Rd, Whitebirk Ind Estate, Blackburn,
BB1 5NA.
Customer Service: [phone] Sales: [phone]
Email: [e-mail]
www.selectmedical.co.uk
PRODUCT OVERVIEW
Environment
Your dynamic maress system is intended for use in the following
environments:
• A care environment where medical supervision and monitoring are
provided (e.g. nursing homes, care home, rehabilitaon facilies etc).
• A domesc environment where the maress is used to alleviate or
compensate for an injury or disability.
Intended Use
OLA 8 is an 8” replacement, dynamic pressure redistribuon system
suitable for individuals up to very high risk of developing a pressure ulcer or
for those with exisng ssue damage.
OLA 4 is a 4” pressure relieving overlay suitable for individuals up to high risk
of developing a pressure ulcer or for those with exisng ssue damage.
OLA 8 & 4 provide regular periods of pressure reducon to vulnerable ssue
areas, aiding blood and lymphac ow which is vital to maintaining healthy
ssue. The maress system is designed to be used on standard or proling
beds.
For assistance in seng up, using or maintaining your dynamic maress
system, or to report unexpected operaon refer to the contact details found
on page 2.
Features
OLA 8 & 4 Maress:
• One in two cell-cycle design giving opmum therapy
• Mul-stretch, waterproof and vapour permeable cover
• CPR pull cord for rapid deaon
• Machine washable up to 95°C
• 1 year warranty
Cauon to highlight potenal hazards that if disregarded could lead to
equipment damage or failure.
2 3

OLA 8 Control Unit (Q2-02):
• Audible low pressure alert
• Pressure adjustment for opmum therapy
• External, easy replacement pump lters
OLA 4 Control Unit (D30):
• Low pressure alert
• Pressure adjustment for opmum therapy
• External, easy replacement pump lters
• The maress system & control unit must be installed and used
in accordance with the informaon provided in this manual.
• The maress system is typically not suitable for children. If it is
to be used by a child ensure a risk assessment has been
undertaken.
• Before using the system ensure that the mains lead is free from
damage and is posioned so as not to cause an obstrucon or
trip hazard.
• Exposure of the control unit to any liquid while it is plugged in
could cause a severe electrical hazard.
• Use care when handling or transporng the control unit.
Dropping or other sudden impacts may result in damage to the
unit.
• Do not open the control unit or aempt to repair or service
the unit. Repairs and servicing should always be undertaken by
suitably trained personnel.
• If the control unit is not funconing properly, or has been
damaged, unplug the unit and take it out of service
immediately.
• Do not use the system near a heat source or naked ame.
• Do not use with hot water boles or electric blankets.
• Do not use liquids near the control unit if plugged in.
• Do not place any objects, such as blankets, on or over the
control unit.
SAFETY
General Safety
• Do not use the control unit near ammable gas or in oxygen rich
environments as this poses a re risk or risk of explosion.
• Always assess the risk of intenonal or unintenonal tampering
of the control unit.
Risk Assessment
It is the responsibility of the carer/care provider to carry out the necessary
risk assessment to ensure the safety of the paent. This should be carried out
before using the maress system.
A risk assessment should include, but is not limited to:
• Product combinaons (bed frame, maress, side rails etc.)
• Extent of ssue damage (if any)
• Entrapment
• Paent falls
• Small adults (and children)
• Paents with learning dicules
• Unauthorised people with access to the controls
Contraindicators
Paent condions for which the applicaon of pressure relief on an
alternang maress system is a contraindicaon are as follows:
• Cervical or skeletal tracon
• Unstable spinal fractures
Other contraindicaons may be relevant which are specic to the paent or
care environment.
Maress Load
4 5
OLA 8 OLA 4
Minimum Weight Limit 32kg (5 stone) 32kg (5 stone)
Maximum Weight Limit 190kg (30 stone) 114kg (18 stone)

SYMBOL DEFINITIONS: CONTROL UNIT & MATTRESS
Control Unit
Warning: beware of potenal hazard
Refer to manual: failure to do so could introduce a hazard
Type BF Applied Part
Applied Part: The parts of the device that come into physical
contact with the user/occupant in order for it to carry out its
intended funcon.
Type BF: Applied parts which are electrically isolated from earth
and other parts of the medical equipment - Complying with
specic requirements for protecon against electric shock to
IEC 60601-1
W.E.E.E Label
(Waste Electrical and Electronic Equipment)
Class II electrical device
The user/occupant is protected by at least two layers of insulaon
between the current carrying parts (e.g. mains cable) – If damage
is noced to the control unit or mains cable assembly turn o at
the mains supply and contact your provider or Select Medical Ltd.
immediately.
IP21 Protected from touch by ngers and objects greater than 12
millimeters. Protected from condensaon.
The following symbols are found on the control unit:
6 7
The following symbols are found on the maress:
Disinfect by wiping the surface using a hypochlorite soluon diluted
1000ppm
95 Machine wash up to 95°C
Tumble dry on a low seng
Do not use harsh abrasives or Phenol cleaners
Do not iron
Ensure system is dry before storing
Do not place heavy objects on surface of cover other than the
paent
Do not use when damp, ensure surface is dry before use
Do not fold. Roll pack the system
Do not use sharp objects
Only use in conjuncon with appropriate medical advice
Maress

CONTROL UNIT/MATTRESS PARTS
Control Unit
Maress
1. Top Cover
2. Air Cells
3. Male Air Connector
4. Base Cover
5. Securing Straps (elascated corner straps only on OLA 4)
6. CPR Pull Cord
89
OLA 8 - Q2-02 Control Unit OLA 4 - D30 Control Unit
1. Control Panel
2. On/O switch
3. Mains Power Cable
4. Female Air Connector Port
5. Air Filter
6. Fuse Holders
7. Cushion Bar
8. Hooks
1. Control Panel
2. On/O switch
3. Mains Power Cable
4. Female Air Connector Port
5. Air Filter
6. Cushion Bar
7. Hooks

1. Carefully open the packaging.
2. Although unlikely, please check the product for any signs of damage. Do
not use if damaged and contact your provider or Select Medical Ltd (see
page 2).
3. Place the maress on top of the bed frame (OLA 8), or on top of the
exisng maress (OLA 4), with the top cover facing upwards and the air
hose at the foot end of the bed.
4. Aach the maress to the bed frame by securing with the adjustable
straps. Addionally, OLA 4 has elascated corner straps to tuck under the
exisng maress.
5. Check the CPR pull-cord is securely in posion.
6. Using the hooks on the back of the control unit, hang the unit over the
frame/board at the foot end of the bed. If there is no foot frame/board
lay the unit on the oor, under the bed with the front control panel facing
upwards.
7. Aach the male air connector on the maress to the female air
connector port on the control unit/pump, ensuring the air hose is not
kinked or trapped between parts of the bed frame/other equipment.
8. Plug the mains cable into a suitable mains supply and switch on the
control unit. At this stage both the mains power and low pressure
indicators will illuminate.
9. The maress will start to inate and will be completely inated within
30 - 40 minutes.
10. Once fully inated, adjust the straps that aach the maress to the bed
frame, ensuring the maress is held in place securely.
11. Cover the maress loosely with a sheet, ensuring it does not interfere
with cell alternaon.
10 11
INSTALLATION
Before installing the maress system please read the warning and
cauon notes carefully. These highlight risk areas to ensure paent
safety.
• Ensure the maress is only used with compable equipment/
accessories.
• Ensure the maress is of the correct type for the paent.
• Ensure the CPR pull-cord is easily accessible at all mes.
• Ensure the plug is accessible at all mes so the maress can be
disconnected from the mains supply quickly, if required.
• Ensure the mains cable is plugged into an appropriate power
source at all mes.
• Ensure the mains cable is not taut, parcularly if being used on
a proling bed that moves up and down (check all posions).
• Ensure that the mains cable does not become compressed,
trapped or damaged by the bed frame or other equipment.
• Replace any damaged cable immediately as these cables can
create a risk of electrocuon and/or re.
• A CE marked extension cable must only be used when it is not
possible to reach a wall socket with the equipment mains cable.
• If an extension cable is used never overload it by plugging in
appliances that together will exceed the maximum current
rang stated for the extension cable.
• Do not use block adaptors.
• Ensure extension cables or sockets are not placed under the
bed frame as liquids could leak onto them posing an electrical/
re risk.
• Ensure the mains supply is compable with the control unit
(see page 23 for electrical specicaon)
• Avoid placing the maress system in direct sunlight as this
could damage the maress cover.
• On proling beds it is essenal that adjustable straps are
secured around the movable secons of the bed frame,
otherwise the maress may be damaged.
• If you are placing the control unit on the oor it is advisable to
place the unit on a rm surface.
• Ensure the mains cable is posioned so as not to cause a trip
hazard.

12 13
Maress Operaon
1. Turn on the power on the control unit. The pump starts to inate the
maress to the pressure selected on the dial.
2. The low pressure indicator (orange) will illuminate as inaon commences.
3. OLA 8 /Q2-02 only - the audible alert is acvated, press the ‘alert mute’
buon to mute the alarm and its indicator will ash.
OPERATION
Control Panel
OLA 8 - Q2-02 Control Unit
1. Pressure Adjustment Dial
2. Alert Mute/Reset
3. Low Pressure Indicator
4. Normal Pressure Indicator
1. Pressure Adjustment Dial
Turn the dial to set the system for opmum performance.
2. Alert Mute/Reset
The audible/visual alarm idenes when the pressure is low. To mute the
audible alarm press the buon. The visible alarm indicator will now ash.
Re-press the buon to reset the alarm.
3. Low Pressure Indicator
A visible indicator (orange) warns that the pressure is below an acceptable
level.
4. Normal Pressure Indicator
A visible indicator (green) idenes that the pressure has reached the
preset level.
OLA 4 - D30 Control Unit
1. Pressure Adjustment Dial
2. Low Pressure Indicator
3.Normal Pressure Indicator
1. Pressure Adjustment Dial
Turn the dial to set the system for opmum performance.
2. Low Pressure Indicator
A visible indicator (orange) warns that the pressure is below an acceptable
level.
3. Normal Pressure Indicator
A visible indicator (green) idenes that the pressure has reached the
preset level.

14 15
4. Once opmum pressure is reached (about 30-40 minutes) the ‘normal
pressure’ indicator will come on and the ‘low pressure’ indicator (and audible
alarm on the OLA 8/Q2-02 ) will turn o.
NB: If the ‘low pressure’ indicator (audible alarm) will not go o, refer to
troubleshoong on page 20.
5. Adjust the ‘pressure/comfort control’ dial to provide a comfortable
pressure level for the paent. Pressure range:
• OLA 4 / D30: 30-80mmHg
• OLA 8 / Q2-02: 20-60mmHg
NB: Hand check - to check if the pressure is adequately supporng the
paent, slide one hand between the air maress and the bed frame under
the paent’s boom. You should be able to slide the hand in-between and
the opmum range is 25 - 40mm (1” to 1.5”).
6. Using clinical judgement and with connuous monitoring of the paent
for up to 72 hours, increase or decrease the pressure levels using the dial to
suit the paents comfort levels. If possible, having regular dialogue with the
paent is key.
NB: The maress can be used in an upright posion, however the pressure
seng may need to be increased. Use clinical judgement to ensure paent
comfort and eecve pressure relief is maintained.
CPR Funcon
In an emergency rapid deaon of the maress may be required. The CPR
pull cord is located at the head end of the maress.
Using Inconnence Products with the Maress
Inconnence products, such as sheets or pads, can be used with the system,
however this may compromise the eecveness of the alternang pressure
distribuon.
Transporng the Maress & Power Cuts
If the maress is disconnected from the power supply so it can be moved, or
in the event of a mains power failure, carry out the following procedure to
maintain maress inaon:
1. Disconnect the male connector from the power unit by squeezing the two
tabs (A) and pulling away from the control unit (B).
To re-inate push the CPR cord back into the closed posion. The maress
will start to inate. Wait for opmal pressure to be reached before using the
maress.
2. Seal using the cap marked “Transport” which for safety is aached to the
male connector.
NB: Complete the acon quickly to limit air
loss.
3. Switch o the control unit.
4. Disconnect from the power supply.
5. The maress can now be moved.
• Carers/care providers should always familiarise themselves with
the posion of the CPR valve.
• If inconnence products are being used it is important to carry
out a risk assessment and regular paent skin checks.

Maress
N.B: Before aempng to clean the maress the top cover should be checked
for physical signs of damage that may lead to strike-through (ingress of uid
through cover). Staining to the underside of the top cover is a sign of
strike-through.
16 17
CLEANING & DECONTAMINATION
Cleaning
Cleaning is required regularly between paents to prevent cross infecon. It is
therefore important to clean and decontaminate the control unit and
maress following these procedures.
Control Unit
1. Check for external damage – do not use if damage is found.
2. Place the pump on a work surface and using a clean cloth wipe the outside
of the case with a prepared sodium hypochlorite soluon (1000ppm).
3. The control unit should be cleaned by starng with the cleanest parts and
systemacally moving to the direst parts. Extra care should be taken around
areas where excess dirt or dust may gather.
4. Change the cloth if it becomes dirty.
5. Once clean, wipe down with a new clean cloth moistened with clean
water to remove detergent residue.
6. Dry o with a paper towel. Always allow the surfaces to dry thoroughly
before pung back into use.
• The maress will remain inated for up to 24 hours - return the
system to the mains supply as soon as possible.
• Whilst unplugged alternang mode will not be operaonal and
pressure relief will not be provided.
• Do not remove the maress from the bed frame if the occupant
is sll on the maress.
• If it is essenal that the paent is moved whilst remaining on the
maress, the maress must be re-plugged in immediately once
the desired locaon has been reached to reduce the risk of ssue
damage.
• Never drag the maress, always carry it.
• Disconnect the mains cable from the power socket before
aempng to clean the control unit.
• Do not immerse or soak the pump.
• Do not spray any cleaning soluon directly on the surface of the
control unit.
• If any of the cleaning/washing instrucons are not followed the
product warranty will be invalidated.
• Do not use phenol based cleaning soluons, solvents, neat
bleach or abrasive products to clean the casing as this may
cause damage.
• Frequent or prolonged exposure to higher concentraon
disinfectant soluons may prematurely age the fabric cover of
the maress.
• Do not use the cover if strike-through or damage is found – risk
of cross infecon. Replace with a new top cover.
• Do not use solvents or alcohol-based cleansers e.g. Phenicol,
Hibiscrub, Clearsol, Stericol or Hycoline as these will destroy the
maress materials.
• Do not autoclave.

18 19
Decontaminaon
1. Unzip the top cover from the maress.
2. The top cover/base cover can be machine washed up to 95°C and tumble
dried on a cool seng.
3. Unsnap the air cells from the maress base on both sides.
4. Carefully clean with (1000ppm) prepared soluon of sodium hypochlorite
and allow to dry completely.
5. Make sure to disconnect all the air cells and spray the cleaning soluon on
all sides, including the connecng tubes and hoses.
6. Re-assemble the maress and lay it out at.
7. Ensure the maress is completely dry before either storing or using for
another paent.
STORAGE
Environmental Condions
The following condions should be followed when storing the maress
system:
• Ambient temperature: -25°C to +70°C
• Humidity: < 93% max, non-condensing
General Cleaning:
1. Wipe down with a clean cloth moistened with a mild detergent and diluted
in warm water (40˚C).
2. Rinse with cold clean water and a clean cloth and allow to fully dry before
use.
• The maress system must be decontaminated prior to any
storage to avoid risk of cross contaminaon.
• Do not fold, crease or stack maresses.
• Do not stack control units.
• Do not store whilst inated.
Storage
1. Detach the control unit from the maress.
2. Pull the CPR cord unl it is open.
3. Ensure there is no air trapped in the cells.
4. Lay the maress out at and roll the maress from the foot end towards
the head end.
5. Store in a sealed polythene bag to protect from dirt, debris, uids etc. with
a suitable idencaon tag.
6. Store the control unit in a separate, sealed polythene bag to protect from
dirt, debris, uids etc. with a suitable idencaon tag.

20
MAINTENANCE
General Maintenance
Select Medical recommend that frequent visual and operaonal
inspecons are undertaken. Clean the air lter, found at the back of the
control unit, once a month with mild detegent. If there are any signs of
damage, or the system is not performing as it should, withdraw it from
service unl the system has been repaired and is t for use again.
Yearly Maintenance
• Check the air lter is in good condion and replace or clean as required.
• Check that all electrical funcons operate correctly on the control unit.
• Check that all audible and visual indicators work appropriately (when
plugged in and unplugged from mains supply).
• Check that the baery is sll funconal and operates in the event of a
power loss.
• Check that the maress reaches the required pressures.
• Check the CPR connecon on the maress.
• Check the cover for tears, punctures, abrasion marks and split seams.
21
TROUBLESHOOTING
Problem Acons
Power Failure 1. Turn o the control unit to silence the alarm and unplug from
the mains supply (NB: the mute buon on OLA 8, Q2-02 does not
silence the power failure indicaon).
2. Check the mains socket is working - plug in a device that is
known to work.
3. Plug the control unit back into the wall socket.
4. Turn on the control unit. If control unit sll fails to operate:
5. Turn o the control unit at the wall & replace plug fuse.
6. Turn on the control unit. If control unit sll fails to operate:
7. Replace control unit fuses – See page 23 for fuse types.
8. Turn on the control unit. If control unit sll fails to operate, turn
o at the mains and contact your approved service provider.
Incomplete
inaon/low
pressure
1. Ensure the maress air connector is properly connected to the
control unit, is not constricted in any way and has no kinks.
2. Ensure the CPR pull-cord is rmly in place and no air is leaking.
3. Turn the unit o and then on again to clear the indicator.
If the ‘low pressure’ indicator connues to illuminate:
4. Remove the top cover and ensure there is no air leakage within
the maress – cells, tubing and connectors.
5. Turn the unit o and then on again to clear the indicator.
If a low pressure indicator is sll evident turn o at the mains and
contact your approved service provider
Alternang
mode failure
1. Turn o the control unit.
2. Disconnect the male air connector to reduce cell pressure.
3. Reconnect air connector.
4. Turn on the control unit.
5. If alternang mode is sll inoperable turn o at the mains and
contact your approved service provider.
Paent is
booming out.
1. Ensure the paent is suited to the rang of the maress.
2. Ensure the paent is centrally posioned on the maress.
3. Increase the pressure seng – Refer to ‘Maress Operaon’
pg 13-14
• DO NOT open the control unit - risk of electrocuon
• If mains plug, cable or outer casing is visibly damaged turn o at
the mains and contact your approved service engineer.
• Always disconnect the control unit from the mains power supply
prior to performing any maintenance procedures (when viable).
• No modicaon of this equipment is allowed.
• The maress system should be vacated by the paent before any
maintenance or inspecon takes place. If this is not possible due
to the paent’s mobility, care should be taken for the service
engineer not to make contact with the paent when working on
electrical items.
• Only Select Medical approved components specied for OLA 8 &
4 are to be used - if in doubt contact Select Medical Ltd or your
local distributor.
• Only authorised service personnel or Select Medical service
engineers should carry out repairs or service acvies. Failure
to do so may result in the product warranty becoming void.
• The maress system should be serviced once a year, as a
minimum.

Classicaon: Electrical shock protecon: Class II, Type BF
Applied Part: Maress
Liquid ingress protecon: IP21
Not AP or APG equipment*
Supply Rang:
Fuse Rang:
Mains Plug:
230V, 50Hz, 12W
Mains Plug – 5A
Q2-02 Control Unit - T1A, 250VAC
D30 Control Unit - T1A, 250VAC (internal)
Type G/BS1363
Maress Dimensions (inated):
Maximum Paent Weight:
No. of cells:
Alternang Therapy:
Cycle Time:
Pressure Range:
OLA 8: 2000mm x 900mm x 200mm
OLA 4: 1850mm x 900mm x 102mm
OLA 8: 190kg (30 stone)
OLA 4: 114kg (18 stone)
OLA 8: 20 OLA 4: 17
AB paern
12 minutes
OLA 8 / Q2-02: 20-60mmHg
OLA 4 / D30: 30-80mmHg
Control Unit Dimensions:
Control Unit Weight:
OLA 8: (L) 206mm x (W) 280mm x (D) 104mm
OLA 4: (L) 260mm x (W) 140mm x (D) 100mm
OLA 8: 2.6kg OLA 4: 2.4kg
Cover Material:
Cell Material:
Base Material:
Polyurethane coated mul-stretch nylon
Nylon/PVC
OLA 8: Nylon/PU
OLA 4: PVC mesh
Transport and Storage Condions:
Operaonal Condions:
Atmospheric Pressure:
Operang Altude:
Polluon:
UV:
Noise level:
Ambient Temp: -25°C to +70°C
Humidity: < 93%, non-condensing
Ambient Temp: +5°C to +40°C
Humidity 15% - 93%, non-condensing
700hPa to 1060hPa
≤ 2000m
Degree 2
Intended for indoor use only
<40dB(A)
Warranty: 1 year
Safety Standards: IEC 60601-1: 2005
IEC 60601-1-2:2007
IEC 60601-1-11:2010
* Not suitable for use in the presence of ammable anaesthec mixtures with air, oxygen or
nitrous oxide.
SPECIFICATION
22 23
The control unit is tested and CE
marked in line with Medical Device
Direcve 93/42/EEC
• Check for signs of of strike-through (uid ingress) to the underside of the
cover.
• Check that all piping and cells within the maress are in good condion
and that there is no kinking evident.
• Check the control unit housing is not cracked or damaged, if damaged the
control unit must be removed from operaon immediately.
• Check that the mains cable and plug are in good condion, if either is
damaged it must be replaced with a complete assembly, the plug must
never be re-wired.
Disposing of Parts
When the electrical system has come to the end of its useful life, contact your
provider or Select Medical Ltd. (see pg 2) to arrange for collecon,
alternavely follow local recycling and W.E.E.E. (Waste Electrical and
Electronic Equipment) policies.
The metal and plasc components used in both the maress and control unit
are also to be separated and disposed of following local recycling policy as
these can also be recovered and reused/recycled.
• The control unit should not be disposed of in general municipal
waste. Some of the electrical components could be harmful
to the environment and where viable the components can be
recovered and reused/recycled.
• The maress system is to be decontaminated before disposal to
avoid risk of cross contaminaon.

Requirements according to IEC 60601-1-2:2007
OLA 8 & 4 are intended for use in the electromagnec environment specied
below.
Guidance and manufacturer’s declaraon –
electromagnec emissions
Emission test Compliance Electromagnec
environment – guidance
RF emission
CISPR 11
Group 1 The control unit uses RF energy only for
its internal funcon. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emission
CISPR 11
Class B OLA 8 & 4 are suitable for use in all
establishments, including domesc
establishments and those directly
connected to the public, low-voltage
power supply network that supplies
buildings used for domesc purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuaons/
icker emissions
IEC 61000-3-3
Complies
24 25
ELECTROMAGNETIC COMPATIBILITY
• The control unit should not be used next to or stacked with
other equipment where possible. If this is unavoidable the
control unit should be observed to verify normal operaon.
The control unit has been designed to meet the EMC requirements of IEC
60601-1-2:2007. This standard denes the levels of immunity to
electromagnec interferences as well as maximum levels of electromagnec
emissions for medical devices. They are in place to provide reasonable
protecon against dangerous interference in a medical or residenal
environment.
Immunity to electromagnec interference - this refers to the levels of
electromagnec interference that the control unit can withstand from
nearby sources radiang radio frequency (RF) energy (e.g. from mobile
phones, network devices etc).
Electromagnec emissions - this refers to the levels of RF energy the control
unit emits.
The immunity levels are set out in the following manufacturers guidance. If
these levels are exceeded then the system may not operate correctly or stop
operang. It is important therefore to try to ascertain the source of the
interference by turning nearby equipment o. There are simple measures
that can be taken to correct the problem:
• Remove or relocate the interfering equipment
• Increase the separaon distance between the control unit and the
interfering equipment
The RF emissions are set out in the following manufacturers guidance. The
control unit generates very low RF energy, however interference to sensive
equipment is sll possible. If interference to radio/tv recepon and/or other
equipment is suspected, turning the control unit o and on can determine if
this is the case. There are simple measures that can be taken to correct the
problem:
• Relocate the receiving antenna
• Increase the separaon distance between the control unit and aected
equipment
Due to the increasing number of wireless devices, such as laptops and mobile
phones, it is important that the system is installed following the
manufacturer’s guidance to ensure connued and reliable operaon.

26 27
Guidance and manufacturer’s declaraon –
electromagnec immunity
Immunity test IEC 60601 test
level
Compliance
level
Electromagnec 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 communicaons
equipment should be used no closer to
any part of the control unit, including
cables, than the recommended separaon
distance calculated from the equaon
applicable to the frequency of the
transmier.
Recommended separaon distance
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
Where P is the maximum output power
rang of the transmier in was (W)
according to the transmier manufacturer
and d is the recommended separaon
distance in metres (m). Field strengths
from xed RF transmiers, as determined
by an electromagnec 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:
N.B: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not
apply in all situaons. Electromagnec propagaon is aected by absorpon and reecon
from structures, objects and people.
* Field strengths from xed transmiers cannot be predicted theorecally with accuracy. To
assess the electromagnec environment due to xed RF transmiers, an electromagnec
site survey should be considered. If the measured eld strength in the locaon in which the
OLA 8 or 4 is used exceeds the applicable RF compliance level above, OLA 8 or 4 should
be observed to verify normal operaon. If abnormal performance is observed, addional
measures may be necessary, such as re-orienteering or relocang the system.
** Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Guidance and manufacturer’s declaraon –
electromagnec immunity
Immunity test IEC 60601 test level Compliance level Electromagnec
environment –
guidance
Electrostac
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be
wood, concrete or
ceramic le.
If oors are
covered with
synthec material,
the relave
humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV dierenal mode
±2 kV common mode
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) ± 1 kV dierenal mode Mains power
quality should be
that of a typical
commercial or
hospital
environment.
Voltage
dips, short
interrupons and
voltage
variaons
on power supply
input 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 cycles
<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 cycles
<5% UT (>95% dip in
UT) for 5 sec
Mains power
quality should be
that of a typical
commercial or
hospital
environment.
PPower
frequency
(50/60Hz)
magnec eld
IEC 61000-4-8
3A/m 3A/m Power frequency
magnec elds
should be at levels
characterisc of a
typical locaon in a
typical commercial
or hospital
environment.
N.B: UT is the a.c. mains voltage prior to applicaon of the test level.

WARRANTY & SERVICE
28 29
OLA 8 & 4 are intended for use in an electromagnec environment in which
radiated RF disturbances are controlled. The customer/user of OLA 8 or 4 can
help prevent electromagnec interference by maintaining a minimum
distance between portable and mobile RF communicaons equipment
(transmiers) and the OLA 8 & 4 system as recommended below, according to
the maximum output power of the communicaons equipment.
Recommended separaon distances between portable and
mobile RF communicaons equipment and the control unit
Rated maximum output
power of transmier (W)
Separaon distance according to frequency of transmier (m)
Electromagnec environment – guidance
150 KHZ TO 80 MHZ
D = 1.2√P
80 MHZ TO 800 MHZ
D = 1.2√P
800 MHZ TO 2.5
GHZ D = 2.3√P
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 transmiers rated at a maximum output power not listed above, the recommended
separaon distance d in metres (m) can be esmated using the equaon applicable to the
frequency of the transmier, where P is the maximum output power rang of the transmit-
ter in was (W) according to the transmier manufacturer.
N.B: At 80 MHz and 800 MHz, the separaon distance for the higher frequency range
applies. These guidelines may not apply in all situaons. Electromagnec propagaon is
aected by absorpon and reecon from structures, objects and people.
• Select Medical Ltd guarantees this equipment under normal use for a
period of 1 year aer delivery to the original purchaser, proof of
purchase must be presented with any claim.
• For any equipment returned within the warranty period and proven to be
defecve we agree to either:
a) correct the defect by product repair
b) replace the product with one of the same or similar design or
c) refund the purchase price, without charge.
Repaired or replaced parts and products are warranted for the remainder
of the original warranty period. You will be charged for repair or
replacement of the product made aer the expiraon of the warranty
period.
• This warranty excludes equipment damage or failure through acts of god,
an incidence of excess voltage or current, shipping, tampering, improper
maintenance, carelessness, accidental damage, negligence or misuse,
or products which have been altered, repaired or dismantled other than
with the manufacturer’s wrien authorizaon and by its approved
procedures and by properly qualied technicians.
• In no event shall Select Medical be liable for any direct or indirect
damages or losses resulng from the use of the equipment.

Contact Information
T: 01254 668899 | E: [email protected]
www.selectmedical.co.uk
Registered in England No. 4281283 | VAT Reg No. 785 7314 91