User Manual - Talley Group

User Manual - Talley Group
...reducing avoidable harms
FUSION™
Mattress and Cushion Systems
User Guidelines
Explanation of Label Symbols and
Statements
Caution
Protect from heat and
radioactive sources
Refer to instructions of use /
booklet
Temperature limitation
Humidity limitation
Medical Devices Directive
93/42/EEC
Atmospheric pressure limitation
North America ETL listed
Suitable for connection to type
BF applied parts
Class II Equipment (Double
Insulated)
Do not dispose of with the
normal household waste
(please refer to www.
talleygroup.com for further
details)
WARNING
This is a statement that alerts
the user to the possibility of
serious injury or other adverse
reactions with the use or
misuse of the device
CAUTION
This is a statement that alerts
the user to the possibility of
a problem with the system
associated with its use or
misuse
Manufacturer
Operating Instructions
Date of Manufacture
Fragile, handle with care
Keep dry
1
IP21
IP: Ingress Protection
2: Protection against fingers or
other object not greater than
80mm in length and 12mm in
diameter
1: Protection from vertically
dripping water
Contents
Page
EXPLANATION OF LABELS SYMBOLS AND STATEMENTS
1
INTRODUCTION2
CAUTIONS AND WARNINGS INFORMATION
3
INSTALLATION AND USER GUIDELINES
5
CARE AND MAINTENANCE
8
FAULT FINDING
10
SPECIFICATIONS12
EMI/EMC STATEMENT AND MANUFACTURER’S DECLARATION14
Introduction
Thank you for choosing to use a Talley pressure area care product from the FUSION™ range,
effective for the prevention and management of pressure ulcers.
The FUSION HYBRID™ mattress combines the comfort and pressure reducing properties of
high performance foam with the clinically proven pressure relieving benefits of a 1-in-2 active
alternating air pressure cycle, all in the same mattress. Used alone, the mattress provides
comfort and pressure care for patients at elevated risk of pressure damage. Once the power
unit is connected, the mattress provides all the benefits associated with an active 1-in-2 cell
cycle alternating air pressure mattress. The versatile FUSION HYBRID™ is suitable for patients
at all risk levels, providing the ability to step up or down according to the level of patient care
required throughout their treatment.
Benefitting from the same features as the mattress, the FUSION HYBRID™ cushion can be
used with or without the power unit depending on the user’s requirement and offers the same
pressure reducing/pressure relieving qualities for when the user is seated out of bed.
The FUSION RESPONSE™ mattress replacement system combines responsive air flow
distribution with high performance foam to provide a support surface that offers reactive
therapy by distributing the patient’s weight over the surface area, reducing average interface
pressures and providing high levels of comfort.
2
Cautions and Warnings
CONTRAINDICATIONS FOR USE
Alternating pressure therapy should not be used for patients with unstable fractures, gross
oedema, burns or an intolerance to motion.
lThere are no special skills required to operate the system.
lThe medical professional is responsible for applying his/her best medical judgment when
using this system.
lSelect correct setting for therapy required. Care should be taken not to accidently change
pressures once set as the efficiency of the therapy may be reduced. This could also be
caused by pets, pests or children.
lThe electricity supply is of the type indicated on the power unit
lCheck the mains lead is free from damage and is positioned so as not to cause an
obstruction, or injury, e.g. strangulation.
lEnsure the mains lead or pump cannot become trapped or crushed, e.g. via raising or
lowering of bed or bed rails or any other moving object.
lThe power unit must only be used with a suitable approved cord and plug set as supplied
by Talley.
lThe system is not used in the presence of flammable anaesthetics
lSuitable for continuous use.
lNot suitable for sterilisation.
lDo not position the power unit to make it difficult to disconnect the power supply, plug or
mattress.
lDo not place device on or near a heat source.
lDo not use with hot water bottles or electric blankets.
lThe materials used in the manufacture of all components of the system comply with the
required fire safety regulations.
lTalley advice against smoking whilst the system is in use, to prevent the accidental
secondary ignition of associated items which may be flammable, such as bed linen.
lDo not allow sharp objects to penetrate the mattress/cushion material.
lDo not modify the mattress, cushion or power unit in any way.
lDo not store in damp conditions.
lNot for use in an oxygen enriched environment.
lNot for use in an outdoor environment.
3
lIntended for home healthcare use and professional healthcare facility environments
where operators with medical training are continually available when patients are
present.
lThe power unit is intended to be hung over the bed’s footboard.
lWireless equipment such as mobile phones should be kept at least 10 feet or 3.3 meters away
from the equipment.
lDo not connect to any other medical device or equipment.
lRisk of fire if incorrect fuse used.
lThe mattress, cushion and pump should be cleaned between patient use, please refer Care
and Maintenance section for all warnings and cautions.
lMattress/cushion must be properly set up as directed.
lCheck periodically to ensure patient support and comfort, adjusting the Comfort Control
setting if desired.
lAll hoses must be free of kinks, twists, properly connected and positioned so as not to cause
an obstruction or injury.
lIn order for the alternating air pressure mattress/cushion to operate effectively, please avoid
placing objects on the surface that may obstruct the movement of air between the cells. For
the same reason, please discourage people from sitting on the edge or on the end of the
mattress whilst it is in use.
l Do not use abrasive cleaners, phenol disinfectants, solvents or alcohol-based cleansers,
e.g. Dettol, Phenicol, Hibiscrub, Clearsol, Stericol, Hycoline, as these may destroy the
cover materials*.
lDo not place heavy objects on the surface of foam mattresses/cushions when not in use.
lIt should be noted that the use of a cushion will increase the patient’s seated height by
approximately 5cm, and care should be taken to ensure the patient’s comfort and security
regarding height of foot and arm rests.
lThe system is used as part of a pressure ulcer prevention program, not solely relied upon for
this purpose.
lThe above warnings, cautions and any safety considerations should be observed on a routine
and regular basis, not only upon installation.
4
Installation and User Guidelines
INSTALLING MATTRESSES
1.
All mattresses: Remove any existing mattress from the bed frame (the FUSION™
mattresses are intended to completely replace the bed mattress).
2.
Place the mattress on the bed frame/bed base. Ensure the printed cover is uppermost
and the mattress hose can exit at the foot end on the right hand side, if applicable. The
FUSION HYBRID™ and FUSION RESPONSE™ mattresses are now ready to use as a static
foam mattress.
3.
Powered mattress only: If using the FUSION HYBRID™ as a powered mattress, suspend
the power unit from the foot board of the bed having first adjusted the hanger brackets as
instructed at the rear of the unit. Alternatively the power unit may be placed on the floor.
4.
The mattress air supply hose can be found at the foot
end of the mattress under the mattress cover skirt.
Attach the mattress air supply hose to the power
unit by matching up the button on the mattress
hose connector with the alignment notch on the
power unit connection port and pushing together
(Fig. 1). Ensure that this has been correctly clicked
into place otherwise a leak may occur.
Fig. 1
6.
Plug the smaller end of the power lead into the left
hand side of the power unit, and the other end into mains outlet in wall.
Ensure that the mains lead and tubing cannot become trapped in the bed frame (the
mattress includes cable management loops for routing of the mains lead).
7.
Switch the power on at the outlet, and at the side of power unit adjacent to the power
lead entry.
8.
The system will display STARTING, then INITIALISING whilst the mattress inflates (this
will take approximately 2 minutes).
Note: It is important that during the INITIALISING phase the mattress connector
is not disconnected from the power unit. If this is done, the power unit must
be switched off, MUTE button pressed when the sounder is heard, the mattress
connector re-engaged, and the power unit restarted. If UNCALIBRATED is displayed when
switched on, the system will continue to operate but should be recalibrated as soon as
possible.
9.
Allow the mattress to inflate before positioning the patient on the mattress. If, however,
the patient is already in-situ, having been using the foam mattress without power, the
mattress will still inflate and there is no need to disturb the patient.
10.Once
5
“click”
inflated
the
system
will
automatically
default
to
ACTIVE
mode.
The comfort setting can be adjusted using the up and down arrow buttons (see
COMFORT CONTROL on page 6).
NB. The power unit will automatically lock 2 minutes after last button operation
when running to prevent inadvertent operation of button functions (except MUTE), as
indicated by ‘ ’ on the display screen. Press and hold the MUTE/UNLOCK button until
power unit beeps if further button operation is needed (i.e. change of therapy mode or
comfort setting).
11. Place the carry bag and user manual in a safe place for future use.
INSTALLING CUSHION
The FUSION HYBRID™ cushion can be used with or without the power unit depending on the
requirements of the user. Place the cushion on a chair, ensuring that it is placed the correct
way up with the BACK labelling facing the back of the chair. The cushion features a non-slip
base for security in the chair. If choosing to use the cushion with the power unit, follow the
connection instructions described in points 4. to 11. above (the cushion will take approx. 30
seconds to inflate).
It should be noted that the use of a cushion will increase the patient’s seated height by
approximately 5cm, and care should be taken to ensure the patient’s comfort and security
regarding height of foot and arm rests.
OPERATION BUTTONS
The operation buttons on the face of the power unit provide the following functions.
COMFORT CONTROL
Air pressure is regulated within each of the cells throughout the cycle so that support,
posture and therapy are constantly maintained at optimum levels, in response to
patient weight, movement and position. Equalisation of cell pressure automatically
takes place at each stage of the 1-in-2 cycle, again to ensure precise pressure
and therapy is provided. The automatic default comfort setting is MEDIUM. However, if the
patient prefers a firmer or softer mattress, increase or decrease the comfort control setting
accordingly using the UP and DOWN arrow buttons (SOFT/MEDIUM/FIRM). The comfort setting
is shown on the display screen. Check periodically to ensure patient support and comfort.
DATA
Pressing the DATA button at any time switches the display into DATA mode. Use the
up and down arrow buttons to scroll through the product data and user information
set. Pressing the DATA button again returns the display to the previous mode.
NB. Used for accessing information only, does not affect mode of operation.
MUTE/UNLOCK
Press to silence the sounder and to clear the message from the display screen. The
power unit will automatically lock 2 minutes after the last button operation when
running to prevent the inadvertent operation of button functions (except MUTE), as indicated
by ‘ ‘ on the display screen. Press and hold the MUTE/UNLOCK button until the power unit
beeps if further button operation is needed (i.e. comfort setting). The power unit will lock
again 2 minutes after the last button operation.
NB. After power failure/switching the power off, pressing MUTE cancels the system’s previous
settings. When power returns the default setting of ACTIVE mode, MEDIUM comfort setting
is invoked. (Note that previous settings are automatically cancelled if the duration between
switch off and switch on is greater than 12 seconds. If power returns before a period of 12
seconds has passed and the MUTE button has not been pressed, the system will return to
the previous mode of operation.)
MAXIMUM USER WEIGHT GUIDELINES
FUSION HYBRID™ mattress: 250kg (39 stone) max.
FUSION RESPONSE™ mattress: 250kg (39 stone) max.
FUSION HYBRID™ cushion: 150kg (24 stone) max.
CPR FACILITY (Fig. 2)
For rapid deflation of the powered mattress, press the
button on the mattress hose connector and pull the
mattress hose away from the power unit to disconnect.
The FUSION™ mattresses can be used on profiling bed
frames, slatted frames, in-filled frames and divans.
Back rests or pillows for support should be placed beneath
the mattress to allow uninterrupted body contact with the mattress surface.
Fig. 2
When a bottom sheet is added to the mattress, ensure that it is left loose to allow the
mattress surface to conform with the patient’s body as much as possible. Avoid using fitted
sheets. The use of incontinence sheets / excessive bedding beneath the patient may reduce
the pressure reducing/relieving effect of the mattress.
To remove air from the mattress when dismantling the system, use the CPR facility as
described above.
Care should be taken when raising and lowering bed safety side rails in order to avoid
possible interference with the mattress air supply hose, if applicable.
A gap of 2.5cm on either side of the mattress should not be exceeded when side rails
are deployed.
7
Care and Maintenance
COVER
Always keep the mattress/cushion cover as clean as is practicable. The material is waterproof
and vapour permeable.
l Inspect top cover for signs of damage or wear which could result in the contamination
of the interior, e.g. tears, holes, damage to seams or zips, underside staining, etc. The
frequency of these checks should be at each decontamination process, i.e. between
patients or patient occupancy (or weekly for longer term patients).
l Care should be taken to avoid puncturing cover with objects such as needles, scalpels,
pat slides, acrylic nails, etc.
l The cover may be removed and cleaned in accordance with The Revised Healthcare
Cleaning Manual June 2009 subject to the following action: Following the use of a
detergent and or disinfectant solution the mattress cover should be rinsed with clean
water using a clean cloth and allowed to dry.
l Frequent or prolonged exposure to high concentrations of aggressive disinfectant
solutions will reduce the useful life of the mattress/cushion cover.
l Where high concentration disinfectants e.g. > 10,000ppm chlorine releasing agent
(e.g. Haztab or bleach) or combined cleaning/chlorine releasing agent (e.g. Chlorcleam,
Actichlor) and detergent solutions are used to remove blood or other body fluids,
mattresses/cushions should be thoroughly rinsed with clean water to remove any
residues. This will help prevent any possible long term compatibility issues associated
with disinfectant residues*.
l Alternatively disinfection may be achieved by laundering cover at temperatures not
exceeding 65 C for 10 minutes or 73 C for 3 minutes which may include a chlorine rinse.
l Do not use abrasive cleaners, phenol disinfectants, solvents or alcohol-based cleansers,
e.g. Dettol, Phenicol, Hibiscrub, Clearsol, Stericol, Hycoline, as these may destroy the
cover materials*.
l Do not iron.
l Ensure that the mattress/cushion cover is thoroughly dried before remaking the bed or
placing in storage.
0
0
INTERIOR COMPONENTS
l Check air cells and mattress/cushion interior for signs of damage or contamination,
e.g. staining or evidence of fluid ingress. The frequency of these checks should be at
each decontamination process, i.e. between patients or patient occupancy (or weekly
for longer term patients).
l Care should be taken to avoid puncturing air cells with objects such as needles, scalpels,
pat slides, acrylic nails, etc.
l The individual cells can also be wiped clean with a mild antiseptic solution*.
l All cells are replaceable and can be obtained easily from Talley.
l Do not immerse the mattress/cushion in water or wet the foam components.
8
POWER UNIT
Always disconnect the power unit from the electricity supply before carrying out maintenance,
repairs, servicing or cleaning. Check all electrical connections and power lead for signs of
excessive wear. The power unit can be wiped down with detergent or disinfectant solution or
wipe*. Do not use solvents. Unsuitable for sterilisation. Dispose of the pump / mattress /
cushion in accordance with the local regulations including WEEE requirements.
* In line with the MHRA Medical Device Alert (MDA/2013/019), Talley advises customers to
use pH neutral, high level disinfectant cleaning products to sanitise reusable medical devices
to prevent damage to materials and the degradation of plastic surfaces after prolonged
use. The use of inappropriate cleaning and detergent materials on medical equipment
could damage surfaces and may compromise the ability to decontaminate medical devices
adequately or may interfere with device function. Talley recommends the use of TECcare®
CONTROL antimicrobial wipes and fluid to clean and decontaminate all products it supplies
to health and social care facilities. TECcare® CONTROL products provide class leading broad
spectrum, high level disinfection with an exceptional safety profile. Being pH neutral TECcare®
CONTROL can be universally used on all hard and soft surfaces without any detrimental
effect. TECcare® CONTROL is CE marked for cleaning medical equipment.
SERVICING
Once the initial guarantee period expires, Talley recommend that all power units should be
serviced annually or as indicated by the ‘hours to service’ display. The unit contains no user
serviceable parts and should only be serviced by either Talley or an authorised dealer. Talley
will make available on request service manuals, component parts lists and other information
necessary for Talley, an authorised dealer or a competent electrical engineer to repair or
service the system. Talley’s standard terms and conditions apply to all sales. A copy is
available on request. For service, maintenance and any questions regarding this, or any other
product, please contact Talley.
It is the customer’s responsibility to ensure the following prior to collection:
l the system is cleaned of any obvious contaminants.
l contamination status is documented.
l assistance is given to Talley personnel to bag the equipment if the mattress has been in
a known or suspected infectious environment.
TRANSPORT AND STORAGE
9
Handle with care. Please report instances of damage or impact to Talley Service Department.
Transport
–25 °C without relative humidity control; and
+70 °C at a relative humidity up to 93 %, non-condensing.
An atmospheric pressure range of 700 hPa to 1 060 hPa.
Suitable for all standard modes of transport when in the correct packaging.
OPERATIONAL CONDITIONS
A temperature range of +5 °C to +40 °C;
A relative humidity range of 15% to 93%, non-condensing; and
Operational Atmospheric Pressure: 700 hPa to 1060 hPa
Suitable for pollution degree 2
Operational altitude ≤ 2 000 m
IP Rating: IP21 pump only
TRANSPORTATION OF MATTRESS SYSTEM
The mattress should be transported flat and not rolled. Mattresses should not be stored more
than 6 high as this can potentially be a safety hazard when handling. To protect the covers,
mattresses should be packed in minimum 200 micron clear polythene.
MANUFACTURER’S GUARANTEE
The FUSION™ power units and mattress are covered by a 24 month manufacturer’s guarantee.
The intended design life is 5 years if fully serviced.
Fault Finding
The power unit can be reset by pressing the MUTE button once. This also silences the
sounder and clears the message from the display screen. All systems have a fault log that
records the last 5 faults via the DATA display mode. If problems reoccur contact Talley.
AC FAIL fault – indicates a mains power failure, a sounder will be heard if power is
interrupted, e.g. power unit switched off, power cut, disconnection of mains lead. Press MUTE
or re-connect to power supply.
ROTOR SYSTEM fault – indicates the automatic sequential cycle has stopped or there is a
fault in the system. Switch power off, press MUTE button, then switch power on again. If the
fault re-occurs, contact Talley.
LOW PRESSURE fault – indicates pressure has fallen below the minimum allowable levels.
Check that the hose is connected to the power unit correctly. Check that the internal cells
are connected and that no cell is punctured. Press the MUTE button to clear the message
and to silence the sounder. If the fault re-occurs, contact Talley.
EMI fault – indicates that the unit detects the pressure sensor amplifier is adversely affected
by external RF fields. This will clear when interference ceases.
OTHER FAULTS
PUMP OR TRIAC fault - indicates a pump control failure or an open pump coil fault. Should
this occur, contact Talley.
10
UNCALIBRATED - contact Talley for recalibration.
If you have any queries relating to this system please contact Talley or your local authorised
dealer.
LOW
PRESSURE
FAULT
ROTOR
SYSTEM
FAULT
PUMP or
TRIAC
FAULT
Check mattress air
supply hose is
correctly attached to
power unit (i.e.
mattress hose
connector is correctly
aligned with power
unit connector and
has clicked into
place).
Reset power unit by
pressing
MUTE button.
Reset power unit by
pressing
MUTE button.
If fault persists,
power unit requires
inspection.
If fault persists,
power unit requires
inspection.
MATTRESS NOT
INFLATING
UNCALIBRATED
Check air cells and
tubing are intact.
(no sounder)
11
Reset power unit by
pressing
MUTE button.
Check that mains
power is connected,
indicated by
illuminated LCD
display, and allow at
least 2 minutes for
mattress to inflate.
If fault persists,
system requires
inspection.
Reset power unit by
pressing
MUTE button.
FAULT
The system will
continue to operate
but contact Talley for
recalibration as soon
as possible.
AC FAIL
FAULT
Indicates mains
power failure. Silence
sounder by
pressing
MUTE button.
Reconnect to power
supply to continue
using mattress.
EMI
FAULT
Caused by external
RF fields. Fault will
clear when
interference ceases.
Specifications
POWER UNIT
(Medical Device Classification: Class IIa)
Model Ref.:
Type 19
Construction:
ABS Plastic
Dimensions:335mm/13.2” x 233mm/9.2” x 165mm/6.5”
Weight:
3.4 kg / 7.5 lbs
Mains Cable:
5 metres / 16.5’
For the USA:- only a hospital grade attachment plug with a 15A
NEMAP 5-15 configuration and 18AWG hospital grade flexible cord is
to be used, as supplied by Talley.
Electricity Supply:
230V ~ 50Hz (CE marked)
120V ~ 60Hz (cETLus listed)
230V ~ 60Hz
Rated Input:
9.4 VA
Fuse Rating:
T500mA 250V HRC (ceramic) 5 x 20 mm
IP Rating:
IP21
Cycle Time:
8 minutes (continuous)
FUSION HYBRID™ MATTRESS
(Medical Device Classification: Class IIa)
Construction:
FOAM FRAME: Combustion modified polyether foam
RX33/190
HEAD SECTION: Combustion modified polyether foam RX39/120
CELLS: PU film encasing combustion modified polyether foam
RX39/120 inner cells
COVER: PU coated stretch 240g/m Polyamide (with PU coated
stretch 215g/m Polyamide non-slip base)
Number of Cells:
18 (10 torso cells + 8 heel zone cells + cut foam head section insert)
Mode of Operation: Reactive static foam / Active 1-in-2 cell cycle
Dimensions*:
1970mm x 880mm x 170mm
Weight:11.9kg
2
2
FUSION HYBRID™ CUSHION
(Medical Device Classification: Class IIa)
CELLS: PU film encasing combustion modified polyether
foam RX39/120 inner cells
COVER: PU coated stretch 240g/m Polyamide (with PU coated
stretch 215g/m Polyamide non-slip base)
Number of Cells:
7
Mode of Operation: Reactive static foam / Active 1-in-2 cell cycle
Dimensions*:
430mm x 430mm x 65mm
Weight:1.1kg
Construction:
2
2
(*UK standard size - approx.max. top surface, inflated +/- 15mm)
12
FUSION RESPONSE™ MATTRESS
(Medical Device Classification: Class I)
Construction:
FOAM FRAME: Combustion modified polyether foam
RX33/190
HEAD SECTION: Combustion modified polyether foam RX39/120
CELLS: PU film encasing combustion modified polyether foam
RX39/120 inner cells
COVER: PU coated stretch 240g/m Polyamide (with PU coated
stretch 215g/m Polyamide non-slip base)
Number of Cells:
18 (10 torso cells + 8 heel zone cells + cut foam head section insert)
Mode of Operation: Reactive static foam with Responsive Airflow Distribution
Dimensions*:
1970mm x 880mm x 170mm
Weight:11.9kg
2
2
Talley manufacture products to comply with National and International safety standards and
are certified to ISO9001, ISO13485 and Directive 93/42/EEC. Every care has been taken
to ensure that the information contained in this manual was correct at the time of going to
press. However, Talley reserve the right to modify the specification of any product without
prior notice in line with a policy of continual product development. Our standard terms and
conditions apply.
13
EMI/EMC Statement and Manufacturer’s Declaration
This equipment has been tested and found to comply with the limits of EN 60601-1-2.
These limits are designed to provide reasonable protection against harmful interference in both a
medical and residential environment. This equipment generates, uses and can radiate radio frequency
energy and, if not used in accordance with manufacturer’s instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception or other
equipment, which can be determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one of the following measures:
l Reorient or relocate the receiving antenna.
l Increase the separation between the equipment.
l Connect the equipment to an outlet on a circuit different from that to which the receiver or equipment
was connected.
The equipment having been tested to operate within the limits of electromagnetic compatibility.
(Immunity to interference from nearby sources radiating radio frequency energy). Sources exceeding
these limits may give rise to operation faults. Where possible the system will sense the interference and
if it is of short duration transparently take countermeasures whilst operating near normally, or failing
this will issue a warning and take measures for the continued safely of the user. Further increased levels
of energy may cause the system to stop operating, continuously generate random faults or continuous
resets.
Try to ascertain the source of the interference by turning nearby or suspect equipment off, and see if the
interference effects stop. In any such event the user is encouraged to try to correct the interference by
one of the following measures:
l Have the interfering equipment repaired or replaced.
l Reorient or relocate the interfering equipment.
l Increase the separation between the equipment and the possible source of the interference.
l Connect the equipment to an outlet on a circuit different from that to which the interfering equipment
was connected.
Information regarding Electro Magnetic Compatibility (EMC) according to IEC60601-1-2
With the increased number of electronic devices such as PC’s and mobile telephones, medical devices
in use may be susceptible to electromagnetic interference from other devices. The EMC (Electro
Magnetic Compatibility) standard IEC60601-1-2 defines the levels of immunity to these electromagnetic
interferences. From the other hand, medical devices must not interfere with other devices. IEC606011-2 also defines the maximum levels of emissions for these medical devices. The FUSION™ conforms to
this IEC60601-1-2 standard for immunity and emission. Nevertheless, special precautions need to be
observed:
l
l
l
l
The FUSION™ needs to be installed and put into service according to the EMC information below.
The FUSION™ is intended for use in the electromagnetic environment specified in the tables below.
The user of the FUSION™ should assure that it is used in such environment.
In general, although the FUSION™ complies too the EMC standards, it can be affected by portable
and mobile RF communications equipment (such as mobile telephones).
The FUSION™ should not be used adjacent to or stacked with other equipment. In case adjacent or
stacked use is necessary, the FUSION™ should be observed to verify normal operation.
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions (IEC 60601-1-2)
Emissions Test
Compliance
RF emissions CISPR 11
Class B
Harmonics emissions 61000-3-2
Class A
Voltage fluctuations / flicker emissions 61000-3-3
Complies
Electromagnetic environment - guidance
The FUSION™ systems are suitable for use in all establishments,
including domestic establishments and those directly connected to
the public low-voltage pump supply network that supplies buildings
used for domestic purposes.
14
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2)
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst IEC
61000-4-4
± 2 kV For mains supply lines
± 1kV For input/output lines
± 2 kV For mains supply lines
± 1kV For input/output lines
Mains supply quality for the mains adapter should be
that of a typical commercial and/or hospital environment.
Surge
IEC61000-4-5
± 1kV line(s) to line
± 1kV line(s) to line
Mains supply quality for the mains adapter should be
that of a typical commercial and/or hospital environment.
Mains power quality should be that of a typical
commercial and/or hospital environment. If the user
of the FUSION™ requires continued operation during
70%Ur (30% dip in Ur) for 25 cycles 70%Ur (30% dip in Ur) for 25 cycles power mains interruption, it is recommended that the
FUSION™ be powered from an uninterruptible power
>5%Ur (>95% dip in Ur) for 5 secs
>5%Ur (>95% dip in Ur) for 5 secs
supply or battery.
Voltage dips, short
interruptions and
voltage variations
on mains supply
IEC 61000-4-11
Mains frequency
(50/60Hz) magnetic
field IEC61000-4-8
Immunity
Test
<5%Ur (>95%Ur) for 0.5 cycle
<5%Ur (>95%Ur) for 0.5 cycle
40%Ur (60% dip in Ur) for 5 cycles
40%Ur (60% dip in Ur) for 5 cycles
Mains frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
and/or hospital environment.
Note: Ur is the A.C. mains voltage prior to application of the test level.
3 A/m
3 A/m
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2)
IEC 60601
Test Level
Compliance
Level
3 V rms
Conducted RF
150 kHz ~ 80 MHz
IEC 61000-4-6
3 V rms
3 V/m
Radiated RF
80 MHz ~
IEC 61000-4-3
2.5 GHz
3 V/m
Electromagnetic Environment - Guidance
Portable and mobile RF communications equipment should be used no closer to any part of the
FUSION™ including cables, than the recommended separation distance calculated from the equation
appropriate to the frequency of the transmitter.
Recommend separation 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 rating of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters as determined by an electromagnetic site
survey,a should be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following symbol:
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and
people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radio, AM and FM radio broadcast,
and TV broadcast cannot be predicted 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 FUSION™ is used exceeds the applicable RF compliance
level above, the FUSION™ should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the FUSION™.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
a
Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the FUSION™
The FUSION™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the FUSION™ can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the FUSION™ as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter in Meters (m)
150 kHz to 80 MHz d = 1.2 √P
80 MHz to 800 MHz d = 1.2 √P
800 MHz to 2.5GHz d = 2.3 √P
0.01
0.01
0.01
0.01
0.12
0.12
0.12
0.12
0.12
0.12
0.12
0.12
0.23
0.23
0.23
0.23
0.1
0.1
0.1
0.1
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in Meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the
transmitter manufacturer. Note: At 80MHz and 800MHz, the separation distance for the higher frequency range applies. Note: These guidelines may not
apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
Output Power of Transmitter in
Watts (W)
This medical device is compliant with:
IEC 60601.1 3rd edition Medical electrical equipment safety and essential performance
IEC 60601.1.11 Home healthcare environment
USER MANUAL PART NUMBER 50-02-07-222/5
Talley Group Limited
Premier Way, Abbey Park Industrial Estate, Romsey, Hampshire, SO51 9DQ England
TEL: +44(0)1794 503500 FAX: +44(0)1794 503555
E-MAIL: [email protected]
www.talleygroup.com
02/2017
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