Nidek Medical Mark 5 Nuvo Lite User manual

Nov 20092010-8401CE Rev B 1
USER'S GUIDE
Mark5Nuvo(OCSI)
LITE
OXYGEN CONCENTRATOR
Federal Law (US) restricts this device to
sale by, or on the order of, a licensed
physician. This oxygen concentrator
should be used only under the supervi-
sion of a licensed physician.
0413:Complieswiththe93/42/EECdirective
certifiedbytheapprovedorganizationno0413.
Danger: Do not smoke when using oxygen or
when near this device .
CONTENTS
: ON (power switched on)
: Off (power switched off)
: Type B device
: Class II protection
: Do not expose to open flames
: Do not use oil or grease
: Technicalinformation
: Consult the accompanying documents
: Keep in the vertical position
: Fragile - handle with care
: Oxygen concentration warning light
GLOSSARY OF SYMBOLS
[Original language is English]
GLOSSARY OF SYMBOLS .......................................1
GENERAL SAFETY GUIDELINES .........................2
I. DESCRIPTION .................................................... 2
I.1. F ront panel (Fig. I. 1) ......................................... 3
I.2. Rear panel (Fig. I. 2) ............................................ 3
II. STARTING-UP / INSTALLATION .................3
II.1. Use in direct oxygen therapy ................................. 3
III. CLEANING-MAINTENANCE..........................4
III.1. Cleaning................................................................. 4
III.2. Everyday disinfection ............................................... 4
III.3. Maintenance ........................................................... 4
IV. USEFUL INFORMATION ............................... 4
IV.1. Accessories and spare parts .................................. 4
IV.2. Materials in direct or indirect contact with patient ... 4
IV.3. Operating principles .............................................. 4
IV.4. Alarms - Safety devices......................................... 5
IV.5. Indicatorlight function ........................................... 5
IV.6. Technical characteristics........................................ 5
IV.7. Standards................................................................ 6
IV.8. Method for disposing of waste ............................... 6
IV.9. Method for disposing of device .............................. 6
IV.10.Troubleshooting ..................................................... 7
APPENDIX A EMC INFORMATION 8

2010-8401CE Rev B2 Nov 2009
USE OF OXYGEN
Oxygenisnotaflammablegas,butitacceleratesthe
combustionofmaterials.Toavoidallrisksoffire,the
MARK 5 Nuvo LITE should be kept away from all
flames, incandescent sources and sources of heat
(cigarettes), as well as any combustible products
such as oil, grease, solvents, aerosols, etc.
Do not use in an explosive atmosphere.
Avoidlettingoxygenaccumulateon anupholstered
seatorother fabrics. Ifthe concentrator isoperating
whilenotsupplyingoxygentoapatient,positionitso
that the gas flow is diluted in the ambient air.
Place the device in a ventilated area free from
smoke and atmospheric pollution (rear filter
unobstructed).
The MARK 5 Nuvo LITE must only be used for
oxygen therapy and onlyon a medical prescription.
The indicated daily duration and flow must be
followed,otherwiseitmaypresentarisktothehealth
of the patient.
Do not use in a specifically magnetic environment
such as: (MRI, X-ray, etc.)
USEAND MAINTENANCEOFTHEDEVICE
Do not open the device while in operation: risk of
electrical shock.
Use the power cord provided, and check that the
electrical characteristics of the power socket used
match those indicated on the manufacturer’s plate
on the rear panel of the machine.
We recommend against the use of extension cords
or adapters, as they are potential sources of sparks
and fire.
The MARK 5 Nuvo LITE has an audible alarm to
warntheuserofproblems.Inorderthatthealarmmay
beheard,themaximumdistancethattheusercanmove
awayfromitmustbedeterminedtosuitthesurrounding
noise level.
GENERAL SAFETY GUIDELINES
Only persons who have read and understood this entire manual
should be allowed to operate the MARK 5 Nuvo LITE.
CONFORMITY WITH IEC60601-1 (§ 6.8.2 B):
"The manufacturer, assembler, installer or distributor are not
consideredtoberesponsiblethemselvesfor theconsequences
on thesafety,reliabilityand characteristics ofa deviceunless:
• Theassembly,fitting,extensions,adjustments,modifications
or repairs have been performed by persons authorized by
the partyinquestion,
• The electricalinstallation of the corresponding premises
complies with local electrical codes. (e.g. IEC / NEC).
• Thedeviceisusedinaccordancewiththeinstructionsforuse."
If the replacement parts used for the periodic servicing by an
approved technician do not comply with the manufacturer’s
specifications,themanufacturerisnotresponsibleinthe event
of an accident.
This device complies with the requirements of the FDA
Quality System Regulation and the 93/42/EEC European
directive but its operation may be affected by other devices
being used near by, such as diathermy and high frequency
electro-surgicalequipment,defibrillators,shortwavetherapy
equipment, mobile telephones, CB and other portable
devices,microwave ovens, induction plates oreven remote
control toys or any other electromagnetic interferences
which exceed the levels specified by the EN 60601-1-2
standard.
I. DESCRIPTION
The MARK 5 Nuvo LITEisintendedto supplysupplemental
oxygentopersonsrequiringlowflowoxygentherapy.Itisnot
intended to be life supporting or life sustaining. It produces
oxygenenrichedproductbyconcentratingtheoxygencontained
in room air. It can be used either to administer oxygen with
nasal cannulas or another probe or mask type of device.
The MARK 5 Nuvo LITE is easy to use.
The singleflowadjustmentknob allows:
• the device to be easily adjusted to the prescribed flow rate,
• the equipment supplier or medical staff to limit flows to a
specific flow rate with a built-in locking device.
It has a power failure alarm and an operating fault alarm.
Note: the performances described pertain to the use of
theMARK5NuvoLITEwiththeaccessoriesrecommended
by Nidek Medical Products, Inc.

Nov 20092010-8401CE Rev B 3
34
5
I.1. Front panel (Fig. I.1)
1 - I/O (ON/OFF) Switch
2 - Indicator Lights
3 - Oxygen enriched air outlet
4 - Flow adjustment knob (l/min.)
5 - Circuit Breaker
I.2. Rear panel (Fig. I.2)
6 - Humidifier
7 - Filter
8 - Power Cord
9 - Hour meter
10 - Technical Label
3
5
1
5
43
7
II. STARTING UP / INSTALLATION
II.1. Use in direct oxygen therapy
a. Ensure that the switch (1) is in the O(OFF) position.
b. If used with a humidifier:
Unscrew the flask and fill it with water up
totheline(seehumidifierinstructions).Then
screw the lid onthe humidifierflask until
there are no leaks.
c.Connecttheoxygentubetothehumidifieroutletnozzleor
to the concentrator outlet if a humidifier has not been
prescribed. The tube between the cannula and theMARK 5
Nuvo LITE should be limited to 20 meters (60 feet)
long, in order to ensure that the oxygen flow rate remains
withinspecificationvalues.
d. Ensure that all of the parts are connected correctly so as
to avoid leaks.
e. Plug the power cable into a power outlet of the correct
voltage and frequency as defined on the
manufacturer's technical label(Fig I2-10).
f. Press the power switch ( I / O ) to the ON position ( I ).
Thegreenindicatorwilllightwhentheoxygenconcentration
exceeds the set point.
g. Turn the flow adjustment knob (4) to the prescribed
value. This knob may have already been locked in the
medicallyprescribed position. In this case,do not force it.
Onlythetechnician ormedicalpersonnelareauthorizedto
release it.
h. Check that the oxygen flows out of the administration
device (nasal cannulas or other) by placing the orifice(s) on
the surface of a glass of water. The flow should disturb the
surface of the water.
i. Adjust the nasal cannula to suit your face.
Remark: the required oxygen concentration is normally
obtained within five minutes after the unit is started.
At the end of the treatment, press the I/O Switch to place
it in the O(OFF) position to stop the device. The oxygen
enriched air flowcontinuesfor approximatelyoneminute
after the device is stopped.
For the equipment supplier or medical staff:
The flow adjustment knob may be locked to limit it to a
specific predetermined value.

2010-8401CE Rev B4 Nov 2009
III. CLEANING - MAINTENANCE
III.1. Cleaning
Onlytheoutsideofthe MARK5Nuvo LITEistobecleaned,
with a soft, dry cloth or, if necessary, a damp sponge, then
thoroughly dried with wipes and an alcohol based solution.
Acetone, solvents or any other inflammable products must
not be used. Do not use abrasive powders.
The removable cabinet air filter (2) must be cleaned in warm
waterandhouseholddetergentweeklyorafterapproximately
100 hours ofuse. More frequentcleaning is recommended in
dustyenviroments
66
9
III.2. Daily disinfection
Because there is a bacterial filter inside the device, daily
disinfection concerns only the external oxygen therapy
accessories: humidifier, probes, nasal cannulas (refer to the
respective instructions for use).
The device must be switched off when alcohol based
solutions are used.
a. The following minimum guidelines must be observed:
•Humidifier : (If prescribed by a physician)
Daily:
• Empty the water from the humidifier.
• Rinse the humidifier flask under running water.
• Fill humidifier up to the mark with distilled water.
Regularly:
• Disinfect the humidifier parts by immersing them in a
disinfectant solution (in general, we recommend using water
containing a small amount of chlorine bleach).
• Rinse and dry.
• Check that the humidifier lid seal is in good condition.
•Oxygen tubing and nasal cannula:
Follow the manufacturer’s instructions.
b. For each new patient:
The humidifier must be sterilized if possible or changed.
The MARK 5 Nuvo LITE must be cleaned and disinfected
as per the above instructions. The bacterial filter inside the
device should be changed. The cabinet air filter may be
changed as well. The entire oxygen administration circuit
(oxygen therapy nasal cannulas, etc.) must be changed.
III.3. Maintenance
Nospecialmaintenanceneedstobecarriedoutbythepatient.
Your equipment supplier performs periodic maintenance
operations to assure continued reliable service from the
MARK 5 Nuvo LITE.
IV. USEFUL INFORMATION
IV.1. Accessories and spare parts
The accessories used with the MARK 5 Nuvo LITE must:
•be oxygen compatible,
•bebiocompatible,
•complywiththegeneral requirementsoftheFDAQuality
SystemRegulation or the 93/42/EEC European Directive
as appropriate.
The connectors, tubes, nasal cannulas, probes or masks
must be designed for oxygen therapy usage.
The accessories with a Nidek Medical part number
reference, or included in the set of accessories supplied with
the device, comply with these requirements.
Contact your dealer to obtain these accessories.
Remark: The use of certain administration accessories
which are not specified for use with this concentrator may
reduce its performance and void the manufacturer’s
responsibility(ISO8359).
AVAILABLE ACCESSORIES
IF PRESCRIBED BY A PHYSICIAN
Humidifier: P/N 9012-8774
Cannula with 2 m (7 ft) tubing: P/N 9012-8780
Extension Tubing 7.7 m(25ft): P/N 9012-8781
Tubing Adapter: P/N 9012-8783
The items listed above are available from
Nidek Medical Products, Inc.
IV.2. Materials in direct or indirect contact with the
patient
Concentrator casing ................................................ ABS
Mains cable ........................................................... PVC
Cabinet Air fFlter................................................. Polyester
I/0 (On/Off) switch....................................................Nylon
Casters .......................................................................Nylon
Flow adjustment knob.................... ........................... ABS
Gas outlet ..................................................... Stainless Steel
Printed labels ............................................... Polycarbonate
Pipe/Tubing..........Aluminium,PVC,polyurethaneorsilicone
Humidifier .................................................... Polypropylene
Filter ............................................................. Polypropylene
1. Filter / Silencer
2. Dust filter
3. Ventilation grill
78
6
910
8
76

Nov 20092010-8401CE Rev B 5
IV.3. Operating principle
Thecompressorsendsfilteredambientairtoasolenoid valve,
which allows compressed air to pass to the column in
production. The columns contain a molecular sieve, whose
function is to adsorb the nitrogen and thus allow oxygen to
pass.
The oxygen enriched product is then directed to a pressure
reducing valve through the adjustable flow valve to the
oxygenoutletfitting.
During this time, the column which is being "regenerated" is
connected to the ambient air and flow of oxygen enriched
productispassedthroughit(fromthecolumn"inproduction").
In thisway, when one column is in production, the other is in
a nitrogen desorption or "regeneration" phase. The oxygen
enriched product finally passes through a bacterial filter
located prior to the oxygen outlet fitting.
IV.5.1. Operating principle
TheOxygen Monitor(2)is anelectronicmodulecapableof
checking the effective oxygen concentration supplied by
the MARK 5 Nuvo LITE concentrator.
The Oxygen Monitor measures the concentration and
activates an audible and visual alarm if it falls below the
alarm set point percentage.
Whenthe MARK5NuvoLITEisstarted,theindicatorlights
operate as follows:
IV.5.2. Green indicator
The green (LED) indicator light indicates that power is
applied to the concentrator and that it is ready to provide
oxygen enriched air to the patient. To be lighted, it is
necessary that the concentrator power plug be inserted
into the wall outlet, that the I/O (On/Off) switch be
actuated and that the oxygen concentration has reached
the alarm set-point
IV.6. Technical characteristics
Dimensions: Lx W xH: 36x23x58.5 cm(14 x 9 x 23 in.)
Caster diameter: 3.8 cm (1.5 in.).
Tiltangle(transport withhumidifierfitted):30o.
Weight: 13 kg. 30 lbs (depends on model)
Noise level 45 to < 40 dBA (depends on model)
Flow values:
12 position flow valve 0.125-5 liters/minute.
(Some models may have other values.)
IV.5.4. Maintenance of the Device Alarms
• No special maintenance is required. The alarm set-point is
factory set and the setting cannot be adjusted. Models
operating at 50 Hz are set at 83% and 60 Hz models are set
at 85%.
• The equipment supplier checks that the device is still
operatingcorrectlywhen the routine checks are performed
on the MARK 5 Nuvo LITE.
IV.4. Alarms - Safety devices
IV.4.1. Alarms
• No voltage detection:
In the event of a loss of mains power, an intermittent audible
alarm is activated and the green light turnsoff. Test alarmby
actuatingtheI/O (On/Off)switchwhenthepowercordisnot
pluggedintothewalloutlet.
• Process fault:
In the case of a process fault, a visible and audible alarm is
activated (continuous red light or lighted alarm and audible
alarm, see p. 7).
• No Oxygen Flow Alarm (if supplied with unit):
The Nuvo Lite Concentrator has a no flow alarm option.
This device provides an continuous audible alarm in the
event the Oxygen flow to patient becomes blocked.
IV.4.2. Safety devices
• Compressormotor:
Thermal safety is ensured by a thermal switch situated in the
motor winding (145 ± 5 oC).
• Electrical protection of the MARK 5 Nuvo LITE:
A 5A circuitbreaker is incorporated into the front cabinet of
all230Vmodels.A10Acircuitbreakerisincludedwith115V
models.
• Safety valve:
This is fitted on the compressor outletand is calibrated to 2.7
bar (40 psig).
• Class II devices with insulated castings (EN60601-1
standard)
The red (LED) indicator light is used to warn the patient of
a system fault. The event that can cause the red (LED)
indicator to be lighted is low oxygen concentration . The
low oxygen concentration red (LED) warning will light
whentheoxygenconcentration fallsbelowapredetermined
set point. When the red (LED) warning light is on for 15
minutes(±2minutes),acontinuousaudiblealarmisactivated.
A audible alarm will sound intermittently on loss of mains
power. Call the equipment supplier to service the device.
IV.5. OCSI (oxygen concentration status indication
module)function
IV.5.3. Red indicator

2010-8401CE Rev B6 Nov 2009
MARK 5 Nuvo LITE Serial No. _____________
Date first used:___________________________
________________________________________
Maintained by: ___________________________
________________________________________
Your distributor: _________________________
Address :________________________________
________________________________________
________________________________________
Telephone : _____________________________
PREVENTIVE MAINTENANCE:
a. Wash cabinet filter weekly
b. Replaceairinletfilterannually
c. Check oxygen concentration every 2 years to
verifythecontinuing OCSIfunction.
The manufacturer’s instructions for the preventive
maintenance of the devices are defined in the
maintenance manual and any updates to it must be
followed.
The work must be carried out by suitably trained
technicians.
Use original spare parts only (see Pg. 7).
Uponrequest,thesuppliercanprovidecircuitdiagrams,
sparepartslists,technicaldetailsoranyotherinformation
of use to qualified technical personnel for parts of the
devicewhicharedesignatedasbeingthemanufacturer’s
responsibility or by the manufacturer as repairable.
IV.8. Method for disposing of waste
All waste from the MARK 5 Nuvo LITE (patient circuit,
filter,etc.)mustbedisposedofusingthemethodsappropriate
to the civil authority of the location where used.
IV.9. Method for disposing of the device
In order to preserve the environment, the concentrator
must only be disposed of using the appropriate methods.
All materials of construction are recycleable.
Furthermore,aspartofthemarking (directive93/42/EEC),
the serial number of the device disposed of must be sent to
the Nidek Medical technical service department if the
unit has the marking.
Accuracy of flow supplied:
In compliance with the ISO 8359 standard, the flow supplied
is equalto the flowset on theflowvalve,accurateto within ±
10 % or 200 ml/min, whichever is the larger of the two.
Oxygen Concentration:
• at 2 l/min: >90%. .
• at 5 l/min: 90%. (+6.5%/-3%)
(Values at 21oC and at one atmosphere pressure).
Maximum recommended flow: 5 l/min.
The variation of the maximum recommended flow does not
exceed ± 10 % of the indicated value when a back pressure
of 7 kPa (1 psig) is applied to the output of the device. The
maximum outlet pressure is 50 kPa (7 psig).
Electrical power supply:
115 V Units 230 V Units
Frequency: 60Hz 50 & 60Hz
Average Power: 330W(avg) 300 W(avg)
Protection Class: Class II Class II
Mains Protection: 10A 5A
Filters:
At the rear of the device: a cabinet air filter.
At the compressor input: a filter cartridge, behind cabinet
air filter.
Before the oxygen outlet: a bacterial filter < 0.3 µm.
(technicianonly)
Air circulation:
A tubeaxial fan cools the compressor compartment
Environmental limit conditions:
The performances of the device (especially the oxygen
concentration)arequotedat21oC(70oF)andoneatmosphere.
They may change with temperature and altitude. For further
information, please consult the maintenance manual.
• The device must be stored, transported and used in the
verticalpositiononly.
• Ambient temperature of between 5oC and 40oC (40oF to
104oF) operation.
• Storage temperature from -20oC to 60oC (-4oF to 160oF).
• Relative humidity of between 15 % and 95 % operation
andstorage, both non-condensing.
• Altitude(21oC): Upto2,286m(7,500ft)withoutdegradation;
Consult yourequipmentproviderforfurtherinformation
regarding 2,286mto 4000 m (7,500 to 13000 ft).
• Complies with EN60601-1 standard;spilling of a glass of
water.
IV. 7. Standards
ISO 8359:1996 Oxygen concentrators for medical use.
EN60601-1[UL60601-1:2003],CAN/CSA-C22.2No.601.1-
M90 w/A1&A2: Electrical Safety- Medical Devices.
EN60601-1-2:2001 ElectromagneticCompatibility

Nov 20092010-8401CE Rev B 7
IV.10. Troubleshooting.
Solutions
Checkthecableconnection.
Checkthecircuitbreaker (5)onthe
frontoftheunit;Resetifnecessary.
Contactyourequipmentsupplier.
Backupcapacitorhasdischarged
operate unit for approximately 10
minutes and retest
Contact your equipment supplier.
Contactyourequipmentsupplier.
Stopthedevicebypressingthe
I-0 (ON/OFF) button and contact
yourequipmentsupplier.
Stopthedeviceandcontactyour
equipmentsupplier.
Stop the device and wait for it to
cooldown.
Cleancabinetfilter. Restart.
Resetcircuitbreaker. If the device
does not start, contact your
equipmentsupplier.
Checkthattubingconnectionsare
secureandthatthehumidifierissealed.
Straightenthetubing;contactyour
equipmentsupplierifdamaged.
Power cable(9)is notcorrectly
pluggedintothe
walloutlet.
Powerfailure.
Oxygenconcentrationistoolow.
Capacitorisnotcharged
Internalelectricalfault.
Faultyindicator.
Pneumaticconnectionbrokenor
otherpressureproblem.
Internal electrical fault.
Pneumaticcircuitfault.
Compressorthermalsafety
devicehasbeenactivated.
Dirty Filters.
Fan is not working.
Tubedisconnectedor
humidifiercapisnottight.
Cannulatubingiskinkedor
restricted.
Observations
The I-0 (ON/OFF) button is in the "I"
(ON) position but the device does not
operate.
Theaudiblealarmsoundsintermittently.
Redlightremainslighted.
Thealarmtestdoesnotwork.
See IV 4.1.
The compressor operates and the
I-0(ON/OFF) button is in the "I"
(ON)positionbutthegreenindicatoris
notlighted.
TheI-0(ON/OFF)button is in the "I"
(ON)positionbutthereisnoflow.The
audiblealarmsoundscontinuously.
TheI-0(ON/OFF)button is in the "I"
(ON)position,thecompressoris
operatingandthereisaflowbutthe
audiblealarmsoundscontinuously.
The compressor stops in mid-cycle,
thenstartsagainafterafewminutes.
The oxygen enriched air flow is
interruptedatthenasalcannulaoutlet.
Theflowatthenasalcannulaoutletis
irregular.
Maintenance Items
CabinetAirFilter: PartRef:8400-1025; Replaceannually,cleaneveryweek.
InletAirFilter: PartRef:8400-1180; Replaceannually,moreoftenindustyenvironment.
Possible Causes

2010-8401CE Rev B8 Nov 2009
Important:
Failure to follow these guidelines listed may result in increased emissions and/or decreased immunity of the
MARK 5 Nuvo LITE concentrator.
* Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.
* Portable and mobile RF communications equipment can affect Medical Electrical Equipment
* The use of Accessories, transducers, and cables other than those specified by the manufacturer, may result in increased
Emissions or decreased Immunity of the MARK 5 Nuvo LITE.
* The MARK 5 Nuvo LITE should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is
necessary, the MARK 5 Nuvo LITE should be observed to verify normal operation in the configuration in which it will be used.
* Use only Nidek replacement electrical parts.
Guidance andManufacturer’s Declaration – Electromagnetic Emissions: The MARK 5 Nuvo LITE is intended for use in the
electromagnetic environment specified below. The user of the MARK 5 Nuvo LITE should assure thatit is used in such an
environment.
Emission tests Compliance Electromagnetic environment - guidance
RF emissions Group 1 The MARK 5 Nuvo LITE uses RFenergyonlyfor its internal function.
CISPR 11 Therefore, its RF emissions are verylow and are not likelyto cause
anyinterference in nearbyelectronic equipment
RF emissions Class B The MARK 5 Nuvo LITE is suitable for use in all establishments,
CISPR11 including domestic establishments and those directlyconnected to the
Harmonic emissions Class A public low - voltage power supplynetwork, thatsupplies buildings used
IEC 61000-3-2 or domestic purposes.
Voltage fluctuations/Flicker emissions Complies
IEC 61000-3-3
Guidance and manufacturer’s declaration – electromagnetic immunity: The Mark 5 Nuvo Lite is intended for use in the
electromagnetic environment specified below. The user of the Mark 5 Nuvo Lite should make sure that it is used in such an
environment.
Immunity Test IEC 60601 Test Levels Compliance Level Electromagnetic Environment -
Guidance
Electrostatic Discharge (ESD) ±6kV contact ±6kV contact Floors should be wood,concrete or ceramic
IEC 61000-4-2 ±8kV air ±8kV air tile. If floors are covered with synthetic
material,the relative humidity should be at
least 30%
Electrical Fast Transient/Burst ±2kV for power supply lines ±2kV for power supply lines Mains power quality should be that of a
IEC 61000-4-4 ±1kV for input/output lines Not applicable. No I /O lines typical commercial or hospital environment.
Surge ±2kV for power supply lines ±2kV for power supply lines Mains power quality should be that of a
IEC 61000-4-5 ±1kV for input/output lines ±1kV for input/output lines typical commercial or hospital environment.
Voltage dips,short <5% U
T
<5% U
T
Mains power quality should be that of a
interruptions and voltage (>95% dip in UT) for 0.5 cycle (>95% dip in UT) for 0.5 cycle typical commercial or hospital environment.
variations on power supply 40% U
T
40% U
T
If the user of the Mark 5 Nuvo Lite requires
input lines. (60% dip in UT) for 5 (60% dip in UT) for 5 continued operation during power mains
IEC 61000-4-11 70% U
T
70% U
T
interruptions, It is recommended that the
(30% dip in UT) for 25 cycles (30% dip in UTfor 25 cycles Mark 5 Nuvo Lite be powered from an
<5% U
T
<5% U
T
uninterruptible power supply or a battery.
(>95% dip in UT) for 5 sec (>95% dip in UT) for 5 sec
Power frequency (50/60 Hz) 3 A/m 3 A/m Power frequency magnetic fields should be
magnetic field at levels characteristic of a typical location in
IEC 61000-4-8 a typical commercial or hospital environment.
NOTE: UTis the a.c. mains voltage prior to application of the test level
APPENDIX A: EMC Information

Nov 20092010-8401CE Rev B 9
Guidance and manufacturer’s declaration – electromagnetic immunity: This MARK 5 Nuvo LITE is intended for use in the
electromagnetic environment specified below. The user of this MARK 5 Nuvo LITE should make sure it is used in such an
environment.
Immunity Test IEC60601 Test Levels Compliance Level Electromagnetic Environment-Guidance
Portable and mobile RFcommunications equipment should be
used no closer to any part of the Mark 5 Nuvo Lite, including
cables, than the recommended separation distance
calculated fromthe equation applicable to the frequency of
the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3 Vrms d =1.2 vP
IEC61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m 3 V/m d =1.2 vP80 MHz to 800 MHz
IEC61000-4-3 80 MHz to 2.5 GHz d =2.3 vP 800 MHz to 2.5 GHz
where Pis the maximumoutput power rating of the trans-
mitter in w atts (W) according to the transmitter manufacturer
and d is the recommended separation distance in meters (m).
Field strengths fromfixed 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 w ith the following symbol:
NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies.:
NOTE2: These guidelines may not apply in allsituations. Electromagnetic propagation is affected by absorption and reflection fromstructures,
objects and people.
a:Field strengths fromfixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FMradio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electro-magnetic environment due to
fixed RFtransmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MARK 5
Nuvo LITE is used exceeds the applicable RF compliance level above, the MARK 5 Nuvo LITE should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocationg the MARK 5 Nuvo LITE.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the
MARK 5 Nuvo LITE device: The MARK 5 Nuvo LITE is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the MARK 5 Nuvo LITE
can help prevent electromagnetic interference
bymaintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
MARK 5 Nuvo LITE as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter (M)
(W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 vPd = 1.2 vPd = 2.3 vP
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 meters (m) can
be estimated using the equation applicable to the frequencyof the transmitter, where P is the maximum output power rating
ofthe transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHzand 800 MHz, the separation distance for the higher frequencyrange applies.
Note 2: These guidelines maynot applyin all situations. Electromagnetic propagation is affected byabsorption and reflection
from structures, objects and people.

2010-8401CE Rev B10 Nov 2009
NOTES
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Nov 20092010-8401CE Rev B 11
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2010-8401CE Rev B12 Nov 2009
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, Alabama 35217 U.S.A.
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