Nidek Medical Mark 5 Nuvo M5C5 User manual

Nov 2004[ code 2010-2224CE Rev C ] 1
USER'S GUIDE
Mark 5 Nuvo(OCSI)
M5C5
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 .
GLOSSARY OF SYMBOLS....................................... 1
GENERAL SAFETY GUIDELINES ......................... 2
I. DESCRIPTION ........................................................ 2
I.1.F
rontpanel (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. Materialsin direct/indirectcontact with patient............4
IV.3. Operatingprinciples ..................................................5
IV.4. Alarms - Safety devices ...........................................5
IV.5. Oxygen Monitor (OCSI) 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
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 concentrationwarning light
GLOSSARY OF SYMBOLS
[Original language is English]

[ code 2010-2224CE Rev C ]2 Nov 2004
USE OF OXYGEN
Oxygenisnotaflammablegas,butitacceleratesthe
combustionofmaterials.Toavoidallrisksoffire,the
MARK 5 Nuvo [M5C5] should be kept away from
allflames,incandescentsourcesandsourcesofheat
(cigarettes), as well as any combustible products
such as oil, grease, solvents, aerosols, etc.
Do not use in an explosive atmosphere.
Avoidlettingoxygenaccumulateonanupholstered
seatorother fabrics. Iftheconcentrator is operating
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 [M5C5] must only be used for
oxygen therapy and only on a medical prescription.
The indicated daily duration and flow must be
followed,otherwiseitmaypresentarisktothehealth
of the patient.
Do not use in a specifically magnetic environment
(MRI, X-ray, etc.)
USE AND MAINTENANCE OF THE DEVICE
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 [M5C5] has an audible alarm to
warntheuserofproblems.Inorderthatthealarmmay
be heard, the maximum distance that the user can
move away from it must be determined to suit the
surrounding noiselevel.
GENERAL SAFETY GUIDELINES
Only persons who have read and understood this entire manual
should be allowed to operate the MARK 5 Nuvo [M5C5].
CONFORMITY WITH IEC60601-1 (§ 6.8.2 B):
"The manufacturer, assembler, installer or distributor are not
consideredtoberesponsiblethemselvesfortheconsequences
onthesafety,reliabilityandcharacteristicsofadeviceunless:
• Theassembly,fitting,extensions,adjustments,modifications
orrepairshavebeenperformedbypersonsauthorizedbythe
partyinquestion,
• The electrical installation 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,themanufacturerisnotresponsibleintheevent
of an accident.
This device complies with the requirements of the FDA
Quality System Regulation and the 93/42/EEC European
directivebutitsoperationmaybeaffectedbyotherdevices
being used near by, such as diathermy and high frequency
electro-surgicalequipment,defibrillators,shortwavetherapy
equipment, mobile telephones, CB and other portable
devices,microwaveovens,inductionplatesorevenremote
control toys or any other electromagnetic interferences
which exceed the levels specified by the EN 60601-1-2
standard.
I. DESCRIPTION
TheMARK5Nuvo[M5C5]isintendedtosupplysupplemental
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 [M5C5] is easy to use.
Thesingle flow adjustmentknob 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
the MARK 5 Nuvo [M5C5] with the accessories
recommended by Nidek Medical Products, Inc.

Nov 2004[ code 2010-2224CE Rev C ] 3
34
5
I.1. Front panel (Fig. I.1)
1 - (I/0) On/Off Power Switch
2 - Humidifier (space reserved)
3 - Oxygen enriched air outlet
4 - Flowadjustmentknob(l/min)
5 - Circuit Breaker
6 - OCSI (Oxygen Concentration
Status Indicator) Indicator Lights
I.2. Rear panel (Fig. I.2)
7 - Cabinet Air Filter
8 - Manufacturer's Technical Label
9 - Power Cord
8
32
3
5
1
5
4
6
3
4
6
3
5
7
7
9
2
1
II. STARTING UP / INSTALLATION
II.1. Use in direct oxygen therapy
a. Ensure that the switch (1) is in the 0(OFF) position.
b. If used with a humidifier:
Unscrew the flask and fill it with water up
totheline(seehumidifierinstructions).Then
screw the lid on the humidifier flask until
there are no leaks.
c. Connect the oxygen tube to the humidifier outlet nozzle or
to the concentrator outlet if a humidifier has not been
prescribed. The tube between the cannula and the MARK 5
Nuvo [M5C5] 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
avoidleaks.
e. Plug the power cable into a power outlet of the correct
voltage and frequency as defined on the
manufacturer's technical label (8).
f. Pressthepowerswitch(I/0) totheONposition (I). The
green indicator will light when the oxygen concentration
exceeds the set point.
g. Turn the flow adjustment knob (4) to the prescribed
value. This knob may have already been locked in the
medically prescribed position. In this case, do not force it.
Onlythetechnicianormedicalpersonnelareauthorizedto
release it. Note: View the flowmeter in the horizontal
plane for accurate settings.
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/0 Switch to place
it in the 0 (OFF) position to stop the device. The oxygen
enriched air flow continues for approximately one minute
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.

[ code 2010-2224CE Rev C ]4 Nov 2004
III. CLEANING - MAINTENANCE
III.1. Cleaning
Only the outside of the MARK 5 Nuvo [M5C5] is to be
cleaned,withasoft,dryclothor,ifnecessary,adampsponge,
thenthoroughlydriedwithwipesandanalcoholbasedsolution.
Acetone, solvents or any other inflammable products must
not be used. Do not use abrasive powders.
The removable cabinet air filter (7) must be cleaned in warm
waterandhouseholddetergentweeklyorafterapproximately
100hours of use. More frequentcleaning isrecommended in
dustyenviroments
66
9
.
II.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
disinfectantsolution (in general,we recommend usingwater
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 [M5C5] must be cleaned and
disinfected as per the above instructions. The bacterial
filter inside the device should be changed. The cabinet air
filtermay be changed as well. Theentire oxygen adminis-
tration 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 [M5C5].
IV. USEFUL INFORMATION
IV.1. Accessories and spare parts
The accessories used with the MARK 5 Nuvo [M5C5] must:
•beoxygencompatible,
•bebiocompatible,
•complywith the generalrequirements of the FDA Quality
System Regulation or the 93/42/EEC European Directive
as appropriate.
The connectors, tubes, nasal cannulas, probes or masks
must be designed for oxygen therapy usage.
TheaccessorieswithaNidekMedicalpartnumber 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...................................... Polycarbonate
Mains cable.................................................................. PVC
Cabinet Air fFlter ..................................................Polyester
I/0 (On/Off) switch.................................................... Nylon
Casters........................................................................ Nylon
Flow adjustment knob.................... .............................ABS
Gasoutlet .................................................................... Brass
Printed labels ................................................ Polycarbonate
Pipe/Tubing..........Aluminium,PVC,polyurethaneorsilicone
Humidifier ......................................................Polypropylene
Filter ...............................................................Polypropylene
Tuyau d'alimentation de NEBAL ..... Silicone
6 Filter / Silencer
7 Cabinet Air Filter
8 Hour Meter
9 Ventilation Grille
10 Battery
78
6
910
8
76

Nov 2004[ code 2010-2224CE Rev C ] 5
IV.3. Operating principle
The compressor sends filtered ambient air to a rotary distri-
bution valve, which allows compressed air to pass to the
columninproduction.Thecolumnscontainamolecularsieve,
whosefunctionistoadsorbthenitrogenandthusallowoxygen
to pass.
The oxygen enriched product is then directed to a pressure
reducing valve through the adjustable flow meter 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 this way, 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. OCSI (oxygen concentration status indication
module)function
IV.5.1. Operating principle
TheOxygenMonitor(6)isanelectronicmodulecapableof
checking the effective oxygen concentration supplied by
the MARK 5 Nuvo [M5C5] concentrator.
The Oxygen Monitor measures the concentration and
activates an audible and visual alarm if it falls below the
alarm set point percentage.
When the MARK 5 Nuvo [M5C5] is started, the indicator
lightsoperate as follows:
IV.5.2. Green indicator
Thegreen indicatorlight 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: L x W x H: 394 x 396 x 706 mm (15.5 x 15.6 x
27.8in.)
Caster diameter: 38 mm (1.5 in.).
Tiltangle(transportwithhumidifier fitted): 70o.
Weight: 23-25 kg. (50 - 55 lbs)
Noise level < 47 dBA (to ISO 8359)
Flow values:
ContinuouslyAdjustableFlowmeter: 0 to5 liters/minute.
(Some models may have other values.)
IV.5.3. Red indicator
IV.5.4. Maintenance of the Device Alarms
•No specialmaintenanceis 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
operatingcorrectlywhentheroutinechecksareperformed
on the MARK 5 Nuvo [M5C5].
IV.4. Alarms - Safety devices
IV.4.1. Alarms
• Novoltage detection:
In the event of a loss of mains power, a continuous audible
alarm is activated and the green light turns off. Test alarm by
actuating the I/O (On/Off) switch when the power cord is not
plugged into the wall receptacle.
• 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).
IV.4.2. Safety devices
• Compressormotor:
Thermal safety is ensured by a thermal switch situated in the
stator winding (145 ± 5 oC).
• Ambientairvalve:
In the case of a negative pressure in the molecular sieve
columns, this valve allows ambient air to enter.
• Electrical protection of the MARK 5 Nuvo [M5C5]:
A5Acircuitbreakerisincorporatedintothefrontcabinetofall
230V models. A 10 A circuit breaker is included with 115V
models.
• Safety valve:
This is fitted on the compressor outlet and is calibrated to 2.7
bar (40 psig).
• Class II devices with insulated castings (EN60601-1
standard)
The red indicator light is used to warn the patient of a
system fault. The two events that can cause the red
indicator to be lighted are low oxygen concentration and
loss of mains power. The low oxygen concentration
warningwilllightwhentheoxygenconcentrationsetpoint
level is not reached. When the red indicator light is lighted
for 15 minutes (±2 minutes), a continuous audible alarm is
activated. Call the equipment supplier to service the device.

[ code 2010-2224CE Rev C ]6 Nov 2004
MARK 5 Nuvo [M5C5] Serial No. ___________
Date first used:___________________________
________________________________________
Maintained by: ___________________________
________________________________________
Your distributor: _________________________
Address :________________________________
________________________________________
________________________________________
Telephone : _____________________________
PREVENTIVE MAINTENANCE:
a. Wash cabinet filter weekly
b. Replaceairinlet filter annually
c. Check oxygen concentration every 2 years to
verifythe continuingOCSI function.
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 [M5C5] (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:
Incompliance with the ISO8359 standard,the flow supplied
is equal to the flow set on the flowmeter, accurate to within
± 10 % or 200 ml/min, whichever is the larger of the two.
Average oxygen content:
• at 2 l/min: 93%.
• at 4 l/min: 93%.
• at 5 l/min: 90%.
(Values at 21oC and at one atmosphere pressure).
Maximumrecommendedflow: 5l/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: 410 W 420 W
Protection Class: Class II Class II
MainsProtection: 10A 5A
Filters:
At the rear of the device: a cabinet air filter.
At the compressor input: a filter cartridge, behind cabinet
airfilter.
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 10oC and 40oC (50oF to
105oF) operation.
• Storage temperature from -20oC to 60oC (0oF to 140oF).
• Relative humidity of between 15 % and 95 % operation
andstorage, both non-condensing.
• Altitude(21oC): Upto1500m(5000ft)withoutdegradation;
Consultyourequipmentproviderforfurtherinformation
regarding 1500 m to 4000 m (5000 to 13000 ft).
• IPX1: Complies with EN60601-1 standard; no particular
protection. 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.
EN60601-1-2:2000 ElectromagneticCompatibility

Nov 2004[ code 2010-2224CE Rev C ] 7
IV.10.Troubleshooting.
Solutions
Checkthecableconnection.
Checkthecircuitbreaker (5)onthe
frontoftheunit;Resetifnecessary.
Contactyourequipmentsupplier.
Replacebattery.
Contactyourequipmentsupplier.
Contactyourequipmentsupplier.
Stopthedevicebypressingthe
I-0(ON/OFF)buttonandcontact
yourequipmentsupplier.
Stopthedeviceandcontactyour
equipmentsupplier.
Stopthedeviceandwaitforitto
cooldown.
Cleancabinetfilter. Restart.
Resetcircuitbreaker. Ifthedevice
doesnotstart,contactyour
equipmentsupplier.
Checkthattubingconnectionsare
secureandthatthehumidifierissealed.
Straightenthetubing;contactyour
equipmentsupplierifdamaged.
Powercable(9)isnotcorrectly
pluggedintothewalloutlet.
Powerfailure.
Oxygenconcentrationistoolow.
Faulty9Voltbattery.
Internalelectricalfault.
Faultyindicator.
Pneumaticconnectionbrokenor
otherpressureproblem.
Internalelectricalfault.
Pneumaticcircuitfault.
Compressorthermalsafety
devicehasbeenactivated.
DirtyFilters.
Fanisnotworking.
Tubedisconnectedorhumidifier
capisnottight.
Cannulatubingiskinkedor
restricted.
Observations
The I-0 (ON/OFF) button is in the "I"
(ON) position but the device does not
operate.
Theaudiblealarmsoundscontinuously.
Redlightremainslighted.
Thealarmtestdoesnotwork.
See IV 4.1.
Thecompressoroperatesandthe
I-0 (ON/OFF)buttonisinthe "I"
(ON)positionbutthegreenindicatoris
notlighted.
TheI-0(ON/OFF)buttonisinthe"I"
(ON)positionbutthereisnoflow.The
audiblealarmsoundscontinuously.
TheI-0(ON/OFF)buttonisinthe"I"
(ON)position,thecompressoris
operatingandthereisaflowbutthe
audiblealarmsoundscontinuously.
Thecompressorstopsinmid-cycle,
thenstartsagainafterafewminutes.
The oxygen enriched air flow is
interruptedatthenasalcannulaoutlet.
Theflowatthenasalcannulaoutletis
irregular.
Maintenance Items
CabinetAirFilter: PartRef:9250-1025; Replaceannually,Cleaneveryweek.
InletAirFilter: PartRef: 9250-1028; Replaceannually,moreoftenindustyenvironment.
Battery,9Volt: PartRef:7206-0027; Replaceannuallyorsoonerifneeded.
Possible Causes

[ code 2010-2224CE Rev C ]8 Nov 2004
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, Alabama 35217 U.S.A.
Tel:[phone] Fax:[phone]
EU Representative
mdiEuropaGmbH
Wittekamp30
D-30163 Hanover
Germany
Tel:[phone]
Fax:[phone]
[email protected]
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