USER'S GUIDE
Mark 5 Nuvo
M5C5
OXYGEN CONCENTRATOR
[Original language is English ]
FederalLaw(US)restricts thisdevicetosale
by, or on the order of, a licensed physician.
This oxygen concentrator should be used
only under the supervision of a licensed
physician.
CONTENTS
Danger: Donot smoke when using oxygen or when
near this device
.
GLOSSARYOF SYMBOLS..........................................1
GENERALSAFETY 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
GLOSSARYOF SYMBOLS
: ON (power switched on)
: Off (power switched off).
: Type B device
IV. USEFULINFORMATION...................................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. Indicator light 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
: Do not use oil or grease.
: Technical information.
: Consult the accompanying documents.
: Class II protection
: Do not expose to open ames.
: Keep in the vertical position.
: Fragile - handle with care.
May 20112010-2224F Rev C 1
GENERALSAFETY GUIDELINES
Only persons who have read and understood this entire manual
should be allowed to operate the MARK 5 Nuvo [M5C5].
USE OF OXYGEN
Oxygen is not a ammable gas, but it accelerates the
combustion of materials. To avoid all risks of re, the
MARK 5 Nuvo [M5C5] should be kept away from
all ames, incandescent sources and sources of heat
(cigarettes),as wellasanycombustibleproductssuch
as oil, grease, solvents, aerosols, etc.
Do not use in an explosive atmosphere.
Avoid letting oxygen accumulate on an upholstered
seat or other fabrics. If the concentrator is operating
whilenot supplyingoxygento apatient, positionit so
that the gas ow is diluted in the ambient air.
Place the device in a ventilatedarea free from smoke
and atmospheric pollution (rear lter unobstructed).
The MARK 5 Nuvo [M5C5] must only be used for
oxygentherapyandonlyonmedicalprescription.The
indicated daily duration and ow must be followed,
otherwise it may present a risk to the health of the
patient.
Do not use in a speci cally magnetic environment
such as (MRI, X-ray, etc.)
CONFORMITYWITH IEC60601-1 (§ 6.8.2 B):
"The manufacturer, assembler, installer or distributor are not
consideredtobe responsiblethemselvesfor theconsequences
onthe safety,reliability andcharacteristics of a device unless:
• The assembly, tting, extensions, adjustments, modi cations
or repairs have been performed by persons authorized by the
party in question,
• 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
speci cations, the manufacturer is not responsible in the event
of an accident.
This device complies with the requirements of the FDAQua-
lity System Regulation but its operation may be affected by
other devices being used near by, such as diathermy and high
frequency electro-surgical equipment, de brillators, short
wave therapy equipment, mobile telephones, CB and other
portabledevices, microwaveovens, television,induction plates or even remote control toys or any other electromagnetic
interferences which exceed the levels speci ed by the EN
60601-1-2 standard.
USEAND 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 re.
The MARK 5 Nuvo [M5C5] has an audible alarm to
warn the user of problems. In order that the alarm
may be heard, the maximum distance that the user
can move away from it must be determined to suit
the surrounding noise level.
2
I. DESCRIPTION
TheMARK5Nuvo[M5C5]isintendedtosupplysupplemental
oxygen to persons requiring low ow oxygen therapy. It is not
intended to be life supporting or life sustaining. It produces
oxygenenrichedproductby concentratingtheoxygen containedinroomair.It canbeusedeithertoadministeroxygenwith
nasal cannulas or another probe or mask type of device.
The MARK 5 Nuvo [M5C5] is easy to use.
The single ow adjustment knob allows:
• the device to be easily adjusted to the prescribed ow rate,
• the equipment supplier or medical staff to limit ows to a
speci c ow rate with a built-in locking device.
It has a power failure alarm and an operating fault alarm.
Note:the performancesdescribed pertainto the useof the
MARK5 Nuvo [M5C5] with the accessoriesrecommended
by Nidek Medical Products, Inc.
May 2011
2010-2224F Rev C
II. STARTING UP / INSTALLATION
II. 1. Use in direct oxygen therapy
6
1
a - Ensure that the switch (1) is in the 0/(OFF) position.
1
b - If used with a humidi er:
3
3
4
4
2
Unscrew the ask and ll it with water up
to the line (see the humidi er instructions).
Then screw the humidi er ask onto its lid
until there are no leaks.
5
5
I. 1. Front panel (Fig. I. 1)
1 - I/0 (ON/OFF) Switch
2 - Humidi er (space reserved)
3 - Oxygen product outlet
4 - Flow adjustment knob (l/min.)
5 - Circuit Breaker
6 - Indicator Lights
c - Connect the oxygen tube to the humidi er outlet nozzle
or to the concentrator outlet if a humidi er has not been
prescribed. The tube between the cannula and the MARK
5 Nuvo [M5C5] should be limited to 60 feet (20 meters)
long, in order to ensure that the oxygen ow rate remains
within speci cation values.
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 de ned on the
manufacturer's technical label(8).
f - Press the power switch (I/0) to the ON position (I). The
red indicator will light and the audible alarm willsound for
a few seconds until system pressure rises to the accepted
level.
g - Turn the ow 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. Only the
technician or medical personnel are authorized to release it.
7
Note: View the owmeter in the horizontal plane for accurate
settings.
7
9
I. 2. Rear panel (Fig. I. 2 )
7 - Cabinet Dust Filter
8 - Technical Label
9 - Power Cord
h - Check that the oxygen ows out of the administration
device (nasal cannulas or other) by placing the ori ce(s) on
8
the surface of a glass of water. The ow should disturb the
surface of the water.
i - Adjust the nasal cannula to suit your face.
Note:therequiredoxygenconcentrationisnormallyobtained
within ve 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 ow continues for approximately 1 minute after
the device is stopped.
For the equipment supplier or medical staff:
The ow adjustment knob may be locked to limit it to a
speci c predetermined value.
May 20112010-2224F Rev C 3
III. CLEANING - MAINTENANCE
III.3. Maintenance
III.1. Cleaning
OnlytheoutsideoftheMARK5Nuvo[M5C5]istobecleaned,
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 in ammable products must
not be used. Do not use abrasive powders.
The removable cabinet dust lter (7) must be cleaned weekly
inwarmwaterandhouseholddetergent or afterapproximately
100 hours of use. More frequent cleaning is recommended
in dusty enviroments. Dry before reinstalling.
7 8
7
9
8
6
6
10
6 Filter / Silencer
7 Cabinet Dust lter
8 Hour Meter
9 Ventilation Grille
10 Battery
10
9
III.2. Everyday disinfection
Due to the presence of the nal product lter inside the de-
vice,everydaydisinfectionconcernsonlytheexternaloxygen
therapy accessories: humidi er, probes, nasal cannulas (refer
to the respective instructions for use).
Nospecial maintenanceneeds tobe carried outby the patient.
The 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:
• be oxygen compatible,
• be biocompatible,
• comply with the general requirements of the FDA Quality
System Regulation.
The connectors, tubes and nasal cannulas must be designed
and approved 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.
Note:
• The use of certain administration accessories which are
not speci ed for use with this concentrator may reduce its
performance and void the manufacturer’s responsibility.
The device must be switched off when alcohol based
solutions are used.
a . The following minimum guidelines must be
observed:
• Humidi er: (If prescribed by a physician)
Clean according to the manufacturer's instructions. If no
instructions are provided, do the following:
Daily:
- Empty the water from the humidi er.
- Rinse the humidi er ask under running water.
- Fill humidi er up to the mark with distilled water.
Regularly:
- Disinfect the humidi er parts by immersing them in a
disinfectant solution (in general, we recommend using a
solution of 1 part vinegar diluted with 10 parts water).
- Rinse and dry.
- Check that the humidi er lid seal is in good condition.
• Oxygen tubing and nasal cannula:
Follow the manufacturer’s instructions.
b. For each new patient:
Follow the instructions from the humidi er manufacturer.
TheMARK5 Nuvo [M5C5]mustbe cleanedanddisinfected
as per the above instructions. The cabinet dust lter should be
washedorreplaced. The entireoxygenadministrationcircuit
(oxygen therapy nasal cannulas, etc.) must be changed.
AVAILABLEACCESSORIES
IF PRESCRIBED BY A PHYSICIAN
Humidi er: 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
TubingAdapter: P/N 9012-8783
The above items are available from
Nidek Medical Products, Inc.
IV.2. Materials in direct or indirect contact with the
patient
Concentrator casing ......................................Polycarbonate
Mains cable...................................................................PVC
Dust lter ...............................................................Polyester
ON/OFF switch...........................................................Nylon
Casters.........................................................................Nylon
Flow adjustment knob...................................................ABS
Gas outlet ....................................................................Brass
Printed labels..................................................Polycarbonate
Pipe / Tubing ...Aluminium, PVC,polyurethane or silicone
Humidi er .....................................................Polypropylene
Filter ............................................................. Polypropylene
4
May 2011
2010-2224F Rev C
IV.3. Operating Principle
IV. 5. Indicator Light Function
The compressor sends ltered room air to a rotary distribution
valve, which allows compressed air to pass to the column in
production.Thecolumns containa molecularsieve thatfunction 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 ow meter to the oxygen outlet tting.
During this time, the column which is being "regenerated"
is connected to the ambient air and ow of oxygen enriched
productispassedthroughit(fromthecolumn"inproduction").
In this way, when one column is in production, the other is
in anitrogen desorption or "regeneration"phase. The oxygen
enriched product nally passes through a bacterial lter located
prior to the oxygen outlet tting.
IV.4.Alarms - Safety devices
IV.4.1Alarm
• No voltage detection:
In the event of a loss of mains power, a continuous audible
alarm is activated. Test alarm by activating I/0 [On/Off]
switch with power cable unplugged from wall receptable.
• Process fault:
Inthe caseof aprocessfault, a visible andaudible alarmis ac-
tivated (continuous red light and audible alarm, see p. 7).
IV. 5.1 Green Indicator
The green 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 receptacle
and that the ON/OFF (I/0) switch be actuated.
IV. 5.2 Red Indicator
The red indicator light is utilized to warn the patient of a
systemfault. Thetwo events that can cause the redindicator
to be lighted are abnormal system pressureand loss of mains
power. The abnormal system pressure warning will light
when product pressure falls below approximately 4 psig or
above approximately 18 psig. The loss of power indicator
will light when mains power is interruptedor the power cord
is not plugged into the wall receptacle.
IV. 5.3. Maintenance of the system alarms:
• No special maintenance is required.
•Theequipment supplier checksthat the unitis stilloperating
correctlywhentheroutinechecksareperformedontheMARK
5 Nuvo [M5C5].
IV. 6. Technical characteristics
IV.4. 2. Safety devices
• Compressor motor:
Thermal safety is ensured by a thermal switch situated in the
stator winding (145 ± 5oC).
• Ambient air valve:
In the case of a negative pressure in the molecular sieve co-
lumns, this valve allows ambient air to enter.
• Electrical protection of the MARK 5 Nuvo [M5C5]
A 5A circuit breaker is incorporated into the front cabinet
of all 230V models. A 10 A circuit breaker is included with
115V models.
• Class II devices with insulated casings (EN60601-1
standard).
• Safety valve:
This is tted on the compressor outlet and is calibrated to
2.7 bar (40 psig).
May 20112010-2224F Rev C 5
Dimensions: L x W x H: 394 x 396 x 706 mm (15.5 x
15.6 x 27.8 in.)
\
Caster diameter: 38 mm (1.5 in.).
Tilt angle (transport with humidi er tted): 70
o
.
Weight: 25-28 kg. (50 - 55 lbs -varies with model)
Noise level: < 48 dBA
Flow values:
ContinuouslyAdjustable Flowmeter: 0 to 5 liters/minute.
(Some models may have other values)
Accuracy of ow supplied:
The ow supplied is equal to the ow set on the owmeter,
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).
Max. recommended ow: 5 l/min.
The variation of the maximum recommended ow 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:
115V Units 230 V Units
Frequency: 60Hz 50/60Hz
Average Power: 410 W 420 W
Protection Class: ClassII Class II
Mains Protection: 10A 5A
Filters:
At the rear of the device: a cabinet dust lter.
At the compressor input: an inlet air lter, behind cabinet
air lter.
Before the oxygen outlet: a nal product lter < 0.3 µm.
(technician only).
Air circulation:
A tubeaxial fan cools the compressor compartment
.
Environmental limit conditions:
The performances of the device (especially the oxygen
concentration)arequotedat 21oC(70oF)andone atmosphere.
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
vertical position only.
• Ambient temperature of between 5oC and 40oC (40oF and
100oF) (operation).
• Storage temperature range -20oC to 60oC. (0oF to140oF).
• Relativehumidity of between 15 % and 95 % operationand
less than 95% storage, both non-condensing.
• Altitude(21oC): Up to 1500 m (5000 ft) without degradation;
Consult your equipment provider for further information
regarding 1500 m to 4000 m (5000 to 13000 ft).
• IPX1: Complies with EN60601-1 standard; spilling of a
glass of water.
IV. 7. Standards
EN60601-1[UL60601-1:2003],CAN/CSA-C22.2No.601.1M90 w/A1&A2: Electrical Safety- Medical Devices.
EN60601-1-2:2000 Electromagnetic Compatibility
IV. 8. Method for disposing of waste
All waste from the MARK 5 Nuvo [M5C5] (patient circuit,
lter, etc.) must be disposed of using the methods appropriate
to the civil authority of the location where disposed.
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 recyclable.
Cabinet
Dust
Filter
Air
Filter
MARK 5 Nuvo [M5C5] Serial No. ____________
Date rst used: ___________________________
_________________________________________
Maintained by: ___________________________
_________________________________________
Your distributor: _________________________
Address : ________________________________
_________________________________________
Telephone : ______________________________
PREVENTIVE MAINTENANCE:
a. Wash cabinet dust lter weekly.
b. Inspect inlet air lter at each patient visit.
Replace lter annually, or more often depending on
environment.
c. Check oxygen concentration every 5,000 hours or
one year.
The manufacturer’s instructions for the preventive
maintenance of the devices are de ned in the
maintenance manual. Check with your service provider
for any updates to the recommended schedules.
The work must be carried out by suitably trained
technicians certi ed by the manufacturer.
Use original spare parts only (see Pg. 7).
Upon request, the supplier can provide circuit diagrams,
sparepartslists,technicaldetails oranyotherinformation
of use to quali ed technical personnel for parts of the
device which are designated as being the manufacturer’s
responsibility or by the manufacturer as repairable.
Medical Device Regulations require users and
service providers to report to the manufacturerany
incident that could, if repeated, result in injury to
6
May 2011
2010-2224F Rev C
IV. 10. Troubleshooting.
Observations
The I-O (ON/OFF) button is in the
ON position but the device does not
operate.
The continuous alarm sounds.
Red light remains lighted.
The alarm test does not work.
See IV. 4.1
The compressor operates and the
I-O (ON/OFF) button is in the ON
position but the green light is not lit.
The I-O (ON/OFF) button is ON and
the compressor is operating but there
is no ow. The audible alarm sounds
continuously.
The I-O (ON/OFF) button is ON,
the compressor is operating, there is
a ow but the audible alarm sounds
continuously.
Possible Causes
Power cable is not correctly
plugged in.
Power failure.
Product pressure is too low or
too high.
Faulty 9 V Battery
Internal electrical fault.
Faulty indicator.
Pneumatic connection broken or
other pressure problem.
Internal electrical fault.
Pneumatic circuit fault.
Solutions
Check the cable connection.
Check the circuit breaker on the
front of the unit under the owmeter.
Contact your equipment supplier.
Replace battery
Contact your equipment supplier.
Contact your equipment supplier.
Stop the device by pressing the
I-O (ON/OFF) button and contact
your equipment supplier.
Stop the device and contact your
equipment supplier.
The compressor stops in mid-cycle,
then starts again after a few minutes.
Compressor thermal safety device has been activated.
Fan is not working.
Stop the device and wait for it to
cool down. Clean cabinet lter. Res-
tart. Reset the circuit breaker.
Contact your equipment supplier.
Dirty Filters.
If the device does not start, contact
your equipment supplier.
The oxygen enriched air ow is inter-
rupted at the nasal cannula outlet.
Tube disconnected or humidi-
er not tight.
Check that tubing connections are
secure and that the tubing is not
kinked.
The ow at the nasal cannula outlet is
irregular.
Cannula tubing is kinked.
Straighten the tubing ; contact your
equipment supplier if damaged.
Maintenance Items
Cabinet Dust Filter - Part Ref: 9250-1025; Wash weekly; Replace as needed.
Inlet Air Filter - Part Ref: 9250-1180; Inspect at each patient visit; Replace annually.
Battery, 9Volt - Part Ref: 7206-0027; Replace annually or sooner if needed.
Please record all maintenance activity on the Maintenance Log found in the Service Manual
and online at www.nidekmedical.com under the 'Maintenance Log' tab.
May 20112010-2224F Rev C 7
MMainain Main Maintenance
This i
Mai
Maintenance Items;
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham,Alabama 35217 U.S.A.
Tel: 205-856-7200 Fax: 205-856-0533
8
May 2011
2010-2224F Rev C
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