Nidek Medical OCSI User manual

May 20112010-2238CE Rev C 1
USER'S GUIDE
Mark 5 Nuvo 8
(OCSI)
OXYGEN CONCENTRATOR
FederalLaw (US) restricts this deviceto sale
by, or on the order of, a licensed physician.
This oxygen concentrator should be used
only under the supervision of a licensed
physician.
0413:Complies with the 93/42/ EEC directive
certi ed by the approved organization no 0413.
Danger: Do not smoke when using oxygen or when
near this device .
GLOSSARY OF 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
IV.USEFULINFORMATION .........................................4
IV.1. Accessories and spare parts.......................................4
IV.2. Materials in direct/indirect contact with patient........4
IV.3. Operating principles..................................................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
V. EMC, Electromagnetic statements...........................8-9
CONTENTS
: ON (power switched on)
: Off (power switched off)
: Type B device
: Class II protection
: Do not expose to open  ames
: Do not use oil or grease
: Technical information
: Consult the accompanying documents
: Keep in the vertical position
: Fragile - handle with care
: Oxygen concentration warning light
GLOSSARY OF SYMBOLS
[Original language is English]

2010-2238CE Rev C
2May 2011
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 8 should be kept away from
all  ames, 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.
Avoid letting oxygen accumulate on an upholstered
seat or other fabrics. If the concentrator is operating
while not supplying oxygen to a patient, position it
so that the gas  ow 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 8 must only be used for oxygen
therapy and only on a medical prescription. 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
(MRI, X-ray, etc.)
USE AND MAINTENANCE OF 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 8 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.
GENERAL SAFETY GUIDELINES
Only persons who have read and understood this entire manual
should be allowed to operate the Mark 5 Nuvo 8.
CONFORMITY WITH IEC60601-1 (§ 6.8.2 B):
"The manufacturer, assembler, installer or distributor are not
consideredtoberesponsiblethemselvesfortheconsequences
on the safety, reliability and characteristics 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).
• The device is used in accordance with the instructions for
use."
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.
ThisdevicecomplieswiththerequirementsoftheFDAQuality
System Regulation and the 93/42/EEC European directive
but its operation may beaffected by other devices being used
near by, such as diathermy and high frequency electro-surgi-
cal equipment, de brillators, short wave therapy equipment,
mobiletelephones,CBandotherportabledevices,microwave
ovens, 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.
I. DESCRIPTION
TheMark5Nuvo8isintendedtosupplysupplementaloxygen
to persons requiring low  ow oxygen therapy. It is not intended
to be life supporting or life sustaining. Itproduces an oxygen
enriched product by concentrating the oxygen contained in
roomair.Itcanbe usedeithertoadministeroxygenwithnasal
cannulas or another probe or mask type of device.
The Mark 5 Nuvo 8 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 performances described pertain to the use of
the Mark 5 Nuvo 8 with the accessories recommended by
Nidek Medical Products, Inc.

May 20112010-2238CE Rev C 3
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I.1. Front panel (Fig. I.1)
1 - (I/0) On/Off Power Switch
2- Humidi er (space reserved)
3 - Oxygen product outlet
4 - Flow adjustment knob (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
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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 humidi er:
Unscrew the  ask and  ll it with water up
to the line (see humidi er instructions). Then
screw the lid on the humidi er  ask until there
are no leaks.
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 tubebetween thecannula andthe Mark5Nuvo8should
belimitedto20meters(60feet)long,inordertoensurethat
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 ).
Thegreenindicatorwilllightwhenthe oxygenconcentration
exceeds the set point. Note: After turning the unit off,
the user must wait 3-5 minutes before turning it back
on. System pressure must dissipate before the unit will
properly restart.
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. Note: View the  owmeter in the horizontal plane for
accurate settings.
h. Check that the oxygen  ows out of the administration
device (nasal cannulas or other) by placing the ori ce(s) on
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 enri-
ched air  ow continues for approximately one 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.

2010-2238CE Rev C
4May 2011
III. CLEANING - MAINTENANCE
III.1. Cleaning
Only the outside of the Mark 5 Nuvo 8 is to be cleaned,
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 air  lter (7) must be cleaned in warm
waterandhouseholddetergentweeklyorafterapproximately
100 hours of use. More frequent cleaning is recommended in
dusty enviroments. Dry before reinstalling.
66
9
.
II.2. Daily disinfection
Because there is a  nal product  lter inside the device, daily
disinfection concerns only the external oxygen therapy
accessories: humidi er, probes, nasal cannulas (refer to the
respective instructions for use).
The device must be switched off when alcohol based so-
lutions 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.
TheMark5Nuvo8mustbecleanedanddisinfectedasperthe
above instructions. The cabinet air  lter should be washed or
replaced. The entire oxygen administration circuit (oxygen
therapy nasal cannulas, etc.) must be changed.
III.3. Maintenance
No special maintenance needs to be carried out by the
patient. Your equipment supplier performs periodic main-
tenance operations to assure continued reliable service from
the Mark 5 Nuvo 8.
Note: If the concentrator unit is to be stored (not used) for
a period of time exceeding 6 months, the 9 volt battery, if
equipped, should be disconnected and removed.
IV. USEFUL INFORMATION
IV.1. Accessories and spare parts
The accessories used with the Mark 5 Nuvo 8 must:
•be oxygen compatible,
•be biocompatible,
•comply with the general requirements 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 theset 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
(ISO 8359).
AVAILABLE ACCESSORIES
IF PRESCRIBED BYA 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
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  lter .....................................................Polyester
I/0 (On/Off) switch......................................................Nylon
Casters.........................................................................Nylon
Flow adjustment knob................................................... ABS
Oxygen product outlet .................................................Brass
Printed labels..................................................Polycarbonate
Pipe/Tubing........Aluminium,PVC, polyurethane or silicone
Humidi er .....................................................Polypropylene
Filter ..............................................................Polypropylene
6 Filter / Silencer
7 Cabinet Air Filter
8 Hour Meter
9 Ventilation Grille
10 Battery, if equipped
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910
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May 20112010-2238CE Rev C 5
IV.3. Operating principle
The compressor sends  ltered ambient air to an electronic
valving system, which allows compressed air to pass to the
column in production. The columns contain a molecular
sieve,whosefunctionis to adsorbthenitrogenandthusallow
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
a nitrogen desorption or "regeneration" phase. The oxygen
enriched product  nally passes through a bacterial  lter located
prior to the oxygen outlet  tting.
IV.5. OCSI (oxygen concentration status indicator) func-
tion
IV.5.1. Operating principle
The oxygen monitor (6) is an electronic module capable of
checking the effective oxygen concentration supplied by the
Mark 5 Nuvo 8 concentrator.
The oxygen monitor measures the concentration and activa-
tes an audible and visual alarm if it falls below the alarm set
point percentage.
When the Mark 5 Nuvo 8 is started, the indicator lights
operates as follows:
IV.5.2. Green indicator (OCSI ONLY)
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 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 27.8 in.)
Caster diameter: 50 mm (2.0 in.).
Tilt angle (transport with humidi er  tted): 70o.
Weight: 24 kg /54 lbs
Noise level < 53 dBA
Flow values:
ContinuouslyAdjustable Flowmeter: 2 to 8 liters/minute.
(Some models may have other values.)
IV.5.3. Red indicator (OCSI ONLY)
IV.5.4. Maintenance of the device alarms
• No special maintenance is required. The alarm set-point is
factorysetandthesettingcannotbeadjusted.Modelsoperating
at 50 Hz are set at 83% and 60 Hz models are set at 85%.
• The equipment supplier checks that the device is still
operating correctly when the routine checks are performed
on the Mark 5 Nuvo 8.
IV.4. Alarms - Safety devices
IV.4.1. Alarms
•No voltage 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/0 (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)
.
•No Oxygen FlowAlarm (Optional):
If supplied the Nuvo 8 Oxygen Concentrator has a No Flow
Alarm. This device provides an continuous audible alarm in
the event the Oxygen Flow to patient becomes blocked.
IV.4.2. Safety devices
•Compressor motor:
Thermal safety is ensured by a thermal switch situated in the
stator winding (145 ± 5 oC).
•Ambient air valve:
In the case of a negative pressure in the molecular sieve colu-
mns, this valve allows ambient air to enter.
•Electrical protection of the Mark 5 Nuvo 8:
A 5A circuit breaker is incorporated into the front cabinet of
all 230Vmodels.A10Acircuit breaker is included with 115V
models.
• Class II devices with insulated castings (EN60601-1
standard)
•Safety valve:
This is  tted on the compressor outlet and is calibrated to 3.4
bar (50 psig).
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
lightedarelowoxygenconcentrationandlossofmainspower.
The low oxygen concentration warning will light when the
oxygen concentration set point 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.