Nidek Mark 5 Nuvo 8 User manual
USER'S GUIDE
Mark 5 Nuvo 8
(OCSI)
OXYGEN CONCENTRATOR
[Original language is English]
FederalLaw(US)restrictsthisdevicetosale
by, or on the order of, a licensed physician.
This oxygen concentrator should be used
only under the supervision of a licensed
physician.
CONTENTS
GLOSSARYOFSYMBOLS..........................................1
GENERALSAFETYGUIDELINES............................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
GLOSSARYOFSYMBOLS
0413: Complies with the 93/42/ EEC directive
certi ed by the approved organization no 0413.
Danger: Donot smokewhenusing oxygen or when
near this device
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
.
: 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
May 20112010-2238CE Rev C 1
GENERALSAFETY GUIDELINES
Only persons who have read and understood this entire manual
should be allowed to operate the Mark 5 Nuvo 8.
USE OFOXYGEN
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 orotherfabrics.Iftheconcentratorisoperating
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.)
CONFORMITYWITH IEC60601-1 (§ 6.8.2 B):
"The manufacturer, assembler, installer or distributor are not
consideredtobe responsiblethemselvesfor theconsequences
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 be affected by other devices being used
near by, such as diathermy and high frequency electro-surgi-
cal equipment, de brillators, short wave therapy equipment,
mobiletelephones,CBand otherportabledevices,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.
USEAND 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.
2
I. DESCRIPTION
TheMark5Nuvo8isintendedtosupplysupplementaloxygen
to persons requiring low ow oxygen therapy. It is not intended
to be life supporting or life sustaining. Itproducesan oxygen
enriched product by concentrating the oxygen contained in
roomair. It can beusedeitherto administer oxygenwithnasal
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 2011
2010-2238CE Rev C
II. STARTING UP / INSTALLATION
6
6
4
4
5
5
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
5
1
1
32
3
3
3
3
4
2
5
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.
Thetubebetweenthecannula and the Mark 5Nuvo8should
belimitedto20meters (60 feet)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 ).
Thegreenindicatorwill light when theoxygenconcentration
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.
9
I.2. Rear panel (Fig. I.2)
7 - Cabinet Air Filter
8 - Manufacturer's Technical Label
9 - Power Cord
g. Turn the ow adjustment knob (4) to the prescribed value.
This knob may have already been locked in the medically
7
8
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.
May 20112010-2238CE Rev C 3
7
III. CLEANING - MAINTENANCE
III.3. 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
waterandhousehold detergentweekly orafterapproximately
100 hours of use. More frequent cleaning is recommended in
dusty enviroments. Dry before reinstalling.
7
8
8
7
9
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 solutions are used.
a. The following minimum guidelines must be
observed:
10
66
6
6
6 Filter / Silencer
7 Cabinet Air Filter
8 Hour Meter
9 Ventilation Grille
10 Battery, if equipped
• 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.
TheMark5Nuvo8mustbecleanedanddisinfectedasper the
above instructions. The cabinet air lter should be washed or
replaced. The entire oxygen administration circuit (oxygen
therapy nasal cannulas, etc.) must be changed.
4
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 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
(ISO 8359).
AVAILABLEACCESSORIES
IF PRESCRIBED BYAPHYSICIAN
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 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
May 2011
2010-2238CE Rev C
Loading...