Nidek Medical Nuvo8 User manual

Page 1 REV A 10/05 2010-2238STD
User’s Guide
Nuvo8
(8 liter)
Oxygen Concentrator
Federal Law (US) restr cts th s dev ce to sale by, or on the
order of, a l censed phys c an. Read and understand th s
ent re manual before us ng th s dev ce.
IMPORTANT SAFETY GUIDELINES 1 ACCESSORIES AND SPARE PARTS 2
DESCRIPTION / PURPOSE OF USE 1 ALARMS AND SAFETY DEVICES 3
START UP / INSTALLATION 2 SPECIFICATIONS 3
CLEANING / MAINTENANCE 2 TROUBLESHOOTING AND SYMBOLS 3
• If you are exper enc ng any s gns of d scomfort consult your Equ pment Prov der or your phys c an mmed ately.
• The un t should only be used for oxygen therapy and by med cal prescr pt on. The prescr bed da ly durat on and flow rate must be
followed, otherw se t may present a r sk to the health of the pat ent.
• Do not leave un t on or unattended f not n use by the pat ent.
• Do not use extens on cords or adapters.
• Do not smoke, or allow others to smoke near the un t wh le n use.
• Do not use n a magnet c env ronment such as MRI, X-ray, etc.
• Do not remove the covers of the un t.
• Do not place un t where the ntake f lter vent lat on could be obstructed or blocked.
• Oxygen s not a flammable gas, but accelerates the combust on of mater als. To avo d all r sks of f re, the un t must be kept away
from all flames, ncandescent sources and sources of heat, as well as any combust ble products such as o l, grease, solvents,
aerosols, etc.
• Th s dev ce compl es w th the requ rements of the FDA Qual ty System Regulat on but ts operat on may be affected by other
dev ces be ng used near by.
GLOSSARY OF SYMBOLS
!
ATTENTION DO NOT GREASE CLASS II DEVICE
DO NOT EXPOSE TO OPEN
FLAMES
TYPE B DEVICE TECHNICAL INFORMATION
DO NOT SMOKE FRAGILE – HANDLE WITH CARE
KEEP IN THE VERTIFICAL
POSITION
The Nuvo8 s ntended solely for med cal use n oxygen therapy programs under the superv s on of a phys c an. Th s dev ce s
ava lable by prescr pt on only and s not ntended to support or susta n l fe. It produces oxygen enr ched product by concentrat ng
the oxygen conta ned n room a r. The prescr bed da ly durat on and flow rate must be followed, otherw se t may present a r sk to
the pat ent’s health.
TABLE OF CONTENTS
IMPO TANT SAFETY GUIDELINES
DESC IPTION / PU POSE OF USE

Page 2 REV A 10/05 2010-2238STD
Front Panel Illustration
1. Power Sw tch
2. Oxygen Outlet
3. Hum d f er (space reserved)
4. Flow Adjustment Knob (l/m n)
On Flowmeter
5. C rcu t Breaker
6. Ind cator L ghts
7. Symbols
ear Panel Illustration
8. External Cab net F lter
9. Techn cal Label
10. Power Cord
1. Ensure that the Power Sw tch (1) s n the (0) Off pos t on.
2. Pos t on un t where the External Cab net F lter (8) s not obstructed.
3. Plug the Power Cord (10) nto a power outlet of the correct voltage and
frequency as def ned on the Techn cal Label (9) located on the rear panel of
the mach ne.
4. Connect oxygen tub ng to the oxygen outlet (2) connector. If a hum d f er
has been prescr bed, add water to the recommended level and attach the
hum d f er to the oxygen outlet (3) then attach the oxygen tub ng to the
hum d f er outlet.
5. Press Power Sw tch to the (I) On pos t on. The Red Ind cator L ght (6) w ll
llum nate and the aud ble alarm w ll sound unt l the system pressure r ses to
the accepted level.
Note: The required oxygen concentration is normally obtained within
five minutes after the machine is turned on.
6. Turn the Flow Adjustment Knob (4) to the prescr bed flow rate. The ball
ns de the flowmeter (4) should be centered on the l ne nd cat ng the flow
rate. V ew the flowmeter n a hor zontal plane for accurate sett ngs.
6. Place your nasal cannula or mask as nstructed by your Equ pment
Prov der.
7. At the end of treatment, press the Power Sw tch (1) to the (0) Off pos t on.
Note: The oxygen enriched air flow continues for approximately one
minute after the machine is turned off.
Note: Unplug the unit before performing maintenance or cleaning.
Only the outs de of the un t s to be cleaned w th a soft dry cloth or, f
necessary, a damp sponge w th a m ld soap. Do not use acetone, solvents,
abras ve powders or any nflammable products to clean the cab net.
The removable External Cab net F lter (8) must be cleaned weekly. More
frequent clean ng may be requ red n dusty env ronments. Clean f lter by
wash ng n soapy water, r ns ng thoroughly and allow ng f lter to a r dry before
replac ng.
Follow Manufacturer’s Instruct ons for the clean ng requ rements of the
Hum d f er ( f prescr bed) and oxygen tub ng, etc.
Note: No additional maintenance is required or should be performed by
the patient. The Manufacturer’s Instructions for Preventative
Maintenance and epair of the Device is defined in the Technical
Manual provided to your Equipment Provider.
The accessor es and spare parts used w th or for th s un t must comply w th
the general requ rements of the FDA Qual ty System Regulat on.
Note: The following accessories are recommended for use with this
unit.
9012-8774 Hum d f er
9012-8777 Cannula L ne Water Trap
9012-8778 Cannula w th 15’ Tub ng
9012-8780 Cannula w th 7’ Tub ng
9012-8781 25’ Tub ng Extens on
9012-8782 Supply L ne Adapter
1
2
3
4
5
6 & 7
8
9
10
STA T UP / INST
ALLATION
CLEANING / MAINTENANCE
ACCESSO IES AND SPA E PA TS

Page 3 REV A 10/05 2010-2238STD
ALA MS / SAFETY DEVICES
• Power Failure Alarm – In the event of a loss of power, a cont nuous aud ble alarm s act vated.
• Process Failure Alarm – In the event of a process fa lure, the Red L ght Ind cator (6) and aud ble alarm s act vated.
• Electrical Protection Device – n the event of a surge or drop n the power supply the C rcu t Breaker (5) w ll tr p.
Restart the un t by depress ng the reset button on the C rcu t Breaker (5)
• Green Light Indicator (6) nd cates that the un t has power and s ready to prov de oxygen enr ched a r to the pat ent.
• ed Light Indicator (6) nd cates that a system fault has occurred or there s no power to the un t.
SPECIFICATIONS
Flow Values: 2 to 8 L ters per M nute Characteristics: Electrical:
Length – 15.5” or 394 mm 120 VAC, 60 Hz, 4.0 amps, 490 watts
Average Oxygen Content: W dth – 15.6” or 396 mm 230 VAC, 50-60Hz, 2.0 amps 490-585 watts
• at 2 L ters per M nute – 93% He ght – 27.8” or 706 mm Two-Prong polar zed plug
• at 6 L ters per M nute – 92% We ght – 54 lbs. or 24 kg. Double Insulated Cab net
• at 8 L ters per M nute – 90% (Var es w th models)
Storage Instructions: Th s dev ce should only be stored, transported and operated n the vert cal pos t on.
Disposal of Device and Accessories: The un t and accessor es (tub ng, hum d f er, etc.) should be d sposed of us ng the methods
appropr ate to the local waste author ty where used.
T OUBLESHOOTING
OBSE VATIONS POSSIBLE CAUSES SOLUTIONS
The (I/0) Power Sw tch s n the (I) On
Pos t on but the dev ce does not operate.
The aud ble alarm sounds cont nuously
Power Cord (10) s not
plugged nto outlet
Power fa lure
Check that the un t s properly plugged nto the electr cal outlet
Check the C rcu t Breaker (5) and reset f necessary
Red L ght Ind cator (6) rema ns l t Product pressure or pur ty s
not at an acceptable level
Contact your Equ pment Prov der
The aud ble alarm does not sound when
un t s f rst turned on
Faulty 9 volt battery
Internal electr cal fault
Contact your Equ pment Prov der
The un t s operat ng but the Green L ght
Ind cator (6) s not l t
Faulty nd cator Contact your Equ pment Prov der
The un t s operat ng but there s no flow
(flowmeter ball not mov ng)
Internal system fa lure Stop dev ce mmed ately and contact your Equ pment Prov der
The un t s operat ng but the aud ble alarm
sounds cont nuously
Internal fault Stop dev ce mmed ately and contact your Equ pment Prov der
The un t suddenly stops and then starts
aga n n a few moments.
D rty F lters
Compressor Thermal Shut-Off
Clean External Cab net F lter (8)
Contact your Equ pment Prov der
The oxygen flow s nterrupted or the flow
at the cannula feels rregular
Tub ng s d sconnected or not
t ght
Tub ng s restr cted
Check tub ng connect ons
Stra ghten tub ng
Contact your Equ pment Prov der
NIDEK MEDICAL PRODUCTS, INC.
3949 VALLEY EAST INDUSTRIAL DRIVE
BIRMINGHAM, ALABAMA 35217 USA