NHT CLINOXX-NHT-10 User manual
USER MANUAL
MODEL: CLINOXX-NHT-10
High Flow Oxygen Concentrator 10LPM
A Nanotech Product
The Science of Hope
NANOFOLD HEALTHCARE TECHNOLOGIES
Specialists In Medical Nanotechnology Research.
Corporate Office:
#3, Bellary Road, RMV Extension, Sadashivanagar,
Bangalore-560080, Karnataka, India.
Manufactured in India by:
Marketed by Nanofold India.
2
• Symbol Key...............................................................................................3
• Special Notes ..........................................................................................4
• Safety Notice............................................................................................4
Chapter 1: Introduction .............................................................................8
• Intended Use ............................................................................................8
• About CLINOXX-NHT-10..........................................................................8
• Parts of Oxygen Concentrator ................................................................8
• Accessories Equipment and Spare Parts ..............................................8
Chapter 2: Conditions of Use ....................................................................9
• Operating Environment............................................................................9
• Storage and Transportation Environment...............................................9
• Classification ...........................................................................................9
• Parameter Configuration.......................................................................10
Chapter 3: Operating Instructions...........................................................11
Chapter 3: Cleaning and Maintenance....................................................13
Chapter 4: Alerts and Troubleshooting ..................................................15
• LCD Indication........................................................................................15
• Troubleshooting Guide .........................................................................16
Chapter 6: Implementing Standards and Waste Disposal ....................17
• Executive Standards .............................................................................17
• Waste Disposal .....................................................................................17
Appendix A: EMC Information.................................................................17
Chapter 7: Warranty Information.............................................................22
Table Of Contents
Symbol Key
Mark Definition
Power On
Power Off
Follow Instruction for Use.
No Smoking
Caution, Consult accompanying documents.
Class II (Double Insulated)
Type BF Applied Part
CE Certification Mark
AC Power
Stacking Limit by Number
This Way Up
Fragile, Handle with Care
Keep Dry
Temperature Limit
No Open Flames
IP21 Drip Proof Equipment
3
Consult Instructions for Use
Stand-By
Warning, Electricity
SPECIAL NOTES
4
Please read this manual carefully before using this product and save it
for future reference.
If you need assistance with this manual, please contact your local DME
or home health provider
The CLINOXX-NHT-10 is a prescription device. Use only the liter setting
prescribed for you.
It is always recommended for critically ill patients to have a backup
oxygen source in case of malfunction.
If patient experiences an adverse reaction contact physician or call 911
immediately.
In case of machine malfunction, contact the home medical equipment
provider; do not attempt to disassemble the CLINOXX-NHT-10.
The CLINOXX-NHT-10 is not intended as life support, it is for
supplemental oxygen use only. Patients with special needs may be unable
to understand the alarm features and should be well supervised while using
an oxygen concentrator.
The CLINOXX-NHT-10 is for single patient use.
Do not adjust the flowmeter float beyond the flow capacity. Long-term
use out of range will reduce the efficiency of the oxygen generator.
Warning
Safety Notice
Please read the following information carefully before
Operating the oxygen concentrator.
Special attention should be paid to reducing the risk of fire when using oxygen therapy. Any
material that is flammable in the air becomes extremely combustible and burns quickly when the
oxygen concentration is high. For safety reasons, all ignitions should be kept away from the
oxygen concentrator. Oil, grease or petroleum substances are prone to strong spontaneous
combustion when exposed to oxygen under pressure. These materials must be kept away from
oxygen concentrators, cannulas, connections, and other oxygen concentrator components. Do
not smoke while using an oxygen concentrator.
Tips for Optimal Performance of the CLINOXX-NHT-10
5
The CLINOXX-NHT-10 should remain upright during use and storage.
The CLINOXX-NHT-10 should be operated in a clean environment.
Excessive dust and moisture can affect optimal performance.
Environmental temperatures for operation should remain between 50°F
and 99°F.
The CLINOXX-NHT-10 should not be moved while in operation.
The CLINOXX-NHT-10 should not be turned on with the flow meter
turned off or less than “0”.
The CLINOXX-NHT-10 will make an exhaust sound while in operation.
The CLINOXX-NHT-10 will vent hot air from the bottom of the unit;
please do not block the vent. Blocking the vent increases risk of fire.
The CLINOXX-NHT-10 should be used for 30+ minutes at each session.
Running the concentrator for short bursts can damage the components over
time.
Do not use the CLINOXX-NHT-10 if the power cord is damaged, the
concentrator has fallen or has been submerged in water.
If any of the above occurs, the unit is working incorrectly or abnormally,
please contact your DME or home health company.
Do not move the CLINOXX-NHT-10 by pulling the power cord.
Do not insert foreign objects into any openings.
Do not block inlets, vents or exhaust ports of the CLINOXX-NHT-10.
Do not place the CLINOXX-NHT-10 on soft surfaces such as beds, sofas,
blankets or cushions, this is a fire hazard.
Do not overfill the humidifier water bottle. This may cause water to enter
the cannula or oxygen outlet port.
Please place the CLINOXX-NHT-10 at least 15 inches away from walls,
curtains and other solid surfaces.
Do not stack objects on top of the CLINOXX-NHT-10.
Do not use parts, accessories, or equipment not approved by NHT.
Do connect the concentrator in parallel or series with other oxygen
concentrators or oxygen therapy devices.
Only use the CLINOXX-NHT-10 power cord made specifically for this
device.
6
Oxygen therapy is a prescription. Flow rates are patient specific. Please
do not change your flow without consulting your physician.
This machine is designed to supplement oxygen, not for first aid or to
sustain life.
Avoid creating sparks near medical oxygen equipment, including static
sparks generated by friction.
Extended use in sub-optimal conditions can affect oxygen purity. This
may cause oxygen levels lower than the patient requires.
If you feel your oxygen therapy is not sufficient, please contact your
physician. DO NOT attempt to change your prescribed liter flow.
The power plug must be unplugged while the CLINOXX-NHT-10
concentrator is not in use.
Contact the physician immediately, if the patient or caregiver finds
insufficient oxygen supply. Do not adjust the oxygen flow unless directed by
a physician or healthcare professional.
Always unplug the CLINOXX-NHT-10 when performing any routine
maintenance to avoid electric shock.
The CLINOXX-NHT-10 is designed to minimize routine maintenance. Yearly maintenance must be
performed by an authorized dealer or NHT certified personnel only.
Maintenance
• Do not use while bathing. If the patient requires continuous O2, the CLINOXX-NHT-10 concentrator
must be placed at least 10 feet from the bathroom.
• Do not touch the oxygen concentrator while wet. Do not use or store this oxygen concentrator near
liquids or other electrically conductive materials.
• Do not touch the CLINOXX-NHT-10 if it should fall into water or other conductive liquid. If this should
occur, unplug the power cord immediately.
Water Safety
• The use of portable communication equipment near the oxygen concentrator may cause interference
to the machine.
• This product cannot be used in environments such as electrocautery, electrosurgery, defibrillation,
X-ray (gamma ray), infrared radiation and transient electromagnetic fields, including magnetic
resonance (MRI) and radio interference.
• Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be more than 12 inches from any part of the equipment.
Otherwise, the performance of the device may be affected.
• This oxygen concentrator cannot be stacked with other equipment. This may result in improper
operation.
Radio frequency interference
7
THIS PAGE IS INTENDED TO SIGN BY THE DISTRIBUOTR/DEALER/RETAILER
SERIAL NUMBER:
Before delivery of the equipment to the customer a copy of this page to be sent to
NAME OF THE BUYER:
TEL:
E MAIL:
DATE OF DELIVERY:
NAME OF THE DEALER/RETAILER:
TEL:
E MAIL:
AUTHORISED SIGNATORY & SEAL
customerser[email protected]
8
Chapter 1: Introduction
About CLINOXX-NHT-10
Intended Use
Your physician has prescribed an oxygen concentrator set at a specific flow setting to meet your needs. DO
NOT change the flow settings unless your health care professional tells you to do so. Please read and
understand this entire manual before using the device.
The CLINOXX-NHT-10 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring
oxygen therapy. The device is not intended to be life supporting or life sustaining.
Technology Background
Parts of High Flow Oxygen Concentrator
Accessory Equipment and Spare Parts
The CLINOXX-NHT-10 produces high flow concentrated oxygen from STATE OF ART ELECTROLYTIC
TECHNOLOGY for delivery to a patient requiring low flow oxygen therapy.
The mechanism of Oxygen Evolution Reaction (OER) and Hydrogen Evolution Reaction (HER) are controlled by
the resistance in the system circuits, mass of nanocluter transport phenomena including ions transfer in the
electrolyte and the gas bubbles covering the electrode surface. The nature and dimensions of the material
used in the electrode produce hydrogenated oxygen from the electrolytic cell and is passed through water
column to remove excess hydrogen molecules through reducing gas temperature.
Your home care provider will show you how to operate the concentrator and will be available to answer any
questions.
• Humidifier Band: The humidifier band secures the humidification bottle to the CLINOXX-NHT-10.
• Hydrogenated Oxygen outlet: the oxygen flows from this port.
• Hydrogenated Oxygen flow meter: The flow meter indicates the liters per minute (lpm) that the oxygen is
flowing from the hydrogenated oxygen outlet port.
• Power switch “ I ” indicates the unit is running
• “ O ” indicates the power is off and oxygen is no longer being delivered to the patient
Intake filter: filters dust particles, this filter must not be removed
Access Panel: allows authorized personnel to access the intake filter
Please use only NHT accessories and spare parts for this device.
9
Chapter 2: Conditions of Use
• Operating Temperature: 50-99° F
• Operating Relative Humidity: 20%RH - 65%RH
• Operating Pressure atmosphere: NTP/STP
• The operating environment should be dry and well ventilated. The CLINOXX-NHT-10 should never be run in
environments that are dusty. Avoid electromagnetic interference when possible.
• This product must be placed upright and vertical during transportation.
• Transport & Storage Temperature: -30OC - 70OC.
• Transport & Storage Relative Humidity: 15-95%RH, No condensation.
• Transport & Storage Pressure Atmosphere: 500-1060hPa.
• IEC Class II Equipment
• Type BF Applied Part
• IP21 Drip Proof
• When the AC power supply voltage exceeds -15% to +10% of the rated voltage, the voltage is too high,
which may result in damage to the equipment. If the voltage is too low, the equipment may not start. If
the grid is unstable, please install a voltage regulator before use.
• The optimal temperature of the environment for CLINOXX-NHT-10 is 50-99°F. Below 50°F, Electrolytic
cell start-up may be difficult. Above 99°F, the Electrolytic cell may overheat and shorten the service life of
the compressor.
• During continuous operation, the time for reaching the specified oxygen content should not exceed 30
minutes.
• Not suitable for use in the presence of a flammable anesthetic mixture or nitrous oxide.
• Air outlet pressure: 0.05±10% MPa
• The expected service life of the product is 5 years.
• If the device is stored in a very cold or very hot environment, it should be allowed to stabilize at room
temperature for 5 hours before use
Operating Environmental
Storage and Transportation Environment
Classification
The CLINOXX-NHT-10 Oxygen Concentrator is classified as:
10
* Device operation above or outside of the voltage, LPM, temperature and humidity values
specified may decrease oxygen concentration levels.
* When the nominal pressure of the oxygen output port is zero, the oxygen concentration is
93%±5% under the operating environment and rated flow rate. See the “Output Oxygen
Concentration and Flow Rate Diagram
Parameter Configuration
Model CLINOXX-NHT-10
Rated power (W)
Energy consumption
Voltage (v)
Flow rate (L/min)
Concentration (Rated flow)
Sound pressure level dB (A)
Sound power level dB (A)
Net weight (kg)
Dimension (mm)
Alarm Signal
160W
1.4kWh/m3 of O2 under NTP
220V-240V ± 5V 50Hz ± 1Hz
0.5~10
93%±5%
≤45
≤55
27kg (Approx)
250L×280W×420H
Alarm Signal Abnormal water level alarm;
Power failure alarm;
Low flow alarm.
Flow (L/min)
Oxygen
Concentration (%)
Relation of outlet Oxygen Concentration and Flow
11
Chapter 3: Operating Instructions
• Please use distilled water only, and replace daily.
• Please do not over fill the humidifier.
1. Select a location that allows the concentrator to draw in room air without being restricted.
Make sure that the device is at least 12 inches away from walls, furniture, curtains that
could impede adequate airflow to the device.
2. Do not place the device near any heat source.
3. Plug the power cord into a grounded electrical outlet.
4. Follow step A or B depending on humidifier use:
A. If you are not using a humidifier:
I) Connect a cannula to the oxygen outlet.
B. If you are using a humidifier, follow the steps below:
I). Remove humidifier bottle from package.
II). Unscrew the lid in a counterclockwise direction, remove the humidification
cup, fill with proper amount of distilled water, and then tighten the lid
clockwise.
III). Install the humidifier with water in the hook and loop fastener on the
top of the CLINOXX-NHT-10 according to the diagram.
IX). Secure the humidifier using the humidifier band.
X). Connect the PVC hose to the oxygen outlet and humidifier inlet according
to the diagram.
XI). Attach the cannula to the humidifier.
Note:
Warning: Do not use extension cords or electrical adapters.
12
5. Turn on the power switch.
6. Adjust the oxygen output flow to prescribed liters per minute by centering flow meterball
on the proper number.
7. Always turn off the CLINOXX-NHT-10 when not using.
• The flow meter adjustment knob increases the flow rate
counterclockwise and decreases the flow rate clockwise.
Note:
Diagram: The Air Path
Oxygen
Concentration
Oxygen Outlet
To Patient
Humdifier
BOTTLE
(not included)
PVC Tubing
(included)
Humidifier bottle fitting
(included)
Oxygen Tube with
Fire safe valves
(not included)
13
1. Outer exhaust fan area to be cleaned weekly. If environmental conditions are less than
optimal, clean more frequently.
2. Cleaning steps are as follows:
a) Rinse the sponge mesh thoroughly using clean water, then allow to air dry
completely.
Chapter 3: Cleaning & Maintenance.
Warning: It is important to unplug the device before you perform any cleaning.
Excessive moisture may impair the operation of the CLINOXX-NHT-10
Image of CLINOXX-NHT-10-EXALTA High Flow Oxygen Concentrator
14
1. Wash your cannula daily. Wash with mild soap and water and allow to air dry.
2. Your cannula should be replaced once a month.
3. To clean the body of the CLINOXX-NHT-10, wipe with a damp towel, mild soap may be
used. Do not submerge the CLINOXX-NHT-10.
4. Humidification bottle: The humidifier water should be replaced every day with distilled
water. Cleaning and disinfection should be done at least weekly with a mild soap and water,
then allowing to air dry. To disinfect use one-part white vinegar and one part distilled water.
Once yearly replacement of the humidifier bottle is recommended.
Cleaning Your CLINOXX-NHT-10 and Accessories:
Image of CLINOXX-NHT-10-EXALTA High Flow Oxygen Concentrator
15
1. When troubleshooting multiple alarms, they will alternate. Alarms and indicators depend
on the highest priority. All of the above alarms are technical alarms, within 3 minutes after
power on, oxygen concentration less than 82% will not alarm.
2. When troubleshooting alarms, identify failure type from LCD and contact NHT
immediately.
3. Alarm system recommended test interval: 18 months.
Note:
Chapter 4: Alerts.
LCD Indication
Sl.
No.
1. System
High
Temp
Temprature
rise abnormal
Red LED illuminates
continuously and
the Audible Alarms
is beeping quickly.
The device is not
operating.
Block the air
outlet of the
oxygen
concentrator,
and alarm
aftera period
of time.
Less than
1 minute.
High
Medium
2. Water
Level
Flow
Output flow
is too low
The sound level
is 60~80dB
The sound level
is60~80dB
Yellow LED illuminates
intermittent
continuously and the
Audible Alarm is
sounding intermittently.
Adjust the
oxygen
flow-meter to
the minimum
level until
alarm stops.
Less than
1 minute.
Loudspeaker
Alarm Visualization
16
Chapter 5: Troubleshooting.
Troubleshooting Guide
Power on, the
equipment is not
working.
Power on, the
equipment is not
working, or works
intermittently.
No oxygen outlet or
the outlet flow is
too small.
No control of the
flow meter ball.
Water backing in
to cannula.
Call service provider or dealer.
* Check the power cord for damage
* Check that plug is secure
If not, call service provider.
* Unlink the cannula
* Re-install the humidifier cap
Call service provider if problem persists
* Tighten the knob
* Turn the knob slowly
Call service provider if problem persists.
* Dry the inside of humidifier cap
* Do NOT use hot water
* Do NOT over-filled humidifier
* Keep the same temperature of equipment
and cannula (place concentrator in the
same room as patient).
Start capacity of
Electrolytic cell is
broken or piston pump
is not working.
Power cord not
plugged securely or
bad contact.
* Oxygen cannula
kinked or blocked.
* Humidifier bottle top
not tightened against
leaks.
* The flow knob is not
tight.
* Turning the knob to
quickly can cause the
ball to be bypassed.
* Temperature
difference can cause
rainout. The
concentrator is too near
the wall, draperies or
furniture. Excessive
tubing separating the
patient and the
concentrator.
Problem Cause Troubleshooting
17
IEC 60601-1: 2012 Medical electrical equipment –Part 1: General requirements for basic
safety and essential performance.
IEC 60601-1-2: 2014 2nd edition, Medical Electrical Equipment, Part 1-2: General
Requirement for Safety – Collateral Standard: Electromagnetic Compatibility –
Requirements and Tests.
IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: General requirements for
basic safety and essential performance — Collateral Standard: General requirements, tests
and guidance for alarm systems in medical electrical equipment and medical electrical
systems +Amendment 1:2012
IEC 60601-1-11: 2015 Medical electrical equipment - Part 1-11: General requirements for
basic safety and essential performance Collateral Standard: Requirements for medical
electrical equipmentand medical electrical systems used in the home healthcare
environment.
BS EN ISO 80601-2-69: 2014 Medical electrical equipment Part 2-69: Particular
requirements for basic safety and essential performance of oxygen concentrator
equipment.
Dispose of the device in accordance with local regulations.
When the product is at the end of its life and the user intends to discard the product, it must
be disposed of separately from other waste. Please contact your local agency or waste
disposal service center for instruction and local disposal laws.
The CLINOXX-NHT-10 series oxygen concentrators can only be connected to the cables
mentioned in the attached documents. The use of accessories and cables outside the
specified connections to the CLINOXX-NHT-10 series oxygen machine may result in
increased emissions or reduced immunity of the CLINOXX-NHT-10 series oxygen
generators.
The CLINOXX-NHT-10 Series Oxygen Concentrators should not be used in close proximity or
stacked with other equipment. If they must be used close to or stacked, they should be
observed to operate properly in the configuration in which they are used.
Chapter 6: Implementing Standards and Waste Disposal
Executive Standards
Waste disposal
Appendix A: EMC Information
This device is designed to conform to the following standards:
Warning:
18
• Operate in strict accordance with the instructions of the CLINOXX-NHT-10 series oxygen
concentrator instruction manual to ensure that the device is not subject to electromagnetic
interference.
• Keep other devices away from this device to reduce the effects of electromagnetic
interference.
• The effect of electromagnetic interference can be mitigated by adjusting the relative
position/mounting angle between the device and other devices.
• Reduce electromagnetic interference by changing the wiring location of other device
power/signal cables.
• Reduce electromagnetic interference by changing the power path of other devices.
This device is intended for use in the electromagnetic environment specified below. The
user of this device should make sure it is used in such an environment.
Solutions to common problems with
electromagnetic compatibility:
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC EMISSIONS:
RF emissions CISPR 11 The device uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
The device is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage power
supply network.
Group 1
RF emissions CISPR 11 Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/Flicker
emissions IEC 61000-3-3
Complies
EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT-GUIDANCE
19
This device is intended for use in the electromagnetic environment specified below. The
user of this device should make sure it is used in such an environment.
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY:
Electrostatic
Discharge
(ESD)IEC
61000-4-2
Electrical Fast
Transient/Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
±8kV contact
±15 kV air
±2 kV for power
supply lines
±1 kV for
input-output lines
±1 kV
differential mode
±2 kV for
common mode
<5% UT (>95% dip in UT)
for 0.5 cycle
40%UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
<5% UT (>95% dip in UT)
for 5 sec
<5% UT (>95% dip in UT)
for 0.5 cycle
40%UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
<5% UT (>95% dip in UT)
for 5 sec
±1 kV
differential mode
±2 kV for
common mode
±2 kV for power
supply lines
±1 kV for
input-output lines
±8kV contact
±15 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Mains power quality
shouldbe that of a typical
home or hospital
environment.
Mains power quality should
be that of a typical home
orhospital environment.
Mains power quality
should be that of a typical
home or hospital
environment.
If the user of the device
requires continued
operation during power
mains interruptions, it is
recommended that the
device be powered from
an uninterruptible power
supplyor a battery.
IMMUNITY
TEST
IEC 60601
TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC
ENVIRONMENTGUIDANCE
20
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of this device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and this device as recommended
below, according to the maximum output power of the communications equipment.
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE
AND MOBILE RFCOMMUNICATIONS EQUIPMENT AND THIS DEVICE:
Power
frequency
(50Hz)
Magnetic field
IEC61000-4-8
Conducted
RFIEC
61000-4-6
Radiated RF
IEC 61000-43
30 A/m
3 Vrm
150 kHz to 80
MHz10V/m
80 MHz to 2.7 GHz
3Vrm
10Vm
30 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical hospital
or home environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
Portable and mobile RF
communications equipment
should be used no closer to
any part of the device,
including cables, than the
Recommended 12 inch
separation distance.
Interference may occur
in the vicinity of equipment
marked with the following
symbol:
IMMUNITY
TEST
IEC 60601
TEST LEVEL
COMPLIANCE LEVEL ELECTROMAGNETIC
ENVIRONMENTGUIDANCE
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