nice Neotech Medical Systems Pvt. Ltd.

nice 5001 Medical Air Compressor

OPERATING/INSTALLATION MANUAL

This operating manual provides all the information necessary for the user to safely set up and operate this
equipment. It is the responsibility of the user to follow the instructions and recommendations provided

73-00-046

Rev.01

Dt. 23/01/2017

nice Neotech Medical Systems Pvt. Ltd.

85. Krishna Industrial Estate, Vannagaram, Mettukuppam Chennai-95.

Ph: 91-44-24764608, Telefax: 91-44-24762594

E-mail: info@niceneotech.com / marketing@niceneotech.com / service@niceneotech.com

Web: www.niceneotech.com
Contents

User Responsibility/Operator Profile

Declaration for Language
Model Description
Definitions
Definition of Warning Indication
Section A: Warnings
Section B: Cautions
Section C: Symbols
Section 1: Description
1.1 Intended Use
1.2 General
Section 2: Installation
2.1 Setup
2.2 Installation of Air compressor
Section 3: Operation
3.1 Control Panel Operation
3.1.1 Display
3.1.2Indicator light
3.1.3Switches
3.2 Installation
Section 4: Cleaning and Maintenance
4.1 Cleaning
4.2 Maintenance
4.3 Recommended Maintenance Schedule
Section 5: Specification
Section 6: Warranty
Section 7: Trouble Shooting
7.1 System Failure
7.2 Maintenance interval
7.3 Disposing of the equipment
Section 8: Spare Parts List
Section 9: Manufacturer EMC Declaration
User Responsibility/Operator profile
This Product will perform in conformity with the description thereof contained in this operating
manual and accompanying labels and/or inserts, when assembled, operated, maintained and
repaired in accordance with the instructions provided. This Product must be checked
periodically. A defective Product should not be used. Parts that are broken, missing, plainly
worn, distorted or contaminated should be replaced immediately. Should such repair or
replacement become necessary, nice Neotech recommends that a telephone or written request
for service advice be made to the nearest nice Neotech Regional Service Center. This Product
or any of its parts should not be repaired other than in accordance with written instructions
provided by nice Neotech and by nice Neotech trained personnel. The Product must not be
altered without the prior written approval of nice Neotech’s Quality Assurance Department. The
user of this Product shall have the sole responsibility for any malfunction which results from
improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than
nice Neotech.

Warning: Before using the nice Neotech Medical Air Compressor, read this entire manual.
Attempting to use this device without a thorough understanding of its operation may result in
patient or user injury. This device should only be operated by personnel trained in its operation
and under the direction of qualified medical personnel familiar with the benefits and risks of this
type of device.

Declaration for Languages

User Manual and label will be provided in the appropriate language to ensure that the user
understands. Language validation will be done for the language of the user manual, Label,
Corresponding documents, when nice Neotech Medical Systems Private Limited supplies to
EU countries.

Model Descriptions:
nice 5001 Medical Air Compressor

Definitions:
O2: Medical Oxygen Gas.
Air: Medical Air.
PSI: Pound per Square Inches (Unit of Pressure for Air/O2).
LPM: Liter per Minute (Unit of Flow for Air/O2).
FIO2: Fractional Concentration of Inspired Oxygen.
NIST: Non-Interchangeable Screw Thread.
DISS: Diameter Indexed Safety System.
Definition of Warning indication:

Three levels of warning indication are used throughout this manual and on the unit. They are
defined as follows,

A DANGER notice indicates an immediately hazardous situation which, if not avoided, will
result in death or serious injury, serious damage to property such as total loss of use of
equipment, and a fire.

A WARNING notice indicates an indirectly (Potentially) hazardous situation which if not

avoided, will result in death or Serious injury, serious damage to property such as total loss of
use of equipment, and a fire.

A CAUTION notice indicates a hazardous situation which, if not avoided can result in minor or
moderate injury, partial damage to property and loss of data stored in computers.
Section A: Warnings

Warning: Before using the nice Neotech Medical Air Compressor, read this entire manual.
Attempting to use this device without a thorough understanding of its operation may result in
patient or user injury. This device should only be operated by personnel trained in its operation
and under the direction of qualified medical personnel familiar with the risks and benefits of this
type of device.

Warning: Do not use the Medical Air Compressor in the presence of flammable anesthetics; a
possible explosion hazard exists under these conditions.

Warning: In a dust free area, keep hands clean and then install the equipment.

Warning: Do not perform the Checkout Procedures (Mechanical and Control Unit) with a
patient.

Warning: Complete the “Checkout Procedures” section of this manual before putting the unit
into operation. If the Medical Air Compressor any portion of the checkout procedures it must be
removed from use and repaired.

Warning: even Small quantity of flammable agents such as ether, alcohol, grease and oil left in
the Medical Air Compressor it can cause fire in connection with oxygen.

Warning: The factory installed air and oxygen gas supply fittings, which contain essential
check valves and filters, must not be substituted.
Section B: Cautions

Caution: Do not autoclave or gas sterilize the Medical Air Compressor. Do not immerse the
device in liquid cleaner.

Caution: Only competent individuals trained in the repair of this equipment should attempt to
service it as detailed in the service manual. The Service Manual provides detailed information
solely for use by individuals having proper knowledge, tools and test equipment, and for service
representatives trained by nice Neotech.

Caution: Use of nonstandard components: Consult the manufacturer for repair and
replacement of components. Use of incorrect component can adversely affect Safety,
performance and/or damage the equipment performance.

Caution: Clean surface using wet cloth dipped in mild soap water and squeeze dry excess
water before use.

Caution: Do not allow water to spill into equipment.

Caution: Avoid using any solvent, spirits, and alcohol to clean plastic parts.

Caution: When using a bottled high pressure gas source, always use a pressure reducing
regulator set within 30-75 psi (2.1-5.2 bar).
Section C: Symbols
Indication
Mark

Caution

Caution, electric shock

Caution, ignition (Indicates possible ignition under certain condition)

Warning

Instruction

Protective Earth (ground)

Warning, Don’t disassembly

Audio Indicator

Off (Power: disconnection from main)

On (Power: connection to the main)

Warning: Condensed water in air supply can cause malfunction of this device.

Symbol for “USE NO OIL”

Refer Instruction for use

Serial Number

Authorized Representative in European Community

Date of Manufacture

Manufacturer

Model Number
Section 1: Description
1.1 Intended Use
1.2 General

1.1 Intended Use

The nice 5001 Medical Air Compressor is used to provide oil less compressed air to respiratory
care devices.

1.2 General

Air Compressor works by providing continuous oil less compressed air to the respiratory care
devices.

Precaution

This equipment is intended for use only by properly trained personnel as directed by an
appropriately qualified attending physician aware of currently known hazards and benefits.
If the equipment is damaged or fails to operate correctly, take it out of service immediately for
examination by a qualified Service Engineer to ensure operational safety. Always carry out a
functional test before use to ensure safety and operational integrity. Oxygen vigorously
supports combustion. Exclude any source of ignition in the presence or oxygen and does not
use oil or grease on oxygen equipment or spontaneous combustion may occur. Oxygen is a
drug and should be prescribed only by a physician. Ensure that the operating instructions and
recommendations contained in this book are thoroughly understood before using the
equipment that the book is always accessible for reference and is stored with the equipment.

1.3 Control Unit

The control unit contains the electronic circuits and controls used to operate the Medical Air
compressor. The control unit performs regular self checks during its operation including
failure diagnostics ETC,

Section2: Installation

2.1 Setup
2.2 Installation of Equipments

2.1 Setup

After removal from the shipping containers, inspect the nice Neotech Air Compressor and all
accessory items for any signs of damage which may have occurred during shipment.
File a damage claim with the shipping carrier if damage has occurred. Also confirm the
presence of all accessory items or factory installed options as listed on the packing slip.
Note: Before switching ON the nice Neotech Air Compressor the following process
has to be carried out.

2.2 Installation of Equipments

1) Open the right side cover of the Air compressor. (Refer fig 1)
2) Unscrew the cover from the motor. (Refer fig 1)
3) Remove cardboard foam three sides of the motor. (Refer fig 3).
4) Insert the Wire clip (brown colour wire) in the 2nd pin of the On/Off Switch. (refer fig
4&5)
5) Don’t alter or remove any other connection/devices on the board, inside the
compressor.
6) Close the motor Cover. (Refer fig 1)
7) Now close the main cover.
8) Switch on the medical air compressor.

Figure 1 Figure 2

Figure 3
Figure 4 Figure 5
Section 3: Operation

3.1 Control Panel Operation

Front Panel Button and Indicators (Figure 1)

1 Pressure gauge
2 Mute Key
3 Status Display
4 AC input indication LED
5 Mute ON indication
6 System failure Indicator
7 Power failure Indicator
8 Power Switch

3.1.1 Displays

 Status Display: It displays the total time.

3.1.2. Indicator Lights

 AC input indication LED: The AC input indicator lights when the AC input is given.
 Mute ON indication: The Mute ON indicator lights when the Mute ON key is pressed.
 Power failure Indicator: The Power failure indicator lights when the Power failure happens.

3.1.3. Switches
 Mute Key: To switch ON the mute.
 Power Switch: To switch ON/OFF the air compressor.
Section 4: Cleaning & Maintenance

4.1 Disassembly for cleaning

 It is recommended that when an infant is discharged, or at least once a week, to thoroughly clean
and disinfect the medical air Compressor. The most effective way to clean is to first
disassemblies in categories according to the method of cleaning required.

Warning: Periodically check the insulation and the connection of the cable it may cause fire because of
poor insulation and short circuits due to aging.

Warning: Switch off the equipment and disconnect the Power cord from the mains before take in to
cleaning

Warning: Don’t pour the water for cleaning it may enter into the electronics circuits it cause short circuit and
get shock.

Caution: Don’t keep the metal surface in wet condition it may cause corrosion and damage the
part

Caution: Use the cleaning solution sparingly on a cloth when cleaning the Infant Radiant Warmer. Do not
saturate the unit - excessive solution causes damage to internal components.

Caution: Use of nonstandard components: Consult the manufacturer for repair and replacement
of components. Use of incorrect component can adversely affect Safety, performance and/or damage the
equipment performance

The following lists recommended cleaning solutions that may be used safely.

Generic Formulation Max Concentration level

Hydrogen peroxide 6%
Sodium hypochlorite compound 0.5 % Aqueous Solution
Quaternary ammonium 0.2 %
Iodophors 50 mg/litre
Glutaraldehyde 2%

Caution: Use of cleaning/disinfecting solutions containing chemicals that are not listed above (i.e. alcohol,
acetone, etc.), or chemicals in greater concentrations than those listed above, may damage the patient probe
or other material being cleaned.

4.2 Life time of product

Since the product is classified under programmable medical electrical system and incase of unavailability of
microcontroller the life time of the product can be considered as minimum five years.
Section 5: Specifications

Mains Voltage : ~230V/50Hz/5A.

Rated Power : 550 Watts

Fuses : 5 amps

Pressure Display : Analogue Gauge 0 to 100 PSI / 0 to 7Kg/Cm2

Display : Compressor Total Running Hours & Compressor Current Running Hours

Output Flow : 50±5 LPM @ 50±5 PSI

Air Quality : 5µ

Dew Point Depression : >3°C below Room Temperature at peak output pressure

Automatic Standby Mode : Optional

Air Connection Input : NIST fitting

Noise Level : 55 dBA @ 1.2 Meter

Power Fail Audio and Visual Indication : If the power supply is disconnected or fails (Non Mutable)

Operating Temp : 0°c to 60°c

IEC 60601-1 Specifications

Type of Protection against electric Shock : Class 1

Degree of Protection against electric Shock : Type B

Mode of Operation : Continuous

Protection against hazardous of explosion : Not protected

Protection against increase of liquid : Not protected

Environment
o o
Operating Temperature : 15 C to 35 C

Operating Relative Humidity : 15 – 90% RH, non condensing

o o
Storage Ambient Temperature : -10 C to 60 C

Storage Relative Humidity : 50 - 90% RH, non-condensing

Altitude : Sea level to 1.9 miles 3 Km

Dimensions : 194 cm (H) x 95 cm (L) x 70 cm (W)

Quality Test Approval

Quality : ISO 9001:2008

: ISO 13485:2003

Electrical Safety : IEC 60601-1:2012

EMC Safety : IEC 60601-1-2:2007

Handling and Storage:

Section 6: Warranty

1. The warranty is confined to the first purchaser of the product only and is not transferrable.
2. Repairs under warranty period shall be carried out by the company authorized personnel only
3. In the event of repairs of any part/s of the unit, this warranty will thereafter continue and remain in force
only for the unexpired period of the warranty. The time taken for repair and in transit whether under the
warranty or otherwise shall not be excluded from the warranty period.
4. In case of any damage to the product/misuse detected by the Authorized service personnel the
warranty conditions are not applicable and repairs will be done subject to availability of parts and on a
chargeable basis only
5. Wear and Tear, and defects caused by manipulation or unsuitable treatment are not included under the
warranty.
6. We warranty this unit for 12 months from the date of Installation. Warranty includes the repair and
replacement of faulty components.
7. Defects caused by improper use, and defects due to causes beyond control like lightning, abnormal
voltage, acts of god, and also defects caused by rats, cockroaches or any other insects will not be
covered under warranty.
8. Warranty is not applicable if the equipment is not purchased from Neotech/authorized Neotech Dealer
9. Warranty is not applicable if the warranty card is not filled and sent back to Neotech.
10. Equipment has an expected shelf life of 5 years and service life of 6 years.

Customer Details cum Warranty Card

Date: __________

Hospital Name & Address: ______________________________________________

___________________________________________________________________

Contact Person & Telephone/Fax No______________________________________

Email ______________________________________________________________

Department: NICU / PICU / OT / Gynecology / Causality / Others _______________

Equipment Name: ____________________________________________________

Model No: ______________________ Sl. No. ______________________________

Date of Purchase: _____________________ Date of Installation _______________

Name of Authorized Dealer: ____________________________________________

Customer Signature & Date Dealer Signature with seal

(I accept the terms & conditions of Warranty)
----------------------------------------------------------------------------------------------------------------------------------------------------
Kindly fill the above and sent the same

From To:
The Service In-charge
nice Neotech Medical Systems Pvt.
Ltd. No, 85. Krishna Industrial Estate,
Vannagaram, Mettukuppam,
Chennai-600095. Tamil Nadu,INDIA
Ph: 91-44-24762594, 24764608
Tele Fax: 91-44-24766920 – Ext: 203
Email: service@niceneotech.com,
info@niceneotech.com
Web: www.niceneotech.com
Toll Free No. 1800-425-2594 (India only)
 Section 7: Trouble Shooting

7.1 General System Failure

7.2 Maintenance interval
7.3 Disposing of the equipment

Sl. No Problem Cause Remedy

Check the unit is Plugged in to Main supply

Power failure LED is ON with audio
1 Power Failure Check the mains are switched ON.
Audio and Visual Indication
Otherwise Contact nice Neotech
System Failure LED is ON with
2 System Failure Contact nice Neotech.
audio Audio and Visual Indication

7.3 Maintenance Intervals:

 Always disinfect and clean the unit and accessories before any maintenance – even when
returning the unit to the supplier for repair.

 Always disconnect power supply before any maintenance.

 Use only nice Neotech’s original parts for maintenance.

Warning: Periodically check the insulation and the connection of the cable it may cause fire because
of poor insulation and short circuits due to aging.

Warning: Don’t misaligned the EMI Shielding and the beads it may cause the EMI interference
to the equipment

Inspection & Maintenance: Yearly by trained Service Personnel.

7.6 Disposing of the Unit:

At the end of its Service life Dispose of the equipment in accordance with National waste
Disposal Regulations or ask a suitable Disposal contractor to dispose of the unit. The local
Environmental agency can supply further details.
Section 8: Spare Parts List

Sl. no Part No Part Name Qty Unit

1. 50-05-093 Air Compressor Control PCB Assembly 1 No.
2. 80-10-002 Power cord Clip- Humidifier 1 No.
3. 88-00-127 Cooling coil 9inch X 9inchX 2 inch 1 No.
4. 88-00-128 Miniature Pressure Regulator- 0.3 to 0.7 bar 1 No.
5. 88-00-129 Miniature Pressure Relief Valve- 0.3 to 0.7 bar 1 No.
6. 90-00-004 Power cord-open Type 1 No.
7. 91-00-003 Switch IRS 16 1 No.
8. 91-00-014 Connector PG 7 1 No.
9. 91-00-165 Oil less Air Compressor 1 No.
10. 91-00-166 AC Axial Fan 1 No.
11. 91-00-051 Battery 9V unchargable 1 No.

Service contact: EU Authorised Representative

nice Neotech Medical Systems Pvt. Ltd. CMC Medical Devices
85. Krishna Industrial Estate, Vannagaram, C/Horacio Lengo Nº 18
Mettukuppam Chennai-600095. Tamil Nadu, INDIA. P 29006, Malaga – Spain
Ph: 91-44-2476 4608 Telefax: 91-44-2476 2594 Mr. Manuel Mateos
E-mail: service@niceneotech.com Manager – Regulatory Affairs
/info@niceneotech.com Tel: +34951214054
Web:www.niceneotech.com / Fax: +34952330100
www.cemark.info/mdd/niceneotech.html mmateos@cmcmedicaldevices.com
www.cmcmedicaldevices.com
 For Complaints/Comments/Suggestions or Feedbacks
Date:

Hospital Name & Address:

Contact Person & Telephone/Fax No_

Email

Department: NICU / PICU / OT / Gynecology / Causality / Others

Equipment Name:

Model No: Sl. No.

Date of Purchase: Date of Installation

Complaints

Comments:

Suggestions:

Feed back:

Kindly fill the above and send the same

From To:
The Marketing In-charge
nice Neotech Medical Systems
Pvt. Ltd. No, 85. Krishna
Industrial Estate, Vannagaram,
Mettukuppam,
Chennai-600095. Tamil Nadu,
INDIA.
Ph: 91-44-24762594, 24764608
Tele Fax: 91-44-24766920 – Ext: 203
Email: marketing@niceneotech.com
Toll Free No. 1800-425-2594 (India only)
Section 9: Manufacturer EMC Declaration

Guidance and manufacturer’s declaration – electromagnetic emissions

The Medical Air Compressor is intended for use in the electromagnetic environment specified below.
The customer or the user of the Medical Air Compressor should assure that it is used in such an environment.
Electromagnetic environment –
Emissions test Compliance
guidance
RF emissions The Medical Air Compressor is
Class A
CISPR 11 suitable for use in all
establishments, including domestic
Harmonic emissions establishments and those directly
Class A
IEC 61000-3-2 connected to the public low voltage
power supply network that supplies
Voltage fluctuations/ buildings used for domestic
flicker emissions Complies purposes.
IEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic immunity

The Medical Air Compressoris intended for use in the electromagnetic environment specified below.
The customer or the user of the Medical Air Compressor should assure that it is used in such an environment.
IEC 60601 Electromagnetic
IMMUNITY test Compliance level
test level environment – guidance
Floors should be wood,
concrete or ceramic tile. If
Electrostatic discharge
± 8 kV contact floors are covered with
(ESD) Criteria A
± 15 kV air Synthetic material, the
IEC 61000-4-2
relative humidity should
be at least 30 %.
± 2 kV for power supply Mains power quality
Electrical fast transient. lines should be that of a typical
Criteria A
IEC 61000-4-4 ± 1 kV for input/output commercial or hospital
lines environment.
Mains power quality
Surge ± 1 kV for Differential Mode should be that of a typical
Criteria A
IEC 61000-4-5 ± 2 kV for commonmode commercial or hospital
environment.
Mains power quality
<5 % UT should be that of a typical
(>95 % dip in UT) commercial or hospital
for 0,5 cycle environment. If the user
40 % UT of the Medical Air
Voltage dips, short
(60 % dip in UT) Compressor requires
interruptions and voltage
for 5 cycles continued operation
variations on power Criteria B
70 % UT during power mains
supply input lines
(30 % dip in UT) interruptions, it is
IEC 61000-4-11
for 25 cycles recommended that the
<5 % UT Medical Air Compressor
(>95 % dip in UT) be powered from an
for 5 s uninterruptible power
supply or a battery.
 Power frequency
Power frequency magnetic fields should be
(50/60 Hz) at levels characteristic of
30 A/m Criteria A
magnetic field a typical location in a
IEC 61000-4-8 typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity

The Medical Air Compressor is intended for use in the electromagnetic environment specified below.
The customer or the user of the Medical Air Compressors should assure that it is used in such an environment.
IEC 60601 Electromagnetic
IMMUNITY test Compliance level
test level environment – guidance
3 Vrms Floors should be wood,
150 kHz to 80 MHz concrete or ceramic tile. If
Conducted RF outside ISM bandsa floors are covered with
Criteria A
IEC 61000-4-6 10 Vrms Synthetic material, the
150 kHz to 80 MHz relative humidity should
in ISM bandsa be at least 30 %.
NOTE UT is the a.c. mains voltage prior to application of the test level.