Seim Nova 1001 NEB Operating instructions

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 1 di 12
ASSISTANCE
Read the instruction manual before using the device.
This manual must be kept with the device for later reference.
SIGNS AND SYMBOLS
This symbol indicates the
compliance with the
essential requirements of
the Directive 93/42/ EEC
of 14 June 1993
concerning medical
devices. Reference IMQ
Spa - Milan
This symbol
indicates an
insulation class I
device.
This symbol indicates
to follow instructions
for use.
This symbol indicates the
date of production (four
digits for the year and two
digits for the month).
This Symbol
indicates a type B
applied part.
This symbol indicates
to consult instructions
for use.
This symbol indicates the
manufacturer.
This symbol
indicates alternate
current
This symbol indicates
direct current
This symbol indicates
manufacturer’s catalogue
number.
This symbol
indicates
manufacturer’s
production lot
number.
This symbol indicates
manufacturer’s
product serial number.
This symbol indicates a
C UTION or W RNING
associated with the device.
This symbol
indicates a single
use device. Do not
reuse the device.
This symbol indicates
the temperature
limitation for
operation, transport
and storage.
This symbol indicates the
humidity limitation for
operation, transport and
storage
This symbol
indicates the
atmospheric
pressure limitation
for operation,
transport and
storage.
This symbol indicates
that interferences may
occur in the vicinity of
equipment marked
with this symbol
This symbol indicates do
not dispose the device
together with unsorted
municipal waste (for EU
only).
This symbol
indicates to keep the
device dry.
IP33
This symbol indicates
the protection against
harmful effects due to
ingress of solid foreign
objects and against
harmful effects due to
the ingress of water.
This symbol indicates to
keep the device away from
sunlight
This symbol
indicates do not
short circuit the
battery
This symbol indicates
the components
material could be
recycled
This symbol indicates do
not dismount or deform
This symbol
indicates do not
expose to fire or
flame
This symbol indicates
compliance with EEC
Directive
This symbol indicates do
not immerse in water or
other liquid
This symbol
indicates do not cut
or open
This symbol indicates
the optimal storage
and employ condition
for the battery
1WARNINGS AND SAFETY INSTRUCTIONS
1.1 APPLICATION
The 1001 NEB ultrasound nebulizer is approved exclusively for the use as described in these user and
maintenance manual. Siem nova can only warranty the safe functioning of the equipment when the 1001 NEB is
used with the Siem nova accessories.
Please read and o serve these warning and safety instructions efore use the device.
Please note that these instructions for use are a general guide for the use of the product.
Medical matters must e addressed y a physician.

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 2 di 12
WARNINGS: The product is designed for the safety care of patient and operator ut some
warnings must e followed.
REMARKS: The users must e a le to read, understand and follow directions provided in this
manual and provided y the physician. If you are dependent on the device for airway suctioning and
a reakdown can lead to a critical situation, you must have another suita le device availa le
1. Only use the 1001 NEB on the person for whom it was ordered and only for its intended use.
2. The equipment must be used by instructed and qualified operators.
3. If you note changing in performances of the equipment, please contact immediately authorized service
center.
4. Do not perform the therapy without your physician supervision.
5. Do not modify the equipment without manufacturer authorization.
6. Do not use the equipment in presence of flammable anesthetic mixture with air, oxygen or nitrogen
protoxid.
7. The use of mobile telephones, cordless telephones and other communication equipments can affect
the 1001 NEB suction pump. safety distance of min. 1 m to the 1001 NEB pump is recommended.
8. Keep the power supply cord away from hot surfaces.
9. Keep the mains plug away from moisture.
10. Never remove the mains plug out of the fixed mains socket by pulling on the power cord!
11. Never leave the device unattended when it is operating.
12. The equipment must stand upright during use.
13. Never use the device while bathing or showering
14. Do not use extension cords with 1001 NEB nebulizer.
15. Keep the power supply cord where you will not fall or trip over it.
16. The power cords or the tubes (for their length) may involve a risk of strangulation.
17. Never place the power supply cord or the tubes around your neck.
18. Some components for their small size could be swallowed causing suffocation
19. Keep the 1001 NEB clean and dry.
20. Never place the pump in water or liquids.
21. Never touch with wet hands electrical parts.
22. If the pump gets wet, rub with dry towel. Do not dry in a microwave.
23. Do not touch the suction pump when it has fallen into water. Unplug device immediately from main power
supply.
24. Keep the equipment away from children and pets.
25. Keep the equipment protected from direct sunlight.
26. Keep the equipment away from heat source
27. Prevent the nebulizer from falling to the floor.
28. Check the general conditions of delivery package of the 1001 NEB for completeness and the presence of all
accessories supplied.
29. In case of an allergic reaction due to the contact with the materials of this device, contact your doctor.
2DESCRIPTION OF THE DEVICE
2.1 Introduction
This 1001 NEB Nebulizer from Siem nova is a professional quality ultrasound nebulizer that combines easy
handling and cleaning with safety features to ensure optimal operation. 1001 NEB Nebulizer has been
manufactured to nebulize medical drugs or demineralized water. The range of the particles size nebulized is from
1 to 6 microns, so they can reach high and low airways.
2.2 Intended use
Nebulizer 1001 NEB has to be temporary used by patients to nebulize drug or water for respiratory system
treatment. This device has to be used in hospital or ambulatory for home assistance. If required a heater for
heating the flow of the nebulized product.
2.3 Contraindications
The device is not suitable for use for thoracic or gastro-intestinal aspiration
2.4 Intended user
The 1001 NEB should only be operated by properly instructed users.
2.5 Service life
The service life of the device is two years (drug nebulization chamber, tube and piezoelectric crystal not
included)

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 3 di 12
Cilinder
humidification
chamber (2)
rm for tube and
liquids (3)
Flexible arm with
tubing support (4)
Polyethylene
corrugated tube
patient (6)
Polyethylene
corrugated tube (5)
Humidification
chamber cap (7)
Nebulisation power
regulator (12)
Heater switch with
light indicator (16)
Drug chamber (8)
Main switch knob and
timer regulator (11)
with green light
Floater (14)
Yellow light for low
level (15)
dult and child
masks (9) (10)
Disposable
atomising chamber
(18)
ir flow regulator
(13)
Disposable
atomising chamber
cap
(19)
2.6 Package contents
(Please ask your supplier in case of missing parts or for additional accessories)
The package contains:
quantity description code Rif.
1 Equipment 1001 NEB (basic unit) 14010 1
1 Cylinder Humidification Chamber 14125 2
1 rm for tube and humidification and physiological solution or drug solutions 14029 3
1 Flexible arm with connection to the tube 14030 4
0.50 m Polyethylene corrugated tube 0.50 m (from flow regulator to chamber) 14033.1 5
1.50 m Polyethylene corrugated tube 1.50 m (from chamber to patient mask) 14033 6
1 Humidification chamber cap 14034.1 7
5 Drug Chamber 14034 8
1 Disposable atomising chamber cap 14091 19
5 Disposable atomising chamber 14091.1 18
2 dult soft mask 14514 9
2 Children soft mask 14516. 10
Optional (on request):
quantity description code Rif.
Heater 14011
ir filter 14040
TROLLEY 14001
3.8 Description
1. Equipment 1001 neb (basic unit)
2. Cilinder Humidification Chamber
3. rm for tube and liquids
4. Flexible arm with tubing support
5. Polyethylene corrugated tube
6. Polyethylene corrugated tube patient
7. Humidification chamber cap
8. Drug chamber
9. dult Mask
10. Child mask
11. Main switch and timer
12. Nebulization power regulator
13. ir flow regulator
14. Floater (for liquid level)
15. Low level light (yellow)
16. Heater switch with light indicator
17. Heater
18. Disposable atomising chamber
19. Disposable atomising chamber cap
.

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 4 di 12
3PREPARATION FOR USE
3.1 CHECKS BEFORE USE
Check 1001 NEB before use:
1. Damage of the power cord or of the main socket,
2. The device must be connected to room equipotential knot (earth knot). User is responsible for this.
3. Obvious equipment damage safety defects (1)
4. Proper functioning of the device.
5. Liquid presence in the humidification chamber (7) and in the drug chamber (if used)
Check all accessories before use:
1. Tubing (5) (6) for cracks, brittle areas and that connections are firmly attached. Replace if necessary
2. Sterile accessories must be checked on the integrity of the packaging before use. Replace if necessary
3. Not sterile and reusable accessories must be cleaned and disinfected before use.
CAUTION: Do not use sterile accessories if the sterile packaging is damaged. Do not reuse
disposa le items or sterile accessories
For continuous operation, turn left the timer kno and the machine will switch on till you turn
right again the kno (the green light will e on), while for a timed operation of 0 to 2 hours, turn the
timer kno to the right and place the arrow on the time required.
CAUTIONS The 1001 NEB device is to e set up in such a way, that a separation from the
mains supply can e easy.
3.2 USE WITH DRUGS
For drug nebulization, the maximum quantity of drug you can nebulize is 10 ml.
1. Put only demineralized water into the humidification chamber (2) until reach to the lowest mark (if
present otherwise 170/180 ml).
2. Put the nebulization chamber (8) into the cylinder.
3. Put the drug inside the drug chamber (8) max 10 ml (cc)
4. Connect the air tubing and turn on the equipment (continuously or by timer)
In order to add liquid, operate with the following instructions:
5. Turn off the device
6. Remove the tubing and then the nebulization chamber
7. Remove nebulization chamber taking it on its top side by doing a small torsion action.
8. dd drug
9. Repeat the operation as previous indications (point 1 to 4)
Liquid has never to e under the lowest level in the humidification cham er. If this happens
the magnetic float in the cylinder will immediately stop the ne ulization and a yellow light will link
(in this situation the air fan will continue to operate)
The use of drug has to e prescri ed y authorized medical operators only.
3.3 USE WITH DEMINERALIZED WATER (HUMIDIFICATION)
For Humidification, the maximum quantity of demineralized water is 300 ml (higher mark on humidification
chamber
1. Put demineralized water into the humidification chamber until reach to the higher mark (if present otherwise
300 ml).
2. Put the nebulization chamber cap (7) on the humidification chamber (2).
3. Connect the air tubing and turn on the equipment (continuously or by timer)
In order to add liquid, operate with the following instructions:
1. Turn off the device
2. Remove the tubing and then the nebulization chamber cap
3. dd demineralized water
4. Repeat the operation as previous indications. (point 1 to 3)
Use only demineralized water.

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 5 di 12
3.4 USE WITH HEATHER
Follow previous instruction for liquid to be nebulized
Replace the tube (6) with the heater (17)
Connect the heather plug in the socket
(on the back of the equipment)
press the heater switch (16),
a light will be turned on
The heater works only when main switch is on
3.5 POWER REGULATION
Regulation rotating knob is on the front side.
The oscillating circuit board can generate a frequency of 1,635 + 1,750 MHz,
which change the effectiveness of nebulization.
Usually better nebulization (crystal life) is obtained keeping the frequency at
an intermediate value.
3.6 HEATER (Available on request)
The Heater should be used for heating the nebulized product’s flow at a max temperature of 37°C. It has to be
inserted into a corrugated tube and supplied accordingly to instructions at point 4.
The use of heater must e prescri ed y authorized medical operators only
3.7 AIR FAN
The air flow produced by the inner fan push the nebulization from the nebulization chamber (or humidification
chamber) to the patient through the corrugated tube. The inlet of the air is filtered by a replaceable foam filter
3.8 FLOW REGULATOR (13)
It is inside the joint connected with the tubing to the nebulization cap (or chamber). By positioning it in suitable
position is possible have the required air flow regulation.
3.9 HUMIDIFICATION CHAMBER (2)
It is an acrylic transparent tube with 2 circular marks showing the lowest and the highest level of
demineralized water level.
3.10 DRUG NEBULIZATION CHAMBER (8)
It is a Polyethilene chamber and it has to be fitted on the humidification Chamber (2) cylindrical container by
pressing it.
WARNING: insert and remove ne ulization cham er only when device is off and removed
from the corrugated tu e.
4 OPERATING INSTRUCTIONS
CAUTIONS:
The 1001 NEB device is to e set up in such a way, that a separation from the mains supply can e
easy.
4.1 Connect 1001 NEB to mains power
1. Check the 1001 NEB before use following the instruction in chapter 4 "Preparation for use”. Check always if
the power supply voltage is suitable equipment voltage.
4.2 Functional check
1. Follow the instruction in chapter 3 preparation for use
2. Turn the On / off knob (2) to switch on the equipment. Turn on left or right the main switch knob (11) (for
continuous or timed operation)
Max air flow No air flow
Heater (17)
Heater plug and
equipment
socket

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 6 di 12
3. Turn the power regulator knob to the desired position (for required nebulization)
4. Turn the air flow regulator to the desired position (for required air flow rate)
4.3 Placing out of operation after use
1. Turn the On / off knob (2) to switch off the equipment.
2. Remove the power cord from the main socket and then from the equipment.
3. Disconnect all the tubing.
4. Remove drug nebulization chamber (8)
5. Remove the liquid inside the humidification chamber (2) pulling out the silicone tubing on the back of the
equipment (see pictures).
6. Clean and disinfect the humidification chamber. (2) See chapter 6 "Cleaning guidelines”
7. Clean and disinfect all the tubing and drug nebulization chamber (8) or humidification chamber cap (7). See
chapter 6 "Cleaning guidelines”
8. For disposable material follow local after-use guidelines (if used)
Warning:
the equipment must e stored a solutely dry (a ove all the humidification
cham er) to avoid corrosion and/or crystal damage
5 TROUBLESHOOTING
In case device doesn’t work properly, please check if the problem can be solved with one of the interventions below mentioned:
DEFECT REASON SOLUTION
Device doesn’t start No power supply Check net voltage and supplying cable
Device doesn’t start No power supply Check the fuses and if they are burnt,
please call technical Assistance
Device doesn’t atomise
Level pilot light is on Liquid level in the cylinder is low Fill up with other demineralized water
Nebulization flow is low Power regulation Turn and set it for increasing the
nebulization rate
Nebulization flow is low Flow valve is closed Open It in suitable position
Device doesn’t produce the required
nebulization Nebulization chamber is broken Replace it
Device doesn’t produce the required
nebulization Nebulization chamber and or the humidification chamber are empty Please put the liquids in the chamber/chambers
Device doesn’t produce the required
nebulization Piezoelectric crystal broken Call technical Assistance
Device doesn’t produce the required
nebulization Electric board problems Call technical Assistance
Device is noisy Fan troubles Call technical Assistance
Outside or inside Liquid leakage Broken humidification chamber and
/or tubing Call technical Assistance
6 CLEANING AND STERILIZATION GUIDELINES
6.1 General notes
a) Follow the cleaning instructions given by your local regulations.
b) Wear protective gloves for cleaning / disinfection.
6.2 Water
Use only the purest quality of water for cleaning. Water hardness is a serious consideration since deposits left on
medical products may not be properly removed. Use demineralized water in order to reduce this problem.
6.3 Disposa le products
These are single use products not intended to be reused. Reuse could cause loss of mechanical, chemical and /
or biological characteristics. Reuse could cause cross contamination.
6.4 Disassem ly
Separate all individual parts before cleaning and disinfecting.
6.5 Cleaning the equipment unit, power cord and stripes
Pull this side for discharge humidification chamber liquid

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 7 di 12
WARNING:
Before cleaning the device, pull power cord out of the main socket. Do not immerse it in water
1. remove the power cord
2. use a soft sponge or tissue with cold disinfectant solution (i.e. solution containing up 2% sodium
hypochlorite) avoiding liquid penetration inside the unit and the power cord.
3. avoid any operation causing liquid penetration inside the equipment.
4. Remove the liquid inside the humidification chamber (2) pulling out the silicone tubing on the back of the
equipment (see pictures).
5. Clean and disinfect the humidification chamber.
6. Follow the cold disinfectant solution manufacturer instruction. Use soft clean cloth to dry
6.6 Cleaning the tu ing
Separate all individual parts before cleaning and disinfecting.
1. Clean components in hot water (60–70 °C) containing a detergent with a pH range between 6.0 and 8.0
only, in order to avoid damage.
2. Soak all parts thoroughly with warm, soapy water (60–70 °C) or in enzymatic detergent for 1–5 minutes.
3. Remove visible dirt with a cleaning tool (i.e. general-purpose cleaning brush, such as pipe cleaners or non-
abrasive lint cloths).
4. Rinse thoroughly in clear water.
5. llow to dry.
6. Check the parts for visible dirt and repeat these steps if necessary.
Warning: the equipment must e stored a solutely dry (a ove all the humidification
cham er) to avoid corrosion and/or crystal damage
6.7 Sterilization (if required) of tu ing cham er and masks
WARNING:
The procedure must e done y the qualified personnel after every use: personnel should have
individual protections such as coats, masks, gloves, screens, glasses, peaks, anti-sprinklings, etc....:
the procedure is intended to reduce the micro ial load, provided for protecting the operator from HIV
contamination ,to limit the risk of infection This procedure requires that all reusa le material came
into contact with potentially infectious materials, shall, after the use, e immediately immersed in a
solution of Phenol for 30 minutes (see hand ook disinfectants).
All the material reusa le after the decontamination and efore the sterilization process must e
thoroughly washed in all its parts.
1. Only cool sterilizing or dipping could be made. Follow instructions of the suitable chemical product
manufacturer for using it.
2. fter 30 sterilizing cycles it is recommended to check the wholeness of the items.
7 MAINTEINANCE
The 1001 NEB ultrasound nebulizer requires few maintenance operations if used following the indication of this
manual.
If a 1001 NEB ultrasound nebulizer within the warranty period due to a manufacturing defect, it will be replaced.
7.1 DAILY CHECK UP
User has to do it each time after using the device:
1 Empty the cylinder of liquid using suitable tool.
2Clean and dry the humidification chamber using a cotton cloth.
3Substitute (if required by doctors) all fittings: corrugated tube, filter, nebulization chamber etc.
otherwise clean and dry them.
4Check, after every use, if magnetic float works good changing the liquid level
7.2 AFTER 100 WORKING HOURS CHECK UP
1 Replace the air filter
7.3 6-12 MONTHS CHECK UP (or after 1000 working hours)
1 Cleaning of the flow valve and general cleaning of electric board and the inner of the equipment.
These maintenance operations have to e done y Siem-Nova or only y Siem-Nova
authorized people. All these operations are necessary for keeping the device fully operative.

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 8 di 12
8 TECHNICAL SPECIFICATION
8.1 Transport/Storage conditions
The 1001 NEB nebulizer and accessories must remain in the packaging for storage and stored at a temperature
range from –25 °C to +70 °C (–13 °F to +158 °F).
8.2 Operating temperature
The 1001 NEB nebulizer and accessories must be operated within a temperature range of +5 °C and +45 °C
(+41 °F and +104 °F). Do not operate the products in extreme cold or heat.
8.3 Transport/Storage/operating conditions (humidity)
The 1001 NEB nebulizer and accessories must remain in the packaging for storage and used at a humidity range
from 15% to 93 %
8.4 Transport/Storage/operating conditions (atmospheric pressure)
The 1001 NEB nebulizer and accessories must remain in the packaging for storage and used at an atmospheric
pressure range from 0,7 bar to 1,06 bar
IP33
8.5 Protection class
The 1001 NEB nebulizer is protected against ingress of dripping water (IP33).
The 1001 NEB equipment is protected against the penetration of liquids and solids (IP33) It is
always good though protect from heavvy rains. During operation and storage, the device should e
kept dry. If the device is completely wet, move it to a dry, dry externally and wait at least 30
minutes efore using it again.
Technical informations:
Dimensions (h x w x l): 30 X 25 X 27 cm (no trolley)
Voltage: 230 V 50 Hz C (other voltage available on request)
Operating cycle: continuous
Power: 90V
Isolation Class: I
Weight: 6,4 Kg (trolley 4 Kg)
CEI EN60601-1 Classification: - Class II device
- pplied part type B
- Device not suitable for use in presence of flammable anesthetic mixture with air,
oxygen or nitrogen protoxid.
Noise: less than 50 dB
ir fan 230V 50Hz C 12,5 W
Inner transformer Input 230V 50Hz C (100V ) output 1 12V 50Hz C / output 2 48V 50Hz C
ULTRASONIC CIRCUIT BOARD E70947 (S)
Input voltage 48 V 50 Hz C
power 30 V ± 5
Ultrasounds frequency from 1,635 MHz to 1.75 MHz
Nebulization effectiveness 1 ml/min ± 0,2
Liquid temperature from 0 to 37°C
Piezoelectric life 2000 h (approx)
HEATER 12 V. 4 A. (Optional)
The heater can be activated by its own switch and it is a yellow light will be turned on. It works only when main switch is on.
The electrical connection socket is on the back side of the equipment.
8.6 OTHER SPARE PARTS LIST
CODE DESCRIPTION N°
14017 Regulating valve of air flow 1
14031 Potentiometer, power regulator 1
14035 Magnetic float for liquid level 1
14037 Electric outlet for anti-noise fuses 1
14038 Electric socket BNC for heater 1
14012 Main switch and timer 1
14040 Air Filter 1
14019 Piezoelectric transducer 1

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 9 di 12
Piezoelectric
transducer
Electric outlet
for anti-noise
fuses
Fuses
9 INFO LEAFLET
10 ELECTRICAL DIAGRAM

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 10 di 12
11 ELECTRICAL COMPONENTS LIST
N Ref. Description
1 PR1 Electrical outlet with anti-noise filter, fn9260b-6- 06, two fuses first type t,f5x20,250
vac,50/60 Hz
1 SW1 two-pole switch with pilot light on/off
1 VENT Ventilator type 8550 N, 230 VAC, 50 Hz, 12 w
1 T transformer toroidal m. 2473-01; -major (dark) 230 vac, 50 Hz, 100 VAT -minor (red) 12 vac, 4 a; -minor (green) 48 vac, 1 a; -minor (yellow) 12 vac, 250 ma; -
thermal security 112 °c.
1 GAL1 float reed fs2301
1 SW2 Two-pole heater’s switch
1 J6 Electrical outlet bnc for heater
1 R5 Linear potentiometer 10 kΩ
1 LP1 Yellow pilot light for heater
1 LP2 Yellow pilot light 12 v for level
1 TDK Atomiser card TDK e70947
1 J1 Six-pole connector for card power supply
1 D1 Rectifier 400 v, 1 a
1 C1 470 µf, 35 v
2 C2,C3 100 NF, 400 v
1 EQ Equipowering knot
1 R1 82 Ω, 1/2 w
1 R2 470 Ω, 3 w
2 R3,R4 100Ω, 1/2 w
1 K1 relay rks-11dx-12
1 F1 fuse 5 a, type t, f5x20
1 F2 fuse 1 a, type t, f5x20
1 F3 fuse 100 ma, type t, f5x20
1 J2 Two-pole connector for heater
1 J3 Two-pole connector for float
1 J4 Two-pole connector for level pilot light
1 J5 Two-pole connector for TDK card
2 RV1 - RV2 SIO V S14K 275
1 Printed circuit of power supplier mod 1001 NEB, with solder resist.
12 DISPOSAL
t the end of their operative life the device and accessories must be disposed of in compliance with the local
regulation and eviromental laws, if no legal regulamentation exists the different material must be sorted and
disposed of separately (see the below table)
Remark: the components of the equipment or accessories don’t contain pthalates or natural latex
Items Material or regulation
1001 NEB ultrasound nebulizer Waste from Electric and Electronic Equipment (WEEE)
Unit case Stainless steel
Humidifier chamber Metacrilate
Tubing, drug chamber Polypropylene
Rubber components Silicone
box Cardboard
manual Paper
13 ELECTROMAGNETIC COMPATIBILITY
The 1001 NEB ultrasound nebulizer is in compliance with the requirements of CEI EN 60601-1-2-2015 for the
electromagnetic compatibility of medical devices, anyhow the use of mobile telephones, L N / WL N,
walkietalkies (two-way radios) and cordless telephones sets could affect the 1001 NEB pump. safety distance
of min. 3.3 ft (1 m) to the equipment is recommended.
ELECTROMAGNETIC EMISSIONS
The 1001 NEB ultrasound ne ulizer is intended for use in the electromagnetic environment specified
elow.
The customer or the user of the 1001 NEB should ensure that it is used in such conditions:
Emissions test Compliance Electromagnetic environment
RF emissions CISPR 11. Group 1 The 1001 NEB uses RF energy only for its internal
function.
Therefore, its RF emissions are very low and are not

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 11 di 12
likely to cause any interference in nearby electronic
equipment nearby.
RF emissions CISPR 11. Class B The 1001 NEB ultrasound nebulizer can be used in all
buildings, including domestic establishments and those
directly connected to a public power supply low voltage
which supplies buildings intended for domestic use.
Harmonic emissions
EN 61000-3-2
Class compliant
Fluctuations emissions
voltage / flicker EN 61000-3-3
Complies
ELECTROMAGNETIC IMMUNITY
The 1001 NEB ultrasound ne ulizer is intended for use in the electromagnetic environment specified
elow. The customer or the user of the 1001 NEB should ensure that it is used in such conditions:
IMMUNITY test Test level
EN 60601-1-2
Compliance level Electromagnetic enviroment
electrostatic
discharge (ESD) EN
61000-4-2
± 6 kV Contact
± 6 kV ir
± 6 kV Contact
± 6 kV ir
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Transient / a
sequence of rapid
electrical impulses to
EN 61000-4-4
± 2 kV for power
supply
± 2 kV for power
supply
The voltage quality should be compatible
with a typical commercial or hospital
environment
Surge
EN 61000-4-5
± 1 kV between
phases
± 2 kV between
phases and earth
± 1 kV differential
mode
± 2 kV common
mode
The voltage quality should be compatible
with a typical commercial or hospital
environment
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
EN 61000-4-11
<5% UT for 0.5
cycles
(> 95% UT hole)
40% UT for 5 cycles
(60% UT hole)
70% UT for 25
cycles
30% UT hole)
<5% UT for 0.5
cycles
(> 95% UT hole)
5% UT for 0.5
cycles
(> 95% UT hole)
40% UT for 5 cycles
(60% UT hole)
70% UT for 25
cycles
30% UT hole)
<5% UT for 0.5
cycles
(> 95% UT hole)
The voltage quality should be compatible
with a typical commercial or hospital
environment. If the 1001 NEB user
requires continued operation also during
power mains voltage black out, it is
recommended to feed the 1001 NEB with
an uninterruptible power supply or
batteries.
Magnetic field to the
mains frequency
(50/60 Hz)
EN61000-4-8
3 /m 3 /m Magnetic fields at mains frequency should
be at levels characteristic of a typical
location in a commercial or hospital
environment.
The 1001 NEB ultrasound ne ulizer is intended for use in the electromagnetic environment specified
elow. The customer or the user of the 1001 NEB should ensure that it is used in such conditions:
Radiated RF
EN 61000-4-3
3 V/m
80 MHz to
2,5 GHz
3 V/m Portable and mobile RF communications equipment should not be
used close to any part of the 1001 NEB ultrasound nebulizer,
including cables than the recommended separation distance
calculated from the equation applicable to the transmitter
frequency.
Recommended separation distance calculated from the
equation applicable to the transmitter frequency.
Recommended separation distance
d = 1.2 x √P 80 MHz to 800 MHz
d = 2.3 x √P 800 MHz to 2.5 GHz
d = 1.2 x √P
where "P" is the maximum rated power of the transformer
output, in watts (W) according to the transmitter manufacturer
and "d" is the recommended separation distance in meters (m).
The field strength of fixed RF transmitters, determined by an
electromagnetic site survey, may be less than the compliance
level in each frequency range.
Interference may occur in the vicinity of equipment marked with
the following symbol:
Conducted RF
EN 61000-4-6
3 V/m
150 MHz
to 80 GHz
3 V
Note 1: t 80 MHz and 800 MHz, the exposure distance for the higher frequency range.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

USER and MAINTENANCE MANUAL
Manufacturer: Siem Nova S.r.l. Legal and operational offices 20087 ROZZ NO (Milano) M DE IN IT LY
Product: ULTR SONIC NEBULIZER Code: 14010 Model: 1001 NEB
Updated: 2018-01-09 reproduction forbidden Pag: 12 di 12
RECOMMENDED SEPARATION DISTANCES BETWEEN RADIOCOMMUNICATION DEVICES
The 1001 NEB ultrasound ne ulizer is intended for use in an electromagnetic environment in which
radiated RF distur ances under control. The customer or the 1001 NEB operator of the device can
help prevent electromagnetic interference y maintaining a minimum distance etween mo ile and
porta le RF communication equipment (transmitters) and the 1001 NEB device as recommended
elow, in relation to the maximum output power the communications equipment.
Maximum nominal power of
the transmitter output (W)
Separation distance to the frequency of the transmitter (m)
From 150 kHz to 80 MHz
d=1,2 x √P
from 80 kHz to 800 MHz
d=1,2 x √P
From 800 kHz to 2,5 GHz
d=2,3 x √P
0,01 0.12 0.12 0.23
0,1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters with a maximum rated output power not listed above, the recommended separation distance
"d", in meters (m) can be calculated using the equation applicable to the frequency of the transmitter, where "p"
is the maximum output power d 'the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: t 80 MHz and 800 MHz, the exposure distance for the higher frequency range.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
14 SPARE PARTS
Use only accessories or spare parts supplied y Siem nova srl. The use of spare parts not
supplied from Siem Nova could invalidate the warranty.
15 WARRANTY
Siem Nova srl (or his authorized distri utor) warrants the device will e free from defects in
materials and workmanship for a period of 2 years from the date of delivery.
Faulty material will e replaced free of charge (except transport cost) during this period if not
resulting from a use or misapplication. Warranty includes defects in materials, components and/or
workmanship only if:
A. THE DEVICE IS USED IN RESPECT TO ALL INSTRUCTIONS OF OPERATOR’S MANUAL;
B. MAINTENANCE IS DONE BY SIEM-NOVA SRL AUTHORIZED PERSONNEL.
C. THE ACCESSORIES USED ARE SUPPLIED BY SIEM NOVA
This will not apply to parts su ject to wear and tear in use (i.e: tu ing, drug ne ulization cham er,
piezoelectric transducer, filters)
To etter ensure compliance with this warranty we recommend the exclusive use of spare parts
supplied y Siem Nova srl.
The right to the replacement of faulty parts will not e recognized y Siem nova srl if any work has
een made on the equipment y unauthorized persons.
16 Technical features update
In order to continuously improve performance, safety and relia ility, all products medical devices
from Siem Nova Srl are periodically reviewed and changes. The instruction manuals are therefore
amended to ensure their continued compliance with the characteristics of the input devices on the
market. If the instruction manual accompanying this device is lost, you can o tain from the
manufacturer a copy of the version corresponding to the device provided supplying serial num er on
the device la el.