1F095028G_14-EN_USER_MANUAL_SI610-1_MKZ2026-1

OPERATION MANUAL
NEONATAL STATIONARY INCUBATOR

SI-610-1 SHELLY
WARNING:
1. Read this Manual carefully before setting the incubator into operation.
Follow all the cautions and warnings herein mentioned.
2. Possession or purchase of this device does not convey any express or
implied license to use the device with unauthorized sensors or cables
which would, alone or in combination with this device, fall within the
scope of one or more of the patents relating to this device
3. Masimo Patents: www.masimo.com/patents.htm
4. Undue operation or use of parts or accessories not supplied or approved
by TSE spol. s r.o. can damage the product or injure a patient/operator.
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Table of Contents
TABLE OF CONTENTS 3
1. PRINCIPLE OF OPERATION 5
2. INDICATION, COUNTER INDICATION 5
3. OPERATION CONDITIONS 6
4. TECHNICAL PARAMETERS 6
5. EXPLANATION OF SYMBOLS 8
6. SAFETY PRECAUTIONS 8
7. PRODUCT DESCRIPTION 19
8. THE INCUBATOR CONTROL PANEL DESCRIPTION 32
9. SETTING THE INCUBATOR INTO OPERATION 37
9.1 BEFORE FIRST USE 37
9.2 BEFORE SWITCHING THE INCUBATOR ON 37
9.3 SWITCHING THE INCUBATOR ON 37
9.4 SWITCHING THE AIR TEMPERATURE MODE ON AND SETTING THE AIR TEMPERATURE
38
9.5 BODY TEMPERATURE MODE 39
9.6 RELATIVE HUMIDITY RH MODE 41
9.7 O2 CONCENTRATION MODE 43
9.8 O2 SATURATION SPO2, PULSE MONITORING 48
9.9 PATIENT WEIGHT MODE 57
9.10 MUTING THE INCUBATOR ACUSTIC ALARM 59
9.11 MINI TRENDS 59
9.12 KEYBOARD LOCKING 59
9.13 SWITCHING THE INCUBATOR OFF 60
10. THE INCUBATOR MENU MODE 61
10.1 PATIENT DATA 61
10.2 TRENDS 66
10.3 ALARMS 68
Operational manual SI-610-1 Version 14 3/104

10.4 DATA 68
10.5 CALIBRATION OF O2 SENSORS 70
10.6 INCUBATOR TEST 70
10.7 INCUBATOR USER SETTINGS – OPTIONS 70
10.8 CLOSING THE MENU 74
11. LIST OF THE ALARMS AND THEIR MEANING 75
12. MAINTENANCE, CLEANING AND DISINFECTION INSTRUCTIONS 84
13. DISPOSAL AND RECYCLING OF DISPOSABLES 97
14. COMPLETION 98
15. STORAGE AND TRANSPORT 98
16. WARRANTY AND SERVICE 99
17. EMC PARAMETERS OF THE INCUBATOR 100
18. ADDITIONAL TECHNICAL PARAMETERS 102
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1. Principle of Operation
Stationary incubator SI-610-1 (hereinafter referred to as the incubator) is designed for intermediate and
intensive care about prematurely born babies of weight up to 10 kg, to whom it provides suitable climatic
conditions (warmth, humidity, oxygen).
The climatic conditions are controlled by an electronic temperature regulator. This regulator regulates
heating of the patient space according to either air or body temperature. The regulation mode is operator
selectable. Temperature is measured by a built-in thermometer and is displayed on the incubator display.
When oxygen is applied its concentration is regulated automatically according to operator’s requirements
and displayed on the incubator display.
A built-in humidifier module enables automatic relative humidity regulation according to operator’s
requirements. Its value is displayed on the incubator display.
Air is also sucked into the patient chamber from the outside. Air purity is ensured by a built-in
bacteriological filter.
Built-in scales enable measurement of patient’s current weight.
The incubator may be optionally equipped with a module for SpO2 monitoring. The module enables
measurement of haemoglobin saturation of arterial blood with oxygen SpO2, pulse, PI, PVI, SpHb.
All the important incubator parameters are watched by a system of alarms. Deviations from these
parameters are indicated optically and acoustically. In case of more serious faults the incubator is
equipped by a circuit that disconnects heating, oxygen input and humidification. The alarm functions are
also backed against power failure.
In order to reduce the loss of the desired values in the patient area (temperature, relative humidity and
oxygen concentration), after opening the front or rear door, the incubator is provided with an automatic
airflow increase system in the patient area.
2. Indication, counter indication

Temperature management and partial monitoring of premature infants and newborn babies with low birth
weight, all newborn babies requiring intensive neonatal care and resuscitation for any reason and last but
not least provision of temperature management to neonates requiring phototherapy application and those
in conditions related to exogenous hypothermia and various aetiologies.
No counter indications are known from the point of view of provision of diagnostic and treatment care in
neonatology and paediatrics. There is a risk of retrolental fibroplasia in application of higher oxygen
concentration in the patient space.

3. Operation Conditions
The incubator may only be operated under the following operation conditions:
- For indoor use (healthcare facility room)
Incubator location - In dust free environment without aggressive fumes
and gases out of direct sunshine
20 – 30 °C, the outside temperature must be at least
Room temperature by 3 C° lower than the required temperature inside
the patient space
Pressure 500 – 1100 hPa
5 - 95 % (non-condensing humidity)
Air humidity - the ambient humidity must at least by 3% lower
than the required humidity inside the patient space
Incubator operational position horizontal
Power supply mains 110V - 230 V (±10%) / 50 - 60 Hz with
O2 supply pressure 400 - 500 kPa according to ČSN EN ISO 7396-1
4. Technical Parameters
Unit type identification SI-610-1
version 1: 230 V (±10%) / 50 – 60 Hz 
Power voltage version 2: 110-115 V (±10%) / 50 – 60 Hz 
version 3: 120-127 V (±10%) / 50 – 60 Hz 
Power input
With fixed height: 550 VA
With adjustable height: 600 VA
Maximum input via the auxiliary sockets 100 W

Dimensions: height without the adjustable leg 1450 mm (1705 mm with the stand)
height with the adjustable leg 1320 - 1520 mm (1575 - 1775 mm with the stand)
length 1150 mm
width 610 mm
Weight: without the adjustable leg 96 kg
with the adjustable leg 106 kg
Noise max. 38 dB
TEMPERATURE MODE
Two operation modes enabling temp. measurement and regulation according to air or body
temperature:
Air temperature mode 20.0 °C - 37.0 °C, in 0.1 °C increments
(adjustment range) 37.1 °C - 39.0 °C, in 0.1 °C increments
34.0 °C - 37.0 °C , in 0.1 °C increments
Body temperature mode (adjustment range)
37.1 °C - 39.0 °C , in 0.1 °C increments
Range of displayed temperature values 10.0 °C - 45.0 °C
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O2 MODE
Enables O2 concentration measurement and control:
O2 concentration adjustment (adjustment range) 22 – 75 %, in 1% increments
The range of O2 concentration on the display 10 – 100 %
O2 probe service life min. 1 year
MODE RELATIVE HUMIDITY RH

Enables relative humidity measurement and regulation:
RH adjustment (adjustment range) 40 – 95 %, in 1% increments
RH display range in RH mode 10 – 99 %
Water tank 1.5 l of demineralized water
WEIGHING MODE
Enables patient weighing:
Scales range max. 6 kg
Range of displayed weight values 0 – 6 kg
SI-610-1 VERSION WITH SpO2 MONITORING

BLOOD SATURATION WITH OXYGEN MODE SpO2 - The MASIMO system
Enables measurement of saturation of arterial blood with oxygen and pulse measurement
Range of displayed SpO2 0 – 100 %
Pulse display range 25 – 240 bpm
PI display range 0 – 20%
PVI display range 0 – 100%
SpHb display range 0 – 25 g/dl
PATIENT DATA
Enables patient data (trends of values and alarms) to be stored and printed
Number of patients in the memory 20*
Number of recorded alarms per patient 100*
Number of recorded weights 100*
Trend recording period 14 days*

*when the number of records is exceeded the oldest record is overwritten automatically.

5. Explanation of Symbols
SYMBOL DESCRIPTION SYMBOL LOCATION
Warning against possible danger, a note in On the device and a note in

the manual the user manual
Read this manual carefully before you

On the device
start to operate the unit
Please refer to the Instruction manual On the device
Type BF applied part that comes into

contact with the patient
On the device label
(body temperature probes T1, T2, SpO2
probes)
Equipotential bonding On the device
On the device and a note in

The unit is classified as electrical waste
the user manual
On the device label and a

Year of manufacturing
note in the user manual
Manufacturer On the device label
Weight of the device On the device label
Maximum weight of the device On the device label
Marking of the conformity assessment

of the product before placing on the On the device label and a
market with the identification number note in the user manual
of the notified body
On the body temperature

Non sterile
sensor label
On the disposable body

Single use only
temperature sensor label
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Storage temperature range On the package
Attention fragile On the package
Protect from weather conditions On the package
Do not tilt On the package
Careful handling On the package
Do not stack On the package
Humidity limitation On the package
Atmospheric pressure limitation On the package

6. Safety Precautions
A/ GENERAL SAFETY INSTRUCTIONS
WARNING:
Use the incubator upon instructions of a physician, who is aware of the so far
known risks and advantages of incubator use.
CAUTION!
1. The incubator may only be operated and cleaned by a person trained in
operation and cleaning of the particular incubator type. Training is provided
by the manufacturer or by an authorized service organization. The trainer will
make an entry about the training in the incubator technical log and into the
handing-over report.
2. Do not use the incubator with an electric or mechanical defect. Call the
service if you find a defect.
3. The incubator may increase patient fluid loss. It is necessary to control the
patient's body temperature while increasing the patient's fluid intake.
A.1 Ambient conditions

CAUTION!
1. The incubator is not designed for use in explosive environment.
2. Incubator requires EMC related measures. It must be installed and put into
operation in accordance with EMC information. Incubator must be placed on
the site - see description in chapter: EMC parameters of the incubator.
WARNING:
1. To ensure the correct temperature regulation function (the accuracy of
±0.3 °C) the incubator air temperature has to be set to at least 3 °C above
the ambient temperature.
2. In lower temperature setting in the patient space (below 30 °C) and RH values
above 60 % the specified temperature regulation accuracy (±0.3 °C) might not
be achieved – the regulation variance depends on the ambient temperature.
3. If the air temperature, oxygen concentration and RH in the patient space are
set to high values at the same time the specified RH regulation accuracy (±5 %)
might not be achieved in low ambient relative humidity.
4. When the patient space is covered with a shading cover the specified
temperature regulation accuracy (±0.3 °C) might not be achieved – the
regulation variance depends on the ambient temperature.
5. The temperature of the O2 incoming to the incubator and the required O2
concentration above 50 % might lead to non-adherence to the required
tolerance in temperature distribution over the patient bed.
6. Direct sunshine, phototherapeutic or other radiant heat sources may cause
temperature increase inside the incubator over the adjusted value. That is
why the incubator should be located to avoid such influences.
7. If the incubator is located under air conditioning vents or in the environment
with a high flow of ambient air it can affect the correct functioning of the
incubator. In this case the specified accuracy of the individual modes of
temperature, relative humidity and oxygen concentration may not be fulfilled
or there may be alarming.
8. Patient’s body temperature has to be monitored during phototherapy
treatment and the patient should be administered higher amount of liquid.
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A.2 Body temperature mode
CAUTION!
1. Do not use body (skin) temperature regulation when the patient has a fever
or is in shock. Body temperature in fever is higher and might lead to
hypothermia.
2. Body temperature in shock is remarkably lower than usually and might lead to
patient overheating.
3. When a defibrillator is applied, the body temperature probes T1 and T2 have
to be removed from the patient and a contact with the probes has to be
avoided.
The incubator is equipped with two body temperature probes T1 a T2. Probe T1 serves for temperature
control in the body temperature mode and T2 only serves for measurement of second temperature value
of the patient. The probes are always attached by their active sides to the baby skin.
The active side of the skin probe
CAUTION!
1. Do not use this probe rectally.
2. Is it possible to use only probes with a valid temperature calibration.
WARNING:
1. A faulty skin temperature probe may only be replaced with the same type,
supplied with the incubator.
2. The body temperature probes are classified as applied parts of BF type. The
patient is not electrically connected with the ground during application.
A.3 O2 concentration mode

The incubator is equipped with a circuit for O2 measurement and regulation inside the chamber.
CAUTION!
1. Do not use O2 with inhalation anaesthetics.
2. Unless the incubator is equipped with the function of O2 blood saturation
measurement the O2 level in the patient’s blood has to be monitored by an
external SpO2 gauge during oxygen dosage.
3. Increased oxygen concentration may only be applied upon doctor’s order.
WARNING:
1. Noise level inside the chamber might increase as a consequence of oxygen
dosage.
2. Monitor the displayed data when oxygen is being dosed.
A.3.1 Fire risk during O2 application
CAUTION!
1. Oxygen application inside the incubator increases fire risk.
2. Do not place any auxiliary devices not approved for operation in explosive
environment inside the incubator.
3. Any parts in the patient space, the O2 gaskets, O2 fittings and O2 hoses must
not get in touch with lubricants.
4. If disinfection agents based on ether are used these substances have to be
thoroughly aired before operating the incubator.
5. Using open fire and smoking is forbidden inside the incubator and close to it.

A.3.2 O2 probes
Operating life of the oxygen measurement probe is approx. 12 months from the first use in normal use.
CAUTION!
1. The oxygen measurement probe contains caustic. In the case of mechanical
damage the liquid may cause heavy burns of skin or eyes. In the case of
exposure rinse the injured spot with water for at least 15 minutes. If eyes
are exposed call a doctor.
2. Oxygen leak to the space under the incubator bath has to be checked at least
once per 6 months. The check has to be performed by a specialist from the
manufacturing company or from an authorized service organization. Unless
the check has been performed within the prescribed period the incubator has
to be put out of operation until the check is done.
A.3.3 The O2 inlet disconnection

CAUTION!
Unless the O2concentration mode is on, the O2 inlet has to be disconnected from
the incubator.
A.4 SpO2 measurement mode

The incubator version with the SpO2 monitor is equipped with a circuit for measurement of arterial blood
saturation with oxygen. The MASIMO system is used.
WARNING:
1. The pulse CO-oximeter is to be operated by, or under the supervision of,
qualified personnel only. The manual, accessories, directions for use, all
precautionary information, and specifications should be read before use.
2. As with all medical equipment, carefully route patient cabling to reduce
the possibility of patient entanglement or strangulation.
3. Do not start or operate the pulse CO-oximeter unless the setup was
verified to be correct.
4. Do not use the pulse CO-oximeter during magnetic resonance imaging
(MRI) or in an MRI environment.
5. Do not use the pulse CO-oximeter if it appears or is suspected to be
damaged.
6. To protect against injury, follow the directions below:
- Do not attempt to sterilize the device.
- Use cleaning solutions only as instructed in this operator's manual.
- Do not attempt to clean the device while monitoring a patient.
7. To protect from electric shock, always remove the sensor and completely
disconnect the pulse CO-oximeter before bathing the patient.
8. If any measurement seems questionable, first check the patient’s vital
signs by alternate means and then check the pulse co-oximeter for proper
functioning.
9. Inaccurate SpO2 readings may be caused by:
- Improper sensor application and placement
- Elevated levels of COHb or MetHb: High levels of COHb or MetHb may
occur with a seemingly normal SpO2. When elevated levels of COHb or
MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood
sample should be performed.
- Elevated levels of bilirubin
- Elevated levels of dyshemoglobin
- Vasospastic disease, such as Raynaud’s, and peripheral vascular
disease
- Hemoglobinopathies and synthesis disorders such as thalassemias, Hb
s, Hb c, sickle cell, etc.
- Hypocapnic or hypercapnic conditions
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- Severe anemia
- Very low arterial perfusion
- Extreme motion artifact
- Abnormal venous pulsation or venous constriction
- Severe vasoconstriction or hypothermia
- Arterial catheters and intra-aortic balloon
- Intravascular dyes, such as indocyanine green or methylene blue
- Externally applied coloring and texture, such as nail polish, acrylic
nails, glitter, etc.
- Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed
or abnormal fingers. etc.
- Skin color disorders
10. Interfering Substances: Dyes or any substance containing dyes that
change usual blood pigmentation may cause erroneous readings.
11. The pulse CO-oximeter should not be used as the sole basis for diagnosis
or therapy decisions. It must be used in conjunction with clinical signs
and symptoms.
12. The pulse CO-oximeter is not an apnea monitor.
13. The pulse CO-oximeter may be used during defibrillation, but this may
affect the accuracy or availability of the parameters and measurements.
14. The pulse CO-oximeter may be used during electrocautery, but this may
affect the accuracy or availability of the parameters and measurements.
15. The pulse CO-oximeter should not be used for arrhythmia analysis.
16. SpO2 is empirically calibrated in healthy adult volunteers with normal
levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).
17. Do not adjust, repair, open, disassemble, or modify the device or
accessories. Injury to personnel or equipment damage could occur.
Return the device for servicing if necessary.
18. Inaccurate SpHb readings may be caused by:
- Improper sensor application
- Intravascular dyes such as indocyanine green or methylene blue
- Externally applied coloring and texture such as nail polish, acrylic
nails, glitter, etc.
- Elevated PaO2 levels
- Elevated levels of bilirubin
- Low arterial perfusion
- Motion artifact
- Low arterial oxygen saturation levels
- Elevated carboxyhemoglobin levels
- Elevated methemoglobin levels
- Hemoglobinopathies and synthesis disorders such as thalassemias,
- Hb s, Hb c, sickle cell, etc.
- Vasospastic disease such as Raynaud's
- Elevated altitude
- Peripheral vascular disease
- Liver disease
- EMI radiation interference

CAUTION!
1. When patients are undergoing photodynamic therapy they may be
sensitive to light sources. Pulse oximetry may be used only under careful
clinical supervision for short time periods to minimize interference with
photodynamic therapy.
2. Do not place the device near electrical equipment that may affect the
device, preventing it from working properly.
3. If SpO2 values indicate hypoxemia, a laboratory blood sample should be
taken to confirm the patient’s condition.
4. If the Low Perfusion message is frequently displayed, find a better
perfused monitoring site. In the interim, assess the patient and, if
indicated, verify oxygenation status through other means.
5. Change the application site or replace the sensor and/or patient cable
when a “Replace sensor” and/or “Replace patient cable”, or a persistent
poor signal quality message (such as “Low SIQ”) is displayed on the host
monitor. These messages may indicate that patient monitoring time is
exhausted on the patient cable or sensor.
6. If using pulse oximetry during full body irradiation, keep the sensor out
of the radiation field. If the sensor is exposed to the radiation, the
reading might be inaccurate or the device might read zero for the
duration of the active irradiation period.
7. The device must be configured to match your local power line frequency
to allow for the cancelation of noise introduced by fluorescent lights and
other sources.
8. To ensure that alarm limits are appropriate for the patient being
monitored, check the limits each time the pulse CO-oximeter is used.
9. Variation in hemoglobin measurements may be profound and may be
affected by sampling technique as well as the patient's physiological
conditions. Any results exhibiting inconsistency with the patient’s
clinical status should be repeated and/or supplemented with additional
test data. Blood samples should be analyzed by laboratory devices prior
to clinical decision making to completely understand the patient’s
condition.
10. Electrical Shock Hazard: Carry out periodic tests to verify that leakage
currents of patient-applied circuits and the system are within acceptable
limits as specified by the applicable safety standards. The summation of
leakage currents must be checked and in compliance with IEC 60601-1
and UL60601-1. The system leakage current must be checked when
connecting external equipment to the system. When an event such as a
component drop of approximately 1 meter or greater or a spillage of
blood or other liquids occurs, retest before further use. Injury to
personnel could occur.
11. Disposal of product - Comply with local laws in the disposal of the device
and/or its accessories.
12. To minimize radio interference, other electrical equipment that emits
radio frequency transmissions should not be in close proximity to the
device.
13. Replace the cable or sensor when a replace sensor or when a low SIQ
message is consistently displayed while monitoring consecutive patients
after completing troubleshooting steps listed in this manual.
Notes:
1. A functional tester cannot be used to assess the accuracy of the pulse co-
oximeter.
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2. High-intensity extreme lights (such as pulsating strobe lights) directed on
the sensor, may not allow the pulse CO-oximeter to obtain vital sign
readings.
3. When using the Maximum Sensitivity setting, performance of the "Sensor
Off" detection may be compromised. If the device is in this setting and
the sensor becomes dislodged from the patient, the potential for false
readings may occur due to environmental "noise" such as light, vibration,
and excessive air movement.
4. Do not loop the patient cabling into a tight coil or wrap around the
device, as this can damage the patient cabling.
5. Additional information specific to the Masimo sensors compatible with
the pulse oximeter, including information about parameter/measurement
performance during motion and low perfusion, may be found in the
sensor's directions for use (DFU).
6. Cables and sensors are provided with X-Cal™ technology to minimize the
risk of inaccurate readings and unanticipated loss of patient monitoring.
Refer to the Cable or Sensor DFU for the specified duration of the patient
monitoring time.
A.5 Incubator operation

The way of handling the incubator is described in this manual.
WARNING:
1. Handling other controls than those located on the control box panel is
forbidden.
2. An operator may also change the bed inclination, control box position and the
height adjustment of the incubator.
A.6 Limitation of the air flow in the incubator

Warm air is blown into the patient space from three sides around the incubator bed. The air is sucked to
the area of the ventilator and heating on one side.
CAUTION!
There must be no obstacles to air exhaustion and sucking in the patient space
(e.g. by napkins or blankets on the incubator bed). The air temperature
measurement might not correspond with the real air temperature over the bed
if the air openings are covered.
AIR EXHAUSTION AIR EXHAUSTION

A.7 To open the patient space
The patient space can be opened by tilting the front or the back door down or by opening the oval port
holes.
CAUTION!
1. The patient space (with a patient inside) may only be open in permanent
supervision of healthcare staff.
2. The baby has to be prevented from falling when the incubator is open.
3. After closing the front or the rear door or the oval port holes the operator has
to check whether they are well closed by means of the hinges.
WARNING:
1. The incubator must not be open longer than necessary.
2. The temperature, oxygen concentration and relative humidity drop when the
incubator is open.
A.8 Use of additional equipment and accessories

The incubator is equipped with hose inputs in the
corners of the upper part. These inputs are
intended for the access of the hoses and cables of
additional equipment and accessories that are
located outside the patient compartment of the
incubator.
CAUTION!
When closing the door, it is necessary to monitor whether any hose or cable
conducted through hose inputs was not loosened and squeezed in a door after
closing. This could cause malfunction of additional appliances or devices.
A.9 Patient bed
WARNING:
1. Withdrawn or tilted bed may only be loaded with the patient’s weight, max.
10 kg.
2. Further bed loading, e.g. with devices, or leaning against the bed is forbidden.
3. Before putting an infant into the incubator the operator has to check whether
the bed with the mattress is correctly located.
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A.10 Shelf
WARNING:
Material of maximum weight of 10 kg can be put on the shelf.
A.11 Storage drawers
CAUTION!
1. Do not lean against the withdrawn drawers or load them more than mentioned
above.
2. The drawers must be closed when the incubator is transported.
WARNING:
1. The maximum load capacity of the big drawer is 5 kg.
2. The maximum load capacity of the small drawer is 2.5 kg.
A.12 Incubator height adjustment
(only for versions with adjustable height)

CAUTION!
1. Do not put your feet on the lower part frame when the height adjustment is
moving.
2. The front or the rear door of the patient space must not be open when the
height adjustment is moving.
A.13 Incubator repairs

Any repair, adjustment or service of the device may only be performed by trained staff of the manufacturer
or an authorized service organization.
Replacement of the fuses, the body temperature, non-invasive pressure, O2 saturation and breath probes
are the only exceptions. Fuses may only be replaced with the same type with the same face values.
Verification of SpO2 functionality is only performed by the appropriate manufacturer or manufacturer-
approved service organizations, measuring devices and testers shall be approved by the manufacturer.
B/ ELECTRIC SHOCK PROTECTION
In terms of electric shock protection the incubator is a Class I device in the sense of the above standards.
It may only be connected to the mains with power disconnection protection. Three-wire power cord
supplied by the manufacturer may only be used.
In the version with monitoring of SpO2 the incubator is a BF type device.

In the version without monitoring of SpO2 (basic version), when the body temperature probe (provided) is
used the incubator is a BF type device (the baby is insulated from the ground and further measurement
probes may be attached to him/her) in the sense of the above standards.
To improve the safety in the environment of a health-care facility the stationary incubator
SI-610-1 may be connected through a cable to terminals of complementary protection circuit as
per ČSN 33 20-00-4-41. The incubator is equipped with a standardized protective terminal.
The incubator may be connected via a special cable to a terminal of a surgery distribution system.
Both ends of the cable are equipped with angle plug contacts 0299-0-0032.
CAUTION!
1. Always disconnect the incubator from the wall socket when cleaning it.
2. Always disconnect the incubator from the wall socket when changing the fuses.
Power cord disconnection from the incubator

To disconnect the power cord from the incubator press the lock buttons on the sides of the plug and pull
the plug out of the incubator socket.
CAUTION !
Never pull the power cord plug out of the socket without pressing the lock
buttons.
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7. Product Description
A/ MECHANICAL PART DESCRIPTION
CONTROL
BOX
UPPER PART
BED
LOWER
PART

LOWER PART
The lower part consists of a carriage and storage
space.
1. Four rotating wheels with brakes prevent the

incubator from undesired movement.
2. The version with adjustable leg enables

vertical movement within the range of 200
mm. A servo motor with a control pedal
facilitates adjustment of the incubator
height.
Neither the front nor the rear door must be

open during the incubator height
adjustment!
3. Withdrawing the drawers

To open the drawers draw them holding the
handle at the front.
The bigger drawer may only be opened to
one side.
The smaller drawer can be opened to both

sides.
The maximum drawer load is specified in

chapter 5, paragraph A.11.
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UPPER PART
Consists of the patient protective cover.
Use the angle profiles for handling the

incubator during transport.
The upper cover removal

1. Hold the side handles on the cover and
remove the cover.
2. Proceed in reverse order when returning the
cover.
3. Check whether the cover is in correct
position after returning it back.
Incorrect positioning of the cover or the

bushings may lead to faulty temperature
regulation, O2 concentration or relative
humidity regulation!
Opening and closing the front and the

back doors of the patient space
Opening the door

1. Turn both the knobs to the vertical position.
A red mark signalling the open door is visible in
the vertical position (the knobs are in vertical
position with the red mark on top in the
unlocked position)
2. Tilt the door down to the vertical position.

Closing the door
1. Tilt the door up.
2. Turn both the knobs to horizontal position so as
the red mark is on the side.
CAUTION!
The knobs have to be in the locked position when the door is closed.
There are five port holes in the side walls.
Opening and closing the port holes
Opening the port holes

1. Press the port hole lock in the middle of the
door
2. The hole opens itself.
Closing the port holes

Press the cover against the lock until it snaps.
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CAUTION!
The port holes are designed for handling the patient inside. The patient must not
be put into or taken out of the incubator through the port holes.
Water tank
A water tank for the humidifier module is located at
the front of the incubator.
See chapter SETTING THE INCUBATOR INTO
OPERATION for water filling instructions.
Toolbar
A toolbar for hanging additional instruments
is located at the side of the incubator.
The maximum bar load is 5 kg.
Vertical bar
The vertical bar is attached to the bottom of the
incubator. It is used to hang additional devices.
The maximum load of the vertical bar is

10 kg.
The vertical bar can be positioned.

1. Loosen the locking screw at the base of the bar.
2. Set the required bar position.
After setting the desired position, tighten

the locking screw.
FIX

Control box
The control box hangs on the adjustable arm of the
stand. The stand is attached to the lower part of
the incubator. The control box contains the
electronic systems that ensure the required
operation parameters. All the current measured
parameters and auxiliary data are displayed on an
LCD display.
The control box height is adjustable after

loosening a setting bolt.
Tighten the setting bolt after changing FIX

the control box position.
The angle of the control box can be adjusted after

loosening a setting bolt.
The maximum control box angle is 270°.

FIX
Tighten the setting bolt after changing
the control box posit
The control box stand position is adjustable.
The bottom of the upper part is enclosed with a

plastic bath for air distribution into the patient
space. The bath is equipped with a heater, a
ventilator and with inputs for oxygen and air
sucked from the outside of the incubator.
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Patient bed - serves as a bed for the newborn baby.
Patient bed inclination
The bed may be inclined in both directions up to 12° by means of an electric device controlled by buttons
on the control panel.
The incubator electronic system enables the bed height adjustment on one side only. If the bed is inclined
on the left side for example and height adjustment on the right side is required, the bed has first to be
levelled on the left and then the position on the right can be adjusted.
CAUTION!
The patient’s position on the bed must be monitored when the bed is being
positioned. No patient body part must exceed the bed outlines.
Use the left keys to position the left side of the bed.
Press keys No. 10 and No. 11 to position the left side of the bed.
Press the appropriate key for the bed movement and hold it until the bed reaches the required position.
Use the right keys to position the right side of the bed.
Press keys No. 12 and No. 13 to position the right side of the bed.
Press the appropriate key for the bed movement and hold it until the bed reaches the required position.

Withdrawing and rotating the patient bed
Withdrawing the bed
The whole bed can be withdrawn from the incubator upper part by 245 mm.
WARNING: The patient bed may only be withdrawn in the horizontal position.
To withdraw the bed press the button and

withdraw the bed.
To rotate the bed

1. The bed may only be rotated in the withdrawn
position. It can be rotated by 45° on the right side.
2. Slightly press on both sides on the bed and turn
the bed counter-clockwise.
3. To return the bed to its original position turn it
clockwise.
CAUTION!
Check that the bed is secured against overturning during rotation.
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X-ray board withdrawing
There is an extensible board at the bottom of the bed
serving for insertion of an X-ray board
1. Open the X-ray door in the front door.
2. Withdraw the board holding the opening in the

middle.
3. Insert an X-ray cartridge.
4. Draw the X-ray board in.
5. Close the X-ray door.
6. Perform the X-raying.
7. Repeat points 1 – 5 to remove the X-ray
cartridge.
SI-610-1 Accessories
1. Additional shelf for the vertical bar

(Art. code 21FF800146)
An additional shelf enables height and side
positioning.
Installation have to be performed by the
manufacturer or by an authorized service.
2. Infusion holder for the vertical bar

A holder enables height and side positioning.
Installation have to be performed by the manufacturer or by
an authorized service.

3. Euro rail for the vertical bar
A Euro rail enables height and side positioning.
Installation have to be performed by the
manufacturer or by an authorized service.
WARNING:
1. The maximum load capacity of the additional shelf is 5 kg.
2. The maximum load capacity of the infusion holder is 2 kg.
3. The maximum load capacity of the Euro rail is 5 kg.
4. Double acrylic cover

The double acrylic cover includes: front door,
back door, right side, back side
5. Toolbar shelf
(Art. code 51FA410044)
6. Hose holder
(Art. code 21FK846093)
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7. Humidifier lid plug
It restricts the retting in the area of the
humectant.
8. Calibration tool air

It enables calibration of oxygen sensors 21 % O2, during sensor calibration at altitude >1000 m.
9. Gel mattress
10. Body temperature probe

(Art. code 1S8ABODYSENA)
11. Incubator cover

(Art. code 5POTAHSHELLY)
12. Positioning aids for newborns (nest, horseshoe)
Additional devices
Incubator possible combinations with other devices: phototherapy lamps, suction pumps, devices for
monitoring vital functions.
CAUTION !
1. Additional devices must be approved according to ČSN EN 60601-1 and must
be approved as a medical device.
2. The leakage currents may increase after connecting additional devices.
3. Always follow the recommendations set by the appliance manufacturer when
using accessories.
B/ THE ELECTRIC EQUIPMENT DESCRIPTION

The incubator consists of three parts: Upper part
Control box
Lower par
The upper part consists of:
the main power source with the power switch, auxiliary sockets, an equipotentionality terminal
and the main fuses: FU1,2 250V / T1.6AL, version 110V – 127V 250V / T3.15AL
FU3,4 250V / F630mAL, version 110V – 127V 250V / T1.25AL
FU5,6 250V / F1.6AL, version 110V – 127V 250V / T2.5AL
FU7,8 250V / F5AL, version 110V – 127V 250V / F5AL
- the air temperature sensor and the air temperature emergency sensor over 38/40 °C (the
sensors are located together under the plastic cover in the corner of the patient space)
- relative humidity sensor (located under the plastic cover with the temperature sensors)
- emergency heating sensor (located in the bath under the heating element)

- O2 sensors (located under the plastic cover in the corner of the patient space)
- humidifier module
- ventilator motor
- heater 230V(115V) / 250W (located in the bath under the chamber, serves for heating air)
- bed positioning motor
- O2 dosage valves
- 2 body (skin) temperature probe sockets T1, T2
- SpO2 probe socket
2 body (skin) temperature probe sockets, an equipotentionality connector (protective connection), the
incubator power switch, the power cable socket and the connector for auxiliary sockets are located on the
left side of the upper part.
In the incubator version with the monitor of SpO2 this block also includes sockets for connecting the SpO2
probe.
Skin Skin
temperature temperature
O2 saturation
(SpO2) probe
socket
Main switch
Protection
interconnection
socket connector
Power cord
socket
Auxiliary
sockets
CAUTION !
1. Devices with a total maximum power of 100W can be connected to the
auxiliary socket connector.
2. The leakage currents may increase after connecting additional devices.
A quick connector for pressurized O2, connection is located at the bottom of the upper part of the incubator
O2 quick
connector
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Control box
The control box is attached on an adjustable stand outside the incubator.

The control box contains the electronic system that controls all the incubator functions. The electronic
system consists of a multiprocessor control system that mutually controls its processes.
Lower part
- The version without the height adjustment contains no electronics.
- The version with the height adjustment – the electronic system is in the lower part:
- height adjustment power source

- height adjustment control pedal
- height adjustment motor

8. The Incubator Control Panel Description
Display No. 1 - graphic LCD display

Displays all the adjusted and measured values, menu screens…….
Key No. 2 - AIR TEMPERATURE mode
Switches the air temperature mode on and together with keys No. 18, 19, 20 serves for
adjustment of required air temperature.
Key No. 3 - BODY TEMPERATURE mode

Switches the body temperature mode on and together with keys No. 18, 19, 20 serves for
adjustment of required body temperature.
Key No. 4 - RELATIVE HUMIDITY mode
Switches the relative humidity (RH) mode on and together with keys No. 18, 19, 20 serves for
adjustment of required relative humidity.
Key No. 5 - OXYGEN CONCENTRATION mode
Switches the O2 concentration mode on and together with keys No. 18, 19, 20 serves for
adjustment of required O2 concentration.
Key No. 6 - SpO2 MONITORING mode

Opens the SpO2 monitoring menu.
Key No. 7 - PATIENT WEIGHING mode
Hold the key pressed for 2 seconds to switch the WEIGHING mode.
Opens the weighing menu. Together with keys No. 18, 19, 20 it serves for selection of required
function in the weighing mode.
Key No. 8 - MINI TREND mode
Opens the mini trend menu of the incubator. In combination with keys 17, 18, 19, 20.
Key No. 8 - INCUBATOR MENU mode

Opens the incubator menu. Together with No. 18, 19, 20, 21 and 22 it serves for selection of
required functions in the incubator menu.
Key No. 9 - N/A
Key No. 10, 12 - BED UP LEFT/RIGHT
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Manual bed tilting left/right.
Key No. 11, 13 - BED DOWN LEFT/RIGHT

Manual bed tilting left/right.
Indicator No. 14 - signalizes keyboard locking.
Key No. 15 - KEYBOARD LOCK
For manual keyboard locking/unlocking.
Key No. 16 - ACOUSTIC ALARM MUTE
Mutes the acoustic alarm for 5 min.
Key No. 17 - ESCAPE
Return in the selected window.
Key No. 18 - OK
Confirms adjusted values and approves alarms.
Key No. 19 - + / UP
Increases the adjusted values of:
- air temperature
- body temperature
- O2
- humidity
- movement within menus
To set the required values in the individual modes press the appropriate key (air, body, O2,
humidity) and then press +.
Key No. 20 - - / DOWN
Decreases the adjusted values of:
- air temperature
- body temperature
- O2
- humidity
- movement within menus
To set the required values in the individual modes press the appropriate key (air, body, O2,
humidity) and then press -.
Key No. 21 - LEFT
Movement within menus.
Key No. 22 - RIGHT

Movement within menus.

The data displayed on the large LCD display
The large display is divided into 3 sections: the top left the top right and the bottom section.
The basic screen

The current measurement values in the
windows of the appropriate modes are
always displayed in colours (green, red,
yellow, white).
The informative or adjusted parameters are
displayed in grey.
The basic screen

After switching the individual modes off the
word OFF is always displayed in the
appropriate mode section.
In the OFF mode the current measurement
value is displayed in grey.
If the body temperature sensor is connected

the current measured temperature is
displayed in green even if the air
temperature mode is on.
When the values of the individual modes

and menus are adjusted the LCD displays
the appropriate screens. To return to the
basic screen close the current screen by
confirming BACK or CANCEL.
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The top left section
Displays the incubator operation values.
air temp. mode window
body temp. mode window
relative humidity RH mode window
O2 concentration mode Window
A window of an active mode shows the current measured value in green (in red if it is out of tolerance)
and the corresponding adjusted value in grey.
A window of an active mode also shows an indicator of the regulator performance (air or body
temperature, humidifier, oxygen dosage). The indicator active part size represents the percentage of
performance of the appropriate mode. Full bar = 100%, no bar = 0%. If any of the modes is inactive
there is OFF displayed in the corresponding window.
The top right section

Displays the values of the SpO2 monitoring .
If any of the modes is inactive, there is OFF displayed in the corresponding window.
The display of the incubator version without the patient SpO2 monitor does not contain the SpO2
windows.
Weight mode sub-window (only in the version

with integrated scales)
Mini trend mode sub-window
Menu mode sub-window

The bottom part
Displays patient data, active alarms, mini trends, real date and time, indication of acoustic alarm
level, failure conditions.
The left part displays the current patient’s

name, surname, date of birth and an
identification number.
There may also be the symbol of a vital function
monitor alarm – a heart, and a symbol of memory
function failure – a crossed CD
The middle part displays current alarms or

selected graphs.
The right part displays the current time and date

and an alarm mute indicator.
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9. Setting the Incubator into Operation
9.1 Before first use
It is necessary to clean and disinfect the incubator prior to first use as described in this manual.
For cleaning and disinfecting, use recommended cleaning agents mentioned in this operation
manual.
9.2 Before switching the incubator on

Before you switch the incubator on plug the power cord into a wall socket, insert the humidifier
module into the incubator and lock it.
If the hospital electricity distribution is equipped with protection interconnection sockets

(equipotentiality), connect the incubator to the appropriate circuit with a special cable. There
is a special connector marked on the left side of the incubator. Push the special cable on
the incubator connector and on the distribution connector. The protective connection cable
ABB – 0299-0-0032/3 is optional and is not supplied with the incubator.
WARNING:
The protective connection cable has to be protected against mechanical
damage and against disconnection.
9.3 Switching the incubator on

Press the power switch on the side of the incubator. When the incubator is on, the main switch is
illuminated in green. Switching on is indicated with a short beep.
A self-test of the electronics runs after switching

the unit on. The test results are shown on the
display.
If any of the LCD displaying points or any of the
indicator in keys does not shine, contact your
service.
The electronic system monitors the time elapsed
from the last service inspection of the unit. If the
set time is expired the operators are informed
that a service inspection is necessary.
The incubator is always set to the AIR mode with
temperature set to 34 °C when it is cold. The O2
concentration and relative humidity modes are
switched off.
If the incubator is switched on within 15 minutes from being switched off a screen with the last
adjusted incubator values appears.
Press Key No. 19 to set the values displayed in the PARAMETERS table.

9.4 Switching the air temperature mode on and setting the air temperature
Press key No. 2 AIR, to open the air temperature setting screen.
The air temperature setting screen also displays the current measured value of the temperature inside
the incubator.
The right column of the screen contains
instructions for the particular screen.
Press key No. 19 or key No. 20 to set

the required air temperature inside the incubator
(in 0.1 °C increments).
Confirm the setting change by key No. 18 .

Unless the key is pressed, a screen saying
that OK has to be pressed appears.
Unless the key is pressed within 5 seconds,

a short audible signal is activated and the new air
temperature setting is not performed.
Measured patient’s body temperatures T1, T2 may be displayed simultaneously in the body T. Window
in the AIR mode after connecting the body temperature sensor to the appropriate socket.
9.4.1 Temperature reduction in the incubator

The adjusted air temperature may be reduced within the rage from -0.1 °C to -1.9 °C.
During temperature reduction in the AIR mode by >2 ºC from the originally set temperature the front
door or the port holes of the patient space may be opened for the necessary time.
CAUTION!
When the door or the port holes of the patient space are open the baby has to
be watched to prevent it from falling from the incubator.
To reduce the temperature press key No. 2 AIR and set the required temperature with key No.
20 . Press key No. 18 to confirm the change. Unless is pressed the new value adjustment
will not be performed.
9.4.2 Setting the temperature above

37 °C
Setting the required air temperature above 37 °C
is only possible by a special intervention of the
operator after pressing OK key during adjustment
of the required temperature.
Pressing keys No. 2 AIR and No. 19 only

allows the temperature to be set up to 37 ºC. To
set the temperature higher hold the key ,

until the information window TO SET THE
TEMPERATURE ABOVE 37 ºC PRESS OK appears on
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the display, and then press . After that the
temperature can be set above 37 °C by pressing
the key .
Temperature adjustment over 37 ºC is

announced by a yellow sign >37 ºC in the display.
9.5 Body temperature mode

Before switching to the BODY mode connect the
body temperature probe to the BODY PROBE T1
socked on the side of the incubator.
1. Connect the body temperature probe T1.

The electronic system checks the proper
connection to the incubator.
2. Attach the T1 probe to the upper part of
patient’s belly, the active side to the skin,
unless otherwise ordered by a physician.
Body temp. probe T2 is an additional
thermometer for informative patient body
temperature measurement.
LIST OF AUTHORIZED TYPES OF BODY TEMPERATURE PROBE

TYPE USE DESCRIPTION ARTICLE NO. TSE
1FF846314 Neonatal /infant Temperature sensor, 150cm 51FF846314
1. Plug the temperature probe T2 in.

2. Attach the T2 probe on a patient’s limb (upper or lower), the active side to the skin.
CAUTION!
Proper attachment of the probe to the patient’s body is necessary for correct
function of the body temperature mode. Probe separation during operation may
lead to wrong function of the body temperature mode.
9.5.1 Switching the mode on and setting the body temperature

Press the key No. 3 BODY to open the temperature adjustment screen.
The body temperature setting screen also displays the current measured value of the body
temperature.
The right column of the screen contains instructions for the particular screen.

Press key No. 19 or the key No. 20 to
set the required body temperature (in 0.1 °C
increments).
Confirm the setting change by key No. 18

.
Unless is pressed, a screen saying that OK

has to be pressed appears.
Unless is pressed within 5 seconds, a short

audible signal is activated and the new air
temperature setting is not performed.
When setting the desired body temperature in the range between 34ºC and 37ºC, the air temperature
in the incubator ranges between 27ºC and 37,5ºC. When setting the body temperature in the range
between 37ºC and 39ºC, the air temperature in the incubator ranges between 27ºC and 38,5ºC. In the
selected body temperature mode, the current air temperature in the incubator is dependent on the
desired temperature of the body and the heat capacity of the patient.
9.5.2 Body temperature reduction

The adjusted body temperature may be reduced within the rage from -0.1 °C to -1.9 °C.
During temperature reduction in the BODY mode by >1 ºC from the originally set temperature the
front door or the port holes of the patient space may be opened for the necessary time.
CAUTION!
When the door or the port holes of the patient space are open the baby has to be
watched to prevent it from falling from the incubator.
To reduce the temperature press key No. 3 BODY and set the required temperature with key No.
20 . Press key No. 18 to confirm the change. Unless is pressed the new value adjustment
will not be performed.
9.5.3 Setting the temperature above 37 °C

Setting the required body temperature above 37 °C is only possible by a special intervention of the
operator after confirmation of the setting by the OK key within adjustment of the required
temperature.
Pressing keys No. 3 BODY and No. 19

only allows the temperature to be set up to 37
ºC. To set the temperature higher hold the key
, until the information window TO SET THE

TEMPERATURE ABOVE 37 ºC PRESS OK appears
on the display, and then press . After that

the body temperature can be set above 37 °C
by pressing the key .
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Temperature adjustment over 37 ºC is
announced by a yellow sign >37 ºC on the
display.
9.6 Relative humidity RH mode

Before you start to humidify check the demineralized water level in the tank at the back of the
incubator and fill in demineralized water if necessary. Always fill the tank with demineralized water
up to the MAX mark.
CAUTION!
1. Only demineralized water may be used for humidification.
2. The demineralised water used must meet the requirements on the bacterial
purity of water specified in ISO 15883-4.
Filling the humidifier tank with water
1. Push the locking lever at the bottom of the

humidifier chamber up, pull the chamber out by
approx. 1 cm and release the locking lever.
2. Withdraw the chamber as it goes to the filling

position. The chamber will remain in a locked
position for refilling.

3. Remove the humectant plug (special
accessories).
4. Add demineralized water as necessary through the opening in the top cover.
5. After filling water, fit the humectant plug.
6. Insert the chamber back inside the incubator. Press it slightly inside, the chamber will get locked
and the cover will close.
WARNING:
1. The water level must not exceed the MAX line on the humidifier chamber front
wall.
2. Change the demineralized water in the humidifier tank every day.
9.6.1 Switching the RELATIVE HUMIDITY (RH) mode on

Press Key No. 4 RELATIVE HUMIDITY.
The relative humidity value is set automatically to 60%. Confirm the switching on by pressing key No.
18 or set the new relative humidity value, see. 9.6.2.
Unless is pressed within 5 seconds the RH MODE ON screen gets closed.
9.6.2 Setting the required RH value

The relative humidity RH setting screen also displays the current measured value of the relative
humidity RH in the incubator.
The right column of the relative humidity RH setting screen contains instructions for the particular
screen.
Press key No. 19 or key No. 20 to set

the required relative humidity RH (in 1%
increments).
. Unless the key is pressed, a screen

saying that OK has to be pressed appears.
Unless the key is pressed within 5

seconds, a short audible signal is activated and
the new relative humidity RH setting is not
performed.
Maximum possible relative humidity (RH) values cannot be achieved under all operating conditions.
Maximum available relative humidity depends on the set air temperature in the incubator,
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temperature, and relative humidity of ambient air, and O2 dosing in the incubator.
At low incubator air temperatures and high RH values, the indicated temperature deviation in the
incubator may be exceeded. If higher air temperature and higher RH values are set, the deviation of
relative humidity may be exceeded.
In such cases, the maximum required relative humidity should be reduced to achieve these
temperature deviations or relative humidity (RH).
9.6.3 Reduction of the required relative humidity (RH) in the incubator

The adjusted relative humidity RH may be reduced within the rage from -1% to - 24% RH.
When the set RH value is reduced by >25% from the originally adjusted value the front door or the
ports of the patient space may be opened.
CAUTION!
To reduce the RH value press key No. 4 RELATIVE HUMIDITY and set the required RH value by
pressing key No. 20 . Press key No. 18 to confirm the change. Unless is pressed the
new value adjustment will not be performed.
9.6.4 Switching the humidifier off

Press key No. 4 and choose the MODE OFF
item with key No. 20 .
Confirm the choice by key No. 18 .
Unless the key is pressed, the relative

humidity mode will not be switched off.
CAUTION!
1. The water must not be drained from the humidifier chamber
earlier than in 30 minutes from switching the humidifier off.
2. Unless the mode is activated, the water must not remain in the humidifier
chamber.
9.7 O2 concentration mode

Before starting oxygen application do the following:
- Connect the incubator to oxygen distribution (400 - 600 KPa) by means of pressure hose. Connect
the pressure hose to the incubator oxygen inlet by a quick connector.
- Adjust the required temperature, let the incubator warm up and the temperature stabilize at
the required value.
- The O2 concentration may only be selected after the incubator temperature stabilization.
If the above conditions are met, you can switch the oxygen concentration mode on.
9.7.1 Switching the O2 concentration mode on

Press Key No. 5 O2 CONCENTRATION.
The O2 concentration value is automatically set to 30%. Confirm the O2 mode switching on by pressing
key No 18 or adjust a new required O2 value, see. 9.7.2.
Unless is pressed within 5 seconds the O2 CONCENTRATION MODE ON screen gets closed.

9.7.2 O2 concentration value adjustment
The O2 concentration setting screen also displays the current measured value of the O2 concentration
in the incubator.
The right column of the O2 concentration setting screen contains instructions for the particular screen.
Press key No. 19 or the key No. 20

to set the required O2 concentration (in 1%
increments).
. Unless the key is pressed, a screen

saying that OK has to be pressed appears.
Unless the key is pressed within 5

seconds, a short audible signal is activated
and the new O2 concentration setting is not
performed.
9.7.3 Reduction of O2 concentration in the incubator

The adjusted O2 concentration may be reduced within the rage from -1% to -2% O2.
When the adjusted O2 concentration is reduced by >3% O2 from the originally adjusted O2
concentration the patient space cover or the port holes can be opened.
CAUTION!
To reduce the O2 concentration value press key No. 5 O2 CONCENTRATION and set the required
O2 concentration value by pressing key No. 20 . Press key No. 18 to confirm the change.
Unless is pressed the new value adjustment will not be performed.
9.7.4 O2 concentration adjustment over 40%

O2 concentration adjustment over 40% is only possible by a special intervention of the operator after
confirmation of the setting by the OK key within adjustment of the required O2 concentration.
Pressing keys No. 5 O2 CONCENTRATION
and No. 19 only allows the O2

concentration to be set up to 40%. To set the
O2 concentration higher hold , until the

information window TO SET THE O2
CONCENTRATION ABOVE 40% PRESS OK appears
on the display, and then press . After that

the O2 concentration can be set above 40% by
pressing .
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O2 concentration adjustment over 40% is
announced by a yellow sign >40% on the
display.
9.7.5 Calibration of the O2 sensors
Remaining time to the next O2 sensor

calibration is displayed at the right bottom of
the O2 window (1d 9h = 1 day 9 hours).
If the O2 mode is active and the O2

calibration time expires, the oxygen dosage
mode is automatically switched off and the
O2 sensor calibration window opens.
WARNING:
To achieve measurement accuracy the sensor has always to be calibrated at the
temperature that will be set in the incubator during oxygen dosage.
During the sensor calibration at altitude exceeding 1000 m, it is necessary to use
air with content O2 20,9 % and oxygen with content O2 100 % for sensor
calibration.
Oxygen content in the air depends on the altitude

Altitude (m) 0 500 1000 1500 2000 2500 3000
Barometric pressure (hPa) 1013 955 899 845 795 747 701
O2 content (%) 100 94 88 82 76 73 68
O2 content in the air (%) 20,95 19,7 18,4 17,1 15,9 15,3 14,2
Press key No. 18 and perform the steps required on the LCD during the calibration. The steps
have to be performed as fast as possible as after a longer delay the window closes automatically and
the calibration has to be started again!

Calibration of the O2 sensors
1. Open the porthole, slide the holder of the
O2 probes upwards and remove it from the
incubator frame.
2. Take the holder of the O2 probes out of the
patient space through the porthole.
3. Close the porthole.

4. Perform the calibration of the sensors in the
air (20,9% O2).
In case of altitude exceeding 1,000 m, it is

necessary to use calibration mixture of air
with 20,9 % O2.
Insert the probe holder in the device for the
sensor calibration O2 in the air. Connect the
hose to the device. Connect the hose to the
bottle with calibration air mixture via the
reduction valve with the outlet pressure 4
bar.
5. Insert the O2 sensor holder into the O2

calibration tool and lock it.
6. Connect an oxygen hose of the O2
distribution system to the O2 calibration
tool.
7. Run oxygen to the O2 calibration tool and
calibrate the O2 sensors to 100 %.
The correct calibration is checked by the

incubator electronic system. If the calibration is
wrong an alarm is displayed on the incubator
display.
CAUTION!
After successful calibration put the O2 sensor holder back into the incubator
without delay.
After calibration of O2 sensor, insert the O2 sensor holder in to the incubator to its original position
and close the port hole.
Key No. 18 can only be pressed after installation of the O2 probes inside the incubator.
If the O2 mode was active before the O2 calibration, a screen with the latest adjusted O2 value is
offered. After confirmation of the value by key No. 18 the oxygen dosage continues at this level.
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9.7.6 O2 sensor re-calibration by an operator
An operator may perform the oxygen sensor
calibration at any time in the MENU mode by
choosing O2 SENSORS CALIBRATION.
Press key No. 9 .
Press key No. 19 or No. 20 to choose

O2 SENSORS CALIBRATION.
Confirm by key No. 18 .
CAUTION!
Before recalibration take the O2 sensor holder out or the incubator and let it
stabilize in the air oxygen for at least 30 minutes
To recalibrate the O2 sensors follow the steps 1 – 7 Calibration of O2 sensors

Follow the on-screen instructions when recalibrating the O2 sensors.
CAUTION!
After successful calibration put the O2 sensor holder back into the incubator
without delay.
If the O2 mode was active before the O2 calibration, a screen with the latest adjusted O2 value is
offered. After confirmation of the value by key No. 18 the oxygen dosage continues at this level.
9.7.7 Switching the O2 concentration mode off
Press key No. 5 and choose the MODE OFF
item with key No. 20 .
Confirm the choice by key No. 18 .
Unless is pressed, the O2 concentration

mode will not be switched off.
CAUTION!
When you finish oxygen dosage disconnect the pressurized oxygen hose from the
incubator O2 quick connector.

9.8 O2 saturation SpO2, pulse monitoring, perfusion index (PI), pleth variability
index (PVI) and SpHb
Only for the incubator version with the SpO2 module Masimo rainbow SET.
The built-in module for monitoring Masimo rainbow SET enables measurement of:
- arterial blood haemoglobin saturation with oxygen SpO2
- pulse frequency
- perfusion index - PI
- non-invasive and continuous assessment of body fluid status - PVI (Pleth Variability Index)
- non-invasive and continuous monitoring of haemoglobin levels - SpHb
Alternatively also measurement of SpHb + special sensor for SpHb measurement can be ordered.
Learn more about the built-in Masimo rainbow SET here: www.masimo.com/home/rainbow-pulse-
co-oximetry
Pulse oximetry is governed by the principles that oxyhaemoglobin, deoxyhaemoglobin,

carboxyhaemoglobin, and methaemoglobin species differ in their absorption of visible and infrared
light. The amount of arterial blood in tissue changes with the pulse (photoplethysmography).
Therefore that amount of light, absorbed by the varying quantities of arterial blood, changes
accordingly.
Apart from O2 saturation, patient’s pulse is also measured in the SpO2 mode. Pulse rate measurement
is based on the optical detection of a peripheral flow.
After switching the SpO2 mode on, the operator may switch on an audible signal accompanying the
pulse indication. This audible signal changes depending on the SpO2 value. The lower SpO2, the lower
the tone. The sound signal accompanying the heartbeat rhythm may be switched off.
PI indicates the strength of the arterial pulse signal. Pi may be used as a diagnostic tool during low
perfusion for the accurate prediction of illness severity.
PVI provides a non-invasive way to determine whether the patient responds to fluids.
In addition, PVI allows the detection of dehydration in patients. PVI may also monitor functional
haemodynamics or forces involved in blood circulation in patients.
PVI is a measure of dynamic changes in the perfusion (PI) that occur during one or more complete
respiratory cycles, and may exhibit changes that reflect physiological factors such as vascular tone,
circulating blood volume, and intravenous pressure excursion.
SpHb is a continuous non-invasive measurement method that allows monitoring of haemoglobin

changes. SpHb represents the total haemoglobin concentration in arterial blood as measured by
rainbow multi-LED sensors which offer non-invasive SpHb measurements. SpHb may facilitate
detection of occult bleeding, help clinicians make more informed blood transfusion decisions, and
detect anemia.
LIST OF AUTHORISED SENSOR TYPES AND SENSOR PATIENT CABLES FOR SpO2 MONITORING
Range of peak MASIMO

Aplication wavelenghts/ optical
Type Use Product Description Part
place light performance of
the sensor No.
SpO2 red 660nm, infrared

M-LNCS Hand thumb, 905nm / ≤15mW (at
Infant 3-20kg, single use 2512
Inf foot thumb 50mA)
adhesive sensor, 46cm
M-LNCS 905nm / ≤15mW (at
Neonatal <3 or >40kg, single use Hand or foot 2514
Neo 50mA)
M-LNCS 905nm / ≤15mW (at
Neonatal <1kg, single use Hand or foot 2516
Neo-Pt 50mA)
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Foot, thumb,
M-LNCS Neonatal/ hand
Multisite Reusable 905nm / ≤15mW (at 2505
YI Adult Foot, thumb,
Sensor, 92cm 50mA)
hand, finger
Rainbow SpO2, SpHb

Hand or foot, 500nm-1300nm /
Infant 3-30kg, single use 2415
R1 20L thumb ≤25mW (at 100mA)
adhesive sensor
SpO2, SpHb
Rainbow 500nm-1300nm /
Neonatal <3 or >30kg, single use Hand or foot 2414
R1 25L ≤25mW (at 100mA)
adhesive sensor
Rainbow patient cable,
RC-04 2406
122cm
CAUTION !
Sensors M-LNCS inf, M-LNCS Neo, M-LNCS Neo-Pt, R1 20L and R1 25L are for
single use only.
In case of re-use of these sensors, the following may occur:
- transmission of infection among patients
- faulty measurement due to poor sensor positioning
- faulty measurement due to sensor damage during washing.
Information on the range of wavelengths of light emitted by the probe can be very useful for
doctors performing photodynamic therapy.
The Pulse Oximeter is calibrated to show functional oxygen saturation.
Accuracy of SpO2 measurement:

- Due to the statistical distribution of the measurement results, only about two-thirds of the
measurements can be expected to be in the ± Arms range from the CO-OXYMETER measured value.
- See the information in the M-LNCS Neo Sample Pack enclosed with the device for the SpO2 probe
type.
The SPO2, Pulse, PI, PVI, and SpHb values on the display, or their alarm may be delayed by a
maximum of 20 seconds over the actual values due to the signal processing and the update period.
Before switching the SpO2 mode on a pulse

oximeter, sensor with the sensor patient cable
has to be connected to the SpO2 socket on the
side of the incubator.
(When disconnecting the sensor cable from the
connector, first press the locking tabs and then
disconnect the connector).
To measure the SpHb, a special sensor designed

for this measurement must be used. The sensor
is marked on the connector label with SpHb +
SpO2.
Then the sensor has to be installed so as the

light source is opposite the photo receiver.
CAUTION !
When installing a specific sensor and an extension cable, refer to the Masimo
package leaflet information.

WARNING:
1. The ray from the light source has to impinge on the photo receiver after passing
through the vascularised tissue in each position of the sensor.
2. For proper measurement of O2 saturation data, avoid too much light (especially
electric or that of variable brightness) and mechanical action on the sensor
location.
3. To achieve precise measurement immovability and secure attachment of the
sensor have to be ensured.
4. Significant reduction of patient's arterial pressure, hypothermia of the limbs
and long-term positioning of the sensor on the same body part results in sudden
attenuation or disappearance of the pulse, which reduces the credibility of the
pulsometric monitoring.
The steps to be followed to activate the SpO2 mode

1. Design of SpO2 sensor variant 1: Attach the SpO2 sensor to the patient and plug it into the
connector of the sensor patient cable. Connect the sensor patient cable to the SpO2 connector
of the incubator.
Design of SpO2 sensor variant 2: Attach the SpO2 sensor to the patient and plug it into the
SpO2 connector of the incubator.
2. Press key No. 6 .

3. Set alarm on/off - par. 9.8.3
4. If the alarm is on, select the type of alarm - par. 9.8.3
5. If the alarm is used, set the alarm lower and upper limits - par. 9.8.4
6. Switch the audible signal of the pulse monitor on/off - par. 9.8.5
7. Set the pulse alarm on / off. If the alarm is on, select the alarm type - item 9.8.6
8. If the alarm is used, set the alarm lower and upper limits - par. 9.8.7
9. Set the period for calculating the average pulse value – par. 9.8.8
10. Set the frequency of the power supply –
par. 9.8.9
11. The electronics automatically
recognizes the active SpHb parameter
Masimo. Set alarm on / off - select the
alarm type – par. 9.8.10
12. If the alarm is used, set the alarm lower
and upper limits - par. 9.8.11
13. Set the value of measurement sensitivity
– par. 9.8.13
14. If the parameters according to the
previous steps have been set you can
choose and confirm ON MODE and start
measuring in the SpO2 mode
9.8.1 Description of the data

displayed in the SpO2 window
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DISPLAYED VALUE DESCRIPTION
High SpO2 /Low pulse possible alarm text SpO2 or PULSE
SpO2 97 % measured SpO2 value
alarm type symbol, see alarm type selection
96 adjusted upper limit of the SpO2 alarm
86 adjusted lower limit of the SpO2 alarm
PULS 120 bpm measured minute value
alarm type symbol, see PULSE alarm type selection
110 adjusted upper limit of the PULSE alarm
50 adjusted lower limit of the PULSE alarm
SENS APOD preset sensitivity value
SIQ signal quality (strength) indicator
PI 11,5 % measured PI value
PVI 15 % measured PVI value
SpHb 15,0 % measured SpHb value
10 adjusted upper limit of the SpHb alarm
1 adjusted lower limit of the SpHb alarm
Low SpHb possible alarm text SpHb
Cable near expiration….. Operating alarms of the MASIMO module
Signal SIQ bar is a signal quality indicator, most useful during motion and low perfusion situations.
The bargraf rises and falls with the pulse, its height indicating signal quality.
Startup procedure for measurement of the MASIMO module
In case the individual signs SpO2, Pulse, PI, PVI,

SpHb of SpO2 monitoring module flash and the
measured data in the respective fields are
either --- or measured values, this is the startup
procedure for the MASIMO module
measurement.
If the measured values SpO2, Pulse, PI, PVI, SpHb
are displayed at the startup procedure, these
values may not be correct.
The displayed values SpO2, Pulz, PI, PVI, SpHb

are correct only when individual signs SpO2,
Pulse, PI, PVI, SpHb are not blinking. The startup
procedure for PI, PVI, SpHb may take several
minutes.
The values are only displayed in the SpO2

window if the SpO2 mode is on. If the mode is
off, the word OFF is displayed in the SpO2
window.

9.8.2 Switching the SpO2 mode ON
Press key No. 19 or key No. 20 to set the MODE ON. Confirm selection by pressing .
Press to activate the SpO2 mode. The field the cursor stands in is highlighted.
The window shows the preset/set values of the
SpO2 mode.
A field containing instructions for the
particular window is displayed at the bottom
of the SpO2 screens.
To store the adjusted SpO2 parameters in the
memory select SAVE AS DEFAULT and
confirm with . These parameters will be

automatically set when the SpO2 mode is
next selected (the alarm volume is always
automatically changed to 100%, the MAX
sensitivity setting is changed to APOD).
To leave the SpO2 mode select CANCEL and
confirm with .
9.8.3 SpO2 - switching the alarm on and selection of the alarm type
The operator may choose from 4 alarm modes
- alarm OFF - the incubator display shows a symbol of a crossed bell

- warning alarm – incubator display shows a symbol of a grey crossed loudspeaker
Only visible alarm is displayed, without acoustic signal
- danger alarm – the incubator display shows a symbol of a yellow loudspeaker

Acoustic-optical alarm is activated (lower priority acoustic signal)
- crisis alarm – the incubator display shows a symbol of a red loudspeaker
Acoustic-optical alarm is activated (acoustic signal with higher priority different acoustic
signal than that of the danger alarm)
Press key No. 19 or No. 20 to set

the ALARM item. Confirm your selection with

the alarm type. Confirm your selection with
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9.8.4 SpO2 - setting the upper / lower
alarm value
Choose the SpO2 HIGH / LOW LIMIT item with
keys No. 19 or No. 20 and press .
Press or to set the required upper

alarm limit within 51 – 100%.
Set the required lower alarm limit within 50 –
99%. Confirm your selection with .
9.8.5 Switching the acoustic signal of

the heartbeat monitor ON/OFF
Choose the PULSE MONITOR item with keys No.
19 or No. 20 and press .
Press or to switch the acoustic signal

of the heartbeat monitor on/off. Confirm your
selection with .
9.8.6 PULSE - Switching alarm on and the alarm type choice



Acoustic-optical alarm is activated (acoustic signal with higher priority different acoustic signal
than that of the danger alarm
Press key No. 19 or No. 20 to set the

PULSE ALARM item. Confirm your selection with

the alarm type. Confirm your selection with

9.8.7 SpO2 - setting the upper / lower
PULSE alarm value
Choose the PULSE HIGH / LOW LIMIT item with
Press or to set the required upper

alarm limit within 20 – 240bpm.
Set the required lower alarm limit within 15 –
235bpm. Confirm your selection with .
9.8.8 SpO2 - setting the period for the

pulse average value calculation
Choose the SpO2 PULSE AVERAGING PERIOD item
with keys No. 19 or No. 20 and press
Press or to set the required averaging

period within 2-16 sec.
Confirm your selection with .
9.8.9 SpO2 – Setting the powerline

frequency
Choose the POWERLINE FREQUENCY item with
Press or to set the current value of

50Hz or 60Hz power frequency.
9.8.10 SpHb - Switching alarm on and the alarm type choice



Acoustic-optical alarm is activated (acoustic signal with higher priority different acoustic signal
than that of the danger alarm
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Choose the SpHb ALARM item with keys No. 19
or No. 20 and press No. 18 .
Select the type of alarm using key No. 19.
or No. 20 . Confirm your selection with

.
9.8.11 SpHb - setting the upper / lower

alarm value
Choose the SpHb LIMIT HIGH / LIMIT LOW item
with keys No. 19 or No. 20 and press No.
18 .
Press or to set the required upper alarm

limit within 2 – 25 g/dl.
Set the required lower alarm limit within 1 - 24
g/dL. Confirm your selection with .
9.8.12 Setting the alarm volume
Choose the item Alarm volume using key No. 19
, No. 20 and confirm by pressing key
No. 18 .
Use the key or to set the desired alarm
volume. Confirm your selection with .
9.8.13 Setting the sensitivity level

The sensitivity adjustment allows you to adjust
the measurable SpO2 sensitivity to the SpO2 signal
level of the patient and the signal quality at the
measurement site.
Choose the item Sensitivity using key No. 19
or key No. 20 and confirm by pressing key
No. 18 .
Use the key or to set the desired

measurement sensitivity.

Max – maximum sensitivity is recommended for patients with weak signals (e.g. high ambient noise
and/or patients with very low perfusion).
Normal - normal sensitivity is recommended for

patients who are experiencing some compromise
in blood flow or perfusion. It is advisable for care
areas where patients are observed frequently,
such as the intensive care unit.
APOD (Adaptive Probe Off Detection) - is the

recommended sensitivity mode where there is a
high probability of the sensor to become
detached. It is also the suggested mode for care
areas where patients are not visually monitored
continuously. This mode delivers enhanced
protection against erroneous pulse rate and
arterial oxygen saturation reading when a sensor
becomes inadvertently detached from a patient due to excessive movement.
9.8.14 Displaying the SpO2 mode alarms

The SpO2 mode and the pulse alarms are displayed on the bottom line of the SpO2 upper window.
In the case of the LOW/HIGH SpO2 alarm the alarm text is displayed and the operator is then informed
on the measured value deviation by flickering measured value (e.g. SpO2 80%).
The chosen SpO2 and pulse alarm type symbol , , , is displayed in the upper right hand
corner of the SpO2 window.
SpHb alarms are displayed on the bottom line of the SpO2 middle window.
In case of LOW / HIGH SpHb alarm, the text of the relevant alarm is displayed and the operator is
also notified of the deviation of the measured value by flashing the measured data (eg SpHb 15,0%).
The chosen PI and PVI / SpHb alarm type symbol , , , is displayed in the upper right hand
corner of the SpO2 window.
Other MASIMO alarms are displayed at the bottom of the SpO2 window.
9.8.15 Muting the SpO2 mode acoustic alarms

The alarm displayed in the SpO2 + PULSE, SpHb
window, is only triggered when alarm is set to
alert , danger or crisis . In case of
danger or crisis , the acoustic alarm can
be muted for 5 min by pressing key No. 16

. The muting of the acoustic alarm is signalled
by flashing the crossed-out speaker symbol at
the right bottom part of the LED display.
Other MASIMO operational alarms are displayed

at the bottom of the SpO2 window. These
alarms can be muted for 5 min. by pressing key
No. 16 . The muting of the acoustic alarm is signalled by flashing the crossed-out speaker symbol
at the right bottom part of the LED display.
When a new alarm is triggered, the muting of the acoustic alarm is automatically cancelled.
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9.8.16 Switching SpO2 mode OFF
Press key No. 6 and set the O2 saturation
SpO2 submenu.
Choose the OFF MODE item with keys No. 19
or No. 20 and confirm your selection with
The SpO2 mode is quit when is pressed.
9.9 PATIENT WEIGHT mode

Only for the incubator with integrated scales.
Weighing modes:
WEIGHT - patient weighing.
This mode enables direct displaying of patient’s weight.
- measuring weight increase/decrease from the last tare setting.
This mode enables direct displaying of patient weight increase/decrease.
TARE - setting the weight on the bed to zero.
CAUTION!
1. When declining the bed in the WEIGHT mode the patient’s position on the bed
has to be watched. No part of the baby’s body must exceed the bed edges.
2. Handling the bed in the WEIGHT mode is not allowed, the scales system may
be damaged.
WARNING:
1. The maximum range of the scales is 6kg.
2. To comply with the high accuracy weight measurement in the NEWBORN
WEIGHING mode it is necessary to lay a newborn in the center of the bed.
3. To comply with the high accuracy weight measurement in the NEWBORN
WEIGHING mode it is necessary that the bed does not touch the front or rear
door.
9.9.1 Switching the WEIGHT mode ON

A field containing instructions for the particular window is displayed at the bottom of the PATIENT
WEIGHT screens.
Press key No. 7 (PATIENT WEIGHT) and hold it for about 2 seconds. The electronic system
automatically shifts the bed to the weighing position.
The instructions displayed in the individual screens of the WEIGHT menu have to be followed:
- LIFT PATIENT UP
- PUT PATIENT DOWN
The incubator electronic system sets the zero automatically before weighing.
WARNING:
To set the scales to zero the change of the weight on the bed must be at least
300 g.

9.9.2 Patient weighing
Choose the WEIGHING mode and confirm with
.
The current measured patient’s weight is
displayed.
Press again for further weight

measurement.
The scales are zeroed before each weighing.
9.9.3 Tare setting

To zero the weight on the bed select the TARE
mode and confirm your selection with .
9.9.4 Measuring patient’s weight

increments/decrements
The current weight increment/decrement is
displayed after each weighing. The
increment/decrement calculation is based on
the previous zeroed weight, see 9.11.3.
The weight increment/decrement from the
previous weighing is displayed at INCREASE FROM
TARE.
9.9.5 Switching the WEIGHING mode

OFF
CANCEL.
Confirm with . The weighing mode will be

finished, the bed will return to the basic position
and normal screen will be displayed.
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9.10 Muting the incubator acoustic
alarm
The acoustic alarm may be muted for 5 minutes
or for 30 minutes until the required
temperature, oxygen and RH values stabilize.
Press key No. 16 . A symbol of crossed

speaker starts to flicker in the bottom right
corner of the display.
When a new alarm occurs the mute function is

automatically interrupted.
9.11 Mini trends

Selected trends are displayed at the bottom of
the basic screen of the LCD.
A mini trend can only be displayed if no alarm is
displayed.
Press key No. 8 . Choose the required mini
trend by keys No. 19 or No. 20 and
press key No. 18 to confirm.
Select the required range selection by or
and press to confirm.
9.12 Keyboard locking

To avoid undesirable adjustment of the incubator values by unauthorized persons the control
electronics enables the keyboard to be locked. The keyboard lock function can be set in the incubator
MENU.
After selecting OFF, keyboard locking function is turned off.
After selecting MANUAL it is necessary to press key No. 15 to lock the keyboard. To unlock the
keyboard again, press the key .
After selecting AUTO 1min - 5min, the buttons will be locked automatically 1 - 5min after the last
button is pressed. To unlock the keys again, press the key .

Locking of the keypad buttons is signaled by the
lighting of the No. 14 light indicator next to the
No. 15 key.
9.13 Switching the incubator off
WARNING:
The incubator may only be switched off of there is no patient inside.
Press the main switch on the side of the incubator. Switching off is signalled by illumination of the
main switch button.
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10. The Incubator MENU Mode
Press key. 9 to display the menu MENU.

the required menu mode. Confirm your
selection with .
SpO2 modes are offered after selection of

PATIENT MONITORING, see chapters 9.8 for
description.
A field containing instructions for the particular window is displayed at the bottom of the menu
screens.
The incubator electronic system monitors the time from the last button pressing on all the menu
screens. Unless none of the keys , , , is pressed within approx. 10 sec an audible alarm
starts, which can be cancelled by pressing. , , .
10.1 Patient data

The incubator is able to store up to 20 patient
cards.
Stored patient cards may be recalled from the
incubator memory.

the PATIENT item. Confirm your selection with
10.1.1 Patient menu

Press key No. 19 or No. 20 to set the required MENU item. Confirm your selection with
.
Choose and confirm SELECT PATIENT, to
choose a patient from the list in memory.
Choose and confirm SHOW PATIENT to choose
a patient from the list to display a patient
card.
Choose and confirm NEW PATIENT, to enter
data of a new patient.
Choose and confirm EDIT PATIENT, to modify
patient’s data
Choose and confirm DELETE PATIENT, to
delete a patient from the list.
Choose and confirm BACK, to return to the
previous screen.
Choose and confirm CANCEL, to close the
PATIENT MENU.

10.1.2 Choosing a patient’s name from
the list

the required name from the list. Confirm your
selection with .
After selection and confirmation the screen shows
the name, surname, date/time of birth.
10.1.3 Entering new patient’s data – the

Patient Card MENU
NEW PATIENT item. Confirm your selection with
Use the keys or to choose the items

NAME, SURNAME, SEX, DATE OF BIRTH, WEIGHT,
LENGTH, ID. Confirm your selection with .
Items NAME, SURNAME, DATE OF BIRTH

are obligatory.
10.1.4 To enter the name and surname

the NAME/SURNAME item.
Use keys , , to enter the name and

surname from the alphabet. Confirm the entered
name / surname with .
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10.1.5 To enter the gender
the SEX item.
Choose the gender with , .
10.1.6 To enter the date and time of

birth
the DATE OF BIRTH item.
Use , to choose the item YEAR, MONTH,

DAY HOUR, MINUTE one after another.
Always confirm your selection with .
Enter all the values with , .
Confirm each entry with .
10.1.7 To enter the patient’s weight at

birth
the WEIGHT item.
Enter the weight at birth with , .
Confirm the entry with .
10.1.8 To enter the patient’s length at

birth
the LENGTH item.
Enter the length at birth with , .
Confirm the entry with .

10.1.9 To enter the patient’s ID
number
the ID item.
Enter the ID number , .

Confirm the entered ID by pressing the button
in the ENTER position.
10.1.10 To file a new patient’s card

the INSERT item.
10.1.11 Modification of a stored

patient card

the EDIT PATIENT item.
Choose the required patient with , .

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Choose the item to be changed with , ,
(NAME, SURNAME, SEX, DATE OF BIRTH,

WEIGHT, LENGTH).
Change the data in the chosen item with ,
, .
To store the modified data select MODIFY and
press .
10.1.12 Deletion of a stored patient card
Press key No. 19 or No. 20 to choose the

DELETE PATIENT item.
Choose the required patient with , .
Press key No. 19 or No. 20 to choose the

DELETE item.
To delete the patient card from the memory
select DELETE and press .

10.2 Trends
Trends of the last 20 patients in the list can be
displayed. Trends of two values can be displayed
in one graph.
The last 100 records are stored in weight trends
for each patient.
Trends are stored every 2 minutes.
Press key No. 9 .

the TRENDS mode.
10.2.1 Trends – patient selection

the required patient.

To return to the menu choose BACK and confirm
with .
To return to the basic screen choose CANCEL and
confirm with .
10.2.2 Trends – to select the trend

No. 1
the first required trend.
Confirm the selected trend with .
10.2.3 Trends – to select the trend

No. 2
the second required trend.
Confirm the selected trend with .
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10.2.4 Trends – setting the time zoom
of the trend display
the required range selection (time zoom).
Press to confirm the selected range.
10.2.5 Trends – to display the trend graph

the individual trend display modes ZOOM+,
ZOOM-, MOVE >, MOVE <, VALUES, BACK,
CANCEL. Confirm the selected mode with .

To change the time zoom of the trend display
choose ZOOM + or ZOOM – and confirm with

.
To shift the displayed trend by the adjusted time
zoom value press MOVE > or MOVE < and confirm
with .
To display the trend in the form of numeric
values press VALUES and confirm with .
Division of the time line depends on the chosen trend graph zoom.
10.2.6 Trends – to display the trend

values
To display the trends in the form of numeric
values press VALUES and confirm with .
Press key No. 19 or No. 20 to move

within the table of the trend.
Press to return to the graph.

10.3 Alarms
The incubator stores the latest 100 alarms for
each patient in the memory.
Press key No. 8 .

the ALARMS mode.
10.3.1 Alarms – patient selection

the required patient.

with .
confirm with .
10.3.2 Alarms – to list the alarms

Press keys No. 19 or No. 20 to choose
the individual alarms, BACK, CANCEL.

with .
confirm with .
10.4 Data
The incubator enables transfer of patient data
on and from a USB flash disk. This function
serves for transferring data (trends, alarms)
between incubators so only the data of one
patient may be stored on one USB flash disc.
This enables uninterrupted data recording when
a patient is transferred from one SI-610-1 to
another.
Press key No. 8 .

the DATA mode.
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10.4.1 Data Import
IMPORT.

Connect a USB flash disk to the USB port on the
side of the control panel and confirm with

.
If the USB flash disc includes data of a patient

who has already data recorded in the incubator
press or , to choose whether the data

in the incubator will be overwritten or not, and
confirm with .
10.4.2 Data export

EXPORT.

Connect a USB flash disk to the USB port on the
side of the control box and confirm with .

If the USB flash disc includes data of another
patient press or , to choose whether

the data in the USB flash disk will be overwritten
or not, and confirm with .
10.4.3 Data – delete all

DELETE ALL function deletes all the patient
records stored in the incubator.

DELETE ALL .

10.5 Calibration of O2 sensors
See chapter 9.7.6 Recalibration of the O2 sensors
by an operator.
10.6 Incubator test
WARNING:
Take the patient out of the incubator before performing the test.
The incubator test checks the important functions of the incubator. The incubator electronic system
is checked within the test. In the second test phase the operator has to press the appropriate keys
upon prompts displayed on the LCD display. The operator is guided through the test by messages on
the LCD display.
The incubator test may be performed by confirming the TEST item in the menu.
Press key No. 8 .

the INCUBATOR TEST mode.
After confirmation of the INCUBATOR TEST

mode the testing procedure starts.
10.7 Incubator user settings – options
Press key No. 9 .

the OPTIONS mode.

with .
confirm with .
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10.7.1 To select the display language
the OPTIONS – LANGUAGE item.
Choose the required language with or
and confirm with .
10.7.2 To set the alarm volume

the OPTIONS – ALARM VOLUME item.
Set the required alarm volume with or
and confirm with .
The alarm volume level is displayed in the

bottom right corner of the display.
- alarm volume 50%
- alarm volume 75%
- alarm volume 100%

10.7.3 Sound of the keys (acoustic signal
when a button on the control panel is pressed)

the OPTIONS – KEYS SOUND item.
Set ON or OFF with keys or .
10.7.4 LCD display backlight intensity

the OPTIONS – DISPLAY BACKLIGHT INTENSITY
item.
Set 50% -100% with keys or .
10.7.5 Time and date setting

the OPTIONS – DATE AND TIME item.
Choose the value you want to change with
or . Confirm your selection with .
required value. Confirm with .
To store the new date and time values choose SET and press to confirm.
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10.7.6 Default settings of the
incubator operation
Choose FACTORY SETTING – YES to delete the

user values/data and to set the below default
values.
The other user values/data remain unchanged.

the OPTIONS – FACTORY SETTING item.
Choose the required setting option with or . Confirm your selection with .
If you choose FACTORY SETTING YES, the factory values will be set.
Table of default setting after choosing FACTORY SETTING – YES

Language English
Key sound ON
Key lock OFF
Mini trends OFF
Illumination intensity 100 %
Date and time 1.1.2000 00:00:00
SpO2 alarm type danger

SpO2 alarm lower limit 96 %
SpO2 alarm upper limit 80 %
Acoustic signal of the heart rhythm monitor OFF

PULSE alarm type danger
PULSE alarm upper limit 120 bpm
PULSE alarm lower limit 50 bpm
Pulse average time 8s
Powerline frequency 50Hz
Alarm Volume 100 %
SpHb OFF
Sensitivity APOD

10.7.7 Device information
Displays the SW versions of the individual
electronic parts of the incubator.
Choose the required DEVICE INFORMATION item
by keys No. 19 or No. 20 .
Press key No. 18 to confirm.
10.7.8 Device state

Enables displaying of alarms that are displayed
after the incubator initial test, with which the
incubator can work.
Choose the required DEVICE STATE item by keys
No. 19 or No. 20 .
Press key No. 18 to confirm the selection.
10.8 Closing the menu
To close the menu press key No. 17 .

The basic screen will be displayed after the
menu is closed.
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11. List of the Alarms and Their Meaning
The alarms are indicated by audible-visual signalling.
Visual signalling is performed by flickering of the appropriate alarm on the LCD and by simultaneous
flickering at the top of the control panel. The audible signal may be muted for 5 minutes by pressing
key No. 16 .
The audible alarms LOW TEMPERATURE, LOW O2 CONCENTRATION, LOW RH are automatically muted
for 30 minutes: - during temperature, O2 concentration or relative humidity start
- after opening the chamber front/rear door
- after a change of temperature, O2 concentration or relative humidity (RH)
The incubator control system differentiates between severities of the individual alarms by
colour and alarm sound.
The visual signal colour identifies alarm priorities as follows:
Red: high priority = immediate operator’s intervention is necessary
Yellow: medium priority = immediate operator’s intervention is not necessary
Audible alarm corresponds with the alarm colour:
For red alarm: … .. … .. … .. = immediate operator’s intervention is necessary
For yellow alarm: … … … = immediate operator’s intervention is not necessary
AUDIBLE FAILURE
FAILURE VISUAL INDICATION REMEDY
INDICATION CAUSE
-Intermittent tone. Failure of the - Check power cord connection.
Red ALARM + -Audible alarm may be incubator internal - The patient has to be transferred
Power failure
POWER FAILURE muted for 5 min by power supply to another incubator, the incubator
SPEAKER key system switched off and a serviceman called
-Intermittent tone. The battery has -The patient has to be transferred to
Red ALARM + -Audible alarm may be not been charged
Battery failure another incubator, the incubator
BATTERY FAILURE muted for 5 min by since the initial 30
SPEAKER key minute charging switched off and a serviceman called
Red ALARM + - Indication
module failure
INCUBATOR - Beta module
FAILURE failure
Failure of the
Red ALARM +
indication module
CLOCK FAILURE clock
Red ALARM + Failure of data
DATABASE recording to the
FAILURE memory
Red ALARM +
Life function
RESUS MODULE module failure
FAILURE
Red ALARM +
INCUBATOR EEPROM failure.
FAILURE 100
Red ALARM +
-Intermittent tone -The patient has to be transferred to
INCUBATOR RTC failure
-Audible alarm may be another incubator, the incubator
System failure FAILURE 101 muted for 5 min by switched off and a serviceman
Red ALARM + pressing SPEAKER key called
Disconnection of
INCUBATOR inner connectors
FAILURE 102
Red ALARM + Ventilator speed
INCUBATOR measurement
FAILURE 103 failure
Red ALARM + Voltage
INCUBATOR measurement
FAILURE 104-108 failure
Red ALARM +
Battery converter
INCUBATOR failure
FAILURE 110
Red ALARM +
INCUBATOR Alarm unit failure
FAILURE 120
Red ALARM + Temperature
TEMPERATURE control failure

AUDIBLE FAILURE
INDICATION CAUSE
MODE FAILURE
208, 209
Red ALARM + Oxygen control The patient has to be transferred
-Intermittent tone failure
System failure OXYGEN MODE to another incubator, the
FAILURE 301 -Audible alarm may
incubator switched off and a
be muted for 5 min
Red ALARM + by pressing serviceman called
RELATIVE SPEAKER key Humidity control
HUMIDITY MODE failure
FAILURE 402, 404
Red ALARM + -Intermittent tone The double air - The patient has to be transferred to
Air sensor -Audible alarm may be temperature
TEMPERATURE another incubator, the incubator
failure muted for 5 min by sensor has broken
MODE FAILURE 200 pressing SPEAKER key down. switched off and a serviceman called.
Temp. difference
Different air Red ALARM + -Intermittent tone higher than - The patient has to be transferred to
-Audible alarm may be >0.5 °C was
temperature TEMPERATURE muted for 5 min by measured by the
another incubator, the incubator
values MODE FAILURE 204 pressing SPEAKER key double air temp. switched off and a serviceman called.
sensor.
The double
Emergency Red ALARM + -Intermittent tone - The patient has to be transferred to
heating
-Audible alarm may be
heating sensor TEMPERATURE muted for 5 min by
temperature another incubator, the incubator
failure MODE FAILURE 203 sensor has broken switched off and a serviceman called.
pressing SPEAKER key
down.
Different Temp. difference
Red ALARM + -Intermittent tone - The patient has to be transferred to
higher than >5 °C
emergency -Audible alarm may be
TEMPERATURE muted for 5 min by
was measured by another incubator, the incubator
heating sensor the double heater
MODE FAILURE 206 pressing SPEAKER key switched off and a serviceman called.
values temp. sensor.
The double
Red ALARM + -Intermittent tone - The patient has to be transferred to
emergency air
Emergency air -Audible alarm may be
TEMPERATURE temperature another incubator, the incubator
sensor failure muted for 5 min by
sensor has broken
MODE FAILURE 201 pressing SPEAKER key switched off and a serviceman called.
down.
Temp. difference
Different Red ALARM + -Intermittent tone higher than - The patient has to be transferred to
-Audible alarm may be >0.5 °C was
emergency air TEMPERATURE muted for 5 min by measured by the
sensor values MODE FAILURE 205 pressing SPEAKER key double emergency switched off and a serviceman called.
air temp. sensor.
The air - Check the doors and portholes for
- Intermittent tone. tightness.
temperature in the
Red ALARM +
Low air - Audible alarm may be - If the failure repeats, the patient has
patient space has
LOW AIR
temperature muted for 5 min by to be transferred to another incubator,
not reached or has
TEMPERATURE pressing SPEAKER key dropped below the
the incubator switched off and
allowable range.
a serviceman called.
The air - Air the incubator.
Red ALARM + - Intermittent tone.
temperature in the - Unless the inside temperature drops
High air - Audible alarm may be
HIGH AIR patient space has the patient has to be transferred
temperature muted for 5 min by
exceeded the
TEMPERATURE pressing SPEAKER key to another incubator, the incubator
allowable limits. switched off and a serviceman called.
- Temperature rise
- 30 minutes without to the set value
Yellow alarm + audible signal after switching the -Automatic mode of setting the device
Air
TEMPERATURE - After 30 minutes temperature on to the required value.
temperature
CHANGE IN change to the low/high - Humidity rise to
setting change temperature alarm with the set value after -Without operator’s intervention.
PROGRESS
audible signal temperature
change
Red ALARM + -Intermittent tone -Confirm the failure by pressing OK,
Skin sensor -Audible alarm may be Skin sensor
SKIN SENSOR 1 the incubator continues in the AIR
failure muted for 5 min by failure.
FAILURE pressing SPEAKER key mode.
-Check the skin sensor connection and
Red ALARM + -Intermittent tone position
Skin sensor
Skin sensor -Audible alarm may be
SKIN SENSOR disconnected from -If the failure does not remove press
disconnection muted for 5 min by
the socket.
DISCONNECTED 1 pressing SPEAKER key OK and the incubator continues in
the AIR mode.
- Intermittent tone. Patient’s body - Check the doors and portholes for
Red ALARM + LOW - Audible alarm may be temperature has
Low body tightness.
BODY muted for 5 min by not reached or has
temperature pressing SPEAKER key. dropped below the - Check the body temperature sensor
TEMPERATURE
- During the rise to the allowable range. attachment.
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AUDIBLE FAILURE
INDICATION CAUSE
set temperature or after - If the failure repeats, the patient has
a change of the set value to be transferred to another incubator,
the alarm is muted for 30 the incubator switched off and
minutes.
Patient’s body - Air the incubator.
Red ALARM + - Intermittent tone. - Unless the body temperature drops
temperature has
High body - Audible alarm may be
HIGH BODY the allowable consult a physician and set higher
temperature muted for 5 min by
limits.
TEMPERATURE pressing SPEAKER key. required temperature or switch to the
air temperature mode.
- Temperature rise
- 30 minutes without to the set value
Yellow alarm + audible signal after switching the -Automatic mode of setting the device
Body
TEMPERATURE - After 30 minutes temperature on to the required value.
temperature change to the low/high - Humidity rise to
CHANGE IN
setting change body temperature alarm the set value after -Without operator’s intervention.
PROGRESS
with audible signal. temperature
change
-Air the incubator
-After temperature drop below 38°C
Red ALARM + -Intermittent tone The inside temp. press OK to cancel the alarm OK
-Audible alarm may be exceeds the
Overheated HEATING MODE muted for 5 min by allowable limit
-If the failure repeats, the patient has
DISCONNECTED pressing SPEAKER key. 38°C/40°C to be transferred to another incubator,
the incubator switched off and
Air circulation - Check the air flow inside the
failure. The incubator, whether the air holes are
Red ALARM + - Intermittent tone.
temperature near free.
Heater - Audible alarm may be
TEMPERATURE muted for 5 min by
the heater >75 °C - If the air holes are free, the patient
overheated
MODE FAILURE 207 pressing SPEAKER key. or has grown by has to be transferred to another
>1.5 °C within 30 incubator, the incubator switched off
sec. and a serviceman called.
Air circulation
failure. The
temperature on - Check the air flow inside the
Covered air
- Intermittent tone. the temperature incubator, if the air holes are free.
holes under Red ALARM +
- Audible alarm may be sensors has not - If the air holes are free, the patient
the INSUFFICIENT AIR muted for 5 min by increased. A high has to be transferred to another
temperature CIRCULATION pressing SPEAKER key. temperature incubator, the incubator switched off
sensors increase has and a serviceman called.
occurred near the
heater.
Red ALARM + -Intermittent tone -The patient has to be transferred to
O2 sensor -Audible alarm may be
OXYGEN MODE muted for 5 min by
O2 sensor failure. another incubator, the incubator
failure
FAILURE 300 pressing SPEAKER key. switched off and a serviceman called
Red ALARM + -Intermittent tone Difference >3% - The patient has to be transferred to
Different O2 DIFFERENT -Audible alarm may be between the O2
muted for 5 min by sensors was
values VALUES FROM O2
pressing SPEAKER key. measured. switched off and a serviceman called.
SENSORS
O2
-Check the oxygen inlet
concentration in
-Intermittent tone -Check whether the chamber doors
the chamber has
Red ALARM + -Audible alarm may and port holes are closed
Low O2 not reached or
LOW O2 be muted for 5 min by -If the failure repeats, the patient has
concentration has dropped
CONCENTRATION pressing SPEAKER to be transferred to another incubator,
below the
key. the incubator switched off and a
allowable range.
serviceman called.
O2
-Intermittent tone -Air the incubator
concentration in
Red ALARM + -Audible alarm may -If the oxygen does not decrease the
High O2 the chamber has
HIGH O2 be muted for 5 min by patient has to be transferred to another
concentration exceeded the
CONCENTRATION pressing SPEAKER incubator, the incubator switched off
allowable range.
key. and a serviceman called.
- O2 adjustment to
- 30 minutes without
Yellow alarm + the set value after -Automatic mode of unit adjustment
audible signal
O2 adjustment O2 activation to required value
O2 ADJUSTMENT IN - after 30 minutes
change switched to high/low O2
- O2 adjustment to
PROGRESS the set value after -Without operator’s intervention
alarm with audible signal
O2 resetting

AUDIBLE FAILURE
INDICATION CAUSE
Oxygen -Air the incubator
Red ALARM + O2 -Intermittent tone concentration on
O2 -If the oxygen does not decrease the
concentration -Audible alarm may be the chamber is >
concentration patient has to be transferred to another
> by 5% + O2 muted for 5 min by by 5% from the
> by 5% pressing SPEAKER key value adjusted by incubator, the incubator switched off
DOSAGE OFF
the operator. and a serviceman called
-Intermittent tone
Relative Red ALARM + -Audible alarm may Relative - The patient has to be transferred to
humidity (RH) HUMIDITY MODE be muted for 5 min by humidity sensor another incubator, the incubator
sensor failure FAILURE 400 pressing SPEAKER failure. switched off and a serviceman called.
key
Failure of the
humidifier Red ALARM + - Intermittent tone. A failure of the - The patient has to be transferred to
- Audible alarm may be sensor of the
water TEMPERATURE muted for 5 min by humidifier water
temperature MODE FAILURE 403 pressing SPEAKER key temperature. switched off and a serviceman called.
sensor
Relative humidity -Check whether the chamber doors and
-Intermittent tone RH in the chamber port holes are closed
Low relative Red ALARM + -Audible alarm may be has not reached or -If the failure repeats, the patient has to be
humidity (RH) LOW RH muted for 5 min by has dropped transferred to another incubator, the
pressing SPEAKER key below the incubator switched off and a serviceman
allowable range. called
Relative humidity -Air the incubator
-Intermittent tone
RH in the chamber -If the relative humidity does not drop the
High relative Red ALARM + -Audible alarm may be
has exceeded the patient has to be transferred to another
humidity (RH) HIGH RH muted for 5 min by
allowable range. incubator, the incubator switched off and a
serviceman called.
- Humidity
adjustment to the
- 30 minutes without
Yellow ALARM + set value after -Automatic mode of unit adjustment
audible signal
humidity activation
RH adjustment HUMIDITY - after 30 minutes to the required value.
- Humidity
change ADJUSTMENT IN switched to high/low
adjustment to set
PROGRESS humidity alarm with -Without operator’s intervention
value after
audible signal
humidity setting
change
Relative humidity -Air the incubator
Red ALARM + -Intermittent tone -Unless the failure disappears the
Relative RH in the chamber
-Audible alarm may be
humidity > by RELATIVE muted for 5 min by
has exceeded the patient has to be transferred to another
30% HUMIDITY > BY 30% adjusted value by incubator, the incubator switched off
30%. and a serviceman called
-Check the humidifier securing
The water level in
Intermittent tone -Fill the tank to maximum.
the tank has
Yellow ALARM + -Audible alarm may be -Unless the failure disappears, the patient
Low water level dropped below the
LOW WATER LEVEL muted for 5 min by minimum
has to be transferred to another incubator,
pressing SPEAKER key the incubator switched off and a serviceman
allowable level.
called.
The humidifier - The patient has to be transferred to
Red ALARM + Intermittent tone
heater has
Humidifier -Audible alarm may be another incubator, the incubator
overheated
HUMIDITY MODE muted for 5 min by
exceeded the
allowable limit switched off and a serviceman called.
FAILURE 401 pressing SPEAKER key
120°C.
Intermittent tone
- Audible alarm is - Check the humidifier securing
Red ALARM + The humidifier - If the failure repeats, the patient has
automatically muted for
Humidifier chamber is drawn
displaced
HUMIDIFIER two minutes
out or badly
to be transferred to another incubator,
DISPLACED -Audible alarm may be the incubator switched off and a
secured.
muted for 5 min by serviceman called.
Red ALARM + - Intermittent tone. The speed of the - The patient has to be transferred to
Ventilator - Audible alarm may be ventilator has
INCUBATOR another incubator, the incubator
failure muted for 5 min by dropped below
FAILURE 109 pressing SPEAKER key 500 rpm. switched off and a serviceman called.
-Close the front/rear door

-If the alarm does not stop after closing
The incubator
the door the patient has to be
Open Yellow ALARM + front/rear door is
Without audible signal transferred to another incubator, the
incubator OPEN INCUBATOR open.
incubator switched off and a
serviceman called.
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AUDIBLE FAILURE
INDICATION CAUSE
Yellow ALARM + Failure of the -The incubator may be operated with
Scales failure Without audible alarm
SCALES FAILURE weighing system this alarm only weighing is impossible.
-The incubator may be operated with
this alarm only height adjustment and
Yellow ALARM + Failure of the weighing is impossible.
Bed lifting
BED LIFTING Without audible signal drive
failure
FAILURE mechanism.
CAUTION!
Do not handle the bed
Low voltage on -The incubator can be operated with
Low battery Yellow ALARM + the alarm battery
Without audible signal
after switching the
this alarm, only the alarm signal in
voltage BATTERY EMPTY
unit on. case of power failure is not possible.
Yellow ALARM +
The time for the
Service SERVICE
Without audible signal service inspection -Call the service.
inspection INSPECTION has passed.
REQUIRED
Alarms of the SpO2 module

The alarms of the SpO2 module are independent on the incubator functions and alarms.
The SpO2 monitor is equipped with acoustic and visible signalling of several levels of parameters in
compliance with the states of sensors and the unit. The alarms have different audible component
(tone and modulation) according to the state of the patient and the device.
Audible alarm characteristics comply with ISO/IEC 9703-2.
Operator can set alarm priority to 4 levels , in relation to the monitored parameters
(SpO2).

- warning alarm – the incubator display shows a symbol of a grey crossed loudspeaker

Acoustic-optical alarm with lower priority is activated (the acoustic signal is formed by 3
individual signals in one packet)
Acoustic-optical alarm with higher priority is activated (the acoustic signal is formed by 3+2
individual signals in one packet)
The emergency alarm signals differ acoustically as well as optically depending on danger priority.
Acoustic signal of the appropriate alarm may be muted for 5 minutes by pressing Key No. 11 .
Acoustic alarm mute is indicated by flickering symbol (yellow loudspeaker), (red loudspeaker)
in the appropriate windows SpO2.

SpO2 alarms displayed at the bottom part of the SpO2 window
VISUAL AUDIBLE
FAILURE FAILURE CAUSE REMEDY
INDICATION INDICATION
An incompatible - Replace sensor patient cable with
SpO2 sensor new - MASIMO system.
INCOMPATIBLE
cable was - If the problem is not solved after
CABLE connected to the connecting a compatible cable, call
incubator. service.
The life span of - Replace SpO2 patient cable with
-Acoustic signal the SpO2 sensor new one.
CABLE EXPIRED
-Audible alarm patient cable has - If the problem is not solved after
Alarm displayed in passed. connecting a new cable, call service.
may be muted
the SpO2 window - Replace the SpO2 patient cable.
for 2 min by
REPLACE CABLE - Check the connection of the
DEFECTIVE pressing Faulty SpO2
sensor and the patient cable of the
SPEAKER key sensor patient
CABLE cable.
sensor in the incubator connector.
- If the problem is not solved, turn off
SpO2 mode and call service.
The connected - Replace sensor patient cable with
UNRECOGNIZED patient cable has new - MASIMO system.
CABLE not been - If the problem is not solved after
recognized. connecting a new cable, call service.
INCOMPATIBLE - Replace SpO2 sensor with new -
An incompatible
SENSOR MASIMO system.
SpO2 sensor was
INCOMPATIBLE - If the problem is not solved after
connected to the
ADHESIVE connecting a new sensor, call
incubator.
SENSOR service.
DEFECTIVE - Check the sensor connection to
SENSOR the incubator connector.
Faulty SpO2 - Replace the sensor.
DEFECTIVE -Acoustic signal sensor.
ADHESIVE Alarm displayed in -Audible alarm - If the problem is not solved, turn off
SENSOR the SpO2 window may be muted SpO2 mode and call service.
SENSOR REPLACE for 2 min by
EXPIRED SENSOR pressing - Replace SpO2 sensor with new.
The life span of
- If the problem is not solved after
ADHESIVE SPEAKER key the SpO2 sensor
connecting a new sensor, call
SENSOR has passed.
service.
EXPIRED
UNRECOGNIZED - Replace SpO2 sensor with new -
The connected
SENSOR MASIMO system.
SpO2 sensor has
UNRECOGNIZED - If the problem is not solved after
not been
ADHESIVE connecting a new sensor, call
recognized.
SENSOR service.
-Acoustic signal - Check the correct location and
Alarm displayed in -Audible alarm attachment of the sensor to the
SENSOR OFF the SpO2 window may be muted The sensor has patient.
fallen from the - Check the connection of the
PATIENT SENSOR OFF for 2 min by patient. sensor connectors.
PATIENT pressing - If the problem is not solved, turn off
SPEAKER key SpO2 mode and call service.
Wrong type of
connected sensor - Check the sensor connection to
CHECK CABLE (with SpHb the incubator connector.
AND SENSOR measurement, no - Replace the sensor.
FAULT Acoustic signal SpHb) - If the problem is not solved, turn off
Alarm displayed in -Audible alarm SpO2 Sensor SpO2 mode and call service.
the SpO2 window may be muted Fault
CHECK CABLE for 2 min by - Check the connection of the
AND SENSOR pressing sensor and the patient cable of the
CHECK SENSOR SPEAKER key Fault sensor sensor in the incubator connector.
CONNECTION connection - Replace the sensor.
- If the problem is not solved, turn off
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VISUAL AUDIBLE
Alarm displayed in
the SpO2 window Faulty
PROGRAMMING programming of
PROGRAMMING ----- Only for service
ERROR SpO2 module
ERROR
Only 5s
Acoustic signal
Alarm displayed in -Audible alarm - Check the connection of the SpO2
No patient cable
NO CABLE the SpO2 window may be muted sensor patient cable to the incubator
plugged into the
connector.
CONNECTED NO CABLE for 2 min by incubator
CONNECTED pressing connector.
connecting the cable, call service.
SPEAKER key
NO ADHESIVE Acoustic signal
SENSOR Alarm displayed in -Audible alarm - Check the connection of the SpO2
SpO2 sensor
CONNECTED the SpO2 window may be muted sensor to the incubator connector.
disconnected from
NO SENSOR for 2 min by the connector.
NO SENSOR connecting the cable, call service.
CONNECTED pressing
CONNECTED
SPEAKER key
Acoustic signal Checking the
-Unless the alarm is automatically
Alarm displayed in -Audible alarm sensor
canceled within about 2 minutes
parameters after
SENSOR the SpO2 window may be muted after the sensor connection, connect
connecting to the
INITIALIZING SENSOR for 2 min by the new sensor.
incubator and
INITIALIZING pressing -Turn off SpO2 mode and call
placing the sensor
SPEAKER key service on next repetition.
on the patient.
Alarm displayed in - Check the correct placement and
Measurement location of the SpO2 sensor.
SPO2 ONLY the SpO2 window error of other
----- - Check the correct sensor type
MODE SPO2 ONLY SpO2 parameters. - If the problem is not solved, call
MODE service.
Alarm displayed in
the SpO2 window
PROGRAMMING SpO2 module
PROGRAMMING ----- Only for service
OK programming OK
OK
Only 5s
Alarm displayed in
CABLE EXPIRED the SpO2 window
(USED) REPLACE CABLE The life span of
- In next patient, replace the sensor
NEXT PATIENT the sensor patient
patient cable or SpO2 sensor with
SENSOR cable or SpO2
new ones.
EXPIRED Alarm displayed in sensor has
----- - If the problem is not solved after
(USED) expired.
the SpO2 window connecting the new sensor patient
ADHESIVE REPLACE cable or a new sensor, call the
If the sensor is
SENSOR SENSOR NEXT service
being used.
EXPIRED PATIENT
(USED)
- Check the correct sensor
connection on the patient.
Alarm displayed in The electronic - Check the condition of the limb to
system is not able be measured.
PULSE SEARCH the SpO2 window -----
to recognise - Unless the alarm is automatically
PULSE SEARCH pulse. canceled within about 2 minutes
after the sensor connection, connect
the new sensor.
Alarm displayed in
The end of SpO2
CABLE NEAR the SpO2 window
----- patient cable life Replace the patient cable
EXPIRATION CABLE NEAR
is approaching.
EXPIRATION
SENSOR NEAR
Alarm displayed in
EXPIRATION The end of SpO2
the SpO2 window
ADHESIVE SENSOR NEAR
----- sensor life is Replace the sensor
SENSOR NEAR approaching.
EXPIRATION
EXPIRATION

VISUAL AUDIBLE
- Check the correct location and
Alarm displayed in cover of the sensor on the patient.
An external
INTERFERRENCE the SpO2 window - Check the correct network
----- radiation strikes
DETECTED INTERFERRENCE the sensor.
frequency setting in the SpO2 menu.
DETECTED - If the problem is not solved, turn off
- Rule out occlusion of blood flow.
- Attempt to warm patient.
- Check the correct location and
Alarm displayed in Low relative attachment of the sensor on the
LOW PERFUSION strength of the patient.
the SpO2 window -----
INDEX pulse at the point - Perform a check on the patient's
LOW PI of measurement. vital functions
- If the problem is not solved, after
consulting the attending physician,
move the sensor to another location.
LOW SPO2
SIGNAL IQ
LOW PR Alarm displayed in
CONFIDENCE the SpO2 window
LOW PI LOW SIGNAL
-----
CONFIDENCE and flashing signs
LOW PVI SpO2, PULS, PI,
CONFIDENCE PVI, SpHb
LOW SpHb
CONFIDENCE
INVALID
FUNCTIONAL
-----
SPO2 Rule out occlusion of blood flow.
in the SpO2 window ----- Weak signal
INVALID PR Verify placement of sensor.
INVALID PI
INVALID PVI
SPO2 STARTUP
STATE
PR STARTUP
STATE
Flashing signs
PI STARTUP
SpO2, PULS, PI, -----
STATE
PVI, SpHb
PVI STARTUP
STATE
SpHb STARTUP
STATE
-Turn the incubator off and on with
Alarm displayed in the power switch
SYSTEM SpO2
the SpO2 window ----- Other reasons - Re-enable SpO2 measurement.
FAILURE FAILURE - If the problem is not solved, call
service
SpO2 alarms displayed at the top and middle part of the SpO2 window
VISUAL AUDIBLE FAILURE
FAILURE REMEDY
INDICATION INDICATION CAUSE
- Check the correct attachment of

O2 saturation has
-Acoustic signal sensor to patient.
Alarm displayed not reached or
O2 -Audible alarm -Check the condition of the limb to
in the SpO2 has dropped
SATURATION may be muted for be measured.
window below the set
LOW 2 min by pressing - If all the previous points are OK
LOW SpO2 limits.
SPEAKER key assess the patient status and check
the low limit setting SpO2.
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-Acoustic signal O2 saturation has
Alarm displayed -Check the correct setting of the
O2 -Audible alarm exceeded the set
in the SpO2 alarm upper limit SpO2.
SATURATION may be muted for limits.
window - Assess the patient status and set
HIGH 2 min by pressing
HIGH SpO2 the alarm upper limit higher SpO2.
SPEAKER key

-Acoustic signal The pulse value the SpO2 sensor to the patient.
Alarm displayed
-Audible alarm has not reached -Check the condition of the limb to
in the SpO2
LOW PULSE may be muted for or has dropped be measured.
window
2 min by pressing below the set - If the above items are OK, assess
LOW PULSE
SPEAKER key limits. the patient status and change the
PULSE lower limit setting

-Acoustic signal the SpO2 sensor to the patient.
Alarm displayed
-Audible alarm The pulse value -Check the condition of the limb to
in the SpO2
HIGH PULSE may be muted for has exceeded the be measured.
window
2 min by pressing set limits. - If the above items are OK, assess
HIGH PULSE
SPEAKER key the patient status and change the
PULSE upper limit setting
- The treating physician must
-Acoustic signal assess the condition of the patient.
Alarm displayed
-Audible alarm SpHb value has - Check that the upper limit of the
in the SpO2
HIGH SpHb may be muted for exceeded the set SpHb alarm is set correctly.
window
2 min by pressing limits. - Assess the patient status and
HIGH SpHb
SPEAKER key change the value of the upper limit
of the SpHb alarm.
- The treating physician must
-Acoustic signal SpHb value has assess the condition of the patient.
Alarm displayed
-Audible alarm not reached or - Check that the upper limit of the
in the SpO2
LOW SpHb may be muted for has dropped SpHb alarm is set correctly.
window
2 min by pressing below the set - Assess the patient status and
LOW SpHb
SPEAKER key limits. change the value of the lower limit
of the SpHb alarm.
Indication of the SpO2 monitor alarms on the

display.
If the alarm of the communication between the
control system and the integrated life function
module is active, the caution symbol and a
FAILURE sign are displayed in the SpO2 windows
of the basic screen.
Indication of internal memory saving failure.

If a crossed disc is displayed at the right hand
bottom of the screen, a failure of patient data
saving in the internal memory has occurred and
no patient data (patient cards, trends,
alarms…) are saved.
The memory saving failure has no influence on

safe operation of the incubator.
Switch the incubator off and on and if the failure
repeats, call the service.

12. Maintenance, Cleaning and Disinfection
Instructions
CAUTION!
1. The patient has to be taken out of the incubator when any maintenance is
performed.
2. The incubator has to be disconnected from the wall socket.
3. Observe the safety instructions mentioned in Chapter 6.
The following maintenance has to be performed to ensure correct operation of the incubator:
A. Cleaning and disinfection of the incubator external surfaces

B. Cleaning and disinfection of parts getting in touch with the patient
C. Maintenance of the mechanical parts
D. Maintenance of the electric equipment
If the incubator is not used for a longer time or is put out of operation (for more than a week) it has
to be cleaned and disinfected before each use.
Cleaning and disinfection have to be performed after each patient change or at least once a week!
CAUTION!
1. In the case of accidental contamination of the unit with biological material,
particularly with blood, it has to be disinfected with an agent with virucidous
effect immediately.
2. Because of oxygen atmosphere oils and greases must not be used.
WARNING:
1. When the incubator is put out of operation the water tank has to be drained
and cleaned.
2. The incubator has to be warmed at least to the ambient temperature when
disinfected.
3. Do not use disinfection agents containing alcohol, acetone or similar organic
solvents for decontamination and cleaning of the incubator, as they may
damage the materials used.
A/ Cleaning and disinfection of the incubator external surface (to be performed

by trained operators)
Clean the incubator external surface with common detergents. Virucid agents may be used for
disinfection.
Be careful not to damage the display plexiglass cover and the keyboard when cleaning the control
panel.
B/ Cleaning and disinfection of the parts getting in touch with the patient (to be
performed by trained operators)
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1. Remove the upper cover
Holding the side handles remove the upper
plexiglass cover.
In the incubator type with the double plexiglass

cover pull the inner pane up out of the side walls.
After replacement of the inner panes check the
correct position of the inner panes in the holders
so that they cannot get loose.
2. Open the front and the back doors

In the incubator type with the double plexiglass
cover unlock the latch, tilt the inner pane down
and remove the inner pane from the front/rear
door.
After replacement of the inner panes check the
latch whether it locks the inner pane and that
the pane cannot get loose.
Remove the silicon bushings from the front and the

back doors and from the side covers.
When returning the bushings back the sealing flag
has to be on the outside of the door!
3. Remove the silicon hose bushings

from the of the plexiglass cover frame.
After replacement of the hose bushings check
the correct positions of the bushing in the lugs
in the frame!
4. Remove the mattress

5. Remove the upper part of the bed
The upper part must be in the basic position (not

turned against the lower part).
6. Remove the lower part of the bed

Removal is only possible in the drawn-in position.
7. Removing the bed guiding board
8. Remove the guiding rails
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9. Remove the bath board
10. Remove the ventilator cover
11. Remove the ventilator propeller

1. Pull the ventilator propeller upwards.
Clean and disinfect the propeller.
Sterilize the propeller at 121 °C, for
10 – 15 min, at 210 – 220 kPa.
2. Clean and disinfect the ventilator propeller

chamber.
3. When assembling the propeller push the

propeller on the shaft as far as it goes.

CAUTION!
1. Do not use sprays when cleaning the bath as they might penetrate into the motor
bearings and cause increased noise.
2. Cleaning agents must not get into the holes for O2 and air suction as they might
restrict the flows and destroy the filters.
WARNING:
The heating element inside the incubator bath may be hot after operation. Clean
and disinfect the heater area at least after 30 minutes after switching the unit off.
Clean and disinfect all the dismantled parts and the whole bath space.
The rubber sealing bushings have to be disinfected with a virucid agent at least once a week.
Cleaning and disinfection of the air flow sensor

The optical sensor is located in the bath under the sensor holder.
1. Clean and disinfect the bath area near the

optical sensor.
2. Clean and disinfect the optical sensor.
3. Wipe any residues of cleaners or disinfectors
off the optical sensor.
CAUTION!
1. Do not press on the optical sensor when cleaning and disinfecting.
2. No residues of cleaners or disinfectors must remain on the optical sensor after
cleaning and disinfection.
Humidifier chamber cleaning and disinfection
WARNING:
1. The water in the humidifier chamber and the heater inside the lower part of
the incubator humidifier chamber may be hot after operation.
2 The humidifier chamber may be drained no earlier than after 30 seconds from
switching the incubator off.
3. Clean and disinfect the heater area at least after 30 minutes after switching
the incubator off.
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Withdraw the chamber as it goes to the filling
position.

Withdraw the chamber as it goes to the position
for removing the humidifier chamber.
3. Pull the humidifier tank upwards out of the

incubator.

humidifier chamber up and withdraw the
humidifier drawer.

5. Remove the upper cover of the humidifier
tank upwards.
6. Remove the sealing bushings from the

humidifier tank.
Procedure for cleaning and disinfecting the humidifier

1. Clean individual parts of the humidifier reservoir thoroughly mechanically (e.g. with a brush and
detergent)
CAUTION !
It is forbidden to use metal brushes and other metal tools to clean the humidifier
reservoir.
2. Any limescale deposits may be removed with limescale removal agent.
WARNING: Only citric acid-based decalcifying agents may be used.
CAUTION !
1. It is forbidden to use hydrochloric acid products that can damage the stainless
steel heating board (corrosion).
2. When using a specific product, read the package leaflet. Do not use agents
damaging stainless steel.
3. The whole humidifier has to be disinfected with a virucid agent or in ethylenoxide vapour at least
once a week.
CAUTION !
Do not use chlorine disinfectants to disinfect the humidifier reservoir. Chlorine can
damage the stainless steel heating board (corrosion).
4. After the cleaning let the humidifier and reservoir parts air so as the remnants of disinfection and
cleaning agents evaporate.
5. Sterilize the humidifier tank with the upper lid and the bushings at 121 °C, for 10 – 15 min at 210
– 220 kPa.
After cleaning and disinfection assemble the humidifier tank in reverse order.
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After the parts’ reassembly, check correct fitting
of the upper cover of the humectant tank.
The cover is fitted correctly if there is no gap
between the cover and the tank. Uncorrect fitting of the upper cover – gap !
Skin probe cleaning and disinfection

Clean and disinfect the skin probe. Be careful not
to damage the probe cable when handling the
probe.
WARNING:
1. It is forbidden to immerse the probe in the disinfectant solution. The probe
can only be wiped with a disinfectant solution.
2. Be careful, cleaning and disinfection agents must not get into the probe plug.
Cleaning and disinfection of the other probes

The air temperature and humidity probes are
located in a plastic holder in the corner of the
patient space. Clean and disinfect the covers of the
probes only.
WARNING:
Be careful, cleaning and disinfection agents must not get into the holes in the
probe plastic cover.

The O2 concentration measurement probes are
located in a plastic holder in the corner of the
patient space.
Clean and disinfect the covers of the probes only.
WARNING:
Be careful, cleaning and disinfection agents must not get into the holes in the
probes.
Cleaning and disinfection of the probes of the module

SpO2
Probes measuring O2 saturation (SpO2)

Clean and disinfect the O2 saturation probe. Be careful not
to damage the probe cable. Be careful, cleaning and
disinfection agents must not get into the connector of the
probe.
WARNING:
1. See the cleaning instructions in the directions for use for the Masimo re-
useable sensors.
2. Unless otherwise specified, do not sterilize sensors or patient cables by
irradiation, steam, autoclave or ethylene oxide.
3. It is forbidden to immerse the probe in the disinfectant solution. The probe
can only be wiped with a disinfectant solution.
4. Be careful, cleaning and disinfection agents must not get into the probe plug.
TABLE OF CLEANING, DISINFECTION AND STERILIZATION OF INDIVIDUAL COMPONENTS
MAINTENANCE CLEANING AND

PART NAME STERILIZATION NOTE
INTERVAL DISINFECTION
Strictly forbidden to use
alcohol based agents !
Weekly/After a
Plexiglass parts Yes --- Recommended agents:
patient switching
INCIDIN® OXYFOAM S
BEVISTOCRYL
Silicon bushings Steam sterilization at 121 °C,
Weekly/After a
and for cables and Yes Yes for 10 – 15 min,
patient switching
hoses at 210 – 220 kPa.
Porthole silicon Weekly/After a ---
Yes ---
gaskets patient switching
Weekly/After a ---
Mattress Yes ---
patient switching
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Weekly/After a ---
Bed parts Yes ---
patient switching
Weekly/After a ---
Bath cover board Yes ---
patient switching
Weekly/After a ---
Ventilator cover Yes ---
patient switching
Steam sterilization at 121 °C,
Weekly/After a
Ventilator propeller Yes Yes for 10 – 15 min,
patient switching
at 210 – 220 kPa.
Cleaning and disinfection
Weekly/After a agents must not leak into the
Ventilation case Yes ---
patient switching ventilator engine, O2 inlet and
the fresh air input holes
Do not use alcohol and
chlorine based agents
Weekly/After a
Humidifier parts Yes Yes Steam sterilization at 121 °C,
patient switching
for 10 – 15 min,
at 210 – 220 kPa.
Steam sterilization at 121 °C,
Humidifier rubber Weekly/After a
Yes Yes for 10 – 15 min,
bushings patient switching
at 210 – 220 kPa.
Weekly/After a
Body heat probe Yes --- agents must not leak into the
patient switching
probe connector
agents must not leak into the
probe connector case.
Heat and „RH“ Weekly/After a
Yes --- Service technician carries out
probe holder patient switching
the cleaning inside the
connector case during
standard service checks.
Weekly/After a
O2 probes holder Yes --- agents must not leak into O2
patient switching
probes.
SpO2 probe with Weekly/After a
Yes --- agents must not leak into the
patient cable patient switching
probe connector.
Incubator control Weekly/After a Do not use alcohol based
Yes ---
panel patient switching agents
The jig for 100% Cleaning and disinfection
Weekly/After a
calibration of O2 Yes --- agents must not block the O2
patient switching
sensors inlet hole.
Other parts of the Weekly/After a
Yes ---
incubator patient switching
RECOMMENDED DISINFECTION AGENTS
NAME USE FOR DO NOT USE FOR

INCIDIN® OXYFOAM S Plexiglass, plastics, mattress, other parts
BEVISTOCRYL Plexiglass, plastics, mattress, other parts
Terralin protect Plexiglass, plastics, mattress, other parts
Oxygenon Liquid Plexiglass, plastics, mattress, other parts
Silicone window seals
DESAM OX Plexiglass, plastics, mattress, other parts
and humidifier seals
Silicone window seals
DESAM EFFECT Plexiglass, plastics, mattress, other parts
and humidifier seals
MELISEPTOL® FOAM
Plastics, mattress, other parts Plexiglass
PURE

INCIDIN® FOAM Mattress, other parts Plexiglass and plastics
BACILLOL® 30 FOAM Plastics, mattress, other parts Plexiglass
DESPREJ® SENSITIVE Plastics, mattress, other parts Plexiglass
CAUTION!
1. Alcohol-containing products (ETHANOL, PROPANOL ...) should not be used to
disinfect the plexiglass parts of the incubator. This may cause cracking of these
parts.
2. It is permitted to use agents based on hydrogen peroxide and polyhexa
methyleneguanidine hydrochloride intended for plexiglass eg.
3. It is necessary to adhere to legal regulations of the country where the incubator
is being used and to use approved cleaning and disinfection agents.
4. When using disinfection and cleaning agents always adhere to application
regulations and recommendations defined by the manufacturer of the particular
agent.
5. Sterilization of components in a steam sterilizer is primarily intended for
cleaning and disinfection. The treated parts may not meet the requirements for
sterility (cannot be classified as a sterile).
6. Repeated steam sterilization causes degradation of used materials. Parts
intended for steam sterilization have a limited lifetime. The estimated service life
is 60 sterilization cycles (or 6 months).
Inspection of the patient circuit assembly after cleaning, disinfection and

sterilizing
1. Install the ventilator cover.
WARNING:
The prescribed temperature distribution in the patient space might not be
achieved or the heater might get overheated without the ventilator cover.
2. Install the bath board.
3. Insert the bed guiding rods.
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CAUTION!
Never install the bed without the guiding rods. The bed might fall off the
incubator when slid out without the guiding rods.
4. Install the bed on the guiding rods.
The orientation of the individual parts of the

bed when reassembling the incubator
All parts of the bed must be assembled so that the

positioning red marks of all individual parts fit
together
WARNING:
In case of the wrong assembling of all parts, the bed cannot be pulled out.
5. Slide the bed out of the incubator to the

extreme position.
6. Turn the bed to the extreme position.
7. Press on the edge of the bed at max. 20N

and check:
- attachment of the bed on the guiding rods
- attachment of the revolving board to the
basic part of the bed.
If the bed is attached correctly it

must not overturn and the patient
must not fall down.
CAUTION!
Never use the incubator without having checked the correct assembly of the
bed.
8. Install the side plexiglass walls.
When the side walls of the plexiglass

cover are fitted correctly, the cover
plate of the bath must be pressed.

CAUTION!
When reassembling the patient compartment side plexiglass, the cutouts in the
patient compartment side plexiglass must press the holders of the tub cover
plate.
Improper use may result in wrong air circulation in the patient area or
overheating of the incubator heater.
9. Install the upper plexiglass cover.
10. Check the correct installation of the side

walls and the upper cover visually.
If the assembly is correct no holes must

appear on the perimeter of the upper
cover.
WARNING:
The required temperature distribution in the patient space might not be reached
if the upper plexiglass cover is not installed properly.
C/ Maintenance of mechanical parts (to be performed by a trained operator)

Replacement of the input air filter
The air input filter has to be changed:

- once per three months in normal dustiness
- if it is obviously dirty
- if an infectious patient was treated in the
incubator
The filter is located in the right part of the

incubator bath. To replace the filter:
- unscrew the filter under the upper part of the

incubator
- mount the new filter
CAUTION! The incubator must not be used without the air filter.
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D/ Maintenance of the electric parts (to be performed by a trained hospital
technician)
Replacement of the main fuses
Unscrew the fuse cover (next to the power cord inlet) with a screwdriver. Remove the fuse cover
and replace the fuse with a new one of the same value.
Skin probe replacement

Use the same type and calibrated probe supplied by the manufacturer.
O2, RH probe replacement

The sensors may only be replaced by a technician of the manufacturer or by an authorized servicing
organization.
O2 saturation (SpO2) probe replacement

Use the same type of probe and patient cable.
Power cord inspection

Check the cord visually before switching the incubator on. Damaged cord may only be replaced by a
technician of the medical facility, see chapter 6. Safety precautions.
Inspection of the heating, measurement probes and other elements.

Perform the inspection within each cleaning. If you find a failure put the incubator out of operation
and contact the service.
13. Disposal and Recycling of Disposables

TSE spol. s r.o. puts stress on environmental friendliness of its products and the materials used for
manufacturing comply with this conception.
Pursuant to Act No. 7/2005 Col. the unit is classified as electrical waste. After its life the unit it
must not be disposed with municipal waste. It has to be taken to a contact place for disposal.
Contact places: TSE spol. s r.o.

Mánesova 390/74
371 52 České Budějovice
WARNING:
Used batteries disposed with household waste may harm the environment
seriously. They release harmful substances, particularly so called heavy metals
after some time, which may contaminate soil or ground and surface water and
have demonstrably harmful influence on human health.
Recycling metal substances contained in batteries may bring substantial
energetic and material savings of raw materials.
Our batteries, their packaging or electric devices containing batteries are
marked with a crossed-out dustbin symbol. The symbol means that the battery
does not belong to a dustbin or a household waste container.
Throwing batteries away into household waste or in the country is strictly
forbidden.

14. Completion
The incubator is supplied as a completely assembled unit (except for accessories and spare parts).
An inspection for completeness has to be performed at the site according to the handing over report,
while care has to be taken to the separately packed accessories.
The forwarder and the supplier has to be notified of possible defects or damages.
Unpacking and commissioning will be performed by a technician of the manufacturer or an authorized
servicing organization.
WARNING:
After unpacking it is necessary to let the device warm up to the ambient
temperature min. 1 hour.
SI-610-1 SHELLY is supplied in the following configuration:

1 x incubator
1 x oxygen inlet
1 x operation manual
1 x body temperature probe 21FF 846 314
1 x air filter PF10 597700131210
The version with SpO2 monitoring:

1 x M-LNCS Neo Sample Pack MASIMO 5NEOSAMPLEPACK
1 x extension cable for SpO2 Rainbow RC-4 probe 5RC04CBL2406
Optional accessories:
protection connection cable ABB – 0299-0-0032/3 50299000323
air filter PF10 597700131210
body temperature probe 21FF 846 314
oxygen sensor 5MLF16ITG
15. Storage and transport

The unit should be stored in the original packing in a dry indoor store. Storage and transport
temperature has to be within +5 and +40 °C and air humidity within 5 to 95% (non-condensing). In
case of export packaging the maximum allowed air humidity for storage is 95% (non-condensing).
The maximum storage time with regard to the backup batteries used is 6 months. After this period
the batteries have to be recharged. Plug the incubator to the wall outlet and switch it on for about
12 hours. Then the incubator may be stored for further 6 months.
Consumables shelf life (recommended by the manufacturers):

Oxygen probe – 6 months
bacteriological filters – according to the shelf life specified on the package
body temperature probe - 3 years
probes for SpO2 mode – according to the shelf life specified on the package
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16. Warranty and Service
The warranty is determined by the contractual conditions agreed upon when selling the equipment.
This warranty does not apply to consumables, for which the lifetime is determined according to the
product technical conditions:
Oxygen probe – 12 months

Bacteriological filters – 3 months
Body temperature probe - 12 months
Sensors and patient cables for SpO2 mode – according to the specified shelf life on the package
Parts intended for steam sterilization – 6 months (60 sterilizing cycles)
Consumables which will be replaced within technical safety inspections are paid for by the user of
the device.
Guarantee or after guarantee reports may only be performed by the manufacturer or a servicing
organization authorized by the manufacturer. The servicing organization must have the appropriate
certificate of servicing activities. Such a certificate is issued by the manufacturer.
Once in 12 months, the incubator parameters must be checked according to the

Technical Log Book.
Inspection may only be performed by the manufacturer or a servicing organization authorized by the
manufacturer.
SpO2 functionality is to be verified only by the manufacturer's authorized personnel or manufacturer-
approved service organization, meters and testers has to be approved by the manufacturer.
Any information on supplies and service may be obtained at the following addresses:
Medical Equipment Sales Department Service Department

TSE spol. s r.o. TSE spol. s r.o.
Mánesova 74 Mánesova 74
371 52 České Budějovice 371 52 České Budějovice
T: +420 386 721 149 +420 386 721 120
medical@tse.cz service@tse.cz
Manufacturer address
TSE spol. s r.o.
Mánesova 74
371 52 České Budějovice
Czech Republic
www.tse-medical.cz

17. EMC parameters of the incubator
The Incubator is Class A in terms of electromagnetic radiation and resistance.
WARNING !
1. Incubator is intended for use by healthcare professionals only.
2. Incubator may cause radio interference or interrupt operation of nearby
device. It may be necessary to re-orient or relocate close devices located
around the incubator or shielding the incubator site.
3. Do not use the incubator in close proximity to other devices. When used
in close proximity or placed on top of each other, the operator must
observe the behavior of the devices in order to verify normal operation in
the configuration in which they will be used.¨
4. Only the probes and cables supplied by the manufacturer or original spare
parts from the manufacturer may be connected to the incubator. Failure
to use original parts may result in increased EMC emissions or lower EMC
resistance of the incubator.
5. It is forbidden to use mobile phones within 2 meters of the incubator! In
a strong electromagnetic field, the function of the incubator electronics
may be interfered with.
List of approved probes and accessories for the incubator:
Title TSE number / manufacturer

Body temperature probe 51FF846314-00
Refer to Sensor table in chapter:
SpO2 sensor - MASIMO
9.8 O2 saturation SpO2, pulse monitoring, PI, PVI, SpHb
52500096AL / NEMA5-15P/IEC-60320-C13 or 58500098AL / CEE
7/7 / IEC-60320-C13 or 58530098AL / AS/NZS4417/IEC-60320-
Power cord 230V
C13 or 58550098AL / CEI23-16/IEC-60320-C13 or 59650098AL
/ BS1363UK10/IEC-60320-C13
Electromagnetic radiation
The incubator is intended for use in the electromagnetic environment specified

below. The customer or user of the incubator must ensure that it is used in such
environment.
Emission test Conformity Electromagnetic environment
The SI610-1 incubator uses RF energy only for its
High-frequency
internal function. Its high-frequency radiation is
radiation Group 1
very low and is unlikely to cause any interference
CISPR 11
with nearby electronic devices.
High-frequency
radiation Class A
CISPR 11
Harmonic radiation The SI610-1 incubator is suitable for use in
Class A
IEC 61000-3-2 medical facilities.
Voltage fluctuations /
flashing radiation Complies
IEC 61000-3-3
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Electromagnetic resistance
The incubator is intended for use in the electromagnetic environment specified

below. The customer or user of the incubator must ensure that it is used in such
environment.
Test level Compliant
Resistance test according to level Electromagnetic environment
IEC 60601
Floors in rooms should be:
- wooden
±8KV for contact ±8KV for contact - concrete
Electrostatic
±2KV, ±4KV, ±2KV, ±4KV, - from ceramic tiles
discharge (ESD)
±8KV, ±15KV for ±8KV, ±15KV for - covered with synthetic material
IEC 61000-4-2
air air (Non-antistatic linoleum) - relative
humidity in rooms must be at least
30%
Fast electric
±0,5KV, ±2KV for ±0,5KV, ±2KV for
transient
power lines power lines The quality of the power supply
phenomenon /
±0,5KV, ±1KV, ±0,5KV, ±1KV, network should be that typical of the
Group of
±2KV at the input ±2KV at the input hospital environment.
impulses
/ output line / output line
IEC 61000-4-4
±1KV between the
±1KV between the
Surge immunity lines The quality of the power supply
lines
test ±2KV between network should be that typical of the
±2KV between the
IEC 61000-4-5 the lines and hospital environment.
lines and ground
ground
0% Ut for 0.5 0% Ut at 10ms
cycle (shrot-term (shrot-term power
power outage) outage)
Short-term The quality of the power supply
0% Ut for 1 cycle 0% Ut at 20ms
voltage dips, network should be that typical of the
(shrot-term (shrot-term power
short hospital environment.
power outage) outage)
interruptions and If the incubator user requires
voltage 0% Ut for 250/300 0% Ut at 5s (shrot- continuous incubator operation during
variations cycles (shrot-term term power a power supply failure, it is necessary
immunity tests power outage) outage) to power the incubator from a
IEC 61000-4-11 continuous power supply (eg UPS)
75% Ut for 25/30 75% Ut at 500ms
cycles (shrot-term (shrot-term
decline of Ut) decline of Ut)
Magnetic field of
Magnetic fields of the network
the network
frequency should be at the levels of a
frequency (50- 30A/m 30A/m
characteristic location in the hospital
60Hz)
environment
IEC 61000-4-8
Ut is the AC mains voltage before applying the test level

18. Additional technical parameters
- power failure
- electronic system failure
- temperature, O2, RH sensors failure
- drop or rise of body/air temperature beyond the
preset limits
- temperature increase to the emergency value
- fan failure
The ALARM signalizes: - O2 concentration drop or rise beyond the preset
limits
- RH drop or rise beyond the preset limits
- humidifier failure
- scales failure
- failure of the electronic system SpO2
- SpO2 sensor failure
- SpO2 drop or rise beyond the preset limits
- SpHb drop or rise beyond the preset limits
Applied part types BF- body temperature probes T1,T2, SpO2 probe
Appliance type Class I
Electromagnetic radiation and resistance Class A
Bacteriological filter in air inlet, max. penetration 1x10-4 %
Max. CO2 concentration inside the patient space 0.3 %
Patient's weight on the bed max. 10kg
TEMPERATURE MODE
Two operation modes enabling temp. measurement and regulation according to air or body
temperature:
Incubator warm-up time by 11 ºC
30 minutes
(according to ČSN IEC601-2-19)
Temperature stabilization maximum time 90 min. (depending on the adjusted level)
Temperature measurement accuracy ± 0.1 °C ±1 digit
Temperature control accuracy ± 0.3 °C from the adjusted value
Air temperature mode

only upon special operator’s intervention after the
Air temperature adjustment over 37.0 °C
>37 °C key is pressed
Automatic adjustment of lower and upper alarm
±2 ºC from the required adjusted temperature
limits
Body temperature mode

only upon special operator’s intervention after the
Body temperature adjustment over 37.0 °C
>37 °C key is pressed
Automatic adjustment of lower and upper alarm
±1 ºC from the required adjusted temperature
limits
10/09/20 1F0 950 28.G 102/104

O2 MODE
Enables O2 concentration measurement and control:
only upon special operator’s intervention after the O2
O2 concentration adjustment over 40%
>40% key is pressed
Attainable O2 concentration inside the
75 % O2
incubator
Lower and upper auto adjustment
± 3% from the required set O2 concentration
alarm limits
O2 concentration measurement accuracy ± 3 % ±1 digit
O2 regulation accuracy ±1.5 % O2 from the adjusted value

Linearity error of O2 concentration
2%
measurement
O2 concentration measurement temp. range -5 °C – +50 °C
Measurement deviation at 0 °C – 50 °C max. 5 %
O2 measurement relative temperature 0 – 99 %
MODE RELATIVE HUMIDITY RH

Enables relative humidity measurement and regulation:
Lower and upper automatic setting of alarm
±25% from the required set relative humidity
limits
Attainable RH inside the incubator 95 %
RH measurement accuracy ± 5 % ±1 digit
RH regulation accuracy ± 5 % from the adjusted temperature
RH measurement temp. range 20 – 45 ºC
*see description in chapter 9.6.2 Setting the required RH value
WEIGHING MODE
Enables patient weighing:
Resolution 1g
±2 g ±1 digit (from 0 kg to 1 kg)
Scales accuracy ±5 g ±1 digit (from 1 kg to 3 kg)
±10 g ±1 digit (from 3 kg to 6 kg)
weight trends
Records
weight increments
BLOOD SATURATION WITH OXYGEN MODE SpO2 - The MASIMO system

Enables measurement of saturation of arterial blood with oxygen and pulse measurement
SpO2 measurement accuracy ± 3 % ±1 digit within 70 – 100 % SpO2
Upper 51 – 100 %
SpO2 alarm setting range
Lower 50 – 99 %
± 3 bpm ±1digit (No Motion)
PULSE measurement accuracy ± 5 bpm ±1digit (Motion)
± 3 bpm ±1digit (Low Perfusion)
Upper 20 – 240 bpm
PULSE alarm adjustment range
Lower 15 – 235 bpm
Pi measurement accuracy ±10 % of PI ( No Motion - RMS)
Upper 2 – 25 g/dl
SpHb alarm adjustment range
Lower 1 – 24 g/dl
SpHb measurement accuracy ±1 g/dL ( No Motion - RMS)

Footnotes
1. SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the
range of 60-100% SpO2, 0-40% SpCO, and 0-15% SpMet against a laboratory CO-Oximeter.
SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from
7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine (79) data samples were
collected over a range of 70-100% Sp02 and 0.5-2.5% MetHb with a resultant accuracy of
2.9% SpO2 and 0.9% SpMet.
2. The Masimo sensors have been validated for no motion accuracy in human blood studies on
healthy adult male and female volunteers with light to dark skin pigmentation in induced
hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG
monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
3. The Masimo sensors have been validated for motion accuracy in human blood studies on
healthy adult male and female volunteers with light to dark skin pigmentation in induced
hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG
monitor. This variation equals plus or minus one standard deviation which encompasses 68%
of the population.
4. The Masimo SET Technology has been validated for low perfusion accuracy in bench top
testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of
greater than 0.02% and transmission of greater than 5% for saturations ranging from 70 to I
00%. This variation equals plus or minus one standard deviation which encompasses 68% of
the population.
5. The Masimo sensors have been validated for pulse rate accuracy for the range of 25-240
bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or
minus one standard deviation which encompasses 68% of the population.
6. SpHb accuracy has been validated on healthy adult male and female volunteers and on
surgical patients with light to dark skin pigmentation in the range of 8-17 g/dl SpHb against
a laboratory CO-oximeter. This variation equals plus or minus one standard deviation which
encompasses 68% of the population. The SpHb accuracy has not been validated with motion
or low perfusion.
7. The following substances may interfere with pulse CO-Oximetry measurements:

- Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO2 and SpCO
measurements
- Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2
measurements.
- Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet
measurements
- Severe anemia may cause erroneous SpO2 readings.
- Dyes, or any substance containing dyes, that change usual blood pigmentation may
cause erroneous readings.
- Elevated levels of total bilirubin may lead to inaccurate SpO2, SpMet, SpCO and SpHb
readings.
10/09/20 1F0 950 28.G 104/104

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OPERATION MANUAL

NEONATAL STATIONARY INCUBATOR

10/09/20 1FO 950 28.G 2/104

2. INDICATION, COUNTER INDICATION 5

8. THE INCUBATOR CONTROL PANEL DESCRIPTION 32

9. SETTING THE INCUBATOR INTO OPERATION 37

9.1 BEFORE FIRST USE 37

9.2 BEFORE SWITCHING THE INCUBATOR ON 37

9.3 SWITCHING THE INCUBATOR ON 37

9.5 BODY TEMPERATURE MODE 39

9.6 RELATIVE HUMIDITY RH MODE 41

9.7 O2 CONCENTRATION MODE 43

9.8 O2 SATURATION SPO2, PULSE MONITORING 48

9.9 PATIENT WEIGHT MODE 57

9.10 MUTING THE INCUBATOR ACUSTIC ALARM 59

9.11 MINI TRENDS 59

9.12 KEYBOARD LOCKING 59

9.13 SWITCHING THE INCUBATOR OFF 60

10. THE INCUBATOR MENU MODE 61

10.1 PATIENT DATA 61

Operational manual SI-610-1 Version 14 3/104

10.5 CALIBRATION OF O2 SENSORS 70

10.6 INCUBATOR TEST 70

10.7 INCUBATOR USER SETTINGS – OPTIONS 70

10.8 CLOSING THE MENU 74

11. LIST OF THE ALARMS AND THEIR MEANING 75

12. MAINTENANCE, CLEANING AND DISINFECTION INSTRUCTIONS 84

13. DISPOSAL AND RECYCLING OF DISPOSABLES 97

15. STORAGE AND TRANSPORT 98

16. WARRANTY AND SERVICE 99

17. EMC PARAMETERS OF THE INCUBATOR 100

18. ADDITIONAL TECHNICAL PARAMETERS 102

10/09/20 1FO 950 28.G 4/104

Built-in scales enable measurement of patient’s current weight.

2. Indication, counter indication

Operational manual SI-610-1 Version 14 5/104

Power supply mains 110V - 230 V (±10%) / 50 - 60 Hz with

O2 supply pressure 400 - 500 kPa according to ČSN EN ISO 7396-1

Maximum input via the auxiliary sockets 100 W

Range of displayed temperature values 10.0 °C - 45.0 °C

10/09/20 1FO 950 28.G 6/104

O2 concentration adjustment (adjustment range) 22 – 75 %, in 1% increments

The range of O2 concentration on the display 10 – 100 %

O2 probe service life min. 1 year

MODE RELATIVE HUMIDITY RH

RH adjustment (adjustment range) 40 – 95 %, in 1% increments

RH display range in RH mode 10 – 99 %

Water tank 1.5 l of demineralized water

Scales range max. 6 kg

Range of displayed weight values 0 – 6 kg

SI-610-1 VERSION WITH SpO2 MONITORING

Pulse display range 25 – 240 bpm

PI display range 0 – 20%

PVI display range 0 – 100%

SpHb display range 0 – 25 g/dl

Number of recorded alarms per patient 100*

Number of recorded weights 100*

Trend recording period 14 days*

Operational manual SI-610-1 Version 14 7/104

SYMBOL DESCRIPTION SYMBOL LOCATION

Warning against possible danger, a note in On the device and a note in

Read this manual carefully before you

Please refer to the Instruction manual On the device

Type BF applied part that comes into