novos KI 1000 User manual

NVS.S9.KK01/Rev.06/06.04.2021
KI 1000
User Manual

NVS.S9.KK01/Rev.06/06.04.2021
WARNING
Registered Information:
This document contains information on which NOVOS assumes the property rights. The information may not be
reproduced in whole or in part unless authorized in writing by NOVOS. These information are the property of
NOVOS, for its intended use only.
Repair/Modifications:
Repairs on this device shall only be carried out by NOVOS or Factory Authorized Service Centers. Information on
repairs can be obtained from NOVOS or Authorized Resellers. NOVOS shall not assume any responsibility for any
injury to persons or damage to property arising directly or indirectly from unauthorized repair or modification of
this device. In addition, any unauthorized repair or modification shall void any warranty provided by NOVOS. This
document is provided for information purposes only. It cannot be changed or updated at will.

NVS.S9.KK01/Rev.06/06.04.2021
Table of Contents
About This Manual ..........................................................................................................................................................1
1. Safety Information.................................................................................................................................................5
1.1. User Obligations for Patient Safety ...................................................................................................................... 5
1.1.1. Patient Monitoring ..................................................................................................................................... 5
1.2. Limitation of Liabilities ......................................................................................................................................... 5
1.3. Usage Restrictions ................................................................................................................................................ 6
1.3.1. Operating........................................................................................................................................................ 6
1.3.2. Power Supply.............................................................................................................................................. 6
1.3.3. Servicing ..................................................................................................................................................... 6
1.3.4. Cleaning and Maintenance......................................................................................................................... 6
1.3.6. Warnings for the Use of the Device............................................................................................................ 7
1.3.7. Bearing Capacity ....................................................................................................................................... 11
1.3.9. Restrictions of the Environment in which the Device will be Used.......................................................... 11
ATTENTION............................................................................................................................................................. 11
1.3.10. Electrical Safety Restrictions .............................................................................................................. 11
1.3.11. Transportation Restrictions................................................................................................................ 12
1.4. Warranty ............................................................................................................................................................ 13
2. Product Description.............................................................................................................................................14
2.1. Usage Purpose.................................................................................................................................................... 14
2.2. Patient Population.............................................................................................................................................. 14
2.3. Life Cycle............................................................................................................................................................. 14
2.4. Main Functions................................................................................................................................................... 15
2.5. Product Parts and Controls................................................................................................................................. 16
2.5.1.Front View ..................................................................................................................................................... 16
2.5.2. Side and Rear View................................................................................................................................... 17
2.5.3. Control Panel Connections ....................................................................................................................... 18
3. General Overview................................................................................................................................................19
3.1. Control Panel...................................................................................................................................................... 19
Knob Button: .......................................................................................................................................................... 19
3.2. Sensors ............................................................................................................................................................... 20
3.2.1. Temperature Sensors ............................................................................................................................... 20
3.2.2. Oxygen/Humidity Sensor Module ............................................................................................................ 21
3.3. TTSS (Target Temperature Surveillance System)................................................................................................ 21
3.4. Canopy................................................................................................................................................................ 22
3.4.1.Front/Rear Access Covers.............................................................................................................................. 18
3.4.3.Double Wall ................................................................................................................................................... 19

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3.4.4.Grommets...................................................................................................................................................... 22
3.5. Baby Bed............................................................................................................................................................. 23
3.6. X-Ray Tray........................................................................................................................................................... 25
3.7. Smart Weighing System (Optional) .................................................................................................................... 25
3.8. Drawers and Cabinet .......................................................................................................................................... 26
3.9. Height Adjustment System (Optional)................................................................................................................ 26
3.10. IV Pole (Optional) ..................................................................................................................................... 27
3.11. Wheel Brakes............................................................................................................................................ 28
3.12. Humidification System.............................................................................................................................. 29
3.12.1. Filling the Water Reservoir ................................................................................................................. 29
3.13. O2System ................................................................................................................................................. 30
3.13.1. Oxygen Inlet Connection .................................................................................................................... 30
3.13.2. Changing Oxygen Cells........................................................................................................................ 31
4. Preparation..........................................................................................................................................................32
4.1. Unpacking and First Installation ......................................................................................................................... 32
5. Use of Device.......................................................................................................................................................38
5.1. Operating KI 1000............................................................................................................................................... 38
5.2. Main Display....................................................................................................................................................... 39
5.2.1. Control Boxes............................................................................................................................................ 40
5.3. Use in Air Mode.................................................................................................................................................. 41
5.3.1. Setting the Air Temperature Target Value ............................................................................................... 41
5.3.2. Setting TTSS Target Skin Temperature ..................................................................................................... 42
5.3.3. Setting Extended Air Temperature Target Point ...................................................................................... 43
5.3.4. Reducing Air Temperature Inside the Canopy.......................................................................................... 43
5.3.5. Air Mode Alarms....................................................................................................................................... 44
5.4. Use in Skin Mode................................................................................................................................................ 44
5.4.1. Attaching/Detaching the Skin Probe ........................................................................................................ 44
5.4.2. Checking the Function of the Temperature Sensors ................................................................................ 45
5.4.3. Setting the Skin Temperature Target Value ............................................................................................. 47
5.4.4. Setting TTSS Target Air Temperature ....................................................................................................... 48
5.4.5. Setting Extended Skin Temperature Target Point .................................................................................... 48
5.4.6. Skin Mode Alarms..................................................................................................................................... 49
5.5. Use of Servo Humidity........................................................................................................................................ 51
5.5.1. Setting Humidity Target Point .................................................................................................................. 51
5.5.2. Humidity Mode Alarms............................................................................................................................. 52
5.6. Use of Servo O2................................................................................................................................................... 53
5.6.1. Setting O2Concentration in Manual Flow Controlled O2System............................................................. 53
5.6.2. Setting the Oxygen Target Point on the Servo Controlled Oxygen System.............................................. 53

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5.6.3. Setting the Expanded Oxygen Concentration Target Point ...................................................................... 54
5.6.4. Calibration of Oxygen Sensors.................................................................................................................. 55
5.6.5. Oxygen Mode Alarms ............................................................................................................................... 57
5.7. Use of Smart Weighing Option........................................................................................................................... 58
5.7.1. Starting the Weighing Procedure ............................................................................................................. 58
5.8. Alarms and Warnings ......................................................................................................................................... 60
5.9. Trend Indication ................................................................................................................................................. 61
5.9.1. Setting the Graphic Type and Duration (Zoom)........................................................................................ 62
5.10. Patient History Records ............................................................................................................................ 63
5.10.1. Viewing Patient History ...................................................................................................................... 63
5.11. Standby Mode .......................................................................................................................................... 65
5.12. Selecting Accessible Modes...................................................................................................................... 66
5.13. Settings..................................................................................................................................................... 67
5.13.1. Configuring Date/Time Settings ......................................................................................................... 68
5.13.2. Configuring System Settings............................................................................................................... 69
5.13.3. Configuring Alarm Settings................................................................................................................. 69
5.13.4. Service Settings................................................................................................................................... 70
5.14. Screen Lock............................................................................................................................................... 70
5.15. Height Adjustment.................................................................................................................................... 71
5.16. Shutting Down KI 1000 ............................................................................................................................. 72
6. Routine Cleaning and Maintenance ....................................................................................................................73
6.1. Cleaning and Disinfection................................................................................................................................... 73
6.1.1. Measures ...................................................................................................................................................... 73
6.1.2. Removal of Incubator Components for Cleaning Purposes...................................................................... 74
6.1.3. Cleaning and Disinfection Procedure ....................................................................................................... 76
6.1.4. Changing Air Filter .................................................................................................................................... 77
6.1.5. Cleaning Skin Probe .................................................................................................................................. 80
6.2. Maintenance List ................................................................................................................................................ 81
6.3. Disposal of the Incubator ................................................................................................................................... 81
6.3.1. Disposal of the Air Filter ........................................................................................................................... 81
6.3.2. Disposal of the O2Sensors........................................................................................................................ 81
6.3.3. Disposal of the Incubator ......................................................................................................................... 81
7. Troubleshooting ..................................................................................................................................................82
7.1. Error Messages................................................................................................................................................... 82
8. Annexes...............................................................................................................................................................83
8.1. Technical Specifications...................................................................................................................................... 83
8.1.1. Device Classification ................................................................................................................................. 83
8.1.2. Environmental Requirements....................................................................................................................... 83
8.1.3. Electrical Properties.................................................................................................................................. 83

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8.1.4. Mechanical Properties.............................................................................................................................. 83
8.1.5. Sensor Features ........................................................................................................................................ 84
8.1.6. Servo Humidity Features .......................................................................................................................... 85
8.1.7. Alarm Features ......................................................................................................................................... 85
8.1.8. Other Properties....................................................................................................................................... 85
8.2. Compatibility ...................................................................................................................................................... 87
8.2.1. Compliance Directive:............................................................................................................................... 88
8.2.2. Guidance and Manufacturer's declaration - Electromagnetic Emissions................................................. 89
8.3. Trademark Registrations .................................................................................................................................... 93
8.4. Manufacturer ..................................................................................................................................................... 93

NVS.S9.KK01/Rev.06/06.04.2021 1
About This Manual
Scope:
This manual contains a detailed description of all sub-components, use and care details of the KI 1000 infant
incubator.
Target Users:
This device should only be used by medical personnel trained in the operation of the device who are aware of
all the risks and benefits of the operation of such devices.
The intended users of this guide are end users of the device, healthcare providers in delivery rooms and
neonatal intensive care units, and hospitals’ biomedical and clinical engineering services.
The product is intended for professional use.
Aim:
This guide is a guide to:
•
Installation
•
Usage
•
Maintenance
of the KI 1000 infant incubator. All features and technical information of the device are listed considering the
user benefit in order to facilitate the efficient use of the device.
Symbols:
This symbol means "Attention, see relevant documentation" and may
appear on any hardware component of the device.
This symbol means the device is in the BF class.
IP20
Protected against solid objects larger than 12.5 mm.
This symbol is used to warn the users of the device against possible risk
or injury. Warnings are instructions that, if not followed, could result in
fatal or serious injury to a user, engineer, patient, or other person, or
could result in improper treatment.
ATTENTION
These are the guidances that may damage the system as described in
this manual, if the attention notes are not followed.
NOTE
NOTE is used where additional information on the subject is given.
ID
Product ID
Manufacturer

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Input voltage
Date of Manufacture
Electrical and electronic equipment waste should not be disposed of in
general municipal waste, but should be collected separately
SN
Serial number
Power
Fuse Box
CE mark Authorized body
See User Manual
Protective Grounding
Alternative Current
This sign on the label indicates that the package should stand upright.
This sign on the label indicates that the contents of the package are
fragile and should be handled with care.
This sign on the label indicates that the package must be protected from
moisture and rain.
Storage temperature and moisture
Operation temperature and moisture

NVS.S9.KK01/Rev.06/06.04.2021 3
Label Information:
Product Identity
Technical Service
Warning
Outer Box Label

NVS.S9.KK01/Rev.06/06.04.2021 4
Reusable Skin
Probe Label
Disposable Skin
Probe Label

NOVOS KI 1000 User Manual
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1.Safety Information
1.1. User Obligations for Patient Safety
ATTENTION
Strictly follow this guide. Any use of the product requires thorough understanding and strict
observation of all sections of these instructions. This equipment should only be used for the purpose
specified in article "Intended Use". Follow all WARNING and ATTENTION notes stated in this manual
and on the label on the device.
The design of this equipment takes into account the relevant literature and labeling on the equipment, the purchase
and use of this equipment is restricted to trained professionals and the specific features of the device are known to
the trained operator. Therefore, instructions, warnings and cautions are mainly limited to the features of the
NOVOS design. This document does not contain references to various hazards open to the consequences of misuse
of the product by a medical professional and the operator of this device, and to potential side effects that may
occur in patients with abnormal conditions. Modification or misuse of the product can be dangerous. NOVOS Tıbbi
Cihazlar disclaims any responsibility for the results of product changes or modifications, and the results that may
result from the combination of this product with other products from NOVOS or other manufacturers, unless such
combination is approved by NOVOS.
The use of this device requires continuous observation of the baby by trained medical personnel in order to
provide immediate corrective action in situations involving risk of injury to the patient.
1.1.1.Patient Monitoring
Operators of this incubator system should recognize their responsibilities in selecting appropriate safety
monitoring that provides adequate information on equipment performance and patient condition. Patient safety
can be achieved through a wide range of different tools, from electronic monitoring of equipment performance
and patient status to simple and direct observation of clinical findings. The responsibility for selecting the best
patient monitoring level rests solely with the operator of the equipment.
1.2. Limitation of Liabilities
NOVOS has liabilities in the production, sale (activities), installation, promotion, use, application and product
production guarantee of goods etc. These liabilities are subject to and are limited to the specific terms described
in this manual. Circumstances that void the warranty, negligence that may occur independently of NOVOS,
product violation, etc. limit the liability of NOVOS regardless of whether it was the fault of NOVOS and regardless
of the manner in which the fault occurred. NOVOS shall not assume any liability for compensation for damages
arising from or related to the products and for the buyer's liabilities to third parties; the buyer shall not have any
right to claim compensation for these damages.

NOVOS KI 1000 User Manual
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1.3. Usage Restrictions
Before using this device, it is important to know, understand and correctly apply the safety measures to be applied.
The precautions mentioned below are intended to prevent a possible risk of injury to the patient or the device
operator who will be treated with the radiant heater, and to guarantee efficient use of the device.
NOVOS does not approve the use of non-original spare parts and accessories with KI1000 Incubator
systems. The use of non-original spare parts and accessories can adversely affect device safety and
performance, and can also seriously harm patient health.
Use only spare parts and accessories recommended by NOVOS.
1.3.1. Operating
•
Read the entire user manual thoroughly before using the device.
•
As with all other medical devices, interventions without understanding how to operate this product can cause
injury to the patient or the user.
•
This device should only be used by healthcare professionals trained in the operation of such devices.
•
Before starting to operate the device, confirm that the device can be operated properly by following the steps in
the “Pre-Start Check” checklist.
NOTE: If any step of the Pre-Start Checklist fails, the device must be taken out of service and the authorized
Novos dealer must be contacted for repair.
1.3.2.Power Supply
•
In case the electricity supplied to the device is cut, the device will give a "Power Failure" alarm.
NOTE: During the power failure, the "Power Failure" alarm is activated with a continuous beep sound. .
This alarm cannot be silenced until power supply is restored.
•
Before any service, maintenance and cleaning procedures, make sure that the power plug is disconnected the
from the socket. Supply power to the device only where you need to operate the device within the scope of
service and maintenance procedures.
1.3.3.Servicing
•
Servicing should only be carried out by persons who have been authorized by Novos to repair this device, in
accordance with the procedures specified in the service manual.
•
Information on extensive repair operations has been included in the service manual for service officers
trained by Novos to provide accurate information to users and to demonstrate the equipment and the test
equipment.
1.3.4.Cleaning and Maintenance
•
The device should not be used in environments with anesthetic substances. Otherwise there is a danger of
explosion.
•
All necessary additional measures are mentioned in the cleaning and maintenance unit of this
document.
1.3.5.Warnings Regarding Indications, Contraindications, Possible Physiological Effects
Indications:
•
Baby's inability to maintain its own warmth despite being dressed and cuddled
•
The baby’s being severely ill and requires close supervision
•
Risk of excessive heat loss in the baby
•
The baby’s having a known infection or developing sepsis
•
Inability to complete the pregnancy period

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Counter Indications:
•
There are no known contraindications.
Side effects:
•
The noise of the incubator disturbs the baby
•
Irregular oxygen supply
Adverse effects:
•
The general routine of separating the mother from the baby, where it is more difficult to keep the baby's body
temperature constant, has an adverse effect on the mother's bond with the baby and the mother's
breastfeeding.
Always consider the physiological risks and fire hazards associated with the use of high O2
concentrations.
.
Considering the physiological effects from OO2, it is mandatory to use the integrated O2
measurement and control system or an independent OO2analyzer and to continuously monitor the
O2concentration for O2management.
Cross infections should be considered when treating twin babies.
1.3.6.Warnings for the Use of the Device
Risk of Injury
Never leave the baby unattended when the canopy, double wall, access hatches or oval windows are open, the bed
is pulled out, or the grommets are removed. There is a risk of injury for the patient. Baby can fall from the
incubator.
Reflective Tapes
In order for the skin temperature to be measured accurately, the skin probe should be fixed to the skin with reflective
fixing tapes.

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Incubator and skin temperature
•
Allow sufficient time for the incubator to reach target temperature before use.
•
Additional external heat sources such as direct sunlight, spotlights, and electric pads or blankets
should be avoided. These can cause the air temperature inside the incubator to rise
uncontrollably.
•
Since the KI 1000 controls the skin temperature of only one baby, the skin temperature control
mode should not be used in twins. Otherwise, there is a risk of hypothermia or overheating for the
baby to which the secondary skin probe is attached. For the care of twins, always the air
temperature control mode should be used.
•
It is the responsibility of the physician to infer from the measured skin temperature.
•
The skin temperature control mode should not be used for babies in shock, as their skin temperatures
are much lower than normal. In this case, controlling skin temperature increases the incubator’s air
temperature too much, which poses a risk of overheating to the baby. In such cases, it is
recommended to use KI 1000 in air temperature control mode.
•
Do not use the skin temperature control mode in babies with fever, as the skin temperature is
higher than normal. In this case, skin temperature control may lower the incubator air
temperature more than necessary, causing a risk of hypothermia.
•
The place of the skin sensor probe on the baby's body should not be confused! The yellow skin
temperature sensor (T1) is used for skin temperature control. Improper positioning of this sensor can
cause the baby to overheat.
•
No blankets or covers should be placed in the warm air duct. Otherwise, the temperature control
system may be damaged and if the air from the warm air duct is directed directly to the baby, there
may be a risk of overheating or burning.
•
When treating older babies, their higher calorie output may cause the air temperature to rise in
KI 1000. In this case, the double wall should be removed.
•
For proper temperature control of the incubator, the room temperature should be at least 3 °C
lower than the incubator's target temperature.

NOVOS KI 1000 User Manual
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•
Medicated aerosol and similar substances should not create fog in the baby capsule. The fumes of
these substances may adversely affect the incubator's operability.
Fixing the Device
Always lock the wheels of the device before placing a baby.
Usage with Phototherapy Device
•
Never cover the phototherapy lamp or incubator canopy with fabric, aluminum foil or other
materials to increase the phototherapy effect. The potential build-up of heat will likely result in the
danger of overheating the baby because the incubator cannot be sufficiently cooled with ambient
air under these conditions.
•
Always wear eye protection for the baby when using phototherapy.
•
During phototherapy, fluid supplementation should be increased to the baby to compensate for
increased dehydration, e.g. parenteral infusion.
•
Baby temperature should be monitored with special care during phototherapy. Absorption of light
through the baby's skin will provide the patient with heat that can increase their core
temperature. For this reason
-
Decrease the incubator air temperature setting by about 2 °C at least 15 minutes before starting
phototherapy.
-
Decrease the humidity value.
-
Room temperature should be at least 3 °C lower than KI 1000 air temperature.
-
When using phototherapy devices that do not have a built-in fan, the air temperature of the
incubator may rise more significantly.
Accompanied Devices
•
All devices to be used with KI 1000 must comply with the IEC 60601 standard.
•
Do not use any unapproved accessories with the KI 1000.
•
Any device or combination of devices that do not comply with the conditions specified in this
manual may adversely affect the functionality of the KI 1000. See the relevant document and the
use of attached devices before using the medical device.
•
Make sure all hoses and cables are routed correctly and securely without obstructions! Otherwise,
be careful against extubation and disconnection hazards.
•
All devices and accessories to be used with KI 1000 are under the responsibility of the operator.
Patient Monitoring.
•
Do not leave the patient unattended while using the device.
•
In addition to the skin temperature measured by the device from the abdominal area, take
temperature measurements at least every two hours using an independent thermometer from
remote points such as the armpits or ears.
•
Follow standard procedures to monitor the patient's body temperature and fluid balance.
•
Never cover the sensor module gaps or never hang anything from the slots in the sensor
module. Remove any dirt from the slots of the sensor.
Fire and other hazards caused by oxygen
•
Do not approach with fire or cigarette! Fabrics, plastics and oils can easily ignite in an oxygen-
rich atmosphere and burn with great intensity.
•
Slowly open the valves on the O2cylinders.
•
Do not operate the KI 1000 in an environment where flammable anesthetic agents or disinfectants
are present. Otherwise there is a risk of explosion.
•
Do not use or store flammable liquids such as alcohol, ether or acetone inside the KI 1000 incubator.
•
Do not use electrical components inside the canopy that are clearly not designed for use in
potentially explosive environments.
•
Use only the original KI 1000 air filter and oxygen sensor.

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Warnings regarding parts of the device
•
Access covers: Make sure the patient is not lying in the closing path when closing the access covers.
When opening and closing covers, make sure hoses and cables are not caught in the moving double
wall.
Canopy: The canopy should not be used as a shelf for clothes, tools, etc. Before moving the canopy,
make sure that nothing is placed on it, such as a phototherapy device. Hold the incubator canopy
securely while tilting it. The canopy hinge lock should be locking itself. When it is locked, do not try to
tilt the canopy further back. Do not tilt the canopy forward. When closed, make sure the canopy is
securely in place
•
Side Oval Windows: When opening and closing side oval windows, make sure hoses and cables are
securely routed and do not come into contact with any obstructions.

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1.3.7.Bearing Capacity
The maximum load bearing capacity of the baby bed is 10 kg. Total body weight should not exceed 10 kg
for twin babies to be treated.
Maximum load bearing capacity of pulled out baby bed is 5kg. Do not lean on or apply weight on the bed
when the bed is pulled out.
1.3.8.EMC Restrictions
ATTENTION
•
This device must be operated in accordance with the EMC information provided in this manual.
•
Cell phones should not be used within 20 m2 of the incubator. Cell phones may impair the functions of
the electromedical device and thus patient safety may be compromised
•
When using this device alongside other devices, it is important to verify normal operation in the
configuration in which it is used.
1.3.9.Restrictions of the Environment in which the Device will be Used
ATTENTION
The device should be used in ideal environmental conditions between 20 °C and 30 °C. Unsuitable, low or high
ambient temperature may affect optimum operation of the device and disrupt the patient's thermal balance. It
should not be used in front of windows that receive direct sunlight etc.
1.3.10.Electrical Safety Restrictions
The power cord plug must be connected to the power input on the wall or pendant in accordance with the
rules of low voltage directive.
This device is to be used only in rooms with line power installations that comply with national safety
standards for hospital patient rooms (e.g. IEC / EN 60601-1 "Safety of Medical Devices" 200-240VAC and 50
Hz). To maintain ground integrity, connect only to a "hospital grade" plug socket.
The power cord plug must be fixed to the power input in the wall or bank, as required by rules of low voltage
directive. An extension cord or multiple sockets should never be used.
If there is no suitable grounding system, the device should not be used.
Some electrical equipment to be connected to the triple socket outlet on the KI 1000 may negatively affect
the medical device, which will cause a decrease in safety.
The total power of the equipment to be connected to the triple socket outlet on the KI 1000 must comply with
the electrical requirements specified on the socket label.

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The total electrical current leakage of all items supplied from the auxiliary electrical outlet should be
less than 500 µA for 230V AC systems. Noncompliance could result in death or serious injury.
Any device to be connected to the KI 1000 must comply with the following standards.
•IEC 60601-1 (EN 60601-1) Medical Electrical Equipment Part 1: General Safety Requirements
•IEC 60601-1 (EN 60601-1) Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety
and Basic Performance Guarantee Standard: Electromagnetic Compatibility; Requirements and Tests
Use only auxiliary electro-medical device that complies with national safety standards for hospital
patient rooms (e.g. IEC / EN 60601-1, “Safety of Medical Equipment”, UL 544). Always observe the
total leakage current and current consumption limits when using the integrated power strip to
connect auxiliary devices! Auxiliary power socket for any type of device can lead to reduced safety
in the system.
The energy provided by the auxiliary power socket is not monitored! Do not connect life support
devices that do not have their own power failure alarm to the auxiliary power outlet.
1.3.11.Transportation Restrictions
Be careful when moving the device on its wheels on uneven surfaces, pavement descents/exits,
while entering/exiting the elevator, as the wheels may be damaged or dislodged.
Make sure that the wheels of the device are not locked during transportation.
Transportation operations while the device is in the box should be carried out by at least two
people.

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1.4. Warranty
All NOVOS products are warranted against manufacturing, workmanship and assembly defects for 12
months from the date of invoice. The conditions for this warranty are listed below;
1. Tax and import expenses of the shipped product are not covered by the warranty.
2. Repair, modification and changes made within the warranty period cannot be used to extend the
specified warranty period.
3. The defect must have been caused by workmanship or material.
4. Only for problems caused by workmanship or materials, the parts replacement, reimbursement or
repair of the product by NOVOS Tıbbi Cihazlar are possible. NOVOS Tıbbi Cihazlar reserves the right to
apply one of the methods specified above, that is deemed appropriate based on the warranty claim.
5. NOVOS Tıbbi Cihazlar cannot be held responsible for the following conditions;
a. Deterioration, wear or abuse of any component of the product
b. Alteration, misuse, damage in transit, or modifications not approved by NOVOS Tıbbi Cihazlar
or an authorized representative thereof.
c. Malfunctions arising from force majeure circumstances and other circumstances for which the
manufacturer is not responsible.
d. Malfunctions caused by voltage fluctuation.
e. Malfunctions caused by inadequate or, if necessary, never provided customer service and
maintenance.
f. Normal wear and tear of working parts.
6. As for the warranty claim for the recovery of damage during transportation;
a. The package/case should always be checked for any signs of damage.
b. If any traces of damage are found, necessary records should be kept for proof of the damage.
c. The carrier should be warned and the damaged product warranty claim form should be filled.
7. In any case, NOVOS Tıbbi Cihazlar is not liable for more than the original selling price.
8. The buyer guarantees that all services and maintenance are carried out in a timely manner by
qualified personnel according to NOVOS service guidelines.
If these liabilities are not fulfilled, all warranty liabilities will expire.
Warranty applications depend on the following:
1. If any malfunction occurs in the device or its parts, NOVOS or its authorized representative must be
notified in writing immediately.
2. Defective devices and parts must be returned to NOVOS or an authorized factory center in accordance
with the instructions of NOVOS service personnel.
3. As a result of evaluations, NOVOS or the authorized factory center must confirm that the warranty
conditions cover this defect.
4. Written notice of the failure of the device or part must be received by NOVOS or authorized factory center
2 weeks before the end of the warranty period.
The above provisions belong to the sole warranty which is applicable and provided by NOVOS. It cannot be
intended to describe or explain the warranty status in any other way.
Dealers and representatives of NOVOS are not authorized to change these warranty conditions.
NOVOS Tıbbi Cihazlar.

NOVOS KI 1000 User Manual
NVS.S9.KK01/Rev.06/06.04.2021 14
2. Product Description
2.1. Usage Purpose
The KI 1000 is an infant incubator system that provides a controlled temperature, humidity and environment with
a high concentration of O2, manufactured for infants up to 5 kg (11 lbs) body weight or 55 cm (22 inches) body
length. The KI 1000 is designed for use in clinical settings where premature babies or sick babies who need to be in
a temperature controlled environment are treated. It is used for the following purposes:
*In cases where a properly isolated air and temperature environment is required for the newborn,
*Transparent canopy when the newborn needs good supervision
*In cases where a suitable heated environment and proper air circulation is needed for the newborn
* When oxygen is needed in different concentrations
*When micro-controlled humidification is needed
*When other optional features are needed, when non-invasive O2ratio or other monitoring
systems are needed
*In cases where the weight of the newborn should be followed up and monitored continuously
2.2. Patient Population
•
Premature babies (less than 35 weeks)
•
Babies born smaller than they normally should
•
Babies with respiratory distress
•
Babies with a heart rhythm disorder
•
Babies who have not developed sucking reflex
•
Babies with various genetic conditions
•
Babies born by cesarean section may not be able to discharge the fluid in the lungs comfortably unlike normal
birth.
This can cause breathing difficulties.
•
Those who cannot keep the body temperature at a certain level.
2.3. Life Cycle
Factors affecting the life cycle are listed below;
•
Capacitance values may change due to the fact that the insulating liquids contained in the capacitors used in
electronic cards decrease with heat and humidity factors after a certain period of time.
•
The silicon structure of semiconductor materials (integrated, diode, etc.) on electronic cards may deteriorate over
time and cause the semiconductor material to become partially or completely dysfunctional.
•
Connectors of sensor-like parts on the device may oxidize over time or plastic parts may deform.
•
Deformation or deterioration may occur in the body and silicon seals of the device over time as a result of cleaning
these parts with disinfectant.
.
•
The rechargeable battery on the motherboard should be changed due to its charge/discharge status over time.
•
The touch screen on the device can lose its sensitivity over time.
Conclusion:
The above mentioned failures or breakdowns partially limit the life of the device. However, with the intervention of
the authorized technical service, the device can be used functionally for an average of 10 years without being
scrapped.
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