novos KR-1000 User manual
1
KR-1000
Baby Radiant Warmer
User Manual
Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
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. This information is
the property of NOVOS, for its intended use only.
NOVOS Tıbbi Cihazlar reserves the right to make changes to the features specified in this document or
to discontinue the related product without making any commitment.
For the most up-to-date information, contact your NOVOS representative.
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.
Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
Table of Contents
About This Manual.................................................................................................................................................. 7
1. Safety Information ........................................................................................................................................ 12
1.1. User Obligations for Patient Safety............................................................................................................ 12
1.1.1. Patient Monitoring.............................................................................................................................. 12
1.2. Limitation of Liabilities ............................................................................................................................... 12
1.3. Usage Restrictions...................................................................................................................................... 12
1.3.1. Operating ............................................................................................................................................ 13
1.3.2. Power Supply....................................................................................................................................... 13
1.3.3. Servicing .............................................................................................................................................. 13
1.3.4. Cleaning and Maintenance.................................................................................................................. 13
1.3.5. Warnings on Indications, Contraindications, Side Effects, Adverse Effects and Possible Physiological
Effects............................................................................................................................................................ 13
1.3.6. Warnings for the Use of the Device .................................................................................................... 14
1.3.7. Bearing Capacity.................................................................................................................................. 15
1.3.8. EMC Restrictions ................................................................................................................................. 16
1.3.9. Restrictions of the Environment in which the Device will be Used..................................................... 16
1.3.10. Electrical Safety Restrictions ............................................................................................................. 16
1.3.11. Transportation Restrictions............................................................................................................... 17
1.4. Warranty .................................................................................................................................................... 18
2. Product Description ...................................................................................................................................... 19
2.1. Usage Purpose............................................................................................................................................ 19
2.2. Patient Population...................................................................................................................................... 19
2.3. Life Cycle .................................................................................................................................................... 19
2.4. Main Functions........................................................................................................................................... 19
2.5. Controls and Gauges .................................................................................................................................. 21
2.5.1. Overview to Control Panel .................................................................................................................. 22
2.5.2. Balance Control Unit ........................................................................................................................... 25
2.5.3. Easypuff Resuscitation Device (Optional) ........................................................................................... 29
2.5.4. Bililed Mini+ Phototherapy (Optional) ................................................................................................ 29
2.5.5. Trendelenburg Control Unit ................................................................................................................ 30
2.5.6. Power Input......................................................................................................................................... 31
2.5.7. Auxiliary Power Socket........................................................................................................................ 31
2.5.8. Height Adjustment Pedals (Optional).................................................................................................. 32
2.6. Other Mechanical Components ................................................................................................................. 33
2.7. Warmer Head............................................................................................................................................. 33
2.7.1. IV Pole (Optional) ................................................................................................................................ 33
2.7.2. Monitor Tray (Optional) ...................................................................................................................... 34
Novos KR-1000 Baby Radiant Warmer User Manual
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2.7.3. Accessory Mounting Rail (Optional).................................................................................................... 34
2.7.4. Power Cable Coil ................................................................................................................................. 35
2.7.5. Acrylic Protective Panels ..................................................................................................................... 35
2.7.6. Rotating Bed (Optional)....................................................................................................................... 35
2.7.7. X-Ray Tray............................................................................................................................................ 36
2.7.8. E Cylinder Slots (Optional)................................................................................................................... 36
2.7.9. Accessory Hanger................................................................................................................................ 36
2.7.10. Rotating Drawer (Optional)............................................................................................................... 37
2.7.11. Auxiliary Tray (Optional) ................................................................................................................... 37
2.7.12. Wheel Locks ...................................................................................................................................... 38
2.8. Temperature Sensors................................................................................................................................. 38
2.8.1. Skin Probe ........................................................................................................................................... 38
2.8.2. Air Probe ............................................................................................................................................. 39
3. Operating Procedure..................................................................................................................................... 40
3.1. Installation.................................................................................................................................................. 40
3.2. Pre-Start Check........................................................................................................................................... 44
3.2.1. Alarm System Check............................................................................................................................ 44
3.2.2. Control Panel Check ............................................................................................................................ 46
3.3. Preparation ................................................................................................................................................ 47
3.4. Essential Use .............................................................................................................................................. 49
3.4.1. Operating Device................................................................................................................................. 49
3.4.2. Placing/Removing Skin Probe.............................................................................................................. 50
3.4.3. Operation Modes ................................................................................................................................ 51
3.5. Alarms ........................................................................................................................................................ 56
4. Troubleshooting ............................................................................................................................................ 58
4.1. Fast Troubleshooting Guide ....................................................................................................................... 58
5. Routine Cleaning and Maintenance.............................................................................................................. 59
5.1. General Cleaning ........................................................................................................................................ 59
5.1.1. Cleaning Skin Probe............................................................................................................................. 60
5.1.2. Cleaning of Baby Bed........................................................................................................................... 60
5.1.3. Approved Solutions............................................................................................................................. 60
5.1.4. After Cleaning...................................................................................................................................... 61
5.2. Maintenance .............................................................................................................................................. 61
5.2.1. General Maintenance.......................................................................................................................... 61
6. Easypuff T-Piece Resuscitation (Optional) .................................................................................................... 63
6.1. Usage Purpose............................................................................................................................................ 63
6.2. User’s Responsibilities for Patient Safety................................................................................................... 63
6.3. Usage Restrictions...................................................................................................................................... 63
Novos KR-1000 Baby Radiant Warmer User Manual
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6.4. Preparation ................................................................................................................................................ 64
6.5. Operating ................................................................................................................................................... 70
6.6. Cleaning and Maintenance......................................................................................................................... 70
7. Bililed Mini+ Phototherapy Unit (Optional) .................................................................................................. 71
7.1. Usage Purpose............................................................................................................................................ 71
7.2. User’s Responsibilities for Patient Safety................................................................................................... 71
7.3. Use Restrictions.......................................................................................................................................... 72
7.4. Preparation ................................................................................................................................................ 72
7.4.1. Placement of the Bililed Mini+ ............................................................................................................ 72
7.4.2. Power Supply Connection ................................................................................................................... 73
7.5. Operating ................................................................................................................................................... 74
7.5.1. Phototherapy Operation ..................................................................................................................... 74
7.5.2. Use of Examination Lamps .................................................................................................................. 81
7.6. Cleaning and Maintenance......................................................................................................................... 83
7.6.1. Cleaning............................................................................................................................................... 83
7.6.2. Maintenance ....................................................................................................................................... 85
8. Venturi Vacuum Unit (Optional) ................................................................................................................... 86
8.1. Usage Purpose............................................................................................................................................ 86
8.2. User’s Responsibilities for Patient Safety................................................................................................... 86
8.3. Operating ................................................................................................................................................... 87
8.4. Cleaning and Maintenance......................................................................................................................... 87
8.4.1. Venturi Vacuum Unit........................................................................................................................... 87
8.4.2. Collection Container............................................................................................................................ 87
8.5. Technical Specifications ............................................................................................................................. 88
9. Annexes......................................................................................................................................................... 89
9.1. Technical Specifications ............................................................................................................................. 89
9.1.1. Environmental Properties ................................................................................................................... 89
9.1.2. Mechanical Properties ........................................................................................................................ 89
9.1.3. Characteristic Properties..................................................................................................................... 89
9.1.4. Other Properties.................................................................................................................................. 90
9.1.5. Accessories and Consumables............................................................................................................. 91
9.2. Compatibility .............................................................................................................................................. 92
9.3. Guidance and Manufacturer's Declaration of Electromagnetic Compatibility .......................................... 93
9.3.1. Electromagnetic Environment............................................................................................................. 93
9.3.2. Electromagnetic Immunity.................................................................................................................. 94
9.3.3. Recommended Separation Distance................................................................................................... 97
9.4. Equipment Classifications .......................................................................................................................... 98
9.5. Trademark Registrations ............................................................................................................................ 98
Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
About This Manual
Scope:
This manual contains a detailed description of all sub-components, use and care details of the KR-
1000 Baby Radiant Warmer System.
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 manual is a guide to the following items of the KR-1000 Baby Radiant Warmer System:
•Installation
•Usage
•Maintenance
All features and technical information of the device are listed considering the user benefit in order to
facilitate the efficient use of the device.
Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
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.
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.
Hot Surface
AC power available
AC power not available
Celsius/Fahrenheit switch
Remote alarm silencer
Alarm silencer button
Setting button for target temperature above 37 °C
Examination light on/off button
Numpad light on/off button
Save/delete button
Weight records difference button
Reset Trendelenburg button
First save button for Trendelenburg
Second save button for Trendelenburg
Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
Trendelenburg position button
Reverse Trendelenburg position button
ID
Product ID.
Manufacturer.
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
Storage temperature and moisture
Operation temperature and moisture
Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
Labels on the Device
Product
Identity
Technical
Service
Warning
Outer Box
Label
Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
Reusable
Skin Probes
Disposable
Skin Probe
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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 Radiant Warmer 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.
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 warmer, and to guarantee
efficient use of the device.
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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 on Indications, Contraindications, Side Effects, Adverse Effects and Possible
Physiological Effects
Indications:
KR-1000 Baby Radiant Warmer is an open incubator system designed to assist the various needs of
newborn infants such as thermoregulation, resuscitation (optional) and weight tracking (optional). It
has the features to apply resuscitation and warming therapies to newborns in the most effective way
to be used in delivery rooms, emergency services and neonatal intensive care units.
Contraindications:
The KR-1000 Baby Radiant Warmer is not designed for domestic use.
There are no known contraindications.
Side Effects:
If the skin probe is not connected, it may cause hyperthermia in infants with high fever.
Excessive use of oxygen level can cause eye damage.
May cause body dehydration, skin rash or irritation.
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Adverse effect:
No adverse effects detected.
Warnings on Possible Physiological Effects:
Potential Risks
There are potential risks such as skin redness and rash in the use of all radiant warmers.
Monitor the patient closely during thermal therapy, taking into account any signs of these risks.
Dehydration and Insensible Fluid Loss
Radiant energy generated in the warmer may increase the insensible fluid loss in the patient.
Necessary measures should be taken to maintain fluid balance during thermotherapy.
Intravenous Tubing Systems
Radiant energy emitted by the device may adversely affect some components in the blood. When
using intravenous tubing systems to transfer blood components to an infant undergoing thermal
therapy on the device, make sure that these tubing are covered with aluminum foil.
Urine Tests and Weight Measurements
Radiant energy emitted by the device can cause urine to evaporate faster. In this case, urinalysis
and weight measurements may be erroneous. It is recommended to change diapers frequently.
Skin temperature
In cases where the skin probe is not connected to the patient, the use of the device carries the risk
of hyperthermia in babies with high fever.
1.3.6.Warnings for the Use of the Device
Operating Mode Selection
Avoid using manual mode if not specifically specified. Using manual mode requires constant
patient supervision. In manual mode, it is the user's responsibility to control the factors such as
ambient air flow, direct sunlight, phototherapy use and to determine the percentage of warming
power accordingly. On the other hand, the warmer power percentage is determined automatically
by the device in baby mode. Baby mode minimizes the need to control the baby and change the
set temperature.
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.
Number of Patients
It is recommended to use KR-1000 for only one patient at a time.
Fixing the Device
Always lock the wheels of the device before placing a baby.
Usage with Phototherapy Device
Phototherapy devices can cause the patient's skin temperature to increase. Monitor skin
temperature continuously with the help of a skin probe. It is recommended to use baby mode
during phototherapy application.
Long Term Use
If the device warmers will be used for a long time, the baby mode should be preferred. If any
alarm is silenced while operating the device in this mode, supervision of patient closely is
recommended.
Accompanied Devices
•All devices to be used with KR-1000 must comply with the IEC 60601 standard.
•Do not use any unapproved accessories with the KR-1000. Do not connect such a device
to the accessory mounting arm.
•KR-1000 is not recommended to be used with an extra thermoregulation device.
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•Any device or combination of devices that do not comply with the conditions specified in
this manual may adversely affect the functionality of the KR-1000. See the relevant
document and the use of attached devices before using the medical device.
Plexiglass Protection Panels
•To open the plexiglass protective panels on the front and both sides of the device, push
the panel in the direction of the arrow mark to release it from its locked hinge and pull it
towards yourself to open the panel to the outside.
•It is risky to leave the baby unattended when the plexiglass protective panels are in the
open position or the rear plexiglass panel is completely removed.
•Make sure the plexiglass protective panels are locked in the closed position.
Warmer Head
Do not hang any objects on the Warmer head.
Distance Between Bed and Warmer Head
The distance of 74 cm between the bed and the warmer head should be maintained. Otherwise,
there may be negative effects on device performance or patient health.
Warming Performance
No object should be placed in the route of heat energy emitted from the warmer (between the
bed and the warmer head). These objects will adversely affect the performance of the device by
absorbing the emitted heat energy.
Examination Lamps
If the examination lamps will be used for a long time, the eyes of the patient should be covered
with a protective eye patch. Otherwise, prolonged exposure to the light intensity provided by the
device may damage the patient's eyes.
Patient Monitoring
It is recommended that you take the following precautions during thermal therapy.
•Do not leave the patient unattended while using the device.
•During thermal therapy, following the patient's instructions, symptoms such as skin
rash, a sense of warmth to be felt by touching, diaphoresis or a rapid heartbeat should
be checked frequently.
•If phototherapy is continuing along with thermal therapy, take a break from
phototherapy for accurate assessment while checking the patient's condition and skin
color.
•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.
•There is no integrated oxygen monitor on the device. When using the Easypuff T-Piece
resuscitator, it is recommended to monitor the set oxygen concentration with an
independent oxygen monitor.
Line all electronic devices, the KR-1000 Baby Radiant Warmer system should be handled with care to
prevent damage. Consider the following measures.
1.3.7.Bearing Capacity
Bed Weight Capacity
The maximum capacity of the baby bed is 10 kg.
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1.3.8.EMC Restrictions
ATTENTION
•This device must be operated in accordance with the EMC information provided in this manual.
•Mobile and portable RF communication equipment can interfere with Medical Electrical Equipment.
•When using this device alongside other devices, it is important to verify normal operation in the
configuration in which it is used.
•The use of electrosurgical devices or other devices that emit high electric fields may adversely affect
the operation of the KR-1000. In this case, the skin probe cable should be kept as far away from these
devices as possible. The excess part of the power cord should not be placed on the baby bed. The use
of such devices may cause inaccurate measurement (display of temperatures above normal) on the
KR-1000 skin probe due to the electrical energy they emit. In such cases, it is recommended to use the
KR-1000 in "Manual" mode and to have the skin probe fixed to the device and the baby so that the
skin temperature can be monitored.
1.3.9.Restrictions of the Environment in which the Device will be Used
Do not use the device in the presence of flammable anesthetics or gases to avoid any risk
of explosion.
Environmental conditions such as airflow can affect the patient's thermal balance.
ATTENTION
•The device should be used in ideal environmental conditions between 20 °C and 30 °C. Unsuitable, low
or high ambient temperature may disrupt the patient's thermal balance.
1.3.10.Electrical Safety Restrictions
Wrap excess cable around the cable shield at the back of the column to prevent the
power cable from tripping.
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 "220 VAC and 50 - 60 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.
The total current drawn from the KR-1000's auxiliary power socket must not exceed the
upper limit of 6A.
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.
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Any device to be connected to the KR-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.
During transport, only move the device using the handles on the back of the device.
Attempts to carry the device by holding it by plexiglass protectors may damage the
device.
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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.
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 aimed
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.
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2.Product Description
2.1. Usage Purpose
KR-1000 is a combined open bed system with a radiant warmer designed for different needs of term
and preterm newborns, especially thermoregulation, resuscitation (optional), weight monitoring
(optional) in delivery rooms, emergency and neonatal intensive care units of hospitals.
2.2. Patient Population
As the information is given below, mature, premature and post-term infants constitute the patient
population:
Normally born babies between 37 and 42 weeks are mature. Babies born before the 37th week are
considered premature and those born after the 42nd week are considered as postmature newborns.
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 membrane key panels on the device may deform over time.
•warming elements may lose their efficiency 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.
2.4. Main Functions
•With the help of modules and features that can be added optionally, different needs of newborns such
as thermoregulation, resuscitation (optional), weight tracking (optional) are met, while the user can
easily access the newborn for any kind of intervention.
•The patient can be easily intervened thanks to the foldable side plexiglass protectors.
•The KR-1000 Baby Radiant Warmer has an intelligent microprocessor control unit to provide optimum
warming support for newborns and easy use for users.
•The warmer module, which contains ceramic warmer elements, ensures that the temperature is
distributed evenly over the bed, ensuring that the whole body of the newborn is heated
homogeneously.
•In pre-warming mode (Pre-Warming), the patient is pre-warmed without triggering any alarm before
the patient is placed on the bed.
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•In manual mode, warming is provided according to the warmer power percentage to be determined by
the user.
•In infant mode (servo-controlled mode), for optimal temperature regulation, the KR-1000 measures the
newborn's skin temperature using a double thermistor probe. In order to maximize the safety and
accuracy of warming during operation, the newborn skin temperature is read with the help of the dual
thermistors in the skin probe and these values are verified at every measurement. For maximum patient
safety, the system checks itself and stops warming and warns the user by giving an alarm in case of
prolonged operation at 100% power (such as the possibility of accidentally disconnection of the skin
probe).
•At the touch of a button, the baby bed can be given a trendelenburg and reverse trendelenburg position
and the bed can be returned to a horizontal position.
•With the help of the wide X-Ray tray and the ± 140° rotating warming head, the patient's X-ray can be
taken without leaving the bed and without interrupting the treatment.
•The user is warned in order to determine the Apgar score with the help of the Apgar timer, which can
be adjusted in 1, 5, 10, 20 minutes periods.
•Thanks to the directional examination lamps, the baby bed is illuminated and optimum vision is
provided.
•Automatically activated control panel key lock prevents the device from being turned off accidentally.
•With the remote alarm silencing feature, the disinfection of the user's hands is maintained during the
operation.
Besides, optionally;
•The 360° rotatable baby bed allows the user to reach different parts of the baby without moving during
the operation.
•With Easypuff, an integrated resuscitation device, the resuscitation process is easily completed, if
required.
oThere are E-Cylinder slots on both sides of the device to provide the Easypuff with medical
grade air and oxygen.
oWith the Air/Oxygen mixer or flow meter system that can be mounted on the accessory arm,
the flow-controlled air/oxygen mixture required for Easypuff operation is provided.
•Oral, tracheal and nasal tracts can be cleaned with the pediatric vacuum unit.
•Thanks to the smart weighing feature, weight tracking can be done without taking the baby to an
external scale.
•Thanks to its height adjustment feature, the device rises by +20 cm and offers an ergonomic use for
different user profiles.
•Thanks to the 360° rotatable drawers, the patient's diapers etc. can be stored and easily accessed if
needed.
•Neonatal jaundice treatment is provided with the help of the integrated Bililed Mini+ phototherapy
system.
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