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novos KI 1000 User Manual

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

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  • Page 1 KI 1000 User Manual NVS.S9.KK01/Rev.06/06.04.2021...
  • Page 2 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.

  • Page 3: Table Of Contents

    Table of Contents About This Manual ................................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.
  • Page 4 Changing Oxygen Cells ........................31 Preparation ................................32 4.1. Unpacking and First Installation ......................... 32 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.
  • Page 5 5.14. Screen Lock ............................... 70 5.15. Height Adjustment............................ 71 5.16. Shutting Down KI 1000 ..........................72 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.
  • Page 6 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.

  • Page 7: About This Manual

    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.
  • Page 8 Input voltage Date of Manufacture Electrical and electronic equipment waste should not be disposed of in general municipal waste, but should be collected separately 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.
  • Page 9 Label Information: Product Identity Technical Service Warning Outer Box Label NVS.S9.KK01/Rev.06/06.04.2021...
  • Page 10 Reusable Skin Probe Label Disposable Skin Probe Label NVS.S9.KK01/Rev.06/06.04.2021...

  • Page 11: Safety Information

    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;...

  • Page 12: Usage Restrictions

    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.

  • Page 13: Warnings For The Use Of The Device

    NOVOS KI 1000 User Manual 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.
  • Page 14 • 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.
  • Page 15 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.
  • Page 16 NOVOS KI 1000 User Manual 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.

  • Page 17: Bearing Capacity

    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.

  • Page 18: Transportation Restrictions

    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. •...

  • Page 19: Warranty

    As a result of evaluations, NOVOS or the authorized factory center must confirm that the warranty conditions cover this defect. 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.

  • Page 20: Product Description

    , 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.

  • Page 21: Main Functions

    • Allows the operator to follow the baby more effectively with its height adjustment feature. The parameters that can be monitored always from the KI 1000 main display are listed below. • Measured and targeted air temperature •...

  • Page 22: Product Parts And Controls

    NOVOS KI 1000 User Manual 2.5. Product Parts and Controls 2.5.1.Front View Monitor Tray / IV Pole Secondary Cover Lock Primary Cover Lock Oxygen/Humidity Sensor Box Side Window with Grommet Canopy Oval Window Oval Window Lock Trendelenburg Adjustment Head Grommet...

  • Page 23: Side And Rear View

    NOVOS KI 1000 User Manual 2.5.2. Side and Rear View Air Filter Housing Oxygen/Humidity Sensor Module Servo O Inlet Lockable Canopy Hinge Manual Flow Controlled O Inlet Product ID Label Control Panel On/Off Switch Internal triple socket Power Supply and Height...

  • Page 24: Control Panel Connections

    NOVOS KI 1000 User Manual 2.5.3. Control Panel Connections All sensors, balance, servo oxygen valves and humidity resistance are connected to the control panel via the connector plate on the right side of the device. Primary Skin Probe Water Level Sensor...

  • Page 25: General Overview

    3. General Overview 3.1. Control Panel The KI 1000 has a fully removable control panel that houses almost all electronic components. . This makes service & maintenance procedures for the KI 1000 very easy. The control panel includes a 7” colored, touchscreen LCD display. Active screen display and button functions change according to the menu used.

  • Page 26: Sensors

    3.2.1. Temperature Sensors Skin Probes KI 1000 has an air temperature sensor located behind the control panel and measuring the temperature of the air returning from the canopy, and also 2 skin temperature sensors. . (Secondary skin probe is an optional feature.)

  • Page 27: Oxygen/Humidity Sensor Module

    3.3. TTSS (Target Temperature Surveillance System) The KI 1000 offers the TTSS feature that informs you of the target air and target skin temperatures regardless of the operating mode (air mode or skin mode). In other words, although the control parameter can only be air or skin temperature in operating mode, the KI 1000 informs you about the deviation from both skin and air temperature and offers an extra safe patient monitoring.

  • Page 28: Canopy

    NOVOS KI 1000 User Manual 3.4. Canopy The KI 1000 has a canopy that can be opened for easy cleaning and disinfection. The canopy can be tilted back. Lockable hinges do not allow the canopy to tilt beyond the specified point.

  • Page 29: Front/Rear Access Covers

    Flip up to activate primary locks. 3.4.2. Oval Windows KI 1000 has a total of 6 oval windows that allow medical staff to use the contamination-preventing elbow method. Thus, possible risk of infection is avoided. To open the oval window;...

  • Page 30: Double Wall

    NOVOS KI 1000 User Manual 3.4.3.Double Wall The KI 1000 has a double wall at the top of the canopy as standard. In addition, double walls surrounding the front and rear covers can be optionally added. To remove upper double wall: Open the front cover.
  • Page 31 NOVOS KI 1000 User Manual • Grab the double wall by the upper edge of the oval window clearance and pull it in the direction shown below. NVS.S9.KK01/Rev.06/06.04.2021...

  • Page 32: Grommets

    Slide the double wall in the direction shown below to lock it. 3.4.4.Grommets KI 1000 has a total of 12 grommets, 4 on the front/rear walls of the canopy and 2 on the side oval windows. These grommets provide access for patient circuits and other sensor cables while maintaining the thermal insulation of the canopy.

  • Page 33: Baby Bed

    NOVOS KI 1000 User Manual 3.5. Baby Bed KI 1000 has a sliding baby bed to provide parental bonding when necessary. The baby bed can be opened from front to back so that 3/4 of its total width remains outside.
  • Page 34 NOVOS KI 1000 User Manual 3.5.1. Tilt Mechanism (Trendelenburg / Reverse Trendelenburg) The smooth tilt mechanism of the KI 1000 provides Trendelenburg/Reverse Trendelenburg positioning at angles of ±12°. • Turn the adjustment knob counterclockwise to tilt up the relevant side and apply the Trendelenburg / Reverse Trendelenburg position.

  • Page 35: X-Ray Tray

    NOVOS KI 1000 User Manual 3.6. X-Ray Tray KI 1000 has an X-Ray tray of which dimensions are 396 mm x 256 mm. For this reason, while the baby is treated in a canopy, the x-ray procedure can be completed without any intervention.

  • Page 36: Drawers And Cabinet

    3.9. Height Adjustment System (Optional) KI 1000 has an optional height adjustment system that can lift the incubator body up to 20 cm. In this way, the incubator height can be adjusted for different medical staff and all controls can be accessed without difficulty.

  • Page 37: Pole (Optional)

    NOVOS KI 1000 User Manual IV Pole (Optional) 3.10. The KI 1000 has an IV pole whose height and position around the vertical axis can be easily adjusted. IV Pole latch IV pole fixing screws To increase the height of the IV pole;...

  • Page 38: Wheel Brakes

    To activate the wheel brake; • Press the outer edge of the brake pedal. Wheel Brakes To release the brake; • Press the inner edge of the brake pedal. Do not force the KI 1000 to move when the wheels locked. NVS.S9.KK01/Rev.06/06.04.2021...

  • Page 39: Humidification System

    NOVOS KI 1000 User Manual 3.12. Humidification System 3.12.1. Filling the Water Reservoir • Disinfect your hands. • Pull out the water reservoir drawer and turn the top cover in the direction of the arrow. • Fill the water reservoir with distilled water until the water level reaches MAX. Note that the water reservoir capacity is 1.7L.

  • Page 40: O 2 System

    System Along with manual flow-controlled oxygen coming from an external flowmeter and directly released into the canopy, the KI 1000 also offers an optional servo oxygen system. 3.13.1. Oxygen Inlet Connection KI 1000 has two oxygen inlets. These are servo controlled O (High Pressure) and manual flow controlled O (Low Pressure).

  • Page 41: Changing Oxygen Cells

    NOVOS KI 1000 User Manual 3.13.2. Changing Oxygen Cells Oxygen cells must be replaced annually to maintain stable measurement of oxygen concentration. The oxygen/humidity sensor module must first be removed from the canopy to replace the oxygen cells; Disconnect the oxygen/humidity sensor module cable from the control panel.
  • Page 42 NOVOS KI 1000 User Manual Unscrew the two screws of the sensor module top hinge and lift the sensor module upwards. After the oxygen/humidity sensor module is removed from the canopy, the sensor module cover must be opened. Unscrew the 4 screws of the sensor box cover.

  • Page 43: Preparation

    NOVOS KI 1000 User Manual 4. Preparation 4.1. Unpacking and First Installation KI 1000 can be grouped into six main parts; Main Body Transport Trolley Monitor Tray / IV Pole Monitor Tray IV Pole Oval Window Seals and Grommets Before starting to assembly;...
  • Page 44 NOVOS KI 1000 User Manual Attach 2 adjacent grommets on each lateral oval window. Grommet 3. Attach 8 grommets to the front and rear walls of the canopy. 4. Lock all the brakes of the transport trolley. 5. Hold the main body by the handles on both sides.
  • Page 45 NOVOS KI 1000 User Manual 6. Lift the main body of the incubator and place it on the transport trolley. 7. Secure the monitor tray and IV pole post to the incubator with two hex screws. 8. Place the monitor tray on the pole and fix it with 4 Phillips screws.
  • Page 46 NOVOS KI 1000 User Manual 9. Attach the IV pole and fix it with plastic-headed clamping screws. 4.2. Pre-Start Check Follow the instructions below before each use. • Check that the equipment is disinfected according to an approved hospital protocol.
  • Page 47 NOVOS KI 1000 User Manual If the primary and secondary locks cannot stay attached or the access cover’s movement is not normal; • Take the device out of service. Always make sure the locks of the access covers are active to avoid the risk of the baby falling out of the incubator.
  • Page 48 NOVOS KI 1000 User Manual The white triangular pieces inside the canopy have a stopper function for the baby bed. Make sure the bed is centered without interrupting air circulation. • Close the front cover. If the bed cannot be pulled out or pushed in;...

  • Page 49: Use Of Device

    Plug the device to the power supply. Do not use extension cords for the power supply on the KI 1000 incubator! Plugging the incubator via an extension cord may result in a risk of electric shock to the patient in the event of a fault in the protective earth conductor, and may cause leakage currents to exceed the allowable limits.

  • Page 50: Main Display

    NOVOS KI 1000 User Manual 5.2. Main Display After “Self-test”; • Main screen appears. • The main screen includes the following parameters; Active Mode Indicator (Green Highlight) Key-lock Unit Indicator Measured Air Temperature Skin Mode Control Box Adjusted Air Temperature Humidity Mode Control Box 37 °...

  • Page 51: Control Boxes

    NOVOS KI 1000 User Manual 5.2.1. Control Boxes The main screen includes 4 control boxes that provide access to target value setting screens for air, skin temperature, humidity and oxygen controls. The green highlighted animation in the upper left corner of the control box indicates that the related mode is active.

  • Page 52: Use In Air Mode

    NOVOS KI 1000 User Manual 5.3. Use in Air Mode Regularly measure baby’s skin temperature! Do not leave the canopy open for any course of time, otherwise the air temperature inside the incubator will drop and this may cause hypothermia.

  • Page 53: Setting Ttss Target Skin Temperature

    NOVOS KI 1000 User Manual If you do not want to change the settings; • Press the return icon. New settings will be canceled. Main screen appears. Previous target point is preserved. 5.3.2. Setting TTSS Target Skin Temperature The "TTSS Target Skin" feature can also be activated on this screen.

  • Page 54: Setting Extended Air Temperature Target Point

    NOVOS KI 1000 User Manual 5.3.3. Setting Extended Air Temperature Target Point When the expanded target point for air temperature is set, special attention should be paid to monitor the baby’s temperature. If the standard target point range (20 °C- 37 °C) is exceeded;...

  • Page 55: Air Mode Alarms

    If present, attach the air probe to the back of the control panel. For other alarms, see the "Alarms and Warnings" section. 5.4. Use in Skin Mode Before using the skin probe, always verify that it is the original NOVOS KI 1000 accessory. 5.4.1. Attaching/Detaching the Skin Probe Attaching the Skin Probe •...

  • Page 56: Checking The Function Of The Temperature Sensors

    5.4.2. Checking the Function of the Temperature Sensors KI 1000 has two skin temperature sensors, Skin1 and Skin2. The skin temperature sensor is used to control the baby's skin temperature. However, the Skin2 temperature sensor allows to monitor the twins' skin temperature.
  • Page 57 The skin temperature control mode should not be used in twins, as the KI 1000 only controls the baby's temperature based on temperature information from the primary skin probe. Otherwise, there is a risk of hypothermia or overheating.

  • Page 58: Setting The Skin Temperature Target Value

    NOVOS KI 1000 User Manual 5.4.3. Setting the Skin Temperature Target Value • To set the target point, press the skin mode check box in the main screen. • The skin mode screen appears. Upper Alarm • Press the skin area.

  • Page 59: Setting Ttss Target Air Temperature

    NOVOS KI 1000 User Manual 5.4.4. Setting TTSS Target Air Temperature The “TTSS Target Air" feature can also be activated on this screen. To activate the target air feature; Upper Alarm Limit TTSS • Select the target air area. Target Air...

  • Page 60: Skin Mode Alarms

    NOVOS KI 1000 User Manual • > 37 °C icon will appear on the main screen. 5.4.6. Skin Mode Alarms In skin mode, alarm thresholds can be set as ±0,3 °C, ±0.5 °C or ±1.0 °C. If the difference between the set and measured skin temperature exceeds the alarm limit;...

  • Page 61: Use Of Servo Humidity

    NOVOS KI 1000 User Manual 5.5. Use of Servo Humidity 5.5.1. Setting Humidity Target Point • To set the target point, press the humidity mode check box in the main screen. • The Set humidity [%] screen is displayed. Upper Alarm...

  • Page 62: Humidity Mode Alarms

    NOVOS KI 1000 User Manual 5.5.2. Humidity Mode Alarms Alarm threshold values for humidity control can be set as ± 5%, ± 10% or ± 15%. If the deviation between the target and measured humidity values exceeds the alarm threshold values;...

  • Page 63: Use Of Servo O

    5.6. Use of Servo O The KI 1000 can apply both servo control and passive oxygen therapy to the baby. Both systems have their own unique oxygen inlet at the back of the device. Please check the "Oxygen Inlet Connection" section.

  • Page 64: Setting The Expanded Oxygen Concentration Target Point

    NOVOS KI 1000 User Manual Upper Alarm Limit • Target Press the oxygen area. Point Lower Alarm Limit • Turn the knob clockwise or press the up arrow to increase the target point. • Turn knob counterclockwise or press the down arrow to decrease the target point.

  • Page 65: Calibration Of Oxygen Sensors

    NOVOS KI 1000 User Manual • Turn the knob clockwise or press the up arrow to continue increasing the target point after 40% (Oxygen concentration can be increased up to 65%). • Turn knob counterclockwise or press the down arrow to decrease the target point.
  • Page 66 NOVOS KI 1000 User Manual • Turn the O Sensor module located on the top right of the canopy. • Press the start button. • The device will calibrate the oxygen sensors and will automatically return to the main screen after calibration is complete.

  • Page 67: Oxygen Mode Alarms

    NOVOS KI 1000 User Manual 5.6.5. Oxygen Mode Alarms Oxygen mode alarm thresholds can be set to ± 3% and ± 5%. If the deviation between the target and measured oxygen concentration value exceeds the alarm threshold values; • A red alarm message appears on the screen; "Low Oxygen Temperature" or "High Oxygen Temperature".

  • Page 68: Use Of Smart Weighing Option

    5.7. Use of Smart Weighing Option KI 1000 balance module is located just below the bed and the x-ray tray. In the weighing process, the whole bed is weighed with the baby, together with the x-ray tray and the items placed on it. Thereafter, the weight of the items on the bed, the bed module and the x-ray tray is then subtracted from the total weight in order to determine the exact weight after the baby is removed from the bed.
  • Page 69 NOVOS KI 1000 User Manual After the taring process is completed; • Place the baby to start the weighing process. • Press the approval icon to save the measured weight. If you do not want to save the weight; •...

  • Page 70: Alarms And Warnings

    5.8. Alarms and Warnings The KI 1000 has 19 different alarms divided into two groups as Red Alarms and Yellow Alarms. The table below shows the alarm list. Here you can also find the background color of the alarm messages expressing the alarm priority.
  • Page 71 NOVOS KI 1000 User Manual Audible alarm is silenced for 5 High Priority Skin1 Sensor Error minutes. Audible alarm is silenced for 5 High Priority Skin2 Sensor Error minutes. Audible alarm is silenced for 5 High Priority Auxiliary Sensor Error minutes.
  • Page 72 NOVOS KI 1000 User Manual Alarm Alarm Silencer Alarm Message Priority Button’s Function Medium The audible alarm is silenced High Humidity Priority for 30 minutes. Medium The audible alarm is silenced Low Humidity Priority for 30 minutes. Medium Replace the air filter! Priority While the alarm silencing is active, the incubator’s operator and medical personnel are fully responsible...

  • Page 73: Trend Indication

    NOVOS KI 1000 User Manual 5.9. Trend Indication Trends show graphically measured/recorded parameters. The data window shows the most recent data in the selected time period. The trend is shown on the main screen, so that both instant and previous values can be observed on the same screen.

  • Page 74: Setting The Graphic Type And Duration (Zoom)

    NOVOS KI 1000 User Manual 5.9.1. Setting the Graphic Type and Duration (Zoom) • Press the area where the Trend image is located on the main screen. • Select the desired trend image from the drop down list; Air temperature...

  • Page 75: Patient History Records

    NOVOS KI 1000 User Manual 5.10. Patient History Records The KI 1000 can store data of 5 different patients. Recorded parameters are; • Air temperature • Primary Skin temperature • Secondary Skin Temperature • Humidity Ratio • Oxygen concentration •...
  • Page 76 NOVOS KI 1000 User Manual If you want to return to the main screen; • Press the return icon. To register a patient when a new baby is placed in the incubator; • Press the new patient button. • Enter the patient's name...

  • Page 77: Standby Mode

    5.11. Standby Mode KI 1000 has a standby mode feature. This mode is used when access covers need to remain open for supply, etc. When the standby mode is activated, all alarms are silenced. To activate the standby mode;...

  • Page 78: Selecting Accessible Modes

    NOVOS KI 1000 User Manual 5.12. Selecting Accessible Modes The modes (control boxes) desired to be displayed on the main screen of the KI 1000 can be selected separately. To change active control boxes on the left of the screen •...

  • Page 79: Settings

    NOVOS KI 1000 User Manual 5.13. Settings KI 1000 can be easily configured through the Settings menu. To access the settings menu; • Press the Settings button. • The settings menu will be displayed on the screen. • Press the Confirm icon to save changes and return to the previous screen.

  • Page 80: Configuring Date/Time Settings

    NOVOS KI 1000 User Manual 5.13.1. Configuring Date/Time Settings To change date/time settings; • Press the DATE/TIME button. • Tap the relevant field to change. • Use the Up Down arrows to change the value. • Press the DATE/TIME Confirm button to save the new date/time settings.

  • Page 81: Configuring System Settings

    NOVOS KI 1000 User Manual 5.13.2. Configuring System Settings To change the temperature and weight units, key tone or interface language; • Press “SYSTEM SETTINGS” button. On this screen; • You can set the temperature unit in Celsius or Fahrenheit, •...

  • Page 82: Service Settings

    Service settings can only be accessed with the service password provided to authorized technical personnel. To avoid equipment damage, please do not attempt to access or change device settings. 5.14. Screen Lock If there is no user login, KI 1000 will automatically lock the screen within a minute. To manually lock the screen; •...

  • Page 83: Height Adjustment

    NOVOS KI 1000 User Manual 5.15. Height Adjustment To use the height adjustment feature; • Connect the AC power cord to the device from the AC input located on the back of the device. • Switch on the height adjustment motor using the On/Off switch.

  • Page 84: Shutting Down Ki 1000

    NOVOS KI 1000 User Manual 5.16. Shutting Down KI 1000 To shut down the device; • Press the On/Off switch located on the right side of the control panel. If the O hose is connected to the source; • Disconnect the hose jack from the source-end.

  • Page 85: Routine Cleaning And Maintenance

    6.1. Cleaning and Disinfection 6.1.1. Measures The KI 1000 incubator system must be thoroughly cleaned and disinfected after each patient, according to approved hospital protocols. Follow the additional instructions that follow along with the specified hospital protocols. Always follow approved hospital protocols for handling equipment contaminated with body fluids.

  • Page 86: Removal Of Incubator Components For Cleaning Purposes

    NOVOS KI 1000 User Manual 6.1.2. Removal of Incubator Components for Cleaning Purposes Remove any installed auxiliary equipment, if any (refer to the specific operating instructions of the relevant equipment for maintenance instructions). • Turn off the device and open the canopy by pulling up on both plastic hinges.
  • Page 87 NOVOS KI 1000 User Manual Remove the canopy base; • Loosen 4 black headed plastic screws and remove canopy base After removing the canopy base, the air ducts are accessible for cleaning and disinfection. Remove all grommets and window seals from the canopy.

  • Page 88: Cleaning And Disinfection Procedure

    NOVOS KI 1000 User Manual Remove the front/rear double wall; • Grab the upper edge of the oval window area and pull in the direction of the arrow indicated in red. Remove the Water Reservoir • Completely remove the water reservoir drawer.

  • Page 89: Changing Air Filter

    The air filter should be changed every 90 days. In some cases, depending on the environment, the air filter needs to be changed sooner if it is visually dirty or damaged. For this purpose, the KI 1000 software can alert you every 15, 30 or 45 days for filter status check.
  • Page 90 NOVOS KI 1000 User Manual • Check the installation date, if already specified. • If it is more than 90 days, replace the filter. After replacing the filter, reset the filter time counter in the software. • Change the air filter on your home screen! Press the warning indicator.
  • Page 91 NOVOS KI 1000 User Manual • After pressing the button, the warning "Change air filter" will disappear from the list of alarms and warnings. NVS.S9.KK01/Rev.06/06.04.2021...

  • Page 92: Cleaning Skin Probe

    NOVOS KI 1000 User Manual 6.1.5. Cleaning Skin Probe Clean reusable (reusable) skin probes with alcohol or detergent or soap solution (maximum 2% in water) in line with the manufacturer's instructions on the use of cleaning agent. Apply the cleaning solution with a clean cloth or sponge and dry all surfaces after cleaning with a clean soft cloth.

  • Page 93: Maintenance List

    Use surface disinfectants based on aldehydes and quaternary ammonium compounds. Use detergent only. Do not use disinfectants that release alkaline or chlorine. Corrosion risk! Use only original KI 1000 air filter! Fire danger! Sterilize the water reservoir for 10-15 minutes at 121 °C...

  • Page 94: Disposal Of The Incubator

    The device should be regularly inspected and maintained at 1-year intervals. Records must be kept in this preventive maintenance. We recommend a service contract with the NOVOS service through your dealer. For repairs of the KI 1000 incubator, we recommend that you contact NOVOS service.

  • Page 95: Troubleshooting

    NOVOS KI 1000 User Manual 7. Troubleshooting 7.1. Error Messages Mess Cause Solution Audible Alarm • Faulty Driver Microprocessor E0 System Error CALL SERVICE! E2 System Error CALL • Defective Air Probe SERVICE! • E3 System Error CALL Defective Fan Probe Error...

  • Page 96: Annexes

    NOVOS KI 1000 User Manual 8. Annexes 8.1. Technical Specifications 8.1.1. Device Classification Protection class Class 1, Type BF Classification in compliance with 93/42/EEC Protection against water and solid objects IP20 8.1.2. Environmental Requirements Operating Temperature 20 - 30 °C...

  • Page 97: Sensor Features

    NOVOS KI 1000 User Manual 1 large drawer and 2 small drawers, optional height Transport Trolley adjustable (+ 20 cm) Wheels In total 4 wheels with brakes Wheel Diameter 125 mm X-Ray Tray Dimensions 396 x 256 mm Maximum Total Weight...

  • Page 98: Servo Humidity Features

    NOVOS KI 1000 User Manual 8.1.6. Servo Humidity Features The Type of Water Used for Humidification Distilled water Water Reservoir Capacity 1,8 L Insufficient Water Level Indicator Water Reservoir Autoclave Feature 8.1.7. Alarm Features Current Alarms Auditory Alarm Silence Button Function Air Sensor Error The auditory alarm cannot be silenced.
  • Page 99 NOVOS KI 1000 User Manual Sensor information recorded at the time of the error Error History can be used for troubleshooting. Standby Mode Displaying Heater Power Percentage In 10% increments Warm Up Time <35 minutes from 22 °C to 33 °C (at 22 °C ambient...

  • Page 100: Compatibility

    NOVOS KI 1000 User Manual 8.2. Compatibility Publishing Date Document Name / Title Body Acce TS EN 60601-1 / Electrical medical equipment-Part 1: General rules for 11-02-2009 ptanc basic safety and required performance 23-03-2016 TS EN 60601-1-2 / Electrical medical equipment-Part 1-2: General rules for basic...

  • Page 101: Compliance Directive

    NOVOS KI 1000 User Manual 8.2.1. Compliance Directive: Council Directive 93/42/EEC of 14 June 1993 on medical devices (1993-07-12 OJ L L 169/1) The Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993 on medical devices, OJ L 169/1 of 1993-07-12 [1]) aims to harmonize the laws related to medical devices within the European Union.

  • Page 102: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    KI 1000 is designed for use in below conditions and environments. Electromagnetic Environment The KI 1000 is intended for use in the electromagnetic environment specified below. The customer or user of the KI 1000 must guarantee that the device will be used in such an environment.
  • Page 103 NOVOS KI 1000 User Manual Electromagnetic Immunity The KI 1000 is intended for use in the electromagnetic environment specified below. The customer or user of the KI 1000 must guarantee that the device will be used in such an environment.
  • Page 104 NOVOS KI 1000 User Manual IEC 60601 Immunity Test Compatibility Electromagnetic Environment experiment level level 3Vrms out of ISM Recommended band Conveyed RF Separation Distance 6Vrms in ISM band 61000-4-6 D = 1,2√ 150kHz to 80MHz. 3 V/m d = 1.2√P 800 MHz to 1000 MHz...
  • Page 105 NOVOS KI 1000 User Manual Recommended Separation Distance Separation distance according to frequency of transmitter (m) Transmitter's highest 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz rated output power �� = ��. �� √ ��...

  • Page 106: Trademark Registrations

    NOVOS KI 1000 User Manual 8.3. Trademark Registrations Novos KI 1000 model is a Novos branded commercial product of Novos Tıbbi Cihazlar Sanayi ve Ticaret İthalat ve İhracat Limited Şirketi. 8.4. Manufacturer Novos Tıbbi Cihazlar Sanayi ve Ticaret İthalat ve İhracat Limited Şirketi Address: İvedikosb Mahallesi 1518 Cad.

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