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EO BABYREST M100 User And Service Manual

Radiant warmer open bed
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BABYREST M100 MODEL RADIANT WARMER
OPEN BED USER, MAINTENANCE and SERVICE
Published Date
Rev. Date/No
Document No
ERTUNÇ ÖZCAN
MANUAL
: 14.07.2016
: 02.05.2024 / 16
: KK-M100-01

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Summary of Contents for EO BABYREST M100

  • Page 1 ERTUNÇ ÖZCAN BABYREST M100 MODEL RADIANT WARMER OPEN BED USER, MAINTENANCE and SERVICE MANUAL Published Date : 14.07.2016 Rev. Date/No : 02.05.2024 / 16 Document No : KK-M100-01...
  • Page 2 3.3.5. PRECAUTIONS FOR THE USE OF OPTIONAL FEATURES ............... 15 3.3.6. CLEANING AND MAINTENANCE PRECAUTIONS .................. 16 3.4. TARGET USER GROUPS FOR BABYREST M100 RADIANT WARMER OPEN BED ..........16 3.5. TRAINING ..............................16 GENERAL INFORMATION ............................. 17 4.1. INTRODUCTION ............................17 4.2.
  • Page 3 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL SYSTEM INSTALLATION AND CONTROL ....................... 25 5.1. MECHANICAL CONTROL ..........................25 5.2. AUXILIARY EQUIPMENT CONTROL ....................... 25 FUNCTIONAL EXPLANATION ..........................26 6.1. GENERAL ..............................26 6.2. USING MANUAL MODE ..........................26 6.2.1. USING MANUAL MODE FOR 6" MONOCHROME SCREEN ..............26 6.2.2.
  • Page 4 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 8.2.1. “HIGH SKIN TEMPERATURE” ALARM....................63 8.2.2. “CRITICAL SKIN TEMPERATURE” ALARM ..................... 64 8.2.3. “LOW SKIN TEMPERATURE” ALARM ....................65 8.2.4. “NO SKIN PROBE” WARNING ......................65 8.2.5. “SKIN PROBE FAILURE” WARNING ...................... 65 8.2.6.
  • Page 5 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 1. COMPANY INFORMATION 1.1. INTRODUCTION ERTUNÇ ÖZCAN Company was founded by Ertunç Özcan in 1968. Since that year, it has been operating as a private association in the fields of import, export, production and service with the aim of selling medical devices and equipment to hospitals and laboratories in Turkey.
  • Page 6 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 1.4.1. CENTER, DESIGN AND PRODUCTION Design and production activities within the scope of ISO 9001:2015, ISO 13485:2016 Standards, MDD 93/42/EEC, MDR EU 2017/745 and FDA Regulations; it covers Design, Production; Sales, Distribution and Technical Service activities of Phototherapy and Incubator Devices and Accessories.
  • Page 7 Magic Loggia M CE Certified Magic Loggia Deluxe CE Certified Babynest H-100 Transport Incubator CE Certified Babyrest M100 Model Radiant Warmer Open Bed CE Certified Babyrest M50 Model Radiant Warmer Open Bed CE Certified Baby Led Force Phototherapy Device CE Certified...
  • Page 8 Use only distilled water Input Unprotected against water and dust Production date IPXO particles NOTE This manual shall explain all the functions and their usage instructions of the Ertunç Özcan brand Babyrest M100 model radiant warmer open bed. 8 / 83...
  • Page 9 IMPORTANT The service life of Babyrest M100 model radiant warmer open bed is 10 years. This is the period of time required to obtain the spare parts necessary to operate the device as described. 9 / 83...
  • Page 10  The misuse of the radiant warmer open bed may injure the patient.  Babyrest M100 must only be used for the purpose mentioned in Intended Use (Section 4.3)  The radiant warmer open bed shall not be used if it is not functioning properly. Technical service must be given by an authorized and qualified personnel.
  • Page 11 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL  Direct sun lights or a near phototherapy device and similar heat producing devices can affect the skin temperature of the newborn. This situation must be given attention.  The values of maximum weight that the parts of the device can carry must be given attention.
  • Page 12 5 kg for the manual stand, and 2,5kg for the drawers. These limits must not be exceeded.  Our Baby Led Force Mini phototherapy device can be used together with our Babyrest M100 Radiant Warmer Bed device. The phototherapy device also needs to be powered from the power supply.
  • Page 13 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL  To connect the heater into a power source, do not use an extension cable. Use only the hospital type power cables and outlets.  Do not use the device in the electromagnetic environments that are stated in the IEC 60601-1-2 standard.
  • Page 14  It must be given attention that the weight of the maximum total auxiliary equipment on the heater must not exceed the maximum value; see the Technical Specifications of Babyrest M100 Infant Heater, which is on the back of this instruction manual.
  • Page 15 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 3.3.5. PRECAUTIONS FOR THE USE OF OPTIONAL FEATURES WARNINGS Always use a patient artificial respiration circuit with an appropriate pressure reducer. Failure  to do so may result in injury or damage to the product.
  • Page 16 Use of the cleaning liquids of the device in a place, where there are anesthetic gases or other  flammable ones, can cause explosion and fire dangers. 3.4. TARGET USER GROUPS FOR BABYREST M100 RADIANT WARMER OPEN BED The following tasks and competencies are expected from the target groups defined for the device. TARGET GROUP...
  • Page 17 The radiant warmer, the operating mode and the temperature control of skin or manual modes are selected from the control module. 4.3. INTENDED USE OF THE DEVICE Babyrest M100 Radiant Warmer Open Bed is a radiant warmer for infants (29 days to 2 years) and neonates (birth to 28 days) who’s classified as; •...
  • Page 18 4.4. ENVIRONMENT OF USE The usage of Ertunç Özcan Babyrest M100 Radiant Warmer Open Bed is appropriate for any hospital department that serves neonatal and infant care, including all levels of the Neonatal Intensive Care Unit (NICU), Special Baby Care Unit, Step Down Nursery, Newborn Nursery, and Pediatrics.
  • Page 19 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 4.6.2. STANDARDS It is designed in compliance with the requirements of the following standards. (93/42/EEC) Directive of Medical Devices, council decisions IEC 60601-1: 2009 IEC 60601-1-2: 2011 IEC 60601-2-21: 2021 (Optional) TS EN ISO 10079-3 Medical Suction Equipment - Part 3 : Suction Equipment Fed by Vacuum...
  • Page 20 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL MODEL M50 6" Monochrome Screen 7" Colored Touch Screen Height (Adjustable) 169 (±1cm) cm Width 60 (±1cm) cm Depth 83 (±1cm) cm Weight ~ 22Kg Turning angle of heater head -130° to +130°(from the center position) Castors 4 X ø75 mm, locking...
  • Page 21 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 4.6.10. RADIANT WARMER OPERATION Radiant Power Heat level 30 % ≤10 mW/cm2 Heat level 60 % ≤18 mW/cm2 Heat level 100 % ≤32 mW/cm2 Bed Canopy (option) concentration with bed canopy on device max.
  • Page 22 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 4.6.15. IP PROTECTION CLASSES AGAINST WATER AND FOREIGN MATERIAL PARTICLES: IPX0 and IP0X Standard Features: Screen • Integrated heater • Intervention lamp • Mattress Tilt feature • X-Ray tray • Skin Probe •...
  • Page 23 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Figure.1 General appearance Figure 2. 7" Colored Touch screen Number Definition Number Optional Features Examination Lamp Monitor Tray Heater IV Pole Examination Lamp 7" Colored Touch-Operated Control Module 6" Monochrome Control Panel Blender...
  • Page 24 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Wheel 4.7. ACCESSORIES LIST The accessories and auxiliary equipment used with the device are CE certified and their list and definitions are given below. PHOTO ACCESSORY AND AUXILIARY EQUIPMENT MANUFACTURER Adapter cable: Use to connect disposable SPO2 probe...
  • Page 25 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 5. SYSTEM INSTALLATION AND CONTROL WARNING: Read this manual completely before using this device. Using the device without completely understanding how to operate can get the patient or the operator injured. Be careful about not damaging the equipment and scratching the unprotected sensitive surfaces, while taking out of the package.
  • Page 26 6. FUNCTIONAL EXPLANATION 6.1. GENERAL This part provides general description about the functions of Babyrest M100 radiant warmer. Start the device from On/Off buttons. At the opening, the device performs a system check with a self-test. Wait for this test to be completed.
  • Page 27 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.2.2. USING MANUAL MODE FOR 7" COLORED TOUCH SCREEN Choose the Manual mode by pressing the Manuel mode function (Figure.3) key. To increase the heating power on the front panel, adjust the desired level of the heating source between 0 % and 100 %, by using the function button.
  • Page 28 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL WARNINGS • It is very important to monitor the skin temperature of the infant, under the radiant heating. While using the heating in the Manual mode, the clinic condition and the skin temperature of the infant must be constantly monitored by using a skin probe.
  • Page 29 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.3.2. USING SKIN MODE FOR 7" COLORED SCREEN Put the skin probe into the socket, on the front panel. Put the infant on the mattress and place the skin probe correctly on the infant’s skin.
  • Page 30 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL WARNING Because it is controlled by the infant parameters, the Skin Mode must be used as much as  possible. It is recommended to frequently check the infant’s condition and keep monitoring.  The skin temperature of the infant, who is under the infant radiant warmer, must be monitored independently.
  • Page 31 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Figure.7 Prewarm Mode 6.5. USING TIMER 6.5.1. ADJUSTMENT OF TIMERS FOR 6" MONOCHROME SCREEN The timer provides the timing of the treatment period and gives an audible warning after the completion of the preset period. At the first minute and then at each five minutes, it gives an audible alarm to warn the user.
  • Page 32 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Figure 8. Timer Setting Completion of the Timer When the treatment period is completed, it gives an audible alarm to warn the user, at the first one minute and at each five minutes.
  • Page 33 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Figure.9 Timer Control 33 / 83...
  • Page 34 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.6. 7" COLORED TOUCH SCREEN APGAR TIMER Apgar timer is active in all modes. The process of Apgar timer starts once you push the Apgar timer button shown in Figure 15. It gives audible alarm in every 1,5,10 minutes after you start timer. Apgar timer warning can be silenced in 10 minutes.
  • Page 35 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.7.2. USING EXAMINATION LAMP FOR 7" COLORED TOUCH SCREEN The device has two units of examination lamps, one of which is on the front panel and the other one is on the warmer.
  • Page 36 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Figure.13 Lamp Control 6.8. KEY LOCK In order to protect the system from accidental interventions, the key lock mechanism has been developed as shown in Figure 14. The scroll bar located at the bottom of the interface can be moved to the right to put the components into passive mode, and by sliding to the left to put them into active mode.
  • Page 37 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Figure 14. Key Lock 6.9. DATE –TIME SETTING By switching to the “Setting” screen shown in Figure 15 with the help of the date-time button located in the upper left corner, the parameters of the real-time clock integration connected to the device can be adjusted.
  • Page 38 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.10. LANGUAGE OPTION The device has two language options, English and Turkish. As shown in Figure 16, you can switch between language options with the help of the “EN” - “TR” button. The device stores the last selected language in its memory and starts from the last selected language when it is turned on again.
  • Page 39 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.11. SCALE The device can measure up to 10 kilograms. Scale symbol is shown in figure 17 in the upper right part of the screen. In addition, calibration should be done so that the scale can measure more accurately.
  • Page 40 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.12. USING TRENDELENBURG The mattress can be adjusted between -8, 5° and +14° to provide the Trendelenburg and Fowler types of positions. To give an inclination to the mattress, grab and squeeze the lock mechanism, located in the right front of the cradle, and adjust the desired inclination.
  • Page 41 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Figure 21. Carriage Arms 6.14. USING SIDE PANELS Opening Side Panels: • In order to open side panels pull the requested panel slightly and pull toward yourself Closing Side Panels: Hold and move slightly the selected side panel.
  • Page 42 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Figure.23 Removing the Side Panel 6.15. GROMMETS The grommets, located in the front and back panels, are designed to hold the cables and hoses up to the diameter size of 34 mm and to reduce the cable crowd around the infant.
  • Page 43 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.16. USING INFANT BED The maximum load that the bed can carry is 10 kg. WARNINGS  Before carrying the bed, ensure that it is flat and the side panels are locked. Use the carriage arm.
  • Page 44 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.18. AUXILIARY EQUIPMENT WARNING: The total of maximum auxiliary equipment weight on the heater must not exceed the permitted maximum limit. 6.18.1. MONITOR TRAY This auxiliary equipment provides a surface to place the devices such as monitors, syringe pump etc.
  • Page 45 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.19. OPTIONAL FEATURES 6.19.1. RESUSCITATION DEVICE PURPOSE OF USE; T-Piece Infant Resuscitator Unit is an easy-to-use, gas-operated medical device that provides control and precise resuscitation of infants up to a maximum of 10 kg in hospital rooms, pediatric rooms and neonatal intensive care units.
  • Page 46 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL thanks to the notches on the flowmeter. The amount of mixture gas flow desired to go to the patient helps to set the desired value by fixing the measurement from the numbers on the flowmeters.
  • Page 47 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL It is connected to the resuscitation unit "T" piece to the "T" piece circuit output section. circuit output The PEEP on the "T" piece is turned off. The hole on the top of the "T" piece is closed by taking it in the palm of the hand.
  • Page 48 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL The hole on the PEEP is opened and closed to ensure the accuracy of the initial safety. This process is repeated several times. After Max.P is set, PIP is slowly opened and the desired PIP setting is made.
  • Page 49 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL PEEP is adjusted by adjusting the cover on the "T" piece circuit. PEEP setting is monitored by manometer. PEEP setting can be adjusted between 1 and 9 cmH2O. 49 / 83...
  • Page 50 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.19.3. USING THE ASPIRATION SYSTEM Vacuum Adjustment Button Close the adjustment button on the Suction (Vacuum) unit. Aspiration Container Connection Port Connect the hose to the suction cup to the connection port on the Suction unit.
  • Page 51 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL There is a strap on the foot of the Tresus device to attach the Suction Cup. Attach the Suction Cup here. 1. Attach the hose that will go to the Suction Cup that you connected...
  • Page 52 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.19.4. OPERATING THE SUCTION (VACUUM) UNIT The Suction (Vacuum) unit will not vacuum unless the adjustment knob on the unit is turned on. The Suction (Vacuum) unit can go up to - 400mmHg. Suction (Vacuum) unit is supplied with air connected to the device.
  • Page 53 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.19.5. USING THE MINI LED PHOTOTHERAPY DEVICE SYSTEM PURPOSE OF USE; Baby Led Force Mini Model Phototherapy Device is a mobile device designed to be used in the treatment of jaundice diseases of newborn babies, providing 400-500 nanometer light that can regulate billuribin by photooxidation.
  • Page 54 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 6.19.7. USING THE ELECTRONIC TRENDELENBURG SYSTEM The device has an electronic trendelenburg system as an optional feature. The system can provide inclination with an angle of ±12 degrees. Trendelenburg system is controlled by two buttons on both sides of the body. The button below provides downward movement and the button above provides upward movement.
  • Page 55 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Functions Key Function On/Off Button: The heater begins to work automatically in its last based mode. Silence: When this button is pressed all of the audible alarms are silenced for 15 minutes (apart from high skin temperature which is 40°C and above).
  • Page 56 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Examination Lamp 1: When the specified part is pressed on the screen, the lamp on the control panel is turned on and off. Examination Lamp 2: When the specified part is pressed on the screen, the lamp on the control panel is turned on and off.
  • Page 57 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL User Language Selection: By pressing the related function button, the language of use is changed from English to Turkish. User Language Selection: By pressing the related function button, the language of use is changed from Turkish to English.
  • Page 58 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 8. ALARMS In the following part, the alarm systems, potential reasons and recommended processes are described. 8.1. 6" MONOCHROME SCREEN ALARM LIST 8.1.1. “CONTROL THE INFANT” ALARM “Control the Infant” is activated when the infant’s skin temperature falls below 30°C in all of the...
  • Page 59 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL • It must be checked that the skin probe is correctly placed on the infant’s skin. A skin probe can be malfunctioning, change the skin probe, if the alarm does not match with the •...
  • Page 60 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL This alarm is not active in the Prewarm or Manual modes. The necessary controls; • It must be checked that the skin probe is correctly placed on the infant’s skin. • The skin probe can be malfunctioning, change the skin probe and have the probe, which is thought to be malfunctioning, checked.
  • Page 61 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL The necessary controls; The heater may have mistakenly removed from the outlet. Check that the cable is connected to • the outlet. 8.1.9. RESUSCITATION DEVICE ALARM In case of oxygen cut-off, air cut-off or inequality of oxygen/air pressure (in cases such as gas leakage), a difference in oxygen/air pressure occurs.
  • Page 62 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL MasimoSET: INTERFERENCE Gives a written and audible alarm when interference is DETECTED detected. MasimoSET: LOW PERFUSION Sounds a written and audible alarm when the perfusion INDEX index is low. MasimoSET: RUNNING IN Sounds a text and audible alarm only once when a demo DEMO MODE or test sensor is connected.
  • Page 63 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 8.2. 7" COLORED TOUCH SCREEN ALARM LIST There is an area in Figure 33 where alarms are monitored to show possible risky situations and to warn the relevant personnel both audibly and visually. While critical alarms cannot be silenced, alarms that have low priority and will not cause serious problems can be silenced for 15 minutes with the help of the "Mute"...
  • Page 64 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Figure 33. High Temperature Alarm WARNING: The infant’s skin temperature must be monitored independently. 8.2.2. “CRITICAL SKIN TEMPERATURE” ALARM “Critical skin temperature” alarm is activated in the Skin Mode, when the difference between the skin temperature and the adjusted skin temperature is 2°C, while the infant’s skin temperature is stable.
  • Page 65 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 8.2.3. “LOW SKIN TEMPERATURE” ALARM Skin Mode “High skin temperature” alarm is activated in the Skin Mode, when the difference between the skin temperature and the adjusted skin temperature reaches to 1°C, while the infant’s skin temperature is stable.
  • Page 66 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL The necessary controls; It must be checked that the skin probe is correctly placed on the infant’s skin. • • The skin probe can be malfunctioning, change the skin probe and have the probe, which is thought to be malfunctioning, checked.
  • Page 67 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 8.2.7. “POWER FAILURE” WARNING In All Modes “Power failure” alarm is activated in all of the modes, when the device’s external power input fails. The device provides a visual and audible alarm by blinking the red indicator light and the heating source is disabled.
  • Page 68 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL MasimoSET: UNIDENTIFIED When an unidentified cable is used, a written and audible CABLE alarm sounds. This alarm cannot be silenced. MasimoSET: FAULTED CABLE When a faulty cable is used, a written and audible alarm sounds.
  • Page 69 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL The measured skin temperature is Turns off only the audible Skin 2°C above the adjusted temperature alarm for 15 minutes Excessive Skin The measured skin temperature is Turns off only the audible Manual Temperature 2°C above the adjusted temperature...
  • Page 70 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 9. CLEANING AND MAINTENANCE-REPAIR WARNING: Do not change the location of the device, before removing all of the auxiliary devices. Before implementing the maintenance or repair processes, unplug the power cable of the device to cut the power.
  • Page 71 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 9.3. CLEANING After each patient or at least once a week, the device must be cleaned and disinfected. The most efficient way is to clean by disassembling. The disassembly steps are described in part 3.6, 3.7 and 3.8.
  • Page 72 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL ATTENTION: • Do not expose a skin probe to an autoclave or do not sterilize with gas. • Be careful that a skin probe is removed from the control equipment by holding only from the plug, in the front panel.
  • Page 73 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 9.3.5. CLEANING MATERIALS Iodophor or detergent with four effects should be used. While using any kinds of antiseptic cleaning material, read the instructions of its manufacturer. ATTENTION:  Do not clean the device with organic solutions, strong acids or bases. These compounds can damage the parts.
  • Page 74 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 10. TROUBLESHOOTING Troubleshooting for the device is given in Table 5. In case the trouble is not detected from the tables, the unit must be repaired by qualified service personnel, who were trained by an Ertunç Özcan technical service.
  • Page 75 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 11. AUXILIARY EQUIPMENT TO BE ORDERED Part No Description of Parts 700-110-007 REUSABLE SKIN SENSOR 410-301-001 BABYREST M-100 IV POLE KIT 410-301-002 BABYREST M-100 MANUAL STAND KIT 301-407-000 BABYREST M-100 CUSHION 75 / 83...
  • Page 76 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL 12. NOTIFIED BODIES INFORMATION ACCORDING TO THE MDD (93/42/EEC) MEDICAL DEVICE DIRECTIVE; When the device features or performances are noticed to have tensions or functioning failures which may cause deaths or cause health issues to the patient or the end-user. When there is a deficiency instruction that may cause these dangers, deactivate the device and contact with our authorized representatives if you are stated in the European community or our head office.
  • Page 77 Guide and Manufacturers Declaration on Electromagnetic Emissions Babyrest M100 radiant warmer open bed is aimed to be used in the below stated electromagnetic environment. The customer or user of the Babyrest M100 radiant warmer open bed, must guaranty to use this device in these environments.
  • Page 78 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Guide and Manufacturers Declaration on Electromagnetic Immunity Babyrest M-100 radiant warmer open bed is aimed to be used in the below stated electromagnetic environment. The customer or user of the Babyrest M-100 radiant warmer open bed, must guaranty to use this device in these environments.
  • Page 79 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL Guide and Manufacturers Declaration on Electromagnetic Protection Babyrest M-100 radiant warmer open bed is aimed to be used in the below stated electromagnetic environment. The customer or user of the Babyrest M-100 radiant warmer open bed, must guaranty to use this device in these environments.
  • Page 80 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL calculated in the suggested stand apart distance of the frequency gaps located on the feeder. • The field strength spread from the stable feeder cell towers for the radio telephones (cellular/wireless) and land radios, amateur radio AM and FM radio broadcast and TV broadcast may not be theory accurately estimated.
  • Page 81 BABYREST M100 USER, MAINTENANCE AND SERVICE MANUAL IEC 60601-1-2 Suitability Electromagnetic environment-Guide Immunity Test Test Level level Information Babyrest M-100 radiant warmer open bed must be used only in environments 3 Vrms that have the lowest RF isolation. Also 150 kHz and...
  • Page 82 Babyrest M-100 Kullanım, Bakım ve Servis Kılavuzu The field strength spread from the stable feeder cell towers for the radio telephones (cellular/wireless) and land radios, amateur radio AM and FM radio broadcast and TV broadcast may not be theory accurately estimated. To evaluate the electromagnetic fields caused by RF feeders, an electromagnetic field research must be considered.
  • Page 83 Babyrest M-100 Kullanım, Bakım ve Servis Kılavuzu 14. ANNEX B -INFORMATION OF COMPLIANCE OF STANDARDS AND DIRECTIVES Ertunç Özcan has approved that; the device, its use, maintenance and service is in accordance with the European Commission Directive 93/42 EEC Medical Device Directive. The second icon states that the electric or electronic equipment shall not be thrown away in a classified municipal waste and that it must be collected separately.