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- Frank`s Hospital Workshop

1. 9 To return to Display 2 press the Home key Re weigh 1 Tore weigh the infant without removing or adding anything to the mattress press the Weight softkey on Display 2 2 Ifany objects are added or removed from the mattress or a power failure occurs refer to Initial Weigh on page 5 28 to ensure accurate measurement of the infant weight EU Scale Measurements The EU scale continuously displays the active weight of the infant in the Trend Alarm window To initiate the weighing function 1 Ifnecessary unlock the keypad 2 AtDisplay 1 press the Display Selection key and select Display 2 3 At Display 2 press the Weight softkey 4 At the Weight screen press the gt 0 T lt softkey NOTE The Lift Baby indicator and Weight Sample bar are displayed The Weight Sample bar is used only to indicate the progress of the zeroing feature 5 Lift the infant off the mattress 6 When the Lift Baby indicator is removed place the infant on the mattress 7 To enter the infant weight for trending press the Store key 8 To return to Display 2 press the Home key Oxygen Control A WARNING If the patient s arterial oxygen levels cannot be maintained when the oxygen control settings is set to maximum the attending physician should prescribe alternate means of oxygenation Failure to do so could result in personal injury or equipment damage In Oxygen Control mode the oxygen sensors and control valv
2. 0 cee tenn 4 20 UPS System Operational Checkout 6 4 4 cas es 4ned bei a Side a cas 4 21 Check On Off Test Switch and Low Battery Alarm oo oooo oooooooo momo 4 21 Test Battery Back up FUnctOR Vee eee ae ete aaa eae 4 22 Rail System Operational Checkout cas eerie aad ARA AE os Fee 4 22 Oxygen Control Module Operational Checkout 0 0 0 4 22 Humidity System Operational Checkout ios cos ii aed eho aie ona tae teen is 4 23 Weighing System Operational Checkout 0000s 4 23 Non EU Scale cis er to BRS SA de BE o PERLE Re Sess 4 23 EU SCAG ais tases tae uae aa ee aaa Ree atest eu Seer T ena eens 4 24 Section 5 Instructions for Use Controls Indicators and Connectors 0 ee eee eee eee eee ee ene 5 1 CODI A tgs A a a oie nk eee tata age 5 1 Incubator Controls y sido pes eds ste dais ds septa a ee 5 1 HIGHS E Sik kia CES Gite oo AG ek eG T eee ek 5 1 SOLES 1 wee staked aire aay A A AA AAA AAA a ee A 5 2 Incubator Indicators 2 sone onesie A Soak oo Oe ee CA ra E ele S 9 5 3 Incubator Connectors oncaeid tee e oa See ee 5 4 Controller Interface Conte cio ds Seep ey Ae a ARES i nd ns Oe 5 4 Serial POL sxc st hae eae aa kh gee A E SS Aiea y Salle 5 4 Sensor Mod le Et DO A Sere Moe E A E deen AE erg Gah eee wet 5 5 Sensor Module Controls seseg dE IS A a aate 5 5 Sensor Module dic dd A ed 5 5 Sensor Module Connectors sene A A Se eas ek Ce aE AA 5 5 E A iho ee aes meee ene st 5 5 Stand Contro
3. WARNING Inspect gas oxygen service components at regular service intervals for signs of corrosion or damage Failure to do so could result in personal injury or equipment damage A WARNING Routinely inspect oxygen cells for signs of degradation or leakage and replace if necessary Failure to do so could result in personal injury or equipment damage A WARNING The administration of oxygen may increase the noise level for the baby within the incubator Personal injury could occur 6 8 2 9 Humidity Precautions A WARNING Higher relative humidity will at any given time decrease an infant s evaporative water loss and may cause an increase in infant temperature This effect is greatest in very low birth weight premature infants The attending physician should prescribe Temperature Control mode temperature setting and humidity output level setting Routinely monitor the infant s rectal and or axillary temperature according to the attending physician s orders or Nursery Standing Orders Failure to do so could result in personal injury 4h WARNING Make sure all hood access door gaskets and tubing ports are properly installed Any open gaps in the incubator hood will reduce the incubator s internal relative humidity Personal injury or equipment damage could occur A WARNING Fill the reservoir to the Maximum Filling Limit line Do not overfill Water spillage may result and personal injury could occur Ay CAUTION
4. on page 5 7 Temperature Window The Temperature window also displays the actual air and or skin temperature and the set Temperature Window point temperature of the controlling parameter A a Temperature xs i 36 0 Skin Pressing the available softkey enables the user skin 1 Skin 2 Humidity to access the corresponding displays or perform 35 6 35 6 Oxygen Humidity a designated function Trend Alarm Window Four standard parameters are presented as trend graphs in the Trend Alarm window see Displays on page 5 9 air temperature skin temperature 1 skin temperature 2 and heater power 40 Air Temp Oxygen 2 Hours Humidity Y Window S 50 so o Set Trend Window Alarm Silence Reset Key 50 50 A Oxygen Window Additional trend displays are also available Menu Options Menu Option when the unit is equipped with any of the KI e Temperature A a rad following Oxygen Servo Control System 35 6 a Ge n Humidity System and Weighing System 35 6 35 6 Oaer The trend time is user selectable in intervals of uee 202 e DD i s 2 4 8 12 and 24 hours These intervals are ia longn E applicable to all parameters except weight i 50 which provides a trend of seven days S A Humidity Window When the Humidity mode is activate
5. verify that the access door swings open Close the doors and check for proper latching and quietness Check that the access door gaskets are properly installed in the port opening behind the access door If installed check that the cuff is properly placed on the access door gasket NOTE When installed correctly there is a small opening in the center of the cuff 5 Check that the inner walls are properly latched 6 Check the mattress elevators a a Open the front and rear optional access panels and check that the front and rear inner walls are properly latched and the door open symbol turns on Close the front and rear access panels and check that the door open symbol on the controller display turn off Rotate the right mattress tilt mechanism knob counterclockwise until it stops Check that the mattress is in the full up position Rotate the knob clockwise until it stops Check that the mattress is level Repeat steps a and b for the left mattress tilt mechanism knob 7 Check the mattress tray operation 18 a Rotate the pawl latches and open the front access panel b Pivot the front access panel to the full open position hanging straight down c Slide out the mattress tray to the fully extended position d Carefully lean on the mattress tray to ensure it is properly supported and provides a firm infant platform Return the mattress tray f Close the front access pa
6. 3 Verify that the stand operates smoothly and adjusts to the desired height 4 Repeat steps 2 and 3 for the foot pedal control at the rear of the unit UPS System Operational Checkout OPTIONAL FACTORY INSTALLED FEATURE FOR C2000e ONLY A WARNING Do not plug the AC input supply power cord of the uninterruptible power supply UPS system into any of the output receptacles on the incubator stand This is a safety hazard and may cause irreparable damage to the UPS system 1 Ensure the AC power cord is plugged into the AC inlet of the UPS electronic module and a properly grounded 3 wire hospital grade or hospital use outlet 2 Ifthe unit is switched off at the UPS electronic module press and hold the On Off Test switch for 1 second or until the system beeps 3 Press the Power Switch on the incubator 4 Verify when initially turned on all LED indicators are turned on the audible alarm pulses and after a few seconds the Bypass LED turns off 5 Ifthe unit fails the self test remove it from service If the unit fails the self test the Fault LED turns on If AC power is still available the Bypass LED is also illuminated BATTERY E Check On Off Test Switch and Low Battery Alarm 6 Atthe UPS electronic module press and hold the On Off Test switch for 1 second or until the system beeps 7 Verify that the system toggles on off 8 Quickly press the On Off Test switch lt 1 second in the line mode and then ve
7. Model C2000e only 85 441 53 MU14779 Drawer housing assembly shallow long Model C2000e only 85 441 56 MU14782 Swivel drawer assembly large C2000e Model C2000e only 13 14 Part Number Description 85 441 60 MU14785 Drawer housing assembly deep short Model C2000e only 85 441 61 MU14786 Drawer housing assembly deep long Model C2000e only Integris Fairfield Rail Acce ssories 85 442 00 MU14790 Monitor shelf assembly high C2000e 85 442 14 MU14791 Monitor shelf assembly low C2000e 85 444 00 MU14792 LV pole assembly C2000e 85 460 02 MU14802 I V resuscitator bag holder assembly 85 460 03 MU14804 Basket 18 0 W x 9 5 D x 4 0 H assembly 85 460 04 MU14806 Basket 6 5 W x 4 0 D x 5 0 H assembly 85 460 05 MU14808 Basket 11 0 W x 4 0 D x 4 0 H assembly 85 460 06 MU14810 Basket pivoting assembly 85 460 07 MU14812 Chart holder assembly 85 460 08 MU14814 Hinged tray 13 5 W x 9 75 D assembly 85 460 09 MU14816 Hinged tray 17 0 W x 11 5 D assembly 85 460 10 MU14818 Cable organizer assembly 85 460 11 MU14820 Horizontal cord wrap assembly 85 460 12 MU14822 Standard cam adapter assembly 85 460 13 MU14824 Ball action adapter assembly 85 460 14 MU14826 Double cam adapter assembly 85 460 15 MU14828 Cam adapter threaded assembly 85
8. Ge 6 sensor module housing Screw the sensor cells into the oxygen cell mounting plate provided Connect the sensor cells to the sensor module NOTE The cable connection can plug into either sensor 7 8 9 10 Install the oxygen cell mounting plate on the sensor module Replace the sensor module in the hood Activate the oxygen system see Oxygen Mode on page 5 30 Calibrate the oxygen system see Oxygen Sensor Calibration on page 5 36 Oxygen Calibration Fixture To install the 100 oxygen calibration fixture NOTE Do not install when the incubator is configured for 21 oxygen see System Configuration on page 5 22 1 Withdraw the sensor module from the hood Pull out on the clip located on the left side of the module and remove the module from the hood Rotate the pawl latches and open the front or rear optional access panel of the incubator 2 3 4 Remove and retain the two mounting screws securing the cover plate slide fixture 5 Remove the cover plate slide fixture If equipped also remove the sensor module slide lock 6 Ensure the proper positioning of the O ring on the provided 100 calibration fixture NOTE The 100 calibration fixture is packaged with a small O ring which is coated with a lubricant The O ring could possibly O N become loose during shipping ii O Ring Proper Positioning 7 Mount the sensor module slide lock and 100 calibration fi
9. If the sensor module is not con nected connect it If the message persists 1 Replace the sensor module 2 Ifthe alarm still continues turn the incubator off and reposition the sensor 3 Ifthe alarm persists remove it from service The Remove Skin 2 Probe alarm is activated While in the Skin mode a second probe is connected to the sensor module Remove the second probe or place the unit in the Air mode While in the Air mode with two probes connected the user attempts to enter the Skin mode Remove the second probe and press the Alarm Silence Reset key The Oxygen Cell Different alarm is activated The oxygen cell readings between the two oxygen cells differ by gt 3 Perform the oxygen calibration see Oxygen Sensor Calibration on page 5 36 The Oxygen Solenoid Failed alarm is activated The oxygen solenoid failed Turn the incubator off and remove 1t from service The Low Humidity alarm is acti vated The humidity reservoir is empty Refill the reservoir If the alarm persists turn the incubator off and remove it from service The Humidity Heater Failed alarm is activated The humidity system malfunctio ined Turn the incubator off and remove it from service The Too Much Weight message is activated Weight in excess of 7 Kg 15 Ib is on the mattress Remove the excess weight When zeroing the scale weight in excess of 3
10. The customer or user of the C2000 should ensure that the unit is used in such an environment Immunity Test IEC 60601 Test Compliance Level Electromagnetic Environment Level Guidance ESD 6 kV contact 6 kV contact The floors should be wood concrete or IEC 61000 4 2 8 kV air 8 kV air ceramic tile If floors are covered with synthetic the relative humidity should be at least 30 EFT 2kV Mains 2kV Mains Mains power quality should be that of a IEC 61000 4 4 1 kV I Os No I Os typical commercial or hospital environment Surge 1 kV Differential 1 kV Differential Mains power quality should be that ofa IEC 61000 4 5 2kV Common 2kV Common typical commercial or hospital environment Voltage Dips Drop out IEC 61000 4 11 gt 95 dip for 0 5 cycle 60 dip for 5 cycle 30 dip in for 25 cycles gt 95 dip for 5 sec onds gt 95 dip for 0 5 cycle 60 dip for 5 cycle 30 dip in for 25 cycles gt 95 dip for 5 sec onds Mains power quality should be that ofa typical commercial or hospital environment If the user of the C2000 requires continued operation during power mains interruptions it is recommended that the C2000 be powered from an uninterruptible power supply or battery Power frequency 50 60 Hz Magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be that of a typical commercial or hospital
11. but the servo controlled oxygen system is not active and or installed This message is displayed after power is supplied from the Main Power switch and the system is performing the self test This message is displayed when no alarm conditions are present and the Alarm Silence Reset key is pressed 17 System Prompt Messages Check Skin Probe Description This message is displayed in the Air mode if the Skin1 probe is electri cally open or shorted or if in the air mode the two Skin1 probe ther mistors deviate by more than 0 8 C or if in either Air or Skin mode the Skin1 probe is lt 16 9 C Check Skin2 Probe This message is displayed in the Air mode if the Skin2 probe is electri cally open or shorted or if in the Air mode the two Skin2 probe ther mistors deviate by more than 0 8 C or if in either Air or Skin mode the Skin2 probe is lt 16 9 C Scale Disconnect This message is displayed when a weighing function is initiated but the controller determines that the scale is disconnected Too Much Weight This message is displayed when the controller determines that the weight placed on the scale is gt 7 Kg Calibration Failed This message is displayed when the scale fails the 5 Kg calibration Clear Mattress This message is displayed when a scale calibration is attempted and there is gt 1 Kg on the mattress Wait This message is displayed during the zeroing
12. 35 6 36 0 i Skin Skin 2 7 select Display 2 356 356 lt r 3 At Display 2 press the Weight softkey 20 Air Temp 2 kours Humidity A 50 S j Oxygen l 50 Set 50 4 Press the gt 0 T lt or Zero softkey The Lift Baby indicator is displayed Air Temperature C 5 Lift the infant off the mattress Set 36 0 36 0 6 When the Lift Baby indicator is removed place the Skin 1 Skin 2 infant on the mattress 35 0 35 1 Weight 1 070 SA 7 The Weight Sample bar fills and the weight of the infant is displayed in the Trend Alarm window m Temperature Store x 35 6 360 gt 0 T lt _ 8 To enter the infant weight in the Trend Alarm Skin 1 Skin 2 K window press the Store key 35 6 35 6 Tome 1 L Humidity Y NOTE The trend of the infant weight is tracked over a period of 7 days or seven 24 hour periods The first stored weight is used as the baseline weight measurement and initiates the count for the first 24 hour period The first trend data represents the difference between the baseline weight measurement and the last weight stored during that 24 hour period Subsequent trend data for the remaining 6 days represent the difference between the last stored weight within a 24 hour period and the baseline weight measurement Set 50 5 Oxygen Y Set 50 50 Weight 1 134 Kg
13. 37 0 C 98 6 F gt 0 T lt Zero Tare or Zero softkey The gt 0 T lt softkey is available at the Weight display When pressed it provides zero setting and tare balancing Incubator Indicators C F indicator Temperature C The C F indicator displays Celsius or Fahrenheit degrees for the air temperature skin temperature and set point parameters Power Failure indicator The Power failure indicator lights when an interruption in power occurs g gt 37 C indicator The gt 37 C indicator lights when the set temperature is set to 37 C 98 6 F or higher iiai Door Open indicator The Door Open indicator lights when the front and or rear optional access panel s open s Lift Baby indicator The Lift Baby indicator is displayed during the zeroing routine It prompts the DEN user to lift the infant from the mattress O J 4 5 kg symbol The 5 kg symbol is displayed during the calibration routine It prompts the user to 5 Kg place a 5 kg weight on the mattress Rotating Wheel symbol The Rotating Wheel symbol indicates the active status of a mode of operation This gt symbol is displayed on the front panel in the respective window of the controlling parameter Weigh Sample bar non EU scales The Weigh Sample bar is used to display the progress of the weight sampling for the scale Level indicator The Level indicator is circular and mounted on the scale When the level indicator bubble i
14. DISS male C2000e 85 62091 R MU16949 Oxygen assembly white DISS female C2000e 85 620 92 R MU16950 Oxygen assembly NIST fitting male C2000e Humidity 83 615 70 R MU17605 Humidity system assembly 120V C2000 Colder Products Company fitting English Spanish French German Italian 83 615 80 R MU17606 Humidity system assembly 230V English Spanish French German Italian 83 615 81 R MU17607 Humidity system 230V Swedish Greek C2000 Colder Products Company fitting 83 61590 R MU17608 Humidity system assembly 100V C2000 Colder Products Company fitting 85 615 70 R MU17609 Humidity system assembly 120V C2000e Colder Products Company fitting 85 615 80 MU14922 Humidity assembly 230V English Spanish French German Italian C2000e 85 615 81 MU14923 Humidity system assembly 230V Swedish Greek C2000e Colder Products Company fitting 83 613 60 R MU13198 Retrofit humidity system reservoir English Spanish French German Italian Drawers and Tank Holder 83 440 00 R MU17879 Swivel drawer assembly large C2000 only 83 441 00 R MU17880 Swivel drawer assembly small C2000 only 83 443 00 MU12952 Oxygen tank bracket assembly Isolette 85 441 17 MU14751 Tray assembly large Model C2000e only 85 441 46 MU14776 Swivel drawer assembly small C2000e Model C2000e only 85 441 52 MU14778 Drawer housing assembly shallow short
15. Dimension Physical Fixed Height Stand Top of hood to floor incubator with FH stand Mattress to floor incubator with FH stand 142 cm 56 12 7 mm 4 100 97 cm 39 12 7 mm Weight without UPS system and accessories 49 4 kg 109 Ib Variable Height Stand Top of hood to floor incubator with VHA stand Mattress to floor incubator with VHA stand 133 35 cm 52 12 7 mm 4 to 152 cm 60 12 7 mm 4 90 17 cm 35 4 12 7 mm to 110 43 12 7 mm 4 Weight with UPS system and accessories lt 97 kg 214 Ib UPS Battery pack weight 9 5 kg 20 9 Ib Electrical Fixed Height Stand Power requirements for 100V 120 FH stand 100V for Model C2000 only 100 V 120 V 50 60 Hz 9 9 A maximum Power requirements for 230V FH stand 230 V 50 60 Hz 9 9 A maximum Variable Height Stand Power requirements for 100 120V VHA stand 100V for Model C2000 only Without UPS 100 V 120 V 50 60 Hz 9 9 A maximum With UPS 120 V 50 60 Hz 11 A maximum Power requirements for 230V VHA stand model With and without UPS 230V 50 60 Hz 9 9 A maximum UPS Feature Input current breaker rating Dimension 15 A for 120 V 7A for 230 V Output circuit breaker rating 10 A for 120 V 5 A for 230 V Input frequency 50 60 Hz auto sensed by the microprocessor 45 65 Hz inverter phase lock frequency ra
16. Electronic Module Controls en Display Panel AC Input Connector The exposed panel of the UPS electronic module contains the following controls 6 e Resettable circuit breaker o e Inverter On Off Test switch located on the o UPS electronic module display panel Q Air Filter Resettable On Off Circuit Breaker UPS Electronic Module Indicators The front panel of the UPS electronic module contains the following indicators Load Level LED Bar when illuminated the 4 LED bars indicate the relative load level range 20 40 40 60 60 80 80 100 Overload LED the red LED indicates an overload condition e System Fault LED the red LED indicates one or more of the following fault conditions the system may need service the connected load is too large or there is a short circuit e Low Battery LED the red LED indicates that the batteries are low and the battery back up mode of the UPS system will soon shut down Battery Level LED Bar when illuminated the 4 LED bars indicate the relative battery condition and back up time available on a scale from Full to Empty Line Load Status LED the blue LED indicates that AC power is available Invertor Status LED the blue LED indicates that the UPS system is on line This LED should always be illuminated while the UPS system is in normal operating mode or in a battery back up mode If the Invertor Status LED is not lit the inverter has shutdown and should
17. The sensor module has one alarm indicator Sensor Module Connectors The following connectors are found on the sensor module e Skin probe 1 connector e Skin probe 2 connector e Oxygen sensor receptacle e Scale connector Skin Probe 1 Connector Alarm Indicator Skin Probe 2 Connector Weighing Scale Connector Air Temperature and Controller Interface Cable Humidity Sensor Housing Oxygen Sensor Receptacle Stand Below are the fixed height and VHA stand controls indicators and connectors Stand Controls Main Circuit Breaker The main circuit breaker is located on the stand assembly for all units not equipped with a uninterruptible power supply UPS system For units equipped with UPS systems refer to UPS Electronic Module on page 5 7 Main Circuit Breaker Locations Incubator Model Stand Configurations Main Circuit Breaker Locations Models C2000 and C2000e Fixed Height stands without UPS sys On the stand column below the AC receptacles tems convenience outlet strip Model C2000e only Fixed height stands with UPS systems On the UPS electronic control module Model C2000e only Variable height adjustable VHA At the rear below the stand column stands without UPS systems Model C2000 only VHA stands without UPS systems At the right side of the unit between the stand legs Model C2000e only VHA stands with UPS systems On the UPS electronic control module
18. Tray Usage A WARNING For infant safety do not leave the infant unattended when the access panel is open Personal injury could occur To use the x ray tray perform the following steps 1 AS eee ae For units equipped with the rail system remove any accessories that may interfere with front access panel movement Rotate the pawl latches and open the front access panel Slide out the x ray tray from under the mattress Mattress Place the x ray cassette in the center of the x ray tray Tray Push the x ray tray back in under the mattress Place the infant at the center of the mattress Close the access panel and ensure the pawl latches are fully engaged When the x ray is completed repeat steps 1 and 2 shave X Ray Tray Remove the x ray cassette from the tray and return the tray 10 Close the access panel and ensure the pawl latches are fully engaged 11 Replace any accessories that were previously removed Non Servo Control Oxygen Usage A WARNING The oxygen flow rates labeled on the incubator and percentages displayed on the oxygen display cannot be used as an accurate indication of oxygen concentrations in an incubator and should only be used as a guide Measure oxygen concentrations with a calibrated oxygen analyzer at intervals directed by the attending physicians Failure to do so could result in personal injury or equipment damage To use non servo control oxygen perform the followin
19. add a flat washer and a nut Rail Sapport 5s 12 Tighten the screw and nut using a hex or Assembly socket wrench 13 Repeat steps 9 through 12 for the 3 remaining secondary rails NOTE Two secondary rail supports are required on both sides of the incubator stand 14 15 16 17 18 19 20 21 22 23 Face the locating holes on the 2 short rails towards the rear of the unit and determine whether they mount to the left or right of the unit At the left or right side of the incubator stand align the 3 screw holes at each end of the corresponding short rail with the 3 screw holes on the 2 corner brackets Lift the short rail over the 2 corner brackets and with a twisting motion engage the long groove of the short rail on the 2 corner brackets Corner Bracket WA Long Rail Short Rail A P THO 0 7 Ja Secondary o Rail Internal Tooth Washer Flat Washer Screw xN Rail Support 10 32 x 7 16 Assembly Ensure that the protruding nuts at each end of the short rail are mounted properly through the mounting holes on the corner brackets Loosely secure the short rail to each corner bracket with 3 screws 10 32 x 7 16 and internal tooth washers using a hex wrench Loosely secure the unfastened end of each secondary rail support to the short rail with the 2 screws 10 32 x 7 16 flat washers and internal tooth washers using a hex wrench Tighten the screws using a hex wren
20. and calibration routine Zeroing Failed This message is displayed when an additional weight in the mattress exceeds 4000 500 g when zeroing during infant weight 100 Cal This message is displayed when the oxygen system is performing 100 calibration 21 Cal This message is displayed when the oxygen system is performing 21 calibration Cal Fail This message is displayed when the oxygen calibration fails Cal Pass This alarm occurs when the oxygen calibration passes Cal Required This message is displayed when oxygen control is selected after a power up or after the sensor module connector is disconnected from the incubator Oxygen Cal Required This message is displayed when re calibration is required to use the oxy gen control This occurs after seven days of continuous oxygen control Slide Out Sensor This message is displayed when the Cal softkey is pressed but the sen sor module is not pulled out into the calibration position 18 Infant Placement To place an infant in the incubator perform the following A WARNING Prior to placing the infant in the incubator pre warm the incubator to the temperature prescribed by the attending physician or according to nursing protocol Failure to do so could result in infant injury Pre warm the incubator If rail accessories are mounted on the front rail remove them Rotate the pawl latches and open the front access panel Place the infant in the center
21. asada ars tdo po ts 6 4 Access Door Gaskets and Tubing Access Ports 20 0 0 cece cee 6 4 Controller Shell and Stand 0 0 ccc eee ee eee eee ees 6 4 Sensor Module Hood and Inner Walls ooooooooooooonoooo 6 5 Heater Radiator and Fan Impelletics24 01 onsen seey edd iaeev RA Dye 6 5 H midity Reservoir nares Is ES PR Ww a ks SA 6 6 Air Intake Microfiltet ou taser Sib oe ee Raho cele AA Mele Raa AERA A 6 6 Base Covers Rail and Accessories Drawers Tank Mounts Monitor Shelf and LV Pole 0 cc eee eee eee eens 6 6 Mattress Mattress Tray X Ray Tray Main Deck Heater Impeller Cover Scale Optional and Mattress Tilt Bars 0 ete nee 6 7 Uninterruptible Power Supply UPS Air Filter 0 eee eee 6 7 Reassembly After Cleaning iS ind t PAA A akc a A dl 6 7 Disposal ii A A BORG did Renee A A GAL Se A Bee ee ed 6 9 Maintenances x 5 0 3 35 a dat io 6 10 UPS Battery Pack Mame od SR ener emg ecg ae 6 10 UPS Electronics Module Maintenance o oooooooororornrorarncnora orcos 6 11 Air Intake Microfilter Maintenance ori PA ta 6 11 Replacement Pants ud A e 6 12 Section 7 Troubleshooting 1 General O E O ON O 7 1 Symptom Cause and Reme e da ida 7 1 vi Section 1 Definitions Intended Use and Disclaimer Definitions This manual contains different typefaces and icons designed to improve readability and increase understanding of its content Note the following examples e Sta
22. eee aa wa eas 5 31 H miditv Mode ras PE E eas EE ADA ER E Aas as 5 31 Humidity Control SetPoint reia 5 32 SV Ge Let MOM MOTI aa So caret A esas A ce A aie a 5 32 X Ray LUST es elas A acd We A A Re CES BA OE BN Oe ee eRe 5 33 Non Seryo Control Oxygen Usage norris Pt dea 5 33 Calibration saie ee at eBay ee Gis GI ee BA AG ASS Wate Eas Ua aS 5 34 Scale Calibration for the Non EU Scale 3 sac pa eel ge dae sae A 5 34 Oxygen Sensor CalDraton ova nie eda hte te aa ade WEA VERE WHO ilo MEM E ERM 5 36 Oxygen Sensor Calibration to Room Air 21 00 0 eee eee 5 36 Oxygen Sensor Calibration to 100 Oxygen 0 ccc eee eee 5 37 Patient Transporters e ithe ine o ca Ce de e adi Mi a cel 5 38 Section 6 Cleaning Maintenance and Replacement Parts Clica 6 tea LA DAR e td E ES a rd E ly RR ES 6 1 General Clear A E A anes 6 1 SEA a A DA Ir See etre di 6 2 SAME E A A A A A A age Mots 6 2 Disinfect 3 ene ecw sate ei ee cows ate A EE Osi aay elu eae Gan el 6 2 Disassembly for Cleaning AA A A eee 6 2 Mattress Tray X Ray Tray Main Deck Scale optional oooo oo ooooo o 6 3 Heater and impeller iaa A A and eae Pas Ce ea Oe OS 6 3 Humidity Tray and Reservoir Non CPC 0 0 0 0 6 3 Humidity Tray and Reservoir CPC 20 0 cette nee ene 6 4 Access Door Gaskets Tubing Iris Entry Port Sleeves Cuffs 6 4 Air Intake Microfilter sia atada 6 4 Cleaning Procede a a tata 6 4 Reusable Skin Temperature Probe
23. environment Guidance and Manufacturer s Declaration Immunity The C2000 is intended for use in the electromagnetic environment specified below The customer or user of the C2000 should ensure that the unit is used in such an environment Immunity IEC 60601 Compliance Electromagnetic Environment Guidance Test Test Level Level Recommended Separation Distance Portable and mobile communications equipment should be separated from the C2000 by no less than the distances calculated listed below Conducted 3 Vrms out V1 3 Vrms RF side ISM V2 10 Vrms D 1 167 P outside ISM IEC 61000 4 20Vrms in 6 ISM bands D 1 2 P in ISM 150 KHz to 80 MHz Radiated RF 10 V m E1 10 V m 7 er D 124P 20 MHz to 800 MHz 80 MHz to 2 5 GHz D 2 3 P 800 MHz to 2 5 GHz where P is the maximum power in watts and D is the recommended separation distance in meters Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance levels V1 V2 and E Recommended Separations Distances for the C2000 The C2000 is intended for use in the electromagnetic environment in which radiated RF disturbances are con trolled The customer or user of the C2000 can help prevent electromagnetic interference by maintaining a mini mum distance between portable and mobile RF Communications Equipment and the C2000 as recommended according to the maximum output
24. failure is detected with the watchdog timer test Controller Failure 11 N A N A This alarm occurs when a failure is detected with the relay test Controller Failure 12 N A N A Not used Controller Failure 13 N A N A This alarm occurs when a failure is detected with the heater circuit after the relays are off for 1 min This can also occur if the current is above the maximum limits during power up Controller Failure 14 N A N A This alarm occurs when the heater current is low Controller Failure 15 N A N A This alarm occurs on start up when it is detected that a single parameter from non volatile mem ory has been modified Controller Failure 16 N A N A This alarm occurs on start up when it is detected that values of multiple parameters from non volatile memory have been modified Controller Failure 17 N A N A This alarm occurs when a periodic check of all parameters stored in non volatile memory deter mines that parameters have been modified with out operator action Heater Failed 1 5 min N A This alarm occurs when the incubator heater thermocouple voltage exceeds 40 mV Heater Failed 2 N A N A This alarm occurs when the heater thermocouple wires are open or shorted Humidity Heater Fail 15 min N A This alarm occurs when the optional humidity system is installed and the humidity heater cir cuit draws too much current Sensor Disconnect N A N A This alarm occurs when communication with the sensor module fails Sensor Out of Posit
25. gt 37 C key is inoperative until the skin set temperature has been set to 37 0 C 98 6 F 4 To confirm the Skin Set Temperature setting and return to Display 1 press the Home softkey NOTE Once stabilized the incubator temperature stays within 0 5 C of the set temperature 5 To lock the keypad press the Keylock key Controller Screen Settings NOTE The following procedures apply only to LCD color screens To select the display color 1 At page 1 of the System Configuration menu press the Display Selection key 2 Use the Up Arrow and Down Arrow keys to select the display colors white on blue default or yellow on black KI J 37 C ID SYSTEM CONFIGURATION 1 OF 2 Humidity Option NO Oxygen Option NO KEON Oxygen Cal Level 21 Skin Temp Alarm Limit 0 5C Skin Control Mode YES Language English Weight Units kg Air Set Temp 35 0 C Altitude Oft om VueLink NO 3 Press the Alarm Silence Reset key to exit the System Configuration menu K SYSTEM CONFIGURATION 2 OF 2 Display Color White on blue Skin Probe Attachment NOTE The sensor module is equipped to accept two skin probes Single Temperature Monitoring 1 4h WARNING Never place the skin temperature probe under the infant or use it rectally Personal injury could occur AA WARNING While operating in the Skin mode insert a skin probe into the Skin
26. he Bare nd Bao ah a ee a AAA e 3 7 Section 4 Installation and Operational Checkout A E rae eee aR aes 4 Unpackasin ee ea ts ee eS ee ADA a a aie 4 2 C2000 Stand Aemet A a abe haha ude Bun gee ee 4 2 CIOU0E Stand Assembly ost ew evidence tite cee cae wire tee he een cows wire aaa ate 4 2 Rail Assembly and Accessories Installation 00 cece cee eens 4 3 Integris Fairfield Compatible Rail Assembly 0 0 0 0 c cece eee 4 3 Deutsche Institute von Normen DIN Rail Assembly 0 0000 cee eee 4 5 Ran A CCC SSOMGSY 955 5 ag Pras gain ach thie OS ae Se PAE Se OWS AOE ae ee 4 7 Hood Shell and Stand Assembly ii hou sae He BV SYS eae ae eee 4 8 Mattress Restraint Strap Installation 2 2 0 0 ec eee een ens 4 9 UPS System Installation iasi wad ahid eee A o c 4 10 A AA A eg hig enact a ahd casts ree ta te ean ig neil Creat ah eae ah 4 11 Non EU Scale Assembly ie 42 25 one patria a ets putas pudo ops 4 11 NT A ins CANE eee Cte teh ike lode OAs 4 12 Humidity Systemi ject see ead Se we hd Be E ee eh ae ee 4 13 Oxygen Control System Li el eee tinira r te A Bee eee AA ee Oe 4 13 Oxygen Sensor Cele vc tay ae Rios Dyess eee ee Ra eee ees 4 13 Oxygen Calibration Fixture ty 322 22 5 455 Fre ede he ok a Ri Sa Sd st as BS ee 4 14 Operational E Recoleta OS PA away SS EA Meormmaderss 4 15 Controller Operational Checkout 03 A AA ie A beau A 4 15 Hood Shell Operational Checkout nessa A a a es 4 17 VHA Stand Operational Checkout
27. in place Weighing System OPTIONAL FEATURE Below are installation procedures for the Non EU and Mattress EU Scale assemblies Non EU Scale Assembly Za To install the weighing system 1 Ifrequired remove all rail accessories from the front rail of the unit 2 Rotate the pawl latches and open the front access panel of the incubator 3 Remove the mattress from the incubator 4 Ensure that the scale cable is located on the right hand side of the incubator towards the sensor module assembly 5 Place the scale in the incubator on the mattress tray 6 Replace the mattress 7 Connect the scale cable to the weight connector on the sensor module assembly see Sensor Module Connectors on page 5 5 8 Ensure all sensor leads are properly routed e Make sure there is sufficient cable slack between the edge of the hood and the scale to permit the mattress tray to be fully withdrawn from the hood and the sensor module can be withdrawn from the hood for O calibration e To allow for correct weight measurements make sure there is no interference or rubbing of the cable with the scale top e Secure the scale cable to the incubator end wall using the cable clips provided on the inside of the incubator wall e Loop the cable at the lower clip 9 Ifrequired place previously removed rail accessories on the front rail of the unit 10 To ensure proper operation perform the scale operational checkout see Weig
28. keep the infant clear of this warm air path Failure to do so could result in personal injury A WARNING To avoid overheating the infant due to direct radiation do not position the incubator in direct sunlight or under other sources of radiant heat 6 8 2 2 A WARNING Do not place surgical covers or blankets over the infant simultaneously with warm air curtain or side vents This may cause heat induced injury and burns A WARNING Phototherapy units located too close to the incubator may affect hood wall temperature incubator hood temperature and infant skin temperature Personal injury or equipment damage could occur A WARNING Phototherapy lamps placed over the top of the incubator hood may interfere with upward travel of the vertical height adjustable stand To prevent this interference always remove the phototherapy lamp prior to positioning the stand A WARNING For proper operation of the incubator use only skin temperature probes from Dr ger Medical Using other probes could result in personal injury or equipment damage AX WARNING Never place the skin temperature probe under the infant or use it rectally Infant injury could occur 6 8 2 6 A WARNING When in skin mode the skin temperature probe must be in direct contact with the skin to provide accurate monitoring of the infant s skin temperature When in skin mode failure to maintain direct skin contact can result in overheating Routinely check the infant
29. latched alarm and silence a current alarm condition Alarm Message area pls Description System Alarms Power Failure N A N A This alarm is activated to signal complete failure of the electrical power or inadvertent disconnec tion from the power source Motor Failed N A N A This alarm is activated when the fan motor speed falls outside specified tolerances for a period of gt 40 s Controller Failure 1 N A N A This alarm is activated if a failure is detected in the EPROM circuitry Controller Failure 2 N A N A Not used Controller Failure 3 N A N A This alarm occurs if a failure is detected in the ambient air probe Controller Failure 4 N A N A This alarm occurs if a failure is detected in the cooling fan Controller Failure 5 N A N A This alarm occurs if a failure is detected with the display test Controller Failure 6 N A N A This alarm occurs if a failure is detected with the serial port loop back test Controller Failure 7 N A N A This alarm occurs when a failure is detected with the power supply voltage Controller Failure 8 N A N A This alarm occurs when a failure is detected with RAM test Alarm Message ae ds Description Controller Failure 9 N A N A This alarm occurs when a failure is detected with real time clock Controller Failure 10 N A N A This alarm occurs when a
30. placed into service and after any disassembly for cleaning or maintenance 1 Place a calibrated oxygen analyzer inside the hood at the center of the mattress Ifnecessary unlock the keypad 2 3 Activate the Oxygen system see Oxygen Mode on page 5 30 4 Set the oxygen set point to 45 see Oxygen Control Set Point on page 5 31 5 Verify the oxygen analyzer reads 45 5 within 5 min 4 22 NOTE If the oxygen analyzer and the oxygen display do not read 45 5 within 5 min contact a local service representative The 5 accuracy applies to units calibrated to 21 oxygen Those calibrated to 100 oxygen are accurate to 3 Humidity System Operational Checkout OPTIONAL FEATURE To perform the the Humidity System Operational Checkout procedure before the system is placed into service and after disassembly for cleaning or maintenance perform the following 1 Make sure the reservoir is full 2 Place the probe of a calibrated hygrometer inside the hood at the center of the mattress 3 Pre warm the incubator to 35 0 C 95 0 F 4 5 6 Activate the Humidity system see Humidity Mode on page 5 31 Set the humidity set point to 50 see Humidity Control Set Point on page 5 32 Verify within 30 min that the hygrometer and the humidity display reads 50 6 relative humidity RH Weighing System Operational Checkout ACCESSORY The weighing system operational chec
31. properly installed Check the installation of the tubing access port The air intake microfilter cover is not properly secured Check and secure the air intake microfilter cover The air intake microfilter is not installed Check the air intake microfilter and install if necessary The internal tubing is not con nected Turn the incubator off and remove it from service High oxygen concentrations exist The air intake microfilter is dirty Replace the air intake microfilter There is a lack of air circulation within the incubator Verify that the impeller is installed If installed turn off the incubator and remove if from ser vice The variable height adjustable stand will not move up or down For non UPS systems only At the stand the Main Power switch is not on Turn on the Main Power switch For UPS systems only At the UPS electronic module the power cord is unplugged Plug the power cord into an appropriate power source For UPS systems only The AC supply power rating is incorrect or the power cord is unplugged At the UPS electronic module plug the power cord into an appro priate AC power source The Motor Failed alarm is acti vated The fan motor malfunctioned Turn the incubator off and remove it from service A heater failure alarm is activated The fan motor malfunctioned or the heater failed Turn the incubator off an
32. should ensure that both equipment and appendages are clear of the unit s travel path Patient and incubator connections must also be checked before adjusting the incubator height Never place any objects on top of the drawer assembly and always check before lowering the VHA to ensure there is sufficient clearance between the incubator and stand assembly Do not raise or lower the unit while installing or removing medical gas tanks from the tank holder assembly Failure to do so could result in personal injury or equipment damage IHA011 5 If equipped with VHA adjust the stand to its lowest position prior to transporting the patient A WARNING Prior to transport always ensure the mattress is level i e not in the Trendelenburg or Reverse Trendelenburg position 6 Ensure the mattress is in the flat position 7 Secure the infant using the restraining straps with the slotted mattress tray NOTE The straps should be placed over the infant and the ends firmly pressed together Care should be taken not to overtighten the straps 8 Ifa monitor is on top of the monitor shelf make sure the monitor straps are properly installed and secured 9 Unplug the power cord from the AC source The unit automatically switches to the battery back up mode A WARNING To prevent transport interference or possible trip and fall hazards always properly secure the power cord Failure to do so could result in personal injury or equipment damage
33. the air temperature skin temperature and set point temperature Home softkey The Home softkey enables the user to return to the previous display On softkey The On softkey is available at the Oxygen and Humidity displays When pressed this softkey activates the Oxygen or Humidity systems Off softkey The Off softkey is available at the Oxygen and Humidity displays When pressed this softkey deactivates the Oxygen or Humidity systems Cal softkey The Cal softkey is available at the Oxygen display and the Weight display When pressed this softkey initiates the calibration function for the oxygen sensors or scale Hours softkey The Hours softkey is available at the Trend display When pressed it enables the user to select either 2 4 8 12 or 24 hour trends for display in the Trend Alarm window Clear softkey The Clear softkey is available at the Trend display When pressed it clears all of the trend data stored in the Trend Alarm window Display softkey The Display softkey is available at the Trend display When pressed it selects one of following trends to display in the Trend Alarm window Air Skin 1 Skin 2 Oxygen Humidity Heater Power or Weight Gain Store softkey The Store softkey is available at the Weight display When pressed it stores the infant weight for trending in the Trend Alarm window gt 37 C softkey The gt 37 C softkey activates the Temperature Override mode greater than
34. to the boiling point Any waterborne bacteria are killed thus preventing transfer into the patient compartment Therefore there is no need to remove the metering valve and the evaporator assembly for cleaning or sterilization Air Intake Microfilter A WARNING A dirty air intake microfilter could affect performance or cause carbon dioxide CO3 build up Ensure that the filter is checked on a routine basis commensurate with local conditions Particularly if the unit is used in an unusually dusty environment more frequent replacements may be necessary Failure to do so could result in infant injury or equipment damage A CAUTION Do not attempt to clean the air intake microfilter Equipment damage could occur Do not clean the air intake microfilter see Air Intake Microfilter Maintenance on page 6 11 Before installing a new air intake microfilter clean the microfilter chamber and its cover with an intermediate level tuberculocidal cleanser disinfectant or equivalent NOTE For US markets only use an intermediate level tuberculocidal cleaners disinfectant registered by the Environmental Protection Agency EPA such as Kleenaseptic b Germicidal Surface Cleanser or a 2 gluteraldehyde solution Base Covers Rail and Accessories Drawers Tank Mounts Monitor Shelf and I V Pole Clean these items with mild detergent and warm water Do not use excessive liquid or harsh cleansers 1 Kleenaseptic b is a registered trade
35. 10 Coil up the power cord and secure it 4h WARNING Always use two people when moving the incubator and patient together When moving the incubator within the same floor space check that the patient is secured safely in the unit and either remove or secure all loose system components to prevent possible patient injury or equipment damage If the move involves varying floor heights or a complete floor level change i e thresholds ramps elevators remove all items either not being used or not necessary for the move lower the VHA I V poles and shelves to their lowest position place all drawers in their locked state and remove all accessories from the front and rear rail position IHA033 A WARNING Always push or pull the incubator forward or backward in a straight line along the length of the stand from the ends Lateral or angular movement across the width can result in inadvertent tip over if the wheels encounter any obstacle Personal injury or equipment damage could occur A WARNING Always close and latch drawers when not in use particularly when the incubator is being moved Personal injury could occur 11 Safely transport the patient within the facility 4h WARNING Do not plug the AC input supply power cord of the uninterruptible power supply UPS system into any of the output receptacles on the incubator stand This is a safety hazard and may cause irreparable damage to the UPS system 12 When the transport i
36. 2000 only 83 444 00 MU12955 LV pole assembly Isolette Model C2000 only 83 930 30 MU13548 Adapter DSub 9 pin male to 25 pin female 85 001 04 MU14688 Straps monitor shelf set of 2 Probes 68 209 47 MU06943 Cover probe Care For Me large 100 68 209 48 MU06944 Cover probe Care For Me standard 100 83 102 21 MU12525 Probe 4 skin temperature disposable box 10 CE Isolette 83 102 41 MU12533 Probe 5 skin temperature reusable 83 104 15 MU12551 Probe 5 large skin temperature box of 10 YIS Yel low Springs Inc Cuffs 68 120 71 MU06571 Iris port cuffs disposable soft 100 68 120 70 MU06570 Access door cuff disposable replacement carton 100 83 300 40 MU12702 Cuff access door reusable carton 10 Isolette Scale Assembly 83 600 50 MU13060 Scale assembly Isolette non EU 83 602 70 MU13089 Scale assembly OIML Isolette for EU Part Number Description Oxygen 83 62092 R MU16947 Oxygen assembly National Institute of Standards and Technology NIST fitting male C2000 83 620 30 MU13223 Cell oxygen 83 62090 R MU16945 Oxygen assembly green Diameter Index Safety System DISS male C2000 83 620 90 MU13237 Oxygen assembly green DISS male C2000 83 620 91 R MU16946 Oxygen assembly white DISS female C2000 85 620 90 R MU16948 Oxygen assembly green
37. 460 19 MU14833 Utility hook assembly Deutsche Institute von Normen DIN Rail Accessories 85 460 42 MU17429 Monitor shelf assembly high C2000e 85 460 43 MU17430 Monitor shelf assembly low C2000e 85 460 44 MU17431 LV pole assembly C2000e 2M86199 Reading lamp 2M85657 NCL examination lamp M24695 Holder for litter bags including 100 litter bags M26146 Basket 150 for disposable gloves M26145 Basket 300 for 300 mm catheters M25121 Basket 600 for 600 mm catheters M24678 Tray 3020 UPS 83 410 08 MU12823 Filter uninterruptible power supply UPS C2000e 85 410 50 MU14734 Battery 3 pack rechargeable 12V 7A a Kleenaseptic b is a registered trademark of Metrex Research Corporation General A WARNING Section 7 Troubleshooting Only facility authorized personnel should perform preventive maintenance or troubleshooting on the Isolette Infant Incubator Models C2000 and C2000e Preventive maintenance performed by unauthorized personnel could result in personal injury or equipment damage If the fault cannot be located refer the unit to qualified service personnel Symptom Cause and Remedy For troubleshooting of the incubator refer to the table below Troubleshooting Symptom There is no system power and the Power Fail alarm does not acti vate The Power Fail alarm activates Possible Cause The incubat
38. 500 g is on the mat tress Remove the excess weight The Scale Disconnected message is activated The cable between the scale and the sensor module is disconnected Re connect the cable between the scale and sensor module A scale failure message is acti vated The cable between the scale and the sensor module is broken A scale malfunction occurred Turn the incubator off and remove it from service Turn the incubator off and remove it from service Symptom The Cal Fail message is dis played Possible Cause The servo controlled oxygen sys tem failed to calibrate Remedy Repeat the calibration procedure If the calibration procedure fails the second time refer the unit to qualified service personnel The Not Installed message is dis played The servo controlled oxygen and or humidity system s is are not installed Install the oxygen and or humidity system s The servo controlled oxygen and or humidity system s is are not activated Set up the oxygen and or humidity system at the System Configura tion Menu see System Configu ration on page 5 22 Manufactured by EC Representative Draeger Medical Systems Inc Drager Medical AG amp Co KG 3135 Quarry Road Germany Telford PA 18969 USA Moislinger Allee 53 55 USA and Canada Customer Support D 23542 Lubeck 800 437 2437 Tel 49 451 882 O http www draege
39. BF type applied part A BF type applied part indicates an applied part isolated from all other parts of the instrument to such a degree that the patient leakage current allowable in a single fault condition is not exceeded e The symbol below indicates AC power AC Power Pro e The symbol below indicates Protective earth ground Protective Earth Ground e The symbol below indicates Caution Hot surface Caution Hot Surface AN e The symbol below indicates Weight limit Weight Limit e The symbol below indicates Consult Accompanying Document on the Battery Weight Battery Weight faa AN e The symbol below indicates Consult Accompanying Document on Battery Pack Orientation Battery Pack Orientation A SE BATTERIES ARE A MATCHED SET REPLACE ALL THREE e The symbol below indicates Power Failure Power Failure z e The symbol below indicates Lock casters when parked on an incline Lock Casters e The symbol below indicates an ELECTROSTATIC DISCHARGE ESD sensitive part Electrostatic Discharge ESD Sensitive Part La e The symbol below indicates Consult accompanying documents on latch lock unlock and rail loading Latch Lock Unlock and Rail Loading gl lal N A e The symbol below indicates Electromagnetic interference Electromagnetic Interfer
40. C2000 Stand Assembly Carefully lift the stand assembly and remove it from the packaging C2000e Stand Assembly 1 Prior to removing the stand assembly from the packing box remove the two 1 2 13 mounting screws and washers securing one leg of the stand assembly to the support 2 Atone side of the pallet remove the 4 lag bolts 25 x 3 from the cradle support 3 Lift that end of the stand remove the cradle support and lower the stand to the pallet 4 Then repeat steps 2 and 3 for the remaining leg C2000e Rail System Assembly 25 x 3 hex head 8x 1 2 13 Screw and Washers 2x Support 3 UN Battery Backup Pallet UPS Assembly i Optional Cradle Support Rail Assembly and Accessories Installation Perform the operation checkout procedure prior to using the rail system see Rail System Operational Checkout on page 4 22 Integris Fairfield Compatible Rail Assembly DIN Rail Assembly To install the rail assembly l Ze Mount a long rail on the tube type rail supports engaging the long groove of the long rail on the 2 flanges of the tube type rail support Align the screw holes on the tube type rail support with the mounting holes on the long rail Secure the long rail to the tube type rail support using 4 screws 10 32 x 7 16 and 4 internal tooth washers Tighten the screws with a 5 32 Allen wrench Integris Fairfield Compatible
41. Drager medical A Drager and Siemens Company Air Shields Isolette Infant Incubator WARNING Models C2000 and C2000e For a full understanding of the performance 3 characteristics of this equipment the user Operating Instructions should carefully read this manual before operating Emergency Care Perioperative Care Critical Care Perinatal Care Home Care Because you care Table of Contents Section 1 Definitions Intended Use and Disclaimer DEMOS lt a is ds a peak Sk AS DS ak a ead ee 1 1 Symbol Definitions 1 IS NAS A A di pias egos Sota 1 1 Technical Definitions a Shad dee Onan ae seed Gee agen lito adie Or alike wane i 1 5 Intended USE es bi E O A eal UATE dea E neater 1 6 Disc a ul lo e a el o al e e do ol e O 1 7 Section 2 Introduction Features and Specifications Totrod cti n A a 2 1 SONT A A da s 2 1 Humidity System Optional E TAE IA AA RA Gene Ae 2 1 H midity Reseller aA 2 1 Manifold Assembly a cas eer ate ae Sh fa 2 1 Evaport tor Assembly vales a eyed Ladue po E ba 2 1 Oxygen Control System Optional 0 ccc ce eee teens 2 1 Weighing System Accessory ys d gies E AAA ad ed Be A 2 2 Non EU Scales a Sa ae a A a Bae yee Bee ae era acy me Ge 2 2 EU Scales eii LAIA 2 2 Uninterruptible Power Supply UPS Optional o oooooooooooonoooooooo o 2 2 Functional Description ss a AAA oe Salta A e nee a oles 2 3 A RA 2 3 Skin Mode o A AE a Berns 2 4 CALMS A O A A
42. Foot Pedal Controls On all variable height adjustable VHA stands foot pedal controls are provided These controls are located on the front and rear bottom of the VHA stand and enable lt the user to adjust the height of the hood and shell assemblies Stand Indicators There are no indicators on the various stand configurations Stand Connectors Convenience Outlet An integral convenience outlet strip is located on the rear panel of all stand configurations AC Input Connector The AC power cord plugs into the AC input connector and provides power to the unit from a properly grounded 3 wire hospital grade or hospital use outlet PAIR AC Input Connector Locations Incubator Model Stand Configurations AC Power Cord Locations Models C2000 and C2000e Fixed Height stands without UPS sys On the stand column below the AC receptacles tems convenience outlet strip Model C2000e only Fixed height stands with UPS systems On the UPS electronic control module Model C2000e only Variable height adjustable VHA At the rear below the stand column stands without UPS systems Model C2000 only VHA stands without UPS systems At the right side of the unit between the stand legs Model C2000e only VHA stands with UPS systems On the UPS electronic control module UPS Electronic Module The UPS electronic module is mounted in the pedestal cover of units equipped with UPS systems UPS
43. HA036 AX WARNING Only connect equipment to the serial port that complies with the relevant IEC standard and use data cables with plastic body connectors Failure to do so could result in personal injury A WARNING The flow rate label on the rear panel is not valid when in oxygen control mode A WARNING Do not connect oxygen hoses to both the non servo control input Inlet 1 and oxygen control servo input Inlet 2 at the same time A WARNING Prior to transport always ensure the mattress is level i e not in the Trendelenburg or Reverse Trendelenburg position Ad WARNING Prior to placing the infant in the incubator pre warm the incubator to the temperature prescribed by the attending physician or according to nursing protocol Failure to do so could result in infant injury CAUTION Do not plug the AC input supply power cord of the uninterruptible power supply UPS system into any of the output receptacles on the incubator stand This is a safety hazard and may cause irreparable damage to the UPS system A CAUTION Do not steam autoclave incubator parts when disassembling for cleaning Equipment damage could occur Section 4 Installation and Operational Checkout Installation Refer to the solette Infant Incubator Models C2000 and C2000e Service Manual for additional installation assembly and disassembly procedures 1 Open the shipping cartons and remove all packing material 2 Unpackag
44. Inspect all cleaned components for any breakage or cracks before reassembling into the incubator 2 Install the heater radiator and fan impeller 3 Install the heater impeller cover A CAUTION Make sure the hood is raised before attempting to install the main deck The hood contains four tabs one at each corner which keep the deck securely in place Installing the main deck when the hood is down may result in damage to the main deck and or jamming of the hood in place 4 Install the main deck 5 Install the mattress tilt bars on the main deck 6 Install the mattress tray x ray tray and scale optional 7 Visually and physically examine the mattress for any holes or cuts that enable the entry of fluids onto the inner foam If the mattress is damaged replace it 8 Install the mattress 9 Install the new disposable or reusable iris entry port sleeves a Install the smaller diameter elastic band of a new sleeve over the inner ring of the port housing b Fold back and slip the larger elastic band over the outer ring of the port housing c Rotate the outer ring to close If properly installed the sleeve opens again when rotation is reversed 10 Install the tubing access grommets into the front and rear edges of each side of the hood NOTE Replace tubing access ports if distorted or torn 11 Install an access door gasket on each access door 12 Stretch the larger diameter elastic band of the new disposab
45. Probe 1 connector Before the probe is placed on the skin thoroughly clean and dry the skin area where the probe is to be placed Skin probe 2 connector Skin probe 1 connector When in skin mode the skin temperature probe must be in direct contact with the skin to provide accurate monitoring of the infant skin temperature When in skin mode failure to maintain direct skin contact can result in overheating Routinely check the infant s condition for correct sensor attachment and feel the infant s skin for signs of overheating 3 Place the probe on the infant a When the infant is on his her back or side place the probe on the abdomen halfway between the xyphoid and the umbilicus b When the infant is prone place the probe on the back of the infant Attach the probe to the infant using a Care For Me cover a Remove the backing from the Care For Me M cover and attach the probe b To stabilize the attached probe place another Care For Me cover over the probe wire approximately 3 cm 1 to 4 cm 2 from the probe tip Set Skin Temperature to the prescribed temperature Once stabilized the infant probe temperature is automatically controlled to within 0 5 C of the set temperature 6 Check the condition of the infant at least every 15 min for correct sensor attachment and feel the skin of the infant for signs of overheating Dual Temperature Monitoring The dual skin temperature monitoring featur
46. Rail Assembly HA Long Rail Long gt i SS Tube Type Rail Support 5 Repeat steps 1 through 4 for the remaining long rail 6 Select one of the short rail assemblies NOTE The position of the locating holes on the short rail assembly determine where the short rails are mounted on the rail assembly Locating Holes 7 Align the 3 screw holes on each of the corner brackets with the 3 screw holes on the front a Long Rail and rear long rails 8 Secure the corner brackets of the short rail assembly to the long rails using 6 screws 10 32 x 7 16 and internal tooth washers 9 Tighten the screws with a 5 32 Allen wrench 10 Repeat steps 7 through 9 for the remaining short rail assembly 11 Secure one end of a secondary rail support with two mounting holes to the short rail assembly using 2 screws 10 32 x 7 16 flat washers and internal tooth washers 12 Secure the other end of the secondary rail support to the tube type rail support a Insert a screw 10 32 x 2 50 flat washer and internal tooth washer through the secondary rail and tube type support b At the other end of the screw add a flat washer and nut c Tighten the screw and nut with a 5 32 Allen wrench or socket wrench 13 Repeat steps 11 and 12 for the 3 remaining secondary rail supports NOTE Two secondary rail supports are required on both sides of the incubator stand 14 Ensure all screws
47. SE Ba TE ll 2 5 Standard Features gcse wan he tee aid Glee ohn CER Vad Be HA AE ew a Ree HAR eS 2 5 Optional ESALUITES ers E Dud waits DRG apd eka AR 2 5 ACCESSES E WS 2 5 SPECIES OI AE weet Rhee AA tess eae Cait 2 6 Standard POr dat Maw aoe ae Aa 2 6 Options and Accessories func a ce e wae A fae nn eee end a ta ees 2 7 Sad cats pe sahtia ee SR eas a pe Dia ee lene ie ds o 2 7 Humidity ED oo hes es Gi ee ts ds a okt 2 8 Oxygen System gee A WEE A a a aed Bs eu A Pee AAA BA a E 2 9 Non EU Weighing Systemics ti nrd deri Soo Bese ore ek SI eee 8 eRe ee a Ss 2 9 EU Weighing Syste lt 250 044 SEA dread A DR 2 9 Rail Accessory Weight Limitations 0 cee cece eee eee eee e eens 2 10 Non Rail Accessory Weight Limitations 00 0 e cee cece eee eens 2 10 Regulations Standards and Codes rai A A AA A A 2 12 Electromagnetic Compatibility EMC Guidance and Manufacturer Declarations 2 12 Device Classification ocre anii sessed hh CW BA Raw ek dwn Uk ales SA Wee ee 2 15 Section 3 Precautions and Safety Tips PLCC AU CLOTS ara e see AA IR ee a ae A I Ae OW eee 3 1 Electrical Precautions sed 3 4 c nes yaa Hansa Paice as Seu seas eee gee ees seks eee 3 1 Explosion Precautions icc s vii eda het eve noe eR AAA ew cae hls VEN ea aie eA 3 2 EMG Precautions a Sete ame Ne 3 3 OXy 20 Precatitions indus da ee advan arta epee la Red Meee aie pio weed 3 4 Humidity e AAA okt tate ae tenes Cl tis ok eS ol eee ak 3 6 Safety APS ASA
48. The sensor module houses two independent oxygen fuel cells When the sensor module is outside of the hood during Oxygen Control mode audible and visual alarms are enabled and the flow of oxygen is interrupted Weighing System Accessory When installed the weighing system is located in a platform under the mattress The scale contains two load beams which perform the actual weighing function The controller processes the load beam information and displays the weight in kilograms or pounds in the Trend Alarm window System prompts are displayed in the Trend Alarm window during the weighing procedure Non EU Scales The Weight softkey allows for repeated re weighing of the infant after the weighing routine has been initiated EU Scales Since the weighing routine is continuous no re weigh function is required to update the weight measurements Uninterruptible Power Supply UPS Optional Bypass Mode When installed the UPS system provides an on line uninterruptible back up power supply to the incubator which can also be used for intra facility transport With batteries fully charged the power available from battery backup is sufficient to maintain a C2000e incubator in operation for 30 min in a 20 C ambient at a set point of 39 C in the Air mode without oxygen or humidity control or additional loads drawn from the accessory outlets Battery back up usage occurs during power failure or while transporting an unplugg
49. Use distilled water only lt 10 ppm total dissolved solids Sterile water is not an acceptable substitute for distilled wate Equipment damage could occur Safety Tips 4h WARNING Federal law restricts this device to sale by or on the order of a physician Otherwise personal injury or equipment damage could occur CFR Requirement A WARNING Thoroughly read and understand the manual prior to use of the incubator Failure to do so could result in personal injury or equipment damage 4h WARNING Incubator misuse may result in harm to an infant Only properly trained personnel should use the incubator as directed by an appropriately qualified attending physician aware of currently known risks and benefits IHA025 6 8 2 1 A WARNING Do not raise the hood at any time while the infant is in the incubator Gain access to the infant by the access panels and access doors Failure to do so could result in personal injury or equipment damage AX WARNING Always use two people when moving the incubator and patient together When moving the incubator within the same floor space check that the patient is secured safely in the unit and either remove or secure all loose system components to prevent possible patient injury or equipment damage If the move involves varying floor heights or a complete floor level change i e thresholds ramps elevators remove all items either not being used or not necessary for the move lower the VHA I V
50. adapter threaded mount 2 2 kg 5 lb Utility hook assembly 2 2 kg 5 Ib Reading lamp 1 3 kg 2 9 lb NCL examination lamp 1 7 kg 3 8 1b Holder for litter bags including 100 litter bags 0 680 kg 1 5 lb Basket 150 for disposable gloves 0 346 kg 0 763 Ib Basket 300 for 300 mm catheters 0 433 kg 0 954 Ib Basket 600 for 600 mm catheters 0 635 kg 1 4 Ib Tray 3020 1 2 kg 2 6 Ib Non Rail Accessory Weight Limitations Feature Monitor shelf assembly high C2000e Dimension 11 kg 25 lb Monitor shelf assembly low C2000e 11 kg 25 1b I V pole assembly C2000e 5 kg 11 1b Tray assembly large 17 6 kg 40 1b Swivel drawer assembly large Tray 0 91 kg 2 lb Drawer 4 5 kg 10 lb Swivel drawer assembly small Tray 0 91 kg 2 lb Drawer 2 2 kg 5 lb Swivel drawer assembly small C2000e Drawer housing assembly shallow short Tray 0 91 kg 2 lb Drawer 2 2 kg 5 lb 2 2 kg 5 1b 10 Feature Drawer housing assembly shallow long Dimension 2 2 kg 5 lb Swivel drawer assembly large C2000e Tray 0 91 kg 2 lb Drawer 4 5 kg 10 lb Drawer housing assembly deep short 4 5 kg 10 Ib Drawer housing assembly deep long 4 5 kg 10 Ib 11 Regulations Standards and Codes The Isolette Infant Incubator Models C2000 and C2000e com
51. ailure for Non UPS Systems A flashing alarm indicator is displayed with a continuous audible alarm to indicate that primary power to the incubator controller failed When the primary power is restored the unit reboots NOTE For power failures lasting 10 min or less the set points selected in the Air mode or Skin mode and operating modes are retained Recovery from Power Failure for UPS Systems Model C2000e Only A CAUTION When operating in the battery back up mode all accessories should be powered off to maximize battery power usage time In the event of power failure the main incubator functions continue without interruption using battery back up power The variable height adjustable VHA stand is inoperable during power outages With batteries fully charged the power available from battery backup is sufficient to maintain a C2000e Isolette Incubator in operation for 30 min in a 20 C ambient at a set point of 39 C in the Air mode without oxygen or humidity control or additional loads drawn from the accessory outlets If the power outage extends beyond the duration of the battery back up mode the Power Failure Alarm is activated A flashing alarm indicator is displayed with a continuous audible alarm to indicate that primary power to the incubator controller failed When the primary power is restored the unit reboots The system should be allowed to charge the battery for a maximum of 8 hours to ensure the battery pack is f
52. al organization alternatively further information can be obtained from our national Dr ger Medical organization Maintenance 4h WARNING Only facility authorized personnel should perform preventive maintenance or troubleshooting on the Isolette Infant Incubator Models C2000 and C2000e Preventive maintenance performed by unauthorized personnel could result in personal injury or equipment damage Facility authorized personnel should routinely inspect the patient compartments for signs of breakage and replace assemblies before placing the incubator into service A WARNING At the end of the life of the Isolette Infant Incubator Models C2000 and C2000e safely dispose of the unit per local requirements Failure to do so could result in personal injury Qualified service personnel should completely check and calibrate the equipment at least annually However Drager Medical recommends quarterly For details refer to the soletteB Infant Incubator Models C2000 and C2000e Service Manual For disposal of parts refer to Disposal on page 6 9 UPS Battery Pack Maintenance A WARNING Inspect the battery module for possible leakage during service intervals and prior to removal and handling The battery module is heavy and therefore requires sufficient strength and the proper lift method in order to avoid injury upon removal or installation Observe local state and federal regulations with regards to handling storage and dispo
53. al use outlet Do not use extension cords If any doubt exists as to the grounding connection do not operate the equipment Personal injury or equipment damage could occur 4 SHOCK HAZARD Due to the risk of electrical shock hazard only qualified personnel with appropriate service documentation should service the unit SHOCK HAZARD To prevent equipment damage or accidental power disconnections do not plug an incubator power cord directly to an AC wall socket when the incubator is mounted on a pedestal stand Always provide power to the incubator by using the power cord coming directly from the pedestal stand 4 SHOCK HAZARD Make sure the building power source is compatible with the electrical specifications shown on the column of the pedestal stand and on the incubator Failure to do so could result in personal injury or equipment damage SHOCK HAZARD The total power of all equipment connected to the convenience outlet strip on the pedestal stand must be within the electrical requirements shown on the rear of the pedestal stand Otherwise personal injury or equipment damage could occur SHOCK HAZARD Batteries can present a risk of electric shock The following precautions should be taken when working on batteries remove watches rings or other metal objects use tools with insulated handles SHOCK HAZARD Some chemical cleaning agents may be conductive and leave a residue that may permit a build up of conductive
54. alibration fixture on the hood see Oxygen Calibration Fixture on page 4 14 Verify the oxygen calibration level setting 21 or 100 at the System Configuration Menu see System Configuration on page 5 22 If required configure the oxygen calibration level setting for 100 Connect an oxygen hose to a 100 medical grade oxygen source at 3 lpm to 5 lpm and to the barb fitting on the calibration fixture Turn on the oxygen At Display 1 press the Oxygen softkey Press the ON softkey and then the Cal softkey Within 5 s withdraw the sensor module from the incubator hood to prevent a Cal Fail message NOTE When calibration is complete the message Cal Pass is displayed in the Oxygen window 9 Remove the oxygen source 10 Slide the sensor module inside the hood 11 Press the ON softkey 12 Use the Up and Down Arrow keys to set the oxygen percentage 13 If the message Cal Fail is displayed repeat the procedure Sensor Module o Sensor Module Out Position 14 If the calibration procedure is unsuccessful a second time refer the unit to qualified service personnel Patient Transport With batteries fully charged the power available from battery backup is sufficient to maintain an Isolette Infant Incubator Model C2000e in operation for 30 min in a 20 C ambient at a set point of 39 C in the Air mode without oxygen or humidity control or additional loads drawn from the ac
55. are fully tightened Deutsche Institute von Normen DIN Rail Assembly 1 Align the 3 screw holes on a corner bracket o with the 3 screw holes on the front and rear D Long Rail long rails s Corner 2 Secure the corner brackets to each end of the Bracket long rail with 3 screws 10 32 x 7 16 and internal tooth washers using a hex wrench 3 Repeat steps 1 and 2 for the remaining 3 corner brackets Internal Tooth Washers __ Screws 10 32 x 7 16 4 Mount a long rail to the rail support assembly engaging the long groove of the long rail with As oS Long Rail the 2 flanges of the tube type rail support i A 5 Align the screw holes on the rail support assembly with the mounting holes on the long Serew 10 32x 7 16 rail 6 Secure the long rail to the rail support l assembly with 4 screws 10 32 x 7 16 and Rail Support A 1 internal tooth washers using a hex wrench di 7 Repeat steps 4 through 6 for the remaining long rail 8 Ifthe secondary rails are installed go to step 14 9 Align the 2 screw holes on the secondary rail with the 2 screw holes on the rail support Screw 10 32 x 2 50 Internal Tooth Washer assembly ao Ae Flat Washer og Rail 10 Mount one end of the secondary rail to a rail va SS s support assembly with a screw 10 32 x ae L Oh 2 50 flat washer and internal tooth washer l Sie a Flat Washer 11 At the other end of the screw 10 32 x 2 50 EN a O
56. ayed 4 Ifnecessary remove any objects from the mattress before pressing the gt 0 T lt softkey see Controls Indicators and Connectors on page 5 1 5 Press the gt 0 T lt softkey twice 24 Verify that the weight display reads zero and is in reverse video Place a weight of known value but less than 7 kg 15 1b on the mattress and verify the correct weight is displayed Remove the weight from the mattress and press the Home softkey Section 5 Instructions for Use Controls Indicators and Connectors The Controls Indicators and Controls subsection lists and describes the controls indicators and connectors on the system Incubator Below are the incubator controls indicators and connectors Incubator Controls Power switch The Main Power On Off switch is used to provide power for the main incubator functions It is located in the front of the unit under the shell assembly Hardkeys Keypad Lock key The Keypad Lock key disables all the controls on the user interface except for the Alarm Silence Reset key After 15 seconds the Keypad Lock LED lights to indicate that the keys are locked Alarm Silence Reset key The Alarm Silence Reset key silences the alarm conditions for 4 5 10 or 15 min If no alarms are present the Alarm Silence Reset key enables a procedural silence To indicate that a silence period is in progress the Alarm Silence Reset LED lights E al Up Down Ar
57. be in automatic bypass mode due to a system failure A blinking Invertor Status LED means that the system is in Sleep mode e Bypass Mode LED the amber LED indicates that output power is supplied via the bypass line filtering only e Load Status LED the blue LED indicates that power is being delivered to the load Uninterruptible Power Supply UPS Indicator Status Mode System Condition Fault Bypass Inv AC LED Beep Bypass Normal Line On On On Line Normal Line On On Line or Overload On On Line Continuous Backup Backup Normal Battery On Twice 8 s Backup Low Battery On Twice s Backup System Fault On Continuous Line System Fault On On On Continuous Line System Fault Line On Continuous Abnormal UPS Electronic Module Connectors The front panel of the UPS electronic module contains the following connectors e AC input e DB9 connector NOTE The DB9 connector is an electronic port for factory use only Displays The electro luminescent EL and LCD controller displays support the following windows Temperature window Trend Alarm window Humidity window and Oxygen window If the oxygen humidity and scale options accessories are installed the associated data are displayed when the control is enabled The UPS electronic module is also equipped with a front display panel see UPS Electronic Module
58. ceptable weights IHA010 WARNING Do not insert any object into any of the ventilation holes or any other opening on the uninterruptible power supply UPS system Doing so may cause personal injury or equipment damage AX WARNING Do not add external batteries to the UPS system Personal injury or equipment damage could occur A WARNING Do not connect the Isolette Infant Incubator Models C2000 or C2000e to a surge suppressor A WARNING Incubator stability can be reduced by both the number of accessories attached the height and loading of accessories as well as their position on the rail It is therefore recommended that rail accessories be kept to a minimum be adjusted to their lowest usable height and with respect to the end rail mounted as close to the center of the incubator as possible A WARNING To prevent transport interference or possible trip and fall hazards always properly secure the power cord Failure to do so could result in personal injury or equipment damage A WARNING To perform the 21 oxygen calibration procedure ensure that the incubator is equipped with the standard sensor module slide lock If the 100 oxygen calibration fixture is used during the 21 calibration procedure the calibration will be inaccurate Infant injury could occur A WARNING Follow all product manufacturer s cleaning instructions Failure to do so could result in personal injury or equipment damage WARNING Failu
59. cessory outlets To transport the patient 4 SHOCK HAZARD To ensure grounding reliability plug the AC power cord only into a properly grounded 3 wire hospital grade or hospital use outlet Do not use extension cords If any doubt exists as to the grounding connection do not operate the equipment Personal injury or equipment damage could occur 1 At the display panel on the UPS electronic module verify the battery level 2 Ifthe battery is not fully charged plug the unit into an acceptable AC power source and ensure that the Resettable circuit breaker is in the On 1 position NOTE Allow a maximum of 8 hours to fully charge the battery pack Do not attempt to transport the patient until the battery is fully charged A CAUTION When operating in the battery back up mode all accessories plugged into the stand receptacles should be powered off to maximize battery power usage time 3 Turn off all accessories plugged into the stand receptacles and remove accessories and items not in use or necessary for the patient care during transport 4 Secure all accessories deemed necessary for patient care during transport 4h WARNING For optimum stability always lower the incubator to its lowest position prior to transport Make sure that items placed on the monitor shelf are properly secured Failure to do so could result in personal injury or equipment damage A WARNING When raising or lowering the incubator the operator
60. ch Repeat steps 15 through 20 for the remaining short rail At each corner of the rail assembly securea Short Rail top corner bumper to a bottom corner bumper with 2 screws 6 32 x 1 00 and 1 screw 8 32 x 2 50 using a phillips head screwdriver Ensure all screws are fully tightened Ap _ Top Corner Bumper e Sf A Y I fay f ae AG J ye a Screw 6 3 x 1 00 Screw 8 32 x 2 50 Bottom Corner Bumper ___ Secondary Rail Suppo Rail Accessories To install rail accessories refer to the Isolette Infant Incubator Retrofit and Upgrade Installation Instructions NOTE The monitor shelf and I V pole can be mounted only on the side rails The monitor shelf can only be secured on the locating holes towards the rear of the unit on the side rails A WARNING Incubator stability can be reduced by both the number of accessories attached the height and loading of accessories as well as their position on the rail It is therefore recommended that rail accessories be kept to a minimum be adjusted to their lowest usable height and with respect to the end rail mounted as close to the center of the incubator as possible A WARNING To avoid injury or equipment damage use only Drager Medical listed latches and accessories with the rail system It is also important to secure the latch properly to the rail as identified in the manual as well as periodically check both the operation and retention of
61. ck the Skin Mode of operation a b Cc d f g Insert a skin probe into the skin probe 1 connector of the sensor module Place the skin probe 10 cm 4 above the center of the mattress Set the skin set temperature to 35 C 95 F When the temperature stabilizes rotate the pawl latches and open the front or rear optional access panel Verify that within approximately 5 min the Low Skin Temperature alarm message is displayed in the Trend Alarm window and the audible alarm sounds Close the front or rear access panel and rotate both latches until fully engaged Press the Alarm Silence Reset key to silence the alarm NOTE The alarm will not occur until the temperature falls 0 5 C or 1 0 C depending on the skin temperature alarm limit setting below set point At high ambient temperatures fanning the air within the hood can be performed to induce the alarm 6 Check the Remove Skin 2 Probe alarm a Cc While operating in the Skin mode with a skin probe connected in the skin probe 1 connector insert a second skin probe into the skin probe 2 connector of the sensor module Verify that when a second probe is connected to the sensor module the Remove Skin 2 Probe alarm message is displayed in the Trend Alarm window and an audible alarm sounds Remove the second skin probe from the skin probe 2 connector 7 Check the Skin Probe Disconnect alarm a c d e In the Skin mode disconnect
62. d the actual and set point humidity values are displayed A rotating wheel is displayed in the upper right hand corner of the Humidity window For systems not configured with humidity the message Not Installed is displayed for a few seconds and then the Humidity window remains blank Oxygen Window When the Oxygen mode is activated the actual and set point oxygen values are displayed A rotating wheel is displayed in the upper right hand corner of the Oxygen window For systems not configured with oxygen the message Not Installed is displayed for a few seconds and then the Oxygen window remains blank System Displays The controller has two system displays Display 1 and Display 2 from which the following displays can be accessed e Temperature e Trend e Weight e Oxygen e Humidity Temperature Displays The temperature displays enable the user to e Select the air skin control set point temperature e Activate the Temperature Override mode See Temperature Settings on page 5 23 Trend Display The trend display enables the user to select one of the following parameters for trending e Air temperature e Skin temperature 1 e Skin temperature 2 e Heater power e Oxygen optional e Humidity optional e Weight optional See Data Trends on page 5 27 Weight Displays The scale displays enable the user to e Store weight measurements for trending e Perform the zero tare function e Calibrate th
63. d C2000e on a bedside patient monitor or a central monitoring system To view patient parameters using the Vuelink Software perform the following procedures 1 Turn off the incubator Power Switch 2 Connect the DB 9 male end of the Vuelink cable to the bottom of the incubator shell assembly see Incubator Connectors on page 5 4 3 Connect the DB 25 female end of the Vuelink cable to the bedside patient monitor or central monitoring system 4 While pressing the Alarm Silence Reset key turn on the incubator Power Switch to enter the System Set Up menu Using the Display Selection key scroll down to the VueLink software option Press the Up Arrow key to select Yes Press the Alarm Silence Reset key to exit the set up menu QO EIN AN On the bedside patient monitor press the Module Setup key The Module Setup window is displayed on the VueLink software screen 9 Press the gray key beneath the HRAS C2000 caption Values for the incubator are displayed on the VueLink software screen of the bedside patient monitor Alarm messages resulting from alarm conditions are displayed automatically NOTE VueLink software does not have touch screen capability NOTE Values from the bedside patient monitor can be archived using a central monitoring system For details on this function contact a local Philips Medical representative 1 VueLink is a trademark of Philips Medical Systems 5 32 X Ray
64. d remove it from service A controller failure alarm is acti vated An internal malfunction occurred Turn the incubator off and remove it from service This is the first time the unit was installed or new software was loaded onto the controller Press the Alarm Silence Reset key If the failure continues turn the incubator off and remove it from service The Key Stuck alarm is activated A controller key malfunction occurred Turn the incubator off and remove it from service The Air Probe Failure alarm is activated The air probe malfunctioned Turn the incubator off and remove it from service The Low Air Flow alarm is acti vated There is a lack of air circulation within the incubator Verify that the impeller is installed If installed turn off the incubator and remove if from ser vice Symptom A sensor module alarm is acti vated Possible Cause A sensor module malfunction occurred Remedy If the alarm persists turn the incu bator off and remove it from ser vice The Sensor Out of Position alarm is activated The sensor module is not in the correct position for calibration or operation Verify proper positioning of the sensor module If the alarm per sists turn the incubator off and remove it from service The Sensor Disconnected alarm is activated The sensor module possibly expe rienced a communications failure
65. d when the oxygen control setting is set to maximum the attending physician should prescribe alternate means of oxygenation Failure to do so could result in personal injury or equipment damage AA WARNING The oxygen concentration inspired by an infant does not accurately determine the partial pressure of oxygen pO in the blood When deemed advisable by the attending physician measure blood pO by accepted clinical techniques Failure to do so could result in personal injury or equipment damage A WARNING The oxygen flow rates labeled on the rear panel cannot be used as an accurate indication of oxygen concentrations in an incubator and should only be used as a guide Measure oxygen concentrations with a calibrated oxygen analyzer at intervals directed by the attending physicians Failure to do so could result in personal injury or equipment damage A WARNING After each change of oxygen flow allow at least 30 min to achieve new concentrations Failure to do so could result in personal injury or equipment damage A WARNING Oxygen levels within the incubator hood environment may be affected when the access doors or access panels are opened Make sure all hood access door gaskets and tubing ports are properly installed Any open gaps in the incubator hood may reduce the incubator s internal oxygen Personal injury could occur A WARNING Compressed gas cylinders such as oxygen cylinders can become hazardous projectiles if t
66. display resolution 1 0 g or 0 04 oz Weight display accuracy 0 2 kg 2 g 2 digit gt 2 kg 45 g digit Maximum tare weight 4 0 kg 8 82 1b 0 5 kg EU Weighing System Feature Dimension Weighing System Maximum capacity 7 kg 151b Minimum capacity 200 g 44 Ib Maximum tare weight 4 0 kg 8 82 lb 0 5 kg Verification scale interval 10 g 022 Ib Scale level sensitivity 90 min 1 min 1 60 degree Weight display accuracy 10 g 022 Ib Weight display update rate ls Weight display resolution 10 g 022 Ib Rail Accessory Weight Limitations Feature Rail system assembly Dimension Total rail accessory weight not to exceed 36 3 kg 80 Ib 13 1 kg 40 Ib per side rail or 6 8 kg 15 Ib per front and rear rail with remaining weight distributed along side rails Monitor shelf assembly high low C2000e 11 kg 25 1b I V pole assembly C2000e 5 kg 11 Ib Basket 18 0 Wx 9 5 Dx 4 0 H 4 4 kg 10 lb Basket 6 5 W x 4 0 D x 5 0 H 2 2 kg 5 lb Basket 11 0 W x 4 0 D x 4 0 H 2 2 kg 5 1b Basket pivoting 2 2 kg 5 1b Chart holder Hinged mayo tray 13 5 W x 9 75 D 2 2 kg 5 Ib Hinged mayo tray 17 0 W x 11 5 D 2 2 kg 5 Ib Cable organizer 2 2 kg 5 lb Horizontal cord wrap 2 2 kg 5 lb Standard cam adapter 2 2 kg 5 lb Ball action adapter 2 2 kg 5 lb Double cam adapter 2 2 kg 5 lb Cam
67. dust or dirt Do not allow cleaning agents to contact electrical components and do not spray cleaning solutions onto any of these surfaces Personal injury or equipment damage could occur SHOCK HAZARD Unplug the unit from its power source prior to cleaning or maintenance For units equipped with an uninterruptible power supply UPS system also remove the battery pack prior to cleaning or maintenance Failure to do so could result in personal injury or equipment damage SHOCK HAZARD Do not expose the unit to excessive moisture that would allow for liquid pooling Personal injury or equipment damage could occur Explosion Precautions 4h WARNING Do not use in the presence of flammable anesthetics Personal injury or equipment damage could occur A WARNING Keep matches and all other sources of ignition out of the room in which the incubator is located Textiles oils and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen Personal injury or equipment damage could occur A WARNING Small quantities of flammable agents such as ethyls and alcohol left in the incubator may cause a fire in connection with oxygen Personal injury or equipment damage could occur 6 8 2 4 A WARNING A fire and explosion hazard exists when performing cleaning or maintenance procedures in an oxygen enriched environment Make sure that the oxygen supply is turned Off and the oxygen hose to the incuba
68. e incubator wall e Loop the cable at the lower clip e Make sure there is sufficient cable slack between the edge of the hood and the scale to permit the mattress tray to be fully withdrawn from the hood and the sensor module can be withdrawn from the hood for O calibration 11 If required place previously removed rail accessories on the front rail of the unit 12 To ensure proper operation perform the scale operational checkout see Weighing System Operational Checkout on page 4 23 Humidity System OPTIONAL FEATURE NOTE The humidity system is normally factory installed To install the humidity system in the field refer to the accompanying installation instructions To install the humidity reservoir l Ze Mount the reservoir and reservoir lid on the humidity tray Insert the humidity tray in the shell and lock the handle Oxygen Control System OPTIONAL FEATURE NOTE The oxygen control system is normally factory installed To install the oxygen control system in the field refer to the accompanying installation instructions Oxygen Sensor Cells To install the oxygen sensor cells l Remove the sensor module from the hood by withdrawing it until it stops Eo Pull out on the clip located on the left side of the module q y and remove the module from the hood gf 3 Remove the oxygen sensor cover Retain the hardware Withdraw the sensor cell connectors from inside the
69. e can be used only in the Air mode When skin probes are inserted into the Skin Probe 1 and Skin Probe 2 connectors the controller displays the respective Skin and Skin 2 temperatures NOTE When a second skin probe is connected to the sensor module while operating in Skin mode an alarm sounds and the Remove Skin 2 Probe alarm is activated Data Trends To select a trend display for viewing perform the following steps 1 Ifnecessary unlock the keypad 2 Access the Trend display a At Display 1 press the Display Selection key and select Display 2 b At Display 2 press the Trend softkey to select the Trend display and view the menu options 3 To clear all previous Trend displays press and hold the Clear softkey 4 Press the Hours softkey to select the trend period 2 4 8 12 or 24 hours NOTE ZX _ Temperature Hours The Hours softkey is not required for trends of 356 380 Clear the infant weight Refer to Scale skin 1 aa Display V 35 6 35 6 Home N F Measurements on page 5 28 a E Humidity 5 To select one of the following Trend 30 displays press the Display Selection key 370 pt aa repeatedly until the desired setting is ID shown e Air temperature e Skin temperature 1 Skin temperature 2 e Heater power e Oxygen optional e Humidity optional e Weight optional 6 To confirm the Tre
70. e module control the concentration level of oxygen from 21 to 65 The alarm limit default is 3 from the current set point If the oxygen concentration rises above or falls below the 3 limit an audible and visual alarm occur and the message Low Oxygen or High Oxygen is displayed in the Trend Alarm window NOTE When using the servo controlled oxygen system during oxygen administration the oxygen concentration guide is not valid Oxygen Mode To activate the Oxygen Control mode 1 Ensure the oxygen supply provides an inlet pressure and inlet flow rate in compliance with the specifications see Oxygen System on page 2 9 2 Connect the oxygen hose at Inlet 2 to the oxygen supply 3 At Display 1 press the Oxygen softkey NOTE If no keys are pressed within 15 s of selecting the Temperature oN IL Oxygen softkey the display automatically reverts to 35 6 360 oF Skin 1 Skin 2 Cal Display 1 35 6 35 6 ome mi 4 Press the ON softkey to activate the Oxygen mode Air Temp us NOTE When the Oxygen mode is activated the rotating wheel is displayed in the Oxygen window Oxygen Y Set 50 so 5 Ifthe message Cal Required is displayed calibrate the oxygen control system see Oxygen Sensor Calibration on page 5 36 6 To deactivate the Oxygen mode press the OFF softkey Oxygen Control Set Point To set the oxygen cont
71. e non EU scale PN 83 600 50 MU13060 only e Select the weight measurement display units See Scale Measurements on page 5 28 and Scale Calibration for the Non EU Scale on page 5 34 5 10 Oxygen Display The Oxygen display enables the user to e Activate the oxygen system e Select the oxygen control set point e Calibrate the oxygen sensor See Oxygen Control on page 5 30 Humidity Display The humidity display enables the user to e Activate the humidity system e Select the humidity control set point See Humidity Settings on page 5 31 11 Factory Default Settings For non UPS systems in the event of a power failure lasting 10 min or less the set points and operating mode are retained For UPS systems in the event of a power failure the incubator operating time is determined by the amount of battery charge remaining when the event occurs When the charge is depleted and the system enters the Power Failure mode the set points and operating mode are retained for 10 min For both UPS and non UPS systems when the incubator power is turned off the temperature set point reverts to the setting selected in the configuration menu see System Configuration on page 5 22 Factory default settings are listed in the table below 5 12 Factory Default Settings System Parameters Defaults Skin set temperature 36 5 C 97 7 F Humid
72. e the hood shell assembly and stand assembly see Unpackaging on page 4 2 NOTE If the packaging and or unit is damaged contact a local service representative WARNING Attach the incubator to the stand using the bolts provided Failure to do so could result in the incubator separating from the stand if sufficiently tilted particularly with the hood open Personal injury or equipment damage could occur 3 one For C2000e systems only install the rail assembly see Rail Assembly and Accessories Installation on page 4 3 For C2000e systems equipped with a uninterruptible power supply UPS system install the electronic module and battery pack see UPS System Installation on page 4 10 and then install the mattress restraint straps see Mattress Restraint Strap Installation on page 4 9 Assemble the hood shell assembly and the stand assembly see Hood Shell and Stand Assembly on page 4 8 To install the weighing system refer to Weighing System on page 4 11 To install the humidity system refer to Humidity System on page 4 13 To install the oxygen control system refer to Oxygen Control System on page 4 13 Before the unit is placed in service perform the operation checkout procedures see Operational Checkout on page 4 15 Unpackaging NOTE When removing the equipment from the cartons take care not to scratch or otherwise damage unprotected surfaces
73. e touch of a ground stud before and during connecting the pins or the use of electrically isolating and antistatic gloves All staff involved in the above shall receive instruction in these procedures AX WARNING The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system Consider the use of the accessory in the patient s vicinity and evidence that the safety certifications of the accessory have been performed in accordance with the appropriate International Electrotechnical Commission IEC 60601 1 and or IEC 60601 1 1 harmonized national standard Personal injury or equipment damage could occur Oxygen Precautions 4h WARNING Improper use of supplemental oxygen may be associated with serious side effects including blindness brain damage and death The risks vary with each infant The qualified attending physician should prescribe the method the concentration and the duration of oxygen administration A WARNING Measure the oxygen concentrations to verify delivery of the prescribed oxygen concentration Failure to do so could result in personal injury or equipment damage A WARNING If it is necessary to administer oxygen in an emergency notify the attending physician immediately Failure to do so could result in personal injury or equipment damage AA WARNING If the patient s arterial oxygen levels cannot be maintaine
74. ed incubator within the facility Output EMI amp Suppression Filter A Regulating Inverter i ees DC to AC Line Mode Inverter AAA y Internal DC to DC Battery Regulating Charger Inverter i gt Back up Mode The UPS system consists of two main components the electronics control module and the battery pack module The battery pack module consists of three sealed gel cell batteries that are charged by the electronics module The electronics module is responsible for monitoring distributing and controlling the power delivered to the incubator The UPS system operates in three modes line back up and bypass Refer to the table below Modes Operating Conditions Line AC input normal load range acceptable inverter DC to AC operational Back up Loss of AC input load range acceptable inverter operational Bypass Loss of inverter output acceptable load power supplied from AC only Functional Description The temperature humidity and oxygen concentration is controlled by the forced air circulation system A controlled amount of room air approximately 7 lpm is drawn through the air intake filter by the motor driven impeller located in the shell The impeller internally recirculates air ata much greater flow than that of the fresh gas inflow The total inflow of fresh and re circulated air is directed around the heater The air enters the infant compartment up thr
75. em Start Up and Shut Down si A AAA RA A ke A EA E 5 20 Syste Start AA EAS AE AAA 5 20 Initial Start up for systems without UPS 0 cece eee eee 5 20 Initial Start up for systems with UPS Model C2000e only 4 5 20 Recovery from Power Failure for non UPS systems 00 000 cece eee 5 21 Recovery from Power Failure for UPS systems Model C2000e only 5 21 System Shut A AA a tN San A te el oi Nd te ted 5 21 System CON TULA E BG OE RY BG BARE ws A ee wae eae 5 22 Variable Height Adjustment y05 2 363 fees as Pe Deda eave tias 5 23 Temperature Settings Li A IRA a eae a oo aaa 5 23 INTE INO Gs E AMES A adh See SE Heed A 5 24 Sham Moden dove 5 24 Controller Screen Sewn GS ii eas tA th gt ig toca Gaeta E ees hee ie 5 25 Skin Probe Attachment hass surte aga bees rats pas ads 5 26 Single Temperature Monitoring ti AS Ge Wen ARS NAS Se 5 26 Dual Temperature Monitoring gt tl hes Ge esd eee A dd ee 5 27 Data rienda Go Oe at ae A ES ey earns Maoh at ene al 5 27 Scale Meas rementS ua AAA Vereen AA a 5 28 Non EU Scale Measurements a ae 5 28 IA Weigh sneons rinata ES ik ww AYO E N S ehamawt ins 5 28 REMAIN alta aidan Od hte as 5 29 EU Scale Measurements ps 43044464 aoe ese A AAA AS 5 29 A A AAS Oe ROB STORE ee A Rea 5 30 Oxygen Mode ee A winds Bee aAA Bee WAR RR Be ade Sea 5 30 Oxygen Control Set Pont 030 54 2 o oa ssn oad wince PRS ad Ok OP and adverse Pacha ees 5 31 H midity Set ngs AAA a ee EA
76. ence 6 Interference can occur in the vicinity of the equipment marked with the Electromagnetic Interference symbol e The symbol below indicates Consult accompanying document on the large tray loading large Tray Loading A e The symbol below indicates a Communication port Communication Port 9 Technical Definitions Incubator temperature Air temperature at a point 4 10 cm above and centered over the mattress surface Control temperature The temperature controller set point selected by the user Average incubator temperature The average of the maximum and minimum incubator temperatures achieved during temperature equilibrium Incubator temperature equilibrium tThe condition reached when the average temperature of the incubator does not vary more than 1 C over a period of 1 hour Temperature uniformity The amount by which the average temperatures at each of four points 4 10 cm above the mattress surface differs from the average incubator temperature at incubator temperature equilibrium Temperature variability The variability of the incubator temperature that will be observed over a 1 hour period after incubator temperature equilibrium has been reached Temperature rise time The time required for the incubator temperature to rise 20 F 11 C when the air control temperature is at least 22 F 12 C above the ambient temperature Temperature overshoot The amount by whic
77. formance of the incubator if the user does not operate the unit in accordance with the instructions fails to follow the maintenance recommendations or makes any repairs with unauthorized components Only qualified service personnel should calibrate and repair it Technical information is available through local distributors All personnel working with the unit should read thoroughly understand and have ready access to this manual Store the manual with the incubator when not in use Please contact your local representative for clarity or further information Notes Section 2 Introduction Features and Specifications Introduction The Introduction subsection provides a system overview and functional description of the Isolette Infant Incubator Models C2000 and C2000e System Overview The Isolette Infant Incubator Models C2000 and C2000e is a modular controller based incubator which enables simultaneous control of temperature oxygen and humidity parameters affecting the infant The incubator hood and shell assemblies are mounted on a variable height adjustable VHA stand or fixed height FH stand The Isolette Infant Incubator Models C2000 and C2000e supports electro luminescent EL and liquid crystal display LCD display technology Humidity System Optional When installed the built in humidifier provides humidification of the incubator from 30 to 95 relative humidity RH in 1 increments When the humid
78. g steps l 2 Make sure all fittings and connections for the supply oxygen are clean Administer oxygen from a wall source or the accessory oxygen cylinder on the incubator pedestal stand Refer to the current edition of Guidelines for Perinatal Care of the American Academy of Pediatrics The American College of Obstetricians and Gynecologists 3 4 NOTE An oxygen concentration guide is provided below This guide is also displayed on the back of the incubator Connect the output of the oxygen flow meter to the barbed fitting labeled Inlet 1 using 3 16 inner diameter surgical tubing Allow oxygen concentrations to stabilize Oxygen Concentration Guide Oxygen Supply Approximate Oxygen 3 Ipm 30 45 6 Ipm 46 60 9 Ipm 50 70 12 Ipm 55 75 15 Ipm 60 80 Calibration Scale Calibration for the Non EU Scale NOTE The procedures described in this section do not apply to the EU Type NAWT weighing system Refer to the Isolette Infant Incubator Type NAWI Weighing System Quick Reference Guide Drager Medical recommends calibrating the scale using a calibrated 5 kg weight upon installation and every six months thereafter NOTE When calibrating the scale the mattress should be level and not in the Trendelenburg or Reverse Trendelenburg position To calibrate the scale l At Display 1 press the Display Selection key 2 At Display 2 press the Weight soft
79. ge IHA011 A WARNING Accessories such as trays baskets and shelves should never be overloaded and are not intended to hold an infant Infant injury could occur IHA014 A WARNING Inspect the battery module for possible leakage during service intervals and prior to removal and handling The battery module is heavy and therefore requires sufficient strength and the proper lift method in order to avoid injury upon removal or installation Observe local state and federal regulations with regards to handling storage and disposal of sealed gel cell batteries IHA021 033 AX WARNING Always close and latch drawers when not in use particularly when the incubator is being moved Personal injury could occur IHA28 A WARNING To avoid injury or equipment damage use only Drager Medical listed latches and accessories with the rail system It is also important to secure the latch properly to the rail as identified in the manual as well as periodically check both the operation and retention of the latch to securely hold the accessory being used When the latch is properly locked both visual and physical feedback are provided The toggle handle will snap into an 8 o clock position on the latch body when locked Total rail load must not exceed 36 3 kg 80 Ib The side rail loads must not exceed 13 61 kg 30 Ib The front and rear rail loads must not exceed 6 8 kg 15 Ib IHA029 4h WARNING The drawers and rail system are labeled for ac
80. h the incubator temperature exceeds the average incubator temperature at incubator temperature equilibrium as a result of an increase in control temperature Temperature correlation Temperature indicator versus incubator temperature The amount the air temperature indicator at incubator temperature equilibrium differs from the incubator temperature Control correlation Incubator temperature versus control temperature The amount the average incubator temperature in Air mode at incubator temperature equilibrium differs from the control temperature Control accuracy Temperature indicator versus control temperature The amount the air temperature indicator in Air mode at incubator temperature equilibrium differs from the control temperature Measurement points Measurements are taken at five points in a plane parallel to and 4 10 cm above the mattress surface One point is 4 10 cm above the center of the mattress the remaining four points are the centers of the four areas formed by lines that divide both the width and length in two parts Intended Use This manual provides an overall functional description and the instructions for use of the Isolette Infant Incubator Models C2000 and C2000e The Isolette Infant Incubator Models C2000 and C2000e should be used only by appropriately trained personnel and under the direction of qualified medical personnel Disclaimer Drager Medical cannot be responsible for the per
81. he gas is released rapidly due to damage or other causes Securely fasten the cylinder Failure to do so could result in personal injury or equipment damage A WARNING Disconnect the incubator from the hospital oxygen source when oxygen is not in use Failure to do so could result in personal injury or equipment damage AX WARNING A dirty air intake microfilter could affect performance or cause carbon dioxide CO3 build up Ensure that the filter is checked on a routine basis commensurate with local conditions Particularly if the unit is used in an unusually dusty environment more frequent replacements may be necessary Failure to do so could result in infant injury or equipment damage WARNING As oxygen use increases the danger of fire do not place auxiliary equipment that produces sparks in an incubator Personal injury or equipment damage could occur 6 8 2 3 A WARNING The oxygen sensor is a sealed unit that contains potassium hydroxide electrolyte If the sensor develops a leak discard it immediately If contact with the skin or clothing occurs rinse the area with a large quantity of water In case of eye contact flush the eye immediately for at least 15 min holding the eye open and call a physician Failure to do so could result in personal injury or equipment damage A WARNING Use only Drager Medical recommended fuel cells for proper operation Failure to do so could result in personal injury or equipment damage
82. he air set temperature is set to 37 0 C 98 6 F 3 To confirm the Air Set Temperature setting and return to Display 1 press the Home softkey NOTE Once stabilized the incubator temperature stays within 0 5 C of the set temperature 4 To lock the keypad press the Keylock key Skin Mode 1 At Display 1 press the Skin softkey to select the Skin mode NOTE If no keys are pressed within 15 s of selecting this display it automatically reverts to Display 1 2 Attach the skin probe to the infant see Skin Probe Attachment on page 5 26 24 3 Set the temperature to the prescribed setting a Press the Up Arrow key to raise the set temperature from 34 0 C 93 2 F to 37 0 C 98 6 F in 0 1 increments In Temperature Override mode press the gt 37 C key and press the Up Arrow key to raise the set temperature from 37 0 C 98 6 F to 38 0 C 100 4 F b Press the Down Arrow key to lower the set temperature from 38 0 C 98 6 F to 34 0 C 93 2 F in 0 1 decrements NOTE gt 37 C ae Temperature 2377 O 35 6 m z Skin 1 Set 35 6 35 6 Home J Hy ES Air Temp ou E s Humidity Set 50 Oxygen Y 50 5o ID The gt 37 C softkey activates the Temperature Override mode greater than 37 0 C 98 6 F The gt 37 C indicator lights and gt 37 C displays in reverse video NOTE The
83. hing System Operational Checkout on page 4 23 A WARNING Utilize cable management clips to avoid infant entanglement and possible injury EU Scale Assembly Yran the Zsolette Infant Incubator Type NAWI Weighing System Quick Reference Guide supplied with the EU scale To install the weighing system 1 Ifrequired remove all rail accessories from the front rail of the unit 2 Rotate the pawl latches and open the front access panel of the incubator 3 Remove the mattress from the incubator 4 Ensure that the scale cable is located on the right hand side of the incubator towards the sensor module 5 Place the scale in the incubator on the mattress tray 6 Verify that the level indicator bubble is within the circle 7 Ifnecessary remove the two level adjuster plugs and then Level Adjusters fine tune the two level adjusters on the scale until the bubble on the level indicator is within the circle For right or left level adjustments use the right hand or left hand mattress tilt mechanism knob 8 Replace the mattress 9 Connect the scale cable to the weight connector on the sensor module assembly see Sensor Module Connectors on page 5 5 Level Indicator A WARNING Utilize cable management clips to avoid infant entanglement and possible injury 10 Ensure all sensor leads are properly routed e Secure the scale cable to the incubator end wall using the cable clips provided on the inside of th
84. his alarm occurs in the Skin mode if the Skin1 probe is electrically open or shorted Air Flow Probe Failed N A N A This alarm occurs if the air flow probe connec tion is open or short circuited Humidity Specific Alarm Low Humidity 15 min N A This alarm occurs when the humidity has not risen to a predetermined threshold within a des ignated amount of time The most likely cause for this alarm is a low water level This alarm is only available when the humidity control is activated Oxygen Specific Alarms High Oxygen 4 min N A This alarm occurs when the displayed oxygen value is gt 3 above the oxygen set point Low Oxygen 4 min 4 min This alarm occurs when the displayed oxygen value is gt 3 below the oxygen set point Oxygen Cell Difference 4 min N A This alarm occurs when the oxygen cell read ings differ by more than 3 As a result the oxygen flow into the system is interrupted 16 Alarm Message E ei Description Oxygen Solenoid Fail N A N A This alarm occurs when the oxygen solenoid voltage is not within limits Slide In Sensor N A N A This alarm occurs after calibration is completed but the sensor module was not returned to the hood position UPS Alarms UPS alarm conditions are signaled with an audible indication generated by the UPS system The Alarm Silence Reset key canno
85. ion 5 min N A This alarm occurs when the sensor module is not in the hood or calibration position Stuck Key N A N A This alarm occurs when a stuck key is detected Skin Mode Disabled N A N A This alarm occurs when the controller is config ured for Air only operation and the Skin mode is selected Sensor Module Failure 1 N A N A This alarm occurs when the sensor module PCB is disconnected Sensor Module Failure 2 N A N A This alarm occurs when the controller detects a relative humidity RH sensor temperature fail ure and humidity is installed Alarm Message Sensor Module Failure 3 Alarm Silence N A Procedural Silence N A Description This alarm occurs when the controller detects a sensor module fan is not rotating Sensor Module Failure 4 N A This alarm occurs when the controller detects a sensor module analog to digital failure Sensor Module Failure 5 N A This alarm occurs when the controller detects an oxygen multiplexer calibration failure Sensor Module Failure 6 N A This alarm occurs when the controller detects a temperature multiplexer calibration failure Sensor Module Failure 7 N A This alarm occurs when the controller detects a sensor module RAM test failure Sensor Module Failure 8 This alarm occurs when the controller detects that the sensor module watchdog reset Temperature Specific Alarm
86. ity set value 50 RH Oxygen control mode Off Oxygen control set 21 value Temperature units ye Weight units kg Trend screen Air 2 hours Language English Altitude 0 ft 0 m Vuelink Off Air set temperature 35 C 95 F Skin control mode Off Skin alarm limit 1 C 33 8 F Humidity control mode Off Oxygen calibration 21 level Color White on blue User latitude 50 N User altitude 0m Calibration latitude 50 N Calibration altitude 0m a Vuelink is a trademark of Philips Medical Systems Alarms An alarm is signaled whenever a condition which could be potentially hazardous is detected System Alarms System alarm conditions are always signaled with a visual and audible indication and an appropriate message in the Trend Alarm window In the event that two or more system alarms occur simultaneously or one after the other the messages that describe the alarms are presented in sequence A total of five messages can be presented in the Trend Alarm window The Alarm Silence Reset key is used to silence the audio alarm for a fixed amount of time and or initiate a silence period before an alarm is actually activated The Alarm Silence Reset key can perform the following functions e Reset one or multiple latched alarms if there are no current alarms present e Silence one or more alarms if no previously latched alarms are present NOTE The Alarm Silence Reset key cannot simultaneously reset a previously
87. ity system senses an absence of water an audible and visual Low Humidity alarm occurs The humidifier is a three part system consisting of a humidity reservoir manifold assembly and evaporator assembly Humidity Reservoir The humidity reservoir has a 1 liter capacity The reservoir permits visual inspection of the water level It is located in a drawer in the front of the incubator shell When the drawer is closed and the latching handle is engaged the reservoir is connected to a manifold Manifold Assembly The manifold assembly allows the water to flow into the metering valve and the evaporator assembly Evaporator Assembly The metering valve regulates the flow of water to the evaporator chamber to maintain a constant level of water ensuring optimum responsiveness of the evaporator heater The evaporator assembly raises the temperature of the water to the boiling point causing vaporization Any waterborne bacteria are killed preventing transfer into the patient compartment The rate of vaporization is determined by the level of power transmitted to the evaporator heater The sensor module located within the hood environment houses the humidity sensor which sends information to the controller module The controller module regulates the output of the evaporator Oxygen Control System Optional When installed the oxygen servo control system adjusts the flow of oxygen within the incubator hood with a valve and an oxygen sensor module
88. key 3 4 At the Weight display press the gt 0 T lt or Zero softkey two times and then press the Display If necessary remove any objects from the mattress Selection key 5 At the Scale Calibration display press the Cal softkey The Wait message is displayed and then replaced with the 5 kg symbol 6 Within 12 s of the 5 kg symbol being displayed place a calibrated 5 kg weight on the center of the mattress NOTE If the 5 kg weight is not placed on the center of the mattress within 12 s after the 5 kg symbol is displayed the Cal Failed message is displayed ar Temperature Cal 35 6 36 0 Skin 1 Skin 2 35 6 35 6 Home Weight 5 000 Kg i 1 7 Wait for the Weight Sample bar to fill and a weight reading of 5 000 kg to be displayed 8 Remove the weight and then press the Home softkey to return to Display 2 35 Oxygen Sensor Calibration NOTE Only single point calibration is required NOTE If the message Cal Required is displayed calibrate the oxygen control system At a minimum daily calibrations are recommended NOTE If the sensor module cable is disconnected from the shell connector during operation the message Cal Required is displayed to indicate that the oxygen control system must be calibrated Oxygen Sensor Calibration to Room Air 21 A WARNING To perform the 21 oxygen calibration procedure ensure that the incubator i
89. kin probes To control the incubator temperature in the skin mode insert a skin probe into the skin probe 1 connector see Controls Indicators and Connectors on page 5 1 When a second skin probe is connected to the sensor module while operating in the skin mode an alarm sounds and the message Remove Skin 2 Probe is displayed To connect a second skin probe select the Air mode first The controller then displays the respective Skin 1 and Skin 2 temperatures monitored by the skin probes If Probe 1 is disconnected from its receptacle while in the Skin mode the skin temperature parameter goes blank on the display an alarm sounds and the heater turns off Features The Features subsection provides a list of the standard and optional features and available accessories for the Isolette Infant Incubator Models C2000 and C2000e Standard Features Standard features include e Oval access doors with a quiet latch Trendelenberg mattress tilt mechanism 0 to 12 e Pedestal base cover C2000e only e Rail system C2000e only Optional Features Options include e Oxygen control system e Humidity system e Fixed height stand without UPS system e VHA stand without UPS system C2000e only e Fixed height stand with UPS system e VHA stand with UPS system Accessories Accessories include e Weighing system e Ventilation support e Temperature probes e Port sleeves and cuffs e 5 kg weight e Gas tank mounts and ta
90. kout should be performed before the system is first placed into service and after any disassembly for cleaning or maintenance 4h WARNING Do not use the scale if it fails to function as described below Refer service to qualified personnel Non EU Scale 1 D Ensure that the mattress is level and not in the Trendelenburg or Reverse Trendelenburg position 2 Activate the Weighing system see Scale Measurements on page 5 28 3 4 5 Verify that the Weight display is shown Remove any objects from the mattress before pressing the Zero softkey Press the Zero softkey software version 2 17 or below or the gt 0 T lt softkey software 2 18 or above twice Verify that the Weight display reads zero and the Weight Sample bar searches Place a weight of known value but less than 7 kg 15 1b on the mattress Verify that when the Weight Sample bar stops searching or the bar is filled a beep sounds and the weight is locked and displayed in the Trend Alarm window Re weigh the object see Re weigh on page 5 29 10 Verify that the display again shows the value of the weight on the mattress EU Scale 1 Ensure that the mattress is level and not in the Trendelenburg or Reverse Trendelenburg position 2 Verify that the bubble on the scale level indicator is within the circle see Controls Indicators and Connectors on page 5 1 Select Display 2 and press the Weight softkey The weight screen is displ
91. le or reusable access door cuff on each required access door gasket NOTE Ensure the cuff has a small opening at its center 13 Ensure that the access door latches with slight pressure and opens when the latch lever is pressed 14 If the air intake microfilter is damaged visibly dirty or older than 3 months replace it 15 Install the air intake microfilter cover and tighten the two thumbscrews 16 If the seal at the rear of the reservoir assembly contains a silicon sponge reassemble the reservoir valve assembly components and then re install it gt NOTE Ensure the spring is in place 17 Replace the lid on the humidity reservoir and place the humidity reservoir in the humidity tray NOTE The unit is shipped with two reservoirs pr 18 Return the tray and reservoir to the shell 19 If required reattach any assemblies previously removed from the transition plate or rail assembly 20 Perform a complete functional checkout before returning the unit to service Refer to Operational Checkout on page 4 15 Disposal This device is subject to EU Directive 2002 96 EC WEEE It is not registered for use in private households and may not be disposed of at municipal collection points for waste electrical and electronic equipment Dr ger Medical has authorized a firm to dispose of this device in the proper manner For more detailed information please contact your local Dr ger Medic
92. lled water only lt 10 ppm total dissolved solids Sterile water is not an acceptable substitute for distilled wate Equipment damage could occur 2 Fill the humidity reservoir with distilled water 3 At Display 1 press the Humidity softkey 4 Press the ON softkey to activate the Humidity mode The rotating wheel indicates the Humidity mode is active The actual RH achievable inside the system is dependent on the incubator set temperature and room conditions 5 To deactivate the Humidity mode press the OFF softkey Humidity Control Set Point 1 Activate the humidity system see Humidity Mode on page 5 31 NOTE ar Temperature Con Jl If no keys are pressed within 15 s of selecting the 35 6 m ie OFF qua Humidity display the display automatically reverts to 35 6 35 6 mE Display 1 Air Temp us Humidity 50 2 Adjust the humidity set point a Press and hold the Up Arrow key to raise the humidity set point from a range of 30 to 95 in 1 increments b Press and hold the Down Arrow key to lower the humidity set point from a range of 95 to 30 in 1 decrements 3 Press the Home softkey to acknowledge the Humidity control setting and return to Display 1 4 Press the Keylock key to lock the keypad VueLink Monitoring VueLink software enables the user to view patient parameters from the Isolette Infant Incubator Models C2000 an
93. ls 2 tava 4 ibs owe haa hoe Wee Ba ae kG ee AS eas ee EA 5 5 M in Circ it Breaker a sade Genet ace a eee aaa were aes os E Gans we 5 5 Foot Pedal Controls gt eowad ages beware Cena ant auaea eter aie eau ad 5 6 Stand Indicators exit a anri aes eaten sO gratis aes Gis ate aA hie MNS Cau ett a gem 5 6 Stand Connectors soe vts pala eel aed eam ae tados ps Splat Lacs 5 6 Convenience Outlet s e a ed ade e Co 5 6 AC Input Connector y A A AAA ad See A 5 6 UPS Electronic Module ta A Behe eee A eevee te Ss 5 7 UPS Electronic Module Controls estrias us IRA A 5 7 UPS Electronic Module Indicators o oooooooocononcrcr ttn nen ees 5 7 UPS Electronic Module Connectors cave sis PA wea RW id ati Solow 5 8 DISPO Alcina ae A aE nat Gad hin A 5 9 Temperature Window ssas sorit A A a weds 5 9 Trend Alarm Window de 5 9 Humidity WNdOwW hn ia See gee ha BOR ar Ak Be HAE ae R E wd Bo 5 9 OxVoen WindOW cistitis Ped oes tas Paden acres Ss 5 9 System Displays A Oe ae aa Aa 5 10 Temperature Displays dE SARA E RA Se 5 10 Trend Display a is Ata 5 10 iii Oxygen Display lt lt sie oak WAH A adie Se Bde WER AAA Ae Se ed Rae 5 11 Humidity Display cress reos id baths Reba ees 5 11 Factory Default Settings 054 45 wens hte ae A wade Ga eae eS 5 12 ALS E SS came sh acca Seu e os 5 13 SISTEMAS E AAA AR 5 13 ESAS a A e a e coa del 5 17 Systemi PrOMPiS aras ds iS a a is a a 5 17 A A A CoE oc 5 19 Operating Iristructions 0 1 AA AA AAA A RA Se 5 20 Syst
94. ly and always check before lowering the VHA to ensure there is sufficient clearance between the incubator and stand assembly Do not raise or lower the unit while installing or removing medical gas tanks from the tank holder assembly Failure to do so could result in personal injury or equipment damage IHA011 If the unit has the optional vertical height adjustable stand it includes two sets of foot pedals one on the front and one on the rear of the unit To adjust the height of the incubator press the up down arrow on the front rear foot pedal of the VHA stand Temperature Settings NOTE The temperature of the warm air entering the patient compartment at the front and rear of the incubator is higher than the typical incubator air temperature NOTE The air curtain that functions when the access panels are open can be disturbed by drafts fans air conditioning etc Take necessary measures to keep the incubator away from these drafts NOTE The attending physician should prescribe the temperature control mode and temperature settings e Before attempting to operate the incubator become familiar with the operating precautions In addition refer to Controls Indicators and Connectors on page 5 1 e If the incubator is turned off or has been out of service for cleaning or maintenance refer to the Isolette Y Infant Incubator Models C2000 and C2000e Service Manual and perform the function checks If the incubator is already i
95. mark of Metrex Research Corporation 6 6 Mattress Mattress Tray X Ray Tray Main Deck Heater Impeller Cover Scale Optional and Mattress Tilt Bars 1 Using an intermediate level tuberculocidal cleanser disinfectant or equivalent thoroughly clean all surfaces of the following e Mattress e Mattress tray e X ray tray e Main deck e Heater impeller cover Scale optional e Mattress tilt bars NOTE For US markets only use an intermediate level tuberculocidal cleaners disinfectant registered by the Environmental Protection Agency EPA such as Kleenaseptic b Germicidal Surface Cleanser or a 2 gluteraldehyde solution 2 Dry all surfaces with a clean cloth or paper towel Uninterruptible Power Supply UPS Air Filter recommended that this procedure be performed without a patient in the NOTE paa PE The filter can be inspected and cleaned during operation However it is dl E lt Q system 1 Grasp the handle and firmly pull the filter cartridge until it is removed from the UPS electronic module 2 Clean the filter by vacuuming any dust accumulated on the filter media NOTE Always clean per recommended methods without the use of any liquids Never substitute reversal of the filter cartridge for cleaning 3 Always replace the filter cartridge after removal for cleaning Reassembly After Cleaning NOTE Harsh cleaning agents may attack some of the plastics used in the patient compartment 1
96. mattress tray and x ray tray 10 Remove the mattress tilt bars 11 Remove the main deck Heater and Impeller 12 Remove the heater impeller cover A WARNING The heater can be sufficiently hot to cause burns avoid removing or touching the heater until the unit has been switched off for at least 45 minutes 13 When the unit has cooled remove the heater and impeller a Remove the heater b Pull the impeller off the motor shaft Humidity Tray and Reservoir Non CPC 14 Pull down on the handle and slide the humidity tray out from the front of the incubator 15 Remove the reservoir from the tray 16 If the seal at the rear of the reservoir assembly contains a silicon sponge perform steps 17 and 18 otherwise go to step 21 17 Compress the ends and lift up on the rear end to remove the a Seal reservoir valve Y Valve Assembh 18 Dismantle the reservoir valve assembly and then place them in the reservoir Spring Silicon Sponge Humidity Tray and Reservoir CPC 19 Pull down on the handle and slide the humidity tray out from the front of the incubator 20 Remove the reservoir from the tray A CAUTION Do not disassemble the CPC valve Equipment damage could occur and performance could be compromised Access Door Gaskets Tubing Iris Entry Port Sleeves Cuffs 21 Remove the disposable access door cuff from each access door by pulling it from the outside 22 Pull the access door gaskets f
97. n every three months or as appropriate the filter and electronics module air inlet holes should be cleaned see Uninterruptible Power Supply UPS Air Filter on page 6 7 Air Intake Microfilter Maintenance Check the air intake microfilter during each preventive maintenance cycle If the air intake microfilter is one of the following replace it e Damaged e Visibly dirty e Older than 3 months Replacement Parts This section provides a listing of replacement parts accessories and single use items Parts not listed here should be replaced by qualified service personnel only NOTE Refer to the Isolette Infant Incubator Upgrade and Retrofit Kit Installation Instructions to upgrade C2000 and C2000e incubators NOTE For C2000e incubator replacement drawers contact technical support Replacement Parts List Part Number Description Miscellaneous 67 020 72 R MU04424 Restraint strap kit 79 251 74 MU10832 Kleenaseptic b trigger spray 12 24 oz 81 502 02 MU11536 Washer sealing oxygen air 83 001 00 MU12249 Mattress foam 83 001 05 MU12254 Ventilator tube support Isolette 83 101 30 MU12504 Filter replacement pack of four Isolette 83 442 00 MU12937 Monitor shelf assembly high Isolette Model C2000 only 83 442 14 MU12948 Monitor shelf assembly low Isolette Model C
98. n service and the function checks have not been performed become familiar with the various aspects of the hood shell operation e Keep the infant clear of the slots where the warm air enters the patient compartment e Routinely monitor the infant rectal and or axillary temperature according to the attending physician orders or Nursery Standing Orders Air Mode To select the air temperature control set point 1 At Display 1 press the Air softkey to select the Air mode NOTE If no keys are pressed within 15 s of selecting this display it automatically reverts to Display 1 2 Set the air temperature to the prescribed setting a Press the Up Arrow key to raise the set temperature from 20 C 68 F to X ar Temperature 377 37 0 C 98 6 F in 0 1 increments In 35 6 EU HH z Skin 1 __ Temperature Override mode press the 35 6 a V Up Arrow key to raise the set sr Tome as 1 JEJ temperature from 37 0 C 98 6 F to os 39 0 C 102 2 F a gt 37 C 25 50 Set Oxygen Y 50 5o b Press the Down Arrow key to lowerthe gp Le set temperature from 39 0 C 98 6 F to 20 C 68 F in 0 1 decrements NOTE The gt 37 C softkey activates the Temperature Override mode greater than 37 0 C 98 6 F The gt 37 C indicator lights and gt 37 C displays in reverse video NOTE The gt 37 C softkey is inoperative until t
99. ncubator is not equipped with a rear optional access panel only perform steps 11 through 13 however if the incubator is equipped with a rear optional access panel perform steps 13 through 16 Locate the corresponding slots on the other side of the mattress tray Repeat steps 5 through 8 Close the front access panel and rotate both sets of pawl latches until they are fully engaged Rotate the pawl latches and open the rear access panel Locate the corresponding slots on the other side of the mattress tray and then repeat steps 5 through 8 Close the rear access panel and then rotate both pawl latches until they are fully engaged UPS System Installation MODEL C2000E ONLY A CAUTION Prior to installing the UPS battery pack the power cord must be removed and the UPS module must be turned off to prevent the unit from spontaneously starting To install the UPS electronic module and battery pack of the UPS system perform the following 1 Facing the front of the unit the UPS electronic Electronic module will slide in from the left hand side of the Module stand into the support plate with the vented brackets Use the 2 fastener screws to secure the UPS Ss ips AD E gt electronic module in place Ss Front View Battery Pack Facing the front of the unit the battery pack will slide in from the right hand side of the stand into the support plate Use the 2 fastener screws to secure the battery pack
100. nd display selection and return to Display 2 press the Home softkey To lock the keypad press the Keylock key Scale Measurements Methods and Techniques to obtain accurate infant weight are described below e Always weigh the infant in the center of the mattress with the mattress in its flat position e Do not allow stuffed toys or other objects on the mattress to lean against the incubator walls or access panels Inaccurate readings can occur e Do not allow the mattress cover to touch the incubator hood e Secure ventilator tubing to the incubator walls in a manner that permits water in the tubing to drain away from the infant NOTE Support the ventilator tubing and I V tubes to ensure they do not touch the mattress e Place the following items so that they return to the same relative position when the infant has been lifted off and returned to the mattress ventilator tubing I V tubes and sensor leads A WARNING For infant safety do not leave the infant unattended when the access panel is open Personal injury could occur NOTE The mattress should be level i e not in the Trendelenburg or Reverse Trendelenburg position Non EU Scale Measurements Below are the steps required for non EU scale measurements only Initial Weigh To perform the initial weighing function 1 Ifnecessary unlock the keypad ay Temperature C Trend Se 2 AtDisplay 1 press the Display Selection key and
101. nd rotate both latches until they are fully engaged Pull the sensor module lock down and check that the sensor module slides in and out of the hood Push the sensor module lock up Sensor Module Lock When the sensor module lock is in the up position check that the sensor module is locked securely in place VHA Stand Operational Checkout OPTIONAL FEATURE A WARNING When raising or lowering the incubator the operator should ensure that both equipment and appendages are clear of the unit s travel path Patient and incubator connections must also be checked before adjusting the incubator height Never place any objects on top of the drawer assembly and always check before lowering the VHA to ensure there is sufficient clearance between the incubator and stand assembly Do not raise or lower the unit while installing or removing medical gas tanks from the tank holder assembly Failure to do so could result in personal injury or equipment damage IHA011 Perform this operational checkout procedure along with the operational checkout procedure for the controller before placing the incubator into service and after any disassembly or maintenance To check the VHA stand 1 Make sure the system is fully powered see System Start Up and Shut Down on page 5 20 2 To raise or lower the stand to the maximum and minimum height press and hold the foot pedal control of the VHA stand at the front of the unit
102. ndard text used for regular information e Boldface text emphasizes a word or phrase e NOTE sets apart special information or important instruction clarification The Definitions subsection contains label symbol definitions and technical definitions Additional definitions of system symbols and icons are located in Section 5 see Controls Indicators and Connectors on page 5 1 Some of the warnings contained in this user manual include number tags or bracketed wording for example 6 8 2 9 or IHA025 These are requirements which are used solely for internal documentation purposes Symbol Definitions e The symbol below highlights a WARNING or CAUTION Warning and Caution A A WARNING identifies situations or actions that may affect patient or user safety Disregarding a warning could result in patient or user injury A CAUTION points out special procedures or precautions that personnel must follow to avoid equipment damage e The symbol below highlights an ELECTRICAL SHOCK HAZARD WARNING Electrical Shock Hazard Warning AN e The symbol below indicates Attention Consult accompanying documents Attention Consult Accompanying Documents e The symbol below indicates a Type BF applied part Type BF Applied Part A The instrument provides a specified degree of protection against electric shock particularly the leakage current and reliability of the protective ground connection with a
103. nel and rotate both latches until they are fully engaged A WARNING A dirty air intake microfilter may affect oxygen concentrations and or cause carbon dioxide build up Check the filter routinely and change at least every three months Failure to do so could result in infant injury or equipment damage 8 Check the air intake microfilter which is located under the rear shell of the incubator a Cc 9 Check the air oxygen system located under the rear shell of the incubator a b Cc Inspect the microfilter If visibly dirty refer to Air Loosen the two thumbscrews of the air intake filter cover and remove the cover Intake Microfilter Maintenance on page 6 11 Install the air intake filter cover Introduce a carefully measured 9 lpm of oxygen into the oxygen input connector Using a calibrated oxygen analyzer monitor the level within the hood Verify that the level reaches the predicted level as indicated on the rear panel of the incubator 9 Ipm equals 50 to 70 10 Check the x ray tray Mattress a f g 11 Check the sensor module lock a Rotate the pawl latches and open the front access panel Pivot the front access panel to the full open position hanging straight down Slide out the x ray tray Check the tray for any defects Ensure the tray slides smoothly in and out of the ney ey opening Return the x ray tray Close the front access panel a
104. nge Battery type gel cell Operational UPS charge time Full capacity after 8 hours UPS operating time With batteries fully charged the power available from battery backup is sufficient to maintain a C2000e incubator in operation for 30 min in a 20 C ambient at a set point of 39 C in the Air mode without oxygen or humidity control or additional loads drawn from the accessory outlets Humidity System Feature Humidity System Dimension Humidity control operating time without refilling 24 hours maximum 85 RH and 36 C in Air mode Humidity control reservoir capacity 1000 ml Humidity control range 30 to 95 in 1 increments at high ambient humidity levels low level humidity settings may not be attainable Humidity control accuracy between 10 and 90 68 F 20 C to 104 F 40 C 6 RH Maximum humidity levels gt 85 incubator set temp at 39 C with at least 30 RH at ambient Oxygen System Feature Dimension Oxygen Control System Oxygen inlet pressure 40 psi to 150 psi Oxygen inlet flow rate 30 liters min Oxygen control range 21 to 65 Oxygen display resolution 1 increments Oxygen control accuracy at 100 3 calibration Oxygen control accuracy at 21 5 calibration Non EU Weighing System Feature Dimension Weighing System Weight display range 0 kg 0 lb to 7 kg 15 1b Weight
105. nks E and D sizes C2000e only Deutsche Institute von Normen DIN and Integris Fairfield rail mounted accessories C2000 only e Non rail mounted accessories Specifications The Specifications subsection provides specifications for the standard and optional features and available accessories of the Isolette Infant Incubator Models C2000 and C2000e It also includes regulation and standards and codes information for the system Standard Features Feature Dimension Physical C2000 Depth 67 31 cm 26 5 Width 102 9 cm 40 5 C2000e Depth 67 31 cm 26 5 Width 120 cm 47 25 including rail width Incubator weight gt 49 kg 108 Ib Mattress tray width 79 cm 31 Mattress tray depth 41 cm 16 Mattress Trendelenburg Reverse Trendelenburg tilt Electrical Convenience outlets Model C2000 100V only Convenience outlets 120V Convenience outlets 230V Chassis current leakage 100V and 120V Chassis current leakage 230V Environmental Continuously variable to 12 1 100V 50 60 Hz 300 W maximum 120V 50 60 Hz 300 W maximum 230V 50 60 Hz 300 W maximum lt 300 pA lt 500 uA Air mode control temperature range 20 0 C 68 0 F to 37 0 C 98 6 F Air mode control override temperature range Skin mode control temperature range 37 0 C 98 6 F to 39 0 C 102 2 F 34 0 C 93 2 F to 37 0 C 98 6 F Skin mode control ove
106. ns then dry with a clean cloth or paper towel Heater Radiator and Fan Impeller 4 SHOCK HAZARD Unplug the unit from its power source prior to cleaning or maintenance For units equipped with an uninterruptible power supply UPS system also remove the battery pack prior to cleaning or maintenance Failure to do so could result in personal injury or equipment damage WARNING Failure to clean the heater radiator and fan impeller could result in sufficient lint build up to reduce airflow which could affect the temperature control and cause high oxygen concentrations Personal injury or equipment damage could occur Remove any lint build up on the heater radiator and fan impeller 1 Kleenaseptic b is a registered trademark of Metrex Research Corporation 2 Kleenaseptic b is a registered trademark of Metrex Research Corporation Humidity Reservoir 44 CAUTION Do not steam autoclave parts when disassembling for cleaning Equipment damage could occur Wipe the heater assembly and the humidity reservoir cap clean using a intermediate level tuberculocidal cleanser disinfectant or equivalent NOTE For US markets only use an intermediate level tuberculocidal cleaners disinfectant registered by the Environmental Protection Agency EPA such as Kleenaseptic b Germicidal Surface Cleanser or a 2 gluteraldehyde solution Do not immerse the heater assembly in liquid NOTE The evaporator raises the temperature of the water
107. of the mattress Close the access panel and ensure the pawl latches are fully engaged DO APN Re install any rail accessories previously removed Operating Instructions The Operating Instructions subsection describes the procedures required to operate the incubator stand options and accessories System Start Up and Shut Down Below are the initial start up procedures for UPS and non UPS systems System Start up Initial Start Up for Systems without UPS To power up the system 1 Verify the power cord from the stand is firmly attached to the connector under the incubator shell assembly 2 Plug the stand power cord into an appropriate AC power source If the unit is equipped with a detachable power cord ensure the AC power cord is attached to the AC inlet of the stand Turn on the Main Power circuit breaker located on the stand 4 Locate the On Off switch under the incubator shell assembly and then turn on the incubator During the self test all indicator lamps light and the audible alarm pulses After the system start up tests the incubator boots up in the Air mode at Display 1 NOTE If the unit fails the self test the alarm sounds and one or more of the following messages are displayed in the Trend Alarm window refer the unit to service Controller Failure 1 through 13 or Check Settings 5 At the incubator controller select the desired system options parameters and operating modes see System Config
108. operation 1 Check the access panel s a e At the controller check that the door open symbol turns on Rotate the pawl latches and open the front and rear optional access panels Pivot the access panels to the full open position hanging straight down Close the access panels and rotate both sets of latches until fully engaged At the controller check that the door open symbol turns off NOTE Both latches must fully engage to avoid accidental opening of the panels 2 Check the hood operation a Rotate the pawl latches and open the front or rear optional access panel If equipped with a weighing scale disconnect the weighing scale cable from the sensor module Close the access panel and rotate both latches until they are fully engaged Slowly tilt the hood back until the hood locks in place To release the hood pull on and hold the knob located on the right rear hinge while closing the hood If equipped with a weighing scale perform steps g through 1 Rotate the pawl latches and open the front or rear optional access panel Reconnect the weighing scale cable to the sensor module Close the access panel and rotate both latches until they are fully engaged 3 Rotate the outer ring of the iris entry ports The iris opens and closes as rotation is continued through 360 4 Check the access door latches and gaskets a Press the door release of each access door and
109. or Main Power switch is Off For non UPS systems only The power cord is unplugged For non UPS systems only The power cord to the incubator is unplugged For UPS systems only The batteries are not charged Remedy At the stand turn on the Main Power switch Make sure that the power cord is plugged into the AC power source If the power cord is detachable also make sure it is firmly attached to the stand receptacle Re attach the power cord to the incubator receptacle After a power failure or prior to initial usage keep power applied continuously to the UPS system for a maximum of 8 hours NOTE Ensure the Resettable circuit breaker is in the On 1 position No data static noise is displayed on screen at system start up Misplaced jumper setting for con troller type Turn the incubator off and remove it from service The Low Air Skin Temperature alarm activates An access door or iris entry port is open Close all access doors and iris entry ports The skin probe is not properly secured to skin in Skin mode only Check the skin probe connection Symptom Low oxygen concentrations exist Possible Cause An access door or iris entry port is open Remedy Close all access doors and iris entry ports An iris entry port sleeve is open or improperly installed Check the installation of the iris entry port A tubing access port is not
110. ough the slots at the front and rear of the main deck It then passes between the front and rear inner walls The air circulates past the sensor module containing the temperature sensing probe which encapsulates the air temperature control thermistor and a high air temperature alarm thermistor After circulating within the infant compartment the air is then re circulated down through a slot in the right end of the main deck and back to the impeller When the front and or rear access panel s of the hood is are open the air continues to flow upward past the opening creating a warm air curtain This curtain minimizes the drop in air temperature within the incubator Temperature is regulated by using either incubator air or skin temperature The front panel keys enable the user to select the desired Air or Skin mode In either mode of operation the heater output is proportional to the amount of heat required to maintain the desired temperature The Air and Skin modes are described below Air Mode In the Air mode the air temperature can be maintained from 20 0 C 68 0 F to 37 0 C 98 6 F as selected by the Up and Down Arrow keys on the front panel In Temperature Override mode the temperature can be maintained from 37 0 C 98 6 0 F to 39 0 C 102 2 F The incubator air temperature is monitored by a probe located in the sensor module and compared with the air set temperature parameter The information from this probe is supplied
111. plies with the following safety standards and performance standards e EN 60601 1 990 Medical Electrical Equipment Part 1 General Requirements for Safety including Amendments 1 and 2 e EN 60601 1 2 2002 Collateral Standard Electromagnetic Compatibility Requirements and Tests e EN 60601 2 19 1996 Particular Requirements for the Safety of Baby Incubators including Amendment 1 Electromagnetic Compatibility EMC Guidance and Manufacturer Declarations Guidance and Manufacturer s Declaration Emissions The C2000 is intended for use in the electromagnetic environment specified below The customer or user of the unit should ensure that the unit is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance Radio frequency RF Group 1 The C2000 uses RF energy only for its internal emissions CISPR 11 function Therefore its RF emissions are very low and are not likely to cause interference with nearby electronic equipment RF emissions Class A The C2000 is suitable for use in all establish CISPR 11 ments including domestic and those directly Harmonics Class A connected to the public low voltage power sup IEC 61000 3 2 ply network that supplies buildings used for Flicker Class A domestic purposes IEC 61000 3 3 Guidance and Manufacturer s Declaration Immunity The C2000 is intended for use in the electromagnetic environment specified below
112. poles and shelves to their lowest position place all drawers in their locked state and remove all accessories from the front and rear rail position IHA033 A WARNING When the front access panel or optional rear is open the temperature display may not accurately reflect the incubator temperature Do not leave the front access panel or optional rear open longer than essential Personal injury could occur A WARNING Positively secure all access panel latches to avoid accidental opening Failure to do so could result in personal injury or equipment damage WARNING For infant safety do not leave the infant unattended when the access panels are open Personal injury could occur A WARNING The use of infant seats or other accessories within the incubator that can alter the airflow pattern and may affect temperature uniformity temperature variability the correlation of the incubator temperature reading to center mattress temperature and infant skin temperature Personal injury could occur A WARNING If airflow passages are not kept clear of obstructions such as blankets and stuffed animals during clinical usage patient safety and incubator performance may be compromised Ay WARNING When the access panels are open a curtain of warm air flows along the length of the mattress toward the top of the access panel openings The temperature of this air curtain is higher than the typical incubator air temperature therefore
113. power of the communications equipment Separation m Separation m E E 150 kHz to 150 kHz to Separation m Reparon m Maximum Output 80 MHz 80 MHz 80 to 800 MHz z to Power Non ISM ISM 2 5 GHz Watts D 12 P RT D 1 167 P D 12 P 0 01 0 1167 m 0 12 m 0 12 m 0 23 m 0 1 0 369 m 0 38 m 0 38 m 0 73 m 1 1 167 m 12m 1 2m 2 3 m 10 3 69 m 3 8 m 3 8 m 7 3 m 100 11 67 m 12m 12m 23 m Device Classification The Isolette Infant Incubator Models C2000 and C2000e meets the requirements for the following classifications Class I Type BF IPX0 Ordinary equipment Not AP Continuous operation 15 Notes Section 3 Precautions and Safety Tips Precautions This section contains a list of electrical explosion EMC oxygen and humidity precautions Electrical Precautions WARNING The total electrical current leakage of all items powered through the incubator including devices on the outlet strip must be less than 300 uA for 120V AC 100V AC systems and less than 500 uA for 230V AC systems Otherwise personal injury or equipment damage could occur A SHOCK HAZARD The potential for electrical shock exists with electrical equipment Establish policies and procedures to educate your staff on the risks associated with electrical equipment A SHOCK HAZARD To ensure grounding reliability plug the AC power cord only into a properly grounded 3 wire hospital grade or hospit
114. rature differs from the set temperature by gt 1 0 C or 0 5 C user selectable 15 Alarm Message Low Skin Temperature Alarm Silence N A Procedural Silence N A Description This alarm occurs when the indicated displayed temperature differs from the set temperature by lt 1 0 C or 0 5 C user selectable Air Probe Failed N A N A This alarm occurs when one of the three ther mistors in the sensor module differ from the other two by 0 8 C or all three thermistors have a measurement error exceeding acceptable lim its Connect Skin 1 Probe N A N A This alarm occurs if the Skin mode is selected and there is no probe in the Skin1 probe connec tor High Skin1 Temperature 15 min N A This alarm occurs when the Air mode is enabled and the infant skin temperature from the Skin1 probe is gt 38 0 C 0 2 C when the Override mode is not active or gt 39 0 C 0 2 C when the gt 37 C mode of operation is active High Skin 2 Tempera ture 15 min N A This alarm occurs when the Air mode is enabled and the infant skin temperature from the Skin2 probe is gt 38 0 C 0 2 C when the Override mode is not active or gt 39 0 C 0 2 C when the gt 37 C mode of operation is active Remove Skin2 Probe This alarm occurs in the Skin mode when a skin probe is inserted into the Skin2 probe connector Skin1 Probe Fail Alarm 5 min N A T
115. re to clean the heater radiator and fan impeller could result in sufficient lint build up to reduce airflow which could affect the temperature control and cause high oxygen concentrations Personal injury or equipment damage could occur A WARNING The heater can be sufficiently hot to cause burns avoid removing or touching the heater until the unit has been switched off for at least 45 minutes 4h WARNING Only facility authorized personnel should perform preventive maintenance or troubleshooting on the Isolette6 Infant Incubator Models C2000 and C2000e Preventive maintenance performed by unauthorized personnel could result in personal injury or equipment damage A WARNING At the end of the life of the Isolette Infant Incubator Models C2000 and C2000e safely dispose of the unit per local requirements Failure to do so could result in personal injury 4h WARNING Failure to adhere to the weight and placement requirements for rail accessories on the rail system can result in personal injury or equipment damage A WARNING This product has been validated with the accessories and options listed in this manual and found to comply with all relevant safety and performance requirements applicable to the device It is therefore the responsibility of that person or organization who makes an unauthorized modification or incorporates an unapproved attachment to the device to ensure that the system still complies with those requirements I
116. rify e Unit switches to battery operation for 10 seconds e AC LED turns off for 10 s and then back on again Test Battery Back up Function 9 Unplug the AC power cord at the electronics module from the AC power source 10 Verify the battery back up audio beeps twice every 8 seconds 11 Verify the AC LED turns off 12 Quickly press the On Off Test switch lt 1 second to silence the audio 13 Re plug the AC power cord into an appropriate power source and verify the following indicator status e AC LED turns on Inv LED and Load LED remain on e Bypass LED turns off Rail System Operational Checkout STANDARD FEATURE ON C2000 ONLY Proper latching of rail accessories to the rail is both visually and physically evident to the user NOTE if E This applies only to the Integris Fairfield compatible rail L Verify that all cam adapter latches are properly secured to the 2 m Integris Fairfield compatible rail when in the locked ERP ETRA ASCSM position 8 o clock 4 o clock NOTE This applies only to the DIN rail Verify that all adapter latches are properly secured to the DIN rail when in the locked position NOTE The mounting adapters lock when the toggle handle is switched to the left position 8 o clock and unlocks when the toggle handle is switched to the right position Oxygen Control Module Operational Checkout OPTIONAL FEATURE Perform the oxygen system operational checkout before the system is first
117. rmedical com Fax 49 451 882 2080 Technical Support 800 437 2437 http www draeger com Fax 215 721 5782 Technical Support 49 1805 372 3437 Fax 49 451 882 3779 Part number Revisions Date 85 990 05 5 October 2006 MU14982 0123 Air Shields is a registered trademark of Draeger Medical Systems Inc Allen is a trademark of Industrial Fasteners Inc Care For Me is a trademark of Draeger Medical Systems Inc Isolette is a registered trademark of Draeger Medical Systems Inc Kleenaseptic B is a registered trademark of Metrex Research Corporation Vuelink is a trademark of Philips Medical Systems Draeger Medical Systems Inc reserves the right to make changes without notice in design specifica tions and models The only warranty Draeger Medical Systems Inc makes is the express written war ranty extended on the sale or rental of its products The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Draeger Medical Systems Inc 2006 by Draeger Medical Systems Inc ALL RIGHTS RESERVED
118. rol set point in accordance with the attending physician recommendations 1 Activate the Oxygen mode see Oxygen Control on page 5 30 2 Adjust the oxygen set point a Press the Up Arrow key to raise the set point from 21 to 65 b Press the Down Arrow to lower the set point from 65 to 21 3 Press the Home softkey to acknowledge the Oxygen Control setting and return to Display 1 4 Press the Keylock key to lock the keypad Humidity Settings A WARNING Higher relative humidity will at any given time decrease an infant s evaporative water loss and may cause an increase in infant temperature This effect is greatest in very low birth weight premature infants The attending physician should prescribe Temperature Control mode temperature setting and humidity output level setting Routinely monitor the infant s rectal and or axillary temperature according to the attending physician s orders or Nursery Standing Orders Failure to do so could result in personal injury NOTE At humidity levels greater than 60 RH condensation may form on the inside walls of the hood This can be minimized or eliminated if desired by changing the set RH to a lower humidity setting If the humidity system is not in use remove the water from the humidity reservoir Humidity Mode 1 Prewarm the incubator in Air mode to the temperature prescribed by the attending physician or according to Nursery Standing Orders A CAUTION Use disti
119. rom each side of the hood to remove them 23 Pull the tubing access grommets from each side of the hood 24 Remove the disposable iris entry port sleeves from the OO retainer rings 8 25 Wipe the retainer rings clean 26 Discard all disposable sleeves and cuffs Air Intake Microfilter 27 Loosen the two thumbscrews to remove the air intake microfilter cover Cleaning Procedures Reusable Skin Temperature Probe Using a facility approved cleanser detergent thoroughly clean all surfaces and dry them with a clean cloth or paper towel Access Door Gaskets and Tubing Access Ports 1 Place the access door gaskets and tubing access ports into a suitable container filled with a cleanser disinfectant 2 Allow them to soak as recommended by the manufacturer of the cleaning solution 3 Remove them and dry them thoroughly with a clean cloth or paper towel Controller Shell and Stand 44 CAUTION When cleaning the interior of the incubator shell prevent liquids from entering the motor shaft opening Equipment damage could occur CAUTION When cleaning the surface of the air circulation well take care to prevent liquids from entering the motor shaft opening Failure to do so could result in equipment damage Use an intermediate level tuberculocidal cleanser disinfectant or equivalent to clean all surfaces thoroughly then dry with a clean cloth or paper towel 6 4 NOTE For US markets only u
120. ronmental Protection Agency EPA such as Kleenaseptic b Germicidal Surface Cleanser or a 2 gluteraldehyde solution e Dilute the disinfectant as specified on the manufacturer label e Thoroughly dry the unit before putting it back into use e After removing all solid wastes and contaminants from the disassembled parts refer to the respective cleaning procedures for the individual parts Disassembly for Cleaning For routine cleaning there is no need to separate the hood and shell assemblies from the stand If separation is necessary refer to disassembly procedures described in the solette Infant Incubator Models C2000 and C2000e Service Manual A CAUTION Prior to disassembling the hood and shell assemblies remove accessories mounted to the rail or transition plate Equipment damage could occur 1 Unplug the unit from its power source 1 Kleenaseptic b is a registered trademark of Metrex Research Corporation 6 2 Mattress Tray X Ray Tray Main Deck Scale optional Mattress and X ray Tray 2 Disconnect the cables from the sensor module Slowly raise the hood 4 Remove the mattress If the incubator is equipped with a weighing scale perform steps 6 through 8 otherwise go to step 8 Heater Impeller Cover 6 Disconnect the scale cable from the sensor module 7 Remove the cable from the clamps that hold it to the incubator 8 Lift the scale from the mattress tray 9 Remove the
121. row keys The Up Arrow and Down Arrow keys enable the user to select settings in the various displays and the System Configuration menu At the Set Up menu the Up Arrow and Down Arrow keys enable the user to select various parameters modes and settings required to operate and control the system D For liquid crystal display LCD controllers when the Keypad Lock key is inactive in Display 1 and Display 2 use the Up Arrow and Down Arrow keys adjust the screen brightness Display Selection key The Display Selection key enables the user to select between displays which are not accessible via softkeys Q Parameter Selection keys Parameter Selection Tool The Parameter Selection keys enable the user to select parameter and menu options at the various displays gt 37 T 2 Softkeys E NM Air softkey The Air softkey selects the Air mode at Display 1 Skin softkey The Skin softkey selects the Skin mode at Display 1 Humidity softkey The Humidity softkey selects the Humidity display at Display 1 Oxygen softkey The Oxygen softkey selects the Oxygen display at Display 1 Trend softkey The Trend softkey selects the Trend display at Display 2 Weight softkey The Weight softkey selects the Weight display at Display 2 and activates the weighing function C F softkey The C F softkey enables the user to select the temperature display units in Celsius or Fahrenheit degrees for
122. rride temperature range 37 0 C 98 6 F to 38 0 C 100 4 F Temperature rise time at 22 C 72 F ambient lt 35 min the actual incubator temperature after the incubator temperature equilibrium is reached Temperature variability lt 05 C Temperature overshoot lt 0 5 C maximum Temperature uniformity with a level mattress lt 0 8 C Correlation of the indicated air temperature to lt 0 8 C Environment temperature operating range Operating temperature RH sensor 20 C 68 F to 30 C 86 F 20 C 68 F to 41 C 106 F Operating temperature oxygen sensor 20 C 68 F to 41 C 106 F Operating humidity range 5 to 99 RH non condensing Feature Noise level within the hood environment Air velocity over the mattress Dimension lt 47 dBa with 37 dBa or less ambient less O administration lt 4 second 10 cm second average of five points at 4 10 cm above the mattress Storage temperature 25 C 13 F to 60 C 140 F Storage humidity range 0 to 99 relative humidity non condensing Carbon Dioxide CO level per EN60601 2 19 Clause 105 lt 0 5 Operational Set point data retention non UPS systems power failures lasting lt 10 min Set point data retention UPS systems power failures lasting lt battery charge depletion time 10 min Options and Accessories Stands Feature
123. s High Temp CutOut 5 min N A Under air control this alarm is activated if the displayed incubator temperature reaches 37 7 C 0 1 C for set temperatures lt 37 C or 39 7 C 0 1 C for set temperatures gt 37 C Under skin control this alarm is activated if the incubator temperature reaches 39 7 C 0 1 C for any set temperature Skin 1 Probe Fail N A N A This alarm is activated when the controlling skin temperature probe only in the Skin mode is mechanically connected but electrically open or short circuited The associated monitoring dis play reads Skin Probe Disconnect 5 min N A This alarm is activated when the Skin1 tempera ture probe only in the Skin mode is removed from the sensor module The associated moni toring display goes blank Remove Skin2 Probe N A N A This alarm occurs when two skin probes are installed and the Skin mode is selected Low Air Flow 15 min 15 min This alarm occurs when an air circulation failure is detected High Air Temperature 15 min N A This alarm occurs when the indicated displayed temperature differs from the set temperature by gt 1 5 C Low Air Temperature 15 min 15 min This alarm occurs when the indicated displayed temperature differs from the set temperature by ee i Ge High Skin Temperature 15 min N A This alarm occurs when the indicated displayed tempe
124. s complete plug the unit into an appropriate AC source to fully charge the battery NOTE Allow a maximum of 8 hours to fully charge the battery pack Do not attempt to transport the patient until the battery is fully charged Section 6 Cleaning Maintenance and Replacement Parts Cleaning A WARNING Follow the product manufacturer s cleaning instructions Failure to do so could result in personal injury or equipment damage A WARNING When performing cleaning and maintenance procedures confirm that the oxygen supply is turned off and that the equipment is disconnected from the oxygen supply A fire and explosion hazard exists when performing cleaning and maintenance procedures in an oxygen enriched environment Personal injury or equipment damage could occur 4 SHOCK HAZARD Some chemical cleaning agents may be conductive and leave a residue that may permit a build up of conductive dust or dirt Do not allow cleaning agents to contact electrical components and do not spray cleaning solutions onto any of these surfaces Personal injury or equipment damage could occur 4 SHOCK HAZARD Unplug the unit from its power source prior to cleaning or maintenance For units equipped with an uninterruptible power supply UPS system also remove the battery pack prior to cleaning or maintenance Failure to do so could result in personal injury or equipment damage 4 SHOCK HAZARD Do not expose the unit to excessive moisture that
125. s condition for correct sensor attachment and feel the infant s skin for signs of overheating 6 8 2 6 A WARNING When an x ray is taken through the hood the hood could show up on the x ray as a radiolucent shadow and could result in incorrect diagnosis A WARNING Attach the incubator to the stand or the vertical height adjustable stand using the bolts provided Failure to do so could result in the incubator separating from the stand if sufficiently tilted particularly with the hood open Personal injury or equipment damage could occur A WARNING Never place objects taller than the top of the wheel casters beneath the incubator stand Placement of objects there could interfere with the stability of the vertical height adjustable stand Personal injury or equipment damage could occur A WARNING To avoid possible tip over or damage to adjacent carts V stands shelves etc keep at least a 12 30 cm perimeter area clear around the vertical height adjustable stand Failure to do so could result in personal injury or equipment damage A WARNING For optimum incubator stability always lock all stand wheels Do not leave the unit unattended when parking on an incline Failure to do so could result in personal injury or equipment damage AX WARNING When operating the variable height adjustable stand always place one hand on the incubator for support to keep from losing your balance Failure to do so could result in personal injur
126. s equipped with the standard sensor module slide lock If the 100 oxygen calibration fixture is used during the 21 calibration procedure the calibration will be inaccurate Infant injury could occur To calibrate the oxygen sensor to room air 21 1 Verify the oxygen calibration level setting 21 or 100 at the System Configuration Menu see System Configuration on page 5 22 If required configure the oxygen calibration level setting for 21 3 Ensure that the incubator is equipped with the standard sensor module slide lock not the 100 10 oxygen calibration fixture At Display 1 press the Oxygen softkey Press the ON softkey and then the Cal softkey The message Slide Out Sensor is displayed Within 5 s withdraw the sensor module from the incubator hood to prevent a Cal Fail message When calibration is complete the message Cal Pass is displayed in the Oxygen window Slide the sensor module inside the hood and then press the ON softkey Use the Up and Down Arrow keys to set the oxygen percentage If the message Cal Fail is displayed repeat the procedure If the calibration procedure is unsuccessful a second time refer the unit to qualified service personnel Sire Sensor Module In postion Sensor Module Out position ms O i Oxygen Sensor Calibration to 100 Oxygen l 2 AA A To perform the 100 oxygen calibration procedure install the 100 oxygen c
127. s within the circle it meets its performance specifications Incubator Connectors Controller Interface Connector The controller interface connector provides communication between the controller and sensor module Controller Interface Connector Serial Port A WARNING A Devices connecting to the serial port must be compliant with EN 60601 1 2 the EMC requirement for Medical a is Devices Failure to do so could result in personal injury le or equipment damage A WARNING Serial Only connect equipment to the serial port that complies Port with the relevant IEC standard and use data cables with plastic body connectors Failure to do so could result in personal injury The serial port is located underneath the incubator shell on the back of the controller and provides an isolated serial communication link This port is used to connect the incubator to a bedside patient monitor or a central monitoring system It enables viewing of the following system parameters using the VueLinkTM system e Air and skin set point temperatures e Current air and skin temperatures e Alarm messages e Oxygen set point e Oxygen level e Humidity set point e Humidity level e Infant weight 1 VueLink is a trademark of Philips Medical Systems 5 4 Sensor Module Below are the sensor module controls indicators and connectors Sensor Module Controls There are no controls on the sensor module Sensor Module Indicators
128. sal of sealed gel cell batteries WARNING Do not add external batteries to the UPS system Personal injury or equipment damage could occur To ensure the useful life of the battery pack module cycle the UPS system every 3 months or as appropriate To cycle the battery pack module 21 With the unit operational and no patient in it or anticipated disconnect the AC supply and allow the system to operate from the batteries until the low battery alarm occurs 22 Restore the AC supply and allow the system to operate a maximum of 8 hours to ensure the battery pack is fully recharged Failure to do this can invalidate the battery warranty If it is anticipated that the battery pack is not to be in use for any extended period of time the system should be left plugged in 24 hours before storage This step ensures that the batteries are fully charged before storage In addition the system should also be removed from storage every 3 months and recharged for 24 hours prior to placing the system back in storage If a loss of battery operation run time is noticed the batteries in the battery pack could possibly require replacement Refer to the so ette Infant Incubator Models C2000 and C2000e Service Manual for replacement procedures UPS Electronics Module Maintenance The module houses a dust filter cartridge that can be easily cleaned The filter should be inspected during each operational checkout and cleaned as required In additio
129. se an intermediate level tuberculocidal cleaners disinfectant registered by the Environmental Protection Agency EPA such as Kleenaseptic b Germicidal Surface Cleanser or a 2 gluteraldehyde solution In addition check for fluids that may have dripped onto the bottom surface of the humidity tray opening If fluids are present use a clean paper towel dampened with a cleaner disinfectant to wipe the surfaces dry Sensor Module Hood and Inner Walls A CAUTION Alcohol can cause crazing small stress cracks of the clear acrylic Do not use alcohol for cleaning Equipment damage could occur A CAUTION Do not expose the clear acyrlic to direct radiation from germicidal lamps Ultraviolet radiation from these sources can cause cracking and or crazing of the acrylic surface 1 Press on the catches located at the top of the inner wall to release the inner wall NOTE The inner walls are hinged on the access panels or rear wall of the incubator 2 Use an intermediate level tuberculocidal cleanser disinfectant or equivalent to clean all surfaces of the hood thoroughly including the sensor module inner walls access doors and access panels NOTE For US markets only use an intermediate level tuberculocidal cleaners disinfectant registered by the Environmental Protection Agency EPA such as Kleenaseptic b Germicidal Surface Cleanser or a 2 gluteraldehyde solution 3 Be sure to clean all holes and indentatio
130. t VueLink Yes No No Color LCD display White on blue Yellow on White on blue black Color EL display Yellow on black does not Yellow on black change color User latitude 30 N 70 N 50 N User altitude 0 m 500 m 1000 m 1500m 0m a VueLink is a trademark of Philips Medical Systems To select desired settings at the System Configuration menu 1 If the incubator is already turned on perform steps 2 and 3 to enter the configuration mode or reboot the system and go to step 5 2 If the keypad is locked press the Keypad Lock key to unlock the keypad 3 Press the following key sequence Display Selection key Trend key Up Arrow key Keypad Lock key Down Arrow key Display Selection key go to step 7 Press and hold the Alarm Silence Reset key Turn the incubator on and continue to hold the Alarm Silence Reset key while the unit powers up Select the menu options using the Display Selection key Select the desired setting s using the Up Arrow and Down Arrow keys eS PN NM gt Press the Alarm Silence Reset key to exit the System Configuration menu Variable Height Adjustment Ay WARNING When raising or lowering the incubator the operator should ensure that both equipment and appendages are clear of the unit s travel path Patient and incubator connections must also be checked before adjusting the incubator height Never place any objects on top of the drawer assemb
131. t be used to silence or reset UPS generated audible alarms Alarm Message ee eae ae Description AC Supply Failure N A N A An audible alarm is produced when the AC sup Alarm plied power fails The system produces two short beeps every 8 seconds Low Battery Alarm N A N A An alarm is produced when the battery voltage is low The system produces two short beeps every second System Fault Alarm N A N A An alarm is produced if the system detects a fault overload or short circuit on the output The system produces a continuous audible alarm System Prompts Below is a description of messages appearing on the controller display screen which do not generate audible or visual alarms System Prompt Messages System Prompt Messages Description Alarm Reset This message is displayed when a previously latched alarm condition has been cleared with the Alarm Silence Reset key Check Settings This message is displayed when a failure is detected with the controller non volatile memory test Keypad Locked This message is displayed when the user presses a key and the Keypad Press Lock key is illuminated and active Not Installed Humidity This message is displayed when humidity control is attempted but the humidity system is not active and or installed Not Installed Oxygen Performing Power Up Tests Procedure Silence This message is displayed when oxygen control is attempted
132. t the incubator can only mount in one orientation Ring Lug Wingnut Power Cord To assemble the hood shell and stand assembly 1 Mount the hood shell assembly on the stand with the provided screws Plug the stand power cord into the incubator power cord receptacle 2 3 Remove the wing nut next to the power cord connector on the stand 4 Place the washer ring lug and a second washer on the stud 5 Install and tighten the wing nut Mattress Restraint Strap Installation MODEL C2000E ONLY Hood Shell Assembly Pawl Latches k Restraining Front Access Panel Mattress Tray Slot 1 Rotate the pawl latches and open the front access panel of the incubator 2 Remove the restraint straps from the packaging NOTE Each package contains two pairs of interlocking restraints 3 Place the restraining strap pairs on the mattress 4 Locate the slots along the side of the mattress tray 5 Lift one end of the restraining strap and turn the hook sideways facing the inner ridge of the mattress tray 6 Slide the hook into the required mattress slot 7 When the hook clears the mattress slot opening turn the hook and then pull upward on the restraining strap 8 Repeat steps 5 through 7 for the remaining pair of restraining straps 10 11 12 13 14 15 16 If necessary adjust the width of the restraining strap so that it extends the across the mattress If the i
133. the latch to securely hold the accessory being used When the latch is properly locked both visual and physical feedback are provided The toggle handle will snap into an 8 o clock position on the latch body when locked Total rail load must not exceed 36 3 kg 80 Ib The side rail loads must not exceed 13 61 kg 30 Ib The front and rear rail loads must not exceed 6 8 kg 15 Ib IHA029 A WARNING Failure to adhere to the weight and placement requirements for rail accessories on the rail system can result in personal injury or equipment damage WARNING This product has been validated with the accessories and options listed in this manual and found to comply with all relevant safety and performance requirements applicable to the device It is therefore the responsibility of that person or organization who makes an unauthorized modification or incorporates an unapproved attachment to the device to ensure that the system still complies with those requirements WARNING Only one monitor shelf should be used per incubator When using the monitor shelf always place the monitor in the center of the shelf ensure that the monitor fits within the border of the shelf and avoid stacking monitors on the shelf The maximum combined weight of all items on the monitor shelf should not exceed 25 Ibs Personal injury or equipment damage could occur Hood Shell and Stand Assembly NOTE The stand and incubator assemblies are keyed so tha
134. the skin probe from the skin probe 1 connector of the sensor module Verify that the skin display goes blank the Skin Probe Disconnect alarm message is displayed in the Trend Alarm window and the audible alarm sounds Press the Alarm Silence Reset key The audible alarm silences for 5 min Reconnect the skin probe in the skin probe 1 connector Verify that the incubator returns to normal operation 8 Check the Maximum Air Temperature a o fF mh 16 Connect a skin probe to the sensor module and select Skin Mode In the Temperature Override mode select a temperature gt 37 C see Skin Mode on page 5 24 Place the skin probe outside the incubator Allow the incubator to heat If the High Temperature Cut Out alarm sounds press the Alarm Silence Reset key Verify that the incubator does not heat above 39 9 C 103 82 F as indicated on the display screen 9 Check the Connect Skin 1 Probe alarm a b While operating in the Air mode disconnect the skin probe 1 and then select the Skin mode Verify that the Connect Skin 1 Probe alarm sounds 10 For LCD color screens only check the screen intensity feature at the system displays see Controls Indicators and Connectors on page 5 1 a b Use the Up Arrow key to increase the screen intensity three levels Use the Down Arrow key to decrease the screen intensity three levels Hood Shell Operational Checkout To check the hood shell
135. to the heater control circuitry which regulates the heater output to maintain the air temperature setting The actual air temperature is shown in the Temperature window A second sensor within the air temperature probe serves as a backup to limit the maximum incubator temperature If the high temperature limit is reached the heater shuts off The infant temperature is a function of 1 the air temperature and 2 the ability of the infant to establish and maintain his her own temperature A small infant or one with underdeveloped homeostatic control may not be able to maintain a stable temperature at the desired level Skin Mode In the Skin mode the Up and Down Arrow keys on the controller front panel are used to select the infant temperature from 34 0 C 93 2 F to 37 0 C 98 6 F In Temperature Override mode the temperature can be selected from 37 0 C 98 6 F to 38 0 C 100 4 F A temperature sensing probe is attached directly to the skin of the infant The information from the probe is supplied to the heater control circuitry which proportions the heater output to maintain the skin set temperature The air temperature is still shown in Skin mode but for information purposes only If the Air mode is selected while the skin probe remains connected the skin temperature parameter continues to display the actual skin temperature However it does not control the incubator temperature The sensor module is equipped to accept two s
136. tor is disconnected when performing cleaning and maintenance procedures Turn off or disconnect oxygen supplies during periods of non use Failure to do so could result in personal injury or equipment damage EMC Precautions 4h WARNING Use of accessories other than those listed and approved for use in this product as original or replacement items may result in increased emissions or decreased immunity 4h WARNING The equipment shall not be used adjacent to other devices unless verification of normal operation in the configuration in which it is to be used can be achieved A WARNING Devices connecting to the serial data port must be compliant with EN 60601 1 2 the EMC requirement for Medical Devices Failure to do so could result in personal injury or equipment damage A WARNING The incubator display may go blank during an episode of static discharge to the sensor module Personal injury or equipment damage could occur 4h WARNING Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual In addition portable and mobile RF communications equipment can effect medical electrical equipment A WARNING Pins of connectors identified with the ESD warning symbol shall not be touched and not be connected unless ESD precautionary procedures are used Such precautionary procedures may include antistatic clothing and shoes th
137. ully charged prior to transport or attempting a transport NOTE For power failures lasting 10 min or less beyond the duration of the battery back up mode the set point selected in the Air mode or Skin mode and operating modes are retained System Shut Down To properly shut down the unit 1 Remove power from any device plugged into the convenience outlet strip 2 Disconnect the incubator from the hospital oxygen source 3 Turn off the Power Switch on the incubator shell to power down the incubator 4 Turn off the main power source If the unit is equipped with a UPS system press the On Off Test switch on the Electronics Module If the unit is not equipped with a UPS system turn off the Main Power circuit breaker on the stand System Configuration The System Configuration menu enables the user to access the system configurable parameters Refer to the table below System Configuration Menu Display Selection Key Selections DEEE Y Key Default Setting Humidity option Yes No No Oxygen option Yes No No Oxygen calibration level 100 21 21 Skin temperature alarm limit 1 0 C 05 C 1 0 C Skin control mode Yes No Yes Language ENG FRN GER SPN ITAL English JAP DUT DAN NOR POL POR SWE FIN GREEK CZECK SLOVAK Weight unit lb kg kg Air set temperature 30 0 C to 37 0 C increments 35 0 C of 1 C Altitude 0 ft 12 000 ft 3657 m 0 ft increments of 2000 f
138. uration on page 5 22 Initial Start Up for Systems with UPS Model C2000e Only To power up the system A CAUTION Do not plug the AC input supply power cord of the uninterruptible power supply UPS system into any of the output receptacles on the incubator stand This is a safety hazard and may cause irreparable damage to the UPS system 1 Plug the power cord of UPS electronic module into an appropriate AC power source 2 Verify the Resettable circuit breaker on the UPS electronic control module is in the On 1 position 3 Press and hold the On Off Test switch until AC power is activated 4 Verify the power cord from the stand is firmly attached to the connector under the incubator shell assembly 5 Locate the On Off switch under the incubator shell assembly and then turn on the incubator During the self test all indicator lamps light and the audible alarm pulses After the system start up tests the incubator boots up in the Air mode at Display 1 5 20 NOTE If the unit fails the self test the alarm sounds and one or more of the following messages appears in the Trend Alarm window refer the unit to service Controller Failure 1 through 13 or Check Settings 6 Select the desired system options parameters and operating modes at the incubator controller see System Configuration on page 5 22 7 Make sure the unit is charged fully charged before using the unit for transport Recovery from Power F
139. would allow for liquid pooling Personal injury or equipment damage could occur CAUTION Do not use harsh cleansers detergents such as scouring pads or heavy duty grease removers or solvents such as acetone Equipment damage could occur General Cleaning Drager Medical recommends cleaning the unit with detergent and warm water Do not use excessive liquid or harsh cleansers The most effective way to clean the unit is to first disassemble the unit and then group the parts and assemblies in categories according to the method of cleaning required Do not use alcohol based products to clean acrylic alcohol clouds the surface At a minimum thoroughly clean and disinfect the incubator upon discharge of an infant However depending on individual facility policy perform this as often as daily if desired Steam Cleaning Do not use any steam cleaning device on the unit Excessive moisture can cause damage Stain Cleaning To remove difficult spots or stains Drager Medical recommends the use of standard household cleansers and a soft bristle brush To loosen heavy dried on soil saturation of the spot could be required Disinfecting e Use an intermediate level tuberculocidal cleanser disinfectant or equivalent only after the unit is empty and disassembled see Disassembly for Cleaning on page 6 2 NOTE For US markets only use an intermediate level tuberculocidal cleaners disinfectant registered by the Envi
140. xture directly under the sensor module opening on the hood assembly 8 Install the two screws to secure the sensor module slide lock and the 100 calibration fixture NOTE Make sure that the brass connector is facing the rear of the incubator and the wording on the label is properly displayed Brass Connector 9 Close the front access panel and rotate the pawl 100 Calibration Fixt re latches until they are fully engaged 10 Install the sensor module assembly in the hood assembly NOTE When the slide lock and 100 calibration fixture are properly installed the slide lock will move up and down smoothly Sensor Module Slide Lock 11 Select the 100 calibration level see System Configuration on page 5 22 14 Operational Checkout Perform the operational checkout procedure before the incubator is first placed into service and after any disassembly for cleaning or maintenance NOTE For units equipped with the rail system and accessories remove any accessories that interfere with the checkout procedure and replace when completed A WARNING Do not use the incubator if it fails to function as described below Refer service to qualified personnel Controller Operational Checkout 4 SHOCK HAZARD Make sure the building power source is compatible with the electrical specifications shown on the column of the pedestal stand or on the incubator Failure to do so could result in personal injur
141. y or equipment damage WARNING To prevent accidental disconnection secure all patient leads infusion lines and ventilator tubing to the mattress with sufficient excess length to allow for the full range of mattress height adjustment AX WARNING For optimum stability always lower the incubator to its lowest position prior to transport Make sure that items placed on the monitor shelf are properly secured Failure to do so could result in personal injury or equipment damage A WARNING Only one monitor shelf should be used per incubator When using the monitor shelf always place the monitor in the center of the shelf ensure that the monitor fits within the border of the shelf and avoid stacking monitors on the shelf The maximum combined weight of all items on the monitor shelf should not exceed 25 Ibs Personal injury or equipment damage could occur A WARNING When raising or lowering the incubator the operator should ensure that both equipment and appendages are clear of the unit s travel path Patient and incubator connections must also be checked before adjusting the incubator height Never place any objects on top of the drawer assembly and always check before lowering the VHA to ensure there is sufficient clearance between the incubator and stand assembly Do not raise or lower the unit while installing or removing medical gas tanks from the tank holder assembly Failure to do so could result in personal injury or equipment dama
142. y or equipment damage 4 SHOCK HAZARD To ensure grounding reliability plug the AC power cord only into a properly grounded 3 wire hospital grade or hospital use outlet Do not use extension cords If any doubt exists as to the grounding connection do not operate the equipment Personal injury or equipment damage could occur 1 Before attempting to perform this procedure refer to Controls Indicators and Connectors on page 5 1 2 Perform the initial power up procedures see System Start Up and Shut Down on page 5 20 3 Check the Power Failure alarm Unplug the power cord from the controller module b Verify that the Power Failure alarm sounds and the Power Fail indicator on the controller lights c Then re connect the power cord to the controller module and verify that after the self test Display 1 is shown on the controller module display screen 4 Check the Low Air Temperature alarm a Rotate the pawl latches and open the front or rear optional access panel of the incubator b Verify that within approximately 5 min the Low Air Temperature alarm message is displayed in the Trend Alarm window and the audible alarm sounds NOTE The alarm will not occur until the temperature falls 2 5 C below set point At high ambient temperatures fanning the air within the hood can be performed to induce the alarm c Close the front or rear access panel and rotate the pawl latches until they are fully engaged 5 Che

- Frank`s Hospital Workshop

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